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Contents Federal Register Vol. 75, No. 61

Wednesday, March 31, 2010

Agency for Healthcare Research and Quality Coast Guard NOTICES RULES Agency Information Collection Activities; Proposals, Drawbridge Operation Regulations: Submissions, and Approvals, 16129–16136 Acushnet River, New Bedford and Fairhaven, MA, Event Common Formats for Patient Safety Data Collection and – Road Race, 16009 Event Reporting, 16140–16142 Atlantic Intracoastal Waterway, Albemarle and Meetings: Chesapeake Canal, Chesapeake, VA, 16004–16005 OS ARRA Expansion of Research Capabilities to Study Chehalis River, Aberdeen, WA, Schedule Change, 16002– CE Complex Patients; Correction, 16149 16004 Hackensack River, Jersey City, NJ, Maintenance, 16009– Agency for Toxic Substances and Disease Registry 16010 NOTICES Lower Grand River, Iberville Parish, LA, 16007–16009 Proposed Substances To Be Evaluated for Set 24 Port of Coos Bay Railroad Bridge, Coos Bay, North Bend, Toxicological Profiles, 16153–16157 OR, 16005–16006 Sacramento River, Sacramento, CA, 16006–16007 Agriculture Department Safety Zones: See Forest Service Red River, MN, 16010–16012 See Grain Inspection, Packers and Stockyards NOTICES Administration Charter Renewal: See Rural Utilities Service Prince William Sound Regional Citizens’ Advisory NOTICES Council, 16159 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16066–16067 Commerce Department See Census Bureau Antitrust Division See International Trade Administration NOTICES See National Oceanic and Atmospheric Administration National Cooperative Research and Production Act of 1993: NOTICES Cooperative Research Group on Integrated Investigations Agency Information Collection Activities; Proposals, of Faulting In Carbonate Strata, 16178 Submissions, and Approvals, 16070–16071 Joint Venture Agreement Between Cambridge Major Laboratories, Inc. And Konarka Technologies, Inc., Consumer Product Safety Commission 16178–16179 RULES Civil Penalty Factors, 15993–16000 Census Bureau NOTICES Defense Department Meetings: See Navy Department Census Scientific Advisory Committee, 16078 Reestablishment of the Census Advisory Committee of Drug Enforcement Administration Professional Associations RULES Reestablishment of the Census Advisory Committee of Electronic Prescriptions for Controlled Substances, 16236– Professional Associations, 16078–16079 16319 Centers for Disease Control and Prevention Education Department NOTICES NOTICES Agency Information Collection Activities; Proposals, Smaller Learning Communities Program, 16082–16088 Submissions, and Approvals, 16128–16129 Election Assistance Commission Centers for Medicare & Medicaid Services NOTICES NOTICES Proposed Information Quality Guidelines Policy, 16088 Meetings: Request for Comments: Medicaid and CHIP Programs; CHIP Working Group Proposed Requirements for Testing of Pilot Voting (April 26, 2010), 16149–16150 Systems to Serve UOCAVA Voters, 16088–16090 Children and Families Administration Employee Benefits Security Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals: Medicaid and CHIP Programs; CHIP Working Group Strengthening Communities Fund Program Evaluation, (April 26, 2010), 16149–16150 16138–16139 Employment and Training Administration Civil Rights Commission RULES NOTICES Temporary Employment of Foreign Workers in the United Meetings; Sunshine Act, 16070 States; CFR Correction, 16000–16001

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NOTICES Federal Communications Commission ETA Program Year 2010 Workforce Investment Act NOTICES Allotments; Wagner–Peyser Act Final Allotments, and Agency Information Collection Activities; Proposals, Workforce Information Grants, 16179–16186 Submissions, and Approvals, 16119–16120 Energy Department Federal Energy Regulatory Commission See Federal Energy Regulatory Commission NOTICES Applications: Environmental Protection Agency Glen Falls Hydro, LLC, et al., 16091 RULES Grand River Dam Authority, 16090–16091 Pesticide Tolerances: Lockhart Power Co., 16092–16093 Cloquintocet–mexyl, 16017–16020 Symbiotics, LLC, et al., 16090 Prevention of Significant Deterioration and Nonattainment Turnbull Hydro, LLC, 16093–16094 New Source Review: Union Electric Company dba Ameren/UE, 16091–16092 Inclusion of Fugitive Emissions, 16012–16017 Upper Peninsula Power Co., et al., 16094 PROPOSED RULES Combined Notice of Filings, 16095–16096 Approval and Promulgation of State Implementation Plan Complaints: Revisions: New England Power Generators Association Inc v. ISO North Dakota; Air Pollution Control Rules, and Interstate New England Inc. et al., 16096–16097 Transport of Pollution for the 1997 PM2.5 and 8-hour Environmental Assessments; Availability, etc.: Ozone NAAQS, etc., 16026–16032 South Carolina Electric and Gas Company, South Approval and Promulgation of State Implementation Plans: Carolina, 16097 Colorado; Interstate Transport of Pollution Revisions for Initial Market-Based Rate Filing: the 1997 8-hour Ozone NAAQS, etc., 16032–16037 NFI Solar LLC, 16097 Hazardous Waste Management System: Patriot Power LLC, 16098 Identification and Listing of Hazardous Waste; Proposed Reliable Power LLC, 16098–16099 Exclusion, 16037–16046 Southern Turner Cimarron I, LLC, 16098 NOTICES Termination of License : Antimicrobial Pesticide Registration Review Dockets Mr. Jerry McMillan and Ms. Christine Smith, 16099– Opened for Review and Comment, 16100–16102 16100 Application for Emergency Exemption, Solicitation of Workshops on Penalty Guidelines: Public Comment: Enforcement of Statutes, Orders, Rules and Regulations, Kasugamycin, 16102–16104 16100 Bromine Registration Review Final Decision; Availability, 16104–16105 Federal Procurement Policy Office Cancellation Order for Amendment to Terminate a Use of NOTICES DCNA Pesticide Registrations: Work Reserved for Performance by Federal Government Dicloran, 16105–16106 Employees, 16188–16197 Draft Toxicological Review of Dichloromethane: In Support of Summary Information on the Integrated Federal Railroad Administration Risk Information System, 16106–16108 NOTICES Meetings: Agency Information Collection Activities; Proposals, Science Advisory Board Trichloroethylene Review Panel, Submissions, and Approvals, 16228–16229 16108–16109 Registration Applications: Federal Reserve System Antimicrobial Pesticide Products, 16109–16113 NOTICES Registration Review Final Decision: Agency Information Collection Activities; Proposals, Bacillus subtilis, 16113–16114 Submissions, and Approvals, 16120–16123 Registration Review; Biopesticides Dockets Opened for Formations of, Acquisitions by, and Mergers of Bank Review and Comment, 16114–16116 Holding Companies, 16123 Registration Review; Pesticide Dockets Opened for Review and Comment, 16117–16119 Federal Trade Commission NOTICES Federal Accounting Standards Advisory Board Analysis of Proposed Consent Order to Aid Public NOTICES Comment: Issuance of Exposure Draft on Accrual Estimates for Grant Dave & Buster’s Inc., 16123–16125 Programs, 16120 Federal Transit Administration Federal Aviation Administration NOTICES RULES Final Circular: Revision of Prohibited Area P–49; Crawford, TX, 15992– Urbanized Area Formula Program, 16229–16233 15993 PROPOSED RULES Fish and Wildlife Service Airworthiness Directives: PROPOSED RULES Turbomeca S.A. MAKILA 1A and 1A1 Turboshaft Endangered and Threatened Wildlife and Plants: Engines, 16022–16023 12-Month Finding on a Petition to List the Tucson Proposed Amendment of Norton Sound Low and Control Shovel-Nosed Snake, 16050–16065 1234L Offshore Airspace Areas: Listing Caseys June Beetle as Endangered and Alaska, 16024–16026 Designation of Critical Habitat, 16046–16049

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Food and Drug Administration Housing and Urban Development Department RULES NOTICES New Animal Drugs: Agency Information Collection Activities; Proposals, Removal of Obsolete and Redundant Regulations, 16001– Submissions, and Approvals: 16002 Allocation of Operating Subsidies Under the Operating NOTICES Fund Formula, 16160 Agency Information Collection Activities; Proposals, Availability for the Alaska Native/Native Hawaiian Submissions, and Approvals: Institutions Assisting Communities Program, 16160– Export of Food and Drug Administration Regulated 16161 Products; Export Certificates, 16137–16138 Energy Conservation for PHA-owned or Leased projects – Meetings: Audits, Utility Allowances, 16161–16162 Anti-Infective Drugs Advisory Committee, 16148–16149 Environmental Impact Statements; Availability, etc.: Antiviral Drugs Advisory Committee, 16151 Yesler Terrace Redevelopment Project, 16162–16163 Public Workshop: FHA Debenture Call, 16163 Pharmaceutical Supply Chain, 16157–16158 Funding Awards: HUD–Veterans Affairs Supportive Housing Program (FY Forest Service 2008 and 2009), 16163–16171 NOTICES Privacy Act; Computer Matching Program, 16171–16173 Meetings: Alpine County Resource Advisory Committee, 16069 Indian Affairs Bureau Southeast Washington Resource Advisory Committee, NOTICES 16069 Agency Information Collection Activities; Proposals, Southwest Idaho Resource Advisory Committee, 16070 Submissions, and Approvals: Navajo Partitioned Lands Grazing Permits, 16174–16175 Grain Inspection, Packers and Stockyards Administration Tribal Energy Resource Agreements, 16173–16174 NOTICES Designation: Indian Health Service Amarillo, TX; Cairo, IL; State of Louisiana; State of North NOTICES Carolina; Belmond, IA; State of New Jersey; and State Agency Information Collection Activities; Proposals, of New York Areas, 16068–16069 Submissions, and Approvals: Champaign, IL; Emmett, MI; Davenport, IA; Enid, OK; Indian Health Service Medical Staff Credentials and Keokuk, IA; Marshall, MI; and Omaha, NE Areas, Privileges Files, 16139–16140 16067–16068 Community-Directed Grant Program: FY 2010 Special Diabetes Program for Indians , 16142– 16148 Health and Human Services Department See Agency for Healthcare Research and Quality Interior Department See Agency for Toxic Substances and Disease Registry See Fish and Wildlife Service See Centers for Disease Control and Prevention See Indian Affairs Bureau See Centers for Medicare & Medicaid Services See National Park Service See Children and Families Administration See Food and Drug Administration International Trade Administration See Health Resources and Services Administration NOTICES See Indian Health Service Amended Final Determination Pursuant to Final Court See National Institutes of Health Decision: NOTICES Call for Co-Sponsors: Circular Welded Carbon Quality Steel Line Pipe from the Office of Healthcare Quality Programs to Prevent People’s Republic of China, 16071–16072 Healthcare-Associated Infections, 16125–16126 Initiation of Antidumping Duty New Shipper Reviews: Meetings: Certain Preserved Mushrooms from the People’s Republic HIT Policy Committee, 16126 of China, 16075–16076 HIT Standards Committee, 16126–16127 Meetings: Presidential Commission for the Study of Bioethical Issues; Civil Nuclear Trade Advisory Committee, 16077–16078 Establishment, 16127 Report to Congress: Retrospective Versus Prospective Antidumping and Countervailing Duty Systems; Request for Comment Health Resources and Services Administration and Public Hearing, 16079–16080 NOTICES Agency Information Collection Activities; Proposals, Justice Department Submissions, and Approvals, 16136–16137 See Antitrust Division See Drug Enforcement Administration Homeland Security Department See Juvenile Justice and Delinquency Prevention Office See Coast Guard NOTICES See National Communications System Lodging of Consent Decrees Under the Comprehensive See U.S. Immigration and Customs Enforcement Environmental Response, Compensation, and Liability RULES Act, 16176–16177 Designation of Greece for the Visa Waiver Program, 15991– Lodging of Material Modification to Consent Decree Under 15992 the Clean Water Act, 16177

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Juvenile Justice and Delinquency Prevention Office Availability of Seats; Request for Applications: NOTICES Fagatele Bay National Marine Sanctuary Advisory Meetings: Council, 16075 Coordinating Council on Juvenile Justice and Flower Garden Banks National Marine Sanctuary Delinquency Prevention, 16177–16178 Advisory Council, 16074–16075 Monterey Bay National Marine Sanctuary Advisory Labor Department Council, 16074 See Employee Benefits Security Administration Marine Mammals; File No. 15206; Application, 16076– See Employment and Training Administration 16077 See Mine Safety and Health Administration Marine Mammals; File No. 15430; Application, 16077 Legal Services Corporation National Park Service NOTICES Meetings; Sunshine Act, 16188 NOTICES Inventory Completion: Management and Budget Office Museum of Cultural and Natural History, Central See Federal Procurement Policy Office Michigan University, Mt. Pleasant, MI, 16175–16176 Mine Safety and Health Administration Navy Department NOTICES NOTICES Affirmative Decisions on Petitions for Modification Granted Environmental Impact Statements; Availability, etc.: in Whole or in Part, 16179 Basewide Water Infrastructure et al. Replacement Petitions for Modification, 16186–16188 Projects, Marine Corps Base Camp Pendleton, San Diego County, CA, 16080–16082 Morris K. Udall Scholarship and Excellence in National Environmental Policy Foundation Nuclear Regulatory Commission NOTICES NOTICES Meetings; Sunshine Act, 16197 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16200 National Aeronautics and Space Administration Exemption: NOTICES FPL Energy Point Beach, LLC; Point Beach Nuclear Plant Meetings: (Units 1 and 2), 16201–16202 NASA Advisory Council Space Operations Committee, Interim Staff Guidance: 16197–16198 Ensuring Hazard-Consistent Seismic Input for Site National Archives and Records Administration Response and Soil Structure Interaction Analyses, NOTICES 16202 Records Schedules; Availability and Request for Comments, Issuance of Regulatory Guide, 16202–16203 16198–16200 Meetings: ACRS Subcommittee on Power Uprates, 16203–16204 National Communications System Advisory Committee on Reactor Safeguards; ACRS NOTICES Subcommittee on EPR, 16203 Meetings: President’s National Security Telecommunications Rural Utilities Service Advisory Committee, 16159–16160 NOTICES Agency Information Collection Activities; Proposals, National Highway Traffic Safety Administration Submissions, and Approvals, 16067 NOTICES Agency Information Collection Activities; Proposals, Securities and Exchange Commission Submissions, and Approvals, 16227–16228 NOTICES Application: National Institutes of Health MCG Capital Corp., 16211–16212 NOTICES MetLife Insurance Company of Connecticut, et al., Meetings: 16205–16211 Center for Scientific Review, 16152 Self-Regulatory Organizations; Proposed Rule Changes: Eunice Kennedy Shriver National Institute of Child Depository Trust Co., 16216–16217 Health and Human Development, 16151 NASDAQ OMX BX, Inc., 16213–16214 National Cancer Institute, 16153 NASDAQ OMX PHLX, Inc., 16219–16221 National Heart, Lung, and Blood Institute, 16152 16152 National Institute of Neurological Disorders and Stroke, NASDAQ Stock Market LLC, 16221–16222, 16224–16225 16153 National Securities Clearing Corp., 16214–16215 NYSE Amex LLC, 16222–16224 National Oceanic and Atmospheric Administration NYSE Arca, Inc., 16217–16219 RULES Fisheries of the Exclusive Economic Zone Off Alaska: Small Business Administration Pollock in the West Yakutat District of the Gulf of Alaska, NOTICES 16021 Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 16204 Availability of Federal Ainancial Assistance: Meetings: Fisheries Finance Program, 16072–16074 Region II Buffalo District Advisory Council, 16204–16205

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State Department U.S. Immigration and Customs Enforcement NOTICES NOTICES Certifications Pursuant to Section 609 of Public Law (101– Agency Information Collection Activities; Proposals, 162), 16225 Submissions, and Approvals: Meetings: Information Relating to Beneficiary of Private Bill, 16158 Organization of American States Specialized Conference on Private International Law Study Group, 16225– 16226 Separate Parts In This Issue Waiver of Restriction on Assistance to the Government of Libya, 16226 Part II Justice Department, Drug Enforcement Administration, 16236–16319 Toxic Substances and Disease Registry Agency See Agency for Toxic Substances and Disease Registry Part III Readers Aids, Cumulative List of Public Laws, 111th Congress, First Session, 16322–16324 Transportation Department See Federal Aviation Administration See Federal Railroad Administration Reader Aids See Federal Transit Administration Consult the Reader Aids section at the end of this page for See National Highway Traffic Safety Administration phone numbers, online resources, finding aids, reminders, NOTICES and notice of recently enacted public laws. Applications for Certificates of Public Convenience and To subscribe to the Federal Register Table of Contents Necessity and Foreign Air Carrier Permits Filed Under LISTSERV electronic mailing list, go to http:// Subpart B, 16226 listserv.access.gpo.gov and select Online mailing list Aviation Proceedings, Agreements Filed, 16226–16227 archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

8 CFR 217...... 15991 14 CFR 73...... 15992 Proposed Rules: 39...... 16022 71...... 16024 16 CFR 1119...... 15993 20 CFR 655...... 16000 21 CFR 558...... 16001 1300...... 16236 1304...... 16236 1306...... 16236 1311...... 16236 33 CFR 117 (7 documents) ...... 16002, 16004, 16005, 16006, 16007, 16009 165...... 16010 40 CFR 51...... 16012 52...... 16012 180...... 16017 Proposed Rules: 52 (2 documents) ...... 16026, 16032 261...... 16037 50 CFR 679...... 16021 Proposed Rules: 17 (2 documents) ...... 16046, 16050

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Rules and Regulations Federal Register Vol. 75, No. 61

Wednesday, March 31, 2010

This section of the FEDERAL REGISTER certain requirements are met. Those (1) Be seeking entry as a tourist for contains regulatory documents having general requirements include, without ninety days or less; applicability and legal effect, most of which limitation: (1) Meeting the statutory rate (2) Be a national of a program country; are keyed to and codified in the Code of of nonimmigrant visa refusal for (3) Present an electronic passport or a Federal Regulations, which is published under nationals of the country; (2) a machine-readable passport issued by a 50 titles pursuant to 44 U.S.C. 1510. government certification that it issues designated VWP participant country to The Code of Federal Regulations is sold by machine-readable passports that comply the air or vessel carrier before the Superintendent of Documents. Prices of with internationally accepted standards; departure; 2 new books are listed in the first FEDERAL (3) a U.S. government determination (4) Execute the required immigration REGISTER issue of each week. that the country’s designation would not forms; negatively affect U.S. law enforcement (5) If arriving by air or sea, arrive on and security interests; (4) an agreement an authorized carrier; DEPARTMENT OF HOMELAND to report, or make available through (6) Not represent a threat to the SECURITY other designated means, to the U.S. welfare, health, safety or security of the government information about the theft United States; 8 CFR Part 217 or loss of passports; (5) government (7) Have not violated U.S. RIN 1601–AA54 acceptance for repatriation any citizen, immigration law during a previous former citizen, or national not later than admission under the VWP; Designation of Greece for the Visa three weeks after the issuance of a final (8) Possess a round-trip ticket; Waiver Program order of removal; and (6) an agreement (9) Waive the right to review or appeal with the United States to share AGENCY: Office of the Secretary, DHS. a decision regarding admissibility or to information regarding whether citizens contest, other than on the basis of an ACTION: Final rule; technical or nationals of the country represent a application for asylum, any action for amendment. threat to the security or welfare of the removal; and SUMMARY: Citizens and eligible nationals United States or its citizens. (10) Obtain an approved travel of participating Visa Waiver Program The INA also sets forth requirements authorization via the Electronic System countries may apply for admission to for continued eligibility and, where for Travel Authorization (ESTA) in appropriate, probation and/or the United States at U.S. ports of entry advance of travel. For more information termination of program countries. as nonimmigrant aliens for a period of about the ESTA, please see the interim The designated countries in the VWP final rule at 73 FR 32440 (June 9, 2008), ninety days or less for business or include Andorra, Australia, Austria, pleasure without first obtaining a and implementing notice at 73 FR 67354 Belgium, Brunei, Czech Republic, (November 13, 2008). See Sections nonimmigrant visa, provided that they Denmark, Estonia, Finland, France, 217(a) and 217(b) of the Immigration are otherwise eligible for admission Germany, Hungary, Iceland, Ireland, and Nationality Act (INA), 8 U.S.C. under applicable statutory and Italy, Japan, Latvia, Liechtenstein, 1187(a)–(b). See also 8 CFR part 217. regulatory requirements. On March 4, Lithuania, Luxembourg, Malta, Monaco, DHS, in consultation with the 2010, the Secretary of Homeland the Netherlands, New Zealand, Norway, Department of State, has evaluated the Security, in consultation with the Portugal, Republic of Korea, San country of Greece for VWP designation Secretary of State, designated Greece as Marino, Singapore, Slovak Republic, to ensure that it meets the requirements a country that is eligible to participate Slovenia, Spain, Sweden, Switzerland, set forth in section 217 of the INA, as in the Visa Waiver Program. and the United Kingdom.1 See 8 CFR amended by section 711 of the Accordingly, this rule updates the list of 217.2(a). Implementing Recommendations of the countries authorized to participate in Citizens and eligible nationals of VWP 9/11 Commission Act of 2007 (9/11 the Visa Waiver Program by adding countries may apply for admission to Act). The Secretary has determined that Greece. the United States at U.S. ports of entry Greece has satisfied the statutory DATES: This final rule is effective on as nonimmigrant visitors for a period of requirements to be a VWP country; April 5, 2010. ninety days or less for business or therefore, the Secretary, in consultation FOR FURTHER INFORMATION CONTACT: pleasure without first obtaining a with the Secretary of State, has nonimmigrant visa, provided that they Gianfranco Corti, Department of designated Greece as a program are otherwise eligible for admission Homeland Security, Office of Policy, country.3 under applicable statutory and (202) 282–8732. This final rule adds Greece to the list SUPPLEMENTARY INFORMATION: regulatory requirements. To travel to the United States under the VWP, an alien of countries authorized to participate in I. Background must be from a participating country 2 For countries designated as VWP member A. The Visa Waiver Program and must satisfy the following: countries prior to November 17, 2008, passports issued before October 26, 2006 [see 8 U.S.C. Pursuant to section 217 of the 1 The United Kingdom refers only to British 1732(c)(2)], need not contain the electronic chip Immigration and Nationality Act (INA), citizens who have the unrestricted right of that includes the biographic and biometric 8 U.S.C. 1187, the Secretary of permanent abode in the United Kingdom (England, information of the passport holder provided the Homeland Security (the Secretary), in Scotland, Wales, Northern Ireland, the Channel passports comply with the International Civil Islands and the Isle of Man); it does not refer to Aviation Organization’s machine-readable consultation with the Secretary of State, British overseas citizens, British dependent standards. may designate certain countries as Visa territories’ citizens, or citizens of British 3 The Secretary of State nominated Greece for Waiver Program (VWP) countries if Commonwealth countries. participation in the VWP on August 31, 2007.

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the VWP. Accordingly, beginning April as a final rule, on the grounds set forth PART 217—VISA WAIVER PROGRAM 5, 2010, citizens and eligible nationals above, a regulatory flexibility analysis is from Greece may apply for admission to not required under the RFA. ■ 1. The general authority citation for part 217 continues to read as follows: the United States at U.S. ports of entry DHS has considered the impact of this as nonimmigrant visitors for a period of rule on small entities and has Authority: 8 U.S.C. 1103, 1187; 8 CFR part ninety days or less for business or determined that this rule will not have 2. pleasure without first obtaining a a significant economic impact on a * * * * * nonimmigrant visa, provided that they substantial number of small entities. ■ 2. In section 217.2 the definition of are otherwise eligible for admission The individual aliens to whom this rule the term ‘‘Designated country’’ in under applicable statutory and applies are not small entities as that paragraph (a) is revised to read as regulatory requirements. term is defined in 5 U.S.C. 601(6). follows: Accordingly, there is no change III. Statutory and Regulatory § 217.2 Eligibility. Requirements expected in any process as a result of this rule that would have a direct effect, (a) * * * A. Administrative Procedure Act either positive or negative, on a small Designated country refers to Andorra, Under the Administrative Procedure entity. Australia, Austria, Belgium, Brunei, Act (5 U.S.C. 553(b)), an agency may Czech Republic, Denmark, Estonia, C. Unfunded Mandates Reform Act of waive the normal notice and comment Finland, France, Germany, Greece, 1995 requirements if it finds, for good cause, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Liechtenstein, Lithuania, that they are impracticable, This rule will not result in the Luxembourg, Malta, Monaco, the unnecessary, or contrary to the public expenditure by State, local, and tribal Netherlands, New Zealand, Norway, interest. The final rule merely lists a governments, in the aggregate, or by the Portugal, Republic of Korea, San country that the Secretary of Homeland private sector, of $100 million or more Marino, Singapore, Slovak Republic, Security, in consultation with the in any one year, and it will not Slovenia, Spain, Sweden, Switzerland, Secretary of State, has designated as a significantly or uniquely affect small and the United Kingdom. The United VWP eligible country in accordance governments. Therefore, no actions were Kingdom refers only to British citizens with 8 U.S.C. 1187(c). This amendment deemed necessary under the provisions who have the unrestricted right of is a technical change simply updating of the Unfunded Mandates Reform Act permanent abode in the United the list of VWP eligible countries. of 1995. Therefore, notice and comment for this Kingdom (England, Scotland, Wales, rule are unnecessary and contrary to the D. Executive Order 12866 Northern Ireland, the Channel Islands public interest because the rule has no and the Isle of Man); it does not refer to This amendment does not meet the substantive impact, is technical in British overseas citizens, British criteria for a ‘‘significant regulatory nature, and relates only to management, dependent territories’ citizens, or action’’ as specified in Executive Order organization, procedure, and practice. citizens of British Commonwealth 12866. For the same reasons, pursuant to 5 countries. After May 15, 2003, citizens U.S.C. 553(d)(3), a delayed effective date E. Executive Order 13132 of Belgium must present a machine- is not required. readable passport in order to be granted This final rule is also excluded from The rule will not have substantial admission under the Visa Waiver the rulemaking provisions of 5 U.S.C. direct effects on the States, on the Program. 553 as a foreign affairs function of the relationship between the National * * * * * United States, because it advances the Government and the States, or on the Janet Napolitano, President’s foreign policy goals, distribution of power and involves a bilateral agreement that the responsibilities among the various Secretary. United States has entered into with levels of government. Therefore, in [FR Doc. 2010–7211 Filed 3–30–10; 8:45 am] Greece, and directly involves accordance with section 6 of Executive BILLING CODE P relationships between the United States Order 13132, DHS has determined that and its alien visitors. Accordingly, DHS this final rule does not have sufficient is not required to provide public notice federalism implications to warrant the DEPARTMENT OF TRANSPORTATION and an opportunity to comment before preparation of a federalism summary implementing the requirements under impact statement. Federal Aviation Administration this final rule. F. Executive Order 12988 Civil Justice 14 CFR Part 73 B. Regulatory Flexibility Act Reform [Docket No. FAA–2009–0921; Airspace The Regulatory Flexibility Act (RFA) This rule meets the applicable Docket No. 09–AWA–3] (5 U.S.C. 603(b)), as amended by the standards set forth in sections 3(a) and RIN 2120–AA66 Small Business Regulatory Enforcement 3(b)(2) of Executive Order 12988. and Fairness Act of 1996 (SBREFA), List of Subjects in 8 CFR Part 217 Revision of Prohibited Area P–49; requires an agency to prepare and make Crawford, TX available to the public a regulatory Air carriers, Aliens, Maritime carriers, flexibility analysis that describes the AGENCY: Passports and visas. Federal Aviation effect of a proposed rule on small Administration (FAA), DOT. entities (i.e., small businesses, small Amendments to the Regulations ACTION: Final rule. organizations, and small governmental jurisdictions) when the agency is ■ For the reasons stated in the preamble, SUMMARY: This action amends required ‘‘to publish a general notice of DHS amends part 217 of title 8 of the Prohibited Area 49 (P–49) Crawford, TX. proposed rulemaking for any proposed Code of Federal Regulations (8 CFR part While the United States Secret Service rule.’’ Because this rule is being issued 217), as set forth below. (USSS) recognizes the ongoing security

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requirement for this prohibited area, it evaluation as the anticipated impact is Time of designation. Continuous. considers reducing prohibited airspace so minimal. Since this is a routine Using agency. United States Secret Service, area appropriate at this time. This action matter that will only affect air traffic Washington, DC. restores previously prohibited airspace procedures and air navigation, it is Issued in Washington, DC, on March 25, to public use within the National certified that this rule, when 2010. Airspace System. promulgated, will not have a significant Kelly Neubecker, DATES: Effective date 0901 UTC, June 3, economic impact on a substantial Acting Manager, Airspace and Rules Group. 2010. number of small entities under the [FR Doc. 2010–7242 Filed 3–30–10; 8:45 am] FOR FURTHER INFORMATION CONTACT: criteria of the Regulatory Flexibility Act. BILLING CODE 4910–13–P Colby Abbott, Airspace and Rules The FAA’s authority to issue rules Group, Office of System Operations regarding aviation safety is found in Airspace and AIM, Federal Aviation Title 49 of the United States Code. CONSUMER PRODUCT SAFETY Administration, 800 Independence Subtitle I, section 106 describes the COMMISSION Avenue, SW., Washington, DC 20591; authority of the FAA Administrator. telephone: (202) 267–8783. Subtitle VII, Aviation Programs, 16 CFR Part 1119 describes in more detail the scope of the SUPPLEMENTARY INFORMATION: agency’s authority. Civil Penalty Factors History This rulemaking is promulgated under the authority described in subtitle AGENCY: Consumer Product Safety On October 5, 2009, the Department VII, part A, subpart I, section 40103. Commission. of the Treasury, USSS, notified the FAA Under that section, the FAA is charged ACTION: Final interpretative rule. that while the security requirements for with prescribing regulations to assign establishing P–49 Crawford, TX (66 FR the use of the airspace necessary to SUMMARY: The Consumer Product Safety 16391) remain valid, consideration of a ensure the safety of aircraft and the Improvement Act of 2008 (‘‘CPSIA’’) modification of the existing prohibited efficient use of airspace. This regulation requires the Consumer Product Safety area was appropriate. After a six-month is within the scope of that authority as Commission (‘‘Commission’’) to issue a security review of P–49, the USSS it amends prohibited airspace in final rule providing its interpretation of determined the dimensions (boundary Crawford, Texas. the civil penalty factors found in the and altitude) of the prohibited area Consumer Product Safety Act (‘‘CPSA’’), could be reduced. This action responds Environmental Review the Federal Hazardous Substances Act to that notification. The FAA has determined that this (‘‘FHSA’’), and the Flammable Fabrics ‘‘ ’’ The Rule action qualifies for categorical exclusion Act ( FFA ), as amended by section 217 under the National Environmental of the CPSIA. These statutory provisions This action amends Title 14 Code of Policy Act in accordance with require the Commission to consider Federal Regulations (14 CFR) part 73 by paragraph 311c, FAA Order 1050.1E, certain factors in determining the revising the legal description for P–49 Environmental Impacts: Policies and amount of any civil penalty to seek. The Crawford, TX. After conducting a Procedures. This airspace action is not Commission published an interim final security review of P–49, the USSS expected to cause any potentially rule on September 1, 2009, providing its notified the FAA to reduce the significant environmental impacts, and interpretation of the statutory factors boundary and altitude dimensions of no extraordinary circumstances exist and seeking public comment. The the prohibited area. This action reduces that warrant preparation of an Commission is now issuing a final rule the boundary from a 3 NM radius to a interpreting the statutory factors. ° ′ ″ environmental assessment. 2 NM radius of lat. 31 34 45 N., DATES: This rule is effective March 31, ° ′ ″ List of Subjects in 14 CFR Part 73 97 32 00 W., and lowers the designated 2010. altitude from ‘‘Surface to but not Airspace, Prohibited areas, Restricted FOR FURTHER INFORMATION CONTACT: including 5,000 feet MSL’’ to ‘‘Surface to areas. but not including 2,000 feet MSL.’’ Melissa V. Hampshire, Assistant Because this action restores Adoption of Amendment General Counsel, Division of Enforcement and Information, Office of previously prohibited airspace to public ■ In consideration of the foregoing, the use, I find that notice and public the General Counsel, Consumer Product Federal Aviation Administration Safety Commission, 4330 East-West procedures under 5 U.S.C. 553(b) are amends 14 CFR part 73 as follows: unnecessary as it would only delay the Highway, Bethesda, Maryland 20814, telephone: 301–504–7631, e-mail: return of the airspace to public use. PART 73—SPECIAL USE AIRSPACE Section 73.89 of Title 14 CFR part 73 [email protected]. ■ was republished in FAA Order 7400.8S, 1. The authority citation for part 73 SUPPLEMENTARY INFORMATION: effective February 16, 2010. continues to read as follows: A. Background The FAA has determined that this Authority: 49 U.S.C. 106(g), 40103, 40113, regulation only involves an established 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– The CPSIA specified that the body of technical regulations for which 1963 Comp., p. 389. Commission, by August 14, 2009, issue a final regulation providing its frequent and routine amendments are § 73.89 [Amended] necessary to keep them operationally interpretation of civil penalty factors in current. Therefore, this regulation: (1) Is ■ 2. § 73.89 is amended as follows: section 20(b) of the CPSA, section not a ‘‘significant regulatory action’’ 5(c)(3) of the FHSA, and section 5(e)(2) under Executive Order 12866; (2) is not * * * * * of the FFA.1 The Commission issued an a ‘‘significant rule’’ under Department of P–49 Crawford, TX [Revised] 1 The Commission voted 4–1 to approve the Final Transportation (DOT) Regulatory Boundaries. That airspace within a 2 NM ° ′ ″ ° ′ ″ Rule as amended. Chairman Tenenbaum, Policies and Procedures (44 FR 11034; radius of lat. 31 34 45 N., long. 97 32 00 W. Commissioner Nord, Commissioner Adler, and February 26, 1979); and (3) does not Designated altitudes. Surface to 2,000 feet Moore voted to approve the final rule as amended. warrant preparation of a regulatory MSL. Continued

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interim final rule providing its appropriate. The Commission will apply FR 43084), the Commission withdrew interpretation on September 1, 2009, its interpretation to these statutory the July 12, 2006, notice of proposed and sought public comment. As a result terms in determining whether and in rulemaking (71 FR 39248). of the comments received and review of what amounts any penalties may be On November 18, 2008, the the interim final rule, certain compromised. Commission staff posted a notice on the information and terms are clarified in As set forth in section 217(a)(4) of the Commission Web site inviting comment this final rule. This rule interprets the CPSIA, new penalty amounts specified on information the Commission should factors in section 20(b) of the CPSA, in section 217(a) of the CPSIA became address in considering the amended section 5(c)(3) of the FHSA and section effective on August 14, 2009 (one year statutory factors under the CPSA, FHSA, 5(e)(2) of the FFA, and describes other after the date of enactment of the and FFA. The Commission staff also factors the Commission may consider in CPSIA). Under the amendments, the invited comment on what other factors determining the amount of a civil maximum penalty amounts increase are appropriate to consider in penalty penalty to be sought for knowing from $8,000 to $100,000 for each determinations including: (1) A violations of section 19 of the CPSA, knowing violation under the CPSA, previous record of compliance; (2) section 4 of the FHSA, and section 5 of FHSA, and FFA. Maximum penalty timeliness of response; (3) safety and the FFA. The statutory factors the amounts for any related series of compliance monitoring; (4) cooperation Commission is required to consider in violations increase from $1,825,000 to and good faith; (5) economic gain from determining the amount of a civil $15,000,000. noncompliance; (6) product failure rate; penalty to seek are the following: The B. Prior Proposal on Civil Penalty and (7) what information the nature, circumstances, extent and Factors Commission should consider in gravity of the violation, including the determining how to mitigate the adverse nature of the product defect or of the On July 12, 2006, the Commission economic impact of a particular penalty substance, the severity of the risk of published a proposed interpretative rule on a small business. The Commission injury, the occurrence or absence of (71 FR 39248) that identified additional staff also invited comment on whether injury, the number of defective products factors to be considered in assessing and it should develop a formula or matrix distributed or the amount of substance compromising civil penalties under for weighing any or all of the various distributed, the appropriateness of the sections 20(b) and (c) of the CPSA. The factors and what criteria it should use penalty in relation to the size of the comment period closed August 11, in any weighting formula or matrix. The business of the person charged, 2006. The Commission received four Commission received 16 comments in comments. including how to mitigate undue response to the 2008 Web site notice adverse economic impacts on small C. CPSIA Requirements and considered the comments in issuing businesses, and such other factors as The enactment of the CPSIA the interim final rule. appropriate. On September 1, 2009, the The statutory factors the Commission superseded the proposed rule by requiring that the Commission provide Commission published an interim final is required to consider in determining interpretative rule setting forth the the amount of a civil penalty to seek are its interpretation of the enumerated statutory factors under section 20(b) of Commission’s interpretation of the the same factors identified in section statutory factors under the CPSA, FHSA, 20(c) of the CPSA, section 5(c)(4) of the the CPSA, section 5(c)(3) of the FHSA, and section 5(e)(2) of the FFA. The and FFA, for seeking and compromising FHSA, and section 5(e)(3) of the FFA for civil penalties. The Commission sought determining whether a civil penalty CPSIA also indicated that under the CPSA, FHSA, and FFA, the Commission comments on the interim final rule. The may be compromised by the Commission received 10 comments in Commission. These statutory provisions should consider the nature, circumstances, extent, and gravity of the response to the September 1, 2009 instruct the Commission to consider the notice. Some commenters responded on following factors in determining the violation in determining the appropriate penalty amount. The statute provides behalf of their trade or industry amount of a compromised penalty, associations. whether it should be remitted or examples of elements that should go mitigated by the Commission, and, in into that consideration. The CPSIA D. Statutory Discussion what amount: The nature, modified the factor of appropriateness of the penalty in relation to the size of 1. What Are the Requirements for circumstances, extent and gravity of the Imposition of Civil Penalties? violation, including the nature of the the business of the person charged by product defect,2 the severity of the risk requiring that this factor include a The determination of the amount of of injury, the occurrence or absence of consideration of how to mitigate undue any civil penalty to seek and/or injury, the number of defective products adverse economic impacts on small compromise should allow for maximum distributed,3 the appropriateness of businesses. This small business analysis flexibility within an identified such penalty in relation to the size of element was added to the CPSA and framework. The CPSIA requirement for the business of the person charged, FHSA but not added to the FFA factor. the Commission to interpret the civil including how to mitigate undue The Commission will consider the penalty factors gives transparency to the adverse economic impacts on small undue adverse economic impacts on regulated community about the businesses, and such other factors as small businesses as another appropriate framework the Commission will use to factor under the FFA. The CPSIA also guide its penalty calculations in the Chairman Tenenbaum, Commissioner Moore and added to the CPSA, FHSA, and FFA a enforcement process and may provide Adler issued a joint statement. Commissioners Nord new catch-all statutory factor ‘‘other incentives for greater compliance. The and Northup each issued statements. All statements are available at http://www.cpsc.gov/pr/ factors as appropriate.’’ The effect of the changes made by various CPSIA statements.html. CPSIA amendments was noted in the provisions to the CPSA, FHSA, and 2 This factor applies only to the CPSA. The FHSA Fall 2008 Current Regulatory Plan and FFA, including those to the CPSA’s factor is ‘‘the nature of the substance.’’ The FFA has the Unified Agenda (RIN: 3041–AC40) prohibited acts and the addition of new no comparable separate factor apart from the nature, circumstances, extent, and gravity of the violation. by stating that the proposed July 2006 prohibited acts, present the regulated 3 The FHSA factor is the ‘‘amount of the rule would be withdrawn. In the community with many new compliance substance.’’ Federal Register of August 26, 2009 (74 challenges and responsibilities.

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Any proposed civil penalty commerce, or importation into the any consumer product containing an determination is based first on a United States of any consumer product, unauthorized third-party certification violation of a prohibited act under the or other product or substance that is mark. 15 U.S.C. 2068(a)(12). CPSA, FHSA, or FFA. Civil penalties regulated under the CPSA or any other Any misrepresentation to Commission may then be sought against any person act enforced by the Commission, that is officers or employees about the scope of who ‘‘knowingly violates’’ section 19 of not in conformity with an applicable consumer products subject to recall or the CPSA, section 4 of the FHSA, or a consumer product safety rule under the material misrepresentation in the course regulation or standard under section 4 CPSA, or any similar rule, regulation, of an investigation under any act of the FFA. The term ‘‘knowingly’’ is standard, or ban under any other act enforced by the Commission also is a defined in section 20(d) of the CPSA, 15 enforced by the Commission. 15 U.S.C. new prohibited act under the CPSA. 15 U.S.C. 2069(d), section 5(c)(5) of the 2068(a)(1). U.S.C. 2068(a)(13). FHSA, 15 U.S.C. 1264(c)(5), and section The CPSA, as amended, adds a new In addition, the CPSA now contains a 5(e)(1) of the FFA, 15 U.S.C. 1194(e)(1), prohibited act for the sale, manufacture, new prohibited act for the exercise or to mean the having of actual knowledge distribution, or importation of products attempt to exercise undue influence on or the presumed having of knowledge subject to a voluntary corrective action a third-party conformity assessment deemed to be possessed by a ‘‘reasonable taken by the manufacturer, in body that tests products for compliance man’’ who acts in the circumstances, consultation with the Commission, and under laws administered by the including knowledge obtainable upon publicly announced by the Commission, Commission. 15 U.S.C. 2068(a)(14). or if the seller, distributor, or the exercise of due care to ascertain the The CPSIA adds to the Commission’s manufacturer knew or should have truth of representations. Since its export prohibition authority section known of such voluntary corrective enactment in 1973, the CPSA always 19(a)(15) of the CPSA, making it illegal contained a civil penalty provision; action. 15 U.S.C. 2068(a)(2)(B). The CPSA, as amended, broadens the to export from the United States for however, until 1990, the FHSA and FFA purposes of sale any consumer product did not contain comparable provisions prohibited act for the sale, offer for sale, manufacture for sale, or distribution or or other product or substance (other for civil penalties. Under the FFA, the than the export of a product or Commission had to seek civil penalties importation of any consumer product or substance permitted by the Secretary of under the Federal Trade Commission other product or substance subject to a the Treasury under section 17(e) of the Act, using the authorities under that act. section 15 mandatory recall order to CPSA) that is subject to court- or The FHSA had no civil penalty include products subject to a section 12 Commission-ordered recall or that is provision. The Consumer Product Safety order. A section 15 order is imposed in banned under the FHSA or subject to a Improvement Act of 1990, Public Law an adjudicative proceeding to declare a voluntary recall announced by the 101–608, 104 Stat. 3110, November 16, product a ‘‘substantial product hazard’’ Commission. 15 U.S.C. 2068(a)(15). 1990, amended section 5 of the FHSA under section 15 of the CPSA, 15 U.S.C. and section 5 of the FFA giving the 2064. A section 12 order, which may The CPSIA also adds a new Commission authority to seek civil include a mandatory order requiring prohibited act that makes it illegal to penalties for knowing violations of notification to purchasers, and repair, violate a Commission order issued those acts. If a penalty settlement cannot replacement, or refund, is one imposed under new section 18(c) of the CPSA, be negotiated between the Commission by a District Court after an ‘‘imminent which allows the Commission to and a person, the Commission may seek hazard’’ proceeding under section 12 of prohibit export for sale of any consumer an action in Federal court to obtain a the CPSA, 15 U.S.C. 2061. product not in conformity with an penalty. See, Advance Machine Co. v. The amended prohibited acts section applicable consumer product safety Consumer Product Safety Commission, of the CPSA is also broadened to rule. 15 U.S.C. 2068(a)(16). 666 F.2d 1166 (8th Cir. 1981); Athlone include the sale, offer for sale, E. Discussion and Response to Industries, Inc. v. Consumer Product manufacture for sale, distribution in Comments on the Interim Final Rule Safety Commission, 707 F.2d 1485 (DC commerce, or importation into the Cir. 1983). United States of a banned hazardous The comments that the Commission substance under the FHSA as an act received on the Interim Final Rule and 2. How Do the CPSIA Amendments to prohibited under the CPSA. 15 U.S.C. the Commission’s responses are the CPSA’s Prohibited Acts Affect Civil 2068(a)(2)(D). discussed in this section of the Penalties? The prohibited act in section 19(a)(6) preamble. of the CPSA relating to certification In the past, the majority of civil 1. Should Penalties Involving Actual under section 14 of the CPSA is newly penalties for prohibited acts were Knowledge Be Higher Than Those expanded to make the failure to furnish imposed either for a knowing failure to Involving Presumed Knowledge? furnish information required by section a certificate required by any other act 15(b) of the CPSA, or for regulatory enforced by the Commission a Some commenters stated that the violations under the CPSA, FHSA, or prohibited act under the CPSA. This Commission should reserve seeking the FFA. The interim final rule described prohibited act now also references a highest penalties only for those how the CPSIA amended these three new tracking label requirement of CPSA violations involving actual knowledge statutes to strengthen the Commission’s section 14(a)(5) by specifying that the where death or serious injury is likely. enforcement ability and allow for more failure to comply with any requirement The commenters suggested that uniform enforcement under the CPSA. of section 14 includes the failure to penalties involving presumed The new amendments expand the acts comply with the requirement for knowledge and circumstances where no prohibited under the CPSA and give the tracking labels or any rule or regulation injury or only minor injury occurred Commission the ability to enforce promulgated under section 14. should result in lower or no penalties. violations of the FHSA, FFA, and other The CPSA statutory language has also Some commenters also suggested that acts enforced by the Commission as been expanded to include a new technical violations should not involve prohibited acts under the CPSA. Thus, prohibited act for the sale, offer for sale, a penalty at all. These commenters the amended CPSA now prohibits the distribution in commerce, or sought clarification of these concepts in sale, offer for sale, distribution in importation into the United States of the rule.

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The CPSA, FHSA, and FFA define 2. In the Final Rule, How Does the Commission may determine are ‘‘knowingly’’ as the having of actual Commission Interpret the Civil Penalty appropriate, and consider all of the knowledge, or the presumed having of Factors? factors in determining the civil penalty amount. knowledge deemed to be possessed by Section 1119.1—Purpose a ‘‘reasonable man’’ who acts in the Section 1119.1 describes the purpose Section 1119.4(a)(3)—Nature of the circumstances, including knowledge Product Defect obtainable upon the exercise of due care of new Part 1119 ‘‘Civil Penalty Factors,’’ to ascertain the truth of representations. explaining that it is the Commission’s The interim final rule indicated that Thus, the knowledge requirements in interpretation of the statutory civil the Commission would consider, under the CPSA, FHSA, and FFA include penalty factors set forth in the this provision, where appropriate and applicable in each particular case, the presumed knowledge, as well as actual Consumer Product Safety Act (15 U.S.C. nature of the hazard presented by the knowledge. Only in section 20(a)(2) is a 2051–2089), the Federal Hazardous product for which a penalty is sought. distinction made and this limits the Substances Act (15 U.S.C. 1261–1278), and the Flammable Fabrics Act (15 The Commission construed this factor civil penalty liability of certain persons U.S.C. 1191–1204). The Commission has as applying broadly to products or without actual knowledge to those who revised the interim final rule’s text in substances that may in fact contain a are not the manufacturer, private labeler the final rule to add clarification on the defect which could create a substantial or distributor of the products involved. underlying goals and policies of civil product hazard (as defined and Aside from this limitation, actual and penalties. explained in 16 CFR 1115.4), to presumed knowledge are treated equally products which present a hazard under the statutes, and both could have Section 1119.2—Applicability because of a violation of a rule, the same consequence for civil penalty Section 1119.2 explains that the part regulation, standard, or ban under the liability. Thus, the Commission declines applies to all civil penalty CPSA, FHSA, and FFA, as well as to any to follow the commenters’ suggestion to determinations that the Commission other violation and how the nature of seek a higher penalty only where there proposes to seek or compromise for those violations relate to the underlying is evidence of actual knowledge and knowing violations of the CPSA, the products or substances. serious injury or death, or a lower or no FHSA, or the FFA. A number of commenters addressed penalty where there is evidence of the definition of ‘‘product defect’’ in Section 1119.3—Definitions presumed knowledge. To follow the section 1119.3 of the interim final rule commenters’ position would treat the Section 1119.3 defines certain terms as overly broad and unnecessarily ‘‘presumed knowledge’’ element used in the rule. The Commission has expansive and inconsistent with the differently than it is treated in the revised the definition of the term Commission’s interpretation of defect as statute. However, the presence or ‘‘product defect’’ from that in the interim used in 16 CFR 1115.4. The commenters absence of actual knowledge could final rule. The term is defined in the pointed out that defining ‘‘product reflect on a person’s culpability and final rule to have the same meaning as defect’’ beyond the definition in section affect the size of the penalty. Moreover, the term ‘‘defect’’ referenced in the CPSA 1115.4 as a product or substance the adoption of the distinction sought and the Commission’s definition of ‘‘associated with a prohibited act’’ had by the commenters would be a ‘‘defect’’ at 16 CFR 1115.4. The term no basis in the statutory language of the formulaic approach to penalty ‘‘violator’’ has been revised to reflect the CPSA and that the definition should be determinations. Almost all the statutory terminology that any ‘‘person’’ clarified to refer only to the commenters opposed the idea that the is subject to civil penalties. As noted in Commission’s definition in 16 CFR Commission adopt such a formulaic the rule, ‘‘person’’ includes any legally 1115.4. approach. However, the Commission responsible party who committed a The Commission agrees that the ‘‘ ’’ has attempted to further clarify in the knowing violation of the CPSA, FHSA definition of product defect in the or FFA. The rule explains that the interim final rule should be revised. The final rule its guidance about what definitions apply for purposes of the Commission agrees that certain CPSA factors may influence the Commission’s rule. violations may not involve a ‘‘product determination under the various defect’’ or a ‘‘defective product.’’ For statutory and other factors. Importantly, Section 1119.4(a)(2)—Nature, example, failure to supply a required in an individual case, the Commission Circumstances, Extent, and Gravity of General Conformity Certification that a the Violation would review the facts and product complies with an applicable circumstances surrounding the The Commission believes that this consumer product safety rule may not violations and the proposed assessment factor allows the Commission to necessarily involve a product defect or of penalties in light of the factors and consider the totality of the a defective product. Thus, ‘‘product framework described in the rule. circumstances surrounding a violation defect’’ may not be a relevant Specific comments relating to each while recognizing that depending upon consideration in such a circumstance. factor are discussed below. The CPSIA the case, the significance and Therefore, the Commission has revised has greatly expanded the number of importance of each factor may vary. The the final rule to clarify that where prohibited acts. Accordingly the Commission also believes that this ‘‘product defect’’ or ‘‘defective product’’ Commission intends to use its civil particular factor allows for does not apply, in such circumstances, penalty authority in a manner best consideration of the seriousness and the other statutory factors will be designed to promote the underlying extent of a particular violation that may considered. goals of the CPSA—specifically that of not otherwise be considered with protecting the public against respect to the other enumerated Section 1119.4(a)(4)—Severity of the unreasonable risks of injury associated statutory factors. Therefore, in each Risk of Injury with consumer products. In so doing, case, the Commission will continue to Several commenters noted that the Commission may reserve the highest look at the enumerated statutory factors, penalties should not be sought for civil penalty for more serious or as well as other factors (described in violations where the products presented extensive violations. section 1119.4(b) below) that the risks of minor or moderate injury.

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The Commission declines to follow language makes no distinction between on the business. When considering how this suggestion. However, the those defective products distributed in to mitigate undue adverse economic Commission notes that minor or commerce that consumers received, and consequences, the Commission will, as moderate injury is considered as a factor those defective products distributed in appropriate, follow its Small Business in the determination of the overall commerce that consumers have not Enforcement Policy set forth at 16 CFR penalty. The Commission refers to the received. Therefore both could be 1020.5. In determining a small discussion of 16 CFR 1115.12 which considered in appropriate cases. With business’s ability to pay a proposed specifies that severity of the risk respect to the number of defective penalty, the Commission may be includes a consideration of the products or amount of substances guided, where appropriate, by the likelihood of an injury occurring, the involved in a recall, the Commission financial factors set forth above. The intended or reasonably foreseeable use clarifies in the rule that the Commission Commission recognizes that on occasion or misuse of the product, and the does not intend to penalize a person’s its announced civil penalty amounts do population group exposed. The decision to conduct a wider-than- not seem to reflect the seriousness of the Commission retains these references in necessary recall undertaken out of an violations due to the Commission’s the final rule. The Commission also abundance of caution. This would not mitigation of the amount of the penalty notes that the interim final rule has been include situations where such a recall is based on ability to pay. While the modified in the final rule to further conducted due to a person’s uncertainty Commission, unlike certain other clarify that the Commission will concerning how many or which federal agencies, has never publicized consider ‘‘illness’’ along with injury and products may need to be recalled. the amount it would have sought absent death as a consideration under this the mitigation, it acknowledges that it Section 1119.4(a)(7)—The factor. The Commission believes that has that authority and may exercise that Appropriateness of Such Penalty in consideration of illness is consistent authority in appropriate circumstances. Relation to the Size of the Business of with the statutory direction which the Person Charged, Including How To Section 1119.4(b)—Other Factors as defines a ‘‘risk of injury’’ in section Mitigate Undue Adverse Economic Appropriate 3(a)(14) of the CPSA to mean a risk of Impacts on Small Businesses death, personal injury, or serious or Some commenters suggested that the frequent illness. The Commission is required to Commission should identify other consider the size of a business in factors that will be considered in Section 1119.4(a)(5)—The Occurrence relation to the amount of the penalty. penalty determinations. The factors the or Absence of Injury This factor reflects the relationship commenters suggested included The Commission received several between the size of the business of the previous record of compliance, good comments suggesting that it should not person charged and the deterrent effect faith, efforts taken to respond to the seek a penalty where the information of, and other policies underlying, civil violations, duration of the violations, the Commission evaluates reveals that penalties. In considering business and compliance with mandatory and/or the violation involved no injury or only ‘‘size,’’ the Commission may look to voluntary standards. The Commission minor injuries have occurred. several factors including but not limited has determined that some of these The Commission declines to follow to the number of employees, net worth, factors would already be evaluated in this suggestion because a violative and annual sales. The Commission may the context of the enumerated statutory product, a product about which a be guided, where appropriate, by any factors to consider, such as the nature, person did not report as required, or relevant financial factors to help circumstances, extent, and gravity of the another type of violation, may present a determine a person’s ability to pay a violation. Therefore, it is not necessary serious risk to consumers even though penalty including but not limited to: to separately enumerate these factors. no injuries have occurred. However, the • Liquidity factors—factors that help Congress clarified in the CPSIA that final rule is further clarified to state that measure a person’s ability to pay its the Commission has the ability to the Commission would consider under short-term obligations; consider factors in addition to the ones this factor whether illnesses or deaths • Solvency factors—factors that help enumerated in the act in individual have occurred, in addition to measure a person’s ability to pay its cases, as appropriate. However, the considering whether injuries have or long-term obligations; and Commission retains the concept from have not occurred. The rule is further • Profitability factors— factors that the interim final rule in the final rule clarified to explain that this measure a person’s level of return on that in any penalty matter the consideration will also involve the investment. Commission and the person are free to number and nature of such injuries, The Commission is aware that raise any other factors they believe are illnesses, or deaths. Finally, the penalties may have adverse economic relevant in determining an appropriate Commission has pointed out that both consequences on persons, including civil penalty amount. Factors not acute and the likelihood for chronic small businesses. The statute requires identified below could therefore be illness will be considered. the Commission to consider how to raised in a penalty matter. The mitigate the adverse economic Commission has determined that the Section 1119.4(a)(6)—The Number of consequences on small businesses only factors listed below should remain with Defective Products Distributed if those consequences would be changes and other clarifications as The Commission is required to ‘‘undue.’’ What the Commission noted: consider the number of defective considers in determining what is • Safety/Compliance Program and/or products or amount of substances ‘‘undue’’ may include, but is not limited System Relating to a Violation: The distributed in commerce. The to, the business’s size and financial Commission listed a number of factors Commission recognizes, as some factors relating to its ability to pay. The relating to consideration of a safety/ commenters pointed out, that the interim final rule is modified in the compliance program or system in the number of defective products in final rule to explain that the burden to interim final rule. The Commission consumers’ hands may be different from present clear, reliable, relevant, and received comments seeking further the number of defective products sufficient evidence relating to a definition of a safety or compliance distributed. However, the statutory business’s size and ability to pay rests program. The rule is intended to

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provide examples of information that a The rule is clarified to reflect this H. Paperwork Reduction Act person should consider, but not to consideration. The rule does not impose any provide one particular model of a information collection requirements. program or system. The Commission Which additional factors the Rather, it describes the statutory civil intends to allow flexibility for the Commission considers in determining penalty factors and how the regulated community. However, the an appropriate penalty amount, Commission interprets those factors. Commission has modified the final rule including, but not limited to, those Accordingly, it is not subject to the from the interim final rule in two listed above, will be unique to each Paperwork Reduction Act, 44 U.S.C. important respects. First, the rule now case. 3501–3520. makes explicit that the burden to A person will be notified of any present clear, reliable, relevant, and factors beyond those enumerated in the I. Environmental Considerations sufficient evidence of any such program statutes that the Commission relies on The Commission’s regulations at 16 and its relevance is on the person as aggravating factors for purposes of CFR 1021.5(a) provide that there are no seeking consideration of this factor. determining a civil penalty amount. CPSC actions that ordinarily produce Second, the rule makes explicit that any significant environmental effects. The such program being asserted as relevant Section 1119.5—Enforcement rule does not fall within the categories to a penalty matter must specifically Notification in 16 CFR 1021.5(b) of CPSC actions relate to the violation or violations at Section 1119.5 of the rule sets forth a that have the potential for producing issue and must be reasonable and notification provision whereby, if it is effective. The Commission recognizes environmental effects. The rule does not believed that a person has violated the that the mere fact of a violation does not have any potential for adversely law and a penalty is sought, the person necessarily render a program ineffective. affecting the quality of the human • History of Noncompliance: Some will be so advised. This provision has environment. Council of Environmental commenters sought greater clarification been informally followed by the Quality regulations at 40 CFR 1508.18(a) on this factor and stated that the Commission in determining the amount provide that agency actions subject to Commission should consider a history of a civil penalty to seek or compromise environmental review ‘‘do not include of compliance as well as for knowing violations. The bringing judicial or administrative noncompliance. The Commission Commission has provided further enforcement actions.’’ Therefore, no declines to add ‘‘compliance’’ in the clarification of this process in the rule. environmental assessment or environmental impact statement is final rule because the factor by its F. Immediate Effective Date nature is intended to address repeat required. violators. However, the Commission The Commission issued an interim List of Subjects in 16 CFR Part 1119 clarifies in the final rule that repeat final rule, in accordance with the violations of the same law or regulation, procedures set forth at 5 U.S.C. 553 of Administrative practice and or prior violations of a different law or the Administrative Procedure Act, on procedure, Business and Industry, regulation enforced by the Commission, September 1, 2009, providing its Consumer protection, Reporting and as well as the number of such interpretation of the penalty factors in recordkeeping requirements. violations, will be considerations. section 20(b) of the CPSA, section ■ Accordingly, the Commission revises • Economic Gain from 5(c)(3) of the FHSA, and section 5(e)(2) 16 CFR Part 1119 to read as follows: Noncompliance: Some comments of the FFA. Maximum civil penalty suggested that the Commission consider amounts have increased for violations PART 1119—CIVIL PENALTY this factor after consideration of the that occurred on or after August 14, FACTORS statutory factors in determining a 2009. This final rule is effective upon penalty amount. The Commission agrees Sec. publication. The rule is interpretative 1119.1 Purpose. that economic gain may be a and does not impose obligations on 1119.2 Applicability. consideration that should be factored in, regulated parties beyond those imposed 1119.3 Definitions. where appropriate, with other factors. by the CPSA, FHSA, and FFA. 1119.4 Factors considered in determining • Failure to respond in a timely and Therefore, there is no need to provide a civil penalties. complete fashion to the Commission’s delayed effective date in order to allow 1119.5 Enforcement notification. requests for information or remedial for regulated parties to prepare for the Authority: 15 U.S.C. 2058, 2063, 2064, action: The Commission received a rule. 2067(b), 2068, 2069, 2076(e), 2084, 1261, number of comments suggesting that 1263, 1264, 1270, 1273, 1278, 1191, 1192, this factor as written implied that a G. Regulatory Flexibility Certification 1193, 1194, 1195, 1196. person may be penalized for exercising their legal rights to disagree and seek The Regulatory Flexibility Act (RFA), § 1119.1 Purpose. counsel on the Commission’s requests 5 U.S.C. 601–612, directs agencies to This part sets forth the Consumer for information or remedial action. The consider the potential impact of Product Safety Commission’s Commission agrees that a person has the regulations on small business and other (Commission) interpretation of the legal right to decline to respond or act small entities. However, the RFA does statutory factors considered in voluntarily and the legal right to seek not apply to rulemaking that is not determining the amount of civil advice on information and remedial subject to the notice and comment penalties that the Commission may seek action requests from the Commission requirement of the Administrative or compromise. The policies behind, and, therefore, is clarifying that it did Procedure Act, 5 U.S.C. 553. and purposes of, civil penalties include not intend to impede such rights. This Interpretative rules, such as the one the following: Deterring violations; factor was intended to address egregious issued by this notice, are not subject to providing just punishment; promoting and dilatory tactics in response to the the notice and comment requirement. respect for the law; promoting full Commission’s written requests for Accordingly, neither an initial nor a compliance with the law; reflecting the information or remedial action but not final regulatory flexibility analysis is seriousness of the violation; and to impede any person’s lawful rights. required for this rule. protecting the public.

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§ 1119.2 Applicability. business of the person charged, have or have not occurred with respect This part applies to all civil penalty including how to mitigate undue to any product or substance associated determinations the Commission may adverse economic impacts on small with a violation, and, if so, the number seek or compromise under the businesses; and and nature of injuries, illnesses, or Consumer Product Safety Act (CPSA) (F) Such other factors as appropriate. deaths. Both acute illnesses and the (15 U.S.C. 2051–2089), the Federal (iii) FFA (15 U.S.C. 1194 (e)(2)). The likelihood of chronic illnesses will be Hazardous Substances Act (FHSA) (15 nature, circumstances, extent, and considered. U.S.C. 1261–1278), and the Flammable gravity of the violations: (6) The number of defective products Fabrics Act (FFA) (15 U.S.C. 1191– (A) The severity of the risk of injury; distributed. The Commission will 1204). Any person who knowingly (B) The occurrence or absence of consider the number of defective violates section 19 of the CPSA, section injury; products or amount of substance (C) The appropriateness of such 4 of the FHSA, or section 5(e) of the distributed in commerce. The statutory penalty in relation to the size of the FFA, is subject to a civil penalty. language makes no distinction between business of the person charged; and those defective products distributed in § 1119.3 Definitions. (D) Such other factors as appropriate. commerce that consumers received and For purposes of this rule, the (2) The nature, circumstances, extent, those defective products distributed in following definitions apply: and gravity of the violation. Under this commerce that consumers have not (a) Product defect means a defect as factor, the Commission will consider the received. Therefore both could be referenced in the CPSA and defined in totality of the circumstances and all considered in appropriate cases. This Commission regulations at 16 CFR other facts concerning a violation. The factor will not be used to penalize a 1115.4. Commission will consider the person’s decision to conduct a wider- (b) Violation means a violation enumerated statutory factors, as well as than-necessary recall out of an committed knowingly, as the term the factors described in paragraph (b) of abundance of caution. This would not ‘‘knowingly’’ is defined in section 19 of this section. include situations where such a recall is the CPSA, section 4 of the FHSA, or (3) Nature of the product defect. The conducted due to a person’s uncertainty section 5 of the FFA. Commission will consider the nature of concerning how many or which (c) Person means any manufacturer the product defect associated with a products may need to be recalled. (including importer), distributor, or CPSA violation. This consideration will (7) The appropriateness of such retailer, as those terms are defined in include, for example, whether the defect penalty in relation to the size of the the CPSA, FHSA, or FFA, and any other arises from the product’s design, business of the person charged, legally responsible party. composition, contents, construction, including how to mitigate undue manufacture, packaging, warnings, or adverse economic impacts on small § 1119.4 Factors considered in instructions, and will include businesses. determining civil penalties. consideration of conditions or (i) The Commission is required to (a) Statutory Factors. (1) Section 20(b) circumstances in which the defect consider the size of the business of the of the CPSA, section 5(c)(3) of the arises. The Commission will also person charged in relation to the FHSA, and section 5(e)(2) of the FFA, consider the nature of the substance amount of the penalty. This factor specify factors considered by the associated with an FHSA violation. Two reflects the relationship between the Commission in determining the amount of the statutory factors in the CPSA civil size of a business and the policies of a civil penalty to be sought upon penalty factors include the terms behind, and purposes of, a penalty (as commencing an action for knowing ‘‘product defect’’ or ‘‘defective products.’’ noted above in § 1119.1). In considering violations of each act. These factors are: However, certain violations of the business size, the Commission may look (i) CPSA (15 U.S.C. 2069(b)). The CPSA, for example, failing to supply a to several factors including, but not nature, circumstances, extent, and required certificate that the product limited to, the number of employees, net gravity of the violation, including: complies with an applicable consumer worth, and annual sales. A business’s (A) The nature of the product defect; product safety rule, do not necessarily size and a business’s ability to pay a (B) The severity of the risk of injury; require that there be a product defect or penalty are separate considerations. In (C) The occurrence or absence of defective product. The terms ‘‘product some cases for small businesses, injury; defect’’ or ‘‘defective products’’ would however, these two considerations may (D) The number of defective products not apply to such situation. In such relate to each other. The Commission distributed; cases, however, the other civil penalty will be guided, where appropriate, by (E) The appropriateness of such factors would still be considered. relevant financial factors to determine a penalty in relation to the size of the (4) Severity of the risk of injury. small business’s ability to pay a penalty, business of the person charged, Consistent with its discussion of including, but not limited to, liquidity, including how to mitigate undue severity of the risk at 16 CFR 1115.12, solvency, and profitability. The burden adverse economic impacts on small the Commission will consider, among to present clear, reliable, relevant, and businesses; and other factors, the potential for serious sufficient evidence relating to a (F) Such other factors as appropriate. injury, illness, or death (and whether business’s size and ability to pay rests (ii) FHSA (15 U.S.C. 1264 (c)(3)). The any injury or illness required medical on the business. nature, circumstances, extent, and treatment including hospitalization or (ii) The statute requires the gravity of the violation, including: surgery); the likelihood of injury; the Commission to consider how to mitigate (A) The nature of the substance; intended or reasonably foreseeable use the adverse economic impacts on small (B) Severity of the risk of injury; or misuse of the product; and the businesses only if those impacts would (C) The occurrence or absence of population at risk (including vulnerable be undue. What the Commission injury; populations such as children, the considers in determining what is undue (D) The amount of substance elderly, or those with disabilities). may include, but is not limited to, the distributed; (5) The occurrence or absence of business’s size and financial factors (E) The appropriateness of such injury. The Commission will consider relating to its ability to pay. When penalty in relation to the size of the whether injuries, illnesses, or deaths considering how to mitigate undue

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adverse economic impacts, the economically from a failure to comply, conditions of similarly employed U.S. Commission will, as appropriate, also including a delay in complying, with workers. These factual determinations follow its Small Business Enforcement the CPSA, FHSA, FFA, and other laws (or a determination that there are not Policy set forth at § 1020.5. that the CPSC enforces, and the sufficient facts to make one or both of (b) Other factors as appropriate. In regulations thereunder. these determinations) are required to determining the amount of any civil (4) Failure to respond in a timely and carry out the policies of the Immigration penalty to be sought for a violation of complete fashion to the Commission’s and Nationality Act (INA), that a the CPSA, FHSA, or FFA, the requests for information or remedial nonimmigrant alien worker not be Commission may consider, as action. The Commission may consider admitted to fill a particular temporary appropriate, such other factors in whether a person’s failure to respond in job opportunity unless no qualifed U.S. addition to those listed in the statutes. a timely and complete fashion to worker is available to fill the job Both the Commission and a person may requests from the Commission for opportunity, and unless the raise any factors they believe are information or for remedial action employment of the foreign worker in the relevant in determining an appropriate should increase a penalty. This factor is job opportunity will not adversely affect penalty amount. A person will be intended to address a person’s dilatory the wages or working conditions of notified of any factors beyond those and egregious conduct in responding to similarly employed U.S. workers. enumerated in the statutes that the written requests for information or (2) The Secretary’s determinations. Commission relies on as aggravating remedial action sought by the Before any factual determination can be factors for purposes of determining a Commission, but not to impede any made concerning the availability of U.S. civil penalty amount. Additional factors person’s lawful rights. workers to perform particular job that may be considered in a case § 1119.5 Enforcement notification. opportunities, two steps must be taken. include, but are not limited to, the First, the minimum level of wages, A person will be informed in writing following: terms, benefits, and conditions for the if it is believed that the person has (1) Safety/compliance program and/or particular job opportunities, below violated the law and if the Commission system relating to a violation. The which similarly employed U.S. workers intends to seek a civil penalty. Any Commission may consider, when a would be adversely affected, must be person who receives such a writing will safety/compliance program and/or established. (The regulations in this part have an opportunity to submit evidence system as established is relevant to a establish such minimum levels for and arguments that it should not pay a violation, whether a person had at the wages, terms, benefits, and conditions of penalty or should not pay a penalty in time of the violation a reasonable and employment.) Second, the wages, terms, the amount sought by the Commission. effective program or system for benefits, and conditions offered and collecting and analyzing information Dated: March 24, 2010. afforded to the aliens must be compared related to safety issues. Examples of Todd A. Stevenson, to the established minimum levels. If it such information would include Secretary, Consumer Product Safety is concluded that adverse effect would incident reports, lawsuits, warranty Commission. result, the ultimate determination of claims, and safety-related issues related [FR Doc. 2010–6940 Filed 3–30–10; 8:45 am] availability within the meaning of the to repairs or returns. The Commission BILLING CODE 6355–01–P INA cannot be made since U.S. workers may also consider whether a person cannot be expected to accept conducted adequate and relevant employment under conditions below premarket and production testing of the the established minimum levels. Florida product at issue; had a program in place DEPARTMENT OF LABOR Sugar Cane League, Inc. v. Usery, 531 F. for continued compliance with all Employment and Training 2d 299 (5th Cir. 1976). relevant mandatory and voluntary safety Administration standards; and other factors as the Once a determination of no adverse effect has been made, the availability of Commission deems appropriate. The 20 CFR Part 655 burden to present clear, reliable, U.S. workers can be tested only if U.S. relevant, and sufficient evidence of such Temporary Employment of Foreign workers are actively recruited through program, system, or testing rests on the Workers in the United States the offer of wages, terms, benefits, and person seeking consideration of this conditions at least at the minimum level factor. CFR Correction or the level offered to the aliens, (2) History of noncompliance. The In Title 20 of the Code of Federal whichever is higher. The regulations in Commission may consider whether or Regulations, Part 500 to End, revised as this part set forth requirements for not a person’s history of noncompliance of April 1, 2009, on page 466, remove recruiting U.S. workers in accordance with the CPSA, FHSA, FFA, and other § 655.0 and correctly reinstate it to read with this principle. laws that the CPSC enforces, and the as follows: (3) Construction. This part and its regulations thereunder, should increase subparts shall be construed to effectuate the amount of the penalty. A person’s § 655.0 Scope and purpose of part. the purpose of the INA that U.S. history of noncompliance may be (a) Subparts A, B, and C—(1) General. workers rather than aliens be employed indicated by, for example, multiple Subparts A, B, and C of this part set out wherever possible. Elton Orchards, Inc. violations of one or more laws or the procedures adopted by the Secretary v. Brennan, 508 F. 2d 493, 500 (1st Cir. regulations that the CPSC enforces, to secure information sufficient to make 1974), Flecha v. Quiros, 567 F. 2d 1154 including repeated violations of the factual determinations of: (i) Whether (1st Cir. 1977). Where temporary alien same law or regulation. History of U.S. workers are available to perform workers are admitted, the terms and noncompliance may include the number temporary employment in the United conditions of their employment must of previous violations or how recently a States, for which an employer desires to not result in a lowering of the terms and previous violation occurred. employ nonimmigrant foreign workers, conditions of domestic workers (3) Economic gain from and (ii) whether the employment of similarly employed, Williams v. Usery, noncompliance. The Commission may aliens for such temporary work will 531 F. 2d 305 (5th Cir. 1976); Florida consider whether a person benefitted adversely affect the wages or working Sugar Cane League, Inc. v. Usery, 531 F.

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2d 299 (5th Cir. 1976), and the job DEPARTMENT OF HEALTH AND 47332). CVM proposed to withdraw the benefits extended to any U.S. workers HUMAN SERVICES new animal drug applications (NADAs) shall be at least those extended to the for those nine products and use alien workers. Food and Drug Administration combinations lacking substantial evidence of effectiveness, following an (b) Subparts D and E. Subparts D and 21 CFR Part 558 opportunity to supplement the NADAs E of this part set forth the process by with labeling conforming to the relevant which health care facilities can file [Docket No. FDA–2003–N–0446] (formerly Docket No. 2003N–0324) findings of effectiveness. For attestations with the Department of applications proposed to be withdrawn, Labor for the purpose of employing or New Animal Drugs; Removal of the agency provided an opportunity for otherwise using nonimmigrant Obsolete and Redundant Regulations hearing. registered nurses under H–1A visas. FDA received hearing requests (c) Subparts F and G. Subparts F and AGENCY: Food and Drug Administration, regarding two products owned by G of this part set forth the process by HHS. Pennfield Oil Co. (Pennfield). One is a which employers can file attestations ACTION: Final rule. bacitracin methylene disalicylate (BMD) with the Department of Labor for the Type A medicated article, NADA 141– SUMMARY: The Food and Drug 137, that is listed in the table in purpose of employing alien Administration (FDA) is removing crewmembers in longshore work under § 558.15(g)(1). This listing is under portions of a regulation that required Fermenta Animal Health Co., which is D-visas and enforcement provisions sponsors to submit data regarding the a predecessor in interest to Pennfield. relating thereto. subtherapeutic use of certain antibiotic, The other is a two-way, fixed- (d) Subparts H and I of this part. nitrofuran, and sulfonamide drugs combination Type A medicated article Subpart H of this part sets forth the administered in animal feed as these containing oxytetracycline and process by which employers can file regulations have been determined to be neomycin sulfate, NADA 138–939, that labor condition applications (LCAs) obsolete or redundant. The portions of is listed in the table in § 558.15(g)(2). with, and the requirements for obtaining the regulation being removed are The agency received only one set of approval from, the Department of Labor provisions listing certain feed use comments on the 2003 proposed rule, to temporarily employ the following combinations for oxytetracycline and from Pennfield. The comment objected three categories of nonimmigrants in the neomycin in the tables contained in that to the removal of § 558.15 until the United States: (1) H–1B visas for regulation. This rule does not finalize issues in the NOOH are addressed. It temporary employment in specialty the provisions of the proposed rule argued that the BMD listing in § 558.15 regarding removing the remainder of the provides evidence of Pennfield’s occupations or as fashion models of regulation. approval, and that removal of that distinguished merit and ability; (2) H– section, without updating the BMD 1B1 visas for temporary employment in DATES: This rule is effective April 30, 2010. listing in part 558, subpart B, would specialty occupations of nonimmigrant result in a lack of recognition in the professionals from countries with which FOR FURTHER INFORMATION CONTACT: regulations of the approval that the United States has entered into William T. Flynn, Center for Veterinary Pennfield currently has. certain agreements identified in section Medicine (HFV–50), 7519 Standish Pl., In 2006, FDA finalized portions of the 214(g)(8)(A) of the INA; and (3) E–3 Rockville, MD 20855, 240–276–9090, e- 2003 proposed rule. In that final rule (71 visas for nationals of the mail: [email protected]. FR 16219, March 31, 2006), FDA Commonwealth of Australia for SUPPLEMENTARY INFORMATION: removed from the tables in § 558.15(g) temporary employment in specialty I. Background products and use combinations that occupations. Subpart I of this part were not approved, and products and establishes the enforcement provisions In the Federal Register of August 8, use combinations whose approval was that apply to the H–1B, H–1B1, and E– 2003 (68 FR 47272), FDA published a reflected in part 558, subpart B. FDA 3 visa programs. notice of proposed rulemaking to retained only the listings for NADA remove 21 CFR 558.15 Antibiotic, 141–137 and NADA 138–939 in those (e) Subparts J and K of this part. nitrofuran, and sulfonamide drugs in tables. In addition, FDA retained Subparts J and K of this part set forth the feed of animals (§ 558.15 (21 CFR § 558.15(a) through (f). FDA stated it the process by which employers can file 558.15)) on the grounds that these intended to finalize the proposed rule to attestations with the Department of regulations were obsolete or redundant. remove all of § 558.15 once, as part of Labor for the purpose of employing The proposed rule explained the nature the DESI program, either the approvals nonimmigrant alien students on F-visas and purpose of § 558.15, and noted that for NADA 141–137 and NADA 138–939 in off-campus employment and most of the products and use have been withdrawn or part 558, enforcement provisions relating thereto. combinations subject to the listings in subpart B has been amended to reflect [43 FR 10312, Mar. 10, 1978, as amended at that section had approvals that were their approvals. 52 FR 20507, June 1, 1987; 55 FR 50510, Dec. already codified in part 558, subpart B Subsequently, Pennfield filed a 6, 1990; 56 FR 24667, May 30, 1991; 56 FR (21 CFR part 558, subpart B). supplement to NADA 138–939 for its 54738, Oct. 22, 1991; 56 FR 56875, Nov. 6, In the same issue of the Federal fixed-combination oxytetracycline/ 1991; 57 FR 1337, Jan. 13, 1992; 57 FR 40989, Register as the proposed rule, FDA’s neomycin Type A medicated articles. Sept. 8, 1992; 69 FR 68226, Nov. 23, 2004; Center for Veterinary Medicine (CVM) The supplemental NADA, which 73 FR 19947, Apr. 11, 2008] published a Notice of Opportunity for provided labeling conforming to the Hearing (NOOH), which announced relevant findings of effectiveness [FR Doc. 2010–7380 Filed 3–30–10; 8:45 am] CVM’s findings of effectiveness for nine announced in the NOOH, was approved BILLING CODE 1505–01–D products and use combinations that on July 2, 2009, and the regulations were listed in § 558.15, but which were were amended in § 558.455 of subpart B subject to the Drug Efficacy Study to reflect that approval (74 FR 40723, Implementation (DESI) program (68 FR August 13, 2009).

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This oxytetracycline/neomycin use benefits as described in the proposed PART 558—NEW ANIMAL DRUGS FOR combination is listed in the table in rule, we retain the benefits for the final USE IN ANIMAL FEEDS § 558.15(g)(2) and is the only use rule. This final rule is expected to combination listed in this provision. provide greater clarity in the regulations ■ 1. The authority citation for 21 CFR Because this use combination’s approval for new animal drugs for use in animal part 558 continues to read as follows: is now reflected in § 558.455, FDA is feeds by deleting obsolete provisions in Authority: 21 U.S.C. 360b, 371. removing § 558.15(g)(2) as obsolete or § 558.15. We do not expect this final redundant. As in the 2006 final rule, rule to result in any direct human or § 558.15 [Amended] FDA is retaining the sole listing in the animal health benefit. Rather, this final ■ 2. In § 558.15, remove and reserve table in § 558.15(g)(1) for NADA 141– rule would remove regulations that are paragraph (g)(2). 137 as well as § 558.15(a) through (f), no longer necessary. and intends to continue to finalize the Dated: March 18, 2010. proposed rule to remove all of § 558.15. B. Compliance Costs Leslie Kux, Acting Assistant Commissioner for Policy. II. Environmental Impact We do not expect the final rule that revokes § 558.15(g)(2) to have a [FR Doc. 2010–7108 Filed 3–30–10; 8:45 am] The agency has determined under 21 substantive effect on any approved new BILLING CODE 4160–01–S CFR 25.30(h) that this action is of a type animal drugs, or to cause any approved that does not individually or new animal drug to lose its marketing cumulatively have a significant effect on ability or experience a loss of sales. DEPARTMENT OF HOMELAND the human environment. Therefore, SECURITY neither an environmental assessment C. Regulatory Flexibility Analysis nor an environmental impact statement The Regulatory Flexibility Act Coast Guard is required. requires agencies to analyze regulatory III. Analysis of Impacts options that would minimize any 33 CFR Part 117 significant impact of a rule on small FDA has examined the impacts of the [Docket No. USCG–2009–0959] entities. FDA has determined that this final rule under Executive Order 12866 final rule does not impose compliance RIN 1625–AA09 and the Regulatory Flexibility Act (5 costs on the sponsors of any products U.S.C. 601–602), and the Unfunded that are currently marketed. Further, it Drawbridge Operation Regulation; Mandates Reform Act of 1995 (Public does not cause any drugs that are Chehalis River, Aberdeen, WA, Law 104–4). Executive Order 12866 currently marketed to lose their Schedule Change directs agencies to assess all costs and marketing ability. We therefore certify benefits of available regulatory AGENCY: Coast Guard, DHS. that this final rule would not have a alternatives and, when regulation is ACTION: Final rule. significant economic effect on a necessary, to select regulatory substantial number of small entities. approaches that maximize net benefits SUMMARY: The Coast Guard is changing (including potential economic, D. Unfunded Mandates Reform Act the regulations that govern the operation environmental, public health and safety, of the U.S. Highway 101 bascule bridge Section 202(a) of the Unfunded and other advantages; distributive across the Chehalis River, mile 0.1, at Mandates Reform Act requires that impacts; and equity). The agency Aberdeen, Washington. At least one- agencies prepare a written statement, believes that this final rule is not a hour notice by telephone will be which includes an assessment of significant regulatory action under the required at all times for draw openings. anticipated costs and benefits, before The change is necessary to allow the Executive order. ‘‘ FDA proposed the removal of § 558.15 proposing any rule that includes any bridge owner to reduce the staffing on August 8, 2003, because it was Federal mandate that may result in the requirements of the bridge in light of the obsolete or redundant. The original expenditure by State, local, and tribal infrequent openings requested for the purpose of § 558.15, requiring the governments, in the aggregate, or by the bridge. private sector, of $100,000,000 or more submission of the results of studies on DATES: This rule is effective April 30, the long-term administration of then- (adjusted annually for inflation) in any ’’ 2010. marketed antimicrobial drugs in animal one year. The current threshold after feed on the occurrence of multiple drug- adjustment for inflation is $133 million, ADDRESSES: Comments and related resistant bacteria associated with these using the most current (2008) Implicit materials received from the public, as animals, was obsolete as FDA had a new Price Deflator for the Gross Domestic well as documents mentioned in this strategy and concept for assessing the Product. FDA does not expect this final preamble as being available in the safety of antimicrobial new animal rule to result in any 1-year expenditure docket, are part of docket USCG–2009– drugs, including subtherapeutic use of that would meet or exceed this amount. 0959 and are available online by going to http://www.regulations.gov., inserting antimicrobials in animal feed, with IV. Paperwork Reduction Act of 1995 regard to their microbiological effects on USCG–2009–0959 in the ‘‘Keyword’’ FDA concludes that this rule does not bacteria of human health concern. This box, and then clicking ‘‘Search’’. This have information collection final rule would delete the only animal material is also available for inspection requirements. drug use combination listed in or copying at the Docket Management § 558.15(g)(2) which is redundant List of Subjects in 21 CFR Part 558 Facility (M–60), U.S. Department of because its approved conditions of use Transportation, West Building, Ground Animal drugs, Animal feeds. are now listed in § 558.455. Floor, Room W12–140, 1200 New Jersey ■ Therefore, under the Federal Food, Avenue, SE., Washington, DC 20590, A. Benefits Drug, and Cosmetic Act and under between 9 a.m. and 5 p.m. Monday Only one set of comments on the authority delegated to the Commissioner through Friday, except Federal holidays. proposal was received by FDA. Because of Food and Drugs, 21 CFR part 558 is FOR FURTHER INFORMATION CONTACT: If these comments did not question the amended as follows: you have questions on this rule, call or

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e-mail Austin Pratt, Chief, Bridge Planning and Review, and does not Federalism Section, Waterways Management require an assessment of potential costs A rule has implications for federalism Branch, 13th Coast Guard District; and benefits under section 6(a)(3) of that under Executive Order 13132, telephone 206–220–7282, e-mail Order. The Office of Management and Federalism, if it has a substantial direct [email protected]. If you have Budget has not reviewed it under that effect on State or local governments and questions on viewing the docket, call Order. The Coast Guard has made this would either preempt State law or Renee V. Wright, Program Manager, determination based on the fact that impose a substantial direct cost of Docket Operations, telephone 202–366– vessel operators will not be significantly compliance on them. We have analyzed 9826. impacted since they will still be able to this rule under that Order and have SUPPLEMENTARY INFORMATION: transit under the bridge by giving one- determined that it does not have hour notice. Regulatory Information implications for federalism. Small Entities On December 4, 2009, we published Unfunded Mandates Reform Act a notice of proposed rulemaking Under the Regulatory Flexibility Act The Unfunded Mandates Reform Act (NPRM) entitled Drawbridge Operation (5 U.S.C. 601–612), we have considered of 1995 (2 U.S.C. 1531–1538) requires Regulations; Chehalis River, Aberdeen, whether this rule would have a Federal agencies to assess the effects of WA, Schedule Change in the Federal significant economic impact on a their discretionary regulatory actions. In Register (74 FR 63695). We received no substantial number of small entities. particular, the Act addresses actions comments on the proposed rule. No The term ‘‘small entities’’ comprises that may result in the expenditure by a public meeting was requested and none small businesses, not-for-profit State, local, or tribal government, in the was held. organizations that are independently aggregate, or by the private sector of Background and Purpose owned and operated and are not $100,000,000 or more in any one year. dominant in their fields, and Though this rule will not result in such This rule enables the Washington governmental jurisdictions with an expenditure, we do discuss the State Department of Transportation, the populations of less than 50,000. effects of this rule elsewhere in this owner of the Chehalis River Bridge, to preamble. operate the draw only if at least one- The Coast Guard certifies under 5 hour notice is provided at all times. U.S.C. 605(b) that this rule would not Taking of Private Property This notice will be given by telephone have a significant economic impact on This rule will not affect a taking of to 360–533–9360. A marine radio will a substantial number of small entities private property or otherwise have also be maintained at the bridge, but because all vessel operators will not be taking implications under Executive will only be monitored when a draw significantly impacted since they will Order 12630, Governmental Actions and tender is present. Previously, one-hour still be able to transit under the bridge Interference with Constitutionally notice was only required between 9 p.m. by giving one-hour notice. Protected Property Rights. and 5 a.m. Assistance for Small Entities Over the years ship traffic has Civil Justice Reform dwindled on this reach of the Chehalis Under section 213(a) of the Small This rule meets applicable standards River. From June through September Business Regulatory Enforcement in sections 3(a) and 3(b)(2) of Executive 2009 the draw did not open for large Fairness Act of 1996 (Pub. L. 104–121), Order 12988, Civil Justice Reform, to oceangoing vessels. The former ship in the NPRM we offered to assist small minimize litigation, eliminate traffic is now focused seaward of the entities in understanding this rule so ambiguity, and reduce burden. bridge following the recent closure of that they can better evaluate its effects Protection of Children timber terminals above the bridge. The on them and participate in the bridge averages only seven openings a rulemaking process. We have analyzed this rule under month during those daylight hours Small businesses may send comments Executive Order 13045, Protection of when a draw operator is present. The on the actions of Federal employees Children from Environmental Health Washington State Department of who enforce, or otherwise determine Risks and Safety Risks. This rule is not Transportation requested this change to compliance with, Federal regulations to an economically significant rule and reduce unnecessary staffing of the the Small Business and Agriculture would not create an environmental risk drawbridge in light of the infrequent Regulatory Enforcement Ombudsman to health or risk to safety that might openings requested for the bridge. and the Regional Small Business disproportionately affect children. Discussion of Comments and Changes Regulatory Fairness Boards. The Indian Tribal Governments Ombudsman evaluates these actions No comments were received on the This rule does not have tribal annually and rates each agency’s proposed rule and no changes were implications under Executive Order responsiveness to small business. If you made to the proposed rule. 13175, Consultation and Coordination wish to comment on actions by with Indian Tribal Governments, Regulatory Analyses employees of the Coast Guard, call because it would not have a substantial We developed this rule after 1–888–REG–FAIR (1–888–734–3247). direct effect on one or more Indian considering numerous statutes and The Coast Guard will not retaliate tribes, on the relationship between the executive orders related to rulemaking. against small entities that question or Federal Government and Indian tribes, Below we summarize our analyses complain about this rule or any policy or on the distribution of power and based on 13 of these statutes or or action of the Coast Guard. responsibilities between the Federal executive orders. Collection of Information Government and Indian tribes. Regulatory Planning and Review This rule calls for no new collection Energy Effects This rule is not a significant of information under the Paperwork We have analyzed this rule under regulatory action under section 3(f) of Reduction Act of 1995 (44 U.S.C. 3501– Executive Order 13211, Actions Executive Order 12866, Regulatory 3520.). Concerning Regulations That

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Significantly Affect Energy Supply, PART 117—DRAWBRIDGE U.S. Department of Transportation, Distribution, or Use. We have OPERATION REGULATIONS West Building Ground Floor, Room determined that it is not a ‘‘significant W12–140, 1200 New Jersey Avenue, SE., ■ energy action’’ under that order because 1. The authority citation for part 117 Washington, DC 20590, between 9 a.m. it is not a ‘‘significant regulatory action’’ continues to read as follows: and 5 p.m., Monday through Friday, under Executive Order 12866 and is not Authority: 33 U.S.C. 499; 33 CFR 1.05–1; except Federal Holidays. Department of Homeland Security Delegation likely to have a significant adverse effect FOR FURTHER INFORMATION CONTACT: No. 0170.1. If on the supply, distribution, or use of you have questions on this rule, call or energy. The Administrator of ■ 2. Revise § 117.1031 to read as e-mail Mr. Bill H. Brazier, Bridge Information and Regulatory Affairs has follows: Management Specialist, Fifth Coast not designated this as a significant § 117.1031 Chehalis River. Guard District; telephone (757) 398– energy action. Therefore, it does not 6422, e-mail [email protected]. If The draw of the U.S. 101 highway require a Statement of Energy Effects you have questions on reviewing the bridge, mile 0.1, at Aberdeen shall open under Executive Order 13211. docket, call Renee V. Wright, Program on signal if at least one-hour notice is Manager, Docket Operations, (202) 366– Technical Standards given at all times by telephone to the 9826. Washington State Department of The National Technology Transfer Transportation. SUPPLEMENTARY INFORMATION: The City and Advancement Act (NTTAA) (15 of Chesapeake, who owns and operates Dated: March 11, 2010. U.S.C. 272 note) directs agencies to use this swing-type bridge, has requested a voluntary consensus standards in their G.T. Blore, temporary deviation from the current regulatory activities unless the agency Rear Admiral, U.S. Coast Guard, Commander, operating regulations set out in 33 CFR provides Congress, through the Office of Thirteenth Coast Guard District. 117.997(i), to facilitate structural Management and Budget, with an [FR Doc. 2010–7166 Filed 3–30–10; 8:45 am] repairs. explanation of why using these BILLING CODE 9110–04–P The SR170 Centerville Turnpike standards would be inconsistent with Bridge has a vertical clearance in the applicable law or otherwise impractical. DEPARTMENT OF HOMELAND closed position to vessels of four feet Voluntary consensus standards are above mean high water. technical standards (e.g., specifications SECURITY Under this temporary deviation, the of materials, performance, design, or drawbridge will be maintained in the operation; test methods; sampling Coast Guard closed to navigation position to procedures; and related management facilitate repairs to structural support systems practices) that are developed or 33 CFR Part 117 stringers on two separate closures. The adopted by voluntary consensus [Docket No. USCG–2010–0185] first closure period will begin at 8 a.m. standards bodies. Drawbridge Operation Regulation; April 10, 2010, until and including 6 p. This rule does not use technical Atlantic Intracoastal Waterway, m. April 11, 2010; and the second standards. Therefore, we did not Albemarle and Chesapeake Canal, closure period scheduled to begin at 8 consider the use of voluntary consensus Chesapeake, VA a.m. on April 17, 2010, until and standards. including 6 p.m. on April 18, 2010. AGENCY: Coast Guard, DHS. Environment Openings will be provided during the ACTION: Notice of temporary deviation closure periods at the following times: We have analyzed this rule under from regulations. on Saturdays at 8 a.m., 10 a.m., noon, Department of Homeland Security 2 p.m., 4 p.m., 6 p.m., 8 p.m., and 10 Management Directive 023–01, and SUMMARY: The Commander, Fifth Coast p.m., and on Sundays at midnight, 2 Commandant Instruction M16475.lD, Guard District, has issued a temporary a.m., 4 a.m., 6 a.m., 8 a.m., 10 a.m., which guides the Coast Guard in deviation from the regulations noon, 2 p.m., 4 p.m., and 6 p.m. complying with the National governing the operation of the SR170 The Atlantic Intracoastal Waterway Environmental Policy Act of 1969 Centerville Turnpike Bridge across the caters to a variety of vessels from tug (NEPA) (42 U.S.C. 4321–4370f), and Atlantic Intracoastal Waterway, and barge traffic to recreational vessels have concluded that this action is one Albemarle and Chesapeake Canal, mile traveling from Florida to Maine. The of a category of actions which do not 15.7, at Chesapeake, VA. The deviation Coast Guard has carefully coordinated individually or cumulatively have a is necessary to facilitate structural the restrictions with commercial and significant effect on the human repairs to the swing span. This recreational waterway users. environment. This rule is categorically deviation allows the drawbridge to Additionally, the Coast Guard will excluded, under figure 2–1, paragraph remain in the closed to navigation inform unexpected users of the (32)(e), of the Instruction. position. waterway through our local and Under figure 2–1, paragraph (32)(e), of DATES: This deviation is effective from broadcast Notices to Mariners of the the Instruction, an environmental 8 a.m. on April 10, 2010 to 6 p.m. on closure periods for the bridge so that analysis checklist and a categorical April 18, 2010. vessels can arrange their transits to exclusion determination are not ADDRESSES: Documents mentioned in minimize any impacts caused by the required. this preamble as being available in the temporary deviation. The Atlantic docket USCG–2010–0185 and are Ocean is the alternate route for vessels List of Subjects in 33 CFR Part 117 available online by going to http:// and the bridge will be able to open in www.regulations.gov, inserting USCG– the event of an emergency. Bridges. 2010–0185 in the ‘‘Keyword’’ box, and In accordance with 33 CFR 117.35(e), ■ For the reasons discussed in the then clicking ‘‘Search’’. This material is the draw must return to its original preamble, the Coast Guard amends 33 also available for inspection or copying operating schedule immediately at the CFR part 117 as follows: the Docket Management Facility (M–30), end of the designated time period. This

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deviation from the operating regulations Docket Operations, telephone 202–366– Order. The Coast Guard has made this is authorized under 33 CFR 117.35. 9826. finding based on the fact that the rule Dated: March 17, 2010. SUPPLEMENTARY INFORMATION: will have no known impact on the maritime public. Waverly W. Gregory, Jr., Regulatory Information Chief, Bridge Administration Branch, Fifth Small Entities On November 16, 2009, we published Coast Guard District. a notice of proposed rulemaking [FR Doc. 2010–7244 Filed 3–30–10; 8:45 am] Under the Regulatory Flexibility Act (NPRM) entitled Drawbridge Operation (5 U.S.C. 601–612), we have considered BILLING CODE 9110–04–P Regulations; Port of Coos Bay Railroad whether this rule would have a Bridge, Coos Bay, North Bend, OR, in significant economic impact on a DEPARTMENT OF HOMELAND the Federal Register (74 FR 58931). No substantial number of small entities. SECURITY comments were received on the The term ‘‘small entities’’ comprises proposed rule. No public meeting was small businesses, not-for-profit Coast Guard requested and none was held. organizations that are independently Background and Purpose owned and operated and are not 33 CFR Part 117 dominant in their fields, and This rule will remove the governmental jurisdictions with [Docket No. USCG–2009–0840] requirements at the Port of Coos Bay populations of less than 50,000. RIN 1625–AA09 Railroad Bridge, Coos Bay, mile 9.0, at North Bend, Oregon for a bell to be rung The Coast Guard certifies under 5 Drawbridge Operation Regulation; Port continuously in foggy weather and that U.S.C. 605(b) that this rule would not of Coos Bay Railroad Bridge, Coos a siren be sounded in foggy weather have a significant economic impact on Bay, North Bend, OR when the swingspan is closed. The a substantial number of small entities movable span is normally kept in the because it will have no known impact AGENCY: Coast Guard, DHS. open position except for the passage of on any vessel traffic. ACTION: Final rule. trains or maintenance work. The rule Assistance for Small Entities will also change the regulation to reflect SUMMARY: The Coast Guard is changing the bridge’s current owner as the Port of Under section 213(a) of the Small the drawbridge operation regulation for Coos Bay. Business Regulatory Enforcement the Coos Bay Railroad Bridge, Coos Bay, The bell and siren at this drawbridge Fairness Act of 1996 (Pub. L. 104–121), mile 9.0, at North Bend, Oregon to are not standard requirements at in the NPRM we offered to assist small delete the requirement for special sound drawbridges and there is nothing entities in understanding the proposed signals used in foggy weather and to specific to this bridge that currently rule so that they can better evaluate its change the name of the owner. The warrants the continuance of these effects on them and participate in the change is necessary to make the sound signals. Vessel traffic through the rulemaking process. signals used at the bridge consistent swingspan includes tugs and tows and Collection of Information with other bridges in the area and to a variety of recreational craft. eliminate the unnecessary special sound Oceangoing ship traffic has diminished This rule would call for no new signals. greatly in recent decades. collection of information under the DATES: This rule is effective April 30, The operating regulations currently in Paperwork Reduction Act of 1995 (44 2010. effect for the bridge are found at 33 CFR U.S.C. 3501–3520.). 117.871. These state that the bridge be ADDRESSES: Comments and related Federalism materials received from the public, as maintained normally in the open well as documents mentioned in this position except for the passage of trains A rule has implications for federalism preamble as being available in this or maintenance. The aforementioned under Executive Order 13132, docket are part of docket USCG–2009– sound signals are also prescribed. Federalism, if it has a substantial direct 0840 and are available online by going Discussion of Comments and Changes effect on State or local governments and to http://www.regulations.gov, inserting would either preempt State law or No comments on the proposed rule USCG–2009–0840 in the ‘‘Keyword’’ impose a substantial direct cost of were received and no changes were box, and then clicking ‘‘Search’’. This compliance on them. We have analyzed made to it. material is also available for inspection this rule under that Order and have or copying at the Docket Management Regulatory Analyses determined that it does not have Facility (M–30), U.S. Department of We developed this proposed rule after implications for federalism. Transportation, West Building Ground considering numerous statutes and Unfunded Mandates Reform Act Floor, Room W12–140, 1200 New Jersey executive orders related to rulemaking. Avenue, SE., Washington, DC 20590– Below we summarize our analyses The Unfunded Mandates Reform Act 0001, between 9 a.m. and 5 p.m., based on 13 of these statutes or of 1995 (2 U.S.C. 1531–1538) requires Monday through Friday, except Federal executive orders. Federal agencies to assess the effects of holidays. their discretionary regulatory actions. In FOR FURTHER INFORMATION CONTACT: If Regulatory Planning and Review particular, the Act addresses actions you have questions on this rule, call or This rule is not a significant that may result in the expenditure by a email Austin Pratt, Chief, Bridge regulatory action under section 3(f) of State, local, or tribal government, in the Section, Waterways Management Executive Order 12866, Regulatory aggregate, or by the private sector of Branch, 13th Coast Guard; telephone Planning and Review, and does not $100,000,000 or more in any one year. 206–220–7282, e-mail require an assessment of potential costs Though this rule will not result in such [email protected]. If you have and benefits under section 6(a)(3) of that an expenditure, we do discuss the questions on viewing the docket, call Order. The Office of Management and effects of this rule elsewhere in this Renee V. Wright, Program Manager, Budget has not reviewed it under that preamble.

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Taking of Private Property technical standards (e.g., specifications DEPARTMENT OF HOMELAND This rule will not affect a taking of of materials, performance, design, or SECURITY private property or otherwise have operation; test methods; sampling taking implications under Executive procedures; and related management Coast Guard Order 12630, Governmental Actions and systems practices) that are developed or Interference with Constitutionally adopted by voluntary consensus 33 CFR Part 117 Protected Property Rights. standards bodies. [Docket No. USCG–2010–0152] This rule does not use technical Civil Justice Reform Drawbridge Operation Regulation; standards. Therefore, we did not This rule meets applicable standards Sacramento River, Sacramento, CA in sections 3(a) and 3(b)(2) of Executive consider the use of voluntary consensus Order 12988, Civil Justice Reform, to standards. AGENCY: Coast Guard, DHS. minimize litigation, eliminate Environment ACTION: Notice of temporary deviation ambiguity, and reduce burden. from regulations. We have analyzed this rule under Protection of Children SUMMARY: The Commander, Eleventh Department of Homeland Security Coast Guard District, has issued a We have analyzed this rule under Management Directive 023–01 and Executive Order 13045, Protection of temporary deviation from the regulation Commandant Instruction M16475.lD, governing the operation of the I Street Children from Environmental Health which guides the Coast Guard in Risks and Safety Risks. This rule is not Drawbridge across the Sacramento complying with the National River, mile 59.4, at Sacramento, CA. The an economically significant rule and Environmental Policy Act of 1969 would not create an environmental risk deviation is necessary to allow the (NEPA) (42 U.S.C. 4321–4370f), and to health or risk to safety that might bridge owner to make bridge repairs. have concluded that this action is one disproportionately affect children. DATES: This deviation is effective from of a category of actions which do not 8 a.m. to 6 p.m. on March 30, 2010. Indian Tribal Governments individually or cumulatively have a ADDRESSES: Documents mentioned in This rule does not have tribal significant effect on the human this preamble as being available in the implications under Executive Order environment. This rule is categorically docket are part of the docket USCG– 13175, Consultation and Coordination excluded, under figure 2–1, paragraph 2010–0152 and are available online by with Indian Tribal Governments, (32)(e), of the Instruction. going to http://www.regulations.gov, because it does not have a substantial Under figure 2–1, paragraph (32)(e), of inserting USCG–2010–0152 in the direct effect on one or more Indian the Instruction, an environmental ‘‘Keyword’’ box and then clicking tribes, on the relationship between the analysis checklist and a categorical ‘‘Search’’. They are also available for Federal Government and Indian tribes, exclusion determination are not inspection or copying at the Docket or on the distribution of power and required for this rule. Management Facility (M–30), U.S. responsibilities between the Federal Department of Transportation, West Government and Indian tribes. List of Subjects in 33 CFR Part 117 Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Energy Effects Bridges. Washington, DC 20590, between 9 a.m. We have analyzed this rule under ■ For the reasons discussed in the and 5 p.m., Monday through Friday, Executive Order 13211, Actions preamble, the Coast Guard amends 33 except Federal holidays. Concerning Regulations That CFR part 117 as follows: Significantly Affect Energy Supply, FOR FURTHER INFORMATION CONTACT: If Distribution, or Use. We have you have questions on this rule, call or PART 117—DRAWBRIDGE e-mail David H. Sulouff, Chief, Bridge determined that it is not a ‘‘significant OPERATION REGULATIONS energy action’’ under that order because Section, Eleventh Coast Guard District; it is not a ‘‘significant regulatory action’’ telephone 510–437–3516, e-mail ■ 1. The authority citation for part 117 [email protected] If you have under Executive Order 12866 and is not continues to read as follows: likely to have a significant adverse effect questions on viewing the docket, call on the supply, distribution, or use of Authority: 33 U.S.C. 499; 33 CFR 1.05–1; Renee V. Wright, Program Manager, energy. The Administrator of Department of Homeland Security Delegation Docket Operations, telephone 202–366– Information and Regulatory Affairs has No. 0170.1.2. 9826. not designated this as a significant SUPPLEMENTARY INFORMATION: Union ■ 2. Revise § 117.871 to read as follows: energy action. Therefore, it does not Pacific Railroad Company requested a require a Statement of Energy Effects § 117.871 Coos Bay. temporary change to the operation of the under Executive Order 13211. I Street Drawbridge, mile 59.4, over The draw of the Port of Coos Bay Sacramento River, at Sacramento, CA. Technical Standards railroad bridge, mile 9.0 at North Bend, The I Street Drawbridge navigation span The National Technology Transfer shall be maintained in the fully open provides 109 feet vertical clearance and Advancement Act (NTTAA) (15 position, except for the crossing of above Mean High Water in the full U.S.C. 272 note) directs agencies to use trains or maintenance. open-to-navigation position, and 30 feet voluntary consensus standards in their Dated: March 11, 2010. vertical clearance above Mean High regulatory activities unless the agency Water when closed. The draw opens on provides Congress, through the Office of G.T. Blore, signal from May 1 through October 31 Management and Budget, with an Rear Admiral, U.S. Coast Guard, Commander, from 6 a.m. to 10 p.m. and from explanation of why using these Thirteenth Coast Guard District. November 1 through April 30 from 9 standards would be inconsistent with [FR Doc. 2010–7159 Filed 3–30–10; 8:45 am] a.m. to 5 p.m. At all other times the applicable law or otherwise impractical. BILLING CODE 9110–04–P draw shall open on signal if at least four Voluntary consensus standards are hours notice is given, as required by 33

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CFR 117.189(a). Navigation on the ADDRESSES: Comments and related comments. The test deviation allowed waterway is commercial and materials received from the public, as the bridges to operate as follows: The recreational. well as documents mentioned in this draw of the LA 75 bridge, mile 38.4 The drawspan will be secured in the preamble as being available in the (Alternate Route) at Bayou Sorrel and closed-to-navigation position from 8 docket, are part of docket USCG–2009– the draw of the LA 77 bridge, mile 47.0 a.m. to 6 p.m. on March 30, 2010, to 0686 and are available online by going (Alternate Route) at Grosse Tete, shall allow the bridge owner to remove and to http://www.regulations.gov, inserting open on signal; except that, from about replace the oil in the operating USCG–2009–0686 in the ‘‘Keyword’’ August 15 to about June 5 (the school machinery for the drawspan. This box, and then clicking ‘‘Search.’’ This year), the draw of the LA 75 bridge need temporary deviation has been material is also available for inspection not be opened from 6 a.m. to 8 a.m. and coordinated with waterway users. There or copying at the Docket Management from 3 p.m. to 5 p.m. and the draw of are no scheduled river boat cruises or Facility (M–30), U.S. Department of the LA 77 bridge need not be opened anticipated levee maintenance during Transportation, West Building Ground from 6 a.m. to 8:30 a.m. and from 2:30 this deviation period. No objections to Floor, Room W12–140, 1200 New Jersey p.m. to 5 p.m., Monday through Friday the proposed temporary deviation were Avenue, SE., Washington, DC 20590, except Federal holidays. The draws raised. The drawspan can be opened between 9 a.m. and 5 p.m., Monday shall open on signal at any time for an with 2 hours advance notice for through Friday, except Federal holidays. emergency aboard the vessel. The test emergencies requiring the passage of SUPPLEMENTARY INFORMATION: period was in effect from November 25, 2009 until December 28, 2009. waterway traffic. Regulatory Information Vessels that can transit the bridge, One comment was received on while in the closed-to-navigation On November 10, 2009, we published November 11, 2009, before the test position, may continue to do so at any a notice of proposed rulemaking deviation went into effect, from a time. (NPRM) entitled Drawbridge Operation mariner expressing concern about the In accordance with 33 CFR 117.35(e), Regulations; Lower Grand River, curfew changes. He is concerned the drawbridge must return to its regular Iberville Parish, LA in the Federal because he believes there is already a operating schedule immediately at the Register (74 FR 57884). We received one congestion problem on the waterway end of the designated time period. This comment on the proposed rule. No during the closure periods and the deviation from the operating regulations public meeting was requested, and none additional 30 minutes would make the is authorized under 33 CFR 117.35. was held. congestion worse. We did not receive any comments during or after the test Background and Purpose Dated: March 15, 2010. deviation. S.P. Metruck, The Iberville Parish School Board The Coast Guard has reviewed bridge Captain, U.S. Coast Guard, Acting requested a change in the operation tender logs from before, during, and Commander, Eleventh Coast Guard District. regulation for the LA 75 pontoon and after the test deviation became effective. [FR Doc. 2010–7249 Filed 3–30–10; 8:45 am] the LA 77 swing bridge across the Lower The logs do not indicate an appreciable BILLING CODE 4910–15–P Grand River, mile 38.4 and 47.0, difference in the number of openings respectively, in Iberville Parish, with the additional 30 minute closure Louisiana. The change would add an period. The Coast Guard also reviewed DEPARTMENT OF HOMELAND additional 30 minutes to the end of each the school buses crossing the bridges SECURITY scheduled closure period to provide during the test deviation. The report more time for school buses to transit indicated that the only time extension Coast Guard across the bridge. Extra time is now needed for the school buses is the needed because one of Iberville Parish’s morning closure for LA 75 pontoon 33 CFR Part 117 high schools has been closed. School bridge at Bayou Sorrel. Based on the bus lines have been rerouted, creating [Docket No. USCG–2009–0686] research and data that was reviewed and the need to have more time to transit the the comment that was received, the RIN 1625–AA09 students over the bridges. Coast Guard has determined that the Presently, 33 CFR 117.478(a) and (b) permanent change to the operating Drawbridge Operation Regulation; states: The draw of the LA 75 bridge, regulation for the Bayou Sorrel, LA 75 Lower Grand River, Iberville Parish, LA mile 38.4 (Alternate Route) at Bayou pontoon bridge morning closure period Sorrel and the draw of the LA 77 bridge, is warranted. The LA 75 pontoon bridge AGENCY: Coast Guard, DHS. mile 47.0 (Alternate Route) at Grosse at Bayou Sorrel afternoon bridge closure ACTION: Final rule. Tete, shall open on signal; except that, and the LA 77 swing bridge at Grosse from about August 15 to about June 5 SUMMARY: The Coast Guard is changing Tete morning and afternoon closures (the school year), the draw of the LA 75 the regulation governing the operation will remain as they are presently bridge need not be opened from 6 a.m. of the LA 75 pontoon bridge, mile 38.4, regulated. to 7:30 a.m. and from 3 p.m. to 4:30 p.m. in Iberville Parish, Louisiana. The and the draw of the LA 77 bridge need Discussion of Comments and Changes Iberville Parish School Board requested not be opened from 6 a.m. to 8 a.m. and The Coast Guard received one that the operating regulation of the LA from 2:30 p.m. to 4:30 p.m., Monday comment from a mariner on November 75 pontoon bridge be changed to add an through Friday except Federal holidays. 11, 2009. Although he recognizes the additional 30 minutes to the end of the The draws shall open on signal at any importance of getting children to school morning scheduled closure period to time for an emergency aboard the vessel. at the proper times, he is worried about provide more time for school buses to Concurrent with the publication of the increase in the duration of time that transit across the bridge. The additional the notice of proposed rulemaking, a the bridges would be closed because it time is needed as a result of school test deviation [USCG–2009–0686] was would add to a current congestion issue redistricting. issued to allow the Iberville Parish during those periods of closure. The DATES: This rule is effective April 30, School Board to test the proposed Coast Guard has analyzed the data and 2010. schedule and to obtain data and public research on the impact of the time

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adjustment on vessel traffic and has entities: The owners or operators of Protection of Children concluded that there is not a significant vessels that would be transiting the We have analyzed this rule under impact. Furthermore, the Coast Guard bridge during that 30 minute increment Executive Order 13045, Protection of has analyzed the data and research on of time. Because the amount of time that Children from Environmental Health the impact the time adjustment has would be added to the current bridge Risks and Safety Risks. This rule is not made on school bus traffic and has closure period is minimal, this rule will an economically significant rule and concluded that the only bridge closure not affect a substantial number of small would not create an environmental risk in need of the time adjustment is the entities and therefore will not have a to health or risk to safety that might morning closure at the LA 75 pontoon substantial economic impact. disproportionately affect children. bridge at Bayou Sorrel. Therefore, this is Assistance for Small Entities the only closure that will be Indian Tribal Governments permanently changed in the regulatory Under section 213(a) of the Small This rule does not have tribal text. Business Regulatory Enforcement implications under Executive Order 13175, Consultation and Coordination Regulatory Analyses Fairness Act of 1996 (Pub. L. 104–121), in the NPRM (SNPRM) we offered to with Indian Tribal Governments, We developed this rule after assist small entities in understanding because it does not have a substantial considering numerous statutes and the rule so that they could better direct effect on one or more Indian executive orders related to rulemaking. evaluate its effects on them and tribes, on the relationship between the Below we summarize our analyses participate in the rulemaking process. Federal Government and Indian tribes, based on 13 of these statutes or or on the distribution of power and executive orders. Collection of Information responsibilities between the Federal Government and Indian tribes. Regulatory Planning and Review This rule calls for no new collection This rule is not a significant of information under the Paperwork Energy Effects regulatory action under section 3(f) of Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under Executive Order 12866, Regulatory 3520). Executive Order 13211, Actions Planning and Review, and does not Federalism Concerning Regulations That require an assessment of potential costs Significantly Affect Energy Supply, and benefits under section 6(a)(3) of that A rule has implications for federalism Distribution, or Use. We have Order. The Office of Management and under Executive Order 13132, determined that it is not a ‘‘significant Budget has not reviewed it under that Federalism, if it has a substantial direct energy action’’ under that order because Order. effect on State or local governments and it is not a ‘‘significant regulatory action’’ We expect the economic impact of would either preempt State law or under Executive Order 12866 and is not this rule to be so minimal that a full impose a substantial direct cost of likely to have a significant adverse effect Regulatory Evaluation is unnecessary. compliance on them. We have analyzed on the supply, distribution, or use of The changes have a minimal impact on this rule under that Order and have energy. The Administrator of the Office maritime traffic transiting the bridge. determined that it does not have of Information and Regulatory Affairs Mariners can plan their trips in implications for federalism. has not designated it as a significant accordance with the scheduled bridge Unfunded Mandates Reform Act energy action. Therefore, it does not openings. The changes to the regulatory require a Statement of Energy Effects text published in the NPRM will be less The Unfunded Mandates Reform Act under Executive Order 13211. restrictive than what was published. of 1995 (2 U.S.C. 1531–1538) requires Technical Standards The afternoon closure at the LA 75 Federal agencies to assess the effects of pontoon bridge at Bayou Sorrel and both their discretionary regulatory actions. In The National Technology Transfer the morning and afternoon closures at particular, the Act addresses actions and Advancement Act (NTTAA) (15 the LA 77 swing bridge at Grosse Tete that may result in the expenditure by a U.S.C. 272 note) directs agencies to use will remain unchanged to what is State, local, or tribal government, in the voluntary consensus standards in their currently published in the operating aggregate, or by the private sector of regulatory activities unless the agency regulations. $100,000,000 (adjusted for inflation) or provides Congress, through the Office of Management and Budget, with an Small Entities more in any one year. Though this rule will not result in such an expenditure, explanation of why using these Under the Regulatory Flexibility Act we do discuss the effects of this rule standards would be inconsistent with (5 U.S.C. 601–612), we have considered elsewhere in this preamble. applicable law or otherwise impractical. whether this rule would have a Voluntary consensus standards are significant economic impact on a Taking of Private Property technical standards (e.g., specifications substantial number of small entities. of materials, performance, design, or This rule will not affect a taking of The term ‘‘small entities’’ comprises operation; test methods; sampling private property or otherwise have small businesses, not-for-profit procedures; and related management taking implications under Executive organizations that are independently systems practices) that are developed or Order 12630, Governmental Actions and owned and operated and are not adopted by voluntary consensus Interference with Constitutionally dominant in their fields, and standards bodies. governmental jurisdictions with Protected Property Rights. This rule does not use technical populations of less than 50,000. Civil Justice Reform standards. Therefore, we did not The Coast Guard certifies under 5 consider the use of voluntary consensus U.S.C. 605(b) that this rule will not have This rule meets applicable standards standards. a significant economic impact on a in sections 3(a) and 3(b)(2) of Executive substantial number of small entities. Order 12988, Civil Justice Reform, to Environment This rule will affect the following minimize litigation, eliminate We have analyzed this rule under entities, some of which might be small ambiguity, and reduce burden. Department of Homeland Security

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Management Directive 023–01 and ACTION: Notice of temporary deviation in the closed position between 10 a.m. Commandant Instruction M16475.lD, from regulations. and 12 p.m. on May 30, 2010. The 10 which guides the Coast Guard in a.m. and 11:15 a.m. openings will be complying with the National SUMMARY: The Commander, First Coast missed as a result of this temporary Environmental Policy Act of 1969 Guard District, has issued a temporary deviation. Vessels able to pass under the (NEPA) (42 U.S.C. 4321–4370f), and deviation from the regulation governing closed draw may do so at any time. have concluded that this action is one the operation of the Route 6 New In accordance with 33 CFR 117.35(e), of a category of actions which do not Bedford Fairhaven Bridge across the the bridge must return to its regular individually or cumulatively have a Acushnet River, mile 0.0, between New operating schedule immediately at the significant effect on the human Bedford and Fairhaven, Massachusetts. end of the designated time period. This environment. This rule is categorically This temporary deviation is necessary to deviation from the operating regulations excluded, under figure 2–1, paragraph facilitate a public event, the Greater is authorized under 33 CFR 117.35. New Bedford Community Health Center (32)(e), of the Instruction. Dated: March 16, 2010. Under figure 2–1, paragraph (32)(e), of 5K Road Race, by allowing the bridge to the Instruction, an environmental remain in the closed position for two Gary Kassof, analysis checklist and a categorical hours during the running of the 5K Road Bridge Program Manager, First Coast Guard exclusion determination are not Race. District. required for this rule. DATES: This deviation is effective from [FR Doc. 2010–7246 Filed 3–30–10; 8:45 am] BILLING CODE 9110–04–P List of Subjects in 33 CFR Part 117 10 a.m. through 12 p.m. on May 30, 2010. Bridges. ADDRESSES: Documents mentioned in ■ For the reasons discussed in the DEPARTMENT OF HOMELAND this preamble as being available in the SECURITY preamble, the Coast Guard amends 33 docket are part of docket USCG–2010– CFR part 117 as follows: 0167 and are available online at http:// Coast Guard PART 117—DRAWBRIDGE www.regulations.gov, inserting USCG– OPERATION REGULATIONS 2009–0001 in the ‘‘Keyword’’ and then 33 CFR Part 117 clicking ‘‘Search’’. They are also [USCG–2010–0029] ■ 1. The authority citation for part 117 available for inspection or copying at continues to read as follows: the Docket Management Facility (M–30), Drawbridge Operation Regulations; Authority: 33 U.S.C. 499; 33 CFR 1.05–1; U.S. Department of Transportation, Hackensack River, Jersey City, NJ, Department of Homeland Security Delegation West Building Ground Floor, Room Maintenance No. 0170.1. W12–140, 1200 New Jersey Avenue, SE., AGENCY: Coast Guard, DHS. ■ 2. In § 117.478 paragraph (a) is revised Washington, DC 20590, between 9 a.m. ACTION: to read as follows: and 5 p.m., Monday through Friday, Notice of temporary deviation except Federal holidays. from regulations. § 117.478 Lower Grand River. FOR FURTHER INFORMATION CONTACT: If SUMMARY: The Commander, First Coast (a) The draw of the LA 75 bridge, mile you have questions on this rule, call or Guard District, has issued a temporary 38.4 (Alternate Route) at Bayou Sorrel, e-mail Mr. John McDonald, Project deviation from the regulation governing shall open on signal; except that from Officer, First Coast Guard District, the operation of the Route 1 & 9 about August 15 to about June 5 (the telephone (617) 223–8364, (Lincoln Highway) Bridge, mile 1.8, school year), the draw need not be [email protected]. If you have across the Hackensack River at Jersey opened from 6 a.m. to 8 a.m. and from questions on viewing the docket, call City, New Jersey. This deviation allows 3 p.m. to 4:30 p.m., Monday through Renee V. Wright, Program Manager, the bridge owner to require a two hour Friday except holidays. The draw shall Docket Operations, telephone 202–366– advance notice for bridge openings open on signal at any time for an 9826. April through September and several emergency aboard a vessel. SUPPLEMENTARY INFORMATION: bridge closures to facilitate bridge * * * * * The Route 6 New Bedford Fairhaven painting operations. Vessels that can Dated: March 15, 2010. Bridge, across the Acushnet River at pass under the draw without a bridge Mary E. Landry, mile 0.0, between New Bedford and opening may do so at all times. Fairhaven, Massachusetts, has a vertical Rear Admiral, U.S. Coast Guard, Commander, DATES: This deviation is effective from clearance in the closed position of 6 feet Eighth Coast Guard District. April 1, 2010 through September 15, at mean high water and 10 feet at mean [FR Doc. 2010–7167 Filed 3–30–10; 8:45 am] 2010. low water. The Drawbridge Operation BILLING CODE 9110–04–P Regulations are listed at 33 CFR ADDRESSES: Documents indicated in this 117.585. The bridge opens on the hour preamble as being available in the docket are part of docket USCG–2010– DEPARTMENT OF HOMELAND from 6 a.m. through 10 a.m. and at a 0029 and are available online at SECURITY quarter past the hour between 11:15 a.m. and 6:15 p.m. The bridge opens on http://www.regulations.gov. They are Coast Guard signal at all other times. also available for inspection or copying The owner of the bridge, at the Docket Management Facility (M– 33 CFR Part 117 Massachusetts Department of 30), U.S. Department of Transportation, Transportation, requested this West Building Ground Floor, Room [Docket No. USCG–2010–0167] temporary deviation to facilitate a W12–140, 1200 New Jersey Avenue, SE., Drawbridge Operation Regulations; public event, the Greater New Bedford Washington, DC 20590, between 9 a.m. Acushnet River, New Bedford and Community Health Center 5K Road and 5 p.m., Monday through Friday, Fairhaven, MA, Event—Road Race Race. except Federal holidays, and the First Under this deviation, the Route 6 New Coast Guard District, Bridge Branch AGENCY: Coast Guard, DHS. Bedford Fairhaven Bridge may remain Office, 408 Atlantic Avenue, Boston,

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Massachusetts 02110, between 7 a.m. Dated: March 16, 2010. Docket Operations, telephone 202–366– and 3 p.m., Monday through Friday, Gary Kassof, 9826. except Federal holidays. Bridge Program Manager, First Coast Guard SUPPLEMENTARY INFORMATION: District. FOR FURTHER INFORMATION CONTACT: If Regulatory Information you have questions on this rule call Joe [FR Doc. 2010–7238 Filed 3–30–10; 8:45 am] Arca, Project Officer, First Coast Guard BILLING CODE 9110–04–P The Coast Guard is issuing this District, at (212) 668–7165. If you have temporary final rule without prior questions on viewing the docket, call notice and opportunity to comment Renee V. Wright, Program Manager, DEPARTMENT OF HOMELAND pursuant to authority under section 4(a) Docket Operations, telephone 202–366– SECURITY of the Administrative Procedure Act 9826. (APA) (5 U.S.C. 553(b)). This provision Coast Guard authorizes an agency to issue a rule SUPPLEMENTARY INFORMATION: The Route without prior notice and opportunity to 1 & 9 (Lincoln Highway) Bridge across 33 CFR Part 165 comment when the agency for good the Hackensack River at mile 1.8, at cause finds that those procedures are Jersey City, New Jersey, has a vertical [Docket No. USCG–2010–0198] ‘‘impracticable, unnecessary, or contrary clearance in the closed position of 35 ’’ RIN 1625–AAOO to the public interest. Under 5 U.S.C. feet at mean high water and 40 feet at 553(b)(B), the Coast Guard finds that mean low water. The bridge opens on Safety Zone; Red River, MN good cause exists for not publishing a signal as required by 33 CFR notice of proposed rulemaking (NPRM) 117.723(a)(5). AGENCY: Coast Guard, DHS. with respect to this rule because The bridge owner, the New Jersey ACTION: Temporary final rule. immediate action is necessary to Department of Transportation, requested provide for the safety of life and a temporary deviation to require at least SUMMARY: The Coast Guard Captain of property on navigable waters. a two hour advance notice for bridge the Port (COTP), Marine Safety Unit Under 5 U.S.C. 553(d)(3), the Coast openings to allow workers sufficient Duluth, MN is establishing a temporary Guard finds that good cause exists for time to clear painting equipment from safety zone on the waters of the Red making this rule effective less than 30 the lift span in order to provide bridge River, MN. This safety zone is being days after publication in the Federal openings. established to ensure the safety of the Register. Good cause for making this In addition, several bridge closures public. The safety zone will prevent rule effective less than 30 days after will be necessary during the effective individuals from entering all navigable publication exists because delaying the time period for this temporary deviation waters of the Red River in the State of effective date would be contrary to in order to facilitate various phases of Minnesota north of a line drawn across public interest because of the dangers this bridge painting project that must be latitude 46°20′00″ N, including those associated with emergency flooding completed with the bridge closed. portions of the river in Wilkin, Clay, conditions on the Red River. Norman, Polk, Marshall and Kittson The exact times and dates for the Background and Purpose bridge closures could not be determined counties, to the United States-Canada prior to publication of this temporary international border. Flooding conditions along the Red deviation. They will be announced in DATES: Effective Date: This rule is River have created serious dangers to the Local Notice to Mariners two weeks effective in the CFR from March 31, the boating public. The strong currents prior to their implementation. A 2010 until 5 p.m. on April 24, 2010. and floating debris associated with the broadcast notice to mariners will also be This rule is effective with actual notice flooding of the Red River necessitate the initiated twenty four hours in advance for purposes of enforcement beginning Coast Guard limiting access to the to further inform mariners of the 12 p.m. March 19, 2010. portions of the river affected by this rule in order to protect the public. proposed bridge closures. ADDRESSES: Documents indicated in this This temporary safety zone is Under this deviation the Route 1 & 9 preamble as being available in the necessary to ensure the safety of the (Lincoln Highway) Bridge shall require docket are part of docket USCG–2010– public from hazards involved with the at least a two hour advance notice for 0198 and are available online by going flooding of the Red River. Restricted bridge openings from April 1, 2010 to http://www.regulations.gov, inserting access to the Red River by the public through September 15, 2010. In USCG–2010–0198 in the ‘‘Keyword’’ will help ensure the safety of persons addition, several bridge closures to be box, and then clicking ‘‘Search.’’ They and property along the Red River. announced as stated above, will occur are also available for inspection or during the effective period of this copying at the Docket Management Discussion of Rule temporary deviation from April 1, 2010 Facility (M–30), U.S. Department of The Coast Guard is establishing a and September 15, 2010. Transportation, West Building Ground temporary safety zone to encompass Vessels able to pass under the closed Floor, Room W12–140, 1200 New Jersey certain waters of the Red River in the draw may do so at all times. Avenue, SE., Washington, DC 20590, Duluth Captain of the Port (COTP) Zone. The waterway is primarily used by between 9 a.m. and 5 p.m., Monday The safety zone will prevent individuals deep draft tankers, tugs and barge units. through Friday, except Federal holidays. from entering all navigable waters of the Waterway users were advised of the FOR FURTHER INFORMATION CONTACT: If Red River in the State of Minnesota requested bridge closure period and you have questions on this temporary north of a line drawn across latitude offered no objection. rule, call or e-mail Aaron L. Gross, Chief 46°20′00″ N, including those portions of In accordance with 33 CFR 117.35(e), of Port Operations, Marine Safety Unit the river in Wilkin, Clay, Norman, Polk, the bridge must return to its regular Duluth, Coast Guard; telephone 218– Marshall and Kittson counties, to the operating schedule immediately at the 720–5286 ext 111, e-mail United States-Canada international end of the designated time period. This [email protected]. If you have border. deviation from the operating regulations questions on viewing the docket, call The COTP may stop enforcement of is authorized under 33 CFR 117.35. Renee V. Wright, Program Manager, this safety zone before 5 p.m. on April

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24, 2010 if river conditions change such the Small Business and Agriculture does not create an environmental risk to that enforcement of the safety zone is no Regulatory Enforcement Ombudsman health or risk to safety that may longer necessary for the public’s safety. and the Regional Small Business disproportionately affect children. COTP will notify the public via a Regulatory Fairness Boards. The Indian Tribal Governments Broadcast Notice to Mariners. Ombudsman evaluates these actions annually and rates each agency’s This rule does not have tribal Regulatory Analyses responsiveness to small business. If you implications under Executive Order We developed this rule after wish to comment on actions by 13175, Consultation and Coordination considering numerous statutes and employees of the Coast Guard, call with Indian Tribal Governments, executive orders related to rulemaking. 1–888–REG–FAIR (1–888–734–3247). because it does not have a substantial Below we summarize our analyses The Coast Guard will not retaliate direct effect on one or more Indian based on 13 of these statutes or against small entities that question or tribes, on the relationship between the executive orders. complain about this rule or any policy Federal Government and Indian tribes, or on the distribution of power and Regulatory Planning and Review or action of the Coast Guard. responsibilities between the Federal This rule is not a significant Collection of Information Government and Indian tribes. regulatory action under section 3(f) of This rule calls for no new collection Energy Effects Executive Order 12866, Regulatory of information under the Paperwork Planning and Review, and does not Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under require an assessment of potential costs 3520). Executive Order 13211, Actions and benefits under section 6(a)(3) of that Concerning Regulations That Order. The Office of Management and Federalism Significantly Affect Energy Supply, Budget has not reviewed it under that A rule has implications for federalism Distribution, or Use. We have Order. under Executive Order 13132, determined that it is not a ‘‘significant Federalism, if it has a substantial direct energy action’’ under that order because Small Entities effect on State or local governments and it is not a ‘‘significant regulatory action’’ Under the Regulatory Flexibility Act would either preempt State law or under Executive Order 12866 and is not (5 U.S.C. 601–612), we have considered impose a substantial direct cost of likely to have a significant adverse effect whether this rule would have a compliance on them. We have analyzed on the supply, distribution, or use of significant economic impact on a this rule under that Order and have energy. The Administrator of the Office substantial number of small entities. determined that it does not have of Information and Regulatory Affairs The term ‘‘small entities’’ comprises implications for federalism. has not designated it as a significant small businesses, not-for-profit energy action. Therefore, it does not organizations that are independently Unfunded Mandates Reform Act require a Statement of Energy Effects owned and operated and are not The Unfunded Mandates Reform Act under Executive Order 13211. dominant in their fields, and of 1995 (2 U.S.C. 1531–1538) requires Technical Standards governmental jurisdictions with Federal agencies to assess the effects of populations of less than 50,000. their discretionary regulatory actions. In The National Technology Transfer The Coast Guard certifies under 5 particular, the Act addresses actions and Advancement Act (NTTAA) (15 U.S.C. 605(b) that this rule will not have that may result in the expenditure by a U.S.C. 272 note) directs agencies to use a significant economic impact on a State, local, or tribal government, in the voluntary consensus standards in their substantial number of small entities. aggregate, or by the private sector of regulatory activities unless the agency This rule will affect the following $100,000,000 (adjusted for inflation) or provides Congress, through the Office of entities, some of which may be small more in any one year. Though this rule Management and Budget, with an entities: The owners or operators of will not result in such an expenditure, explanation of why using these vessels intending to transit or anchor in we do discuss the effects of this rule standards would be inconsistent with the portions of the Red River affected by elsewhere in this preamble. applicable law or otherwise impractical. this safety zone. Voluntary consensus standards are This safety zone will not have a Taking of Private Property technical standards (e.g., specifications significant economic impact on a This rule will not cause a taking of of materials, performance, design, or substantial number of small entities for private property or otherwise have operation; test methods; sampling the following reasons: Few small taking implications under Executive procedures; and related management business entities operate on the affected Order 12630, Governmental Actions and systems practices) that are developed or portion of the river and this rule will be Interference with Constitutionally adopted by voluntary consensus enforced for a limited time, only until Protected Property Rights. standards bodies. the Red River is deemed safe to transit. This rule does not use technical Civil Justice Reform standards. Therefore, we did not Assistance for Small Entities This rule meets applicable standards consider the use of voluntary consensus Under section 213(a) of the Small in sections 3(a) and 3(b)(2) of Executive standards. Business Regulatory Enforcement Order 12988, Civil Justice Reform, to Environment Fairness Act of 1996 (Pub. L. 104–121), minimize litigation, eliminate we offer to assist small entities in ambiguity, and reduce burden. We have analyzed this rule under understanding the rule so that they can Department of Homeland Security better evaluate its effects on them and Protection of Children Management Directive 023–01 and participate in the rulemaking process. We have analyzed this rule under Commandant Instruction M16475.lD, Small businesses may send comments Executive Order 13045, Protection of which guide the Coast Guard in on the actions of Federal employees Children from Environmental Health complying with the National who enforce, or otherwise determine Risks and Safety Risks. This rule is not Environmental Policy Act of 1969 compliance with, Federal regulations to an economically significant rule and (NEPA) (42 U.S.C. 4321–4370f), and

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have concluded this action is one of a (3) The ‘‘on-scene representative’’ of March 31, 2010. This action puts in category of actions that do not the Captain of the Port is any Coast place an additional stay for 18 months, individually or cumulatively have a Guard commissioned, warrant or petty which we believe will allow for significant effect on the human officer who has been designated by the sufficient time for EPA to propose, take environment. This rule is categorically Captain of the Port to act on his behalf. public comment on, and issue a final excluded, under figure 2–1, paragraph The on-scene representative of the action concerning the inclusion of (34)(g), of the Instruction. This rule Captain of the Port will be aboard either fugitive emissions in the federal PSD involves the establishment of a a Coast Guard or Coast Guard Auxiliary program. temporary safety zone to protect the vessel. The Captain of the Port or his DATES: The amendments to 40 CFR parts public from dangerous water conditions. designated on-scene representative may 51 and 52 in this rule are effective from An environmental analysis checklist be contacted via VHF Channel 16. April 1, 2010 through October 3, 2011. and a categorical exclusion (4) Vessel operators desiring to enter Effective April 1, 2010, the following determination are available in the or operate within the safety zone shall Code of Federal Regulations sections are docket where indicated under contact the Captain of the Port Duluth administratively stayed until October 3, ADDRESSES. or his on-scene representative to obtain 2011: 40 CFR 51.165(a)(1)(v)(G), permission to do so. Vessel operators List of Subjects in 33 CFR Part 165 (a)(1)(vi)(C)(3), (a)(1)(ix), given permission to enter or operate in (a)(1)(xxviii)(B)(2), (a)(1)(xxviii)(B)(4), Harbors, Marine safety, Navigation the safety zone must comply with all (a)(1)(xxxv)(A)(1), (a)(1)(xxxv)(B)(1), (water), Reporting and recordkeeping directions given to them by the Captain (a)(1)(xxxv)(C), (a)(1)(xxxv)(D), requirements, Security measures, of the Port Duluth or his on-scene (a)(2)(ii)(B), (a)(6)(iii), (a)(6)(iv), and Waterways. representative. (f)(4)(i)(D); 40 CFR 51.166, (a)(7)(iv)(b), ■ For the reasons discussed in the March 19, 2010. (b)(2)(v), (b)(3)(iii)(c), (b)(3)(iii)(d), preamble, the Coast Guard amends 33 M.P. Lebsack, (b)(20), (b)(40)(ii)(b), (b)(40)(ii)(d), CFR part 165 as follows: Commander, U.S. Coast Guard, Captain of (b)(47)(i)(a), (b)(47)(ii)(a), (b)(47)(iii), PART 165—REGULATED NAVIGATION the Port Duluth. (b)(47)(iv), (r)(6)(iii) and (r)(6)(iv), and AREAS AND LIMITED ACCESS AREAS [FR Doc. 2010–7158 Filed 3–30–10; 8:45 am] (w)(4)(i)(d); 40 CFR part 51, Appendix BILLING CODE 9110–04–P S, paragraphs II.A.5(vii), II.A.6(iii), ■ 1. The authority citation for part 165 II.A.9, II.A.24(ii)(b), II.A.24(ii)(d), continues to read as follows: II.A.30(i)(a), II.A.30(ii)(a), II.A.30(iii), Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. ENVIRONMENTAL PROTECTION II.A.30(iv), IV.I.1(ii), IV.J.3, IV.J.4, and Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; AGENCY IV.K.4(i)(d); and 40 CFR 52.21, 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; (a)(2)(iv)(b), (b)(2)(v), (b)(3)(iii)(b), Pub. L. 107–295, 116 Stat. 2064; Department 40 CFR Parts 51 and 52 (b)(3)(iii)(c), (b)(20), (b)(41)(ii)(b), of Homeland Security Delegation No. 0170.1. [EPA–HQ–OAR–2004–0014: FRL–9131–9; (b)(41)(ii)(d), (b)(48)(i)(a), (b)(48)(ii)(a), ■ 2. Add § 165.T09–0198 to read as 2060–AP73] (b)(48)(iii), (b)(48)(iv), (r)(6)(iii), follows: (r)(6)(iv), and (aa)(4)(i)(d). Prevention of Significant Deterioration § 165.T09–0198 Safety zone; Red River, ADDRESSES: Docket: All documents in MN. (PSD) and Nonattainment New Source the docket are listed in the http:// Review (NSR): Inclusion of Fugitive www.regulations.gov index. Although (a) Location. The following area is a Emissions; Final Rule; Stay temporary safety zone: All navigable listed in the index, some information is waters of the Red River in the State of AGENCY: Environmental Protection not publicly available, e.g., confidential Minnesota north of a line drawn across Agency (EPA). business information or other ° ′ ″ information whose disclosure is latitude 46 20 00 N, including those ACTION: Final rule. portions of the river in Wilkin, Clay, restricted by statute. Certain other Norman, Polk, Marshall and Kittson SUMMARY: In this final action, EPA is material, such as copyrighted material, counties, to the United States-Canada issuing a stay for 18 months of the is not placed on the Internet and will be international border. inclusion of fugitive emissions publicly available only in hard copy (b) Enforcement period. This rule is requirements in the federal Prevention form. Publicly available docket effective from 12 p.m. on March 19, of Significant Deterioration (PSD) materials are available either 2010 until 5 p.m. on April 24, 2010. If program published in the Federal electronically through http:// the river conditions change such that Register on December 19, 2008, in the www.regulations.gov or in hard copy at enforcement of the safety zone is final rule entitled, ‘‘Prevention of the EPA Docket Center, Public Reading unnecessary prior to 5 p.m. on April 24, Significant Deterioration (PSD) and Room, EPA West, Room 3334, 1301 2010, the COTP will notify the public Nonattainment New Source Review Constitution Ave., NW., Washington, via a Broadcast Notice to Mariners. (NSR): Reconsideration of Fugitive DC 20460. The Public Reading Room is (c) Regulations. (1) In accordance with Emissions’’ (‘‘Fugitive Emissions Rule’’). open from 8:30 a.m. to 4:30 p.m., the general regulations in section 165.23 The Fugitive Emissions Rule under the Monday through Friday, excluding legal of this part, entry into, transiting, or federal PSD program requires that holidays. The telephone number for the anchoring within this safety zone is fugitive emissions be included in Public Reading Room is (202) 566–1742, prohibited unless authorized by the determining whether a physical or and the telephone number for the Air Captain of the Port Duluth, or his operational change results in a major Docket is (202) 566–1744. designated on-scene representative. modification only for sources in FOR FURTHER INFORMATION CONTACT: Ms. (2) This safety zone is closed to all industries that have been designated Carrie Wheeler, Air Quality Policy vessel traffic, except as may be through rulemaking under section 302(j) Division, (C504–03), U.S. permitted by the Captain of the Port of the Clean Air Act (Act or CAA). The Environmental Protection Agency, Duluth or his designated on-scene existing stay is in effect for 3 months; Research Triangle Park, NC 27711; representative. that is, from December 31, 2009 until telephone number (919) 541–9771; fax

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number (919) 541–5509; or e-mail I. General Information groups. The majority of sources address: [email protected]. potentially affected are expected to be in A. Does this action apply to me? the following groups. SUPPLEMENTARY INFORMATION: Entities potentially affected by this action include sources in all industry

Industry group SIC a NAICS b

Electric Services ...... 491 ...... 221111, 221112, 221113, 221119, 221121, 221122. Petroleum Refining ...... 291 ...... 324110. Industrial Inorganic Chemicals ...... 281 ...... 325181, 325120, 325131, 325182, 211112, 325998, 331311, 325188. Industrial Organic Chemicals ...... 286 ...... 325110, 325132, 325192, 325188, 325193, 325120, 325199. Miscellaneous Chemical Products ...... 289 ...... 325520, 325920, 325910, 325182, 325510. Natural Gas Liquids ...... 132 ...... 211112. Natural Gas Transport ...... 492 ...... 486210, 221210. Pulp and Paper Mills ...... 261 ...... 322110, 322121, 322122, 322130. Paper Mills ...... 262 ...... 322121, 322122. Automobile Manufacturing ...... 371 ...... 336111, 336112, 336211, 336992, 336322, 336312, 336330, 336340, 336350, 336399, 336212, 336213. Pharmaceuticals ...... 283 ...... 325411, 325412, 325413, 325414. Mining ...... 211, 212, 213 ...... 21. Agriculture, Fishing and Hunting ...... 111, 112, 113, 115 .... 11. a Standard Industrial Classification. b North American Industry Classification System.

Entities potentially affected by the J. Executive Order 12898: Federal Actions rule contained in the federal PSD subject rule for this proposed action also To Address Environmental Justice in program at 40 CFR parts 51 and 52. The include state, local, and tribal Minority Populations and Low-Income letter also indicated that we would governments. Populations publish a notice of proposed rulemaking K. Determination Under Section 307(d) ‘‘in the near future’’ to address the B. Where can I get a copy of this L. The Congressional Review Act specific issues for which we are granting document and other related M. Basis for Making This Rule Effective on reconsideration.2 information? the Date of Publication IV. Statutory Authority The administrative stay of the In addition to being available in the Fugitive Emissions Rule became II. This Action docket, an electronic copy of this final effective on September 30, 2009. See 74 rule is also be available on the World A. Background FR 50115, FR Doc. E9–23503. As noted Wide Web in the regulations and On December 19, 2008, the EPA above, our authority under section standards section of our NSR home page (‘‘we’’) issued a final rule revising our 307(d)(7)(B) to stay a rule or portion located at http://www.epa.gov/nsr. requirements of the major NSR thereof solely under the Administrator’s C. How is this preamble organized? programs regarding the treatment of discretion is limited to 3 months. An fugitive emissions (‘‘Fugitive Emissions interim final determination was made to I. General Information Rule’’). 73 FR 77882. The final rule provide an additional stay for 3 months. A. Does this action apply to me? required fugitive emissions to be This additional stay became effective on B. Where can I get a copy of this document December 31, 2009. See 74 FR 65692. and other related information? included in determining whether a C. How is this preamble organized? physical or operational change results in B. Final Rule II. This Action a major modification only for sources in A. Background industries that have been designated In this final rule we are staying the B. Final Rule through rulemaking under section 302(j) Fugitive Emissions Rule for 18 months. C. Comments and Responses of the CAA. The final rule amended all As described above, the same provisions D. Basis for Making This Rule Effective on portions of the major NSR program were administratively stayed for 3 the Date of Publication regulations: Permit requirements, the months; however, that stay ended on III. Statutory and Executive Order Review PSD program, and the emission offset December 30, 2009. To avoid a gap A. Executive Order 12866: Regulatory between the end of the stay and the Planning and Review interpretive ruling. B. Paperwork Reduction Act On February 17, 2009, the Natural proposed additional stay, an interim C. Regulatory Flexibility Act Resources Defense Council submitted a final determination was made to D. Unfunded Mandates Reform Act petition for reconsideration of the provide an additional stay for 3 months, E. Executive Order 13132: Federalism December 2008 final rule as provided ending on March 31, 2010. We believe F. Executive Order 13175: Consultation for in CAA 307(d)(7)(B).1 the 18 month additional stay is needed and Coordination With Indian Tribal On April 24, 2009, we responded to and will provide adequate time for EPA Governments the February 17, 2009 petition by letter to propose, take comment on, and issue G. Executive Order 13045: Protection of indicating that we were convening a a final action on issues that are Children From Environmental Health associated with the inclusion of fugitive and Safety Risks reconsideration proceeding for the H. Executive Order 13211: Actions inclusion of fugitive emissions emissions. Therefore, we are issuing this Concerning Regulations That challenged in the petition and granting stay of the final Fugitive Emissions Rule Significantly Affect Energy Supply, a 3-month administrative stay of the in the federal PSD program at 40 CFR 51 Distribution, or Use I. National Technology Transfer and 1 John Walke, NRDC, EPA–HQ–OAR–2004–0014– 2 Lisa Jackson, U.S. EPA, EPA–HQ–OAR–2004– Advancement Act 0060. 0014–0062.

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and 52 for 18 months, until October 3, III. Statutory and Executive Order EPA is taking this action to propose an 2011. Reviews additional stay to the regulations at 40 CFR parts 51 and 52 concerning the A. Executive Order 12866: Regulatory C. Comments and Responses inclusion of fugitive emissions. No costs Planning and Review When we proposed this stay on are associated with this amendment. This action is not a ‘‘significant February 11, 2010, we did not take regulatory action’’ under the terms of D. Unfunded Mandates Reform Act comment on any substantive issues Executive Order 12866 (58 FR 51735, This action does not contain a federal concerning the inclusion of fugitive October 4, 1993) and is therefore not emissions in the NSR program as stated mandate under the provisions of Title II subject to review under the Executive of the Unfunded Mandates Reform Act in the Fugitive Emissions Rule. Order. Comments sought were to be limited to of 1995 (UMRA), 2 U.S.C. 1531–1538 for the issue of whether to establish this B. Paperwork Reduction Act state, local, and tribal governments, in additional stay and how long this stay This action does not impose an the aggregate, or the private sector in any one year. This action only proposes would be. [75 FR 6823 at 6825]. information collection burden under the provisions of the Paperwork Reduction to put in place an additional stay of the We received three comments on the regulations at 40 CFR parts 51 and 52 proposal for this additional stay of the Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). This action concerning the inclusion of fugitive Fugitive Emissions Rule. The first only issues a stay of the Fugitive emissions. Thus, this rule is not subject commenter supported the additional Emissions Rule for 18 months. to the requirements of sections 202 or stay for ‘‘18 months, 24 months, or However, the Office of Management 205 of the Unfunded Mandates Reform however long it takes for the current and Budget (OMB) has previously Act (UMRA). administration to reverse the rule and approved the information collection This final rule is also not subject to return to EPA’s longstanding, lawful, requirements contained in the existing the requirements of section 203 of and more protective approach.’’ regulations under the provisions of the UMRA because it contains no regulatory One industry coalition commenter Paperwork Reduction Act, 44 U.S.C. requirements that might significantly or opposed the additional 18 month stay to 3501 et seq. and has assigned OMB uniquely affect small governments. control number 2060–0003 [EPA ICR ‘‘take substantive action and facilitate E. Executive Order 13132: Federalism resolution of this significant permit No. 1230.21]. The OMB control numbers applicability issue.’’ Further, the for EPA’s regulations in 40 CFR are This final rule does not have commenter suggested that any delay listed in 40 CFR part 9. federalism implications. It will not have ‘‘makes compliance with already C. Regulatory Flexibility Act substantial direct effects on the states, complex PSD and NSR rules just that on the relationship between the national The Regulatory Flexibility Act (RFA) government and the states, or on the more difficult.’’ No additional detail is generally requires an agency to prepare provided regarding the difficulties with distribution of power and a regulatory flexibility analysis of any responsibilities among the various compliance for these rules. We agree rule subject to notice and comment with the industry coalition commenter levels of government, as specified in EO rulemaking requirements under the 13132. This action only stays the that EPA should take substantive action Administrative Procedure Act or any to facilitate resolution of this regulations at 40 CFR parts 51 and 52 other statute unless the agency certifies concerning the inclusion of fugitive applicability issue. However, we believe that the rule will not have a significant emissions. that 18 months is necessary to allow economic impact on a substantial EPA sufficient time to propose, take number of small entities. Small entities F. Executive Order 13175: Consultation public comment on, and issue a final include small businesses, small and Coordination With Indian Tribal action concerning the inclusion of organizations, and small governmental Governments fugitive emissions in the federal PSD jurisdictions. This action does not have tribal program. The commenter does not For purposes of assessing the impacts implications, as specified in EO 13175 provide further details to demonstrate of this rule on small entities, small (65 FR 67249, November 9, 2000). This how this stay negatively impacts entity is defined as: (1) A small business as defined by the Small Business action will not impose any new compliance. In our view, it is imperative obligations or enforceable duties on the Fugitive Emissions Rule continue to Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental tribal governments. Thus, EO 13175 be stayed while we undergo the does not apply to this action. reconsideration process to reduce jurisdiction that is a government of a city, county, town, school district or confusion. If it is effective during this G. Executive Order 13045: Protection of special district with a population of less process and the Rule is ultimately Children From Environmental Health than 50,000; and (3) a small changed, it would only further and Safety Risks organization that is any not-for-profit complicate compliance with PSD and enterprise which is independently EPA interprets EO 13045 (62 FR NSR rules, an issue of concern for the owned and operated and is not 19885, April 23, 1997) as applying only commenter. dominant in its field. to those regulatory actions that concern The final commenter did not After considering the economic health or safety risks, such that the comment specifically on the proposed impacts of this final rule on small analysis required under section 5–501 of additional stay, but instead stated that entities, I certify that this action will not the EO has the potential to influence the ‘‘further reconsideration is have a significant economic impact on regulation. This action is not subject to unnecessary.’’ We believe this comment a substantial number of small entities. EO 13045 because this proposal only addresses the underlying substance of This final rule will not impose any new proposes to put in place an additional the Fugitive Emissions rule, which is requirements on small entities. We have stay of the regulations at 40 CFR parts beyond the scope of this action. determined that small businesses will 51 and 52 concerning the inclusion of not incur any adverse impacts because fugitive emissions.

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H. Executive Order 13211: Actions section 307(d). Section 307(d)(1)(V) List of Subjects Concerning Regulations That provides that the provisions of section 40 CFR Part 51 Significantly Affect Energy Supply, 307(d) apply to ‘‘such other actions as Distribution, or Use the Administrator may determine.’’ Administrative practices and procedures, Air pollution control, This action is not a ‘‘significant L. The Congressional Review Act regulatory action’’ under the terms of Carbon monoxide, Fugitive emissions, The Congressional Review Act, 5 Executive Order 12866 (58 FR 51735, Intergovernmental relation, Lead, U.S.C. 801 et seq., as added by the Small October 4, 1993) and is therefore not Nitrogen dioxide, Ozone, Particulate Business Regulatory Enforcement subject to review under the Executive matter, Reporting and recordkeeping Fairness Act of 1996, generally provides Order. requirements, Sulfur oxides, that before a rule may take effect, the Transportation, Volatile organic I. National Technology Transfer and agency promulgating the rule must compounds. Advancement Act submit a rule report, which includes a 40 CFR Part 52 Section 12(d) of the National copy of the rule, to each House of the Technology Transfer and Advancement Congress and to the Comptroller General Administrative practices and Act of 1995 (‘‘NTTAA’’), Public Law of the United States. EPA will submit a procedures, Air pollution control, 104–113, 12(d) (15 U.S.C. 272 note) report containing this rule and other Carbon monoxide, Fugitive emissions, directs EPA to use voluntary consensus required information to the U.S. Senate, Incorporation by reference, standards in its regulatory activities the U.S. House of Representatives, and Intergovernmental relation, Lead, unless to do so would be inconsistent the Comptroller General of the United Nitrogen dioxide, Ozone, Particulate with applicable law or otherwise States prior to publication of the rule in matter, Reporting and recordkeeping impractical. Voluntary consensus the Federal Register. A Major rule requirements, Sulfur oxides, standards are technical standards (e.g., cannot take effect until 60 days after it Transportation, Volatile organic materials specifications, test methods, is published in the Federal Register. compounds. ‘‘ ’’ sampling procedures, and business This action is not a major rule as Dated: March 24, 2010. defined by 5 U.S.C. 804(2). This rule practices) that are developed or adopted Lisa P. Jackson, will be effective April 1, 2010. by voluntary consensus standards Administrator. bodies. NTTAA directs EPA to provide M. Basis for Making This Rule Effective ■ For the reasons discussed in the Congress, through OMB, explanations on the Date of Publication preamble, the EPA amends 40 CFR parts when the Agency decides not to use Section 553(d) of the Administrative available and applicable voluntary 51 and 52 as follows: Procedure Act (APA), 5 U.S.C. 553(b), consensus standards. PART 51—[AMENDED] This final rulemaking does not generally provides that rules may not involve technical standards. Therefore, take effect earlier than 30 days after they ■ 1. The authority citation for part 51 EPA is not using any voluntary are published in the Federal Register. continues to read as follows: consensus standards. However, EPA is issuing this final rule under section 307(d)(1) of the CAA, Authority: 23 U.S.C. 101; 42 U.S.C. 7401– J. Executive Order 12898: Federal which states: 7671q. Actions To Address Environmental ‘‘The provisions of section 553 through 557 § 51.165 [Amended] Justice in Minority Populations and * * * of Title 5 shall not, except as expressly 2. Effective April 1, 2010, 40 CFR Low-Income Populations provided in this section, apply to actions to 51.165(a)(1)(v)(G), (a)(1)(vi)(C)(3), which this subsection applies.’’ Executive Order 12898 (59 FR 7629 (a)(1)(ix), (a)(1)(xxviii)(B)(2), (Feb. 16, 1994)) establishes federal Thus, section 553(d) of the APA does (a)(1)(xxviii)(B)(4), (a)(1)(xxxv)(A)(1), executive policy on environmental not apply to this rule. EPA is (a)(1)(xxxv)(B)(1), (a)(1)(xxxv)(C), justice. Its main provision directs nevertheless acting consistently with (a)(1)(xxxv)(D), (a)(2)(ii)(B), (a)(6)(iii), federal agencies, to the greatest extent the policies underlying APA section (a)(6)(iv), and (f)(4)(i)(D) are stayed until practicable and permitted by law, to 553(d) in making this rule effective on October 3, 2011. make environmental justice part of their the date of publication. APA section 3. Effective April 1, 2010 through mission by identifying and addressing, 553(d)(3) provides an exception when October 3, 2011, amend 40 CFR 51.165 as appropriate, disproportionately high the agency finds good cause exists for a to add paragraph (a)(4) to read as and adverse human health or period less than 30 days before follows: environmental effects of their programs, effectiveness. We find good cause exists policies, and activities on minority to make this rule effective upon § 51.165 Permit requirements. populations and low-income publication. A gap between the current (a) * * * populations in the United States. stay that ends on March 31, 2010 and (4) Each plan may provide that the EPA has determined that this final the effective date of this stay could provisions of this paragraph do not rule will not have disproportionately result in administrative and regulatory apply to a source or modification that high and adverse human health or confusion if the stayed provisions came would be a major stationary source or environmental effects on minority and/ back into effect, only to be stayed again major modification only if fugitive or low income populations. This rule a short time later. In order to avoid this emission to the extent quantifiable are stays the regulations at 40 CFR parts 51 potential gap, this rule is effective upon considered in calculating the potential and 52 concerning the inclusion of publication. to emit of the stationary source or fugitive emissions. modification and the source does not IV. Statutory Authority belong to any of the following K. Determination Under Section 307(d) The statutory authority for this action categories: Pursuant to sections 307(d)(1)(J) and is provided by section 301(a) of the CAA (i) Coal cleaning plants (with thermal 307(d)(1)(V) of the CAA, the as amended (42 U.S.C. 7601(a)). This dryers); Administrator determines that this notice is also subject to section 307(d) (ii) Kraft pulp mills; action is subject to the provisions of of the CAA (42 U.S.C. 7407(d)). (iii) Portland cement plants;

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(iv) Primary zinc smelters; to the extent quantifiable, are Appendix S to Part 51—Emission Offset (v) Iron and steel mills; considered in calculating the potential Interpretative Ruling (vi) Primary aluminum ore reduction to emit of the stationary source or * * * * * plants; modification and such source does not (vii) Primary copper smelters; belong to any following categories: II. * * * (viii) Municipal incinerators capable (a) Coal cleaning plants (with thermal F. Fugitive emission sources. Section IV.A. of charging more than 250 tons of refuse dryers); of this Ruling shall not apply to a source or per day; (b) Kraft pulp mills; modification that would be a major stationary (ix) Hydrofluoric, sulfuric, or citric source or major modification only if fugitive (c) Portland cement plants; emissions, to the extent quantifiable, are acid plants; (d) Primary zinc smelters; considered in calculating the potential to (x) Petroleum refineries; (e) Iron and steel mills; emit of the stationary source or modification (xi) Lime plants; (f) Primary aluminum ore reduction and such source does not belong to any (xii) Phosphate rock processing plants; following categories: plants; (g) Primary copper smelters; (1) Coal cleaning plants (with thermal (xiii) Coke oven batteries; (h) Municipal incinerators capable of dryers); (xiv) Sulfur recovery plants; charging more than 250 tons of refuse (2) Kraft pulp mills; (xv) Carbon black plants (furnace per day; (3) Portland cement plants; process); (4) Primary zinc smelters; (i) Hydrofluoric, sulfuric, or nitric (5) Iron and steel mills; (xvi) Primary lead smelters; acid plants; (xvii) Fuel conversion plants; (6) Primary aluminum ore reduction (j) Petroleum refineries; plants; (xviii) Sintering plants; (k) Lime plants; (7) Primary copper smelters; (xix) Secondary metal production (l) Phosphate rock processing plants; (8) Municipal incinerators capable of plants; (m) Coke oven batteries; charging more than 250 tons of refuse per (xx) Chemical process plants—The (n) Sulfur recovery plants; day; term chemical processing plant shall not (o) Carbon black plants (furnace (9) Hydrofluoric, sulfuric, or nitric acid plants; include ethanol production facilities process); that produce ethanol by natural (10) Petroleum refineries; (p) Primary lead smelters; (11) Lime plants; fermentation included in NAICS codes (q) Fuel conversion plants; 325193 or 312140; (12) Phosphate rock processing plants; (r) Sintering plants; (13) Coke oven batteries; (xxi) Fossil-fuel boilers (or (s) Secondary metal production (14) Sulfur recovery plants; combination thereof) totaling more than plants; (15) Carbon black plants (furnace process); 250 million British thermal units per (t) Chemical process plants—The term (16) Primary lead smelters; hour heat input; chemical processing plant shall not (17) Fuel conversion plants; (xxii) Petroleum storage and transfer include ethanol production facilities (18) Sintering plants; units with a total storage capacity (19) Secondary metal production plants; that produce ethanol by natural (20) Chemical process plants—The term exceeding 300,000 barrels; fermentation included in NAICS codes (xxiii) Taconite ore processing plants; chemical processing plant shall not include 325193 or 312140; ethanol production facilities that produce (xxiv) Glass fiber processing plants; (u) Fossil-fuel boilers (or combination (xxv) Charcoal production plants; ethanol by natural fermentation included in thereof) totaling more than 250 million NAICS codes 325193 or 312140; (xxvi) Fossil fuel-fired steam electric British thermal units per hour heat (21) Fossil-fuel boilers (or combination plants of more than 250 million British input; thereof) totaling more than 250 million thermal units per hour heat input; (v) Petroleum storage and transfer British thermal units per hour heat input; (xxvii) Any other stationary source units with a total storage capacity (22) Petroleum storage and transfer units category which, as of August 7, 1980, is with a total storage capacity exceeding exceeding 300,000 barrels; being regulated under section 111 or 300,000 barrels; (w) Taconite ore processing plants; 112 of the Act. (23) Taconite ore processing plants; (x) Glass fiber processing plants; (24) Glass fiber processing plants; * * * * * (y) Charcoal production plants; (25) Charcoal production plants; § 51.166 [Amended] (z) Fossil fuel-fired steam electric (26) Fossil fuel-fired steam electric plants plants of more than 250 million British of more than 250 million British thermal ■ 4. Effective April 1, 2010, 40 CFR thermal units per hour heat input; units per hour heat input; 51.166(a)(7)(iv)(b), (b)(2)(v), (b)(3)(iii)(c), (aa) Any other stationary source (27) Any other stationary source category (b)(3)(iii)(d), (b)(20), (b)(40)(ii)(b), category which, as of August 7, 1980, is which, as of August 7, 1980, is being (b)(40)(ii)(d), (b)(47)(i)(a), (b)(47)(ii)(a), being regulated under section 111 or regulated under section 111 or 112 of the Act. (b)(47)(iii), (b)(47)(iv), (r)(6)(iii) and 112 of the Act; or * * * * * (r)(6)(iv), and (w)(4)(i)(d) are stayed * * * * * until March 31, 2010. PART 52—[AMENDED] ■ 5. Effective April 1, 2010 through Appendix S to 40 CFR part 51 ■ [Amended] 8. The authority citation for part 52 October 3, 2011, amend 40 CFR 51.166 continues to read as follows: to add paragraph (i)(l)(ii) to read as ■ 6. Effective April 1, 2010, 40 CFR part Authority: 42 U.S.C. 7401 et seq. follows: 51, Appendix S, paragraphs II.A.5(vii), § 51.166 Prevention of significant II.A.6(iii), II.A.9, II.A.24(ii)(b), § 52.21 [Amended] deterioration of air quality. II.A.24(ii)(d), II.A.30(i)(a), II.A.30(ii)(a), ■ 9. Effective April 1, 2010, 40 CFR * * * * * II.A.30(iii), II.A.30(iv), IV.I.1(ii), IV.J.3, 52.21, (a)(2)(iv)(b), (b)(2)(v), (b)(3)(iii)(b), (i) * * * IV.J.4, and IV.K.4(i)(d) are stayed until (b)(3)(iii)(c), (b)(20),(b)(41)(ii)(b), (1) * * * October 3, 2011. (b)(41)(ii)(d), (b)(48)(i)(a),(b)(48)(ii)(a), (ii) The source or modification would ■ 7. Effective April 1, 2010 through (b)(48)(iii), (b)(48)(iv), (r)(6)(iii), be a major stationary source or major October 3, 2011, amend Appendix S to (r)(6)(iv), and (aa)(4)(i)(d) are stayed modification only if fugitive emissions, part 51 to add II.F to read as follows: until October 3, 2011.

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■ 10. Effective April 1, 2010 through ENVIRONMENTAL PROTECTION (703) 347–8825; e-mail address: October 3, 2011, amend 40 CFR 52.21 to AGENCY [email protected]. add (i)(l)(vii) to read as follows: SUPPLEMENTARY INFORMATION: 40 CFR Part 180 § 52.21 Prevention of significant I. General Information deterioration of air quality. [EPA–HQ–OPP–2009–0714; FRL–8816–3] A. Does this Action Apply to Me? * * * * * Cloquintocet-mexyl; Pesticide (i) * * * Tolerances You may be potentially affected by (1) * * * this action if you are an agricultural (vii) The source or modification AGENCY: Environmental Protection producer, food manufacturer, or would be a major stationary source or Agency (EPA). pesticide manufacturer. Potentially major modification only if fugitive ACTION: Final rule. affected entities may include, but are emissions, to the extent quantifiable, are not limited to those engaged in the considered in calculating the potential SUMMARY: EPA is amending 40 CFR following activities: to emit of the stationary source or 180.560 to add a reference to the active • Crop production (NAICS code 111). modification and the source does not ingredient flucarbazone-sodium (wheat • Animal production (NAICS code belong to any of the following only) to the tolerance for the inert 112). categories: ingredient cloquintocet-mexyl (acetic • Food manufacturing (NAICS code (a) Coal cleaning plants (with thermal acid [(5-chloro-8-quinolinyl) oxy]-, 1- 311). dryers); methylhexyl ester; CAS Reg. No. 99607– • Pesticide manufacturing (NAICS (b) Kraft pulp mills; 70–2) and its acid metabolite (5-chloro- code 32532). (c) Portland cement plants; 8-quinolinoxyacetic acid) on wheat This listing is not intended to be (d) Primary zinc smelters; forage, wheat grain, wheat hay, and exhaustive, but rather to provide a guide (e) Iron and steel mills; wheat straw. Arysta LifeScience North for readers regarding entities likely to be (f) Primary aluminum ore reduction America, LLC requested this tolerance affected by this action. Other types of plants; amendment under the Federal Food, entities not listed in this unit could also (g) Primary copper smelters; Drug, and Cosmetic Act (FFDCA). be affected. The North American (h) Municipal incinerators capable of Industrial Classification System charging more than 250 tons of refuse DATES: This regulation is effective (NAICS) codes have been provided to per day; March 31, 2010. Objections and requests assist you and others in determining (i) Hydrofluoric, sulfuric, or nitric for hearings must be received on or whether this action might apply to acid plants; before June 1, 2010, and must be filed (j) Petroleum refineries; in accordance with the instructions certain entities. If you have any (k) Lime plants; provided in 40 CFR part 178 (see also questions regarding the applicability of (l) Phosphate rock processing plants; Unit I.C. of the SUPPLEMENTARY this action to a particular entity, consult (m) Coke oven batteries; INFORMATION). the person listed under FOR FURTHER INFORMATION CONTACT. (n) Sulfur recovery plants; ADDRESSES: EPA has established a (o) Carbon black plants (furnace docket for this action under docket B. How Can I Get Electronic Access to process); identification (ID) number EPA–HQ– Other Related Information? (p) Primary lead smelters; OPP–2009–0714. All documents in the (q) Fuel conversion plants; You may access a frequently updated (r) Sintering plants; docket are listed in the docket index electronic version of EPA’s tolerance (s) Secondary metal production available at http://www.regulations.gov. regulations at 40 CFR part 180 through plants; Although listed in the index, some the Government Printing Office’s e-CFR (t) Chemical process plants—The term information is not publicly available, cite at http://www.gpoaccess.gov/ecfr. chemical processing plant shall not e.g., Confidential Business Information C. Can I File an Objection or Hearing include ethanol production facilities (CBI) or other information whose Request? that produce ethanol by natural disclosure is restricted by statute. fermentation included in NAICS codes Certain other material, such as Under section 408(g) of FFDCA, 21 325193 or 312140; copyrighted material, is not placed on U.S.C. 346a, any person may file an (u) Fossil-fuel boilers (or combination the Internet and will be publicly objection to any aspect of this regulation thereof) totaling more than 250 million available only in hard copy form. and may also request a hearing on those British thermal units per hour heat Publicly available docket materials are objections. You must file your objection input; available in the electronic docket at or request a hearing on this regulation (v) Petroleum storage and transfer http://www.regulations.gov, or, if only in accordance with the instructions units with a total storage capacity available in hard copy, at the OPP provided in 40 CFR part 178. To ensure exceeding 300,000 barrels; Regulatory Public Docket in Rm. S– proper receipt by EPA, you must (w) Taconite ore processing plants; 4400, One Potomac Yard (South Bldg.), identify docket ID number EPA–HQ– (x) Glass fiber processing plants; 2777 S. Crystal Dr., Arlington, VA. The OPP–2009–0714 in the subject line on (y) Charcoal production plants; Docket Facility is open from 8:30 a.m. the first page of your submission. All (z) Fossil fuel-fired steam electric to 4 p.m., Monday through Friday, requests must be in writing, and must be plants of more than 250 million British excluding legal holidays. The Docket mailed or delivered to the Hearing Clerk thermal units per hour heat input; Facility telephone number is (703) 305– as required by 40 CFR part 178 on or (aa) Any other stationary source 5805. before June 1, 2010. category which, as of August 7, 1980, is FOR FURTHER INFORMATION CONTACT: In addition to filing an objection or being regulated under section 111 or Karen Samek, Registration division hearing request with the Hearing Clerk 112 of the Act; or (7505P), Office of Pesticide Programs, as described in 40 CFR part 178, please * * * * * Environmental Protection Agency, 1200 submit a copy of the filing that does not [FR Doc. 2010–7036 Filed 3–30–10; 8:45 am] Pennsylvania Ave., NW., Washington, contain any CBI for inclusion in the BILLING CODE 6560–50–P DC 20460–0001; telephone number: public docket that is described in

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ADDRESSES. Information not marked active ingredient from the tolerance reader is referred to the final rules confidential pursuant to 40 CFR part 2 expression. establishing tolerances for cloquintocet- may be disclosed publicly by EPA In the Federal Register of October 7, mexyl that published in in the Federal without prior notice. Submit this copy, 2009 (74 FR 51597) (FRL–8792–7), EPA Register of March 5, 2008, December 16, identified by docket ID number EPA– issued a notice pursuant to section 2005, and June 22, 2000. 408(d)(3) of FFDCA, 21 U.S.C. HQ–OPP–2009–0714, by one of the A. Toxicological Profile following methods: 346a(d)(3), announcing the filing of the • Federal eRulemaking Portal: http:// above-referenced pesticide petition (PP EPA has evaluated the available www.regulations.gov. Follow the on-line 9E7592) by Arysta LifeScience North toxicity data and considered its validity, instructions for submitting comments. America, LLC. The petition requested completeness, and reliability as well as • Mail: Office of Pesticide Programs that 40 CFR 180.560 be amended by the relationship of the results of the (OPP) Regulatory Public Docket (7502P), expanding the tolerance to cover studies to human risk. EPA has also considered available information Environmental Protection Agency, 1200 cloquintocet-mexyl residues when used concerning the variability of the Pennsylvania Ave., NW., Washington, in formulation with the active sensitivities of major identifiable DC 20460–0001. ingredient flucarbazone-sodium on wheat. No numerical change to the subgroups of consumers, including • Delivery: OPP Regulatory Public tolerances for the specific wheat infants and children. Specific Docket (7502P), Environmental commodities was sought. That notice information on the studies received and Protection Agency, Rm. S–4400, One referenced a summary of the petition the nature of the adverse effects caused Potomac Yard (South Bldg.), 2777 S. prepared by Arysta LifeScience North by cloquintocet-mexyl as well as the no- Crystal Dr., Arlington, VA. Deliveries America, LLC, the registrant, which is observed-adverse-effect-level (NOAEL) are only accepted during the Docket available to the public in the docket, and the lowest-observed-adverse-effect- Facility’s normal hours of operation http://www.regulations.gov. There were level (LOAEL) from the toxicity studies (8:30 a.m. to 4 p.m., Monday through no comments received in response to are discussed in the final rules Friday, excluding legal holidays). the notice of filing. published on March 5, 2008, December Special arrangements should be made 16, 2005, and June 22, 2000. In these for deliveries of boxed information. The III. Aggregate Risk Assessment and final rules, the Agency reviewed the Docket Facility telephone number is Determination of Safety available information on cloquintocet- (703) 305–5805. Section 408(b)(2)(A)(i) of FFDCA mexyl submitted by the petitioners as II. Petition for Tolerance allows EPA to establish a tolerance (the well as additional information available legal limit for a pesticide chemical to EPA. The toxicity database is EPA has received a petition from residue in or on a food) only if EPA sufficient for cloquintocet-mexyl and Arysta LifeScience North America, LLC, determines that the tolerance is ‘‘safe.’’ has not changed since the time of those 15401 Weston Parkway, Cary, NC Section 408(b)(2)(A)(ii) of FFDCA publications. Therefore, only a brief 27513, requesting an amendment to the defines ‘‘safe’’ to mean that ‘‘there is a summary is provided here. existing tolerances for the inert reasonable certainty that no harm will Cloquintocet-mexyl has a low order of ingredient (safener) (acetic acid [(5- result from aggregate exposure to the acute oral, dermal, and inhalation chloro-8-quinolinyl) oxy]-, 1- pesticide chemical residue, including toxicity. It is slightly irritating to the methylhexyl ester; CAS Reg. No. 99607– all anticipated dietary exposures and all eyes and non-irritating to the skin. 70–2) and its acid metabolite (5-chloro- other exposures for which there is Cloquintocet-mexyl is a skin sensitizer. 8-quinolinoxyacetic acid). For ease of reliable information.’’ This includes The chemical is not genotoxic and is not reading this document, acetic acid [(5- exposure through drinking water and in a reproductive and developmental chloro-8-quinolinyl) oxy]-, 1- residential settings, but does not include toxicant. There is no evidence of methylhexyl ester will be referred to as occupational exposure. Section neurotoxicity in the available studies. cloquintocet-mexyl. EPA published two 408(b)(2)(C) of FFDCA requires EPA to Cloquintocet-mexyl is classified as ‘‘not final rules to establish tolerances for the give special consideration to exposure likely to be a human carcinogen.’’ The safener under 40 CFR 180.560 in the of infants and children to the pesticide main metabolite for cloquintocet-mexyl Federal Register of June 22, 2000 (65 FR chemical residue in establishing a is 5-chloro-8-quin-linoxyacetic acid, and 38757) (FRL–6592–4) and the Federal tolerance and to ‘‘ensure that there is a testing on the metabolite is part of the Register of December 16, 2005 (70 FR reasonable certainty that no harm will toxicology database for cloquintocet- 74679) (FRL–7753–4). These tolerances result to infants and children from mexyl. For additional information on establish tolerances for cloquintocet- aggregate exposure to the pesticide the human health toxicity data for mexyl when used as an inert ingredient chemical residue. . . .’’ cloquintocet-mexyl and its metabolite, (safener) in pesticide formulations Consistent with section 408(b)(2)(D) see EPA’s Electronic Docket at http:// containing the active ingredients of FFDCA, and the factors specified in www regulations.gov and the Federal pinoxaden (wheat or barley) or section 408(b)(2)(D) of FFDCA, EPA has Register of March 5, 2008, December 16, clodinafop-propargyl (wheat only). In reviewed the available scientific data 2005, and June 22, 2000. addition, a final rule that established and other relevant information in tolerances for this safener was support of this action. EPA has B. Exposure Assessment published in the Federal Register of sufficient data to assess the hazards of In examining aggregate exposure, the March 5, 2008 (73 FR 11816) (FRL– and to make a determination on FFDCA section 408 directs EPA to 8350–8). That final rule amended 40 aggregate exposure for the chemical. consider available information CFR 180.560 by adding a reference to The Agency’s decision document for concerning exposures from the pesticide the active ingredient pyroxsulam (wheat this action is available on EPA’s residue in food and all other non- only), and increased the existing Electronic Docket at http:// occupational exposures, including tolerances for residues of cloquintocet- www.regulations.gov/ under docket ID drinking water from ground water or mexyl in or on wheat, forage and wheat, number EPA–HQ–OPP–2009–0714. For surface water and exposure through hay, and removed the specification of a the full toxicity data and information on pesticide use in gardens, lawns, or 1:4 ratio inert ingredient safener to which this risk assessment is based, the buildings (residential and other indoor

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uses). In the 2008 rulemaking, EPA EPA support the choice of a different on the considerations in this unit, the assessed human exposure to factor. Agency does not believe that conducting cloquintocet-mexyl from use on wheat 2. Prenatal and postnatal sensitivity. acute and subchronic neurotixicty and barley. EPA assumed that 100% of There was no evidence of increased studies will result in a NOAEL less than the wheat and barley crops were treated susceptibility of in utero or post-natal the NOAEL of 4.3 mg/kg/day. Therefore, with cloquintocet-mexyl and that exposure to rats or rabbits in the there is no need for additional residues on all wheat and barley prenatal developmental studies or in uncertainty factors (UF). Confirmatory commodities were at the tolerance level. rats in the 2-generation reproduction acute and subchronic neurotoxicity The Agency has determined that this study. NOAELs for maternal/parental studies will be required as a condition assessment is sufficient for the current toxicity were either less than or equal to of registration. amendment to the cloquintocet-mexyl the NOAELs for fetal or reproductive ii. There is no indication of tolerance expression because no new toxicity. quantitative or qualitative increased crops are being added and the label 3. Conclusion. EPA has determined susceptibility of rats or rabbits to in requirements limit the total number of that reliable data show that the safety of utero and/or postnatal exposure to applications from all of the various infants and children would be cloquintocet-mexyl in the available cloquintocet-mexyl safener products to adequately protected if the FQPA SF toxicity database. one application from this group of were reduced to 1X. That decision is iii. There is no indication that pesticides on a crop per growing season. based on the following findings: cloquinocet-mexyl is a neurotoxic For additional information on the i. The toxicity database for chemical and thus there is no need for exposure assessment for cloquintocet- cloquintocet-mexyl is complete, except a developmental neurotoxicity study or mexyl, see the docket and the Federal for immunotoxicity and neurotoxicity additional UFs to account for Register of March 5, 2008. studies. EPA began requiring these neurotoxicity. studies on December 26, 2009. In the iv. The dietary (food and drinking C. Cumulative Effects From Substances absence of specific immunotoxicity water) exposure assessments will not With a Common Mechanism of Toxicity studies, EPA has evaluated the available underestimate the potential exposures Section 408(b)(2)(D)(v) of FFDCA toxicity data for cloquintocet-mexyl and for infants and children from the use of requires that, when considering whether determined that an additional database cloquintocet-mexyl (currently there are to establish, modify, or revoke a uncertainty factor is not needed to no proposed residential uses and tolerance, the Agency consider account for potential immunotoxicity. therefore non-occupational exposure is ‘‘available information’’ concerning the EPA’s determination is based on the not expected). cumulative effects of a particular following considerations. For additional information on the pesticide’s residues and ‘‘other There was some indication of possible Safety Factor determination for infants substances that have a common immunotoxicity in the form of and children for cloquintocet-mexyl, see mechanism of toxicity.’’ lymphoid hyperplasia of the thymus in the docket and the Federal Register of EPA has not found cloquintocet- male rats (without any histopathology March 5, 2008. mexyl to share a common mechanism of changes in the study) at the LOAEL of toxicity with any other substances, and 73.5 milligrams/kilogram/day (mg/kg/ E. Aggregate Risks and Determination of cloquintocet-mexyl does not appear to day) in the combined chronic/ Safety produce a toxic metabolite produced by oncogenicity study in rats (with a EPA determines whether acute and other substances. For the purposes of NOAEL of 36.4 mg/kg/day). This effect chronic pesticide exposures are safe by this tolerance action, therefore, EPA has was observed only in males. No blood comparing aggregate exposure estimates assumed that cloquintocet-mexyl does parameters were affected. In addition, to the acute population adjusted dose not have a common mechanism of cloquintocet-mexyl does not belong to a (aPAD) and chronic population adjusted toxicity with other substances. For class of chemicals that would be dose (cPAD). The aPAD and cPAD information regarding EPA’s efforts to expected to be immunotoxic. A clear represent the highest safe exposures, determine which chemicals have a NOAEL was established for these effects taking into account all appropriate safty common mechanism of toxicity and to (36.4 mg/kg/day), and the regulatory factors (SFs). EPA calculates the aPAD evaluate the cumulative effects of such endpoint of 4.3 mg/kg/day (the NOAEL and cPAD by dividing the point of chemicals, see EPA’s website at http:// from the combined chronic/ departure (POD) by all applicable UFs. www.epa.gov/pesticides/cumulative. oncogenicity study) is nearly 10X below For linear cancer risks, EPA calculates the NOAEL for the possible the probability of additional cancer D. Safety Factor for Infants and immunotoxic effect. Therefore, based on cases given the estimated aggregate Children the considerations in this unit, EPA exposure. Short-term, intermediate- 1. In general. Section 408(b)(2)(C) of does not believe that conducting term, and chronic-term risks are FFDCA provides that EPA shall apply immunotoxicity testing will result in a evaluated by comparing the estimated an additional tenfold (10X) margin of NOAEL significantly less than the aggregate food, water, and residential safety for infants and children in the NOAEL of 4.3 mg/kg/day already exposure to the POD to ensure that the case of threshold effects to account for established for cloquintocet-mexyl, and margin of exposure (MOE) called for by prenatal and postnatal toxicity and the an additional factor (UFDB) for database the product of all applicable UFs is not completeness of the database on toxicity uncertainties is not needed to account exceeded. and exposure unless EPA determines for potential immunotoxicity. A In the 2005 and 2008 rulemakings for based on reliable data that a different confirmatory immunotoxicity study will cloquintocet-mexyl, EPA concluded that margin of safety will be safe for infants be required as a condition of the aggregate risks from exposure to and children. This additional margin of registration. cloquintocet-mexyl did not exceed 1% safety is commonly referred to as the No acute and subchronic of the aPAD or cPAD for the most FQPA SF. In applying this provision, neurotoxicity studies are available, exposed population groups. (73 FR EPA either retains the default value of however, there is no evidence of 11819); (70 FR 74685). These findings 10X, or uses a different additional safety neurotoxicity in the toxicology database are applicable to this tolerance factor when reliable data available to on cloquintocet-mexyl. Therefore, based amendment.

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Based on these risk assessments, EPA Risks (62 FR 19885, April 23, 1997). Senate, the U.S. House of concludes that there is a reasonable This final rule does not contain any Representatives, and the Comptroller certainty that no harm will result to the information collections subject to OMB General of the United States prior to general population, or to infants and approval under the Paperwork publication of this final rule in the children from aggregate exposure to Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not cloquintocet-mexyl and its acid seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. metabolite (5-chloro-8- considerations under Executive Order 804(2). quinolinoxyacetic acid). 12898, entitled Federal Actions to Address Environmental Justice in List of Subjects in 40 CFR Part 180 IV. Other Considerations Minority Populations and Low-Income A. Analytical Enforcement Methodology Populations (59 FR 7629, February 16, Environmental protection, 1994). Administrative practice and procedure, Adequate enforcement methodology Agricultural commodities, Pesticides is available to enforce the tolerance Since tolerances and exemptions that and pests, Reporting and recordkeeping expression. The method may be are established on the basis of a petition requirements. requested from: Chief, Analytical under section 408(d) of FFDCA, such as Chemistry Branch, Enviromental the tolerance in this final rule, do not Dated: March 22, 2010. require the issuance of a proposed rule, Science Center, 701 Mapes Rd., Ft. Lois Rossi, Meade, MD 20755–5350; e-mail address: the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et Director, Registration Division, Office of [email protected]. For the Pesticide Programs. complete description of Analytical seq.) do not apply. This final rule directly regulates Methods for cloquintocet-mexyl, see the ■ Therefore, 40 CFR chapter I is growers, food processors, food handlers, docket and the Federal Register of amended as follows: and food retailers, not States or tribes, December 16, 2005. nor does this action alter the PART 180—[AMENDED] B. International Residue Limits relationships or distribution of power There are no Codex tolerances for and responsibilities established by ■ 1. The authority citation for part 180 cloquintocet-mexyl. Congress in the preemption provisions continues to read as follows: of section 408(n)(4) of FFDCA. As such, V. Conclusions the Agency has determined that this Authority: 21 U.S.C. 321(q), 346a and 371. Therefore, 40 CFR 180.560 is action will not have a substantial direct ■ 2. Section 180.560, revise paragraph amended by establishing a tolerance for effect on States or tribal governments, (a) to read as follows: the combined residues of cloquintocet- on the relationship between the national mexyl (acetic acid [(5-chloro-8- government and the States or tribal § 180.560 Cloquintocet-mexyl; tolerances quinolinyl) oxy]-, 1-methylhexyl ester; governments, or on the distribution of for residues. CAS Reg. No. 99607–70–2) and its acid power and responsibilities among the (a) General. Tolerances are various levels of government or between metabolite (5-chloro-8-quinlinoxyacetic established for the combined residues of the Federal Government and Indian acid) when used as an inert ingredient cloquintocet-mexyl (acetic acid [(5- (safener) in pesticide formulations tribes. Thus, the Agency has determined chloro-8-quinolinyl) oxy]-, 1- containing the active ingredients that Executive Order 13132, entitled methylhexyl ester; CAS Reg. No. 99607– flucarbazone-sodium (wheat only), Federalism (64 FR 43255, August 10, pinoxaden (wheat or barley), 1999) and Executive Order 13175, 70–2) and its acid metabolite (5-chloro- clodinafop-propargyl (wheat only), or entitled Consultation and Coordination 8-quinlinoxyacetic acid) when used as pyroxsulum (wheat only) in or on with Indian Tribal Governments (65 FR an inert ingredient (safener) in pesticide barley, grain at 0.1 ppm; barley, hay at 67249, November 9, 2000) do not apply formulations containing the active 0.1 ppm; barley, straw at 0.1 ppm; to this final rule. In addition, this final ingredients, flucarbazone-sodium wheat, forage at 0.2 ppm; wheat, grain rule does not impose any enforceable (wheat only), pinoxaden (wheat or at 0.1 ppm; wheat, hay at 0.5 ppm; and duty or contain any unfunded mandate barley), clodinafop-propargyl (wheat wheat, straw at 0.1 ppm. as described under Title II of the only), or pyroxsulum (wheat only) in or Unfunded Mandates Reform Act of 1995 on the following food commodities: VI. Statutory and Executive Order (UMRA) (Public Law 104–4). Reviews This action does not involve any Commodity Parts per This final rule establishes tolerances technical standards that would require million under section 408(d) of FFDCA in Agency consideration of voluntary response to a petition submitted to the consensus standards pursuant to section Barley, grain ...... 0.1 Agency. The Office of Management and 12(d) of the National Technology Barley, hay ...... 0.1 Budget (OMB) has exempted these types Transfer and Advancement Act of 1995 Barley, straw ...... 0.1 of actions from review under Executive (NTTAA), Public Law 104–113, section Wheat, forage ...... 0.2 Order 12866, entitled Regulatory 12(d) (15 U.S.C. 272 note). Wheat, grain ...... 0.1 Planning and Review (58 FR 51735, Wheat, hay ...... 0.5 October 4, 1993). Because this final rule VII. Congressional Review Act Wheat, straw ...... 0.1 has been exempted from review under The Congressional Review Act, 5 Executive Order 12866, this final rule is U.S.C. 801 et seq., generally provides * * * * * not subject to Executive Order 13211, that before a rule may take effect, the [FR Doc. 2010–6890 Filed 3–30–10; 8:45 am] entitled Actions Concerning Regulations agency promulgating the rule must BILLING CODE 6560–50–S That Significantly Affect Energy Supply, submit a rule report to each House of Distribution, or Use (66 FR 28355, May the Congress and to the Comptroller 22, 2001) or Executive Order 13045, General of the United States. EPA will entitled Protection of Children from submit a report containing this rule and Environmental Health Risks and Safety other required information to the U.S.

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DEPARTMENT OF COMMERCE public viewing until after the comment and, (2) the harvest capacity and stated period has closed. Comment will intent on future harvesting patterns of National Oceanic and Atmospheric generally be posted without change. All vessels in participating in this fishery. Administration Personal Identifying Information (for Classification example, name, address, etc.) 50 CFR Part 679 voluntarily submitted by the commenter This action responds to the best may be publicly accessible. Do not [Docket No. 0910131362–0087–02] available information recently obtained submit Confidential Business from the fishery. The Assistant RIN 0648–XV61 Information or otherwise sensitive or Administrator for Fisheries, NOAA protected information. (AA), finds good cause to waive the Fisheries of the Exclusive Economic NMFS will accept anonymous requirement to provide prior notice and Zone Off Alaska; Pollock in the West comments (enter N/A in the required opportunity for public comment Yakutat District of the Gulf of Alaska fields, if you wish to remain pursuant to the authority set forth at 5 anonymous). You may submit AGENCY: U.S.C. 553(b)(B) as such requirement is National Marine Fisheries attachments to electronic comments in Service (NMFS), National Oceanic and impracticable and contrary to the public Microsoft Word, Excel, WordPerfect, or interest. This requirement is Atmospheric Administration (NOAA), Adobe PDF file formats only. Commerce. impracticable and contrary to the public FOR FURTHER INFORMATION CONTACT: Josh interest as it would prevent NMFS from ACTION: Temporary rule; modification Keaton, 907–586–7228. of a closure. responding to the most recent fisheries SUPPLEMENTARY INFORMATION: NMFS data in a timely fashion and would SUMMARY: NMFS is opening directed manages the groundfish fishery in the delay the opening of pollock in the West fishing for pollock in the West Yakutat GOA exclusive economic zone Yakutat District of the GOA. NMFS was District of the Gulf of Alaska (GOA). according to the Fishery Management unable to publish a notice providing This action is necessary to fully use the Plan for Groundfish of the Gulf of time for public comment because the 2010 total allowable catch (TAC) of Alaska (FMP) prepared by the North most recent, relevant data only became pollock in the West Yakutat District of Pacific Fishery Management Council available as of March 25, 2010. the GOA. under authority of the Magnuson- The AA also finds good cause to Stevens Fishery Conservation and DATES: Effective 1200 hrs, Alaska local waive the 30–day delay in the effective Management Act. Regulations governing date of this action under 5 U.S.C. time (A.l.t.), March 26, 2010, through fishing by U.S. vessels in accordance 2400 hrs, A.l.t., December 31, 2010. 553(d)(3). This finding is based upon with the FMP appear at subpart H of 50 the reasons provided above for waiver of Comments must be received at the CFR part 600 and 50 CFR part 679. prior notice and opportunity for public following address no later than 4:30 NMFS closed directed fishing for comment. p.m., A.l.t., April 12, 2010. pollock in the West Yakutat District of ADDRESSES: Send comments to Sue the GOA under § 679.20(d)(1)(iii) on Without this inseason adjustment, Salveson, Assistant Regional March 23, 2010 (75 FR 14498, March 26, NMFS could not allow the fishery for Administrator, Sustainable Fisheries 2010). pollock in the West Yakutat District of Division, Alaska Region, NMFS, Attn: As of March 25, 2010, NMFS has the GOA to be harvested in an expedient Ellen Sebastian. You may submit determined that approximately 681 manner and in accordance with the comments, identified by RIN 0648– metric tons of pollock remain in the regulatory schedule. Under XV61, by any one of the following directed fishing allowance for pollock in § 679.25(c)(2), interested persons are methods: the West Yakutat District of the GOA. invited to submit written comments on • Electronic Submissions: Submit all Therefore, in accordance with this action to the above address until electronic public comments via the § 679.25(a)(1)(i), (a)(2)(i)(C), and April 12, 2010. Federal eRulemaking Portal: http:// (a)(2)(iii)(D), and to fully utilize the This action is required by § 679.20 www.regulations.gov. 2010 TAC of pollock in the West and § 679.25 and is exempt from review • Mail: P.O. Box 21668, Juneau, AK Yakutat District of the GOA, NMFS is under Executive Order 12866. 99802. terminating the previous closure and is Authority: 16 U.S.C. 1801 et seq. • Fax: (907) 586–7557. reopening directed fishing for pollock in • Hand delivery to the Federal the West Yakutat District of the GOA. Dated: March 26, 2010. Building: 709 West 9th Street, Room The Administrator, Alaska Region Emily H. Menashes, 420A, Juneau, AK. (Regional Administrator) considered the Acting Director, Office of Sustainable All comments received are a part of following factors in reaching this Fisheries, National Marine Fisheries Service. the public record. No comments will be decision: (1) the current catch of pollock [FR Doc. 2010–7231 Filed 3–26–10; 4:15 pm] posted to http://www.regulations.gov for in the West Yakutat District of the GOA BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 75, No. 61

Wednesday, March 31, 2010

This section of the FEDERAL REGISTER the instructions for sending your personal information you provide. We contains notices to the public of the proposed comments electronically. will also post a report summarizing each issuance of rules and regulations. The • Mail: Docket Management Facility, substantive verbal contact with FAA purpose of these notices is to give interested U.S. Department of Transportation, 1200 personnel concerning this proposed AD. persons an opportunity to participate in the New Jersey Avenue, SE., West Building Using the search function of the Web rule making prior to the adoption of the final rules. Ground Floor, Room W12–140, site, anyone can find and read the Washington, DC 20590–0001. comments in any of our dockets, • Hand Delivery: Deliver to Mail including, if provided, the name of the DEPARTMENT OF TRANSPORTATION address above between 9 a.m. and 5 individual who sent the comment (or p.m., Monday through Friday, except signed the comment on behalf of an Federal Aviation Administration Federal holidays. association, business, labor union, etc.). • Fax: (202) 493–2251. You may review the DOT’s complete 14 CFR Part 39 Contact Turbomeca, 40220 Tarnos, Privacy Act Statement in the Federal France; telephone 33 05 59 74 40 00; fax Register published on April 11, 2000 [Docket No. FAA–2009–0982; Directorate 33 05 59 74 45 15, for the service (65 FR 19477–78). Identifier 2009–NE–19–AD] information identified in this proposed Discussion RIN 2120–AA64 AD. The European Aviation Safety Agency Examining the AD Docket Airworthiness Directives; Turbomeca (EASA), which is the Technical Agent S.A. MAKILA 1A and 1A1 Turboshaft You may examine the AD docket on for the Member States of the European Engines the Internet at http:// Community, has issued EASA www.regulations.gov; or in person at the Airworthiness Directive 2009–0090, AGENCY: Federal Aviation Docket Operations office between 9 a.m. dated April 28, 2009 (referred to after Administration (FAA), DOT. and 5 p.m., Monday through Friday, this as ‘‘the MCAI’’), to correct an unsafe ACTION: Notice of proposed rulemaking except Federal holidays. The AD docket condition for the specified products. (NPRM). contains this proposed AD, the The MCAI states: regulatory evaluation, any comments The installation of TU250 CS boards, SUMMARY: We propose to adopt a new received, and other information. The however, has resulted in a few occurrences airworthiness directive (AD) for the street address for the Docket Operations of erratic engine behaviour, in the form of products listed above. This proposed office (telephone (800) 647–5527) is the unexpected N1 variations and/or AD results from mandatory continuing same as the Mail address provided in illumination of the ‘‘GOV’’ warning light. The airworthiness information (MCAI) the ADDRESSES section. Comments will conclusions from an investigation by issued by an aviation authority of be available in the AD docket shortly Turbomeca are that these malfunctions are another country to identify and correct after receipt. due to a lapse of quality control in the varnishing process applied to the boards, and an unsafe condition on an aviation FOR FURTHER INFORMATION CONTACT: product. The MCAI describes the unsafe that only boards in a specific serial number Kevin Dickert, Aerospace Engineer, ‘‘ ’’ condition as: The installation of TU250 range, as defined under Applicability and Engine Certification Office, FAA, Engine referred to below as the ‘‘suspect batch,’’ are CS boards, however, has resulted in a and Propeller Directorate, 12 New affected. few occurrences of erratic engine England Executive Park, Burlington, MA behaviour, in the form of unexpected N1 You may obtain further information by 01803; e-mail: [email protected]; examining the MCAI in the AD docket. variations and/or illumination of the telephone (781) 238–7117, fax (781) ‘‘GOV’’ warning light. The conclusions 238–7199. Relevant Service Information from an investigation by Turbome´ca are SUPPLEMENTARY INFORMATION: that these malfunctions are due to a Turbomeca S.A. has issued Mandatory Service Bulletins No. 298 73 lapse of quality control in the Comments Invited 0809, Version A, dated February 12, varnishing process applied to the We invite you to send any written boards, and that only boards in a 2008; and No. 298 73 0810, Version B, relevant data, views, or arguments about dated April 27, 2009. The actions specific serial number range, as defined this proposed AD. Send your comments ‘‘ ’’ described in this service information are under Applicability and referred to to an address listed under the below as the ‘‘suspect batch,’’ are intended to correct the unsafe condition ADDRESSES section. Include ‘‘Docket No. identified in the MCAI. affected. FAA–2009–0982; Directorate Identifier We are proposing this AD to prevent 2009–NE–19–AD’’ at the beginning of FAA’s Determination and Requirements loss of automatic engine control during your comments. We specifically invite of This Proposed AD flight due to an uncommanded engine comments on the overall regulatory, This product has been approved by roll-back, which could result in the economic, environmental, and energy the aviation authority of France, and is inability to continue safe flight. aspects of this proposed AD. We will approved for operation in the United DATES: We must receive comments on consider all comments received by the States. Pursuant to our bilateral this proposed AD by April 30, 2010. closing date and may amend this agreement with France, they have ADDRESSES: You may send comments by proposed AD based on those comments. notified us of the unsafe condition any of the following methods: We will post all comments we described in the MCAI and service • Federal eRulemaking Portal: Go to receive, without change, to http:// information referenced above. We are http://www.regulations.gov and follow www.regulations.gov, including any proposing this AD because we evaluated

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all information provided by EASA and this proposed AD and placed it in the board, P/N 0 177 99 716 0, with an S/N from determined the unsafe condition exists AD docket. 241EL to 1192EL (inclusive), that has fewer and is likely to exist or develop on other than 200 hours-since-new (HSN). Use List of Subjects in 14 CFR Part 39 products of the same type design. paragraph 2 of Turbomeca S.A. Mandatory Air transportation, Aircraft, Aviation Service Bulletin (MSB) No. 298 73 0809 Costs of Compliance safety, Incorporation by reference, Version A, dated February 12, 2008, to Based on the service information, we Safety. replace the boards. (2) During the next 500-hour inspection, estimate that this proposed AD would The Proposed Amendment affect about 10 products of U.S. registry. replace any CS board, P/N 0 177 99 716 0, We also estimate that it would take Accordingly, under the authority with a S/N from 241EL to 1192EL (inclusive), about 1 work-hour per product to delegated to me by the Administrator, that has 200 HSN or more. Use paragraph 2 comply with this proposed AD. The the FAA proposes to amend 14 CFR part of Turbomeca S.A. MSB No. 298 73 0810 average labor rate is $85 per work-hour. 39 as follows: Version B, dated April 27, 2009, to replace Required parts would cost about $3,500 the boards. PART 39—AIRWORTHINESS per product. Based on these figures, we FAA AD Differences estimate the cost of the proposed AD on DIRECTIVES (f) This AD differs from the Mandatory U.S. operators to be $35,850. 1. The authority citation for part 39 Continuing Airworthiness Information Authority for This Rulemaking continues to read as follows: (MCAI) and/or service information as Authority: 49 U.S.C. 106(g), 40113, 44701. follows: Title 49 of the United States Code (1) This AD requires replacing within 50 specifies the FAA’s authority to issue § 39.13 [Amended] operating hours after the effective date of this rules on aviation safety. Subtitle I, 2. The FAA amends § 39.13 by adding AD, all comparator/selector boards, P/N 0 section 106, describes the authority of the following new AD: 177 99 716 0, with an S/N from 241EL to the FAA Administrator. ‘‘Subtitle VII: Turbomeca S.A.: Docket No. FAA–2009– 1192EL (inclusive) that have fewer than 200 Aviation Programs,’’ describes in more HSN. detail the scope of the Agency’s 0982; Directorate Identifier 2009–NE– 19–AD. (2) This AD requires replacing at the next authority. 500-hour routine inspection after the We are issuing this rulemaking under Comments Due Date effective date of this AD, all comparator/ the authority described in ‘‘Subtitle VII, (a) We must receive comments by April 30, selector boards, P/N 0 177 99 716 0, with a Part A, Subpart III, Section 44701: 2010. S/N from 241EL to 1192EL (inclusive) that General requirements.’’ Under that Affected Airworthiness Directives (ADs) have 200 HSN or more. section, Congress charges the FAA with (b) None. promoting safe flight of civil aircraft in Other FAA AD Provisions air commerce by prescribing regulations Applicability (g) Alternative Methods of Compliance for practices, methods, and procedures (c) This AD applies to Turbomeca S.A. (AMOCs): The Manager, Engine Certification the Administrator finds necessary for Makila 1A and 1A1 turboshaft engines with Office, FAA, has the authority to approve safety in air commerce. This regulation a comparator/selector (CS) board, part AMOCs for this AD, if requested using the is within the scope of that authority number (P/N) 0 177 99 716 0, and a serial procedures found in 14 CFR 39.19. number (S/N) between 241EL and 1192EL because it addresses an unsafe condition Related Information that is likely to exist or develop on (inclusive) installed. These engines are installed on, but not limited to, Eurocopter (h) Refer to MCAI EASA Airworthiness products identified in this rulemaking AS 332 C, AS 332 C1, AS 332 L, and AS 332 action. Directive 2009–0090, dated April 28, 2009, L1 helicopters. and Turbomeca S.A. Mandatory Service Regulatory Findings Reason Bulletins No. 298 73 0809, Version A, dated February 12, 2008; and No. 298 73 0810, We determined that this proposed AD (d) The EASA AD 2009–0090, dated April Version B, dated April 27, 2009, for related would not have federalism implications 28, 2009, states that this AD results from the information. Contact Turbomeca, 40220 under Executive Order 13132. This following: Tarnos, France; telephone 33 05 59 74 40 00; proposed AD would not have a (1) The installation of TU250 CS boards, fax 33 05 59 74 45 15, for a copy of this substantial direct effect on the States, on however, has resulted in a few occurrences of erratic engine behaviour, in the form of service information. the relationship between the national unexpected N1 variations and/or (i) Contact Kevin Dickert, Aerospace Government and the States, or on the illumination of the ‘‘GOV’’ warning light. The Engineer, Engine Certification Office, FAA, distribution of power and conclusions from an investigation by Engine and Propeller Directorate, 12 New responsibilities among the various Turbome´ca are that these malfunctions are England Executive Park, Burlington, MA levels of government. due to a lapse of quality control in the 01803; e-mail: [email protected]; varnishing process applied to the boards, and For the reasons discussed above, I telephone (781) 238–7117, fax (781) 238– certify this proposed regulation: that only boards in a specific serial number ‘‘ ’’ 7199, for more information about this AD. 1. Is not a ‘‘significant regulatory range, as defined under Applicability and referred to below as the ‘‘suspect batch’’, are Issued in Burlington, Massachusetts, on action’’ under Executive Order 12866; affected. March 19, 2010. 2. Is not a ‘‘significant rule’’ under the (2) We are issuing this AD to prevent loss Peter A. White, DOT Regulatory Policies and Procedures of automatic engine control during flight due (44 FR 11034, February 26, 1979); and to an uncommanded engine roll-back, which Assistant Manager, Engine and Propeller 3. Will not have a significant could result in the inability to continue safe Directorate, Aircraft Certification Service. economic impact, positive or negative, flight. [FR Doc. 2010–7160 Filed 3–30–10; 8:45 am] on a substantial number of small entities Actions and Compliance BILLING CODE 4910–13–P under the criteria of the Regulatory (e) Unless already done, do the following Flexibility Act. actions. We prepared a regulatory evaluation (1) Within 50 operating hours from the of the estimated costs to comply with effective date of this AD, replace any CS

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DEPARTMENT OF TRANSPORTATION Communications should identify both Sound Low and Control 1234L Offshore docket numbers (FAA Docket No. FAA– Airspace Areas in Alaska. Federal Aviation Administration 2010–0071 and Airspace Docket No. 10– The Norton Sound Low Offshore AAL–1) and be submitted in triplicate to Airspace Area would be modified by 14 CFR Part 71 the Docket Management Facility (see lowering the offshore airspace floor to ADDRESSES section for address and 1,200 feet mean sea level (MSL) at the [Docket No. FAA–2010–0071; Airspace phone number). You may also submit Docket No. 10–AAL–1] following airports; within 73 miles of comments through the Internet at Clarks Point, King Salmon, Kivalina, RIN 2120–AA66 http://www.regulations.gov. Kwethluk, Napakiak, Scammon Bay, Commenters wishing the FAA to Shaktooklik, and Tooksook Bay; within Proposed Amendment of Norton acknowledge receipt of their comments 74 miles of Elim and Manokotak, and Sound Low and Control 1234L on this action must submit with those within 72.5 miles of Red Dog. Offshore Airspace Areas; Alaska comments a self-addressed, stamped postcard on which the following The Control 1234L Offshore Airspace AGENCY: Federal Aviation statement is made: ‘‘Comments to FAA Area would be modified by lowering the Administration (FAA), DOT. Docket No. FAA–2010–0071 and offshore airspace floor to 1,200 feet ACTION: Notice of proposed rulemaking Airspace Docket No. 10–AAL–1.’’ The above the surface within 73 miles of (NPRM). postcard will be date/time stamped and Nikolski, and Toksook Bay Airports. returned to the commenter. Offshore airspace areas are published SUMMARY: This action proposes to All communications received on or in paragraph 2003 of FAA Order modify the Norton Sound Low and before the specified closing date for 7400.9T dated August 27, 2009 and Control 1234L Offshore Airspace Areas comments will be considered before effective September 15, 2009, which is in Alaska. This action would lower the taking action on the proposed rule. The incorporated by reference in 14 CFR airspace floors to provide controlled proposal contained in this action may 71.1. The offshore airspace areas listed airspace beyond 12 miles from the coast be changed in light of comments in this document will be published of the United States given that there is received. All comments submitted will subsequently in the Order. a requirement to provide Instrument be available for examination in the The FAA has determined that this Flight Rules (IFR) en route Air Traffic public docket both before and after the proposed regulation only involves an Control (ATC) services and within closing date for comments. A report established body of technical which the United States is applying summarizing each substantive public regulations for which frequent and domestic ATC procedures. contact with FAA personnel concerned routine amendments are necessary to DATES: Comments must be received on with this rulemaking will be filed in the keep them operationally current. or before May 17, 2010. docket. Therefore, this proposed regulation: (1) ‘‘ ’’ ADDRESSES: Send comments on this Availability of NPRMs Is not a significant regulatory action proposal to the U.S. Department of under Executive Order 12866; (2) is not Transportation, Docket Operations, M– An electronic copy of this document a ‘‘significant rule’’ under Department of 30, 1200 New Jersey Avenue, SE., West may be downloaded through the Transportation (DOT) Regulatory Building Ground Floor, Room W12–140, Internet at http://www.regulations.gov. Policies and Procedures (44 FR 11034; Washington, DC 20590–0001; telephone: Recently published rulemaking February 26, 1979); and (3) does not (202) 366–9826. You must identify FAA documents can also be accessed through warrant preparation of a regulatory the FAA’s Web page at http:// evaluation as the anticipated impact is Docket No. FAA–2010–0071 and _ www.faa.gov/air traffic/publications/ so minimal. Since this is a routine Airspace Docket No. 10–AAL–1 at the _ beginning of your comments. You may airspace amendments/. matter that will only affect air traffic also submit comments through the You may review the public docket procedures and air navigation, it is Internet at http://www.regulations.gov. containing the proposal, any comments certified that this proposed rule, when received, and any final disposition in FOR FURTHER INFORMATION CONTACT: Ken promulgated, will not have a significant person in the Dockets Office (see economic impact on a substantial McElroy, Airspace and Rules Group, ADDRESSES section for address and Office of System Operations Airspace number of small entities under the phone number) between 9 a.m. and 5 criteria of the Regulatory Flexibility Act. and AIM, Federal Aviation p.m., Monday through Friday, except The FAA’s authority to issue rules Administration, 800 Independence Federal holidays. An informal docket regarding aviation safety is found in Avenue, SW., Washington, DC 20591; may also be examined during normal Title 49 of the United States Code. telephone: (202) 267–8783. business hours at the office of the Subtitle I, section 106 describes the SUPPLEMENTARY INFORMATION: Alaskan Service Center, Operations authority of the FAA Administrator. Support Group, Federal Aviation Comments Invited Subtitle VII, Aviation Programs, Administration, 222 West 7th Avenue, describes in more detail the scope of the Interested parties are invited to Box 14, Anchorage, AK 99513. participate in this proposed rulemaking Persons interested in being placed on agency’s authority. by submitting such written data, views, a mailing list for future NPRMs should This rulemaking is promulgated or arguments as they may desire. contact the FAA’s Office of Rulemaking, under the authority described in subtitle Comments that provide the factual basis (202) 267–9677, for a copy of Advisory VII, part A, subpart I, section 40103. supporting the views and suggestions Circular No. 11–2A, Notice of Proposed Under that section, the FAA is charged presented are particularly helpful in Rulemaking Distribution System, which with prescribing regulations to assign developing reasoned regulatory describes the application procedure. the use of the airspace necessary to decisions on the proposal. Comments ensure the safety of aircraft and the are specifically invited on the overall The Proposal efficient use of airspace. This regulation regulatory, aeronautical, economic, The FAA is proposing an amendment is within the scope of that authority as environmental, and energy-related to Title 14 Code of Federal Regulations it modifies offshore airspace areas in aspects of the proposal. (14 CFR) part 71 to modify the Norton Alaska.

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ICAO Considerations List of Subjects in 14 CFR Part 71 74-mile radius of the Manokotak Airport, AK, and within a 73-mile radius of the Napakiak As part of this proposal relates to Airspace, Incorporation by reference, Airport, AK, and within a 77.4-mile radius of navigable airspace outside the United Navigation (air). the Nome VORTAC, AK, and within a 71NM States, this notice is submitted in The Proposed Amendment radius of the New Stuyahok Airport, AK, and accordance with the International Civil within a 73-mile radius of the Noatak Aviation Organization (ICAO) In consideration of the foregoing, the Airport, AK, and within a 72.5-mile radius of International Standards and Federal Aviation Administration the Red Dog Airport, AK, and within a 73- mile radius of the Scammon Bay Airport, AK, Recommended Practices. proposes to amend 14 CFR part 71 as follows: and within a 73-mile radius of the Shaktoolik The application of International Airport, AK, and within a 74-mile radius of Standards and Recommended Practices PART 71—DESIGNATION OF CLASS A, the Selawik Airport, AK, and within a 73- by the FAA, Office of System B, C, D, AND E AIRSPACE AREAS; AIR mile radius of the St. Michael Airport, AK, and within a 73-mile radius of the Toksook Operations Airspace and AIM, Airspace TRAFFIC SERVICE ROUTES; AND and Rules Group, in areas outside the Bay Airport, AK, and within a 30-mile radius REPORTING POINTS of lat. 66°09′58″ N., long. 166°30′03″ W., and United States domestic airspace, is within a 30-mile radius of lat. 66°19′55″ N., governed by the Convention on 1. The authority citation for part 71 long. 165°40′32″ W., and that airspace International Civil Aviation. continues to read as follows: extending upward from 700 feet MSL within Specifically, the FAA is governed by Authority: 49 U.S.C. 106(g), 40103, 40113, 8 miles west and 4 miles east of the 339° Article 12 and Annex 11, which pertain 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– bearing from the Port Heiden NDB/DME, AK, to the establishment of necessary air 1963 Comp., p. 389. extending from the Port Heiden NDB/DME, navigational facilities and services to AK, to 20 miles north of the Port Heiden § 71.1 [Amended] promote the safe, orderly, and NDB/DME, AK, and within a 25-mile radius of the Nome Airport, AK. expeditious flow of civil air traffic. The 2. The incorporation by reference in purpose of Article 12 and Annex 11 is 14 CFR 71.1 of FAA Order 7400.9T, * * * * * to ensure that civil aircraft operations Airspace Designations and Reporting Control 1234L, AK [Amended] Points, signed August 27, 2009, and on international air routes are That airspace extending upward from performed under uniform conditions. effective September 15, 2009, is to be 2,000 feet above the surface within an area The International Standards and amended as follows: bounded by a line beginning at lat. 58°06′57″ Recommended Practices in Annex 11 N., long. 160°00′00″ W., then south along Paragraph 6007 Offshore Airspace Areas. ° ′ ″ apply to airspace under the jurisdiction 160 00 00 W. longitude, until it intersects of a contracting state, derived from * * * * * the Anchorage Air Route Traffic Control Center (ARTCC) boundary; then southwest, ICAO. Annex 11 provisions apply when Norton Sound Low, AK [Amended] northwest, north, and northeast along the air traffic services are provided and a That airspace extending upward from Anchorage ARTCC boundary to lat. 62°35′00″ contracting state accepts the 14,500 feet MSL within an area bounded by N., long. 175°00′00″ W., to lat. 59°59′57″ N., responsibility of providing air traffic a line beginning at lat. 56°42′59″ N., long. long. 168°00′08″ W., to lat. 57°45′57″ N., services over high seas or in airspace of 160°00′00″ W., north by a line 12 miles from long. 161°46′08″ W., to the point of undetermined sovereignty. A and parallel to the U.S. coastline to the beginning; and that airspace extending ° ′ ″ contracting state accepting this intersection with 164 00 00 W., longitude upward from 1,200 feet above the surface responsibility may apply the near the outlet to Kotzebue Sound, then within a 26.2-mile radius of Eareckson Air north to the intersection with a point 12 Station, AK, within an 11-mile radius of International Standards and miles from the U.S. coastline, then north by Adak Airport, AK, and within 16 miles of Recommended Practices that are a line 12 miles from and parallel to the Adak Airport, AK, extending clockwise from consistent with standards and practices shoreline to lat. 68°00′00″ N., to lat. 68°00′00″ the 033° bearing to the 081° bearing from the utilized in its domestic jurisdiction. N., long. 168°58′23″ W., to lat. 65°00′00″ N., Mount Moffett NDB, AK, and within a 10- In accordance with Article 3 of the long. 168°58′23″ W., to lat. 62°35′00″ N., mile radius of Atka Airport, AK, and within long. 175°00′00″ W., to lat. 59°59′57″ N., a 10.6-mile radius from Cold Bay Airport, Convention, state-owned aircraft are ° ′ ″ ° ′ ″ exempt from the Standards and long. 168 00 08 W., to lat. 57 45 57 N., AK, and within 9 miles east and 4.3 miles long. 161°46′08″ W., to lat. 58°06′57″ N., west of the 321° bearing from Cold Bay Recommended Practices of Annex 11. long. 160°00′00″ W., to the point of Airport, AK, extending from the 10.6-mile The United States is a contracting state beginning; and that airspace extending radius to 20 miles northwest of Cold Bay to the Convention. Article 3(d) of the upward from 1,200 feet MSL north of the Airport, AK, and 4 miles each side of the Convention provides that participating Alaska Peninsula and east of 160° W. 070° bearing from Cold Bay Airport, AK, state aircraft will be operated in longitude within 73 miles of the Port Heiden extending from the 10.6-mile radius to 13.6 international airspace with due regard NDB/DME, AK, and north of the Alaska miles northeast of Cold Bay Airport, AK, and for the safety of civil aircraft. Since this Peninsula and east of 160° W. longitude within a 26.2-mile radius of Eareckson Air ° action involves, in part, the designation within an 81.2-mile radius of the Perryville Station, AK, and west of 160 W. longitude of navigable airspace outside the United Airport, AK, and north of the Alaska within an 81.2-mile radius of Perryville Peninsula and east of 160° W. longitude Airport, AK, and within a 73-mile radius of States, the Administrator is consulting within a 72.8-mile radius of the Chignik the Nikolski Airport, AK, within a 74-mile with the Secretary of State and the Airport, AK, and within a 35-mile radius of radius of the Manokotak Airport, AK, and Secretary of Defense in accordance with lat. 60°21′17″ N., long. 165°04′01″ W., and within a 73-mile radius of the Clarks Point the provisions of Executive Order within a 73-mile radius of the Chevak Airport, AK and west of 160° W. longitude 10854. Airport, AK, and within a 73-mile radius of within a 73-mile radius of the Port Heiden the Clarks Point Airport, AK, and within a NDB/DME, AK, and within a 10-mile radius Environmental Review 73-mile radius of the Elim Airport, AK, and of St. George Airport, AK, and within a 73- This proposal will be subject to an within a 45-mile radius of the Hooper Bay mile radius of St. Paul Island Airport, AK, Airport, AK, and within a 73-mile radius of and within a 20-mile radius of Unalaska environmental analysis in accordance the King Salmon Airport, AK, and within a Airport, AK, extending clockwise from the with FAA Order 1050.1E, 73-mile radius of the Kivalina Airport, AK, 305° bearing from the Dutch Harbor NDB, ‘‘Environmental Impacts: Policies and and within a 74-mile radius of the Kotzebue AK, to the 075° bearing from the Dutch Procedures,’’ prior to any FAA final VOR/DME, AK, and within a 73-mile radius Harbor NDB, AK, and west of 160° W. regulatory action. of the Kwethluk Airport, AK, and within a longitude within a 25-mile radius of the

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Borland NDB/DME, AK, and west of 160° W. ENVIRONMENTAL PROTECTION INFORMATION CONTACT if you are faxing longitude within a 72.8-mile radius of AGENCY comments). Chignik Airport, AK; and that airspace • Mail: Callie Videtich, Director, Air extending upward from 700 feet above the 40 CFR Part 52 Program, Environmental Protection surface within a 6.9-mile radius of Eareckson [EPA–R08–OAR–2009–0282; FRL–9131–5] Agency (EPA), Region 8, Mailcode 8P– Air Station, AK, and within a 7-mile radius AR, 1595 Wynkoop Street, Denver, of Adak Airport, AK, and within 5.2 miles Approval and Promulgation of State Colorado 80202–1129. ° • northwest and 4.2 miles southeast of the 061 Implementation Plan Revisions; State Hand Delivery: Callie Videtich, bearing from the Mount Moffett NDB, AK, of North Dakota; Air Pollution Control Director, Air Program, Environmental extending from the 7-mile radius of Adak Rules, and Interstate Transport of Protection Agency (EPA), Region 8, Airport, AK, to 11.5 miles northeast of Adak Mailcode 8P–AR, 1595 Wynkoop, Pollution for the 1997 PM2.5 and 8-Hour Airport, AK, and within a 6.5-mile radius of Ozone NAAQS: ‘‘Significant Denver, Colorado 80202–1129. Such King Cove Airport, and extending 1.2 miles Contribution to Nonattainment’’ and deliveries are only accepted Monday ° either side of the 103 bearing from King ‘‘Interference With Prevention of through Friday, 8 a.m. to 4:30 p.m., Cove Airport from the 6.5-mile radius out to Significant Deterioration’’ excluding Federal holidays. Special 8.8 miles, and within a 6.4-mile radius of the Requirements arrangements should be made for Atka Airport, AK, and within a 6.3-mile deliveries of boxed information. radius of Nelson Lagoon Airport, AK, and AGENCY: Environmental Protection Instructions: Direct your comments to within a 6.3-mile radius of the Nikolski Agency (EPA). Docket ID No. EPA–R08–OAR–2009– Airport, AK, and within a 6.4-mile radius of ACTION: Proposed rule. 0282. EPA’s policy is that all comments Sand Point Airport, AK, and within 3 miles received will be included in the public each side of the 172° bearing from the SUMMARY: The Environmental Protection docket without change and may be Borland NDB/DME, AK, extending from the Agency is proposing to approve State made available online at http:// 6.4-mile radius of Sand Point Airport, AK, to Implementation Plan (SIP) revisions www.regulations.gov, including any 13.9 miles south of Sand Point Airport, AK, submitted by the State of North Dakota personal information provided, unless and within 5 miles either side of the 318° on April 6, 2009. Specifically, EPA is the comment includes information bearing from the Borland NDB/DME, AK, proposing approval of revisions to the claimed to be Confidential Business extending from the 6.4-mile radius of Sand North Dakota air pollution control rules Information (CBI) or other information Point Airport, AK, to 17 miles northwest of regarding prevention of significant whose disclosure is restricted by statute. Sand Point Airport, AK, and within 5 miles deterioration of air quality, and partial Do not submit information that you either side of the 324° bearing from the approval of the SIP revision ‘‘Interstate consider to be CBI or otherwise Borland NDB/DME, AK, extending from the Transport of Air Pollution’’ addressing protected through http:// 6.4-mile radius of Sand Point Airport, AK, to the requirements of Clean Air Act www.regulations.gov or e-mail. The 17 miles northwest of the Sand Point Airport, section 110(a)(2)(D)(i) for the 1997 PM2.5 http://www.regulations.gov Web site is AK, and within a 6.6-mile radius of St. and 8-hour ozone National Ambient Air an ‘‘anonymous access’’ system, which George Airport, AK, and within an 8-mile Quality Standards (NAAQS). For the means EPA will not know your identity radius of St. Paul Island Airport, AK, and 8 latter, EPA proposes approval of the or contact information unless you miles west and 6 miles east of the 360° North Dakota Interstate Transport SIP provide it in the body of your comment. bearing from St. Paul Island Airport, AK, to sections that address the requirements If you send an e-mail comment directly 14 miles north of St. Paul Island Airport, AK, of section 110(a)(2)(D)(i) prohibiting a to EPA, without going through http:// and within 6 miles west and 8 miles east of state’s emissions from contributing www.regulations.gov, your e-mail ° the 172 bearing from St. Paul Island Airport, significantly to any other state’s address will be automatically captured AK, to 15 miles south of St. Paul Island nonattainment of the NAAQS, or from and included as part of the comment Airport, AK, and within a 6.4-mile radius of interfering with any other state’s that is placed in the public docket and Unalaska Airport, AK, and within 2.9 miles required measures to prevent significant made available on the Internet. If you ° each side of the 360 bearing from the Dutch deterioration of its air quality. EPA will submit an electronic comment, EPA Harbor NDB, AK, extending from the 6.4-mile act at a later date on the North Dakota recommends that you include your radius of Unalaska Airport, AK, to 9.5 miles Interstate Transport SIP sections that name and other contact information in north of Unalaska Airport, AK; and that address the remaining two requirements the body of your comment and with any airspace extending upward from the surface of section 110(a)(2)(D)(i), prohibiting a disk or CD–ROM you submit. If EPA within a 4.6-mile radius of Cold Bay Airport, state’s emissions from interfering with cannot read your comment due to AK, and within 1.7 miles each side of the any other state’s maintenance of the ° technical difficulties and cannot contact 150 bearing from Cold Bay Airport, AK, NAAQS, or with any other state’s you for clarification, EPA may not be extending from the 4.6-mile radius to 7.7 required measures to protect visibility. able to consider your comment. miles southeast of Cold Bay Airport, AK, and This action is being taken under section Electronic files should avoid the use of within 3 miles west and 4 miles east of the 110 of the Clean Air Act. special characters, any form of 335° bearing from Cold Bay Airport, AK, DATES: Comments must be received on encryption, and be free of any defects or extending from the 4.6-mile radius to 12.2 viruses. For additional instructions on miles northwest of Cold Bay Airport, AK. or before April 30, 2010. ADDRESSES: Submit your comments, submitting comments, go to Section I. Issued in Washington, DC, on March 24, identified by Docket ID No. EPA–R08– General Information of the 2010. OAR–2009–0282, by one of the SUPPLEMENTARY INFORMATION section of Kelly Neubecker, following methods: this document. Acting Manager, Airspace and Rules Group. • http://www.regulations.gov. Follow Docket: All documents in the docket [FR Doc. 2010–7266 Filed 3–30–10; 8:45 am] the on-line instructions for submitting are listed in the http:// www.regulations.gov index. Although BILLING CODE 4910–13–P comments. • E-mail: [email protected] and listed in the index, some information is [email protected]. not publicly available, e.g., CBI or other • Fax: (303) 312–6064 (please alert information whose disclosure is the individual listed in the FOR FURTHER restricted by statute. Certain other

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material, such as copyrighted material, complete version of the comment that to nonattainment of the NAAQS in any will be publicly available only in hard includes information claimed as CBI, a other state, element (1), and interference copy. Publicly-available docket copy of the comment that does not with required measures by any other materials are available either contain the information claimed as CBI state to prevent significant deterioration electronically in http:// must be submitted for inclusion in the (PSD) of its air quality, element (3). www.regulations.gov or in hard copy at public docket. Information so marked III. What Is the State Process To Submit the Air Program, Environmental will not be disclosed except in This Material to EPA? Protection Agency (EPA), Region 8, accordance with procedures set forth in Mailcode 8P–AR, 1595 Wynkoop, 40 CFR part 2. Section 110(k) of the CAA addresses Denver, Colorado 80202–1129. EPA 2. Tips for Preparing Your Comments. EPA’s rulemaking action on SIP requests that if at all possible, you When submitting comments, remember submissions by states. The CAA contact the individual listed in the FOR to: requires states to observe certain FURTHER INFORMATION CONTACT section to a. Identify the rulemaking by docket procedural requirements in developing view the hard copy of the docket. You number and other identifying SIP revisions for submittal to EPA. may view the hard copy of the docket information (subject heading, Federal Section 110(a)(2) of the CAA requires Monday through Friday, 8 a.m. to 4 Register date and page number). that each SIP revision be adopted after p.m., excluding Federal holidays. b. Follow directions—The agency may reasonable notice and public hearing. FOR FURTHER INFORMATION CONTACT: ask you to respond to specific questions This must occur prior to the revision Domenico Mastrangelo, Air Program, or organize comments by referencing a being submitted by a state to EPA. U.S. Environmental Protection Agency, Code of Federal Regulations (CFR) part The North Dakota Department of Region 8, Mailcode 8P–AR, 1595 or section number. Health (NDDH) held a public hearing on c. Explain why you agree or disagree; Wynkoop, Denver, Colorado 80202– October 7, 2008 for revisions to suggest alternatives and substitute 1129, (303) 312–6436, subsection 33–15–15–01.02 of the language for your requested changes. [email protected]. NDAC and for the addition to the North d. Describe any assumptions and Dakota SIP of the Interstate Transport SUPPLEMENTARY INFORMATION: provide any technical information and/ non-regulatory provisions. The NDDH or data that you used. Definitions adopted the provisions on April 1, 2009 e. If you estimate potential costs or and submitted them to EPA on April 6, For the purpose of this document, we burdens, explain how you arrived at 2009. are giving meaning to certain words or your estimate in sufficient detail to In a March 2, 2010 email, EPA initials as follows: allow for it to be reproduced. requested that the North Dakota Air (i) The words or initials Act or CAA f. Provide specific examples to Quality Division clarify the State mean or refer to the Clean Air Act, illustrate your concerns, and suggest commitment, stated in the Interstate unless the context indicates otherwise. alternatives. Transport SIP submitted to EPA April 6, g. Explain your views as clearly as (ii) The words EPA, we, us or our 2009, to EPA’s interim policy on the use possible, avoiding the use of profanity mean or refer to the United States of PM as surrogate for PM . In a or personal threats. 10 2.5 Environmental Protection Agency. March 8, 2010 letter to the Region 8 Air h. Make sure to submit your (iii) The initials SIP mean or refer to Program, the North Dakota Air Quality comments by the comment period State Implementation Plan. Division clarified its interpretation of deadline identified. (iv) The words North Dakota and EPA’s Surrogate Policy. This State mean the State of North Dakota. II. What Action Is EPA Proposing? correspondence is included in this Table of Contents EPA is proposing approval of action’s supporting docket available for public review. I. General Information revisions to the State provisions on the What Should I Consider as I Prepare My prevention significant deterioration We have evaluated the submittal by Comments for EPA? (PSD) of air quality in subsection 33– the NDDH and have determined that the II. What Action Is EPA Proposing? 15–15–01.2 of the North Dakota State met the requirements of section III. What Is the State Process to Submit This Administrative Code (NDAC), and is 110(a)(2) of the CAA for reasonable Material to EPA? also proposing partial approval of the notice and public hearing. IV. EPA’s Review and Technical Information North Dakota Interstate Transport of Air A. Prevention of Significant Deterioration IV. EPA’s Review and Technical Provisions Pollution SIP for the 1997 PM2.5 and 8- Information hour ozone National Ambient Air B. Interstate Transport SIP A. Prevention of Significant V. Proposed Action Quality Standards (NAAQS). The VI. Statutory and Executive Order Reviews revisions to NDAC subsection 33–15– Deterioration Provisions 15–01.2, and the addition to the North The revisions to subsection 33–15– I. General Information Dakota SIP of section 7.8, ‘‘Interstate 15–01.2 updated to August 1, 2007 the What should I consider as I prepare Transport of Air Pollution,’’ were baseline date for incorporation by my comments for EPA? adopted by the State of North Dakota on reference of the Federal requirements at 1. Submitting CBI. Do not submit CBI April 1, 2009 and submitted to EPA on 40 CFR 52.21. In addition, various to EPA through http:// April 6, 2009. EPA is proposing to administrative corrections and www.regulations.gov or e-mail. Clearly approve the revision of NDAC clarifications were made. As these mark the part or all of the information subsection 33–15–15–01.02, revisions were made to make the PSD that you claim to be CBI. For CBI incorporating changes to 40 CFR 52.21 provisions consistent with Federal information in a disk or CD ROM that made by EPA through August 1, 2007. requirements, they are approvable. you mail to EPA, mark the outside of the EPA also proposes to approve the disk or CD ROM as CBI and then language and demonstrations of the B. Interstate Transport SIP identify electronically within the disk or North Dakota Interstate Transport SIP The interstate transport provisions at CD ROM the specific information that is that address two elements of section CAA section 110(a)(2)(D)(i), also claimed as CBI. In addition to one 110(a)(2)(D)(i): significant contribution referred to as the ‘‘good neighbor’’

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provisions, require that each state SIP section 110(a)(2)(D)(i) are consistent designated both areas nonattainment for contain adequate provisions prohibiting with EPA’s 2006 guidance and the violations of the 1997 annual PM2.5 emissions that adversely affect another referenced implementation rules for standards. See 70 FR 944 (January 5, state’s air quality through interstate ozone and PM2.5. 2005), and 40 CFR 81.314 and 81.327. transport of air pollutants. Section A number of considerations provide Significant Contribution Element— 110(a)(2)(D)(i) contains four evidence that North Dakota emissions PM requirements or elements: (1) 2.5 are unlikely to contribute significantly Significant contribution to Section 110(a)(2)(D)(i) provides that to the violations of the 1997 annual nonattainment of the NAAQS in any EPA cannot approve a state’s SIP for a PM2.5 standards in Libby. First, Libby is other state; (2) interference with new or revised NAAQS unless it more than 650 miles straight west of maintenance of the NAAQS by any contains adequate measures to prohibit Bismarck, and any impact from North other state; (3) interference with any emissions from sources within the state Dakota emissions would have to rely on other state’s required measures to from contributing significantly to strong easterly winds that rarely occur prevent significant deterioration of its nonattainment of the NAAQS in another in the State.3 This substantial distance air quality; and (4) interference with any state. EPA’s August 15, 2006, guidance and the rarity of easterly surface winds, other state’s required measures to to states concerning section while not outcome determinative given protect visibility. On August 15, 2006, 110(a)(2)(D)(i) recommended various the distances across which PM2.5 can EPA issued guidance for SIP methods by which states might evaluate transport, support a conclusion that submissions addressing the section whether or not its emissions North Dakota emissions are unlikely to 110(a)(2)(D)(i) requirements for the 1997 significantly contribute to violations of contribute significantly to violations of 1 PM2.5 and 8-hour ozone standards. In the 1997 PM2.5 standards in another the 1997 annual PM2.5 standard in November 2005 (70 FR 71612) and May state. Among other methods, EPA Libby. Second, in the process of 2008 (43 FR 28321), EPA finalized recommended consideration of available designating Libby nonattainment for regulations implementing Phase II of the EPA modeling conducted in these standards, EPA noted the 1997 8-hour ozone NAAQS, and the conjunction with CAIR, or in the predominantly local origins of PM2.5 New Source Review (NSR) Program for absence of such EPA modeling, nonattainment in Libby.4 While the the 1997 PM2.5 NAAQS. consideration of other information such predominance of local sources does not To demonstrate that its SIP satisfies as the amount of emissions, the alone rule out the possibility of impacts the requirements for significant geographic location of violating areas, from interstate transport, this fact in contribution to nonattainment, North meteorological data, or various other conjunction with the distance and the Dakota relies on a combination of: (a) forms of information that would be near absence of easterly winds in North EPA modeling analysis results relevant to assessing the likelihood of Dakota supports a conclusion that North published in Federal Register notices as significant contribution to violations of Dakota emissions are unlikely to part of the Clean Air Interstate Rule the NAAQS in another state. It should contribute significantly to violations in (CAIR) rulemaking process; 2 (b) be noted that significant contribution to Libby. Third, during the ten years for monitoring data gathered by states and nonattainment is not restricted to which monitoring data are available, reported to EPA in the Air Quality impacts upon areas that are formally from 1999 to 2008, annual PM2.5 design System (AQS) database; and (c) designated nonattainment. Consistent values at all other monitors in Montana consideration of geographical and with EPA’s approach in CAIR, this remained significantly below the 15 μg/ meteorological factors affecting the impact must be evaluated with respect m3 nonattainment threshold. Annual to monitors showing a violation of the likelihood of significant pollution PM2.5 design values for most of these transport from North Dakota to the NAAQS (70 FR 25172, May 12, 2005, monitors remained at levels equal to, or and 63 FR 57371, October 27, 1998). closest PM2.5 and 8-hour ozone less than, two thirds of the NAAQS. nonattainment areas or violating Furthermore, although relevant Even the three highest design values at monitors in other states. In this action information other than modeling may be these monitors were 20 percent lower EPA also expands on the analysis of considered in assessing the likelihood of than the level of the annual standard.5 geographical and meteorological factors, significant contribution to violations of The fact that monitors located the 1997 PM2.5 standard in another state, and of ozone and PM2.5 concentration between North Dakota and Libby are not levels reflecting AQS monitoring data. EPA notes that no single piece of registering violations of the NAAQS EPA deems that the North Dakota information in the following discussion does not conclusively establish that Interstate Transport SIP sections is by itself dispositive of the issue. emissions from North Dakota could not addressing requirements (1) and (3) of Instead, the total weight of all the contribute in the aggregate to violations evidence taken together supports the 1 Memorandum from William T. Harnett entitled conclusion that emissions within North 3 Distances from Bismarck, North Dakota, to areas ‘‘Guidance for State Implementation Plan (SIP) Dakota do not significantly contribute to in other states are intended to approximate the Submissions to Meet Current Outstanding violations in another state of the 1997 average transport distance of emissions from sources in North Dakota to such areas. For surface Obligations Under Section 110(a)(2)(D)(i) for the 8- PM2.5 standard. ‘‘ hour Ozone and PM2.5 National Ambient Air Although significant contribution wind directions, see Climate of North Dakota- Quality Standards,’’ (Aug. 15, 2006) (‘‘2006 Wind,’’ USGS web page at http:// Guidance’’). This EPA guidance document is one of must be measured not just against www.npwrc.usgs.gov/resource/habitat/climate/ the documents available for review in the docket nonattainment areas, but against areas wind.htm, visited February 10, 2010, and available document entitled: ‘‘Relevant Guidance and with monitors showing violations of the for review in EPA’s January 14, 2010 docket Supporting Documentation for the Proposed NAAQS, nonattainment areas are a memorandum: ‘‘Relevant Guidance and Supporting Rulemaking Federal Register Action Docket ID # Documentation for the Proposed Rulemaking EPA–R08–OAR–2009–0282.’’ convenient starting point for the Federal Register Action Docket ID # EPA–R08– 2 In this action the expression ‘‘CAIR’’ refers to the analysis. For the 1997 annual PM2.5 OAR–2009–0282.’’ final rule published in the May 12, 2005 Federal standard, Libby, in Lincoln County, 4 ‘‘Technical Support for State and Tribal Air Register and entitled ‘‘Rule to Reduce Interstate Montana, and Chicago, in Cook County, Quality Fine Particle (PM2.5) Designations,’’ Chapter Transport of Fine Particulate Matter and Ozone 6, pp. 347–352, December 2004. (Clean Air Interstate Rule); Revisions to Acid Rain Illinois, are the designated 5 In 2001, 2002 and 2006, design values for two Program; Revisions to NOX SIP Call; Final Rule’’ (70 nonattainment areas closest to the State monitors in Missoula County were 11.1, 11.4 and FR 25162). of North Dakota. In 2005, EPA 11.8 μg/m3. Computed from AQS monitoring data.

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in Libby, but this fact combined with contribution to nonattainment areas, but to 14.1 μg/m3 in Clinton County, and other relevant evidence such as the also to areas with monitors showing from 12.5 to 13.3 μg/m3 in Muscatine distance, wind direction, and localized violations of the NAAQS. A review of County. nature of the violations in Libby again the AQS monitoring data for adjacent The data and weight of evidence supports the North Dakota’s Interstate downwind states shows that it is highly analysis presented above support the Transport SIP conclusion on PM2.5 unlikely that emissions from North conclusion of the North Dakota contribution. Finally, by 2007–2008, the Dakota contribute significantly to Interstate Transport SIP (adopted April annual PM2.5 design values for the Libby downwind areas that have monitors 1, 2009 and submitted April 6, 2009) nonattainment area itself fell below the showing violations of the 1997 24-hour that emissions from North Dakota do not level of the NAAQS, a reduction and annual PM2.5 NAAQS. Between contribute significantly to attributed to an effective wood stove 1999 and 2008 there were no violations nonattainment in any other state for the replacement program that decreased of the 1997 PM2.5 NAAQS at any of the 1997 PM2.5 NAAQS, consistently with PM2.5 emissions by approximately 59 monitors in adjacent downwind states, the requirements of element (1) of CAA percent.6 In other words, were there such as Minnesota, South Dakota and section 110(a)(2)(D)(i). 9 emissions from North Dakota sources Iowa. Significant Contribution Element— In South Dakota, monitors in reaching Libby, they would no longer be 8-Hour Ozone significantly contributing to violations Minnehaha and Brookings Counties had of the NAAQS in that location. the highest design values for 1997 24- As noted above, Section Similarly, available information hour PM2.5 standards during the 1999– 110(a)(2)(D)(i) provides that EPA cannot indicates that North Dakota emissions 2008 period. Their design values approve a state’s SIP for a new or are unlikely to contribute significantly ranged, respectively, from 23 to 28 and revised NAAQS unless it contains to the violations of the 1997 annual from 21 to 26 μg/m3, as compared with adequate measures to prohibit emissions PM2.5 standards in Cook County Illinois. the 1997 24-hour PM2.5 NAAQS of 65 from sources within the state from 3 In its rulemaking process for CAIR, EPA μg/m . For annual PM2.5, Codington and contributing significantly to determined which states should be Minnehaha Counties had the monitors nonattainment of the NAAQS in another subject to the rule due to their with the highest design values, ranging state. EPA’s August 15, 2006, guidance significant contribution to from 9.5 to 10.3 μg/m3, and from 9.3 to to states concerning section 3 nonattainment of the 1997 PM2.5 10.4 μg/m , respectively, as compared to 110(a)(2)(D)(i) recommended various NAAQS in other states. This the annual NAAQS of 15 μg/m3. methods by which states might evaluate determination included a modeling In Minnesota, during 1999–2008, the whether or not its emissions analysis of the contributions by upwind highest design values for 1997 24-hour significantly contribute to violations of states to a violating monitor in Cook PM2.5 NAAQS occurred for monitors in the 1997 ozone standards in another County, which is approximately 750 the Twin Cities’ Hennepin and Ramsey state. Among other methods, EPA miles southeast of Bismarck, North Counties, where they ranged, recommended consideration of available Dakota. According to modeling cited in respectively, from 23 to 32 and from 26 EPA modeling conducted in the CAIR proposal of January 30, 2004 to 36 μg/m3. The highest design values conjunction with CAIR, or in the (69 FR 4566), EPA estimated that the for annual PM2.5 reflected PM2.5 absence of such EPA modeling, maximum contribution by emissions monitored levels also in these two consideration of other information such from sources in North Dakota to counties, and ranged, respectively, from as the amount of emissions, the downwind counties predicted to have 8.9 to 11.9 μg/m3 and from 10.7 to 13.8 geographic location of violating areas, 3 violating monitors for the PM2.5 annual μg/m . It must be noted that the highest meteorological data, or various other standard in the 2010 base year was to design value of 13.8 μg/m3, for a forms of information that would be Cook County. EPA estimated that the monitor in Ramsey County, reflected relevant to assessing the likelihood of North Dakota annual average annual PM2.5 concentrations registered significant contribution to violations of contribution to Cook County would be during the 1999–2001 time span. After the NAAQS in another state. The 3 0.12 μg/m (Table V–5, 69 FR 4608), an 2001, PM2.5 concentrations in Ramsey assessment of significant contribution to amount well below 0.20 μg/m3, the County decreased steadily, and between nonattainment is not restricted to threshold set by EPA in CAIR for the 2006 and 2008 the highest design value impacts upon areas that are formally initial determination of whether a state for any of the Minnesota monitoring designated nonattainment. Consistent would be subject to the rule (70 FR stations was 11.2 μg/m3, significantly with EPA’s approach in CAIR, this 25188–91).7 The CAIR modeling below the annual NAAQS. impact must be evaluated with respect analysis thus provides support for the In Iowa, the highest 24-hour PM2.5 to monitors showing a violation of the conclusion that emissions from North design values during the 1999–2008 NAAQS (70 FR 25172, May 12, 2005, Dakota are not significantly contributing years reflected pollutant concentrations and 63 FR 57371, October 27, 1998). to violations of the 1997 annual PM2.5 registered at monitors in Clinton and Furthermore, although relevant NAAQS in Cook County.8 Muscatine Counties. In these counties, information other than modeling may be As mentioned above, EPA must design values ranged, respectively, from considered in assessing the likelihood of consider not only significant 28 to 36 and from 34 to 38 μg/m3, as significant contribution to violations of compared with the 1997 24-hour PM2.5 the 1997 8-hour ozone standard in 6 State of Montana, Department of Environmental NAAQS of 65 μg/m3. The highest another state, EPA notes that no single Quality, ‘‘State Implementation Plan-Libby Annual annual PM2.5 design values occurred in piece of information in the following PM2.5 Control Plan,’’ submitted to EPA April 1, 2008. the same counties, and ranged from 11.7 discussion is by itself dispositive of the 7 This threshold was upheld by the U.S. Court of issue. Instead, the total weight of all the Appeals for the DC Circuit in its adjudication of 9 Unless otherwise referenced, for AQS evidence taken together supports the consolidated challenges to CAIR. See North monitoring data and related design values conclusion that emissions from North Carolina v. EPA, 531 F.3d 896, 930 (DC Cir. 2008). referenced in this action see Table 1 and Table 2 Dakota sources are unlikely to 8 As EPA only evaluated sources of NOX and SO2 in the docket document entitled: ‘‘Relevant in CAIR, the CAIR modeling analysis, like the other Guidance and Supporting Documentation for the contribute significantly to violations in evidence considered in this action, is not by itself Proposed Rulemaking Federal Register Action another state of the 1997 8-hour ozone dispositive of the issue of significant contribution. Docket ID # EPA–R08–OAR–2009–0282.’’ standard.

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Although significant contribution possibility of significant contribution to states.15 However, the CAIR modeling must be measured not just against this area’s nonattainment. analysis results for Minnesota provide nonattainment areas, but against areas Another transport factor is wind us the opportunity to draw inferences with monitors showing violations of the direction. Research for North Dakota about ozone contribution from North NAAQS, nonattainment areas are a and states immediately to the south and Dakota sources to nonattainment in the convenient starting point for the east shows that in North Dakota both Illinois/Wisconsin area. It must be noted analysis. For the 1997 8-hour ozone surface and regional transport winds that Minnesota is nearly half as distant NAAQS, the North Dakota Interstate from the northeast, needed to transport from this nonattainment area as North Transport SIP revision identifies the ozone to the DMA/NFR area, are Dakota (400 miles as compared with Denver Metro Area/North Front Range generally rare. Thirty years of data 700),16 and that to reach the Illinois/ (DMA/NFR) in Colorado, and the collected by the United States Wisconsin nonattainment area, ozone Illinois and Wisconsin counties along Geological Survey (USGS) on surface transport winds from Minnesota would the southwestern shores of Lake wind direction for several North Dakota have to have a northwesterly orientation Michigan as the closest designated locations show that there was much similar to that necessary for substantial nonattainment areas.10 EPA’s evaluation variability by location and time of the ozone transport from North Dakota. In of whether emissions from North Dakota year, with the exception of northeasterly addition, the CAIR modeling analysis contribute significantly to the ozone winds, which were very infrequent.12 estimated the Minnesota’s NOX nonattainment in these areas is based on For long range transport winds, a emissions for the 2010 base year to be an examination of how geographical and modeling analysis of ozone dispersion approximately twice as large as the NOX meteorological factors affect transport during the summer months (June to emissions from North Dakota’s sources from North Dakota to the two areas August) of the five year period 1991– (381,500 as compared with 182, 800 noted above. Our approach does not rely 1995 shows that on high local ozone tons).17 Finally, the CAIR analysis on a quantitative determination of North days North Dakota and states determined that emissions from Dakota’s contribution, as EPA did for immediately to the south or east were Minnesota were below the initial other states in its CAIR rulemaking, but characterized by southerly regional threshold for including states in CAIR.18 on a weight-of-evidence analysis based transport winds. On high regional ozone In light of this CAIR determination, and on qualitative assessments and days, during the same period transport of Minnesota’s larger NOX emissions estimates of the relevant factors. While winds did not have a prevailing and shorter distance to the conclusions reached for each of the orientation, and certainly not a nonattainment area, it is plausible to factors considered in the following northeasterly one.13 To the extent that conclude that NOX emissions from analysis are not in and by themselves these results are representative of North Dakota sources are not likely to determinative, consideration of the general ozone transport patterns not contribute significantly to likely effect of all factors provides a limited to the 1991–95 period, the rarity nonattainment of the 1997 8-hour ozone reliable qualitative conclusion on of northeasterly winds in North Dakota standard in the Illinois and Wisconsin whether North Dakota’s emissions are and adjacent areas provides evidence counties along the southwestern shores likely to contribute significantly to that NO emissions from North Dakota of Lake Michigan. X Additional ozone transport factors nonattainment in the DMA/NFR area are likely to be transported in a specific to North Dakota are distance and the Illinois/Wisconsin Counties. direction away from the Colorado DMA/ The DMA/NFR nonattainment area is from the nonattainment area and NFR nonattainment area, and therefore approximately 550 miles southwest of prevailing orientation of the winds. As supports the conclusion that emissions Bismarck, North Dakota.11 Distance per noted above, Bismarck is approximately sources in North Dakota are unlikely to se is not an obstacle to long range 700 miles from the Illinois/Wisconsin contribute significantly to violations of transport of ozone and/or its precursors, nonattainment area, a distance which the 1997 ozone NAAQS in Denver.14 as discussed in the January 30, 2004 does not exclude the realistic possibility notice proposing CAIR (69 FR 4599); The Illinois/Wisconsin counties along that significant ozone transport might the southwestern shores of Lake NOX (the primary ozone precursor that occur. Research on surface wind was the object of the CAIR transport Michigan (which make up the other direction in North Dakota, reflected in study) may be transported for long nonattainment area within possible the USGS data referenced earlier, shows distances, contributing significantly to transport distance of North Dakota) are a great variability depending on location high ozone concentrations in other approximately 700 miles east-southeast and time of the year. Northwesterly states. However, with increasing from Bismarck. The CAIR modeling winds are more frequent than distance there are greater opportunities domain for 8-hour ozone transport southwesterly or southeasterly winds analysis included only the eastern half for ozone and/or NOX dispersion and/or considered separately, but less frequent removal from the atmosphere due to the of North Dakota, and the CAIR modeling effects of winds and chemical sink analysis did not determine whether 15 69 FR 4584 (Jan. 30, 2004) (‘‘We are deferring processes. In this context, one may NOX emissions from North Dakota findings for Texas, Oklahoma, Kansas, Nebraska, conclude that the 550 mile distance sources contributed significantly to South Dakota and North Dakota, which at this time ozone nonattainment in any downwind cannot be assessed on the same bases as States to between North Dakota and the DMA/ the east because they are only partially included in NFR reduces but does not exclude the the modeling domain * * *’’). 12 See USGS data in EPA’s January 14, 2010 16 The 400 mile distance to the nonattainment 10 The Wisconsin nonattainment areas for the docket memorandum: ‘‘Relevant Guidance and area is calculated from St. Cloud, and is intended 1997 8-hour ozone standard include: Door, Supporting Documentation for the Proposed to be a rough approximation of the average Kewaunee, Manitowoc, Sheboygan, Ozaukee, Rulemaking Federal Register Action Docket ID # transport distance of NOX emission sources from Washington, Milwaukee, Waukesha, Racine and EPA–R08–OAR–2009–0282.’’ Minnesota. Kenosha counties; the Chicago nonattainment area 13 Ozone Transport Assessment Group (OTAG), 17 69 FR 4590. includes Cook County and several adjacent Illinois Air Quality Analysis Workgroup, ‘‘3.3 Climatology 18 Minnesota was not listed among the upwind and Indiana counties (69 FR 23858, April 30, 2004). of Ozone Synoptic scale Transport in the Eastern states that contribute significantly to downwind 11 Distances from Bismarck, North Dakota, to US,’’ Figures 1(a) and 5(a), pp. 3, 6, January 11, counties projected nonattainment for 8-hour ozone areas in other states are intended to approximate 1998. The high ozone days included the days with in the 2010 base year, and is not a CAIR state for the average transport distance of emissions from ozone concentrations in the 90th percentile. the 8-hour ozone standard. 69 FR 4602, Table V– sources in North Dakota to such areas. 14 Ibid. 2; 70 FR 25167.

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than the two combined. On the other 2004. In other words, were there significant deterioration of its air hand, as noted earlier in this review, emissions from North Dakota sources quality. The State of North Dakota during the ozone season of the years reaching the Illinois and Wisconsin interstate transport SIP is consistent 1991–1995, on local high ozone days counties along the western rim of Lake with the 2006 guidance. The SIP regional transport winds in North Michigan, they would no longer be indicates in Section 7.8.1, subsection C, Dakota were predominantly southerly, significantly contributing to violations ‘‘Impact on Prevention of Significant and on high regional ozone days they of the NAAQS in that area.21 Deterioration (PSD),’’ that the State’s SIP lacked a prevailing orientation. There As mentioned above, EPA must provisions include an EPA-approved was no strong northwesterly component consider not only significant PSD program applicable to all regulated that might allow for significant transport contribution to nonattainment areas, but pollutants. North Dakota’s regulations 19 of NOX to the Illinois/Wisconsin area. also to areas with monitors showing for its PSD program were federally- To the extent that these results are violations of the NAAQS. A review of approved and made part of the SIP on representative of general ozone the AQS monitoring data for adjacent November 2, 1979 (44 FR 63103). On transport patterns not limited to the downwind states shows that it is highly July 19, 2007, EPA approved the North 1991–95 period, one may add the unlikely that emissions from North Dakota PSD revisions incorporating relative infrequency of northwesterly Dakota contribute significantly to EPA’s December 31, 2002 NSR Reforms transport winds from North Dakota to downwind areas that have monitors into the State’s regulations (72 FR the other factors that make it unlikely showing violations of the 1997 8-hour 39564). North Dakota does not have for emissions from North Dakota sources ozone NAAQS. Between 1999 and 2008 nonattainment areas for any of the to contribute significantly to there were no violations of the 1997 8- criteria pollutants and therefore does nonattainment in the noted Illinois/ hour ozone NAAQS at any of the not have a Nonattainment New Source Wisconsin area. monitors in adjacent downwind states, Review (NNSR) program. This conclusion is supported by the such as Minnesota, South Dakota and Consistent with EPA’s November 29, recent attainment demonstration Iowa. 2005 Phase II rule for the 1997 8-hour developed for the nonattainment The design values for Minnesota, ozone standard (70 FR 71612), the State counties along the western shores of South Dakota and Iowa during the updated, effective April 1, 2009, its PSD Lake Michigan by the Wisconsin 1999–2008 years remained substantially provisions by incorporating by reference Department of Natural Resources below the 1997 NAAQS in most most of the federal provisions at 52.21, (WDNR). The WDNR analysis identifies counties, as shown by the highest including the definition of regulated heavy industrial activity and dense design values. In South Dakota, the NSR pollutant at 52.21(b)(50), listing urbanization as the major local highest design values were in Custer NOX as an ozone precursor. As contributors to the high ozone and Jackson Counties, where they discussed elsewhere in this notice, EPA concentrations in the Illinois and peaked, respectively, at 71 and at 68 proposes in this action to approve the Wisconsin Counties along the ppb. In Minnesota, the highest design April 1, 2009 update. Thus, the April 1, southwestern shores of Lake Michigan. values were in Anoka and Washington 2009 update, taken together with Regional ozone transport is thought to Counties, where they peaked at 75 ppb. interstate transport SIP section 7.8.1, contribute from 40 to 60% of the In Iowa, the highest design values were subsection C, satisfies the requirements maximum ozone concentrations in the in Clinton and Scott Counties, where of the third element of CAA section Lake Michigan airshed, and the they reached levels between 78 and 80 110(a)(2)(D)(i) for the 1997 8-hour ozone contributing transport is estimated to ppb in the early part of the 1999–2008 standard. originate from south-southwesterly period, and decreased to levels, For PM2.5, North Dakota’s SIP declares areas, within a span of 160 to 270 respectively, between 67 and 72, and 65 that the State will follow EPA’s interim degrees. Any ozone transport from and 70 ppb during 2006–2008. The guidance on use of PM10 as a surrogate North Dakota would fall outside this decrease of Iowa ozone levels between for PM2.5. In response to EPA’s request span. The WDNR finding, in 1998 and 2008 can be gauged by of March 2, 2010, the North Dakota Air combination with the results of the comparing the peak levels of 79–80 ppb Quality Division, in a March 8, 2010 analysis for other transport factors in 2000–2003 with peak levels of 70–75 letter to the EPA Region 8 Air Program, presented above, strengthens the ppb in 2006–2008. has clarified an ambiguity in its conclusion that it is unlikely that The data and weight of evidence interpretation of the interim guidance. emissions from North Dakota sources analysis presented above support the The letter states that, until the guidance contribute significantly to the conclusion of the North Dakota is ended or replaced, North Dakota will nonattainment of the Illinois/Wisconsin Interstate Transport SIP (adopted April apply it consistent with EPA’s Counties on the southwestern shores of 1, 2009 and submitted April 6, 2009) interpretation of the federal case law Lake Michigan.20 that emissions from North Dakota do not relevant to the use of the PM10 Surrogate Finally, by 2008, the 8-hour ozone contribute significantly to Policy (see 75 FR 6827, 6831–32, design values for the Illinois and nonattainment in any other state for the February 11, 2010). The State will also Wisconsin nonattainment counties 1997 8-hour ozone NAAQS, consistently take into account the limits provided in along the shores of Lake Michigan fell with the requirements of element (1) of the policy itself, such as the need to below the level of the NAAQS, a CAA section 110(a)(2)(D)(i). identify the technical difficulties that reduction attributed to the justify the application of the policy in implementation of State and Federal Interference With PSD Element—PM2.5 each specific case (75 FR 6834). With control measures since the designation and Ozone that clarification, the North Dakota of these counties as nonattainment in The third element of section Interstate Transport SIP satisfies the 110(a)(2)(D)(i) requires a SIP to contain requirements of the third element of 19 Ibid. adequate provisions prohibiting section 110(a)(2)(D)(i) for the 1997 PM2.5 20 Wisconsin Department of Natural Resources, emissions that interfere with any other NAAQS. ‘‘Attainment Demonstration—The Wisconsin On the basis of the data and analysis Counties of Kenosha, Racine, Milwaukee, state’s required measures to prevent Waukesha, Ozaukee, Washington, Sheboygan, presented above, EPA concludes that Manitowoc and Door,’’ pp. 8, 51, September 2009. 21 Ibid. p. 14. the North Dakota Interstate Transport

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non-regulatory provisions adopted into • Does not contain any unfunded ENVIRONMENTAL PROTECTION the State SIP April 1, 2009 satisfactorily mandate or significantly or uniquely AGENCY address the requirements of elements (1) affect small governments, as described and (3) of section 110(a)(2)(D)(i) for the in the Unfunded Mandates Reform Act 40 CFR Part 52 1997 PM and 8-hour ozone standards. 2.5 of 1995 (Pub. L. 104–4); [EPA–R08–OAR–2007–1032; FRL–9131–4] V. Proposed Action • Does not have Federalism Approval and Promulgation of State EPA is proposing approval of implications as specified in Executive Implementation Plans; State of revisions, submitted by the Governor of Order 13132 (64 FR 43255, August 10, Colorado; Interstate Transport of North Dakota with a letter dated April 1999); Pollution Revisions for the 1997 8-Hour 6, 2009, to the prevention of significant • Is not an economically significant Ozone NAAQS: ‘‘Significant deterioration provisions in subsection regulatory action based on health or Contribution to Nonattainment’’ 33–15–15 of the NDAC, and partial safety risks subject to Executive Order Requirement approval of the addition to the State SIP 13045 (62 FR 19885, April 23, 1997); of the ‘‘Interstate Transport of Air AGENCY: Environmental Protection • Is not a significant regulatory action Pollution’’ SIP addressing the Agency (EPA). subject to Executive Order 13211 (66 FR requirements of Clean Air Act section ACTION: Proposed rule. 110(a)(2)(D)(i) for the 1997 PM2.5 and 8- 28355, May 22, 2001); hour ozone National Ambient Air • Is not subject to requirements of SUMMARY: The Environmental Protection Quality Standards (NAAQS). For the Section 12(d) of the National Agency (EPA) is proposing partial North Dakota Interstate Transport SIP, Technology Transfer and Advancement approval of the State Implementation EPA is proposing approval of: (a) The Act of 1995 (15 U.S.C. 272 note) because Plan (SIP) revisions ‘‘State of Colorado introductory language in the State SIP application of those requirements would Implementation Plan to Meet the Section 7.8; (b) the ‘‘Overview’’ language be inconsistent with the Clean Air Act; Requirements of Clean Air Act Section in subsection A., Section 7.8.1; (c) and 110(a)(2)(D)(i)(I)—Interstate Transport language in Section 7.8.1, subsection B., Regarding the 1997 8-Hour Ozone • Does not provide EPA with the ‘‘Nonattainment and Maintenance Area Standard’’ submitted by the State of Impact,’’ that specifically addresses discretionary authority to address, as Colorado on June 18, 2009. The element (1) of section 110(a)(2)(D)(i), the appropriate, disproportionate human Colorado Interstate Transport SIP requirement that the SIP contain health or environmental effects, using revisions submitted June 18, 2009 adequate provisions prohibiting practicable and legally permissible address the requirements of Clean Air emissions from North Dakota from methods, under Executive Order 12898 Act section 110(a)(2)(D)(i)(I) for the 1997 contributing significantly to (59 FR 7629, February 16, 1994). 8-hour ozone National Ambient Air nonattainment in any other state; and In addition, this rule does not have Quality Standards (NAAQS). In this (d) Section 7.8.1, subsection C, ‘‘Impact tribal implications as specified by Federal Register action EPA proposes on Prevention of Significant Executive Order 13175 (65 FR 67249, approval of the Colorado SIP sections Deterioration (PSD).’’ November 9, 2000), because the SIP is that address the requirement of section VI. Statutory and Executive Order not approved to apply in Indian country 110(a)(2)(D)(i)(I) prohibiting a state’s emissions from contributing Review located in the state, and EPA notes that significantly to any other state’s it will not impose substantial direct Under the Clean Air Act, the nonattainment of the NAAQS. EPA will Administrator is required to approve a costs on tribal governments or preempt act at a later date on the Colorado SIP submission that complies with the tribal law. Interstate Transport SIP sections that provisions of the Act and applicable List of Subjects in 40 CFR Part 52 address the requirement prohibiting a Federal regulations. 42 U.S.C. 7410(k); state’s emissions from interfering with 40 CFR 52.02(a). Thus, in reviewing SIP Environmental protection, Air any other state’s maintenance of the submissions, EPA’s role is to approve pollution control, Incorporation by NAAQS. This action is being taken state choices, provided that they meet reference, Intergovernmental relations, under section 110 of the Clean Air Act. the criteria of the Clean Air Act. Nitrogen dioxide, Ozone, Particulate DATES: Comments must be received on Accordingly, this action merely matter, Reporting and recordkeeping approves state law as meeting Federal or before April 30, 2010. requirements, Volatile organic requirements and does not impose ADDRESSES: Submit your comments, compounds. additional requirements beyond those identified by Docket ID No. EPA–R08– imposed by state law. For that reason, Authority: 42 U.S.C. 7401 et seq. OAR–2007–1032, by one of the following methods: this action: Dated: March 18, 2010. • Is not a ‘‘significant regulatory • http://www.regulations.gov. Follow Carol L. Campbell, action’’ subject to review by the Office the on-line instructions for submitting of Management and Budget under Acting Assistant Regional Administrator, comments. Executive Order 12866 (58 FR 51735, Region 8. • E-mail: [email protected] and October 4, 1993); [FR Doc. 2010–6894 Filed 3–30–10; 8:45 am] [email protected]. • Does not impose an information BILLING CODE 6560–50–P • Fax: (303) 312–6064 (please alert collection burden under the provisions the individual listed under FOR FURTHER of the Paperwork Reduction Act (44 INFORMATION CONTACT if you are faxing U.S.C. 3501 et seq.); comments). • Is certified as not having a • Mail: Callie Videtich, Director, Air significant economic impact on a Program, Environmental Protection substantial number of small entities Agency (EPA), Region 8, Mailcode under the Regulatory Flexibility Act (5 8P–AR, 1595 Wynkoop Street, Denver, U.S.C. 601 et seq.); Colorado 80202–1129.

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• Hand Delivery: Callie Videtich, Protection Agency (EPA), Region 8, 2. Tips for Preparing Your Comments. Director, Air Program, Environmental Mailcode 8P–AR, 1595 Wynkoop, When submitting comments, remember Protection Agency (EPA), Region 8, Denver, Colorado 80202–1129. EPA to: Mailcode 8P–AR, 1595 Wynkoop, requests that if at all possible, you a. Identify the rulemaking by docket Denver, Colorado 80202–1129. Such contact the individual listed in the FOR number and other identifying deliveries are only accepted Monday FURTHER INFORMATION CONTACT section to information (subject heading, Federal through Friday, 8 a.m. to 4:30 p.m., view the hard copy of the docket. You Register date and page number). excluding Federal holidays. Special may view the hard copy of the docket b. Follow directions—The agency may arrangements should be made for Monday through Friday, 8 a.m. to ask you to respond to specific questions deliveries of boxed information. 4 p.m., excluding Federal holidays. or organize comments by referencing a Instructions: Direct your comments to FOR FURTHER INFORMATION CONTACT: Code of Federal Regulations (CFR) part Docket ID No. EPA–R08–OAR–2007– Domenico Mastrangelo, Air Program, or section number. 1032. EPA’s policy is that all comments U.S. Environmental Protection Agency, c. Explain why you agree or disagree; received will be included in the public Region 8, Mailcode 8P–AR, 1595 docket without change and may be suggest alternatives and substitute Wynkoop, Denver, Colorado 80202– language for your requested changes. made available online at http:// 1129, (303) 312–6436, d. Describe any assumptions and www.regulations.gov, including any [email protected]. personal information provided, unless provide any technical information and/ the comment includes information SUPPLEMENTARY INFORMATION: or data that you used. claimed to be Confidential Business Definitions e. If you estimate potential costs or Information (CBI) or other information burdens, explain how you arrived at For the purpose of this document, we whose disclosure is restricted by statute. your estimate in sufficient detail to are giving meaning to certain words or Do not submit information that you allow for it to be reproduced. consider to be CBI or otherwise initials as follows: (i) The words or initials Act or CAA f. Provide specific examples to protected through http:// mean or refer to the Clean Air Act, illustrate your concerns, and suggest www.regulations.gov or e-mail. The unless the context indicates otherwise. alternatives. http://www.regulations.gov Web site is (ii) The words EPA, we, us or our g. Explain your views as clearly as ‘‘ ’’ an anonymous access system, which mean or refer to the United States possible, avoiding the use of profanity means EPA will not know your identity Environmental Protection Agency. or personal threats. or contact information unless you (iii) The initials SIP mean or refer to h. Make sure to submit your provide it in the body of your comment. State Implementation Plan. comments by the comment period If you send an e-mail comment directly (iv) The words Colorado and State deadline identified. to EPA, without going through http:// mean the State of Colorado. www.regulations.gov, your e-mail II. Background Information address will be automatically captured Table of Contents and included as part of the comment Section 110(a)(2)(D)(i) of the CAA I. General Information requires that a state’s SIP must contain that is placed in the public docket and What Should I Consider as I Prepare My made available on the Internet. If you Comments for EPA? adequate provisions prohibiting any submit an electronic comment, EPA II. Background Information source or other type of emissions recommends that you include your III. What Action Is EPA Proposing? activity within the state from emitting name and other contact information in IV. What Is the State Process To Submit any air pollutant in amounts which will: the body of your comment and with any These Materials to EPA? (1) Contribute significantly to disk or CD–ROM you submit. If EPA V. EPA’s Review and Technical Information nonattainment of the NAAQS in any VI. Proposed Action other state; (2) interfere with cannot read your comment due to VII. Statutory and Executive Order Reviews technical difficulties and cannot contact maintenance of the NAAQS by any you for clarification, EPA may not be I. General Information other state; (3) interfere with any other able to consider your comment. state’s required measures to prevent What Should I Consider as I Prepare My significant deterioration of air quality; Electronic files should avoid the use of Comments for EPA? special characters, any form of or (4) interfere with any other state’s encryption, and be free of any defects or 1. Submitting CBI. Do not submit CBI required measures to protect visibility. viruses. For additional instructions on to EPA through http:// On June 11, 2008, the State of Colorado submitting comments, go to Section I. www.regulations.gov or e-mail. Clearly submitted to EPA an Interstate General Information of the mark the part or all of the information Transport SIP addressing the interstate SUPPLEMENTARY INFORMATION section of that you claim to be CBI. For CBI transport requirements of CAA section this document. information in a disk or CD–ROM that 110(a)(2)(D)(i) for the 1997 PM2.5 and Docket: All documents in the docket you mail to EPA, mark the outside of the 8-hour ozone NAAQS. In response to are listed in the http:// disk or CD–ROM as CBI and then EPA’s concerns with the June 11, 2008 www.regulations.gov index. Although identify electronically within the disk or submittal, on December 30, 2008 the listed in the index, some information is CD–ROM the specific information that State adopted and on June 18, 2009 not publicly available, e.g., CBI or other is claimed as CBI. In addition to one submitted a revised SIP addressing the information whose disclosure is complete version of the comment that requirements of elements (1) and (2) of restricted by statute. Certain other includes information claimed as CBI, a section 110(a)(2)(D)(i) for the 1997 material, such as copyrighted material, copy of the comment that does not 8-hour ozone NAAQS. The State of will be publicly available only in hard contain the information claimed as CBI Colorado is planning to submit in June copy. Publicly available docket must be submitted for inclusion in the 2010 further revisions addressing the materials are available either public docket. Information so marked requirements of elements (3) and (4) for electronically in http:// will not be disclosed except in the 1997 8-hour ozone NAAQS and the www.regulations.gov or in hard copy at accordance with procedures set forth in requirements of elements (1) through (4) the Air Program, Environmental 40 CFR part 2. for the 1997 PM2.5 NAAQS.

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III. What Action Is EPA Proposing? V. EPA’s Review and Technical state. Among other methods, EPA Information recommended consideration of available EPA is proposing partial approval of The interstate transport provisions at EPA modeling conducted in the Colorado Interstate Transport of Air 2 CAA section 110(a)(2)(D)(i), also conjunction with CAIR, or in the Pollution SIP addressing the absence of such EPA modeling, requirements of CAA section referred to as the ‘‘good neighbor’’ provisions, require that each state’s SIP consideration of other information such 110(a)(2)(D)(i)(I) for the 1997 8-hour as the amount of emissions, the ozone NAAQS. On December 30, 2008, contain adequate provisions prohibiting emissions that adversely affect any other geographic location of violating areas, the Colorado Air Quality Control meteorological data, or various other Commission (AQCC) adopted the ‘‘State state’s air quality through interstate transport of air pollutants. As discussed forms of information that would be of Colorado Implementation Plan to in the Background Information section relevant to assessing the likelihood of Meet the Requirements of the Clean Air significant contribution to violations of of this notice, a state’s SIP must contain Act Section 110(a)(2)(d)(i)(I)—Interstate the NAAQS in another state. The provisions that satisfy the four elements Transport Regarding the 1997 8-Hour assessment of significant contribution to of section 110(a)(2)(D)(i). On August 15, Ozone Standard.’’ Colorado submitted nonattainment is not restricted to 2006, EPA issued guidance for SIP the December 30, 2008 SIP revision to impacts upon areas that are formally submissions addressing the EPA on June 18, 2009. In this Federal designated nonattainment. Consistent requirements of section 110(a)(2)(D)(i) Register action EPA is proposing to with EPA’s approach in CAIR, this for the 1997 PM and 8-hour ozone approve only the language and 2.5 impact must be evaluated with respect NAAQS.1 The portions of the Colorado demonstration that addresses element to any monitors showing a violation of Interstate Transport SIP revision that (1) of section 110(a)(2)(D)(i): Prohibition the NAAQS (70 FR 25172, May 12, address element (1) of section 2005, and 63 FR 57371, October 27, of significant contribution to 110(a)(2)(D)(i) for the 1997 8-hour ozone 1998). Furthermore, although relevant nonattainment of the 1997 8-hour ozone NAAQS are consistent with EPA’s 2006 information other than modeling may be NAAQS in any other state. guidance. considered in assessing the likelihood of To demonstrate that emissions from IV. What Is the State Process To Submit significant contribution to violations of Colorado do not contribute significantly These Materials to EPA? the 1997 8-hour ozone standard in to nonattainment of the 1997 8-hour another state, EPA notes that no single Section 110(k) of the CAA addresses ozone NAAQS in any other state, the piece of information in the following EPA’s rulemaking action on SIP Colorado Interstate Transport SIP relies discussion is by itself dispositive of the submissions by states. The CAA on a combination of: (a) Modeling issue. Instead, the total weight of all the requires states to observe certain analysis done by the State as part of the evidence taken together supports the procedural requirements in developing attainment demonstration SIP for the conclusion that emissions from SIP revisions for submittal to EPA. Denver Metropolitan Area/North Front Colorado sources are unlikely to Section 110(a)(2) of the CAA requires Range (DMA/NFR) nonattainment area contribute significantly to violations of that each SIP revision be adopted after for the 1997 8-hour ozone standard; (b) the 1997 8-hour ozone standard in any reasonable notice and public hearing. monitoring data gathered by states and This must occur prior to the revision other state. reported to EPA in the Air Quality The Colorado Interstate Transport SIP being submitted by a state to EPA. System (AQS) database; and (c) uses results from Colorado’s 2009 The Colorado AQCC held a public considerations of geographical and ‘‘8-Hour Ozone Attainment Plan’’ for the hearing in December 2008 for the meteorological factors. In this action, DMA/NFR nonattainment area, and a interstate transport SIP revision: ‘‘State EPA expands on the analysis of report from the Western States Air of Colorado Implementation Plan to geographical and meteorological factors, Resource (WESTAR) Council to Meet the Requirements of Clean Air Act and of ozone concentration levels underscore that: (a) Local anthropogenic Section 110(a)(2)(D)(i)(I)—Interstate reflecting AQS monitoring data. ozone contribution to high ozone Section 110(a)(2)(D)(i) provides that Transport Regarding the 1997 8-Hour concentrations in Denver is only about EPA cannot approve a state’s SIP for a Ozone Standard.’’ The AQCC adopted 25%; and (b) on days of highest ozone new or revised NAAQS unless it this revision on December 30, 2008, and concentrations (reflecting a design value contains adequate measures to prohibit the State submitted it to EPA on of 84.9 ppb) in the DMA/NFR area, the emissions from sources within the state June 18, 2009. projected design values decrease to 63 from contributing significantly to ppb or less for all downwind Colorado On November 18, 2009, the AQCC nonattainment of the NAAQS in another counties east of an imaginary north- provided EPA with an exact color state. EPA’s August 15, 2006 guidance south line approximately 70 miles east duplicate of the SIP adopted by the to states concerning section from Denver.3 EPA does not accept the AQCC on December 30, 2008 and 110(a)(2)(D)(i) recommended various State of Colorado Interstate Transport included in the June 18, 2009 submittal methods by which states might evaluate SIP assessment that these results to EPA. In the original submittal, AQCC whether or not its emissions provided a black and white copy. The significantly contribute to violations of 2 In this action the expression ‘‘CAIR’’ refers to the SIP’s color duplicate, available for the 1997 ozone standards in another review as part of the Docket, makes it final rule published in the May 12, 2005 Federal Register and entitled ‘‘Rule to Reduce Interstate easier to understand modeling results 1 Memorandum from William T. Harnett entitled Transport of Fine Particulate Matter and Ozone reported in several graphs that are part Guidance for State Implementation Plan (SIP) (Clean Air Interstate Rule); Revisions to Acid Rain of the SIP technical demonstration. Submissions to Meet Current Outstanding Program; Revisions to NOX SIP Call; Final Rule’’ (70 Obligations Under Section 110(a)(2)(D)(i) for the FR 25162). 3 EPA has reviewed the submittal from 8-hour Ozone and PM2.5 National Ambient Air See Figure 5, page 15 of the Interstate Transport the State of Colorado and has Quality Standards (Aug. 15, 2006) (‘‘2006 SIP submitted June 18, 2009. It must be noted that determined that the State met the Guidance’’). Available for review in EPA’s January the modeling analysis domain for the DMA/NFR 14, 2010 docket document entitled: ‘‘Relevant attainment plan was limited to the State territory, requirements for reasonable notice and Guidance and Supporting Documentation for the and that the 70-mile distance represents the public hearing under section 110(a)(2) Proposed Rulemaking Federal Register Action approximate distance from Denver to the western of the CAA. Docket ID # EPA–R08–OAR–2007–1032. border of Morgan County.

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demonstrate that ‘‘ the magnitude of have detailed modeling for Colorado representative of general ozone ozone transport from Colorado to other and nearby downwind states, our transport patterns not limited to the states is too low to significantly approach does not rely on a quantitative 1991–1995 period, the weak western contribute to nonattainment in * * * determination of Colorado’s component of long range transport any other state with respect to the 0.08 contribution, as EPA did for other states winds during high ozone days in the ppb NAAQS.’’ 4 Similarly, EPA does not in its CAIR rulemaking, but on a weight- States east and north of Colorado accept the claim in Colorado’s SIP that of-evidence analysis based on provides evidence that NOX emissions the absence of violations of the 8-hour qualitative assessments and estimates of from Colorado are unlikely to contribute ozone NAAQS in adjacent downwind the relevant factors. While conclusions significantly to violations of the 1997 states such as Kansas, Nebraska and reached for each of the factors ozone NAAQS in the Illinois/Wisconsin Wyoming suffices to show that considered in the following analysis are counties along the southwestern shores emissions from Colorado sources do not not in and by themselves determinative, of Lake Michigan. significantly affect farther downwind consideration of all of these factors Additional circumstantial evidence ozone nonattainment areas such as St. provides a reliable qualitative supporting this conclusion is found in Louis.5 The relatively limited conclusion on whether Colorado’s technical documentation developed in contribution of local emissions to emissions are likely to contribute recent years by the States of Kansas and nonattainment in the DMA/NFR, the significantly to nonattainment in the St. Wisconsin. To support its Interstate quick drop in ozone levels in the Louis and the Illinois/Wisconsin areas. Transport SIP, the State of Kansas easternmost Colorado counties, and The Illinois/Wisconsin nonattainment submitted to EPA Region 7 technical even the substantial gap between the area is approximately 900 miles east/ documentation that includes back 1997 NAAQS and design values in northeast from the Colorado DMA/NFR trajectory analyses gauging the pathway adjacent downwind states do not area. Distance per se is not an obstacle of air masses impacting the Illinois/ exclude a potential significant to long range transport of ozone and/or Wisconsin nonattainment area on the contribution from Colorado emissions to its precursors, as discussed in the four days with highest ozone downwind nonattainment areas. January 30, 2004 notice proposing CAIR concentrations during each of the years However, as a reflection of emission (69 FR 4599). NOx, the primary ozone 2005–2007. The back trajectory analyses levels, the relatively (to the 1997 8-hour precursor that was the object of the in Appendix G of the technical support ozone NAAQS) moderate ozone CAIR transport study, may be section show that, for the four days with concentrations in eastern Colorado and transported for long distances, the highest ozone readings, none of the in adjacent downwind states somewhat contributing significantly to high ozone pathways followed by air masses reduces the probability of significant concentrations in other states. However, moving into the Chicago Metropolitan ozone contribution from Colorado with increasing distance there are Statistical Area (MSA) or into several of emission sources to considerably farther greater opportunities for ozone or NOX the Wisconsin nonattainment counties downwind nonattainment areas such as dispersion and/or removal from the came from Colorado. Since these back St. Louis, Missouri, and Chicago, atmosphere due to the effect of winds or trajectories refer to the pathways of air Illinois. chemical sink processes. As a result, masses and not specifically to ozone In addition, significant contribution one may conclude that the 900-mile transport, the results of this analysis should be measured not just against distance from Colorado sources of NOX cannot be considered determinative as nonattainment areas, but also against emissions and the Illinois/Wisconsin to the significant contribution of ozone areas with monitors showing violations area reduces, but does not exclude, the or NOX from Colorado emissions to the of the NAAQS. That said, possibility of significant contribution to nonattainment counties along the nonattainment areas are a convenient this area’s nonattainment. southwestern shores of Lake Michigan. starting point for EPA’s analysis. For the Another transport factor is wind However, the lack of any back 1997 8-hour ozone NAAQS, the St. direction. For long range transport trajectories from Colorado indicates that Louis area and the Illinois and winds, a modeling analysis of ozone it is unlikely that NOX emissions from Wisconsin Counties along the dispersion during the summer months the State contribute significantly to the southwestern shore of Lake Michigan (June to August) of the five-year period nonattainment of the Illinois/Wisconsin (Illinois/Wisconsin area) are the 1991–1995 shows that on high local area. designated downwind nonattainment ozone days the prevailing long range Further support is given by a recent areas closest to Colorado.6 EPA’s transport winds in States immediately attainment demonstration by the evaluation of whether emissions from to the east and north of Colorado Wisconsin Department of Natural Colorado contribute significantly to (Kansas, Nebraska, South Dakota, Iowa, Resources (WDNR) for the ozone nonattainment in these areas Minnesota, and North Dakota) had a nonattainment counties along the relies on an examination of a variety of southerly direction. On high regional southwestern shores of Lake Michigan.8 data and analysis that provide insight ozone days, during the same period, The WDNR analysis identifies heavy on ozone transport from Colorado to regional transport winds in the same industrial activity and dense these two areas. Because EPA does not States were southwesterly, but with a urbanization as the major local westerly component so weak that a contributors to the high ozone 4 ‘‘State of Colorado Implementation Plan to Meet greater portion of NOX emissions from concentrations in the Indiana, Illinois the Requirements of Clean Air Act Section Colorado would likely remain and Wisconsin Counties along the 110(a)(2)(D)(i)(I)—Interstate Transport Regarding significantly west of the Illinois/ southwestern shores of Lake Michigan. the 1997 8-hour Ozone Standard,’’ p. 17, December 7 12, 2009. Wisconsin nonattainment area. To the Between 40 and 60 percent of the 5 Ibid., pp. 8–9. extent that these results are maximum ozone concentrations in the 6 The Wisconsin nonattainment areas for the 1997 Lake Michigan airshed is attributed to 8-hour ozone standard include: Door, Kewaunee, 7 Ozone Transport Assessment Group (OTAG), Manitowoc, Sheboygan, Ozaukee, Washington, Air Quality Analysis Workgroup: ‘‘3.3 Climatology 8 Wisconsin Department of Natural Resources, Milwaukee, Waukesha, Racine and Kenosha of Ozone Synoptic Scale Transport in the Eastern ‘‘Attainment Demonstration—The Wisconsin counties; the Chicago nonattainment area includes US,’’ Figures 1(a) and 5(a), pp. 3, 6, January 11, Counties of Kenosha, Racine, Milwaukee, Cook County and several adjacent Illinois and 1998. High ozone days were days with ozone Waukesha, Ozaukee, Washington, Sheboygan, Indiana counties (69 FR 23858, April 30, 2004). concentrations in the 90th percentile. Manitowoc and Door,’’ September 2009.

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regional transport, occurring from earlier shows that, during the five years adjacent downwind states, such as emission sources located within a from 1991 to 1995, on high ozone days Kansas, Nebraska and Wyoming. south-southwesterly arc spanning from regional transport winds in Kansas and Design values for the years 2005– 160 to 270 degrees (compass direction). Missouri have a prevailing southerly 2007 14 show that in adjacent downwind Colorado’s location at the western orientation. To the extent that these states such as Kansas, Nebraska, and margins of this arc (Denver is results are representative of general Wyoming, there were no violations of approximately 260 degrees southwest of ozone transport patterns not limited to the 1997 8-hour ozone NAAQS, and that Chicago) substantially reduces the the 1991–95 period, they indicate that in most counties ozone levels remained likelihood for NOX emissions from the ozone/NOX emissions from Colorado substantially below the NAAQS. In State to contribute significantly to reaching Kansas or Missouri were very Kansas, the 2007 design value for Trego nonattainment in the Illinois/Wisconsin likely to be redirected northward and County, the county with a monitoring area.9 Given the southerly orientation of away from the St. Louis area, thus station closest to Colorado, was 71 ppb, regional transport winds in States east lessening the likelihood for a significant or 16 percent below the ozone NAAQS. and north of Colorado, it is likely that ozone contribution to nonattainment The counties that had the highest design Colorado ozone or NOX emissions from Colorado. values are at or near the eastern edge of would be heavily dispersed in a the state, about 400 miles from northward direction west of this Results from other studies are Colorado’s eastern border, and their nonattainment area. consistent with these tentative design values ranged from 76 ppb for Finally, by 2008, the 8-hour ozone conclusions. In a study published by Johnson and Sumner Counties to 77 ppb design values for the Illinois and OTAG in 1997, the St. Louis area for Leavenworth and Wyandotte Wisconsin nonattainment counties showed higher ozone concentrations (70 Counties. In Nebraska and Wyoming, along the shores of Lake Michigan fell as compared with 55 ppb) on days with the highest ozone design values did not below the level of the NAAQS, a winds from the south or the east than on exceed 69 ppb in Douglas County, reduction attributed to the days with winds from the west (the Nebraska and 72 ppb in Sublette implementation of State and Federal general direction from Colorado) or County, Wyoming. control measures since the designation southwest.12 More recent back trajectory The historical trend over the period of these counties as nonattainment in analyses gauging the pathway of air 1998–2008 for the 1997 8-hour ozone 2004. In other words, were there masses impacting St. Louis on days of design values in these states places the emissions from Colorado sources high ozone allow similar conclusions. 2005–2007 data reviewed above in reaching the Illinois and Wisconsin The State of Kansas’ technical context. In Nebraska, ozone design counties along the western rim of Lake documentation supporting its Interstate values were consistently low throughout Michigan, they would no longer be Transport SIP (approved by EPA in the period. In Wyoming, design values significantly contributing to violations March 2007) include back trajectory were also constant in most of the of the NAAQS in that area.10 analyses independent of their source monitored areas, where ozone The other nonattainment area, St. regions (i.e., Colorado or Kansas.) The monitoring only began between 2003 Louis and adjacent counties, is results show that for each of the 2005– and 2005. Kansas design values show a approximately 800 miles straight east 2007 years, on the four days with the clear trend of declining ozone levels from the Colorado DMA/NFR area. This highest ozone readings the frequency of from the late 1990s to the most recent substantial distance does not, in and by trajectory ‘‘contribution’’ from Colorado years. In Linn, Sedgwick, and Sumner itself, exclude the possibility of to St. Louis was negligible. There is only Counties, design values decreased from significant contribution from Colorado’s one instance of a 500 meter trajectory highs ranging between 77 and 82 ppb NOX emissions to nonattainment in the from Colorado, while there were none during 2000–2003 to levels ranging St. Louis area. However, it is also for transport at 1500 meter of altitude.13 between 66 and 75 ppb in 2006–2008. sufficient to provide many opportunities These findings, in combination with the The data and weight of evidence for ozone dispersion and removal from other circumstantial evidence examined analysis presented above support the the atmosphere due to the effect of above, strengthen the conclusion that it conclusion of the Colorado Interstate winds and chemical sink processes, and is unlikely that emissions from Colorado Transport SIP (adopted into the State thus reduce the likelihood of significant sources contribute significantly to the SIP on December 30, 2008 and contribution from Colorado to nonattainment of the St. Louis area. submitted to EPA June 18, 2009) that nonattainment in this area. As mentioned above, EPA must emissions from Colorado do not The impact of wind direction on consider not only significant contribute significantly to ozone transport from Colorado to the St. contribution to nonattainment areas, but nonattainment in any other state for the Louis area is gauged through the results also to areas with monitors showing 1997 8-hour ozone NAAQS, consistently of several findings. Kansas, immediately violations of the NAAQS. A review of with the requirements of element (1) of east of Colorado and west of Missouri, CAA section 110(a)(2)(D)(i). is characterized by strong southerly the AQS monitoring data for adjacent surface winds that match prevailing downwind states shows that it is highly VI. Proposed Action unlikely that emissions from Colorado regional transport winds, which have a EPA is proposing partial approval of southerly orientation during days of contribute significantly to downwind areas that have monitors showing the Colorado SIP to meet the elevated ozone concentration. requirements of Section 110(a)(2)(D)(i)(I) Throughout 2005 its winds averaged violations of the 1997 8-hour ozone NAAQS. Between 1999 and 2008 there regarding the 1997 ozone standard. daily speeds slightly over 9 mph.11 The Specifically, in this action EPA is OTAG modeling analysis referred to were no violations of the 1997 8-hour ozone NAAQS at any of the monitors in proposing to approve only the language and demonstration that, in this SIP 9 Ibid., p. 51. revision, address the requirements of 10 12 OTAG, ‘‘Ozone as Function of Local Wind Ibid. element (1): Prohibition of significant 11 See the January 4, 2007 State of Kansas Speed and Direction: Evidence of Local and submittal to EPA of Interstate Transport SIP Regional Transport,’’ p. 33, July 26, 1997. revisions, Document ID# EPA–R07–OAR–2007– 13 Document ID# EPA–R07–OAR–2007–0141– 14 See Table 4, pages 7 and 8, of the Colorado 0141–0003, pp. 6–7. 0003, Appendix G. Interstate Transport SIP.

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contribution to nonattainment of the In addition, this rule does not have conclude that Tokusen’s process 1997 8-hour ozone NAAQS in any other tribal implications as specified by minimizes short-term and long-term state. At a later date, EPA will act on the Executive Order 13175 (65 FR 67249, threats from the petitioned waste to language and demonstration addressing November 9, 2000), because the SIP is human health and the environment. element (2): prohibition of interference not approved to apply in Indian country DATES: We will accept comments until with maintenance of the 1997 8-hour located in the state, and EPA notes that April 30, 2010. We will stamp ozone NAAQS in any other state. it will not impose substantial direct comments postmarked after the close of costs on tribal governments or preempt VII. Statutory and Executive Order the comment period as ‘‘late.’’ These tribal law. Review ‘‘late’’ comments may not be considered in formulating a final decision. Under the Clean Air Act, the List of Subjects in 40 CFR Part 52 ADDRESSES: Submit your comments, Administrator is required to approve a Environmental protection, Air identified by Docket ID No. EPA–R06– SIP submission that complies with the pollution control, Incorporation by RCRA–2009–0549 by one of the provisions of the Act and applicable reference, Intergovernmental relations, following methods: Federal regulations. 42 U.S.C. 7410(k); Nitrogen dioxide, Ozone, Particulate 1. Federal e-Rulemaking Portal: 40 CFR 52.02(a). Thus, in reviewing SIP matter, Reporting and recordkeeping http://www.regulations.gov: Follow the submissions, EPA’s role is to approve requirements, Volatile Organic on-line instructions for submitting state choices, provided that they meet Compounds. comments. the criteria of the Clean Air Act. Authority: 42 U.S.C. 7401 et seq. 2. E-mail: [email protected]. Accordingly, this action merely 3. Mail: Youngmoo Kim, approves state law as meeting Federal Dated: March 18, 2010. Carol L. Campbell, Environmental Protection Agency, requirements and does not impose Multimedia Planning and Permitting additional requirements beyond those Acting Deputy Regional Administrator, Region 8. Division, RCRA Branch, Mail Code: imposed by state law. For that reason, 6PD–C, 1445 Ross Avenue, Dallas, TX [FR Doc. 2010–6893 Filed 3–30–10; 8:45 am] this action: 75202. • Is not a ‘‘significant regulatory BILLING CODE 6560–50–P 4. Hand Delivery or Courier: Deliver action’’ subject to review by the Office your comments to: Youngmoo Kim, of Management and Budget under Environmental Protection Agency, Executive Order 12866 (58 FR 51735, ENVIRONMENTAL PROTECTION Multimedia Planning and Permitting October 4, 1993); AGENCY Division, RCRA Branch, Mail Code: • Does not impose an information 6PD–C, 1445 Ross Avenue, Dallas, TX collection burden under the provisions 40 CFR Part 261 75202. of the Paperwork Reduction Act (44 [EPA–R06–RCRA–2009–0549; SW–FRL– Instructions: Direct your comments to U.S.C. 3501 et seq.); 9131–6] • Is certified as not having a Docket ID No. EPA–R06–RCRA–2009– significant economic impact on a Hazardous Waste Management 0549. EPA’s policy is that all comments substantial number of small entities System; Identification and Listing of received will be included in the public under the Regulatory Flexibility Act (5 Hazardous Waste; Proposed Exclusion docket without change and may be U.S.C. 601 et seq.); made available online at http:// • Does not contain any unfunded AGENCY: Environmental Protection www.regulations.gov, including any mandate or significantly or uniquely Agency (EPA). personal information provided, unless affect small governments, as described ACTION: Proposed rule and request for the comment includes information in the Unfunded Mandates Reform Act comment. claimed to be Confidential Business of 1995 (Pub. L. 104–4); Information (CBI) or other information • Does not have Federalism SUMMARY: EPA is proposing to grant a whose disclosure is restricted by statute. implications as specified in Executive petition submitted by Tokusen USA, Do not submit information that you Order 13132 (64 FR 43255, August 10, Inc. (called just Tokusen hereinafter) to consider to be CBI or otherwise 1999); exclude (or delist) a wastewater protected through http:// • Is not an economically significant treatment plant (WWTP) sludge filter www.regulations.gov or e-mail. The regulatory action based on health or cake (called just sludge hereinafter) http://www.regulations.gov Web site is safety risks subject to Executive Order generated by Tokusen in Conway, AR an ‘‘anonymous access’’ system, which 13045 (62 FR 19885, April 23, 1997); from the lists of hazardous wastes. EPA means EPA will not know your identity • Is not a significant regulatory action used the Delisting Risk Assessment or contact information unless you subject to Executive Order 13211 (66 FR Software (DRAS) in the evaluation of provide it in the body of your comment. 28355, May 22, 2001); the impact of the petitioned waste on If you send an e-mail comment directly • Is not subject to requirements of human health and the environment. to EPA without going through Section 12(d) of the National EPA bases its proposed decision to www.regulations.gov, your e-mail Technology Transfer and Advancement grant the petition on an evaluation of address will be automatically captured Act of 1995 (15 U.S.C. 272 note) because waste-specific information provided by and included as part of the comment application of those requirements would the petitioner. This proposed decision, that is placed in the public docket and be inconsistent with the Clean Air Act; if finalized, would exclude the made available on the internet. If you and petitioned waste from the requirements submit an electronic comment, EPA • Does not provide EPA with the of hazardous waste regulations under recommends that you include your discretionary authority to address, as the Resource Conservation and name and other contact information in appropriate, disproportionate human Recovery Act (RCRA). the body of your comment and with any health or environmental effects, using If finalized, EPA would conclude that disk or CD–ROM you submit. If EPA practicable and legally permissible Tokusen’s petitioned waste is non- cannot read your comment due to methods, under Executive Order 12898 hazardous with respect to the original technical difficulties and cannot contact (59 FR 7629, February 16, 1994). listing criteria. EPA would also you for clarification, EPA may not be

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able to consider your comment. B. Who Is Tokusen and What Process Does respect to the original listing criteria. If Electronic files should avoid the use of It Use To Generate the Petitioned Waste? EPA had found, based on this review, special characters, any form of C. How Did Tokusen Sample and Analyze that the waste remained hazardous encryption, and be free of any defects or the Data in This Petition? based on the factors for which the waste D. What Were the Results of Tokusen’s viruses. Analyses? was originally listed, EPA would have Docket: All documents in the E. How Did EPA Evaluate the Risk of proposed to deny the petition. EPA electronic docket are listed in the Delisting This Waste? evaluated the waste with respect to http://www.regulations.gov index. F. What Did EPA Conclude About other factors or criteria to assess Although listed in the index, some Tokusen’s Analysis? whether there is a reasonable basis to information is not publicly available, G. What Other Factors Did EPA Consider believe that such additional factors e.g., CBI or other information whose in Its Evaluation? could cause the waste to be hazardous. disclosure is restricted by statute. H. What Is EPA’s Evaluation of This EPA considered whether the waste is Certain other material, such as Delisting Petition? acutely toxic, the concentration of the IV. Next Steps copyrighted material, will be publicly A. With What Conditions Must the constituents in the waste, their tendency available only in hard copy. Publicly Petitioner Comply? to migrate and to bioaccumulate, their available docket materials are available B. What Happens if Tokusen Violates the persistence in the environment once either electronically in http:// Terms and Conditions? released from the waste, plausible and www.regulations.gov or in hard copy at V. Public Comments specific types of management of the the Environmental Protection Agency, A. How May I as an Interested Party petitioned waste, the quantities of waste RCRA Branch, 1445 Ross Avenue, Submit Comments? generated, and waste variability. EPA Dallas, TX 75202. The hard copy RCRA B. How May I Review the Docket or Obtain believes that the petitioned waste does Copies of the Proposed Exclusion? not meet the listing criteria and thus regulatory docket for this proposed rule, VI. Statutory and Executive Order Reviews EPA–R06–RCRA–2009–0549, is should not be a listed waste. EPA’s available for viewing from 9 a.m. to 4 I. Overview Information proposed decision to delist waste from Tokusen is based on the information p.m., Monday through Friday, excluding A. What Action Is EPA Proposing? Federal holidays. The public may copy submitted in support of this rule, material from any regulatory docket at EPA is proposing: including descriptions of the wastes and no cost for the first 100 pages, and at (1) To grant Tokusen’s delisting analytical data from the Conway, AR fifteen cents per page for additional petition to have its WWTP sludge facility. copies. EPA requests that you contact excluded, or delisted, from the definition of a hazardous waste; and C. How Will Tokusen Manage the Waste, the person listed in the FOR FURTHER subject to certain verification and if It Is Delisted? INFORMATION CONTACT section to schedule your inspection. The monitoring conditions. If the sludge is delisted, the WWTP (2) To use the Delisting Risk interested persons wanting to examine sludge from Tokusen will be disposed at Assessment Software (DRAS) to these documents should make an a RCRA Subtitle D landfill: The Waste evaluate the potential impact of the appointment with the office at least 24 Management Industrial Landfill, North petitioned waste on human health and hours in advance. Little Rock, Arkansas. the environment. The Agency used this FOR FURTHER INFORMATION CONTACT: For model to predict the concentration of D. When Would the Proposed Delisting technical information regarding the hazardous constituents released from Exclusion Be Finalized? Tokusen, contact Youngmoo Kim at the petitioned waste, once it is RCRA section 3001(f) specifically 214–665–6788 or by e-mail at disposed. requires EPA to provide a notice and an [email protected]. opportunity for comment before B. Why Is EPA Proposing To Approve Your requests for a hearing must granting or denying a final exclusion. This Delisting? reach EPA by April 15, 2010. The Thus, EPA will not grant the exclusion request must contain the information Tokusen’s petition requests an until it addresses all timely public described in § 260.20(d). exclusion from the F006 waste listing comments (including those at public SUPPLEMENTARY INFORMATION: The pursuant to 40 CFR 260.20 and 260.22. hearings, if any) on this proposal. information in this section is organized Tokusen does not believe that the RCRA section 3010(b)(1) at 42 USCA as follows: petitioned waste meets the criteria for 6930(b)(1), allows rules to become I. Overview Information which EPA listed it. Tokusen also effective in less than six months when A. What Action Is EPA Proposing? believes no additional constituents or the regulated facility does not need the B. Why is EPA Proposing To Approve This factors could cause the waste to be six-month period to come into Delisting? hazardous. EPA’s review of this petition compliance. That is the case here, C. How Will Tokusen Manage the Waste, included consideration of the original because this rule, if finalized, would if It Is Delisted? listing criteria and the additional factors reduce the existing requirements for D. When Would the Proposed Delisting Exclusion Be Finalized? required by the Hazardous and Solid persons generating hazardous wastes. E. How Would This Action Affect States? Waste Amendments of 1984 (HSWA). EPA believes that this exclusion II. Background See section 3001(f) of RCRA, 42 U.S.C. should be effective immediately upon A. What Is the History of the Delisting 6921(f), and 40 CFR 260.22(d)(1)–(4) final publication because a six-month Program? (hereinafter all sectional references are deadline is not necessary to achieve the B. What Is a Delisting Petition, and What to 40 CFR unless otherwise indicated). purpose of section 3010(b), and a later Does It Require of a Petitioner? In making the initial delisting effective date would impose C. What Factors Must EPA Consider in determination, EPA evaluated the unnecessary hardship and expense on Deciding Whether To Grant a Delisting Petition? petitioned waste against the listing this petitioner. These reasons also III. EPA’s Evaluation of the Waste criteria and factors cited in provide good cause for making this rule Information and Data § 261.11(a)(2) and (a)(3). Based on this effective immediately, upon final A. What Waste Did Tokusen Petition EPA review, EPA agrees with the petitioner publication, under the Administrative To Delist? that the waste is non-hazardous with Procedure Act, 5 U.S.C. 553(d).

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E. How Would This Action Affect Individual waste streams may vary, (2)(iii and iv) and (c)(2)(i), called the States? however, depending on raw materials, ‘‘mixture’’ and ‘‘derived-from’’ rules, industrial processes, and other factors. respectively. These wastes are also Because EPA is issuing this exclusion Thus, while a waste described in these eligible for exclusion and remain under the Federal RCRA delisting regulations or resulting from the hazardous wastes until excluded. See 66 program, only states subject to Federal operation of the mixture or derived-from FR 27266 (May 16, 2001). RCRA delisting provisions would be rules generally is hazardous, a specific affected. This would exclude states III. EPA’s Evaluation of the Waste waste from an individual facility may which have received authorization from Information and Data not be hazardous. EPA to make their own delisting For this reason, 40 CFR 260.20 and A. What Waste Did Tokusen Petition decisions. 260.22 provide an exclusion procedure, EPA To Delist? EPA allows states to impose their own called delisting, which allows persons On March 25, 2009, Tokusen non-RCRA regulatory requirements that to prove that EPA should not regulate a are more stringent than EPA’s, under petitioned EPA to exclude from the lists specific waste from a particular of hazardous wastes contained in section 3009 of RCRA, 42 U.S.C. 6929. generating facility as a hazardous waste. These more stringent requirements may § 261.31, WWTP sludge (F006) include a provision that prohibits a B. What Is a Delisting Petition, and generated from its facility located in Federally issued exclusion from taking What Does It Require of a Petitioner? Conway, Arkansas. The waste falls effect in the state. Because a dual system under the classification of listed waste A delisting petition is a request from pursuant to § 261.31. Specifically, in its (that is, both Federal (RCRA) and state a facility to EPA or an authorized state (non-RCRA programs) may regulate a petition, Tokusen requested that EPA to exclude wastes from the list of grant a standard exclusion for 2,000 petitioner’s waste, EPA urges petitioners hazardous wastes. The facility petitions to contact the state regulatory authority cubic yards per year of the WWTP EPA because it does not consider the sludge. to establish the status of their wastes wastes hazardous under RCRA under the state law. regulations. B. Who Is Tokusen and What Process EPA has also authorized some states In a delisting petition, the petitioner Does It Use To Generate the Petitioned (for example, Louisiana, Oklahoma, must show that wastes generated at a Waste? Georgia, Illinois) to administer a RCRA particular facility do not meet any of the The Tokusen USA, Inc. facility delisting program in place of the Federal criteria for which the waste was listed. produces high-carbon steel tire cord for program, that is, to make state delisting The criteria for which EPA lists a waste use in radial tire manufacturing. The decisions. Therefore, this exclusion are in part 261 and further explained in steel cord is produced from steel rod does not apply in those authorized the background documents for the listed which has been reduced in size and states unless that state makes the rule waste. electroplated with copper and zinc to part of its authorized program. If In addition, under 40 CFR 260.22, a produce a brass coating. The facility Tokusen transports the petitioned waste petitioner must prove that the waste generates F006 filter cake by the to or manages the waste in any state does not exhibit any of the hazardous dewatering of wastewater sludge with delisting authorization, Tokusen waste characteristics (that is, generated at the on-site wastewater must obtain delisting authorization from ignitability, reactivity, corrosivity, and treatment plants. This waste is stored that state before it can manage the waste toxicity) and present sufficient on-site less than 90 days and is then as non-hazardous in the state. information for EPA to decide whether transported from the site to the RCRA factors other than those for which the II. Background Subtitle C facility, Chemical Waste waste was listed warrant retaining it as Management in Sulphur, LA 70556. A. What Is the History of the Delisting a hazardous waste. (See Part 261 and the Program? background documents for the listed C. How Did Tokusen Sample and waste.) Analyze the Data in This Petition? EPA published an amended list of Generators remain obligated under To support its petition, Tokusen hazardous wastes from non-specific and RCRA to confirm whether their waste specific sources on January 16, 1981, as submitted: remains non-hazardous based on the (1) Historical information on waste part of its final and interim final hazardous waste characteristics even if generation and management practices; regulations implementing section 3001 EPA has ‘‘delisted’’ the waste. (2) Analytical results from four of RCRA. EPA has amended this list samples for total concentrations of several times and published it in 40 CFR C. What Factors Must EPA Consider in Deciding Whether To Grant a Delisting compounds of concern (COCs); 261.31 and 261.32. (3) Analytical results from four Petition? EPA lists these wastes as hazardous samples for Toxicity Characteristic because: (1) The wastes typically and Besides considering the criteria in 40 Leaching Procedure (TCLP) extract frequently exhibit one or more of the CFR 260.22(a) and section 3001(f) of values of COCs; and characteristics of hazardous wastes RCRA, 42 U.S.C. 6921(f), and in the (4) Multiple pH testing for the identified in Subpart C of Part 261 (that background documents for the listed petitioned waste. is, ignitability, corrosivity, reactivity, wastes, EPA must consider any factors and toxicity), (2) the wastes meet the (including additional constituents) other D. What Were the Results of Tokusen’s criteria for listing contained in than those for which EPA listed the Analyses? § 261.11(a)(2) or (a)(3), or (3) the wastes waste, if a reasonable basis exists that EPA believes that the descriptions of are mixed with or derived from the these additional factors could cause the the Tokusen analytical characterization treatment, storage or disposal of such waste to be hazardous. provide a reasonable basis to grant characteristic and listed wastes and EPA must also consider as hazardous Tokusen’s petition for an exclusion of which therefore become hazardous waste mixtures containing listed the WWTP sludge. EPA believes the under § 261.3(a)(2)(iv) or (c)(2)(i), hazardous wastes and wastes derived data submitted in support of the petition known as the ‘‘mixture’’ or ‘‘derived- from treating, storing, or disposing of show the WWTP sludge is non- from’’ rules, respectively. listed hazardous waste. See § 261.3(a) hazardous. Analytical data for the

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WWTP sludge samples included in the and has determined that it satisfies EPA Tokusen’s waste are presently below March 2009 petition were used in the criteria for collecting representative health-based levels used in the delisting DRAS to develop delisting levels. The samples of the variations in constituent decision-making. EPA believes that data summaries for COCs are presented concentrations in the WWTP sludge. In Tokusen has successfully demonstrated in Table I. EPA has reviewed the addition, the data submitted in support that the WWTP sludge is non- sampling procedures used by Tokusen of the petition show that constituents in hazardous.

ANALYTICAL RESULTS/MAXIMUM ALLOWABLE DELISTING CONCENTRATION [Wastewater treatment sludge; Tokusen, Conway, Arkansas]

Maximum allow- Maximum total Maximum TCLP able TCLP Constituents (mg/kg) (mg/L) delisting level (mg/L)

Antimony ...... 11.9 <0.3 0.4 Arsenic ...... 26.3 J 0.12 1.59 Barium ...... 111 0.313 (100) Chromium ...... 38.9 <0.02 (5.0) Cobalt ...... <9.69 0.059 0.8 Copper ...... 4090 30 91.3 Lead ...... 334 0.06 2.32 Nickel ...... 35.6 0.774 50.5 Selenium ...... 253 0.21 (1.0) Acetone ...... 0.0293 BJ 0.0429 1950 Zinc ...... 26400 553 748 Notes: 1. These levels represent the highest constituent concentration found in any one sample and do not necessarily represent the specific level found in one sample. 2. The delisting levels are from the DRAS analyses except the chemical concentrations with a parenthesis which are the TCLP regulatory lev- els. 3. J: Estimated Value.

E. How Did EPA Evaluate the Risk of and non-cancer hazard index of 1.0). to predict possible risks associated with Delisting This Waste? The DRAS program can back-calculate releases of waste constituents through the acceptable receptor well surface pathways (e.g., volatilization For this delisting determination, EPA concentrations (referred to as from the landfill). As in the above used such information gathered to compliance-point concentrations) using groundwater analyses, the DRAS uses identify plausible exposure routes (i.e., standard risk assessment algorithms and the risk level, the health-based data and groundwater, surface water, air) for EPA health-based numbers. Using the standard risk assessment and exposure hazardous constituents present in the maximum compliance-point algorithms to predict maximum petitioned waste. EPA determined that concentrations and EPA’s Composite compliance-point concentrations of disposal in a landfill is the most Model for Leachate Migration with waste constituents at a hypothetical reasonable, worst-case disposal scenario Transformation Products (EPACMTP) point of exposure. Using fate and for Tokusen’s petitioned waste. EPA fate and transport modeling factors, the transport equations, the DRAS uses the applied the Delisting Risk Assessment DRAS further back-calculates the maximum compliance-point Software (DRAS) described in 65 FR maximum permissible waste constituent concentrations and back-calculates the 58015 (September 27, 2000), 65 FR concentrations not expected to exceed maximum allowable waste constituent 75637 (December 4, 2000), and 73 FR the compliance-point concentrations in concentrations (or ‘‘delisting levels’’). 28768 (May 19, 2008) to predict the groundwater. In most cases, because a delisted maximum allowable concentrations of EPA believes that the EPACMTP fate waste is no longer subject to hazardous hazardous constituents that may be and transport model represents a waste control, EPA is generally unable released from the petitioned waste after reasonable worst-case scenario for to predict, and does not presently disposal and determined the potential possible groundwater contamination control, how a petitioner will manage a impact of the disposal of Tokusen’s resulting from disposal of the petitioned waste after delisting. Therefore, EPA petitioned waste on human health and waste in a landfill, and that a reasonable currently believes that it is the environment. A copy of this worst-case scenario is appropriate when inappropriate to consider extensive site- software can be found on the world evaluating whether a waste should be specific factors when applying the fate wide web at http://www.epa.gov/ relieved of the protective management and transport model. EPA does control reg5rcra/wptdiv/hazardous/delisting/ constraints of RCRA Subtitle C. The use the type of unit where the waste is dras-software.html. In assessing of some reasonable worst-case scenarios disposed. The waste must be disposed potential risks to groundwater, EPA resulted in conservative values for the in the type of unit the fate and transport used the maximum waste volumes and compliance-point concentrations and model evaluates. the maximum reported extract ensures that the waste, once removed The DRAS results which calculate the concentrations as inputs to the DRAS from hazardous waste regulation, will maximum allowable concentration of program to estimate the constituent not pose a significant threat to human chemical constituents in the waste are concentrations in the groundwater at a health or the environment. presented in Table I. Based on the hypothetical receptor well down The DRAS also uses the maximum comparison of the DRAS and TCLP gradient from the disposal site. Using estimated waste volumes and the Analyses results found in Table I, the the risk level (carcinogenic risk of 10 ¥5 maximum reported total concentrations petitioned waste should be delisted

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because no constituents of concern constituents in Tokusen’s waste are Subtitle C of RCRA. Managing the tested are likely to be present or formed presently below the compliance point WWTP sludge as a hazardous waste as reaction products or by-products in concentrations used in the delisting until initial verification testing is Tokusen waste. decision and would not pose a performed will protect against improper substantial hazard to the environment. handling of hazardous material. If EPA F. What Did EPA Conclude About determines that the data collected under Tokusen’s Analysis? EPA believes that Tokusen has successfully demonstrated that the this paragraph do not support the data EPA concluded, after reviewing WWTP sludge is non-hazardous. provided for in the petition, the Tokusen’s processes that no other EPA therefore, proposes to grant an exclusion will not cover the petitioned hazardous constituents of concern, other exclusion to Tokusen in Conway, waste. The exclusion is effective upon than those for which tested, are likely to Arkansas, for the WWTP sludge publication in the Federal Register but be present or formed as reaction described in its petition. EPA’s decision the disposal as non-hazardous cannot products or by-products in the waste. In to exclude this waste is based on begin until the verification sampling is addition, on the basis of explanations descriptions of the treatment activities completed. and analytical data provided by associated with the petitioned waste (3) Verification Testing Requirements: Tokusen, pursuant to § 260.22, EPA and characterization of the WWTP Tokusen must complete a rigorous concludes that the petitioned waste do sludge. verification testing program on the not exhibit any of the characteristics of If EPA finalizes the proposed rule, WWTP sludge to assure that the sludge ignitability, corrosivity, reactivity or EPA will no longer regulate the does not exceed the maximum levels toxicity. See §§ 261.21, 261.22 and petitioned waste under Parts 262 specified in paragraph (1) of the 261.23, respectively. through 268 and the permitting exclusion language. This verification program operates on two levels. The G. What Other Factors Did EPA standards of Part 270. Tokusen must first part of the verification testing Consider in Its Evaluation? comply with the LDR requirements before disposing of the delisted waste program consists of testing the WWTP During the evaluation of Tokusen’s because the LDR attaches at the point of sludge for specified indicator petition, EPA also considered the generation of the waste. The delisting, if parameters as per paragraph (1) of the potential impact of the petitioned waste granted, will absolve the generator from exclusion language. If EPA determines via non-groundwater routes (i.e., air his obligation of handling the waste as that the data collected under this emission and surface runoff). With hazardous. The appropriate waste code paragraph do not support the data regard to airborne dispersion in for this waste is F006. The LDR provided for the petition, the exclusion particular, EPA believes that exposure treatment standard for F006 is found in will not cover the generated wastes. If to airborne contaminants from 40 CFR 268.40. the data from the initial verification Tokusen’s petitioned waste is unlikely. testing program demonstrate that the Therefore, no appreciable air releases IV. Next Steps leachate meets the delisting levels, are likely from Tokusen’s waste under A. With What Conditions Must the Tokusen may request quarterly testing. any likely disposal conditions. EPA Petitioner Comply? EPA will notify Tokusen in writing, if evaluated the potential hazards and when it may replace the testing resulting from the unlikely scenario of The petitioner, Tokusen, must comply conditions in paragraph (3)(A) with the airborne exposure to hazardous with the requirements in 40 CFR Part testing conditions in (3)(B) of the constituents released from Tokusen’s 261, Appendix IX, Table 1. The text exclusion language. waste in an open landfill. The results of below gives the rationale and details of The second part of the verification this worst-case analysis indicated that those requirements. testing program is the quarterly testing there is no substantial present or (1) Delisting Levels: of representative samples of WWTP potential hazard to human health and This paragraph provides the levels of sludge for all constituents specified in the environment from airborne exposure constituents for which Tokusen must paragraph (1) of the exclusion language. to constituents from Tokusen’s WWTP test the WWTP sludge, below which EPA believes that the concentrations of waste. these wastes would be considered non- the constituents of concern in the hazardous. EPA selected the set of WWTP sludge may vary over time. H. What Is EPA’s Evaluation of This inorganic and organic constituents Consequently this program will ensure Delisting Petition? specified in paragraph (1) of 40 CFR Part that the sludge is evaluated in terms of The descriptions of Tokusen’s 261, Appendix IX, Table 1, (the variation in constituent concentrations hazardous waste process and analytical exclusion language) based on in the waste over time. characterization provide a reasonable information in the petition. EPA The proposed subsequent testing basis for EPA to grant the exclusion. The compiled the inorganic and organic would verify that Tokusen operates a data submitted in support of the petition constituents list from the composition of treatment facility where the constituent show that constituents in the waste are the waste, descriptions of Tokusen’s concentrations of the WWTP sludge do below the leachable concentrations (see treatment process, previous test data not exhibit unacceptable temporal and Table I). EPA believes that Tokusen’s provided for the waste, and the spatial levels of toxic constituents. EPA waste, F006 from copper and zinc respective health-based levels used in is proposing to require Tokusen to electroplating process to produce a brass delisting decision-making. These analyze representative samples of the coating will not impose any threat to delisting levels correspond to the WWTP sludge quarterly during the first human health and the environment. allowable levels measured in the TCLP year of waste generation. Tokusen Thus, EPA believes Tokusen should concentrations. would begin quarterly sampling 60 days be granted an exclusion for the WWTP (2) Waste Holding and Handling: after the final exclusion as described in sludge. EPA believes the data submitted The purpose of this paragraph is to paragraph (3)(B) of the exclusion in support of the petition show ensure that Tokusen manages and language. Tokusen’s WWTP sludge is non- disposes of any WWTP sludge that EPA, per paragraph 3(C) of the hazardous. The data submitted in contains hazardous levels of inorganic exclusion language, is proposing to end support of the petition show that and organic constituents according to the subsequent testing conditions after

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the first year, if Tokusen has (b) If it uses any new manufacturing If an immediate threat to human health demonstrated that the waste or production process(es), or and the environment presents itself, consistently meets the delisting levels. significantly changes from the current EPA will continue to address these To confirm that the characteristics of the process(es) described in their petition; situations on a case by case basis. Where waste do not change significantly over or necessary, EPA will make a good cause time, Tokusen must continue to analyze (c) If it makes any changes that could finding to justify emergency rulemaking. a representative sample of the waste on affect the composition or type of waste See APA section 553 (b). an annual basis. Annual testing requires generated. (7) Notification Requirements analyzing the full list of components in Tokusen must manage waste volumes In order to adequately track wastes paragraph (1) of the exclusion language. greater than 2,000 cubic yards per year that have been delisted, EPA is If operating conditions change as of WWTP waste as hazardous until EPA requiring that Tokusen provide a one- described in paragraph (4) of the grants a new exclusion. When this time notification to any state regulatory exclusion language; Tokusen must exclusion becomes final, Tokusen’s agency through which or to which the reinstate all testing in paragraph (1) of management of the wastes covered by delisted waste is being carried. Tokusen the exclusion language. Tokusen must this petition would be relieved from must provide this notification 60 days prove through a new demonstration that Subtitle C jurisdiction, and the WWTP before commencing this activity. their waste meets the conditions of the sludge from Tokusen will be disposed to exclusion. If the annual testing of the the RCRA Subtitle D landfill of Waste B. What Happens if Tokusen Violates waste does not meet the delisting Management Industrial Subtitle D the Terms and Conditions? requirements in paragraph (1), Tokusen landfill in North Little Rock, AR. If Tokusen violates the terms and must notify EPA according to the (6) Re-opener: conditions established in the exclusion, requirements in paragraph (6) of the The purpose of paragraph (6) of the EPA will start procedures to withdraw exclusion language. The facility must exclusion language is to require the exclusion. Where there is an provide sampling results that support Tokusen to disclose new or different immediate threat to human health and the rationale that the delisting exclusion information related to a condition at the the environment, EPA will evaluate the should not be withdrawn. facility or disposal of the waste, if it is need for enforcement activities on a (4) Changes in Operating Conditions: pertinent to the delisting. Tokusen must case-by-case basis. EPA expects Paragraph (4) of the exclusion also use this procedure if the waste Tokusen to conduct the appropriate sample in the annual testing fails to language would allow Tokusen the waste analysis and comply with the meet the levels found in paragraph (1). flexibility of modifying its processes (for criteria explained above in paragraph (1) This provision will allow EPA to example, changes in equipment or of the exclusion. change in operating conditions) to reevaluate the exclusion, if a source improve its treatment process. However, provides new or additional information V. Public Comments to EPA. EPA will evaluate the Tokusen must prove the effectiveness of A. How May I as an Interested Party information on which EPA based the the modified process and request Submit Comments? approval from EPA. Tokusen must decision to see if it is still correct, or if manage wastes generated during the circumstances have changed so that the EPA is requesting public comments new process demonstration as information is no longer correct or on this proposed decision. Please send hazardous waste until it has obtained would cause EPA to deny the petition, three copies of your comments. Send written approval and paragraph (3) of if presented. two copies to Ben Banipal, Section the exclusion language is satisfied. This provision expressly requires Chief of the Corrective Action and (5) Data Submittals: Tokusen to report differing site Waste Minimization Section (6PD–C), To provide appropriate conditions or assumptions used in the Multimedia Planning and Permitting documentation that Tokusen’s WWTP petition in addition to failure to meet Division, Environmental Protection sludge is meeting the delisting levels, the annual testing conditions within 10 Agency (EPA), 1445 Ross Avenue, Tokusen must compile, summarize, and days of discovery. If EPA discovers such Dallas, Texas 75202. Send a third copy keep delisting records on-site for a information itself or from a third party, to the Hazardous Waste Division, minimum of five years. It should keep it can act on it as appropriate. The Arkansas Department of Environmental all analytical data obtained through language being proposed is similar to Quality, P.O. Box 8913, Little Rock, AR paragraph (3) of the exclusion language those provisions found in RCRA 72118. Identify your comments at the including quality control information regulations governing no-migration top with this regulatory docket number: for five years. Paragraph (5) of the petitions at § 268.6. ‘‘EPA–R06–RCRA–2009–0549.’’ You exclusion language requires that EPA believes that it has the authority may submit your comments Tokusen furnish these data upon under RCRA and the Administrative electronically to Youngmoo Kim at request for inspection by any employee Procedures Act (APA), 5 U.S.C. 551 [email protected]. or representative of EPA or the State of (1978) et seq., to reopen a delisting You should submit requests for a Arkansas. decision. EPA may reopen a delisting hearing to Ben Banipal, Section Chief of If the proposed exclusion is made decision when it receives new the Corrective Action and Waste final, it will apply only to 2,000 cubic information that calls into question the Minimization Section (6PD–C), yards per year of wastewater treatment assumptions underlying the delisting. Multimedia Planning and Permitting sludge generated at Tokusen after EPA believes a clear statement of its Division, U.S. Environmental Protection successful verification testing. authority in delistings is merited in light Agency, 1445 Ross Avenue, Dallas, EPA would require Tokusen to file a of EPA’s experience. See Reynolds Texas 75202. new delisting petition under any of the Metals Company at 62 FR 37694 and 62 B. How May I Review the Docket or following circumstances: FR 63458 where the delisted waste (a) If it significantly alters the leached at greater concentrations in the Obtain Copies of the Proposed manufacturing process treatment system environment than the concentrations Exclusion? except as described in paragraph (4) of predicted when conducting the TCLP, You may review the RCRA regulatory the exclusion language; thus leading EPA to repeal the delisting. docket for this proposed rule at the

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Environmental Protection Agency 9, 2000). Thus, Executive Order 13175 a rule of particular applicability. Region 6, 1445 Ross Avenue, Dallas, does not apply to this rule. This rule Executive Order (EO) 12898 (59 FR 7629 Texas 75202. It is available for viewing also is not subject to Executive Order (Feb. 16, 1994)) establishes federal in EPA Freedom of Information Act 13045, ‘‘Protection of Children from executive policy on environmental Review Room from 9 a.m. to 4 p.m., Environmental Health Risks and Safety justice. Its main provision directs Monday through Friday, excluding Risks’’ (62 FR 19885, April 23, 1997), federal agencies, to the greatest extent Federal holidays. Call (214) 665–6444 because it is not economically practicable and permitted by law, to for appointments. The public may copy significant as defined in Executive make environmental justice part of their material from any regulatory docket at Order 12866, and because the Agency mission by identifying and addressing, no cost for the first 100 pages, and at does not have reason to believe the as appropriate, disproportionately high fifteen cents per page for additional environmental health or safety risks and adverse human health or copies. addressed by this action present a environmental effects of their programs, disproportionate risk to children. The policies, and activities on minority VI. Statutory and Executive Order basis for this belief is that the Agency populations and low-income Reviews used the DRAS program, which populations in the United States. Under Executive Order 12866, considers health and safety risks to EPA has determined that this ‘‘Regulatory Planning and Review’’ (58 children, to calculate the maximum proposed rule will not have FR 51735, October 4, 1993), this rule is allowable concentrations for this rule. disproportionately high and adverse not of general applicability and This rule is not subject to Executive human health or environmental effects therefore is not a regulatory action Order 13211, ‘‘Actions Concerning on minority or low-income populations subject to review by the Office of Regulations That Significantly Affect because it does not affect the level of Management and Budget (OMB). This Energy Supply, Distribution, or Use’’ (66 protection provided to human health or rule does not impose an information FR 28355 May 22, 2001), because it is the environment. The Agency’s risk collection burden under the provisions not a significant regulatory action under assessment did not identify risks from of the Paperwork Reduction Act of 1995 Executive Order 12866. This rule does management of this material in a (44 U.S.C. 3501 et seq.) because it not involve technical standards; thus, Subtitle D landfill. Therefore, EPA does applies to a particular facility only. the requirements of section 12(d) of the not believe that any populations in Because this rule is of particular National Technology Transfer and proximity of the landfills used by this applicability relating to a particular Advancement Act of 1995 (15 U.S.C. facility should not be adversely affected facility, it is not subject to the regulatory 272 note) do not apply. As required by by common waste management flexibility provisions of the Regulatory section 3 of Executive Order 12988, practices for this delisted waste. Flexibility Act (5 U.S.C. 601 et seq.), or ‘‘Civil Justice Reform,’’ (61 FR 4729, to sections 202, 204, and 205 of the February 7, 1996), in issuing this rule, Lists of Subjects in 40 CFR Part 261 Unfunded Mandates Reform Act of 1995 EPA has taken the necessary steps to Environmental protection, Hazardous (UMRA) (Pub. L. 104–4). Because this eliminate drafting errors and ambiguity, Waste, Recycling, Reporting and rule will affect only a particular facility, minimize potential litigation, and recordkeeping requirements. it will not significantly or uniquely provide a clear legal standard for Authority: Sec. 3001(f) RCRA, 42 U.S.C. affect small governments, as specified in affected conduct. The Congressional 6921(f). section 203 of UMRA. Because this rule Review Act, 5 U.S.C. 801 et seq., as Dated: March 17, 2010. will affect only a particular facility, this added by the Small Business Regulatory proposed rule does not have federalism Enforcement Fairness Act of 1996, Susan Spalding, implications. It will not have substantial generally provides that before a rule Acting Director, Multimedia Planning and direct effects on the States, on the may take effect, the agency Permitting Division, Region 6. relationship between the national promulgating the rule must submit a For the reasons set out in the government and the States, or on the rule report which includes a copy of the preamble, 40 CFR part 261 is proposed distribution of power and rule to each House of the Congress and to be amended as follows: responsibilities among the various to the Comptroller General of the United levels of government, as specified in States. Section 804 exempts from PART 261—IDENTIFICATION AND Executive Order 13132, ‘‘Federalism,’’ section 801 the following types of rules LISTING OF HAZARDOUS WASTE (64 FR 43255, August 10, 1999). Thus, (1) rules of particular applicability; (2) 1. The authority citation for part 261 Executive Order 13132 does not apply rules relating to agency management or continues to read as follows: to this rule. Similarly, because this rule personnel; and (3) rules of agency will affect only a particular facility, this organization, procedure, or practice that Authority: 42 U.S.C. 6905, 6912(a), 6921, proposed rule does not have tribal do not substantially affect the rights or 6922, and 6938. implications, as specified in Executive obligations of non-agency parties 5 2. In Table 1 of Appendix IX of part Order 13175, ‘‘Consultation and U.S.C. 804(3). EPA is not required to 261 add the following waste stream in Coordination with Indian Tribal submit a rule report regarding this alphabetical order by facility to read as Governments’’ (65 FR 67249, November action under section 801 because this is follows:

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Appendix IX to Part 261—Waste Excluded Under § 260.20 and 260.22

TABLE 1—WASTE EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description

******* Tokusen, USA Inc ...... Conway AR ...... Wastewater Treatment Sludge (EPA Hazardous Waste No. F006) generated at a maximum an- nual rate of 2,000 cubic yards per calendar year after [insert publication date of the final rule] will be disposed in Subtitle D landfill. For the exclusion to be valid, Tokusen must implement a verification testing program that meets the following paragraphs: (1) Delisting Levels: All leachable concentrations for those constituents must not exceed the following levels (mg/l for TCLP). (A) Inorganic Constituents: Antimony—0.4; Arsenic—1.59; Barium—100; Chromium—5.0; Cobalt—0.8; Copper—91.3; Lead—2.32; Nickel—50.5; Sele- nium—1.0; Zinc—748. (B) Organic Constituents: Acetone—1950. (2) Waste Management: (A) Tokusen must manage as hazardous all WWTP sludge generated, until it has completed initial verification testing described in paragraph (3)(A) and (B), as ap- propriate, and valid analyses show that paragraph (1) is satisfied and approval is received by EPA. (B) Levels of constituents measured in the samples of the WWTP sludge that do not exceed the levels set forth in paragraph (1) are non-hazardous. Tokusen can manage and dispose of the non-hazardous WWTP sludge according to all applicable solid waste regula- tions. (C) If constituent levels in a sample exceed any of the Delisting Levels set in para- graph (1) Tokusen can collect one additional sample and perform expedited analyses to verify if the constituent exceeds the delisting level. If this sample confirms the exceedance, Tokusen must, from that point forward, treat all the waste covered by this exclusion as haz- ardous until it is demonstrated that the waste again meets the levels in paragraph (1). Tokusen must manage and dispose of the waste generated under Subtitle C of RCRA from the time that it becomes aware of any exceedance. (D) Upon completion of the verification testing described in paragraph 3(A) and (B) as appropriate and the transmittal of the results to EPA, and if the testing results meet the requirements of paragraph (1), Tokusen may pro- ceed to manage its WWTP sludge as non-hazardous waste. If subsequent Verification Test- ing indicates an exceedance of the Delisting Levels in paragraph (1), Tokusen must manage the WWTP sludge as a hazardous waste after it has received approval from EPA as de- scribed in paragraph (2)(C). (3) Verification Testing Requirements: Tokusen must perform sample collection and analyses, including quality control procedures, using appropriate methods. As applicable to the meth- od-defined parameters of concern, analyses requiring the use of SW–846 methods incor- porated by reference in 40 CFR 260.11 must be used without substitution. As applicable, the SW–846 methods might include Methods 8260B, 1311/8260B, 8270C, 6010B, 7470, 9034A, ASTMD–4982B, ASTMD–5049, E413.2. Methods must meet Performance Based Measure- ment System Criteria in Which The Data Quality Objectives are to demonstrate that rep- resentative samples of sludge meet the delisting levels in paragraph (1). If EPA judges the process to be effective under the operating conditions used during the initial verification test- ing, Tokusen may replace the testing required in paragraph (3)(A) with the testing required in paragraph (3)(B). Tokusen must continue to test as specified in paragraph (3)(A) until and unless notified by EPA in writing that testing in paragraph (3)(A) may be replaced by para- graph (3)(B). (A) Initial Verification Testing: After EPA grants the final exclusion, Tokusen must do the following: (i) Within 60 days of this exclusion becoming final, collect eight sam- ples, before disposal, of the WWTP sludge. (ii) The samples are to be analyzed and com- pared against the Delisting Levels in paragraph (1). (iii) Within sixty (60) days after this ex- clusion becomes final, Tokusen will report initial verification analytical test data for the WWTP sludge, including analytical quality control information for the first thirty (30) days of operation after this exclusion becomes final. Tokusen must request in writing that EPA allow Tokusen to substitute the testing conditions in (3)(B) for (3)(A). (B) Subsequent Verification Testing: Following written notification by EPA, Tokusen may substitute the testing conditions in (3)(B) for (3)(A). Tokusen must continue to monitor operating conditions, and analyze two representative samples of the wastewater treatment sludge for each quarter of operation dur- ing the first year of waste generation. The samples must represent the waste generated dur- ing the quarter. If levels of constituents measured in the samples of the WWTP sludge that do not exceed the levels set forth in paragraph (1) in two consecutive quarters after this ex- clusion become effective, Tokusen can manage and dispose of the WWTP sludge according to all applicable solid waste regulations. After the first year of analytical sampling verification sampling can be performed on a single annual sample of the wastewater treatment sludge. The results are to be compared to the Delisting Levels in paragraph (1). (C) Termination of Testing: (i) After the first year of quarterly testing, if the Delisting Levels in paragraph (1) are met, Tokusen may then request in writing that EPA not require quarterly testing. (ii) Fol- lowing cancellation of the quarterly testing, Tokusen must continue to test a representative sample for all constituents listed in paragraph (1) annually.

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TABLE 1—WASTE EXCLUDED FROM NON-SPECIFIC SOURCES—Continued

Facility Address Waste description

(4) Changes in Operating Conditions: If Tokusen significantly changes the process described in its petition or starts any processes that generate(s) the waste that may or could significantly affect the composition or type of waste generated as established under paragraph (1) (by il- lustration, but not limitation, changes in equipment or operating conditions of the treatment process), it must notify EPA in writing; it may no longer handle the wastes generated from the new process as non-hazardous until the wastes meet the delisting Levels set in para- graph (1) and it has received written approval to do so from EPA. (5) Data Submittals: Tokusen must submit the information described below. If Tokusen fails to submit the required data within the specified time or maintain the required records on-site for the specified time, EPA, at its discretion, will consider this sufficient basis to reopen the ex- clusion as described in paragraph 6. Tokusen must: (A) Submit the data obtained through paragraph(3) to the Section Chief, Corrective Action and Waste Minimization Section, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733, Mail Code, (6PD–C) within the time specified. (B) Compile records of operating conditions and analytical data from para- graph (3), summarized, and maintained on-site for a minimum of five years. (C) Furnish these records and data when EPA or the state of Arkansas requests them for inspection. (D) Send along with all data a signed copy of the following certification statement, to attest to the truth and accuracy of the data submitted: Under civil and criminal penalty of law for the mak- ing or submission of false or fraudulent statements or representations (pursuant to the appli- cable provisions of the Federal Code, which include, but may not be limited to, 18 U.S.C. 1001 and 42 U.S.C. 6928), I certify that the information contained in or accompanying this document is true, accurate and complete. As to the (those) identified section(s) of this docu- ment for which I can not personally verify its (their) truth and accuracy I certify as the com- pany official having supervisory responsibility for the persons who, acting under my direct in- structions, made the verification that this information is true, accurate and complete. If any of this information is determined by EPA in its sole discretion to be false, inaccurate or incom- plete, and upon conveyance of this fact to the company, I recognize and agree that this ex- clusion of waste will be void as if it never had effect or to the extent directed by EPA and that the company will be liable for any actions taken in contravention of the company’s RCRA and CERCLA obligations premised upon the company’s reliance on the void exclu- sion. (6) Re-Opener: (A) If, any time after disposal of the delisted waste, Tokusen possesses or is otherwise made aware of any environmental data (including but not limited to leachate data or groundwater monitoring data) or any other data relevant to the delisted waste indicating that any constituent identified for the delisting verification testing is at level higher than the delisting level allowed by the Division Director in granting the petition, then the facility must report the data, in writing, to the Division Director within 10 days of first possessing or being made aware of that data. (B) If the annual testing of the waste does not meet the delisting requirements in paragraph (1), Tokusen must report the data in writing to the Division Direc- tor within 10 days of first possessing or being made aware of that data. (C) If Tokusen fails to submit the information described in paragraphs (5), (6)(A) or (6)(B) or if any other informa- tion is received from any source, the Division Director will make a preliminary determination as to whether the reported information requires EPA action to protect human health and/or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. (D) If the Di- vision Director determines that the reported information does require action, EPA’s Division Director will notify the facility in writing of the actions the Division Director believes are nec- essary to protect human health and the environment. The notice shall include a statement of the proposed action and a statement providing the facility with an opportunity to present in- formation as to why the proposed action by EPA is not necessary. The facility shall have 10 days from the date of the Division Director’s notice to present such information. (E) Following the receipt of information from the facility described in paragraph (6)(D) or (if) no information is presented under paragraph(6)(D)) the initial receipt of information described in paragraphs (5), (6)(A) or (6)(B), the Division Director will issue a final written determination describing EPA’s actions that are necessary to protect human health and/or the environment. Any re- quired action described in the Division Director’s determination shall become effective imme- diately, unless the Division Director provides otherwise. (7) Notification Requirements: Tokusen must do the following before transporting the delisted waste. Failure to provide this notification will result in a violation of the delisting petition and a possible revocation of the decision. (A) Provide a one-time written notification to any state Regulatory Agency to which or through which it will transport the delisted waste described above for disposal, 60 days before beginning such activities. (B) Update one-time written no- tification, if it ships the delisted waste into a different disposal facility. (C) Failure to provide this notification will result in a violation of the delisting variance and a possible revocation of the decision.

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[FR Doc. 2010–7037 Filed 3–30–10; 8:45 am] Public Comments section below for (4) Specific information on areas that BILLING CODE 6560–50–P?≤ more information). provide habitat for Casey’s June beetle FOR FURTHER INFORMATION CONTACT: Jim that we did not discuss in the proposed Bartel, Field Supervisor, U.S. Fish and rule, whether such areas contain the DEPARTMENT OF THE INTERIOR Wildlife Service, Carlsbad Fish and physical and biological features Wildlife Office, 6010 Hidden Valley essential to the conservation of Casey’s Fish and Wildlife Service Road, Suite 101, Carlsbad, CA 92011; June beetle, and what special telephone (760) 431–9440; facsimile management considerations or 50 CFR Part 17 (760) 431–5901. If you use a protections may be required to maintain telecommunications device for the deaf or enhance the essential features. [Docket No. FWS-R8-ES-2009-0019] (TDD), call the Federal Information (5) Land-use designations and current [MO 92210-0-0008 B2] Relay Service (FIRS) at (800) 877–8339. or planned activities in the subject areas SUPPLEMENTARY INFORMATION: and their possible impacts on proposed RIN 1018-AV91 critical habitat. Public Comments (6) Any foreseeable economic, Endangered and Threatened Wildlife national security, or other relevant and Plants; Listing Casey’s June We intend that any final action impact that may result from designating Beetle as Endangered and Designation resulting from the proposed rule will be particular areas as critical habitat, and, of Critical Habitat based on the best scientific data available and will be as accurate and as in particular, any impacts to small AGENCY: Fish and Wildlife Service, effective as possible. Therefore, we entities (such as small businesses or Interior. request comments or information from small governments), and the benefits of ACTION: Proposed rule; reopening of the public, other concerned government including or excluding areas from the comment period, notice of availability agencies, the scientific community, proposed designation that exhibit these of draft economic analysis, and industry, or other interested party impacts. amended required determinations. during this reopened comment period (7) Whether any particular area being on the proposed rule to list the Casey’s proposed as critical habitat should be SUMMARY: We, the U.S. Fish and June beetle (Dinacoma caseyi) with excluded under section 4(b)(2) of the Wildlife Service (Service), announce the critical habitat that was published in the Act, and whether the benefits of reopening of the comment period on our Federal Register on July 9, 2009 (74 FR potentially excluding any particular July 9, 2009, proposed listing and 32857), including the DEA of the area outweigh the benefits of including critical habitat designation for Casey’s proposed critical habitat designation that area under section 4(b)(2) of the June beetle (Dinacoma caseyi) under the and the amended required Act. Endangered Species Act of 1973, as determinations section provided in this (8) Whether inclusion of tribal lands amended (Act). We also announce the document. We are particularly of the Agua Caliente Band of Cahuilla availability of the draft economic interested in comments concerning: Indians of the Agua Caliente Indian analysis (DEA), and an amended (1) Any available information on Reservation, California (preferred name required determinations section of the known or suspected threats and ‘‘Agua Caliente Band of Cahuilla proposal. We are reopening the proposed or ongoing projects with the Indians’’), in Riverside County is comment period for an additional 30 potential to threaten Casey’s June beetle, appropriate and why. days to allow all interested parties an specifically: (9) The likelihood of adverse social opportunity to comment simultaneously (a) The present or threatened reactions to the designation of critical on the proposed listing and critical destruction, modification or curtailment habitat, and how the consequences of habitat designation, the DEA, and the of its habitat or range; such reactions, if they occur, would amended required determinations (b) Overutilization for commercial, relate to the conservation of the species section. If you submitted comments recreational, scientific, or educational and regulatory benefits of the proposed previously, you do not need to resubmit purposes; critical habitat designation. them because we have already (c) Disease or predation; (10) Information on the extent to incorporated them into the public (d) The inadequacy of existing which the description of potential record and will fully consider them in regulatory mechanisms; and economic impacts in the DEA is preparation of the final rule. (e) Other natural or manmade factors complete and accurate. affecting its continued existence. (11) The potential effects of climate DATES: We will consider comments that (2) Additional information concerning change on this species and its habitat we receive on or before April 30, 2010. the range, distribution, and population and whether the critical habitat may ADDRESSES: You may submit comments size of this species, including the adequately account for these potential by one of the following methods: locations of any additional populations effects. • Federal eRulemaking Portal: http:// of this species. (12) Whether our approach to www.regulations.gov. Follow the (3) The reasons why we should or designating critical habitat could be instructions for submitting comments to should not designate habitat as ‘‘critical improved or modified in any way to Docket No. FWS–R8–ES–2009–0019. habitat’’ under section 4 of the provide an opportunity for greater • U.S. mail or hand-delivery: Public Endangered Species Act of 1973, as public participation and understanding, Comments Processing, Attn: FWS–R8– amended (Act; 16 U.S.C. 1531 et seq.), or to assist us in accommodating public ES–2009–0019; Division of Policy and including whether there are threats to concerns and comments. Directives Management; U.S. Fish and Casey’s June beetle from human activity, If you submitted comments or Wildlife Service; 4401 N. Fairfax Drive, the degree of which can be expected to information on the proposed rule (74 FR Suite 222; Arlington, VA 22203. increase due to the designation, and 32857) during the initial comment We will post all comments on http:// whether that increase in threat period from July 9, 2009, to September www.regulations.gov. This generally outweighs the benefit of designation, 8, 2009, please do not resubmit them. means that we will post any personal such that the designation of critical These comments are included in the information you provide us (see the habitat is not prudent. public record for this rulemaking, and

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we will fully consider them in the the Act, published in the Federal the Act and other Federal, State, and preparation of our final determination. Register on August 8, 2006 (71 FR local regulations). The baseline, Our final determination concerning 44960); the 12–month finding, therefore, represents the costs incurred listing the Casey’s June beetle as an published in the Federal Register on regardless of whether critical habitat is endangered species and designating July 5, 2007 (72 FR 36635); or the designated. The ‘‘with critical habitat’’ critical habitat will take into proposed listing and designation of scenario describes the incremental consideration all written comments and critical habitat rule, published in the impacts associated specifically with the any additional information we receive Federal Register on July 9, 2009 (74 FR designation of critical habitat for the during both comment periods. On the 32857). Alternatively, you may contact species. The incremental conservation basis of public comments, we may, the Carlsbad Fish and Wildlife Office efforts and associated impacts are those during the development of our final (see FOR FURTHER INFORMATION CONTACT). not expected to occur absent the critical determination, find that areas within the Section 3 of the Act defines critical habitat designation for Casey’s June proposed critical habitat designation do habitat as ‘‘(i) the specific areas within beetle. In other words, the incremental not meet the definition of critical the geographical area occupied by the costs are those attributable solely to the habitat, that some modifications to the species, at the time it is listed in designation of critical habitat above and described boundaries are appropriate, or accordance with... [the Act], on which beyond the baseline costs. The DEA also that areas may or may not be are found those physical or biological discusses the potential benefits appropriate for exclusion under section features (I) essential to the conservation associated with the designation of 4(b)(2) of the Act. of the species and (II) which may critical habitat, but does not monetize You may submit your comments and require special management these benefits. The incremental impacts materials concerning the proposed rule considerations or protection; and (ii) are the impacts we may consider in the and the DEA associated with the specific areas outside the geographical final designation of critical habitat when proposed critical habitat designation by area occupied by the species at the time evaluating the benefit of excluding one of the methods listed in the it is listed . . . upon a determination by particular areas under section 4(b)(2) of ADDRESSES section. the Secretary that such areas are the Act. The analysis forecasts both If you submit a comment via http:// essential for the conservation of the baseline and incremental impacts likely www.regulations.gov, your entire species’’ (16 USC 1532(5)(A)). If the to occur if we finalize the proposed submission—including any personal proposed rule is made final, section 7 of designation of critical habitat. identifying information—will be posted the Act will prohibit destruction or The primary intended benefit of on the website. If your submission is adverse modification of critical habitat critical habitat is to support the made via hard copy that includes by any activity funded, authorized, or conservation of endangered and personal identifying information, you carried out by any Federal agency. threatened species, such as the Casey’s may request at the top of your document Federal agencies proposing actions that June beetle. Thus, attempts to develop that we withhold this information from may affect critical habitat must consult monetary estimates of the benefits of public review. However, we cannot with us on the effects of their proposed this proposed critical habitat guarantee that we will be able to do so. actions, under section 7(a)(2) of the Act. designation would focus on the public’s We will post all hardcopy comments on willingness to pay to achieve the Draft Economic Analysis http://www.regulations.gov. Please conservation benefits to the beetle include sufficient information with your Section 4(b)(2) of the Act requires that resulting from this designation. comments to allow us to verify any we designate critical habitat based upon Quantification and monetization of scientific or commercial information the best scientific and commercial data species conservation benefits requires you include. available, after taking into consideration information on the incremental change Comments and materials we receive, the economic impact, impact on in the probability of Casey’s June beetle as well as supporting documentation national security, or any other relevant conservation that is expected to result used to prepare this notice, will be impact of specifying any particular area from the designation. No studies exist available for public inspection on http:// as critical habitat. that provide such information for this www.regulations.gov, or by We prepared a DEA (Industrial species. Even if this information existed, appointment, during normal business Economics Inc. 2010) that identifies and the published valuation literature does hours, at the U.S. Fish and Wildlife analyzes the potential impacts not support monetization of incremental Service, Carlsbad Fish and Wildlife associated with the proposed changes in conservation probability for Office (see FOR FURTHER INFORMATION designation of critical habitat for Casey’s this species. Because it is not possible CONTACT). You may obtain copies of the June beetle that we published in the to determine the probability that proposed listing and proposed critical Federal Register on July 9, 2009 (74 FR benefits will occur in this instance, the habitat (74 FR 32857) and the DEA on 32857). The DEA quantifies the Service has decided not to include such the Internet at http:// economic impacts of all potential estimates in the DEA. Rather than rely www.regulations.gov at Docket No. conservation efforts for Casey’s June on economic measures, the Service FWS-R8-ES-2009-0019, or by mail from beetle; some of these costs will likely be believes that the direct benefits of the the Carlsbad Fish and Wildlife Office incurred regardless of whether or not we proposed rule are best expressed in (see FOR FURTHER INFORMATION CONTACT). finalize the critical habitat. The biological terms that can be weighed economic impact of the proposed against the expected cost impacts of the Background critical habitat designation is analyzed rulemaking. It is our intent to discuss only those by comparing scenarios both ‘‘with The DEA (made available with the topics directly relevant to the proposed critical habitat’’ and ‘‘without critical publication of this notice and referred to designation of critical habitat for Casey’s habitat.’’ The ‘‘without critical habitat’’ throughout this document unless June beetle in this document. For more scenario represents the baseline for the otherwise noted) estimates the detailed information on the taxonomy, analysis, considering protections that foreseeable economic impacts of the biology, and ecology of Casey’s June are already in place for the species or proposed critical habitat designation for beetle, please refer to the 90–day finding that will be in place for the species Casey’s June beetle. The economic on the petition to list the species under upon listing (such as protections under analysis identifies potential incremental

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costs as a result of the proposed critical associated with residential and whether the proposed designation habitat designation, which are those commercial development and public would result in a significant economic costs attributed to critical habitat over projects and activities, such as impact on a substantial number of small and above those baseline costs economic impacts on water entities. Based on comments we receive, associated solely with the listing. It also management and transportation we may revise this determination as part discusses the potential economic projects, Federal lands, small entities, of a final rulemaking. benefits of the proposed designation. and the energy industry. Decision- According to the Small Business The DEA describes economic impacts of makers can use this information to Administration, small entities include Casey’s June beetle conservation efforts assess whether the effects of the critical small organizations, such as associated with the following categories habitat designation might unduly independent nonprofit organizations; of activity: (1) residential and burden a particular group or economic small governmental jurisdictions, commercial development, (2) tribal sector. including school boards and city and activities, (3) flood control activities, town governments that serve fewer than Required Determinations—Amended and (4) recreational activities. 50,000 residents; and small businesses Baseline economic impacts are those In our proposed rule that published in (13 CFR 121.201). Small businesses impacts that result from listing and the Federal Register on July 9, 2009 (74 include manufacturing and mining other conservation efforts for Casey’s FR 32857), we indicated we would defer concerns with fewer than 500 June beetle. Conservation efforts related our determination of compliance with employees, wholesale trade entities to development activities constitute the several statutes and Executive Orders with fewer than 100 employees, retail majority of total baseline costs until the information concerning and service businesses with less than $5 (approximately 80 percent) in areas of potential economic impacts of the million in annual sales, general and proposed critical habitat. Impacts to designation and potential effects on heavy construction businesses with less flood control activities comprise the landowners and stakeholders became than $27.5 million in annual business, remaining approximately 20 percent of available in the DEA. We have now special trade contractors doing less than impacts. Total future baseline impacts made use of the DEA to make these $11.5 million in annual business, and are estimated to be $12,703,600 determinations. In this document, we agricultural businesses with annual ($1,182,600 annualized) in present affirm the information in our proposed sales less than $750,000. To determine value terms using a 7 percent discount rule concerning Executive Order (E.O.) if potential economic impacts to these rate over the next 20 years (2010 to 12866 (Regulatory Planning and small entities are significant, we 2029) in areas proposed as critical Review), E.O. 13132 (Federalism), E.O. considered the types of activities that habitat (Industrial Economics Inc. 2010, 12988 (Civil Justice Reform), the might trigger regulatory impacts under pp. ES-7). Paperwork Reduction Act, the National the proposed designation as well as Almost all incremental impacts Environmental Policy Act, the types of project modifications that may attributed to the proposed critical President’s memorandum of April 29, result. In general, the term significant habitat designation are expected to be 1994, ‘‘Government-to-Government economic impact is meant to apply to a related to development activities Relations with Native American Tribal typical small business firm’s business (approximately 100 percent). The DEA Governments’’ (59 FR 22951), and E.O. operations. estimates total potential incremental 12630 (Takings). However, based on the To determine if the proposed economic impacts in areas proposed as DEA data, we revised our required designation of critical habitat for Casey’s critical habitat over the next 20 years determinations concerning the June beetle would affect a substantial (2010 to 2029) to be $9,792,270 Regulatory Flexibility Act (5 U.S.C. 601 number of small entities, we consider ($924,131 annualized) in present value et seq.), the Unfunded Mandates Reform the number of small entities affected terms using a 7 percent discount rate Act (2 U.S.C. 1501 et seq.), and E.O. within particular types of economic (Industrial Economics Inc. 2010, p. ES- 13211 (Energy Supply, Distribution, or activities, such as residential and 8). This value is based on an assumption Use). commercial development. In order to of total avoidance of designated areas determine whether it is appropriate for Regulatory Flexibility Act (5 U.S.C. 601 and thus represents the upper-bound our agency to certify that this rule et seq.) potential cost for each project. As such, would not have a significant economic it likely overstates the expected absolute Under the Regulatory Flexibility Act impact on a substantial number of small cost of future actions to protect critical (RFA) (5 U.S.C. 601 et seq.), as amended entities, we considered each industry or habitat. by the Small Business Regulatory category individually. If we finalize this The DEA considers both economic Enforcement Fairness Act (5 U.S.C. proposed listing and proposed critical efficiency and distributional effects. In 802(2)), whenever an agency is required habitat designation, Federal agencies the case of habitat conservation, to publish a notice of rulemaking for must consult with us under section 7 of efficiency effects generally reflect the any proposed or final rule, it must the Act if their activities may affect the ‘‘opportunity costs’’ associated with the prepare and make available for public species or the designated critical commitment of resources to comply comment a regulatory flexibility habitat. Incremental impacts to small with habitat protection measures (such analysis that describes the effect of the entities may occur as a direct result of as lost economic opportunities rule on small entities (i.e., small a required consultation under section 7 associated with restrictions on land businesses, small organizations, and of the Act. Additionally, even in the use). The DEA also addresses how small government jurisdictions), as absence of a Federal nexus, indirect potential economic impacts are likely to described below. However, no incremental impacts may still result be distributed, including an assessment regulatory flexibility analysis is required because, for example, a city may request of any local or regional impacts of if the head of an agency certifies the rule project modifications due to the habitat conservation and the potential will not have a significant economic designation of critical habitat via its effects of conservation activities on impact on a substantial number of small review under the California government agencies, private entities. Based on our DEA of the Environmental Quality Act (CEQA). businesses, and individuals. The DEA proposed critical habitat designation, In the DEA of the proposed critical measures lost economic efficiency we provide our analysis for determining habitat designation, we evaluate the

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potential economic effects on small sector, and includes both ‘‘Federal concludes incremental impacts may business entities resulting from intergovernmental mandates’’ and occur due to project modifications that implementation of conservation actions ‘‘Federal private sector mandates.’’ may need to be made for development related to the proposed critical habitat These terms are defined in 2 U.S.C. and flood control activities; however, for Casey’s June beetle. The DEA 658(5)-(7). ‘‘Federal intergovernmental these are not expected to affect small identifies the estimated incremental mandate’’ includes a regulation that governments. Incremental impacts impacts associated with the proposed ‘‘would impose an enforceable duty stemming from various species rulemaking as described in Appendix A upon State, local, or Tribal conservation and development controls of the DEA, and evaluates the potential governments,’’ with two exceptions. It are expected to be borne by the for economic impacts related to activity excludes ‘‘a condition of federal Riverside County Flood Control and categories including residential and assistance.’’ It also excludes ‘‘a duty Water Conservation District (FCWCD), commercial development, tribal arising from participation in a voluntary which is not considered a small activities, flood control activities, and Federal program,’’ unless the regulation government based on the county’s recreational activities (Industrial ‘‘relates to a then-existing Federal population. Consequently, we do not Economics, Inc. 2010). The DEA program under which $500,000,000 or believe that the critical habitat concludes that the incremental impacts more is provided annually to State, designation would significantly or resulting from this rulemaking that may local, and Tribal governments under uniquely affect small government be borne by small businesses will be entitlement authority,’’ if the provision entities. As such, a Small Government associated only with development. would ‘‘increase the stringency of Agency Plan is not required. Incremental impacts are either not conditions of assistance’’ or ‘‘place caps expected for the other types of activities upon, or otherwise decrease, the Federal Executive Order 13211—Energy Supply, considered or, if expected, will not be Government’s responsibility to provide Distribution, and Use borne by small entities. funding’’ and the State, local, or Tribal On May 18, 2001, the President issued As discussed in Appendix A of the governments ‘‘lack authority’’ to adjust E.O. 13211 on regulations that DEA, the only impacts of the proposed accordingly. ‘‘Federal private sector significantly affect energy supply, rule on small businesses would mandate’’ includes a regulation that distribution, and use. Executive Order potentially result from lost land values ‘‘ would impose an enforceable duty 13211 requires agencies to prepare associated with the identified upon the private sector, except (i) a Statements of Energy Effects when development projects. In the 20–year condition of Federal assistance; or (ii) a undertaking certain actions. The OMB’s timeframe for the analysis, three duty arising from participation in a guidance for implementing this developers may experience impacts. ’’ voluntary Federal program. Executive Order outlines nine outcomes The potential incremental costs are The designation of critical habitat that may constitute ‘‘a significant expected to vary by project, depending does not impose a legally binding duty adverse effect’’ when compared to no on the size and the value of the land. on non-Federal Government entities or The total annualized incremental private parties. Under the Act, the only regulatory action. As discussed in impacts are forecast at approximately regulatory effect is that Federal agencies Appendix A, the DEA finds that none of $965,000 (discounted at 7 percent). The must ensure that their actions do not these criteria are relevant to this SBREFA analysis estimates that three destroy or adversely modify critical analysis. The DEA identified no small businesses may be affected by the habitat under section 7. Designation of potentially affected entities involved in designation of critical habitat (Industrial critical habitat may indirectly impact the production of energy, and a Economics, Inc. 2010, pp. A-3–A-6). non-Federal entities that receive Federal Statement of Energy Effects is therefore Because only three small businesses funding, assistance, or permits, or that not required. may be affected, we do not find that the otherwise require approval or References Cited number of small entities that would be authorization from a Federal agency for significantly affected is substantial. an action may be indirectly impacted by A complete list of all references we In summary, we considered whether the designation of critical habitat. cited in the proposed rule and in this the proposed rule would result in a However, the legally binding duty to document is available on the Internet at significant economic impact on a avoid destruction or adverse http://www.regulations.gov or by substantial number of small entities. For modification of critical habitat rests contacting the Carlsbad Fish and the above reasons and based on squarely on the Federal agency. Wildlife Office (see FOR FURTHER currently available information, we Furthermore, to the extent that non- INFORMATION CONTACT section). certify that, if adopted, the proposed Federal entities are indirectly impacted Author critical habitat would not have a because they receive Federal assistance significant economic impact on a or participate in a voluntary Federal aid The primary authors of this notice are substantial number of small entities. program, the Unfunded Mandates the staff members of the Carlsbad Fish Therefore, an initial regulatory Reform Act would not apply, nor would and Wildlife Office (see FOR FURTHER flexibility analysis is not required. critical habitat shift the costs of the large INFORMATION CONTACT). entitlement programs listed above on to Unfunded Mandates Reform Act (2 State governments. Authority U.S.C. 1501 et seq.) (b) As discussed in the DEA of the The authority for this action is the In accordance with the Unfunded proposed designation of critical habitat Endangered Species Act of 1973 as Mandates Reform Act (2 U.S.C. 1501), for Casey’s June beetle, we do not amended (16 U.S.C. 1531 et seq.). we make the following findings: believe that the rule would significantly (a) This rule would not produce a or uniquely affect small governments Dated: March 23, 2010 Federal mandate. In general, a Federal because it would not produce a Federal Will Shafroth, mandate is a provision in legislation, mandate of $100 million or greater in Acting Assistant Secretary for Fish and statute, or regulation that would impose any year; that is, it is not a ‘‘significant Wildlife and Parks. an enforceable duty upon State, local, or regulatory action’’ under the Unfunded [FR Doc. 2010–7131 Filed 3–30–10; 8:45 am] Tribal governments, or the private Mandates Reform Act. The DEA BILLING CODE 4310–55–S

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DEPARTMENT OF THE INTERIOR telecommunications device for the deaf and (B). In response to the NOI, we (TDD), please call the Federal agreed to submit a 90–day finding to the Fish and Wildlife Service Information Relay Service (FIRS) at 800- Federal Register as expeditiously as 877-8339. possible. 50 CFR Part 17 SUPPLEMENTARY INFORMATION: On July 29, 2008, we made our 90– day finding that the petition presented [Docket No. FWS-R2-ES-2009-0070] Background [MO 92210-0-0008-B2] substantial scientific information Section 4(b)(3)(B) of the Endangered indicating that listing the Tucson Endangered and Threatened Wildlife Species Act of 1973, as amended (Act) shovel-nosed snake (Chionactis and Plants; 12-Month Finding on a (16 U.S.C. 1531 et seq.), requires that, occipitalis klauberi) may be warranted. Petition to List the Tucson Shovel- for any petition containing substantial The finding and our initiation of a status Nosed Snake (Chionactis occipitalis scientific or commercial information review was published in the Federal klauberi) as Threatened or Endangered indicating that listing the species may Register on July 29, 2008 (73 FR 43905). with Critical Habitat be warranted, we make a finding within This notice constitutes the 12–month 12 months of the date of receipt of the finding on the December 15, 2004, AGENCY: Fish and Wildlife Service, petition. In this finding we determine petition to list the Tucson shovel-nosed Interior. that the petitioned action is: (a) Not snake as threatened or endangered. ACTION: Notice of 12–month petition warranted, (b) warranted, or (c) finding. warranted, but immediate proposal of a Species Information regulation implementing the petitioned Species Description SUMMARY: We, the U.S. Fish and action is precluded by other pending Wildlife Service (Service), announce a proposals to determine whether species The Tucson shovel-nosed snake is a 12–month finding on a petition to list are threatened or endangered, and small snake (250–425 millimeters (mm) the Tucson shovel-nosed snake expeditious progress is being made to (9.84–16.73 inches (in) total length) in (Chionactis occipitalis klauberi) as add or remove qualified species from the family Colubridae, with a shovel- threatened or endangered with critical the Lists of Endangered and Threatened shaped snout, an inset lower jaw, and habitat under the Endangered Species Wildlife and Plants. Section 4(b)(3)(C) of coloring that mimics coral snakes Act of 1973, as amended (Act). After the Act requires that we treat a petition (Mahrdt et al. 2001, p. 731.1). The most review of the best scientific and for which the requested action is found notable features of the Tucson shovel- commercial information available, we to be warranted but precluded as though nosed snake distinguishing it from the find that listing the Tucson shovel- resubmitted on the date of such finding, other subspecies are (a) the red nosed snake as threatened or that is, requiring a subsequent finding to crossbands suffused with dark pigment, endangered throughout its range is be made within 12 months. We must making them appear brown or partly warranted. Currently, however, listing publish these 12–month findings in the black, and (b) both black and red the Tucson shovel-nosed snake is Federal Register. crossbands not encircling the body precluded by higher priority actions to (Center for Biological Diversity 2004, p. amend the Lists of Endangered and Previous Federal Actions 2). Threatened Wildlife and Plants. Upon We received a petition, dated Taxonomy publication of this 12–month petition December 15, 2004, from the Center for finding, we will add the Tucson shovel- Biological Diversity requesting that we In considering taxonomic data, the nosed snake to our candidate species list the Tucson shovel-nosed snake as Service relies ‘‘on standard taxonomic list. We will develop a proposed rule to threatened or endangered throughout its distinctions and the biological expertise list the Tucson shovel-nosed snake as range and designate critical habitat of the Department and the scientific our priorities allow. We will make any within its range in the United States. community concerning the relevant determination on critical habitat during The petition, which was clearly taxonomic group’’ (50 CFR §424.11(a)) development of the proposed rule. identified as such, contained detailed and ‘‘on the basis of the best scientific and commercial information’’ (50 CFR DATES: The finding announced in this information on the natural history, document was made on March 31, 2010. biology, current status, and distribution §424.11(b)). The Service, not any of the Tucson shovel-nosed snake. It professional organization or expert, ADDRESSES: This finding is available on also contained information on what the bears the responsibility for deciding the Internet at http:// petitioner reported as potential threats what taxonomic entities are to be www.regulations.gov at Docket Number to the subspecies from urban protected under the Act. We address FWS-R2-ES-2009-0070. Supporting development, agricultural practices, any conflicting information or expert documentation we used in preparing collecting, inadequacy of existing opinion by carefully evaluating the this finding is available for public regulations, drought, and climate underlying scientific information and inspection, by appointment, during change. In response to the petitioner’s weighing its reliability and adequacy normal business hours by contacting the requests, we sent a letter to the according to the considerations of the U.S. Fish and Wildlife Service, Arizona petitioner, dated September 7, 2005, Act and our associated policies and Ecological Services Office, 2321 West explaining that, due to funding procedures and using the best scientific Royal Palm Road, Suite 103, Phoenix, constraints in fiscal year 2005, we information available. AZ 85021-4951. Please submit any new would not be able to address the Taxonomic nomenclature for the information, comments, or questions petition in a timely manner. On Tucson shovel-nosed snake has changed concerning this finding to the above February 28, 2006, the petitioner filed a over time. The snake was first described address. 60–day notice of intent to sue (NOI) the as a subspecies, Sonora occipitalis FOR FURTHER INFORMATION CONTACT: Department of the Interior for failure to klauberi, by Stickel in 1941 (p. 138). Steve Spangle, Field Supervisor, issue 90–day and 12–month findings, The genus was changed to Chionactis Arizona Ecological Services Office (see and a proposed listing rule, as two years later (Stickel 1943, pp. 122– ADDRESSES) (telephone 602-242-0210; appropriate, in response to the petition 123). Since being described, the Tucson facsimile 602-242-2513). If you use a as required by 16 U.S.C. 1533(b)(3)(A) shovel-nosed snake has been widely

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accepted as a subspecies (Klauber 1951, and De Jesus-Escobar 2000, Fig. 1; actually located (Boundy 2008, p. 3; p. 187; Stebbins 2003, p. 394; Crother Mahrdt et al. 2001, p. 731.2; Leach´ e and Burbrink 2008, p. 2; Crother 2008b, p. 2008a, p. 48; Collins and Taggart 2009, Reeder 2002, p. 202; Krysko and Judd 3; Holm 2008, p. 2). p. 28), and is one of four currently 2006, p. 18; Wake 2006, p. 11). The two species experts believed that recognized subspecies of the Western Following this practice, intergrade there is some agreement between shovel-nosed snake, Chionactis zones are identified, but not assigned to morphological and mitochondrial DNA occipitalis (Crother 2008a, p. 48; Collins either of the subspecies. As such, we data, and supported acknowledging C. and Taggart 2009, p. 28). find that including all shovel-nosed o. klauberi as a unique taxonomic entity In our 90–day finding for this petition snakes within the intergrade zone into (Holm 2008, p. 1; Rosen 2008a, pp. 6– (73 FR 43905), we determined that a the subspecies taxon of the Tucson 12). One of the experts suggested a range recent study of genetic variation of shovel-nosed snake would not be similar to the one that is currently mitochondrial DNA (Wood et al. 2006, consistent with current scientific recognized for klauberi (Holm 2008, p. hereafter Wood et al. 2008) found practice in describing the ranges of 5) and the other, although significant geographical structuring subspecies and the intergrade zone recommending retaining the current suggesting two distinct subspecies of between them, and, therefore, we do not subspecies boundaries, acknowledged Western shovel-nosed snake rather than consider shovel-nosed snakes within the that the genetic data, as represented by four, combining western populations of intergrade zone to be members of the nesting clades in Wood et al. (2008), Chionactis occipitalis occipitalis, the Tucson shovel-nosed snake subspecies. argue for a much larger range that Mojave shovel-nosed snake, with In order to be compliant with 50 CFR includes eastern populations of C. o. Chionactis occipitalis talpina, the 424.11(a) and to understand the annulata (Rosen 2008a, p. 11). Nevada shovel-nosed snake; and taxonomic entity to consider for listing, According to most phylogenetic southeastern populations of C. o. the Service requested review and input species concepts, the taxonomists occipitalis with Chionactis occipitalis on the issue of taxonomic classification (Boundy 2008, Burbrink 2008, Crother annulata, the Colorado Desert shovel- and distribution of the Tucson shovel- 2008b, Frost 2008) are using a criterion nosed snake, and C. o. klauberi. nosed snake from nine individuals with for species, not subspecies, and all four However, this study’s inference was biological and taxonomic expertise and of these reviewers acknowledge that, based on a single genetic marker of background in this issue. Of the nine, following this reasoning, they do not mitochondrial DNA and did not include six provided comments and input on believe subspecies are real biological examination of nuclear markers, which specific questions we asked regarding units and that the concept of subspecies would more fully elucidate our the issue of determining species and is antiquated. However, the Act understanding of the taxonomic subspecies, taxonomic classification, recognizes conservation concern below standing of this subspecies. Therefore, and geographical ranges (including the the level of species by defining ‘‘species’’ in our 90–day finding, we continued to location of the boundary between the to include subspecies and vertebrate accept the currently recognized Tucson shovel-nosed snake and the Distinct Population Segments. arrangement of subspecies, which intergrade zone) based on recent and Published lists of reptile and amphibian includes C. o. klauberi (Mardt et al. historical studies and publications taxa, including those authored by our 2001). related to Tucson shovel-nosed snake taxonomic peer reviewers (for example, Additionally, the petition requested taxonomic classification. Crother 2008a, Collins and Taggart 2009 that the Service consider an ‘‘intergrade We considered publications by (F. Burbrink is an author on the snake zone’’ between the Tucson shovel-nosed Collins and Taggart (2009), Crother section)), still include subspecies, and snake and the Colorado Desert shovel- (2008a), Wood et al. (2008), Rosen the International Code of Zoological nosed snake as part of the Tucson (2003), Mahrdt et al. (2001), Klauber Nomenclature (ICZN), a universally shovel-nosed snake’s range. An (1951), and the input from our solicited accepted system of nomenclature (Frost intergrade zone is an area of overlap review by current experts in the field et al. 2009, pp. 136–137), includes between the ranges of two subspecies (four herpetological taxonomists and articles pertaining to the naming of where individuals may possess two C. occipitalis experts). The four subspecies (ICZN 1999). Therefore, we intermediate characters (attributes or herpetological taxonomists believed continue to recognize subspecies as features that distinguish a subspecies, that, based on the most recent genetic unique taxonomic entities, including such as coloration) or traits of both work by Wood et al. (2008) using the Tucson shovel-nosed snake. subspecies. It is generally recognized mitochondrial DNA, the subspecies C. o. Additionally, mitochondrial DNA, as and accepted by practitioners of klauberi does not warrant taxonomic analyzed by Wood et al. (2008), subspecies taxonomy that intergrade recognition (Boundy 2008, p. 2; represents a single genetic locus that zones may exist between the ranges of Burbrink 2008, p. 2; Crother 2008b, p. accumulates mutations relatively two subspecies where the diagnostic 2; Frost 2008, p. 2). They suggested, slowly, and therefore differences characters of both subspecies may be based on Wood et al. (2008), that two between groups based on mitochondrial found (Mayr 1942, p. 107; Huxley 1943, lineages of C. occipitalis exist in the DNA typically reflect historical p. 210–211; Mayr 1963, p. 368; Mayr northwestern and southeastern portions separation of groups rather than more 1969, pp. 193–196; Mayr 1970, pp. 219– of the species’ range, which are not recent population-level differences 226; Wake 1997, pp. 7761–7762; consistent with the current subspecies (Fallon 2007a, p. 1191). As a result, Rodrı´guez-Robles and De Jesus-Escobar designations and their current ranges. differentiation at mitochondrial genes 2000, p. 42; Isaac et al. 2004, p. 465; Three of the taxonomists, plus one of reflects deep historical separation rather Krysko and Judd 2006, p. 18; Wake the species experts, suggested additional than more recent divergence, and does 2006, p. 12). Current practice in the studies using nuclear DNA markers or not reflect evolutionary difference scientific literature is to objectively microsatellites (numerous short shaped by the organism’s ecology and describe the ranges of different segments of DNA that are distributed environment (Fallon 2007a, p. 1191). subspecies and any intergrade zones throughout the genetic material of an Genetic differences among groups that between them with narrative organism) were needed to determine if have experienced more recent descriptions, maps, or both (e.g., Wake C. o. klauberi is distinct, and if so, separation (such as those below the 1997, pp. 7761–7767; Rodrı´guez-Robles where the boundaries of its range are species level) may require combinations

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of markers and/or additional genetic by noting that individual shovel-nosed 1996, p. 12). Sex ratios for shovel-nosed data to reveal variation, if it exists snakes in captivity each consumed five snakes appear to be skewed towards (Fallon 2007a, p. 1192). Microsatellites to eight crickets per week and showed males, but this is likely due to sampling provide a highly variable marker widely significant weight loss after a 2- to 3– bias, as most shovel-nosed snake accepted as appropriate for detecting week lapse in feeding. sightings are on roads, and males likely changes at this level (Fallon 2007a, p. Like the other three subspecies of the cross roads more frequently in search of 1191), and would be applicable in western shovel-nosed snake, the Tucson females (Rosen et al. 1996, p. 21). Rosen determining the subspecies status of the shovel-nosed snake uses ‘‘sand et al. (1996, p. 21) observed 1 female to Tucson shovel-nosed snake. swimming’’ as its primary locomotion. 1.21 male shovel-nosed snakes while on For the available information we The snake moves using a sideways foot in the Mohawk Dunes, suggesting considered, we find that uncertainty swaying motion while it is either on or that the extreme skewing seen in road exists in both the taxonomic entity and under the sand or loose soil (Stebbins collection represents observational bias. subspecies range of C. o. klauberi. 2003, p. 393). Klauber (1951, p. 192) Klauber (1951, p. 185) indicates that Information submitted by four of the six suggests that shovel-nosed snakes rarely scattered sand hummocks, crowned experts who provided input on these move more than 30.5 m (100 ft) in one with mesquite or other desert shrubs, issues indicated that, while there are night, as they do not normally move are favorite refuges for shovel-nosed certain aspects of existing information great distances below the sand surface; snakes. Rosen (2003, p. 8) suggests that that support rejecting the petitioned however, Rorabaugh (2002, p. 42) the Tucson shovel-nosed snake is found entity, there is uncertainty, and documented one shovel-nosed snake (C. in more productive creosote-mesquite additional work is needed to clarify the o. annulata) that moved 37 m (121 ft) in floodplain environments, differing from validity and distribution of the about 2 hours. Shovel-nosed snakes the habitats preferred by other subspecies (Boundy 2008, p. 3; Burbrink were thought to be primarily nocturnal subspecies of the Western shovel-nosed 2008, p. 2; Crother 2008b, p. 3; Holm in activity, but specimens have been snake. Rosen (2003, p. 8) describes the 2008, p. 2). Specifically, they suggest documented as active during associated soils of the Tucson shovel- that nuclear DNA markers or crepuscular (dawn and dusk) and nosed snake as soft, sandy loams, with microsatellites be used to determine if daylight hours (C. occipitalis: Rosen et sparse gravel. C. o. klauberi is distinct, and if so, al. 1996, pp. 21–22; C. o. annulata: Distribution where the boundary between it and the Rorabaugh 2002, pp. 42–43; Brennan intergrade zone is actually located. and Holycross 2006, p. 98). Shovel- The subspecies was historically Public comment received related to this nosed snakes are predominantly active known from Pima County in the Avra 12–month finding both supported the at air temperatures between 70 and 90 and Santa Cruz valleys (Rosen 2003, p. need for nuclear DNA markers or degrees Fahrenheit (21 and 32 degrees 4) and from western Pinal and a portion microsatellites (Arizona Game and Fish Celsius) and when surface temperatures of eastern Maricopa counties (Klauber Department 2008, p. 3; Fallon 2007b, in the sun are between 75 and 115 1951, p. 196). pp. 1–2; Jones 2008, p. 2), as well as degrees Fahrenheit (24 and 46 degrees As of 2001, over one-third of the range questioned the validity of the Celsius) (Klauber 1951, p. 187; of the Tucson shovel-nosed snake subspecies based on Wood et al. (2008) Rorabaugh 2002, pp. 42–43). Rosen et (Mardt et al. 2001, p. 731.2) had been (Carothers et al. 2008, pp. 9–14; James al. (1996, p. 21) and Rorabaugh (2002, converted to either urban development 2008, pp. 4–5; Taczanowsky 2008, pp. p. 42) have also observed that shovel- or agriculture (U.S. Geological Survey 1–2; Warren 2008, pp. 1 and 6). nosed snakes have been documented to National Gap Analysis Program 2004). Therefore, because we received be active in the morning and just before The area between the Tucson and inconclusive expert opinion regarding sunset. Rosen et al. (1996, p. 21) further Phoenix metropolitan areas is believed the subspecies status of the Tucson note that activity seems to be highest to encompass the majority of the current shovel-nosed snake, as well as when summer and spring temperatures range of this subspecies, particularly recommendations that further genetic are moderate and when the relative west of Tucson northward along Avra study (nuclear DNA or microsatellites) humidity is high. Valley in Pima County to western Pinal is needed before this determination can Reproductive studies have not been County, and then north into eastern be made, we regard the currently conducted specific to C. o. klauberi; Maricopa County, although no recognized taxonomic status and however, some information is available systematic surveys have been conducted distribution of C. o. klauberi (Mardt et for shovel-nosed snakes in general, to assess the status of Tucson shovel- al. 2001) as the best available science, which appear similar to that of other nosed snakes throughout their range with the understanding that, as we fossorial (burrowing) North American (Arizona Game and Fish Department acquire more information, the definition desert snakes in which sperm formation 2008, p. 2). The last verifiable record of of this taxonomic entity (including its coincides with the period of maximum the Tucson shovel-nosed snake in Pima range) may change, and our finding may aboveground activity (Goldberg and County was in 1979, near the need to be revisited. Rosen 1999, pp. 155 and 157). intersection of Avra Valley Road and Reproductive activity for shovel-nosed Sanders Road in the Avra Valley (Rosen Biology snakes occurs in April through July, and 2003, p. 10). Although habitat still exists The diet of shovel-nosed snakes the clutch size ranges from two to four in Pima County, the current distribution consists of a variety of invertebrates, eggs (Klauber 1951, p. 194; Goldberg and abundance in Pima County is including scorpions, beetle larvae, and Rosen 1999, p. 156), although unknown. Most of the currently spiders, crickets, centipedes, native Brennan and Holycross (2006, p. 98) occupied range of the Tucson shovel- roaches, and ants, (Mattison 1989, p. 25; state that clutch size is from two to nine nosed snake is believed to lie in Rosen et al. 1996, pp. 22–23; Brennan eggs. southwestern Pinal County and eastern and Holycross 2006, p. 98). Glass (1972, Limited information suggests the Maricopa County, where the most recent p. 447) and Rosen et al. (1996, p. 22) existence of four age classes in the records occur (Rosen 2008b, p. 8; Mixan suggest that shovel-nosed snakes eat Western shovel-nosed snake, based on and Lowery, p. 1). relatively frequently. The authors (pp. snout-to-vent length (SVL): 0.5, 1.5, 2.5, Survey efforts on the Florence 22–23) further support this observation and 3.5 years and older (Rosen et al. Military Reservation (Mixan and Lowery

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2008) and in the northern Avra Valley of the threats to the Tucson shovel- negate the fact that development likely (Rosen 2003, 2004, and 2008b) provide nosed snake. still will continue in the future, the only recent intensive survey data although perhaps at a slower pace than A. The present or threatened available. Dr. Rosen conducted road in the earlier part of this century. For destruction, modification, or surveys in 2003, 2004, and 2007, as well instance, the most recent draft Pinal curtailment of its habitat or range. as trap arrays in 2007. From the road County Comprehensive Plan (February surveys he detected four Tucson shovel- Urban and Rural Development 2009) acknowledges that the county is nosed snakes, plus one photo-vouchered As of 2001, more than 20 percent of in the middle of the Sun Corridor specimen from 2006, all near Eloy and the area within the range of the Tucson Megapolitan (Tucson, Phoenix, and the Picacho in Pinal County, Arizona shovel-nosed snake had been converted corridor between them), and proposes (Rosen 2004, p. 18; 2008b, p. 2). The to urban development (U.S. Geological four shorter-term Growth Areas to trap arrays, which were set in Survey National Gap Analysis Program define areas where development will previously occupied habitat in Pima 2004). The effects of urban and rural occur or be encouraged to develop over County, did not result in any Tucson development are expected to increase as the next decade, although it does not shovel-nosed snake captures. In the human populations increase. The mean to discourage growth outside of spring and summer of 2008, the Arizona human population in Arizona increased these areas (Pinal County Game and Fish Department conducted by 394 percent from 1960 to 2000 Comprehensive Plan 2009, p. 109). Tucson shovel-nosed snake surveys on (Social Science Data Analysis Network These four Growth Areas (Gateway/ the Florence Military Reservation in 2000, p. 1) and another 26.7 percent Superstition Vistas, West Pinal, Red Pinal County, Arizona. A total of 29 from 2000 to 2008 (U.S. Census Bureau Rock, and Tri-Communities) fall either Tucson shovel-nosed snakes were found 2008, p. 1). Since 2000, population completely or partially within the range during these surveys: 6 within trap growth rates in Arizona counties where of the Tucson shovel-nosed snake. The arrays west of State Route 79 and 23 as Gateway/Superstition Vistas Growth road kill mortalities on State Route 79 the Tucson shovel-nosed snake historically occurred or may still occur Area alone encompasses 71,225 hectares (Mixan and Lowery 2008, p. 5). (176,000 acres, or 275 square miles) of In 2006, the Arizona Game and Fish have varied by county but are no less remarkable: Maricopa (28.7 percent); State Trust land, at least two-thirds of Department coordinated attempts to which falls within the range of the collect shovel-nosed snake tissues for Pima (19.9 percent); and Pinal (82.1 percent) (U.S. Census Bureau 2008, p. snake, and it is anticipated that more genetic analyses. Based on these efforts, than 800,000 to more than 1,000,000, populations are persisting in areas 1). Increasing human populations threaten the Tucson shovel-nosed snake people will one day live in this dominated by creosote flats along State development (Pinal County Route 79, north of Florence and south as further modification and loss of habitat is required to accommodate this Comprehensive Plan 2009, p. 115). The of Florence Junction; along Maricopa Comprehensive Plan (2009, p. 117) Road (including State Route 238) growth. Human population growth trends in identifies many kilometers (miles) of between Maricopa and Gila Bend (likely new freeways and principal arterials in including much of the Rainbow Valley Arizona are expected to continue into the future. By 2030, projections estimate this Growth Area at buildout, which the and lower Vekol Wash); east of the San plan acknowledges may take over a half Tan Mountains; along State Route 349 the population in Arizona will have more than doubled when compared to century to realize (p. 115). Roads can between Maricopa and Casa Grande; have a negative effect on reptiles in south of Interstate 8 near the northern the 2000 population estimate (U.S. general, and snakes specifically, and boundary of the Tohono O’odham Census Bureau 2005, p. 1). In particular, pose a threat to the Tucson shovel- Reservation; and in the vicinity of the a wide swath (called the Sun Corridor nosed snake, as well. This is discussed Santa Cruz Flats near Eloy and Picacho ‘‘Megapolitan’’) from the international in more detail in the Road Construction, (Arizona Game and Fish Department border in Nogales, through Tucson, Use, and Maintenance section below. 2008, p. 2). Phoenix, and north past the Prescott area is predicted to house eight million Additionally, the Maricopa County Factors Affecting the Tucson Shovel- people by 2030 (Gammage et al. 2008, Comprehensive Plan calls for Growth Nosed Snake pp. 15 and 22–23). This Megapolitan Areas to the south and east of the Section 4 of the Act (16 U.S.C. 1533), encompasses the entire historical range Chandler and Mesa areas, which are and implementing regulations at 50 CFR of the Tucson shovel-nosed snake and within the range of the Tucson shovel- 424, set forth procedures for adding would contain approximately 82.5 nosed snake (Maricopa County species to the Federal Lists of percent more residents in 2030 than in Comprehensive Plan 2002 (revised), p. Endangered and Threatened Wildlife 2000 (Gammage et al. 2008, pp. 22–23). 92). City comprehensive plans within and Plants. A species, subspecies, or In response to our 90–day finding on the range of the snake also call for future distinct population segment of the Tucson shovel-nosed snake, we Growth Areas; for example, the City of vertebrate taxa may be determined to be received information stating that the Eloy has designated six Growth Areas endangered or threatened due to one or prospect of continuing development is encompassing 15,520 acres mostly along more of the five factors described in no longer a threat to the snake because the Interstate 10 corridor (City of Eloy section 4(a)(1) of the Act: (A) The of current economic conditions, and General Plan 2004, pp. 7-6 through 7- present or threatened destruction, that these conditions have not only 10), of which more than half fall within modification, or curtailment of its halted most real estate projects in the range of the snake. These Growth habitat or range; (B) overutilization for central Arizona, but have also Areas include the locations of some of commercial, recreational, scientific, or eliminated the demand for State Trust the most recent sightings of the snake educational purposes; (C) disease or land in central Arizona to be sold for (Rosen 2008b, p. 8). While much of this predation; (D) the inadequacy of development (James 2008, p. 10). We area has already been impacted by existing regulatory mechanisms; or (E) acknowledge that development pressure development or irrigated agriculture, other natural or manmade factors across Arizona has slowed due to the any remaining habitat for the Tucson affecting its continued existence. Below recent economic downturn and housing shovel-nosed snake will likely be we provide a summary of our analysis market collapse. However, this does not negatively affected as development and

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its associated infrastructure progress where it occurs through: (1) (Ouren et al. 2007, pp. 20–21). This into these areas. fragmentation, modification, and threat may be even more extensive from James (2008, p. 9) also stated that, as destruction of habitat; (2) increased OHVs than from conventional vehicles a consequence of restrictions imposed genetic isolation; (3) alteration of because OHV trails often travel through on both agricultural and municipal uses movement patterns and behaviors; (4) undeveloped habitat. In particular, the of groundwater by Arizona law, facilitation of the spread of non-native Gateway/Superstition Vistas Growth development within the range of the species via human vectors; (5) increased Area has been and continues to be Tucson shovel-nosed snake, particularly recreational access and the likelihood of impacted by OHV use, although the in Pinal County, has primarily involved subsequent, decentralized urbanization; Arizona State Land Department is in the the conversion of agricultural land to (6) interference with or inhibition of process of fencing off a part of this area municipal uses. Although James (2008, reproduction; and (7) population sinks for dust-abatement reasons (Windes p. 9) considers the actual impact of through direct mortality (resulting in 2009, pers. comm.). development on suitable habitat for the unnaturally high death rates that exceed Solar Power Facilities and Transmission Tucson shovel-nosed snake to be birth rates within a population) (Rosen Corridors exaggerated, we did not find evidence to and Lowe 1994, pp. 146–148; Carr and support this claim. As of 2001, more Fahrig 2001, pp. 1074–1076; Hels and Solar radiation levels in the than one third of the area within the Buchwald 2001, p. 331; Smith and Dodd Southwest, including Arizona, are some range of the snake was in agricultural 2003, pp. 134–138; Angermeier et al. of the highest in the world, and interest use or under development (U.S. 2004, pp. 19–24; Shine et al. 2004, pp. in tapping into this source of potential Geological Survey National Gap 9–11; Andrews and Gibbons 2005, pp. energy is growing. Of the solar Analysis Program 2004). We 777–781; Roe et al. 2006, p. 161). technologies available to harness this acknowledge that the conversion of Roe et al. (2006, p. 161) conclude that energy, Concentrating Solar Power agricultural land to municipal uses has mortality rates due to roads are higher (CSP) technologies are the most likely to occurred and continues to occur within in mobile species, such as shovel-nosed be used, although photovoltaic cells the range of the Tucson shovel-nosed snakes (active hunters), than those of could be used in some cases. CSP snake (as noted above). Much of the more sedentary species, which more technologies use mirrors to reflect and land in the western half of Pinal County commonly employ sit-and-wait foraging concentrate sunlight onto receivers that is primarily used for irrigated strategies. Mixan and Lowery (2008, p. collect solar energy and convert it to agriculture because of low desert valleys 5) found 23 Tucson shovel-nosed snakes heat. This thermal energy can then be (Arizona Department of Agriculture dead on the road near the Florence used to produce electricity via a steam 2009, p. 1), which includes a large Military Reservation over 45 days of turbine or heat engine driving a portion of the range of the Tucson survey efforts, indicating this subspecies generator. shovel-nosed snake. However, the is vulnerable to road mortality. The Within Arizona, the Bureau of Land above-mentioned Gateway/Superstition effect of road mortality of snakes Management (BLM) has received 35 Vistas Growth Area occurs on 71,225 becomes most significant in the case of solar right-of-way applications, hectares (176,000 acres, or 275 square small, highly fragmented populations including one that is pending on 850 miles) of Arizona State Trust land that, where removal of mature females from hectares (2,100 acres) approximately 19 while portions of it are moderately the population may appreciably degrade kilometers (12 miles) south of Eloy, grazed, are not currently in irrigated the viability of a population. which is within the range of the Tucson agriculture. Additionally, conversion Additionally, if snakes traverse only 37 shovel-nosed snake (BLM 2009b, p. 1 from agriculture to residential m (121 ft) each night (Rorabaugh 2002, and map). Additionally, within Arizona, development involves building p. 42), roads that are wider than this the Arizona State Land Department is additional roadways and transportation may serve as barriers, further considering solar projects on some of corridors, which may negatively affect fragmenting the population. the lands under its jurisdiction. These the snake, even in pockets of remaining Off-highway vehicle (OHV) use has potential sites are mostly west of habitat (see Road Construction, Use, and grown considerably in Arizona. As of Phoenix and Gila Bend, but one project Maintenance section below). Therefore, 2007, 385,000 OHVs were registered in could be located along Interstate 10 in while development may be occurring on Arizona (a 350 percent increase since the vicinity of Red Rock, which is lands that were already compromised by 1998) and 1.7 million people (29 within the range of the Tucson shovel- a previous use, it still poses a threat, as percent of the Arizona’s public) engaged nosed snake. Little information is areas of remaining habitat (especially in off-road activity from 2005 to 2007 available about these projects, so we do within the Sun Corridor Megapolitan) (Sacco 2007, pers. comm.). Over half of not know the exact location or extent of are expected to be developed for OHV users reported that merely driving each project (Scott 2009, p. 29). residential and commercial use over the off-road was their primary activity, Solar energy development and next decade and beyond. versus using the OHV for the purpose of transmission corridors pose similar hunting, fishing, or hiking (Sacco 2007, threats to the Tucson shovel-nosed Road Construction, Use, and pers. comm.). Given the pervasive use of snake as development and roadway Maintenance OHVs on the landscape, OHV-related projects (see Rural and Urban As noted in the previous section, mortalities are likely a threat to Tucson Development and Road Construction, roadways and transportation corridors shovel-nosed snakes. Ouren et al. (2007, Use, and Maintenance sections above). are expected to increase over the next pp. 16–22) provided additional data on An average utility-scale solar facility to decade and beyond as counties within the effects of OHV use on wildlife. generate 250 megawatts of electricity the range of the Tucson shovel-nosed Specifically, OHV use may cause would occupy about 506 hectares (1,250 snake, and particularly in Pinal County, mortality or injury to species that acres) of land (BLM 2009a, p. 1), and continue to develop residential and attempt to cross trails created through would involve removal of all vegetation commercial infrastructure. Roads pose occupied habitat, and may even lead to within this area. Additionally, CSP unique threats to herpetofauna and depressed populations of snakes facilities employ liquids such as oils or specifically to the Tucson shovel-nosed depending on the rate of use and molten salts to create steam to power snake, its prey base, and the habitat number of trails within a given area conventional turbines and generators, as

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well as various industrial fluids, such as Wildfires native desert vegetation (Buffelgrass hydraulic fluids, coolants, and Fire has become an increasingly Working Group 2007, p. 2). These lubricants, all of which may present a significant threat in the Sonoran Desert. changes can negatively affect the habitat contaminants-related risk should these Esque and Schwalbe (2002, pp. 180– and prey base of the Tucson shovel- fluids leak onto the ground (Scott 2009, 190) discuss the effect of wildfires in the nosed snake, although precisely how p. 12). New transmission lines would Arizona Upland and Lower Colorado snake populations would respond is need to be built to these facilities, as River subdivisions of Sonoran unknown. well as additional roads to maintain the desertscrub, both of which are found in Summary of Factor A facilities, likely increasing traffic in the range of the Tucson shovel-nosed these areas. These activities pose a Much of the habitat within the range snake. The widespread invasion of non- of the Tucson shovel-nosed snake threat to the Tucson shovel-nosed snake native annual grasses appears to be through removal and contamination of already has been converted to largely responsible for altered fire development or agriculture, and remaining habitat and increased regimes that have been observed in potential for road kill mortality. remaining habitat continues to be these communities, which are not threatened by both these land uses, as Agricultural Uses adapted to fire (Esque and Schwalbe well as the construction of large-scale 2002, p. 165). In areas comprised solar power facilities and transmission While the number of farms in Arizona entirely of native species, ground lines. By the year 2030, the human has almost doubled since 1997, the total vegetation density is mediated by barren population in Arizona is expected to be amount of farmed area has decreased spaces that do not allow fire to carry more than double the 2000 population, (U.S. Department of Agriculture 2009, p. across the landscape. However, in areas particularly in the Sun Corridor 7). Within Maricopa, Pima, and Pinal where non-native grasses have become Megapolitan, which is an area counties, the amount of irrigated established, the fine fuel load is completely encompassing the range of farmland decreased from 2002 to 2007 continuous, and fire is capable of the Tucson shovel-nosed snake. Road by 13.5 percent (58,724 hectares spreading quickly and efficiently (Esque construction, maintenance, and use (145,109 acres)), 4.1 percent (3,327 and Schwalbe 2002, p. 175). Non-native have been documented to affect this hectares (8,222 acres), and 0.7 percent annual grasses prevalent within the subspecies directly through mortality (2,366 hectares (5,846 acres)), range of the Tucson shovel-nosed snake and indirectly through habitat loss and respectively (U.S. Department of include brome grasses (Bromus rubens fragmentation, the impacts of which Agriculture 2009, p. 273). This decrease and B. tectorum) and Mediterranean will likely increase with new in irrigated farmland is likely due to the grasses (Schismus spp.) (Esque and development and an increasing human conversion of agricultural areas to urban Schwalbe 2002, p. 165). The perennial population. The need for alternative development. As of 2001, more than 10 African buffelgrass (Pennisetum ciliare), energy sources is continuing to rise, percent of the area within the range of which also poses a fire risk to Sonoran which will lead to construction of solar the Tucson shovel-nosed snake had desertscrub, is prevalent within the energy facilities and transmission been converted to agriculture (U.S. range of the snake in the Avra and Santa corridors in the State of Arizona, some Geological Survey National Gap Cruz valleys (Van Devender and Dimmit of which will likely be sited within the Analysis Program 2004). 2006, p. 5), as well as along Interstate range of the Tucson shovel-nosed snake. 10 to the City of Phoenix (Kidnocker Agricultural use within the range of the Pinal County is the county with the 2009, p. 1). snake has been decreasing, a trend that most agricultural production within the After disturbances such as fire, non- will probably continue as land use range of the Tucson shovel-nosed snake. native grasses may exhibit dramatic converts from agriculture to residential In 2007, the amount of farmland still in population explosions, which hasten and commercial development. production in Pinal County was 125,420 their effect on native vegetation Agriculture that persists will continue hectares (309,920 acres), or communities. Additionally, with to impact the snake by reducing the approximately nine percent of the entire increased fire frequency, these available prey base and fragmenting county (U.S. Department of Agriculture population explosions may lead to a habitat. The threat of wildfire due to 2009, p. 273). Much of this land, type-conversion of the vegetation non-native plants is expected to rise, however, is in the western half of the community from desert scrub to given the prevalence of Mediterranean county (Arizona Department of grassland (Esque and Schwalbe 2002, grasses, brome grasses, and especially Agriculture 2009, p. 1), which is within pp. 175–176; Overpeck and Weiss 2005, buffelgrass within the range of the the range of the Tucson shovel-nosed p. 2075). Fires carried by the fine fuel Tucson shovel-nosed snake and the snake. Conversion of low desert valleys loads created by non-native grasses invasive nature of these grasses. How to farmland renders habitats unsuitable often burn at unnaturally high snakes would respond to vegetation for the Tucson shovel-nosed snake. temperatures, which may result in soils community change brought about by Agricultural practices can impact this becoming hydrophobic (water increasing fire frequency is unknown. subspecies in a number of ways. repelling), exacerbating sheet erosion, The best available information indicates Farmers typically use pesticides and and contributing large amounts of shovel-nosed snakes travel only short herbicides to maintain high agricultural sediment to receiving drainages and distances (37 m (121 ft)), which likely yields, but because arthropods are the water bodies (Esque and Schwalbe 2002, makes the subspecies particularly primary food for the snake (Mattison pp. 177–178). Buffelgrass, in particular, susceptible to habitat fragmentation as 1989, p. 25; Rosen et al. 1996, pp. 22– is acknowledged as one of the most barriers formed by the above-mentioned 23), the loss or contamination of this serious invasive weeds in the Sonoran threats isolate small populations from prey base may cause mortality, impaired Desert due to its ability to spread one another. Therefore, we find that the health, or abandonment of an area. exponentially (Buffelgrass Working present or threatened destruction, Additionally, traffic associated with Group 2007, p. 2). It has the potential modification, or curtailment of its agricultural roads can result in mortality to invade much of southern and central habitat or range is a threat to the Tucson of individuals (see Road Construction, Arizona, which can lead to recurring shovel-nosed snake within the Use, and Maintenance section above). grassland fires and the destruction of foreseeable future.

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B. Overutilization for commercial, conservation and a stimulus to Service) in that all uses of the land must recreational, scientific, or educational conservation partners to strategically benefit the 13 Trust beneficiaries, the purposes. think about their roles in prioritizing largest of which are the Common Based on the information available, conservation efforts (Arizona Game and Schools (Arizona State Land overutilization of the Tucson shovel- Fish Department 2006, p. 2). A Tier 1b Department 2009a, p. 1). Arizona State species is one that requires immediate nosed snake does not appear to pose a Trust Lands are managed to enhance conservation actions aimed at threat to this subspecies. Shovel-nosed value and optimize economic return for improving conditions through snakes in general, and Tucson shovel- the Trust beneficiaries (Arizona State intervention at the population or habitat nosed snakes in particular, are not Land Department 2009b, p. 1), which level (Arizona Game and Fish regularly seen in the pet trade (Arizona can include the sale or long-term lease Department 2006, p. 32). The CWCS, Game and Fish Department 2008). There of lands for commercial or residential however, does not provide regulatory have been few scientific or educational development. Although State lands protection for the snake. It serves only studies of Tucson shovel-nosed snakes currently provide open space within the to prioritize funds and guide over the years, and most recently they range of the Tucson shovel-nosed snake, implementation of conservation have been limited largely to surveys there are no known plans to require activities for Arizona’s vulnerable protection of habitat on State lands, and (Arizona Game and Fish Department wildlife (Arizona Game and Fish no other protections are afforded the 2008). Few animals have been collected Department 2006, p. 9). The Arizona snake on State lands. for these studies other than animals Game and Fish Department does not found on highways, where their survival have specified or mandated recovery BLM manages some lands within the was already likely compromised. goals for the Tucson shovel-nosed range of the Tucson shovel-nosed snake. Additionally, Arizona State University snake, but it continues as a strong BLM currently has no regulations to and the University of Arizona recently partner in research and survey efforts protect the Tucson shovel-nosed snake, began to accept photographic vouchers, that further our understanding of and does not survey for the snake or its versus physical specimens, in their current populations within Arizona. habitat. BLM lands usually are secure respective museum collections, which With a valid hunting license, the from agricultural and urban may reduce the amount of collection. Arizona Game and Fish Department development; however, BLM may We believe these measures reduce the allows for take of up to four Tucson dispose of lands identified under its necessity for field biologists to collect shovel-nosed snakes per person per year land use planning through the Federal physical specimens (unless discovered as specified in Commission Order Land Policy and Management Act of postmortem) for locality voucher Number 43. The Arizona Game and Fish 1976 (43 U.S.C. 1701 et seq.), and may purposes and, therefore, further reduce Department defines ‘‘take’’ as ‘‘pursuing, also issue permits for uses such as solar impacts to vulnerable populations of the shooting, hunting, fishing, trapping, facilities and rights-of-way. Tucson shovel-nosed snake. Based on killing, capturing, snaring, or netting Additionally, the open space provided this information, we find that wildlife or the placing or using any net by BLM lands can be and often is overutilization for commercial, or other device or trap in a manner that recreational, scientific, or educational heavily impacted by OHV use, which may result in the capturing or killing of may pose a threat to the Tucson shovel- purposes is not a threat to the Tucson wildlife.’’ If more than four are to be shovel-nosed snake. nosed snake (see Road Construction, collected (e.g., for research purposes), a Use, and Maintenance under Factor A scientific collecting permit must be C. Disease or Predation above). obtained. It is illegal to commercially Disease in Tucson shovel-nosed sell, barter, or trade any native Arizona Some lands within the range of the snakes has not yet been documented as wildlife. Tucson shovel-nosed snake are owned a specific threat. However, little is While we are aware that the Arizona by county, city, or private entities. known about disease in wild snakes. Game and Fish Department enforces These lands may provide habitat for the Predation on Chionactis occipitalis by a these laws to the extent that it can, Tucson shovel-nosed snake if they are variety of carnivores has been encounters between humans and maintained as natural open space; documented, including by various Tucson shovel-nosed snakes can result however, there are no regulatory snakes, foxes, coyotes, shrikes, and owls in the capture, injury, or death of the mechanisms in place to protect the (Brennan and Holycross 2006, p. 98). snake due to the lay person’s fear or snake should the land use change. However, we are not aware of data dislike of snakes, and the snake’s We are aware of three habitat suggesting that predation poses a threat resemblance to venomous coral snakes conservation plans currently being beyond that expected in a normally (Rosen and Schwalbe 1988, p. 43; Ernst developed that include the Tucson functioning ecosystem. Therefore, we do and Zug 1996, p. 75; Green 1997, pp. shovel-nosed snake as a covered not consider disease or predation a 285–286; Nowak and Santana-Bendix species: the Pima County Multi-species threat to Tucson shovel-nosed snakes. 2002, p. 39). We believe that Conservation Plan, the Town of Marana unregulated take may occur, but it is D. Inadequacy of existing regulatory Habitat Conservation Plan, and the City likely infrequent because Tucson mechanisms. of Tucson’s Avra Valley Habitat shovel-nosed snakes generally are Conservation Plan. As none of these The Tucson shovel-nosed snake is difficult to locate in the wild. considered a ‘‘Tier 1b Species of The majority of currently known plans have been finalized, we will not Greatest Conservation Need’’ in the populations of Tucson shovel-nosed explore the adequacies of these plans as Arizona Game and Fish Department snakes occur on lands managed by the possible regulatory mechanisms for the draft document, Arizona’s Arizona State Land Department, which snake. Comprehensive Wildlife Conservation at present has no regulations or The Gila River Indian Community Strategy (CWCS) (Arizona Game and programs to protect the subspecies. owns lands within the range of the Fish Department 2006, pp. 32 and 723). State Trust Land is distinguished from Tucson shovel-nosed snake. We are not The purpose of the CWCS is to provide public land (such as Federal land aware of any mechanisms in place to a foundation for the future of wildlife administered by the BLM or U.S. Forest protect the snake on their lands.

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Summary of Factor D southwestern Arizona and southeastern size and trends for the Tucson shovel- Currently, there are no regulatory California) that experience less nosed snake is not available. As of 2001, mechanisms in place that specifically precipitation and higher temperatures over one-third of the area within the target the conservation of the Tucson and are characterized by simpler range of the snake had been converted shovel-nosed snake or its habitat. vegetation communities (Turner and to either urban development or Regulations protecting the quantity and Brown 1982, pp. 190–202) than that agriculture. There are indications that in quality of open space are inadequate to found within the range of the Tucson the Avra Valley, where the snake was protect the habitat of the Tucson shovel- shovel-nosed snake. Hence, if climates once present, it has now disappeared or nosed snake, particularly in the face of dry and become warmer, with persists in such low numbers that it is the significant population growth concomitant changes in vegetation difficult to locate. In other areas (e.g., communities, the Tucson shovel-nosed Florence Military Reservation), the expected within the historical range of snake may be able to persist under those snake appears to be persisting. the snake discussed under Factor A. conditions. However, the precise habitat Therefore, based on the best available Therefore, we consider the inadequacy components and ecological information, we find that the only of existing regulatory mechanisms a relationships necessary for persistence information we have indicates that threat to the Tucson shovel-nosed are unknown, so predicting the response populations in the Avra Valley have snake. of the snake to environmental change declined, which is near development E. Other natural or manmade factors induced by climate change is and agriculture; while in areas with affecting its continued existence. speculative. If changes include little or no development or agriculture, Seager et al. (2007, pp. 1181-1184) increased fire frequency due to the population is persisting. We evaluated existing and potential analyzed 19 different computer models increasing non-native plants, this tends threats to the Tucson shovel-nosed of differing variables to estimate the to increase uncertainty in predicting snake to determine what effects on the future climatology of the southwestern population response, because how the subspecies are currently occurring, United States and northern Mexico in snake responds to these fire-altered whether these threats are likely to response to predictions of changing communities is unknown. At this time, it is not possible to determine how these increase or decrease in the future, and climatic patterns. All but one of the 19 changes will affect the Tucson shovel- which of the impacts may be expected models predicted a drying trend within nosed snake, as potential trajectories of to rise to the level of a threat to the the Southwest; one predicted a trend vegetation change within the range of subspecies, either rangewide or at the toward a wetter climate (Seager et al. the subspecies are difficult to predict population level. We examined threats 2007, p. 1181). A total of 49 projections due to uncertain changes in warm posed by urban and rural development; were created using the 19 models; all season precipitation variability and fire road construction, use, and but 3 of the projections predicted a shift (Overpeck and Weiss 2005, p. 2075), maintenance; solar power facilities and to increasing dryness in the Southwest and the response of the snake to transmission corridors; agricultural as early as 2021–2040 (Seager et al. changing vegetation communities is uses; wildfires; overutilization; disease 2007, p. 1181). The current prognosis speculative. and predation; the inadequacy of for climate change impacts on the existing regulatory mechanisms; and Sonoran Desert of the American Summary of Factor E climate change. We did not find that Southwest includes fewer frost days; Temperatures in the desert Southwest overutilization, disease, or predation are warmer temperatures; greater water are expected to rise in the next two currently threatening the Tucson demand by plants, animals, and people; decades and likely throughout the 21st shovel-nosed snake. We also found it and an increased frequency of extreme century (Intergovernmental Panel on likely that the threat of agricultural uses weather events (heat waves, droughts, Climate Change 2007, pp. 45–46), with will decrease in the future, as farmland and floods) (Overpeck and Weiss 2005, an increased frequency of extreme is and will continue to be converted to p. 2074; Archer and Predick 2008, p. weather events, such as heat waves, residential and commercial uses. 24). How climate change will affect droughts, and floods. We do not know Next we considered whether any of summer precipitation is less certain, the extent to which changing climate the potential threats are likely to because precipitation predictions are patterns will affect the Tucson shovel- increase within the foreseeable future. based on continental-scale general nosed snake; however, this Data suggest that urban and rural circulation models that do not yet environmental change injects additional development in most of the snake’s account for land use and land cover uncertainty into the future status of the range is likely to increase in the future. change effects on climate or regional subspecies. Comprehensive Plans encompassing the phenomena, such as those that control entire range of the snake encourage large monsoonal rainfall in the Southwest Finding Growth Areas in the next 20 years and (Overpeck and Weiss 2005, p. 2075; In our review of the status of the beyond, portions of which occur in Archer and Predick 2008, pp. 23–24). Tucson shovel-nosed snake, we Tucson shovel-nosed snake habitat not Some models predict dramatic changes carefully examined the best scientific already impacted by development or in Southwestern vegetation and commercial information available. agriculture. These Plans also call for an communities as a result of climate We identified a number of potential increase in roads and transportation change (Overpeck and Weiss 2005, p. threats to this species, including: urban corridors, which have been documented 2074; Archer and Predick 2008, p. 24), and rural development; road to impact the snake through direct especially as wildfires carried by non- construction, use, and maintenance; mortality. Additionally, development of native plants (e.g., buffelgrass) concentrating solar power facilities and solar energy facilities and transmission potentially become more frequent, transmission corridors; agriculture; corridors throughout the State is being promoting the presence of exotic species wildfires; and lack of adequate pursued, and demand for these facilities over native ones (Overpeck and Weiss management and regulation. will likely increase. Some of these 2005, p. 2075). The shovel-nosed snake Limited surveys have been conducted facilities are being considered within currently persists, often in abundance, only in small parts of its range, so the range of the Tucson shovel-nosed within portions of its range (e.g., information on rangewide population snake and have the potential to degrade

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or destroy approximately 506 hectares We have reviewed the available redundancy of the species. The (1,250 acres), on average, of habitat per information to determine if the existing contribution must be at a level such that facility. We also believe that wildfires and foreseeable threats pose an its loss would result in a decrease in the due to infestations of non-native grasses emergency. We have determined that an ability to conserve the species. (especially buffelgrass) in the snake’s emergency listing is not warranted for If an analysis of whether a species is habitat, which has native plants not this subspecies at this time because, threatened or endangered in a adapted to survive wildfires, are likely within the current distribution of the significant portion of its range is to increase in frequency and magnitude subspecies throughout its range, there appropriate, we engage in a systematic in the future as these invasive grasses are at least some populations of the process that begins with identifying any continue to spread rapidly. It appears Tucson shovel-nosed snake that exist in portions of the range of the species that that the snake only travels short relatively natural conditions that are warrant further consideration. The range distances, which makes the subspecies unlikely to change in the short-term. of a species can theoretically be divided particularly susceptible to habitat However, if at any time we determine into portions in an infinite number of fragmentation, as barriers created by that emergency listing of the Tucson ways. However, there is no purpose in development, roads, solar facilities, and shovel-nosed snake is warranted, we analyzing portions of the range that are wildfires isolate populations from one will initiate an emergency listing. not reasonably likely to be significant another. We found that regulations are The Service adopted guidelines on and threatened or endangered. To not in place to minimize or mitigate September 21, 1983 (48 FR 43098) to identify only those portions that warrant these threats to the Tucson shovel-nosed establish a rational system for allocating further consideration, we determine snake and its habitat, and, therefore, available appropriations to the highest whether there is substantial information they are likely to put the snake at risk priority species when adding species to indicating that (i) the portions may be of local extirpation or extinction. the Lists of Endangered or Threatened significant and (ii) the species may be in Climate change is likely to continue Wildlife and Plants or reclassifying danger of extinction there or likely to for the next century, but there is threatened species to endangered status. become so within the foreseeable future. uncertainty as to how climate change, The system places greatest importance In practice, a key part of this analysis is described under Factor E, will affect the on the immediacy and magnitude of whether the threats are geographically Tucson shovel-nosed snake and its threats, but also factors in the level of concentrated in some way. If the threats habitat. Predictions are that taxonomic distinctiveness by assigning to the species are essentially uniform priority in descending order to throughout its range, no portion is likely temperatures in the Southwestern monotypic genera, full species, and to warrant further consideration. United States will continue to increase, subspecies (or equivalently, distinct Moreover, if any concentration of with extreme weather events (such as population segments of vertebrates). We threats applies only to portions of the heat waves, drought, and flooding) assigned the Tucson shovel-nosed snake range that are unimportant to the occurring with more frequency. How an LPN of 3, based on our finding that conservation of the species, such summer precipitation may be affected is the subspecies faces imminent and high- portions will not warrant further less certain. Current models suggest that magnitude threats from the present or consideration. a 10- to 20–year (or longer) drought is threatened destruction, modification, or On the basis of an analysis of factors anticipated, and some models predict curtailment of its habitat and the that may threaten the Tucson shovel- dramatic changes in Southwestern inadequacy of existing regulatory nosed snake, we have determined that vegetation communities as a result of mechanisms. One or more of the threats listing is warranted throughout its climate change, although trajectories of discussed above is occurring or is range. Therefore, it is not necessary to vegetation change are difficult to predict expected to occur throughout the entire conduct further analysis with respect to because of variability in warm season range of this subspecies. These threats the significance of any portion of its precipitation and fire frequency. These are on-going and, in some cases (e.g., range at this time. We will further changes could affect the habitat of the loss of habitat through urban analyze whether threats may be Tucson shovel-nosed snake, but because development), considered irreversible. disproportionate and warrant further of the lack of specific modeling data While we conclude that listing the consideration as a significant portion of within the range of the snake, we cannot Tucson shovel-nosed snake is its range at such time that we develop predict how climate change will impact warranted, an immediate proposal to list a proposed listing determination. the Tucson shovel-nosed snake now or this subspecies is precluded by other Preclusion and Expeditious Progress in the foreseeable future. higher priority listing, which we We next considered whether the address below. Preclusion is a function of the listing existing level of threats causes us to priority of a species in relation to the conclude that the species is in danger of Significant Portion of the Range resources that are available and extinction now or in the foreseeable The Act defines an endangered competing demands for those resources. future. The threats discussed above, species as one ‘‘in danger of extinction Thus, in any given fiscal year (FY), particularly those that lead to a loss of throughout all or a significant portion of multiple factors dictate whether it will habitat, are likely to reduce the its range,’’ and a threatened species as be possible to undertake work on a population of Tucson shovel-nosed one ‘‘likely to become an endangered proposed listing regulation or whether snakes across its entire range. Given the species within the foreseeable future promulgation of such a proposal is limited geographic distribution of this throughout all or a significant portion of warranted but precluded by higher- snake and the fact that its entire range its range.’’ The term ‘‘significant portion priority listing actions. lies within the path of future of its range’’ is not defined by the The resources available for listing development, we believe the subspecies statute. For the purposes of this finding, actions are determined through the is likely to become in danger of a significant portion of a species’ range annual Congressional appropriations extinction within the foreseeable future. is an area that is important to the process. The appropriation for the Therefore, we find that listing the conservation of the species because it Listing Program is available to support Tucson shovel-nosed snake throughout contributes meaningfully to the work involving the following listing its range is warranted. representation, resiliency, or actions: proposed and final listing rules;

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90–day and 12–month findings on some funds are available for other work In FY 2010, expeditious progress is petitions to add species to the Lists of in the Listing Program: ‘‘The critical that amount of work that can be Endangered and Threatened Wildlife habitat designation subcap will ensure achieved with $10,471,000, which is the and Plants (Lists) or to change the status that some funding is available to amount of money that Congress of a species from threatened to address other listing activities’’ (House appropriated for the Listing Program endangered; annual determinations on Report No. 107 - 103, 107th Congress, 1st (that is, the portion of the Listing prior ‘‘warranted but precluded’’ petition Session, June 19, 2001). In FY 2002 and Program funding not related to critical findings as required under section each year until FY 2006, the Service has habitat designations for species that are 4(b)(3)(C)(i) of the Act; critical habitat had to use virtually the entire critical already listed). However these funds are petition findings; proposed and final habitat subcap to address court- not enough to fully fund all our court- rules designating critical habitat; and mandated designations of critical ordered and statutory listing actions in litigation-related, administrative, and habitat, and consequently none of the FY 2010, so we are using $1,114,417 of program-management functions critical habitat subcap funds have been our critical habitat subcap funds in (including preparing and allocating available for other listing activities. In order to work on all of our required budgets, responding to Congressional FY 2007, we were able to use some of petition findings and listing and public inquiries, and conducting the critical habitat subcap funds to fund determinations. This brings the total public outreach regarding listing and proposed listing determinations for amount of funds we have for listing critical habitat). The work involved in high-priority candidate species. In FY action in FY 2010 to $11,585,417. preparing various listing documents can 2009, while we were unable to use any Starting in FY 2010, we are also using be extensive and may include, but is not of the critical habitat subcap funds to our funds to work on listing actions for limited to: gathering and assessing the fund proposed listing determinations, foreign species since that work was best scientific and commercial data we did use some of this money to fund transferred from the Division of available and conducting analyses used the critical habitat portion of some Scientific Authority, International as the basis for our decisions; writing proposed listing determinations, so that Affairs Program to the Endangered and publishing documents; and the proposed listing determination and Species Program. Our process is to make obtaining, reviewing, and evaluating proposed critical habitat designation our determinations of preclusion on a public comments and peer review could be combined into one rule, nationwide basis to ensure that the comments on proposed rules and thereby increasing efficiency in our species most in need of listing will be incorporating relevant information into work. In FY 2010, we are using some of addressed first and also because we final rules. The number of listing the critical habitat subcap funds to fund allocate our listing budget on a actions that we can undertake in a given actions with statutory deadlines. nationwide basis. The $11,585,417 is year also is influenced by the Thus, through the listing cap, the being used to fund work in the complexity of those listing actions; that critical habitat subcap, and the amount following categories: compliance with is, more complex actions generally are of funds needed to address court- court orders and court-approved more costly. For example, during the mandated critical habitat designations, settlement agreements requiring that past several years, the cost (excluding Congress and the courts have in effect petition findings or listing publication costs) for preparing a 12– determined the amount of money determinations be completed by a month finding, without a proposed rule, available for other listing activities. specific date; section 4 (of the Act) has ranged from approximately $11,000 Therefore, the funds in the listing cap, listing actions with absolute statutory for one species with a restricted range other than those needed to address deadlines; essential litigation-related, and involving a relatively court-mandated critical habitat for administrative, and listing program- uncomplicated analysis to $305,000 for already listed species, set the limits on management functions; and high- another species that is wide-ranging and our determinations of preclusion and priority listing actions for some of our involving a complex analysis. candidate species. The allocations for We cannot spend more than is expeditious progress. each specific listing action are identified appropriated for the Listing Program Congress also recognized that the in the Service’s FY 2010 Allocation without violating the Anti-Deficiency availability of resources was the key Table (part of our administrative Act (see 31 U.S.C. § 1341(a)(1)(A)). In element in deciding, when making a 12– record). addition, in FY 1998 and for each fiscal month petition finding, whether we year since then, Congress has placed a would prepare and issue a listing In FY 2007, we had more than 120 statutory cap on funds which may be proposal or instead make a ‘‘warranted species with an LPN of 2, based on our expended for the Listing Program, equal but precluded’’ finding for a given September 21, 1983, guidance for to the amount expressly appropriated species. The Conference Report assigning an LPN for each candidate for that purpose in that fiscal year. This accompanying Public Law 97-304, species (48 FR 43098). Using this cap was designed to prevent funds which established the current statutory guidance, we assign each candidate an appropriated for other functions under deadlines and the warranted-but- LPN of 1 to 12, depending on the the Act (for example, recovery funds for precluded finding, states (in a magnitude of threats (high vs. moderate removing species from the Lists), or for discussion on 90–day petition findings to low), immediacy of threats (imminent other Service programs, from being used that by its own terms also covers 12– or nonimminent), and taxonomic status for Listing Program actions (see House month findings) that the deadlines were of the species (in order of priority: Report 105-163, 105th Congress, 1st ‘‘not intended to allow the Secretary to monotypic genus (a species that is the Session, July 1, 1997). delay commencing the rulemaking sole member of a genus); species; or part Recognizing that designation of process for any reason other than that of a species (subspecies, distinct critical habitat for species already listed the existence of pending or imminent population segment, or significant would consume most of the overall proposals to list species subject to a portion of the range)). The lower the Listing Program appropriation, Congress greater degree of threat would make listing priority number, the higher the also put a critical habitat subcap in allocation of resources to such a petition listing priority (that is, a species with an place in FY 2002 and has retained it [that is, for a lower-ranking species] LPN of 1 would have the highest listing each subsequent year to ensure that unwise.’’ priority). Because of the large number of

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high-priority species, we further ranked resources are also a factor in deadlines; and final listing the candidate species with an LPN of 2 determining high-priority species determinations for those species that by using the following extinction-risk provided with funding. Finally, were proposed for listing with funds type criteria: International Union for the proposed rules for reclassification of from previous fiscal years. This work Conservation of Nature and Natural threatened species to endangered are includes all the actions listed in the Resources (IUCN) Red list status/rank, lower priority, since as listed species, tables below under expeditious Heritage rank (provided by they are already afforded the protection progress. NatureServe), Heritage threat rank of the Act and implementing (provided by NatureServe), and species regulations. As explained above, a determination currently with fewer than 50 We assigned the Tucson shovel-nosed that listing is warranted but precluded individuals, or 4 or fewer populations. snake an LPN of 3, based on our finding must also demonstrate that expeditious Those species with the highest IUCN that the subspecies faces immediate and progress is being made to add or remove rank (critically endangered), the highest high-magnitude threats from the present qualified species to and from the Lists Heritage rank (G1), the highest Heritage or threatened destruction, modification, of Endangered and Threatened Wildlife threat rank (substantial, imminent or curtailment of its habitat; predation; and Plants. (Although we do not discuss threats), and currently with fewer than and the inadequacy of existing it in detail here, we are also making 50 individuals, or fewer than 4 regulatory mechanisms. One or more of expeditious progress in removing populations, comprised a group of the threats discussed above are species from the list under the Recovery approximately 40 candidate species occurring in each known population in program, which is funded by a separate (‘‘Top 40’’). These 40 candidate species the United States and throughout line item in the budget of the have had the highest priority to receive historically occupied habitats in Endangered Species Program. As funding to work on a proposed listing Mexico. These threats are on-going and, explained above in our description of determination. As we work on proposed in some cases (e.g., nonnative species), the statutory cap on Listing Program considered irreversible. Pursuant to the and final listing rules for these 40 funds, the Recovery Program funds and 1983 Guidelines, a ‘‘species’’ facing candidates, we are applying the ranking actions supported by them cannot be criteria to the next group of candidates imminent high-magnitude threats is considered in determining expeditious with LPN of 2 and 3 to determine the assigned an LPN of 1, 2, or 3 depending progress made in the Listing Program.) next set of highest priority candidate on its taxonomic status. Because the ‘‘ ’’ species. Tucson shovel-nosed snake is a As with our precluded finding, To be more efficient in our listing subspecies, we assigned it an LPN of 3 expeditious progress in adding qualified process, as we work on proposed rules (the highest category available for a species to the Lists is a function of the for these species in the next several subspecies). Therefore, work on a resources available and the competing years, we are preparing multi-species proposed listing determination for the demands for those funds. Given that proposals when appropriate, and these Tucson shovel-nosed snake is precluded limitation, we find that we are making may include species with lower priority by work on higher priority candidate progress in FY 2010 in the Listing if they overlap geographically or have species (i.e., species with LPN of 2); Program. This progress included the same threats as a species with an listing actions with absolute statutory, preparing and publishing the following LPN of 2. In addition, available staff court-ordered, or court-approved determinations:

TABLE 1. ACTIONS TAKEN BY THE LISTING PROGRAM OF THE U.S. FISH AND WILDLIFE SERVICE FROM THE BEGINNING OF FY2010 TO DATE.

Publication Date Title Actions FR Pages

10/08/2009 Listing Lepidium papilliferum (Slickspot Peppergrass) as a Final Listing Threatened 74 FR 52013-52064 Threatened Species Throughout Its Range

10/27/2009 90-day Finding on a Petition To List the American Dipper in the Notice of 90–day Petition Finding, 74 FR 55177-55180 Black Hills of South Dakota as Threatened or Endangered Not substantial

10/28/2009 Status Review of Arctic Grayling (Thymallus arcticus) in the Notice of Intent to Conduct Status 74 FR 55524-55525 Upper Missouri River System Review

11/03/2009 Listing the British Columbia Distinct Population Segment of the Proposed Listing Threatened 74 FR 56757-56770 Queen Charlotte Goshawk Under the Endangered Species Act: Proposed rule.

11/03/2009 Listing the Salmon-Crested Cockatoo as Threatened Throughout Proposed Listing Threatened 74 FR 56770-56791 Its Range with Special Rule

11/23/2009 Status Review of Gunnison sage-grouse (Centrocercus minimus) Notice of Intent to Conduct Status 74 FR 61100-61102 Review

12/03/2009 12-Month Finding on a Petition to List the Black-tailed Prairie Notice of 12–month petition finding, 74 FR 63343-63366 Dog as Threatened or Endangered Not warranted

12/03/2009 90-Day Finding on a Petition to List Sprague’s Pipit as Notice of 90–day Petition Finding, 74 FR 63337-63343 Threatened or Endangered Substantial

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TABLE 1. ACTIONS TAKEN BY THE LISTING PROGRAM OF THE U.S. FISH AND WILDLIFE SERVICE FROM THE BEGINNING OF FY2010 TO DATE.—Continued

Publication Date Title Actions FR Pages

12/15/2009 90-Day Finding on Petitions To List Nine Species of Mussels Notice of 90–day Petition Finding, 74 FR 66260-66271 From Texas as Threatened or Endangered With Critical Substantial Habitat

12/16/2009 Partial 90-Day Finding on a Petition to List 475 Species in the Notice of 90–day Petition Finding, 74 FR 66865-66905 Southwestern United States as Threatened or Endangered Not substantial and Subtantial With Critical Habitat; Proposed Rule

12/17/2009 12–month Finding on a Petition To Change the Final Listing of Notice of 12–month petition finding, 74 FR 66937-66950 the Distinct Population Segment of the Canada Lynx To Warranted but precluded Include New Mexico

1/05/2010 Listing Foreign Bird Species in Peru and Bolivia as Endangered Proposed ListingEndangered 75 FR 605-649 Throughout Their Range

1/05/2010 Listing Six Foreign Birds as Endangered Throughout Their Proposed ListingEndangered 75 FR 286-310 Range

1/05/2010 Withdrawal of Proposed Rule to List Cook’s Petrel Proposed rule, withdrawal 75 FR 310-316

1/05/2010 Final Rule to List the Galapagos Petrel and Heinroth’s Final Listing Threatened 75 FR 235-250 Shearwater as Threatened Throughout Their Ranges

1/20/2010 Initiation of Status Review for Agave eggersiana and Solanum Notice of Intent to Conduct Status 75 FR 3190-3191 conocarpum Review

2/09/2010 12–month Finding on a Petition to List the American Pika as Notice of 12–month petition finding, 75 FR 6437-6471 Threatened or Endangered; Proposed Rule Not warranted

2/25/2010 12-Month Finding on a Petition To List the Sonoran Desert Notice of 12–month petition finding, 75 FR 8601-8621 Population of the Bald Eagle as a Threatened or Endangered Not warranted Distinct Population Segment

2/25/2010 Withdrawal of Proposed Rule To List the Southwestern Withdrawal of Proposed Rule to List 75 FR 13068-13071 Washington/Columbia River Distinct Population Segment of Coastal Cutthroat Trout (Oncorhynchus clarki clarki) as Threatened

3/18/2010 90-Day Finding on a Petition to List the Berry Cave salamander Notice of 90-day Petition Finding, 75 FR 13068-13071 as Endangered Substantial

3/23/2010 90 Day Finding on a Petition to List the Southern Hickorynut Notice of 90-day Petition Finding, 75 FR 13717-13720 Mussel (Obovaria jacksoniana) as Endangered or Threatened Not substantial

3/23/2010 90-Day Finding on a Petition to List the Striped Newt as Threat- Notice of 90-day Petition Finding, 75 FR 13720-13726 ened Substantial

3/23/2010 12-Month Findings for Petitions to List the Greater Sage-Grouse Notice of 12-month petition finding, 75 FR 13910-14014 (Centrocercus urophasianus) as Threatened or Endangered Warranted but precluded

Our expeditious progress also timelines, that is, timelines required they overlap geographically or have the includes work on listing actions that we under the Act. Actions in the bottom same threats as the species with the funded in FY 2010 but have not yet section of the table are high-priority high priority. Including these species been completed to date. These actions listing actions. These actions include together in the same proposed rule are listed below. Actions in the top work primarily on species with an LPN results in considerable savings in time section of the table are being conducted of 2, and selection of these species is and funding, as compared to preparing under a deadline set by a court. Actions partially based on available staff separate proposed rules for each of them in the middle section of the table are resources, and when appropriate, in the future. being conducted to meet statutory include species with a lower priority if

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TABLE 2. LISTING ACTIONS FUNDED IN FY 2010 BUT NOT YET COMPLETED.

Species Action

Actions Subject to Court Order/Settlement Agreement

6 Birds from Eurasia Final listing determination

Flat-tailed horned lizard Final listing determination

6 Birds from Peru Proposed listing determination

Sacramento splittail Proposed listing determination

Mono basin sage-grouse 12–month petition finding

Greater sage-grouse 12–month petition finding

Big Lost River whitefish 12–month petition finding

White-tailed prairie dog 12–month petition finding

Gunnison sage-grouse 12–month petition finding

Wolverine 12–month petition finding

Arctic grayling 12–month petition finding

Agave eggergsiana 12–month petition finding

Solanum conocarpum 12–month petition finding

Mountain plover 12–month petition finding

Hermes copper butterfly 90–day petition finding

Thorne’s hairstreak butterfly 90–day petition finding

Actions with Statutory Deadlines

48 Kauai species Final listing determination

Casey’s june beetle Final listing determination

Georgia pigtoe, interrupted rocksnail, and rough hornsnail Final listing determination

2 Hawaiian damselflies Final listing determination

African penguin Final listing determination

3 Foreign bird species (Andean flamingo, Chilean woodstar, St. Lucia forest thrush) Final listing determination

5 Penguin species Final listing determination

Southern rockhopper penguin – Campbell Plateau population Final listing determination

5 Bird species from Colombia and Ecuador Final listing determination

7 Bird species from Brazil Final listing determination

Queen Charlotte goshawk Final listing determination

Salmon crested cockatoo Proposed listing determination

Black-footed albatross 12–month petition finding

Mount Charleston blue butterfly 12–month petition finding

Least chub1 12–month petition finding

Mojave fringe-toed lizard1 12–month petition finding

Pygmy rabbit (rangewide)1 12–month petition finding

Kokanee – Lake Sammamish population1 12–month petition finding

Delta smelt (uplisting) 12–month petition finding

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TABLE 2. LISTING ACTIONS FUNDED IN FY 2010 BUT NOT YET COMPLETED.—Continued

Species Action

Cactus ferruginous pygmy-owl1 12–month petition finding

Northern leopard frog 12–month petition finding

Tehachapi slender salamander 12–month petition finding

Coqui Llanero 12–month petition finding

Susan’s purse-making caddisfly 12–month petition finding

White-sided jackrabbit 12–month petition finding

Jemez Mountains salamander 12–month petition finding

Dusky tree vole 12–month petition finding

Eagle Lake trout1 12–month petition finding

29 of 206 species 12–month petition finding

Desert tortoise – Sonoran population 12–month petition finding

Gopher tortoise – eastern population 12–month petition finding

Amargosa toad 12–month petition finding

Wyoming pocket gopher 12–month petition finding

Pacific walrus 12–month petition finding

Wrights marsh thistle 12–month petition finding

67 of 475 southwest species 12–month petition finding

9 Southwest mussel species 12–month petition finding

14 parrots (foreign species) 12–month petition finding

Southeastern pop snowy plover & wintering pop. of piping plover1 90–day petition finding

Eagle Lake trout1 90–day petition finding

Ozark chinquapin1 90–day petition finding

Smooth-billed ani1 90–day petition finding

Bay Springs salamander1 90–day petition finding

Mojave ground squirrel1 90–day petition finding

32 species of snails and slugs1 90–day petition finding

Calopogon oklahomensis1 90–day petition finding

42 snail species 90–day petition finding

White-bark pine 90–day petition finding

Puerto Rico harlequin 90–day petition finding

Fisher – Northern Rocky Mtns. population 90–day petition finding

Puerto Rico harlequin butterfly1 90–day petition finding

42 snail species (Nevada & Utah) 90–day petition finding

HI yellow-faced bees 90–day petition finding

Red knot roselaari subspecies 90–day petition finding

Honduran emerald 90–day petition finding

Peary caribou 90–day petition finding

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TABLE 2. LISTING ACTIONS FUNDED IN FY 2010 BUT NOT YET COMPLETED.—Continued

Species Action

Western gull-billed tern 90–day petition finding

Plain bison 90–day petition finding

Giant Palouse earthworm 90–day petition finding

Mexican gray wolf 90–day petition finding

Spring Mountains checkerspot butterfly 90–day petition finding

Spring pygmy sunfish 90–day petition finding

San Francisco manzanita 90–day petition finding

Bay skipper 90–day petition finding

Unsilvered fritillary 90–day petition finding

Texas kangaroo rat 90–day petition finding

Spot-tailed earless lizard 90–day petition finding

Eastern small-footed bat 90–day petition finding

Northern long-eared bat 90–day petition finding

Prairie chub 90–day petition finding

10 species of Great Basin butterfly 90–day petition finding

High Priority Listing Actions3

19 Oahu candidate species3 (16 plants, 3 damselflies) (15 with LPN = 2, 3 with LPN = 3, 1 with LPN =9) Proposed listing

17 Maui-Nui candidate species3 (14 plants, 3 tree snails) (12 with LPN = 2, 2 with LPN = 3, 3 with LPN = Proposed listing 8)

Sand dune lizard3 (LPN = 2) Proposed listing

2 Arizona springsnails3 (Pyrgulopsis bernadina (LPN = 2), Pyrgulopsis trivialis (LPN = 2)) Proposed listing

2 New Mexico springsnails3 (Pyrgulopsis chupaderae (LPN = 2), Pyrgulopsis thermalis (LPN = 11)) Proposed listing

2 mussels3 (rayed bean (LPN = 2), snuffbox No LPN) Proposed listing

2 mussels3 (sheepnose (LPN = 2), spectaclecase (LPN = 4),) Proposed listing

Ozark hellbender2 (LPN = 3) Proposed listing

Altamaha spinymussel3 (LPN = 2) Proposed listing

5 southeast fish3 (rush darter (LPN = 2), chucky madtom (LPN = 2), yellowcheek darter (LPN = 2), Proposed listing Cumberland darter (LPN = 5), laurel dace (LPN = 5))

8 southeast mussels (southern kidneyshell (LPN = 2), round ebonyshell (LPN = 2), Alabama pearlshell Proposed listing (LPN = 2), southern sandshell (LPN = 5), fuzzy pigtoe (LPN = 5), Choctaw bean (LPN = 5), narrow pigtoe (LPN = 5), and tapered pigtoe (LPN = 11))

3 Colorado plants3 (Pagosa skyrocket (Ipomopsis polyantha) (LPN = 2), Parchute beardtongue Proposed listing (Penstemon debilis) (LPN = 2), Debeque phacelia (Phacelia submutica) (LPN = 8)) 1 Funds for listing actions for these species were provided in previous FYs. 2 We funded a proposed rule for this subspecies with an LPN of 3 ahead of other species with LPN of 2, because the threats to the species were so imminent and of a high magnitude that we considered emergency listing if we were unable to fund work on a proposed listing rule in FY 2008. 3 Funds for these high-priority listing actions were provided in FY 2008 or 2009

We have endeavored to make our relevant law and regulations, and considering ways to streamline listing actions as efficient and timely as constraints relating to workload and processes or achieve economies of scale, possible, given the requirements of the personnel. We are continually such as by batching related actions

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together. Given our limited budget for Therefore, we will continue to accept Author implementing section 4 of the Act, these additional information and comments The primary author of this notice is actions described above collectively from all concerned governmental the Arizona Ecological Services Office constitute expeditious progress. agencies, the scientific community, (see FOR FURTHER INFORMATION CONTACT The Tucson shovel-nosed snake will industry, or any other interested party section). be added to the list of candidate species concerning this finding. upon publication of this 12–month Authority References Cited finding. We will continue to monitor the The authority for this action is section status of this species as new information A complete list of all references cited 4 of the Endangered Species Act of becomes available. This review will in this document is available on the 1973, as amended (16 U.S.C. 1531 et determine if a change in status is seq.). warranted, including the need to make Internet at http://www.regulations.gov prompt use of emergency listing and upon request from the Field Dated: March 18, 2010 procedures. Supervisor at the Arizona Ecological Rowan W. Gould, We intend that any proposed listing Services Office (see ADDRESSES section). Acting Director, Fish and Wildlife Service. action for the Tucson shovel-nosed [FR Doc. 2010–7133 Filed 3–30–10; 8:45 am] snake will be as accurate as possible. BILLING CODE 4310–55–S

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Notices Federal Register Vol. 75, No. 61

Wednesday, March 31, 2010

This section of the FEDERAL REGISTER the collection of information unless it for 100 percent of the project cost, can contains documents other than rules or displays a currently valid OMB control serve rural areas with population not in proposed rules that are applicable to the number. excess of 5,000, and household income public. Notices of hearings and investigations, should not exceed 100 percent of a Rural Utilities Service committee meetings, agency decisions and State’s non-metropolitan median rulings, delegations of authority, filing of Title: Preloan Procedures and household income. Grants under this petitions and applications and agency Requirements for Telecommunications statements of organization and functions are program may be made to public bodies examples of documents appearing in this Program. and private nonprofit corporations section. OMB Control Number: 0572–0079. serving rural areas. Summary of Collection: The Rural Need and Use of the Information: Utilities Service (RUS) is a credit agency RUS will collect the information from DEPARTMENT OF AGRICULTURE of the U.S. Department of Agriculture. It applicants applying for grants under 7 makes mortgage loans and loan CFR part 1778. The information is Submission for OMB Review; guarantees to finance unique to each borrower and emergency Comment Request telecommunications, electric, and water situation. Applicants must demonstrate and waste facilities in rural areas with that there is an imminent emergency or March 26, 2010. a loan portfolio that totals nearly $42 that a decline occurred within 2 years The Department of Agriculture has billion. RUS manages loan programs in of the date the application was filed submitted the following information accordance with the Rural with Rural Development. collection requirement(s) to OMB for Electrification Act of 1936, 7 U.S.C. 901 Description of Respondents: State, review and clearance under the et seq. as amended, (RE Act). Section Local or Tribal Government; not-for- Paperwork Reduction Act of 1995, 201 of the RE Act authorizes the profit institutions. Public Law 104–13. Comments Administrator to make loans to qualified Number of Respondents: 100. regarding (a) whether the collection of telephone companies for the purpose of Frequency of Responses: Reporting: information is necessary for the proper providing telephone service to the On occasion. performance of the functions of the widest practicable number of rural Total Burden Hours: 400. agency, including whether the subscribers. Rural Utility Service information will have practical utility; Need and Use of the Information: (b) the accuracy of the agency’s estimate RUS will collect information using Title: Water and Waste Disposal of burden including the validity of the several forms to determine an Programs Guaranteed Loans. methodology and assumptions used; (c) applicant’s eligibility to borrow from OMB Control Number: 0572–0122. Summary of Collection: The Rural ways to enhance the quality, utility and RUS under the terms of the RE Act. The Utilities Service (RUS) is authorized by clarity of the information to be information is also used to determine Section 306 of the Consolidated Farm collected; (d) ways to minimize the that the Government’s security for loans and Rural Development Act (7 U.S.C. burden of the collection of information made by RUS are reasonably adequate 1926) to make loans to public agencies, on those who are to respond, including and that the loans will be repaid within nonprofit corporations, and Indian through the use of appropriate the time agreed. Without the Tribes for the development of water and automated, electronic, mechanical, or information, RUS could not effectively waste disposal facilities primarily other technological collection monitor each borrower’s compliance servicing rural residents. The Waste and techniques or other forms of information with the loan terms and conditions to Water Disposal Programs (WW) of RUS technology should be addressed to: Desk properly ensure continued loan Officer for Agriculture, Office of provide insured loan and grant funds security. Information and Regulatory Affairs, Description of Respondents: Business through the WW program to finance Office of Management and Budget or other for-profit; not-for-profit many types of projects varying in size (OMB), and complexity. The Waste and Water _ institutions. OIRA [email protected] or Number of Respondents: 50. Disposal Guaranteed Program is fax (202) 395–5806 and to Departmental Frequency of Responses: Reporting: implemented through 7 CFR part 1779. Clearance Office, USDA, OCIO, Mail On occasion. The guaranteed loan program Stop 7602, Washington, DC 20250– Total Burden Hours: 3,539. encourages lender participation and 7602. Comments regarding these provides specific guidance in the information collections are best assured Rural Utilities Service processing and servicing of guaranteed of having their full effect if received Title: 7 CFR Part 1778, Emergency and WW loans. within 30 days of this notification. Imminent Community Water Assistance Need and Use of the Information: Copies of the submission(s) may be Grants. Rural Development’s field offices will obtained by calling (202) 720–8681. OMB Control Number: 0572–0110. collect information from applicants/ An agency may not conduct or Summary of Collection: The Rural borrowers, lenders, and consultants to sponsor a collection of information Utilities Service (RUS) is authorized determine eligibility, project feasibility unless the collection of information under Section 306A of the Consolidated and to ensure borrowers operate on a displays a currently valid OMB control Farm and rural Development Act, (7 sound basis and use loan funds for number and the agency informs U.S.C. 1926(a) to provide grants to rural authorized purposes. There are agency potential persons who are to respond to areas and small communities to secure forms required as well as other the collection of information that such adequate quantities of safe water. Grants requirements that involve certifications persons are not required to respond to made under this program shall be made from the borrower, lenders, and other

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parties. Failure to collect proper practical utility; (b) the accuracy of the Agriculture, Rural Utilities Service, at information could result in improper agency’s estimate of the burden of the (202) 720–7853. FAX: (202) 720–8435. determinations of eligibility, improper collection of information including the All responses to this notice will be use of funds and or unsound loans. validity of the methodology and summarized and included in the request Description of Respondents: Business assumptions used; (c) ways to enhance for OMB approval. All comments will or other for-profit; not-for-profit the quality, utility, and clarity of the also become a matter of public record. institutions; State, Local or Tribal information to be collected; and (d) Dated: March 25, 2010. Government. ways to minimize the burden of the Jessica Zufolo, Number of Respondents: 15. collection of information on Deputy Administrator, Rural Utilities Service. Frequency of Responses: Reporting: respondents, including through the use On occasion. of appropriate automated, electronic, [FR Doc. 2010–7125 Filed 3–30–10; 8:45 am] Total Burden Hours: 858. mechanical or other technological BILLING CODE P Charlene Parker, collection techniques or other forms of information technology. Comments may Departmental Information Collection DEPARTMENT OF AGRICULTURE Clearance Officer. be sent to Michele Brooks, Director, Program Development and Regulatory [FR Doc. 2010–7195 Filed 3–30–10; 8:45 am] Grain Inspection, Packers and Analysis, U.S. Department of Stockyards Administration BILLING CODE 3410–15–P Agriculture, Rural Utilities Service, STOP 1522, 1400 Independence Ave., Designation for the Champaign, IL; DEPARTMENT OF AGRICULTURE SW., Washington, DC 20250–1522. Fax: Emmett, MI; Davenport, IA; Enid, OK; (202) 720–8435. Keokuk, IA; Marshall, MI; and Omaha, Rural Utilities Service Title: 7 CFR Part 1794, Environmental NE Areas policies and Procedures. AGENCY: Information Collection Activity; OMB Control Number: 0572–0117. Grain Inspection, Packers and Comment Request Type of Request: Extension of a Stockyards Administration, USDA. currently approved collection. ACTION: Notice. AGENCY: Rural Utilities Service, USDA. Abstract: The information collection SUMMARY: GIPSA is announcing the ACTION: Notice and request for contained in this rule are requirements comments. designation of the following prescribed by the National organizations to provide official services SUMMARY: The Rural Utilities Service Environmental Policy Act of 1969 under the United States Grain Standards (RUS), in accordance with the (NEPA), as amended (42 U.S.C. 4321– Act, as amended (USGSA): Champaign- Paperwork Reduction Act of 1995 (44 4346), the Council on Environmental Danville Grain Inspection Departments, U.S.C. chapter 35, as amended), invites Quality (CEQ) Regulations for Inc. (Champaign); Detroit Grain comments on the following information Implementing the Procedural Provisions Inspection Service, Inc. (Detroit); collections for which the Agency of NEPA (40 CFR parts 1500–1508), and Eastern Iowa Grain Inspection and intends to request approval from the Executive Orders. Weighing Service, Inc. (Eastern Iowa); Office of Management and Budget USDA Rural Development Enid Grain Inspection Company, Inc. (OMB). administers rural utilities programs (Enid); Keokuk Grain Inspection Service through the Rural Utilities Service (Keokuk); Michigan Grain Inspection DATES: Comments on this notice must be (Agency). Agency applicants provide received by June 1, 2010. Services, Inc. (Michigan); and Omaha environmental documentation, as Grain Inspection Service, Inc. (Omaha). FOR FURTHER INFORMATION CONTACT: prescribed by the rule, to assure that DATES: Effective Date: April 1, 2010. Michele Brooks, Director, Program policy contained in NEPA is followed. Development and Regulatory Analysis, The burden varies depending on the ADDRESSES: William A. Ashley, Acting U.S. Department of Agriculture, Rural type, size, and location of each project, Branch Chief, Review Branch, Utilities Service, 1400 Independence which then prescribes the type of Compliance Division, GIPSA, USDA, Ave., SW., STOP 1522, Room 5162, information collection involved. The STOP 3604, Room 1647–S, 1400 South Building, Washington, DC 20250– collection of information is only that Independence Avenue, SW., 1522. Telephone: (202) 690–1078. Fax: information that is essential for the Washington, DC 20250–3604. (202) 720- 8435. Agency to provide environmental FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: The Office safeguards and to comply with NEPA as William A. Ashley, 202–720–8262 or of Management and Budget’s (OMB) implemented by the CEQ regulations. [email protected]. regulation (5 CFR part 1320) Estimate of Burden: Public reporting Read Applications: All applications implementing provisions of the burden for this collection of information and comments will be available for Paperwork Reduction Act of 1995 (Pub. is estimated to average 146 hours per public inspection at the office above L. 104–13) requires that interested response. during regular business hours (7 CFR members of the public and affected Respondents: Business or other for- 1.27(c)). agencies have an opportunity to profit and non-for-profit institutions. SUPPLEMENTARY INFORMATION: In the comment on information collection and Estimated Number of Respondents: September 4, 2009, Federal Register (74 recordkeeping activities [see 5 CFR 1,339. FR 45803), GIPSA requested 1320.8(d)]. This notice identifies Estimated Number of Responses per applications for designation to provide information collections that RUS is Respondent: 2 official services in the geographic areas submitting to OMB for extension. Estimated Total Annual Burden on presently serviced by the agencies Comments are invited on: (a) Whether Respondents: 486,440 hours. named above. Applications were due by this collection of information is Copies of this information collection October 1, 2009. necessary for the proper performance of can be obtained from MaryPat Daskal, Champaign, Detroit, Eastern Iowa, the functions of the agency, including Program Development and Regulatory Enid, Keokuk, Michigan, and Omaha whether the information will have Analysis, United States Department of were the sole applicants for

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designations to provide official services Champaign, Detroit, Eastern Iowa, Enid, actions to provide official services in the in these areas. As a result, GIPSA did Keokuk, Michigan, and Omaha are able specified areas are effective April 1, not ask for additional comments. to provide official services in the 2010 and terminate on March 31, 2013. GIPSA evaluated all available geographic areas specified in the Interested persons may obtain official information regarding the designation September 4, 2009 Federal Register for services by calling the telephone criteria in section 7(f)(1) of the USGSA which they applied. These designation (7 U.S.C. 79(f)) and determined that numbers listed below:

Designation Designation Official agency Headquarters location and telephone start end

Champaign ...... Champaign, IL (217–398–0723). Additional Locations: Hoopeston, IL; 4/1/2010 3/31/2013 Lake Village, IN; and Terre Haute, IN. Detroit ...... Emmett, MI (810–395–2105) ...... 4/1/2010 3/31/2013 Eastern Iowa...... Davenport, IA (563–322–7149). Additional Locations: Dubuque, IA; 4/1/2010 3/31/2013 Muscatine, IA; Gladstone, IL; and Rochelle, IL. Enid ...... Enid, OK (916–374–9700). Additional Location: Catoosa, OK ...... 4/1/2010 3/31/2013 Keokuk ...... Keokuk, IA (319–524–6482). Additional Location: Havana, IL ...... 4/1/2010 3/31/2013 Michigan ...... Marshall, MI (269–781–2711). Additional Locations: Cairo, OH and 4/1/2010 3/31/2013 Carrollton, MI. Omaha ...... Omaha, NE (402–341–6739) ...... 4/1/2010 3/31/2013

Section 7(f)(1) of the USGSA designation. In addition, we are asking FOR FURTHER INFORMATION CONTACT: authorizes GIPSA’s Administrator to for comments on the quality of services William A. Ashley, 202–720–8262 or designate a qualified applicant to provided by the following designated [email protected]. provide official services in a specified agencies: Amarillo Grain Exchange, Inc. SUPPLEMENTARY INFORMATION: area after determining that the applicant (Amarillo); Cairo Grain Inspection Section is better able than any other applicant Agency, Inc. (Cairo); Louisiana 7(f)(1) of the United States Grain to provide such official services (7 Department of Agriculture and Forestry Standards Act (USGSA) (7 U.S.C. 71– U.S.C. 79(f)(1)). (Louisiana); North Carolina Department 87k) authorizes GIPSA’s Administrator Under section 7(g)(1) of the USGSA, of Agriculture (North Carolina); and to designate a qualified applicant to designations of official agencies are D. R. Schaal Agency, Inc. (Schaal). provide official services in a specified area after determining that the applicant effective for 3 years unless terminated DATES: Applications and comments is better able than any other applicant by the Secretary; however, designations must be received by April 30, 2010. to provide such official services. Under may be renewed according to the ADDRESSES: Submit applications and section 7(g)(1) of the USGSA, criteria and procedures prescribed in comments concerning this notice using section 7(f) of the Act. designations of official agencies are any of the following methods: effective for 3 years unless terminated • Internet: Apply using FGISonline Authority: 7 U.S.C. 71–87k. by the Secretary, but may be renewed (https://fgis.gipsa.usda.gov/ according to the criteria and procedures J. Dudley Butler, default_home_FGIS.aspx) by clicking on prescribed in section 7(f) of the Act. Administrator, Grain Inspection, Packers and the Delegations/Designations and Export Stockyards Administration. Registrations (DDR) link. You will need Areas Open for Designation [FR Doc. 2010–7120 Filed 3–30–10; 8:45 am] to obtain an FGISonline customer BILLING CODE 3410–KD–P number and USDA eAuthentication Amarillo username and password prior to Pursuant to Section 7(f)(2) of the Act, applying. Submit comments at http:// the following geographic areas, in the DEPARTMENT OF AGRICULTURE www.regulations.gov. Instructions for States of Oklahoma and Texas are Grain Inspection, Packers and submitting and reading comments are assigned to this official agency: detailed on the site. • Stockyards Administration • Armstrong (north of Prairie Dog Hand Delivery/Courier Address: Town Fork of the Red River), Carson, Opportunity for Designation in the William A. Ashley, Acting Review Childress, Collingsworth, Dallam, Deaf Amarillo, TX; Cairo, IL; State of Branch Chief, Compliance Division, Smith (east of U.S. Route 385), Donley, GIPSA, USDA, Room 1647–S, 1400 Louisiana; State of North Carolina; Gray, Hansford, Hall (east of U.S. Route Independence Avenue, SW., Belmond, IA; State of New Jersey; and 287), Harley, Hemphill, Hutchinson, State of New York Areas; Request for Washington, DC 20250. • Mail: William A. Ashley, Acting Lipscomb, Moore, Ochiltree, Oldham, Comments on the Official Agencies Potter, Randall (north of Prairie Dog Servicing These Areas Review Branch Chief, Compliance Division, GIPSA, USDA, STOP 3604, Town Fork of the Red River, State Route 217 and FM 1062), Roberts, Sherman, AGENCY: Grain Inspection, Packers and 1400 Independence Avenue, SW., and Wheeler Counties in Texas. Stockyards Administration, USDA. Washington, DC 20250–3604. • • Beaver, Cimarron, and Texas ACTION: Notice. Fax: William A. Ashley, 202–690– 2755. Counties in Oklahoma. SUMMARY: • The designations of the E-mail: Cairo official agencies listed below will end [email protected]. on September 30, 2010. We are asking Read Applications and Comments: Pursuant to Section 7(f)(2) of the Act, persons or governmental agencies All applications and comments will be the following geographic areas, in the interested in providing official services available for public inspection at the States of Illinois, Kentucky, and in the areas presently served by these office above during regular business Tennessee are assigned to this official agencies to submit an application for hours (7 CFR 1.27(c)). agency:

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• Alexander, Jackson County (south County; and North Central Coop, Forest, Southeast Washington Resource of State Route 3, State Route 149, and Holmes, Wright County (serviced by Advisory Committee will conduct a State Route 13; west of U.S. Route 51), Sioux City Inspection and Weighing business meeting. The meeting is open Johnson, Hardin, Massac, Pope, Pulaski, Service Company). to the public. • Randolph County (south of State Route Faribault, Freeborn, and Mower DATES: Wednesday, April 7, 2010, 150 and south of State Route 3), and Counties in Minnesota. beginning at 6:30 p.m. • Union Counties in Illinois. The entire States of New Jersey and ADDRESSES: Pomeroy Ranger District • Ballard, Calloway, Carlisle, Fulton, New York, except those export port Office, 71 West Main Street, Pomeroy, Graves, Hickman, Livingston, Lyon, locations within the States which are Washington. Marshall, McCracken, and Trigg serviced by GIPSA. SUPPLEMENTARY INFORMATION: Agenda Counties in Kentucky. Opportunity for Designation • Benton, Dickson, Henry, Houston, topics will include review and approval Humphreys, Lake, Montgomery, Obion, Interested persons or governmental of project proposals, and is an open Stewart, and Weakley Counties in agencies may apply for designation to public forum. Tennessee. provide official services in the FOR FURTHER INFORMATION CONTACT: The Cargill, Inc., grain elevator in geographic areas specified above under Monte Fujishin, Designated Federal Tiptonville, Lake County, Tennessee, the provisions of section 7(f) of the Official, at (509) 843–1891 or e-mail which is located within Cairo’s assigned USGSA and 7 CFR 800.196(d). [email protected]. areas, is currently serviced, and will Designation in the specified geographic Dated: March 24, 2010. continue to be serviced by Midsouth areas is for the period beginning October Monte Fujishin, 1, 2010, and ending September 30, 2013. Grain Inspection Service. District Ranger, Pomeroy Ranger District, To apply for designation or for more Umatilla National Forest. Louisiana information, contact William A. Ashley Pursuant to Section 7(f)(2) of the Act, at the address listed above or visit [FR Doc. 2010–7116 Filed 3–30–10; 8:45 am] the entire State of Louisiana, except GIPSA’s Web site at http:// BILLING CODE 3410–BH–P those export port locations within the www.gipsa.usda.gov. State which are serviced by GIPSA, is Request for Comments DEPARTMENT OF AGRICULTURE assigned to this official agency. We are publishing this notice to Forest Service North Carolina provide interested persons the Pursuant to Section 7(f)(2) of the Act, opportunity to comment on the quality Alpine County Resource Advisory the entire State of North Carolina, of services provided by the Amarillo, Committee (RAC) except those export port locations Cairo, Louisiana, North Carolina, and within the State which are serviced by Schaal official agencies. In the AGENCY: Forest Service, USDA. GIPSA, is assigned to this official designation process, we are particularly ACTION: Notice of meeting. agency. interested in receiving comments citing SUMMARY: The Alpine County Resource reasons and pertinent data supporting or Schaal Advisory Committee (RAC) will hold a objecting to the designation of the meeting. Pursuant to Section 7(f)(2) of the Act, applicants. Submit all comments to the following geographic areas, in the William A. Ashley at the above address DATES: The meeting will be held on States of Iowa, Minnesota, New Jersey, or at http://www.regulations.gov. April 20, 2010, and will begin at 6 p.m. and New York are assigned to this We consider applications, comments, The meeting will be held in Alpine official agency: and other available information when County at the Alpine Early Learning • Butler (north of County Road C23 determining which applicant will be Center, 100 Foothill Road, Markleeville, and County Road C33, east of County designated. CA 96120. Road T47, and west of State Highway FOR FURTHER INFORMATION CONTACT: Authority: 7 U.S.C. 71–87k. 188/County Road T64), Cerro Gordo, Marnie Bonesteel, RAC Coordinator, Floyd (west of County Road T64 and J. Dudley Butler, USDA, Humboldt-Toiyabe National north of County Road B60), Franklin Administrator, Grain Inspection, Packers and Forest, Carson Ranger District, 1536 S. (north of County Road C55, County Stockyards Administration. Carson Street, Carson City, NV 89701 Road C25, and County Road C23 and [FR Doc. 2010–7122 Filed 3–30–10; 8:45 am] (775) 352–1240; E–MAIL west of U.S. Route 65, County Road S41, BILLING CODE 3410–KD–P [email protected]. and County Road S56), Hancock, SUPPLEMENTARY INFORMATION: Agenda Kossuth (east of U.S. Route 169), items to be covered include: (1) Mitchell, Winnebago, Worth, Wright DEPARTMENT OF AGRICULTURE Congratulate new members (2) Discuss (north of State Route 3 and Interstate 35 and vote on committee bylaws and elect Forest Service and east of State Route 17 and U.S. a chairperson (3) Review Title II projects Route 65) Counties in Iowa. and recommend projects for funding (4) The following grain elevators, located Notice of Southeast Washington Resource Advisory Committee Meeting Public Comment. The meeting is open within Schaal’s assigned geographic to the public. Public input opportunity areas in the State of Iowa, are not AGENCY: Forest Service, USDA. will be provided and individuals will serviced by Schaal: (1) Agvantage F.S., ACTION: Notice of meeting. have the opportunity to address the Chapin, Franklin County; (2) Five Star Committee at that time. Coop, Rockwell, Cerro Gordo County SUMMARY: Pursuant to the authorities in (both serviced by Central Iowa Grain the Federal Advisory Committee Act Dated: March 23, 2010. Inspection Service, Inc.); and (3) West (Pub. L. 92–463) and under the Secure Genny E. Wilson, Bend Elevator Co., Algona, Kossuth Rural Schools and Community Self- Designated Federal Officer. County; Stateline Coop, Burt, Kossuth Determination Act of 2000, as amended, [FR Doc. 2010–6998 Filed 3–30–10; 8:45 am] County; Gold-Eagle, Goldfield, Wright (Pub. L. 110–343), the Umatilla National BILLING CODE 3410–11–M

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DEPARTMENT OF AGRICULTURE Meeting Agenda explore the use of the Internet for the This meeting is open to the public, 2020 Census as an alternative means for Forest Service except where noted otherwise. the public to respond to the Census. Therefore, we have established the 2010 Notice of Southwest Idaho Resource I. Approval of Agenda Census Quality Survey (CQS), formerly Advisory Committee Meeting II. Program Planning known as the Internet Reinterview • Approval of Letter to Youngstown, AGENCY: Forest Service, USDA. Evaluation, as a research component Ohio City Council Members re under the 2010 Census Program for ACTION: Notice of meeting. Racially Bifurcated Test Results in Evaluations and Experiments (CPEX). the Police and Fire Departments Projects under the 2010 CPEX will SUMMARY: Pursuant to the authorities in • Update on Status of 2010 guide future census design as well as the Federal Advisory Committee Act Enforcement Report—Some of the benefit other ongoing programs (Pub. L. 92–463) and under the Secure discussion of this agenda item may conducted by the Census Bureau, such Rural Schools and Community Self- be held in closed session. as the American Community Survey. Determination Act of 2000, as amended, • Update on Status of Title IX As with previous decennial censuses (Pub. L. 110–343), the Boise, Payette, Project—Some of the discussion of dating back to 1950, the Census Bureau and Sawtooth National Forests’ this agenda item may be held in conducts a formal program to assess the Southwest Idaho Resource Advisory closed session. census and experimental tests that Committee will conduct a business III. Adjourn meeting. The meeting is open to the examine methodologies, techniques, public. The Commission’s next scheduled and strategies that will potentially meeting is Friday, April 16, 2010, the improve the way the Census Bureau DATES: Thursday, April 15, 2010, details of which will be published in the conducts the next decennial census. For beginning at 10:30 a.m. Federal Register eight days prior to that experimental studies, the actual ADDRESSES: Idaho Counties Risk meeting. decennial census environment is Management Program Building, 3100 CONTACT PERSON FOR FURTHER required because it provides the South Vista Avenue, Boise, Idaho. INFORMATION: Lenore Ostrowsky, Acting necessary conditions to learn the true SUPPLEMENTARY INFORMATION: Agenda Chief, Public Affairs Unit (202) 376– effects of new ideas within the context topics will include review and approval 8591. TDD: (202) 376–8116. of the actual effects of national of project proposals, and is an open Persons with a disability requiring advertising, outreach partnerships, and public forum. special services, such as an interpreter other events that occur only during a FOR FURTHER INFORMATION CONTACT: Dale for the hearing impaired, should contact census. Olson, Designated Federal Official, at Pamela Dunston at least seven days The 2010 CQS seeks to build on (208) 347–0322 or e-mail prior to the meeting at 202–376–8105. previous Internet data collection [email protected]. TDD: (202) 376–8116. research in order to set the stage for the Dated: March 22, 2010. Dated: March 29, 2010. Internet testing cycle for the 2020 Census. The main objective is to Suzanne C. Rainville, David Blackwood, General Counsel. estimate measurement errors, such as Forest Supervisor, Payette National Forest. simple response variance and bias of [FR Doc. 2010–7313 Filed 3–29–10; 4:15 pm] [FR Doc. 2010–7006 Filed 3–30–10; 8:45 am] responses from a census mail BILLING CODE 6335–01–P BILLING CODE 3410–11–M questionnaire compared to those from a census Internet questionnaire. The reinterviews will be conducted with a DEPARTMENT OF COMMERCE sample of 2010 Census mail COMMISSION ON CIVIL RIGHTS Submission for OMB Review; respondents in order to provide Sunshine Act Notice Comment Request estimates of measurement errors associated with the design and content AGENCY: United States Commission on The Department of Commerce will of a self-administered census Internet Civil Rights. submit to the Office of Management and questionnaire. Since the measurement ACTION: Notice of meeting cancellation. Budget (OMB) for clearance the error structure may differ depending on following proposal for collection of whether a respondent has only one SUMMARY: On March 18, 2010 (75 FR information under the provisions of the response mode option (i.e. mail or 13076) the U.S. Commission on Civil Paperwork Reduction Act (44 U.S.C. Internet) versus having a choice Rights announced a business meeting to chapter 35). between the two modes, we are testing be held on Friday, March 26, 2010 at the Agency: U.S. Census Bureau. both ‘push’ and ‘choice’ strategies. A Commission’s headquarters. On Title: 2010 Census Quality Survey. sample of the 2010 Census mail Thursday, March 25, 2010, the meeting Form Number(s): D–1R1. questionnaire respondents will be was cancelled. The decision to cancel OMB Control Number: None. invited to complete an Internet the meeting was too close in time to the Type of Request: New collection. reinterview (‘push’ Internet), which has day of the meeting for the publication of Burden Hours: 43,810. the same content as the 2010 mail a cancellation notice to appear in Number of Respondents: 262,857. questionnaire. A separate sample of the advance of the scheduled meeting date. Average Hours per Response: 10 2010 Census mail questionnaire The details of the cancelled meeting are: minutes. respondents will be invited to complete DATE AND TIME: Friday, March 26, 2010; Needs and Uses: As the 2010 Census a mail reinterview (‘push’ mail) with the 11:30 a.m. EDT. nears, planning for the 2020 Census is same 2010 content. A third sample of PLACE: Via Teleconference. Public Dial already underway. One particular area the 2010 Census mail questionnaire in: 1–800–597–7623. Conference ID # of interest for the 2020 Census is to respondents will be invited to complete 63007474. make the Census cost-effective and a reinterview with the choice of mail or Meeting open to public. accurate. The Census Bureau will Internet modes (‘choice’ Internet/mail).

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The data from the Internet reinterview integrated with response option and DEPARTMENT OF COMMERCE will be compared with the data from the contact strategy research within the mail reinterview to provide additional 2020 testing cycle to establish the International Trade Administration information for estimating measurement optimal Internet data collection strategy errors associated with responses from for the 2020 Census. [C–570–936] each of the data collection modes as The 2010 CQS is intended to provide well as response option strategies. Circular Welded Carbon Quality Steel estimates of measurement error Internet reinterview data will also be Line Pipe from the People’s Republic associated with the design and content compared to 2010 Census mail of China: Notice of Amended Final of a self-administered census Internet questionnaire data for the same Determination Pursuant to Final Court households to estimate gross difference questionnaire. The overall goal is to Decision rates. A similar comparison will be design the most effective census Internet made for the mail reinterview to questionnaire, given the time and AGENCY: Import Administration, estimate gross difference rates for the resource constraints, and then evaluate International Trade Administration, mail mode. These gross difference rates its associated measurement error and Department of Commerce. will be compared to estimate the usability issues. The Internet instrument SUMMARY: On December 11, 2009, the measurement error that arises from is not intended to simply replicate the United States Court of International Internet versus census mail 2010 Census mail questionnaire in an Trade (CIT) sustained the Department of questionnaires. In addition to estimating electronic mode. Rather, the goal is to Commerce’s (the Department) remand measurement errors, a key objective of evaluate measurement error associated determination in Circular Welded the evaluation is to collect data related with an Internet questionnaire that Carbon Quality Steel Line Pipe from the to respondent interaction with a census exploits the advantages of the electronic People’s Republic of China: Final Internet questionnaire such as break-off technology, while still retaining the Affirmative Countervailing Duty rates and completion times. Laboratory meaning and intent of the questions and Determination, 73 FR 70961 (Nov. 24, usability testing will also provide data response options from the mail form. 2008) (Line Pipe from the PRC), (e.g., eye-tracking and mouse-tracing Likewise, this evaluation is not amended by Circular Welded Carbon results) on navigational issues. Note that intended to evaluate public compliance Quality Steel Line Pipe from the we are currently considering tracing (as measured by unit-level response People’s Republic of China: Notice of mouse movement for a sample of survey rates). An Internet response strategy Amended Final Affirmative respondents, which would include study within the 2010 Census Countervailing Duty Determination and presentation of an informed consent production cycle (or shortly after) Notice of Countervailing Duty Order, 74 statement. would be limited by the 2010 Integrated FR 4136 (Jan. 23, 2009) (Amended Line The Internet and mail reinterviews Communication Program (ICP) messages Pipe from the PRC). Because all will be conducted in late summer of stating that there is no Internet data litigation in this matter has concluded, 2010, after the census enumeration collection for the 2010 Census. the Department is issuing the amended activities have been completed, to final determination in Line Pipe from minimize the risk to the 2010 Census Affected Public: Individuals or the PRC in accordance with the CIT’s data collection. However, the households. decision. reinterviews will be conducted as close Frequency: One-time only. EFFECTIVE DATE: March 31, 2010. to the census enumeration as feasible to Respondent’s Obligation: Voluntary. FOR FURTHER INFORMATION CONTACT: effectively compare reinterview results John to the 2010 Census self-administered Legal Authority: Title 13, United Conniff, AD/CVD Operations, Office 3, mail questionnaire. Presumably, the States Code, Sections 141 and 193. Import Administration, International results collected within the census OMB Desk Officer: Brian Harris- Trade Administration, U.S. Department environment will reflect a more Kojetin, (202) 395–7314. of Commerce, 14th Street and generalizable measurement error Constitution Ave., NW., Washington, Copies of the above information DC 20230; telephone: 202/482–1009. structure than results from a mid-decade collection proposal can be obtained by SUPPLEMENTARY INFORMATION: census test instrument. In addition, we calling or writing Diana Hynek, hope to capitalize on respondents’ Departmental Paperwork Clearance Background awareness of the 2010 Census to obtain Officer, (202) 482–0266, Department of a higher response to the reinterviews On November 24, 2008, the Commerce, Room 6625, 14th and Department published its affirmative than would be possible in the absence Constitution Avenue, NW., Washington, of the 2010 Census environment. countervailing duty determination in DC 20230 (or via the Internet at However, for the Internet reinterview, Line Pipe from the PRC. On January 23, [email protected]). compliance may suffer from public 2009, the Department published an messaging informing potential Written comments and amended affirmative countervailing respondents that there is no Internet recommendations for the proposed duty determination in conjunction with response option in the 2010 Census. information collection should be sent the countervailing duty order. See As with all CPEX experiments and within 30 days of publication of this Amended Line Pipe from the PRC. After evaluations, the 2010 CQS is primarily notice to Brian Harris-Kojetin, OMB correcting for ministerial errors, the designed for use by the Census Bureau Desk Officer either by fax (202–395– Department calculated an amended to inform early 2020 Census testing and 7245) or e-mail ([email protected]). subsidy rate for Huludao Seven–Star Steel Pipe Group Co., Ltd. (Huludao planning. The intent is to use the 2010 Dated: March 26, 2010. CQS quantitative results, in Seven Star Group), Huludao Steel Pipe combination with the usability Glenna Mickelson, Industrial Co. Ltd. (Huludao Steel Pipe), laboratory results, to focus the Census Management Analyst, Office of the Chief and Huludao Bohai Oil Pipe Industrial Bureau’s Internet development/design Information Officer. Co. Ltd. (Huludao Bohai) (collectively, resources for early decade testing. This [FR Doc. 2010–7177 Filed 3–30–10; 8:45 am] the Huludao Companies) of 31.29 questionnaire design work will be BILLING CODE 3510–07–P percent. Id.

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In Line Pipe from the PRC, the results of the Department’s remand purposes which could contribute to over Department found that suppliers of hot– redetermination, i.e., the inclusion of capitalization of the fishing industry. rolled steel were government–owned the previously excluded supplier to the DATES: All loan funds available for FY with a single exception for the Huludao subsidy calculations. Accordingly, we 2010 must be obligated before Companies. Accordingly, the will instruct CBP to collect cash September 30, 2010. Department determined that supplier to deposits of estimated countervailing ADDRESSES: Applicants may obtain be a private company and thus did not duties at the rate of 33.00 percent of the information and send loan applications include the hot–rolled steel from that free on board (f.o.b.) invoice price on all to the nearest Financial Services Branch supplier in the Huludao Companies’ shipments of subject merchandise from (FSB). FSB locations and contact subsidy calculation. Petitioners, United the Huludao Companies entered or information are: States Steel Corporation and Maverick withdrawn from warehouse, for 1. Northwest Financial Services Tube Corporation, challenged Line Pipe consumption, on or after publication Branch, F/MB53, National Marine from the PRC before the CIT, arguing in date of this notice in the Federal Fisheries Service, National Oceanic and relevant part that the Department erred Register. Additionally, we will instruct Atmospheric Administration, 7600 Sand in finding that supplier of hot–rolled CBP to collect cash deposits of Point Way NW, (BIN C15700), Seattle, steel to the Huludao Companies to be a estimated countervailing duties at the WA 98115, Branch Chief: Scott private company and not a state–owned rate of 36.53 percent of the f.o.b. invoice Houghtaling, Phone: (206) 526–6122. enterprise. On September 10, 2009, the price on all shipments of subject 2. Northeast Financial Services CIT granted the Department’s request for merchandise from companies subject to Branch, F/MB51, National Marine a voluntary remand for the limited the all–others rate pursuant to section Fisheries Service, National Oceanic and purpose of ‘‘reconsidering and, as 705(c)(5)(A) of the Act, entered or Atmospheric Administration, 55 Great necessary, correcting a potential error withdrawn from warehouse, for Republic Drive, Suite 02–700, related to the factual finding concerning consumption, on or after publication Gloucester, MA 01930–2209, Branch the ownership of a supplier of hot– date of this notice in the Federal Chief: Ron Linsky, Phone: (978) 281– rolled steel’’ to the Huludao Companies. Register. 9154. United States Steel Corp. et al. v. United This determination is published 3.Southeast Financial Services States, Consol. Court No. 09–00086 (Ct. pursuant to sections 705(d) and 777(i) of Branch, National Marine Fisheries Int’l Trade Sept. 10, 2009) (order the Act. Service, F/MB52, National Oceanic and granting motion for voluntary remand). Dated: March 25, 2010. Atmospheric Administration, 263 13th The Department issued its remand Ronald K. Lorentzen, Avenue South, St. Petersburg, FL redetermination on October 20, 2009. 33702–2432, Branch Chief: Shawn Deputy Assistant Secretary for Import See United States Steel Corp. et al. v. Administration. Berry, Phone: (727) 824–5342. United States, Consol. Court No. 09– In addition, information is available at [FR Doc. 2010–7216 Filed 3–30–10; 8:45 am] 00086, Final Redetermination Pursuant www.nmfs.noaa.gov/mb/ to Remand (Oct. 20, 2009) (Final BILLING CODE 3510–DS–S financiallservices/ffp.htm Redetermination). On remand, the SUPPLEMENTARY INFORMATION: Department determined its previous DEPARTMENT OF COMMERCE I. Introduction finding concerning the private ownership of the supplier of hot–rolled National Oceanic and Atmospheric A. Background steel to the Huludao Companies to be in Administration The FFP’s primary statutory authority error. The Department corrected for that is found in Title XI of the Merchant RIN 0648–XV46 error by finding the supplier in question Marine Act, 1936, as amended and now to be government–owned through the recodified at 46 U.S.C. 53701, et application of adverse facts available. Fisheries Finance Program; Final Program Notice and Announcement of seq(Title XI). The Sustainable Fisheries See Final Redetermination at 3. As a Act (SFA) (Pub. L. 104–297) amended result of that correction, the Department Availability of Federal Financial Assistance section 1104A(a)(7) of Title XI of the calculated a revised subsidy rate for the Merchant Marine Act (46 U.S.C. App. Huludao Companies of 33.43 percent AGENCY: National Marine Fisheries 1274) and section 303(d)(4) of the and a revised all–others rate pursuant to Service (NMFS), National Oceanic Magnuson-Stevens Fishery section 705(c)(5)(A) of the Tariff Act of andAtmospheric Administration, Conservation and Management Act 1930, as amended (the Act), of 36.74 Department of Commerce. (Magnuson-Stevens Act) (16 U.S.C. 1801 percent.1 Id. at 4. ACTION: Announcement of availability of et seq.) to authorize IFQ financing. Amended Final Determination Federal financial assistance. Title XI is the credit authority under which NMFS will make these loans. On December 11, 2009, the CIT SUMMARY: NMFS announces the This authority is subject to the Federal sustained the Department’s remand availability of long-term direct loans Credit Reform Act of 1990 (FCRA) (2 redetermination in its entirety. See made underthe Fisheries Finance U.S.C. 661) which requires estimated United States Steel Corp. et al. v. United Program (FFP). The FFP provides net loan losses (FCRA cost) to be States, Slip Op. 09–137 (Ct. Int’l Trade financing for the purchase of used appropriated at the time Congress Dec. 11, 2009). vessels or the reconstruction of vessels authorizes annual loan ceilings. Because there is now a final and (limited to reconstructions that do not The amount of annual FCRA credit conclusive decision in the court add to fishing capacity); refinancing for authority available is a ratio of the proceeding, we are further amending existing debt obligations; financing or FCRA cost rate and the FCRA cost Line Pipe from the PRC to reflect the refinancing fisheries shoreside facilities appropriated. The current cost rate or aquacultural facilities; and the estimate based on the historical 1 The all-others rate was recalculated using a simple average of the two responding firms’ subsidy purchase or refinancing of Individual performance of FFP’s loan programs is rates. See Line Pipe from the PRC, 73 FR at 70962- Fishing Quota (IFQ) in the North zero. Consequently, no loan subsidy is 63. Pacific. FFP loans are not issued for required. For Fiscal Year 2010 (FY10),

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however, there is appropriated refinanced (rather than financed) is presently facing such criminal charges $59,000,000.00 in loan authority for the lower than its original purchase price, as fraud, theft, perjury, or other matters traditional loan program and applicants may be required to provide which significantly reflect on the $16,000,000.00 for the IFQ loan an additional down payment. applicant’s management honesty or program. 2. Loan amount. There is no financial integrity. It is estimated that these credit maximum or minimum loan amount 3. A false statement on an application authorities will fund approximately 31 3. Interest rate. Each loan’s annual is grounds for denial or termination of traditional loans and 54 IFQ loans. interest rate will be 2 percent higher funds and grounds for possible Applications will generally be reviewed than the U.S. Treasury’s cost of punishment by a fine or imprisonment in the order they are received. The FFP’s borrowing public funds of an equivalent as provided in 18 U.S.C. 1001. traditional priorities are: maturity. For example, the annual loan 4. Applicants must submit a 1. Aquacultural facilities interest rate would, on January 15, 2010, completed Form CD–511, ‘‘Certifications construction, reconstruction, have been approximately 6.09 percent Regarding Debarment, Suspension and reconditioning, and acquisition for a 15-year maturity. Interest is simple Other Responsibility Matters; Drug-Free 2. Fisheries shoreside facilities interest and the rate is fixed. Workplace Requirements and construction, reconstruction, 4. Maturity. Loan maturity may not Lobbying,’’ and the following reconditioning, and acquisition; exceed 25 years, but may be shorter explanations are hereby provided: 3. Fishing vessel reconstruction, depending on the useful life of the i. Nonprocurement Debarment and reconditioning and acquisition. The FFP assets being financed and credit and Suspension. Prospective participants (as rule, however, prohibits loans that other considerations. defined at 15 CFR 26.105) are subject to increase existing harvesting capacity, as 5. Repayment. Repayment will be by 15 CFR part 26, ‘‘Nonprocurement does the FFP’s loan authority equal quarterly installments of principal Debarment and Suspension,’’ and the appropriations language. FFP loans may and interest. related section of the certification form not consequently originally finance 6. Security. For IFQ loans, the loan QS applies; either vessel construction or will, in every case, be the primary ii. Anti-Lobbying. Persons (as defined reconstruction that increases vessel security for the loan. For traditional at 15 CFR 28.105) are subject to the harvesting capacity. The FFP will not loans, the FFP will require, at a lobbying provisions of 31 U.S.C. 1352. make vessel loans in fisheries listed as minimum, a pledge of the property ‘‘Limitation on use of appropriated overfished or subject to overfishing in being financed or refinanced or funds to influence certain Federal the recent Status of the U.S. Fisheries, adequate substitute collateral. NMFS contracting and financial transactions,’’ published by the National Marine may require additional collateral to and the lobbying section of the Fisheries Service, at the time of ensure the security position of the certification form prescribed above application. primary collateral. NMFS may require applies to applications/bids for grants, all parties with significant ownership cooperative agreements, and contracts B. Catalog of Federal Domestic interests (eg. the applicant, a for more than $100,000, and loans and Assistance corporation or partnership) to loan guarantees for more than $150,000 The FFP is listed in the ‘‘Catalog of personally guarantee the loan the certification form applies. Federal Domestic Assistance’’ under repayment. Some credit risks may 5. An applicant classified for tax number 11.415: Fisheries Finance require additional security. purposes as in individual, partnership, Program. 7. Application fee. The application fee proprietorship, corporation, or medical is 0.5 percent of the loan amount for corporation is required to submit a II. Eligible Applicants which an applicant applies. Half the taxpayer identification number (TIN) An applicant, either an individual or application fee is fully earned at the (either social security number, employer a business entity must be a citizen of the time NMFS accepts the application. The identification number as applicable, or United States as described in 46 U.S.C. other half is fully earned only when registered foreign organization number) 104, or an entity who is a citizen for the NMFS issues an approval in principle on Form W–9, ‘‘Payers Request for purpose of documenting a vessel in the letter approving an application. Once it Taxpayer Identification Number.’’ Tax- coastwise trade under 46 U.S.C. 50501. has issued an approval in principle exempt organizations and corporations Applicants for an IFQ loan must be letter, NMFS will not return the second (with the exception of medical eligible to hold the IFQ in the North half of the application fee. corporations) are excluded from this Pacific fishery that is subject of the loan. requirement. Recipients who either fail IV. Administrative Requirements to provide their TIN or provide an III. Loan Terms and Conditions 1. In accordance with the provisions incorrect TIN may have funding 1. Down payment. Applicants for of the Debt Collection Improvement Act suspended until the requirement is met. financing the purchase of traditional of 1996, a person may not obtain any Disclosure of a Recipient’s TIN is loan assets or IFQ (rather than Federal financial assistance in the form mandatory for Federal income tax refinancing) must fund 20 percent of the of a loan (other than a disaster loan) or reporting purposes under the authority purchase cost from funds other than loan guarantee if the person has an of 26 U.S.C., Section 6011 and 6109(d), loan proceeds. Applications for outstanding debt (other than a debt and 26 CFR, Section 301.6109–1. This is refinancing a traditional loan can not under the Internal Revenue Code of to ensure the accuracy of income exceed 80 percent of the project’s 1986) with any Federal agency which is computation by the IRS. This depreciated actual cost. For IFQ in a delinquent status, as determined information will be used to identify an applicants if the current market value of under standards prescribed by the individual who is compensated with QS, whose purchase cost is being Secretary of the Treasury. DOC funds or paid interest under the refinanced (rather than financed), is 2. Applicants may be subject to a Prompt Payment Act. higher than its original purchase price, name-check review process. Name 6. An audit of a Program loan may be applicants may need less, or no, down checks are intended to reveal if any key conducted at any time. Auditors, payment. However, if the current value individuals associated with the selected at the discretion of the of QS whose purchase cost is being applicant have been convicted of or are Department of Commerce’s Office of

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Inspector General, shall have access to and professional affiliations; philosophy The Advisory Council represents the any and all books, documents, papers regarding the protection and coordination link between the and records of the obligor or any other management of marine resources; and Sanctuary and the state and federal party to a financing, that the auditor(s) possibly the length of residence in the management agencies, user groups, deem pertinent, whether written, area affected by the sanctuary. researchers, educators, policy makers, printed, recorded, produced or Applicants who are chosen for the and other various groups that help to reproduced by any mechanical, Education primary should expect to focus efforts and attention on the central magnetic or other process or medium. serve until February 2011 and California coastal and marine applicants who are chosen for the ecosystems. Classification Conservation alternate should expect to The Advisory Council functions in an Neither the Administrative Procedure serve until February 2013. advisory capacity to the Sanctuary Act nor any other law requires prior DATES: Applications are due by April Superintendent and is instrumental in notice and opportunity for public 30, 2010. helping develop policies, program goals, comment about this document (which ADDRESSES: Application kits may be and identify education, outreach, concerns loans). Consequently, the obtained from 299 Foam Street, research, long-term monitoring, resource Regulatory Flexibility Act does not Monterey, CA 93940 or online at protection, and revenue enhancement require a regulatory flexibility analysis. http://montereybay.noaa.gov/. priorities. The Advisory Council works This notice is not significant for Completed applications should be sent in concert with the Sanctuary purposes of E.O. 12866. to the same address. Superintendent by keeping him or her This notice contains and refers to FOR FURTHER INFORMATION CONTACT: informed about issues of concern collection-of-information requirements Nicole Capps, 299 Foam Street, throughout the Sanctuary, offering subject to the Paperwork Reduction Act. Monterey, CA 93940, (831) 647–4206, recommendations on specific issues, The application requirements contained [email protected]. and aiding the Superintendent in in the Notice have been approved under achieving the goals of the Sanctuary SUPPLEMENTARY INFORMATION: OMB control number 0648–0012. The program within the context of Notwithstanding any other provision of MBNMS Advisory Council was California’s marine programs and established in March 1994 to assure law, no person is required to respond to, policies. continued public participation in the nor shall any person be subject to a Authority: 16 U.S.C. 1431, et seq. penalty for failure to comply with, a management of the Sanctuary. Since its establishment, the Advisory Council has (Federal Domestic Assistance Catalog collection of information subject to the Number 11.429 Marine Sanctuary Program) requirements of the Paperwork played a vital role in decisions affecting Dated: March 22, 2010. Reduction Act unless that collection of the Sanctuary along the central information displays a currently valid California coast. Daniel J. Basta, The Advisory Council’s twenty voting OMB control number. Director, Office of National Marine members represent a variety of local Sanctuaries, National Ocean Service, Dated: March 26, 2010. user groups, as well as the general National Oceanic and Atmospheric John Oliver, public, plus seven local, state and Administration. Deputy Assistant Administrator For federal governmental jurisdictions. In [FR Doc. 2010–7001 Filed 3–30–10; 8:45 am] Operations, National Marine Fisheries addition, the respective managers or BILLING CODE 3510–NK–M Service. superintendents for the four California [FR Doc. 2010–7264 Filed 3–30–10; 8:45 am] National Marine Sanctuaries (Channel BILLING CODE 3510–22–S Islands National Marine Sanctuary, DEPARTMENT OF COMMERCE Cordell Bank National Marine Sanctuary, Gulf of the Farallones National Oceanic and Atmospheric DEPARTMENT OF COMMERCE National Marine Sanctuary and the Administration Monterey Bay National Marine Availability of Conservation Seat for National Oceanic and Atmospheric Sanctuary) and the Elkhorn Slough the Flower Garden Banks National Administration National Estuarine Research Reserve sit Marine Sanctuary Advisory Council Availability of Seats for the Monterey as non-voting members. Four working groups support the Bay National Marine Sanctuary AGENCY: Office of National Marine Advisory Council: The Research Advisory Council Sanctuaries (ONMS), National Ocean Activity Panel (‘‘RAP’’) chaired by the Service (NOS), National Oceanic and AGENCY: Office of National Marine Research Representative, the Sanctuary Atmospheric Administration (NOAA), Sanctuaries (ONMS), National Ocean Education Panel (‘‘SEP’’) chaired by the Department of Commerce (DOC). Service (NOS), National Oceanic and Education Representative, the ACTION: Notice and request for Atmospheric Administration (NOAA), Conservation Working Group (‘‘CWG’’) applications. Department of Commerce (DOC). chaired by the Conservation ACTION: Notice and request for Representative, and the Business and SUMMARY: The ONMS is seeking applications. Tourism Activity Panel (‘‘ETAP’’) applications for the following vacant chaired by the Business/Industry seat on the Flower Garden Banks SUMMARY: The ONMS is seeking Representative, each dealing with National Marine Sanctuary Advisory applications for the following vacant matters concerning research, education, Council: Conservation. Applicants are seats on the Monterey Bay National conservation and human use. The chosen based upon their particular Marine Sanctuary Advisory Council: working groups are composed of experts expertise and experience in relation to Conservation alternate and Education from the appropriate fields of interest the seat for which they are applying; primary. Applicants are chosen based and meet monthly, or bi-monthly, community and professional affiliations; upon their particular expertise and serving as invaluable advisors to the philosophy regarding the protection and experience in relation to the seat for Advisory Council and the Sanctuary management of marine resources; and which they are applying; community Superintendent. possibly the length of residence in the

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area affected by the sanctuary. ACTION: Notice and request for DEPARTMENT OF COMMERCE Applicants who are chosen as members applications. should expect to serve three-year terms, International Trade Administration pursuant to the council’s Charter. SUMMARY: The ONMS is seeking [A–570–851] DATES: Applications are due by May 28, applications for the following vacant 2010. seats on the Fagatele Bay National Certain Preserved Mushrooms From Marine Sanctuary Advisory Council: the People’s Republic of China: Notice ADDRESSES: Application kits may be Research, Education, Commercial of Initiation of Antidumping Duty New obtained from Jennifer Morgan, NOA– Fishing, Ocean Recreation, Youth, Shipper Reviews Flower Garden Banks National Marine Tutuila: East Side, Tutila: West Side, Sanctuary, 4700 Avenue U, Bldg. 216, AGENCY: Import Administration, Galveston, TX 77551 or downloaded and Manua Islands. Applicants are International Trade Administration, from the sanctuary Web site http:// chosen based upon their particular Department of Commerce. expertise and experience in relation to flowergarden.noaa.gov. Completed SUMMARY: The Department of Commerce the seat for which they are applying; applications should be sent to the same (the Department) has received requests community and professional affiliations; address. for new shipper reviews of the philosophy regarding the protection and antidumping duty order on certain FOR FURTHER INFORMATION CONTACT: management of marine resources; and preserved mushrooms from the People’s Jennifer Morgan, NOAA–Flower Garden possibly the length of residence in the Republic of China (PRC). See Notice of Banks National Marine Sanctuary, 4700 area affected by the sanctuary. Avenue U, Bldg. 216, Galveston, TX Amendment of Final Determination of Applicants who are chosen as members Sales at Less Than Fair Value and 77551, 409–621–5151 ext. 103, should expect to serve 3-year terms, [email protected]. Antidumping Duty Order: Certain pursuant to the council’s Charter. Preserved Mushrooms From the People’s SUPPLEMENTARY INFORMATION: Located in DATES: Applications are due by April Republic of China, 64 FR 8308 the northwestern Gulf of Mexico, the 30, 2010. (February 19, 1999). In accordance with Flower Garden Banks National Marine section 751(a)(2)(B) of the Tariff Act of Sanctuary includes three separate areas, ADDRESSES: Application kits may be 1930, as amended (the Act), and 19 CFR known as East Flower Garden, West obtained from Emily Gaskin, Fagatele 351.214(d), we are initiating Flower Garden, and Stetson Banks. The Bay National Marine Sanctuary, antidumping duty new shipper reviews Sanctuary was designated on January American Samoa Department of of Zhangzhou Tongfa Foods Industry 17, 1992. Stetson Bank was added to the Commerce Office, Executive Office Co., Ltd. (Tongfa) and Shandong Fengyu Sanctuary in 1996. The Sanctuary Building, Utulei. Completed Edible Fungus Corporation Ltd. Advisory Council will consist of no applications should be returned to the (Fengyu). The period of investigation more than 21 members; 16 non- same address. (POI) of these new shipper reviews is governmental voting members and 5 FOR FURTHER INFORMATION CONTACT: February 1, 2009 through January 31, governmental non-voting members. The Emily Gaskin at (684) 633–5155 ext. 271 2010. Council may serve as a forum for or [email protected]. DATES: consultation and deliberation among its Effective Date: March 31, 2010. members and as a source of advice to SUPPLEMENTARY INFORMATION: The FOR FURTHER INFORMATION CONTACT: Fred the Sanctuary manager regarding the Fagatele Bay National Marine Sanctuary Baker, Scott Hoefke, or Robert James, management of the Flower Garden Advisory Council was established in AD/CVD Operations, Office 7, Import Banks National Marine Sanctuary. 1986 pursuant to Federal law to ensure Administration, International Trade continued public participation in the Administration, U.S. Department of Authority: 16 U.S.C. Sections 1431, et seq. Commerce, 14th Street and Constitution (Federal Domestic Assistance Catalog management of the sanctuary. The Number 11.429 Marine Sanctuary Program) Sanctuary Advisory Council brings Avenue, NW., Washington, DC 20230, members of a diverse community telephone: (202) 482–2924, (202) 482– Dated: March 16, 2010. 4947, or (202) 482–0649, respectively. Daniel J. Basta, together to provide advice to the Sanctuary Manager (delegated from the SUPPLEMENTARY INFORMATION: Director, Office of National Marine Sanctuaries, National Ocean Service, Secretary of Commerce and the Under Background Secretary for Oceans and Atmosphere) National Oceanic and Atmospheric On February 19, 1999, the Department on the management and protection of Administration. published the antidumping duty order the Sanctuary, or to assist the National [FR Doc. 2010–7002 Filed 3–30–10; 8:45 am] on certain preserved mushrooms from Marine Sanctuary Program in guiding a BILLING CODE 3510–NK–M the PRC. See Notice of Amendment of proposed site through the designation or Final Determination of Sales at Less the periodic management plan review Than Fair Value and Antidumping Duty process. DEPARTMENT OF COMMERCE Order: Certain Preserved Mushrooms Authority: 16 U.S.C. 1431, et seq. National Oceanic and Atmospheric From the People’s Republic of China, 64 Administration (Federal Domestic Assistance Catalog FR 8308 (February 19, 1999). Thus, the Number 11.429 Marine Sanctuary Program) antidumping duty order on certain preserved mushrooms from the PRC has Availability of Seats for the Fagatele Dated: March 22, 2010. Bay National Marine Sanctuary a February anniversary month. On Advisory Council Daniel J. Basta, February 25, 2010 and February 26, Director, Office of National Marine 2010, the Department received requests AGENCY: Office of National Marine Sanctuaries, National Ocean Service, for new shipper reviews from Tongfa Sanctuaries (ONMS), National Ocean National Oceanic and Atmospheric and Fengyu, respectively. In their Service (NOS), National Oceanic and Administration. respective requests for reviews, Tongfa Atmospheric Administration (NOAA), [FR Doc. 2010–7000 Filed 3–30–10; 8:45 am] and Fengyu identified themselves as Department of Commerce (DOC). BILLING CODE 3510–NK–M both exporters and producers of the

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subject merchandise. The Department These reviews cover the period with section 751(a)(2)(B) of the Act and determined that both requests contained February 1, 2009 through January 31, 19 CFR 351.214 and 351.221(c)(1)(i). certain deficiencies and requested that 2010. We intend to issue the Dated: March 26, 2010. both respondents correct their preliminary results of these reviews no John M. Andersen, submissions. See March 11, 2010 and later than 180 days after the date on March 17, 2009 letters from Robert which these reviews are initiated, and Acting Deputy Assistant Secretary for Antidumping and Countervailing Duty James, Program Manager, to Tongfa and the final results within 90 days after the Operations. Fengyu, respectively. In accordance date on which we issue the preliminary [FR Doc. 2010–7355 Filed 3–30–10; 8:45 am] with the Department’s requests, Tongfa results. See section 751(a)(2)(B)(iv) of and Fengyu corrected the problems in the Act and 19 CFR 351.214(h)(i). BILLING CODE 3510–DS–P their initial submissions in revised In cases involving non-market economies, the Department requires that submissions dated March 18, 2010 and DEPARTMENT OF COMMERCE March 23, 2010, respectively. For the a company seeking to establish purpose of initiating these new shipper eligibility for an antidumping duty rate National Oceanic and Atmospheric reviews, the Department determines that separate from the country-wide rate Administration Tongfa and Fengyu’s original provide evidence of de jure and de facto absence of government control over the submissions were timely filed. RIN 0648–XV57 Pursuant to the requirements set forth company’s export activities. See, e.g., in section 751(a)(2)(B)(i) of the Act and Wooden Bedroom Furniture from the Marine Mammals; File No. 15206 19 CFR 351.214(b)(2), Tongfa and People’s Republic of China: Initiation of Fengyu certified that (1) they did not Antidumping Duty New Shipper AGENCY: National Marine Fisheries export subject merchandise to the Reviews, 75 FR 10214, 10215 (March 5, Service (NMFS), National Oceanic and United States during the POI (see 2010). Accordingly, we will issue Atmospheric Administration (NOAA), section 751(a)(2)(B)(i)(I) of the Act and questionnaires to Tongfa and Fengyu Commerce. 19 CFR 351.214(b)(2)(i); (2) since the that will include a separate rates ACTION: Notice; receipt of application. initiation of the investigation they have section. These reviews will proceed if never been affiliated with any company the response provides sufficient SUMMARY: Notice is hereby given that that exported subject merchandise to the indication that Tongfa and Fengyu are Sea World LLC, 9205 South Park Center United States during the POI, including not subject to either de jure or de facto Loop, Suite 400, Orlando, FL 32819, has those companies not individually government control with respect to their applied in due form for a permit to examined during the investigation (see exports of preserved mushrooms. import one beluga whale section 751(a)(2)(B)(i)(II) and19 CFR However, if Tongfa and Fengyu do not (Delphinapterus leucas) for the 351.214(b)(2)(iii)(A)); and (3) their demonstrate eligibility for separate purposes of public display. export activities were not controlled by rates, they will be deemed not to have DATES: Written or telefaxed comments the central government of the PRC (see met the requirements of section must be received on or before April 30, 19 CFR 351.214(b)(2)(iii)(B)). 751(2)(B)(i) of the Act and 19 CFR 2010. Additionally, in accordance with 19 351.214(b)(2)(i), and therefore not ADDRESSES: The application and related CFR 351.214(b)(2)(iv), Tongfa and separate from the PRC-wide entity. We documents are available for review will therefore rescind the new shipper Fengyu submitted documentation upon written request or by appointment establishing the following: (1) The date reviews. See, e.g., Certain Preserved in the following offices: on which they first shipped subject Mushrooms from the People’s Republic Permits, Conservation and Education merchandise to the United States; (2) of China: Notice of Initiation of Division, Office of Protected Resources, the volume of their first shipments; and Antidumping Duty New Shipper Review, NMFS, 1315 East-West Highway, Room (3) the date of their first sales to 74 FR 15698 (April 7, 2009). 13705, Silver Spring, MD 20910; phone unaffiliated customers in the United We will instruct the CBP to allow, at (301) 713–2289; fax (301) 713–0376; and States. They also certified they had no the option of the importer, the posting, Southeast Region, NMFS, 263 13th shipments to the United States during until the completion of the review, of a Avenue South, Saint Petersburg, FL the period subsequent to their first bond or security in lieu of a cash 33701; phone (727) 824–5312; fax (727) shipments. deposit for certain entries of the subject merchandise produced and exported by 824–5309. Initiation of Reviews Tongfa and produced and exported by Written comments on this application Based on information on the record Fengyu in accordance with section should be submitted to the Chief, and in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR Permits, Conservation and Education 751(a)(2)(B) of the Act and section 351.214(e). Because Tongfa and Fengyu Division, at the address listed above. 351.214(d) of the Department’s certified that they both produce and Comments may also be submitted by regulations, we find that the requests export the subject merchandise, the facsimile to (301) 713–0376, or by email Tongfa and Fengyu submitted meet the sales of which form the basis for their to [email protected]. statutory and regulatory requirements new shipper review requests, we will Please include the File No. in the for initiation of new shipper reviews. instruct CBP to permit the use of a bond subject line of the email comment. See Memoranda to the File through only for entries of subject merchandise Those individuals requesting a public Richard Weible, ‘‘Initiation of AD New which Tongfa and Fengyu both hearing should submit a written request Shipper Review: Certain Preserved produced and exported. to the Chief, Permits, Conservation and Mushrooms from the People’s Republic Interested parties may submit Education Division at the address listed of China (A–570–851),’’ dated March 31, applications for disclosure under above. The request should set forth the 2010. Accordingly, we are initiating administrative protective order in specific reasons why a hearing on this new shipper reviews of the antidumping accordance with 19 CFR 351.305 and application would be appropriate. duty order on certain preserved 351.306. FOR FURTHER INFORMATION CONTACT: mushrooms from the PRC manufactured These initiations and this notice are Jennifer Skidmore or Kristy Beard, (301) and exported by Tongfa and Fengyu. issued and published in accordance 713–2289.

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SUPPLEMENTARY INFORMATION: The DEPARTMENT OF COMMERCE Zoological Garden. The applicant subject permit is requested under the requests this import for the purpose of authority of the Marine Mammal National Oceanic and Atmospheric public display. The receiving facility, Protection Act of 1972, as amended (16 Administration the Louisville Zoological Garden is: (1) U.S.C. 1361 et seq.), and the regulations RIN 0648–XV58 open to the public on regularly governing the taking and importing of scheduled basis with access that is not marine mammals (50 CFR part 216). Marine Mammals; File No. 15430 limited or restricted other than by The applicant requests authorization charging for an admission fee; (2) offers AGENCY: National Marine Fisheries an educational program based on to import one male adult beluga whale Service (NMFS), National Oceanic and from the Vancouver Aquarium Marine professionally accepted standards of the Atmospheric Administration (NOAA), Association of Zoos and Aquariums; Science Center, British Columbia, Commerce. Canada to Sea World of Texas. The and (3) holds an Exhibitor’s License, ACTION: Notice; receipt of application. applicant requests this import for the number 61–C–0106, issued by the U.S. Department of Agriculture under the purpose of public display. The receiving SUMMARY: Notice is hereby given that Animal Welfare Act (7 U.S.C. §§ 2131 - facility, Sea World of Texas, 10500 the Louisville Zoological Garden, 1100 SeaWorld Drive, San Antonio, TX 78251 59). Trevilian Way, P.O. Box 37250, In addition to determining whether is: (1) open to the public on regularly Louisville, KY 40233, has applied in the applicant meets the three public scheduled basis with access that is not due form for a permit to import one display criteria, NMFS must determine limited or restricted other than by South African fur seal (Arctocephalis whether the applicant has demonstrated charging for an admission fee; (2) offers pusillus) for the purposes of public that the proposed activity is humane an educational program based on display. and does not represent any unnecessary professionally accepted standards of the DATES: Written or telefaxed comments risks to the health and welfare of marine Association of Zoos and Aquariums and must be received on or before April 30, mammals; that the proposed activity by the Alliance for Marine Mammal Parks 2010 itself, or in combination with other and Aquariums; and (3) holds an activities, will not likely have a Exhibitor’s License, number 58–C–0077, ADDRESSES: The application and related significant adverse impact on the issued by the U.S. Department of documents are available for review species or stock; and that the applicant’s Agriculture under the Animal Welfare upon written request or by appointment expertise, facilities and resources are Act (7 U.S.C. §§ 2131 - 59). in the following offices: Permits, Conservation and Education adequate to accomplish successfully the In addition to determining whether Division, Office of Protected Resources, objectives and activities stated in the the applicant meets the three public NMFS, 1315 East-West Highway, Room application. display criteria, NMFS must determine 13705, Silver Spring, MD 20910; phone In compliance with the National whether the applicant has demonstrated (301) 713–2289; fax (301) 713–0376; and Environmental Policy Act of 1969 (42 that the proposed activity is humane Southeast Region, NMFS, 263 13th U.S.C. 4321 et seq.), an initial and does not represent any unnecessary Avenue South, Saint Petersburg, FL determination has been made that the risks to the health and welfare of marine 33701; phone (727) 824–5312; fax (727) activity proposed is categorically mammals; that the proposed activity by 824–5309. excluded from the requirement to itself, or in combination with other Written comments on this application prepare an environmental assessment or activities, will not likely have a should be submitted to the Chief, environmental impact statement. significant adverse impact on the Permits, Conservation and Education Concurrent with the publication of species or stock; and that the applicant’s Division, at the address listed above. this notice in the Federal Register, expertise, facilities and resources are Comments may also be submitted by NMFS is forwarding copies of this adequate to accomplish successfully the facsimile to (301) 713–0376, or by email application to the Marine Mammal objectives and activities stated in the [email protected]. Commission and its Committee of application. Please include the File No. in the Scientific Advisors. In compliance with the National subject line of the email comment. Dated: March 26, 2010. Environmental Policy Act of 1969 (42 Those individuals requesting a public Tammy C. Adams, hearing should submit a written request U.S.C. 4321 et seq.), an initial Acting Chief, Permits, Conservation and determination has been made that the to the Chief, Permits, Conservation and Education Division, Office of Protected activity proposed is categorically Education Division at the address listed Resources, National Marine Fisheries Service. excluded from the requirement to above. The request should set forth the [FR Doc. 2010–7257 Filed 3–30–10; 8:45 am] specific reasons why a hearing on this prepare an environmental assessment or BILLING CODE 3510–22–S environmental impact statement. application would be appropriate. Concurrent with the publication of FOR FURTHER INFORMATION CONTACT: this notice in the Federal Register, Jennifer Skidmore or Kristy Beard, (301) DEPARTMENT OF COMMERCE NMFS is forwarding copies of this 713–2289. application to the Marine Mammal SUPPLEMENTARY INFORMATION: The International Trade Administration subject permit is requested under the Commission and its Committee of Civil Nuclear Trade Advisory authority of the Marine Mammal Scientific Advisors. Committee Public Meeting Protection Act of 1972, as amended (16 Dated: March 26, 2010. U.S.C. 1361 et seq.), and the regulations AGENCY: International Trade Tammy C. Adams, governing the taking and importing of Administration, DOC. Acting Chief, Permits, Conservation and marine mammals (50 CFR part 216). ACTION: Notice of Federal advisory Education Division, Office of Protected The applicant requests authorization committee meeting. Resources, National Marine Fisheries Service. to import one female adult South [FR Doc. 2010–7260 Filed 3–30–10; 8:45 am] African fur seal from the Toronto Zoo, SUMMARY: This notice sets forth the BILLING CODE 3510–22–S Ontario, Canada to the Louisville schedule and proposed agenda of the

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next meeting of the Civil Nuclear Trade two (2) minutes per person, with a total technology, and statistics. Last minute Advisory Committee (CINTAC). The public comment period of 30 minutes. changes to the agenda are possible, members will discuss issues outlined in Individuals wishing to reserve speaking which could prevent giving advance the following agenda. time during the meeting must contact public notice of schedule adjustments. DATES: The meeting is scheduled for: Mr. Caliva and submit a brief statement DATES: April 22–23, 2010. On April 22, Thursday, April 15, 2010, from 1 p.m. of the general nature of the comments the meeting will begin at approximately to 4 p.m. Eastern Daylight Time (EDT). and the name and address of the 8:30 a.m. and adjourn at approximately ADDRESSES: The meeting will be held in proposed participant by 5 p.m. EST on 5 p.m. On April 23, the meeting will Room 4830, U.S. Department of Friday, April 9, 2010. If the number of begin at approximately 8:30 a.m. and Commerce, Herbert Clark Hoover registrants requesting to make adjourn at approximately 12 p.m. Building, 1401 Constitution Ave, NW., statements is greater than can be ADDRESSES: The meeting will be held at Washington, DC 20230. reasonably accommodated during the Hilton Crystal City Hotel, 2399 Jefferson FOR FURTHER INFORMATION CONTACT: Mr. meeting, the International Trade Davis Highway, Arlington, Virginia Frank Caliva, Office of Energy & Administration (ITA) may conduct a 22202. lottery to determine the speakers. Environmental Industries, International FOR FURTHER INFORMATION CONTACT: Jeri Trade Administration, Room 4053, 1401 Speakers are requested to bring at least Green, Committee Liaison Officer, Constitution Ave, NW., Washington, DC 20 copies of their oral comments for Department of Commerce, U.S. Census 20230. (Phone: 202–482–8245; Fax: distribution to the participants and Bureau, Room 8H182, 4600 Silver Hill 202–482–5665; e-mail: public at the meeting. Road, Washington, DC 20233, telephone Any member of the public may [email protected]). 301–763–6590. For TTY callers, please submit pertinent written comments use the Federal Relay Service 1–800– SUPPLEMENTARY INFORMATION: concerning the CINTAC’s affairs at any 877–8339. Background: The CINTAC was time before and after the meeting. SUPPLEMENTARY INFORMATION: established under the discretionary Comments may be submitted to the Members authority of the Secretary of Commerce Civil Nuclear Trade Advisory of the C–SAC are appointed by the and in accordance with the Federal Committee, Office of Energy & Director, U.S. Census Bureau. The Advisory Committee Act (5 U.S.C. Environmental Industries, Room 4053, Committee provides scientific and technical expertise, as appropriate, to App.), in response to an identified need 1401 Constitution Ave NW., address Census Bureau program needs for consensus advice from U.S. industry Washington, DC 20230. To be and objectives. The Committee has been to the U.S. Government regarding the considered during the meeting, established in accordance with the development and administration of comments must be received no later Federal Advisory Committee Act (Title programs to expand United States than 5 p.m. EST on Friday, April 9, 5, United States Code, Appendix 2, exports of civil nuclear goods and 2010, to ensure transmission to the Section 10). services in accordance with applicable Committee prior to the meeting. United States regulations, including The meeting is open to the public, Comments received after that date will and a brief period is set aside for public advice on how U.S. civil nuclear goods be distributed to the members but may and services export policies, programs, comments and questions. Persons with not be considered at the meeting. extensive questions or statements must and activities will affect the U.S. civil Copies of CINTAC meeting minutes nuclear industry’s competitiveness and submit them in writing at least three will be available within 90 days of the days before the meeting to the ability to participate in the international meeting. market. Committee Liaison Officer named Topics to be considered: The agenda Dated: March 25, 2010. above. Seating is available to the public for the April 15, 2010, CINTAC meeting Henry P. Misisco, on a first-come, first-served basis. is as follows: Deputy Assistant Secretary for This meeting is physically accessible 1. Welcome & introduction of Manufacturing, Acting. to people with disabilities. Requests for members attending for the first time. [FR Doc. 2010–7209 Filed 3–30–10; 8:45 am] sign language interpretation or other 2. Discussion of civil nuclear trade BILLING CODE 3510–DR–P auxiliary aids should also be directed to priority issues. the Committee Liaison Officer as soon Public Participation: The meeting will as known, and preferably two weeks be open to the public and the room is DEPARTMENT OF COMMERCE prior to the meeting. disabled-accessible. Public seating is Dated: March 25, 2010. limited and available on a first-come, Bureau of the Census Thomas L. Mesenbourg, first-served basis. Members of the public Census Scientific Advisory Committee Deputy Director, Bureau of the Census. wishing to attend the meeting must [FR Doc. 2010–7241 Filed 3–30–10; 8:45 am] notify Mr. Frank Caliva at the contact AGENCY: Bureau of the Census, BILLING CODE 3510–07–P information above by 5 p.m. EST on Department of Commerce. Friday, April 9, 2010, in order to pre- ACTION: Notice of public meeting. register for clearance into the building. DEPARTMENT OF COMMERCE Please specify any requests for SUMMARY: The Bureau of the Census reasonable accommodation at least five (U.S. Census Bureau) is giving notice of Bureau of the Census business days in advance of the a meeting of the Census Scientific meeting. Last minute requests will be Advisory Committee (C–SAC). The Reestablishment of the Census accepted, but may be impossible to fill. Committee will address policy, Advisory Committee of Professional A limited amount of time will be research, and technical issues relating to Associations available for pertinent brief oral a full range of Census Bureau programs AGENCY: Bureau of the Census, comments from members of the public and activities, including Department of Commerce. attending the meeting. To accommodate communications, decennial, ACTION: Notice of advisory committee as many speakers as possible, the time demographic, economic, field reestablishment. for public comments will be limited to operations, geographic, information

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SUMMARY: Notice is hereby given that advantages and disadvantages of other electronic filing issues should be the Secretary of Commerce has prospective and retrospective addressed to Andrew Lee Beller, Import determined that the reestablishment of antidumping and countervailing duty Administration Webmaster, at (202) an advisory committee of technical systems. The report is currently 482–0866, e-mail address: webmaster- advisors is necessary and in the public scheduled to be transmitted to Congress [email protected]. interest. Accordingly, the Bureau of the on June 14, 2010. As part of its analysis, Hearing Date: The hearing will be Census (Census Bureau) has chartered the conferees requested that the held on April 27, 2010 starting at 9:30 the Census Scientific Advisory Department of Commerce (the a.m. in the auditorium at the Committee (CSAC), which succeeds the Department) address the extent to which Department of Commerce, 14th Street Census Advisory Committee of each type of system would likely and Constitution Avenue, NW., Professional Associations (CACPA). The achieve the goals of: (1) Remedying Washington DC. charter for the CACPA expired on injurious dumping or subsidized Hearing Participation: The hearing is February 1, 2010. exports to the United States; (2) open to the public. There are no FOR FURTHER INFORMATION CONTACT: minimizing uncollected duties; (3) prerequisites or conditions on Contact Jeri Green, Chief, Census reducing incentives and opportunities participating at the hearing. All are Advisory Committee Office, U.S. Census for importers to evade antidumping and welcome to speak at the hearing subject Bureau, Washington, DC 20233, countervailing duties; (4) effectively to the guidelines outlined in this notice. telephone 301–763–2075, targeting high-risk importers; (5) Those wishing to speak at the hearing [email protected]. addressing the impact of retrospective must notify the Department no later rate increases on U.S. importers and than April 13, 2010. The request can be SUPPLEMENTARY INFORMATION: The CSAC their employees; and (6) creating sent by e-mail to webmaster- will advise the Census Bureau’s Director minimal administrative burden. [email protected] or in writing to the on the full range of Census Bureau To help in its analysis, the address below. Individual presentations programs and activities. The CSAC will Department is inviting the public to will be limited to five minutes to allow provide scientific and technical comment on the issue and the specific for possible questions from the Chair expertise from the following disciplines: points raised by the conferees as well as and the panel. Written comments, Demography, economics, geography, identify additional issues or though strongly encouraged, are not psychology, statistics, survey considerations that it believes are required for those making presentations methodology, social and behavioral deserving of the Department’s attention within the five minute time limit. sciences, Information Technology and as it prepares its report. The Department Anyone requiring additional time for computing, marketing and other fields is also notifying the public that it will their presentation must seek an of expertise, as appropriate, to address hold a public hearing on April 27, 2010. extension of the time limit at the time Census Bureau program needs and Date for Submitting Comments: The of their notification to the Department. objectives. Department requests that comments be Additional time may be granted as time The CSAC will function solely as an submitted by 5 p.m., April 20, 2010. and the number of participants permits. advisory body and in compliance with Comments should be limited to no more Also, please be aware that foreign provisions of the Federal Advisory than 25 pages. Comments may be nationals wishing to attend or Committee Act. Copies of the charter submitted electronically or in writing. participate in the hearing may be will be filed with the appropriate Electronic comments should be required to provide certain Committees of the Congress and with submitted to webmaster- identification information to the [email protected]. If you submit the Library of Congress. Department by April 23, 2010 in order comments electronically, you do not Dated: March 25, 2010. to gain access to the building. For need to also submit comments in Thomas L. Mesenbourg, further information, please contact Kelly writing. People wishing to comment in Parkhill at (202) 482–3791. Deputy Director, Bureau of the Census. writing should file, by the date specified [FR Doc. 2010–7250 Filed 3–30–10; 8:45 am] above, a signed original and four copies ADDRESSES: Comments may be BILLING CODE 3510–07–P of each set of comments at the address submitted electronically or in writing. listed below. The Department will not Electronic comments should be accept nor consider comments submitted to webmaster- DEPARTMENT OF COMMERCE accompanied by a request that a part or [email protected]. If you submit comments electronically, you do not International Trade Administration all of the material be treated confidentially because of its business need to submit comments in writing. People wishing to comment in writing Report to Congress: Retrospective proprietary nature or for any other should file a signed original and four Versus Prospective Antidumping and reason. copies of each set of comments by 5 Countervailing Duty Systems; Request All comments will be available for p.m., April 20, 2010. Such comments for Comment and Notice of a Public public inspection at Import should be addressed to Ronald K. Hearing Administration’s Central Records Unit, Room 1117, between the hours of 8:30 Lorentzen, Deputy Assistant Secretary AGENCY: Import Administration, a.m. and 5 p.m. on business days. In for Import Administration, Room 1870, International Trade Administration, addition, all comments will be made Department of Commerce, 14th Street Department of Commerce. available to the public in Portable and Constitution Ave., NW., Background: In the conference report Document Format (PDF) on the Internet Washington, DC 20230. accompanying the 2010 Consolidated at the Import Administration Web site at FOR FURTHER INFORMATION CONTACT: Appropriations Act, Public Law: 111– the following address: http:// Kelly Parkhill at (202) 482–3791. 117, the conferees directed the Secretary www.trade.gov/ia/. To the extent New Reporting Requirements: There of Commerce to work with the possible, all comments will be posted are no new paperwork or reporting Secretaries of the Departments of within 48 hours. Any questions requirements as a result of the action. In Homeland Security and the Treasury to concerning file formatting, document addition, all responses to the conduct an analysis of the relative conversion, access on the Internet, or Department’s Federal Register notice

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requests for information, including this Diego, California 92132. Written The water infrastructure projects were request, are strictly voluntary. comments may also be submitted via fax initially included in the November 12, Dated: March 26, 2010. at 619–532–4160, or e-mailed to 2008, Notice of Intent (NOI) for Ronald K. Lorentzen, [email protected]. MCBCP’s Basewide Utilities Infrastructure project (73 FR 66879). Deputy Assistant Secretary for Import FOR FURTHER INFORMATION CONTACT: Mr. Administration. Jesse Martinez, NAVFAC Southwest at These two water infrastructure projects telephone 619–532–3844, fax 619–532– were removed from that EIS for [FR Doc. 2010–7217 Filed 3–30–10; 8:45 am] potential re-design and to develop BILLING CODE 3510–DS–P 4160, or e-mail: [email protected]. additional alternatives for analysis. Purpose and Need: The proposed These two water infrastructure projects are independent of the Basewide DEPARTMENT OF DEFENSE action is needed to modernize and expand the capacity and capability of Utilities Infrastructure projects and meet different needs. Department of the Navy MCBCP’s aging (1940s/1950s era) potable water system and roadway Preliminary Alternatives Notice of Intent To Prepare an infrastructure. Due to the existing Environmental Impact Statement for potable water system infrastructure’s The EIS will address the proposed Basewide Water Infrastructure and lack of redundancy/backup and its alternative sites, alignments, and Stuart Mesa Bridge Replacement continued deteriorating condition, construction methods as described Projects at Marine Corps Base Camp portions of MCBCP have experienced below. Pendleton, San Diego County, CA more frequent interruptions to water Advanced Water Treatment (AWT) delivery services. Wildfires have also AGENCY: Department of the Navy, DoD. North and Associated Facilities damaged system components (e.g. (MILCON P–1044) ACTION: Notice. power feeds, pump stations, pipes, etc.), with resulting service interruptions. As Four alternatives involving a SUMMARY: In accordance with Section combination of two AWT sites and two 102(2)(c) of the National Environmental the potable water system continues to age, and as demand increases, the pipeline routes are being evaluated. All Policy Act (NEPA)of 1969 (42 U.S.C. alternatives include construction of a 4332 (2) (c)), as implemented by the frequency of the interruptions will also increase, adversely affecting MCBCP’s 54,000-square-foot AWT facility, 80,000 Council on Environmental Quality linear feet (LF) of new and replacement Regulations (40 CFR Parts 1500–1508), mission. Repairs to and maintenance actions for the system are becoming water lines, pump stations with the Department of the Navy intends to emergency generators, connection to prepare an Environmental Impact more frequent and more expensive. In the case of the roadway system, the existing reservoirs and distribution Statement (EIS) and conduct a public system, a brine disposal system, and scoping meeting for the proposed Stuart Mesa Bridge, together with nearby roadway segments and the plant access improvements. The replacement of the Stuart Mesa Bridge proposed AWT facility would process and installation and operation of water adjacent intersection of Stuart Mesa Road and Vandegrift Boulevard, up to 7.5 million gallons per day (mgd) infrastructure improvements throughout and would include micro-filtration, Marine Corps Base Camp Pendleton represents a critical roadway connection on the main internal north-south granulated activated carbon, and reverse (MCBCP) in San Diego County, osmosis. The facility would be designed California. connector in the southern and western portions of MCBCP. The roadway link in modular form for ease of DATES: The Department of the Navy will has been severed in the past by flooding, expandability; however there are no review all comments received during underscoring the need for an all-weather current plans for expansion. the 30-day public scoping period, which solution. Alternative 1. Under this alternative starts with the publication of this Notice The purpose of the proposed action is the AWT facility would be constructed of Intent. A public scoping meeting, to enhance the ability of MCBCP to at a location about 1500 feet south of using an informal open house format, efficiently meet its mission by Basilone Road (Site 6). Raw water, will be held in the San Clemente developing new or upgraded, reliable, treated water, and brine would be Community Center, 100 North Calle and compliant infrastructure systems conveyed via new proposed lines. Raw Seville, San Clemente, California 92672, necessary to sustain military training water lines would extend from the from 6 p.m. to 8 p.m. on April 16, 2010. and operations and quality of life existing wells to the AWT facility. The meeting will be announced by services on MCBCP. The purpose is to Treated water lines would extend from notices published in the North County provide (1) secure and more effective the AWT facility to the west to serve the Times and San Clemente Sun Post use of water resources, improved San Onofre Housing Areas and the 51 News. The public is invited to attend potable water quality and capacity, Area (San Onofre); to the north to serve the meeting at their convenience during treatment and delivery capabilities, and the 62 Area (San Mateo), 63 Area the meeting hours and can view project- water system redundancy necessary to (Cristianitos), and 64 Area (Talega); and related displays and speak with reliably and efficiently deliver potable to the east along Basilone Road to serve Department of the Navy and MCBCP water in the northern region of MCBCP; the 52 Area (School of Infantry) and 53 representatives and resource staff. A (2) improved delivery of Basewide water Area (Horno). Potable water loops eight court reporter will be available at the services during periods of scheduled, inches in diameter would be installed meeting to accept oral comments. unscheduled, and emergency system within each cantonment and housing ADDRESSES: Written comments on the interruption; and (3) roadway area. Bicycle lanes and/or pedestrian scope of the MCBCP Basewide Water improvements necessary to maintain trails could also be included over Infrastructure and Stuart Mesa Bridge efficient all-weather traffic accessibility proposed water lines where feasible. Replacement EIS should be directed to: to key areas in the southern portion of Either horizontal directional drilling Mr. Jesse Martinez, Naval Facilities MCBCP that are now severed during (HDD) to extend lines beneath San Engineering Command (NAVFAC) periodic flooding in the vicinity of the Onofre Creek and San Mateo Creek or Southwest, 1220 Pacific Highway, San Stuart Mesa Bridge. suspension of the pipelines over the

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creeks would be incorporated to northeast on the west side of the Santa the Vandegrift Boulevard/Magazine minimize impacts. Margarita River along North River Road, Road pump station east of the 22 Area Following water treatment at the passing east of the 32 Area (Marine Air (Chappo) before connecting to the AWT AWT, brine would be disposed via Control Squadron-1) and 33 Area South at Haybarn Canyon as well as ocean outfall and/or injection wells. The (Margarita) and west of the 23 Area several reservoirs along a ridge above brine disposal line would extend from (Marine Corps Air Station Camp the AWT South (Reservoirs 13151, the AWT facility to the south to connect Pendleton) to Basilone Road and on to 13154, 24140, 24174, and 240173). to the proposed injection wells east of connect to the AWT South facility at Interstate 5 (I–5) and/or to the existing Haybarn Canyon as well as several Stuart Mesa Bridge Replacement and Unit 1 ocean intake pipeline at San reservoirs along a ridge above the AWT Flood Control Improvements (P–0139) Onofre Nuclear Generating Station South (Reservoirs 13151, 13154, 24140, Four alternatives including a (SONGS). The line to SONGS would 24174, and 240173). The second branch combination of two flood control extend beneath I–5 via HDD. Brine would continue south along Stuart Mesa methods and the use of a temporary disposal would make up approximately Road, passing under or suspending over bridge during construction are being 8 to 10 percent of the capacity of the the Santa Margarita River, to Vandegrift evaluated. All alternatives include proposed AWT or a maximum volume Boulevard before turning north and demolition of the existing Stuart Mesa of approximately 0.6 to 0.75 mgd. The terminating approximately one mile Bridge and construction of a new four ocean outfall disposal would use the north at an existing Vandegrift lane bridge and flood protection existing SONGS former Unit 1, 12-foot- Boulevard/Magazine Road pump station measures. diameter, 3,200-foot-long cooling water and several nearby reservoirs Alternative 1. Construction would intake structure located on the Pacific (Reservoirs 20813, 20814, 20815, consist of a new cast-in-place Ocean floor. Deep injection wells 200814, and 200815). prestressed concrete bridge (approximately 1,000 feet deep) would The pipelines would be HDD under or (approximately 1,200 feet long by 56 be located south and east of the existing suspended over San Onofre Creek, Las feet wide) with pile foundations, new San Onofre percolation ponds. Flores Creek, Aliso Canyon drainage, approach road and bridge abutments, Alternative 2. Under this alternative, French Creek, and two locations on the earthwork and grading, rock protection raw water, treated water, and brine Santa Margarita River to avoid impacts and revetment, bridge deck, guard rails, would be conveyed via three proposed to these areas. night lighting, asphalt pavement, and new pipelines located primarily in El The project would also include the pavement marking and signs. construction and operation of three Camino Real instead of Basilone Road as The project includes ‘‘100-year storm’’ pump stations along the alignment. One proposed under Alternative 1. flood protection control measures to Alternative 3. Under this alternative, pump station would be located within protect Stuart Mesa Road and Vandegrift the AWT facility would be located the footprint of the AWT North and a Boulevard. They consist of levees; toe immediately south of Basilone Road second pump station would be located scour protection along the levee; a storm (Site 4). Water conveyance pipelines within a developed parking lot at the water drain system consisting of would be the same as Alternative 1. AWT South. A third pump station culverts, inlets, outlets, headwalls, Alternative 4. Under this alternative, would be located in an existing parking the AWT facility would be located area on the southwest side of the channels, and earth and concrete immediately south of Basilone Road intersection of El Camino Real and Las ditches. Supporting activities would (Site 4). Water conveyance pipelines Pulgas Road. Bicycle lanes and/or include the construction and relocation would be the same as Alternative 2. pedestrian trails could also be included of utilities (electrical, communications/ over proposed water lines where information lines, water main) during Connection of North and South Water feasible. the demolition and construction of the Systems (MILCON P–1045) Alternative 2. The proposed north- new bridge. Under this alternative, no Four alternatives involving different south pipeline would start at the new temporary replacement bridge would be pipeline routes are being evaluated. AWT North facility (P–1044) and extend constructed over the Santa Margarita Alternative 1. Under this alternative, south in El Camino Real to Las Pulgas River and traffic would need to utilize approximately 90,000 LF of potable Road and run north in Las Pulgas Road alternate routes during this time. water lines sized up to 36 inches in to Basilone Road. The water line would Alternative 2. Under this alternative, diameter to connect the northern and then extend along Basilone Road to a temporary use bridge would be southern water systems of MCBCP. The Vandegrift Boulevard and run east to constructed to allow vehicular traffic water line would start at the new AWT connect to the AWT South at Haybarn along Stuart Mesa Road to continue to North facility (P–1044) and extend Canyon as well as several reservoirs cross the Santa Margarita River. Bridge south on an alignment using El Camino along a ridge above the AWT South construction would be the same as Real to Stuart Mesa Road. Dividing at (Reservoirs 13151, 13154, 24140, 24174, Alternative 1. the junction of Stuart Mesa Road and and 240173). This alternative would Alternative 3. Under this alternative, Las Pulgas Road, one branch would run require two additional pump stations, flood walls would be constructed rather north along Las Pulgas Road to the 43 for a total of five pump stations. than levees. No temporary replacement Area (Las Pulgas). This lateral pipeline Alternative 3. This alternative would bridge would be constructed over the would be approximately 10 to 14 inches be similar to Alternative 1 except it Santa Margarita River. Bridge in diameter and would connect to the would not include the segment on the construction would be the same as Las Pulgas distribution system to link west side of the Santa Margarita River Alternative 1. developments in the Las Pulgas, Las along North River Road and could Alternative 4. This alternative would Flores, and Stuart Mesa areas to the include a 1.0 mile line connecting to be similar to Alternative 3, with the connected northern and southern water reservoir 32911 at 32 Area (Marine Air exception of a construction phase systems. The other branch would Control Squadron-1). temporary use bridge, which would continue along Stuart Mesa Road before Alternative 4. This alternative would allow traffic along Stuart Mesa Road to splitting again into two more branches. be similar in alignment to Alternative 3, continue to cross the Santa Margarita One of these branches would extend with an additional pipe segment from River during demolition of the existing

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bridge and construction of the new Dated: March 25, 2010. SUPPLEMENTARY INFORMATION: bridge. A.M. Vallandingham, Invitation to Comment: We invite you Lieutenant Commander, Judge Advocate to submit comments regarding this Environmental Issues and Resources To Generals Corps, U.S. Navy, Federal Register notice. To ensure that your comments Be Examined Liaison Officer. have maximum effect in developing the The EIS will evaluate the potential [FR Doc. 2010–7183 Filed 3–30–10; 8:45 am] notice of final priorities, requirements, environmental effects associated with BILLING CODE 3810–FF–P definition, and selection criteria, we urge you to identify clearly the specific each of the alternatives. Issues to be proposed priority, requirement, addressed include, but are not limited DEPARTMENT OF EDUCATION definition, or selection criterion that to; geology, topography and soils, each comment addresses. hydrology and water quality, biological Smaller Learning Communities We invite you to assist us in resources, cultural resources, land use, Program complying with the specific visual resources, socioeconomics and requirements of Executive Order 12866 Catalog of Federal Domestic Assistance environmental justice, traffic, air and its overall requirement of reducing quality, noise, public health and safety, (CFDA) Number: 84.215L. AGENCY: Office of Elementary and regulatory burden that might result from services and utilities, and coastal zone Secondary Education, Department of the proposed priorities, requirements, management. Relevant and reasonable Education. definition, and selection criteria. Please measures that could alleviate let us know of any further ways we ACTION: Notice of proposed priorities, environmental effects will be requirements, definition, and selection could reduce potential costs or increase considered. criteria. potential benefits while preserving the effective and efficient administration of Schedule SUMMARY: The Assistant Secretary for the program. Comments on the scope of this EIS Elementary and Secondary Education During and after the comment period, must be received by April 30, 2010. The proposes priorities, requirements, a you may inspect all public comments Department of the Navy will publish a definition, and selection criteria under about this notice in room 3E308, 400 Notice of Availability (NOA) in the the Smaller Learning Communities Maryland Avenue, SW., Washington, DC, between the hours of 8:30 a.m. and Federal Register and local media when (SLC) program. The Assistant Secretary 4:00 p.m., Washington, DC time, the Draft EIS is issued for public review. will use these priorities, requirements, definition, and selection criteria, in Monday through Friday of each week A 45-day public comment period will addition to any other previously except Federal holidays. start upon publication of the NOA in the established priorities and requirements, Assistance to Individuals with Federal Register. The Department of the for a competition using fiscal year (FY) Disabilities in Reviewing the Navy will consider and respond to all 2009 funds and may use them in later Rulemaking Record: On request we will comments received on the Draft EIS years. We take this action to focus provide an appropriate accommodation when preparing the Final EIS. The Federal financial assistance on an or auxiliary aid to an individual with a Department of the Navy expects to issue identified national need. We intend disability who needs assistance to the Final EIS in July 2011, which will these priorities, requirements, review the comments or other be available for a 30-day public definition, and selection criteria to documents in the public rulemaking comment period. The Department of the enhance the effectiveness of SLC record for this notice. If you want to Navy will consider all comments projects in improving academic schedule an appointment for this type of received on the Final EIS in preparing achievement and helping to prepare accommodation or auxiliary aid, please for the Record of Decision. students for postsecondary education contact the person listed under FOR and careers. FURTHER INFORMATION CONTACT. Other Agency Involvement DATES: We must receive your comments Purpose of Program: The SLC program The Department of the Navy will on or before April 30, 2010. awards discretionary grants to local undertake appropriate consultations ADDRESSES: Address all comments about educational agencies (LEAs) to support with regulatory entities pursuant to the the proposed priorities, requirements, the restructuring of large public high schools (i.e., schools with enrollments Endangered Species Act, Clean Water definition, and selection criteria to of 1,000 or more students) into smaller Act, National Historic Preservation Act, Angela Hernandez-Marshall, U.S. Department of Education, 400 Maryland units for the purpose of improving and any other applicable law or academic achievement in large public regulation. Consultation will include Avenue, SW., LBJ, Room 3E308, Washington, DC 20202–6200. high schools. These smaller units but is not limited to the following include freshman academies, multi- Federal, State, and local agencies: U.S. If you prefer to send your comments through the Internet, use the following grade academies organized around Fish and Wildlife Service; National address: career interests or other themes, Oceanic and Atmospheric [email protected]. ‘‘houses’’ in which small groups of Administration Fisheries; State Historic You must include the term ‘‘SLC students remain together throughout Preservation Officer; American Indian Proposed Requirements’’ in the subject high school, and autonomous schools- Tribes; U.S. Army Corps of Engineers; line of your electronic message. within-a-school. These structural U.S. Environmental Protection Agency; FOR FURTHER INFORMATION CONTACT: changes are typically complemented by all local Historic Site Boards and Angela Hernandez-Marshall. Telephone: other personalization strategies, such as Heritage organizations; California (202) 205–1909 or by e-mail: student advisories, family advocate Regional Water Quality Control Board; [email protected]. systems, and mentoring programs. California Coastal Commission; San If you use a telecommunications Program Authority: 20 U.S.C. 7249. Diego Air Pollution Control District; and device for the deaf (TDD), call the Applicable Program Regulations: (a) the County of San Diego, Department of Federal Relay Service (FRS), toll-free, at The Education Department General Environmental Health. 1–800–877–8339. Administrative Regulations (EDGAR) in

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34 CFR parts 75, 77, 79, 80, 81, 82, 84, applications, and promote the equitable common planning time for all teachers 85, 97, 98, and 99. (b) The final priority, distribution of limited SLC grant funds. within a school. Instead, grantees could requirements, definitions, and selection Note: As used in this notice, the terms choose to focus on a single grade level, criteria published in the Federal smaller learning community and large high such as ninth grade, or on particular Register on April 28, 2005 (70 FR school have the meanings assigned to them content areas. 22233) (the 2005 SLC NFP). (c) The in the 2005 SLC NFP. We believe that this proposed priority notice of final priority, requirements, Proposed Priorities: This notice will help enhance the effectiveness of and selection criteria published in the contains two proposed priorities. These SLC projects in improving academic Federal Register on May 18, 2007 (72 proposed priorities would be in achievement and the preparation of FR 28426) (the 2007 SLC NFP). addition to the priority established in students for postsecondary education Background: Creating a more the 2007 SLC NFP (Preparing All and careers by ensuring that students personalized learning experience for Students to Succeed in Postsecondary receive the academic and personal students has been a prominent part of supports they need to achieve. high school improvement efforts in Education and Careers). recent years. Several evaluations have Proposed Priority 1: Common Planning Proposed Priority 1—Common Planning found, generally, that the Time for Teachers Time for Teachers implementation of SLCs and Background: Providing teachers with This proposed priority would support complementary personalization regular and ongoing opportunities for projects that increase the amount of strategies can reduce disruptive structured collaboration and planning time regularly provided to teachers who behavior, create a more orderly during or immediately following the share the same students or teach the environment for learning, and increase school day is considered by many same academic subject for common student attendance and graduation rates researchers and practitioners to be key planning and collaboration during or (Lee and Smith 1995; Wasley et al., to improving instruction and ensuring immediately following the school day 2000; McMullan, Sipe, and Wolf, 1994; that students receive the academic and without decreasing the amount of time Quint, 2006; National Research Council, provided to teachers for individual 2004). Dropout Prevention: A Practice personal supports they need to achieve at high levels. For example, this practice planning and preparation. To meet this Guide, published in 2008 by the priority, the common planning time Institute of Education Sciences’ What is common among many high- performing schools, including, must be used for one or more of the Works Clearinghouse, recommended following activities: that schools implement SLCs and other particularly, those with high concentrations of economically (1) Structured examination of student personalization strategies as part of a work and outcome data. comprehensive approach to reducing disadvantaged or low-achieving (2) Collaborative professional the dropout rate (Institute of Education students (Mass Insight Education and development and coaching, including Sciences, 2008). Research Institute, 2007; Odden, 2007; However, evaluation data have not Dyke, 2008; Herman, et al., 2008; classroom observation. shown that these structural changes and Education Resource Strategies, 2009; (3) Identifying instructional and other personalization strategies, by Perlman and Redding, 2009; Strozier, interventions for struggling students. themselves, improve student academic 2009). In these high-performing schools, (4) Curriculum and assessment achievement and readiness for common planning time is used for a development. variety of activities, including the postsecondary education and careers. Proposed Priority 2: Persistently analysis of student work and outcome Student learning gains have been seen Lowest-Achieving Schools—Secondary data, collaborative professional only in those schools that also have Schools made considerable changes in development and instructional curriculum and instruction (Bernstein, coaching, and developing or Background: The Secretary has et al., 2005; Kahne, Sporte, et al., 2006; coordinating the implementation of established a goal of turning around, Quint, 2006; Rhodes, Smerdon, 2005). curricula and assessments. By providing over the next five years, the 5,000 Similarly, some large comprehensive teachers with regular and ongoing lowest-achieving schools nationwide as high schools that have not implemented opportunities for collaboration, these part of a comprehensive strategy for SLCs have significantly increased schools also promote a strong sense of dramatically reducing the drop-out rate, student achievement in reading or shared responsibility among teachers for improving high school graduation rates, mathematics and narrowed achievement improving student academic and increasing the number of students gaps by implementing more rigorous achievement (Louis and Marks, 1998; who graduate prepared for success in courses, providing extra support to Symonds, 2004; Mass Insight Education college and the workplace. struggling students, and systematically and Research Institute, 2007; Silva, The SLC program can be an important using data to improve instruction (ACT, 2009). source of funding to support turnaround Inc. and the Education Trust, 2005; For these reasons, we propose a efforts in a State’s persistently lowest- Billig, Jaime, et al., 2005; National priority to allow grantees to use SLC achieving high schools. For this reason, Center for Educational Accountability, funds to pay the necessary personnel we propose to establish a priority for 2005; Robinson, et al., 2005). and other costs associated with SLC projects that include one or more For these reasons, we are proposing increasing common planning time for schools that have been identified by a priorities and selection criteria that are teachers. Under the proposed priority, State as a persistently lowest-achieving specifically intended to promote the applicants could, for example, propose school. close integration of SLC implementation to use grant funds to hire additional Proposed Priority 2—Persistently with systematic efforts to improve teachers, pay substitute teachers, or Lowest-Achieving Schools—Secondary curriculum and instruction. We also extend the school day in order to Schools propose certain other requirements and provide teachers with more time for a definition to clarify statutory common planning and collaboration. This proposed priority would support provisions, improve the management of Under the proposed priority, we SLC projects that include one or more grant activities, facilitate the review of would not require that grantees increase schools that have been identified by a

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State as a persistently lowest-achieving Proposed Requirement 1—Budget and of the project as described in its school. Performance Periods approved application. For the purpose of this priority, the In its application, the applicant must term ‘‘persistently lowest-achieving Background: In the 2007 SLC NFP, we provide detailed, yearly budget school’’ is defined as it is under the established a requirement pursuant to information for the total grant period Department’s State Fiscal Stabilization which SLC grant funds were awarded in requested. two increments over a 60-month Fund Program (see 74 FR 58436, 58487), Proposed Requirement 2—Maximum School Improvement Grants (see 74 FR performance period: An initial award for the first 36 months of the Award Amounts and Number of 65618, 65652), and Race to the Top Schools Fund (see 74 FR 59836, 59840). performance period and a continuation Background: In order to ensure that Types of Priorities: award for the remaining 24 months of the performance period. Through this applicants have sufficient funding for When inviting applications for a Proposed Budget and Performance the personnel expenditures likely competition using one or more Periods requirement, we would reduce needed to meet the requirements of priorities, we designate the type of each the duration of the initial award from 36 Proposed Priority 1—Common Planning priority as absolute, competitive to 24 months and make continuation Time for Teachers (i.e., increasing the preference, or invitational through a awards annually thereafter. We propose amount of time that teachers are notice in the Federal Register. The this change because making the initial provided regularly for common effect of each type of priority follows: award for a period of 24 months would planning and collaboration), we are Absolute priority: Under an absolute give grantees until the end of the second proposing to increase the maximum, 60- priority, we consider only applications school year after the award is made (i.e., month award amounts per school by that meet the priority (34 CFR the 2011–12 school year) to implement $750,000. Based on our informal 75.105(c)(3)). all or most of the components of their consultations with LEA and school Competitive preference priority: projects and demonstrate substantial officials in different parts of the country, Under a competitive preference priority, progress. As we do not expect to make we believe that this additional $750,000 we give competitive preference to an new awards until after the start of the should be sufficient to support a application by either (1) awarding 2010–2011 school year, we recognize significant increase in common additional points, depending on the that grantees likely will need more than planning time for teachers in at least extent to which the application meets 12 months to implement their projects one grade level of the school. In addition, we are proposing to the competitive priority (34 CFR fully and demonstrate substantial reduce the number of schools that an 75.105(c)(2)(i)); or (2) selecting an progress. Further, we propose the LEA may apply on behalf of in a single application that meets the priority over change to 24 months, based on our application from eight to five because, an application of comparable merit that belief that, an SLC grantee that requires in the past, many grantees have does not meet the priority (34 CFR more than an initial 24 months to show experienced great difficulties managing 75.105(c)(2)(ii)). progress is likely experiencing and overseeing project activities at more Invitational priority: Under an significant management problems and than five schools. In such cases, invitational priority we are particularly may not merit continued funding. For implementation progress has been slow interested in applications that meet the similar reasons, we are proposing to and uneven and several grantees invitational priority. However, we do make continuation awards annually decided to remove one or more schools not give an application that meets the after this initial 24 month budget from their grants. priority a preference over other period. SLC grantees should be able to applications (34 CFR 75.105(c)(1)). Finally, through this requirement, we demonstrate each year that they are are proposing that applications Proposed Requirements: The continuing to make substantial progress requesting more funds than the Assistant Secretary for Elementary and in implementing their projects. In maximum amounts specified for any Secondary Education proposes the addition, making continuation awards school or for the total grant will not be following requirements for this program. on an annual basis will better ensure read as part of the regular application We may apply these requirements in that SLC grantees do not receive more process. In previous SLC competitions, any year in which this program is in funds than they are able to expend to some applicants requested more funds effect. implement their projects. For a variety than the amount that we indicated Note: These proposed requirements would of reasons, some SLC grantees have been would be available for a grant. These be in addition to the application unable to expend all of the funds they applications included activities that requirements required under title V, part D, requested at the time they submitted could only be implemented if the subpart 4, section 5441(b) of the ESEA, and their applications. As a result, a number applicants received a funding amount the following requirements established in the of SLC grantees have returned 2005 SLC NFP and the 2007 SLC NFP: that exceeded the maximum amount significant amounts of funds to the specified by the Department. This United States Treasury when their strategy put at a competitive Requirement Notice grants have ended. disadvantage other applicants that Consortium Applica- 2005 SLC NFP. Proposed Budget and Performance requested funds within the tions and Edu- Periods: Grantees will be awarded Department’s specified funding range cational Service implementation grants for a period up to and proposed a less extensive set of Agencies. 60 months, with the initial award to activities. For this reason, we propose to Student Placement .... 2005 SLC NFP. provide funding for the first 24 months review only those applications that Including All Students 2005 SLC NFP. of the performance period. Funding for request an amount that does not exceed Indirect Costs ...... 2007 SLC NFP. the remainder of the performance period the maximum amounts specified for the Required Meetings 2007 SLC NFP. will be made annually, contingent on grants. Sponsored by the the availability of funds and each Proposed Maximum Award Amounts Department. Previous Grantees .... 2007 SLC NFP. grantee’s substantial progress toward and Number of Schools: An eligible accomplishing the goals and objectives LEA may receive, on behalf of a single

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school, up to $2,500,000 of SLC grant included in the 2007 SLC NFP). These annual performance objectives to be funds, depending upon student are the same indicators used by States used for each of these indicators. enrollment in the school, for the entire to measure the progress of LEAs and Specifically, each applicant must use 60-month project period. high schools under Part A of Title I of the following performance indicators to The following chart provides the the ESEA. We propose that performance measure the progress of each school ranges of awards per high school size: objectives for these indicators equal or included in its application: exceed the annual measurable objectives (a) The percentage of students who SLC GRANT AWARD RANGES established by the State in its approved score at or above the proficient level on accountability plan for Part A of Title I the reading/language arts and Student enroll- Award ranges per school of the ESEA. Because school-level data mathematics assessments used by the ment for these indicators are now available to State to determine whether a school has 1,000–2,000 the Department through using the EDEN made adequate yearly progress under Students ...... $1,750,000–$2,000,000 Submission System (ESS), it is Part A of Title I of the ESEA, as well as 2,001–3,000 unnecessary for the Department to these percentages disaggregated by Students ...... 1,750,000–2,250,000 continue to collect them directly from subject matter and the following 3,001 and Up .... 1,750,000–2,500,000 grantees. subgroups: We also propose to continue (1) Major racial and ethnic groups. An LEA may include up to five measuring the extent to which the (2) Students with disabilities. schools in a single application for a SLC graduates of each school included in an (3) Students with limited English grant. Therefore, an LEA applying on SLC grant enter postsecondary proficiency. behalf of a group of eligible schools education in the semester following (4) Economically disadvantaged would be able to receive up to high school graduation. Because students. $12,500,000 for its SLC grant. enrolling in postsecondary education is (b) The school’s graduation rate, as Applications requesting more funds a nearly universal aspiration among defined in the State’s approved than the maximum amounts specified high school students and their parents, accountability plan for Part A of Title I for any school or for the total grant will we believe that this measurement of the ESEA, as well as the graduation not be read as part of the regular continues to be useful and we believe rates for the following subgroups: application process. However, if, after that grantees should be held (1) Major racial and ethnic groups. the Secretary selects applications to be (2) Students with disabilities; accountable for helping them achieve (3) Students with limited English funded, it appears that additional funds this goal. We propose that performance remain available, the Secretary has the proficiency; and objectives for this indicator exceed the (4) Economically disadvantaged option of reviewing applications that baseline level of performance and give students; and requested funds exceeding the particular emphasis to narrowing any (c) The percentage of all graduates maximum amounts specified. Under gaps between students in general and who enroll in postsecondary education this requirement, if the Secretary economically disadvantaged students, in the semester following high school chooses to fund any of the additional students from major racial and ethnic graduation, as well as the percentage applications, selected applicants will be groups, students with disabilities, and disaggregated by the following required to work with the Department to students with limited English subgroups: revise their proposed budgets to fit proficiency. Because data for this (1) Major racial and ethnic groups. within the appropriate funding range. indicator are not reported by SEAs (2) Students with disabilities. Proposed Requirement 3—Performance through ESS (an electronic system that (3) Students with limited English Indicators facilitates the efficient and timely proficiency. transmission of data from SEAs to the (4) Economically disadvantaged Background: While creating SLCs can Department), we propose to continue to students. appeal to teachers, students, and parents require grantees to provide these data on Each applicant must identify in its for many reasons, their fundamental an annual basis. We further propose to application its performance objectives purpose is to improve academic require grantees to use administrative for each of these indicators for each year achievement and student success after records that document student of the project period and provide high school. Therefore, it is important enrollment in postsecondary education baseline data for the third indicator that assistance provided under the SLC as the principal source of data for this (postsecondary enrollment). The program support and enhance the efforts indicator because these data are likely to Department will obtain baseline data for of LEAs and schools to improve student be more accurate and less costly to the first and second performance academic achievement and preparation obtain than information gathered indicators (student performance on for and enrollment in postsecondary through student and parent surveys. reading/language arts and mathematics education. Because these administrative records assessments and the graduation rate) In order to ensure that SLC projects may not provide data on all of a school’s and data on the extent to which each ultimately achieve these important graduates (e.g., in the case of most State school included in a grant achieves its outcomes, we must ensure that each longitudinal databases, students who annual performance objectives for each funded SLC project measures its enroll in postsecondary education in year of the project period from the data progress in improving student academic another State), we propose to permit that are now reported to the Department achievement and related outcomes. For grantees to supplement the data by SEAs using the EDEN Submission this reason, we propose to continue to obtained from administrative records System (ESS). Grantees are not required measure the progress of grantees using with information gathered through to provide these data. two indicators: (1) Student performance surveys that are administered after high Each grantee must report to the on reading/language arts and school graduation. Department annually on the extent to mathematics assessments and (2) high Proposed Performance Indicators: which each school in its grant achieves school graduation rates (these two Each applicant must identify in its its performance objectives for the third indicators are reflected in paragraphs (1) application the following specific proposed indicator (postsecondary and (2) of the Performance Indicators performance indicators as well as the enrollment).

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Finally, grantees must use applications from LEAs applying on grantees have not chosen to commission administrative records maintained by behalf of schools that are being evaluations that provide them with State, national, or regional entities that constructed and do not have an active useful implementation information or already collect data on student student enrollment at the time of have not used the information provided enrollment in postsecondary education application. LEAs may apply on behalf by these evaluations to improve their as the principal source of data for this of no more than five schools. Along management of their projects. Instead, performance indicator. These with its application, each applicant many grantees have commissioned administrative records include, for must provide, for each school included evaluations chiefly to comply with our example, data available through State in its application: requirement. Given the often longitudinal databases or other sources. (a) The school’s name, postal mailing considerable cost of these evaluations Grantees may supplement these records address, and the 12-digit identification and their limited usefulness to grantees, with data collected through surveys number assigned the school by the we believe it would be prudent to cease administered to students or parents after National Center for Education Statistics; to require grantees to commission them. graduation. and A grantee may still choose to use grant (b) Evidence that, during the current funds to support a project evaluation if Proposed Requirement 4—School school year or the most recently Report Cards the evaluation is related clearly to the completed school year, the school is a goals of the project and necessary for the Background: In the 2005 SLC NFP, we large public high school (i.e., an entity proper and efficient performance and established a requirement for the SLC that includes grades 11 and 12 and has administration of the grant award. program pursuant to which applicants an enrollment of 1,000 or more students Proposed Evaluation Requirement: were required to include school report in grades 9 and above (see Definitions in We propose to eliminate the cards with their applications to verify 2005 SLC NFP) and, thus, is eligible to requirement established by the 2005 the accuracy of the student achievement receive assistance under this program. SLC NFP that each applicant provide they reported. This requirement created To meet this requirement, the assurances that it will support an a significant paperwork burden for enrollment figures provided in the evaluation of the project that will many applicants because, in some States evidence must be based upon data from produce an annual report for each year and LEAs, school report cards are the current school year or the most of the performance period. expansive, extending over 10 to 20 recently completed school year. In pages. With school-level student addition, this evidence must include a Proposed Requirement 7—Grant Award achievement data now available to the copy of either: Administration Department through ESS, it is no longer (a) The form or report that the LEA Background: The responsibilities of a necessary to require applicants to submits to the SEA to report the project director for an SLC grant include provide school report cards to verify the school’s student enrollment (or student coordinating grant activities to ensure accuracy of the student achievement membership, as it is sometimes that they are carried out on time and data they report in their applications. described) on or around October 1 of Proposed School Report Cards each year. within budget, overseeing the fiscal Requirement: No applicant is required (b) A document provided by the SEA management of the project, and to include in its application any report that identifies the school’s enrollment fulfilling performance reporting and card for the schools included in its on or around October 1 of each year. other requirements established by the application. Department. We propose to establish a Proposed Requirement 6—Evaluation minimum time commitment for this Proposed Requirement 5—Evidence of Background: In the 2005 SLC NFP, we position to ensure that the project Eligibility established requirements that each SLC director has sufficient time to carry out Background: We propose to require grantee support an independent, these responsibilities. In our experience, each applicant to provide, along with its formative evaluation of its project that many of the grants in which the time application, the name of, and other reported its findings to the grantee (i.e., commitment of the project director was identifying information about, each its LEA) on not less than an annual less than the minimum we are school included in its application and basis. Each grantee was required to proposing have experienced significant evidence of each such school’s provide each annual evaluation report implementation delays. In some cases, enrollment during the current or most to the Department at the same time it these grant recipients were unable to recently completed school year. This reported annually on its progress in implement key elements of their information is necessary so that the implementing its project. The purpose approved applications. We note that Department can verify that each of the of this requirement was to provide the under our proposal, applicants could schools in the applicant’s application project director and other LEA and continue to include the salary and other meets the program’s eligibility school personnel information that costs of the project director in their requirements. We propose to require would be useful in gauging the project’s proposed budgets. that evidence of enrollment consist of progress and identifying areas for Proposed Grant Award information reported by the LEA to the improvement. The Department also Administration: Grantees must SEA or produced by the SEA so that provided grantees with technical designate a single project director who there is no ambiguity for applicants assistance materials to help them secure will be principally responsible for about the evidence that they must qualified evaluators and evaluations overseeing the implementation of the submit to establish school eligibility. that would produce information to more proposed project and communicating Proposed Evidence of Eligibility effectively manage their projects. After with the Department. Requirement: LEAs, including schools carefully reviewing the annual Each grantee must ensure that its funded by the Bureau of Indian evaluation reports that have been designated project director—for a grant Education and educational service submitted by grantees since FY 2006, that includes one school—be not less agencies, applying on behalf of large we have concluded that, generally, this than fifty percent of a full-time public high schools, are eligible to apply requirement has not achieved its equivalent (FTE) position and that the for a grant. We will not accept intended purpose. For the most part, time commitment of a project director

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for a grant that includes more than one $500. It includes, but is not limited to, postsecondary education and careers school be not less than one FTE. office equipment and furnishings, without need for remediation; modular offices, telephone networks, (3) Helping students who enter high Proposed Requirement 8—Use of Funds information technology equipment and school with reading/English language for Equipment systems, air conditioning equipment, arts or mathematics skills that are Background: While we recognize that reproduction and printing equipment, significantly below grade-level to ‘‘catch equipment can be an effective tool for and motor vehicles. up’’ and attain, maintain and exceed enhancing instruction and improving Proposed Selection Criteria: proficiency by providing supplemental student achievement and is essential to The Assistant Secretary for instruction and supports to these carrying out a variety of administrative Elementary and Secondary Education students during the ninth grade and, to activities, numerous other sources of proposes the following selection criteria the extent necessary, in later grades; funds are available to LEAs and schools for evaluating an application under this (4) Increasing the amount of time to acquire equipment. We, therefore, program. We may apply one or more of regularly provided to teachers for propose to limit the use of SLC grant these criteria in any year in which this common planning and collaboration funds for the purchase or use of program is in effect. These proposed during or immediately following the equipment in order to focus grant funds selection criteria are intended to replace school day, without decreasing the on the personnel, technical assistance, the selection criteria established for the amount of time provided to teachers for professional development and other SLC program in the 2005 SLC NFP and individual planning and preparation; costs related to implementing the 2007 SLC NFP. (5) Ensuring, through technical significant structural and instructional In the notice inviting applications or assistance, professional development, reforms that will improve student the application package or both we will and other means, that teachers use academic achievement and preparation announce the maximum possible points opportunities for common planning and for postsecondary education. assigned to each criterion. collaboration effectively to improve Proposed Use of Funds for Equipment (a) Quality of the Project Design. In instruction and student academic Requirement: For each budget period of determining the quality of the design of achievement; the grant award, a grantee may not use the proposed project, we will consider (6) Increasing the participation of more than one percent of the total grant the extent to which— students, particularly low-income award for the acquisition of equipment (1) Teachers, school administrators, students, in Advanced Placement, (as that term is defined in this notice). parents, and community stakeholders International Baccalaureate, or dual Proposed Definition: support the proposed project and have credit courses (such as dual enrollment Background: We are proposing to been and will continue to be involved or early college programs) that offer define the term equipment because we in its development and implementation; students the opportunity to earn propose to limit the use of SLC grant (2) The applicant has carried out simultaneously both high school and funds for the purchase of equipment sufficient planning and preparatory college credit; and elsewhere in this notice. Under Office of activities to enable it to implement the (7) Increasing the percentage of Management and Budget Circular A–87, proposed project during the school year students who enter postsecondary Cost Principles for State, Local, and in which the grant award will be made; education in the semester following Indian Tribal Governments, an item is (3) School administrators, teachers, high school graduation by delivering considered to be ‘‘equipment’’ if, among and other school employees will receive comprehensive guidance and academic other things, it is nonexpendable, effective, ongoing technical assistance advising to students and their parents tangible personal property having a and professional development in that includes assistance in selecting useful life of more than one year and implementing structural and courses and planning a program of has an acquisition cost which equals or instructional reforms and providing study that will provide the academic exceeds the lesser of the capitalization effective instruction; and preparation needed to succeed in level established by the governmental (4) The applicant demonstrates that postsecondary education, early and unit for financial statement purposes, or the proposed project is aligned with and ongoing college awareness and planning $5,000. We are proposing to reduce the advances a coordinated, district-wide activities, and help in identifying and acquisition cost threshold to the lesser strategy to improve student academic applying for financial aid for of the capitalization level established by achievement and preparation for postsecondary education. the governmental unit for financial postsecondary education and careers (c) Support for Implementation. In statement purposes or $500 in order to without need for remediation. determining the adequacy of the support include laptop and desktop computers, (b) Quality of Project Services. In the applicant will provide for printers, and other office and classroom determining the quality of the services implementation of the proposed project, equipment that some SLC grantees have to be provided by the proposed project, we will consider the extent to which— sought to purchase with grant funds. we will consider the extent to which the (1) The management plan is likely to Proposed Definition: proposed project is likely to be effective achieve the objectives of the proposed In addition to the definitions set out in— project on time and within budget and in the authorizing statute, 34 CFR 77.1, (1) Creating an environment in which includes clearly defined responsibilities and the 2005 SLC NFP, we propose that multiple teachers and other adults and detailed timelines and milestones the following definition also apply to within the school know the needs, for accomplishing project tasks; and this program: interests, and aspirations of each (2) The project director and other key Equipment means an article of student well, closely monitor each personnel are qualified and have nonexpendable, tangible personal student’s progress, and provide the sufficient authority to carry out their property that has a useful life of more academic and other support each responsibilities, and their time than one year and that has an student needs to succeed; commitments are appropriate and acquisition cost which equals or (2) Equipping all students with the adequate to implement the SLC project exceeds the lesser of the capitalization reading/English language arts, effectively. level established by the governmental mathematics, and science knowledge (d) Need for the Project. In unit for financial statement purposes, or and skills they need to succeed in determining the need for the proposed

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project, we will consider the extent to Paperwork Reduction Act of 1995 ACTION: Notice and request for public which the applicant has identified (PRA) comment on Proposed Information specific gaps and weaknesses in the Quality Guidelines Policy. Certain sections of the proposed preparation of all students for priorities, requirements, definition, and postsecondary education and careers SUMMARY: The U.S. Election Assistance selection criteria for the SLC grant without need for remediation, the Commission (EAC) seeks public program contain changes to information nature and magnitude of those gaps and comment on the Proposed Information collection requirements already weaknesses, and the extent to which the Quality Guidelines policy. The policy approved by the Office of Management proposed project will address those gaps outlines the EAC’s directives and and Budget (OMB) under OMB control and weaknesses effectively. required procedures to implement the number 1810–0676 (1890–0001). We OMB Guidelines for Ensuring and Final Priorities, Requirements, will be publishing a separate notice in Maximizing the Quality, Objectivity, Definition, and Selection Criteria the Federal Register requesting Utility, and Integrity of Information comments on these changes. Disseminated by Federal Agencies, 67 We will announce the final priorities, Intergovernmental Review: This FR 8452 (‘‘OMB Guidelines’’). The EAC requirements, definition, and selection program is subject to Executive Order developed the Proposed Information criteria in a notice in the Federal 12372 and the regulations in 34 CFR Quality Guidelines to meet its Register. We will determine the final part 79. One of the objectives of the obligations under the OMB Guidelines priorities, requirements, definitions, and Executive order is to foster an and to codify its high standards of selection criteria after considering intergovernmental partnership and a quality in the production of information responses to this notice and other strengthened federalism. The Executive disseminated outside the agency. information available to the Department. order relies on processes developed by DATES: Written comments must be This notice does not preclude us from State and local governments for proposing additional priorities, submitted on or before 4 p.m. EDT on coordination and review of proposed April 30, 2010. requirements, definitions, and selection Federal financial assistance. criteria, subject to meeting applicable Comments: Public comments are rulemaking requirements. This document provides early invited on the information contained in notification of our specific plans and the policy. Comments on the proposed Note: This notice does not solicit actions for this program. policy should be submitted applications. In any year in which we choose Accessible Format: Individuals with electronically to [email protected]. to use one or more of these priorities, Written comments on the proposed requirements, definition, and selection disabilities can obtain this document in criteria, we invite applications through a accessible format (e.g., braille, large policy can also be sent to the U.S. notice in the Federal Register. print, audiotape, or computer diskette) Election Assistance Commission, 1201 on request to the program contact New York Avenue, NW., Suite 300, Executive Order 12866: This notice person listed under FOR FURTHER Washington, DC 20005, ATTN: has been reviewed in accordance with INFORMATION CONTACT. Proposed Information Quality Executive Order 12866. Under the terms Electronic Access to This Document: Guidelines Policy. of the order, we have assessed the You can view this document, as well as Obtaining a Copy of the Policy: To potential costs and benefits of this all other documents of this Department obtain a free copy of the policy: (1) regulatory action. published in the Federal Register, in Access the EAC Website at http:// The potential costs associated with text or Adobe Portable Document www.eac.gov; (2) write to the EAC this proposed regulatory action are Format (PDF) on the Internet at the (including your address and phone those resulting from statutory following site: http://www.ed.gov/news/ number) at U.S. Election Assistance requirements and those we have fedregister. To use PDF you must have Commission, 1201 New York Avenue, determined as necessary for Adobe Acrobat Reader, which is NW., Suite 300, Washington, DC 20005, administering this program effectively available free at this site. ATTN: Information Quality Guidelines. and efficiently. Note: The official version of this document FOR FURTHER INFORMATION CONTACT: Ms. Tamar Nedzar, Ms. Karen Lynn-Dyson In assessing the potential costs and is the document published in the Federal or Ms. Shelly Anderson at (202) 566– benefits—both quantitative and Register. Free Internet access to the official edition of the Federal Register and the Code 3100. qualitative—of this proposed regulatory of Federal Regulations is available on GPO action, we have determined that the Access at: http://www.gpoaccess.gov/nara/ Thomas R. Wilkey, benefits of the proposed priorities, index.html. Executive Director, U.S. Election Assistance requirements, definition, and selection Commission. criteria justify the costs. Dated: March 26, 2010. [FR Doc. 2010–7134 Filed 3–30–10; 8:45 am] We have determined, also, that this Thelma Mele´ndez de Santa Ana, BILLING CODE 6820–KF–P regulatory action does not unduly Assistant Secretary for Elementary and interfere with State, local, and tribal Secondary Education. governments in the exercise of their [FR Doc. 2010–7255 Filed 3–30–10; 8:45 am] ELECTION ASSISTANCE COMMISSION governmental functions. BILLING CODE 4000–01–P Notice: Request for Substantive Discussion of Costs and Benefits: Comments on the EAC’s Proposed Elsewhere in this notice we discuss the Requirements for the Testing of Pilot potential costs and benefits, both ELECTION ASSISTANCE COMMISSION Voting Systems To Serve UOCAVA quantitative and qualitative, of the Voters proposed priorities, requirements, Proposed Information Quality AGENCY: definition, and selection criteria under Guidelines Policy United States Election the background sections to the Assistance Commission. Priorities, Requirements, Definition, and AGENCY: U.S. Election Assistance ACTION: Request for public comment on Selection Criteria. Commission (EAC). proposed requirements for the testing of

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pilot voting systems to be used to serve Since there was not sufficient time to NDAA. The TGDC has been tasked to UOCAVA voters. define and implement a large project for consider the full range of remote voting 2002, the project was planned for architectures, including instances where SUMMARY: The U.S. Election Assistance implementation for the November 2004 the voter can use his own personal Commission (EAC) is publishing for election. Seven states agreed to computer for voting. The pilot testing public comment a set of proposed participate and worked with FVAP to requirements, that the EAC is currently requirements for the testing of pilot develop system requirements and developing, will be provided to the voting systems to be used by operating procedures. However, the TGDC as the basis and starting point for jurisdictions to serve Uniformed and Secure Electronic Registration and their research and deliberations. Overseas voters. Voting Experiment (SERVE) was Project Summary: Since 2008, several SUPPLEMENTARY INFORMATION: cancelled before it was deployed due to states have enacted legislation enabling Background: The Uniformed and concerns raised by several computer them to conduct electronic voting Overseas Citizens Absentee Voting Act scientists. These individuals contended projects for UOCAVA voters, beginning (UOCAVA) of 1986 protects the right to that the use of personal computers over with the 2010 elections. To be prepared vote in Federal elections for this defined the Internet could not be made secure to support the states with these projects, category of citizens. UOCAVA sets out enough for voting and consequently in July 2009 the EAC convened a federal and state responsibilities to called for the project to be terminated. UOCAVA Working Group to consider assist these voters in exercising their The Department of Defense, citing a lack how to adapt the EAC’s Testing and voting rights. The Secretary of Defense of public confidence in the SERVE Certification Program to accommodate is the presidential designee responsible system, decided the project could not UOCAVA pilot systems. It was for the Federal functions of the Act. The continue under these circumstances. concluded that two products were Federal Voting Assistance Program In response to this development, the needed: (1) A modified set of system (FVAP) administers this law on behalf Fiscal Year 2005 National Defense testing requirements; and (2) a revised of the Secretary of Defense and works Authorization Act (section 567 of Pub. testing and certification process. It was cooperatively with other Federal L. 108–375;118 Stat. 119) repealed the determined that a working group would agencies and state and local election requirement for the Secretary of Defense assist the EAC in drafting the testing officials to carry out its provisions. to conduct an electronic voting requirements and EAC staff would adapt demonstration project ‘‘until the first the certification process to UOCAVA legislation was enacted regularly scheduled general election for accommodate the UOCAVA pilot before the advent of today’s global federal office which occurs after the program. electronic communications technology. Election Assistance Commission (EAC) The EAC UOCAVA Working Group Consequently it relied on U.S. domestic notifies the Secretary that the has taken much the same approach as and military mail systems as well as Commission has established electronic the state pilot project working groups. foreign postal systems for the absentee voting guidelines and certifies The source materials drawn on for this worldwide distribution of election that it will assist the Secretary in effort included: the Voluntary Voting materials. By the mid-1990s it became carrying out the project’’. Pursuant to System Guidelines (VVSG) 1.0 ; the apparent that the mail transit time and this legislation, in September 2005, the VVSG 1.1; the VVSG 2.0; the VOI, unreliable delivery posed significant EAC requested its voting system SERVE; FIPS; and NIST Special barriers for many UOCAVA citizens, advisory group, the Technical Publications. One significant difference preventing them from successfully Guidelines Development Committee in the EAC Working Group approach exercising their right to vote. At the (TGDC), to add this subject on their was the technology scope covered by same time the Internet was being widely research agenda; however the request the requirements. The VOI, SERVE and adopted by businesses, governments was declined. Okaloosa system requirements were and the general public. Therefore it was Since that time legislation dealing tailored specifically for the particular a natural development for FVAP and with a number of UOCAVA voting system implementations developed for states to consider the potential of the issues were under consideration by those projects. However, since many Internet as an alternative to the ‘‘by- Congress. Ultimately, passed as part of different types of remote voting systems mail’’ UOCAVA process. the Fiscal Year 2010 National Defense could be submitted to the EAC FVAP sponsored Voting Over the Authorization Act (NDAA) (section 581 certification program, the EAC Working Internet (VOI), a small pilot project for of Pub. L. 111–84), the Military and Group defined generic system the November 2000 general election, to Overseas Voters Empowerment Act requirements to provide for system examine the feasibility of using Internet contains a provision allowing the design flexibility. technology. Four states participated in Secretary of Defense to establish one or Pilot projects are small in scale and this experiment, which enabled voters more pilot programs to test the short in duration. Consequently, to use their own personal computers to feasibility of new election technology certification for pilot systems needs to securely register to vote, request and for UOCAVA voters. This provision be quicker and less expensive than the receive absentee ballots, and return their requires the EAC and the National regular process currently used for voted ballots. Following the successful Institute of Standards and Technology conventional systems with an expected completion of the VOI project, in the (NIST) to provide best practices or life of more than 10 years. Nevertheless, Fiscal Year 2002 National Defense standards to support these pilot since actual votes will be cast using the Authorization Act (section 1604 of Pub. programs, ‘‘in accordance with voting systems utilized in the pilot L. 107–107:115 Stat. 1277), Congress electronic absentee voting guidelines project, the certification process must instructed the Secretary of Defense to established under’’ the earlier FY2005 retain sufficient rigor to provide carry out a larger demonstration project NDAA. In December 2009, the EAC reasonable assurance that the pilot for the November 2002 general election. directed the TGDC to begin this work as systems will operate correctly and This project was to be ‘‘carried out with a top research priority. The EAC expects securely. participation of sufficient numbers of this work to result in the comprehensive There is a fundamental dichotomy in absent uniformed services voters so that set of remote electronic voting system complexity in remote voting the results are statistically significant’’. guidelines as mandated by the FY2005 architectures: those where the voting

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platform is controlled (e.g., provided by http://www.eac.gov. This publication original and eight copies should be the election jurisdiction); and those and request for comment is not required mailed to: Kimberly D. Bose, Secretary, where it is not controlled (e.g., the voter under the rulemaking, adjudicative, or Federal Energy Regulatory Commission, uses his own personal computer). Since licensing provisions of the 888 First Street, NE., Washington, DC the EAC plans to have the pilot Administrative Procedures Act (APA). It 20426. For more information on how to certification process ready for is a voluntary effort by the EAC to submit these types of filings please go implementation during the first half of gather input from the public on the to the Commission’s Web site located at 2010, it was decided that the EAC EAC’s administrative procedures for http://www.ferc.gov/filing- would focus its efforts on controlled certifying voting systems to be used in comments.asp. More information about platform architectures servicing pilot projects. Furthermore, this request this project can be viewed or printed on multiple jurisdictions. This is a highly by the EAC for public comment is not the eLibrary link of the Commission’s secure remote voting solution and the intended to make any of the APA’s Web site at http://www.ferc.gov/docs- Okaloosa Project provides an rulemaking provisions applicable to filing/elibrary.asp. Enter the docket implementation example for reference. development of this or future EAC number (P–11910–004) in the docket Defining requirements for this class of procedural programs. number field to access the document. system architecture was determined to An electronic copy of the proposed For assistance, call toll-free 1–866–208– provide a reasonable test case that could guidance may be found on the EAC’s 3372. be completed within the available Web site at http://www.eac.gov. Kimberly D. Bose, timeframe. In addition, most of the core FOR FURTHER INFORMATION CONTACT: system processing functions are the Matthew Masterson, Phone (202) 566– Secretary. same for both types of architectures, so 3100, e-mail votingsystemguidelines@ [FR Doc. 2010–7143 Filed 3–30–10; 8:45 am] a substantial number of requirements eac.gov. BILLING CODE 6717–01–P will carry over as this work is expanded to include other methods of remote Alice Miller, electronic voting. Chief Operating Officer, U.S. Election DEPARTMENT OF ENERGY The UOCAVA Pilot requirements Assistance Commission. [FR Doc. 2010–7199 Filed 3–30–10; 8:45 am] Federal Energy Regulatory document contains testable Commission requirements for the following areas: BILLING CODE 6820–KF–P (1) Functional Requirements. [Project No. 1494–384] (2) Usability. (3) Software. DEPARTMENT OF ENERGY Grand River Dam Authority; Notice of (4) Security. Application for Amendment of License (5) Quality Assurance. Federal Energy Regulatory and Soliciting Comments, Motions To (6) Configuration Management. Commission Intervene, and Protests (7) Technical Data Package. [ Project No. 11910–004] March 24, 2010. (8) Systems Users Manual. Take notice that the following Symbiotics, LLC; AG Hydro, LLC; DATES: Comments must be received on hydroelectric application has been filed Notice of Application for Transfer of or before 4 p.m. EST on April 15, 2010. with the Commission and is available License, and Soliciting Comments and Submission of Comments: The public for public inspection: Motions To Intervene may submit comments through one of a. Application Type: Non-project use the two different methods provided by March 24, 2010. of project lands and waters. the EAC: (1) e-mail submissions to On March 8, 2010, Symbiotics, LLC b. Project No: 1494–384. [email protected]; (2) by (transferor) and AG Hydro, LLC c. Date Filed: March 11, 2010, mail to Voluntary Voting System (transferee) filed an application for supplemented on March 17, 2010. Guidelines Comments, U.S. Election transfer of license of the Applegate Dam d. Applicant: Grand River Dam Assistance Commission, 1201 New York Project, located on the Applegate River Authority. Ave., NW., Suite 300, Washington, DC in Jackson County, Oregon. e. Name of Project: Pensacola Project. 20005. Applicants seek Commission approval f. Location: The proposed non-project In order to allow efficient and to transfer the license for the Applegate use is located on Grand Lake O’ the effective review of comments the EAC Dam from the transferor to the Cherokees in Delaware County, requests that: transferee. Oklahoma. (1) Comments refer to the specific Applicant Contact: For both the g. Filed Pursuant to: Federal Power section that is the subject of the transferor and transferee is Mr. Brent Act, 16 U.S.C. 791a–825r. comment. Smith, 4110 East 300 North, P.O. Box h. Applicant Contact: Ms. Tamara E. (2) General comments regarding the 535, Rigby, ID 83442, phone (208) 745– Jahnke, Assistant General Council, entire document or comments that refer 0834. Grand Dam River Authority, P.O. Box to more than one section be made as FERC Contact: Robert Bell, (202) 502– 409, Vinita, Oklahoma 74301, (918) specifically as possible so that EAC can 6062. 256–5545. clearly understand to which portion(s) Deadline for filing comments and i. FERC Contact: Any questions on of the documents the comment refers. motions to intervene: 30 days from the this notice should be addressed to (3) To the extent that a comment issuance of this notice. Comments and Shana High at (202) 502–8674. suggests a change in the wording of a motions to intervene may be filed j. Deadline for filing comments, requirement or section of the guidelines, electronically via the Internet. See 18 motions to intervene, and protest: April please provide proposed language for CFR 385.2001(a)(1)(iii)(2008) and the 26, 2010. the suggested change. instructions on the Commission’s Web Comments, Motions to Intervene, and All comments submitted will be site under the ‘‘e-Filing’’ link. If unable Protests may be filed electronically via published at the end of the comment to be filed electronically, documents the Internet. See, 18 CFR period on the EAC’s Web site at may be paper-filed. To paper-file, an 385.2001(a)(1)(iii) and the instructions

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on the Commission’s Web site at http:// n. Comments, Protests, or Motions to Energy Partners, LLC, 27 Vaughan www.ferc.gov under the ‘‘e-Filing’’ link. Intervene: Anyone may submit Avenue, Newport, RI 02840, phone If unable to be filed electronically, comments, a protest, or a motion to (401) 619–4872 documents may be paper-filed. To intervene in accordance with the FERC Contact: Robert Bell, (202) 502– paper-file, an original and eight copies requirements of Rules of Practice and 6062. should be mailed to: Secretary, Federal Procedure, 18 CFR 385.210, .211, .214. Deadline for filing comments and Energy Regulatory Commission, 888 In determining the appropriate action to motions to intervene: 30 days from the First Street, NE., Washington, DC 20426. take, the Commission will consider all issuance of this notice. Comments and For more information on how to submit protests or other comments filed, but motions to intervene may be filed these types of filings, please go to the only those who file a motion to electronically via the Internet. See 18 Commission’s Web site located at http:// intervene in accordance with the CFR 385.2001(a)(1)(iii)(2008) and the www.ferc.gov.filing-comments.asp. Commission’s Rules may become a instructions on the Commission’s Web Please include the project number (P– party to the proceeding. Any comments, site under the ‘‘e-Filing’’ link. If unable 1494–384) on any comments or motions protests, or motions to intervene must to be filed electronically, documents filed. be received on or before the specified may be paper-filed. To paper-file, an The Commission’s Rules of Practice comment date for the particular original and eight copies should be and Procedure require all interveners application. mailed to: Kimberly D. Bose, Secretary, filing documents with the Commission o. Any filings must bear in all capital Federal Energy Regulatory Commission, to serve a copy of that document on letters the title ‘‘COMMENTS’’, 888 First Street, NE., Washington, DC. each person whose name appears on the ‘‘PROTEST’’, or ‘‘MOTION TO 20426. For more information on how to official service list for the project. INTERVENE’’, as applicable, and the submit these types of filings please go Further, if an intervener files comments Project Number of the particular to the Commission’s Web site located at or documents with the Commission application to which the filing refers. http://www.ferc.gov/filing- relating to the merits of an issue that p. Agency Comments: Federal, State, comments.asp. More information about may affect the responsibilities of a and local agencies are invited to file this project can be viewed or printed on particular resource agency, they must comments on the described application. the eLibrary link of Commission’s Web also serve a copy of the document on A copy of the application may be site at http://www.ferc.gov/docs-filing/ that resource agency. A copy of any obtained by agencies directly from the elibrary.asp. Enter the docket number motion to intervene must also be served Applicant. If an agency does not file (P–11143–020) in the docket number upon each representative of the comments within the time specified for field to access the document. For Applicant specified in the particular filing comments, it will be presumed to assistance, call toll-free 1–866–208– application. have no comments. One copy of an 3372. k. Description of Request: GRDA agency’s comments must also be sent to Kimberly D. Bose, requests Commission authorization to the Applicant’s representatives. permit BAK, LLC, d/b/a Elk River Secretary. Landing to expand its current marina. Kimberly D. Bose, [FR Doc. 2010–7142 Filed 3–30–10; 8:45 am] After completing the proposed Secretary. BILLING CODE 6717–01–P expansion, the marina would have three [FR Doc. 2010–7145 Filed 3–30–10; 8:45 am] docks, with a total of 86 covered boat BILLING CODE 6717–01–P slips, and a concession dock. DEPARTMENT OF ENERGY l. Locations of the Application: A Federal Energy Regulatory copy of the application is available for DEPARTMENT OF ENERGY Commission inspection and reproduction at the Commission’s Public Reference Room, Federal Energy Regulatory [ Project No. 459–297] located at 888 First Street, NE., Room Commission Union Electric Company dba Ameren/ 2A, Washington, DC 20426, or by calling [Project No. 11143–020] (202) 502–8371. This filing may also be UE; Notice of Application for viewed on the Commission’s Web site at Glen Falls Hydro, LLC; Essex Energy Amendment of License and Soliciting http://www.ferc.gov using the ‘‘eLibrary’’ Partners, LLC; Notice of Application Comments, Motions To Intervene, and link. Enter the docket number excluding for Transfer of License, and Soliciting Protests the last three digits in the docket Comments and Motions To Intervene March 24, 2010. number field to access the document. Take notice that the following You may also register online at http:// March 24, 2010. hydroelectric application has been filed www.ferc.gov/docs-filing/ On March 8, 2010, Glen Falls Hydro, with the Commission and is available esubscription.asp to be notified via e- LLC (transferor) and Essex Energy for public inspection: mail of new filings and issuances Partners, LLC (transferee) filed an a. Application Type: Non-project use related to this or other pending projects. application for transfer of license of the of project lands and waters. For assistance, call 1–866–208–3676 or Glen Falls Project, located on the b. Project No: 459–297. e-mail [email protected], Moosup River in Windham County, c. Date Filed: March 18, 2010 . for TTY, call (202) 502–8659. A copy is Connecticut. d. Applicant: Union Electric Company also available for inspection and Applicants seek Commission approval dba Ameren/UE. reproduction at the address in item (h) to transfer the license for the Glen Falls e. Name of Project: Osage above. Project from the transferor to the Hydroelectric Project. m. Individuals desiring to be included transferee. f. Location: The proposed non-project on the Commission’s mailing list should Applicant Contact: For transferor Mr. use is located in Linn Creek Cove, on so indicate by writing to the Secretary John Gauvin, Glen Falls Hydro, LLC, Lake of the Ozarks, in Camden County, of the Commission. 340 Prospect Street, Moosup, CT 06354, Missouri. phone (860) 564–7786. For the g. Filed Pursuant to: Federal Power transferee Mr. Bruce DiGennaro, Essex Act, 16 U.S.C. 791a–825r.

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h. Applicant Contact: Mr. Mark For assistance, call 1–866–208–3676 or with the Commission and is available Jordan, Ameren/UE, P.O. Box 780, MC e-mail [email protected], for public inspection. CP–850, Jefferson City, MO 65102, (573) for TTY, call (202) 502–8659. A copy is a. Type of Application: New Major 681–7246. also available for inspection and License. i. FERC Contact: Any questions on reproduction at the address in item (h) b. Project No.: P–2621–009. this notice should be addressed to above. c. Date filed: November 16, 2009. Shana High at (202) 502–8674. m. Individuals desiring to be included d. Applicant: Lockhart Power j. Deadline for filing comments, on the Commission’s mailing list should Company. motions to intervene, and protest: April so indicate by writing to the Secretary e. Name of Project: Pacolet 26, 2010. of the Commission. Hydroelectric Project. Comments, Motions to Intervene, and n. Comments, Protests, or Motions to f. Location: On the Pacolet River, near Protests may be filed electronically via Intervene: Anyone may submit the Town of Pacolet, Spartanburg the Internet. See, 18 CFR comments, a protest, or a motion to County, South Carolina. The project 385.2001(a)(1)(iii) and the instructions intervene in accordance with the does not occupy Federal Lands. on the Commission’s Web site at requirements of Rules of Practice and g. Filed Pursuant to: Federal Power http://www.ferc.gov under the ‘‘e-Filing’’ Procedure, 18 CFR 385.210, .211, .214. Act 16 U.S.C. 791 (a)—825(r) h. Applicant Contact: Bryan D. Stone, link. If unable to be filed electronically, In determining the appropriate action to Chief Operating Officer, Lockhart Power documents may be paper-filed. To take, the Commission will consider all Company, P.O. Box 10, 420 River Street, paper-file, an original and eight copies protests or other comments filed, but Lockhart, South Carolina 29364; should be mailed to: Secretary, Federal only those who file a motion to Telephone (864) 545–2211. Energy Regulatory Commission, 888 intervene in accordance with the First Street, NE., Washington, DC 20426. i. FERC Contact: Lee Emery, Commission’s Rules may become a Telephone (202) 502–8379, or by e-mail For more information on how to submit party to the proceeding. Any comments, these types of filings, please go to the at [email protected]. protests, or motions to intervene must Commission’s Web site located at j. Deadline for filing motions to be received on or before the specified http://www.ferc.gov.filing- intervene and protests, comments, comment date for the particular comments.asp. Please include the recommendations, terms and application. project number (P–459–297) on any conditions, and prescriptions is 60 days o. Any filings must bear in all capital comments or motions filed. from the issuance of this notice; reply The Commission’s Rules of Practice letters the title ‘‘COMMENTS’’, comments are due 105 days from the and Procedure require all interveners ‘‘PROTEST’’, or ‘‘MOTION TO issuance date of this notice. filing documents with the Commission INTERVENE’’, as applicable, and the All documents (original and eight to serve a copy of that document on Project Number of the particular copies) may be filed electronically via each person whose name appears on the application to which the filing refers. the Internet. See 18 CFR official service list for the project. p. Agency Comments: Federal, state, 385.2001(a)(1)(iii) and the instructions Further, if an intervener files comments and local agencies are invited to file on the Commission’s Web site (http:// or documents with the Commission comments on the described application. www.ferc.gov/docs-filing/ferconline.asp) relating to the merits of an issue that A copy of the application may be under the ‘‘eFiling’’ link. For a simpler may affect the responsibilities of a obtained by agencies directly from the method of submitting text only particular resource agency, they must Applicant. If an agency does not file comments, click on ‘‘Quick Comment.’’ also serve a copy of the document on comments within the time specified for For assistance, please contact FERC that resource agency. A copy of any filing comments, it will be presumed to Online Support at motion to intervene must also be served have no comments. One copy of an [email protected]; call toll- upon each representative of the agency’s comments must also be sent to free at (866) 208–3676; or, for TTY, Applicant specified in the particular the Applicant’s representatives. contact (202) 502–8659. Although the application. Kimberly D. Bose, Commission strongly encourages k. Description of Request: The Secretary. electronic filing, documents may also be licensee requests Commission [FR Doc. 2010–7147 Filed 3–30–10; 8:45 am] paper-filed. To paper-file, mail an authorization to permit Y Investments to original and eight copies to: Kimberly D. BILLING CODE 6717–01–P construct a 27-slip residential Bose, Secretary, Federal Energy community dock. The dock would serve Regulatory Commission, 888 First a planned residential community. DEPARTMENT OF ENERGY Street, NE., Washington, DC 20426. l. Locations of the Application: A The Commission’s Rules of Practice copy of the application is available for Federal Energy Regulatory require all intervenors filing documents inspection and reproduction at the Commission with the Commission to serve a copy of Commission’s Public Reference Room, that document on each person on the located at 888 First Street, NE., Room [Project No. 2621–009] official service list for the project. 2A, Washington, DC 20426, or by calling Further, if an intervener files comments (202) 502–8371. This filing may also be Lockhart Power Company; Notice of or documents with the Commission viewed on the Commission’s Web site at Application Accepted for Filing, relating to the merits of an issue that http://www.ferc.gov using the ‘‘eLibrary’’ Soliciting Motions To Intervene and may affect the responsibilities of a link. Enter the docket number excluding Protests, Ready for Environmental particular resource agency, they must the last three digits in the docket Analysis, and Soliciting Comments, also serve a copy of the document on number field to access the document. Recommendations, Terms and that resource agency. You may also register online at http:// Conditions, and Prescriptions k. This application has been accepted www.ferc.gov/docs-filing/ for filing and is now is ready for esubscription.asp to be notified via e- March 24, 2010. environmental analysis. mail of new filings and issuances Take notice that the following l. Project Description: The proposed related to this or other pending projects. hydroelectric application has been filed Pacolet Project would consist of two

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developments; one that is an existing, on or before the specified comment date DEPARTMENT OF ENERGY licensed development (the Lower for the particular application. Federal Energy Regulatory Pacolet development) and a new All filings must (1) bear in all capital Commission development (Upper Pacolet letters the title ‘‘PROTEST’’, ‘‘MOTION development). The project would have TO INTERVENE’’, ‘‘COMMENTS,’’ [Project No. 12597–021; Project No. 12598– an annual generation of 8.092 gigawatt- ‘‘REPLY COMMENTS,’’ 019] hours. The proposed project would ‘‘RECOMMENDATIONS,’’ ‘‘TERMS AND consist of the facilities described below. Turnbull Hydro, LLC; Notice of ’’ ‘‘ ’’ CONDITIONS, or PRESCRIPTIONS; Application Accepted for Filing, The Upper Pacolet development would (2) set forth in the heading the name of consist of: (1) An existing 315-foot-long by Soliciting Comments, Motions To 18-foot-high concrete and rubble masonry the applicant and the project number of Intervene and Protests, and Ready for dam, with the addition of 3-foot-high the application to which the filing Environmental Analysis; Soliciting flashboards; (2) an existing 30-acre reservoir, responds; (3) furnish the name, address, Recommendations and Terms and with a useable storage capacity of 90 acre-feet and telephone number of the person Conditions for the Proposed Changes at elevation 519.0 feet North American protesting or intervening; and (4) to the Transmission Line Routes Vertical Datum 1988 (NAVD 88); (3) new otherwise comply with the requirements vertical slide intake gates with rack and March 24, 2010. pinion operators, sluice gates, and trashracks of 18 CFR 385.2001 through 385.2005. having a 1-inch clear bar spacing with a trash All comments, recommendations, terms Take notice that the following rake; (4) a new 24-foot-wide by 40-foot-long and conditions or prescriptions must set hydroelectric application has been filed concrete powerhouse that would contain a forth their evidentiary basis and with the Commission and is available vertical Kaplan turbine with an estimated otherwise comply with the requirements for public inspection: generating capacity of 1,100 kilowatts (kW); of 18 CFR 4.34(b). Agencies may obtain a. Type of Application: Amendment (5) a tailrace with a 40-foot-long guide wall; of License. copies of the application directly from (6) a new 200-foot-long, 34 kilovolt (kV) b. Project Nos.: 12597–021 and P– transmission line; (7) a proposed substation; the applicant. A copy of any protest or 12598–019. and (8) appurtenant facilities. motion to intervene must be served c. Date Filed: February 17, 2010, and The Lower Pacolet development (all upon each representative of the supplemented March 17 and 23, 2010. existing facilities) would consist of: (1) A applicant specified in the particular 347-foot-long by 24-foot-high concrete and d. Applicant: Turnbull Hydro, LLC. rubble masonry dam, with 4-foot-high application. A copy of all other filings e. Name of Project: Lower and Upper flashboards; (2) three sand gates; (3) an 11- in reference to this application must be Turnbull Drop, respectively. acre reservoir, with a useable storage capacity accompanied by proof of service on all f. Location: The projects are located of 44-acre feet at an elevation of 492.0 feet persons listed in the service list on the Spring Valley Canal in Teton NAVD 88 ; (4) an intake structure equipped prepared by the Commission in this County, Montana. with trashracks having a 1.375-inch clear bar proceeding, in accordance with 18 CFR g. Filed Pursuant to: Federal Power spacing and a trash rake; (5) a 100-foot-long Act, 16 U.S.C. 791a-825r. by 10-foot-diameter penstock; (6) a 67-foot- 4.34(b) and 385.2010. long by 32-foot-wide concrete powerhouse, h. Applicant Contact: Mr. Ted You may also register online at http:// Sorenson, Turnbull Hydro, LLC, 5203 integral with the dam, containing two www.ferc.gov/docs-filing/ vertical Leffel Type Z turbines, each South 11th East, Idaho Falls, ID 83404, generating 400 kilowatts (kW); (7) a tailrace esubscription.asp to be notified via e- (208) 522–8069. with a 340-foot-long curved training wall; (8) mail of new filings and issuances i. FERC Contact: Any questions a 250-foot-long, 34.5-kV transmission line; related to this or other pending projects. regarding this notice should be directed and (9) appurtenant facilities. For assistance, contact FERC Online to Mr. Jeremy Jessup (202) 502–6779 or m. A copy of the application is Support. [email protected]. available for review at the Commission o. A license applicant must file no j. Deadline for filing motions to in the Public Reference Room or may be later than 60 days following the date of intervene and protests, comments, viewed on the Commission’s Web site at issuance of this notice: (1) A copy of the recommendations, and preliminary http://www.ferc.gov using the ‘‘eLibrary’’ water quality certification; (2) a copy of terms and conditions (terms and link. Enter the docket number excluding the request for certification, including conditions for transmission line routes the last three digits in the docket proof of the date on which the certifying only), is 60 days from the issuance of number field to access the document. agency received the request; or (3) this notice; reply comments are due 105 days from the issuance date of this For assistance, contact FERC Online evidence of waiver of water quality Support at notice. All documents may be filed certification. [email protected]. A copy is electronically via the Internet. See, 18 also available for inspection and Kimberly D. Bose, CFR 385.2001(a)(1)(iii) and the reproduction at the address in item h Secretary. instructions on the Commission’s Web ‘‘ above. [FR Doc. 2010–7146 Filed 3–30–10; 8:45 am] site at http://www.ferc.gov under the e- n. Anyone may submit comments, a Filing’’ link. If unable to be filed protest, or a motion to intervene in BILLING CODE 6717–01–P electronically, documents may be paper- accordance with the requirements of filed. To paper-file, an original and eight Rules of Practice and Procedure, 18 CFR copies should be mailed to: Secretary, 385.210, .211, .214. In determining the Federal Energy Regulatory Commission, appropriate action to take, the 888 First Street, NE., Washington, DC Commission will consider all protests or 20426. For more information on how to other comments filed, but only those submit these types of filings, please go who file a motion to intervene in to the Commissions Web site located at accordance with the Commission’s http://ferc.gov.filing-comments.asp. Rules may become a party to the Please include the project numbers proceeding. Any comments, protests, or (P–12597–021 and P–12598–019) on any motions to intervene must be received comments, motions, recommendations,

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or preliminary terms and conditions only those who file a motion to DEPARTMENT OF ENERGY filed. intervene in accordance with the k. Description of Request: At the Commission’s Rules may become a Federal Energy Regulatory Lower Turnbull Drop Project, the party to the proceeding. Any comments, Commission applicant proposes to (1) change the protests, or motions to intervene must hydraulic capacity from 600 cfs to 750 be received on or before the specified [Project No. 10856–079] cfs; (2) change the authorized installed comment date for the particular capacity from 6,150 kW to 7,700 kW; application. Upper Peninsula Power Company; and (3) change from two turbines to a North American Hydro Holdings, LLC; single turbine. At the Upper Turnbull o. Filing and Service of Responsive Notice of Application for Transfer of Drop Project, the applicant proposes to Documents: All filings must (1) bear in License, and Soliciting Comments and (1) change the hydraulic capacity from all capital letters the title ‘‘PROTEST’’, Motions To Intervene 600 cfs to 750 cfs; (2) change the ‘‘MOTION TO INTERVENE’’, authorized installed capacity from 4,100 ‘‘COMMENTS,’’ ‘‘REPLY COMMENTS,’’ March 24, 2010. kW to 5,300 kW; and (3) change from ‘‘RECOMMENDATIONS,’’ or ’’ TERMS On March 17, 2010, Upper Peninsula two turbines to a single turbine. AND CONDITIONS’’ (transmission line Power Company (transferor) and North Additionally, at the Lower Turnbull routes only); (2) set forth in the heading American Hydro Holdings, LLC Drop Project, the applicant proposes to the name of the applicant and the (transferee) filed an application for (1) change the entire transmission line project numbers of the application to transfer of license of the AuTrain to 69 kV and eliminate the remote which the filing responds; (3) furnish Project, located on the Upper AuTrain electrical substation and (2) change the the name, address, and telephone River in Alger County, Michigan. length and location of the 69 kV number of the person protesting or transmission line. At the Upper Applicants seek Commission approval intervening; and (4) otherwise comply Turnbull Drop Project, the applicant to transfer the license for the AuTrain with the requirements of 18 CFR proposes to (1) change the entire Project from the transferor to the transmission line to 69 kV and eliminate 385.2001 through 385.2005. All transferee. the remote electrical substation and (2) comments, motions to intervene or Applicant Contact: For transferor Mr. change the length and location of the 69 protests must set forth their evidentiary Terry P. Jensky, Upper Peninsula Power kV transmission line. The filing of terms basis and otherwise comply with the Company, 700 N Adams Street, Green and conditions (see section ‘‘o’’ below) requirements of 18 CFR 4.34(b). All Bay, WI 54307, phone (920) 433–2900. are only being requested by this notice comments, motions to intervene or For the transferee Mr. Charles F. Alberg, for the applicant’s proposal regarding protests should relate to project works North American Hydro Holdings, LLC, changes to the transmission line routes. which are the subject of the license 116 State Street, Neshkoro, WI 54960, l. Locations of the Application: A amendment. Agencies may obtain phone (920) 293–4628 copy of the application is available for copies of the application directly from inspection and reproduction at the FERC Contact: Robert Bell, (202) 502– the applicant. A copy of any protest or 6062. Commission’s Public Reference Room, motion to intervene must be served located at 888 First Street, NE., Room upon each representative of the Deadline for filing comments and 2A, Washington, DC 20426, or by calling applicant specified in the particular motions to intervene: 30 days from the (202) 502–8371. This filing may also be application. If an intervener files issuance of this notice. Comments and motions to intervene may be filed viewed on the Commission’s Web site at comments or documents with the http://www.ferc.gov using the ‘‘eLibrary’’ electronically via the Internet. See 18 Commission relating to the merits of an link. Enter the docket number excluding CFR 385.2001(a)(1)(iii)(2008) and the issue that may affect the responsibilities the last three digits in the docket instructions on the Commission’s number field to access the document. of a particular resource agency, they website under the ‘‘e-Filing’’ link. If You may also register online at http:// must also serve a copy of the document unable to be filed electronically, www.ferc.gov/docs-filing/ on that resource agency. A copy of all documents may be paper-filed. To esubscription.asp to be notified via e- other filings in reference to this paper-file, an original and eight copies mail of new filings and issuances application must be accompanied by should be mailed to: Kimberly D. Bose, related to this or other pending projects. proof of service on all persons listed in Secretary, Federal Energy Regulatory For assistance, call 1–866–208–3676 or the service list prepared by the Commission, 888 First Street, NE., e-mail [email protected], Commission in this proceeding, in Washington, DC 20426. For more for TTY, call (202) 502–8659. A copy is accordance with 18 CFR 4.34(b) and information on how to submit these also available for inspection and 385.2010. types of filings please go to the reproduction at the address in item (h) Commission’s Web site located at http:// Kimberly D. Bose, above. www.ferc.gov/filing-comments.asp. m. Individuals desiring to be included Secretary. More information about this project can on the Commission’s mailing list should [FR Doc. 2010–7144 Filed 3–30–10; 8:45 am] be viewed or printed on the eLibrary so indicate by writing to the Secretary BILLING CODE 6717–01–P link of Commission’s Web site at http:// of the Commission. www.ferc.gov/docs-filing/elibrary.asp. n. Comments, Protests, or Motions to Enter the docket number (P–10856–079) Intervene: Anyone may submit in the docket number field to access the comments, a protest, or a motion to document. For assistance, call toll-free intervene in accordance with the 1–866–208–3372. requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. Kimberly D. Bose, In determining the appropriate action to Secretary. take, the Commission will consider all [FR Doc. 2010–7141 Filed 3–30–10; 8:45 am] protests or other comments filed, but BILLING CODE 6717–01–P

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DEPARTMENT OF ENERGY and Order Approving Market Based Rate wholesale sales of energy, capacity Tariff and Request for Expedited under FERC Electric Tariff, Original Federal Energy Regulatory Consideration. Volume 1, effective 3/24/10. Commission Filed Date: 03/19/2010. Filed Date: 03/23/2010. Accession Number: 20100322–0203. Accession Number: 20100324–0207. Combined Notice of Filings # 1 Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time March 24, 2010. on Monday, March 29, 2010. on Tuesday, April 13, 2010. Take notice that the Commission Docket Numbers: ER10–727–001. Docket Numbers: ER10–913–000. received the following electric corporate Applicants: AEP Retail Energy Applicants: NASDAQ OMX filings: Partners LLC. Commodities Clearing—Delivery LLC. Docket Numbers: EC10–55–000. Description: AEP Retail Energy Description: NASDAQ OMX Applicants: Noble Chateaugay Partners LLC submits the results of the Commodities Clearing—Delivery LLC Windpark, LLC, Noble Ellenburg Commission’s market power screen and submits application for authorization to Windpark, LLC, Noble Clinton pivotal supplier screen for the PJM make market based wholesale sales of Windpark I, LLC, Noble Altona balancing authority to their February 12, energy, capacity, etc to be effective 3/ Windpark, LLC. 2010. 24/2010. Description: Application for Filed Date: 03/23/2010. Filed Date: 03/23/2010. Authorization of Transfer of Certain Accession Number: 20100324–0204. Accession Number: 20100324–0208. Limited Interconnection Facilities under Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Section 203 of the Federal Power Act, on Tuesday, March 30, 2010. on Tuesday, April 13, 2010. and Request for Waivers of Filing Docket Numbers: ER10–769–002. Docket Numbers: ER10–914–000. Requirements. Applicants: Glenwood Energy Applicants: NASDAQ OMX Filed Date: 03/24/2010. Partners, LTD. Commodities Clearing—Finance LLC. Accession Number: 20100324–5032. Description: Glenwood Energy Description: NASDAQ OMX Comment Date: 5 p.m. Eastern Time Partners, LTD submits petition for Commodities Clearing—Finance LLC on Wednesday, April 14, 2010. acceptance of Initial Rate Schedule, submits its application for authorization Take notice that the Commission Waivers and Blanket Authority. to make market-based wholesale sales of received the following electric rate Filed Date: 03/23/2010. energy, capacity, and certain ancillary filings: Accession Number: 20100324–0206. services etc. Docket Numbers: ER03–198–014. Comment Date: 5 p.m. Eastern Time Filed Date: 03/23/2010. Applicants: Pacific Gas and Electric on Tuesday, April 13, 2010. Accession Number: 20100324–0209. Company. Docket Numbers: ER10–792–001. Comment Date: 5 p.m. Eastern Time Description: Pacific Gas and Electric Applicants: TC Energy Trading, LLC. on Tuesday, April 13, 2010. Company Notice of Non-Material Description: TC Energy Trading, LLC Docket Numbers: ER10–918–000. Change in Status. submits Substitute Original Sheet No 3 Applicants: Maine Public Service Filed Date: 03/24/2010. to its market based rate application. Company. Accession Number: 20100324–5037. Filed Date: 03/22/2010. Description: Maine Public Service Comment Date: 5 p.m. Eastern Time Accession Number: 20100323–0206. Company submits Original Sheet No 34 on Wednesday, April 14, 2010. Comment Date: 5 p.m. Eastern Time et al to FERC Electric Rate Schedule 30 Docket Numbers: ER04–449–022. on Monday, April 12, 2010. with Algonquin Northern Maine Gen Applicants: New York Independent Docket Numbers: ER10–812–001. Co. System Operator, Inc. Applicants: Power Choice, Inc. Filed Date: 03/22/2010. Description: ISO New York Description: Amendment to Accession Number: 20100323–0204. Independent System Operator submits Application of Power Choice Inc. Comment Date: 5 p.m. Eastern Time proposed modifications. Filed Date: 03/24/2010. on Monday, April 12, 2010. Filed Date: 03/23/2010. Accession Number: 20100324–5002. Docket Numbers: ER10–919–000. Accession Number: 20100323–0233. Comment Date: 5 p.m. Eastern Time Applicants: ISO New England Inc. Comment Date: 5 p.m. Eastern Time on Wednesday, April 14, 2010. Description: ISO New England, Inc et on Tuesday, April 13, 2010. Docket Numbers: ER10–899–000. al submits an executed non-confirming Docket Numbers: ER10–495–001. Applicants: Consulting Gasca & Standard Large Generator Applicants: Midwest Independent Associates, LLC. Interconnection Agreement. Transmission System Operator, Inc. Description: Consulting Gasca & Filed Date: 03/22/2010. Description: Midwest Independent Associates, LLC submits a Petition for Accession Number: 20100323–0203. Transmission System Operator, Inc Acceptance of Initial Tariff, Waivers and Comment Date: 5 p.m. Eastern Time submits a revised fully executed Blanket Authority. on Monday, April 12, 2010. Amended and Restated Large Generator Filed Date: 03/24/2010. Docket Numbers: ER10–920–000. Interconnection Agreement with Accession Number: 20100324–0215. Applicants: Maine Public Service Pemeroy Wind Farm, LLC. Comment Date: 5 p.m. Eastern Time Company. Filed Date: 03/22/2010. on Wednesday, April 14, 2010. Description: Maine Public Service Accession Number: 20100323–0202. Docket Numbers: ER10–912–000. Company submits revised executed Comment Date: 5 p.m. Eastern Time Applicants: NASDAQ OMX interconnection agreement with on Monday, April 12, 2010. Commodities Clearing—Contract Algonquin Northern Maine Gen Co etc. Docket Numbers: ER10–662–001. Merchant LLC. Filed Date: 03/22/2010. Applicants: CER Generation, LLC. Description: NASDAQ OMX Accession Number: 20100323–0201. Description: CER Generation, LLC Commodities Clearing—Contract Comment Date: 5 p.m. Eastern Time submits amendment to application for Merchant LLC submits application for on Monday, April 12, 2010. Blanket Authorizations, Certain Waivers authorization to make market-based Docket Numbers: ER10–921–000.

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Applicants: Indiana Michigan Power tariff sheets that clarify certain Washington, DC. There is an Company. provisions of Market Rule 1 etc. eSubscription link on the Web site that Description: Indiana Michigan Power Filed Date: 03/24/2010. enables subscribers to receive e-mail Company submits Notice of Accession Number: 20100324–0212. notification when a document is added Cancellation of Service Agreement 4, Comment Date: 5 p.m. Eastern Time to a subscribed dockets(s). For First Revised Sheet 1. on Wednesday, April 14, 2010. assistance with any FERC Online Filed Date: 03/23/2010. Take notice that the Commission service, please e-mail Accession Number: 20100323–0231. received the following open access [email protected]. or call Comment Date: 5 p.m. Eastern Time transmission tariff filings: (866) 208–3676 (toll free). For TTY, call on Tuesday, April 13, 2010. Docket Numbers: OA08–62–006. (202) 502–8659. Docket Numbers: ER10–922–000. Applicants: California Independent Nathaniel J. Davis, Sr., Applicants: Cleco Power LLC. System Operator Corporation. Description: Cleco Power LLC submits Description: California Independent Deputy Secretary. an Electric System Interconnection System Operator Corp submits a [FR Doc. 2010–7135 Filed 3–30–10; 8:45 am] Agreement. compliance filing pursuant to the BILLING CODE 6717–01–P Filed Date: 03/23/2010. Commission’s 1/21/10 Order. Accession Number: 20100323–0232. Filed Date: 03/22/2010. DEPARTMENT OF ENERGY Comment Date: 5 p.m. Eastern Time Accession Number: 20100323–0205. on Tuesday, April 13, 2010. Comment Date: 5 p.m. Eastern Time Federal Energy Regulatory Docket Numbers: ER10–924–000. on Monday, April 12, 2010. Commission Applicants: Noble Americas Gas & Any person desiring to intervene or to Power Corp. protest in any of the above proceedings [Docket No. EL10–50–000; Docket No. ER10–787–000] Description: Noble Americas Gas & must file in accordance with Rules 211 Power Corp submits notice of and 214 of the Commission’s Rules of New England Power Generators succession to reflect its succession to Practice and Procedure (18 CFR 385.211 Association Inc., Complainant v. ISO and adoption of Noble Energy Marketing and 385.214) on or before 5 p.m. Eastern New England Inc., Respondent; ISO & Trades Corp’s Rate Schedule No 1. time on the specified comment date. It New England Inc. and New England Filed Date: 03/23/2010. is not necessary to separately intervene Power Pool; Notice of Complaint Accession Number: 20100324–0201. again in a subdocket related to a Comment Date: 5 p.m. Eastern Time compliance filing if you have previously March 24, 2010. on Tuesday, April 13, 2010. intervened in the same docket. Protests Take notice that on March 23, 2010, Docket Numbers: ER10–925–000. will be considered by the Commission pursuant to section 206 of the Rules and Applicants: Southwest Power Pool, in determining the appropriate action to Practice and Procedure, 18 CFR 385.206 Inc. be taken, but will not serve to make and sections 206 of the Federal Power Description: Southwest Power Pool, protestants parties to the proceeding. Act, 16 U.S.C. 824(e), New England Inc submits an executed Large Generator Anyone filing a motion to intervene or Power Generators Association Inc. Interconnection Agreement with Laredo protest must serve a copy of that (Complainant) filed a formal complaint Ridge Wind, LLC. document on the Applicant. In reference against ISO New England Inc. Filed Date: 03/23/2010. to filings initiating a new proceeding, (Respondent) alleging that, the Accession Number: 20100324–0202. interventions or protests submitted on Respondent’s current and proposed Comment Date: 5 p.m. Eastern Time or before the comment deadline need tariffs governing the Forward Capacity on Tuesday, April 13, 2010. not be served on persons other than the market (FCM) are unjust and Docket Numbers: ER10–927–000. Applicant. unreasonable. Applicants: PPL Southwest The Commission encourages The Complainant certifies that copies Generation Holdings, LLC. electronic submission of protests and of the complaint were served on the Description: PPL Southwest interventions in lieu of paper, using the contacts for the Respondent and the Generation Holdings, LLC submits FERC Online links at http:// New England Power Pool as listed on Notice of Cancellation of its FERC www.ferc.gov. To facilitate electronic the Commission’s list of Corporate Electric Tariff, Original Volume 1. service, persons with Internet access Officials and on parties and regulatory Filed Date: 03/24/2010. who will eFile a document and/or be agencies the Complainant reasonably Accession Number: 20100324–0214. listed as a contact for an intervenor expects to be affected by this Complaint, Comment Date: 5 p.m. Eastern Time must create and validate an including all of the parties that have on Wednesday, April 14, 2010. eRegistration account using the intervened in Docket ER10–787–000. Docket Numbers: ER10–928–000. eRegistration link. Select the eFiling Any person desiring to intervene or to Applicants: WPS Empire State, Inc. link to log on and submit the protest this filing must file in Description: WPS Empire State, Inc intervention or protests. accordance with Rules 211 and 214 of submits the Notice of Cancellation re Persons unable to file electronically the Commission’s Rules of Practice and market-based rate tariff, FERC Electric should submit an original and 14 copies Procedure (18 CFR 385.211, 385.214). Tariff, Third Revised Volume No. 1. of the intervention or protest to the Protests will be considered by the Filed Date: 03/24/2010. Federal Energy Regulatory Commission, Commission in determining the Accession Number: 20100324–0213. 888 First St., NE., Washington, DC appropriate action to be taken, but will Comment Date: 5 p.m. Eastern Time 20426. not serve to make protestants parties to on Wednesday, April 14, 2010. The filings in the above proceedings the proceeding. Any person wishing to Docket Numbers: ER10–929–000. are accessible in the Commission’s become a party must file a notice of Applicants: ISO New England Inc., eLibrary system by clicking on the intervention or motion to intervene, as New England Power Pool. appropriate link in the above list. They appropriate. The Respondent’s answer Description: ISO New England are also available for review in the and all interventions, or protests must submits transmittal letter and revised Commission’s Public Reference Room in be filed on or before the comment date.

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The Respondent’s answer, motions to measures, would not constitute a major Any person desiring to intervene or to intervene, and protests must be served federal action that would significantly protest should file with the Federal on the Complainants. affect the quality of the human Energy Regulatory Commission, 888 The Commission encourages environment. First Street, NE., Washington, DC 20426, electronic submission of protests and A copy of the EA is available for in accordance with Rules 211 and 214 interventions in lieu of paper using the review at the Commission in the Public of the Commission’s Rules of Practice ‘‘eFiling’’ link at http://www.ferc.gov. Reference Room or may be viewed on and Procedure (18 CFR 385.211 and Persons unable to file electronically the Commission’s Web site at http:// 385.214). Anyone filing a motion to should submit an original and 14 copies www.ferc.gov using the ‘‘eLibrary’’ link. intervene or protest must serve a copy of the protest or intervention to the Enter the docket number excluding the of that document on the Applicant. Federal Energy Regulatory Commission, last three digits in the docket number 888 First Street, NE., Washington, DC field to access the document. For Notice is hereby given that the 20426. assistance, contact FERC Online deadline for filing protests with regard This filing is accessible on-line at Support at to the applicant’s request for blanket http://www.ferc.gov, using the [email protected]; toll-free authorization, under 18 CFR part 34, of ‘‘eLibrary’’ link and is available for at 1–866–208–3676, or for TTY, 202– future issuances of securities and review in the Commission’s Public 502–8659. assumptions of liability, is April 5, Reference Room in Washington, DC. You may also register online at 2010. There is an ‘‘eSubscription’’ link on the http://www.ferc.gov/docs-filing/ The Commission encourages Web site that enables subscribers to esubscription.asp to be notified via e- electronic submission of protests and receive e-mail notification when a mail of new filings and issuances interventions in lieu of paper, using the document is added to a subscribed related to this or other pending projects. FERC Online links at http:// docket(s). For assistance with any FERC For assistance, contact FERC Online www.ferc.gov. To facilitate electronic Online service, please e-mail Support. service, persons with Internet access [email protected], or call Any comments should be filed within (866) 208–3676 (toll free). For TTY, call 45 days from the date of this notice and who will eFile a document and/or be (202) 502–8659. be addressed to: Kimberly D. Bose, listed as a contact for an intervenor Comment Date: 5 p.m. Eastern Time Secretary, Federal Energy Regulatory must create and validate an on April 6, 2010. Commission, 888 First Street, NE., eRegistration account using the Washington, DC 20426. Please affix eRegistration link. Select the eFiling Kimberly D. Bose, Project No. 516 to all comments. link to log on and submit the Secretary. Comments may be filed electronically intervention or protests. [FR Doc. 2010–7150 Filed 3–30–10; 8:45 am] via the Internet in lieu of paper. The Persons unable to file electronically BILLING CODE 6717–01–P Commission strongly encourages should submit an original and 14 copies electronic filings. See 18 CFR of the intervention or protest to the 385.2001(a)(1)(iii) and the instructions DEPARTMENT OF ENERGY Federal Energy Regulatory Commission, on the Commission’s Web site (http:// 888 First St., NE., Washington, DC Federal Energy Regulatory www.ferc.gov) under the ‘‘e-Filing’’ link. 20426. Commission For further information, contact Lee Emery by telephone at (202) 502–8379, The filings in the above-referenced [Project No. 516–459] or by e-mail at [email protected]. proceeding are accessible in the Commission’s eLibrary system by South Carolina Electric and Gas Kimberly D. Bose, clicking on the appropriate link in the Company, South Carolina; Notice of Secretary. above list. They are also available for Availability of Environmental [FR Doc. 2010–7148 Filed 3–30–10; 8:45 am] review in the Commission’s Public Assessment BILLING CODE 6717–01–P Reference Room in Washington, DC. March 24, 2010. There is an eSubscription link on the Web site that enables subscribers to In accordance with the National DEPARTMENT OF ENERGY Environmental Policy Act of 1969 and receive e-mail notification when a the Federal Energy Regulatory Federal Energy Regulatory document is added to a subscribed Commission’s (Commission or FERC’s) Commission dockets(s). For assistance with any regulations, 18 Code of Federal FERC Online service, please e-mail [Docket No. ER10–904–000] Regulations (CFR) Part 380 (Order No. [email protected]. or call 486, 52 FR 47897), the Office of Energy NFI Solar LLC; Supplemental Notice (866) 208–3676 (toll free). For TTY, call Projects has reviewed South Carolina That Initial Market-Based Rate Filing (202) 502–8659. Electric and Gas Company’s application Includes Request for Blanket Section Nathaniel J. Davis, Sr., for license for the Saluda Hydroelectric 204 Authorization Project (FERC Project No. 516), located Deputy Secretary. on Saluda River in Richland, Lexington, March 24, 2010. [FR Doc. 2010–7138 Filed 3–30–10; 8:45 am] Saluda, and Newberry counties, near This is a supplemental notice in the BILLING CODE 6717–01–P Columbia, South Carolina. The project above-referenced proceeding of NFI does not occupy any Federal lands. Solar, LLC’s application for market- Staff prepared a draft environmental based rate authority, with an assessment (EA), which analyzes the accompanying rate tariff, noting that potential environmental effects of such application includes a request for relicensing the project, and concludes blanket authorization, under 18 CFR that licensing the project, with Part 34, of future issuances of securities appropriate environmental protective and assumptions of liability.

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DEPARTMENT OF ENERGY document is added to a subscribed 888 First St., NE., Washington, DC dockets(s). For assistance with any 20426. Federal Energy Regulatory FERC Online service, please e-mail The filings in the above-referenced Commission [email protected]. or call proceeding are accessible in the [Docket No. ER10–892–000] (866) 208–3676 (toll free). For TTY, call Commission’s eLibrary system by (202) 502–8659. clicking on the appropriate link in the Southern Turner Cimarron I, LLC; above list. They are also available for Nathaniel J. Davis, Sr., Supplemental Notice That Initial review in the Commission’s Public Market-Based Rate Filing Includes Deputy Secretary. Reference Room in Washington, DC. Request for Blanket Section 204 [FR Doc. 2010–7136 Filed 3–30–10; 8:45 am] There is an eSubscription link on the Authorization BILLING CODE 6717–01–P Web site that enables subscribers to receive e-mail notification when a March 24, 2010. document is added to a subscribed This is a supplemental notice in the DEPARTMENT OF ENERGY dockets(s). For assistance with any above-referenced proceeding of FERC Online service, please e-mail Southern Turner Cimarron I, LLC’s Federal Energy Regulatory Commission [email protected]. or call application for market-based rate (866) 208–3676 (toll free). For TTY, call authority, with an accompanying rate (202) 502–8659. tariff, noting that such application [Docket No. ER10–903–000] includes a request for blanket Nathaniel J. Davis, Sr., authorization, under 18 CFR part 34, of Patriot Power LLC; Supplemental Deputy Secretary. future issuances of securities and Notice That Initial Market-Based Rate [FR Doc. 2010–7139 Filed 3–30–10; 8:45 am] assumptions of liability. Filing Includes Request for Blanket BILLING CODE 6717–01–P Any person desiring to intervene or to Section 204 Authorization protest should file with the Federal March 24, 2010. Energy Regulatory Commission, 888 DEPARTMENT OF ENERGY First Street, NE., Washington, DC 20426, This is a supplemental notice in the in accordance with Rules 211 and 214 above-referenced proceeding of Patriot Federal Energy Regulatory of the Commission’s Rules of Practice Power LLC’s application for market- Commission based rate authority, with an and Procedure (18 CFR 385.211 and [ Docket No. ER10–881–000] 385.214). Anyone filing a motion to accompanying rate tariff, noting that intervene or protest must serve a copy such application includes a request for Reliable Power LLC; Supplemental of that document on the Applicant. blanket authorization, under 18 CFR Notice That Initial Market-Based Rate Notice is hereby given that the part 34, of future issuances of securities Filing Includes Request for Blanket deadline for filing protests with regard and assumptions of liability. Section 204 Authorization to the applicant’s request for blanket Any person desiring to intervene or to authorization, under 18 CFR part 34, of protest should file with the Federal March 24, 2010. future issuances of securities and Energy Regulatory Commission, 888 This is a supplemental notice in the assumptions of liability, is April 13, First Street, NE., Washington, DC 20426, above-referenced proceeding of Reliable 2010. in accordance with Rules 211 and 214 Power, LLC’s application for market- The Commission encourages of the Commission’s Rules of Practice based rate authority, with an electronic submission of protests and and Procedure (18 CFR 385.211 and accompanying rate tariff, noting that interventions in lieu of paper, using the 385.214). Anyone filing a motion to such application includes a request for FERC Online links at http:// intervene or protest must serve a copy blanket authorization, under 18 CFR www.ferc.gov. To facilitate electronic of that document on the Applicant. Part 34, of future issuances of securities service, persons with Internet access Notice is hereby given that the and assumptions of liability. who will eFile a document and/or be deadline for filing protests with regard Any person desiring to intervene or to listed as a contact for an intervenor to the applicant’s request for blanket protest should file with the Federal must create and validate an authorization, under 18 CFR part 34, of Energy Regulatory Commission, 888 eRegistration account using the future issuances of securities and First Street, NE., Washington, DC 20426, eRegistration link. Select the eFiling assumptions of liability, is April 13, in accordance with Rules 211 and 214 link to log on and submit the 2010. of the Commission’s Rules of Practice intervention or protests. The Commission encourages and Procedure (18 CFR 385.211 and Persons unable to file electronically electronic submission of protests and 385.214). Anyone filing a motion to should submit an original and 14 copies interventions in lieu of paper, using the intervene or protest must serve a copy of the intervention or protest to the FERC Online links at http:// of that document on the Applicant. Federal Energy Regulatory Commission, www.ferc.gov. To facilitate electronic Notice is hereby given that the 888 First St., NE., Washington, DC service, persons with Internet access deadline for filing protests with regard 20426. who will eFile a document and/or be to the applicant’s request for blanket The filings in the above-referenced listed as a contact for an intervenor authorization, under 18 CFR Part 34, of proceeding are accessible in the must create and validate an future issuances of securities and Commission’s eLibrary system by eRegistration account using the assumptions of liability, is April 13, clicking on the appropriate link in the eRegistration link. Select the eFiling 2010. above list. They are also available for link to log on and submit the The Commission encourages review in the Commission’s Public intervention or protests. electronic submission of protests and Reference Room in Washington, DC. Persons unable to file electronically interventions in lieu of paper, using the There is an eSubscription link on the should submit an original and 14 copies FERC Online links at http:// Web site that enables subscribers to of the intervention or protest to the www.ferc.gov. To facilitate electronic receive e-mail notification when a Federal Energy Regulatory Commission, service, persons with Internet access

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who will eFile a document and/or be Comments, protests, and project has not operated since October listed as a contact for an intervenor interventions may be filed electronically 1, 2008, and the owner does not intend must create and validate an via the Internet in lieu of paper; see 18 to bring the project back into operation. eRegistration account using the CFR 385.2001(a)(1)(iii) and the On October 19, 2009, Commission staff eRegistration link. Select the eFiling instructions on the Commission’s Web wrote Ms. Burkhart requesting she file link to log on and submit the site under the ‘‘e-Filing’’ link. The either a detailed plan and schedule to intervention or protests. Commission strongly encourages resume generation at the project along Persons unable to file electronically electronic filings. Please include the with a transfer of license application, or should submit an original and 14 copies project number (P–9907–018) on any a request to voluntarily surrender the of the intervention or protest to the documents or motions filed. license. No response was filed. On Federal Energy Regulatory Commission, The Commission’s Rules of Practice January 13, 2010, Commission staff sent 888 First St., NE., Washington, DC and Procedure require all intervenors a letter to Mr. McMillan and Ms. Smith, 20426. filing documents with the Commission with a copy to Ms. Burkhart, requesting The filings in the above-referenced to serve a copy of that document on them to show cause why the proceeding are accessible in the each person in the official service list Commission should not initiate a Commission’s eLibrary system by for the project. Further, if an intervenor proceeding for terminating the license clicking on the appropriate link in the files comments or documents with the based upon implied surrender. No above list. They are also available for Commission relating to the merits of an response was filed to the show cause review in the Commission’s Public issue that may affect the responsibilities letter. Reference Room in Washington, DC. of a particular resource agency, they l. This notice is available for review There is an eSubscription link on the must also serve a copy of the document and reproduction at the Commission in Web site that enables subscribers to on that resource agency. the Public Reference Room, Room 2A, receive e-mail notification when a j. Description of Existing Facilities: 888 First Street, NE., Washington, DC document is added to a subscribed The project consists of the following 20426. The filing may also be viewed on dockets(s). For assistance with any facilities: (1) An existing earthfill 10- the Web at http://www.ferc.gov using FERC Online service, please e-mail foot-high Lake Creek diversion dam; (2) the ‘‘eLibrary’’ link. Enter the docket [email protected]. or call an existing 15-inch-diameter, 2,300-foot- number, here P–9907–018, in the docket (866) 208–3676 (toll free). For TTY, call long buried PVC penstock; (3) a number field to access the document. (202) 502–8659. powerhouse containing one generating For assistance, call toll-free 1–866–208– unit with a rated capacity of 110 3676 or e-mail Nathaniel J. Davis, Sr., kilowatts; (4) a 200-foot-long, 34.5-kV [email protected]. For TTY, Deputy Secretary. transmission line connected to Idaho call (202) 502–8659. A copy is also [FR Doc. 2010–7137 Filed 3–30–10; 8:45 am] Power Company lines; (5) a wooden fish available for review and reproduction at BILLING CODE 6717–01–P ladder in a riprap-lined spillway; and the address in item g above. (6) appurtenant facilities. m. Individuals desiring to be included k. Description of Proceeding: Section on the Commission’s mailing list should DEPARTMENT OF ENERGY 6.4 of the Commission’s regulations (18 so indicate by writing to the Secretary CFR 6.4) provides, among other things, of the Commission. Federal Energy Regulatory that it is deemed to be the intent of a n. Comments, Protests, or Motions to Commission licensee to surrender a license, if the Intervene—Anyone may submit a [Project No. 9907–018] licensee abandons a project for a period protest or a motion to intervene in of three years. accordance with the requirements of Mr. Jerry McMillan and Ms. Christine The Director of Hydropower Rules of Practice and Procedure, 18 CFR Smith; Notice of Termination of Licensing issued a 50-year license to A. 385.210, 385.211, and 385.214. In License by Implied Surrender and W. Brown, Co. for the Sunshine Power determining the appropriate action to Soliciting Comments, Protests, and Project on March 20, 1987 (38 FERC ¶ take, the Commission will consider all Motions To Intervene 62,282). The project was transferred to protests filed, but only those who file a Mr. Jerry McMillan and Ms. Christine motion to intervene in accordance with March 24, 2010. Smith by order on February 23, 1996 (74 the Commission’s Rules may become a Take notice that the following FERC ¶ 62,092). On January 26, 2006, party to the proceeding. Any protests or hydroelectric proceeding has been Ms. Smith informed the Commission motions to intervene must be received initiated by the Commission: that in August of 2005, Mr. McMillan on or before the specified deadline date a. Type of Proceeding: Termination of deeded Ms. Smith his interest in the for the particular application. license by implied surrender Sunshine Project. In response, on April o. Filing and Service of Responsive b. Project No.: P–9907–018 Documents—All filings must (1) bear in c. Licensees: Mr. Jerry McMillan and 6, 2006, Commission staff requested Ms. all capital letters the title ‘‘PROTEST’’, Ms. Christine Smith Smith file an application for transfer of d. Name of Project: Sunshine Power license with the Secretary of the ‘‘MOTION TO INTERVENE,’’ Project Commission. Ms. Smith failed to file a ‘‘COMMENTS’’, ‘‘RECOMMENDATIONS e. Location: The Sunshine Power transfer application. FOR TERMS AND CONDITIONS: (2) set Project is located on Lake Creek in On August 13, 2007, Commission staff forth in the heading the project number Lemhi County, Idaho. received a letter from Ms. Smith stating of the proceeding to which the filing f. Issued Pursuant to: 18 CFR 6.4. that she had sold the project to Ms. responds; (3) furnish the name, address, g. Licensee Contact: Mr. Jerry Claudia Burkhart. Commission staff and telephone number of the person McMillan, 1157 North Hughes Street, wrote to Ms. Burkhart on August 21, protesting or intervening; and (4) Centerville, UT 84014, (801) 808–6997. 2008, stating that she needed to file a otherwise comply with the requirements h. FERC Contact: Kelly Houff, (202) transfer of license application with the of 18 CFR 385.2001 through 385.2005. 502–6393, [email protected]. Commission’s Secretary. Once again, no All comments, recommendations, or i. Deadline for filing responsive transfer application was filed. terms and conditions must set forth documents: April 26, 2010. According to Commission records, the their evidentiary basis and otherwise

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comply with the requirements of 18 CFR Guidelines will be applied and to including its effects on human health 4.34(b). Any of the above mentioned answer questions about the Penalty and the environment. documents must be filed by providing Guidelines. In that regard, questions are DATES: Comments must be received on the original and eight copies to: The being solicited from the public in or before June 1, 2010. Secretary, Federal Energy Regulatory advance of the workshops. Please ADDRESSES: Submit your comments Commission, 888 First Street, NE., submit questions on the Penalty identified by the docket identification Washington, DC 20426. An additional Guidelines to Jeremy Medovoy, (ID) number for the specific pesticide of copy must be sent to Director, Division Attorney-Advisor, Office of interest provided in the table in Unit of Hydropower Administration and Enforcement, Division of Investigations, III.A., by one of the following methods: Compliance, Office of Energy Projects, by e-mail at [email protected]. • Federal eRulemaking Portal: Federal Energy Regulatory Commission, Workshop participants will also have an http://www.regulations.gov. Follow the at the above address. opportunity to ask questions at the on-line instructions for submitting p. Agency Comments—Federal, State, workshops, but due to time limitations, comments. and local agencies are invited to file questions in advance are encouraged. • Mail: Office of Pesticide Programs comments on the described proceeding. Commission conferences are (OPP) Regulatory Public Docket (7502P), If any agency does not file comments accessible under section 508 of the Environmental Protection Agency, 1200 within the time specified for filing Rehabilitation Act of 1973. For Pennsylvania Ave., NW., Washington, comments, it will be presumed to have accessibility accommodations please DC 20460–0001. no comments. send an e-mail to [email protected] • Delivery: OPP Regulatory Public or call toll free 1–866–208–3372 (voice) Kimberly D. Bose, Docket (7502P), Environmental or 202–208–1659 (TTY), or send a FAX Secretary. Protection Agency, Rm. S–4400, One to 202–208–2106 with the required Potomac Yard (South Bldg.), 2777 S. [FR Doc. 2010–7149 Filed 3–30–10; 8:45 am] accommodations. Crystal Dr., Arlington, VA. Deliveries BILLING CODE 6717–01–P Questions about the workshops may are only accepted during the Docket be directed to Jeremy Medovoy by e- Facility’s normal hours of operation mail at [email protected] or by DEPARTMENT OF ENERGY (8:30 a.m. to 4 p.m., Monday through telephone at 202–502–6768. Friday, excluding legal holidays). Federal Energy Regulatory Kimberly D. Bose, Special arrangements should be made Commission Secretary. for deliveries of boxed information. The Docket Facility telephone number is [FR Doc. 2010–7140 Filed 3–30–10; 8:45 am] [Docket No. PL10–4–000] (703) 305–5805. BILLING CODE 6717–01–P Instructions: Direct your comments to Enforcement of Statutes, Orders, Rules the docket ID numbers listed in the table and Regulations; Notice of Workshops in Unit III.A. for the pesticides you are on Penalty Guidelines ENVIRONMENTAL PROTECTION commenting on. EPA’s policy is that all March 24, 2010. AGENCY comments received will be included in the docket without change and may be The staff of the Federal Energy [EPA–HQ–OPP–2010–0032; FRL–8810–1] Regulatory Commission (Commission) made available on-line at http:// will hold three workshops to provide a Antimicrobial Pesticide Registration www.regulations.gov, including any forum for interested participants to ask Review Dockets Opened for Review personal information provided, unless questions on the interpretation and and Comment the comment includes information application of the Policy Statement on claimed to be Confidential Business Penalty Guidelines, which the AGENCY: Environmental Protection Information (CBI) or other information Commission recently issued on March Agency (EPA). whose disclosure is restricted by statute. 18, 2010.1 Staff will hold the first ACTION: Notice. Do not submit information that you workshop on April 7, 2010, from 9:30 consider to be CBI or otherwise a.m. to 12 p.m. Eastern Daylight Time, SUMMARY: EPA has established protected through regulations.gov or e- in the Commission Meeting Room (2C) registration review dockets for the mail. The regulations.gov website is an at the Commission’s Washington, DC pesticides listed in the table in Unit ‘‘anonymous access’’ system, which headquarters, 888 First Street, NE. To III.A. With this document, EPA is means EPA will not know your identity accommodate participants outside of opening the public comment period for or contact information unless you Washington, DC, this workshop will be these registration reviews. Registration provide it in the body of your comment. webcast, but will not be transcribed. All review is EPA’s periodic review of If you send an e-mail comment directly interested parties are invited, and there pesticide registrations to ensure that to EPA without going through is no registration list or registration fee each pesticide continues to satisfy the regulations.gov, your e-mail address to attend. statutory standard for registration, that will be automatically captured and Staff will also hold similar workshops is, the pesticide can perform its included as part of the comment that is in Houston, Texas on April 14, 2010, intended function without unreasonable placed in the docket and made available and in San Francisco, California on adverse effects on human health or the on the Internet. If you submit an April 15, 2010. The times and locations environment. Registration review electronic comment, EPA recommends of these later workshops will be dockets contain information that will that you include your name and other provided in a subsequent notice. These assist the public in understanding the contact information in the body of your workshops will not be webcast. types of information and issues that the comment and with any disk or CD-ROM The purpose of the workshops will be Agency may consider during the course you submit. If EPA cannot read your to have staff discuss how the Penalty of registration reviews. Through this comment due to technical difficulties program, EPA is ensuring that each and cannot contact you for clarification, 1 Enforcement of Statutes, Orders, Rules, and pesticide’s registration is based on EPA may not be able to consider your Regulations, 130 FERC ¶ 61,220 (2010). current scientific and other knowledge, comment. Electronic files should avoid

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the use of special characters, any form listed under FOR FURTHER INFORMATION development, implementation, and of encryption, and be free of any defects CONTACT. enforcement of environmental laws, or viruses. regulations, and policies. To help B. What Should I Consider as I Prepare All documents in the docket are listed address potential environmental justice My Comments for EPA? in the docket index available at http:// issues, the Agency seeks information on www.regulations.gov. Although listed in 1. Submitting CBI. Do not submit this any groups or segments of the the index, some information is not information to EPA through population who, as a result of their publicly available, e.g., CBI or other regulations.gov or e-mail. Clearly mark location, cultural practices, or other information whose disclosure is the part or all of the information that factors, may have atypical or restricted by statute. Certain other you claim to be CBI. For CBI disproportionately high and adverse material, such as copyrighted material, information in a disk or CD-ROM that human health impacts or environmental is not placed on the Internet and will be you mail to EPA, mark the outside of the effects from exposure to the pesticide(s) publicly available only in hard copy disk or CD-ROM as CBI and then discussed in this document, compared form. Publicly available docket identify electronically within the disk or to the general population. materials are available either in the CD-ROM the specific information that is II. Authority electronic docket at http:// claimed as CBI. In addition to one www.regulations.gov, or, if only complete version of the comment that EPA is initiating its reviews of the available in hard copy, at the OPP includes information claimed as CBI, a pesticides identified in this document Regulatory Public Docket in Rm. S– copy of the comment that does not pursuant to section 3(g) of the Federal 4400, One Potomac Yard (South Bldg.), contain the information claimed as CBI Insecticide, Fungicide, and Rodenticide 2777 S. Crystal Dr., Arlington, VA. The must be submitted for inclusion in the Act (FIFRA) and the Procedural hours of operation of this Docket public docket. Information so marked Regulations for Registration Review at Facility are from 8:30 a.m. to 4 p.m., will not be disclosed except in 40 CFR part 155, subpart C. Section 3(g) Monday through Friday, excluding legal accordance with procedures set forth in of FIFRA provides, among other things, holidays. The Docket Facility telephone 40 CFR part 2. that the registrations of pesticides are to 2. Tips for preparing your comments. number is (703) 305–5805. be reviewed every 15 years. Under When submitting comments, remember FOR FURTHER INFORMATION CONTACT: For FIFRA section 3(a), a pesticide product to: pesticide specific information contact: i. Identify the document by docket ID may be registered or remain registered The Chemical Review Manager number and other identifying only if it meets the statutory standard identified in the table in Unit III.A. for information (subject heading, Federal for registration given in FIFRA section the pesticide of interest. Register date and page number). 3(c)(5). When used in accordance with For general information contact: ii. Follow directions. The Agency may widespread and commonly recognized Lance Wormell, Antimicrobials Division ask you to respond to specific questions practice, the pesticide product must (7510P), Office of Pesticide Programs, or organize comments by referencing a perform its intended function without Environmental Protection Agency, 1200 Code of Federal Regulations (CFR) part unreasonable adverse effects on the Pennsylvania Ave., NW., Washington, or section number. environment; that is, without any DC 20460–0001; telephone number: iii. Explain why you agree or disagree; unreasonable risk to man or the (703) 603–0523; fax number: (703) 308– suggest alternatives and substitute environment, or a human dietary risk 8090; e-mail address: language for your requested changes. from residues that result from the use of [email protected]. iv. Describe any assumptions and a pesticide in or on food. SUPPLEMENTARY INFORMATION: provide any technical information and/ III. Registration Reviews or data that you used. I. General Information v. If you estimate potential costs or A. What Action is the Agency Taking? A. Does this Action Apply to Me? burdens, explain how you arrived at your estimate in sufficient detail to As directed by FIFRA section 3(g), This action is directed to the public allow for it to be reproduced. EPA is reviewing the pesticide in general, and may be of interest to a vi. Provide specific examples to registrations identified in the table in wide range of stakeholders including illustrate your concerns and suggest this unit to assure that they continue to environmental, human health, alternatives. satisfy the FIFRA standard for farmworker, and agricultural advocates; vii. Explain your views as clearly as registration—that is, they can still be the chemical industry; pesticide users; possible, avoiding the use of profanity used without unreasonable adverse and members of the public interested in or personal threats. effects on human health or the the sale, distribution, or use of viii. Make sure to submit your environment. A pesticide’s registration pesticides. Since others also may be comments by the comment period review begins when the Agency interested, the Agency has not deadline identified. establishes a docket for the pesticide’s attempted to describe all the specific 3. Environmental justice. EPA seeks to registration review case and opens the entities that may be affected by this achieve environmental justice, the fair docket for public review and comment. action. If you have any questions treatment and meaningful involvement At present, EPA is opening registration regarding the applicability of this action of any group, including minority and/or review dockets for the cases identified to a particular entity, consult the person low income populations, in the in the following table.

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TABLE—REGISTRATION REVIEW DOCKETS OPENING

Registration Review Case Name and Chemical Review Manager, Telephone Number, E-mail Number Docket ID Number Address

Decyl isononyl dimethyl ammonium EPA–HQ–OPP–2010–0005 Monisha Harris chloride (DIDAC) (case 5013) (703) 308–0410 [email protected]

1-(3-chloroally)-3,5,7,-Triaza-1- EPA–HQ–OPP–2010–0004 K. Avivah Jakob azoniaadamantane (CTAC)(Case (703) 305–1328 3069). [email protected]

Thymol (5-methyl-2-isopropyl-1-phe- EPA–HQ–OPP–2010–0002 Monisha Harris nol) (case 3143) (703) 308–0410 [email protected]

1,3,5-Triazine-2,4-diamine, N- EPA–HQ–OPP–2010–0003 Eliza Blair cyclopropyl-N’-(1,1-dimethylethyl)- (703) 308–7279 6-(methylthio)- (case 5031) [email protected]

B. Docket Content www.epa.gov/oppsrrd1/ Decyl isononyl dimethyl ammonium _ 1. Review dockets. The registration registration review. chloride, Dowicil 100, Thymol (5- 3. Information submission review dockets contain information that methyl-2-isopropyl-1-phenol), 1,3,5- requirements. Anyone may submit data the Agency may consider in the course Triazine-2,4-diamine, N-cyclopropyl-N’- or information in response to this of the registration review. The Agency (1,1-dimethylethyl)-6-(methylthio)-. document. To be considered during a may include information from its files Dated: February 23, 2010. pesticide’s registration review, the including, but not limited to, the Joan Harrigan Farrelly, submitted data or information must following information: Director, Antimicrobials Division, Office of • meet the following requirements: An overview of the registration • To ensure that EPA will consider Pesticide Programs. review case status. data or information submitted, [FR Doc. 2010–7239 Filed 3–30–10; 8:45 a.m.] • A list of current product interested persons must submit the data BILLING CODE 6560–50–S registrations and registrants. or information during the comment • Federal Register notices regarding period. The Agency may, at its any pending registration actions. discretion, consider data or information ENVIRONMENTAL PROTECTION • Federal Register notices regarding submitted at a later date. AGENCY current or pending tolerances. • The data or information submitted • Risk assessments. [EPA–HQ–OPP–2010–0179; FRL–8816–6] must be presented in a legible and • Bibliographies concerning current useable form. For example, an English Kasugamycin; Receipt of Application registrations. translation must accompany any for Emergency Exemption, Solicitation • Summaries of incident data. material that is not in English and a of Public Comment • Any other pertinent data or written transcript must accompany any information. AGENCY: information submitted as an Environmental Protection Each docket contains a document Agency (EPA). summarizing what the Agency currently audiographic or videographic record. Written material may be submitted in ACTION: Notice. knows about the pesticide case and a paper or electronic form. preliminary work plan for anticipated • SUMMARY: EPA has received a specific Submitters must clearly identify exemption request from the Michigan data and assessment needs. Additional the source of any submitted data or documents provide more detailed Department of Agriculture to use the information. pesticide kasugamycin (CAS No. 6980– information. During this public • Submitters may request the 18–3 to treat up to 10,000 acres of comment period, the Agency is asking Agency to reconsider data or apples to control fire blight. The that interested persons identify any information that the Agency rejected in additional information they believe the a previous review. However, submitters applicant proposes the use of a new Agency should consider during the must explain why they believe the chemical which has not been registered registration reviews of these pesticides. Agency should reconsider the data or by EPA. EPA is soliciting public The Agency identifies in each docket information in the pesticide’s comment before making the decision the areas where public comment is registration review. whether or not to grant the exemption. specifically requested, though comment • As provided in 40 CFR 155.58, the DATES: Comments must be received on in any area is welcome. registration review docket for each or before April 15, 2010. 2. Other related information. More pesticide case will remain publicly ADDRESSES: Submit your comments, information on these cases, including accessible through the duration of the identified by docket identification (ID) the active ingredients for each case, may registration review process; that is, until number EPA–HQ–OPP–2010–0179, by be located in the registration review all actions required in the final decision one of the following methods: schedule on the Agency’s website at on the registration review case have • Federal eRulemaking Portal: http:// http://www.epa.gov/oppsrrd1/ been completed. www.regulations.gov. Follow the on-line registration_review/schedule.htm . instructions for submitting comments. Information on the Agency’s registration List of Subjects • Mail: Office of Pesticide Programs review program and its implementing Environmental protection, (OPP) Regulatory Public Docket (7502P), regulation may be seen at http:// Antimicrobials, Pesticides and pests, Environmental Protection Agency, 1200

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Pennsylvania Ave., NW., Washington, Regulatory Public Docket in Rm. S– public docket. Information so marked DC 20460–0001. 4400, One Potomac Yard (South Bldg.), will not be disclosed except in • Delivery: OPP Regulatory Public 2777 S. Crystal Dr., Arlington, VA. The accordance with procedures set forth in Docket (7502P), Environmental hours of operation of this Docket 40 CFR part 2. Protection Agency, Rm. S–4400, One Facility are from 8:30 a.m. to 4 p.m., 2. Tips for preparing your comments. Potomac Yard (South Bldg.), 2777 S. Monday through Friday, excluding legal When submitting comments, remember Crystal Dr., Arlington, VA. Deliveries holidays. The Docket Facility telephone to: are only accepted during the Docket number is (703) 305–5805. i. Identify the document by docket ID Facility’s normal hours of operation FOR FURTHER INFORMATION CONTACT: Keri number and other identifying (8:30 a.m. to 4 p.m., Monday through Grinstead, Registration Division information (subject heading, Federal Friday, excluding legal holidays). (7505P), Office of Pesticide Programs, Register date and page number). Special arrangements should be made Environmental Protection Agency, 1200 ii. Follow directions. The Agency may for deliveries of boxed information. The Pennsylvania Ave., NW., Washington, ask you to respond to specific questions Docket Facility telephone number is DC 20460–0001; telephone number: or organize comments by referencing a (703) 305–5805. (703) 308–8373; fax number: (703) 605– Code of Federal Regulations (CFR) part Instructions: Direct your comments to 0781; e-mail address: or section number. docket ID number EPA–HQ–OPP–2010– [email protected]. iii. Explain why you agree or disagree; 0179. EPA’s policy is that all comments suggest alternatives and substitute received will be included in the docket SUPPLEMENTARY INFORMATION: language for your requested changes. without change and may be made I. General Information iv. Describe any assumptions and available on-line at http:// provide any technical information and/ www.regulations.gov, including any A. Does this Action Apply to Me? or data that you used. personal information provided, unless You may be potentially affected by v. If you estimate potential costs or the comment includes information this action if you are an agricultural burdens, explain how you arrived at claimed to be Confidential Business producer, food manufacturer, or your estimate in sufficient detail to Information (CBI) or other information pesticide manufacturer. Potentially allow for it to be reproduced. whose disclosure is restricted by statute. affected entities may include, but are vi. Provide specific examples to Do not submit information that you not limited to: illustrate your concerns and suggest consider to be CBI or otherwise • Crop production (NAICS code 111). alternatives. protected through regulations.gov or e- • Animal production (NAICS code vii. Explain your views as clearly as mail. The regulations.gov website is an 112). possible, avoiding the use of profanity ‘‘anonymous access’’ system, which • Food manufacturing (NAICS code or personal threats. means EPA will not know your identity 311). viii. Make sure to submit your or contact information unless you • Pesticide manufacturing (NAICS comments by the comment period provide it in the body of your comment. code 32532). deadline identified. If you send an e-mail comment directly This listing is not intended to be 3. Environmental justice. EPA seeks to to EPA without going through exhaustive, but rather provides a guide achieve environmental justice, the fair regulations.gov, your e-mail address for readers regarding entities likely to be treatment and meaningful involvement will be automatically captured and affected by this action. Other types of of any group, including minority and/or included as part of the comment that is entities not listed in this unit could also low income populations, in the placed in the docket and made available be affected. The North American development, implementation, and on the Internet. If you submit an Industrial Classification System enforcement of environmental laws, electronic comment, EPA recommends (NAICS) codes have been provided to regulations, and policies. To help that you include your name and other assist you and others in determining address potential environmental justice contact information in the body of your whether this action might apply to issues, the Agency seeks information on comment and with any disk or CD-ROM certain entities. If you have any any groups or segments of the you submit. If EPA cannot read your questions regarding the applicability of population who, as a result of their comment due to technical difficulties this action to a particular entity, consult location, cultural practices, or other and cannot contact you for clarification, the person listed under FOR FURTHER factors, may have atypical or EPA may not be able to consider your INFORMATION CONTACT. disproportionately high and adverse comment. Electronic files should avoid human health impacts or environmental B. What Should I Consider as I Prepare the use of special characters, any form effects from exposure to the pesticides My Comments for EPA? of encryption, and be free of any defects discussed in this document, compared or viruses. 1. Submitting CBI. Do not submit this to the general population. Docket: All documents in the docket information to EPA through are listed in the docket index available www.regulations.gov or e-mail. Clearly II. What Action is the Agency Taking? at http://www.regulations.gov. Although mark the part or all of the information Under section 18 of the Federal listed in the index, some information is that you claim to be CBI. For CBI Insecticide, Fungicide, and Rodenticide not publicly available, e.g., CBI or other information in a disk or CD-ROM that Act (FIFRA) (7 U.S.C. 136p), at the information whose disclosure is you mail to EPA, mark the outside of the discretion of the Administrator, a restricted by statute. Certain other disk or CD-ROM as CBI and then Federal or State agency may be material, such as copyrighted material, identify electronically within the disk or exempted from any provision of FIFRA is not placed on the Internet and will be CD-ROM the specific information that is if the Administrator determines that publicly available only in hard copy claimed as CBI. In addition to one emergency conditions exist which form. Publicly available docket complete version of the comment that require the exemption. Michigan materials are available either in the includes information claimed as CBI, a Department of Agriculture has requested electronic docket at http:// copy of the comment that does not the Administrator to issue a specific www.regulations.gov, or, if only contain the information claimed as CBI exemption for the use of kasugamycin available in hard copy, at the OPP must be submitted for inclusion in the on apples to control fire blight.

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Information in accordance with 40 CFR pesticide continues to satisfy the from 8:30 a.m. to 4 p.m., Monday part 166 was submitted as part of this statutory standard for registration, that through Friday, excluding legal request. is, that the pesticide can perform its holidays. The Docket Facility telephone As part of this request, the applicant intended function without causing number is (703) 305–5805. unreasonable adverse effects on human asserts that kasugamycin is needed to II. Background control streptomycin-resistant strains of health or the environment. Through this Erwinia amylovora, the causal pathogen program, EPA is ensuring that each A. What Action is the Agency Taking? of fire blight, due to the lack of available pesticide’s registration is based on Pursuant to 40 CFR 155.58(c), this alternatives and effective control current scientific and other knowledge, notice announces the availability of practices. Without the use of including its effects on human health EPA’s final registration review decision kasugamycin the applicant states that and the environment. for bromine, case 4015. Bromine is a up to 50% of the yield of susceptible FOR FURTHER INFORMATION CONTACT: For bromide releasing antimicrobial apple varieties could be lost in 2010. pesticide specific information, contact: pesticide that is registered as a The Applicant proposes to make no K. Avivah Jakob, Antimicrobials mildewstat/mildewcide, bactericide, more than three applications of Division (7510P), Office of Pesticide fungistate, fungicide, virucide, and Kasumin 2L on 10,000 acres of apples Programs, Environmental Protection insecticide. Bromine is registered for between April 20, 2010 and May 31, Agency, 1200 Pennsylvania Ave., NW., use to control bacteria and fungi on 2010 in Berrien, Cass, Ionia, Kent, Washington, DC 20460–0001; telephone surfaces of agricultural, commercial, Montcalm, Newaygo, Oceana, Ottawa, number: (703) 305–1328; fax number: institutional, industrial, residential, and and Van Buren counties in Michigan. As (703) 308–8090; e-mail address: public access premises and equipment. currently proposed, the maximum [email protected]. It is also registered for use to treat/ amount of product to be applied would For general information on the disinfect potable water (examples of be 15,000 gallons. registration review program, contact: potable water system treatment sites This notice does not constitute a Lance Wormell, Antimicrobials Division include, but are not restricted to, aboard decision by EPA on the application (7510P), Office of Pesticide Programs, ships and on oil and gas drilling/ itself. The regulations governing section Environmental Protection Agency, 1200 production platforms). 18 of FIFRA require publication of a Pennsylvania Ave., NW., Washington, Pursuant to 40 CFR 155.57, a notice of receipt of an application for a DC 20460–0001; telephone number: registration review decision is the specific exemption proposing use of a (703) 603–0523; fax number: (703) 308– Agency’s determination whether a new chemical (i.e., an active ingredient) 8090; e-mail address: wormell.lance pesticide meets, or does not meet, the which has not been registered by EPA. @epa.gov. standard for registration in FIFRA. EPA The notice provides an opportunity for SUPPLEMENTARY INFORMATION: has considered bromine in light of the public comment on the application. FIFRA standard for registration. The The Agency will review and consider I. General Information Final Decision document in the docket all comments received during the A. Does this Action Apply to Me? describes the Agency’s rationale for issuing a registration review final comment period in determining This action is directed to the public whether to issue the specific exemption decision for this pesticide. in general, and may be of interest to a In addition to the final registration requested by the Michigan Department wide range of stakeholders including of Agriculture. review decision document, the environmental, human health, farm registration review docket for bromine List of Subjects worker, and agricultural advocates; the also includes other relevant documents chemical industry; pesticide users; and Environmental protection, Pesticides related to the registration review of this members of the public interested in the and pests. case. The combined final work plan and sale, distribution, or use of pesticides. proposed registration review decision Dated: March 12, 2010. Since others also may be interested, the was posted to the docket and the public Daniel J. Rosenblatt, Agency has not attempted to describe all was invited to submit any comments or Acting Director, Registration Division, Office the specific entities that may be affected new information. During the 60–day of Pesticide Programs. by this action. If you have any questions comment period, no public comments [FR Doc. 2010–6790 Filed 3–30–10; 8:45 am] regarding the applicability of this action were received. BILLING CODE 6560–50–S to a particular entity, consult the Pursuant to 40 CFR 155.58(c), the pesticide specific contact person listed registration review case docket for under FOR FURTHER INFORMATION bromine will remain open until all ENVIRONMENTAL PROTECTION CONTACT. actions required in the final decision AGENCY B. How Can I Get Copies of this have been completed. [EPA–HQ–OPP–2009–0167; FRL–8811–4] Document and Other Related Background on the registration review Information? program is provided at: http:// Bromine Registration Review Final www.epa.gov/oppsrrd1/ Decision; Notice of Availability EPA has established a docket for this registration_review. Links to earlier action under docket identification (ID) documents related to the registration AGENCY: Environmental Protection number EPA–HQ–OPP–2009–0167. review of this pesticide are provided at: Agency (EPA). Publicly available docket materials are http://www.epa.gov/oppsrrd1/ ACTION: Notice. available either in the electronic docket registration_review/bromine/index.htm at http://www.regulations.gov, or, if only . SUMMARY: This notice announces the available in hard copy, at the Office of availability of EPA’s final registration Pesticide Programs (OPP) Regulatory B. What is the Agency’s Authority for review decision for the pesticide Public Docket in Rm. S–4400, One Taking this Action? Bromine, case 4015. Registration review Potomac Yard (South Bldg.), 2777 S. Section 3(g) of FIFRA and 40 CFR part is EPA’s periodic review of pesticide Crystal Dr., Arlington, VA. The hours of 155, subpart C, provide authority for registrations to ensure that each operation of this Docket Facility are this action.

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List of Subjects Agency, 1200 Pennsylvania Ave., NW., registrant of the products in Table 1 of Environmental protection, Washington, DC 20460–0001; telephone this unit, in sequence by EPA company Registration review, Pesticides and number: (703) 306–0469; fax number: number. pests, Antimicrobials, Bromine. (703) 308–7070; e-mail address: [email protected]. TABLE 2.—REGISTRANTS OF Dated: February 3, 2010. CANCELLED AND AMENDED USE Joan Harrigan Farrelly. SUPPLEMENTARY INFORMATION: Director, Antimicrobials Division, Office of I. General Information EPA Company Company Name and Ad- Pesticide Programs. Number dress A. Does this Action Apply to Me? [FR Doc. 2010–7045 Filed 3–30–10; 8:45 am] BILLING CODE 6560–50–S This action is directed to the public 10163 Gowan Company in general, and may be of interest to a P.O. Box 5569 wide range of stakeholders including Yuma, AZ 85366-5569 ENVIRONMENTAL PROTECTION environmental, human health, and AGENCY agricultural advocates; the chemical III. Summary of Public Comments Received and Agency Response to [EPA–HQ–OPP–2005–0265; FRL–8815–8] industry; pesticide users; and members of the public interested in the sale, Comments Dicloran; Cancellation Order for distribution, or use of pesticides. Since During the public comment period Amendment to Terminate a Use of others also may be interested, the provided, EPA received no comments in DCNA Pesticide Registrations Agency has not attempted to describe all response to the December 2, 2009 the specific entities that may be affected Federal Register notice announcing the AGENCY: Environmental Protection by this action. If you have any questions Agency’s receipt of the request for Agency (EPA). regarding the applicability of this action voluntary cancellation and amendment ACTION: Notice. to a particular entity, consult the person to terminate use on carrots of products listed under FOR FURTHER INFORMATION SUMMARY: This notice announces EPA’s listed in Table 1 in Unit II. CONTACT. order for the label amendment, which IV. Cancellation Order was voluntarily requested by the B. How Can I Get Copies of this Pursuant to FIFRA section 6(f), EPA registrant and accepted by the Agency, Document and Other Related hereby approves the requested to terminate use on carrots for pesticide Information? amendment to terminate the carrot use registrations listed in Table 1 in Unit II. EPA has established a docket for this of dicloran registrations identified in pursuant to section 6(f)(1) of the Federal action under docket identification (ID) Table 1 in Unit II. Accordingly, the Insecticide, Fungicide, and Rodenticide number EPA–HQ–OPP–2005–0265. Agency for product registrations Act (FIFRA), as amended. This Publicly available docket materials are identified in Table 1 in Unit II. Any cancellation order follows a December available either in the electronic docket distribution, sale, or use of existing 2, 2009 (74 FR 63151) Federal Register at http://www.regulations.gov, or, if only Notice of Receipt of Request from the stocks of the products identified in available in hard copy, at the Office of registrant listed in Table 2 in Unit II. to Table 1 in Unit II. in a manner Pesticide Programs (OPP) Regulatory voluntarily amend to terminate dicloran inconsistent with any of the Provisions Public Docket in Rm. S–4400, One (DCMA) use on carrots. In its December for Disposition of Existing Stocks set Potomac Yard (South Bldg.), 2777 S. 2, 2009 Notice, EPA indicated that it forth in Unit VI. will be considered a Crystal Dr., Arlington, VA. The hours of would issue an order implementing the violation of FIFRA. operation of this Docket Facility are cancellation and amendment to from 8:30 a.m. to 4 p.m., Monday V. What is the Agency’s Authority for terminate the use on carrot, unless the through Friday, excluding legal Taking this Action? Agency received substantive comments holidays. The Docket Facility telephone Section 6(f)(1) of FIFRA provides that within the 30–day comment period that number is (703) 305–5805. a registrant of a pesticide product may would merit its further review of these at any time request that any of its requests, or unless the registrant II. What Action is the Agency Taking? pesticide registrations be canceled or withdrew their request within this This notice announces the amended to terminate one or more uses. period. The 30–day comment period amendment to terminate use on carrots, FIFRA further provides that, before ended on January 4, 2010, at which time as requested by registrants, of products acting on the request, EPA must publish the Agency did not receive any registered under section 3 of FIFRA. The a notice of receipt of any such request comments on the notice. Further, the affected registrations are listed in in the Federal Register. Thereafter, registrant did not withdraw their sequence by registration number in following the public comment period, request. Accordingly, EPA hereby issues Table 1 of this unit. the Administrator may approve such a in this notice a cancellation order request. granting the requested use termination. TABLE 1.—DICLORAN REGISTRATION VI. Provisions for Disposition of Any distribution, sale, or use of the WITH CARROT USE CANCELLATION products subject to this cancellation Existing Stocks order is permitted only in accordance EPA’s existing stocks policy (56 FR EPA Registration Product Name with the terms of this order, including Number 29362) provides that: ‘‘If a registrant any existing stocks provisions. requests to voluntarily cancel a DATES: The cancellations are effective as 10163-189 Botran 75-W Fungicide registration where the Agency has published in the Federal Register on 10163-195 Botran Technical identified no particular risk concerns, November 2, 2010. the registrant has complied with all FOR FURTHER INFORMATION CONTACT: 10163-226 Botran 5-F Fungicide applicable conditions of reregistration, James Parker, Pesticides Re-evaluation conditional registration, and data call Division (7508P) , Office of Pesticide Table 2 of this unit includes the ins, and the registration is not subject to Programs, Environmental Protection names and addresses of record for the a Registration Standard, Label

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Improvement Program, or reregistration 635/R–10/003). The draft assessment May 4, 2010, indicate that you wish to decision, the Agency will generally was prepared by the National Center for make oral comments at the session, and permit a registrant to sell or distribute Environmental Assessment (NCEA) indicate the length of your presentation. existing stocks for 1 year after the within EPA’s Office of Research and When you register, please indicate if cancellation request was received. Development (ORD). The public you will need audio-visual aid (e.g., Persons other than registrants will comment period and external peer laptop computer and slide projector). In generally be allowed to sell, distribute, review meeting, which will be general, each presentation should be no or use existing stocks until such stocks scheduled at a later date and announced more than 30 minutes. If, however, there are exhausted.’’ in the Federal Register, are separate are more requests for presentations than Existing stocks are those stocks of processes that provide opportunities for the allotted time allows, then the time registered pesticide products which are all interested parties to comment on the limit for each presentation will be currently in the United States and assessment. EPA intends to forward the adjusted. A copy of the agenda for the which were packaged, labeled, and public comments that are submitted in listening session will be available at the released for shipment prior to the accordance with this notice to the peer meeting. If no speakers have registered effective date of the cancellation action. review panel prior to the meeting for by May 4, 2010, the listening session The effective date of this use their consideration. When finalizing the will be cancelled, and EPA will notify cancellation is November 2, 2010. The draft assessment, EPA intends to those registered of the cancellation. cancellation order that is the subject of consider any public comments that EPA Listening session participants who this notice includes the following receives in accordance with this notice. want EPA to share their comments with existing stock provisions: EPA is also announcing a listening the external peer reviewers should also The registrant may sell and distribute session to be held on May 11, 2010, submit written comments during the existing stocks of products listed in during the public comment period for public comment period using the Table 1 in Unit II. until November 2, this draft assessment. This listening detailed and established procedures 2010. Persons other than the registrant session is a step in EPA’s revised IRIS described in the SUPPLEMENTARY may sell and distribute existing stocks process, announced on May 21, 2009, INFORMATION section of this notice. of products listed in Table 1 in Unit II. for developing human health Comments submitted to the docket prior until exhausted. Use of the products assessments for inclusion in the IRIS to the end of the public comment period listed in Table 1 in Unit II. may be database. The purpose of the listening will be submitted to the external peer exhausted, provided that such use is session is to allow all interested parties reviewers and considered by EPA in the consistent with the terms of the to present scientific and technical disposition of public comments. All previously approved labeling on, or that comments on draft IRIS health comments received will be submitted to accompanied, the canceled product. assessments to EPA and other interested the docket, but comments received after parties during the public comment the public comment period closes will List of Subjects period and before the peer review not be submitted to the external peer Environmental protection, Pesticides meeting. EPA welcomes the comments reviewers and will only be considered and pests. that will be provided to the Agency by by EPA if time permits. Dated: March 16, 2010. the listening session participants. The ADDRESSES: The draft ‘‘Toxicological comments will be considered by the Richard P. Keigwin, Jr., Review of Dichloromethane: In Support Agency as it revises the draft assessment of Summary Information on the Director, Pesticides Re-evalution Division, in response to the independent SAB Office of Pesticide Programs. Integrated Risk Information System peer review and the public comments. (IRIS)’’ is available primarily via the [FR Doc. 2010–6887 Filed 3–30–10; 8:45 am] All presentations submitted to EPA Internet on the NCEA home page under BILLING CODE 6560–50–S according to the instructions below will the Recent Additions and Publications become part of the official public menus at http://www.epa.gov/ncea. A record. limited number of paper copies are ENVIRONMENTAL PROTECTION EPA is releasing this draft assessment available from the Information AGENCY solely for the purpose of pre- Management Team (Address: [FRL–9132–5; Docket ID No. EPA–HQ–ORD– dissemination peer review under Information Management Team, 2010–0224] applicable information quality National Center for Environmental guidelines. This assessment has not Assessment (Mail Code: 8601P), U.S. Draft Toxicological Review of been formally disseminated by EPA. It Environmental Protection Agency, 1200 Dichloromethane: In Support of does not represent and should not be Pennsylvania Avenue, NW., Summary Information on the construed to represent any Agency Washington, DC 20460; telephone: 703– Integrated Risk Information System policy or determination. 347–8561; facsimile: 703–347–8691). If (IRIS) DATES: The public comment period you request a paper copy, please AGENCY: Environmental Protection begins March 31, 2010, and ends June provide your name, mailing address, Agency (EPA). 1, 2010. Comments should be in writing and the assessment title. ACTION: Notice of Public Comment and must be received by EPA by June Comments may be submitted Period and Listening Session. 1, 2010. electronically via http:// The listening session on the draft www.regulations.gov, by e-mail, by mail, SUMMARY: EPA is announcing a 60-day assessment for dichloromethane will be by facsimile, or by hand delivery/ public comment period and a public held on May 11, 2010, beginning at 9 courier. Please follow the detailed listening session for the external review a.m. and ending at 4 p.m., Eastern instructions provided in the draft human health assessment titled, Daylight Time. If you would like to SUPPLEMENTARY INFORMATION section of ‘‘Toxicological Review of attend the listening session, you should this notice. Dichloromethane: In Support of register by May 4, 2010. If you would The listening session on the draft Summary Information on the Integrated like to make a presentation at the Dichloromethane assessment will be Risk Information System (IRIS)’’ (EPA/ listening session, you should register by held at the EPA offices at Potomac Yard

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North Building, Room 7100, 2733 South Protection Agency, 1200 Pennsylvania 2822T), U.S. Environmental Protection Crystal Drive, Arlington, Virginia 22202. Ave., NW., Washington, DC 20460; Agency, 1200 Pennsylvania Ave., NW., To attend or give verbal comments at telephone: 202–566–1752; facsimile: Washington, DC 20460. The telephone the listening session, register by May 4, 202–566–1753; or e-mail: number is 202–566–1752. If you provide 2010, via the Internet at https:// [email protected]. comments by mail, please submit one www2.ergweb.com/projects/ For information on the public unbound original with pages numbered conferences/peerreview/register- listening session, please contact consecutively, and three copies of the dichl.htm. You may also register via e- Christine Ross, IRIS Staff, National comments. For attachments, provide an mail at [email protected] (subject line: Center for Environmental Assessment index, number pages consecutively with Dichloromethane Listening Session), (Mail Code: 8601P), U.S. Environmental the comments, and submit an unbound please indicate whether you would like Protection Agency, 1200 Pennsylvania original and three copies. to make oral comments, and include Avenue, NW., Washington, DC 20460; • Hand Delivery: The OEI Docket is your name, title, affiliation, full address telephone: 703–347–8592; facsimile: located in the EPA Headquarters Docket and contact information). You may also 703–347–8689; or e-mail: Center, EPA West Building, Room 3334, register by phone at 781–674–7374 or [email protected]. 1301 Constitution Ave., NW., toll free at 800–803–2833, or by faxing If you have questions about the Washington, DC. The EPA Docket a registration request to 781–674–2906 assessment, please contact Glinda S. Center’s Public Reading Room is open (please reference the ‘‘Dichloromethane Cooper, National Center for from 8:30 a.m. to 4:30 p.m., Monday Listening Session’’ and include your Environmental Assessment, U.S. through Friday, excluding legal name, title, affiliation, full address and Environmental Protection Agency, 1200 holidays. The telephone number for the contact information). Please note that to Pennsylvania Ave., 8601P, Washington, Public Reading Room is 202–566–1744. gain entrance to this EPA building to DC 20460, telephone: 703–347–8636; Deliveries are only accepted during the attend the meeting, attendees must have facsimile: 703–347–8689; or e-mail: docket’s normal hours of operation, and photo identification with them and [email protected]. special arrangements should be made must register at the guard’s desk in the SUPPLEMENTARY INFORMATION: for deliveries of boxed information. If you provide comments by hand lobby. The guard will retain your photo I. Information About IRIS identification and will provide you with delivery, please submit one unbound a visitor’s badge. At the guard’s desk, EPA’s IRIS is a human health original with pages numbered attendees should give the name assessment program that evaluates consecutively, and three copies of the Christine Ross and the telephone quantitative and qualitative risk comments. For attachments, provide an number 703–347–8592 to the guard on information on effects that may result index, number pages consecutively with duty. The guard will contact Ms. Ross from exposure to specific chemical the comments, and submit an unbound who will meet you in the reception area substances found in the environment. original and three copies. EPA recommends that you include to escort you to the meeting room. When Through the IRIS Program, EPA your name and other contact you leave the building, please return provides the highest quality science- information in the body of your your visitor’s badge to the guard and based human health assessments to comment and with any disk or CD–ROM you will receive your photo support the Agency’s regulatory you submit. If EPA cannot read your identification. activities. The IRIS database contains comment and cannot contact you for A teleconference line will also be information for more than 540 chemical clarification, EPA may not be able to available for registered attendees/ substances that can be used to support consider your comment. speakers. The teleconference number is the first two steps (hazard identification and dose-response evaluation) of the Instructions: Direct your comments to 866–299–3188 and the access code is Docket ID No. EPA–HQ–ORD–2010– 926–378–7897, followed by the pound risk assessment process. When supported by available data, IRIS 0224. Please ensure that your comments sign (#). The teleconference line will be are submitted within the specified activated at 8:45 a.m., and you will be provides oral reference doses (RfDs) and inhalation reference concentrations comment period. Comments received asked to identify yourself and your after the closing date will be marked affiliation at the beginning of the call. (RfCs) for chronic noncancer health effects and cancer assessments. ‘‘late,’’ and may only be considered if Information on Services for time permits. It is EPA’s policy to Individuals with Disabilities: EPA Combined with specific exposure information, government and private include all comments it receives in the welcomes public attendance at the public docket without change and to ‘‘Dichloromethane Listening Session’’ entities use IRIS to help characterize public health risks of chemical make the comments available online at and will make every effort to http://www.regulations.gov, including substances in a site-specific situation accommodate persons with disabilities. any personal information provided, and thereby support risk management For information on access or services for unless a comment includes information decisions designed to protect public individuals with disabilities, please claimed to be Confidential Business health. contact Christine Ross by phone: 703– Information (CBI) or other information 347–8592 or by e-mail at II. How To Submit Comments to the whose disclosure is restricted by statute. [email protected]. To request Docket at http://www.regulations.gov Do not submit information that you accommodation of a disability, please Submit your comments, identified by consider to be CBI or otherwise make the proper notification, preferably Docket ID No. EPA–HQ–ORD–2010– protected through http:// at least 10 days prior to the meeting, to 0224, by one of the following methods: www.regulations.gov or e-mail. The give EPA as much time as possible to • http://www.regulations.gov: Follow http://www.regulations.gov Web site is process your request. the on-line instructions for submitting an ‘‘anonymous access’’ system, which FOR FURTHER INFORMATION CONTACT: For comments. means EPA will not know your identity information on the public comment • E-mail: [email protected]. or contact information unless you period, please contact the Office of • Facsimile: 202–566–1753. provide it in the body of your comment. Environmental Information (OEI) Docket • Mail: Office of Environmental If you send an e-mail comment directly (Mail Code: 2822T), U.S. Environmental Information (OEI) Docket (Mail Code: to EPA without going through http://

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www.regulations.gov, your e-mail DATES: There will be a public (RfCs) for noncancer effects and oral address will be automatically captured teleconference on April 20, 2010 from slope factors and oral and inhalation and included as part of the comment 2:30 p.m. to 4:30 p.m. (Eastern Time). unit risks for cancer effects. IRIS is that is placed in the public docket and The public meeting will be held on May prepared and maintained by EPA’s made available on the Internet. If you 10, 2010 from 9 a.m. to 5 p.m. (Eastern National Center for Environmental submit an electronic comment, EPA Time), May 11, 2010 from 9 a.m. to 5 Assessment (NCEA) within the Office of recommends that you include your p.m. and May 12, 2010 from 9 a.m. to Research and Development (ORD). name and other contact information in 3 p.m. (Eastern time). In 2001, ORD developed a draft IRIS the body of your comment and with any ADDRESSES: The teleconference will be Toxicological Assessment for TCE, disk or CD–ROM you submit. If EPA conducted by phone only. The face-to- which was released for public comment cannot read your comment due to face meeting on May 10–12, 2010 will and external peer review. In 2002, the technical difficulties and cannot contact be held at The Hilton Embassy Row Environmental Health Committee of the you for clarification, EPA may not be Hotel, 2015 Massachusetts Avenue, SAB reviewed the draft TCE Assessment able to consider your comment. NW., Washington, DC 20036; telephone and made several recommendations to Electronic files should avoid the use of (202) 265–1600. strengthen the dose-response special characters and any form of FOR FURTHER INFORMATION CONTACT: Any assessment. In 2004, in preparation for encryption and be free of any defects or member of the public wishing to obtain development of a new TCE assessment, viruses. For additional information information concerning the public the National Research Council (NRC) about EPA’s public docket visit the EPA teleconference and/or public meeting was requested to provide a scientific Docket Center homepage at http:// may contact Dr. Marc Rigas, Designated consultation on key scientific issues www.epa.gov/epahome/dockets.htm. Federal Officer (DFO), EPA Science related to assessing the human health Docket: All documents in the docket Advisory Board Staff Office (1400F), risks of TCE, including those relevant to hazard characterization/mode of action, are listed in the http:// U.S. Environmental Protection Agency, physiologically-based pharmacokinetic www.regulations.gov index. Although 1200 Pennsylvania Avenue, NW., (PBPK) modeling, and dose-response listed in the index, some information is Washington, DC 20460; by telephone/ assessment. ORD has taken the not publicly available, e.g., CBI or other voice mail at (202) 343–9978 or at recommendations and conclusions information whose disclosure is [email protected]. General included in the NRC’s report, which restricted by statute. Certain other information about the SAB, as well as was released in 2006, into account as it material, such as copyrighted material, any updates concerning the meeting developed a new revised draft IRIS will be publicly available only in hard announced in this notice, may be found Toxicological Assessment for TCE. ORD copy. Publicly available docket on the EPA Web site at http:// has requested that the SAB review its materials are available either www.epa.gov/sab. electronically in http:// revised draft assessment. SUPPLEMENTARY INFORMATION: Pursuant In response to ORD’s request, the SAB www.regulations.gov or in hard copy at to the Federal Advisory Committee Act Staff Office solicited nominations of the OEI Docket in the EPA Headquarters (FACA), 5 U.S.C., App. 2, notice is experts and formed a review panel for Docket Center. hereby given that the SAB TCE [Federal Register Notice dated Dated: March 25, 2010. Trichloroethylene Review Panel will October 22, 2009 (74 FR 54563–54564)]. Lynn Flowers, hold a public teleconference to discuss The panel will conduct a review of Acting Director, National Center for the plans for the subsequent public face- EPA’s October 2009 External Review Environmental Assessment. to-face meeting to conduct a peer review Draft of its Toxicological Review of [FR Doc. 2010–7210 Filed 3–30–10; 8:45 am] of the EPA’s Toxicological Review of Trichloroethylene in Support of BILLING CODE 6560–50–P Trichloroethylene in Support of Summary Information on the Integrated Summary Information on the Integrated Risk Information System (IRIS). Risk Information System (IRIS), External Specifically, the panel is being asked to ENVIRONMENTAL PROTECTION Review Draft (October 2009). The SAB provide recommendations on AGENCY was established pursuant to 42 U.S.C. physiologically-based pharmacokinetic 4365 to provide independent scientific (PBPK) modeling, meta-analysis for [FRL–9132–1] and technical advice to the cancer epidemiology, components of the Administrator on the technical basis for TCE hazard assessment and dose- Science Advisory Board Staff Office; Agency positions and regulations. The response assessment. The purpose of the Notification of a Public Teleconference SAB is a Federal Advisory Committee teleconference is for the panel to receive and Public Meeting of the SAB chartered under FACA. The SAB will a briefing on the assessment and for Trichloroethylene (TCE) Review Panel comply with the provisions of FACA members to clarify the charge to the and all appropriate SAB Staff Office panel. During the face-to-face meeting, AGENCY: Environmental Protection procedural policies. the panel will review the assessment. Agency (EPA). Background: EPA’s Integrated Risk Availability of Meeting Materials: ACTION: Notice. Information System (IRIS) is an Agendas and materials in support of electronic database containing these meetings will be placed on the SUMMARY: The EPA Science Advisory descriptive and quantitative EPA Web site at http://www.epa.gov/sab Board (SAB) Staff Office announces two toxicological information on human in advance of each meeting. For public meetings of the SAB health effects that may result from technical questions and information Trichloroethylene (TCE) Review Panel: chronic exposure to various substances concerning EPA’s draft document, a teleconference and a face-to-face in the environment. This information please contact Dr. Weihsueh Chiu at meeting to review EPA’s Toxicological supports human health risk assessments (703) 347–8607, or Review of Trichloroethylene in Support and includes hazard identification, [email protected]. of Summary Information on the dose-response data and derivations of Procedures for Providing Public Input: Integrated Risk Information System oral reference doses (RfDs) and Interested members of the public may (IRIS), External Review Draft. inhalation reference concentrations submit relevant written or oral

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information for the SAB ENVIRONMENTAL PROTECTION means EPA will not know your identity Trichloroethylene Review Panel to AGENCY or contact information unless you provide it in the body of your comment. consider during this advisory activity. [EPA–HQ–OPP–2009–0936; FRL–8806–9] Oral Statements: In general, individuals If you send an e-mail comment directly or groups requesting an oral Antimicrobial Pesticide Products; to EPA without going through presentation at a public teleconference Registration Applications regulations.gov, your e-mail address will be limited to three minutes per will be automatically captured and speaker, with no more than a total of 30 AGENCY: Environmental Protection included as part of the comment that is minutes for all speakers. At the face-to- Agency (EPA). placed in the docket and made available face meeting, presentations will be ACTION: Notice. on the Internet. If you submit an limited to five minutes, with no more electronic comment, EPA recommends SUMMARY: This notice announces receipt than a total of one hour for all speakers. that you include your name and other of applications to register new contact information in the body of your Each person making an oral statement antimicrobial pesticide products comment and with any disk or CD-ROM should consider providing written containing new active ingredients, you submit. If EPA cannot read your comments as well as their oral statement pursuant to the provisions of section comment due to technical difficulties so that the points presented orally can 3(c) of the Federal Insecticide, and cannot contact you for clarification, be expanded upon in writing. Interested Fungicide, and Rodenticide Act EPA may not be able to consider your parties should contact Dr. Marc Rigas, (FIFRA), as amended. EPA is publishing comment. Electronic files should avoid DFO, in writing (preferably via e-mail) this notice of such applications, the use of special characters, any form at the contact information noted above pursuant to section 3(c)(4) of FIFRA. of encryption, and be free of any defects by April 13, 2010 for the teleconference DATES: Comments must be received on or viruses. and by May 3, 2010 for the face-to-face or before April 30, 2010. Docket: All documents in the docket meeting, to be placed on the list of ADDRESSES: Submit your comments, are listed in the docket index available public speakers. Written Statements: identified by docket identification (ID) at http://www.regulations.gov. Although Written statements should be supplied number specified for the pesticide of listed in the index, some information is to the DFO via e-mail at the contact interest as shown in Unit II., by one of not publicly available, e.g., CBI or other information noted above by April 13, the following methods: information whose disclosure is 2010 for the teleconference and by May • Federal eRulemaking Portal: http:// restricted by statute. Certain other 3, 2010 for the face-to-face meeting so www.regulations.gov. Follow the on-line material, such as copyrighted material, that the information may be made instructions for submitting comments. is not placed on the Internet and will be available to the Committee members for • Mail: Office of Pesticide Programs publicly available only in hard copy their consideration. Written statements (OPP) Regulatory Public Docket (7502P), form. Publicly available docket should be supplied in one of the Environmental Protection Agency, 1200 materials are available either in the following electronic formats: Adobe Pennsylvania Ave., NW., Washington, electronic docket at http:// Acrobat PDF, MS Word, MS DC 20460–0001. www.regulations.gov, or, if only PowerPoint, or Rich Text files in IBM– • Delivery: OPP Regulatory Public available in hard copy, at the OPP PC/Windows 98/2000/XP format. Docket (7502P), Environmental Regulatory Public Docket in Rm. S– Submitters are requested to provide Protection Agency, Rm. S–4400, One 4400, One Potomac Yard (South Bldg.), versions of signed documents, Potomac Yard (South Bldg.), 2777 S. 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket submitted with and without signatures, Crystal Dr., Arlington, VA. Deliveries Facility are from 8:30 a.m. to 4 p.m., because the SAB Staff Office does not are only accepted during the Docket Monday through Friday, excluding legal publish documents with signatures on Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through holidays. The Docket Facility telephone its Web sites. Friday, excluding legal holidays). number is (703) 305–5805. Accessibility: For information on Special arrangements should be made FOR FURTHER INFORMATION CONTACT: A access or services for individuals with for deliveries of boxed information. The contact person is listed at the end of disabilities, please contact Dr. Marc Docket Facility telephone number is each registration application summary Rigas at (202) 343–9978 or (703) 305–5805. and may be contacted by telephone or [email protected]. To request Instructions: Direct your comments to e-mail. The mailing address for each accommodation of a disability, please the docket ID number specified for the contact person listed is: Registration contact Dr. Rigas preferably at least ten pesticide of interest as shown in the Division (7505P), Office of Pesticide days prior to each meeting to give EPA registration application summary. EPA’s Programs, Environmental Protection as much time as possible to process policy is that all comments received Agency, 1200 Pennsylvania Ave., NW., your request. will be included in the docket without Washington, DC 20460–0001. change and may be made available on- SUPPLEMENTARY INFORMATION: Dated: March 24, 2010. line at http://www.regulations.gov, Vanessa T. Vu, including any personal information I. General Information Director, EPA Science Advisory Staff Office. provided, unless the comment includes A. Does this Action Apply to Me? [FR Doc. 2010–7229 Filed 3–30–10; 8:45 am] information claimed to be Confidential BILLING CODE 6560–50–P Business Information (CBI) or other You may be potentially affected by information whose disclosure is this action if you are an agricultural restricted by statute. Do not submit producer, food manufacturer, or information that you consider to be CBI pesticide manufacturer. Potentially or otherwise protected through affected entities may include, but are regulations.gov or e-mail. The not limited to: regulations.gov website is an • Pesticide manufacturing (NAICS ‘‘anonymous access’’ system, which code 32532).

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This listing is not intended to be vii. Explain your views as clearly as 5. Registration Number/File Symbol: exhaustive, but rather provides a guide possible, avoiding the use of profanity 63838–RN. Docket ID Number: EPA– for readers regarding entities likely to be or personal threats. HQ–OPP–2009–0996. Company name affected by this action. Other types of viii. Make sure to submit your and address: Enviro Tech Chemical entities not listed in this unit could also comments by the comment period Services, Inc., 500 Winmoore Way, be affected. The North American deadline identified. Modesto, CA 95358. Active ingredient: Industrial Classification System II. Registration Applications Potassium hypochlorite. Proposed Uses: (NAICS) codes have been provided to Use on porous food and non-food assist you and others in determining EPA received applications as follows to register new antimicrobial pesticide contact surfaces, treatment of sewage whether this action might apply to and wastewater effluent, disinfection of certain entities. If you have any products containing new active ingredients pursuant to the provisions drinking water, pulp and paperboard questions regarding the applicability of water treatment, farm premises this action to a particular entity, consult of section 3(c) of FIFRA, and is treatment, treatment of laundry, and the person listed under FOR FURTHER publishing this notice of such agricultural and aquacultural uses. INFORMATION CONTACT. applications pursuant to section 3(c)(4) of FIFRA. Notice of receipt of these Contact: Wanda Henson (703) 308– B. What Should I Consider as I Prepare applications does not imply a decision 6345; [email protected]. My Comments for EPA? by the Agency on the applications. 6. Registration Number/File Symbol: 1. Registration Number/File Symbol: 67071–R. Docket ID Number: EPA–HQ– 1. Submitting CBI. Do not submit this 1258–RGEE. Docket ID Number: EPA– OPP–2009–1001. Company name and information to EPA through HQ–OPP–2009–0999. Company name regulations.gov or e-mail. Clearly mark and address: Arch Chemicals Inc., 501 address: Acti-Chem Specialties, Inc., 56 the part or all of the information that Merrit 7, Norwalk, CT 06856. Active Quarry Rd., Trumbell, CT 06611. Active you claim to be CBI. For CBI ingredient: Copper 2-pyridinethiol-1-/ ingredient: Tetramethyiol information in a disk or CD-ROM that oxide. Proposed Use: For formulation of acetylenediruea. Proposed Uses: you mail to EPA, mark the outside of the antifoulant paints. Contact: Martha Material preservative in adhesives, disk or CD-ROM as CBI and then Terry, (703) 308–217; building materials, lattices, paints, and identify electronically within the disk or [email protected]. coatings. Contact: Demson Fuller, (703) CD-ROM the specific information that is 2. Registration Number/File Symbol: 308–8062; [email protected]. claimed as CBI. In addition to one 2693–EER. Docket ID Number: EPA– 7. Registration Number/File Symbol: complete version of the comment that HQ–OPP–2009–0998. Company name includes information claimed as CBI, a 85249–R. Docket ID Number: EPA–HQ– and address: International Paint LLC, OPP–2009–1012. Company name and copy of the comment that does not 2270 Morris Ave., Union, NJ 07083. contain the information claimed as CBI address: HeiQ Materials AG. Agent Active ingredient: Copper pyrithione; (Gaughan Consulting), 1369 Gwynedale must be submitted for inclusion in the Cuprous oxide. Proposed Uses: For Way, Lansdale, PA 19446. Active public docket. Information so marked antifoulant paint to be used below the ingredient: Silver. Proposed Uses: will not be disclosed except in waterline on fiberglass, wood, and accordance with procedures set forth in properly primed metal boat hulls and Antimicrobial and preservative additive 40 CFR part 2. parts in fresh, salt, and brackish waters. used to treat fibers, plastics, polymers, 2. Tips for preparing your comments. Contact: Martha Terry, (703) 308–6217; latex products, and ceramics. Contact: When submitting comments, remember [email protected]. Demson Fuller, (703) 308–8062; to: 3. Registration Number/File Symbol: [email protected]. i. Identify the document by docket ID 5383–RGI. Docket ID Number: EPA– 8. Registration Number/File Symbol: number and other identifying HQ–OPP–2009–1000. Company name 85808–R. Docket ID Number: EPA–HQ– information (subject heading, Federal and address: Troy Chemical, Inc., 8 OPP–2009–0997. Company name and Register date and page number). If you Vreeland Rd., P.O. Box 955, Florham address: Schulke & Mayr GMBH Agent are commenting in a docket that Park, NJ 07932–4200. Active ingredient: (Technology Sciences Group, Inc.), 1150 addresses multiple products, please Terbutryn. Proposed Uses: 18th St., NW., Suite 1000, Washington, indicate to which registration number(s) Manufacturing use product for joint DC 20036. Active ingredient: N, N,- your comment applies. compound, masonry coatings, paints, methalylenbis [5-methyloxazolidin]. ii. Follow directions. The Agency may roof coatings, sealants, stuccos, and Proposed Uses: Oilfield muds, fuels, plastic and wood protection stains. ask you to respond to specific questions and metalworking fluid preservative. Contact: Jacqueline Campbell- or organize comments by referencing a Contact: Demson Fuller, (703) 308– McFarlane, (703) 308–6416, campbell- Code of Federal Regulations (CFR) part 8062; [email protected]. or section number. [email protected]. 4. Registration Number/File Symbol: iii. Explain why you agree or disagree; 5383–RGO. Docket ID Number: EPA– List of Subjects suggest alternatives and substitute HQ–OPP–2009–1006. Company name language for your requested changes. Environmental protection, and address: Troy Chemical, Inc., 8 Antimicrobial pesticides and pest. iv. Describe any assumptions and Vreeland Rd., P.O. Box 955, Florham provide any technical information and/ Park, NJ 07932–4200. Active ingredient: Dated: March 15, 2010. or data that you used. Terbutryn. Proposed Uses: End use Joan Harrigan Farrelly, v. If you estimate potential costs or product for joint compound, masonry Director, Antimicrobial Division, Office of burdens, explain how you arrived at coatings, paints, roof coatings, sealants, Pesticide Programs. your estimate in sufficient detail to stuccos, and plastic and wood [FR Doc. 2010–6792 Filed 3–30–10; 8:45 am] allow for it to be reproduced. protection stains. Contact: Jacqueline vi. Provide specific examples to Campbell-McFarlane, (703) 308–6416, BILLING CODE 6560–50–S illustrate your concerns and suggest campbell- alternatives. [email protected].

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ENVIRONMENTAL PROTECTION or contact information unless you for readers regarding entities likely to be AGENCY provide it in the body of your comment. affected by this action. Other types of If you send an e-mail comment directly entities not listed in this unit could also [EPA–HQ–OPP–2009–0935; FRL–8807–1] to EPA without going through be affected. The North American Antimicrobial Pesticide Products; regulations.gov, your e-mail address Industrial Classification System Registration Applications will be automatically captured and (NAICS) codes have been provided to included as part of the comment that is assist you and others in determining AGENCY: Environmental Protection placed in the docket and made available whether this action might apply to Agency (EPA). on the Internet. If you submit an certain entities. If you have any ACTION: Notice. electronic comment, EPA recommends questions regarding the applicability of that you include your name and other this action to a particular entity, consult SUMMARY: This notice announces receipt contact information in the body of your the person listed under FOR FURTHER of applications to register new uses for comment and with any disk or CD-ROM INFORMATION CONTACT. pesticide products containing currently you submit. If EPA cannot read your registered active ingredients, pursuant comment due to technical difficulties B. What Should I Consider as I Prepare to the provisions of section 3(c) of the and cannot contact you for clarification, My Comments for EPA? Federal Insecticide, Fungicide, and EPA may not be able to consider your 1. Submitting CBI. Do not submit this Rodenticide Act (FIFRA), as amended. comment. Electronic files should avoid information to EPA through EPA is publishing this notice of such the use of special characters, any form regulations.gov or e-mail. Clearly mark applications, pursuant to section 3(c)(4) of encryption, and be free of any defects the part or all of the information that of FIFRA. or viruses. you claim to be CBI. For CBI DATES: Comments must be received on Docket: All documents in the docket information in a disk or CD-ROM that or before April 30, 2010. are listed in the docket index available you mail to EPA, mark the outside of the ADDRESSES: Submit your comments, at http://www.regulations.gov. Although disk or CD-ROM as CBI and then identified by docket identification (ID) listed in the index, some information is identify electronically within the disk or number specified within the table not publicly available, e.g., CBI or other CD-ROM the specific information that is below, by one of the following methods: information whose disclosure is claimed as CBI. In addition to one • Federal eRulemaking Portal: http:// restricted by statute. Certain other complete version of the comment that www.regulations.gov. Follow the on-line material, such as copyrighted material, includes information claimed as CBI, a instructions for submitting comments. is not placed on the Internet and will be copy of the comment that does not • Mail: Office of Pesticide Programs publicly available only in hard copy contain the information claimed as CBI (OPP) Regulatory Public Docket (7502P), form. Publicly available docket must be submitted for inclusion in the Environmental Protection Agency, 1200 materials are available either in the public docket. Information so marked Pennsylvania Ave., NW., Washington, electronic docket at http:// will not be disclosed except in DC 20460–0001. www.regulations.gov, or, if only accordance with procedures set forth in • Delivery: OPP Regulatory Public available in hard copy, at the OPP 40 CFR part 2. Docket (7502P), Environmental Regulatory Public Docket in Rm. S– 2. Tips for preparing your comments. Protection Agency, Rm. S–4400, One 4400, One Potomac Yard (South Bldg.), When submitting comments, remember Potomac Yard (South Bldg.), 2777 S. 2777 S. Crystal Dr., Arlington, VA. The to: Crystal Dr., Arlington, VA. Deliveries hours of operation of this Docket i. Identify the document by docket ID are only accepted during the Docket Facility are from 8:30 a.m. to 4 p.m., number and other identifying Facility’s normal hours of operation Monday through Friday, excluding legal information (subject heading, Federal (8:30 a.m. to 4 p.m., Monday through holidays. The Docket Facility telephone Register date and page number). If you Friday, excluding legal holidays). number is (703) 305–5805. are commenting in a docket that Special arrangements should be made FOR FURTHER INFORMATION CONTACT: A addresses multiple products, please for deliveries of boxed information. The contact person is listed at the end of indicate to which registration number(s) Docket Facility telephone number is each registration application summary your comment applies. (703) 305–5805. and may be contacted by telephone or ii. Follow directions. The Agency may Instructions: Direct your comments to e-mail. The mailing address for each ask you to respond to specific questions docket ID number specified for the contact person listed is: Registration or organize comments by referencing a pesticide of interest as shown in the Division (7505P), Office of Pesticide Code of Federal Regulations (CFR) part registration application summaries. Programs, Environmental Protection or section number. EPA’s policy is that all comments Agency, 1200 Pennsylvania Ave., NW., iii. Explain why you agree or disagree; received will be included in the docket Washington, DC 20460–0001. suggest alternatives and substitute without change and may be made SUPPLEMENTARY INFORMATION: language for your requested changes. iv. Describe any assumptions and available on-line at http:// I. General Information www.regulations.gov, including any provide any technical information and/ personal information provided, unless A. Does this Action Apply to Me? or data that you used. the comment includes information You may be potentially affected by v. If you estimate potential costs or claimed to be Confidential Business this action if you are an agricultural burdens, explain how you arrived at Information (CBI) or other information producer, food manufacturer, or your estimate in sufficient detail to whose disclosure is restricted by statute. pesticide manufacturer. Potentially allow for it to be reproduced. Do not submit information that you affected entities may include, but are vi. Provide specific examples to consider to be CBI or otherwise not limited to: illustrate your concerns and suggest protected through regulations.gov or e- • Pesticide manufacturing (NAICS alternatives. mail. The regulations.gov website is an code 32532). vii. Explain your views as clearly as ‘‘anonymous access’’ system, which This listing is not intended to be possible, avoiding the use of profanity means EPA will not know your identity exhaustive, but rather provides a guide or personal threats.

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viii. Make sure to submit your HQ–OPP–2009–0993. Company name Carbamic acid. Proposed Uses: Metal comments by the comment period and address: Arch Chemical Co, 1955 working fluid. Contact: ShaRon Carlisle, deadline identified. Lake Park Dr., Suite 100, Smyrna, GA (703) 308–6427; 30080. Active ingredient: Calcium [email protected]. II. Registration Applications hypochlorite; Zinc sulfate monohydrate. 13. Registration Number/File Symbol: EPA received applications as follows Proposed Uses: Swimming pool water 5383–135. Docket ID. Number: EPA– to register new uses of pesticide sanitizer. Contact: Wanda Henson (703) HQ–OPP–2009–0950. Company name products containing currently registered 308–6345; [email protected]. and address: Troy Chemical, Inc., 8 active ingredients pursuant to the 7. Registration Number/File Symbol: Vreekand Rd, PO Box 955, Floraham provisions of section 3(c) of FIFRA, and 1258–1249. Docket ID. Number: EPA– Park, NJ 07932. Active ingredient: 1,2- is publishing this notice of such HQ–OPP–2009–0975. Company name Benziosthiazolin. Proposed Uses: applications pursuant to section 3(c)(4) and address: Arch Chemical Co, 1955 Material preservative for paint with of FIFRA. Notice of receipt of these Lake Park Dr., Suite 100, Smyrna, GA public health claims. Contact: Demson applications does not imply a decision 30080. Active ingredient: N-Butyl-1,2- Fuller, (703) 308–8063; by the Agency on the applications. Benzisothiazol-3-one. Proposed Uses: [email protected]. 1. Registration Number/File Symbol: Material preservative for plastic, 14. Registration Number/File Symbol: 100–1233. Docket ID. Number: EPA– metalworking fluids, rubber and 39967–25. Docket ID. Number: EPA– HQ–OPP–2009–0970. Company name coatings. Contact: Martha Terry, (703) HQ–OPP–2009–0947. Company name and address: Syngenta Crop Protection, 308–6217; [email protected]. and address: Lanxess Corp., 111 RDC Inc., P.O. Box 18300, Greensboro, NC 8. Registration Number/File Symbol: Park West Drive, Pittsburgh, PA 15275– 27419. Active ingredient: Propiconazole. 1258–1286. Docket ID. Number: EPA– 1112. Active ingredient: Sodium p- Proposed Uses: Materials preservative HQ–OPP–2009–0994. Company name chloro-m-creosolate. Proposed Uses: for latex paint, coatings and stains. and address: Arch Chemical Co, 1955 Materials preservative for industrial Contact: Stacey Grigsby, (703) 305– Lake Park Dr., Suite 100, Smyrna, GA lubricants. Contact: Heather Garvie, 6440; [email protected]. 30080 Active ingredient: N-Butyl-1,2- (703) 308–0034; 2. Registration Number/File Symbol: Benzisothiazol-3-one Proposed Uses: [email protected]. 464–682. Docket ID. Number: EPA–HQ– Material preservative for plastic, 15. Registration Number/File Symbol: OPP–2009–0992. Company name and metalworking fluids, rubber and 47371–161. Docket ID. Number: EPA– address: Dow Chemical Co., 1803 Bldg., coatings. Contact: Martha Terry, (703) HQ–OPP–2009–0940. Company name Midland, MI 48674. Active ingredient: 308–6217; [email protected]. and address: H&S Chemical Division, 90 2,6-Dimethyl-m-dioxan-4-ol acetate 9. Registration Number/File Symbol: Boroline Rd., Allendale, NJ 07401. Proposed Uses: Material preservative for 1624–RGN. Docket ID. Number: EPA– Active ingredient: n-Alkyl(C14 50%, adhesive, paints, coatings, textiles and HQ–OPP–2009–0972. Company name C12 40%, C16 10%) dimethyl benzyl leather. Contact: Martha Terry, (703) and address: US Borax Inc c/o Delta ammonium chloride. Proposed Uses: 308–6217; [email protected]. Analytical Corp., 12510 Prosperity Dr., Material preservative for treatment of 3. Registration Number/File Symbol: Suite 160, Silver Spring, MD 20904. sponges. Contact: Tracy Lantz, (703) 707–307. Docket ID. Number: EPA–HQ– Active ingredient: Boric acid. Proposed 308–6415; [email protected]. OPP–2009–0953. Company name and Uses: Material preservative for paints, 16. Registration Number/File Symbol: address: Rohm & Haas, 100 coatings, stains and ink dyes. Contact: 63838–2. Docket ID. Number: EPA–HQ– Independence Mall West, Philadelphia, Stacey Grigsby, (703) 305–6440; OPP–2009–0991. Company name and PA 19106. Active ingredient: 4,5- [email protected]. address: Enviro Tech Chemical Dichloro-2-n-octyl-4-isothiazolin-3 one 10. Registration Number/File Symbol: Services, P.O. Box 577470, Modesto, CA Proposed Uses: Wood preservative 1839–155. Docket ID. Number: EPA– 95357. Active ingredient: Hydrogen intended for use in aquatic HQ–OPP–2009–0955. Company name peroxide; Peroxyacetic acid. Proposed environments. Contact: Demson Fuller and address: Stepan Chemical, 22 W Uses: Treatment of wastewater and (703) 308–8063; [email protected]. Frontage Rd, Northfield, Il 60093. Active sewage. Contact: Karen Leavy, (703) 4. Registration Number/File Symbol: ingredient: Alkyl dimethyl ethylbenzyl 308–6237; [email protected]. 1043–REL Docket ID. Number: EPA– ammonium chloride. Proposed Uses: 17. Registration Number/File Symbol: HQ–OPP–2009–0954. Company name Food contact surface sanitizer in public 68660–RG. Docket ID. Number: EPA– and address: Steris Corporation, 7501 eating establishments. Contact: HQ–OPP–2009–0995. Company name Page Ave, St Louis, MO 63133. Active Jacqueline Campbell-McFarlane, (703) and address: Solvay Chemical Inc., 3333 ingredient: Tetra-acetyl- 308–6416, campbell- Richmond Ave, Houston, TX 77098. ethyllenediamine. Proposed Uses: [email protected]. Active ingredient: Hydrogen peroxide. Disinfectant for use on hard non-porous 11. Registration Number/File Symbol: Proposed Uses: Sterilant for aseptic food surfaces in institutional settings 4582–TE. Docket ID. Number: EPA–HQ– packaging. Contact: Demson Fuller, Contact: Demson Fuller (703) 308–8063; OPP–2009–0971. Company name and (703) 308–8062; [email protected]. [email protected]. address: Colgate-Palmolive, 909 River 18. Registration Number/File Symbol: 5. Registration Number/File Symbol: Rd, P.O. Box 1343, Piscataway, NJ 70087–E. Docket ID. Number: EPA–HQ– 1258–RGEO. Docket ID. Number: EPA– 08855–1343. Active ingredient: L-Lactic OPP–2009–0944. Company name and HQ–OPP–2009–0973. Company name acid. Proposed Uses: Dishwashing address: Coating Systems Laboratories and address: Arch Chemical Co, 1955 Detergent/Sanitizer Contact: Stacey Inc, 211 E. Clinton Dr. Chandler, AZ Lake Park Dr., Suite 100, Smyrna, GA Grigsby, (703) 305–6440; 85225. Active ingredient: 3-(tri- 30080.Active ingredient: Calcium [email protected]. hydroxysilyl) propyl ammonium hypochlorite; Zinc sulfate monohydrate. 12. Registration Number/File Symbol: chloride. Proposed Uses: Algicide for Proposed Uses: Swimming pool water 5383–89. Docket ID. Number: EPA–HQ– closed system ponds and swimming sanitizer. Contact: Wanda Henson, (703) OPP–2009–0939. Company name and pools/spas. Contact: Jacqueline 308–6345; [email protected]. address: Troy Chemical Corp., 8 Campbell-McFarlane, (703) 308–6416; 6. Registration Number/File Symbol: Vreeland Rd, PO Box 955, Florham campbell- 1258–RGGR. Docket ID. Number: EPA– Park, NJ 07932–4200. Active ingredient: [email protected].

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19. Registration Number/File Symbol: Contact: Karen Leavy, (703) 308–6237; List of Subjects 71227–7. Docket ID. Number: EPA–HQ– [email protected]. Environmental protection, 25. Registration Number/File Symbol: OPP–2009–0951. Company name and Antimicrobial pesticides and pest. address: Sinanen Company, LTD Agent 82544–R. Docket ID. Number: EPA–HQ– (Agion Technologies Inc.), 60 Audubon OPP–2009–0969. Company name and Dated: March 15, 2010. Rd., Wakeffield, MA 01880. Active address: Samsung Electronics Co.,Ltd., Joan Harrigan Farrelly, Agent (Keller and Heckman LLP) 101 G ingredient: Elemental copper; silver. Director, Antimicrobial Division, Office of Proposed Uses: Materials preservative in Street, N.W., Suite 500 West, Pesticide Programs. water bottle dispensers, ice trays, water Washington, D.C. 20001. Active bottles. Contact: Demson Fuller, (703) ingredient: Silver as metallic. Proposed [FR Doc. 2010–6793 Filed 3–30–10; 8:45 am] 308–8062; [email protected]. Uses: Silver use in washing machine. BILLING CODE 6560–50–S 20. Registration Number/File Symbol: Contact: Karen Leavy, (703) 308–6237; 71654–6. Docket ID. Number: EPA–HQ– [email protected]. 26. Registration Number/File Symbol: ENVIRONMENTAL PROTECTION OPP–2009–0938. Company name and AGENCY address: E.I. Dupont De Nemours and 84545–I. Docket ID. Number: EPA–HQ– Ccompany, Dupont Chemical Solutions OPP–2009–0945. Company name and [EPA–HQ–OPP–2007–1026; FRL–8816–2] Enterprises, PO Box 80402, Wilmington, address: SBiomed LLC, 1272 South Delaware 19880–0402. Active 1280 West Orem, Utah 84058. Active Bacillus subtilis; Registration Review ingredient: Potassium ingredient: Hydrogen peroxide; Final Decision; Notice of Availability peroxymonosulfate; Sodium chlorite. Peroxyacetic acid . Proposed Uses: Use as sporicidal decontaminant. Contact: AGENCY: Environmental Protection Proposed Uses: Food use in presence of Agency (EPA). farm animals; first food use to control Karen Leavy, (703) 308–6237; viruses, bacteria, fungi, and algae in [email protected]. ACTION: Notice. 27. Registration Number/File Symbol: poultry and swine feeding sites while 84545–O. Docket ID. Number: EPA–HQ– SUMMARY: This notice announces the animals are present. Contact: ShaRon OPP–2009–0967. Company name and availability of EPA’s final registration Carlisle, (703) 308–6427; address: SBiomed LLC, 1272 South review decision for the pesticide [email protected]. 1280 West Orem, Utah 84058. Active Bacillus subtilis, case 6012. Registration 21. Registration Number/File Symbol: ingredient: Silver. Proposed Uses: Use review is EPA’s periodic review of 72920–R. Docket ID. Number: EPA–HQ– as sporicidal decontaminant. Contact: pesticide registrations to ensure that OPP–2009–0948. Company name and Karen Leavy, (703) 308–6237; each pesticide continues to satisfy the address: Vorigen, Inc., 5076 CR # 342, [email protected]. statutory standard for registration, that Navosota, TX 77868. Active ingredient: 28. Registration Number/File Symbol: is, that the pesticide can perform its Silver. Proposed Uses: Control of 84622–1. Docket ID. Number: EPA–HQ– intended function without causing legionella in water systems. Contact: OPP–2009–0946. Company name and unreasonable adverse effects on human Demson Fuller, (703) 308–8063; address: SBiomed LLC, 1272 South health or the environment. Through this [email protected]. 1280 West Orem, Utah 84058. Active program, EPA is ensuring that each 22. Registration Number/File Symbol: ingredient: Hydrogen peroxide; pesticide’s registration is based on 72992–RL. Docket ID. Number: EPA– Peroxyacetic acid. Proposed Uses: current scientific and other knowledge, HQ–OPP–2009–0974. Company name Control of Bacillus anthracis on hard including its effects on human health and address: Lewis & Harrison c/o non-porous surfaces. Contact: Karen and the environment. Chrysal International BV, 122 C Street, Leavy, (703) 308–6237; FOR FURTHER INFORMATION CONTACT: For NW Suite 740, Washington DC 20001. [email protected]. pesticide specific information, contact: Active ingredient: Silver nitrate. 29. Registration Number/File Symbol: Susanne Cerrelli, Biopesticides and Proposed Uses: Material preservative for 84630–E. Docket ID. Number: EPA–HQ– Pollution Prevention Division (7511P), textile, plastic, metals, rubber and OPP–2009–0943. Company name and Office of Pesticide Programs, coatings. Contact: Martha Terry, (703) address: Transtex Technologies, 9600 Environmental Protection Agency, 1200 308–6217; [email protected]. Rue Ingnace, Suite D, Brossard, Quebec, Pennsylvania Ave., NW., Washington, 23. Registration Number/File Symbol: Canada J4Y 2R4. Active ingredient: n- DC 20460–0001; telephone number: 84526–G. Docket ID. Number: EPA–HQ– Alkyl(C14 50%, C12 40%, C16 10%) (703) 308–8077; fax number: (703) 308– OPP–2009–0976. Company name and dimethyl benzyl ammonium chloride 7026; e-mail address: address: Lewis & Harrison c/o Sanosil and Silver. Proposed Uses: Material [email protected]. USA, LLC, 122 C Street, NW, Suite 740, preservative for natural and synthetic For general information on the Washington DC 20001. Active fibers and textiles. Contact: Jacqueline registration review program, contact: ingredient: Hydrogen peroxide; Silver. Campbell-McFarlane, (703) 308–6416, Kevin Costello, Pesticide Re-evaluation Proposed Uses: For microbial control in campbell-mcFarlane.jacqueline Division (7508P), Office of Pesticide re-circulating cooling water systems and @epa.gov. Programs, Environmental Protection industrial process water systems. 30. Registration Number/File Symbol: Agency, 1200 Pennsylvania Ave., NW., Contact: Martha Terry (703) 308–6217; 86256–R. Docket ID. Number: EPA–HQ– Washington, DC 20460–0001; telephone [email protected]. OPP–2009–0941. Company name and number: (703) 305–5026; fax number: 24. Registration Number/File Symbol: address: AbTech Industries Inc, 4110 N (703) 308–8090; e-mail address: 82544–E. Docket ID. Number: EPA–HQ– Scottsdale Rd., Suite 235, Scottsdale, costello.kevin @epa.gov. OPP–2009–0968. Company name and AZ 85251. Active ingredient: 3- address: Samsung Electronics Co.,Ltd., (trimethoxylsilyl) SUPPLEMENTARY INFORMATION: Agent (Keller and Heckman LLP) 101 G propyldimethyloctadecyl ammonium I. General Information Street, N.W., Suite 500 West, chloride. Proposed Uses: Sponge for Washington, D.C. 20001. Active treatment of industrial, municipal and A. Does this Action Apply to Me? ingredient: Silver asmetallic. Proposed storm water. Contact: Tracy Lantz (703) This action is directed to the public Uses: Silver use in washing machine 308–6415; [email protected]. in general, and may be of interest to a

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wide range of stakeholders including pod vegetables, peanuts, soybeans, period, the public comments received environmental, human health, farm alfalfa, forage and turf grasses, wheat, were not substantive and did not affect worker, and agricultural advocates; the barley, corn, and canola. It is also used the Agency’s final decision. chemical industry; pesticide users; and in greenhouses to treat peat moss and In accordance with 40 CFR 155.58(c), members of the public interested in the soil intended for seeding, potting, or the registration review case docket for sale, distribution, or use of pesticides. transplanting non-bearing fruit and Bacillus subtilis will remain open until Since others also may be interested, the vegetable seedlings and as a foliar spray all actions required in the final decision Agency has not attempted to describe all on asparagus, cole crops, bulb have been completed. the specific entities that may be affected vegetables, berry crops, cucurbits, Background on the registration review by this action. If you have any questions flowers, bedding plants, ornamentals, program is provided at: http:// regarding the applicability of this action tropical plants, fruiting vegetables, www.epa.gov/oppsrrd1/ to a particular entity, consult the grape, leafy vegetables, pome fruit, stone registration_review. Links to earlier pesticide specific contact person listed fruit, strawberry, tuber/root and corm documents related to the registration under FOR FURTHER INFORMATION vegetables, turf, sod, lawns, trees, and review of this pesticide are provided at: CONTACT. shrubs. Bacillus subtilis strain QST 713 http:/www.epa.gov/oppsrrd1/ is used to prevent or reduce several registration_review/bacillus_subtilis/ B. How Can I Get Copies of this types of fungal and bacterial pests on index.htm. Document and Other Related artichoke, asparagus, avocado, beans, B. What is the Agency’s Authority for Information? beets, berries, brassica crops, bulb Taking this Action? EPA has established a docket for this vegetables, celery, cereal grains, citrus, action under docket identification (ID) coffee, corn, cucurbits, beans, eggplant, Section 3(g) of FIFRA and 40 CFR part number EPA–HQ–OPP–2007–1026. grapes, herbs/spices, hops, kiwi, 155, subpart C, provide authority for Publicly available docket materials are kohlrabi, leafy vegetables, legumes, this action. available either in the electronic docket melons, oil seed crops, oil palm, okra, List of Subjects at http://www.regulations.gov, or, if only peanuts, peppers, pome fruit, rice, root/ available in hard copy, at the Office of tuber crops, silage crops, stone fruits, Environmental protection, Bacillus Pesticide Programs (OPP) Regulatory tomatoes, tree nuts, tropical fruits, field subtilis, Pesticide and pest, Registration Public Docket in Rm. S–4400, One roses, forestry seedlings, lawns, review. Potomac Yard (South Bldg.), 2777 S. ornamental flowering plants, Dated: March 24, 2010. Crystal Dr., Arlington, VA. The hours of ornamental foliage plants, ornamental Keith A. Matthews, operation of this Docket Facility are trees and shrubs, seed production crops, Acting Director, Biopesticides and Pollution from 8:30 a.m. to 4 p.m., Monday sod, tobacco, and turf. Bacillus subtilis Prevention Division, Office of Pesticide through Friday, excluding legal var. amyloliquefaciens strain FZB24 is Programs. holidays. The Docket Facility telephone used for plant strengthening, enhancing [FR Doc. 2010–7237 Filed 3–30–10; 8:45 a.m.] number is (703) 305–5805. growth, increasing yields and BILLING CODE 6560–50–S suppressing soil-borne fungal diseases II. Background such as Rhizoctonia and Fusarium as a A. What Action is the Agency Taking? dip for seedlings, transplants, plugs, ENVIRONMENTAL PROTECTION tubers, bulbs, corms, cuttings and roots AGENCY In accordance with 40 CFR 155.58(c), of ornamentals, shrubs and trees, and as [EPA–HQ–OPP–2010–0118; FRL–8816–1] this notice announces the availability of a spray over furrows for ornamentals, EPA’s final registration review decision shrubs, trees, turf, vegetables, herbs and Registration Review; Biopesticides for Bacillus subtilis, case 6012. The spices, and other crops. It is also Bacillus subtilis case consists of four Dockets Opened for Review and incorporated into soils, soil-less growing Comment strains: Strain GB03; Strain MBI 600; media and mushroom spawn media and Strain QST 713; and var. as a drench for interiorscapes and AGENCY: Environmental Protection amyloliquefaciens Strain FZB24. All potted orchids and ferns. Agency (EPA). four strains occur ubiquitously in the In accordance with 40 CFR 155.57, a ACTION: Notice. environment: Bacillus subtilis strain registration review decision is the GB03 is used to prevent, control and Agency’s determination whether a SUMMARY: EPA has established suppress plant disease on barley, pesticide meets, or does not meet, the registration review dockets for the berries, bulb vegetables, cole crops, standard for registration in FIFRA. EPA pesticides listed in the table in Unit cotton, cucurbits, fruiting vegetables, has considered Bacillus subtilis in light III.A. With this document, EPA is herbs, leafy crops, legumes, ornamental of the FIFRA standard for registration. opening the public comment period for plants and cuttings, peanuts, root/tuber The Bacillus subtilis Final Decision these registration reviews. Registration and corm vegetables, soybeans, document in the docket describes the review is EPA’s periodic review of tomatoes, trees, tropical plants, turf, and Agency’s rationale for issuing a pesticide registrations to ensure that wheat. Bacillus subtilis strain GB03 is registration review final decision for each pesticide continues to satisfy the applied as an irrigation application, pre- this pesticide. statutory standard for registration, that plant soak, overhead spray, soil drench, In addition to the final registration is, the pesticide can perform its seed dressing, tank mix, or hydroponic review decision document, the intended function without unreasonable system treatment; Bacillus subtilis strain registration review docket for Bacillus adverse effects on human health or the MBI 600 is used to suppress disease subtilis also includes other relevant environment. Registration review organisms such as Botrytis, Alternaria, documents related to the registration dockets contain information that will Rhizoctonia, and Fusarium and is also review of this case. The proposed assist the public in understanding the used to promote more effective registration review decision was posted types of information and issues that the nodulation by nitrogen-fixing bacteria to to the docket and the public was invited Agency may consider during the course improve yields. It is used as a seed and to submit any comments or new of registration reviews. Through this in-furrow treatment on cotton, seed and information. During the comment program, EPA is ensuring that each

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pesticide’s registration is based on comment. Electronic files should avoid the part or all of the information that current scientific and other knowledge, the use of special characters, any form you claim to be CBI. For CBI including its effects on human health of encryption, and be free of any defects information in a disk or CD-ROM that and the environment. or viruses. you mail to EPA, mark the outside of the DATES: Comments must be received on Docket: All documents in the docket disk or CD-ROM as CBI and then or before June 1, 2010. are listed in the docket index available identify electronically within the disk or at http://www.regulations.gov. Although ADDRESSES: Submit your comments CD-ROM the specific information that is listed in the index, some information is identified by the docket identification claimed as CBI. In addition to one not publicly available, e.g., CBI or other (ID) number for the specific pesticide of complete version of the comment that information whose disclosure is interest provided in the table in Unit includes information claimed as CBI, a restricted by statute. Certain other III.A., by one of the following methods: copy of the comment that does not material, such as copyrighted material, • Federal eRulemaking Portal: http:// contain the information claimed as CBI is not placed on the Internet and will be www.regulations.gov. Follow the on-line must be submitted for inclusion in the publicly available only in hard copy instructions for submitting comments. public docket. Information so marked form. Publicly available docket • Mail: Office of Pesticide Programs will not be disclosed except in materials are available either in the (OPP) Regulatory Public Docket (7502P), accordance with procedures set forth in electronic docket at http:// Environmental Protection Agency, 1200 40 CFR part 2. www.regulations.gov, or, if only Pennsylvania Ave., NW., Washington, 2. Tips for preparing your comments. available in hard copy, at the OPP DC 20460–0001. When submitting comments, remember Regulatory Public Docket in Rm. S– • Delivery: OPP Regulatory Public to: 4400, One Potomac Yard (South Bldg.), Docket (7502P), Environmental i. Identify the document by docket ID 2777 S. Crystal Dr., Arlington, VA. The Protection Agency, Rm. S–4400, One number and other identifying hours of operation of this Docket Potomac Yard (South Bldg.), 2777 S. information (subject heading, Federal Facility are from 8:30 a.m. to 4 p.m., Crystal Dr., Arlington, VA. Deliveries Register date and page number). Monday through Friday, excluding legal are only accepted during the Docket holidays. The Docket Facility telephone ii. Follow directions. The Agency may Facility’s normal hours of operation number is (703) 305–5805. ask you to respond to specific questions (8:30 a.m. to 4 p.m., Monday through or organize comments by referencing a FOR FURTHER INFORMATION CONTACT: For Friday, excluding legal holidays). Code of Federal Regulations (CFR) part pesticide specific information contact: Special arrangements should be made or section number. for deliveries of boxed information. The The Regulatory Action Leader (RAL) identified in the table in Unit III.A. for iii. Explain why you agree or disagree; Docket Facility telephone number is suggest alternatives and substitute (703) 305–5805. the pesticide of interest. For general information contact: language for your requested changes. Instructions: Direct your comments to iv. Describe any assumptions and the docket ID numbers listed in the table Kevin Costello, Pesticide Re-evaluation Division (7508P), Office of Pesticide provide any technical information and/ in Unit III.A. for the pesticides you are or data that you used. commenting on. EPA’s policy is that all Programs, Environmental Protection v. If you estimate potential costs or comments received will be included in Agency, 1200 Pennsylvania Ave., NW., burdens, explain how you arrived at the docket without change and may be Washington, DC 20460–0001; telephone your estimate in sufficient detail to made available on-line at http:// number: (703) 305–5026; fax number: allow for it to be reproduced. www.regulations.gov, including any (703) 308–8090; e-mail address: personal information provided, unless [email protected]. vi. Provide specific examples to the comment includes information SUPPLEMENTARY INFORMATION: illustrate your concerns and suggest alternatives. claimed to be Confidential Business I. General Information Information (CBI) or other information vii. Explain your views as clearly as whose disclosure is restricted by statute. A. Does this Action Apply to Me? possible, avoiding the use of profanity Do not submit information that you This action is directed to the public or personal threats. consider to be CBI or otherwise in general, and may be of interest to a viii. Make sure to submit your protected through regulations.gov or e- wide range of stakeholders including comments by the comment period mail. The regulations.gov website is an environmental, human health, deadline identified. ‘‘anonymous access’’ system, which farmworker, and agricultural advocates; 3. Environmental justice. EPA seeks to means EPA will not know your identity the chemical industry; pesticide users; achieve environmental justice, the fair or contact information unless you and members of the public interested in treatment and meaningful involvement provide it in the body of your comment. the sale, distribution, or use of of any group, including minority and/or If you send an e-mail comment directly pesticides. Since others also may be low income populations, in the to EPA without going through interested, the Agency has not development, implementation, and regulations.gov, your e-mail address attempted to describe all the specific enforcement of environmental laws, will be automatically captured and entities that may be affected by this regulations, and policies. To help included as part of the comment that is action. If you have any questions address potential environmental justice placed in the docket and made available regarding the applicability of this action issues, the Agency seeks information on on the Internet. If you submit an to a particular entity, consult the person any groups or segments of the electronic comment, EPA recommends listed under FOR FURTHER INFORMATION population who, as a result of their that you include your name and other CONTACT. location, cultural practices, or other contact information in the body of your factors, may have atypical or comment and with any disk or CD-ROM B. What Should I Consider as I Prepare disproportionately high and adverse you submit. If EPA cannot read your My Comments for EPA? human health impacts or environmental comment due to technical difficulties 1. Submitting CBI. Do not submit this effects from exposure to the pesticide(s) and cannot contact you for clarification, information to EPA through discussed in this document, compared EPA may not be able to consider your regulations.gov or e-mail. Clearly mark to the general population.

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II. Authority 3(c)(5). When used in accordance with registrations identified in the table in EPA is initiating its reviews of the widespread and commonly recognized this unit to assure that they continue to pesticides identified in this document practice, the pesticide product must satisfy the FIFRA standard for in accordance with section 3(g) of the perform its intended function without registration—that is, they can still be Federal Insecticide, Fungicide, and unreasonable adverse effects on the used without unreasonable adverse Rodenticide Act (FIFRA) and the environment; that is, without any effects on human health or the Procedural Regulations for Registration unreasonable risk to man or the environment. A pesticide’s registration Review at 40 CFR part 155, subpart C. environment, or a human dietary risk review begins when the Agency Section 3(g) of FIFRA provides, among from residues that result from the use of establishes a docket for the pesticide’s other things, that the registrations of a pesticide in or on food. registration review case and opens the pesticides are to be reviewed every 15 III. Registration Reviews docket for public review and comment. years. Under FIFRA, a pesticide product A. What Action is the Agency Taking? At present, EPA is opening registration may be registered or remain registered review dockets for the cases identified only if it meets the statutory standard As directed by FIFRA section 3(g), in the following table. for registration given in FIFRA section EPA is reviewing the pesticide

TABLE—REGISTRATION REVIEW DOCKETS OPENING

Registration Review Case Name and Number Docket ID Number RAL, Telephone Number, E-mail Address

Vegetable and flower oils (case # EPA–HQ–OPP–2009–0904 Menyon Adams, (703) 347–8496, [email protected] 8201)

Menthol (case # 4063) EPA–HQ–OPP–2009–0900 Colin Walsh, (703) 308–0298, [email protected]

Agrobacterium radiobacter (case EPA–HQ–OPP–2009–0878 Ann Sibold, (703) 305–6502, [email protected] number 4101)

B. Docket Content 2. Other related information. More • Submitters may request the Agency information on these cases, including 1. Review dockets. The registration to reconsider data or information that the active ingredients for each case, may review dockets contain information that the Agency rejected in a previous be located in the registration review the Agency may consider in the course review. However, submitters must schedule on the Agency’s website at of the registration review. The Agency explain why they believe the Agency http://www.epa.gov/oppsrrd1/ may include information from its files should reconsider the data or registration_review/schedule.htm. including, but not limited to, the information in the pesticide’s Information on the Agency’s registration following information: registration review. • review program and its implementing An overview of the registration regulation may be seen at http:// As provided in 40 CFR 155.58, the review case status. registration review docket for each • www.epa.gov/oppsrrd1/ A list of current product registration_review. pesticide case will remain publicly registrations and registrants. accessible through the duration of the • 3. Information submission Federal Register notices regarding requirements. Anyone may submit data registration review process; that is, until any pending registration actions. or information in response to this all actions required in the final decision • Federal Register notices regarding document. To be considered during a on the registration review case have current or pending tolerances. pesticide’s registration review, the been completed. • Risk assessments. submitted data or information must • Bibliographies concerning current meet the following requirements: List of Subjects registrations. • To ensure that EPA will consider Environmental protection, Pesticides • Summaries of incident data. data or information submitted, and pests, Vegetable and flower oils, • Any other pertinent data or interested persons must submit the data Menthol and Agrobacterium information. or information during the comment radiobacter. Each docket contains a document period. The Agency may, at its summarizing what the Agency currently discretion, consider data or information Dated: March 25, 2010. knows about the pesticide case and a submitted at a later date. Keith A. Matthews, preliminary work plan for anticipated • The data or information submitted data and assessment needs. Additional must be presented in a legible and Acting Director, Biopesticides and Pollution documents provide more detailed useable form. For example, an English Prevention Division, Office of Pesticide Programs. information. During this public translation must accompany any comment period, the Agency is asking material that is not in English and a [FR Doc. 2010–7234 Filed 3–30–10; 8:45 am] that interested persons identify any written transcript must accompany any BILLING CODE 6560–50–S additional information they believe the information submitted as an Agency should consider during the audiographic or videographic record. registration reviews of these pesticides. Written material may be submitted in The Agency identifies in each docket paper or electronic form. the areas where public comment is • Submitters must clearly identify the specifically requested, though comment source of any submitted data or in any area is welcome. information.

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ENVIRONMENTAL PROTECTION for deliveries of boxed information. The The Chemical Review Manager AGENCY Docket Facility telephone number is identified in the table in Unit III.A. for (703) 305–5805. the pesticide of interest. [EPA–HQ–OPP–2010–0128; FRL–8814–4] Instructions: Direct your comments to For general information contact: Registration Review; Pesticide the docket ID numbers listed in the table Kevin Costello, Pesticide Re-evaluation Dockets Opened for Review and in Unit III.A. for the pesticides you are Division (7508P), Office of Pesticide Comment commenting on. EPA’s policy is that all Programs, Environmental Protection comments received will be included in Agency, 1200 Pennsylvania Ave., NW., AGENCY: Environmental Protection the docket without change and may be Washington, DC 20460–0001; telephone Agency (EPA). made available on-line at http:// number: (703) 305–5026; fax number: ACTION: Notice. www.regulations.gov, including any (703) 308–8090; e-mail address: personal information provided, unless costello.kevin @epa.gov. SUMMARY: EPA has established the comment includes information SUPPLEMENTARY INFORMATION: registration review dockets for the claimed to be Confidential Business pesticides listed in the table in Unit Information (CBI) or other information I. General Information III.A. With this document, EPA is whose disclosure is restricted by statute. A. Does this Action Apply to Me? opening the public comment period for Do not submit information that you This action is directed to the public these registration reviews. Registration consider to be CBI or otherwise in general, and may be of interest to a review is EPA’s periodic review of protected through regulations.gov or e- wide range of stakeholders including pesticide registrations to ensure that mail. The regulations.gov website is an environmental, human health, each pesticide continues to satisfy the ‘‘anonymous access’’ system, which farmworker, and agricultural advocates; statutory standard for registration, that means EPA will not know your identity the chemical industry; pesticide users; is, the pesticide can perform its or contact information unless you and members of the public interested in intended function without unreasonable provide it in the body of your comment. the sale, distribution, or use of adverse effects on human health or the If you send an e-mail comment directly pesticides. Since others also may be environment. Registration review to EPA without going through interested, the Agency has not dockets contain information that will regulations.gov, your e-mail address attempted to describe all the specific assist the public in understanding the will be automatically captured and entities that may be affected by this types of information and issues that the included as part of the comment that is action. If you have any questions Agency may consider during the course placed in the docket and made available regarding the applicability of this action of registration reviews. Through this on the Internet. If you submit an to a particular entity, consult the person program, EPA is ensuring that each electronic comment, EPA recommends listed under FOR FURTHER INFORMATION pesticide’s registration is based on that you include your name and other CONTACT. current scientific and other knowledge, contact information in the body of your including its effects on human health comment and with any disk or CD-ROM B. What Should I Consider as I Prepare and the environment. This document you submit. If EPA cannot read your My Comments for EPA? also announces the Agency’s intent not comment due to technical difficulties 1. Submitting CBI. Do not submit this to open a registration review docket for and cannot contact you for clarification, information to EPA through pirimicarb. This pesticide does not EPA may not be able to consider your regulations.gov or e-mail. Clearly mark currently have any actively registered comment. Electronic files should avoid the part or all of the information that pesticide products and is therefore not the use of special characters, any form you claim to be CBI. For CBI scheduled for review under the of encryption, and be free of any defects information in a disk or CD-ROM that registration review program. or viruses. you mail to EPA, mark the outside of the DATES: Comments must be received on Docket: All documents in the docket disk or CD-ROM as CBI and then or before June 1, 2010. are listed in the docket index available identify electronically within the disk or ADDRESSES: Submit your comments at http://www.regulations.gov. Although CD-ROM the specific information that is identified by the docket identification listed in the index, some information is claimed as CBI. In addition to one (ID) number for the specific pesticide of not publicly available, e.g., CBI or other complete version of the comment that interest provided in the table in Unit information whose disclosure is includes information claimed as CBI, a III.A., by one of the following methods: restricted by statute. Certain other copy of the comment that does not • Federal eRulemaking Portal: http:// material, such as copyrighted material, contain the information claimed as CBI www.regulations.gov. Follow the on-line is not placed on the Internet and will be must be submitted for inclusion in the instructions for submitting comments. publicly available only in hard copy public docket. Information so marked • Mail: Office of Pesticide Programs form. Publicly available docket will not be disclosed except in (OPP) Regulatory Public Docket (7502P), materials are available either in the accordance with procedures set forth in Environmental Protection Agency, 1200 electronic docket at http:// 40 CFR part 2. Pennsylvania Ave., NW., Washington, www.regulations.gov, or, if only 2. Tips for preparing your comments. DC 20460–0001. available in hard copy, at the OPP When submitting comments, remember • Delivery: OPP Regulatory Public Regulatory Public Docket in Rm. S– to: Docket (7502P), Environmental 4400, One Potomac Yard (South Bldg.), i. Identify the document by docket ID Protection Agency, Rm. S–4400, One 2777 S. Crystal Dr., Arlington, VA. The number and other identifying Potomac Yard (South Bldg.), 2777 S. hours of operation of this Docket information (subject heading, Federal Crystal Dr., Arlington, VA. Deliveries Facility are from 8:30 a.m. to 4 p.m., Register date and page number). are only accepted during the Docket Monday through Friday, excluding legal ii. Follow directions. The Agency may Facility’s normal hours of operation holidays. The Docket Facility telephone ask you to respond to specific questions (8:30 a.m. to 4 p.m., Monday through number is (703) 305–5805. or organize comments by referencing a Friday, excluding legal holidays). FOR FURTHER INFORMATION CONTACT: For Code of Federal Regulations (CFR) part Special arrangements should be made pesticide specific information contact: or section number.

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iii. Explain why you agree or disagree; issues, the Agency seeks information on practice, the pesticide product must suggest alternatives and substitute any groups or segments of the perform its intended function without language for your requested changes. population who, as a result of their unreasonable adverse effects on the iv. Describe any assumptions and location, cultural practices, or other environment; that is, without any provide any technical information and/ factors, may have atypical or unreasonable risk to man or the or data that you used. disproportionately high and adverse environment, or a human dietary risk v. If you estimate potential costs or human health impacts or environmental from residues that result from the use of burdens, explain how you arrived at effects from exposure to the pesticides a pesticide in or on food. your estimate in sufficient detail to discussed in this document, compared III. Registration Reviews allow for it to be reproduced. to the general population. vi. Provide specific examples to A. What Action is the Agency Taking? illustrate your concerns and suggest II. Authority alternatives. EPA is initiating its reviews of the As directed by FIFRA section 3(g), vii. Explain your views as clearly as pesticides identified in this document EPA is reviewing the pesticide possible, avoiding the use of profanity pursuant to section 3(g) of the Federal registrations identified in the table in or personal threats. Insecticide, Fungicide, and Rodenticide this unit to assure that they continue to viii. Make sure to submit your Act (FIFRA) and the Procedural satisfy the FIFRA standard for comments by the comment period Regulations for Registration Review at registration—that is, they can still be deadline identified. 40 CFR part 155, subpart C. Section 3(g) used without unreasonable adverse 3. Environmental justice. EPA seeks to of FIFRA provides, among other things, effects on human health or the achieve environmental justice, the fair that the registrations of pesticides are to environment. A pesticide’s registration treatment and meaningful involvement be reviewed every 15 years. Under review begins when the Agency of any group, including minority and/or FIFRA, a pesticide product may be establishes a docket for the pesticide’s low income populations, in the registered or remain registered only if it registration review case and opens the development, implementation, and meets the statutory standard for docket for public review and comment. enforcement of environmental laws, registration given in FIFRA section At present, EPA is opening registration regulations, and policies. To help 3(c)(5). When used in accordance with review dockets for the cases identified address potential environmental justice widespread and commonly recognized in the following table.

TABLE—REGISTRATION REVIEW DOCKETS OPENING

Registration Review Case Name Chemical Review Manager, Telephone Number, E-mail and Number Docket ID Number Address

Amitraz (0234) EPA–HQ–OPP–2009-1015 James Parker, (703) 306–0469 [email protected]

Sodium acifluorfen (2605) EPA–HQ–OPP–2010–0135 Christina Scheltema, (703) 308–2201 [email protected]

Allethrin stereoisomers (0437) EPA–HQ–OPP–2010-0022 Molly Clayton, (703) 603–0522 [email protected]

Bentazon (0182) EPA–HQ–OPP–2010–0117 Joy Schnackenbeck, (703) 308–8072 [email protected]

Clofencet (7015) EPA–HQ–OPP–2009-0760 Wilhelmena Livingston, (703) 308–8025 [email protected]

Chlorpyrifos-methyl (8011) EPA–HQ–OPP–2010-0119 Katie Weyrauch, (703) 308–0166 [email protected]

Deltamethrin (7414) EPA–HQ–OPP–2009-0637 Jill Bloom, (703) 308–8019 [email protected]

Hexazinone (0266) EPA–HQ–OPP–2009–0755 Dana Friedman, (703) 347–8827 [email protected]

Hymexazol (7016) EPA–HQ–OPP–2010-0127 Kelly Ballard, (703) 305–8126 [email protected]

Tralomethrin (7400) EPA–HQ–OPP–2010–0116 Joy Schnackenbeck, (703) 308–8072 [email protected]

EPA is also announcing that it will registrations with this active ingredient B. Docket Content not be opening a docket for pirimicarb and to propose revocation of any because this pesticide is not included in affected tolerances that are not 1. Review dockets. The registration any products actively registered under supported for import purposes only. review dockets contain information that FIFRA section 3. The Agency will take the Agency may consider in the course separate actions to cancel any remaining of the registration review. The Agency FIFRA section 24(c) Special Local Needs may include information from its files

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including, but not limited to, the • Submitters must clearly identify the The FCC may not conduct or sponsor following information: source of any submitted data or a collection of information unless it • An overview of the registration information. displays a currently valid OMB control review case status. • Submitters may request the Agency number. No person shall be subject to • A list of current product to reconsider data or information that any penalty for failing to comply with registrations and registrants. the Agency rejected in a previous a collection of information subject to the • Federal Register notices regarding review. However, submitters must Paperwork Reduction Act (PRA) that any pending registration actions. explain why they believe the Agency does not display a currently valid OMB • Federal Register notices regarding should reconsider the data or control number. current or pending tolerances. information in the pesticide’s DATES: Written Paperwork Reduction • Risk assessments. registration review. Act (PRA) comments should be • Bibliographies concerning current As provided in 40 CFR 155.58, the submitted on or before June 1, 2010. If registrations. registration review docket for each you anticipate that you will be • Summaries of incident data. pesticide case will remain publicly submitting PRA comments, but find it • Any other pertinent data or accessible through the duration of the difficult to do so within the period of information. registration review process; that is, until time allowed by this notice, you should Each docket contains a document all actions required in the final decision advise the FCC contact listed below as summarizing what the Agency currently on the registration review case have soon as possible. been completed. knows about the pesticide case and a ADDRESSES: Direct all PRA comments to preliminary work plan for anticipated List of Subjects Nicholas A. Fraser, Office of data and assessment needs. Additional Management and Budget, via fax at 202– documents provide more detailed Environmental protection, Pesticides 395–5167 or via the Internet at information. During this public and pests. [email protected] and comment period, the Agency is asking Dated: March 22, 2010. to the Federal Communications that interested persons identify any Richard P. Keigwin, Jr., Commission via email to [email protected]. additional information they believe the Director, Pesticide Re-evaluation Division, FOR FURTHER INFORMATION CONTACT: Agency should consider during the Office of Pesticide Programs. Judith B. Herman, Office of Managing registration reviews of these pesticides. Director, (202) 418–0214. For additional The Agency identifies in each docket [FR Doc. 2010–6888 Filed 3–30–10; 8:45 am] BILLING CODE 6560–50–S information, contact Judith B. Herman, the areas where public comment is 202–418–0214, judth– specifically requested, though comment [email protected]. in any area is welcome. 2. Other related information. More FEDERAL COMMUNICATIONS SUPPLEMENTARY INFORMATION: information on these cases, including COMMISSION OMB Control Number: 3060–0710. Title: Policy and Rules Under Parts 1 the active ingredients for each case, may Notice of Public Information and 51 Concerning Implementation of be located in the registration review Collection(s) Being Reviewed by the the Local Competition Provisions in the schedule on the Agency’s website at Federal Communications Commission, Telecommunications Act of 1996, CC http://www.epa.gov/oppsrrd1/ Comments Requested Docket No. 96–98. registration_review/schedule.htm. Form No.: N/A. Information on the Agency’s registration March 25, 2010. Type of Review: Extension of a review program and its implementing SUMMARY: The Federal Communications currently approved collection. regulation may be seen at http:// Commission, as part of its continuing Respondents: Business or other for www.epa.gov/oppsrrd1/ effort to reduce paperwork burden _ profit. registration review. invites the general public and other Number of Respondents and 3. Information submission Federal agencies to take this Responses: 15,282 responses; 1,067,987 requirements. Anyone may submit data opportunity to comment on the responses. or information in response to this following information collection(s), as Estimated Time Per Response: .50 – document. To be considered during a required by the Paperwork Reduction 2,880 hours. pesticide’s registration review, the Act (PRA) of 1995, 44 U.S.C. 3501 – Frequency of Response: On occasion submitted data or information must 3520. Comments are requested reporting requirement, recordkeeping meet the following requirements: concerning: (a) whether the proposed requirement and third party disclosure • To ensure that EPA will consider collection of information is necessary requirements. data or information submitted, for the proper performance of the Obligation to Respond: Required to interested persons must submit the data functions of the Commission, including obtain or retain benefits. Statutory or information during the comment whether the information shall have authority for this information collection period. The Agency may, at its practical utility; (b) the accuracy of the is contained in 47 U.S.C. sections 1 – 4, discretion, consider data or information Commission’s burden estimate; (c) ways 201 – 205, 214, 224, 251, 252, 303(r) and submitted at a later date. to enhance the quality, utility, and 601. • The data or information submitted clarity of the information collected; (d) Total Annual Burden: 645,798 hours. must be presented in a legible and ways to minimize the burden of the Total Annual Cost: N/A. useable form. For example, an English collection of information on the Privacy Act Impact Assessment: N/A. translation must accompany any respondents, including the use of Nature and Extent of Confidentiality: material that is not in English and a automated collection techniques or The Commission is not requesting written transcript must accompany any other forms of information technology, respondents to submit confidential information submitted as an and (e) ways to further reduce the information to the Commission. If the audiographic or videographic record. information collection burden on small respondents wish to submit information Written material may be submitted in business concerns with fewer than 25 which they believe is confidential, they paper or electronic form. employees. may request confidential treatment of

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such information under 47 CFR 0.459 of entitled Accrual Estimates for Grant displays a currently valid OMB control the Commission’s rules. Programs. The proposed Technical number. Needs and Uses: The Commission Release provides guidance supporting Request for Comment on Information will submit this expiring information cost-effective development of reasonable Collection Proposals collection to the Office of Management estimates of accrual liabilities for grant and Budget (OMB) after this comment programs. The following information period in order to obtain the full three The Exposure Draft is available on the collections, which are being handled year clearance from them. There is no FASAB home page http:// under this delegated authority, have change in the reporting, recordkeeping www.fasab.gov/exposure.html. Copies received initial Board approval and are and/or third party disclosure can be obtained by contacting FASAB at hereby published for comment. At the requirements. However, there is a (202) 512–7350. end of the comment period, the significant decrease of 409,352 total Respondents are encouraged to proposed information collections, along annual burden hours and a $625,000 comment on any part of the exposure with an analysis of comments and decrease in annual costs. This is due to draft. Written comments are requested recommendations received, will be several reasons including 1) re– by April 22, 2010, and should be sent submitted to the Board for final calculations of each burden estimate; 2) to: approval under OMB delegated re–estimate of the estimated time Wendy M. Payne, Executive Director, authority. Comments are invited on the burden for some of the information Federal Accounting Standards Advisory following: collection categories; and 3) less time Board, 441 G Street, NW., Suite 6814, a. Whether the proposed collection of per response due to familiarity gained Mail Stop 6K17V, Washington, DC information is necessary for the proper over the years of performing these 20548. performance of the Federal Reserve’s functions. functions; including whether the FOR FURTHER INFORMATION CONTACT: The Commission adopted rules and information has practical utility; regulations to implement parts of Wendy Payne, Executive Director, at b. The accuracy of the Federal Sections 251 and 252 that affect local (202) 512–7350. Reserve’s estimate of the burden of the competition. Incumbent local exchange Authority: Federal Advisory Committee proposed information collection, carriers (LECs) are required to offer Act, Pub. L. 92–463. including the validity of the interconnection, unbundled network Dated: March 26, 2010. methodology and assumptions used; elements, transport and termination and Charles Jackson, c. Ways to enhance the quality, wholesale rates for certain services to Federal Register Liaison Officer. utility, and clarity of the information to be collected; and new entrants. Incumbent LECs must [FR Doc. 2010–7248 Filed 3–30–10; 8:45 am] price such services at rates that are cost– d. Ways to minimize the burden of BILLING CODE 1610–02–P based and just and reasonable and information collection on respondents, provide access to right–of–way as well including through the use of automated as establish reciprocal compensation collection techniques or other forms of arrangements for the transport and FEDERAL RESERVE SYSTEM information technology. termination of telecommunications DATES: Comments must be submitted on traffic. Proposed Agency Information Collection Activities; Comment or before June 1, 2010. Federal Communications Commission. Request ADDRESSES: You may submit comments, Bulah P. Wheeler, identified by FR 2046, FR 2060, FR AGENCY: Board of Governors of the Acting Associate Secretary, 2572, FR 4006, FR 4008, FR 4010, FR Federal Reserve System. Office of the Secretary, 4011, FR 4012, FR 4017, FR 4019, FR SUMMARY: 4023, FR 4013, or FR 4014 by any of the Office of Managing Director. Background. On June 15, 1984, the Office of Management and following methods: [FR Doc. 2010–7168 Filed 3–30–10; 8:45 am] Budget (OMB) delegated to the Board of • Agency Web Site: http:// BILLING CODE 6712–01–S Governors of the Federal Reserve www.federalreserve.gov. Follow the System (Board) its approval authority instructions for submitting comments at under the Paperwork Reduction Act http:/www.federalreserve.gov/ FEDERAL ACCOUNTING STANDARDS (PRA), as per 5 CFR 1320.16, to approve generalinfo/foia/ProposedRegs.cfm. ADVISORY BOARD of and assign OMB control numbers to • Federal eRulemaking Portal: collection of information requests and www.regulations.gov. Follow the Notice of Issuance of Exposure Draft requirements conducted or sponsored instructions for submitting comments. on Accrual Estimates for Grant by the Board under conditions set forth • E-mail: Programs in 5 CFR Part 1320 Appendix A.1. [email protected]. AGENCY: Federal Accounting Standards Board-approved collections of Include the OMB control number in the Advisory Board. information are incorporated into the subject line of the message. • FAX: 202–452–3819 or 202–452– ACTION: Notice. official OMB inventory of currently approved collections of information. 3102. Board Action: Pursuant to 31 U.S.C. Copies of the Paperwork Reduction Act • Mail: Jennifer J. Johnson, Secretary, 3511(d), the Federal Advisory Submission, supporting statements and Board of Governors of the Federal Committee Act (Pub. L. 92–463), as approved collection of information Reserve System, 20th Street and amended, and the FASAB Rules of instruments are placed into OMB’s Constitution Avenue, NW., Washington, Procedure, as amended in April, 2004, public docket files. The Federal Reserve DC 20551. notice is hereby given that the may not conduct or sponsor, and the All public comments are available from Accounting and Auditing Policy respondent is not required to respond the Board’s web site at http:// Committee (AAPC) has issued an to, an information collection that has www.federalreserve.gov/generalinfo/ Exposure Draft of a new Federal been extended, revised, or implemented foia/ProposedRegs.cfm as submitted, Financial Accounting Technical Release on or after October 1, 1995, unless it unless modified for technical reasons.

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Accordingly, your comments will not be Federal Reserve review balance sheet creditors that have engaged in one or edited to remove any identifying or data in determining whether to extend more of the practices identified in contact information. Public comments credit and to help ascertain whether Section 505 of the Credit Card Act. may also be viewed electronically or in undue use is made of such credit. Current Actions: The Federal Reserve paper form in Room MP–500 of the Borrowers report certain balance sheet proposes to discontinue collection of Board’s Martin Building (20th and C data for a period that encompasses the the FR 2572S data. As directed by the Streets, NW.) between 9 a.m. and 5 p.m. dates of borrowing. Section 505 of the Credit Card Act, the on weekdays. Current Actions: The Federal Reserve Federal Reserve Board conducted a one- Additionally, commenters should proposes to revise the FR 2046 time survey regarding the extent to send a copy of their comments to the consistent with the 2009 revisions to the which credit card issuers adjust OMB Desk Officer by mail to the Office Weekly Report of Selected Assets and consumer credit lines or interest rates of Information and Regulatory Affairs, Liabilities of Domestically Chartered based on certain factors. The Credit U.S. Office of Management and Budget, Commercial Banks and U.S. Branches Card Act required the Federal Reserve New Executive Office Building, Room and Agencies of Foreign Banks (FR Board to complete the survey and 10235, 725 17th Street, NW., 2644; OMB No. 7100–0075). FR 2046 submit a report to Congress by May 22, Washington, DC 20503 or by fax to 202– respondents that also file the FR 2644 2010. For this reason, the Federal 395–6974. need not report data items that are Reserve is proposing to discontinue the FOR FURTHER INFORMATION CONTACT: A common to both reports. The recent FR 2572S. copy of the PRA OMB submission, changes to the FR 2644 included new Proposal To Approve Under OMB including the proposed reporting form reporting of total deposits and the Delegated Authority the Extension for and instructions, supporting statement, elimination of a separate data item for Three Years, Without Revision, of the and other documentation will be placed total loans. As a result, FR 2046 Following Reports into OMB’s public docket files, once respondents that also file the FR 2644 or approved. These documents will also be the weekly Report of Transaction 1. Report title: Survey to Obtain made available on the Federal Reserve Accounts, Other Deposits and Vault Information on the Relevant Market in Board’s public Web site at: http:// Cash (FR 2900; OMB No. 7100–0087) Individual Merger Cases. need not provide data on total deposits, Agency form number: FR 2060. www.federalreserve.gov/boarddocs/ OMB control number: 7100–0232. reportforms/review.cfm or may be but must provide data on total loans. 2. Report title: Report of Terms of Frequency: On occasion. requested from the agency clearance Reporters: Small businesses and Credit Card Plans and the Report of officer, whose name appears below. consumers. Michelle Shore, Federal Reserve Terms of Credit Card Plans Annual reporting hours: 9 hours. Board Clearance Officer (202–452– Supplemental Survey. Estimated average hours per response: 3829), Division of Research and Agency form numbers: FR 2572 and Small businesses, 10 minutes; Statistics, Board of Governors of the FR 2572S, respectively. Consumers, 6 minutes. Federal Reserve System, Washington, OMB control number: 7100–0239. Number of respondents: 25 small Frequency: FR 2572, Semi-annual; DC 20551. Telecommunications Device businesses and 50 consumers per and FR 2572S, one-time. for the Deaf (TDD) users may contact survey. (202–263–4869). Reporters: Commercial banks, savings General description of report: This banks, industrial banks, and savings and information collection is voluntary Proposal To Approve Under OMB loans associations. pursuant to the Change in Bank Control Delegated Authority the Extension for Annual reporting hours: FR 2572, 75 Act (12 U.S.C. 1817(j)(7)(A) and (B)), the Three Years, With Revision, of the hours; and FR 2572S, 263 hours. Bank Merger Act (12 U.S.C. 1828(c)(5)), Following Reports Estimated average hours per response: FR 2572, 0.25 hours; and FR 2572S, 1.50 and section 3(c)(1) of the Bank Holding 1. Report title: Report of Selected Company Act (BHC Act) (12 U.S.C. Balance Sheet Items for Discount hours. Number of respondents: FR 2572, 150; 1842(c)(1)). Individual responses are Window Borrowers. confidential pursuant to the Freedom of Agency form numbers: FR 2046. and FR 2572S, 175. General description of report: This Information Act (5 U.S.C. 552 (b)(4) and OMB control number: 7100–0289. (b)(6)) for small businesses and Frequency: On occasion. information collection is authorized pursuant section 136(b) of the Truth in consumers, respectively. Reporters: Depository institutions. Abstract: The Federal Reserve uses Annual reporting hours: Primary and Lending Act, 15 U.S.C. 1646(b). this information to define relevant Secondary Credit, 1 hour; Seasonal Reporting the FR 2572 is required of the banking markets for specific merger and Credit, 386 hours. 25 largest issuers; other financial acquisition applications and to evaluate Estimated average hours per response: institutions participate voluntarily. The changes in competition that would Primary and Secondary Credit, 0.75 data are not considered confidential. Reporting the FR 2572S data is result from proposed transactions. hour; Seasonal Credit, 0.25 hour. 2. Report title: Request for Extension Number of respondents: Primary and mandatory and the identity of survey of Time to Dispose of Assets Acquired Secondary Credit, 1; Seasonal Credit, respondents is considered confidential in Satisfaction of Debts Previously 103. (5 U.S.C 552(b)(4)). General description of report: This Abstract: The FR 2572 collects data Contracted. on credit card pricing and availability Agency form number: FR 4006. information collection is required to OMB control number: 7100–0129. obtain a benefit pursuant to section 10B from a sample of at least 150 financial Frequency: Annual. and 19(b)(7) of the Federal Reserve Act institutions that offer credit cards to the Reporters: BHCs. (12 U.S.C. 347b and 461(b)(7)) and is general public. The information Annual reporting hours: 505 hours. given confidential treatment (5 U.S.C. collected on the FR 2572 is reported to Estimated average hours per response: 552(b)(4)). Congress and made available to the 5 hours. Abstract: The Federal Reserve’s public in order to promote competition Number of respondents: 101. Regulation A, Extensions of Credit by within the industry. The FR 2572S General description of report: This Federal Reserve Banks, requires that the gathers information on the number of information collection is required to

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obtain a benefit pursuant to sections 4(a) FR 4011: 10 hours; FR 4012: BHCs of this information would cause and 4(c)(2) of the BHC Act [12 U.S.C. decertified as financial holding substantial harm to the competitive 1843(a) and (c)(2)] and may be given companies (FHCs) 1 hour, FHCs back position of the entity, and (b)(8) if the confidential treatment upon request. into compliance 10 hours; FR 4017: 4 information is related to examination, The Federal Reserve has established a hours; FR 4019: Regulatory relief operating, or condition reports prepared procedure for requesting an extension in requests 1 hour, Portfolio company by, on behalf of, or for the use of an its Regulation Y [12 CFR 225.22(d)(1) notification 1 hour; and FR 4023: 50 agency responsible for the regulation or and 225.140]. hours. supervision of financial institutions. Abstract: BHC that acquired voting Number of respondents: FR 4010: Since the Federal Reserve does not securities or assets through foreclosure BHC 35, FBOs 6; FR 4011: 6; FR 4012: collect the FR 4023, no issue of in the ordinary course of collecting a BHCs decertified as FHCs 80, FHCs back confidentiality under the FOIA arises. debt previously contracted may not into compliance 20; FR 4017: 3; FR FOIA will only be implicated if the retain ownership of those shares or 4019: Regulatory relief requests 5, Board’s examiners retained a copy of the assets for more than two years without Portfolio company notification 2; FR records in their examination or prior Federal Reserve approval. There is 4023: 60. supervision of the institution, and no formal reporting form and each General description of report: The FR would likely be exempt from disclosure request for extension must be filed at 4010 is required to obtain a benefit and pursuant to FOIA (5 U.S.C. 552(b)(4), the appropriate Reserve Bank of the is authorized under Section 4(l)(1)(C) of (b)(6), and (b)(8)). BHC. The Federal Reserve uses the the BHC Act, 12 U.S.C. 1843(l)(1)(C); Abstract: Each BHC or FBO seeking information provided in the request to section 8(a) of the International Banking FHC status must file the FR 4010 fulfill its statutory obligation to Act, 12 U.S.C. 3106(a); and sections declaration, which includes information supervise BHCs. 225.82 and 225.91 of Regulation Y, 12 needed to verify eligibility for FHC 3. Report title: Stock Redemption CFR 225.82 and 225.91. status. By filing the FR 4011, a requestor Notification. The FR 4011 is voluntary and is may ask the Board to determine that an Agency form number: FR 4008. authorized under Sections 4(j) and 4(k) activity is financial in nature, to issue OMB control number: 7100–0131. of the BHC Act, 12 U.S.C. 1843(j) an advisory opinion that an activity is Frequency: On occasion. through (k); and sections 225.88, and within the scope of an activity Reporters: BHCs. 225.89, of Regulation Y, 12 CFR 225.88, previously determined to be financial in Annual reporting hours: 155 hours. and 225.89. nature, or to approve engagement in an Estimated average hours per response: The FR 4012 is mandatory and is activity complementary to a financial 15.5 hours. authorized under Section 4(l)(1) and activity. Any FHC ceasing to meet Number of respondents: 10 4(m) of the BHC Act, 12 U.S.C. capital or managerial prerequisites for General description of report: This 1843(l)(1) and (m); section 8(a) of the FHC status must notify the Board of the information collection is mandatory International Banking Act, 12 U.S.C. deficiency by filing the FR 4012 and pursuant to Sections 5(b) and (c) of the 3106(a); and sections 225.83 and 225.93 often must submit plans to the Board to BHC Act (12 U.S.C. 1844(b) and (c)) and of Regulation Y, 12 CFR 225.83 and cure the deficiency. Any SMB seeking to is generally not given confidential 225.93. establish a financial subsidiary must treatment. However, a respondent may The FR 4017 is required to obtain a seek the Board’s prior approval by request that the information be kept benefit and is authorized under Section submitting the FR 4017. Any FHC confidential on a case-by-case basis. 9 of the Federal Reserve Act, 12 U.S.C. seeking to extend the 10-year holding Abstract: The BHC Act and 335; and section 208.76 of Regulation H, period for a merchant banking Regulation Y generally require a BHC to 12 CFR 208.76. investment must submit the FR 4019 to seek prior Federal Reserve approval The FR 4019 is required to obtain a apply for the Board’s prior approval, before purchasing or redeeming its benefit and is authorized under Section and a FHC also must notify the Board equity securities. Given that a BHC is 4(k)(7) of the BHC Act, 12 U.S.C. if it routinely manages or operates a exempt from this requirement if it meets 1843(k)(7); and sections 225.171(e)(3), portfolio company for more than nine certain financial, managerial, and 225.172(b)(4), and 225.173(c)(2) of months. All FHCs engaging in merchant supervisory standards, only a small Regulation Y, 12 CFR 225.171(e)(3), banking activities must keep records of portion of proposed stock redemptions 225.172(b)(4), and 225.173(c)(2). those activities, and make them actually require the prior approval of The FR 4023 is mandatory and is available to examiners as specified in the Federal Reserve. There is no formal authorized under Section 4(k)(7) of the the FR 4023 requirements. reporting form. The Federal Reserve BHC Act, 12 U.S.C. 1843(k)(7); and There are no formal reporting forms uses the information provided in the sections 225.171(e)(4) and 225.175 of for these collections of information, redemption notice to fulfill its statutory Regulation Y, 12 CFR 225.171(e)(4) and which are event generated, though in obligation to supervise BHCs. 225.175. each case the type of information 4. Report title: Information Collections For the FR 4010, FR 4011, FR 4017, required to be filed is described in the Related to the Gramm-Leach-Bliley FR 4019, and information related to a Board’s regulations. These collections of (GLB) Act. failure to meet capital requirements on information are required pursuant to Agency form number: FR 4010, FR the FR 4012, a company may request amendments made by the GLB Act to 4011, FR 4012, FR 4017, FR 4019, and confidential treatment of the the BHC Act or the Federal Reserve Act, FR 4023. information contained in these or Board regulations issued to carry out OMB control number: 7100–0292. information collections pursuant to the GLB Act. Frequency: On occasion. section (b)(4) and (b)(6) of the Freedom 5. Report title: Notice Claiming Status Reporters: BHCs, foreign banking of Information Act (FOIA)(5 U.S.C. 552 as an Exempt Transfer Agent. organizations (FBOs), and state member (b)(4) and (b)(6)). Information related to Agency form number: FR 4013. banks (SMBs). a failure to meet management OMB control number: 7100–0137. Annual reporting hours: 3,485 hours. requirements on the FR 4012 is Frequency: On occasion. Estimated average hours per response: confidential and exempt from disclosure Reporters: BHCs, and certain trust FR 4010: BHC 3 hours, FBOs 3.5 hours; under section (b)(4), because the release companies.

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Annual reporting hours: 20 hours. appropriate Reserve Bank of the SMB. Trust into a national bank and thereby Estimated average hours per response: The Federal Reserve uses the merging it with Morgan Stanley Bank, 2 hours. information provided in the notice to N.A., which will be relocated to Number of respondents: 10. fulfill its statutory obligation to Purchase, New York. General description of report: This supervise SMBs. Board of Governors of the Federal Reserve information collection is mandatory System, March 26, 2010. pursuant to section 17A(c) of the Board of Governors of the Federal Reserve Robert deV. Frierson, Securities Exchange Act of 1934 (15 System, March 26, 2010. Deputy Secretary of the Board. U.S.C. 78q–1(c)) as amended by the Jennifer J. Johnson, [FR Doc. 2010–7182 Filed 3–30–10; 8:45 am] Securities Acts Amendments of 1975. Secretary of the Board. The Federal Reserve is authorized to BILLING CODE 6210–01–S [FR Doc. 2010–7164 Filed 3–30–10; 8:45 am] collect these data from state member banks or their subsidiaries, and BHCs or BILLING CODE 6210–01–P their subsidiaries (except national banks FEDERAL TRADE COMMISSION and state nonmember banks that are FEDERAL RESERVE SYSTEM [File No. 082 3153] insured by the FDIC) by 15 U.S.C. 78c(a)(34)(B)(ii). The data collected are Formations of, Acquisitions by, and Dave & Buster’s, Inc.; Analysis of not given confidential treatment. Mergers of Bank Holding Companies Proposed Consent Order to Aid Public Abstract: Banks, BHCs, and trust Comment companies subject to the Federal The companies listed in this notice AGENCY: Federal Trade Commission. Reserve’s supervision that are low- have applied to the Board for approval, volume transfer agents voluntarily file pursuant to the Bank Holding Company ACTION: Proposed Consent Agreement. Act of 1956 (12 U.S.C. 1841 et seq.) the notice on occasion with the Federal SUMMARY: The consent agreement in this (BHC Act), Regulation Y (12 CFR Part Reserve. Transfer agents are institutions matter settles alleged violations of 225), and all other applicable statutes that provide securities transfer, federal law prohibiting unfair or and regulations to become a bank registration, monitoring, and other deceptive acts or practices or unfair holding company and/or to acquire the specified services on behalf of securities methods of competition. The attached assets or the ownership of, control of, or issuers. The purpose of the notice, Analysis to Aid Public Comment the power to vote shares of a bank or which is effective until the agent describes both the allegations in the bank holding company and all of the withdraws it, is to claim exemption draft complaint and the terms of the banks and nonbanking companies from certain rules and regulations of the consent order — embodied in the owned by the bank holding company, Securities and Exchange Commission consent agreement — that would settle including the companies listed below. (SEC). The Federal Reserve uses the these allegations. notices for supervisory purposes The applications listed below, as well as other related filings required by the DATES: Comments must be received on because the SEC has assigned to the or before April 26, 2010. Federal Reserve responsibility for Board, are available for immediate ADDRESSES: Interested parties are collecting the notices and verifying their inspection at the Federal Reserve Bank invited to submit written comments accuracy through examinations of the indicated. The applications also will be electronically or in paper form. respondents. There is no formal available for inspection at the offices of Comments should refer to ‘‘Dave & reporting form and each notice is filed the Board of Governors. Interested Buster’s, File No. 082 3153’’ to facilitate as a letter. persons may express their views in 6. Report title: Investment in Bank writing on the standards enumerated in the organization of comments. Please Premises Notification. the BHC Act (12 U.S.C. 1842(c)). If the note that your comment — including Agency form number: FR 4014. proposal also involves the acquisition of your name and your state — will be OMB control number: 7100–0139. a nonbanking company, the review also placed on the public record of this Frequency: On occasion. includes whether the acquisition of the proceeding, including on the publicly Reporters: SMBs. nonbanking company complies with the accessible FTC website, at (http:// Annual reporting hours: 7 hours. standards in section 4 of the BHC Act www.ftc.gov/os/publiccomments.shtm). Estimated average hours per response: (12 U.S.C. 1843). Unless otherwise Because comments will be made 30 minutes. noted, nonbanking activities will be public, they should not include any Number of respondents: 13. conducted throughout the United States. sensitive personal information, such as General description of report: This Additional information on all bank an individual’s Social Security Number; information collection is required to holding companies may be obtained date of birth; driver’s license number or obtain a benefit pursuant to Section from the National Information Center other state identification number, or 24A(a) of the Federal Reserve Act (12 website at www.ffiec.gov/nic/. foreign country equivalent; passport U.S.C. 371d(a)) and is not given Unless otherwise noted, comments number; financial account number; or confidential treatment. However, a regarding each of these applications credit or debit card number. Comments respondent may request confidential must be received at the Reserve Bank also should not include any sensitive treatment for all or part of a notification, indicated or the offices of the Board of health information, such as medical which would be reviewed on a case-by- Governors not later than April 26, 2010. records or other individually case basis. A. Federal Reserve Bank of New identifiable health information. In Abstract: The Federal Reserve Act York (Ivan Hurwitz, Bank Applications addition, comments should not include requires an SMB to seek prior Federal Officer) 33 Liberty Street, New York, any ‘‘[t]rade secret or any commercial or Reserve approval before making an New York 10045–0001: financial information which is obtained investment in bank premises that 1. Morgan Stanley, New York, New from any person and which is privileged exceeds certain thresholds. There is no York; to acquire 100 percent of the or confidential....,’’ as provided in formal reporting form, and each voting shares of Morgan Stanley Private Section 6(f) of the FTC Act, 15 U.S.C. required request for prior approval must Bank, N.A., Jersey City, New Jersey, as 46(f), and Commission Rule 4.10(a)(2), be filed as a notification with the a result of converting Morgan Stanley 16 CFR 4.10(a)(2). Comments containing

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material for which confidential effort to remove home contact in the United States. Consumers may treatment is requested must be filed in information for individuals from the pay for purchases at these locations paper form, must be clearly labeled public comments it receives before with credit and debit cards (collectively, ‘‘Confidential,’’ and must comply with placing those comments on the FTC ‘‘payment cards’’) or cash. In conducting FTC Rule 4.9(c), 16 CFR 4.9(c).1 website. More information, including its business, Dave & Buster’s routinely Because paper mail addressed to the routine uses permitted by the Privacy collects information from consumers to FTC is subject to delay due to Act, may be found in the FTC’s privacy obtain authorization for payment card heightened security screening, please policy, at (http://www.ftc.gov/ftc/ purchases, including the credit card consider submitting your comments in privacy.shtm). account number, expiration date, and an electronic security code for payment electronic form. Comments filed in FOR FURTHER INFORMATION CONTACT: authorization. This information is electronic form should be submitted by Katrina Blodgett (202-326-3158), Bureau particularly sensitive because it can be using the following weblink: (https:// of Consumer Protection, 600 used to facilitate payment card fraud public.commentworks.com/ftc/ Pennsylvania Avenue, NW, Washington, and other consumer fraud. daveandbusters) and following the D.C. 20580. instructions on the web-based form. To The Commission’s complaint alleges SUPPLEMENTARY INFORMATION: ensure that the Commission considers Pursuant that since at least April 2007, Dave & an electronic comment, you must file it to section 6(f) of the Federal Trade Buster’s engaged in a number of on the web-based form at the weblink: Commission Act, 38 Stat. 721, 15 U.S.C. practices that, taken together, failed to (https://public.commentworks.com/ftc/ 46(f), and § 2.34 the Commission Rules provide reasonable and appropriate daveandbusters). If this Notice appears of Practice, 16 CFR 2.34, notice is security for personal information on its at (http://www.regulations.gov/search/ hereby given that the above-captioned computer networks. Among other index.jsp), you may also file an consent agreement containing a consent things, Dave & Buster’s: (a) failed to electronic comment through that order to cease and desist, having been employ sufficient measures to detect website. The Commission will consider filed with and accepted, subject to final and prevent unauthorized access to all comments that regulations.gov approval, by the Commission, has been computer networks or to conduct forwards to it. You may also visit the placed on the public record for a period security investigations, such as by FTC website at (http://www.ftc.gov/) to of thirty (30) days. The following employing an intrusion detection read the Notice and the news release Analysis to Aid Public Comment system and monitoring system logs; (b) describing it. describes the terms of the consent failed to adequately restrict third-party A comment filed in paper form agreement, and the allegations in the access to its networks, such as by should include the ‘‘Dave & Buster’s, complaint. An electronic copy of the restricting connections to specific IP File No. 082 3153’’ reference both in the full text of the consent agreement addresses or granting temporary, limited text and on the envelope, and should be package can be obtained from the FTC access; (c) failed to monitor and filter mailed or delivered to the following Home Page (for March 25, 2010), on the outbound traffic from its networks to address: Federal Trade Commission, World Wide Web, at (http:// identify and block export of sensitive Office of the Secretary, Room H-135 www.ftc.gov/os/actions.shtm). A paper personal information without (Annex D), 600 Pennsylvania Avenue, copy can be obtained from the FTC authorization; (d) failed to use readily NW, Washington, DC 20580. The FTC is Public Reference Room, Room 130-H, available security measures to limit requesting that any comment filed in 600 Pennsylvania Avenue, NW, access between in-store networks, such paper form be sent by courier or Washington, D.C. 20580, either in as by using firewalls or isolating the overnight service, if possible, because person or by calling (202) 326-2222. payment card system from the rest of U.S. postal mail in the Washington area Public comments are invited, and may the corporate network; and (e) failed to and at the Commission is subject to be filed with the Commission in either use readily available security measures delay due to heightened security paper or electronic form. All comments to limit access to its computer networks precautions. should be filed as prescribed in the through wireless access points on the The Federal Trade Commission Act ADDRESSES section above, and must be networks. (‘‘FTC Act’’) and other laws the received on or before the date specified The complaint further alleges that DATES between April 30, 2007 and August 28, Commission administers permit the in the section. 2007, an intruder, exploiting some of collection of public comments to Analysis of Agreement Containing these vulnerabilities, connected to Dave consider and use in this proceeding as Consent Order to Aid Public Comment & Buster’s networks numerous times appropriate. The Commission will The Federal Trade Commission has without authorization, installed consider all timely and responsive accepted, subject to final approval, a unauthorized software, and intercepted public comments that it receives, consent agreement from Dave & personal information in transit from in- whether filed in paper or electronic Buster’s, Inc. (‘‘Dave & Buster’s’’). store networks to its credit card form. Comments received will be The proposed consent order has been processing company. The breach available to the public on the FTC placed on the public record for thirty compromised approximately 130,000 website, to the extent practicable, at (30) days for receipt of comments by unique payment cards used by (http://www.ftc.gov/os/ interested persons. Comments received consumers in the United States. publiccomments.shtm). As a matter of during this period will become part of The proposed order applies to discretion, the Commission makes every the public record. After thirty (30) days, personal information Dave & Buster’s the Commission will again review the collects from or about consumers. It 1 The comment must be accompanied by an explicit request for confidential treatment, agreement and the comments received, contains provisions designed to prevent including the factual and legal basis for the request, and will decide whether it should Dave & Buster’s from engaging in the and must identify the specific portions of the withdraw from the agreement and take future in practices similar to those comment to be withheld from the public record. appropriate action or make final the alleged in the complaint. The request will be granted or denied by the Commission’s General Counsel, consistent with agreement’s proposed order. Part I of the proposed order requires applicable law and the public interest. See FTC Dave & Buster’s owns and operates 53 Dave & Buster’s to establish and Rule 4.9(c), 16 CFR 4.9(c). restaurant and entertainment complexes maintain a comprehensive information

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security program in writing that is its compliance with the order. For most DATES: Expressions of interest for FY reasonably designed to protect the records, the order requires that the 2010–11 must be received no later than security, confidentiality, and integrity of documents be retained for a five-year cob April 15, 2010. personal information collected from or period. For the third-party assessments ADDRESSES: Expressions of interest, about consumers. The security program and supporting documents, Dave & comments, and questions may be must contain administrative, technical, Buster’s must retain the documents for submitted by e-mail to [email protected]; by and physical safeguards appropriate to a period of three years after the date that regular mail to Office of Healthcare Dave & Buster’s size and complexity, the each assessment is prepared. Part IV Quality, Department of Health and nature and scope of its activities, and requires dissemination of the order now Human Services, 200 Independence the sensitivity of the personal and in the future to principals, officers, Ave., SW., Room 716G, Washington, DC information collected from or about directors, and managers at corporate 20201, or via fax to 202–401–9547. consumers. Specifically, the order headquarters, regional offices, and at requires Dave & Buster’s to: each store having responsibilities FOR FURTHER INFORMATION CONTACT: ∑ Designate an employee or relating to the subject matter of the Daniel Gallardo via electronic mail to employees to coordinate and be order. Part V ensures notification to the [email protected]; or by phone accountable for the information security FTC of changes in corporate status. Part at 202–690–2470. program. VI mandates that Dave & Buster’s submit SUPPLEMENTARY INFORMATION: ∑ Identify material internal and an initial compliance report to the FTC, Healthcare-associated infections (HAIs) external risks to the security, and make available to the FTC exact a significant toll on human life. confidentiality, and integrity of personal subsequent reports. Part VII is a They are among the leading causes of information that could result in the provision ‘‘sunsetting’’ the order after preventable death in the United States, unauthorized disclosure, misuse, loss, twenty (20) years, with certain accounting for an estimated 1.7 million alteration, destruction, or other exceptions. infections and 99,000 associated deaths compromise of such information, and The purpose of the analysis is to aid in 2002. In hospitals, they are a assess the sufficiency of any safeguards significant cause of morbidity and in place to control these risks. public comment on the proposed order. ∑ It is not intended to constitute an mortality. In addition to the substantial Design and implement reasonable human suffering caused by healthcare- safeguards to control the risks identified official interpretation of the proposed order or to modify its terms in any way. associated infections, the financial through risk assessment, and regularly burden attributable to the infections is By direction of the Commission. test or monitor the effectiveness of the staggering. It is estimated that safeguards’ key controls, systems, and Donald S. Clark healthcare-associated infections cause procedures. $28 to $33 billion in excess healthcare ∑ Develop and use reasonable steps to Secretary costs each year. For these reasons, the select and retain service providers [FR Doc. 2010–7127 Filed 3–30–10: 1:29 pm] prevention and reduction of healthcare- capable of appropriately safeguarding BILLING CODE 6750–01–S associated infections is a top priority for personal information they receive from the U.S. Department of Health and respondents, and require service Human Services (HHS). providers by contract to implement and maintain appropriate safeguards. DEPARTMENT OF HEALTH AND The HHS Steering Committee for the ∑ Evaluate and adjust its information HUMAN SERVICES Prevention of Healthcare-Associated security program in light of the results Infections, led by Dr. Don Wright, of the testing and monitoring, any Call for Co-Sponsors for Office of Deputy Assistant Secretary for material changes to its operations or Healthcare Quality’s Programs to Healthcare Quality, was established in business arrangements, or any other Strengthen Coordination and Impact July 2008. The Steering Committee was circumstances that it knows or has National Efforts in the Prevention of charged with developing a reason to know may have a material Healthcare-Associated Infections comprehensive strategy to prevent and impact on the effectiveness of its (HAIs) reduce healthcare-associated infections information security program. and issuing a plan which establishes AGENCY: Department of Health and Part II of the proposed order requires national goals for healthcare-associated Human Services, Office of the Secretary, that Dave & Buster’s obtain within 180 infection prevention and outlines key Office of Public Health and Science, days, and on a biennial basis thereafter actions for achieving identified short- Office of Healthcare Quality. for ten (10) years, an assessment and and long-term objectives. The plan, report from a qualified, objective, ACTION: Notice. released in January 2009 as the HHS independent third-party professional, Action Plan, is also intended to enhance certifying, among other things, that it SUMMARY: The U.S. Department of collaboration with external stakeholders has in place a security program that Health and Human Services (HHS), to strengthen coordination and impact provides protections that meet or exceed Office of Public Health and Science of national efforts. the protections required by Part I of the (OPHS), Office for Healthcare Quality Therefore, OHQ is interested in proposed order; and its security (OHQ) announces the opportunity to establishing partnerships with private program is operating with sufficient collaborate with the U.S. Department of and public professional health effectiveness to provide reasonable Health and Human Services (HHS). HHS organizations in order to further the assurance that the security, invites public and private professional efforts in the prevention of Healthcare- confidentiality, and integrity of health related organizations to Associated Infections. As partners with consumers’ personal information is participate as collaborating co-sponsors OHQ, professional health related protected. in the development and implementation organizations can bring their ideas, Parts III through VII of the proposed of an innovative program that advances expertise, administrative capabilities, order are reporting and compliance the goals enumerated in the HHS Action and resources in the development of a provisions. Part III requires Dave & Plan to prevent Healthcare-Associated program(s) that promotes the reduction Buster’s to retain documents relating to Infections. and prevention of Healthcare-

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Associated Infections at the National the contact person for up-to-date Dated: March 18, 2010. level. information on this meeting. A notice in Judith Sparrow, Given OHQ’s objective, entities which the Federal Register about last minute Office of Programs and Coordination, Office have similar goals and consistent modifications that impact a previously of the National Coordinator for Health interests, appropriate expertise and announced advisory committee meeting Information Technology. resources, and which would like to cannot always be published quickly [FR Doc. 2010–6601 Filed 3–30–10; 8:45 am] pursue a Co-Sponsorship opportunity enough to provide timely notice. BILLING CODE 4150–45–P with OHQ, are encouraged to reply to this notice with a program proposal. Agenda: The committee will hear Working together, these partnerships reports from its workgroups, including DEPARTMENT OF HEALTH AND will provide opportunities to promote the Meaningful Use Workgroup, the HUMAN SERVICES the prevention and reduction of Certification/Adoption Workgroup, the healthcare-associated infections. NHIN Workgroup, the Privacy & Office of the National Coordinator for Security Policy Workgroup, and the Health Information Technology; HIT Dated: March 22, 2010. Strategic Plan Workgroup. ONC intends Standards Committee Advisory Don Wright, to make background material available Meeting; Notice of Meeting Deputy Assistant Secretary for Healthcare to the public no later than two (2) Quality, Office of Healthcare Quality, Office AGENCY: Office of the National of Public Health and Science. business days prior to the meeting. If Coordinator for Health Information [FR Doc. 2010–7227 Filed 3–30–10; 8:45 am] ONC is unable to post the background Technology, HHS. material on its Web site prior to the BILLING CODE 4150–28–P ACTION: Notice of meeting. meeting, it will be made publicly available at the location of the advisory This notice announces a forthcoming DEPARTMENT OF HEALTH AND committee meeting, and the background meeting of a public advisory committee HUMAN SERVICES material will be posed on ONC’s Web of the Office of the National Coordinator site after the meeting, at http:// for Health Information Technology Office of the National Coordinator for healthit.hhs.gov. (ONC). The meeting will be open to the Health Information Technology; HIT Procedure: Interested persons may public. Policy Committee Advisory Meeting; Name of Committee: HIT Standards Notice of Meeting present data, information, or views, orally or in writing, on issues pending Committee. General Function of the Committee: AGENCY: Office of the National before the committee. Written To provide recommendations to the Coordinator for Health Information submissions may be made to the contact Technology, HHS. National Coordinator on standards, person on or before April 13, 2010. Oral implementation specifications, and ACTION: Notice of meeting. comments from the public will be certification criteria for the electronic scheduled between approximately 3:30 exchange and use of health information This notice announces a forthcoming p.m. to 4 p.m. Time allotted for each meeting of a public advisory committee for purposes of adoption, consistent presentation is limited to three minutes. of the Office of the National Coordinator with the implementation of the Federal If the number of speakers requesting to for Health Information Technology Health IT Strategic Plan, and in (ONC). The meeting will be open to the comment is greater than can be accordance with policies developed by public. reasonably accommodated during the the HIT Policy Committee. Name of Committee: HIT Policy scheduled open public hearing session, Date and Time: The meeting will be Committee. ONC will take written comments after held on April 28, 2010, from 9 a.m. to General Function of the Committee: the meeting until close of business. 4 p.m./Eastern Time. To provide recommendations to the Persons attending ONC’s advisory Location: The Omni Shoreham Hotel, National Coordinator on a policy committee meetings are advised that the 2500 Calvert Street, NW., Washington, framework for the development and agency is not responsible for providing DC. The hotel telephone number is 202– adoption of a nationwide health access to electrical outlets. 234–0700. information technology infrastructure Contact Person: Judy Sparrow, Office that permits the electronic exchange and ONC welcomes the attendance of the of the National Coordinator, HHS, 330 C use of health information as is public at its advisory committee Street, SW., Washington, DC 20201, consistent with the Federal Health IT meetings. Seating is limited at the 202–205–4528, Fax: 202–690–6079, e- Strategic Plan and that includes location, and ONC will make every mail: [email protected]. Please call recommendations on the areas in which effort to accommodate persons with the contact person for up-to-date standards, implementation physical disabilities or special needs. If information on this meeting. A notice in specifications, and certification criteria you require special accommodations the Federal Register about last minute are needed. due to a disability, please contact Judy modifications that impact a previously Date and Time: The meeting will be Sparrow at least seven (7) days in announced advisory committee meeting held on April 21, 2010, from 10 a.m. to advance of the meeting. cannot always be published quickly 4 p.m./Eastern Time. ONC is committed to the orderly enough to provide timely notice. Location: The Omni Shoreham Hotel, conduct of its advisory committee Agenda: The committee will hear reports from its workgroups, including 2500 Calvert Street, NW., Washington, meetings. Please visit our Web site at DC. The hotel telephone number is 202– the Clinical Operations, Clinical http://healthit.hhs.gov for procedures 234–0700. Quality, Privacy & Security, and Contact Person: Judy Sparrow, Office on public conduct during advisory Implementation Workgroups. ONC of the National Coordinator, HHS, 330 C committee meetings. intends to make background material Street, SW., Washington, DC 20201, Notice of this meeting is given under available to the public no later than two 202–205–4528, Fax: 202–690–6079, e- the Federal Advisory Committee Act (2) business days prior to the meeting. mail: [email protected]. Please call (Pub. L. 92–463, 5 U.S.C., App. 2). If ONC is unable to post the background

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material on its Web site prior to the Authority: Executive Order 13251, dated who will be drawn from fields of meeting, it will be made publicly November 24, 2009. The Presidential bioethics, science, medicine, available at the location of the advisory Commission for the Study of Bioethical technology, engineering, law, Issues will be governed by provisions of the committee meeting, and the background Federal Advisory Committee Act, Public Law philosophy, theology, and other areas of material will be posed on ONC’s Web 92–463, as amended (5 U.S.C. App.), which the humanities or social sciences. site after the meeting, at http:// sets forth standards for the formation and use Commission members shall be healthit.hhs.gov of advisory committees. appointed by the President. The Procedure: Interested persons may SUMMARY: The U.S. Department of President shall designate a Chair and present data, information, or views, Health and Human Services announces Vice Chair from among the members of orally or in writing, on issues pending establishment of the Presidential the Commission. At least one, and not before the committee. Written Commission for the Study of Bioethical more than three members, may be submissions may be made to the contact Issues (the ‘‘Commission’’), as directed bioethicists or scientists drawn from the person on or before April 20, 2010. Oral by Executive Order 13521. executive branch, as designated by the comments from the public will be FOR FURTHER INFORMATION CONTACT: Ms. scheduled between approximately 3 President; members who are selected Diane M. Gianelli, Acting Executive p.m. and 3:30 p.m./Eastern Time. Time from the Federal sector to fill these Director, Presidential Commission on allotted for each presentation will be positions on the Commission will be the Study of Bioethical Issues; limited to three minutes each. If the classified as regular government Department of Health and Human number of speakers requesting to employees. The Commission members Services; and/or Ms. Judith E. Crawford, who are selected from the public and/ comment is greater than can be Administrative Director, Presidential reasonably accommodated during the or private sector will be classified as Commission on the Study of Bioethical special government employees. scheduled open public hearing session, Issues; Department of Health and ONC will take written comments after Human Services. Both Ms. Gianelli and Administrative Management and the meeting until close of business. Ms. Crawford work in the Commission’s Support. HHS will provide funding and Persons attending ONC’s advisory office located at: 1425 New York administrative support for the committee meetings are advised that the Avenue, NW., Suite C100; Washington, Commission to the extent permitted by agency is not responsible for providing DC 20005; Telephone: (202) 233–3960; law within existing appropriations. Staff access to electrical outlets. Fax: (202) 233–3990. will be assigned to a program office ONC welcomes the attendance of the SUPPLEMENTARY INFORMATION: established to support the activities of public at its advisory committee Under Executive Order 13521, the President the Commission. Management and meetings. Seating is limited at the directed that the Commission shall be location, and ONC will make every oversight for support services provided established within the Department of effort to accommodate persons with to the Commission will be the Health and Human Services (HHS). To physical disabilities or special needs. If responsibility of the Office of Public comply with the authorizing directive you require special accommodations Health and Science, which is a staff and guidelines under the Federal due to a disability, please contact Judy division within HHS Office of the Advisory Committee Act (FACA), a Sparrow at least seven (7) days in Secretary. All executive departments charter has been filed with the advance of the meeting. and agencies and all entities within the Committee Management Secretariat in ONC is committed to the orderly Executive Office of the President shall the General Services Administration conduct of its advisory committee provide information and assistance to (GSA), the appropriate committees in meetings. Please visit our Web site at the Commission as the Chair may the Senate and U.S. House of http://healthit.hhs.gov for procedures request for purposes of carrying out the Representatives, and the Library of on public conduct during advisory Commission’s functions, to the extent Congress to establish the Commission as committee meetings. a non-discretionary Federal advisory permitted by law. Notice of this meeting is given under The Commission has been established the Federal Advisory Committee Act committee. The charter was filed on to replace the President’s Council on (Pub. L. 92–463, 5 U.S.C., App. 2). March 10, 2010. Objectives and Scope of Activities. Bioethics. The Council was established Dated: March 18, 2010. The Commission shall advise the by Executive Order 13237, dated Judith Sparrow, President on bioethical issues that may November 28, 2001. Council operations Office of Programs and Coordination, Office emerge as consequences of advances in were terminated on September 30, 2009. of the National Coordinator for Health biomedicine and related areas of science The authorizing directive for the Information Technology. and technology. The Commission shall Commission, Executive Order 13521, [FR Doc. 2010–6600 Filed 3–30–10; 8:45 am] pursue its work with the goal of supersedes Executive Order 13237. BILLING CODE 4150–45–P identifying and promoting policies and practices that ensure scientific research, A copy of the Commission charter can healthcare delivery, and technological be obtained from the designated DEPARTMENT OF HEALTH AND innovation are conducted in an ethically contacts or by accessing the FACA HUMAN SERVICES responsible manner. The Commission database that is maintained by the GSA shall not be responsible for the review Committee Management Secretariat. The Establishment of the Presidential and approval of specific projects. The Web site for the FACA database is Commission for the Study of Commission may accept suggestions of http://fido.gov/facadatabase/. Bioethical Issues issues for consideration from executive Dated: March 25, 2010. AGENCY: Office of Public Health and departments and agencies and the Howard K. Koh, Science, Office of the Secretary, public as it deems appropriate to support its mission. Assistant Secretary for Health, Office of Department of Health and Human Public Health and Science. Services. Membership and Designation. The Commission shall be an expert panel [FR Doc. 2010–7232 Filed 3–30–10; 8:45 am] ACTION: Notice. composed of not more than 13 members, BILLING CODE 4154–06–P

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DEPARTMENT OF HEALTH AND standard of five servings a day of fruits markets (2,348 respondents); and HUMAN SERVICES and vegetables. residents of neighborhoods in which the In response to this growing public NYC Health Bucks program operates Centers for Disease Control and health crisis, the Division of Nutrition, (1,000 respondents). Prevention Physical Activity, and Obesity (DNPAO) The evaluation plan calls for local at the Centers for Disease Control and [30Day–10–10AJ] community organizations to complete a Prevention (CDC), is working to identify web-based questionnaire at the Agency Forms Undergoing Paperwork promising local programs and policies conclusion of the farmers’ market Reduction Act Review designed to prevent childhood obesity. season. Farmers’ market managers will Priority is being given to programs and complete a written survey during the The Centers for Disease Control and policies targeting improved eating farmers’ market season, with in-person Prevention (CDC) publishes a list of habits and physical activity levels follow up by trained interviewers on information collection requests under among children in low-income site at farmers’ markets for managers review by the Office of Management and communities. who do not respond to the initial The New York City Health Bucks Budget (OMB) in compliance with the mailing. Farmers’ market vendors will program, operated by the New York City Paperwork Reduction Act (44 U.S.C. complete a written survey administered Department of Health and Mental Chapter 35). To request a copy of these by trained interviewers on site at Hygiene (DOHMH), is one example of requests, call the CDC Reports Clearance farmers’ markets, and trained this type of initiative. The program Officer at (404) 639–5960 or send an e- interviewers will also conduct written operates in three high-need, mail to [email protected]. Send written point-of-purchase intercept surveys underserved New York City comments to CDC Desk Officer, Office of with farmers’ market consumers. neighborhoods: The South Bronx, North Management and Budget, Washington, Finally, telephone interviews will be and Central Brooklyn, and East and DC or by fax to (202) 395–5806. Written conducted with a random sample of Central Harlem. Through the program, comments should be received within 30 residents in neighborhoods in which the targeted neighborhood residents are days of this notice. NYC Health Bucks program operates, provided with $2 ‘‘Health Bucks’’ that and in-depth information will be Proposed Project can be redeemed at local farmers’ collected from farmers’ market Evaluation of Childhood Obesity markets for the purchase of fresh, consumers and vendors through focus Prevention and Control Initiative: New locally-grown fruits and vegetables. The groups. York City Health Bucks Program Health Bucks program is intended to —New—National Center for Chronic increase fresh fruit and vegetable The results of the evaluation study Disease Prevention and Health purchases and consumption, and to will be used to: Assess the program’s Promotion (NCCDPHP), Centers for increase access at the community level ability to improve nutrition behaviors Disease Control and Prevention (CDC). by attracting local farmers to these among targeted participants; identify underserved areas. factors serving as barriers and Background and Brief Description CDC plans to sponsor an evaluation of facilitators to program implementation Childhood obesity is a major public the NYC Health Bucks program in 2010. and expected outcomes; provide health concern. One out of every five Information will be collected from five feedback to the DOHMH for the children is affected by overweight or groups of respondents: Local purposes of program improvement; and obesity in the United States, making it community organizations involved in share results with other entities the most prevalent nutritional disease of distributing Health Bucks to individuals interested in implementing similar this population. Although increased (200 respondents); farmers’ market programs. consumption of fruits and vegetables managers operating New York City Information collection will be has been found to reduce long-term farmers’ markets (90 respondents); conducted in English and Spanish. obesity risk, as well as risk of heart farmers’ market vendors selling at New There are no costs to respondents other disease and some cancers, relatively few York City farmers’ markets (474 than their time, and participation is children and adolescents consume the respondents); farmers’ market voluntary. The total estimated USDA recommended minimum consumers at New York City farmers’ annualized burden hours are 660.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Average Type of respondents Form type Number of responses per burden respondents respondent (in hours)

Local Community Organizations ...... Local Community Organization Survey ...... 200 1 10/60 Farmers’ Market Managers ...... Farmers’ Market Managers Survey ...... 90 1 8/60 Farmers’ Market Vendors ...... Farmers’ Market Vendor Survey ...... 450 1 7/60 Farmers’ Market Vendor Focus Group ...... 24 1 2 Farmers’ Market Consumers ...... Consumer Point-of-Purchase Survey ...... 2,300 1 7/60 Consumer Focus Group ...... 48 1 2 NYC Health Bucks Neighborhood Residents Neighborhood Resident Survey ...... 1,000 1 9/60

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Dated: March 22, 2010. Proposed Project realities. The result was Implementing Integrating Chronic Care and Business Maryam I. Daneshvar, Studying the Implementation of a Strategies in the Safety Net: A Toolkit Acting Reports Clearance Officer, Centers for Chronic Care Toolkit and Practice for Primary Care Practices and Clinics. Disease Control and Prevention. Coaching In Practices Serving The Toolkit was piloted in two [FR Doc. 2010–7171 Filed 3–30–10; 8:45 am] Vulnerable Populations California safety net clinics. BILLING CODE 4163–18–P An important part of AHRQ’s mission Recognizing that merely distributing the is to disseminate information and tools Toolkit was unlikely to foster adoption that can support improvement in quality DEPARTMENT OF HEALTH AND of CCM, the intervention included six and safety in the U.S. health care months of practice coaching delivered HUMAN SERVICES community. This proposed information by the MacColl Institute. Practice collection supports that part of AHRQ’s Coaches (PC) are health care or related Agency for Healthcare Research and mission by further refining the practice Quality professionals who help primary care coaching delivered in conjunction with practices in a variety of quality a previously developed toolkit, Agency Information Collection improvement and research activities. Implementing Integrating Chronic Care PCs made two site visits to each site and Activities: Proposed Collection; and Business Strategies in the Safety Comment Request participated in weekly team meetings by Net: A Toolkit for Primary Care phone. They also interacted with the Practices and Clinics. AHRQ requests sites through e-mail and phone contact. AGENCY: Agency for Healthcare Research that the Office of Management and The lack of documentation available and Quality, HHS. Budget approve, under the Paperwork on coaching led to the development of ACTION: Notice. Reduction Act of 1995, AHRQ’s a practice coaching manual, which was intention to collect information needed funded by AHRQ through a contract SUMMARY: This notice announces the to determine whether practice coaching with the RAND Corporation. intention of the Agency for Healthcare is effective in facilitating adoption of the Development of the Coaching Manual Research and Quality (AHRQ) to request Chronic Care Model (CCM) for entailed conducting a literature review, improving treatment and management that the Office of Management and interviewing practice coaching experts, of chronic medical conditions by Budget (OMB) approve the proposed and incorporating evaluation results primary care physicians, especially from the coaching provided in information collection project: those who care for underserved conjunction with the Toolkit. The ‘‘Studying the Implementation of a populations. This project is being Coaching Manual was published in the Chronic Care Toolkit and Practice conducted pursuant to AHRQ’s winter of 2009. The literature review Coaching In Practices Serving statutory authority to conduct and and interviews revealed that there are a Vulnerable Populations.’’ In accordance support research on health care and on number of different models of practice with the Paperwork Reduction Act, 44 systems for the delivery of such care, coaching. However, knowledge is scant U.S.C. 3501–3520, AHRQ invites the including activities with respect to about how practice coaching is best public to comment on this proposed quality measurement and improvement performed, under what conditions information collection. and with respect to clinical practice, practice coaching is most successful, This proposed information collection including primary care and practice- and the costs of coaching and being was previously published in the Federal oriented research. 42 U.S.C. 299a(a)(2) coached. Pilot testing the Toolkit with a Register on February 1, 2010 and and (4). This project will be conducted low-intensity practice coaching strategy by AHRQ through a contract with the allowed 60 days for public comment. proved insufficient to encourage University of Minnesota. One comment was received. The practices to use the Toolkit Although 1,500 physician practices in independently. The Toolkit was purpose of this notice is to allow an the U.S. and internationally have been subsequently streamlined based on pilot additional 30 days for public comment. involved in CCM quality improvement sites’ reports that the initial Toolkit was DATES: Comments on this notice must be efforts, most patients still do not receive not easy to use. This project will explore received by April 30, 2010. their chronic care in accordance with the implementation of the revised CCM. One factor affecting CCM Toolkit along with a more intensive ADDRESSES: Written comments should implementation has been that having practice coaching strategy, providing be submitted to: AHRQ’s OMB Desk teams attend collaborative meetings lessons on methods to improve chronic Officer by fax at (202) 395–6974 (three two-day meetings over a nine- care in clinical practices that serve (attention: AHRQ’s desk officer) or by e- month period) is burdensome, vulnerable populations. mail at [email protected] especially for under-resourced (attention: AHRQ’s desk officer). providers. An attempt to use the Method of Collection Copies of the proposed collection Internet as a virtual collaborative met This project will include the plans, data collection instruments, and with disappointing results. Another following data collections: barrier to adoption of the CCM in (1) Key Informant Interviews with specific details on the estimated burden settings that serve vulnerable providers, staff and practice coaches can be obtained from the AHRQ Reports populations is the scarcity of resources from 20 safety net practices that Clearance Officer. to implement and sustain the CCM. In participate in the practice coaching FOR FURTHER INFORMATION CONTACT: 2006 AHRQ contracted with the RAND intervention. These will be used to Doris Lefkowitz, AHRQ Reports Corporation, Group Health’s MacColl describe the process and content of Clearance Officer, (301) 427–1477, or by Institute, and the California Health Care practice coaching, perceived changes e-mail at Safety Net Institute (SNI) to develop a from the coaching intervention at the [email protected]. toolkit that informs safety net providers practice, provider and patient levels, on how to redesign their systems of care factors that impeded or facilitated the SUPPLEMENTARY INFORMATION: along the lines of the Chronic Care coaching intervention and Model while attending to their financial implementation of practice changes

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through the coaching process, overall care (CCM components), these also intervention and again at the end of the satisfaction with practice coaching, and include organizational will for change intervention. Key informant interviews recommendations for improvement. (Priority) and capacity and skill in the will also be conducted with up to 3 (2) Primary Care Practice Profile conduct of the actual change processes primary care providers and 2 other staff (PCPP). This questionnaire will be and strategies. members from each of the 20 practices completed by a single individual at each (6) Patient Assessment of Chronic (10 per year) prior to start of the site, either the medical director or chief Illness Care (PACIC)—The 20-item intervention, and again at 3-month administrator, and will provide an PACIC consists of five subscales which follow-up after the intervention is overview of each replication site that assess components of the CCM: Patient completed. Each interview takes about 1 will help place intervention activities activation, delivery system design/ hour. and outcomes in context for each site. decision support, goal setting, problem- solving/contextual counseling, and The Primary Care Practice Profile will It covers demographics of patients be administered once and will be served, patient flow, disease health followup and coordination. (7) Consumer Assessment of completed by one staff person from each outcomes, most frequent diagnoses, practice and takes 30 minutes to most frequent referrals, number of staff Healthcare Providers and Systems— complete. The Physician Practice by discipline, staff and patient Primary Care Adult—This questionnaire Connections-Readiness Survey (PPC– satisfaction, processes of care, and assesses patient experiences in three RS) will be completed pre, post and at organizational processes. areas: Getting appointments and 3-month follow-up by three individuals (3) Physician Practice Connections- healthcare when needed; how well from each of the 20 practices Readiness Survey (PPC–RS)—This doctors communicate, and courteous (individuals with the appropriate questionnaire asks about the presence of and helpful office staff. knowledge to complete the survey will 53 practice systems in 5 of the 6 (8) Primary Care Staff Satisfaction be identified by the medical director of domains of the Chronic Care Model: Survey—This questionnaire assesses each site). It takes 90 minutes to Clinical information systems staff satisfaction with their work (information systems, presence of environment. It consists of 8 4-point complete. The Assessment of Chronic registry or organized database, and likert scale items and 2 open-ended Illness Care (ACIC) will be completed by questions, and was developed by the systematic monitoring of patient 4 staff and 4 primary care providers per Institute for Healthcare Improvement. population); decision support (clinician practice at pre, post and 3-month (9) Chart Audits—Chart audits will be follow-up and takes 30 minutes to reminders and alerts for lab tests, and conducted at baseline, the end of the 10- visits or guidelines related to individual complete. The Change Process month coaching intervention, and at 3- Capability Questionnaire (CPCQ) will be patient care), delivery system redesign month follow-up to assess changes in (services for managing patients with completed by 4 staff and 4 primary care patient care quality over the course of providers per practice at pre, post and chronic illness involving multiple the intervention. A chart abstraction clinicians and care between visits), 3-month follow-up and takes 15 minutes form will be developed to collect these to complete. The Primary Care Staff health care organization (performance data. This data collection will be tracking and feedback, process of using Satisfaction Survey (PCSSS) will be performed by the project staff and will completed by 4 staff and 4 primary care clinical information systems to not impose a burden on the aggregate and report on key indicators, providers per practice at pre, post and participating sites. Therefore, OMB 3-month follow-up and takes 15 minutes and use of data for benchmarking clearance is not required for this data performance and informing QI to complete. The Patient Assessment of collection. Chronic Illness Care (PACIC) will be activities), and clinical quality Clinic staff will be provided with a improvement (presence of formal completed by 3,000 adult patients paper version of the surveys as well as (1,500 annually) with chronic illness processes to assess care, develop the option to complete the surveys on interventions, and use data to monitor and requires 15 minutes to complete. line using a secure on-line survey The Consumer Assessment of the effects). program. With the exception of the staff (4) Assessment of Chronic Illness Care Healthcare Providers and Systems— surveys, no special information Primary Care Adult (CAHPS) will be (ACIC)—The ACIC is contained in the technology will be used to collect completed by 3,000 adult patients Toolkit and yields subscale scores and information, since many of the data (1,500 annually) with chronic illness a total score. Subscale scores reflect collection forms are standardized and requires 45 minutes to complete. CCM components and include: instruments available in hard-copy Both patient surveys will be Community linkages, self-management form, and special permission from the administered to adult patients with a support, decision support, delivery developers would be required to create chronic disease who receive care at the system design, information systems, and electronic versions of these forms. The practices during a 2-day data collection organization of care. information collection is a one-time period immediately before, immediately (5) Change Process Capability only project; thus, there would be little after, and at 3-month follow-up. The Questionnaire (CPCQ)—The CPCQ benefit in reduced burden from surveys will be administered during the assesses 30 factors and strategies that automated information collection tools post visit period in the wait room, by a experienced quality improvement for the other instruments. leaders ranked as most important for bi-lingual Spanish-English research successful implementation. A recent Estimated Annual Respondent Burden assistant. The total annualized burden validation study found good predictive Exhibit 1 shows the estimated hours are estimated to be 1,984 hours. validity. Items correlating with the PPC– annualized burden hours for the Exhibit 2 shows the estimated RS were eliminated after the initial respondents’ time to participate in this annualized cost burden associated with validation study so there is little to no two-year study. Key informant the respondent’s time to participate in overlap across the two measures. In interviews will be conducted with this study. The total annualized cost addition to changes in the content of practice coaches at midpoint in the burden is estimated to be $60,714.

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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Number of re- Form name Number of sponses per Hours per Total burden respondents respondent response hours

Key informant interviews with practice coaches ...... 2 2 1 4 Key informant interviews with providers (3 per practice interviewed twice) ... 10 6 1 60 Key informant interviews with staff (2 per practice interviewed twice) ...... 10 4 1 40 Primary Care Practice Profile (PCPP) ...... 10 1 30/60 5 Physician Practice Connections—Readiness Survey (PPC–RS) (3 per prac- tice × 3 times) ...... 10 9 1.5 135 Assessment of Chronic Illness Care (ACIC) (8 per practice × 3 times) ...... 10 24 30/60 120 Change Process Capability Questionnaire (CPCQ) (8 per practice × 3 times) ...... 10 24 15/60 60 Primary Care Staff Satisfaction Survey (PCSSS) (8 per practice 3 × times) 10 24 15/60 60 Patient Assessment of Chronic Illness Care (PACIC) ...... 1,500 1 15/60 375 Consumer Assessment of Healthcare Providers and Systems—Primary Care Adult (CAHPS) ...... 1,500 1 45/60 1,125

Total ...... 3,072 na na 1,984

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Number of Total burden Average hour- Total cost Form name respondents hours ly wage rate * burden

Key informant interviews with practice coaches ...... 2 4 $42.00 $168 Key informant interviews with providers ...... 10 60 77.64 4,658 Key informant interviews with staff ...... 10 40 32.64 1,306 Primary Care Practice Profile (PCPP) ...... 10 5 77.64 388 Physician Practice Connections—Readiness Survey (PPC–RS) ...... 10 135 77.64 10,481 Assessment of Chronic Illness Care (ACIC) ...... 10 120 ** 55.14 6,617 Change Process Capability Questionnaire (CPCQ) ...... 10 60 ** 55.14 3,308 Primary Care Staff Satisfaction Survey ...... 10 60 ** 55.14 3,308 Patient Assessment of Chronic Illness Care (PACIC) ...... 1,500 375 20.32 7,620 Consumer Assessment of Healthcare Providers and Systems—Primary Care Adult (CAHPS) ...... 1,500 1,125 20.32 22.860

Total ...... 3,072 1,984 na 60,714 * Based upon the mean of the average wages, May 2008 National Occupational and Wage Estimates accessed on December 14, 2009 at: http://www.bls.gov/oes/current/oes_nat.htm#b29–0000. National Compensation Survey: ** Average for 4 staff ($32.64/hr) and 4 physician clinicians ($77.64/hr).

Estimated Annual Costs to the Federal research. The total cost over two years Government is estimated to be $600,000. Exhibit 3 shows the estimated total and annualized cost to conduct this

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized cost

Project Development ...... $162,744 $81,372 Data Collection Activities ...... 92,994 46,497 Data Processing and Analysis (20%) ...... 92,994 46,497 Publication of Results ...... 23,248 11,624 Project Management ...... 92,994 46,497 Overhead ...... 135,026 67,513

Total ...... 600,000 300,000

Request for Comments necessary for the proper performance of the proposed collection(s) of AHRQ healthcare research and information; (c) ways to enhance the In accordance with the above-cited healthcare information dissemination quality, utility, and clarity of the Paperwork Reduction Act legislation, functions, including whether the information to be collected; and (d) comments on AHRQ’s information collection are requested with regard to information will have practical utility; ways to minimize the burden of the any of the following: (a) Whether the (b) the accuracy of AHRQ’s estimate of collection of information upon the proposed collection of information is burden (including hours and costs) of respondents, including the use of

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automated collection techniques or Proposed Project This study is being conducted by other forms of information technology. AHRQ through its contractor, Boston Reductions of Infection Caused by University, pursuant to AHRQ’s Comments submitted in response to Carbapenem Resistant statutory authority to conduct and this notice will be summarized and Enterobacteriaceae (KPC) Producing support research on healthcare and on included in the Agency’s subsequent Organisms Through the Application of systems for the delivery of such care, request for OMB approval of the Recently Developed CDC/HICPAC including activities with respect to the proposed information collection. All Recommendations quality, effectiveness, efficiency, comments will become a matter of Healthcare Acquired Infections (HAIs) appropriateness and value of healthcare public record. caused almost 100,000 deaths among services and with respect to quality Dated: March 19, 2010. the 2.1 million people who acquired measurement and improvement. 42 Carolyn M. Clancy, infections while hospitalized in 2000, U.S.C. 299a(a)(1) and (2). Director. and HAI rates have risen relentlessly Method of Collection [FR Doc. 2010–6776 Filed 3–30–10; 8:45 am] since then. On March 20, 2009, the Centers for Disease Control (CDC) and This project will include the BILLING CODE 4160–90–M the Healthcare Infections Control following data collections from the Practices Advisory Committee (HICPAC) intensive care unit (ICU) staff within developed infection control (IC) each of three participating hospitals: DEPARTMENT OF HEALTH AND (1) Pre-intervention focus groups will HUMAN SERVICES guidance for Klebsiella pneumonia carbapenemase-producing (KPC) be conducted separately with managers isolates, as they have been rapidly and staff. The purpose of these focus Agency for Healthcare Research and groups is to identify potential problems emerging as a significant challenge in Quality in the implementation that can be healthcare settings. The danger of these addressed through various means (e.g., bacteria is that they are resistant to Agency Information Collection additional education, other changes in carbapenem (a class of beta-lactam Activities: Proposed Collection; process). Another purpose is to antibiotics with a broad spectrum of Comment Request understand the existing approach to antibacterial activity) and cannot be quality improvement, the connection(s) treated by the most commonly AGENCY: Agency for Healthcare Research between overall approach to quality prescribed antibiotics. Limited and Quality, HHS. improvement and to KPC infection treatment options mean that infections ACTION: Notice. control practices, current practices at caused by carbapenem resistant bacteria the hospital of quality reporting and result in substantial mortality and accountability, and constraints and SUMMARY: This notice announces the morbidity. obstacles to quality improvement as intention of the Agency for Healthcare The CDC and HICPAC seen in their roles. Staff members Research and Quality (AHRQ) to request recommendations draw on infection identified for the focus groups will be that the Office of Management and control strategies which have been those with the most first-hand Budget (OMB) approve the proposed applied to these pathogens in other knowledge of existing quality information collection project: settings, and other evidence based improvement efforts, and KPC infection ‘‘Reductions of Infection Caused by strategies in infection control. There has control practices. Carbapenem Resistant been little research, however, on the (2) Clinical staff survey. Factors Enterobacteriaceae (KPC) Producing implementation of control strategies to identified in the pre-intervention focus Organisms through the Application of prevent the spread of these KPC groups will be used to inform the Recently Developed CDC/HICPAC infections. The goal of this project is to development of a self-administered Recommendations.’’ In accordance with understand how these recommendations survey of staff knowledge of and the Paperwork Reduction Act, 44 U.S.C. can best be implemented and how attitudes toward KPC surveillance and 3501–3520, AHRQ invites the public to effective these recommendations will be infection control procedures. comment on this proposed information in practice. This research will advance Respondents will be health care workers collection. private and public efforts to improve on the units where these new guidelines health care quality by improving have been implemented. Findings from DATES: Comments on this notice must be measures to control the spread of a the survey will be used to assess barriers received by June 1, 2010. dangerous organism. This research will perceived by the staff, potential ADDRESSES: Written comments should also provide data for the development of differences across units, and potential be submitted to: Doris Lefkowitz, an implementation toolkit that hospitals differences by employee/occupational Reports Clearance Officer, AHRQ, by e- can use to prevent the spread of group. mail at [email protected]. carbapenem resistant bacteria. The (3) Post-intervention focus groups (6 toolkit may include the following types months after implementation of new Copies of the proposed collection of resources: General information about KPC IC guidelines) will be conducted plans, data collection instruments, and the implementation of evidenced-based separately with managers and staff. The specific details on the estimated burden clinical practices, resource materials, purpose of these focus groups is to can be obtained from the AHRQ Reports and tools and methods that users can identify actual problems experienced in Clearance Officer. adopt to conduct point prevalence the initial implementation and possible FOR FURTHER INFORMATION CONTACT: surveys, protocols and tools that users measures to address, and to identify Doris Lefkowitz, AHRQ Reports can adopt to specify when active KPC successful practices to include in a Clearance Officer, (301) 427–1477, or by surveillance is needed, and resources toolkit that hospitals can use to e-mail at for approaching the problem as a team- implement the CDC and HICPAC [email protected]. based quality-improvement effort. recommendations. OMB clearance will be sought for this In addition to developing a toolkit, SUPPLEMENTARY INFORMATION: toolkit once it is developed. AHRQ plans to disseminate the lessons

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learned from this project about how average of 9 per year for 2 years) from Finally, respondents from the pre- hospitals can best implement the CDC each of the 3 participating hospitals and intervention focus groups will guidance for KPC screening and will take about 1 hour. Pre-intervention participate in post-intervention focus infection control, in order to inform focus groups with also be conducted groups approximately four months after efforts to change practice in this area. with 2 managers (an average of 1 per the initiation of the intervention. They will not last more than an hour each. Estimated Annual Respondent Burden year for 2 years) from each hospital and will take about an hour to complete. The total annualized burden hours are The estimated annualized burden estimated to be 68 hours. hours for respondents to participate in The clinical staff survey will be Exhibit 2 shows the estimated this two year research project are administered to 20 clinical staff (an annualized cost burden associated with presented in Exhibit 1. Pre-intervention average of 10 per year for 2 years) from the respondents’ time to participate in focus groups with clinical staff will be each hospital and will take 15 minutes this research. The total annualized cost conducted with 18 staff members (an to complete. burden is estimated to be $3,108.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Number of re- Data collection Number of sponses per Hours per Total burden respondents respondent response hours

Pre-intervention focus groups with clinical staff * ...... 3 9 1 27 Pre-intervention focus groups with managers * ...... 3 1 1 3 Clinical staff survey ...... 3 10 15/60 8 Post-intervention focus groups with clinical staff * ...... 3 9 1 27 Post-intervention focus groups with managers * ...... 3 1 1 3

Total ...... 15 n/a n/a 68 * Individuals that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC leaders, QI team members and unit staff. Managers include the chief nursing officer and chief medical officer.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Number of Total burden Average hour- Total cost Data collection respondents hours ly wage rate burden

Pre-intervention focus groups with clinical staff ...... 3 27 * $36.73 $992 Pre-intervention focus groups with managers ...... 3 3 ** 138.38 415 Clinical staff survey ...... 3 8 * 36.73 294 Post-intervention focus groups with clinical staff ...... 3 27 * 36.73 992 Post-intervention focus groups with managers ...... 3 3 ** 138.38 415

Total ...... 15 68 na 3,108 * Based upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the Bureau of Labor Statistics in May 2008. ** Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published by http://www.salary.com; 3 chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour.

Estimated Annual Costs to the Federal this two year research project. Project implementation. The total cost is Government development covers steps taken to estimated to be $500,001. Exhibit 3 shows the annualized and revise the research plan and begin total cost to the federal government for

EXHIBIT 3—ANNUALIZED AND TOTAL COST TO THE FEDERAL GOVERNMENT

Cost component Annualized cost Total cost

Project Management ...... $125,526 $251,052 Project Development ...... 54,622 109,244 Data Collection Activities ...... 41,864 83,728 Travel ...... 4,000 8,000 Overhead ...... 23,754 47,507

Total ...... 250,001 500,001

Request for Comments any of the following: (a) Whether the functions, including whether the proposed collection of information is information will have practical utility; In accordance with the above-cited necessary for the proper performance of (b) the accuracy of AHRQ’s estimate of Paperwork Reduction Act legislation, AHRQ healthcare research and burden (including hours and costs) of comments on AHRQ’s information healthcare information dissemination the proposed collection(s) of collection are requested with regard to

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information; (c) ways to enhance the specific details on the estimated burden development of this update to the quality, utility, and clarity of the can be obtained from the AHRQ Reports Health Plan Survey has been part of the information to be collected; and (d) Clearance Officer. ‘‘Ambulatory CAHPS (A–CAHPS) ways to minimize the burden of the FOR FURTHER INFORMATION CONTACT: Initiative,’’ which arose as a result of collection of information upon the Doris Lefkowitz, AHRQ Reports extensive research conducted with respondents, including the use of Clearance Officer, (301) 427–1477, or by users. AHRQ released the CAHPS automated collection techniques or e-mail at Health Plan Survey 4.0, along with other forms of information technology. [email protected]. guidance on how to customize and Comments submitted in response to administer it. The National Quality SUPPLEMENTARY INFORMATION: this notice will be summarized and Forum endorsed the 4.0 version of the included in the Agency’s subsequent Proposed Project Health Plan Survey in July 2007. request for OMB approval of the The CAHPS Health Plan Database Collection of Information for Agency proposed information collection. All uses data from AHRQ’s standardized for Healthcare Research and Quality’s comments will become a matter of CAHPS Health plan survey to provide (AHRQ) Consumer Assessment of public record. comparative results to health care Healthcare Providers and Systems Dated: March 19, 2010. purchasers, consumers, regulators and (CAHPS) Health Plan Survey policy makers across the country. The Carolyn M. Clancy, Comparative Database Database also provides data for AHRQ’s Director. The Agency for Healthcare Research annual National Healthcare Quality and [FR Doc. 2010–6778 Filed 3–30–10; 8:45 am] and Quality (AHRQ) requests that the National Healthcare Disparities Reports. BILLING CODE 4160–90–M Office of Management and Budget Voluntary participants include public (OMB) approve, under the Paperwork and private employers, State Medicaid Reduction Act of 1995, AHRQ’s agencies, State Children’s Health DEPARTMENT OF HEALTH AND collection of information for the AHRQ Insurance Programs (SCHIP), CMS, and HUMAN SERVICES Consumer Assessment of Healthcare individual health plans. Providers and Systems (CAHPS) The collection of information for the Agency for Healthcare Research and Database for Health Plans. The CAHPS Quality CAHPS Database for Health Plans is Health Plan Database consists of data being conducted pursuant to AHRQ’s from the AHRQ CAHPS Health Plan Agency Information Collection statutory authority to conduct and Survey. Activities: Proposed Collection; support research on health care and Health plans in the U.S. are asked to Comment Request systems for the delivery of such care, voluntarily submit data from the survey including activities with respect to the AGENCY: Agency for Healthcare Research to AHRQ, through its contractor, Westat. quality, effectiveness, efficiency, and Quality, HHS. The CAHPS Database was developed by appropriateness and value of health care ACTION: Notice. AHRQ in 1998 in response to requests services. See 42 U.S.C. 299a(a)(1). from health plans, purchasers, and the SUMMARY: This notice announces the Centers for Medicare & Medicaid Method of Collection intention of the Agency for Healthcare Services (CMS) to provide comparative Information for the CAHPS Health Research and Quality (AHRQ) to request data to support public reporting of Plan Database has been collected by that the Office of Management and health plan ratings, health plan AHRQ through its contractor Westat on Budget (OMB) approve the proposed accreditation and quality improvement. an annual basis since 1998. Health plans information collection project: The CAHPS Health Plan Survey is a are asked to voluntarily submit their ‘‘Collection of Information for Agency tool for collecting standardized data to the comparative database in June for Healthcare Research and Quality’s information on enrollees’ experiences of each year. The data are cleaned with (AHRQ) Consumer Assessment of with health plans and their services. standardized programs, then aggregated Healthcare Providers and Systems The development of the CAHPS Health and used to produce comparative results ® (CAHPS ) Health Plan Survey Plan Survey began in 1995, when AHRQ for commercial (adult and child), Comparative Database.’’ In accordance awarded the first set of CAHPS grants to Medicaid (adult and child), and with the Paperwork Reduction Act, 44 Harvard, RTI, and RAND. In 1997 the Medicare (adult) populations for the two U.S.C. 3501–3520, AHRQ invites the CAHPS 1.0 survey was released by the most recent years. In addition, public to comment on this proposed CAHPS Consortium. The CAHPS individual participant reports are information collection. Consortium refers to the research produced that display the participating This proposed information collection organizations involved in the organizations’ own results compared to was previously published in the Federal development, dissemination, and appropriate comparisons derived from Register on January 25th, 2010 and support of CAHPS products. The the National, regional and product-type allowed 60 days for public comment. No current Consortium includes AHRQ, distributions on a password-protected comments were received. The purpose CMS, RAND, Yale School of Public section of the online reporting system. of this notice is to allow an additional Health, and Westat. The CAHPS Health Plan Database 30 days for public comment. Since that time, the Consortium has receives the data from three sources. DATES: Comments on this notice must be clarified and updated the survey First, commercial health plan data is received by April 30, 2010. instrument to reflect field test results; purchased by the CAHPS Health Plan ADDRESSES: Written comments should feedback from industry experts; reports Database directly from the National be submitted to: AHRQ’s OMB Desk from health plan participants, data Committee for Quality Assurance Officer by fax at (202) 395–6974 collection vendors, and other users; and (NCQA). The data is collected by NCQA (attention: AHRQ’s desk officer) or by e- evidence from cognitive testing and from those who participate in its mail at [email protected] focus groups. In November 2006, the accreditation program. Second, (attention: AHRQ’s desk officer). CAHPS Consortium released the latest Medicare data is provided by CMS Copies of the proposed collection version of the instrument: The CAHPS through an agency data use agreement. plans, data collection instruments, and Health Plan Survey 4.0. The The Medicare data is collected by CMS

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and their contractor from beneficiaries providing their contact information for a total of 60 participants, representing who were enrolled in a managed care access to the on-line data submission 45 individual organizations and 15 health plan. Third, Medicaid data is system, sign and submit a data use vendors, submitted data for 244 health collected by the CAHPS Health Plan agreement (DUA), and provide health plans (an average of about 4 health Database. Medicaid agencies and their plan characteristics such as health plan plans per participant). vendors directly submit their Medicaid name, product type, type of population Exhibits 1 and 2 are based on the health plan survey data to the CAHPS surveyed, health plan state, and plan estimated number of individual Health Plan Database through an online name to appear in the reporting of their participants (participating organizations data submission system. Data submitted results. and/or vendors) who will complete the by Medicaid plans are compiled along Each vendor that submits files on database submission steps and forms in with the data received from CMS and behalf of a Medicaid agency or the coming years, and is not based on NCQA to comprise the CAHPS Health individual health plan must also the total number of health plans that are Plan Survey comparative database. complete the registration form in order submitted. The number of respondents to obtain access to the on-line and burden hours are based on an Estimated Annual Respondent Burden submission system. The vendor, on estimated slight increase in the number Each year State Medicaid agencies behalf of their client, may also complete of participants to 70 in 2010 and 2011. and individual health plans decide additional information about survey In Exhibit 1, the 70 participants that whether to participate in the database administration (CAHPS survey version will complete the registration form and and prepare their materials and dataset used, mode of survey administration, submit information to the CAHPS for submission to the CAHPS Health total enrollment count, description of Health Plan Database are a combination Plan Database. Participating how the sample was selected), submit a of an estimated 50 State Medicaid organizations are typically State copy of the questionnaire used, and agencies and individual health plans, Medicaid agencies with multiple health submit one data file per health plan. and 20 estimated vendors. The 50 State plans. However, individual health plans Commercial health plan data is received Medicaid agencies or individual health are also encouraged to submit their data directly from NCQA. Medicare health plans will sign and submit a DUA. to the CAHPS Database. The number of plan data is received from CMS. Vendors do not sign or submit DUAs. data submissions per registrant varies The burden hours and costs below Health plan information and data files from participant to participant and year pertain only to the collection of are submitted for each health plan. to year because some participants Medicaid data from State Medicaid Exhibit 1 shows an estimated total of submit data for multiple health plans, agencies and individual Medicaid 280 health plans (70 estimated while others may only submit survey health plans because those are the only participants with 4 health plans per data for one plan. entities that submit data through the participant). The total burden hours for Each organization that decides to data submission process (other data are completing the registration, DUA and participate in the database must have obtained directly from NCQA and CMS data submission process are estimated their POC complete a registration form as noted earlier in Section 2). In 2009, to be 722 hours.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Number of Number of Form name respondents/ responses Hours per Total burden POCs per POC response hours

Registration Form and Data Submission * ...... 70 1 7.6 532 Data Use Agreement ** ...... 50 1 1 50 Health Plan Information *** ...... 70 4 30/60 140

Total ...... 190 NA NA 722 * The online Registration Form requires about 5 minutes to complete; however over 7 hours is required to plan/prepare for the data submis- sion. This includes the amount of time the participating organization, and others (CEO, lawyer, vendor) typically spend deciding whether to par- ticipate in the database and preparing their materials and dataset for submission to the CAHPS Health Plan Database and performing the sub- mission. ** The Data Use Agreement requires about 3 minutes to complete; however about 57 minutes is required for the participating organization to review the agreement prior to signing. This includes the review by the organization’s CEO or legal department. *** A few health plans may submit their data directly, however most health plan data will be submitted by the POC.

Exhibit 2 shows the estimated submission process. The cost burden is annualized cost burden based on the estimated to be $31,046 annually. respondents’ time to complete the

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Number of Total burden Average hour- Total cost Form name respondents hours ly wage rate ** burden

Registration Form and Data Submission * ...... 70 532 $43.00 $22,876 Data Use Agreement ...... 50 50 43.00 2,150 Health Plan Information ...... 70 140 43.00 6,020

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EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued

Number of Total burden Average hour- Total cost Form name respondents hours ly wage rate ** burden

Total ...... 190 722 NA 31,046 * Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept of Labor, Bureau of Labor Statistics’ May 2008 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—located at http://www.bls.gov/oes/current/oes_nat.htm. ** Wage rate of $43.00 is based on the mean hourly wages for Medical and Health Services Managers. Wage rate of $42.67 is the weighted mean hourly wage for: Medical and Health Services Managers ($42.67 × 2.6 hours = $110.95), Lawyers ($59.98 × .5 hours = $29.99), Chief Ex- ecutives ($89.16 × .5 hours = $44.58), and Computer programmer ($35.32 × 4 hours = $141.28) [Weighted mean = ($110.95 + 29.99 + 44.58 = 141.28)/7.6 hours = $326.80/7.6 hours = $43.00/hour].

Estimated Annual Costs to the Federal comments will become a matter of Proposed Project: The Health Education Government public record. Assistance Loan (HEAL) Program: Exhibit 3 shows the estimated Dated: March 19, 2010. Physician’s Certification of Borrower’s Total and Permanent Disability Form annualized cost to the government for Carolyn M. Clancy, developing, maintaining and managing (OMB No. 0915–0204)—Extension Director. the Health Plan Database and analyzing [FR Doc. 2010–6780 Filed 3–30–10; 8:45 am] The Health Education Assistance the data and reporting results. The cost Loan (HEAL) program provided is estimated to be $260,000 annually. BILLING CODE 4160–90–M federally-insured loans to students in Annualized costs for collecting and schools of allopathic medicine, processing the CAHPS Health Plan osteopathic medicine, dentistry, Database are based upon 10 years of DEPARTMENT OF HEALTH AND HUMAN SERVICES veterinary medicine, optometry, historical project costs. Start-up costs podiatric medicine, pharmacy, public were present in the early years of the Health Resources and Services health, allied health, or chiropractic, database only. Administration and graduate students in health administration or clinical psychology EXHIBIT 3—ESTIMATED ANNUALIZED Agency Information Collection through September 30, 1998. Eligible COST Activities: Proposed Collection: lenders, such as banks, savings and loan Comment Request associations, credit unions, pension Annualized funds, State agencies, HEAL schools, Cost component cost In compliance with the requirement and insurance companies, made new Database Maintenance ...... $50,000 for opportunity for public comment on refinanced HEAL loans which are Data Submission ...... 100,000 proposed data collection projects insured by the Federal Government Data Analysis and Reporting 110,000 (section 3506(c)(2)(A) of Title 44, United against loss due to borrower’s death, States Code, as amended by the disability, bankruptcy, and default. The Total ...... 260,000 Paperwork Reduction Act of 1995, Pub. basic purpose of the program was to L. 104–13), the Health Resources and assure the availability of funds for loans Request for Comments Services Administration (HRSA) to eligible students who needed to In accordance with the above-cited publishes periodic summaries of borrow money to pay for their Paperwork Reduction Act legislation, proposed projects being developed for educational loans. Currently, the comments on AHRQ’s information submission to Office of Management program monitors the federal liability, collection are requested with regard to and Budget (OMB) under the Paperwork and assists in default prevention any of the following: (a) Whether the Reduction Act of 1995. To request more activities. proposed collection of information is information on the proposed project or The HEAL borrower, the borrower’s necessary for the proper performance of to obtain a copy of the data collection physician, and the holder of the loan AHRQ healthcare research and plans and draft instruments, call the completes the Physician’s Certification healthcare information dissemination HRSA Reports Clearance Officer on form to certify that the HEAL borrower functions, including whether the (301) 443–1129. meets the total and permanent disability information will have practical utility; provisions. The Department uses this (b) the accuracy of AHRQ’s estimate of Comments are invited on: (a) Whether form to obtain detailed information burden (including hours and costs) of the proposed collection of information about disability claims which includes the proposed collection(s) of is necessary for the proper performance the following: (1) The borrower’s information; (c) ways to enhance the of the functions of the agency, including consent to release medical records to the quality, utility, and clarity of the whether the information shall have Department of Health and Human information to be collected; and (d) practical utility; (b) the accuracy of the Services and to the holder of the ways to minimize the burden of the agency’s estimate of the burden of the borrower’s HEAL loans, (2) pertinent collection of information upon the proposed collection of information; (c) information supplied by the certifying respondents, including the use of ways to enhance the quality, utility, and physician, (3) the physician’s automated collection techniques or clarity of the information to be certification that the borrower is unable other forms of information technology. collected; and (d) ways to minimize the to engage in any substantial gainful Comments submitted in response to burden of the collection of information activity because of a medically this notice will be summarized and on respondents, including through the determinable impairment that is included in the Agency’s subsequent use of automated collection techniques expected to continue for a long and request for OMB approval of the or other forms of information indefinite period of time or to result in proposed information collection. All technology. death, and (4) information from the

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lender on the unpaid balance. Failure to claim. No changes have been made to The estimate of burden for the submit the required documentation will the current form. Physician’s Certification form is as result in disapproval of a disability follows:

Responses Type of respondent Number of re- per respond- Number of re- Minutes per Total burden spondents ent sponses response hours

Borrower ...... 75 1 75 5 6 Physician ...... 75 1 75 30 38 Loan Holder ...... 13 6 78 10 13

Total ...... 163 ...... 228 ...... 57

E-mail comments to DATES: Submit written or electronic estimate of the burden of the proposed [email protected] or mail the HRSA comments on the collection of collection of information, including the Reports Clearance Officer, Room 10–33, information by June 1, 2010. validity of the methodology and Parklawn Building, 5600 Fishers Lane, ADDRESSES: Submit electronic assumptions used; (3) ways to enhance Rockville, MD 20857. Written comments comments on the collection of the quality, utility, and clarity of the should be received within 60 days of information to http:// information to be collected; and (4) this notice. www.regulations.gov. Submit written ways to minimize the burden of the Dated: March 25, 2010. comments on the collection of collection of information on Sahira Rafiullah, information to the Division of Dockets respondents, including through the use Management (HFA–305), Food and Drug of automated collection techniques, Director, Division of Policy and Information Coordination. Administration, 5630 Fishers Lane, rm. when appropriate, and other forms of 1061, Rockville, MD 20852. All information technology. [FR Doc. 2010–7251 Filed 3–30–10; 8:45 am] comments should be identified with the BILLING CODE 4165–15–P Export of Food and Drug docket number found in brackets in the Administration Regulated Products: heading of this document. Export Certificates (OMB Control DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Number 0910–0498)—Extension HUMAN SERVICES Jonna Capezzuto, Office of Information Management, Food and Drug In April 1996, a law entitled ‘‘The Food and Drug Administration Administration, 1350 Piccard Dr., PI50– FDA Export Reform & Enhancement Act 400B, Rockville, MD 20850, 301–796– of 1996’’ (FDAERA) amended sections 801(e) and 802 of the act (21 U.S.C. [Docket No. FDA–2010–N–0161] 3794, [email protected]. 381(e) and 382). It was designed to ease Agency Information Collection SUPPLEMENTARY INFORMATION: Under the restrictions on exportation of Activities; Proposed Collection; PRA (44 U.S.C. 3501–3520), Federal unapproved pharmaceuticals, biologics, Comment Request; Export of Food and agencies must obtain approval from the and devices regulated by FDA. Section Drug Administration Regulated Office of Management and Budget 801(e)(4) of the FDAERA provides that Products: Export Certificates (OMB) for each collection of persons exporting certain FDA-regulated information they conduct or sponsor. products may request FDA to certify AGENCY: Food and Drug Administration, ‘‘Collection of information’’ is defined in that the products meet the requirements HHS. 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) of 801(e) and 802 or other requirements ACTION: Notice. and includes agency requests or of the act. This section of the law requirements that members of the public requires FDA to issue certification SUMMARY: The Food and Drug submit reports, keep records, or provide within 20 days of receipt of the request Administration (FDA) is announcing an information to a third party. Section and to charge firms up to $175 for the opportunity for public comment on the 3506(c)(2)(A) of the PRA (44 U.S.C. certifications. proposed collection of certain 3506(c)(2)(A)) requires Federal agencies This new section of the act authorizes information by the agency. Under the to provide a 60-day notice in the FDA to issue export certificates for Paperwork Reduction Act of 1995 (the Federal Register concerning each regulated pharmaceuticals, biologics, PRA), Federal agencies are required to proposed collection of information, and devices that are legally marketed in publish notice in the Federal Register including each proposed extension of an the United States, as well as for these concerning each proposed collection of existing collection of information, same products that are not legally information, including each proposed before submitting the collection to OMB marketed but are acceptable to the extension of an existing collection of for approval. To comply with this importing country, as specified in information, and to allow 60 days for requirement, FDA is publishing notice sections 801(e) and 802 of the act. FDA public comment in response to the of the proposed collection of has developed five types of certificates notice. This notice solicits comments on information set forth in this document. that satisfy the requirements of section information collection requirements With respect to the following 801(e)(4)(B) of the act: (1) Certificates to imposed on firms that intend to export collection of information, FDA invites Foreign Governments, (2) Certificates of to countries that require an export comments on these topics: (1) Whether Exportability, (3) Certificates of a certificate as a condition of entry for the proposed collection of information Pharmaceutical Product, (4) Non- FDA-regulated products, is necessary for the proper performance Clinical Research Use Only Certificates, pharmaceuticals, biologics, and devices of FDA’s functions, including whether and (5) Certificates of Free Sale. Table as indicated in the Federal Food, Drug, the information will have practical 1 of this document lists the different and Cosmetic Act (the act) as amended. utility; (2) the accuracy of FDA’s certificates and details their use:

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TABLE 1.—EXPORT CERTIFICATES

Type of Certificate Use

‘‘Supplementary Information Certificate to Foreign Government Re- For the export of products legally marketed in the United States quests’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)’’

‘‘Supplementary Information Certificate of Exportability Requests’’ For the export of products not approved for marketing in the United ‘‘Exporter’s Certification Statement Certificate of Exportability’’ States (unapproved products) that meet the requirements of sections 801(e) or 802 of the act

‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ Conforms to the format established by the World Health Organization ‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical and is intended for use by the importing country when the product in Product’’ question is under consideration for a product license that will author- ize its importation and sale or for renewal, extension, amending, or reviewing a license

‘‘Supplementary Information Non-Clinical Research Use Only Certifi- For the export of a non-clinical research use only product, material, or cate’’ component that is not intended for human use which may be mar- ‘‘Exporter’s Certification Statement Non-Clinical Research Use Only)’’ keted in, and legally exported from the United States under the act

Certificate of Free Sale For food, cosmetic products, and dietary supplements that may be le- gally marketed in the United States

FDA will continue to rely on self- the appropriate center, but also at the Investigations for followup. Making or certification by manufacturers for the time that they submit the certification to submitting to FDA false statements on first three types of certificates listed in the foreign government. any documents may constitute table 1 of this document. Manufacturers The appropriate FDA centers will violations of 18 U.S.C. 1001, with are requested to self-certify that they are review product information submitted penalties including up to $250,000 in in compliance with all applicable by firms in support of their certificate fines and up to 5 years imprisonment. requirements of the act, not only at the and any suspected case of fraud will be FDA estimates the burden of this time that they submit their request to referred to FDA’s Office of Criminal collection of information as follows:

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Annual Frequency Total Annual Hours per FDA Center Respondents per Response Responses Response Total Hours

Center for Biologics Evaluation and Research 2,114 1 2,114 1 2,114

Center for Drug Evaluation and Research 5,251 1 5,251 2 10,502

Center for Devices and Radio- logical Health 6,463 1 6,463 2 12,926

Center for Veterinary Medicine 855 1 855 1 855

Center for Food Safety and Ap- plied Nutrition 1,794 5 8,970 2 17,940

Total 44,337 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 25, 2010. DEPARTMENT OF HEALTH AND OMB No.: New collection. Leslie Kux, HUMAN SERVICES Description: This proposed Acting Assistant Commissioner for Policy. information collection activity is to Administration for Children and [FR Doc. 2010–7111 Filed 3–30–10; 8:45 am] obtain evaluation information from Families BILLING CODE 4160–01–S Strengthening Communities Fund (SCF) Agency Recordkeeping/Reporting grantees. Grantees include participants Requirements Under Emergency in two SCF grant programs contributing Review by the Office of Management to the economic recovery as authorized and Budget (OMB) in the American Recovery and Reinvestment Act of 2009 (ARPA). The Title: Strengthening Communities SCF evaluation is an important Fund Program Evaluation. opportunity to examine the outcomes

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achieved by the Strengthening progress and measure increased Respondents: SCF Grantees (both the Communities Fund in meeting its organizational capacity of grantees is Nonprofit Capacity Building Program objective of improving the capacity of each of the two SCF programs. The and the Government Capacity Building grantees that include Nonprofit purpose of this request will be to Program) made up of State, local, and organizations and State, Local and establish the approved baseline Tribal governments, as well as nonprofit Tribal Governments. The evaluation for instruments for follow-up data organizations. each program will be designed to assess collection.

ANNUAL BURDEN ESTIMATES

Number of Average bur- Instrument Number of responses per den hours per Total burden respondents respondent response hours

Nonprofit Capacity Building Program Performance Progress Report (PPR) .. 35 4 1 140 Government Capacity Building PPR ...... 49 4 1 196

Estimated Total Annual Burden This proposed information collection care providers who seek to transfer Hours: 336. project was previously published in the between IHS health care facilities. Additional Information: ACF is Federal Register (74 FR 63754) on National health care standards requesting that OMB grant a 180 day December 4, 2009 and allowed 60 days developed by the Centers for Medicare approval for this information collection for public comment. No public and Medicaid Services (formerly the under procedures for emergency comment was received in response to Health Care Financing Administration), processing by April 15, 2010. A copy of the notice. The purpose of this notice is the Joint Commission on the this information collection, with to allow 30 days for public comment to Accreditation of Healthcare applicable supporting documentation, be submitted directly to OMB. Organizations (JCAHO), and other may be obtained by calling the Proposed Collection: Title: 0917– accrediting organizations require health Administration for Children and 0009, ‘‘Indian Health Service Medical care facilities to review, evaluate and Families, Reports Clearance Officer, Staff Credentials and Privileges Files.’’ verify the credentials, training and Robert Sargis at (202) 690–7275. Type of Information Collection experience of medical staff applicants Comments and questions about the Request: Extension, without revision, of prior to granting medical staff information collection described above currently approved information privileges. In order to meet these should be directed to the Office of collection, 0917–0009, ‘‘Indian Health standards, IHS health care facilities Information and Regulatory Affairs, Service Medical Staff Credentials and require all medical staff applicants to Attn: OMB Desk Officer for ACF, Office Privileges Files’’ agreement. provide information concerning their of Management and Budget, Paperwork Form Numbers(s): None. education, training, licensure, and work Reduction Project, 725 17th Street NW., Need and Use of Information experience and any adverse disciplinary Washington, DC 20503, FAX (202) 395– Collection: This collection of actions taken against them. This 6974. information is used to evaluate information is then verified with Dated: March 22, 2010. individual health care providers references supplied by the applicant Robert Sargis, applying for medical staff privileges at and may include: Former employers, Reports Clearance Officer. IHS health care facilities. The educational institutions, licensure and [FR Doc. 2010–6999 Filed 3–30–10; 8:45 am] Department of Health and Human certification boards, the American BILLING CODE 4184–01–M Services operates health care facilities Medical Association, the Federation of that provide health care services to State Medical Boards, the National American Indians and Alaska Natives. Practitioner Data Bank, and the DEPARTMENT OF HEALTH AND To provide these services, the IHS applicants themselves. HUMAN SERVICES employs (directly and under contract) In addition to the initial granting of several categories of health care medical staff membership and clinical Indian Health Service providers including: Physicians (M.D. privileges, JCAHO standards require and D.O.), dentists, psychologists, that a review of the medical staff be Request For Public Comment: 30-Day optometrists, podiatrists, audiologists, conducted not less than every two years. Proposed Information Collection: physician assistants, certified registered This review evaluates the current Indian Health Service Medical Staff nurse anesthetists, nurse practitioners, competence of the medical staff and Credentials and Privileges Files and certified nurse midwives. IHS verifies whether they are maintaining AGENCY: Indian Health Service, HHS. policy specifically requires physicians the licensure or certification ACTION: Notice. and dentists to be members of the health requirements of their specialty. care facility medical staff where they The medical staff credentials and SUMMARY: In compliance with Section practice. Health care providers become privileges records are maintained at the 3506(c)(2)(A) of the Paperwork medical staff members, depending on health care facility where the health Reduction Act of 1995, which requires the local health care facility’s care provider is a medical staff member. 30 days for public comment on capabilities and medical staff bylaws. The establishment of these records at proposed information collection There are three types of IHS medical IHS health care facilities is not optional; projects, the Indian Health Service (IHS) staff applicants: (1) Health care such records must be established and has submitted to the Office of providers applying for direct accredited by JCAHO. Prior to the Management and Budget (OMB) a employment with IHS; (2) contractors establishment of this JCAHO request to review and approve the who will not seek to become IHS requirement, the degree to which information collection listed below. employees; and (3) employed IHS health medical staff applications were

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maintained at all health care facilities in technology to make the application The table below provides: Types of the United States that are verified for electronically available on the Internet. data collection instruments, Estimated completeness and accuracy varied Affected Public: Individuals and number of respondents, Number of greatly across the Nation. households. annual number of responses, Average The application process has been burden per response, and Total annual streamlined and is using information Type of Respondents: Individuals. burden hours.

Estimated num- Average burden Data collection instrument(s) ber of respond- Responses per hour per Total annual bur- ents respondent response* den hours

Application to Medical Staff ...... 570 1 1.00 (60 mins) .. 570 Reference Letter ...... 1710 1 0.33 (20 mins) .. 570 Reappointment Request ...... 190 1 1.00 (60 mins) .. 190 Ob-Gyn Privileges ...... 20 1 1.00 (60 mins) .. 20 Internal Medicine ...... 325 1 1.00 (60 mins) .. 325 Surgery Privileges ...... 20 1 1.00 (60 mins) .. 20 Psychiatry Privileges ...... 13 1 1.00 (60 mins) .. 13 Anesthesia Privileges ...... 15 1 1.00 (60 mins) .. 15 Dental Privileges ...... 150 1 0.33 (20 mins) .. 50 Optometry Privileges ...... 21 1 0.33 (20 mins) .. 7 Psychology Privileges ...... 30 1 0.17 (10 mins) .. 5 Audiology Privileges ...... 7 1 0.08 (5 mins) .... 1 Podiatry Privileges ...... 7 1 0.08 (5 mins) .... 1 Radiology Privileges ...... 8 1 0.33 (20 mins) .. 3 Pathology Privileges ...... 3 1 0.33 (20 mins) .. 1

Total ...... 3,089 ...... 1,791 * For ease of understanding, burden hours are provided in actual minutes. There are no capital costs, operating costs and/or maintenance costs to respondents.

Request For Comments: Your written Clearance Officer, 801 Thompson confidential information regarding the comments and/or suggestions are Avenue, TMP, Suite 450, Rockville, MD quality and safety of healthcare invited on one or more of the following 20852–1627; call non-toll free (301) delivery. The Patient Safety Act (at 42 points: (a) Whether the information 443–5932; send via facsimile to (301) U.S.C. 299b–23) authorizes the collection activity is necessary to carry 443–9879; or send your e-mail requests, collection of this information in a out an agency function; (b) whether the comments, and return address to: standardized manner, as explained in agency processes the information [email protected]. the related Patient Safety and Quality collected in a useful and timely fashion; Comment Due Date: Comments Improvement Final Rule, 42 CFR part 3 (c) the accuracy of public burden regarding this information collection are (Patient Safety Rule), published in the estimate (the estimated amount of time best assured of having full effect if Federal Register on November 21, 2008: needed for individual respondents to received within 30 days of the date of 73 FR 70731–70814. As authorized by provide the requested information); (d) this publication. the Secretary of HHS, AHRQ whether the methodology and Dated: March 19, 2010. coordinates the development of a set of assumptions used to determine the common definitions and reporting estimate is logical; (e) ways to enhance Yvette Roubideaux, formats (Common Formats) that allow the quality, utility, and clarity of the Director, Indian Health Service. healthcare providers to voluntarily information being collected; and (f) [FR Doc. 2010–7253 Filed 3–30–10; 8:45 am] collect and submit standardized ways to minimize the public burden BILLING CODE 4165–16–P information regarding patient safety through the use of automated, events. The purpose of this notice is to electronic, mechanical, or other announce the availability of the technological collection techniques or DEPARTMENT OF HEALTH AND expanded and enhanced Common other forms of information technology. HUMAN SERVICES Formats Version 1.1—including Direct Comments to OMB: Send your updated event descriptions, reports, written comments and suggestions Agency for Healthcare Research and Quality data elements, and technical regarding the proposed information specifications for software developers— collection contained in this notice, Common Formats for Patient Safety and the process for their continued especially regarding the estimated Data Collection and Event Reporting refinement. public burden and associated response DATES: Ongoing public input. time to: Office of Management and AGENCY: Agency for Healthcare Research ADDRESSES: Budget, Office of Regulatory Affairs, and Quality (AHRQ), HHS. The Common Formats Attention: Desk Officer for IHS, New Version 1.1 can be accessed ACTION: Notice of Availability— electronically at the following HHS Web Executive Office Building, Room 10235, Common Formats Version 1.1. Washington, DC 20503. site: http://www.PSO.AHRQ.gov/ Send Comments and Requests for SUMMARY: The Patient Safety and index.html. Further Information: To request more Quality Improvement Act of 2005, 42 FOR FURTHER INFORMATION CONTACT: information on the proposed collection U.S.C. 299b–21 to b–26, (Patient Safety Marcy Opstal, Center for Quality or to obtain a copy of the data collection Act) provides for the formation of Improvement and Patient Safety, AHRQ, instrument(s) and/or instruction(s) Patient Safety Organizations (PSOs), 540 Gaither Road, Rockville, MD 20850; contact: Mr. Hershel Gorham, Reports which collect, aggregate, and analyze Telephone (toll free): (866) 403–3697;

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Telephone (local): (301) 427–1111; TTY applies to all patient safety concerns of the Common Formats. The inventory (toll free): (866) 438–7231; TTY (local): including: now numbers 69 and includes many (301) 427–1130; E-mail: • Incidents—patient safety events systems from the private sector, [email protected]. that reached the patient, whether or not including prominent academic settings, there was harm, hospital systems, and international SUPPLEMENTARY INFORMATION: • Near misses or close calls—patient reporting systems (e.g., from the United Background safety events that did not reach the Kingdom and the Commonwealth of The Patient Safety Act and Patient patient, and Australia). In addition, virtually all • Unsafe conditions—circumstances Safety Rule establish a framework by major Federal patient safety reporting that increase the probability of a patient which doctors, hospitals, and other systems are included, such as those safety event. healthcare providers may voluntarily from the Centers for Disease Control and Common Formats Version 1.1 is report information regarding patient Prevention (CDC), the Food and Drug currently limited to patient safety safety events and quality of care. Administration (FDA), the Department reporting for acute care hospitals and is Information that is assembled and of Defense (DoD), and the Department of designed to support the first stage in the developed by providers for reporting to Veterans Affairs (VA). improvement cycle. Version 1.1 Since February 2005, AHRQ has PSOs and the information received and includes two general types of formats, coordinated an interagency Federal analyzed by PSOs—called ‘‘patient generic and event specific. The generic Patient Safety Work Group (PSWG) to safety work product’’—is privileged and Common Formats pertain to all patient assist AHRQ with developing and confidential. Patient safety work safety concerns. The three generic maintaining the Common Formats. The product is used to identify events, formats are: Healthcare Event Reporting PSWG includes major health agencies patterns of care, and unsafe conditions Form, Patient Information Form, and within the HHS CDC, Centers for that increase risks and hazards to Summary of Initial Report. The event- Medicare & Medicaid Services, FDA, patients. Definitions and other details specific Common Formats pertain to Health Resources and Services about PSOs and patient safety work frequently-occurring and/or serious Administration, the Indian Health product are included in the Patient patient safety events. The eight event- Service, the National Institutes of Safety Rule. specific formats are: Blood or Blood Health, the National Library of The Patient Safety Act and Patient Product, Device or Medical/surgical Medicine, the Office of the National Safety Rule require PSOs, to the extent Supply, Fall, Healthcare-Associated Coordinator for Health Information practical and appropriate, to collect Infection, Medication or Other Technology, the Office of Public Health patient safety work product from Substance, Perinatal, Pressure Ulcer, and Science, the Substance Abuse and providers in a standardized manner in and Surgery or Anesthesia. Mental Health Services order to permit valid comparisons of The Common Formats Version 1.1 has Administration—as well as the DoD and similar cases among similar providers. a defined focus on patient safety the VA. The collection of patient safety work reporting for acute care hospitals. It The PSWG assists AHRQ with product allows the aggregation of should be noted, however, that the assuring the consistency of definitions/ sufficient data to identify and address privilege and confidentiality protections formats with those of relevant underlying causal factors of patient of the Patient Safety Act and Patient government agencies as refinement of safety problems. Both the Patient Safety Safety Rule apply to patient safety work the Common Formats continues. To the Act and Patient Safety Rule can be product developed under the aegis of a extent practicable, the Common Formats accessed electronically at http:// PSO with respect to healthcare in any are also aligned with World Health www.PSO.AHRQ.gov/regulations/ setting. Future versions of the Common Organization (WHO) concepts, regulations.htm. Formats are being developed for other framework, and definitions, contained In order to facilitate standardized data settings such as: Skilled nursing in their draft International Classification collection, the Secretary of HHS facilities (SNFs), ambulatory surgery for Patient Safety (ICPS). authorized AHRQ to develop and centers, and physician and practitioner maintain the Common Formats to Common Formats Version 1.1— offices. Technical Specifications Enhancements improve the safety and quality of AHRQ’s Common Formats Version 1.1 healthcare delivery. In August 2008, includes: The technical specifications promote AHRQ issued the initial release of the • Descriptions of patient safety events standardization by ensuring that data formats, Version 0.1 Beta. The second and unsafe conditions to be reported collected by PSOs and other entities are release of the Common Formats, Version (event descriptions), clinically and electronically 1.0, was announced in the Federal • Specifications for patient safety comparable. The specifications also Register on September 2, 2009: 74 FR aggregate reports and individual event provide direction to software 45457–45458. summaries, developers, so the Common Formats can • Definition of Common Formats Delineation of data elements to be be implemented electronically, and to collected for specific types of events, PSOs, so the Common Formats can be The term ‘‘Common Formats’’ is used • A user’s guide and quick guide, and submitted electronically to the PSO to describe clinical definitions and • Technical specifications for Privacy Protection Center (PPC) for data technical requirements developed for electronic data collection and reporting. de-identification and transmission to the uniform collection and reporting of the Network of Patient Safety Databases Common Formats Development patient safety data, including all (NPSD). supporting material. The Common In anticipation of the need for The technical specifications consist of Formats are not intended to replace any Common Formats, AHRQ began their the following: current mandatory reporting system, development in 2005 by creating an • Data dictionary—defines data collaborative/voluntary reporting inventory of functioning private and elements and their attributes (data system, research-related reporting public sector patient safety reporting element name, answer values, field system, or other reporting/recording systems. This inventory provides an length, guide for use, etc.) included in system. The scope of Common Formats evidence base that informs construction Common Formats Version 1.1;

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• Clinical document architecture More information on the Common will be targeted to reduce the risk of (CDA) implementation guide—provides Formats Version 1.1, including the diabetes in at-risk individuals, provide instructions for developing a Health feedback process, can be obtained services that target those with new onset Level Seven (HL7) CDA Extensible through AHRQ’s PSO Web site: http:// diabetes, provide high quality care to Markup Language (XML) file to transmit www.PSO.AHRQ.gov/index.html. those with diagnosed diabetes, and/or the Common Formats patient safety data Dated: March 19, 2010. reduce the complications of diabetes. from the PSO to the PPC using the The purpose of the FY 2010 SDPI Carolyn M. Clancy, Common Formats; Community-Directed grant program is to Director. • Validation rules and errors support diabetes treatment and document—specifies and defines the [FR Doc. 2010–6781 Filed 3–30–10; 8:45 am] prevention programs that have a validation rules that will be applied to BILLING CODE 4160–90–M program plan which integrates at least the Common Formats data elements one IHS Diabetes Best Practice and that submitted to the PPC; have a program evaluation plan in place DEPARTMENT OF HEALTH AND • Common Formats flow charts— which includes tracking outcome HUMAN SERVICES diagrams the valid paths to complete measures. generic and event specific formats (a Indian Health Service This is not an application for complete event report); continued funding as was previously • Local specifications—provides FY 2010 Special Diabetes Program for available for Community-Directed grant specifications for processing, linking Indians Community-Directed Grant programs. and reporting on events and details Program specifications for reports; and Background • Metadata registry—includes Announcement Type: New/Competing Diabetes Among American Indian/ descriptive facts about information Continuation. Alaska Native Communities contained in the data dictionary to Funding Opportunity Number: HHS– illustrate how such data corresponds 2010–IHS–SDPI–0004. During the past 50 years, type 2 with similar data elements used by diabetes has become a major public Catalog of Federal Domestic Assistance health issue in many AI/AN other Federal agencies and standards Number: 93.237 development organizations [e.g., HL–7, communities, and it is increasingly Key Dates: International Standards Organization recognized that AI/AN populations have (ISO)]. Application Deadline: April 30, 2010. a disproportionate burden of diabetes Review Date: June 21–24, 2010. (Ghodes, 1995). In 2006, 16.1% of AI/ Commenting on Common Formats Earliest Anticipated Start Date: July 15, ANs age 20 years or older had diagnosed Version 1.1 2010. diabetes (unpublished IHS Diabetes To allow for greater participation by Other information: This Program Statistics, 2006) compared to the private sector in the subsequent announcement will be open throughout 7.8% for the non-Hispanic white development of the Common Formats, Fiscal Year (FY) 2010 based on existing population (CDC, 2007). In addition, AI/ AHRQ engaged the National Quality budget cycles. Refer to application AN people have higher rates of diabetes- Forum (NQF), a non-profit organization instructions for additional details. This related morbidity and mortality than the focused on healthcare quality, to solicit current announcement targets grantees general U.S. population (Carter, 1996; comments and advice to guide the that currently operate under a budget Harris, 1995; Gilliland, 1997). Strategies further refinement of the Common cycle that begins on June 1. to address the prevention and treatment Formats. The NQF began this process I. Funding Opportunity Description of diabetes in AI/AN communities are with feedback on AHRQ’s 0.1 Beta urgently needed. release of the Common Formats. The Statutory Authority Under the Balanced Budget Act of NQF also convened an expert panel to The Indian Health Service (IHS) is 1997, Congress authorized the IHS to review the comments received on accepting grant applications for the FY administer the SDPI grant program. Common Formats Version 1.0 and 2010 Special Diabetes Program for SDPI grants are programmatically provide feedback to AHRQ. Based upon Indians (SDPI) Community-Directed directed by the IHS Division of Diabetes the expert panel’s feedback, AHRQ, in grant program. This competitive grant Treatment and Prevention (DDTP). conjunction with the PSWG, has further announcement is open to all existing Special Diabetes Program for Indians revised and refined the Common SDPI grantees that have an active grant Formats that are now available as in place and are in compliance with the The SDPI is a $150 million per year Version 1.1. previous terms and conditions of the grant program. Over 330 programs have AHRQ is committed to continuing grant. This program is authorized under received SDPI Community-Directed refinement of the Common Formats. The H.R. 6331 ‘‘Medicare Improvement for grants annually since 1998. In addition, Agency is specifically interested in Patients and Providers Act of 2008’’ 66 demonstration projects have been obtaining feedback from both the private (Section 303 of Pub. L. 110–275) and the funded annually since 2004 to address and public sectors, particularly from Snyder Act, 25 U.S.C. 13. The program prevention of type 2 diabetes or those who use the Common Formats, to is described in the Catalog of Federal cardiovascular disease risk reduction. A guide their improvement. Although Domestic Assistance (CDFA) under Congressional re-authorization in 2008 AHRQ’s Version 1.1 has been developed 93.237. extended the SDPI through FY 2011. based on evidence, consensus of the II. Award Information PSWG, public comments and input, and Overview feedback from the NQF expert panel, the The SDPI seeks to support diabetes Type of Awards formats do not fully reflect the treatment and prevention activities for Grants. refinement that comes from large-scale American Indian/Alaska Native (AI/AN) use and repeated revision. The process communities. Grantees will implement Estimated Funds Available for updating and refining the formats programs based on identified diabetes- The total amount of funding will be an iterative one. related community needs. Activities identified for FY 2010 SDPI

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Community-Directed grant program is conditions of the SDPI grant in order to 2. Cost Sharing or Matching $104.8 million. Funds available to each receive funding under this IHS Area and to urban Indian health announcement. The FY 2010 Special Diabetes programs have been determined through Non-profit Tribal organizations and Program for Indians (SDPI) Community- Tribal consultation. Within each Area, national or regional health boards are Directed grant program does not require local Tribal consultation guided IHS not eligible, consistent with past Tribal matching funds or cost sharing. decision-making on how much funding consultation. Applicants that do not 3. Other Requirements is available per eligible applicant. FY meet these eligibility requirements will 2010 SDPI funding remains unchanged have their applications returned without A. Program Coordinator from FY 2009, per Tribal consultation. further consideration. All awards issued under this Under this announcement, only one Provide information about the SDPI announcement are subject to the SDPI Community-Directed diabetes Program Coordinator on the ‘‘Key availability of funds. In the absence of grant will be awarded per entity. If a Contacts Form’’ which is included in the funding, the agency is under no Tribe submits an application, their local application package. The Program obligation to make awards funded under IHS facility cannot apply; if the Tribe Coordinator must meet the following this announcement. does not submit an application, the IHS requirements: • Anticipated Number of Awards facility can apply. Tribes that are Have relevant health care education awarded grant funds may sub-contract and/or experience. Approximately 150 awards will be with local IHS facilities to provide • Have experience with program issued for Budget Cycle IV. Applications specific clinical services. In this case, will be accepted from grantees whose management and grants program the Tribe would be the primary SDPI management, including skills in current SDPI FY 2009 grants end on grantee and the Federal entity would program coordination, budgeting, May 31, 2010. Additionally, applicants have a sub-contract within the Tribe’s reporting and supervision of staff. from Budget Cycles I, II or III that were SDPI grant. deemed ineligible due to incomplete • Have a working knowledge of applications or that possessed Collaborative Arrangements diabetes. delinquent OMB A–133 financial audits Tribes are encouraged to collaborate B. Documentation of Support can resubmit applications under the with any appropriate local entities timelines for Budget Cycle IV. including IHS facilities. If a Tribe seeks Tribal Organizations Project Period to provide specific clinical or support services, it may implement sub- Existing SDPI grantees must submit a The project period for grants made contracts with these entities in order to current, signed and dated Tribal under this announcement is 24 months, transfer funds. The amount of SDPI resolution or Tribal letter of support subject to the availability of funds. funding that the Tribe receives remains from all Indian Tribe(s) served by the project. Applications from each Tribal III. Eligibility Information the same. The Tribe, as the primary grantee, arranges with the entity to organization must include specific 1. Eligible Applicants provide specified services that support resolutions or letters of support from all Eligible applicants include the the program’s plan. The entity may Tribes affected by the proposed project following: request direct costs only. activities. • Federally-recognized Tribes When a Tribe sub-contracts with the If the Tribal resolution or Tribal letter operating an Indian health program local IHS facility, application of support is not submitted with the operated pursuant to a contract, grant, requirements for collaborative application, it must be received in the cooperative agreement, or compact with arrangements include: Division of Grants Operations (DGO) by the IHS pursuant to the Indian Self- • A signed Memorandum of June 15, 2010. This date is prior to the Determination and Education Agreement (MOA) must be submitted objective review dates, June 21–24, Assistance Act (ISDEAA), (Pub. L. 93– with the SDPI application. The MOA 2010. 638). must include the scope of work assigned • Tribal organizations operating an to the sub-contracting IHS facility. Title V Urban Indian Health Programs • Indian health program operated The IHS Area Director and the Urban Indian health programs must pursuant to a contract, grant, Tribal Chairperson must give signed submit a letter of support from the cooperative agreement, or compact with approval of the MOA. organization’s board of directors. Urban the IHS pursuant to the ISDEAA, (Pub. • The Tribe’s application must Indian health programs are non-profit L. 93–638). include additional SF–424 and SF– organizations and must also submit a • Urban Indian health programs that 424A forms that are completed by the copy of the 501(c)(3) Certificate. All operate a Title V Urban Indian Health IHS facility which includes a budget letters of support must be included in Program: This includes programs narrative and a face page that is signed the application or submitted to the DGO currently under a grant or contract with by the Chief Executive Officer (CEO). the IHS under Title V of the Indian by June 15, 2010. This date is prior to Applications With Sub-Grants Health Care Improvement Act, (Pub. L. the objective review dates, June 21–24, 93–437). Programs that submit one application 2010. • Indian Health Service facilities on behalf of multiple organizations (sub- IHS Hospitals or Clinics (refer to paragraph 3 below in this grantees) must submit copies of selected Section). application forms and documents for IHS facilities must submit a letter of Current SDPI grantees are eligible to each of their sub-grantees. (See Section support from the CEO. The apply for competing continuation IV, Subsection 2 for specifics.) All sub- documentation must be received in the funding under this announcement and grantees must meet the eligibility DGO by June 15, 2010. This date is prior must demonstrate that they have requirements noted in Subsection 1 to the objective review dates, June 21– complied with previous terms and above. 24, 2010.

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IV. Application and Submission services must submit the documents A3.1 Name. Information noted below for the sub-contractor: A3.2 Title. • MOA that is signed by the primary A3.3 Brief description of tasks/ 1. Obtaining Application Materials grantee, the sub-contractor, the IHS Area activities. The application package and Director and the Tribal Chairperson. A3.4 Is this person already on staff instructions may be found at • SF–424 and SF–424A forms with your SDPI or diabetes program? www.Grants.gov. completed by the IHS facility (in A3.5 What percent FTE of this addition to the primary applicant’s SF– 2. Content and Form of Application person’s salary will be paid using SDPI 424 forms). Submission funds? A separate budget is required for the Section 4: Diabetes Audit Review Mandatory documents for all sub-contract, but the primary grantee’s Obtain copies of your local IHS applicants include: application must reflect the total budget Diabetes Care and Outcomes Audit • Application forms: for the entire cost of the project. Reports for 2008 and 2009. Review and Æ SF–424. Public Policy Requirements: All Æ compare the results for these two years. SF–424A. Federal-wide public policies apply to Work with your local audit coordinator Æ SF–424B. Æ IHS grants with the exception of the or Area Diabetes Consultant (ADC) if Key Contacts Form. Discrimination Policy. • Budget Narrative. you need help. • Project Narrative. Requirements for Project and Budget A4.1 Provide a list of results for • Tribal Resolution or Tribal Letter of Narratives three to five items/elements (e.g., A1c, eye exam, education, etc.) that improved Support (Tribal Organizations only). A. Project Narrative: This narrative • Letter of Support from from 2008 to 2009. should be a separate Word document Organization’s Board of Directors (Title A4.2 Provide a list of three to five that is no longer than 13–17 pages (see V Urban Indian Health Programs only). items/elements that need to be • 501(c)(3) Certificate (Title V Urban page limitations for each Part noted improved. Indian Health Programs only). below) with consecutively numbered A4.3 Describe how your program • CEO Letters of Support (IHS pages. Be sure to place all responses and will address these three to five items/ facilities only). required information in the correct elements that need to be improved or • 2008 and 2009 IHS Diabetes Care section or they will not be considered or describe how your program will work and Outcomes Audit Report. scored. If the narrative exceeds the page with your local health care facility to • Biographical sketches for all Key limit, only the first 13–17 pages will be address these areas. Personnel. reviewed. There are three parts to the Section 5: Collaboration • Disclosure of Lobbying Activities narrative: Part A—Program Information; A5.1 Describe existing partnerships (SF–LLL) (if applicable). Part B—Program Planning and and collaborations that your program • Documentation of OMB A–133 Evaluation; and Part C—Program has in place. required Financial Audit for FY 2007 Report. A sample project narrative and A5.2 Describe new partnerships and and FY 2008. Acceptable forms of template are available in the application collaboration that your program is documentation include: instructions. See below for additional Æ planning to implement. E-mail confirmation from Federal details about what must be included in Part B: Program Planning and Audit Clearinghouse (FAC) that audits the narrative. Evaluation (no more than 3 pages, with were submitted; or Part A: Program Information (no more Æ 2 pages for each additional Best Face sheets from audit reports. than 4 pages) Practice) These can be found on the FAC Web Section 1: Community Needs Section 1: Overview site: http://harvester.census.gov/fac/ Assessment Each 2009 IHS Diabetes Best Practice A1.1 Describe the burden of diabetes dissem/accessoptions.html?submit includes two specific measures that are in your community. Include estimates of =Retrieve+Record. called ‘‘key measures.’’ Programs may the number of people diagnosed with track additional measures based on local Mandatory Documents for Programs diabetes and the total number of people. priorities. A list of all Best Practices is That Propose Sub-Grantees Describe how you calculated these located in the application instructions. The primary grantee for applications estimates. that propose sub-grantees must submit A1.2 Briefly describe the top This list provides a short description of all of the mandatory documents listed diabetes-related health issues in your the contents and key measures for each above. In addition, they must submit the community. Best Practice. following documents for each sub- A1.3 Briefly describe the unique B1.1 List which IHS Diabetes Best grantee: challenges your program experiences Practice(s) your program will implement • SF–424, SF–424A, SF–424B and related to prevention and treatment of in order to address the needs that were Key Contacts Form. diabetes. identified in your community • Project Narrative. Section 2: Leadership Support assessment. • Budget Narrative. A2.1 Question: Has at least one Section 2: Program Planning • 2008 and 2009 IHS Diabetes Care organization administrator or Tribal Provide the information requested and Outcomes Audit Reports. leader agreed to be actively involved in below separately for each Best Practice A separate budget is required for each your program’s work? (Yes or No). that will be implemented: sub-grantee, but the primary grantee’s A2.2 Provide the name and role or B2.1 Target Population: What application must reflect the total budget position that this leader holds. population will you target? for the entire cost of the project. A2.3 Describe how this leader will B2.2 Goal: Describe the goal that be involved with your program. your program wants to achieve as a Mandatory Documents for Programs Section 3: Personnel result of implementing the selected Best That Propose Sub-Contracts With Local Using the table format that is in the Practice. IHS Facilities application instructions, provide the B2.3 Objectives/Measures: List the Programs that propose sub-contracts following information for each person objective(s) your program will work to with IHS facilities to provide clinical who will be paid with SDPI funds: accomplish, with at least one measure

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identified for each objective. Be sure to C3.3 Describe materials or products 4. Intergovernmental Review include the two key measures for your your SDPI program has developed. Executive Order 12372 requiring selected Best Practice and use the Section 4: Other Information intergovernmental review is not Specific, Measurable, Action-oriented, C4.1 Provide any additional applicable to this program. Realistic and Time-bound (SMART) information about your SDPI program. format (see application instructions for 5. Funding Restrictions additional information). Also, indicate B. Budget Narrative (no more than 4 pages) A. Pre-award costs are allowable how frequently your program will pending prior approval from the The budget narrative should explain review data for each measure. (Choose awarding agency. However, in why each budget item on the SF–424A from the following options: weekly, accordance with 45 CFR Part 74 and 92, is necessary and relevant to the twice a month, monthly, every other pre-award costs are incurred at the proposed project. month, or quarterly). applicant’s risk. The awarding office is B2.4 Activities: List the activities 3. Submission Dates and Times under no obligation to reimburse such that your program will do to meet the costs if for any reason the applicant Applications are to be submitted selected Best Practice objectives. These does not receive an award or if the electronically through Grants.gov by could be events you will organize, award is less than anticipated. April 30, 2010 at 12 midnight Eastern services you will offer, materials you B. The available funds are inclusive of Standard Time (EST). Any application will develop and implement, or other direct and appropriate indirect costs received after the application deadline activities. (see Section VI, Subsection 3). will not be accepted for processing, and Section 3: Evaluation C. Only one grant will be awarded per it will be returned to the applicant(s) B3.1 Describe how your program applicant. will track activities for the selected Best without further consideration for Practice(s). funding. 6. Electronic Submission Requirements B3.2 Describe how your program If technical challenges arise and the Use the http://www.Grants.gov Web will collect and track data on all applicants need help with the electronic site to submit an application measures (listed in Section 2 above) for application process, contact Grants.gov electronically; select the ‘‘Apply for the selected Best Practice(s). Customer Support via e-mail to Grants’’ link on the homepage. B3.3 Describe how your program [email protected] or at (800) 518– Download a copy of the application will collect stories about individual 4726. Customer Support is available to package, complete it offline, and then participants, community events, address questions 24 hours a day, 7 days upload and submit the application via program staff, and other aspects of your a week (except on Federal holidays). If the Grants.gov Web site. Electronic program. problems persist, contact Tammy copies of the application may not be Part C: Program Report (no more than Bagley, Senior Grants Policy Analyst, submitted as attachments to e-mail 4 pages) IHS Division of Grants Policy (DGP) messages addressed to IHS employees or Section 1: Major Accomplishments ([email protected]) at (301) 443– offices. and Activities 5204 to describe the difficulties being Applicants that receive a waiver to C1.1 Describe three major experienced. Be sure to contact Ms. accomplishments that your SDPI submit paper application documents Bagley at least ten days prior to the must follow the rules and timelines that program achieved in the past 12 application deadline. Please do not months. are noted below. The applicant must contact the DGP until you have received seek assistance at least ten days prior to C1.2 Describe three to five major a Grants.gov tracking number. In the accomplishments that your SDPI the application deadline. event you are not able to obtain a Applicants that do not adhere to the program has achieved since it began. tracking number, call the DGP as soon C1.3 Describe one story that timelines for Central Contractor Registry as possible. exemplifies a major program (CCR) and/or Grants.gov registration accomplishment from the past year. If an applicant needs to submit a and/or request timely assistance with C1.4 Describe your SDPI program’s paper application instead of submitting technical issues will not be considered primary activities during the past 12 electronically via Grants.gov, prior for a waiver to submit a paper months. approval must be requested and application. C1.5 Describe your SDPI program‘s obtained (see information under Please be aware of the following: • primary activities since it began. Subsection 6 ’’ Electronic Submission Paper applications are not the Section 2: Challenges Requirements’’ for additional preferred method for submitting C2.1 Describe the two or three information). The waiver must be applications. biggest challenges that your SDPI documented in writing (e-mails are • If you have problems electronically program encountered in the past 12 acceptable), before submitting a paper submitting your application on-line, months. application. After a waiver is received, contact Grants.gov Customer Support C2.2 Describe how your SDPI the application package must be via e-mail to [email protected] or at program addressed these challenges. downloaded by the applicant from (800) 518–4726. Customer Support is C2.3 Indicate if you successfully Grants.gov. Once completed and available to address questions 24 hours addressed these challenges. (If so, why; printed, the original application and a day, 7 days a week (except on Federal if not, why not.) two copies must be sent to Denise E. holidays). If problems persist, contact Section 3: Dissemination Clark, Division of Grants Operations Tammy Bagley, Senior Grants Policy C3.1 Describe three to five major (DGO) ([email protected]), 801 Analyst, DGP, at (301) 443–5204. lessons that your SDPI program has Thompson Avenue, TMP, Suite 360, • Upon contacting Grants.gov, obtain learned since it began. Rockville, MD 20852. Paper a tracking number as proof of contact. C3.2 Describe how your SDPI applications that are submitted without The tracking number is helpful if there program has shared the lessons that you a waiver will be returned to the are technical issues that cannot be have learned with other diabetes applicant without review or further resolved and a waiver to submit a paper programs. consideration. application must be obtained.

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• If it is determined that a waiver is • The applicant must provide the Scoring of Applications needed, the applicant must submit a Funding Opportunity Number: HHS– request in writing (e-mails are 2010–IHS–SDPI–0004. Points will be assigned in each acceptable) to [email protected] category adding up to a total of 100. A DUNS Number that includes a justification for the need minimum score of 60 points is required to deviate from the standard electronic Applicants are required to have a for funding. Points will be assigned as submission process. If the waiver is DUNS number to apply for a grant or follows: approved, the application package must cooperative agreement from the Federal • Project Narrative: A total of 90 be downloaded by the applicant from Government. The DUNS number is a possible points are available for this Grants.gov. Once completed and nine-digit identification number, which information. It is divided into two parts: printed, it should be sent directly to the uniquely identifies business entities. Program Information (20 possible DGO by the deadline date of April 30, Many organizations may already have a points); Program Planning/Evaluation 2010 (see Section IV, Subsection 3 for DUNS number. Obtaining a DUNS (60 possible points); and Program details). number is easy and there is no charge. Report (10 possible points). • Upon entering the Grants.gov site, To obtain a DUNS number or to find out • Budget Narrative: A total of 10 there is information that outlines the if your organization already has a DUNS possible points are available for this requirements to the applicant regarding number, access http://fedgov.dnb.com/ information. electronic submission of an application webform. through Grants.gov, as well as the hours Applicants must also be registered 2. Review and Selection Process of operation. with the CCR. A DUNS number is Each application will be prescreened • Applicants are strongly encouraged required before an applicant can by DGO staff for eligibility and not to wait until the deadline date to complete their CCR registration. completeness as outlined in this begin the application process through Registration with the CCR is free of Funding Opportunity Announcement. Grants.gov as the registration process for charge. Applicants may register online Applications from entities that do not CCR and Grants.gov could take up to at http://www.ccr.gov. More detailed meet eligibility criteria or that are fifteen working days. information regarding the DUNS, CCR, incomplete will not be reviewed. • In order to use Grants.gov, the and Grants.gov processes can be found Applicants will be notified by the DGO applicant must have a Dun and at: http://www.Grants.gov. that their application did not meet Bradstreet (DUNS) Number and register V. Application Review Information minimum requirements. in the Central Contractor Registration After being prescreened by the DGO, (CCR). A minimum of ten working days 1. Criteria applications will be reviewed by an should be allowed to complete CCR Criteria that will be used to evaluate Objective Review Committee (ORC) and registration. See Subsection 8 below for the application are divided into three assigned a score. The ORC is an more information. categories. They include: objective review group that will be • All documents must be submitted • convened by the DDTP in consultation electronically, including all information Project Narrative with the DGP as required by Department typically included on the SF–424 and The project narrative is divided into of Health and Human Services (HHS) all necessary assurances and three parts: Part A—Program Grants Policy. certifications. Information; Part B—Program Planning/ • Please use the optional attachment Evaluation; and Part C—Project Report. To obtain a minimum score for feature in Grants.gov to attach Required information includes topics funding, applicants must address all additional documentation that may be such as: Community needs assessment, program requirements and provide all requested by IHS. leadership support, use of Diabetes required documentation. Applicants • The application must comply with Audit results, selected Best Practice(s), that receive less than a minimum score any page limitation requirements overall evaluation plan and project will be informed via e-mail of their described in the Funding accomplishments. For each Best application’s deficiencies. (See Section Announcement. Practice that will be implemented, 6 below for application revision • After you electronically submit address: target population, goal, guidance). A summary statement your application, you will receive an objectives/measures, review of key outlining the weaknesses of the automatic acknowledgment from measures, and activities (see Section IV, application will be provided to these Grants.gov that contains a Grants.gov Part B, Section 2). applicants. The summary statement will • tracking number. The DGO will Budget Narrative be sent to the Authorized Organizational download your application from The budget narrative provides Representative (AOR) that is identified Grants.gov and provide necessary copies additional explanation to support the on the face page of the application. to the DDTP. Neither the DGO nor the information provided on the SF–424A Review of Applications With Sub- DDTP will notify applicants that the form. Budget categories to address Grants application has been received. include: Personnel, fringe benefits, • You may access the electronic travel, equipment and supplies, When an application is submitted on application package and instructions for contractual/consultant and behalf of multiple organizations (sub- this Funding Opportunity constructions/alterations/renovations. grantees), the review score will be a Announcement on http:// In addition to a line item budget, combined score that is based on www.Grants.gov. provide a brief justification of each information provided by all of these • You may search for the application budget item and how they support organizations. project objectives. package on Grants.gov either with the Programmatic Requirements CFDA number or the Funding • Key Contacts Form Opportunity Number. Both numbers are This form seeks to obtain contact Funded applicants (grantees) must identified in the heading of this information about only one person: the meet the following programmatic announcement. project’s SDPI Program Coordinator. requirements:

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A. Implement an IHS Diabetes Best outlines the weaknesses of the initial with revisions receives the minimum Practice application. score for funding or above, the applicant will be informed via a NoA. Grantees must implement A. Revision to Initial Application recommended services and activities If the Review Committee determines Applicants will have five business from at least one 2009 IHS Diabetes Best that the application with revisions still days from the date that the summary Practice. They should implement does not receive a fundable score, statement is sent via e-mail to submit recommendations based on program applicants will be informed in writing hard copies of their application need, strengths, and resources. Program of their application’s deficiencies. revisions. Along with the revised Technical Assistance from Area activities, services and key measures application documents, applicants must Diabetes Consultants (ADCs) is available from the selected Best Practice(s) must prepare and submit an Introduction of to all applicants in all cycles that did be documented in the project narrative not more than three pages that not/do not receive fundable scores. (see Section IV, Part B, Section 2). summarizes the substantial additions, These applicants are encouraged to B. Implement Program and Evaluation deletions, and changes. The contact the ADC for their area to obtain Plans Introduction must also include assistance. Contact information for Grantees must follow the plans responses to the criticism and issues ADCs can be found on the Division of submitted with their application when raised in the summary statement. Diabetes Web site http:// implementing each selected Best The Introduction and revised www.diabetes.ihs.gov/ Practice and their evaluation processes. application documents must be mailed index.cfm?module= A minimum evaluation requirement is directly to the DGO to the attention of peopleADCDirectory. to monitor the key measures over time. Denise Clark, Lead Grants Management 7. Anticipated Announcement and Programs may track additional measures Specialist ([email protected]) at: Award Dates based on local priorities. Division of Grants Operations, 801 Thompson Avenue, TMP, Suite 360, Grantees that receive a fundable score C. Participate in Training and Peer-to- Rockville, MD 20852. will be notified of their approval for Peer Learning Sessions Technical assistance will be available funding via the NoA. Grantees must participate in SDPI to applicants as they prepare VI. Award Administration Information training sessions and peer-to-peer resubmission documentation. 1. Award Notices learning activities. Training sessions An Ad Hoc Review Committee will be will be primarily conference calls or convened specifically to review the The NoA will be prepared by the DGO combined WebEx/conference calls. initial application revisions. If the and sent via postal mail to each Grantees will be expected to: revised application receives the applicant that is approved for funding • Participate in interactive discussion minimum score for funding or above, under this announcement. This during conference calls. the applicant will be informed via a document will be sent to the person • Share activities, tools and results. Notice of Award (NoA). If the Review who is listed on the SF–424 as the AOR. • Share problems encountered and Committee determines that the The NoA will be signed by the Grants how barriers are broken down. application with revisions still does not Management Officer. The NoA is the • Share materials presented at receive a fundable score, the applicant authorizing document for which funds conferences and meetings. will be informed of their application’s are dispersed to the approved entities. • Participate and share in other deficiencies via a second summary The NoA serves as the official relevant activities. statement that will be e-mailed to the notification of the grant award and Sessions, which will be led by DDTP, AOR. reflects the amount of Federal funds DGO, or their agents, will address B. Second Application Revision awarded, the purpose of the grant, the clinical and other topics. Topics will terms and conditions of the award, the include: program planning and Applicants will have five business effective date of the award, and the evaluation, enhancing accountability days from the date that the second budget/project period. The NoA is the through data management, and summary statement is sent via e-mail to legally binding document. Applicants improvement of principles and submit hard copies of their application who are disapproved based on the ORC processes. Grantees will integrate revisions. Along with the revised score will receive a copy of the information and ideas in order to application documents, applicants must summary statement which identifies the enhance effectiveness. Anticipated prepare and submit an Introduction of weaknesses and strengths of the outcomes from participating in the not more than three pages that application submitted. The AOR serves learning sessions are improved summarizes the substantial additions, as the business point of contact for all communication and sharing among deletions, and changes. The business aspects of the award. grantees, increased use of data for Introduction must also include The anticipated NoA date for all improvement, and enhanced responses to the criticism and issues applicants that score well in the ORC accountability. raised in the summary statement. review for Cycle IV is July 15, 2010. The Introduction and revised Application Revisions application documents must, again, be 2. Administrative Requirements If an application does not receive a mailed directly to the DGO to the Grants are administered in accordance minimum score for funding from the attention of Denise Clark, Lead Grants with the following regulations, policies, ORC, the applicant will be informed via Management Specialist and Office of Management and Budget a summary statement that will be sent ([email protected]) at: Division of (OMB) cost principles: to the AOR via e-mail. The applicant Grants Operations, 801 Thompson A. The criteria as outlined in this then has two opportunities to submit Avenue, TMP, Suite 360, Rockville, MD Funding Opportunity Announcement. revisions to their application. Before 20852. B. Administrative Regulations for application revisions can be submitted, A second Ad Hoc Review Committee Grants: the AOR must have received a summary will be convened to review the second • 45 CFR Part 92—Uniform statement from the previous review that application revisions. If the application Administrative Requirements for Grants

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and Cooperative Agreements to State, B. Financial Status Reports • Denise Clark, Lead Grants Local and Tribal Governments. Management Specialist, DGO • Annual financial status reports are 45 CFR Part 74—Uniform required until the end of the project ([email protected]), Division of Administrative Requirements for period. Reports must be submitted Grants Operations, 801 Thompson Awards and Subawards to Institutions annually no later than 30 days after the Avenue, TMP, Suite 360, Rockville, MD of Higher Education, Hospitals, Other 20852, (301) 443–5204. end of each specified reporting period. • Non-Profit Organizations, and The final financial status report is due For Grants.gov electronic Commercial Organizations. application process, contact: within 90 days after the end of the 24 • C. Grants Policy: month project period. Standard Form Tammy Bagley, Grants Policy, DGP • HHS Grants Policy Statement, 269 (long form for those reporting ([email protected]), (301) 443– Revised 01/2007. program income; short form for all 5204, Grants Policy Web site:http:// D. Cost Principles: others) will be used for financial www.ihs.gov/NonMedicalPrograms/ • OMB Circular A–87—State, Local, gogp/index.cfm?module=gogp_funding. reporting. • and Indian Tribal Governments (Title 2 Grantees are responsible and For programmatic questions, Part 225). contact: accountable for accurate reporting of the • • OMB Circular A–122—Non-Profit Progress Reports and Financial Status Bonnie Bowekaty, Program Organizations (Title 2 Part 230). Reports (FSR). According to SF–269 Assistant, DDTP E. Audit Requirements instructions, the final SF–269 must be ([email protected]), (505) 248– • 4182; OMB Circular A–133—Audits of verified from the grantee records to • States, Local Governments, and Non- support the information outlined in the Lorraine Valdez, Deputy Director, Profit Organizations. FSR. DDTP ([email protected]), (505) 248–4182; 3. Indirect Costs Failure to submit required reports • within the time allowed may result in Area Diabetes Consultants Web site: This section applies to all grant suspension or termination of an active http://www.ihs.gov/MedicalPrograms/ recipients that request reimbursement of grant, withholding of additional awards diabetes/index.cfm?module= indirect costs in their grant application. for the project, or other enforcement peopleADCDirectory. In accordance with HHS Grants Policy actions such as withholding of Dated: March 12, 2010. Statement, Part II–27, IHS requires payments or converting to the Yvette Roubideaux, applicants to obtain a current indirect reimbursement method of payment. Director, Indian Health Service. cost rate agreement prior to award. The Continued failure to submit required [FR Doc. 2010–7103 Filed 3–30–10; 8:45 am] rate agreement must be prepared in reports may result in one or both of the BILLING CODE 4165–16–P accordance with the applicable cost following: (1) The imposition of special principles and guidance as provided by award provisions; and (2) the non- the cognizant agency or office. A current funding or non-award of other eligible DEPARTMENT OF HEALTH AND rate covers the applicable grant projects or activities. This applies HUMAN SERVICES activities under the current award’s whether the delinquency is attributable budget period. If the current rate is not to the failure of the grantee organization Food and Drug Administration on file with the DGO at the time of or the individual responsible for [Docket No. FDA–2010–N–0001] award, the indirect cost portion of the preparation of the reports. budget will be restricted. The C. FY 2007 and FY 2008 Single Audit Anti-Infective Drugs Advisory restrictions remain in place until the Committee; Notice of Meeting current rate is provided to the DGO. Reports (OMB A–133) Generally, indirect costs rates for IHS Applicants who have an active SDPI AGENCY: Food and Drug Administration, grantees are negotiated with the HHS grant are required to be up-to-date in the HHS. Division of Cost Allocation http:// submission of required audit reports. ACTION: Notice. rates.psc.gov/ and the Department of the These are the annual financial audit Interior (National Business Center) at reports required by OMB A–133, audits This notice announces a forthcoming http://www.aqd.nbc.gov/indirect/ of state, local governments, and non- meeting of a public advisory committee indirect.asp. If your organization has profit organizations that are submitted. of the Food and Drug Administration questions regarding the indirect cost Documentation of (or proof of (FDA). The meeting will be open to the policy, please contact the DGO at (301) submission) of current FY 2007 and FY public. 443–5204. 2008 Financial Audit Reports is Name of Committee: Anti-Infective mandatory. Acceptable forms of Drugs Advisory Committee. 4. Reporting Requirements documentation include: e-mail General Function of the Committee: The DDTP and the DGO have confirmation from FAC that audits were To provide advice and requirements for progress reports and submitted; or face sheets from audit recommendations to the agency on financial reports based on the terms and reports. Face sheets can be found on the FDA’s regulatory issues. conditions of this grant as noted below. FAC Web site: http:// Date and Time: The meeting will be harvester.census.gov/fac/dissem/ held on April 29, 2010, from 8 a.m. to A. Progress Reports accessoptions.html?submit= 5 p.m. Program progress reports are required Retrieve+Records. Location: Hilton Washington DC/ semi-annually. These reports must Telecommunication for the hearing Silver Spring, The Ballrooms, 8727 include at a minimum: Reporting of Best impaired is available at: TTY (301) 443– Colesville Rd., Silver Spring, MD. The Practice measures; and a brief 6394. hotel phone number is 301–589–5200. comparison of actual accomplishments Contact Person: Minh Doan, Center to the goals established for the budget VII. Agency Contacts for Drug Evaluation and Research (HFD– period or provide sound justification for • For Grants Budget Management, 21), Food and Drug Administration, the lack of progress. contact: 5600 Fishers Lane (for express delivery,

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5630 Fishers Lane, rm. 1093), Rockville, conduct a lottery to determine the DEPARTMENT OF HEALTH AND MD 20857, 301–827–7001, FAX: 301– speakers for the scheduled open public HUMAN SERVICES 827–6776, e-mail: hearing session. The contact person will [email protected], or FDA notify interested persons regarding their Centers for Medicare & Medicaid Advisory Committee Information Line, request to speak by April 8, 2010. Services 1–800–741–8138 (301–443–0572 in the Persons attending FDA’s advisory [CMS–2312–N] Washington, DC area), code committee meetings are advised that the 3014512530. Please call the Information DEPARTMENT OF LABOR Line for up-to-date information on this agency is not responsible for providing access to electrical outlets. meeting. A notice in the Federal Employee Benefits Security Register about last minute modifications FDA welcomes the attendance of the Administration that impact a previously announced public at its advisory committee advisory committee meeting cannot meetings and will make every effort to Medicaid and CHIP Programs; Meeting always be published quickly enough to accommodate persons with physical of the CHIP Working Group—April 26, provide timely notice. Therefore, you disabilities or special needs. If you 2010 should always check the agency’s Web require special accommodations due to site and call the appropriate advisory a disability, please contact Minh Doan AGENCIES: Centers for Medicare & committee hot line/phone line to learn at least 7 days in advance of the Medicaid Services (CMS), Department about possible modifications before meeting. of Health and Human Services (DHHS); coming to the meeting. Employee Benefits Security Agenda: On April 29, 2010, the FDA is committed to the orderly Administration (EBSA), Department of committee will discuss the efficacy and conduct of its advisory committee Labor (DOL). safety of new drug application (NDA) meetings. Please visit our Web site at ACTION: Notice. 21–242, artesunate rectal suppositories, http://www.fda.gov/Advisory submitted by the World Health Committees/AboutAdvisoryCommittees/ SUMMARY: This notice announces the Organization, for the proposed use as a ucm111462.htm for procedures on first meeting of the Medicaid, Children’s single dose for the initial treatment of public conduct during advisory Health Insurance Program (‘‘CHIP’’), and patients with acute malaria who cannot committee meetings. Employer-Sponsored Coverage take medication by mouth and for Notice of this meeting is given under Coordination Working Group (referred whom injectable treatment is not the Federal Advisory Committee Act (5 to as the ‘‘CHIP Working Group’’). The available. U.S.C. app. 2). CHIP Working Group will meet to FDA intends to make background address objectives specified under material available to the public no later Dated: March 25, 2010. section 311(b)(1)(C) of the Children’s than 2 business days before the meeting. Jill Hartzler Warner, Health Insurance Program If FDA is unable to post the background Acting Associate Commissioner for Special Reauthorization Act of 2009. This material on its Web site prior to the Medical Programs. meeting is open to the public. meeting, the background material will [FR Doc. 2010–7113 Filed 3–30–10; 8:45 am] DATES: Meeting Date: Monday, April 26, be made publicly available at the BILLING CODE 4160–01–S 2010 from 9 a.m. to 5 p.m., Eastern location of the advisory committee Standard Time (E.S.T.). meeting, and the background material Deadline for Registration without Oral will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND Presentation: April 21, 2010, 12 p.m., the meeting. Background material is HUMAN SERVICES E.S.T. available at http://www.fda.gov/ Deadline for Registration of Oral AdvisoryCommittees/Calendar/ Agency for Healthcare Research and Presentations: April 12, 2010 12 p.m., default.htm. Scroll down to the Quality E.S.T. appropriate advisory committee link. Deadline for Submission of Oral Procedure: Interested persons may Notice Of Amendment—OS ARRA Remarks and Written Comments: April present data, information, or views, Expansion of Research Capabilities To 12, 2010 12 p.m., E.S.T. orally or in writing, on issues pending Study CE Complex Patients (R24) SEP Deadline for Requesting Special before the committee. Written Meeting Accommodations: April 12, 2010 12 submissions may be made to the contact p.m., E.S.T. person on or before April 15, 2010. Oral With this correction notice, the ADDRESSES: Meeting Location: The presentations from the public will be Agency for Healthcare Research and scheduled between approximately 1 meeting will be held at the Omni Quality (AHRQ) informs the public of p.m. to 2 p.m. Those desiring to make Shoreham, 2500 Calvert Street, NW. at an amendment made to the notice formal oral presentations should notify Connecticut Avenue in Washington, DC subject mentioned above published on the contact person and submit a brief 20008. statement of the general nature of the March 18, 2010 Vol. 75, No. 52, Second Submission of Testimony: evidence or arguments they wish to paragraph of pages 13 135–13136. Testimonies should be mailed to Stacey present, the names and addresses of The revised should read: ‘‘DATE: Green, Designated Federal Official proposed participants, and an April 15–16, 2010 (Open on April 15 (DFO), Centers for Medicare & Medicaid indication of the approximate time from 8 a.m. to 8:15 am. and closed for Services, 7500 Security Boulevard, Mail requested to make their presentation on the remainder of the meeting)’’. stop C2–04–04, Baltimore, MD 21244– 1850, or contact the DFO via e-mail at or before April 7, 2010. Time allotted for Dated: March 19, 2010. each presentation may be limited. If the [email protected]. Carolyn M. Clancy, number of registrants requesting to FOR FURTHER INFORMATION CONTACT: speak is greater than can be reasonably Director. Stacey Green, DFO, Centers for accommodated during the scheduled [FR Doc. 2010–6784 Filed 3–30–10; 8:45 am] Medicare & Medicaid Services, DHHS at open public hearing session, FDA may BILLING CODE 4160–90–M (410) 786–6102, or Amy Turner,

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Employee Benefits Security Services (DHHS); State directors of the health plans and title XIX and XXI State Administration, DOL at (202) 693–8335. Medicaid Program under title XIX of the plans. News media representatives must Act; State directors of the State • An opportunity for public comment contact the CMS Press Office, (202) 690– Children’s Health Insurance Program and testimony. 6145. Please refer to the Internet at under title XXI of the Act; employers, http://www.cms.hhs.gov/FACA, or including owners of small businesses For additional information and http://www.dol.gov/ebsa/CHIP.html for and their trade or industry clarification on these topics, contact the additional information and updates on representatives and certified human DFO as provided in the FOR FURTHER committee activities. resource and payroll professionals; plan INFORMATION CONTACT section of this SUPPLEMENTARY INFORMATION: administrators and plan sponsors of notice. Individual or organizational group health plans as defined in section stakeholders that represent the focus I. Background 607(1) of the Employee Retirement area of the CHIP Working Group In accordance with section 10(a) of Income Security Act of 1974, as wishing to present a 5–minute oral the Federal Advisory Committee Act amended; health insurance issuers; and testimony on agenda issues must (FACA), this notice announces the first representatives of children and other register with the DFO by the date listed meeting of the Medicaid, CHIP, and beneficiaries of medical assistance in the DATES section of this notice. Employer-Sponsored Coverage under title XIX of the Act or child Testimony is limited to agenda topics Coordination Working Group (‘‘CHIP health assistance or other health only. The number of oral testimonies Working Group’’). The Secretary of benefits coverage under title XXI of the may be limited by the time available. A Health and Human Services and the Act. Members serve for the duration of written copy of the presenter’s oral Secretary of Labor are required under the committee. remarks must be submitted to the DFO section 311(b)(1)(C) of the Children’s The current members are: for distribution to CHIP Working Group Health Insurance Program • Department of Labor: Phyllis Borzi; members for review before the meeting Reauthorization Act (CHIPRA) of 2009 • Department of HHS: Victoria by the date listed in the DATES section (Pub. L. 111–3), enacted February 4, Wachino; of this notice. Individual and 2009, to jointly establish a CHIP • State Representatives, including organizational stakeholders not Working Group. The membership of the Medicaid and CHIP Directors: Mari scheduled to speak may also submit group is based on nominations Spaulding-Bynon, Rhonda Medows, written comments to the DFO for submitted in response to a Federal Howard ‘‘Rocky’’ King, Ann Clemency distribution by the date listed in the Register solicitation notice published on Kohler; Janet Olszewski, Linda DATES section of this notice. May 1, 2009 (74 FR 20323). The CHIP Sheppard, and Anita Smith; Working Group will meet two times to • Employers, Plan Sponsors, and Plan III. Meeting Registration and Security develop a model coverage coordination Administrators: Emma Bennett- Information disclosure form for group health plan Williams, Barbara Caress, Roberta The meeting is open to the public, but administrators to send to States upon Casper Watson, Greta Cowart, Kaye attendance is limited to the space request regarding benefits available Pestaina, and Mark Stember; available. Persons wishing to attend this under the plan. This notice will enable • Health Insurance Issuers: Terry meeting must register by contacting the States to determine the availability and Bayer, Ellyn Fuchsteiner, and Kevin cost-effectiveness of providing premium Hayden; and DFO at the address listed in the assistance to individuals eligible for • Representatives of Children and ADDRESSES section of this notice or by benefits under titles XIX or XXI of the Other Beneficiaries of Medical telephone at the number listed in the Social Security Act (the Act) to enable Assistance: Joan Alker, George Askew, FOR FURTHER INFORMATION CONTACT them to enroll in group health plans. Miguel Carranza, and Karen Pollitz. section of this notice by the date The CHIP Working Group will identify specified in the DATES section of this and report on the impediments to the II. Meeting Format and Agenda notice. effective coordination of coverage The meeting will commence with Individuals requiring sign language available to families that include welcoming remarks for the CHIP interpretation or other special employees of employers that maintain Working Group by Departmental accommodations must contact the DFO group health plans and members who representatives. In addition, the agenda via the contact information specified in are eligible for medical assistance under will focus on the following: the FOR FURTHER INFORMATION CONTACT title XIX of the Act or child health • Opening statements from the Co- section of this notice by the date listed assistance or other health benefits Chairs, as well as introductions and in the DATES section of this notice. coverage under title XXI of the Act. remarks by other CHIP Working Group Not later than August 5, 2010, the members; Authority: Section 1868 of the Social CHIP Working Group must submit to the • Swearing in of members; Security Act (42 U.S.C. 1395ee) and section Secretary of Labor and the Secretary of • An overview of FACA 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, Health and Human Services the model requirements; section 10(a)). coverage coordination disclosure form • An overview by DOL and HHS staff Dated: March 25, 2010. and the report containing of the deliverables that the CHIP Charlene Frizzera, recommendations for appropriate Working Group is responsible for under Acting Administrator, Centers for Medicare measures for addressing the CHIPRA: & Medicaid Services. impediments to the effective + A model coverage coordination Dated: March 23, 2010. coordination of coverage. disclosure form for plan administrators The CHIP Working Group consists of of group health plans. Michael L. Davis, 22 individuals, including 2 Co-Chairs. + A report containing Deputy Assistant Secretary, Employee Members of the CHIP Working Group recommendations for appropriate Benefits Security Administration, Department are composed of representatives of the measures for addressing the of Labor. Department of Labor (DOL); the impediments to the effective [FR Doc. 2010–7225 Filed 3–29–10; 8:45 am] Department of Health and Human coordination of coverage between group BILLING CODE 4120–01–P; 4510–29–P

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DEPARTMENT OF HEALTH AND meeting, the background material will DEPARTMENT OF HEALTH AND HUMAN SERVICES be made publicly available at the HUMAN SERVICES location of the advisory committee Food and Drug Administration meeting, and the background material National Institutes of Health [Docket No. FDA–2010–N–0001] will be posted on FDA’s Web site after the meeting. Background material is Eunice Kennedy Shriver National Antiviral Drugs Advisory Committee; available at http://www.fda.gov/ Institute of Child Health & Human Notice of Meeting AdvisoryCommittees/Calendar/ Development; Notice of Meeting default.htm. Scroll down to the AGENCY: Food and Drug Administration, appropriate advisory committee link. Pursuant to section 10(a) of the HHS. Procedure: Interested persons may Federal Advisory Committee Act, as ACTION: Notice. present data, information, or views, amended (5 U.S.C. App.), notice is orally or in writing, on issues pending hereby given of a meeting of the This notice announces a forthcoming Scientific Management Review Board. meeting of a public advisory committee before the committee. Written The meeting will be open to the of the Food and Drug Administration submissions may be made to the contact public, with attendance limited to space (FDA). The meeting will be open to the person on or before May 18, 2010. Oral available. Registration is required since public. presentations from the public will be space is limited. Please visit the Name of Committee: Antiviral Drugs scheduled between approximately 1 conference Web site for information on Advisory Committee. p.m. and 2 p.m. Those desiring to make General Function of the Committee: formal oral presentations should notify meeting logistics and to register for the To provide advice and the contact person and submit a brief meeting http:// recommendations to the agency on statement of the general nature of the www.circlesolutions.com/ncs/ncsac/ FDA’s regulatory issues. evidence or arguments they wish to index.cfm. Individuals who plan to Date and Time: The meeting will be present, the names and addresses of attend and need special assistance, such held on June 2, 2010, from 8 a.m. to 5 proposed participants, and an as sign language interpretation or other p.m. indication of the approximate time reasonable accommodations, should Location: Hilton Washington DC/ requested to make their presentation on notify the Contact Person listed below Silver Spring, The Ballrooms, 8727 or before May 10, 2010. Time allotted in advance of the meeting. Colesville Rd., Silver Spring, MD. The for each presentation may be limited. If Name of Committee: National Children’s hotel phone number is 301–589–5200. the number of registrants requesting to Study Advisory Committee. Contact Person: Paul Tran, Center for speak is greater than can be reasonably Date: April 27, 2010. Drug Evaluation and Research (HFD– accommodated during the scheduled Time: 9 a.m.to 12 p.m. 21), Food and Drug Administration, open public hearing session, FDA may Agenda: The agenda will include an 5600 Fishers Lane (for express delivery, conduct a lottery to determine the update on the current status of the Study, a 5630 Fishers Lane, rm. 1093), Rockville, speakers for the scheduled open public legislative update, and a discussion MD 20857, 301–827–7001, FAX: 301– hearing session. The contact person will pertaining to the National Children’s Study 827–6776, e-mail: notify interested persons regarding their Communications Plan. [email protected], or FDA request to speak by May 11, 2010. Place: Fishers Lane Conference Center, 5635 Fishers Lane, Rockville, MD 20852. Persons attending FDA’s advisory Advisory Committee Information Line, Contact Person: Jessica E. DiBari, MHS, 1–800–741–8138 (301–443–0572 in the committee meetings are advised that the Executive Secretary, National Children’s Washington, DC area), code agency is not responsible for providing Study, Eunice Kennedy Shriver National 3014512531. Please call the Information access to electrical outlets. Institute of Child Health and Human Line for up-to-date information on this FDA welcomes the attendance of the Development, NIH, 6100 Executive Blvd., meeting. A notice in the Federal public at its advisory committee Room 3A01, Bethesda, MD 20892, (301) 451– Register about last minute modifications meetings and will make every effort to 2135. that impact a previously announced accommodate persons with physical Any interested person may file written advisory committee meeting cannot disabilities or special needs. If you comments with the committee by forwarding always be published quickly enough to require special accommodations due to the statement to the Contact Person listed on provide timely notice. Therefore, you a disability, please contact Paul Tran at this notice. The statement should include the should always check the agency’s Web least 7 days in advance of the meeting. name, address, telephone number and when applicable, the business or professional site and call the appropriate advisory FDA is committed to the orderly affiliation of the interested person. For committee hot line/phone line to learn conduct of its advisory committee about possible modifications before additional information about the Federal meetings. Please visit our Web site at Advisory Committee meeting, please contact coming to the meeting. http://www.fda.gov/Advisory Circle Solutions at [email protected]. Agenda: On June 2, 2010, the Committees/AboutAdvisoryCommittees/ (Catalogue of Federal Domestic Assistance committee will discuss biologics license ucm111462.htm for procedures on application (BLA) 125283, Program Nos. 93.864, Population Research; public conduct during advisory 93.865, Research for Mothers and Children; motavizumab, MedImmune, LLC, committee meetings. 93.929, Center for Medical Rehabilitation proposing an indication for the Notice of this meeting is given under Research; 93.209, Contraception and prevention of serious lower respiratory the Federal Advisory Committee Act (5 Infertility Loan Repayment Program, National tract disease caused by respiratory U.S.C. app. 2). Institutes of Health, HHS) syncytial virus (RSV) in children at high risk of RSV disease. Dated: March 23, 2010. Dated: March 24, 2010. FDA intends to make background Jill Hartzler Warner, Jennifer Spaeth, material available to the public no later Acting Associate Commissioner for Special Director, Office of Federal Advisory than 2 business days before the meeting. Medical Programs. Committee Policy. If FDA is unable to post the background [FR Doc. 2010–7114 Filed 3–30–10; 8:45 am] [FR Doc. 2010–7187 Filed 3–30–10; 8:45 am] material on its Web site prior to the BILLING CODE 4160–01–S BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND Institute, 6701 Rockledge Drive, Room 7180, Activities, National Heart, Lung, and Blood HUMAN SERVICES Bethesda, MD 20892–7924. 301–435–0725. Institute, National Institutes of Health, 6701 [email protected]. Rockledge Drive, Room 7100, Bethesda, MD National Institutes of Health (Catalogue of Federal Domestic Assistance 20892. (301) 435–0260. Program Nos. 93.233, National Center for [email protected]. National Heart, Lung, and Blood Sleep Disorders Research; 93.837, Heart and Any interested person may file written Institute; Notice of Closed Meetings Vascular Diseases Research; 93.838, Lung comments with the committee by forwarding Diseases Research; 93.839, Blood Diseases the statement to the Contact Person listed on Pursuant to section 10(d) of the and Resources Research, National Institutes this notice. The statement should include the Federal Advisory Committee Act, as of Health, HHS) name, address, telephone number and when amended (5 U.S.C. App.), notice is Dated: March 25, 2010. applicable, the business or professional affiliation of the interested person. hereby given of the following meetings. Jennifer Spaeth, The meetings will be closed to the In the interest of security, NIH has Director, Office of Federal Advisory instituted stringent procedures for entrance public in accordance with the Committee Policy. provisions set forth in sections onto the NIH campus. All visitor vehicles, [FR Doc. 2010–7184 Filed 3–30–10; 8:45 am] including taxicabs, hotel, and airport shuttles 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P will be inspected before being allowed on as amended. The contract proposals and campus. Visitors will be asked to show one the discussions could disclose form of identification (for example, a confidential trade secrets or commercial DEPARTMENT OF HEALTH AND government-issued photo ID, driver’s license, property such as patentable material, HUMAN SERVICES or passport) and to state the purpose of their and personal information concerning visit. individuals associated with the contract National Institutes of Health Information is also available on the proposals, the disclosure of which Institute’s/Center’s home page: http:// would constitute a clearly unwarranted National Heart, Lung, and Blood www.nhlbi.nih.gov/meetings/index.htm, invasion of personal privacy. Institute; Notice of Meeting where an agenda and any additional information for the meeting will be posted Name of Committee: National Heart, Lung, Pursuant to section 10(d) of the when available. and Blood Institute Special Emphasis Panel, Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance Loan Repayment Program (L30’s). amended (5 U.S.C. App.), notice is Program Nos. 93.233, National Center for Date: April 28, 2010. hereby given of a meeting of the Sleep Disorders Research; 93.837, Heart and Time: 8 a.m. to 5 p.m. National Heart, Lung, and Blood Vascular Diseases Research; 93.838, Lung Agenda: To review and evaluate contract Diseases Research; 93.839, Blood Diseases proposals. Advisory Council. and Resources Research, National Institutes Place: National Institute of Health, The meeting will be open to the of Health, HHS) Bethesda, MD 20892 (Telephone Conference public as indicated below, with Call). attendance limited to space available. Dated: March 25, 2010. Contact Person: Robert Blaine Moore, Individuals who plan to attend and Jennifer Spaeth, Ph.D., Scientific Review Officer, Review need special assistance, such as sign Director, Office of Federal Advisory Branch/DERA, National Heart, Lung, and language interpretation or other Committee Policy. Blood Institute, 6701 Rockledge Drive, Room reasonable accommodations, should 7213, Bethesda, MD 20892. 301–594–8394. [FR Doc. 2010–7181 Filed 3–30–10; 8:45 am] [email protected]. notify the Contact Person listed below BILLING CODE 4140–01–P in advance of the meeting. Name of Committee: National Heart, Lung, The meeting will be closed to the and Blood Institute Special Emphasis Panel, Echocardiography Reading Center for public in accordance with the DEPARTMENT OF HEALTH AND Atherosclerosis Risk in Communities Study. provisions set forth in sections HUMAN SERVICES Date: April 29, 2010. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8 a.m. to 1 p.m. as amended. The grant applications and National Institutes of Health Agenda: To review and evaluate contract the discussions could disclose proposals. confidential trade secrets or commercial Center for Scientific Review; Amended Place: Hyatt Regency Bethesda, One property such as patentable material, Notice of Meeting Bethesda Metro Center, 7400 Wisconsin and personal information concerning Avenue, Bethesda, MD 20814. individuals associated with the grant Notice is hereby given of a change in Contact Person: Tony L Creazzo, Ph.D., the meeting of the Center for Scientific Scientific Review Officer, Review Branch/ applications, the disclosure of which would constitute a clearly unwarranted Review Special Emphasis Panel, April DERA, National Heart, Lung, and Blood 7, 2010, 8 a.m. to April 8, 2010, 5 p.m., Institute, 6701 Rockledge Drive, Room 7180, invasion of personal privacy. Bethesda, MD 20892–7924. 301–435–0725. National Institutes of Health, 6701 Name of Committee: National Heart, Lung, Rockledge Drive, Bethesda, MD 20892 [email protected]. and Blood Advisory Council. Name of Committee: National Heart, Lung, Date: May 26, 2010. which was published in the Federal and Blood Institute Special Emphasis Panel, Open: 8 a.m. to 12 p.m. Register on March 17, 2010, 75 FR Cardiovascular Outcomes Research Center for Agenda: To discuss program policies and 12766. the Atherosclerosis Risk in Communities issues. The meeting will be held April 14, Study. Place: National Institutes of Health, 2010 to April 15, 2010. The meeting Date: April 29, 2010. Building 31, 31 Center Drive, Conference time and location remain the same. The Time: 1:30 p.m. to 4 p.m. Room 10, Bethesda, MD 20892. Agenda: To review and evaluate contract Closed: 1 p.m. to 5 p.m. meeting is closed to the public. proposals. Agenda: To review and evaluate grant Dated: March 24, 2010. Place: Hyatt Regency Bethesda, One applications. Jennifer Spaeth, Bethesda Metro Center, 7400 Wisconsin Place: National Institutes of Health, Director, Office of Federal Advisory Avenue, Bethesda, MD 20814. Building 31, 31 Center Drive, Conference Committee Policy. Contact Person: Tony L Creazzo, Ph.D., Room 10, Bethesda, MD 20892. Scientific Review Officer, Review Branch/ Contact Person: Stephen C. Mockrin, Ph.D., [FR Doc. 2010–7180 Filed 3–30–10; 8:45 am] DERA, National Heart, Lung, and Blood Director, Division of Extramural Research BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND of Scientific Counselors, National Environmental Response, HUMAN SERVICES Institute of Neurological Disorders and Compensation, and Liability Act of 1980 Stroke. The meeting will be closed to (CERCLA) Set 24 toxicological profile National Institutes of Health the public as indicated below in development. ATSDR’s Division of accordance with the provisions set forth Toxicology and Environmental National Cancer Institute; Notice of in section 552b(c)(6), Title 5 U.S.C., as Medicine is soliciting public comments Closed Meeting amended for the review, discussion, and on the list of proposed substances to be Pursuant to section 10(d) of the evaluation of individual intramural evaluated for toxicological profile Federal Advisory Committee Act, as programs and projects conducted by the development. ATSDR also will consider amended (5 U.S.C. App.), notice is National Institute of Neurological the nomination of any additional, hereby given of the following meeting. Disorders and Stroke, including substances, not on this list, that may The meeting will be closed to the consideration of personnel have public health implications. public in accordance with the qualifications and performance, and the DATES: Nominations must be submitted provisions set forth in sections competence of individual investigators, within 30 days of the publication of this 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the disclosure of which would notice. as amended. The grant applications and constitute a clearly unwarranted the discussions could disclose invasion of personal privacy. ADDRESSES: Nominations may be confidential trade secrets or commercial Name of Committee: Board of Scientific submitted electronically. Refer to the property such as patentable material, Counselors, National Institute of section Submission of Nominations and personal information concerning Neurological Disorders and Stroke. (following) for the specific address. individuals associated with the grant Date: June 13–14, 2010. FOR FURTHER INFORMATION CONTACT: applications, the disclosure of which Time: 7 a.m. to 6 p.m. For would constitute a clearly unwarranted Agenda: To review and evaluate personal further information, contact: invasion of personal privacy. qualifications and performance, and Commander Jessilynn B. Taylor, competence of individual investigators. Division of Toxicology and Name of Committee: National Cancer Place: Hyatt Regency Bethesda, One Environmental Medicine, Agency for Institute Special Emphasis Panel; Cancer Bethesda Metro Center, 7400 Wisconsin Toxic Substances and Disease Registry, Immunotherapy Trials Network. Avenue, Diplomat/Ambassador Room, 1600 Clifton Road, F–62, Atlanta, GA, Date: June 7, 2010. Bethesda, MD 20814. Time: 8 a.m. to 5 p.m. Contact Person: Alan P. Koretsky, PhD, 30333; telephone: (770) 488–3313; or e- Agenda: To review and evaluate grant Scientific Director, Division of Intramural mail: [email protected]. applications. Research, National Institute of Neurological Place: Gaithersburg Hilton, 620 Perry SUPPLEMENTARY INFORMATION: The Disorders & Stroke, NIH, 35 Convent Drive, Superfund Amendments and Parkway, Gaithersburg, MD 20877. Room 6A 908, Bethesda, MD 20892. 301– Contact Person: Kenneth L. Bielat, Ph.D., 435–2232. [email protected]. Reauthorization Act of 1986 (SARA) [42 Scientific Review Officer, Special Review U.S.C. 9601 et seq.] amended the (Catalogue of Federal Domestic Assistance and Logistics Branch, Division of Extramural CERCLA (or Superfund) [42 U.S.C. 9601 Activities, National Cancer Institute, 6116 Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, et seq.] by establishing certain Executive Boulevard, Room 7147, Bethesda, requirements for ATSDR and the U.S. MD 20892–8329, 301–496–7576, Biological Basis Research in the [email protected]. Neurosciences, National Institutes of Health, Environmental Protection Agency (EPA) HHS) with regard to hazardous substances (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; Dated: March 24, 2010. most commonly found at facilities on 93.393, Cancer Cause and Prevention Jennifer Spaeth, the CERCLA NPL. Among these statutory requirements is a mandate for Research; 93.394, Cancer Detection and Director, Office of Federal Advisory Diagnosis Research; 93.395, Cancer Committee Policy. the Administrator of ATSDR to prepare Treatment Research; 93.396, Cancer Biology toxicological profiles for each substance [FR Doc. 2010–7088 Filed 3–30–10; 8:45 am] Research; 93.397, Cancer Centers Support; included on the Priority List of 93.398, Cancer Research Manpower; 93.399, BILLING CODE 4140–01–P Hazardous Substances. This identifies Cancer Control, National Institutes of Health, 275 hazardous substances that ATSDR HHS) and EPA have determined pose the most Dated: March 24, 2010. DEPARTMENT OF HEALTH AND HUMAN SERVICES significant potential threat to human Jennifer Spaeth, health (http://www.atsdr.cdc.gov/cercla/ Director, Office of Federal Advisory Agency for Toxic Substances and 07list.html). The availability of the Committee Policy. Disease Registry revised list of the 275 priority [FR Doc. 2010–7178 Filed 3–30–10; 8:45 am] substances was announced in the [ATSDR–259] BILLING CODE 4140–01–P Federal Register on March 6, 2008 (73 Proposed Substances To Be Evaluated FR 12178). For prior versions of the list for Set 24 Toxicological Profiles of substances, see Federal Register DEPARTMENT OF HEALTH AND notices dated April 17, 1987 (52 FR HUMAN SERVICES AGENCY: Agency for Toxic Substances 12866); October 20, 1988 (53 FR 41280); and Disease Registry (ATSDR), October 26, 1989 (54 FR 43619); October National Institutes of Health Department of Health and Human 17, 1990 (55 FR 42067); October 17, National Institute of Neurological Services (HHS). 1991 (56 FR 52166); October 28, 1992 Disorders and Stroke; Notice of Closed ACTION: Request for comments on the (57 FR 48801); February 28, 1994 (59 FR Meeting proposed substances to be evaluated for 9486); April 29, 1996 (61 FR 18744; Set 24 toxicological profiles. November 17, 1997 (62 FR 61332); Pursuant to section 10(d) of the October 21, 1999 (64 FR 56792); October Federal Advisory Committee Act, as SUMMARY: This notice announces the list 25, 2001 (66 FR 54014); and November amended (5 U.S.C. App.), notice is of proposed substances that will be 7, 2003 (68 FR 63098), December 7, hereby given of a meeting of the Board evaluated for Comprehensive 2005 (70 FR 72840).

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Proposed Substances To Be Evaluated toxicological profile development. This public health concern. The following for Set 24 Toxicological Profiles list is compiled from ATSDR’s Priority list of 240 proposed substances will be Each year, ATSDR develops a list of List of Hazardous Substances and from considered for Set 24 Toxicological substances to be considered for previously nominated substances of Profile development.

Substances CAS Nos.

1 ...... METHANE ...... 000074–82–8 2 ...... BROMODICHLOROETHANE ...... 000683–53–4 3 ...... 1,2,3–TRICHLOROBENZENE ...... 000087–61–6 4 ...... POLONIUM–210 ...... 013981–52–7 5 ...... LEAD–210 ...... 014255–04–0 6 ...... NEPTUNIUM–237 ...... 013994–20–2 7 ...... S,S,S–TRIBUTYL PHOSPHOROTRITHIOATE ...... 000078–48–8 8 ...... BROMINE ...... 007726–95–6 9 ...... DICOLFOL ...... 000115–32–2 10 ...... PARATHIION ...... 000056–38–2 11 ...... TRICHLOROFLUOROETHANE ...... 027154–33–2 12 ...... TRIFLURALIN ...... 000152–09–8 13 ...... PENTACHLOROBENZENE ...... 000608–93–5 14 ...... TRICHLOROETHANE ...... 025323–89–1 15 ...... PALLADIUM ...... 007440–05–3 16 ...... DIBENZOFURAN ...... 000132–64–9 17 ...... 2,4-DIMETHYLPHENOL ...... 000105–67–9 18 ...... TETRACHLOROETHANE ...... 025322–20–7 19 ...... BIS(2-METHOXYETHYL)PHTHALATE ...... 034006–76–3 20 ...... BUTYL BENZYL PHTHALATE ...... 000085–68–7 21 ...... 1,2,4-TRICHLOROBENZENE ...... 000120–82–1 22 ...... NITRITE ...... 014797–65–0 23 ...... NITRATE ...... 014797–55–8 24 ...... POTASSIUM–40 ...... 013966–00–2 25 ...... THORIUM–227 ...... 015623–47–9 26 ...... PHORATE ...... 000298–02–2 27 ...... DIMETHOATE ...... 000060–51–5 28 ...... ACTINIUM–227 ...... 014952–40–0 29 ...... STROBANE ...... 008001–50–1 30 ...... 4–AMINOBIPHENYL ...... 000092-67–1 31 ...... ARSINE ...... 007784–42–1 32 ...... NALED ...... 000300–76–5 33 ...... ETHOPROP ...... 013194–48–4 34 ...... CARBOPHENOTHION ...... 000786–19–6 35 ...... 2,4–D ACID ...... 000094–75–7 36 ...... DIURON ...... 000330–54–1 37 ...... BUTYLATE ...... 002008–41–5 38 ...... DIMETHYL FORMAMIDE ...... 000068–12–2 39 ...... DICHLOROBENZENE ...... 025321–22–6 40 ...... ETHYL ETHER ...... 000060–29–7 41 ...... DICHLOROETHANE ...... 001300–21–6 42 ...... PHOSPHINE ...... 007803–51–2 43 ...... TRICHLOROBENZENE ...... 012002–48–1 44 ...... PENTAERYTHRITOL TETRANITRATE ...... 000078–11–5 45 ...... BIS(2-ETHYLHEXYL)ADIPATE ...... 000103–23–1 46 ...... CARBAZOLE ...... 000086–74–8 47 ...... METHYL ISOBUTYL KETONE ...... 000108–10–1 48 ...... CARBARYL ...... 000063–25–2 49 ...... MERCURY ...... 007439–97–6 50 ...... METHYLMERCURY ...... 022967–92–6 51 ...... MERCURIC CHLORIDE ...... 007487–94–7 52 ...... POLYCHLORINATED BIPHENYLS ...... 001336–36–3 53 ...... AROCLOR 1254 ...... 011097–69–1 54 ...... AROCLOR 1260 ...... 011096–82–5 55 ...... AROCLOR 1248 ...... 012672–29–6 56 ...... AROCLOR 1242 ...... 053469–21–9 57 ...... AROCLOR ...... 012767–79–2 58 ...... AROCLOR 1221 ...... 011104–28–2 59 ...... AROCLOR 1016 ...... 012674–11–2 60 ...... AROCLOR 1232 ...... 011141–16–5 61 ...... AROCLOR 1240 ...... 071328–89–7 62 ...... TETRACHLOROBIPHENYL ...... 026914–33–0 63 ...... POLYCYCLIC AROMATIC HYDROCARBONS ...... 130498–29–2 64 ...... BENZO(A)PYRENE ...... 000050–32–8 65 ...... BENZO(B)FLUORANTHENE ...... 000205–99–2 66 ...... DIBENZO(A,H)ANTHRACENE ...... 000053–70–3 67 ...... BENZO(A)ANTHRACENE ...... 000056–55–3 68 ...... BENZO(K)FLUORANTHENE ...... 000207–08–9

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Substances CAS Nos.

69 ...... BENZOFLUORANTHENE ...... 056832–73–6 70 ...... FLUORANTHENE ...... 000206–44–0 71 ...... CHRYSENE ...... 000218–01–9 72 ...... ACENAPHTHENE ...... 000083–32–9 73 ...... INDENO(1,2,3–CD)PYRENE ...... 000193–39–5 74 ...... BENZOPYRENE ...... 073467–76–2 75 ...... PHENANTHRENE ...... 000085–01–8 76 ...... PYRENE ...... 000129–00–0 77 ...... FLUORENE ...... 000086–73–7 78 ...... ANTHRACENE ...... 000120–12–7 79 ...... BENZO(A)FLUORANTHENE ...... 000203–33–8 80 ...... BENZO(GHI)PERYLENE ...... 000191–24–2 81 ...... ACENAPHTHYLENE ...... 000208–96–8 82 ...... BENZO(J)FLUORANTHENE ...... 000205–82–3 83 ...... BENZO(E)PYRENE ...... 000192–97–2 84 ...... BENZOPERYLENE ...... 011057–45–7 85 ...... BENZO(B)ANTHRACENE ...... 000092–24–0 86 ...... DIBENZ(A,J)ANTHRACENE ...... 000224–41–9 87 ...... BENZO(GHI)FLUORANTHENE ...... 000203–12–3 88 ...... 1–METHYLPYRENE ...... 002381–21–7 89 ...... CHLOROFORM ...... 000067–66–3 90 ...... DDT, P,P′- ...... 000050–29–3 91 ...... DDE, P,P′- ...... 000072–55–9 92 ...... DDD, P,P′- ...... 000072–54–8 93 ...... DDT, O,P′- ...... 000789–02–6 94 ...... DDD, O,P′- ...... 000053–19–0 95 ...... DDE, O,P′- ...... 003424–82–6 96 ...... TRICHLOROETHYLENE ...... 000079–01–6 97 ...... DIELDRIN ...... 000060–57–1 98 ...... ALDRIN ...... 000309–00–2 99 ...... CHLORDANE ...... 000057–74–9 100 ...... CIS–CHLORDANE ...... 005103–71–9 101 ...... TRANS–CHLORDANE ...... 005103–74–2 102 ...... OXYCHLORDANE ...... 027304–13–8 103 ...... GAMMA–CHLORDENE ...... 056641–38–4 104 ...... CHLORDANE, TECHNICAL ...... 012789–03–6 105 ...... ALPHA–CHLORDENE ...... 056534–02–2 106 ...... NONACHLOR, TRANS- ...... 039765–80–5 107 ...... NONACHLOR, CIS- ...... 005103–73–1 108 ...... CHLORDENE ...... 003734–48–3 109 ...... HEXACHLOROBUTADIENE ...... 000087–68–3 110 ...... COAL TAR CREOSOTE ...... 008001–58–9 111 ...... COAL TARS ...... 008007–45–2 112 ...... DDD, P,P′- ...... 000072–54–8 113 ...... COAL TAR PITCH ...... 065996–93–2 114 ...... BENZIDINE ...... 000092–87–5 115 ...... TOXAPHENE ...... 008001–35–2 116 ...... TETRACHLOROETHYLENE ...... 000127–18–4 117 ...... 1,2–DIBROMOETHANE ...... 000106–93–4 118 ...... DISULFOTON ...... 000298–04–4 119 ...... 3,3′-DICHLOROBENZIDINE ...... 000091–94–1 120 ...... ENDRIN ...... 000072–20–8 121 ...... ENDRIN KETONE ...... 053494–70–5 122 ...... ENDRIN ALDEHYDE ...... 007421–93–4 123 ...... BERYLLIUM ...... 007440–41–7 124 ...... 1,2–DIBROMO–3–CHLOROPROPANE ...... 000096–12–8 125 ...... DIBROMOCHLOROPROPANE ...... 067708–83–2 126 ...... PENTACHLOROPHENOL ...... 000087–86–5 127 ...... DI–N–BUTYL PHTHALATE ...... 000084–74–2 128 ...... ENDOSULFAN ...... 000115–29–7 129 ...... ENDOSULFAN SULFATE ...... 001031–07–8 130 ...... ENDOSULFAN, ALPHA ...... 000959–98–8 131 ...... ENDOSULFAN, BETA ...... 033213–65–9 132 ...... METHOXYCHLOR ...... 000072–43–5 133 ...... METHANE ...... 000074–82–8 134 ...... TOLUENE ...... 000108–88–3 135 ...... 2–HEXANONE ...... 000591–78–6 136 ...... 2,3,7,8–TETRACHLORODIBENZO–P–DIOXIN ...... 001746–01–6 137 ...... HEXACHLORODIBENZO–P–DIOXIN ...... 034465–46–8 138 ...... HEPTACHLORODIBENZO–P–DIOXIN ...... 037871–00–4 139 ...... TETRACHLORODIBENZO–P–DIOXIN ...... 041903–57–5 140 ...... PENTACHLORODIBENZO–P–DIOXIN ...... 036088–22–9 141 ...... 1,2,3,4,6,7,8–HEPTACHLORODIBENZO–P–DIOXIN ...... 035822–46–9 142 ...... OCTACHLORODIBENZO–P–DIOXIN ...... 003268–87–9

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Substances CAS Nos.

143 ...... 1,2,3,6,7,8–HEXACHLORODIBENZO–P–DIOXIN ...... 057653–85–7 144 ...... 1,2,3,4,7,8–HEXACHLORODIBENZO–P–DIOXIN ...... 039227–28–6 145 ...... 1,2,3,7,8,9–HEXACHLORODIBENZO–P–DIOXIN ...... 019408–74–3 146 ...... 1,2,3,7,8–PENTACHLORODIBENZO–P–DIOXIN ...... 040321–76–4 147 ...... DI(2–ETHYLHEXYL)PHTHALATE ...... 000117–81–7 148 ...... 1,1–DICHLOROETHENE ...... 000075–35–4 149 ...... METHYLENE CHLORIDE ...... 000075–09–2 150 ...... BROMODICHLOROETHANE ...... 000683–53–4 151 ...... 1,2–DICHLOROETHANE ...... 000107–06–2 152 ...... 2,4,6–TRICHLOROPHENOL ...... 000088–06–2 153 ...... TETRACHLOROPHENOL ...... 025167–83–3 154 ...... 2,4–DICHLOROPHENOL ...... 000120–83–2 155 ...... 2,4,5–TRICHLOROPHENOL ...... 000095–95–4 156 ...... 2–CHLOROPHENOL ...... 000095–57–8 157 ...... 2,3,4,5–TETRACHLOROPHENOL ...... 004901–51–3 158 ...... 2,3,5,6–TETRACHLOROPHENOL ...... 000935–95–5 159 ...... 2,3,4,6–TETRACHLOROPHENOL ...... 000058–90–2 160 ...... 4–CHLOROPHENOL ...... 000106–48–9 161 ...... CHLOROPHENOL ...... 025167–80–0 162 ...... 2,4–DINITROPHENOL ...... 000051–28–5 163 ...... BIS(2–CHLOROETHYL) ETHER ...... 000111–44–4 164 ...... ASBESTOS ...... 001332–21–4 165 ...... CHRYSOTILE ASBESTOS ...... 012001–29–5 166 ...... AMOSITE ASBESTOS ...... 012172–73–5 167 ...... HEXACHLOROBENZENE ...... 000118–74–1 168 ...... 2,4–DINITROTOLUENE ...... 000121–14–2 169 ...... DINITROTOLUENE ...... 025321–14–6 170 ...... 2,6–DINITROTOLUENE ...... 000606–20–2 171 ...... RADIUM–226 ...... 013982–63–3 172 ...... RADIUM ...... 007440–14–4 173 ...... RADIUM–228 ...... 015262–20–1 174 ...... RADIUM–224 ...... 013233–32–4 175 ...... ETHION ...... 000563–12–2 176 ...... THORIUM ...... 007440–29–1 177 ...... THORIUM–230 ...... 014269–63–7 178 ...... THORIUM–228 ...... 014274–82–9 179 ...... 4,6–DINITRO–O–CRESOL ...... 000534–52–1 180 ...... CHLOROBENZENE ...... 000108–90–7 181 ...... N–NITROSODI–N–PROPYLAMINE ...... 000621–64–7 182 ...... 1,2,3–TRICHLOROBENZENE ...... 000087–61–6 183 ...... POLONIUM–210 ...... 013981–52–7 184 ...... CHLORPYRIFOS ...... 002921–88–2 185 ...... NEPTUNIUM–237 ...... 013994–20–2 186 ...... CHLORDECONE ...... 000143–50–0 187 ...... MIREX ...... 002385–85–5 188 ...... S,S,S–TRIBUTYL PHOSPHOROTRITHIOATE ...... 000078–48–8 189 ...... BROMINE ...... 007726–95–6 190 ...... DICOFOL ...... 000115–32–2 191 ...... PARATHION ...... 000056–38–2 192 ...... SELENIUM ...... 007782–49–2 193 ...... TRICHLOROFLUOROETHANE ...... 027154–33–2 194 ...... TRIFLURALIN ...... 001582–09–8 195 ...... 4,4’-METHYLENEBIS(2–CHLOROANILINE) ...... 000101–14–4 196 ...... PENTACHLOROBENZENE ...... 000608–93–5 197 ...... 1,1–DICHLOROETHANE ...... 000075–34–3 198 ...... 1,2,3,4,6,7,8,9–OCTACHLORODIBENZOFURAN ...... 039001–02–0 199 ...... HEPTACHLORODIBENZOFURAN ...... 038998–75–3 200 ...... 2,3,4,7,8–PENTACHLORODIBENZOFURAN ...... 057117–31–4 201 ...... HEXACHLORODIBENZOFURAN ...... 055684–94–1 202 ...... PENTACHLORODIBENZOFURAN ...... 030402–15–4 203 ...... 2,3,7,8–TETRACHLORODIBENZOFURAN ...... 051207–31–9 204 ...... DIBENZOFURANS, CHLORINATED ...... 042934–53–2 205 ...... 1,2,3,4,6,7,8–HEPTACHLORODIBENZOFURAN ...... 067562–39–4 206 ...... 1,2,3,7,8,9–HEXACHLORODIBENZOFURAN ...... 072918–21–9 207 ...... TETRACHLORODIBENZOFURAN ...... 030402–14–3 208 ...... 1,2,3,6,7,8–HEXACHLORODIBENZOFURAN ...... 057117–44–9 209 ...... 1,2,3,4,7,8–HEXACHLORODIBENZOFURAN ...... 070648–26–9 210 ...... 2,3,4,6,7,8–HEXACHLORODIBENZOFURAN ...... 060851–34–5 211 ...... 1,2,3,7,8–PENTACHLORODIBENZOFURAN ...... 057117–41–6 212 ...... 1,2,3,4,7,8,9–HEPTACHLORODIBENZOFURAN ...... 055673–89–7 213 ...... 1,1,2–TRICHLOROETHANE ...... 000079–00–5 214 ...... HEXACHLOROCYCLOPENTADIENE ...... 000077–47–4 215 ...... 1,2–DIPHENYLHYDRAZINE ...... 000122–66–7 216 ...... 1,2–DICHLOROETHENE, TRANS- ...... 000156–60–5

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Substances CAS Nos.

217 ...... 1,2–DICHLOROETHYLENE ...... 000540–59–0 218 ...... 1,2–DICHLOROETHENE, CIS- ...... 000156–59–2 219 ...... CARBON DISULFIDE ...... 000075–15–0 220 ...... PALLADIUM ...... 007440–05–3 221 ...... CHLOROETHANE ...... 000075–00–3 222 ...... ACETONE ...... 000067–64–1 223 ...... DIBENZOFURAN ...... 000132–64–9 224 ...... 2,4–DIMETHYLPHENOL ...... 000105–67–9 225 ...... CHLOROMETHANE ...... 000074–87–3 226 ...... BIS(2–METHOXYETHYL) PHTHALATE ...... 034006–76–3 227 ...... BUTYL BENZYL PHTHALATE ...... 000085–68–7 228 ...... N–NITROSODIMETHYLAMINE ...... 000062–75–9 229 ...... 1,2,4–TRICHLOROBENZENE ...... 000120–82–1 230 ...... N–NITROSODIPHENYLAMINE ...... 000086–30–6 231 ...... 2–BUTANONE ...... 000078–93–3 232 ...... FLUORINE ...... 007782–41–4 233 ...... HYDROGEN FLUORIDE ...... 007664–39–3 234 ...... FLUORIDE ION ...... 016984–48–8 235 ...... AMMONIA ...... 007664–41–7 236 ...... COPPER ...... 065357–62–2 237 ...... CHLORINE DIOXIDE ...... 010049–04–4 238 ...... PBBs ...... 059536–65–1 239 ...... PBDEs ...... 001163–19–5 240 ...... SYNTHETIC VITREOUS FIBERS ...... NONE

Submission of Nominations for the Dated: March 26, 2010. Center, Bethesda, MD 20814; Phone: Evaluation Set 24 Proposed Substances: Ken Rose, 301–657–1234; FAX: 301–657–6453. Today’s notice also invites voluntary Associate Director, Office of Policy, Planning Contact: Wanda Neal, Parenteral Drug public nominations for substances not and Evaluation, National Center for Association, PDA Global Headquarters, listed in this notice. Nominations are Environmental Health/Agency for Toxic Bethesda Towers, 4350 East-West Hwy., most useful if they include the Substances and Disease Registry. Suite 200, Bethesda, MD 20814; Phone: nominator, including full name, title, [FR Doc. 2010–7169 Filed 3–30–10; 8:45 am] 301–656–5900, ext. 149. affiliation, e-mail address, and BILLING CODE 4163–70–P Accommodations: Attendees are telephone number. responsible for their own accommodations. To make reservations ATSDR will evaluate all data and DEPARTMENT OF HEALTH AND at the Hyatt Regency Bethesda, at the information associated with nominated HUMAN SERVICES reduced conference rate, contact the substances and will determine the final Hyatt Regency Bethesda (see Location), list of substances to be chosen for Food and Drug Administration citing meeting code ‘‘PDA.’’ Room Rates toxicological profile development. [Docket No. FDA–2010–N–0001] are: Single: $209, plus 13% state and Substances will be chosen according to local taxes and Double: $234, plus 13% ATSDR’s specific guidelines for Pharmaceutical Supply Chain; Public state and local taxes. Reservations can selection, found in the Selection Criteria Workshop be made on a space and rate availability announced in the Federal Register on basis. AGENCY: Food and Drug Administration, Registration: You are encouraged to May 7, 1993 (87 FR 27288). HHS. Submission of Comments: Submit register at your earliest convenience. ACTION: Notice of public workshop. The PDA registration fees cover the cost comments via e-mail at: of facilities, materials, and breaks. Seats [email protected]. Please SUMMARY: The Food and Drug are limited; please submit your include ‘‘Set 24’’ in the subject line of Administration (FDA) is announcing a public workshop entitled ‘‘2010 PDA/ registration as soon as possible. the e-mail. Or, mail to: Commander Conference space will be filled in order Jessilynn B. Taylor, Division of FDA Pharmaceutical Supply Chain Workshop—Enough Talk: Let’s Find of receipt of registration. Those accepted Toxicology and Environmental in to the conference will receive Medicine, 1600 Clifton Road, MS F–62, and Implement Solutions.’’ The workshop, cosponsored with the confirmation. Registration will close Atlanta, GA 30333; e-mail: after applicable conference is filled. [email protected]. Parenteral Drug Association (PDA), will focus on solutions to reduce the risk to Onsite registration will be available on Please ensure that your comments are product quality in the pharmaceutical a space-available basis on the day of the submitted within the specified supply chain. public conference beginning at 7 a.m. on nomination period. Nominations Date and Time: The conference will Monday, April 26, 2010. The cost of registration is as follows: received after the closing date will be be held on Monday, April 26, 2010, marked as late and may be considered from 8 a.m. to 6 p.m.; Tuesday, April 27, PDA Members $1850 only if time and resources permit. 2010, from 7:15 a.m. to 5:45 p.m.; and PDA Nonmembers $2099 PDA Member Government $530 Wednesday, April 28, 2010, from 7:15 PDA Nonmember Government $530 a.m. to 1:15 p.m. PDA Member Health Authority $700 Location: The public workshop will PDA Nonmember Health Authority $800 be held at the Hyatt Regency Bethesda, PDA Member Academic $700 7400 Wisconsin Ave., 1 Bethesda Metro PDA Nonmember Academic $780

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PDA Member Students $280 Dated: March 25, 2010. proposed collection of information, PDA Nonmember Students $310 Leslie Kux, including the validity of the If you need special accommodations Acting Assistant Commissioner for Policy. methodology and assumptions used; due to a disability, please contact [FR Doc. 2010–7151 Filed 3–30–10; 8:45 am] (3) Enhance the quality, utility, and Wanda Neal, PDA (see Contact) at least BILLING CODE 4160–01–S clarity of the information to be 7 days in advance of the workshop. collected; and Registration instructions: To register, (4) Minimize the burden of the DEPARTMENT OF HOMELAND please submit your name, affiliation, collection of information on those who SECURITY mailing address, phone, FAX number, are to respond, including through the and e-mail address, along with a check use of appropriate automated, or money order payable to ‘‘PDA.’’ Mail United States Immigration and electronic, mechanical, or other to: PDA, Global Headquarters, Bethesda Customs Enforcement technological collection techniques or Towers, 4350 East-West Hwy., Suite Agency Information Collection 200, Bethesda, MD 20814. To register other forms of information technology, Activities: Extension of an Existing via the Internet, go to See PDA Web site, e.g., permitting electronic submission of Information Collection; Comment www.pda.org/supplychain2010 (FDA responses. Request has verified the Web site address, but is Overview of This Information not responsible for subsequent changes ACTION: 30-Day notice of information Collection: to the Web site after this document collection for review; Form G–79A, (1) Type of Information Collection: publishes in the Federal Register). The Information Relating to Beneficiary of Extension of a currently approved registrar will also accept payment by Private Bill; OMB Control No. 1653– information collection. major credit cards (VISA/MasterCard 0026. only). For more information on the (2) Title of the Form/Collection: meeting, or for questions on registration, The Department of Homeland Information Relating to Beneficiary of contact the PDA: Phone: 301–656–5900, Security, U.S. Immigration and Customs Private Bill. FAX: 301–986–1093, or e-mail: Enforcement (USICE), has submitted the (3) Agency form number, if any, and [email protected]. following information collection request the applicable component of the for review and clearance in accordance SUPPLEMENTARY INFORMATION: A reliable Department of Homeland Security with the Paperwork Reduction Act of supply of high quality, safe, and sponsoring the collection: Form G–79A. 1995. The information collection was effective drug products and drug U.S. Immigration and Customs previously published in the Federal ingredients depends upon a series of Enforcement. Register on January 19, 2010 Vol. 75 No. controls across the entire supply chain 11 2881, allowing for a 60 day public (4) Affected public who will be asked from sourcing of incoming starting comment period. No comments were or required to respond, as well as a brief materials to distribution controls to received on this information collection. abstract: Primary: Individuals or marketing. Recent experiences in the The purpose of this notice is to allow Households. The information collected market have highlighted the need for an additional 30 days for public on the Form G–79A is necessary for U.S. effective controls across the supply comments. Comments are encouraged Immigration and Customs Enforcement chain. There is a surge in global and will be accepted for thirty days to provide reports to Congress on cooperation and efforts toward April 30, 2010. Written comments and Private Bills when requested. harmonization of good manufacturing suggestions from the public and affected practices (GMPs) and good distribution (5) An estimate of the total number of agencies regarding items contained in respondents and the amount of time practices (GDPs) and controls pertaining this notice and especially with regard to estimated for an average respondent to to the supply chain among members of the estimated public burden and respond: 100 responses at 60 minutes (1 industry and regulatory agencies. associated response time should be hour) per response. Understanding and securing the entire directed to the Office of Information and ingredient manufacturing and Regulatory Affairs, Office of (6) An estimate of the total public distribution chain helps to ensure the Management and Budget. Comments burden (in hours) associated with the quality and safety of medicines for should be addressed to OMB Desk collection: 100 annual burden hours. patients. Officer, for U. S. Immigration and Through a series of plenary sessions Requests for a copy of the proposed Customs Enforcement, Department of information collection instrument, with and working group breakout sessions, Homeland Security, and sent via the workshop will provide participants instructions; or inquiries for additional electronic mail to information should be requested via e- the opportunity to: [email protected] or faxed • mail to: [email protected] with ‘‘Form Hear from senior FDA personnel on to (202) 395–5806. G–79A’’ in the subject line. the current regulatory environment. Written comments and suggestions • Share improvements in programs from the public and affected agencies Dated: March 26, 2010. and technology. concerning the proposed collection of Joseph M. Gerhart, • Identify any barriers to securing the information should address one or more Chief, Records Management Branch, U.S. entire ingredient manufacturing and of the following four points: Immigration and Customs Enforcement, distribution chain and associated (1) Evaluate whether the proposed Department of Homeland Security. actions to implement effective solutions. collection of information is necessary [FR Doc. 2010–7186 Filed 3–30–10; 8:45 am] for the proper performance of the Personnel with experience related to BILLING CODE 9111–28–P supply chain issues, including quality functions of the agency, including and technical functions, will find this whether the information will have level of information exchange with practical utility; members of industry and regulatory (2) Evaluate the accuracy of the agencies useful to their specific areas. agencies estimate of the burden of the

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DEPARTMENT OF HOMELAND The Assistant Commandant for DEPARTMENT OF HOMELAND SECURITY Marine Safety and Environmental SECURITY Protection (G–M), redelegated Coast Guard recertification authority for advisory National Communications System [USCG–2010–0121] councils, or groups, to the Commander, [Docket No. NCS–2010–0001] Seventeenth Coast Guard District on Prince William Sound Regional February 26, 1999 (letter #16450). President’s National Security Citizens’ Advisory Council Telecommunications Advisory On September 16, 2002, the Coast (PWSRCAC) Charter Renewal Committee Guard published a policy statement, 67 AGENCY: Coast Guard, DHS. FR 58440, which changed the AGENCY: National Communications ACTION: Notice of recertification. recertification procedures such that System, DHS. applicants are required to provide the ACTION: Notice of open advisory SUMMARY: The purpose of this notice is USCG with comprehensive information committee meeting. to inform the public that the Coast every three years (triennially). For each Guard has recertified the Prince William of the two years between the triennial SUMMARY: The President’s National Sound Regional Citizens’ Advisory application procedures, applicants Security Telecommunications Advisory Council (PWSRCAC) as an alternative Committee (NSTAC) will hold its voluntary advisory group for Prince submit a letter requesting recertification that includes a description of any annual meeting on May 6, 2010. The William Sound, Alaska. This meeting will be open to the public. certification allows the PWSRCAC to substantive changes to the information DATES: May 6, 2010, from 2:30 p.m. monitor the activities of terminal provided at the previous triennial until 5:30 p.m. facilities and crude oil tankers under the recertification. Further, public comment Prince William Sound Program is not solicited prior to recertification ADDRESSES: The meeting will take place established by statute. during streamlined years, only during at the U.S. Chamber of Commerce, 1615 H Street, NW., Washington, DC. If you DATES: This recertification is effective the triennial comprehensive review. desire meeting materials, please contact for the period from March 1, 2010 The Alyeska Pipeline Service through February 28, 2011. Ms. Sue Daage at (703) 235–4964 or by Company pays the PWSRCAC $2.9 e-mail at [email protected] by 5 p.m. FOR FURTHER INFORMATION CONTACT: million annually in the form of a long- April 29, 2010. If you desire to submit LCDR Ken Phillips, Seventeenth Coast term contract. In return for this funding, comments regarding the May 6, 2010, Guard District (dpi), by telephone at the PWSRCAC must annually show that meeting, comments must be identified (907) 463–2821, or by mail at P.O. Box it ‘‘fosters the goals and purposes’’ of by Docket No. NCS–2010–0001 and may 25517, Juneau, Alaska 99802. OPA 90 and is ‘‘broadly representative be submitted by one of the following SUPPLEMENTARY INFORMATION: of the communities and interests in the methods: Background and Purpose vicinity of the terminal facilities and • Federal eRulemaking Portal: http:// Prince William Sound.’’ The PWSRCAC As part of the Oil Pollution Act of www.regulations.gov. Follow the 1990, Congress passed the Oil Terminal is an independent, nonprofit instructions for submitting comments. • E-mail: [email protected]. Include and Oil Tanker Environmental organization founded in 1989. Though it docket number in the subject line of the Oversight and Monitoring Act of 1990 receives Federal oversight like many message. (the Act), 33 U.S.C. 2732, to foster a independent, non-profit organizations, • Mail: Office of the Manager, long-term partnership among industry, it is not a Federal agency. The National Communications System, government, and local communities in PWSRCAC is a local organization that Government Industry Planning and overseeing compliance with predates the passage of OPA 90. The Management Branch, Department of environmental concerns in the existence of the PWSRCAC was Homeland Security, 245 Murray Lane, operation of crude oil terminals and oil specifically recognized in OPA 90 SW., Washington, DC 20598–0615. tankers. where it is defined as an ‘‘alternate • Fax: (866) 466–5370. On October 18, 1991, the President voluntary advisory group.’’ delegated his authority under 33 U.S.C Instructions: All submissions received Alyeska funds the PWSRCAC, and the ‘‘ 2732(o) to the Secretary of must include the words Department of Coast Guard makes sure the PWSRCRC Homeland Security’’ and NCS–2010– Transportation in Executive Order operates in a fashion that is broadly 12777, section 8(g) (see 56 FR 54757; 0001, the docket number for this action. consistent with OPA 90. October 22, 1991) for purposes of Comments received will be posted without alteration at http:// certifying advisory councils, or groups, Recertification subject to the Act. On March 3, 1992, www.regulations.gov, including any the Secretary redelegated that authority By letter dated February 24, 2010, the personal information provided. Docket: For access to the docket, to the Commandant of the Coast Guard Commander, Seventeenth Coast Guard background documents or comments (see 57 FR 8582; March 11, 1992). The District, certified that the PWSRCAC received by the NSTAC, go to http:// Commandant redelegated that authority qualifies as an alternative voluntary www.regulations.gov. to the Chief, Office of Marine Safety, advisory group under 33 U.S.C. 2732(o). Security and Environmental Protection This recertification terminates on FOR FURTHER INFORMATION CONTACT: Ms. (G–M) on March 19, 1992 (letter #5402). February 28, 2011. Sue Daage, Government Industry On July 7, 1993, the USCG published Planning and Management Branch, at Dated: February 24, 2010. a policy statement, 58 FR 36504, to (703) 235–4964, e-mail: clarify the factors that shall be C.C. Colvin, [email protected], or write to the considered in making the determination Rear Admiral, U.S. Coast Guard Commander, Deputy Manager, National as to whether advisory councils, or Seventeenth Coast Guard District. Communications System, Department of groups, should be certified in [FR Doc. 2010–7157 Filed 3–30–10; 8:45 am] Homeland Security, 245 Murray Lane, accordance with the Act. BILLING CODE 9110–04–P SW., Washington, DC 20598–0615.

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SUPPLEMENTARY INFORMATION: The USER information line and TTY automated in the Subsidy and Grant NSTAC advises the President on issues numbers, telephone numbers are not Information System (SAGIS). and problems related to implementing toll-free.) Agency form number: HUD–52722, national security and emergency HUD–52723, and HUD–53087. FOR FURTHER INFORMATION CONTACT: preparedness telecommunications Members of affected public: Public Dacia Rogers, Office of Policy, Programs policy. Notice of this meeting is given Housing Agencies. and Legislative Initiatives, PIH, under the Federal Advisory Committee Estimation of the total number of Department of Housing and Urban Act (FACA), Public Law 92–463 (1972), hours needed to prepare the information Development, 451 7th Street, SW., as amended appearing in 5 U.S.C. App. collection including number of Room 4116, Washington, DC 20410; 2. At the upcoming meeting, the NSTAC respondents: 6,955 respondents telephone 202–402–3374 (this is not a Principals will receive Government annually with 1 response per toll-free number). stakeholder comments and updates on respondent for forms HUD–52722 and the progress of the Communications SUPPLEMENTARY INFORMATION: The HUD–52723 for a total of 13,919 Resiliency Task Force and the Department will submit the proposed responses; and 1 response per 9 Cybersecurity Collaboration Task Force. information collection to OMB for respondents for form HUD–53087 for a review, as required by the Paperwork total of 9 responses. Average time per Dated: March 24, 2010. Reduction Act of 1995 (44 U.S.C. response for each form is .75 hours and James Madon, Chapter 35, as amended). This Notice is total annual burden hours are 10,439. Director, National Communications System. soliciting comments from members of Status of the proposed information [FR Doc. 2010–7205 Filed 3–30–10; 8:45 am] the public and affected agencies collection: Extension of currently BILLING CODE P concerning the proposed collection of approved collection. information to: (1) Evaluate whether the Authority: Section 3506 of the Paperwork proposed collection of information is Reduction Act of 1995, 44 U.S.C. Chapter 35, DEPARTMENT OF HOUSING AND necessary for the proper performance of as amended. URBAN DEVELOPMENT the functions of the agency, including Dated: March 22, 2010. whether the information will have [Docket No. FR–5383–N–04] Merrie Nichols-Dixon, practical utility; (2) evaluate the Acting Deputy Assistant Secretary for Policy, Notice of Proposed Information accuracy of the agency’s estimate of the Programs, and Legislative Initiatives. burden of the proposed collection of Collection for Public Comment; [FR Doc. 2010–7102 Filed 3–30–10; 8:45 am] information; (3) enhance the quality, Allocation of Operating Subsidies BILLING CODE 4210–67–P Under the Operating Fund Formula: utility, and clarity of the information to Data Collection be collected; and (4) minimize the burden of the collection of information DEPARTMENT OF HOUSING AND AGENCY: Office of the Assistant on those who are to respond, including URBAN DEVELOPMENT Secretary for Public and Indian through the use of appropriate Housing, HUD. automated collection techniques or [Docket No. FR–5382–N–04] ACTION: Notice. other forms of information technology, e.g., permitting electronic submission of Notice of Proposed Information SUMMARY: The proposed information responses. Collection for Public Comment: Notice of Funding Availability for the Alaska collection requirement described below This Notice also lists the following Native/Native Hawaiian Institutions will be submitted to the Office of information: Management and Budget (OMB) for Assisting Communities (AN/NHIAC) Title of Proposal: Allocation of Program review, as required by the Paperwork Operating Subsidies Under the Reduction Act. The Department is Operating Fund Formula: Data AGENCY: Office of the Assistant soliciting public comments on the Collection. Secretary for Policy Development and subject proposal. OMB Control Number: 2577–0029. Research, HUD. DATES: Comments Due Date: June 1, Description of the need for the ACTION: Notice. 2010. information and proposed use: Section SUMMARY: The proposed information ADDRESSES: Interested persons are 9(f) of the United States Housing Act of collection requirement described below invited to submit comments regarding 1937 establishes an Operating Fund for will be submitted to the Office of this proposal. Comments should refer to the purpose of making assistance Management and Budget (OMB) for the proposal by name/or OMB Control available to public housing agencies review, as required by the Paperwork number and should be sent to: Leroy (PHAs) which assistance is determined Reduction Act. The Department is McKinney, Jr., Departmental Reports using a formula approach under the soliciting public comments on the Management Officer, QDAM, Operating Fund Program. PHAs subject proposal. Department of Housing and Urban compute their operating subsidy Development, 451 7th Street, SW., eligibility by completing the following DATES: Comment Due Date: June 1, Room 4178, Washington, DC 20410– HUD prescribed forms, as applicable, 2010. 5000; telephone 202.402.8048 (this is each fiscal year: Calculation of Utilities ADDRESSES: Interested persons are not a toll-free number), or e-mail Mr. Expense Level (HUD–52722); Operating invited to submit comments regarding McKinney at Fund Calculation of Operating Subsidy this proposal. Comments should refer to [email protected] for a copy of (HUD–52723); and Calculation of the proposal by name and/or OMB the proposed forms, or other available Subsidies for Operations: Non-Rental Control Number and should be sent to: information. Persons with hearing or Housing (HUD–53087). HUD uses the Reports Liaison Officer, Office of Policy speech impairments may access this information on these forms to determine Development and Research, Department number through TTY by calling the toll- the operating subsidy obligation and of Housing and Urban Development, free Federal Information Relay Service proration level for each PHA. The three 451 7th Street, SW., Room 8228, at (800) 877–8339. (Other than the HUD forms listed in this collection are Washington, DC 20410–6000.

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FOR FURTHER INFORMATION CONTACT: the quality, utility, and clarity of the Agency Form Numbers: SF–424, SF– Susan Brunson, 202–708–3061, ext. information to be collected; and (4) 424 Supplement, SF–LLL, HUD–424– 3852 (this is not a toll-free number), for minimize the burden of the collection of CB, HUD–2730, HUD–2880, HUD–2993, copies of the proposed forms and other information on those who are to HUD–2994–A, HUD–96011, and HUD– available documents. respond; including through the use of 96010. SUPPLEMENTARY INFORMATION: The appropriate automated collection Members of the Affected Public: Department of Housing and Urban techniques or other forms of information Alaska Native Institutions (ANI) and Development will submit the proposed technology, e.g., permitting electronic Native Hawaiian Institutions (NHI) of extension of information collection to submission of responses. Higher Education that meet the statutory This Notice also lists the following OMB for review, as required by the definition established in Title III, Part A, information: Paperwork Reduction Act of 1995 (44 Section 317 of the Higher Education Act Title of Proposal: Notice of Funding U.S.C. Chapter 35, as amended). of 1965, as amended by the Higher This Notice is soliciting comments Availability for the Alaska Native/ Education Amendments of 1998 (Pub. L. from members of the public and affected Native Hawaiian Institutions Assisting 105–244; enacted October 7, 1998). agencies concerning the proposed Communities (AN/NHIAC) Program. collection of information to: (1) Evaluate OMB Control Number: 2528–0206. Estimation of the total number of whether the proposed collection of Description of the Need for the hours needed to prepare the information information is necessary for the proper Information and Proposed Use: The collection including number of performance of the functions of the information is being collected to select respondents, frequency of response, and agency, including whether the applicants for award in this statutorily hours of response: Information pursuant information will have practical utility; created competitive grant program and to grant award will be submitted once (2) evaluate the accuracy of the agency’s too monitor performance of grantees to a year. The following chart details the estimate of the burden of the proposed ensure they meet statutory and program respondent burden on an annual and collection of information; (3) enhance goals and requirements. semi-annual basis:

Number of Total annual Hours per respondents responses response Total hours

Applicants ...... 20 20 40 800 Quarterly Reports ...... 10 40 6 240 Final Reports ...... 10 10 8 80 Recordkeeping ...... 10 10 5 50

Total ...... 59 1170

Status of the proposed information review, as required by the Paperwork Department of Housing and Urban collection: Pending OMB approval. Reduction Act. The Department is Development, 451 7th Street, SW., Authority: Section 3506 of the Paperwork soliciting public comments on the Room 4116, Washington, DC 20410; Reduction Act of 1995, 44 U.S.C. Chapter 35, subject proposal. telephone 202–402–3374 (this is not a as amended. DATES: Comments Due Date: June 1, toll-free number). Dated: March 19, 2010. 2010. SUPPLEMENTARY INFORMATION: The Raphael W. Bostic, ADDRESSES: Interested persons are Department will submit the proposed Assistant Secretary for Policy Development invited to submit comments regarding information collection to OMB for and Research. this proposal. Comments should refer to review, as required by the Paperwork [FR Doc. 2010–7223 Filed 3–30–10; 8:45 am] the proposal by name/or OMB Control Reduction Act of 1995 (44 U.S.C. BILLING CODE 4210–67–P number and should be sent to: Leroy Chapter 35, as amended). This Notice is McKinney, Jr., Departmental Reports soliciting comments from members of Management Officer, QDAM, the public and affected agencies DEPARTMENT OF HOUSING AND Department of Housing and Urban concerning the proposed collection of URBAN DEVELOPMENT Development, 451 7th Street, SW., information to: (1) Evaluate whether the [Docket No. FR–5383–N–05] Room 4178, Washington, DC 20410– proposed collection of information is 5000; telephone 202–402–8048 (this is necessary for the proper performance of Notice of Proposed Information not a toll-free number), or e-mail Mr. the functions of the agency, including Collection for Public Comment; Energy McKinney at whether the information will have Conservation for PHA-Owned or [email protected] for a copy of practical utility; (2) evaluate the Leased Projects—Audits, Utility the proposed forms, or other available accuracy of the agency’s estimate of the Allowances information. Persons with hearing or burden of the proposed collection of speech impairments may access this AGENCY: Office of the Assistant information; (3) enhance the quality, number through TTY by calling the toll- Secretary for Public and Indian utility, and clarity of the information to free Federal Information Relay Service Housing, HUD. be collected; and (4) minimize the at 800–877–8339. (Other than the HUD burden of the collection of information ACTION: Notice of proposed information USER information line and TTY collection. on those who are to respond, including numbers, telephone numbers are not through the use of appropriate SUMMARY: The proposed information toll-free.) automated collection techniques or collection requirement described below FOR FURTHER INFORMATION CONTACT: other forms of information technology; will be submitted to the Office of Dacia Rogers, Office of Policy, Programs e.g., permitting electronic submission of Management and Budget (OMB) for and Legislative Initiatives, PIH, responses.

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This notice also lists the following Development Block Grant (CDBG) Kristen Larson, Project Funding and information: Administration Unit) intend to prepare Agreements Coordinator, City of Seattle Title of Proposal: Energy Conservation an Environmental Impact Statement Human Services Department, CDBG for PHA-owned or Leased Projects— (EIS) for the Yesler Terrace Administration Unit, Audits, Utility Allowances. Redevelopment Project, located in the [email protected], P.O. Box OMB Control Number: 2577–0062. City of Seattle, King County, WA. The 34215, Seattle, WA 98124–4215, (f) 206– Description of the Need for the project proponent is the Seattle Housing 621–5003 (NEPA). Information and Proposed Use: In Authority. The City of Seattle Human For additional background support of national energy conservation Services Department and the Seattle information on the project proposal, goals, Public Housing Agencies (PHAs) Housing Authority, acting jointly as lead please see the Seattle Housing Authority establish allowances for PHA-furnished agencies, will prepare the EIS under the Web site: http:// utilities and for resident-purchased authority of the City of Seattle Human www.seattlehousing.org/redevelopment/ utilities. PHAs document, and provide Services Department as the Responsible yesler-terrace/. for resident inspection, the basis upon Entity for compliance with the National Public Participation: A public EIS which allowances and schedules Environmental Policy Act (NEPA) in Scoping meeting/open house will be surcharges (and revisions thereof) are accordance with 42 U.S.C. 5304(g) and held to provide an additional established. PHAs complete energy 42 U.S.C. 1437x and HUD regulations at opportunity for the public to learn more audits, benefit/cost analyses for 24 CFR 58.4, and under the Seattle about the proposed actions and to individual vs. master metering. PHAs Housing Authority’s role as lead agency provide verbal or written comment on review tenant utility allowances. in accordance with the Washington the scope of the EIS. At the meeting, the Agency Form Numbers, if Applicable: State Environmental Policy Act (SEPA). public will be able to view graphics Form HUD–50078. The EIS will be a joint NEPA and SEPA illustrating preliminary redevelopment Members of Affected Public: State, document. The EIS will satisfy concepts associated with the proposed Local, or Tribal Government; Public requirements of SEPA (RCW 43.21C) actions and speak with staff of the Housing Agencies (PHAs). and the SEPA Rules (WAC 197–11) Seattle Housing Authority, the City of Estimation of the Total Number of which require that all State and local Seattle and members of the consultant Hours Needed to Prepare the government agencies consider the team providing technical analyses in Information Collection Including environmental consequences of projects support of the project. Written Number of Respondents, Frequency of over which they have discretionary comments may be mailed, sent via fax Response, and Hours of Response: 4,130 authority before acting on those or e-mailed to the Seattle Housing respondents; requiring annually of 4,130 projects. The proposed action is subject Authority contact listed above or responses; 79,330 total burden hours; to compliance with NEPA, because submitted at the EIS Scoping Meeting. The meeting/open house will be held average of 19.21 burden hours per funds from the public housing programs at the Yesler Terrace Gym (835 Yesler respondent. under Title I of the United States Way, Seattle, WA 98122) on April 29, Status of the Proposed Information Housing Act of 1937 (HOPE VI, Capital 2010. An open house will be held from Collection: Revision of a currently Funds, Demolition/Disposition) will 6–7 p.m. and public comments on the approved collection. used for this project (24 CFR scope will be taken at 7 p.m. For 58.1(b)(6)(i)). This notice is given in Authority: Section 3506 of the Paperwork accommodations and translation Reduction Act of 1995, 44 U.S.C. Chapter 35, accordance with the Council on services in conjunction with the public as amended. Environmental Quality regulations at 40 meeting please contact Collette Frazier, Dated: March 22, 2010. CFR parts 1500–1508. All interested (p) (206) 615–3556. Federal, State, and local agencies, Merrie Nichols-Dixon, SUPPLEMENTARY INFORMATION: Indian Tribes, groups, and the public Acting Deputy Assistant Secretary for Policy, are invited to comment on the scope of Project Name and Description Programs, and Legislative Initiatives, PP. the EIS. If you are an agency with The Seattle Housing Authority and [FR Doc. 2010–7101 Filed 3–30–10; 8:45 am] jurisdiction by law over natural or other BILLING CODE 4210–67–P the City of Seattle Human Services public resources affected by the project, Department will consider a proposal for the Seattle Housing Authority and the a phased redevelopment of the existing City of Seattle Human Services DEPARTMENT OF HOUSING AND Yesler Terrace residential community to Department need to know what URBAN DEVELOPMENT a mixed-use residential community on a environmental information germane to 28-acre site on the southern slope of [Docket No. FR–5408–N–01] your statutory responsibilities should be First Hill in Seattle, WA. The proposed included in the EIS. Notice of Intent To Prepare an project is generally bounded by ADDRESSES: Comments relating to the Environmental Impact Statement for Interstate 5 on the west, Alder Street scope of the EIS are requested and will and Fir Street on the north, 12th Avenue the Yesler Terrace Redevelopment be accepted by the contact persons Project on the east, and Washington Street on listed below until May 17, 2010. Any the south. AGENCY: Office of the Assistant person or agency interested in receiving The proposed project would include Secretary for Community Planning and a notice and wishing to make comment development of a mix of affordable and Development, HUD. on the scope of the EIS should contact market-rate housing, office and retail ACTION: Notice. the persons listed below. uses, as well as parks and open space, FOR FURTHER INFORMATION CONTACT: enhanced landscaping, improved streets SUMMARY: The Department of Housing Stephanie Van Dyke, Development and a system of pedestrian and bike and Urban Development (HUD) gives Director of the Seattle Housing improvements. All existing residential notice to the public, agencies, and Authority, structures on the site would be Indian Tribes that the Seattle Housing [email protected], demolished under the Proposed Action; Authority and the City of Seattle Human P.O. Box 19028, Seattle, WA 98109– other structures on the site may also be Services Department (Community 1028, (f) 206–615–3539 (SEPA) and demolished. The existing Yesler Terrace

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community center would be retained. It Lead Agencies of the Treasury, and are, therefore, is anticipated that the redevelopment of As a lead agency, the City of Seattle, ‘‘outstanding’’ as of March 31, 2010. The Yesler Terrace will take approximately through its Human Services date of the call is July 1, 2010. 15 to 20 years to complete. Department, is the responsible entity The debentures will be redeemed at The proposed actions may involve the (RE) for this project in accordance with par plus accrued interest. Interest will following: Comprehensive Plan 24 CFR part 58, ‘‘Environmental Review cease to accrue on the debentures as of Amendment, text amendment to the Procedures for Entities Assuming HUD the call date. At redemption, final Land Use Code to allow a new zone for Environmental Responsibilities.’’ As a interest on any called debentures will be Yesler Terrace, street vacation, RE, the City of Seattle Human Services paid along with the principal. Payment preliminary and final plat approval, Department assumes the responsibility of final principal and interest due on adoption of a Planned Action for environmental review, decision- July 1, 2010 will be made automatically Ordinance, Development Agreement making, and action that would to the registered holder. approval, other construction and otherwise apply to HUD under NEPA. During the period from the date of building permits and other Federal, In addition, the Seattle Housing this notice to the call date, debentures State and local approvals for Authority is the State Environmental that are subject to the call may not be redevelopment of the Yesler Terrace Policy Act (SEPA) lead agency used by the mortgagee for a special community. responsible for preparing an redemption purchase in payment of a The EIS is also intended to fulfill Environmental Impact Statement (EIS). mortgage insurance premium. SEPA requirements for a Planned Questions may be directed to the No transfer of debentures covered by Action environmental review for the individuals named in this notice under the foregoing call will be made on the portion of the site west of Boren the heading FOR FURTHER INFORMATION books maintained by the Treasury Avenue, per RCW 43.21C.031, SMC CONTACT. Department on or after June 14, 2010. This debenture call does not affect the 25.05.164 [et seq.], and SHA Resolution Date Issued: March 9, 2010. ‘‘ right of the holder of a debenture to sell 4945. According to SEPA, a Planned Mercedes Marquez, Action’’ is a designation for a project or or assign the debenture on or after this Assistant Secretary for Community Planning date. elements of a project that shifts and Development. environmental review from the time a [FR Doc. 2010–7099 Filed 3–30–10; 8:45 am] Dated: February 22, 2010. permit application is made to an earlier BILLING CODE 4210–67–P David H. Stevens, phase in the process, such as at the Assistant Secretary for Housing—Federal Comprehensive Plan amendment and/or Housing Commissioner. rezone phase. The intent of this DEPARTMENT OF HOUSING AND [FR Doc. 2010–7096 Filed 3–30–10; 8:45 am] designation is to provide a more URBAN DEVELOPMENT BILLING CODE 4210–67–P streamlined environmental process by using an existing EIS prepared at this [Docket No. FR–5389–N–02] earlier stage for SEPA compliance for Notice of FHA Debenture Call DEPARTMENT OF HOUSING AND long-term actions. URBAN DEVELOPMENT This is to be a combined document— AGENCY: Office of the Assistant an EIS under the State of Washington Secretary for Housing—Federal Housing [Docket No. FR–5213–FA–02] State Environmental Policy Act (RCW Commissioner, HUD. Announcement of Funding Awards for 43.21C. and WAC 197–11) and an EIS ACTION: Notice. the HUD-Veterans Affairs Supportive under NEPA (42 U.S.C. 4321) and Housing (HUD–VASH) Program for SUMMARY: This Notice announces a implementing regulations of the Council Fiscal Years (FY) 2008 and 2009 on Environmental Quality (40 CFR parts debenture recall of certain Federal 1500–1508) and HUD (24 CFR part 58). Housing Administration (FHA) AGENCY: Office of Public and Indian Alternatives: Preliminary Yesler debentures, in accordance with Housing, HUD. Terrace redevelopment concepts call for authority provided in the National ACTION: Announcement of funding redevelopment over a range of: 3,000 to Housing Act. awards. 5,000 residential units; 800,000 to 1.2 FOR FURTHER INFORMATION CONTACT: million square feet of office/institutional Yong Sun, FHA Financial Reporting SUMMARY: In accordance with Section space; and 40,000 to 88,000 square feet Division, Department of Housing and 102(a)(4)(C) of the Department of of retail space. The EIS will analyze Urban Development, 451 Seventh Street, Housing and Urban Development three redevelopment alternatives SW., Room 5148, Washington, DC Reform Act of 1989, this announcement representing a range of densities and 20410, telephone (202) 402–4778. This notifies the public of funding decisions intensities of uses, a redevelopment is not a toll-free number. made by the Department for funding alternative consistent with existing SUPPLEMENTARY INFORMATION: Pursuant under the FY 2008 and FY 2009 HUD– zoning, and a no-action alternative. to section 207(j) of the National Housing VASH program. This announcement Probable Environmental Effects: The Act, 12 U.S.C. 1713(j), and in contains the consolidated names and following subject areas will be analyzed accordance with HUD’s regulation at 24 addresses of those award recipients in the combined EIS for probable CFR 207.259(e)(3), the Assistant selected for funding under both the environmental effects: Earth, Air Secretary for Housing—Federal Housing Consolidated Appropriations Act, 2008 Quality, Water, Plants and Animals, Commissioner, with the approval of the (Pub. L. 110–161) and the Omnibus Energy, Environmental Health, Noise, Secretary of the Treasury, announces Appropriations Act, 2009 (Pub. L. 111– Land Use, Housing, Aesthetics, Light the call of all FHA debentures, with a 8). and Glare, Recreation, Historic coupon rate of 5 percent or above, FOR FURTHER INFORMATION CONTACT: Resources, Cultural Resources, except for those debentures subject to Danielle Bastarache, Director, Housing Transportation, Public Utilities, Public ‘‘debenture lock agreements,’’ that have Voucher Programs, Office of Public and Services, Socioeconomics/ been registered on the books of the Indian Housing, Department of Housing Environmental Justice. Bureau of the Public Debt, Department and Urban Development, 451 Seventh

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Street, SW., Room 4228, Washington, Appropriations Acts require HUD to program taking into account the DC 20410, telephone number (202) 402– distribute assistance without population of homeless veterans 5264. For the hearing or speech competition, to public housing agencies needing services in the area, the number impaired, this number may be accessed (PHAs) that partner with eligible of homeless veterans recently served by via TTY (text telephone) by calling the Veterans Affairs Medical Centers the homeless programs at each VAMC, Federal Information Relay Service at 1 (VAMCs) or other entities as designated geographic distribution, and the VA’s (800) 877–8339. (Other than the ‘‘800’’ by the VA. As required by statute, case management resources. After TTY number, these telephone numbers selection was based on geographical considering location and administrative are not toll-free.) need for such assistance as identified by performance of PHAs in the jurisdiction SUPPLEMENTARY INFORMATION: The the VA, public housing agency of each VAMC, HUD invited PHAs to Consolidated Appropriations Act, 2008 performance, and other factors as apply for HUD–VASH vouchers. In (Pub. L. 110–161) (‘‘2008 Appropriations specified by the HUD in consultation accordance with Section 102(a)(4)(C) of Act’’) made $75 million available for with the VA. On May 6, 2008 (73 FR the Department of Housing and Urban HUD–VASH, an initiative that combines 25026), HUD published in the Federal Development Reform Act of 1989 (103 HUD Housing Choice Voucher (HCV) Register a notice that set forth the Stat. 1987, 42 U.S.C. 3545), today’s rental assistance for homeless veterans policies and procedures for the Federal Register publication lists in with case management and clinical administration of tenant-based Section 8 Appendix A the names, addresses, services provided by the Department of HCV rental assistance under the HUD– number of vouchers and amounts of the Veterans Affairs (VA) at its medical VASH program administered by local 238 PHAs to which awards were made centers and in the community. The HCV PHAs that have partnered with local VA under the FY2008 and FY2009 HUD– program is authorized under section medical centers. The Federal Register VASH initiative to serve a total of 334 8(o)(19) of the United States Housing published a correction of the May 6, VA sites. Act of 1937. The Omnibus 2008 notice on May 19, 2008 (73 FR Appropriations Act, 2009 (Pub. L. 111– 28863). Dated: January 8, 2010. 8) (‘‘2009 Appropriations Act’’) made an As required by the FY 2008 and FY Sandra B. Henriquez, additional $75 million available to 2009 Appropriations Acts, the VA Assistant Secretary for Public and Indian HUD–VASH. Both the 2008 and 2009 identified VAMCs to participate in the Housing.

APPENDIX A

Recipient Address City State Zip code Amount Vouchers

2008 VASH Recipients

Alaska Housing Finance Corp...... P.O. Box 101020 ...... Anchorage ...... AK ..... 99510 $233,066 35 Housing Authority of Birmingham Dis- 1826 3rd Avenue S. ... Birmingham ...... AL ..... 35233 669,539 105 trict. Housing Authority of Tuscaloosa ...... P.O. Box 2281 ...... Tuscaloosa ...... AL ..... 35403 151,658 35 Housing Authority of Tuskegee ...... 2901 Davison Street .. Tuskegee Institute ...... AL ..... 36083 111,594 35 Housing Authority of the City of North P.O. Box 516 ...... North Little Rock ...... AR .... 72115 508,750 105 Little Rock. Fayetteville Housing Authority ...... #1 North School Ave- Fayetteville ...... AR .... 72701 138,642 35 nue. City of Phoenix ...... 251 W. Washington Phoenix ...... AZ ..... 85003 790,726 105 Street. City of Tucson ...... P.O. Box 27210 ...... Tucson ...... AZ ..... 85726 402,041 70 State of Arizona ...... 1110 W. Washington, Phoenix ...... AZ ..... 85007 188,118 35 Suite 310. San Francisco Housing Authority ...... 440 Turk Street ...... San Francisco ...... CA .... 94102 1,518,754 105 City of Los Angeles Housing Authority 2600 Wilshire Blvd. .... Los Angeles ...... CA .... 90057 7,537,622 840 City of Fresno Housing Authority ...... P.O. Box 11985 ...... Fresno ...... CA .... 93776 199,886 35 County of San Bernardino Housing 715 E. Brier Dr...... San Bernardino ...... CA .... 92408 262,378 35 Authority. County of Santa Clara Housing Au- 505 W. Julian Street .. San Jose ...... CA .... 95110 901,505 70 thority. City of Pittsburg Housing Authority ..... 916 Cumberland Pittsburg ...... CA .... 94565 376,081 35 Street. San Diego Housing Commission ...... 1122 Broadway, Suite San Diego ...... CA .... 92101 1,018,798 105 300. City of Long Beach Housing Authority 521 East 4th Street .... Long Beach ...... CA .... 90802 686,398 70 Colorado Department of Human Serv- 4020 S. Newton St. .... Denver ...... CO .... 80236 1,004,170 210 ices. West Haven Housing Authority ...... 15 Glade Street ...... West Haven ...... CT ..... 06516 587,882 70 D.C. Housing Authority ...... 1133 N. Capitol Street, Washington ...... DC .... 20002 1,689,341 140 NE. Wilmington Housing Authority ...... 400 Walnut Street ...... Wilmington ...... DE .... 19801 242,222 35 Housing Authority of Tampa ...... 1529 W. Main Street .. Tampa ...... FL ..... 33607 897,007 105 Orlando Housing Authority ...... 390 North Bumby Ave- Orlando ...... FL ..... 32803 498,103 70 nue. Housing Authority of West Palm 1715 Division Avenue West Palm Beach ...... FL ..... 33407 995,186 105 Beach. Housing Authority of Miami Beach ..... 200 Alton Road ...... Miami Beach ...... FL ..... 33139 763,447 105 Pinellas County Housing Authority ..... 11479 Ulmerton Road Largo ...... FL ..... 33778 711,799 105

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Gainesville Housing Authority ...... Post Office Box 1468 Gainesville ...... FL ..... 32602 408,610 70 Housing Authority of Alachua County 703 NE First Street .... Gainesville ...... FL ..... 32601 386,921 70 City of Pensacola Section 8 ...... P.O. Box 12910 ...... Pensacola ...... FL ..... 32521 177,866 35 Housing Authority of Augusta ...... P.O. Box 3246 ...... Augusta ...... GA .... 30914 196,081 35 Housing Authority Dekalb County ...... 750 Commerce Drive, Decatur ...... GA .... 30030 2,965,620 350 Suite 201. Georgia Department of Community Af- 60 Executive Parkway Atlanta ...... GA .... 30329 197,673 35 fairs. South, NE. Guam Housing and Urban Renewal 117 Bien Venida Ave- Sinajana ...... GQ .... 96910 119,472 10 Authority. nue. Hawaii Public Housing Authority ...... P.O. Box 17907 ...... Honolulu ...... HI ...... 96817 715,604 70 City of Des Moines Municipal Housing 100 East Euclid, Suite Des Moines ...... IA ...... 50313 162,145 35 Agency. 101. City of Iowa City ...... 410 E. Washington Iowa City ...... IA ...... 52240 160,520 35 Street. Boise City Housing Authority ...... 1276 River Street, Boise ...... ID ...... 83702 107,849 20 Suite 300. Chicago Housing Authority ...... 626 W. Jackson Blvd. Chicago ...... IL ...... 60661 942,631 105 Housing Authority of Cook County ..... 175 W. Jackson, Suite Chicago ...... IL ...... 60604 650,471 70 350. City of N. Chicago Housing Authority 1440 Jackson Street .. North Chicago ...... IL ...... 60064 272,462 35 Fort Wayne Housing Authority ...... P.O. Box 13489 ...... Fort Wayne ...... IN ...... 46869 184,960 35 Indianapolis Housing Agency ...... 1919 North Meridian Indianapolis ...... IN ...... 46202 447,166 70 Street. Topeka Housing Authority ...... 2010 SE. California Topeka ...... KS ..... 66607 135,790 35 Avenue. Wichita Housing Authority ...... 332 Riverview Street .. Wichita ...... KS ..... 67203 173,405 35 Housing Authority of the City of Leav- 200 Shawnee Street .. Leavenworth ...... KS ..... 66048 482,038 105 enworth. Louisville Housing Authority ...... 420 S. 8th Street ...... Louisville ...... KY ..... 40203 418,748 70 Lexington Fayette Urban County 300 West New Circle Lexington ...... KY ..... 40505 172,168 35 Housing Authority. Road. Kenner Housing Authority ...... 1013 31st Street ...... Kenner ...... LA ..... 70065 1,148,414 140 Alexandria Housing Authority ...... P.O. Box 8219 ...... Alexandria ...... LA ..... 71306 166,349 35 Bossier Parish Police Jury ...... 3022 Old Minden Bossier City ...... LA ..... 71112 149,104 35 Road, Suite 206. Boston Housing Authority ...... 52 Chauncy Street ..... Boston ...... MA .... 02111 1,321,702 105 Northampton Housing Authority ...... 49 Old South Street— Northampton ...... MA .... 01060 487,402 70 Suite 1. Comm. Dev. Prog. Comm. of Ma., 100 Cambridge Street, Boston ...... MA .... 02114 736,781 70 E.O.C.D. Suite 300. Cecil County Housing Agency ...... 200 Chesapeake Elkton ...... MD .... 21921 429,500 70 Blvd., Suite 1800. Baltimore Co. Housing Office ...... 6401 York Road ...... Baltimore ...... MD .... 21212 741,623 105 Maine State Housing Authority ...... 353 Water Street ...... Augusta ...... ME .... 04330 199,084 35 Saginaw Housing Commission ...... P.O. Box 3225 ...... Saginaw ...... MI ..... 48605 167,559 35 Battle Creek Housing Comm...... 250 Champion Street Battle Creek ...... MI ..... 49017 125,357 35 Ann Arbor Housing Commission ...... 727 Miller Avenue ...... Ann Arbor ...... MI ..... 48103 554,467 70 Michigan State Housing Dev. Author- 735 E. Michigan Ave- Lansing ...... MI ..... 48912 598,538 105 ity. nue. Minneapolis Public Housing Authority 1001 Washington Ave- Minneapolis ...... MN .... 55401 601,415 70 nue N. St. Louis Housing Authority ...... 4100 Lindell Boulevard Saint Louis ...... MO .... 63108 227,779 35 Housing Authority of Kansas City, 301 E. Armour Blvd.— Kansas City ...... MO .... 64111 418,438 70 Missouri. #200. Columbia Housing Authority ...... 201 Switzler Street ..... Columbia ...... MO .... 65203 166,585 35 Jackson Housing Authority ...... P.O. Box 11327 ...... Jackson ...... MS .... 39283 205,036 35 MT Department of Commerce ...... P.O. Box 200545 ...... Helena ...... MT .... 59620 141,683 35 Housing Authority of the City of Ashe- P.O. Box 1898 ...... Asheville ...... NC .... 28802 171,818 35 ville. Housing Authority of the County of P.O. Box 399 ...... Zebulon ...... NC .... 27597 288,112 35 Wake. Housing Authority of Rowan County ... 310 Long Meadow Salisbury ...... NC .... 28147 232,609 35 Drive. Fargo Housing And Redevelopment P.O. Box 430 ...... Fargo ...... ND .... 58107 131,153 35 Authority. Omaha Housing Authority ...... 540 S. 27th Street ...... Omaha ...... NE .... 68105 206,732 35 Housing Authority of Lincoln ...... 5700 R Street ...... Lincoln ...... NE .... 68505 144,816 35 Manchester Housing Authority ...... 198 Hanover Street .... Manchester ...... NH .... 03104 274,352 35 New Jersey Department of Commu- 101 South Broad Trenton ...... NJ ..... 08625 646,406 70 nity Affairs. Street.

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Albuquerque Housing Authority ...... 1840 University Boule- Albuquerque ...... NM .... 87106 192,276 35 vard SE. County of Clark Housing Authority ..... 5390 E. Flamingo Las Vegas ...... NV .... 89122 842,688 105 Road. Nevada Rural Housing Authority ...... 3695 Desatoya Drive Carson City ...... NV .... 89701 407,291 70 Housing Authority of Syracuse ...... 516 Burt St ...... Syracuse ...... NY .... 13202 193,536 35 New York City Housing Authority ...... 250 Broadway ...... New York ...... NY .... 10007 9,383,229 1015 Albany Housing Authority ...... 200 South Pearl St ..... Albany ...... NY .... 12202 184,737 35 Housing Authority of Rochester ...... 675 West Main St., Rochester ...... NY .... 14611 159,655 35 Suite 100. Town of Amherst ...... 1195 Main St ...... Buffalo ...... NY .... 14209 151,284 35 NYS Housing Trust Fund Corporation 25 Beaver St., 7th New York ...... NY .... 10004 785,043 140 Floor. Columbus Metro. Housing Authority ... 880 East 11th Ave ..... Columbus ...... OH .... 43211 212,701 35 Cuyahoga MHA ...... 1441 W. 25th Street ... Cleveland ...... OH .... 44113 680,728 105 Cincinnati Metropolitan Housing Au- 16 W. Central Park- Cincinnati ...... OH .... 45202 430,189 70 thority. way. Dayton Metropolitan Housing Author- 400 Wayne Ave., P.O. Dayton ...... OH .... 45401 183,683 35 ity. Box 8750. Chillicothe Met. Housing Authority ...... 178 W. 4th Street ...... Chillicothe ...... OH .... 45601 168,454 35 Oklahoma City Housing Authority ...... 1700 NE. 4th Street ... Oklahoma City ...... OK .... 73117 190,819 35 Muskogee Housing Authority ...... 220 N. 40th Street ...... Muskogee ...... OK .... 74401 117,428 35 Housing Authority of Portland ...... 135 SW. Ash Street ... Portland ...... OR .... 97204 469,098 70 Housing Authority of Douglas County 902 West Stanton Roseburg ...... OR .... 97470 133,736 35 Street. Housing Authority of Jackson County 2231 Table Rock Medford ...... OR .... 97501 173,809 35 Road. Philadelphia Housing Authority ...... 12 S. 23rd Street ...... Philadelphia ...... PA ..... 19103 717,482 105 Allegheny County Housing Authority .. 625 Stanwix Street ..... Pittsburgh ...... PA ..... 15222 379,302 70 Housing Authority of the County of 114 Woody Drive ...... Butler ...... PA ..... 16001 184,750 35 Butler. Erie City Housing Authority ...... 606 Holland Street ..... Erie ...... PA ..... 16501 153,069 35 Hous. Authority of the Co. of Chester 30 W. Barnard St West Chester ...... PA ..... 19382 887,783 105 Street. Wilkes Barre Housing Authority ...... 50 Lincoln Plaza, S. Wilkes Barre ...... PA ..... 18702 159,667 35 Wilkes Barre Blvd. Lebanon County Housing Authority .... 303 Chestnut Street ... Lebanon ...... PA ..... 17042 344,795 70 Providence H. A...... 100 Broad Street ...... Providence ...... RI ...... 02903 266,713 35 Puerto Rico Dept of Housing ...... P.O. Box 21365 ...... San Juan ...... RQ .... 00928 111,365 20 Housing Authority of Charleston ...... 550 Meeting Street ..... Charleston ...... SC .... 29403 360,872 70 Housing Authority of Columbia ...... 1917 Harden Street .... Columbia ...... SC .... 29204 383,116 70 Sioux Falls Housing & Redevelop- 630 S. Minnesota Ave- Sioux Falls ...... SD .... 57104 175,568 35 ment Commission. nue. Pennington County Housing & Rede- 1805 W. Fulton Street, Rapid City ...... SD .... 57702 169,961 35 velopment Comm. Ste. 101. Meade County Housing & Redevelop- 1220 Cedar Street, Sturgis ...... SD .... 57785 138,508 35 ment Commission. Apartment 113. Memphis Housing Authority ...... P.O. Box 3664 ...... Memphis ...... TN ..... 38103 626,081 105 Housing Authority of Johnson City ..... P.O. Box 59 ...... Johnson City ...... TN ..... 37605 286,440 70 Metropolitan Developmnt & Housing 701 6th St ...... Nashville ...... TN ..... 37202 385,342 70 Agncy. Housing Authority of El Paso ...... 5300 E. Paisano Dr .... El Paso ...... TX ..... 79905 192,759 35 Houston Housing Authority ...... 2640 Fountain View ... Houston ...... TX ..... 77057 2,844,534 385 San Antonio Housing Authority ...... 818 Flores St ...... San Antonio ...... TX ..... 78295 423,830 70 Housing Authority of Dallas ...... 3939 N. Hampton Dallas ...... TX ..... 75212 784,312 105 Road. Housing Authority of Waco ...... P.O. Box 978 ...... Waco ...... TX ..... 76703 539,078 105 Housing Authority of Salt Lake City .... 1776 S. West Temple Salt Lake City ...... UT ..... 84115 220,109 35 Richmond Redevelopment & Housing P.O. Box 26887 ...... Richmond ...... VA ..... 23261 242,206 35 Authority. Roanoke Redevelopment & Housing P.O. Box 6359 ...... Roanoke ...... VA ..... 24017 169,210 35 Authority. Hampton Redevelopement & Housing P.O. Box 280 ...... Hampton ...... VA ..... 23669 993,283 140 Authority. Vermont State Housing Authority ...... 1 Prospect Street ...... Montpelier ...... VT ..... 05602 109,495 20 Seattle Housing Authority ...... 120 Sixth Avenue Seattle ...... WA .... 98109 406,511 52 North. King County Housing Authority ...... 600 Andover Park Seattle ...... WA .... 98188 431,621 53 West. Pierce County Housing Authority ...... P.O. Box 45410 ...... Tacoma ...... WA .... 98445 225,901 35 Spokane Housing Authority ...... 55 W. Mission Avenue Spokane ...... WA .... 99201 165,635 35

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Housing Authority of the City of Walla 501 Cayuse Street ..... Walla Walla ...... WA .... 99362 278,670 70 Walla. Housing Authority of the City of Mil- P.O. Box 324 ...... Milwaukee ...... WI ..... 53201 384,241 70 waukee. Tomah Housing Authority ...... 819 Superior Avenue Tomah ...... WI ..... 54660 53,596 35 Huntington Wv Housing Authority ...... P.O. Box 2183 ...... Huntington ...... WV .... 25722 160,726 35 Martinsburg Housing Authority ...... 703 S. Porter Avenue Martinsburg ...... WV .... 25401 152,027 35 Clarksburg Housing Authority ...... 433 Baltimore Avenue Clarksburg ...... WV .... 26301 120,880 35 Housing Authority of the City of Chey- 3304 Sheridan Street Cheyenne ...... WY .... 82009 347,592 70 enne.

2009 VASH Recipients

Alaska Housing Finance Corporation P.O. Box 101020 ...... Anchorage ...... AK ..... 99510 209,277 35 Housing Authority of the City of Mont- 1020 Bell Street ...... Montgomery ...... AL ..... 36104 185,507 35 gomery. Housing Authority of Huntsville ...... P.O. Box 486 ...... Huntsville ...... AL ..... 35804 172,523 35 Housing Authority of Bessemer ...... P.O. Box 1390 ...... Bessemer ...... AL ..... 35021 436,797 70 Housing Authority of the City of North P.O. Box 516 ...... North Little Rock ...... AR .... 72115 96,820 20 Little Rock. City of Phoenix ...... 251 W. Washington Phoenix ...... AZ ..... 85003 855,038 105 Street, Floor 4. City of Tucson ...... P.O. Box 27210 ...... Tucson ...... AZ ..... 85726 417,221 70 City of Mesa ...... 415 N. Pasadena ...... Mesa ...... AZ ..... 85201 235,367 35 San Francisco Housing Authority ...... 440 Turk Street ...... San Francisco ...... CA .... 94102 1,008,492 70 County of Los Angeles Housing Au- 2 S. Coral Circle ...... Monterey Park ...... CA .... 91755 2,797,092 280 thority. Oakland Housing Authority ...... 1619 Harrison Street .. Oakland ...... CA .... 94612 1,337,422 105 City of Los Angeles Housing Authority 2600 Wilshire Blvd ..... Los Angeles ...... CA .... 90057 996,056 105 City of Fresno Housing Authority ...... P.O. Box 11985 ...... Fresno ...... CA .... 93776 209,174 35 County of Sacramento Housing Au- 701 12th Street ...... Sacramento ...... CA .... 95814 578,793 70 thority. Housing Authority of the County of 601–24th Street ...... Bakersfield ...... CA .... 93301 174,267 35 Kern. County of Santa Barbara Housing Au- P.O. Box 397 ...... Lompoc ...... CA .... 93438 302,112 35 thority. County of San Joaquin Housing Au- P.O. Box 447 ...... Stockton ...... CA .... 95201 251,426 35 thority. County of Riverside Housing Authority 5555 Arlington Avenue Riverside ...... CA .... 92504 776,053 105 Tulare County Housing Authority ...... P.O. Box 791 ...... Visalia ...... CA .... 93279 195,981 35 County of Monterey Housing Authority 123 Rico Street ...... Salinas ...... CA .... 93907 264,520 35 County of Butte Housing Authority ..... 2039 Forest Ave., Chico ...... CA .... 95928 182,081 35 Suite # 10. County of Marin Housing Authority ..... 4020 Civic Center San Rafael ...... CA .... 94903 418,286 35 Drive. County of Santa Clara Housing Au- 505 W. Julian Street .. San Jose ...... CA .... 95110 1,693,609 140 thority. San Diego Housing Commission ...... 1122 Broadway Suite San Diego ...... CA .... 92101 1,013,637 105 300. City of Long Beach Housing Authority 521 East 4th Street .... Long Beach ...... CA .... 90802 1,049,687 105 Mendocino County ...... 1076 N. State Street .. Ukiah ...... CA .... 95482 213,295 35 City of Santa Rosa ...... P.O. Box 1806 ...... Santa Rosa ...... CA .... 95402 296,429 35 County of Orange Housing Authority .. 1770 North Broadway Santa Ana ...... CA .... 92706 745,382 70 County of San Diego ...... 3989 Ruffin Road ...... San Diego ...... CA .... 92123 937,823 105 Housing Authority of the City and Box 40305, Mile High Denver ...... CO .... 80204 1,181,620 140 County of Denver. Station. Housing Authority of Pueblo ...... 1414 N. Santa Fe Pueblo ...... CO .... 81003 185,153 35 Ave., 10th Floor. Fort Collins Housing Authority ...... 1715 W. Mountain Av- Fort Collins ...... CO .... 80521 531,697 70 enue. Grand Junction Housing Authority ...... 1011 North Tenth Grand Junction ...... CO .... 81501 172,297 35 Street. Hartford Housing Authority ...... 180 Overlook Terrace Hartford ...... CT ..... 06106 283,080 35 Housing Authority of the City of New P.O. Box 1912 ...... New Haven ...... CT ..... 06509 355,357 35 Haven. Waterbury Housing Authority ...... 2 Lakewood Road ...... Waterbury ...... CT ..... 06704 246,906 35 D.C. Housing Authority ...... 1133 N. Capitol Street Washington ...... DC .... 20002 2,021,458 175 NE. Housing Authority of Jacksonville ...... 1300 Broad St. Street Jacksonville ...... FL ..... 32202 1,411,780 210 St. Petersburg Housing Authority ...... 11479 Ulmerton Road Largo ...... FL ..... 33778 573,291 70 Housing Authority of Tampa ...... 1529 W. Main Street .. Tampa ...... FL ..... 33607 309,330 35

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Orlando Housing Authority ...... 390 North Bumby Ave- Orlando ...... FL ..... 32803 729,331 105 nue. Housing Authority of Daytona Beach .. 211 N. Ridgewood Daytona Beach ...... FL ..... 32114 219,714 35 Ave., Suite 200. Housing Authority of Sarasota ...... 1300 6th Street ...... Sarasota ...... FL ..... 34236 304,370 35 Housing Authority of West Palm 1715 Division Avenue West Palm Beach ...... FL ..... 33407 354,403 35 Beach. City of Lakeland Housing Authority .... P.O. Box 1009 ...... Lakeland ...... FL ..... 33802 195,623 35 Housing Authority of Miami Beach ..... 200 Alton Road ...... Miami Beach ...... FL ..... 33139 531,154 70 Panama City Housing Authority ...... 804 E. 15th Street ...... Panama City ...... FL ..... 32405 197,832 35 Housing Authority of the City of 524 S. Hopkins Ave- Titusville ...... FL ..... 32796 414,515 70 Titusville. nue. Housing Authority of the City of Fort 4224 Michigan Avenue Fort Myers ...... FL ..... 33916 340,112 70 Meyers. Broward County Housing Authority ..... 4780 N. State Road 7 Lauderdale Lakes ...... FL ..... 33319 812,745 70 Housing Authority of Lee County ...... 14170 Warner Circle .. North Fort Myers ...... FL ..... 33903 174,769 35 Housing Authority of Augusta ...... P.O. Box 3246 ...... Augusta ...... GA .... 30914 208,557 35 Housing Authority of Dekalb County ... 750 Commerce Drive, Decatur ...... GA .... 30030 1,127,269 140 Suite 201. Georgia Department of Community Af- 60 Executive Parkway Atlanta ...... GA .... 30329 609,645 105 fairs. South, NE. Guam Housing and Urban Renewal 117 Bien Venida Ave- Sinajana ...... GQ .... 96910 124,142 10 Authority. nue. Hawaii Public Housing Authority ...... P.O. Box 17907 ...... Honolulu ...... HI ...... 96817 363,545 35 City of Des Moines Municipal Housing 100 East Euclid, Suite Des Moines ...... IA ...... 50313 159,910 35 Authority. 101. Mason City Housing Authority ...... 22 N. Georgia—#214 Mason City ...... IA ...... 50401 110,305 35 Boise City Housing Authority ...... 1276 River Street, Boise ...... ID ...... 83702 106,589 20 Suite 300. Chicago Housing Authority ...... 626 W. Jackson Blvd Chicago ...... IL ...... 60661 984,977 105 City of Danville Housing Authority ...... P.O. Box 168 ...... Danville ...... IL ...... 61834 153,409 35 Rockford Housing Authority ...... 223 S. Winnebago Rockford ...... IL ...... 61102 179,432 35 Street. Housing Authority of Cook County ..... 175 W. Jackson, Suite Chicago ...... IL ...... 60604 322,749 35 350. City of N. Chicago Housing Authority 1440 Jackson Street .. North Chicago ...... IL ...... 60064 285,313 35 City of Fort Wayne Housing Authority P.O. Box 13489 ...... Fort Wayne ...... IN ...... 46869 184,692 35 Indianapolis Housing Agency ...... 1919 North Meridian Indianapolis ...... IN ...... 46202 220,611 35 Street. Bloomington Housing Authority ...... 1007 N. Summit Street Bloomington ...... IN ...... 47404 203,898 35 Marion Housing Authority ...... 601 S. Adams Street .. Marion ...... IN ...... 46953 137,255 35 Topeka Housing Authority ...... 2010 SE. California Topeka ...... KS ..... 66607 129,976 35 Avenue. Wichita Housing Authority ...... 332 Riverview Street .. Wichita ...... KS ..... 67203 170,693 35 Louisville Housing Authority ...... 420 S. 8th Street ...... Louisville ...... KY ..... 40203 637,836 105 Lexington Fayette Urban County 300 West New Circle Lexington ...... KY ..... 40505 195,422 35 Housing Authority. Road. Newport Housing Authority ...... P.O. Box 72459 ...... Newport ...... KY ..... 41072 167,815 35 Lafayette (City) Housing Authority ...... 115 Katie Drive ...... Lafayette ...... LA ..... 70501 150,723 35 Kenner Housing Authority ...... 1013 31st Street ...... Kenner ...... LA ..... 70065 316,704 35 Bossier Parish Police Jury ...... 3022 Old Minden Bossier City ...... LA ..... 71112 164,155 35 Road, Suite 206. Boston Housing Authority ...... 52 Chauncy Street ..... Boston ...... MA .... 02111 1,315,498 105 Cambridge Housing Authority ...... 675 Massachusetts Cambridge ...... MA .... 02139 476,676 35 Avenue. New Bedford Housing Authority ...... 134 South Second New Bedford ...... MA .... 02741 246,688 35 Street. Worcester Housing Authority ...... 40 Belmont Street ...... Worcester ...... MA .... 01605 243,505 35 Northampton Housing Authority ...... 49 Old South Street— Northampton ...... MA .... 01060 235,375 35 Suite 1. Braintree Housing Authority ...... 25 Roosevelt Street ... Braintree ...... MA .... 02184 376,236 35 Chelmsford Housing Authority ...... 10 Wilson Street ...... Chelmsford ...... MA .... 01824 265,528 35 Community Development Program, 100 Cambridge Street, Boston ...... MA .... 02114 339,396 35 Comm. of MA. Suite 300. Housing Authority Prince George’s 9400 Peppercorn Largo ...... MD .... 20774 439,519 35 County. Place, Suite 200. Baltimore County Housing office ...... 6401 York Road ...... Baltimore ...... MD .... 21212 525,512 70 Portland Housing Authority ...... 14 Baxter Boulevard .. Portland ...... ME .... 04101 277,261 35 Battle Creek Housing Commission ..... 250 Champion Street Battle Creek ...... MI ..... 49017 132,381 35 Lansing Housing Commission ...... 310 Seymour Avenue Lansing ...... MI ..... 48933 202,216 35 Kent County Housing Commission ..... 82 Ionia Avenue, NW. Grand Rapids ...... MI ..... 49503 247,387 35 Suite 390.

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Michigan State Housing Development 735 E. Michigan Ave- Lansing ...... MI ..... 48912 992,758 175 Authority. nue. St. Paul Public Housing Authority ...... 555 N. Wabasha Saint Paul ...... MN .... 55102 270,759 35 Street Suite 400. Minneapolis Public Housing Authority 1001 Washington Ave- Minneapolis ...... MN .... 55401 303,276 35 nue N. St. Cloud Hra ...... 1225 W. Saint Ger- Saint Cloud ...... MN .... 56301 173,399 35 main. St. Louis Housing Authority ...... 4100 Lindell Boulevard Saint Louis ...... MO .... 63108 215,553 35 Columbia Housing Authority ...... 201 Switzler Street ..... Columbia ...... MO .... 65203 179,046 35 Joplin Housing Authority ...... 1834 W. 24th Street ... Joplin ...... MO .... 64804 112,366 35 Housing Authority of Biloxi ...... P.O. Box 447 ...... Biloxi ...... MS .... 39533 230,230 35 Jackson Housing Authority ...... P.O. Box 11327 ...... Jackson ...... MS .... 39283 207,936 35 Housing Authority of Billings ...... 2415 1st Avenue N .... Billings ...... MT .... 59101 156,954 35 Housing Authority of the City of Wil- P.O. Box 899 ...... Wilmington ...... NC .... 28402 82,712 15 mington. Hou of the City of Charlotte ...... P.O. Box 36795 ...... Charlotte ...... NC .... 28236 266,918 35 Housing Authority of the City of Ashe- P.O. Box 1898 ...... Asheville ...... NC .... 28802 166,359 35 ville. Fayetteville Metropolitan Housing Au- P.O. Box 2349 ...... Fayetteville ...... NC .... 28302 106,697 20 thority. Greensboro Housing Authority ...... P.O. Box 21287 ...... Greensboro ...... NC .... 27420 175,781 35 Housing Authority of Winston-Salem .. 500 West Fourth Winston-Salem ...... NC .... 27101 177,327 35 Street, Suite 300. Housing Authority of the County of P.O. Box 399 ...... Zebulon ...... NC .... 27597 515,362 70 Wake. Housing Authority of the City of P.O. Box 1426 ...... Greenville ...... NC .... 27835 140,175 35 Greenville. Fargo Housing And Redevelopment P.O. Box 430 ...... Fargo ...... ND .... 58107 131,830 35 Authority. Omaha Housing Authority ...... 540 S. 27th Street ...... Omaha ...... NE .... 68105 197,067 35 Manchester Housing Authority ...... 198 Hanover Street .... Manchester ...... NH .... 03104 271,561 35 Long Branch Housing Authority ...... P.O. Box 337 ...... Long Branch ...... NJ ..... 07740 379,682 35 Jersey City Housing Authority ...... 400 U.S. Highway #1 Jersey City ...... NJ ..... 07306 592,192 70 Camden Housing Authority ...... 2021 Watson Street ... Camden ...... NJ ..... 08105 286,649 35 Paterson Housing Authority ...... 60 Van Houten Street Paterson ...... NJ ..... 07505 378,658 35 New Brunswick Housing Authority ...... P.O. Box 110 ...... New Brunswick ...... NJ ..... 08903 347,757 35 New Jersey Department of Commu- 101 South Broad Trenton ...... NJ ..... 08625 637,224 70 nity Affairs. Street. Albuquerque Housing Authority ...... 1840 University Boule- Albuquerque ...... NM .... 87106 181,012 35 vard SE. Las Cruces Housing Authority ...... 926 S. San Pedro Las Cruces ...... NM .... 88001 161,013 35 Street. Santa Fe County Housing Authority ... 52 Camino De Jacobo Santa Fe ...... NM .... 87507 264,898 35 City of Reno Housing Authority ...... 1525 E. 9th Street ...... Reno ...... NV .... 89512 218,419 35 County of Clark Housing Authority ..... 5390 E. Flamingo Las Vegas ...... NV .... 89122 1,494,483 175 Road. Housing Authority of Syracuse ...... 516 Burt St ...... Syracuse ...... NY .... 13202 193,090 35 New York City Housing Authority ...... 250 Broadway ...... New York ...... NY .... 10007 2,622,952 280 Albany Housing Authority ...... 200 South Pearl St ..... Albany ...... NY .... 12202 372,050 70 Housing Authority of Rome ...... 205 St. Peter’s Ave .... Rome ...... NY .... 13440 136,720 35 Housing Authority of Rochester ...... 675 West Main St. Rochester ...... NY .... 14611 162,283 35 Suite 100. Poughkeepsie Housing Authority ...... 4 Howard Street ...... Poughkeepsie ...... NY .... 12601 222,791 35 Town of Amherst ...... 1195 Main St ...... Buffalo ...... NY .... 14209 304,786 70 NYS Housing Trust Fund Corporation 25 Beaver St, 7th New York ...... NY .... 10004 1,435,674 175 Floor. Columbus Metropolitan Housing Au- 880 East 11th Ave ..... Columbus ...... OH .... 43211 205,551 35 thority. Cuyahoga Metropolitan Housing Au- 1441 W. 25th Street ... Cleveland ...... OH .... 44113 467,896 70 thority. Cincinnati Metropolitan Housing Au- 16 W. Central Park- Cincinnati ...... OH .... 45202 204,712 35 thority. way. Lucas Metropolitan Housing Authority P.O. Box 477 ...... Toledo ...... OH .... 43697 184,318 35 Akron Metropolitan Housing Authority 100 W. Cedar Street .. Akron ...... OH .... 44307 195,985 35 Athens Metropolitan Housing Authority 10 Hope Drive ...... Athens ...... OH .... 45701 155,823 35 Oklahoma City Housing Authority ...... 1700 NE. 4th Street ... Oklahoma City ...... OK .... 73117 184,939 35 Housing Authority of Portland ...... 135 SW. Ash Street ... Portland ...... OR .... 97204 240,639 35 Housing Authority & Community Serv- 177 Day Island Road Eugene ...... OR .... 97401 178,318 35 ices Agency of Lane County. Housing Authority of Jackson County 2231 Table Rock Medford ...... OR .... 97501 354,333 70 Road.

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Linn-Benton Housing Authority ...... 1250 SE. Queen Ave Albany ...... OR .... 97322 181,818 35 Philadelphia Housing Authority ...... 12 S. 23rd Street ...... Philadelphia ...... PA ..... 19103 663,622 105 Allegheny County Housing Authority .. 625 Stanwix Street ..... Pittsburgh ...... PA ..... 15222 187,995 35 Harrisburg Housing Authority ...... 351 Chestnut Street ... Harrisburg ...... PA ..... 17101 229,013 35 Housing Authority of the County of 114 Woody Drive ...... Butler ...... PA ..... 16001 76,344 15 Butler. Delaware County Housing Authority ... 1855 Constitution Ave- Woodlyn ...... PA ..... 19094 274,485 35 nue. Hous Authority of the County of Ches- 30 W. Barnard Street West Chester ...... PA ..... 19382 287,768 35 ter. Wilkes Barre Housing Authority ...... 50 Lincoln Plaza, S. Wilkes Barre ...... PA ..... 18702 156,785 35 Wilkes Barre Blvd. Lebanon County Housing Authority .... 303 Chestnut Street ... Lebanon ...... PA ..... 17042 99,544 20 Blair County Housing Authority ...... P.O. Box 167 ...... Hollidaysburg ...... PA ..... 16648 124,395 35 Providence Housing Authority ...... 100 Broad Street ...... Providence ...... RI ...... 02903 239,459 35 Puerto Rico Deparment of Housing .... P.O. Box 21365 ...... San Juan ...... RQ .... 00928 199,033 35 Housing Authority of Columbia ...... 1917 Harden Street .... Columbia ...... SC .... 29204 198,835 35 Housing Authority Greenville ...... P.O. Box 10047 ...... Greenville ...... SC .... 29603 189,619 35 Housing Authority of Myrtle Beach ..... P.O. Box 2468 ...... Myrtle Beach ...... SC .... 29578 189,891 35 Pennington County Housing & Rede- 1805 W. Fulton Street, Rapid City ...... SD .... 57702 170,767 35 velopment Comm. Ste. 101. Memphis Housing Authority ...... P.O. Box 3664 ...... Memphis ...... TN ..... 38103 121,432 20 Knoxville Community Devel. Corp ...... P.O. Box 3550 ...... Knoxville ...... TN ..... 37927 182,089 35 Chattanooga Housing Authority ...... P.O. Box 1486 ...... Chattanooga ...... TN ..... 37401 182,751 35 Metropolitan Development & Housing 701 6th St ...... Nashville ...... TN ..... 37202 192,078 35 Agency. Housing Authority of Dickson ...... 333 Martin Luther King Dickson ...... TN ..... 37055 161,769 35 Jr. Boulevard. Housing Authority of Oak Ridge ...... 10 Van Hicks Lane ..... Oak Ridge ...... TN ..... 37830 150,834 35 Austin Housing Authority ...... P.O. Box 6159 ...... Austin ...... TX ..... 78762 583,843 70 Housing Authority of El Paso ...... 5300 E. Paisano Dr .... El Paso ...... TX ..... 79905 192,720 35 Fort Worth Housing Authority ...... 1201 13th St ...... Fort Worth ...... TX ..... 76101 647,941 105 Houston Housing Authority ...... 2640 Fountain View ... Houston ...... TX ..... 77057 1,509,320 210 San Antonio Housing Authority ...... 818 Flores St ...... San Antonio ...... TX ..... 78295 470,815 70 Housing Authority of Dallas ...... 3939 N. Hampton Dallas ...... TX ..... 75212 821,591 105 Road. Galveston Housing Authority ...... 4700 Broadway Street Galveston ...... TX ..... 77551 225,015 35 Housing Authority of Abilene ...... P.O. Box 60 ...... Abilene ...... TX ..... 79604 297,186 70 Panhandle Community Services ...... P.O. Box 32150 ...... Amarillo ...... TX ..... 79120 157,385 35 Central Texas Council of Govern- P.O. Box 729 ...... Belton ...... TX ..... 76513 163,501 35 ments. Deep East Texas Council of Govern- 210 Premier Drive ...... Jasper ...... TX ..... 75951 177,306 35 ments. Housing Authority of Salt Lake City .... 1776 S. West Temple Salt Lake City ...... UT ..... 84115 435,308 70 Norfolk Redevelopment & Housing P.O. Box 968 ...... Norfolk ...... VA ..... 23501 261,571 35 Authority. Fairfax County Redevelopment And 3700 Pender Drive Fairfax ...... VA ..... 22030 426,409 35 Housing Authority. Suite 300. City of Virginia Beach ...... Princess Anne Park Virginia Beach ...... VA ..... 23456 270,541 35 Municipal Center— Building 18a. Virginia Housing Development Author- P.O. Box 4545 ...... Richmond ...... VA ..... 23220 226,776 35 ity. Vermont State Housing Authority ...... 1 Prospect Street ...... Montpelier ...... VT ..... 05602 195,007 35 Seattle Housing Authority ...... 120 Sixth Avenue Seattle ...... WA .... 98109 455,610 53 North. King County Housing Authority ...... 600 Andover Park Seattle ...... WA .... 98188 526,969 52 West. Housing Authority of the City of Brem- P.O. Box 4460 ...... Bremerton ...... WA .... 98312 222,766 35 erton. Housing Authority of the City of Ta- 902 S. L Street ...... Tacoma ...... WA .... 98405 270,487 35 coma. Housing Authority of the City of Van- 2500 Main Street ...... Vancouver ...... WA .... 98660 406,718 70 couver. Housing Authority of Snohomish 12625 4th Avenue W. Everett ...... WA .... 98204 296,495 35 County. Suite 200. Housing Authority of the City of Yak- 810 N. 6th Avenue ..... Yakima ...... WA .... 98902 161,987 35 ima. Housing Authority of Thurston County 503 West Fourth Ave- Olympia ...... WA .... 98501 204,256 35 nue. Pierce County Housing Authority ...... P.O. Box 45410 ...... Tacoma ...... WA .... 98445 240,955 35 Spokane Housing Authority ...... 55 W. Mission Avenue Spokane ...... WA .... 99201 173,416 35

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APPENDIX A—Continued

Recipient Address City State Zip code Amount Vouchers

Housing Authority of the City of Mil- P.O. Box 324 ...... Milwaukee ...... WI ..... 53201 193,382 35 waukee. Madison Community Development P.O. Box 1785 ...... Madison ...... WI ..... 53701 224,674 35 Authority. Racine County Housing Authority ...... 837 S. Main Street ..... Racine ...... WI ..... 53403 177,360 35 Huntington WV Housing Authority ...... P.O. Box 2183 ...... Huntington ...... WV .... 25722 165,746 35 Housing Authority of Raleigh County .. P.O. Box 2618 ...... Beckley ...... WV .... 25802 123,560 35

[FR Doc. 2010–7219 Filed 3–30–10; 8:45 am] of Housing and Urban Development, them to verify the accuracy of income BILLING CODE 4210–67–P 451 Seventh Street, SW., Room 10276, reported by the tenants (participants) of Washington, DC 20410–0500. HUD rental assistance programs and (2) Communications should refer to the contract administrators (CAs) overseeing DEPARTMENT OF HOUSING AND above docket number and title. and monitoring O/A operations as well URBAN DEVELOPMENT Comments sent by facsimile are not as independent public auditors (IPAs) [Docket No. FR–5386–N–01] acceptable. A copy of each that audit both PHAs and O/As. SSA communication submitted will be data will also continue to be used to Privacy Act of 1974; Notice of available for public inspection and validate information provided by Modification of Existing Computer copying between 8 a.m. and 5 p.m. borrowers and co-borrowers applying Matching Program Between the weekdays at the above address. for and obtaining insurance for Federal Department of Housing and Urban FOR FURTHER INFORMATION CONTACT: For Housing Administration (FHA) Development (HUD) and the Social Privacy Act inquires: Office of the Chief mortgages. The HUD–SSA computer Security Administration (SSA): Information Officer, contact Donna matching program will be modified to Matching Tenant Data in Assisted Robinson-Staton, Departmental Privacy now include program participants of Housing Programs Act Officer, HUD, 451 Seventh Street, HUD’s new Disaster Housing Assistance SW., Room 2256, Washington, DC Program (DHAP). AGENCY: Office of the Chief Information 20410, telephone number (202) 402– Administrators of HUD rental Officer, HUD. 8073. For program information: Office of assistance programs rely upon the ACTION: Notice of modification of Public and Indian Housing, contact accuracy of tenant-reported income to Existing Computer Matching Program. Nicole Faison, Program Advisor for the determine participant eligibility for and Office of Public Housing and Voucher level of, rental assistance. The computer SUMMARY: Pursuant to the Computer Programs, Department of Housing and matching program will provide Matching and Privacy Protection Act of Urban Development, 451 Seventh Street, indicators of potential under-reported 1988, as amended, and the Office of SW., Room 4214, Washington, DC tenant income that will require Management and Budget’s (OMB) 20410, telephone number (202) 402– additional verification to identify Guidance on the statute (5 U.S.C. 552a, 4267; Office of Housing, contact Gail inappropriate (excess or insufficient) as amended), HUD is providing notice Williamson, Director of the Housing rental assistance, and perhaps of its intent to modify an existing Assistance Policy Division, Department administrative or legal actions. The computer matching program with SSA of Housing and Urban Development, matching program will be carried out to to include the Disaster Housing 451 Seventh Street, SW., Room 6138, detect inappropriate (excessive or Assistance Program (DHAP) as a Washington, DC 20410, telephone insufficient) rental assistance under covered HUD rental assistance program number (202) 402–2473. (These are not sections 221(3), 221(d)(5), and 236 of for the purpose of income verifications toll free telephone numbers). A the National Housing Act, the United and computer matching. telecommunications device for hearing- States Housing Act of 1937, section 101 DATES: Effective Date: The modification and speech-impaired individuals (TTY) of the Housing and Community to the existing computer matching is available at (800) 877–8339 (Federal Development Act of 1965, section 202 of program and its matching activities may Information Relay Service). the Housing Act of 1959, section 811 of commence after the respective Data SUPPLEMENTARY INFORMATION: This the Cranston-Gonzalez National Integrity Boards (DIBs) of both agencies Notice supersedes a similar notice Affordable Housing Act, the Native approve and sign the agreement published in the Federal Register (FR) American Housing Assistance and Self- modification, and after, the later of the on March 11, 2009 at 74 FR 10605. On Determination Act of 1996, and the following: (1) 30 days after HUD March 11, 2009, Section 239 of HUD’s Quality Housing and Work publishes notice of the modification in 2009 Appropriations Act modified Responsibility Act (QHWRA) of 1998. the Federal Register; (2) at least 40 days Section 904 of the Stewart B. McKinney The program will also provide for after HUD files a report of the Act of 1988, as amended, to include the verification of Social Security numbers modification with the Office of Disaster Housing Assistance Program (SSNs) for tenants participating in Management and Budge (OMB), and the (DHAP). Computer matching for covered rental assistance programs, and Congressional committees, unless participants of the Disaster Housing borrowers and co-borrowers applying comments are received, which result in Assistance Program is expected to begin for mortgage insurance for FHA loans a contrary determination no sooner than April 2010. HUD will through HUD. This Notice provides an Comments Due Date: April 30, 2010. continue to obtain SSA data and make overview of computer matching for ADDRESSES: Interested persons are the results available to (1) program HUD’s rental assistance programs. invited to submit comments regarding administrators such as public housing Specifically, the Notice describes HUD’s this notice to the Rules Docket Clerk, agencies (PHAs) and private owners and program for computer matching of its Office of General Counsel, Department management agents (O/As) to enable tenant data to SSA’s death data, Social

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Security (SS) and Supplemental the HUD-provided income information their income at least annually. However, Security Income (SSI) benefits data. to owners responsible for determining under the QHWRA of 1998, PHAs must The Computer Matching and Privacy the participant’s eligibility or level of offer public housing tenants the option Protection Act (CMPPA) of 1988, an benefits. to pay a flat rent, or an income-based amendment to the Privacy Act of 1974 II. Covered Programs rent annually. Those tenants who select (5 U.S.C. 552a), OMB’s guidance on this a flat rent will be required to recertify statute entitled ‘‘Final Guidance This Notice of computer matching income at least every three years. In Interpreting the Provisions of Public program applies to the following rental addition, the Changes to the Admissions Law 100–503, the CMPPA of 1988’’ assistance programs: and Occupancy Final Rule (March 29, (OMB Guidance), and OMB Circular No. A. Disaster Housing Assistance Program 2000; 65 FR 16692) specified that A–130 requires publication of notices of (DHAP) household composition must be computer matching programs. Appendix B. Public Housing recertified annually for tenants who I to OMB’s Revision of Circular No. A– C. Section 8 Housing Choice Voucher select a flat rent or income-based rent. 130, ‘‘Transmittal Memorandum No. 4, (HCV) Management of Federal Information D. Project-Based Voucher Other objectives of this computer Resources,’’ prescribes Federal agency E. Section 8 Moderate Rehabilitation matching program include: (1) responsibilities for maintaining records F. Project-Based Section 8 Increasing the availability of rental about individuals. In compliance with 1. New Construction assistance to individuals who meet the the CMPPA and Appendix I to OMB 2. State Agency Financed requirements of the rental assistance Circular No. A–130, copies of this notice 3. Substantial Rehabilitation programs; (2) after removal of personal are being provided to the Committee on 4. Section 202/8 identifiers, conducting analyses of the Government Reform and Oversight of 5. Rural Housing Services Section Social Security death data and benefit the House of Representatives, the 515/8 information, and income reporting of Committee of Homeland Security and 6. Loan Management Set-Aside program participants; and (3) measure Governmental Affairs of the Senate, and (LMSA) improper payments due to under- OMB’s Office of Information and 7. Property Disposition Set-Aside reporting of income and/or overpayment Regulatory Affairs. (PDSA) of subsidy on behalf of deceased I. Authority G. Section 101 Rent Supplement program participants (single member H. Section 202/162 Project Assistance households). This matching program is being Contract (PAC) conducted pursuant to the Privacy Act I. Section 202 Project Rental Assistance IV. Program Description of 1974 (5 U.S.C. 552a); 542(b) of the Contract (PRAC) 1998 Appropriations Act (Pub. L. 105– In this computer matching program, J. Section 811 Project Rental Assistance 65); section 904 of the Stewart B. tenant-provided information included Contract (PRAC) McKinney Homeless Assistance K. Section 236 in HUD’s automated systems of records Amendments Act of 1988, as amended L. Section 236 Rental Assistance known as Tenant Rental Assistance (42 U.S.C. 3544); section 165 of the Program Certification System (TRACS) (HUD/H– Housing and Community Development M. Section 221(d)(3) Below Market 11) and the Inventory Management Act of 1987 (42 U.S.C. 3543); the Interest Rate (BMIR) System (IMS), formerly known as the National Housing Act (12 U.S.C. 1701– Public and Indian Housing Information 1750g); the United States Housing Act of Note: This Notice does not apply to the Center (PIC) (HUD/PIH–4), will be Low Income Housing Tax Credit (LIHTC) or 1937 (42 U.S.C. 1437–1437z); section compared to data from SSA databases. 101 of the Housing and Community the Rural Housing Services Section 515 without Section 8 programs. The notices for these systems were Development Act of 1965 (12 U.S.C. published at 62 FR 11909 and 73 FR 1701s); the Native American Housing III. Objectives To Be Met by the 58256, respectively. HUD will disclose Assistance and Self-Determination Act Matching Program to SSA only tenant personal identifiers, of 1996 (25 U.S.C. 4101 et seq.); and the i.e., full name, Social Security number, QHWRA Act of 1998 (42 U.S.C. HUD’s primary objective in and date of birth. SSA will match the 1437a(f)). The Housing and Community implementing the computer matching HUD-provided personal identifiers to Development Act of 1987 authorizes program is to verify the income of HUD to require participants (and individuals participating in the rental personal identifiers included in their applicants) in HUD-administered assistance programs identified in various systems of records identified in programs involving loan and rental section II above to determine the Section IV of this notice. SSA will assistance to disclose to HUD their appropriate level of rental assistance, validate HUD-provided personal social security numbers (SSNs) as a and to detect, deter, reduce and correct identifiers and provide income data to condition of continuing (or initial) fraud and abuse in rental assistance HUD only for individuals with matched eligibility for participation in the programs. In meeting this objective, personal identifiers. SSA will also programs. The QHWRA of 1998, section HUD also is carrying out its provide the date of death or indication 508(d), 42 U.S.C. 1437a(f) authorizes the responsibility under 42 U.S.C. 1437f(K) of death for any program participant Secretary of HUD to require disclosure to ensure that income data provided to whose HUD-supplied personal by the tenant to the PHA of income POAs by household members is identifiers are successfully matched information received by the tenant from complete and accurate. HUD’s various against SSA databases. For any HUD as part of the income verification assisted housing programs, individual whose personal identifiers procedures of HUD. The QHWRA was administered through POAs, require do not match the personal identifiers in amended by Public Law 106–74, which that applicants and participants meet the SSA database, SSA will provide extended the disclosure requirements to certain income and other criteria to be HUD with an error message, which will participants in section 8, section 202, eligible for rental assistance. In describe the reason(s) for no match (i.e. and section 811 assistance programs. addition, tenants generally are required incorrect date of birth or surname, or The participants are required to disclose to report the amounts and sources of invalid Social Security number).

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A. Income Verification with tenants. Additionally, serious (60–0058) for the purpose of validating Any match (i.e., a ‘‘hit’’) will be further violations, which POAs, HUD Program SSNs of borrowers and co-borrowers of reviewed by HUD, the POAs, or the staff, or the HUD OIG verify, should be FHA mortgages and participants of HUD HUD Office of Inspector General (OIG) referred for full investigation and rental assistance programs to identify to determine whether the income appropriate civil and/or criminal noncompliance with program eligibility reported by tenants to the program proceedings. requirements. The Computerized Homes With respect to SSA-provided error administrator is correct and complies Underwriting Management System messages regarding HUD-provided with HUD and program administrator (HUD/H–5), published at 57 FR 62142 tenant, and matched borrower or co- requirements. Specifically, current or on December 29, 1997 is the HUD FHA borrower personal identifiers, the POA system of records used to match data prior SS and SSI benefit information and FHA administrator/agent will transferred from SSA’s Master Files of and other data will be sought directly confirm its file and system Social Security Number Holder and SSN from tenants. For public housing and documentation to confirm accuracy of Applications (60–0058) to the HUD Section 8 tenant-based HCV programs, data elements, and make any necessary mainframe. Mortgagees enter SSN data tenants will be required to provide corrections. If there is no error in the and review the returning verification/ PHAs with original SSA benefit documentation, the POAs and FHA failure data through the FHA verification letters dated within the last administrators/agents will notify the Connection. HUD will compare tenant 60 days for comparison to computer individual of the error and request that SSNs provided by POAs to reveal matching results for accuracy. For the individual contact the SSA to duplicate SSNs and potential duplicate multifamily housing programs, tenants correct any SSA data errors. POAs and rental assistance. must provide O/As with SSA benefit FHA administrators/agents cannot verification letters dated within the last correct such errors. VI. Period of the Match 120 days. For SS and SSI benefit The computer matching program will information for prior years, the tenant V. Records To Be Matched be conducted according to the computer may be required to provide POAs with SSA will conduct the matching of matching agreement between HUD and an original benefit history document tenant SSNs and additional identifiers the SSA. The computer matching from SSA if there is a dispute regarding (surnames and dates of birth) to tenant agreement for the planned matches will historical income information obtained data that HUD supplies from its systems terminate either when the purpose of through the computer matching of records known as the Tenant Rental the computer matching program is program. Assistance Certification System accomplished, or 18 months from the B. Administrative or Legal Actions (TRACS) (HUD/H–11) and the Inventory date the original agreement was signed, Management System (IMS), formerly the whichever comes first. The agreement Regarding all the matching described Public and Indian Housing Information may be extended for one 12-month in this notice, POAs will take Center (PIC) (HUD/PIH–4). Program period, with the mutual agreement of all appropriate action in consultation with administrators utilize the form HUD– involved parties, if the following tenants to: (1) Resolve income 50058 module within the IMS system conditions are met: disparities between tenant-reported and and the form HUD–50059 module (1) Within three months of the SSA-reported data; and (2) Use correct within the TRACS to provide HUD with expiration date, all Data Integrity Boards income amounts in determining rental the tenant data. review the agreement, find that the assistance. SSA will match the tenant records program will be conducted without POAs must compute the rent in full included in HUD/H–11 and HUD/PIH– change, and find a continued favorable compliance with all applicable statutes, 4 to their systems of records known as examination of benefit/cost results; and regulations and administrator policies. SSA’s Master Files of Social Security (2) All parties certify that the program POAs must ensure that they use the Number Holders, and SSN Applications has been conducted in compliance with correct income and correctly compute (60–0058), Master Beneficiary Record the agreement. the rent. In order to protect any (60–0090), and Supplemental Security The agreement may be terminated, individual whose records are used in Income Record (60–103). The notice for prior to accomplishment of the this matching program, POAs may not these systems was published at 71 FR computer matching purpose or 18 suspend, terminate, reduce, or make a 1795 on January 11, 2006. HUD will months from the date the agreement is final denial of any rental assistance to place the resulting matched data into its signed (whichever comes first), by the any tenant, or take other adverse action Enterprise Income Verification (EIV) mutual agreement of all involved parties against the tenant as a result of system (HUD/PIH–5). The notice for this within 30 days of written notice. information produced by this matching system was initially published at 70 FR Dated: March 25, 2010. program until: (a) The tenant has 41780 on July 20, 2005, and amended Jerry E. Williams, received notice from the POA of its on September 1, 2009 (74 FR 45235) to findings and has been informed of the reflect changes in the following Chief Information Officer. opportunity to contest such findings; (b) categories (sections): Categories of [FR Doc. 2010–7220 Filed 3–30–10; 8:45 am] The POA has independently verified the Individuals Covered by the System, BILLING CODE 4210–67–P information; and (c) either the notice Categories of Records in the System, period provided in applicable Purposes of the System, and Routine regulations of the program, or 30 days, Uses of Records Maintained in the DEPARTMENT OF THE INTERIOR whichever is later, has expired. System, Including Categories of Users ‘‘Independently verified’’ in item (b) and Purposes of Such Users. The tenant Bureau of Indian Affairs means the specific information relating records (one record for each family Renewal of Agency Information to the tenant that is used as a basis for member) include these data elements: Collection for Tribal Energy Resource an adverse action has been investigated full name, SSN, and date of birth. Agreements; Comment Request and confirmed by the POA. (5 U.S.C. HUD data will also be matched to the 552a) As such, POAs must resolve SSA’s Master Files of Social Security AGENCY: Bureau of Indian Affairs, income discrepancies in consultation Number Holders, and SSN Applications Interior.

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ACTION: Notice of submission to the 25 CFR part 224 will allow IEED to Constitution Avenue, NW., Washington, Office of Management and Budget. determine the capacity of tribes to DC 20245. Before including your manage the development of energy address, phone number, e-mail address SUMMARY: As required by the Paperwork resources on tribal lands. Information or other personally identifiable Reduction Act, the Office of Indian collected: information, be advised that your entire Energy and Economic Development • Enables IEED to engage in a comment—including your personally (IEED), in the Office of the Assistant consultation process with tribes that is identifiable information—may be made Secretary—Indian Affairs, is submitting designed to foster optimal pre-planning public at any time. While you may the information collection titled ‘‘Tribal of development proposals and speed up request that we withhold your Energy Resource Agreements (TERAs)’’ the review and approval process for personally identifiable information, we to the Office of Management and Budget TERA agreements; cannot guarantee that we will be able to (OMB) for renewal. The information • Provides wide public notice and do so. collection is currently authorized by opportunity for review of TERA OMB has up to 60 days to make a OMB Control Number 1076–0167, agreements by the public, industry, and decision on the submission for renewal, which expires March 31, 2010. The government agencies; but may make the decision after 30 information collection requires Indian • Ensures that the public has an days. Therefore, to receive the best tribes interested in entering into a TERA avenue for review of the performance of consideration of your comments, you or who already have a TERA to provide tribes in implementing a TERA; should submit them closer to 30 days • certain information, including Creates a process for preventing than 60 days. information as part of the application damage to sensitive resources as well as for, and implementation, reassumption, ensuring that the public has fully III. Data and rescission of the TERA. communicated with the tribe in the OMB Control Number: 1076–0167. DATES: Interested persons are invited to petition process; Title: Tribal Energy Resource submit comments on or before April 30, • Ensures that a tribe is fully aware of Agreements, 25 CFR Part 224. 2010. any attempt by the Department of the Brief Description of Collection: ADDRESSES: You may submit comments Interior to resume management Submission of this information is on the information collection to the authority over energy resources on tribal required for Indian tribes to apply for, lands; and implement, reassume, or rescind a Desk Officer for Department of the • Interior at the Office of Management and Ensures that the tribal government TERA that has been entered into in Budget, by facsimile to (202) 395–5806 fully endorses any relinquishment of a accordance with the Energy Policy Act or you may send an e-mail to: TERA. of 2005 and 25 CFR part 224. This collection also requires the tribe to [email protected]. Please II. Request for Comments notify the public of certain actions. send a copy of your comments to Darryl IEED requests that you send your Francois, Department of the Interior, Response is required to obtain a benefit. comments on this collection to the Type of Review: Extension without Office of Indian Energy and Economic location listed in the ADDRESSES section. change of a currently approved Development, Room 20—South Interior Your comments should address: (a) The collection. Building, 1951 Constitution Avenue, necessity of the information collection Respondents: Indian tribes. NW., Washington, DC 20245, fax (202) for the proper performance of the Number of Respondents: 14 (4 208–4564; e-mail: agencies, including whether the applicant tribes and 10 tribes with a [email protected]. information will have practical utility; TERA). FOR FURTHER INFORMATION CONTACT: (b) the accuracy of our estimate of the Frequency of Response: On occasion. Darryl Francois, Department of the burden (hours and cost) of the collection Total Number of Responses: 34. Interior, Office of Indian Energy and of information, including the validity of Estimated Time per Response: Ranges Economic Development, Room 20— the methodology and assumptions used; from 32 hours to 1,080 hours. South Interior Building, 1951 (c) ways we could enhance the quality, Estimated Total Annual Burden: Constitution Avenue, NW., Washington, utility and clarity of the information to 10,752 hours. DC 20245, fax (202) 208–4564; e-mail: be collected; and (d) ways we could Estimated Nonhour Cost Burden: [email protected], telephone minimize the burden of the collection of $48,200. (202) 219–0740. the information on the respondents, Alvin Foster, SUPPLEMENTARY INFORMATION: such as through the use of automated Acting Chief Information Officer—Indian collection techniques or other forms of Affairs. I. Abstract information technology. [FR Doc. 2010–7172 Filed 3–30–10; 8:45 am] The Energy Policy Act of 2005 (Pub. Please note that an agency may not BILLING CODE 4310–4J–P L. 109–58) authorizes the Secretary to sponsor or conduct, and an individual approve individual TERAs. The intent need not respond to, a collection of of these agreements is to promote tribal information unless it has a valid OMB DEPARTMENT OF THE INTERIOR oversight and management of energy Control Number. Response to the and mineral resource development on information collection is required to Bureau of Indian Affairs tribal lands and further the goal of obtain a benefit. Indian self-determination. A TERA It is our policy to make all comments Renewal of Agency Information offers a tribe an alternative for available to the public for review at the Collection for Navajo Partitioned developing energy-related business following location, during the hours of Lands Grazing Permits; Request for agreements and awarding leases and 9 a.m.–5 p.m., Eastern Daylight Savings Comments granting rights-of-way for energy Time, Monday through Friday except AGENCY: Bureau of Indian Affairs, facilities without having to obtain for legal holidays: Department of the Interior. further approval from the Secretary. Interior, Office of Indian Energy and ACTION: Notice of submission to the This information collection Economic Development, Office of Management and Budget. conducted under TERA regulations at Room 20—South Interior Building, 1951

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SUMMARY: As required by the Paperwork disclosure burden is associated with required for Navajo Nation Reduction Act, the Bureau of Indian this collection. representatives, members, and Affairs (BIA) is submitting the authorized tribal organizations to II. Request for Comments information collection, titled ‘‘Navajo obtain, modify or assign a grazing Partitioned Lands Grazing Permits, 25 The BIA requests that you send your permit on Navajo partitioned lands. CFR 161’’ to the Office of Management comments on this collection to the Response is required to obtain a benefit. and Budget (OMB) for renewal. The locations listed in the ADDRESSES Type of Review: Extension without information collection is currently section. Your comments should address: change of a currently approved authorized by OMB Control Number (a) The necessity of the information collection. 1076–0162, which expires March 31, collection for the proper performance of Respondents: Tribes, tribal 2010. The information collection the agencies, including whether the organizations, and individual Indians. requires the Navajo Nation, members of information will have practical utility; Number of Respondents: 700. the Navajo Nation, and tribal (b) the accuracy of the agencies’ Total Number of Responses: 3,120. organizations authorized by the Navajo estimate of the burden (hours and cost) Estimated Time per Response: Varies, Nation to submit certain information in of the collection of information, from 15 minutes to 1 hour. order to obtain, modify, or assign a including the validity of the Estimated Total Annual Burden: grazing permit. methodology and assumptions used; (c) 1,188 hours. DATES: Interested persons are invited to ways we could enhance the quality, Alvin Foster, utility and clarity of the information to submit comments on or before April 30, Acting Chief Information Officer—Indian 2010. be collected; and (d) ways we could Affairs. minimize the burden of the collection of ADDRESSES: You may submit comments the information on the respondents, [FR Doc. 2010–7174 Filed 3–30–10; 8:45 am] on the information collection to the such as through the use of automated BILLING CODE 4310–4J–P Desk Officer for Department of the collection techniques or other forms of Interior at the Office of Management and information technology. DEPARTMENT OF THE INTERIOR Budget, by facsimile to (202) 395–5806 Please note that an agency may not or you may send an e-mail to: sponsor or conduct, and an individual _ National Park Service OIRA [email protected]. Please need not respond to, a collection of send a copy of your comments to David information unless it has a valid OMB Notice of Inventory Completion: Edington, Office of Trust Services, Control Number. Museum of Cultural and Natural Bureau of Indian Affairs, Department of It is our policy to make all comments History, Central Michigan University, the Interior, 1849 C Street, NW., Mail available to the public for review at the Mt. Pleasant, MI Stop 4655, Washington, DC 20240, location listed in the ADDRESSES section facsimile: (202) 219–0006, or e-mail during the hours of 9 a.m.–5 p.m., AGENCY: National Park Service, Interior. [email protected]. Eastern Time, Monday through Friday ACTION: Notice. FOR FURTHER INFORMATION CONTACT: except for legal holidays. Before You Notice is here given in accordance may request further information or including your address, phone number, e-mail address or other personally with the Native American Graves obtain copies of the information Protection and Repatriation Act collection request submission from identifiable information, be advised that your entire comment—including your (NAGPRA), 25 U.S.C. 3003, of the David Edington, telephone: (202) 513– completion of an inventory of human 0886. personally identifiable information— may be made public at any time. While remains and associated funerary objects SUPPLEMENTARY INFORMATION: you may request that we withhold your in the possession of the Museum of Cultural and Natural History, Central I. Abstract personally identifiable information, we cannot guarantee that we will be able to Michigan University, Mt. Pleasant, MI. The BIA is seeking renewal of the do so. The human remains and associated approval for the information collection OMB has up to 60 days to make a funerary objects were removed from conducted under 25 CFR part 161, decision on the submission for renewal, Arenac, Isabella, and Saginaw Counties, implementing the Navajo-Hopi but may make the decision after 30 MI. Settlement Act of 1974, 24 U.S.C. 640d– days. Therefore, to receive the best This notice is published as part of the 6402–31, as amended by the Navajo- consideration of your comments, you National Park Service’s administrative Hopi Indian Relocation Amendments should submit them closer to 30 days responsibilities under NAGPRA, 25 Acts of 1980, 94 Stat. 929, and the than 60 days. U.S.C. 3003 (d)(3). The determinations Federal court decisions of Healing v. As required under 5 CFR 1320.8(d), a in this notice are the sole responsibility Jones, 174 F. Supp.211 (D. Ariz. 1959) Federal Register notice soliciting of the museum, institution, or Federal (Healing I), Healing v. Jones, 210 F. comments on this collection of agency that has control of the Native Suppl 126 (D. Ariz. 1962), aff’d 363 U.S. information was published on February American human remains and 758 (1963) (Healing II), Hopi Tribe v. 24, 2010 (75 FR 8731). No comments associated funerary objects. The Watt, 530 F. Supp. 1217 (D. Ariz. 1982), were received. This notice provides the National Park Service is not responsible and Hopi Tribe v. Watt, 719 F.2d 314 public with an additional 30 days in for the determinations in this notice. (9th Cir. 1983). which to comment on the following A detailed assessment of the human This information collection allows information collection activity. remains was made by the Museum of BIA to receive the information necessary Cultural and Natural History to determine whether an applicant to III. Data professional staff and physical obtain, modify, or assign a grazing OMB Control Number: 1076–0162. anthropologists from Western Michigan permit on Navajo-partitioned lands is Title: Navajo Partitioned Lands University, Kalamazoo, MI, and the eligible and complies with all Grazing Permits, 25 CFR 161. University of Western Ontario, Canada, applicable grazing requirements. No Brief Description of Collection: and in consultation with representatives third party notification or public Submission of this information is of the Little Traverse Bay Bands of

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Odawa Indians, Michigan, and the identified. The 372 associated funerary Traverse Bay Bands of Odawa Indians, Saginaw Chippewa Indian Tribe of objects are 285 ceramic sherds, 76 Michigan, and the Saginaw Tribe of Michigan. pieces of lithic debitage, 4 scrapers, 1 Chippewa Indians of Michigan, as the In 1970, human remains representing piece of copper, 1 abrading stone, 1 aboriginal occupants of the lands a minimum of two individuals were projectile point, 1 piece of conch, 1 bag encompassing the present-day Arenac, removed from Point Lookout, 20AC18, of ochre, 1 pipe and 1 pipe fragment. Isabella, and Saginaw Counties, MI. The in Arenac County, MI. Students from Archeological evidence dates the Review Committee considered the Central Michigan University and material from the Early Late Woodland proposal at its May 23 - 24, 2009 amateur archeologists excavated the site Era, and the determination is supported meeting and recommended disposition and the material was immediately by publications of the State of the human remains and associated turned over to the Museum of Cultural Archaeologist’s Office of Michigan. The funerary objects to the Little Traverse and Natural History. No known human remains were identified as being Bay Bands of Odawa Indians, Michigan, individuals were identified. The 11 of Native American ancestry based on and the Saginaw Tribe of Chippewa associated funerary objects are 2 archeological dating and osteological Indians of Michigan. A September 16, (reconstructed) ceramic vessels, 1 piece examination. 2009, letter on behalf of the Secretary of of worked bone, 1 small sheet of copper, The area of Arenac, Isabella, and Interior from the Designated Federal 1 bag of ochre sand, 1 stone object, 1 bag Saginaw Counties in mid-Michigan has Official transmitted the authorization of ceramic sherds, 1 group of copper a long established history of Native for the museum to effect disposition of beads and bead fragments, 1 stone tool, American occupation before European the culturally unidentifiable human 1 bone needle, and 1 tooth from an encroachment in the early 17th century. remains and associated funerary objects unknown animal. The Anishnaabek, which is comprised to the two Indian tribes listed above Archeological evidence dates the of the Odawa/Ottawa, Ojibwe/Chippewa contingent on the publication of a material from the Early Late Woodland and Potawatomi, have long called this Notice of Inventory Completion in the Era, and the determination is supported area home. Officials of the Museum of Federal Register. This notice fulfills by publications of the State Cultural and Natural History have that requirement. Archaeologist’s Office of Michigan. The reasonably determined that the Representatives of any other Indian human remains were identified as being individuals described above from tribe that believes itself to be culturally of Native American ancestry based on Arenac, Isabella, and Saginaw Counties affiliated with the human remains and archeological dating and osteological are Native American, however, officials associated funerary objects should examination. of the Museum of Cultural and Natural contact Dr. Pamela Gates, NAGPRA In 1970–1971, human remains History have determined that the Representative, Museum of Cultural and representing a minimum of 18 evidence is insufficient to determine Natural History, 103 Rowe Hall, Central individuals were removed from Indian cultural affiliation with any present-day Michigan University, Mt. Pleasant, MI Mound Park, 20IB1, in Isabella County, Indian tribe. 48859, telephone (989) 774–3341, before MI. Faculty and students from Central Officials of the Museum of Cultural Michigan University excavated the site and Natural History have determined April 30, 2010. Disposition of the and the material was immediately that, pursuant to 25 U.S.C. 3001 (9–10), human remains and associated funerary turned over to the Museum of Cultural the human remains described above objects to the Little Traverse Bay Bands and Natural History. No known represent the physical remains of 144 of Odawa Indians, Michigan, and the individuals were identified. The five individuals of Native American Saginaw Tribe of Chippewa Indians of associated funerary objects are one celt, ancestry. Officials of the Museum of Michigan may proceed after that date if one projectile point, and three ceramic Cultural and Natural History also have no additional claimants come forward. sherds. determined that, pursuant to 25 U.S.C. The Museum of Cultural and Natural Archeological evidence dates the 3001 (3)(A), the 388 objects described History is responsible for notifying the material from the Early Late Woodland above are reasonably believed to have Little Traverse Bay Bands of Odawa Era, and the determination is supported been placed with or near individual Indians, Michigan, and the Saginaw by publications of the State human remains at the time of death or Tribe of Chippewa Indians of Michigan Archaeologist’s Office of Michigan. The later as part of the death rite or that this notice has been published. human remains were identified as being ceremony. Lastly, officials of the Dated: March 2, 2010 of Native American ancestry based on Museum of Cultural and Natural History Sherry Hutt, archeological dating and osteological have determined that, pursuant to 25 Manager, National NAGPRA Program. examination. U.S.C. 3001 (2), a relationship of shared [FR Doc. 2010–7254 Filed 3–30–10; 8:45 am] From 1968 to 1970, and in 1972, group identity cannot be reasonably BILLING CODE 4312–50–S human remains representing a traced between the Native American minimum 124 individuals were human remains and associated funerary removed from the Frazier-Tyra site, objects and any present-day Indian DEPARTMENT OF JUSTICE 20SA9, in Saginaw County, MI. tribe. Amateur archeologists excavated the The Native American Graves Notice of Lodging of Consent Decrees site from 1968 to 1970, and turned over Protection and Repatriation Review Under the Comprehensive the material to the Anthropology Committee (Review Committee) is Environmental Response, Department of Central Michigan responsible for recommending specific Compensation, and Liability Act University, which transferred it to the actions for disposition of culturally (CERCLA) Museum of Cultural and Natural History unidentifiable human remains. In in the early 1990s. Students from February 2009, the Museum of Cultural Notice is hereby given that on March Central Michigan University excavated and Natural History requested that the 1, 2010, a proposed Consent Decree in the site again in 1972, and immediately Review Committee recommend the case of United States and the Coeur turned over the materials they found to disposition of the 144 culturally d’Alene Tribe v. Sidney Resources the Museum of Cultural and Natural unidentifiable human remains and Corp., civ. no. 10–00112–BLW, was History. No known individuals were associated funerary objects to the Little lodged concurrently with the filing of a

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complaint in the United States District to the Consent Decree Library at the P.O. Box 7611, U.S. Department of Court for the District of Idaho. stated address. Justice, Washington, DC 20044–7611. Comments should refer to United States The United States and the Coeur Maureen Katz, d’Alene Tribe (‘‘Tribe’’) filed a complaint and the State of Indiana v. City of Assistant Section Chief, Environmental Anderson, Indiana, Civil Action No. IP against Sidney Resources Corp. Enforcement Section, Environment and 02–1103 C M/S (S.D. Ind.) and D.J. Ref. (‘‘Sidney’’) alleging that Sidney is liable Natural Resources Division. No. 90–5–2–1–07043/2. [FR Doc. 2010–7118 Filed 3–30–10; 8:45 am] pursuant to Section 107(a) of CERCLA The First Decree Modification may be for response costs and natural resources BILLING CODE 4410–15–P examined at: (1) The offices of the damages in connection with Operable United States Attorney, 10 West Market Unit Three of the Bunker Hill Mining DEPARTMENT OF JUSTICE Street, Suite 2100, Indianapolis, and Metallurgical Complex Superfund Indiana; and (2) the offices of the U.S. Site in northern Idaho. The U.S. Notice of Lodging of Material Environmental Protection Agency, 77 Environmental Protection Agency has Modification to Consent Decree Under West Jackson Boulevard, 14th Floor, incurred response costs and the U.S. the Clean Water Act Chicago, Illinois. During the public Department of the Interior, U.S. comment period, the First Decree Department of Agriculture and the Tribe Pursuant to Department of Justice Modification may also be examined on are trustees of injured natural resources policy, notice is hereby given that, on the following Department of Justice Web for the Site. The proposed Consent March 26, 2010, a proposed First site: http://www.usdoj.gov/enrd/ Decree is based on a financial analysis Material Modification to Consent Decree Consent_Decrees.html. A copy of the (‘‘First Decree Modification’’) in United that Sidney has no ability to pay. Sidney First Decree Modification may also be States and the State of Indiana v. City does not currently own property within obtained by mail from the Department of Anderson, Indiana, Civil Action No. the Site. The Decree requires Sidney to of Justice Consent Decree Library, P.O. IP 02–1103 C M/S (S.D. Ind.) was lodged Box 7611, Washington, DC 20044–7611 assign its interests in insurance policies with the United States District Court for to a trust, for the benefit of EPA and the or by faxing or e-mailing a request to the Southern District of Indiana. The Tonia Fleetwood natural resource trustees. The Decree original Consent Decree in this matter, ([email protected]), fax no. grants Sidney a covenant not to sue for entered on September 18, 2002, (202) 514–0097, phone confirmation response costs and natural resource addressed alleged violations of the number (202) 514–1547. In requesting a damages in connection with the Site. Clean Water Act, 33 U.S.C. 1251–1387, copy from the Consent Decree Library, and corresponding state law by the City For thirty (30) days after the date of please enclose a check in the amount of of Anderson (‘‘Anderson’’). Among other this publication, the Department of $2.75 (11 pages at 25 cents per page things, the 2002 Consent Decree Justice will receive comments relating to reproduction cost) payable to the U.S. required Anderson to develop and the Consent Decree. Comments should Treasury. be addressed to the Assistant Attorney implement a Long Term Control Plan to control Combined Sewer Overflows General, Environment and Natural Maureen M. Katz, from its combined sewer system. Since Resources Division, and either e-mailed Assistant Chief, Environmental Enforcement entry of the 2002 Consent Decree, Section, Environment and Natural Resources to [email protected] or Anderson has been developing a Long Division. mailed to P.O. Box 7611, U.S. Term Control Plan in consultation with [FR Doc. 2010–7208 Filed 3–30–10; 8:45 am] Department of Justice, Washington, DC the U.S. Environmental Protection BILLING CODE 4410–15–P 20044–7611. In either case, the Agency and the Indiana Department of comments should refer to United States Environmental Management. The and the Coeur d’Alene Tribe v. Sidney control plan alternative that Anderson DEPARTMENT OF JUSTICE Resources Corp., D.J. Ref. No. 90–11–3– selected under that proposed Long Term 128/8. Control Plan would require an array of Coordinating Council on Juvenile During the comment period, the sewer system and wastewater treatment Justice and Delinquency Prevention Consent Decree may be examined on the plant improvement projects, at an [OJP (OJJDP) Docket No. 1514] following Department of Justice Web estimated cost of more than $160 site: http://www.usdoj.gov/enrd/ million. The First Decree Modification Meeting of the Coordinating Council Consent_Decrees.html. A copy of the would require Anderson to adhere to a on Juvenile Justice and Delinquency new three-phase Long Term Control Consent Decree may also be obtained by Prevention Plan implementation schedule: (1) mail from the Consent Decree Library, Phase I would be completed by no later AGENCY: Coordinating Council on P.O. Box 7611, U.S. Department of than December 31, 2014; (2) Phase II Juvenile Justice and Delinquency Justice, Washington, DC 20044–7611, or would be completed by no later than Prevention. by faxing or e-mailing a request to Tonia December 31, 2019; and (3) Phase III ACTION: Notice of meeting. Fleetwood ([email protected]), would be completed by no later than SUMMARY: fax no. (202) 514–0097, phone December 31, 2029. The Coordinating Council on confirmation number (202) 514–1547. In The Department of Justice will receive Juvenile Justice and Delinquency requesting a copy from the Consent comments relating to the First Decree Prevention (Council) announces its Decree Library, please enclose a check Modification for a period of thirty (30) April 2010 meeting. in the amount of $14.25 (25 cents per days from the date of this publication. DATES: Friday, April 16, 2010 from 11 page reproduction cost) payable to the Comments should be addressed to the a.m. to 12:30 p.m. United States Treasury or, if by e-mail Assistant Attorney General, ADDRESSES: The meeting will take place or fax, forward a check in that amount Environment and Natural Resources in the third floor main conference room Division, and mailed either at the U.S. Department of Justice, Office electronically to pubcomment- of Justice Programs, 810 7th St. NW., [email protected] or in hard copy to Washington, DC 20531.

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FOR FURTHER INFORMATION CONTACT: Visit www.juvenilecouncil.gov no later than withdrawn as parties to this venture. the Web site for the Coordinating Monday, April 12, 2010. Should The changes in its nature and objectives Council at http:// problems arise with web registration, are: The period of performance has been www.juvenilecouncil.gov or contact call Daryel Dunston at 240–221–4343 or extended to December 31, 2011. Robin Delany-Shabazz, Designated send a request to register for the April No other changes have been made in Federal Official, by telephone at 202– 16, 2010 Council meeting to Mr. either the membership or planned 307–9963 [Note: this is not a toll-free Dunston. Include name, title, activity of the group research project. telephone number], or by e-mail at organization or other affiliation, full Membership in this group research [email protected]. The address and phone, fax and e-mail project remains open, and the meeting is open to the public. information and send to his attention participants intend to file additional SUPPLEMENTARY INFORMATION: The either by fax to 301–945–4295, or by e- written notifications disclosing all Coordinating Council on Juvenile mail to [email protected]. changes in membership. Justice and Delinquency Prevention, [Note: these are not toll-free telephone On September 10, 2007, Cooperative established pursuant to Section 3(2)A of numbers.] Additional identification Research Group on Integrated the Federal Advisory Committee Act (5 documents may be required. Space is Investigation of Faulting in Carbonate U.S.C. App. 2) will meet to carry out its limited. Strata filed its original notification advisory functions under Section 206 of pursuant to Section 6(a) of the Act. The Note: Photo identification will be required Department of Justice published a notice the Juvenile Justice and Delinquency for admission to the meeting. Prevention Act of 2002, 42 U.S.C. 5601, in the Federal Register pursuant to et seq. Documents such as meeting Written Comments: Interested parties Section 6(b) of the Act on November 7, announcements, agendas, minutes, and may submit written comments and 2007 (72 FR 62870). reports will be available on the questions by Monday, April 12, 2010, to Robin Delany-Shabazz, Designated Patricia A. Prink, Council’s Web page, http:// Deputy Director of Operations, Antitrust www.JuvenileCouncil.gov., where you Federal Official for the Coordinating Council on Juvenile Justice and Division. may also obtain information on the [FR Doc. 2010–7004 Filed 3–30–10; 8:45 am] meeting. Delinquency Prevention, at BILLING CODE 4410–11–M Although designated agency [email protected]. The representatives may attend, the Council Coordinating Council on Juvenile Justice and Delinquency Prevention membership is composed of the DEPARTMENT OF JUSTICE Attorney General (Chair), the expects that the public statements Administrator of the Office of Juvenile presented will not repeat previously Antitrust Division Justice and Delinquency Prevention submitted statements. (Vice Chair), the Secretary of Health and Jeff Slowikowski, Notice Pursuant to the National Human Services (HHS), the Secretary of Acting Deputy Administrator. Cooperative Research and Production Labor, the Secretary of Education, the [FR Doc. 2010–7175 Filed 3–30–10; 8:45 am] Act of 1993—Joint Venture Agreement Secretary of Housing and Urban Between Cambridge Major BILLING CODE 4410–18–P Development, the Director of the Office Laboratories, Inc. and Konarka of National Drug Control Policy, the Technologies, Inc., in Furtherance of Chief Executive Officer of the DEPARTMENT OF JUSTICE NIST Cooperative Agreement Corporation for National and (Proposal Number 00–00–7749) Community Service, and the Assistant Antitrust Division Secretary of Homeland Security for U.S. Notice is hereby given that, on Immigration and Customs Enforcement. Notice Pursuant to the National February 18, 2010, pursuant to Section Up to nine additional members are Cooperative Research and Production 6(a) of the National Cooperative appointed by the Speaker of the House Act of 1993—Cooperative Research Research and Production Act of 1993, of Representatives, the Senate Majority Group on Integrated Investigations of 15 U.S.C. 4301 et seq. (‘‘the Act’’), Joint Leader, and the President of the United Faulting in Carbonate Strata Venture Agreement Between Cambridge States. Other federal agencies take part Major Laboratories, Inc. and Konarka in Council activities including the Notice is hereby given that, on Technologies, Inc., in Furtherance of Departments of Agriculture, Defense, February 25, 2010, pursuant to Section NIST Cooperative Agreement (Proposal the Interior, and the Substance Abuse 6(a) of the National Cooperative Number 00–00–7749) (‘‘Cambridge and and Mental Health Services Research and Production Act of 1993, Konarka 00–00–7749’’) has filed written Administration of HHS. 15 U.S.C. 4301 et seq. (‘‘the Act’’), notifications simultaneously with the Southwest Research Institute (‘‘SwRI’’): Attorney General and the Federal Trade Meeting Agenda Cooperative Research Group on Commission disclosing (1) the identities The agenda for this meeting will Integrated Investigations of Faulting in of the parties to the venture and (2) the include: (a) Reports from the Council’s Carbonate Strata has filed written nature and objectives of the venture. Operations Committee and Issue Team; notifications simultaneously with the The notifications were filed for the (b) presentations on juvenile Attorney General and the Federal Trade purpose of invoking the Act’s provisions information systems work and Commission disclosing changes in its limiting the recovery of antitrust children’s exposure to violence and c) membership, nature and objective. The plaintiffs to actual damages under update on and discussion of notifications were filed for the purpose specified circumstances. reconstruction of the Juvenile Justice of extending the Act’s provisions Pursuant to Section 6(b) of the Act, system in New Orleans. limiting the recovery of antitrust the identities of the parties to the plaintiffs to actual damages under venture are: Konarka Technologies, Inc., Registration specified circumstances. Specifically, Lowell, MA; and Cambridge Major For security purposes, members of the ConocoPhillips Co., Houston, TX; and Laboratories, Inc., Germantown, WI. The public who wish to attend the meeting Shell International Exploration & general area of Cambridge and Konarka must pre-register online at http:// Production, Inc., Houston, TX have 00–00–7749’s planned activity is to

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develop commercializable organic of Labor (Secretary) may modify the Regulation Affected: 30 CFR 75.1101– photovoltaic modules that are application of a mandatory safety 1(b) (Deluge-type water spray systems). transparent to any pre-selected region of standard to that mine if the Secretary • Docket Number: M–2009–003–M the visible spectrum. This unique determines that: (1) An alternative FR Notice: 74 FR 27186 (June 8, 2009). feature enables the application of these method exists that will guarantee no Petitioner: Resolution Copper Mining, colored, transparent, power producing less protection for the miners affected LLC, 102 Magma Heights, P.O. Box modules in windows for commercial than that provided by the standard; or 1944, Superior, Arizona 85273. and residential building and (2) that the application of the standard Mine: Resolution Copper Mine, greenhouses. will result in a diminution of safety to MSHA I.D. No. 02–00152, located in the affected miners. Pinal County, Arizona. Patricia A. Brink, MSHA bases the final decision on the Deputy Director of Operations, Antitrust Regulation Affected: 30 CFR 57.15031 petitioner’s statements, any comments (Location of self-rescue devices). Division. and information submitted by interested [FR Doc. 2010–7003 Filed 3–30–10; 8:45 am] persons, and a field investigation of the Dated: March 26, 2010. BILLING CODE 4410–11–M conditions at the mine. In some Patricia W. Silvey, instances, MSHA may approve a Director, Office of Standards, Regulations and petition for modification on the Variances. DEPARTMENT OF LABOR condition that the mine operator [FR Doc. 2010–7196 Filed 3–30–10; 8:45 am] complies with other requirements noted BILLING CODE 4510–43–P Mine Safety and Health Administration in the decision. Notice of Affirmative Decisions on II. Granted Petitions for Modification DEPARTMENT OF LABOR Petitions for Modification Granted in On the basis of the findings of Whole or in Part MSHA’s investigation, and as designee Employment and Training AGENCY: Mine Safety and Health of the Secretary, MSHA has granted or Administration partially granted the following petitions Administration (MSHA), Labor. Employment and Training ACTION: Notice of affirmative decisions for modification: • Docket Number: M–2008–047–C Administration Program Year (PY) 2010 on petitions for modification granted in Workforce Investment Act (WIA) whole or in part. FR Notice: 73 FR 69680 (November 19, 2008). Allotments; PY 2010 Wagner-Peyser SUMMARY: The Mine Safety and Health Petitioner: Knight Hawk Coal, LLC, Act Final Allotments and PY 2010 Administration (MSHA) enforces mine 7290 County Line Road, Cutler, Illinois Workforce Information Grants operator compliance with mandatory 62238. AGENCY: Employment and Training safety and health standards that protect Mine: Prairie Eagle Underground Administration, Labor. miners and improve safety and health Mine, MSHA I.D. No. 11–03147, located ACTION: conditions in U.S. mines. This Federal in Perry County, Illinois. Notice. Regulation Affected: 30 CFR 75.1101– Register Notice (FR Notice) notifies the SUMMARY: This Notice announces 1(b) (Deluge-type water spray systems). public that it has investigated and allotments for PY 2010 for WIA Title I issued a final decision on certain mine • Docket Number: M–2009–008–C FR Notice: 73 FR 23745 (May 20, Youth, Adults and Dislocated Worker operator petitions to modify a safety Activities programs; final allotments for standard. 2009). Petitioner: Excel Mining, LLC, Box Employment Service (ES) activities ADDRESSES: Copies of the final decisions 4126, State Highway 194 West, under the Wagner-Peyser Act for PY are posted on MSHA’s Web Site at http: Pikeville, Kentucky 41501. 2010 and Workforce Information Grants //www.msha.gov/indexes/petition.htm. Mine: Mine No. 3, MSHA I.D. No. 15– allotments for PY 2010. Allotments for The public may inspect the petitions 08079, located in Pike County, the Work Opportunity Tax Credits will and final decisions during normal Kentucky. be announced separately. business hours in MSHA’s Office of Regulation Affected: 30 CFR 75.503 The WIA allotments for States and the Standards, Regulations and Variances, (18.35) (Permissible electric face State final allotments for the Wagner- 1100 Wilson Boulevard, Room 2349, equipment; maintenance). Peyser Act are based on formulas Arlington, Virginia 22209. All visitors • Docket Number: M–2009–012–C defined in their respective statutes. The must first stop at the receptionist desk FR Notice: 74 FR 23746 (May 20, WIA allotments for the outlying areas on the 21st Floor to sign-in. 2009). are based on a formula determined by FOR FURTHER INFORMATION CONTACT: Petitioner: Wolf Run Mining the Secretary. As required by WIA Roslyn B. Fontaine, Acting Deputy Company, 1 Edmiston Way, section 182(d), on February 17, 2000, a Director, Office of Standards, Buckhannon, West Virginia 26201. Notice of the discretionary formula for Regulations and Variances at 202–693– Mine: Imperial Mine, MSHA I.D. No. allocating PY 2000 funds for the 9475 (Voice), [email protected] 46–09115, located in Upshur County, outlying areas (American Samoa, Guam, (E-mail), or 202–693–9441 (Telefax), or West Virginia. Marshall Islands, Micronesia, Northern Barbara Barron at 202–693–9447 Regulation Affected: 30 CFR 75.1101– Marianas, Palau, and the Virgin Islands) (Voice), [email protected] (E- 1(b) (Deluge-type water spray systems). was published in the Federal Register at mail), or 202–693–9441 (Telefax). • Docket Number: M–2009–013–C 65 FR 8236 (February 17, 2000). The [These are not toll-free numbers]. FR Notice: 74 FR 27185 (June 8, 2009). rationale for the formula and SUPPLEMENTARY INFORMATION: Petitioner: Wolf Run Mining methodology was fully explained in the Company, Rt. 3, Box 146, Philippi, West February 17, 2000, Federal Register I. Introduction Virginia 26416. Notice. The formula for PY 2010 is the Under section 101 of the Federal Mine Mine: Sentinel Mine, MSHA I.D. No. same as used for PY 2000 and is Safety and Health Act of 1977, a mine 46–04168, located in Barbour County, described in the section on Youth operator may petition and the Secretary West Virginia. Activities program allotments.

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Comments are invited on the formula Amendments Act of 2003, which averages for the 12-month period, July used to allot funds to the outlying areas. provides for consolidation of all 2008 through June 2009; DATES: Comments on the formula used funding, including WIA Title I, for the (2) Number of excess unemployed to allot funds to the outlying areas must Marshall Islands and Micronesia into individuals or the ASU excess be received by April 30, 2010. supplemental funding grants in the (depending on which is higher), ADDRESSES: Submit written comments Department of Education (48 U.S.C. averages for the same 12-month period to the Employment and Training 1921 d (f)(1)(B)(iii)). used for ASU unemployed data; and Administration, Office of Financial and The Department of Education’s (3) Number of economically Administrative Management, 200 appropriations now include funding for disadvantaged youth (age 16 to 21, Constitution Ave., NW., Room N–4702, these supplemental grants; therefore, excluding college students and Washington, DC 20210, Attention: Mr. WIA Title I funds are no longer being military), from special 2000 Census Kenneth Leung, (202) 693–3471 provided for these two areas. The calculations. As done beginning with the PY 2006 (phone), (202) 693–2859 (fax), e-mail: Compact, as amended by Section 309 of allotments, the ASU data for the PY [email protected]. Division D of Public Law 111–117, the Consolidated Appropriations Act, 2010 2010 allotments was identified by the FOR FURTHER INFORMATION CONTACT: WIA (in the Department of Education’s States using special 2000 Census data Youth Activities allotments—Evan General Provisions), extends the based on households, obtained under Rosenberg at (202) 693–3593 or LaSharn availability of programs previously Employment and Training Youngblood at (202) 693–3606; WIA available to Palau through September Administration contract with the Adult and Dislocated Worker Activities 2010, including WIA Title I funding Census Bureau and provided to States and ES final allotments—Mike Qualter provisions. by the Bureau of Labor Statistics. at (202) 693–3014; Workforce The methodology for distributing Adult Employment and Training Information Grant allotments—Anthony funds to all outlying areas is not Activities Allotments. The total Adult Dais at (202) 693–2784. specified by WIA, but is at the Employment and Training Activities SUPPLEMENTARY INFORMATION: The Secretary’s discretion. The methodology appropriation is $861,540,000. Table II Department of Labor (DOL or used is the same as used since PY 2000, shows the PY 2010 Adult Employment Department) is announcing WIA i.e., funds are distributed among the and Training Activities allotments and allotments for PY 2010 for Youth remaining areas by formula based on comparison to PY 2009 allotments by Activities, Adults and Dislocated relative share of number of unemployed, State. Like the Youth Activities Worker Activities, and Wagner-Peyser a 90 percent hold-harmless of the prior program, the total available for the Act PY 2010 final allotments. This year share, a $75,000 minimum, and a outlying areas was reserved at 0.25 notice provides information on the 130 percent stop-gain of the prior year percent of the full amount appropriated amount of funds available during PY share. As in PY 2009, data for the for Adult Activities. As discussed in the 2010 to States with an approved WIA relative share calculation in the PY 2010 Youth Activities paragraph, beginning Title I and Wagner-Peyser Act Strategic formula were from 2000 Census data for in PY 2005, WIA funding for the Plan for PY 2010, and information all outlying areas, obtained from the Marshall Islands and Micronesia is no regarding allotments to the outlying Bureau of the Census (Bureau) and are longer provided; instead, funding is areas. based on 2000 Census surveys for those provided in the Department of The allotments are based on the funds areas conducted either by the Bureau or Education’s appropriation. The Adult appropriated in the Consolidated the outlying areas under the guidance of Activities funds for grants to the Appropriations Act, 2010, Public Law the Bureau. The total amount available remaining outlying areas, for which the 111–117, December 16, 2009. Included for Native Americans is 1.5 percent of distribution methodology is at the below are tables listing the PY 2010 the total amount for Youth Activities, in Secretary’s discretion, were distributed allotments for programs under WIA accordance with WIA section 127. After among the areas by the same principles, Title I Youth Activities (Table I), Adult determining the amount for the outlying formula and data as used for outlying and Dislocated Workers Employment areas and Native Americans, the amount areas for Youth Activities. After and Training Activities (Tables II and available for allotment to the States for determining the amount for the outlying III, respectively), and the PY 2010 PY 2010 is $907,897,792. This total areas, the amount available for Wagner-Peyser Act final allotments amount was below the required $1 allotments to the States is $859,386,150. (Table IV). Also attached is the PY 2010 billion threshold specified in section Like the Youth Activities program, the Workforce Information Grant table 127(b)(1)(C)(iv)(IV); therefore, as in PY WIA minimum provisions were not (Table V). 2009, the WIA additional minimum applied for the PY 2010 allotments Youth Activities Allotments. PY 2010 provisions were not applied, and, because the total amount available for Youth Activities funds under WIA total instead, as required by WIA, the Job the States was below the $960 million $924,069,000. Table I includes a Training Partnership Act (JTPA) section threshold required for Adult Activities breakdown of the Youth Activities 202(a)(3) (as amended by section 701 of in section 132(b)(1)(B)(iv)(IV). Instead, program allotments for PY 2010 and the Job Training Reform Amendments of as required by WIA, the minimum provides a comparison of these 1992) minimums of 90 percent hold- allotments were calculated using the allotments to PY 2009 Youth Activities harmless of the prior year allotment JTPA section 202(a)(3) (as amended by allotments for all States, outlying areas, percentage and 0.25 percent State section 701 of the Job Training Reform Puerto Rico and the District of minimum floor were used. Also, as Amendments of 1992) minimums of 90 Columbia. Before determining the required by WIA, the provision applying percent hold-harmless of the prior year amount available for States, the total a 130 percent stop-gain of the prior year allotment percentage and 0.25 percent funding available for the outlying areas allotment percentage was used. The State minimum floor. Also, like the was reserved at 0.25 percent of the full three formula factors required in WIA Youth Activities program, a provision amount appropriated for Youth use the following data for the PY 2010 applying a 130 percent stop-gain of the Activities. On December 17, 2003, the allotments: prior year allotment percentage was President signed Public Law 108–188, (1) Number of unemployed for Areas used. The three formula factors use the the Compact of Free Association of Substantial Unemployment (ASUs), same data as used for the PY 2010

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Youth Activities formula, except that (3) Number of long-term unemployed, allotment. The set-aside funds were data from the 2000 Census for the averages for the 12-month period, distributed in two steps to States that number of economically disadvantaged October 2008 through September 2009. have lost in relative share of resources adults (age 22 to 72, excluding college Since the Dislocated Worker from the previous year. In Step 1, States students and military) were used. Activities formula has no floor amount that have a CLF below one million and or hold-harmless provisions, funding Dislocated Worker Employment and are also below the median CLF density changes for States directly reflect the were maintained at 100 percent of their Training Activities Allotments. The total impact of changes in the number of Dislocated Worker appropriation is relative share of prior year resources. unemployed. All remaining set-aside funds were $1,413,000,000. The total appropriation Discontinuance of Additional includes formula funds for the States, distributed on a pro-rata basis in Step 2 Funding from WIA Section 173(e) for to all other States losing in relative while the National Reserve is used for Adult/Dislocated Worker Activities for National Emergency Grants, technical share from the prior year but not Eligible States. Section 173(e) of WIA meeting the size and density criteria for assistance and training, demonstration facilitated the transition from the JTPA projects, and the outlying areas’ Step 1. The distribution of Employment to the WIA Adult formula by providing Service funds (Table IV) includes Dislocated Worker allotments. Table III funding from the National Reserve to shows the PY 2010 Dislocated Worker $701,860,926 for States, as well as States meeting certain criteria. However, $1,715,074 for outlying areas. Activities fund allotments by State. Like the WIA formula has been in effect for the Youth and Adult Activities a decade and the transition is complete. Under section 7 of the Wagner-Peyser programs, the total available for the Therefore, in accordance with language Act, 10 percent of the total sums allotted outlying areas was reserved at 0.25 in the Department of Labor to each State shall be reserved for use percent of the full amount appropriated Appropriations Act, 2010, no PY 2010 by the Governor to provide performance for Dislocated Worker Activities. WIA funds will be obligated to carry out incentives for ES offices, services for funding for the Marshall Islands and Section 173(e) of the WIA. groups with special needs, and for the Micronesia is no longer provided, as Wagner-Peyser Act Employment extra costs of exemplary models for discussed above. The Dislocated Worker Service Final Allotments. The delivering job services. Activities funds for grants to outlying appropriated level for PY 2010 for ES Workforce Information Grants areas, for which the distribution grants totals $703,576,000. After Allotments. Total PY 2010 funding for methodology is at the Secretary’s determining the funding for outlying Workforce Information Grants discretion, were distributed among the areas, allotments to States were allotments to States is $32,000,000. The remaining areas by the same pro rata calculated using the formula set forth at allotment figures for each State are share as the areas received for the PY section 6 of the Wagner-Peyser Act (29 listed in Table V. Funds are distributed 2010 WIA Adult Activities program, the U.S.C. 49e). PY 2010 formula allotments by administrative formula, with a same methodology used in PY 2009. For were based on each state’s share of reserve of $176,800 for Guam and the the State distribution of formula funds, calendar year 2009 monthly averages of Virgin Islands. The remaining funds are the three formula factors required in the civilian labor force (CLF) and distributed to the States with 40 percent WIA use the following data for the PY unemployment. The Secretary of Labor distributed equally to all States and 60 2010 allotments: is required to set aside up to three percent distributed based on each percent of the total available funds to (1) Number of unemployed, averages State’s share of CLF for the 12 months assure that each State will have ending September 2009. for the 12-month period, October 2008 sufficient resources to maintain through September 2009; statewide employment service activities, Signed at Washington, DC on this 22nd day (2) Number of excess unemployed, as required under section 6(b)(4) of the of March 2010. averages for the 12-month period, Wagner-Peyser Act. In accordance with Jane Oates, October 2008 through September 2009; this provision, the three percent set- Assistant Secretary, Employment and and aside funds are included in the total Training Administration.

TABLE I—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA YOUTH ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009

State PY 2009 PY 2010 Difference % Difference

Total ...... $924,069,000 $924,069,000 $0 0.00

Alabama ...... 9,059,768 11,777,698 2,717,930 30.00 Alaska ...... 3,061,576 2,755,418 (306,158) ¥10.00 Arizona ...... 13,869,309 15,982,731 2,113,422 15.24 Arkansas ...... 9,385,022 8,446,520 (938,502) ¥10.00 California ...... 145,161,310 136,875,948 (8,285,362) ¥5.71 Colorado ...... 9,236,777 11,132,070 1,895,293 20.52 Connecticut ...... 8,583,204 8,869,254 286,050 3.33 Delaware ...... 2,269,744 2,269,744 0 0.00 District of Columbia ...... 3,087,869 2,779,082 (308,787) ¥10.00 Florida ...... 33,348,363 43,352,872 10,004,509 30.00 Georgia ...... 24,394,229 28,251,785 3,857,556 15.81 Hawaii ...... 2,269,744 2,690,193 420,449 18.52 Idaho ...... 2,269,744 2,950,667 680,923 30.00 Illinois ...... 48,384,035 43,545,632 (4,838,403) ¥10.00 Indiana ...... 18,417,265 19,697,136 1,279,871 6.95 Iowa ...... 4,023,109 4,750,212 727,103 18.07 Kansas ...... 5,539,524 5,930,458 390,934 7.06

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TABLE I—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA YOUTH ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009—Continued

State PY 2009 PY 2010 Difference % Difference

Kentucky ...... 13,775,333 14,303,105 527,772 3.83 Louisiana ...... 15,566,262 14,009,636 (1,556,626) ¥10.00 Maine ...... 3,339,802 3,476,520 136,718 4.09 Maryland ...... 9,011,703 11,311,383 2,299,680 25.52 Massachusetts ...... 19,319,917 17,387,925 (1,931,992) ¥10.00 Michigan ...... 57,520,566 51,768,509 (5,752,057) ¥10.00 Minnesota ...... 13,837,056 14,264,509 427,453 3.09 Mississippi ...... 14,535,436 13,081,892 (1,453,544) ¥10.00 Missouri ...... 19,757,091 17,781,382 (1,975,709) ¥10.00 Montana ...... 2,269,744 2,344,418 74,674 3.29 Nebraska ...... 2,290,428 2,518,508 228,080 9.96 Nevada ...... 5,888,382 7,654,897 1,766,515 30.00 New Hampshire ...... 2,269,744 2,269,744 0 0.00 New Jersey ...... 16,205,512 20,938,294 4,732,782 29.20 New Mexico ...... 4,850,334 4,365,301 (485,033) ¥10.00 New York ...... 55,635,768 51,835,670 (3,800,098) ¥6.83 North Carolina ...... 19,500,888 25,351,154 5,850,266 30.00 North Dakota ...... 2,269,744 2,269,744 0 0.00 Ohio ...... 43,682,103 39,313,893 (4,368,210) ¥10.00 Oklahoma ...... 6,773,423 6,970,582 197,159 2.91 Oregon ...... 11,720,493 13,707,810 1,987,317 16.96 Pennsylvania ...... 31,617,301 31,871,328 254,027 0.80 Puerto Rico ...... 33,024,567 29,722,110 (3,302,457) ¥10.00 Rhode Island ...... 4,364,513 4,531,698 167,185 3.83 South Carolina ...... 19,222,108 17,299,897 (1,922,211) ¥10.00 South Dakota ...... 2,269,744 2,269,744 0 0.00 Tennessee ...... 19,522,993 18,716,506 (806,487) ¥4.13 Texas ...... 63,783,091 57,404,782 (6,378,309) ¥10.00 Utah ...... 3,941,414 3,547,273 (394,141) ¥10.00 Vermont ...... 2,269,744 2,269,744 0 0.00 Virginia ...... 10,098,341 13,127,843 3,029,502 30.00 Washington ...... 18,236,698 17,997,280 (239,418) ¥1.31 West Virginia ...... 4,156,224 3,924,261 (231,963) ¥5.58 Wisconsin ...... 10,740,989 13,963,286 3,222,297 30.00 Wyoming ...... 2,269,744 2,269,744 0 0.00

State Total ...... 907,897,792 907,897,792 0 0.00

American Samoa ...... 131,813 131,813 0 0.00 Guam ...... 1,072,924 1,072,924 0 0.00 Northern Marianas ...... 397,035 397,035 0 0.00 Palau ...... 75,000 75,000 0 0.00 Virgin Islands ...... 633,401 633,401 0 0.00

Outlying Areas Total ...... 2,310,173 2,310,173 0 0.00

Native Americans ...... 13,861,035 13,861,035 0 0.00

TABLE II—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA ADULT ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009

State PY 2009 PY 2010 Difference % Difference

Total ...... $861,540,000 $861,540,000 $0 0.00

Alabama ...... 8,881,745 11,546,269 2,664,524 30.00 Alaska ...... 2,923,068 2,630,761 (292,307) ¥10.00 Arizona ...... 13,256,136 15,227,363 1,971,227 14.87 Arkansas ...... 8,829,357 7,946,421 (882,936) ¥10.00 California ...... 139,444,084 131,676,574 (7,767,510) ¥5.57 Colorado ...... 8,341,034 10,028,610 1,687,576 20.23 Connecticut ...... 7,632,284 7,899,746 267,462 3.50 Delaware ...... 2,148,465 2,148,465 0 0.00 District of Columbia ...... 2,685,463 2,416,917 (268,546) ¥10.00 Florida ...... 33,848,953 44,003,639 10,154,686 30.00 Georgia ...... 22,833,446 26,468,737 3,635,291 15.92 Hawaii ...... 2,148,465 2,786,714 638,249 29.71 Idaho ...... 2,148,465 2,793,005 644,540 30.00 Illinois ...... 44,888,169 40,399,352 (4,488,817) ¥10.00 Indiana ...... 16,349,181 17,396,927 1,047,746 6.41

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TABLE II—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA ADULT ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009—Continued

State PY 2009 PY 2010 Difference % Difference

Iowa ...... 2,706,167 3,329,069 622,902 23.02 Kansas ...... 4,703,065 4,907,309 204,244 4.34 Kentucky ...... 14,258,220 14,765,556 507,336 3.56 Louisiana ...... 15,147,944 13,633,150 (1,514,794) ¥10.00 Maine ...... 3,146,947 3,276,134 129,187 4.11 Maryland ...... 8,545,357 10,691,615 2,146,258 25.12 Massachusetts ...... 17,533,066 15,779,759 (1,753,307) ¥10.00 Michigan ...... 53,707,324 48,336,592 (5,370,732) ¥10.00 Minnesota ...... 12,099,930 12,498,015 398,085 3.29 Mississippi ...... 13,528,436 12,175,592 (1,352,844) ¥10.00 Missouri ...... 18,243,831 16,419,448 (1,824,383) ¥10.00 Montana ...... 2,148,465 2,281,343 132,878 6.18 Nebraska ...... 2,148,465 2,148,465 0 0.00 Nevada ...... 5,904,037 7,675,248 1,771,211 30.00 New Hampshire ...... 2,148,465 2,148,465 0 0.00 New Jersey ...... 16,336,946 20,803,661 4,466,715 27.34 New Mexico ...... 4,629,318 4,166,386 (462,932) ¥10.00 New York ...... 54,853,314 51,297,403 (3,555,911) ¥6.48 North Carolina ...... 17,991,679 23,389,183 5,397,504 30.00 North Dakota ...... 2,148,465 2,148,465 0 0.00 Ohio ...... 40,703,627 36,633,264 (4,070,363) ¥10.00 Oklahoma ...... 6,353,066 6,516,603 163,537 2.57 Oregon ...... 11,013,161 12,848,682 1,835,521 16.67 Pennsylvania ...... 28,797,617 29,034,229 236,612 0.82 Puerto Rico ...... 35,033,711 31,530,340 (3,503,371) ¥10.00 Rhode Island ...... 3,666,405 3,919,536 253,131 6.90 South Carolina ...... 18,131,016 16,317,914 (1,813,102) ¥10.00 South Dakota ...... 2,148,465 2,148,465 0 0.00 Tennessee ...... 18,859,653 18,105,616 (754,037) ¥4.00 Texas ...... 59,776,554 53,798,899 (5,977,655) ¥10.00 Utah ...... 3,129,661 2,816,695 (312,966) ¥10.00 Vermont ...... 2,148,465 2,148,465 0 0.00 Virginia ...... 9,098,617 11,828,202 2,729,585 30.00 Washington ...... 16,872,727 16,563,114 (309,613) ¥1.83 West Virginia ...... 4,194,765 4,058,158 (136,607) ¥3.26 Wisconsin ...... 9,022,419 11,729,145 2,706,726 30.00 Wyoming ...... 2,148,465 2,148,465 0 0.00

State Total ...... 859,386,150 859,386,150 0 0.00

American Samoa ...... 122,595 122,595 0 0.00 Guam ...... 997,885 997,885 0 0.00 Northern Marianas ...... 369,268 369,268 0 0.00 Palau ...... 75,000 75,000 0 0.00 Virgin Islands ...... 589,102 589,102 0 0.00

Outlying Areas Total ...... 2,153,850 2,153,850 0 0.00

TABLE III—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA DISLOCATED WORKER ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009

State PY 2009 PY 2010 Difference % Difference

Total ...... $1,466,891,000 $1,413,000,000 ($53,891,000) ¥3.67

Alabama ...... 12,621,558 17,669,335 5,047,777 39.99 Alaska ...... 3,392,665 2,187,095 (1,205,570) ¥35.53 Arizona ...... 16,648,405 22,788,184 6,139,779 36.88 Arkansas ...... 7,192,470 6,867,051 (325,419) ¥4.52 California ...... 212,284,647 192,413,016 (19,871,631) ¥9.36 Colorado ...... 13,837,694 14,509,305 671,611 4.85 Connecticut ...... 14,238,672 11,850,579 (2,388,093) ¥16.77 Delaware ...... 1,950,897 2,778,921 828,024 42.44 District of Columbia ...... 3,628,361 2,990,511 (637,850) ¥17.58 Florida ...... 77,059,075 83,019,633 5,960,558 7.74 Georgia ...... 41,902,519 40,912,792 (989,727) ¥2.36 Hawaii ...... 2,067,480 3,268,124 1,200,644 58.07 Idaho ...... 2,709,982 4,536,856 1,826,874 67.41 Illinois ...... 65,561,923 54,673,396 (10,888,527) ¥16.61 Indiana ...... 25,076,767 27,257,656 2,180,889 8.70

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TABLE III—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WIA DISLOCATED WORKER ACTIVITIES STATE ALLOTMENTS; COMPARISON OF PY 2010 VS PY 2009—Continued

State PY 2009 PY 2010 Difference % Difference

Iowa ...... 4,999,095 5,888,367 889,272 17.79 Kansas ...... 4,978,239 6,855,442 1,877,203 37.71 Kentucky ...... 17,901,696 18,089,024 187,328 1.05 Louisiana ...... 8,857,065 9,812,674 955,609 10.79 Maine ...... 4,373,817 4,578,544 204,727 4.68 Maryland ...... 10,767,103 15,543,289 4,776,186 44.36 Massachusetts ...... 20,303,163 22,706,846 2,403,683 11.84 Michigan ...... 75,050,239 64,544,036 (10,506,203) ¥14.00 Minnesota ...... 20,054,286 18,020,939 (2,033,347) ¥10.14 Mississippi ...... 13,594,096 9,867,047 (3,727,049) ¥27.42 Missouri ...... 24,710,779 22,223,344 (2,487,435) ¥10.07 Montana ...... 1,679,893 2,174,950 495,057 29.47 Nebraska ...... 2,478,758 2,428,300 (50,458) ¥2.04 Nevada ...... 13,691,153 14,124,712 433,559 3.17 New Hampshire ...... 2,393,494 3,181,956 788,462 32.94 New Jersey ...... 31,288,216 33,365,324 2,077,108 6.64 New Mexico...... 2,832,500 4,093,214 1,260,714 44.51 New York ...... 63,490,356 65,534,311 2,043,955 3.22 North Carolina ...... 42,493,181 44,039,515 1,546,334 3.64 North Dakota ...... 876,713 690,086 (186,627) ¥21.29 Ohio ...... 55,974,110 51,610,221 (4,363,889) ¥7.80 Oklahoma ...... 5,762,276 6,905,534 1,143,258 19.84 Oregon ...... 16,418,257 20,167,658 3,749,401 22.84 Pennsylvania ...... 40,639,918 39,561,993 (1,077,925) ¥2.65 Puerto Rico ...... 28,244,122 17,054,847 (11,189,275) ¥39.62 Rhode Island ...... 7,601,362 6,227,600 (1,373,762) ¥18.07 South Carolina ...... 23,633,802 23,089,893 (543,909) ¥2.30 South Dakota ...... 912,475 1,000,388 87,913 9.63 Tennessee ...... 27,141,982 26,930,077 (211,905) ¥0.78 Texas ...... 51,436,825 61,378,563 9,941,738 19.33 Utah ...... 3,383,375 4,625,970 1,242,595 36.73 Vermont ...... 1,673,255 1,787,950 114,695 6.85 Virginia ...... 13,503,287 18,472,220 4,968,933 36.80 Washington ...... 21,181,897 24,271,171 3,089,274 14.58 West Virginia...... 3,424,387 4,551,211 1,126,824 32.91 Wisconsin ...... 15,363,236 19,934,322 4,571,086 29.75 Wyoming ...... 558,477 786,008 227,531 40.74

State Total ...... 1,183,840,000 1,183,840,000 0 0.00

American Samoa ...... 208,735 201,066 (7,669) ¥3.67 Guam ...... 1,699,037 1,636,618 (62,419) ¥3.67 Northern Marianas ...... 628,730 605,632 (23,098) ¥3.67 Palau ...... 127,698 123,006 (4,692) ¥3.67 Virgin Islands ...... 1,003,028 966,178 (36,850) ¥3.67

Outlying Areas Total ...... 3,667,228 3,532,500 (134,728) ¥3.67

National Reserve ...... 279,383,772 225,627,500 (53,756,272) ¥19.24

TABLE IV—U. S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; EMPLOYMENT SERVICE (WAGNER-PEYSER); PY 2010 FINAL VS PY 2009 FINAL ALLOTMENTS

Final Final State PY 2009 PY 2010 Difference % Difference

Total ...... $703,576,000 $703,576,000 $0 0.00

Alabama ...... 9,048,957 9,042,125 (6,832) ¥0.08 Alaska ...... 7,648,207 7,648,207 0 0.00 Arizona ...... 12,477,755 12,822,660 344,905 2.76 Arkansas ...... 5,880,640 5,773,513 (107,127) ¥1.82 California ...... 83,452,931 84,038,299 585,368 0.70 Colorado ...... 11,037,674 10,944,825 (92,849) ¥0.84 Connecticut ...... 7,905,625 7,843,690 (61,935) ¥0.78 Delaware ...... 1,965,210 1,965,210 0 0.00 District of Columbia ...... 2,536,120 2,479,777 (56,343) ¥2.22 Florida ...... 39,347,985 40,350,319 1,002,334 2.55 Georgia ...... 20,807,886 20,714,232 (93,654) ¥0.45 Hawaii ...... 2,534,022 2,525,177 (8,845) ¥0.35

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TABLE IV—U. S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; EMPLOYMENT SERVICE (WAGNER-PEYSER); PY 2010 FINAL VS PY 2009 FINAL ALLOTMENTS—Continued

Final Final State PY 2009 PY 2010 Difference % Difference

Idaho ...... 6,372,318 6,372,318 0 0.00 Illinois ...... 29,435,140 29,258,315 (176,825) ¥0.60 Indiana ...... 13,961,618 13,903,821 (57,797) ¥0.41 Iowa ...... 6,620,728 6,548,144 (72,584) ¥1.10 Kansas ...... 6,106,309 6,048,497 (57,812) ¥0.95 Kentucky ...... 9,142,999 9,125,242 (17,757) ¥0.19 Louisiana ...... 9,223,752 9,018,836 (204,916) ¥2.22 Maine ...... 3,789,556 3,789,556 0 0.00 Maryland ...... 11,883,400 11,800,235 (83,165) ¥0.70 Massachusetts ...... 14,326,399 14,269,289 (57,110) ¥0.40 Michigan ...... 24,621,640 24,475,871 (145,769) ¥0.59 Minnesota ...... 12,250,556 12,164,816 (85,740) ¥0.70 Mississippi ...... 6,427,984 6,285,179 (142,805) ¥2.22 Missouri ...... 13,146,226 13,030,412 (115,814) ¥0.88 Montana ...... 5,207,490 5,207,490 0 0.00 Nebraska ...... 6,258,380 6,258,380 0 0.00 Nevada ...... 6,167,234 6,370,598 203,364 3.30 New Hampshire ...... 2,873,239 2,859,890 (13,349) ¥0.46 New Jersey ...... 18,943,556 18,931,877 (11,679) ¥0.06 New Mexico ...... 5,843,720 5,843,720 0 0.00 New York ...... 40,607,026 40,405,589 (201,437) ¥0.50 North Carolina ...... 19,706,162 20,093,605 387,443 1.97 North Dakota ...... 5,302,783 5,302,783 0 0.00 Ohio ...... 26,681,937 26,537,471 (144,466) ¥0.54 Oklahoma ...... 6,951,895 6,902,154 (49,741) ¥0.72 Oregon ...... 8,702,863 8,902,979 200,116 2.30 Pennsylvania ...... 26,826,020 26,651,245 (174,775) ¥0.65 Puerto Rico ...... 8,253,932 8,070,562 (183,370) ¥2.22 Rhode Island ...... 2,661,374 2,652,902 (8,472) ¥0.32 South Carolina ...... 9,957,757 9,953,286 (4,471) ¥0.04 South Dakota ...... 4,900,991 4,900,991 0 0.00 Tennessee ...... 13,173,347 13,154,566 (18,781) ¥0.14 Texas ...... 48,305,269 48,080,415 (224,854) ¥0.47 Utah ...... 7,638,164 7,468,473 (169,691) ¥2.22 Vermont ...... 2,295,903 2,295,903 0 0.00 Virginia ...... 15,659,584 15,795,653 136,069 0.87 Washington ...... 14,623,623 14,688,343 64,720 0.44 West Virginia ...... 5,609,667 5,609,667 0 0.00 Wisconsin ...... 12,954,947 12,881,393 (73,554) ¥0.57 Wyoming ...... 3,802,426 3,802,426 0 0.00

State Total ...... 701,860,926 701,860,926 0 0.00

Guam ...... 329,219 329,219 0 0.00 Virgin Islands ...... 1,385,855 1,385,855 0 0.00

Outlying Areas Total ...... 1,715,074 1,715,074 0 0.00

TABLE V—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WORKFORCE INFORMATION GRANTS TO STATES; PY 2010 VS PY 2009 ALLOTMENTS

State PY 2009 PY 2010 Difference % Difference

Total ...... $32,000,000 $32,000,000 $0 0.00

Alabama ...... 513,199 505,992 (7,207) ¥1.40 Alaska ...... 288,558 288,781 223 0.08 Arizona ...... 626,020 631,779 5,759 0.92 Arkansas ...... 413,813 412,277 (1,536) ¥0.37 California ...... 2,507,217 2,515,778 8,561 0.34 Colorado ...... 583,382 577,959 (5,423) ¥0.93 Connecticut ...... 476,002 475,973 (29) ¥0.01 Delaware ...... 299,219 298,498 (721) ¥0.24 District of Columbia ...... 285,208 285,170 (38) ¥0.01 Florida ...... 1,388,142 1,377,429 (10,713) ¥0.77 Georgia ...... 842,605 832,325 (10,280) ¥1.22 Hawaii ...... 325,132 324,368 (764) ¥0.23 Idaho ...... 338,097 337,134 (963) ¥0.28 Illinois ...... 1,070,081 1,056,837 (13,244) ¥1.24

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TABLE V—U.S. DEPARTMENT OF LABOR; EMPLOYMENT AND TRAINING ADMINISTRATION; WORKFORCE INFORMATION GRANTS TO STATES; PY 2010 VS PY 2009 ALLOTMENTS—Continued

State PY 2009 PY 2010 Difference % Difference

Indiana ...... 642,235 637,859 (4,376) ¥0.68 Iowa ...... 451,190 450,390 (800) ¥0.18 Kansas ...... 427,610 430,687 3,077 0.72 Kentucky ...... 495,574 498,273 2,699 0.54 Louisiana ...... 494,844 499,711 4,867 0.98 Maine ...... 332,053 331,210 (843) ¥0.25 Maryland ...... 612,613 608,631 (3,982) ¥0.65 Massachusetts ...... 662,375 665,387 3,012 0.45 Michigan ...... 855,176 840,933 (14,243) ¥1.67 Minnesota ...... 606,203 606,706 503 0.08 Mississippi ...... 407,221 404,978 (2,243) ¥0.55 Missouri ...... 615,454 613,786 (1,668) ¥0.27 Montana ...... 306,660 306,340 (320) ¥0.10 Nebraska ...... 366,425 365,970 (455) ¥0.12 Nevada ...... 414,616 416,502 1,886 0.45 New Hampshire ...... 335,737 335,493 (244) ¥0.07 New Jersey ...... 796,139 800,638 4,499 0.57 New Mexico ...... 361,891 362,201 310 0.09 New York ...... 1,420,420 1,439,096 18,676 1.31 North Carolina ...... 805,049 803,030 (2,019) ¥0.25 North Dakota ...... 290,398 289,915 (483) ¥0.17 Ohio ...... 982,778 974,547 (8,231) ¥0.84 Oklahoma ...... 459,625 461,686 2,061 0.45 Oregon ...... 484,917 487,891 2,974 0.61 Pennsylvania ...... 1,027,599 1,032,188 4,589 0.45 Puerto Rico ...... 412,752 408,794 (3,958) ¥0.96 Rhode Island ...... 315,475 314,349 (1,126) ¥0.36 South Carolina ...... 508,829 512,460 3,631 0.71 South Dakota ...... 299,586 299,507 (79) ¥0.03 Tennessee ...... 621,026 616,563 (4,463) ¥0.72 Texas ...... 1,680,566 1,704,900 24,334 1.45 Utah ...... 415,279 414,068 (1,211) ¥0.29 Vermont ...... 288,282 288,734 452 0.16 Virginia ...... 748,577 753,436 4,859 0.65 Washington ...... 671,927 679,171 7,244 1.08 West Virginia ...... 344,271 342,209 (2,062) ¥0.60 Wisconsin ...... 624,534 624,061 (473) ¥0.08 Wyoming ...... 280,619 280,600 (19) ¥0.01

State Total ...... 31,823,200 31,823,200 0 0.00

Guam ...... 92,899 92,899 0 0.00 Virgin Islands ...... 83,901 83,901 0 0.00

Outlying Areas Total ...... 176,800 176,800 0 0.00

[FR Doc. 2010–6696 Filed 3–30–10; 8:45 am] filed by the parties listed below to Attention: Patricia W. Silvey, Director, BILLING CODE 4510–FN–P modify the application of existing Office of Standards, Regulations and mandatory safety standards published Variances. in Title 30 of the Code of Federal 4. Hand-Delivery or Courier: MSHA, DEPARTMENT OF LABOR Regulations. Office of Standards, Regulations and Variances, 1100 Wilson Boulevard, DATES: Mine Safety and Health Administration All comments on the petitions Room 2350, Arlington, Virginia 22209– must be received by the Office of 3939, Attention: Patricia W. Silvey, Petitions for Modification Standards, Regulations and Variances Director, Office of Standards, on or before April 30, 2010. AGENCY: Mine Safety and Health Regulations and Variances. Administration (MSHA), Labor. ADDRESSES: You may submit your MSHA will consider only comments comments, identified by ‘‘docket ACTION: Notice of petitions for postmarked by the U.S. Postal Service or ’’ modification of existing mandatory number on the subject line, by any of proof of delivery from another delivery safety standards. the following methods: service such as UPS or Federal Express 1. Electronic Mail: Standards- on or before the deadline for comments. SUMMARY: Section 101(c) of the Federal [email protected]. Individuals who submit comments by Mine Safety and Health Act of 1977 and 2. Facsimile: 1–202–693–9441. hand-delivery are required to check in 30 CFR Part 44 govern the application, 3. Regular Mail: MSHA, Office of at the receptionist desk on the 21st processing, and disposition of petitions Standards, Regulations and Variances, floor. for modification. This notice is a 1100 Wilson Boulevard, Room 2350, Individuals may inspect copies of the summary of petitions for modification Arlington, Virginia 22209–3939, petitions and comments during normal

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business hours at the address listed functional test will be corrected Regulation Affected: 30 CFR 75.1101– above. immediately; and (3) the procedure used 1(b) (Deluge-type water spray systems). FOR FURTHER INFORMATION CONTACT: to perform the functional test will be Modification Request: The petitioner Barbara Barron, Office of Standards, posted at or near each belt drive that requests a modification of the existing Regulations and Variances at 202–693– utilizes a deluge-type water spray fire standard to permit an alternate method 9447 (Voice), [email protected] suppression system. The petitioner of compliance with the blow-off dust (E-mail), or 202–693–9441 (Telefax). asserts that the proposed alternative cover requirement at deluge-type water [These are not toll-free numbers]. method will provide a measure of spray systems. In lieu of using blow-off protection equal to or greater than that dust covers, the petitioner proposes to: SUPPLEMENTARY INFORMATION: of the standard. (1) Once every 7 days, a person trained I. Background Docket Number: M–2010–012–C. in the testing procedures specific to the water deluge-type fire suppression Section 101(c) of the Federal Mine Petitioner: White Buck Coal Company, systems utilized at each belt drive will: Safety and Health Act of 1977 (Mine P.O. Box 180, Leivasy, West Virginia (a) Conduct a visual examination of Act) allows the mine operator or 26676. each water deluge-type fire suppression representative of miners to file a Mine: Grassy Creek Mine, MSHA I.D. system; (b) conduct a functional test of petition to modify the application of any No. 46–08365 and Hominy Creek Mine, the water deluge-type fire suppression mandatory safety standard to a coal or MSHA I.D. No. 46–09266, located in systems by actuating the system; and (c) other mine if the Secretary determines Nicholas County, West Virginia; and any malfunction or clogged nozzle that: (1) An alternative method of Pocahontas Mine, MSHA I.D. No. 46– detected as a result of the examination achieving the result of such standard 09154, located in Greenbrier County, and functional test will be recorded in exists which will at all times guarantee West Virginia. a book maintained on the surface for no less than the same measure of Regulation Affected: 30 CFR 75.1101– that purpose. The record will be made protection afforded the miners of such 1(b) (Deluge-type water spray systems). available to the authorized mine by such standard; or (2) that the Modification Request: The petitioner representative of the Secretary and application of such standard to such requests a modification of the existing retained at the mine for one year; (2) any mine will result in a diminution of standard to eliminate the use of blow- malfunction or clogged nozzle detected safety to the miners in such mine. In off dust covers for the spray nozzles of as a result of the weekly examination or addition, the regulations at 30 CFR a deluge-type water spray system. As an functional test will be corrected 44.10 and 44.11 establish the alternative to using the blow-off dust immediately; (3) the written procedure requirements and procedures for filing covers, the petitioner proposes the used to perform the functional test will petitions for modification. following terms and conditions: (1) A person trained in the testing procedures be provided to each individual trained II. Petitions for Modification specific to the deluge-type water spray in the testing procedure for reference; Docket Number: M–2010–011–C. fire suppression systems utilized at each and (4) conducting weekly functional Petitioner: Alex Energy, Jerry Fork belt drive will once each week: (a) tests of the water deluge-type fire Road, Drennen, West Virginia 26667. Conduct a visual examination of each of suppression systems as the proposed Mine: Jerry Fork Eagle Mine, MSHA I. the deluge-type water spray fire alternative method will provide for a D. No. 46–08787, located in Nicholas suppression systems; (b) conduct level of safety equal to or greater than County, West Virginia. functional test of the deluge-type water the statute in place. The petitioner Regulation Affected: 30 CFR 75.1101– spray fire suppression systems by asserts that the proposed alternative 1(b) (Deluge-type water spray systems). actuating the system and watching its method will at all times guarantee no Modification Request: The petitioner performance; and (c) record the results less than the same measure of protection requests a modification of the existing of the examination and functional test afforded the miners by such standard standard to eliminate the use of blow- in a book maintained on the surface for with no diminution of safety to the off dust covers for the spray nozzles of that purpose. The record will be made miners. a deluge-type water spray system. As an available to the authorized Docket Number: M–2010–014–C. alternative to using the blow-off dust representative of the Secretary and Petitioner: Sunrise Coal, LLC, 1183, covers, the petitioner proposes the retained at the mine for one year; (2) any East Canvasback Drive, Terre Haute, following terms and conditions: (1) A malfunction or clogged nozzle detected Indiana 47802. person trained in the testing procedures as a result of the weekly examination or Mine: Carlisle Mine, MSHA I.D. No. specific to the deluge-type water spray functional test will be corrected 12–02349, located in Sullivan County, fire suppression systems utilized at each immediately; and (3) the procedure used Indiana. belt drive will once each week: (a) to perform the functional test will be Regulation Affected: 30 CFR 75.1101– Conduct a visual examination of each of posted at or near each belt drive that 1(b) (Deluge-type water spray systems). the deluge-type water spray fire utilizes a deluge-type water spray fire Modification Request: The petitioner suppression systems; (b) conduct suppression system. The petitioner requests a modification of the existing functional test of the deluge-type water asserts that the proposed alternative standard to permit weekly examinations spray fire suppression systems by method will provide a measure of and functional testing of the deluge-type actuating the system and watching its protection equal to or greater than that water fire suppression systems in lieu of performance; and (c) record the results of the standard. providing blow-off dust covers. The of the examination and functional test Docket Number: M–2010–013–C. petitioner states that: (1) Conducting a in a book maintained on the surface for Petitioner: RoxCoal, Inc., 1576 weekly examination and functional test that purpose. The record will be made Stoystown Road, P.O. Box 149, of the deluge water fire suppression available to the authorized Friedens, Pennsylvania 15541. systems will provide an improvement in representative of the Secretary and Mine: Quecreek No. 1 Mine, MSHA I. safety and insure that the spray nozzles retained at the mine for one year; (2) any D. No. 36–08746, and Roytown Deep do not become plugged; and (2) malfunction or clogged nozzle detected Mine, MSHA I.D. No. 36–09260, located replacing the dust caps creates an as a result of the weekly examination or in Somerset County, Pennsylvania. unnecessary hazard by exposing miners

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to the risk of a slip/fall type accident. LEGAL SERVICES CORPORATION 295–1500 or The petitioner asserts that this petition [email protected]. Sunshine Act Meetings of the Board of upon approval will be mandated Dated: March 29, 2010. Directors and Five Committees of the throughout the Carlisle Mine and will Patricia D. Batie, provide no less than the same measure Board Corporate Secretary. of protection afforded by the standard. Notice [FR Doc. 2010–7388 Filed 3–29–10; 4:15 pm] Docket Number: M–2010–015–C. DATE AND TIME: The Legal Services BILLING CODE 7050–01–P Petitioner: Sunrise Coal, LLC, 1183 Corporation Board of Directors will East Canvasback Drive, Terre Haute, meet on April 7, 2010 at 12 p.m., Indiana 47802. Eastern Time. OFFICE OF MANAGEMENT AND Mine: Carlisle Mine, MSHA I.D. No. LOCATION: Legal Services Corporation, BUDGET 12–02349, located in Sullivan County, 3333 K Street, NW., Washington, DC Indiana. 20007, 3rd Floor Conference Center. Office of Federal Procurement Policy Regulation Affected: 30 CFR 75.1700 PUBLIC OBSERVATION: For all meetings Work Reserved for Performance by (Oil and gas wells). and portions thereof open to public Federal Government Employees Modification Request: The petitioner observation, members of the public who AGENCY: Office of Management and requests a modification of the existing are unable to attend but wish to listen Budget, Office of Federal Procurement standard to permit mine through or near to the proceedings may do so by Policy. (whenever the safety barrier diameter is following the telephone call-in reduced to a distance less than the directions given below. You are asked to ACTION: Notice of proposed policy letter. District Manager would approve keep your telephone muted to eliminate background noises. From time to time SUMMARY: The Office of Federal pursuant to 75.1700) plugged oil and gas Procurement Policy (OFPP) in the Office wells penetrating the Indian V coal the Chairman may solicit comments from the public. of Management and Budget (OMB) is seam. The petitioner has listed in this issuing a proposed policy letter to petition a complete list of procedures to Call-in Directions for Open Session(s) provide guidance to Executive be utilized when plugging oil and gas • Call toll-free number: 1–(866) 451– Departments and agencies on wells. Persons may review these 4981; circumstances when work must be procedures at the MSHA address listed • When prompted, enter the reserved for performance by Federal in this notice. The petitioner asserts that following numeric pass code: government employees. The the proposed alternative method will at 5907707348; Presidential Memorandum on all times guarantee no less than the • When connected to the call, please Government Contracting, issued on same measure of protection afforded to ‘‘MUTE’’ your telephone immediately. March 4, 2009, directs OMB to clarify the miners under 30 CFR 75.1700. STATUS OF MEETING: Open. when governmental outsourcing of Docket Number: M–2010–016–C. MATTERS TO BE CONSIDERED: services is, and is not, appropriate, consistent with section 321 of the Petitioner: Lone Mountain Processing, Board of Directors Inc., Drawer C, St. Charles, Virginia National Defense Authorization Act 24282. Agenda (NDAA) for FY 2009. Section 321 requires OMB to (i) create a single Open Session Mine: Huff Creek No. 1 Mine, MSHA definition for the term ‘‘inherently I.D. No. 15–17234, Darby Fork No. 1 1. Approval of agenda; governmental function’’ that addresses Mine, MSHA I.D. No. 15–02263, Clover 2. Consider and act on nominations any deficiencies in the existing Fork No. 1 Mine, MSHA I.D. No. 15– for the Chairman of the Board of definitions and reasonably applies to all 18647, all located in Harlan County, Directors; agencies; (ii) establish criteria to be used Kentucky. 3. Consider and act on nominations by agencies to identify ‘‘critical’’ Regulation Affected: 30 CFR 75.208 for the Vice Chairman of the Board of functions and positions that should only (Warning devices). Directors; be performed by federal employees; and 4. Consider and act on delegation to (iii) provide guidance to improve Modification: The petitioner requests Chairman of authority to make a modification of the existing standard internal agency management of Committee assignments; functions that are inherently to permit a readily visible warning to be 5. Public comment; posted, or a physical barrier to be governmental or critical. The 6. Consider and act on other business; Presidential Memorandum is available installed on the second row of 7. Consider and act on motion to permanent roof support outby at http://www.whitehouse.gov/ adjourn meeting. _ _ unsupported roof to impede travel the press office/. CONTACT PERSON FOR INFORMATION: beyond permanent support, except Memorandum-for-the-Heads-of- Katherine Ward, Executive Assistant to during the installation of roof supports. Executive-Departments-and-Agencies- the Vice President & General Counsel, at The petitioner asserts that the proposed Subject-Government/. (202) 295–1500. Questions may be sent alternative method will at all times Section 321 may be found at http:// by electronic mail to guarantee no less than the same measure thomas.loc.gov/cgi-bin/query/ [email protected]. ~ of protection afforded by the F?c110:5:./temp/ c110wWVqGQ: appropriate portion of 30 CFR 75.208. SPECIAL NEEDS: Upon request, meeting e178256. notices will be made available in Comment Date: OFPP invites Dated: March 26, 2010. alternate formats to accommodate visual interested parties from both the public Patricia W. Silvey, and hearing impairments. Individuals and private sectors to provide comments Director. who have a disability and need an to be considered in the formulation of [FR Doc. 2010–7197 Filed 3–30–10; 8:45 am] accommodation to attend the meeting the final policy letter. Interested parties BILLING CODE 4510–43–P may notify Katherine Ward, at (202) should submit comments in writing to

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the address below on or before June 1, governmental functions would be agency maintains control of its mission 2010. strengthened to ensure that performance and operations; (4) provide criteria for ADDRESSES: Comments may be of such functions does not expand to identifying agency personnel with submitted by any of the following include performance of inherently responsibility for (a) maintaining methods: governmental functions or otherwise sufficient organic expertise and • E-mail: interfere with federal employees’ ability technical capability within the agency, [email protected]. to carry out their inherently and (b) issuing guidance for internal • Facsimile: 202–395–5105. governmental responsibilities. In activities associated with determining • Mail: Office of Federal Procurement addition, consistent with section 321, a when work is to be reserved for Policy, ATTN: Mathew Blum, New new category, ‘‘critical function,’’ would performance by Federal employees; and Executive Office Building, Room 9013, be defined to help agencies identify and (5) solicit the views of the public 724 17th Street, NW., Washington, DC build sufficient internal capacity to regarding these matters. 20503. effectively perform and maintain control OMB’s OFPP reviewed current laws, Instructions: Please submit comments over functions that are core to the regulations, policies, and reports only and cite ‘‘Proposed OFPP Policy agency’s mission and operations. addressing the definition of inherently Letter’’ in all correspondence. All • Outline a series of agency governmental functions and the comments received will be posted, management responsibilities to reservation of work for government without change, to http:// strengthen accountability for the employees. The review was conducted www.whitehouse.gov/omb/ effective implementation of these with the assistance of an interagency procurement/workreserved/ policies. Agencies would be required to team that included representatives from work_comments.html, without take specific actions, before and after the Chief Acquisition Officers Council redaction, so commenters should not contract award, to prevent contractor and the Chief Human Capital Officers include information that they do not performance of inherently governmental Council. As part of this effort, OFPP wish to be posted (for example because functions and overreliance on reviewed the definition of inherently they consider it personal or business- contractors in ‘‘closely associated’’ and governmental functions in the Federal confidential). critical functions. Agencies would also Activities Inventory Reform Act (FAIR be required to develop agency-level Act), Public Law 105–270, section 2383 FOR FURTHER INFORMATION CONTACT: procedures, provide training, and of title 10 (which cites to definitions in Mathew Blum, OFPP, (202) 395–4953 or designate senior officials to be the Federal Acquisition Regulation [email protected]. responsible for implementation of these (FAR)), the FAR, OMB Circular A–76, SUPPLEMENTARY INFORMATION: policies. OFPP Policy Letter 92–1, Inherently A. Overview After public comment is considered Governmental Functions (which was and the policy letter is finalized, rescinded and superseded by OMB OFPP is issuing a proposed policy appropriate changes will be made to the Circular A–76 in 2003) and reports by letter to provide guidance addressing Federal Acquisition Regulation (FAR). the Government Accountability Office when work must be reserved for B. Background (GAO). OFPP also reviewed the analyses performance by federal employees. The in a recent report by the Congressional policy letter is intended to implement The Presidential Memorandum on Research Service, Inherently direction in the President’s March 4, Government Contracting requires the Governmental Functions and 2009, Memorandum on Government Director of OMB to develop guidance Department of Defense Operations: Contracting that requires OMB to addressing when governmental Background, Issues, and Options for ‘‘clarify when governmental outsourcing outsourcing of services is, and is not, Congress (June 2009) and relevant for services is and is not appropriate, appropriate. The Memorandum states findings and recommendations set forth consistent with section 321 of Public that the line between inherently in the Report of the Acquisition Law 110–417 (31 U.S.C. 501 note).’’ The governmental activities that should not Advisory Panel (January 2007), available proposed policy letter would: be outsourced and commercial activities at https://www.acquisition.gov/comp/ • Clarify what functions are that may be subject to private-sector aap/documents/Chapter6.pdf. The inherently governmental and must performance has become blurred, which Panel concluded, among other things, always be performed by federal may have led to the performance of that ‘‘[t]here is a need to assure that the employees. A single definition of inherently governmental functions by increase in contractor involvement in ‘‘inherently governmental function’’ contractors and, more generally, an agency activities does not undermine built around the well-established overreliance on contractors by the the integrity of the government’s statutory definition in the Federal government. It directs OMB to clarify decision-making processes.’’ See the Activities Inventory Reform Act (FAIR when outsourcing is, and is not, Panel’s Report at 392. Act), Public Law 105–270, would appropriate, consistent with section 321 To supplement this review, OMB held replace existing definitions in regulation of the NDAA for FY 2009. a public meeting and solicited and policy. The FAIR Act defines an Section 321 directed OMB to: (1) comments from the public last spring activity as inherently governmental Create a single, consistent definition for and summer to inform the development when it is so intimately related to the the term ‘‘inherently governmental of guidance. Comments were public interest as to mandate function’’ that addresses any specifically sought regarding the performance by Federal employees. deficiencies in the existing definitions definition of inherently governmental Examples and tests would be provided and reasonably applies to all agencies; functions and criteria for identifying to help agencies identify inherently (2) develop criteria for identifying critical functions. See 74 FR 25775 (May governmental functions. critical functions with respect to the 29, 2009) for a copy of the notice. OMB • Help agencies identify when other agency’s missions and structure; (3) received 11 comments addressing these functions (or portions of functions) need develop criteria for determining issues. For a copy of public comments, to be performed by Federal employees. positions dedicated to critical functions go to http://www.whitehouse.gov/omb/ Existing guidance addressing functions which should be reserved for federal assets/procurement_govcontracting/ closely associated with inherently employees to ensure the department or public_comments.pdf. For a transcript

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of the public meeting, go to http:// defines an activity as inherently variations in the language used by the www.whitehouse.gov/omb/assets/ governmental when it is so intimately three sources to describe the types of procurement_gov_contracting/ related to the public interest as to functions included in the definition. In transcript_public_meeting.pdf. mandate performance by Federal particular, the FAIR Act states that the Respondents generally favored the employees.) Develop guidance to help term includes activities that require the definition of ‘‘inherently governmental agencies identify whether a given ‘‘exercise of discretion’’ in applying function’’ found in the FAIR Act. Some function falls within the definition of ‘‘Federal Government authority,’’ concern was raised regarding changes ‘‘inherently governmental function’’ or is whereas the Circular speaks in terms of made to the definition by OMB Circular otherwise closely associated with the the exercise of ‘‘substantial discretion’’ A–76 when the Circular was revised in performance of inherently governmental in applying ‘‘sovereign’’ Federal 2003. functions. Provide tests for analyzing government authority. It is unclear what Some respondents recommended that whether a function is inherently the impact of this type of variation has the criteria OMB develops to identify governmental based on the nature of the been. This notwithstanding, these critical functions and positions reserved function and the level of discretion to be variations can create confusion and for federal employees be tied to mission exercised in performing the function. uncertainty. performance. Some cautioned that these Reinforce management The proposed policy letter adopts the criteria should also guard against the responsibilities—both before and after FAIR Act definition as the single, contracting out of a function if such contract award—to guard against government-wide definition. This action poses too great a risk of creating contractor performance of inherently definition reflects longstanding OFPP a single point of mission failure. governmental functions. guidance that had been set out in OFPP However, at least one commenter Concern: Some government Policy Letter 92–1. 57 FR 45096 expressed the view that, as long as the organizations may be overly reliant on (September 30, 1992). Most public overall function is managed by a federal contractors to perform critical functions commenters expressed general employee, not every position that, while not inherently governmental, satisfaction with the statutory definition performing a critical function needs to still need to be performed by Federal in the FAIR Act, while also be performed by federal employees in employees. acknowledging uncertainties as to its order to protect the government’s Proposed actions: Provide guidance construction and application in interest and prevent mission failure. for determining the criticality of particular circumstances. Another commenter stated that tasks functions. Identify criteria for b. Guidance. The proposed policy closely associated with governmental determining when positions dedicated letter provides guidance to help decision-making should not be to performing critical functions must or agencies determine whether a given contracted out unless the government should be reserved for Federal employee function meets the definition of an can effectively guard against or performance. Hold appropriate officials ‘‘inherently governmental function.’’ The otherwise mitigate conflicts of interest. accountable for ensuring adequate proposed policy letter retains a list of Based on this review and analysis has been performed to establish examples of inherently governmental consideration of the public comments, the sufficiency of internal capability in functions, currently found in FAR OFPP has: (1) Developed a proposed the event that contractors are to perform Subpart 7.5. OFPP would also create policy letter and (2) formulated a list of part of the function. tests for agencies to use in determining tailored questions to elicit feedback on Concern: There is insufficient whether functions not appearing on the specific issues that will help inform its management attention focused on list otherwise fall within the definition ‘‘ deliberations in shaping final guidance. ensuring work is properly reserved for of inherently governmental. The nature federal employees and maintaining of the function’’ test would ask agencies C. Proposed Policy Letter certain critical capability levels in- to consider whether the direct exercise of sovereign power is involved. Such 1. Summary house. An appropriate governance and review structure must be established to functions are uniquely governmental OFPP has developed a proposed support the successful performance of and, therefore, inherently governmental. policy letter to improve the rules these duties. The ‘‘discretion’’ test would ask agencies addressing the proper roles of the public Proposed actions: Require agencies to to evaluate whether the discretion and private sectors in performing work develop agency-level procedures, associated with the function, when for the government. The policy letter is conduct training, periodically review exercised by a contractor, would have designed to address a number of internal controls used to monitor the effect of committing the government weaknesses with existing rules that are implementation of this authority, and to a course of action. This test was affecting the efficiency and effectiveness designate one or more senior officials to included in OFPP Policy Letter 92–1, of government performance. These be responsible for implementation and Inherently Governmental Functions, and weaknesses are summarized below maintenance of the policy. currently may be found in OMB Circular along with a brief description of how A–76 (see Attachment A, para. B(1)(b)), they would be addressed. 2. Inherently Governmental Functions which rescinded Policy Letter 92–1. Concern: The line has been blurred There are three main sources for OFPP seeks to clarify and reinforce between functions that are inherently definitions and guidance addressing that agencies have both pre-award and governmental and those that are not, inherently governmental function: (1) post-award responsibilities for potentially leading to confusion and to The FAIR Act, (2) the FAR, and (3) OMB evaluating whether a function is inappropriate judgments about when Circular A–76. inherently governmental and taking contractors may perform work that a. Definition. The FAIR Act, FAR, and steps to avoid transferring inherently should be reserved for performance by Circular A–76 each make clear that the governmental authority to a contractor, Federal employees. term ‘‘inherently governmental such as through inadequate attention to Proposed actions: Adopt the FAIR Act function’’ addresses functions that are so contract administration. For proposed definition of ‘‘inherently governmental intimately related to the public interest work, a determination that the work is function’’ as the single government-wide as to require performance by federal not inherently governmental should be definition of this term. (The FAIR Act government employees. There are some made prior to issuance of the

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solicitation, preferably during paragraph 5, below, for additional account factors such as the agency’s acquisition planning. For ongoing discussion on new agency mission, the complexity of the function contracts, agencies should review how responsibilities for management and and need for specialized skill, and the work is performed, focusing, in monitoring). effect of contractor default on mission particular, on functions that are closely performance. The proposed guidance is 4. Critical functions associated with inherently built around the general principle that governmental activities and professional Since at least the early 1990s, the more critical a function is, the and technical services, to ensure the government-wide policy addressing greater the need for internal capability scope of the work or the circumstances when work must be reserved for Federal to maintain control of the agency’s have not changed to the point that employees has focused almost mission and operations. This is most inherently governmental authority has exclusively on the definition of obviously the case where the function is been transferred to the contractor. ‘‘inherently governmental’’ functions critical to achievement of the agency’s and functions closely associated with core mission, but even for functions that 3. Functions That Are Closely inherently governmental functions. This may not be viewed as critical, such as Associated With Inherently narrow focus has been cited as a cause functions that are not directly involved Governmental Functions of inadequate attention to maintaining a in performing the core mission, the Policy guidance addressing inherently residual Federal core capability when agency may determine that the function governmental functions must also considering contractor performance of is, nonetheless, sensitive enough as to address functions closely associated critical functions that are tied to an require that many, most, or, in some with inherently governmental functions agency’s mission. The Acquisition situations, all positions be filled by to properly ensure that work that is Advisory Panel, established by Congress Federal employees. intimately related to the public interest in 2003 to review the federal acquisition Finally, if an agency determines that is performed by Federal employees. system, concluded in its 2007 report it has sufficient internal capability to Closely associated functions approach that the consequences of this inattention control its mission and operations, the the status of inherently governmental to contractor performance of critical proposed policy would require the work because of the nature of these functions include ‘‘the loss of consideration of cost to establish the functions and the risk that their institutional memory, the inability to be extent to which additional critical work performance, if not appropriately certain whether the contractor is is performed by Federal employees, managed, may materially limit Federal properly performing the specified work unless performance and risk officials’ performance of inherently at a proper price and the inability to be considerations in favor of Federal governmental functions. sure that decisions are being made in employee performance would clearly The proposed policy letter retains an the public interest rather than in the outweigh cost considerations. illustrative list of functions closely interest of the contractors performing associated with inherently the work.’’ Following the issuance of the 5. Management Attention governmental functions from current Panel’s report, Congress, in the FY 2009 A clear understanding of FAR coverage. The guidance requires NDAA, directed OMB to develop responsibilities and heightened agencies to take a number of steps criteria for agencies to use in identifying management attention will be required related to these functions. First, the ‘‘critical’’ functions and in determining to ensure that work that should be proposed policy letter reiterates the when such functions, or parts thereof, performed by Federal employees is requirement set forth in section 736 of must be retained for performance by reserved for performance by them. Division D of the Omnibus federal employees. The proposed policy letter lays out Appropriations Act, 2009, Public Law Consistent with section 321 of the FY the determinations that must be 111–8, to give special consideration to 2009 NDAA, the proposed policy letter documented by the agency head or reserving these functions to provides guidance to address the designated requirements official before a performance by federal employees. handling of critical functions and the contract solicitation is issued to show Second, the proposed policy letter lays maintenance of a core capability by that functions to be acquired by contract out the responsibilities agencies must Federal employees. The proposed policy are not inherently governmental. It perform if they determine that letter would define critical function to would also require agencies to contractor performance of a function mean a function whose importance to determine (also before issuing a closely associated with an inherently the agency’s mission and operation solicitation) that they have sufficient governmental function is appropriate. requires that at least a portion of the internal capability to control their These responsibilities include pre- function must be reserved to federal mission and operations. During contract establishing in the contract specified employees in order to ensure the agency performance, agencies would be ranges of acceptable decisions, has sufficient internal capability to required to (1) monitor how contractors subjecting the contractor’s discretionary effectively perform and maintain control are performing contracts, especially decision to final approval by an agency of its mission and operations. Agencies those involving work closely associated official, assigning a sufficient number of would be held responsible for ensuring with inherently governmental functions qualified federal employees with a sufficient number of positions or professional and technical services, appropriate expertise to administer the performing critical work are filled by and (2) take appropriate action where work, and taking steps to avoid or federal employees with appropriate internal control of mission and mitigate conflicts of interest. Each of training, experience, and expertise to operations is at risk due to these actions is designed to help ensure understand the agency’s requirements, inappropriate or excessive reliance on that the contractor’s activities do not formulate alternatives, manage the work contractors to perform critical functions. expand to include inherently product, and manage any contractors Finally, the proposed policy letter governmental responsibilities. Although used to support the Federal workforce. would require agencies to strengthen these actions should currently be taken, The proposed guidance would also internal agency management. Each they are not enumerated in one require agencies to evaluate whether agency with 100 or more full-time guidance document and often are given they have sufficient internal capability federal employees in the prior fiscal insufficient management attention (see on a case-by-case basis, taking into year would be required to identify one

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or more senior officials to be to inform government officials and those determinations of responsibility, accountable for the development and where contractors are limiting or determinations and findings, and implementation of agency policies, constraining government exercise of justifications; procedures, and training to ensure the inherently governmental ii. Post-award acquisition support, appropriate reservation of work for responsibilities? such as functions involving the use of federal employees. The selected officials e. What, if any, changes should be contractors to manage other contractors, would be expected to facilitate the made to existing laws that currently the development of contractor meaningful involvement of all relevant deem specific functions or the work performance assessments, review of offices. In addition, agencies would be performed by specific organizations to contract claims, and the preparation of expected to develop and maintain (1) be inherently governmental? termination settlement proposals; internal procedures, to be reviewed by iii. Procurement management reviews; 3. Closely Associated and Critical iv. Management of Federal grantees; agency management every two years, Functions and (2) training plans to help their v. Strategic planning; employees understand and meet their a. Should the policy letter set out a vi. Lead systems integration; responsibilities. presumption, or a requirement, in favor vii. Physical security involving: of performance of ‘‘closely associated’’ A. Guard services, convoy security D. Solicitation of Public Comment and/or critical functions by federal services, pass and identification OFPP welcomes comments on the employees? services, plant protection services, the proposed policy letter. Respondents are b. What, if any, additional guidance operation of prison or detention also encouraged to offer their views on may help agencies differentiate between facilities; the following questions, many of which critical functions and functions that are B. Security services other than those are designed to help elicit feedback on closely associated with the performance described in A; or specific aspects of the draft guidance. of inherently governmental functions? C. The use of deadly force, including c. Should these categories be merged combat, security operations performed 1. Definitions and treated in identical fashion? Why or in direct support of combat, and a. If the FAIR Act definition of why not? security that could evolve into combat; ‘‘inherently governmental’’ is adopted, d. What, if any, additional guidance viii. Cyber security, including IT what additional definitional might be provided to help agencies network security; clarification is needed, if any? identify the extent to which a critical ix. Support for intelligence activities, b. What additional guidance should function may be performed by a such as covert operations; be provided to make clear that contractor? x. The assistance, reinforcement or identifying ‘‘critical’’ work is driven by e. Should the policy clarify whether rescue of individuals who become mission and circumstance, which will determinations regarding criticality are engaged in hostilities or offensive differ between agencies and within to be made at the departmental or responses to hostile acts or agencies over time? Is there a term other component level? demonstrated hostile intentions; and than ‘‘critical’’ that might be used to xi. Intelligence interrogation of 4. Non-critical Functions more clearly convey this principle? detainees, including interrogations in c. What, if any, additional guidance a. What, if any, additional guidance connection with hostilities. should be provided to address what is may help agencies differentiate between c. Should the guidance provide an meant by the term ‘‘public interest’’? functions that are critical and those that illustrative list of functions that are are not? presumed to be critical? Why or why 2. Inherently Governmental Functions b. Should guidance allow agency not? If so, what functions should be a. Does the ‘‘discretion’’ test (which is heads to identify categories of service included on the list? derived from OMB Circular A–76, contracts that may be presumed to be 6. Human Capital Planning Attachment A and, before that, OFPP non-critical? Why or why not? Policy Letter 92–1) help or hinder a. How, if at all, should this guidance 5. Specific Functions identification of inherently address the problem of limitations on governmental functions? How might the a. What functions, in particular, are the number of authorized Federal language in the proposed policy letter the most difficult to properly classify as positions and the impact of such be improved to make it more useful? inherently governmental, closely limitations on decisions about reserving b. Does the proposed ‘‘nature of the associated with inherently work for Federal employees? function’’ test help in the identification governmental, critical, or non-critical— b. How, if at all, should this guidance of inherently governmental functions? and why? What specific steps should be address the potential nexus between How might the coverage of this test in taken to address this challenge? decisions regarding reserving work for the proposed policy letter be improved b. What should guidance say—in Federal employees and the to make it more useful? place of, or in addition to, the draft unavailability of certain capabilities and c. Should consideration be given to guidance or currently existing federal expertise among Federal employees establishing a ‘‘principal-agent’’ test that regulations or policies—to address the (e.g., ‘‘hard to fill’’ labor categories), and would require agencies to identify use (if any) of contractors performing the impact of Federal salary limits on functions as inherently governmental any of the following functions? hiring people with those capabilities where serious risks could be created by i. Pre-award acquisition support, such and expertise? the performance of these functions by as acquisition planning, market c. Should the guidance address when those outside government, because of research, development of independent it is appropriate to temporarily contract the difficulty of ensuring sufficient government cost estimates, and for performance of work that is control over such performance? preparation of documentation in generally reserved for Federal d. What, if any, additional guidance support of contract award, including employees? might help agencies differentiate preparation of: price negotiation d. How, if at all, should this guidance between circumstances where memoranda and price reasonableness address situations where there is no contractors are being used appropriately determinations, technical evaluations, basis to reserve work for Federal

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employees, but the government is not in addressed in a question and answer 2. Authority. This policy letter is issued a position to provide adequate oversight format? Examples of questions might pursuant to section 6(a) of the Office of of a contractor, whether due to the include the following: Federal Procurement Policy Act, 41 U.S.C. unavailability of federal employees with • What steps should contractor 405(a), the President’s March 4, 2009, employees be required to take when Memorandum on Government Contracting, the skills needed for contract and section 321 of the FY 2009 National management or for other reasons? working on a government site to ensure Defense Authorization Act, Public Law 110– e. What, if any, additional guidance their status is clearly understood? 417. might be provided to help an agency • Under what, if any, circumstances 3. Definitions. analyze whether it has the best mix of may a contractor attend a policy-making ‘‘Inherently governmental function,’’ as private and public sector labor? Are meeting? defined in section 5 of the Federal Activities there benchmarks that exist to help • Under what, if any, circumstances Inventory Reform Act, Public Law 105–270, agencies make this determination? Can may a contractor represent an agency at means a function that is so intimately related the concept of ‘‘overreliance’’ be a policy-making meeting? to the public interest as to require performance by Federal Government effectively understood without also 10. Management Responsibilities employees. providing guidance on ‘‘underreliance’’? What, if any, additional guidance (a) The term includes functions that Why or why not? require either the exercise of discretion in should be provided to ensure the applying Federal Government authority or 7. Scope of Coverage policies and practices discussed in the the making of value judgments in making a. How, if at all, should the draft draft guidance are given appropriate decisions for the Federal Government, guidance address advisory and management attention? including judgments relating to monetary assistance services? What, if any, transactions and entitlements. An inherently 11. Inventories of Federal and governmental function involves, among other changes should be considered to FAR Contractor Employees Subpart 37.2 to improve how agencies things, the interpretation and execution of the laws of the United States so as— draw upon the skills of the public and a. What is the best way to optimize the value of Federal employee (1) To bind the United States to take or not private sectors? to take some action by contract, policy, b. How, if at all, should the draft inventories that agencies prepare under the FAIR Act and OMB Circular A–76 regulation, authorization, order, or otherwise; guidance address personal services (2) To determine, protect, and advance contracting? What, if any, changes to support policies for identifying work United States economic, political, territorial, should be considered to FAR Subpart to be reserved for performance by property, or other interests by military or 37.104 to improve how agencies draw Federal employees? diplomatic action, civil or criminal judicial upon the skills of the public and private b. What is the best way to optimize proceedings, contract management, or sectors? the value of the contractor employee otherwise; c. What additional guidance, if any, inventory required by section 743 of (3) To significantly affect the life, liberty, Division C of the FY 2010 Consolidated or property of private persons; would be beneficial to improve (4) To commission, appoint, direct, or understanding and implementation of Appropriations Act, Public Law 111– 117 (for civilian agencies) and section control officers or employees of the United policies addressing functions that must States; or be reserved for performance by Federal 807 of the National Defense (5) To exert ultimate control over the employees? Authorization Act for FY 2008, Public acquisition, use, or disposition of the d. What additional guidance, if any, Law 110–181 (for defense agencies), to property, real or personal, tangible or would be beneficial to improve support policies for identifying work to intangible, of the United States, including the understanding and implementation of be reserved for performance by Federal collection, control, or disbursement of policies addressing functions that may employees and those that may continue appropriations and other Federal funds. to be performed by contractors? (b) The term does not normally include— be performed by contractors? (1) Gathering information for or providing 8. Form of Coverage Daniel I. Gordon, advice, opinions, recommendations, or ideas Administrator, Office of Federal Procurement to Federal Government officials; or Is an OFPP policy letter an effective Policy. (2) Any function that is primarily vehicle to serve as the main document Policy Letter No. 10–XX ministerial and internal in nature (such as for consolidated policy guidance on the To the Heads of Executive Departments And building security, mail operations, operation subject of work reserved for Federal Establishments of cafeterias, housekeeping, facilities employees and maintaining certain Subject: Work Reserved for Performance by operations and maintenance, warehouse critical capability levels in-house? Does Federal Government Employees operations, motor vehicle fleet management it effectively address the affected 1. Purpose. This guidance establishes operations, or other routine electrical or stakeholder communities? If not, which Executive Branch policy addressing when mechanical services). work must be reserved for performance by ’’Critical function’’ means a function that is communities are not properly addressed necessary to the agency being able to and what form should the guidance take federal employees. The policy is intended to assist agency officers and employees in effectively perform and maintain control of and why? ensuring that only federal employees perform its mission and operations. A function that 9. Implementation work that is inherently governmental or would not expose the agency to risk of otherwise needs to be reserved to the public mission failure if performed entirely by a. What best practices (e.g., sector. contractors is not a critical function. flowcharts, decision trees, checklists, Nothing in this guidance is intended to 4. Policy. It is the policy of the Executive handbooks) exist to help agencies discourage the appropriate use of contractors. Branch to ensure that government action is identify which functions should be Contractors can provide expertise, taken as a result of informed, independent reserved for performance by Federal innovation, and cost-effective support to judgments made by government officials. employees? Note: Respondents are federal agencies for a wide range of services. Adherence to this policy will ensure that the Reliance on contractors is not, by itself, a act of governance is performed, and decisions encouraged to submit copies of, or cause for concern, provided that the work of significant public interest are made, by provide citations to, relevant documents that they perform is not work that should be officials who are ultimately accountable to with their responses. reserved for federal employees and that the President and bound by laws controlling b. What questions arise most federal officials are appropriately managing the conduct and performance of Federal frequently that might be suitably contractor performance. employees that are intended to protect or

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benefit the public and ensure the proper use (iii) Consider the impact of decisions to using the tests below. A function meeting of funds appropriated by Congress. To establish a specified level of government either of these tests would be inherently implement this policy, agencies must reserve employee authorizations (or military end governmental. certain work for performance by federal strength) or available funding on the ability (1) The nature of the function. Functions employees and take special care to retain to use Federal employees for work that which involve the exercise of sovereign sufficient management oversight over how should be reserved for performance by such powers—that is, powers that are uniquely contractors are used to support government employees. governmental—are inherently governmental operations and ensure that Federal (2) Agencies’ annual Human Capital Plan by their very nature. Examples of functions employees have the technical skills and for Acquisition shall identify specific that, by their nature, are inherently expertise needed to maintain control of the strategies and goals for addressing both the governmental are an ambassador representing agency mission and operations. size and capability of the acquisition the United States, a police officer arresting a (a) Performance of work by federal workforce, including program managers and person, and a judge sentencing a person employees. To ensure that work that should contracting officer technical representatives. convicted of a crime to prison. A function be performed by federal employees is The number of personnel required to may be classified as inherently governmental properly reserved for government administer a particular contract is a based strictly on its uniquely governmental performance, agencies shall: management decision to be made after nature and without regard to the type or level (1) Ensure that service contractors do not analysis of a number of factors. These of discretion associated with the function. perform inherently governmental functions include, among others: (2) The exercise of discretion. (i) A (see section 5–1); (i) The scope of the activity in question; function requiring the exercise of discretion (2) Give special consideration to federal (ii) The technical complexity of the project shall be deemed inherently governmental if employee performance of functions closely or its compontents; the exercise of such discretion commits the associated with inherently governmental (iii) The technical capability, numbers, and government to a course of action where two functions and, when such work is performed workload of federal mangement officials; or more alternative courses of action exist by contractors, provide greater attention and (iv) The inspection techniques available; and decision making is not already limited or an enhanced degree of management oversight (v) The proven adequacy and reliability of guided by existing policies, procedures, of the contractors’ activities to ensure that contractor project management; directions, orders, and other guidance that: contractors’ duties do not expand to include (vi) The sophistication and track record of (A) Identify specified ranges of acceptable performance of inherently governmental contract administration organizations within decisions or conduct concerning the overall functions (see section 5–2a); and the agency; and policy or direction of the action; and (3) Ensure that federal employees perform (vii) The importance and criticality of the (B) Subject the discretionary authority to critical functions to the extent necessary for function. final approval or regular oversight by agency the agency to operate effectively and 5. Implementation guidelines and officials. maintain control of its mission and responsibilities. Agencies shall use the (ii) The fact that decisions are made, and operations (see section 5–2b). guidelines below to determine (1) whether discretion exercised, by a contractor in (b) Management of federal contractors. their requirements involve the performance performing its duties under the contract— When work need not be reserved for Federal of inherently government functions, such as how to allocate the contractor’s own performance and contractor performance is functions closely associated with inherently or subcontract resources, what conclusions to appropriate, agencies shall take steps to governmental functions, or critical functions; emphasize and, unless specified in the employ an adequate number of government and (2) the type and level of management contract, what techniques and procedures to personnel to ensure that contract attention necessary to ensure that functions employ, whether and whom to consult, what administration protects the public interest that should be reserved for federal research alternatives to explore given the through the active and informed management performance are not materially limited by or scope of the contract, or how frequently to and oversight of contractor performance, effectively transferred to contractors. The test—is not determinative of whether the especially where contracts have been latter determination typically requires contractor is performing an inherently awarded for the performance of critical agencies to consider the totality of government function. A function involving functions, functions closely associated with circumstances surrounding how, where, and the exercise of discretion may be the performance of inherently governmental when work is to be performed. appropriately performed consistent with the functions, or where, due to the nature of the 5–1. Inherently governmental functions. restrictions in this section where the contract services provided, there is a Agencies shall ensure that inherently contractor does not have the authority to potential for confusion as to whether an governmental functions are reserved decide on the overall course of action, but is activity is being performed by government exclusively for performance by federal tasked to develop options or implement a employees or contractors. Contract employees. course of action, and the agency official has management should be appropriate to the (a) Determining whether a function is the ability to countervail the contractor’s nature of the contract, ensure that the inherently governmental. Every federal action. By contrast, contractor performance contract is under the control of government government organization performs some would be inappropriate where the officials at all times, and make clear to the work that is so intimately related to the contractor’s involvement is or would be so public when citizens are receiving service public interest as to require performance by extensive, or the contractor’s work product so from contractors. federal government employees. Agencies close to a final agency product, as to (c) Strategic human capital planning. (1) should review the definition of inherently effectively preempt the federal officials’ As part of strategic human capital planning, governmental function in section 3, any other decision-making process, discretion or agencies shall— statutory provisions that identify a function authority. (i) Dedicate a sufficient amount of work on as inherently governmental, and the (b) Responsibilities—(1) Pre-award. critical functions to performance by federal illustrative list of inherently governmental Agencies shall determine prior to issuance of employees in order to build competencies functions in Appendix A. In no case should a solicitation that none of the functions to be (both knowledge and skills), provide for any function described in the definition, contracted are inherently governmental. The continuity of operations, and retain identified in statute as inherently agency head or designated requirements institutional knowledge of government governmental, or appearing on the list be official shall provide the contracting officer, operations, including those unique to the considered for contract performance. If a concurrent with transmittal of the statement agency’s mission; function is not listed in Appendix A or of work (or any modification thereof), a (ii) Ensure that sufficient personnel is identified in a statutory provision as written determination that none of the available to manage and oversee the inherently governmental, agencies should functions to be performed are inherently contractor’s performance and evaluate and determine whether the function otherwise governmental. If a function is not listed in approve or disapprove the contractor’s work falls within the definition in section 3 by Appendix A, it still may be inherently products and services, recruiting and evaluating, on a case-by-case basis, the nature governmental. Accordingly, the retaining the necessary federal talent where of the work and the level of discretion determination should take into it is lacking; and associated with performance of the work consideration, as necessary, the tests in

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paragraph (a). The file should include the that are closely associated with the of the government might confuse contractor analysis that supports the determination and performance of inherently governmental personnel or work products with government this analysis should establish, at a minimum, functions. officials or work products, respectively; and that: (b) Special consideration for federal (4) Take appropriate steps to avoid or (i) The function to be contracted does not employee performance. mitigate conflicts of interest, such as by: appear on the list in Appendix A; (1) If the agency determines the function is (i) Conducting pre-award conflict of (ii) A statute, such as an annual closely associated with the performance of an interest reviews, to ensure contract appropriations act, does not identify the inherently governmental function, section performance is in accordance with objective function as inherently governmental or 736 of Division D of the Omnibus standards and contract specifications, and otherwise require it to be performed by Appropriations Act, 2009, Public Law 111– developing a conflict of interest mitigation Federal employees; and 8, requires civilian agencies subject to the plan, if needed, that identifies the conflict (iii) The proposed role for the contractor is FAIR Act to give special consideration to and specific actions that will be taken to not so extensive that the ability of senior using federal employees to perform the lessen the potential for conflict of interest or agency management to develop and consider function. Civilian agencies shall refer to OMB reduce the risk involved with a potential options is or would be preempted or Memorandum M–09–26, Managing the Multi- conflict of interest; inappropriately restricted. Sector Workforce (July 29, 2009), Attachment (ii) Physically separating contractor (2) Post-award. Agencies should review, on 3 for criteria addressing the in-sourcing of personnel from government personnel at the an ongoing basis, the functions being work under Public Law 111–8. Memorandum worksite; performed by their contractors, paying M–09–26 explains that federal employee (iii) Ensuring contractors are clearly particular attention to the way in which performance would be expected if either identified as such in work product and on contractors are performing, and agency contractor performance causes the agency to work support systems, such as in electronic personnel are managing, contracts involving lack sufficient internal expertise to maintain mail systems and phone messaging systems, functions that are closely associated with control of its mission and operations or and on signature blocks, security and other inherently governmental functions (see analysis suggests that public sector identification badges, and office name plates; subsections 5–2a and Appendix B) or performance is more cost effective and it is (iv) Having contractor personnel work off- contracts for professional and technical feasible to hire federal employees to perform site, if cost-effective and without derogation services. If a determination is made that the the function. The OMB Memorandum is to the work to be performed; contractor is performing work that is available at http://www.whitehouse.gov/omb/ (v) Excluding contractors from subsequent inherently governmental (or involves assets/memoranda_fy2009/m-09-26.pdf. competitions if conflicts cannot be avoided; unauthorized personal services), but the (2) The Department of Defense shall— or contract, properly defined, does not entail (i) Ensure special consideration is given to (vi) Performing work with federal performance of inherently governmental federal employee performance consistent employees if (A) contractor conflicts cannot functions, the agency shall take prompt with the requirements of 10 U.S.C. 2463; and be satisfactorily resolved or (B) decision- action to ensure performance by government (ii) To the maximum extent practicable, making would be at risk of being transferred employees of the inherently governmental minimize reliance on contractors performing to the private sector because contractors have responsibilities. In some cases, government functions closely associated with inherently such influence and insight into government control over, and performance of, these governmental functions consistent with 10 decision making or government officials responsibilities can be reestablished by U.S.C. 2330a. would rely too heavily on contractor inputs strengthening contract oversight using (c) Responsibilities. If the agency (or rely almost exclusively on contractor fact- government employees with appropriate determines that contractor performance of a finding or memory). subject matter expertise and following the function closely associated with an (5) Make a written determination protocols identified in FAR 37.114 (see also inherently governmental function is concurrent with transmittal of the statement section 5.2a, below). In other cases, agencies appropriate and cost-effective, the agency of work (or any modification thereof) to the may need to in-source work on an shall— contracting officer that accelerated basis through the timely (1) Limit or guide a contractor’s exercise of (i) The function is closely associated with development and execution of a hiring plan discretion and retain control of government an inherently governmental function; timed, if possible, to permit the non-exercise operations by both— (ii) Private sector performance of the of an option or the termination of that (i) Pre-establishing in the contract specified function is appropriate and the most cost portion of the contract being used to fulfill ranges of acceptable decisions and/or effective source of support for the agency; inherently governmental responsibilities. conduct; and and 5–2. Other work that must be reserved for (ii) Pre-establishing a process for subjecting (iii) The agency has sufficient internal federal employees. In some cases, work that the contractor’s discretionary decisions and/ capability to control its missions and is not inherently governmental must also be or conduct to final approval by the agency operations, oversee the contractor’s reserved for performance by federal official; performance of the contract, limit or guide employees. Such reservation will be required (2) Assign a sufficient number of qualified the contractor’s exercise of discretion, ensure under certain circumstances for functions government employees, with expertise to reasonable identification of contractors and that are closely associated with the administer or perform the work, to give contractor work products, and avoid or performance of inherently governmental heightened management attention to the mitigate conflicts of interest and functions and critical functions. contractor’s activities, in particular, to ensure unauthorized personal services. 5–2a. Functions closely associated with the that they do not expand to include inherently 5–2b. Critical functions. Agencies shall performance of inherently governmental governmental functions, are not performed in dedicate a sufficient number of federal functions. Agencies shall give special ways not contemplated by the contract so as employees to the performance of critical consideration to federal employee to become inherently governmental, do not functions so that federal employees may performance of functions closely associated undermine the integrity of the government’s maintain control of agencies’ mission and with inherently governmental functions. decision-making process, and do not interfere operations. (a) Determining whether a function is with federal employees’ performance of the (a) Criteria for determining when critical closely associated with the performance of an closely-associated inherently governmental positions must be reserved for federal inherently governmental function. Certain functions (see section 5–1(b)(2) for guidance employee performance. Determining the services and actions that generally are not on steps to take where a determination is criticality of a function requires the exercise considered to be inherently governmental made that the contract is being used to fulfill of informed judgment by agency officials. In functions may approach being in that responsibilities that are inherently making that determination, the officials shall category because of the nature of the function governmental); consider the importance that a function holds and the risk that performance may impinge (3) Ensure that a reasonable identification for the agency and its mission and on federal officials’ performance of an of contractors and contractor work products operations. The more critical the function, inherently governmental function. Appendix is made whenever there is a risk that the more important that the agency have B provides a list of examples of functions Congress, the public, or other persons outside internal capability to maintain control of its

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mission and operations. Examples of highly critical functions. In these situations, www.whitehouse.gov/omb/assets/omb/ critical functions might include: designing requiring activities should work with their procurement/memo/a123_guidelines.pdf and constructing the next generation of human capital office to develop and execute (e) Designation of responsible management satellites at the National Aeronautics and a hiring and/or development plan. Requiring official(s). Each federal agency with 100 or Space Administration, analyzing areas of tax activities should also work with the more full-time employees in the prior fiscal law that impose significant compliance acquisition office to address the handling of year shall identify one or more senior burdens on taxpayers for the Internal ongoing contracts and the budget and finance officials to be accountable for the Revenue Service’s Office of the Taxpayer offices to secure the necessary funding to development and implementation of agency Advocate, and performing mediation services support the needed in-house capacity. policies, procedures, and training to ensure for the Federal Mediation and Conciliation Agencies should also consider application of the appropriate reservation of work for Service. Where a critical function is not the responsibilities outlined in 5–2a(c), as federal employees in accordance with this inherently governmental, the agency may appropriate. guidance. Each such agency shall submit the appropriately consider filling positions (ii) If an agency has sufficient internal names and titles of the designated officials, dedicated to the function with both federal capability to control its mission and along with contact information, to OMB by employees and contractors. However, to meet operations, the extent to which additional June 30 of each year. This information may its fiduciary responsibility to the taxpayers, work is performed by federal employees be provided with the agency’s submission of the agency must have a sufficient internal should be based on cost considerations commercial and inherently governmental capability to control its mission and unless performance and risk considerations activities submitted pursuant to the FAIR Act operations and must ensure it is cost effective in favor of federal employee performance and OMB Circular A–76. to contract for the services. will clearly outweigh cost considerations. 7. Federal Acquisition Regulatory Council. (1) Sufficient internal capability— Supporting cost analysis should address the Pursuant to subsections 6(a) and 25(f) of the (i) Generally requires that an agency have full costs of government and private sector Office of Federal Procurement Policy Act, 41 an adequate number of positions filled by performance and provide like comparisons of U.S.C. 405(a) and 421(f), the Federal federal employees with appropriate training, costs that are of a sufficient magnitude to Acquisition Regulatory Council shall ensure experience, and expertise (organic and influence the final decision on the most cost that the policies established herein that technical) to understand the agency’s effective source of support for the pertain to the acquisition of services are requirements, formulate alternatives, take organization. incorporated in the FAR in a timely manner. other appropriate actions to properly manage 6. Additional agency responsibilities. (a) 8. Judicial review. This policy letter is not and be accountable for the work product, and Duty of federal employees. Every federal intended to provide a constitutional or continue critical operations in the event of employee has an obligation to help avoid the statutory interpretation of any kind and it is contractor default; and performance by contractors of not intended, and should not be construed, (ii) Further requires that an agency have responsibilities that should be reserved to to create any right or benefit, substantive or the ability and internal expertise to manage federal employees. As part of this obligation, procedural, enforceable at law by a party any contractors used to support the federal federal employees who rely on contracts or against the United States, its agencies, its workforce and evaluate their work product. their work product must take appropriate officers, or any person. It is intended only to (2) Determinations concerning what steps, in accordance with agency procedures, provide policy guidance to agencies in the constitutes sufficient internal capability must to ensure that any final agency action exercise of their discretion concerning be made on a case-by-case basis taking into complies with the laws and policies of the federal contracting. Thus, this policy letter is account, among other things: United States and reflects the independent not intended, and should not be construed, (i) The agency’s mission; conclusions of agency officials and not those to create any substantive or procedural basis (ii) The complexity of the function and the of contractors, who may not be motivated on which to challenge any agency action or need for specialized skill; solely by the public interest, and who may inaction on the ground that such action or (iii) The current strength of the agency’s in- be beyond the reach of management controls inaction was not in accordance with this house organic and technical expertise; applicable to federal employees. These steps policy letter. (iv) The current strength (capability and shall include increased attention and 9. Effective date. This policy letter is capacity) of the agency’s acquisition examination where contractor work product effective [insert date 30 days after issuance of workforce; involves advice, opinions, recommendations, final policy letter] (v) The effect of contractor default on reports, analyses, and similar deliverables Appendix A. Examples of inherently mission performance; and that are to be considered in the course of a governmental functions (vi) The enforceability of criminal federal employee’s official duties and may sanctions for crimes performed by have the potential to influence the authority, The following is an illustrative list of contractors as compared to those applicable accountability, and responsibilities of the functions considered to be inherently to federal employees. employee. governmental. (b) Responsibilities—(1) Pre-award. (i) (b) Development of agency procedures. 1. The direct conduct of criminal Agencies shall determine prior to issuance of Agencies shall develop and maintain internal investigation. a solicitation for private-sector performance procedures to address the requirements of 2. The control of prosecutions and of any aspect of a critical function that the this guidance. Such procedures shall be performance of adjudicatory functions (other agency has sufficient internal capability to reviewed by agency management no less than than those relating to arbitration or other control its mission and operations. The every two years. methods of alternative dispute resolution). agency head or designated requirements or (c) Training. Agencies shall develop 3. The command of military forces, human capital official shall provide the training plans to help their employees especially the leadership of military contracting officer, concurrent with understand and meet their responsibilities personnel who are members of the combat, transmittal of the statement of work (or any under this guidance. The plan should combat support or combat service support modification thereof) a written determination include training, no less than every two role. and analysis. years, to improve employee awareness of 4. The conduct of foreign relations and the (ii) If an agency has sufficient internal their responsibilities. determination of foreign policy. capability to control its mission and (d) Review of internal management 5. The determination of agency policy, operations, the extent to which additional controls. Agencies should periodically such as determining the content and work is performed by federal employees evaluate the effectiveness of their internal application of regulations, among other should be determined consistent with the management controls for reserving work for things. parameters set forth in subsection (2)(ii) federal employees and identify any material 6. The determination of Federal program below. weaknesses in accordance with OMB priorities or budget requests. (2) Post-award. (i) Agencies should be alert Circular A–123, Management’s 7. The direction and control of Federal for situations where internal control of Responsibility for Internal Control, and employees. mission and operations is at risk due to OFPP’s Guidelines for Assessing the 8. The direction and control of intelligence overreliance on contractors to perform Acquisition Function, available at http:// and counter-intelligence operations.

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9. The selection or non-selection of (b) routine voucher and invoice as prisoner detention or transport and non- individuals for Federal Government examination. military national security details. employment. 18. The control of the Treasury accounts. [FR Doc. 2010–7329 Filed 3–30–10; 8:45 am] 10. The approval of position descriptions 19. The administration of public trusts. BILLING CODE P and performance standards for Federal 20. The drafting of Congressional employees. testimony, responses to Congressional 11. The determination of what Government correspondence, or agency responses to audit property is to be disposed of and on what reports from the Inspector General, the MORRIS K. UDALL AND STEWART L. terms (although an agency may give Government Accountability Office, or other UDALL FOUNDATION contractors authority to dispose of property federal audit entity. at prices with specified ranges and subject to Sunshine Act Meetings other reasonable conditions deemed Appendix B. Examples of functions appropriate by the agency). closely associated with the performance Time and Date: 9 a.m. to 12 p.m., 12. In Federal procurement activities with of inherently governmental functions Friday, April 16, 2010. respect to prime contracts: Place: The offices of the Morris K. Udall (a) determining what supplies or services The following is an illustrative list is of functions that are closely associated with the and Stewart L. Udall Foundation, 130 are to be acquired by the Government South Scott Avenue, Tucson, AZ 85701. (although an agency may give contractors performance of inherently governmental authority to acquire supplies at prices within functions. Status: This meeting will be open to the specified ranges and subject to other 1. Services that involve or relate to budget public, unless it is necessary for the reasonable conditions deemed appropriate by preparation, including workforce modeling, Board to consider items in executive the agency); fact finding, efficiency studies, and should- session. (b) participating as a voting member on any cost analyses. Matters To Be Considered: (1) A report source selection boards; 2. Services that involve or relate to on the U.S. Institute for Environmental (c) approval of any contractual documents, reorganization and planning activities. Conflict Resolution; (2) A report from to include documents defining requirements, 3. Services that involve or relate to the Udall Center for Studies in Public incentive plans, and evaluation criteria; analyses, feasibility studies, and strategy Policy; (3) A report on the Native options to be used by agency personnel in (d) awarding contracts; Nations Institute; (4) Program Reports; (e) administering contracts (including developing policy. ordering changes in contract performance or 4. Services that involve or relate to the and (5) A Report from the Management contract quantities, taking action based on development of regulations. Committee. evaluations of contractor performance, and 5. Services that involve or relate to the Portions Open to the Public: All accepting or rejecting contractor products or evaluation of another contractor’s sessions with the exception of the services); performance. session listed below. (f) terminating contracts; 6. Services in support of acquisition Portions Closed to the Public: Executive (g) determining whether contract costs are planning. session. reasonable, allocable, and allowable; and 7. Assistance in contract management Contact Person for More Information: (h) participating as a voting member on (particular where a contractor might Ellen K. Wheeler, Executive Director, performance evaluation boards. influence official evaluations of other 13. The approval of agency responses to contractors’ offers). 130 South Scott Avenue, Tucson, AZ Freedom of Information Act requests (other 8. Technical evaluation of contract 85701, (520) 901–8500. than routine responses that, because of proposals. Dated: March 24, 2010. statute, regulation, or agency policy, do not 9. Assistance in the development of Ellen K. Wheeler, require the exercise of judgment in statements of work. Executive Director, Morris K. Udall and determining whether documents are to be 10. Support in preparing responses to Stewart L. Udall Foundation, and Federal released or withheld), and the approval of Freedom of Information Act requests. Register Liaison Officer. agency responses to the administrative 11. Work in any situation that permits or appeals of denials of Freedom of Information might permit access to confidential business [FR Doc. 2010–7012 Filed 3–30–10; 8:45 am] Act requests. information and/or any other sensitive BILLING CODE 6820–FN–M 14. The conduct of administrative hearings information (other than situations covered by to determine the eligibility of any person for the National Industrial Security Program a security clearance, or involving actions that described in FAR 4.402(b)). NATIONAL AERONAUTICS AND affect matters of personal reputation or 12. Dissemination of information regarding SPACE ADMINISTRATION eligibility to participate in government agency policies or regulations, such as programs. attending conferences on behalf of an agency, [Notice (10–036)] 15. The approval of federal licensing conducting community relations campaigns, actions and inspections. or conducting agency training courses. NASA Advisory Council; Space 16. The determination of budget policy, 13. Participation in any situation where it Operations Committee; Meeting guidance, and strategy. might be assumed that participants are 17. The collection, control, and agency employees or representatives. AGENCY: National Aeronautics and disbursement of fees, royalties, duties, fines, 14. Participation as technical advisors to a Space Administration. taxes and other public funds, unless source selection board or as nonvoting ACTION: Notice of meeting. authorized by statute, such as title 31 U.S.C. members of a source evaluation board. 952 (relating to private collection contractors) 15. Service as arbitrators or provision of SUMMARY: In accordance with the and title 31 U.S.C. 3718 (relating to private alternative dispute resolution (ADR) services. Federal Advisory Committee Act, Public attorney collection services), but not 16. Construction of buildings or structures Law 92–463, as amended, the National including: intended to be secure from electronic (a) collection of fees, fines, penalties, costs eavesdropping or other penetration by Aeronautics and Space Administration or other charges from visitors to or patrons foreign governments. announces a meeting of the NASA of mess halls, post or base exchange 17. Provision of inspection services. Advisory Council Space Operations concessions, national parks, and similar 18. Drafting of legal advice and Committee. entities or activities, or from other persons, interpretations of regulations and statutes to DATES: Tuesday, April 13, 2010, 3–5 where the amount to be collected is easily government officials. calculated or predetermined and the funds 19. Provision of special non-law- p.m. CDT. collected can be easily controlled using enforcement security activities that do not ADDRESSES: NASA Johnson Space standard cash management techniques, and directly involve criminal investigations, such Center’s Gilruth Center, Lone Star

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Room, 18753 Space Center Blvd., records is completed, NARA will send are media neutral unless the item is Houston, TX 77058. a copy of the schedule. NARA staff limited to a specific medium. (See 36 FOR FURTHER INFORMATION CONTACT: Mr. usually prepare appraisal CFR 1225.12(e).) Jacob Keaton, Space Operations Mission memorandums that contain additional No Federal records are authorized for Directorate, National Aeronautics and information concerning the records destruction without the approval of the Space Administration Headquarters, covered by a proposed schedule. These, Archivist of the United States. This Washington, DC 20546, 202/358–1507, too, may be requested and will be approval is granted only after a Jacob.keaton@nasagov. provided once the appraisal is thorough consideration of their completed. Requesters will be given 30 administrative use by the agency of SUPPLEMENTARY INFORMATION: The days to submit comments. origin, the rights of the Government and agenda for the meeting includes the ADDRESSES: of private persons directly affected by following topics: You may request a copy of any records schedule identified in this the Government’s activities, and —Space Shuttle Program Transition notice by contacting the Life Cycle whether or not they have historical or Plan. Management Division (NWML) using other value. The meeting will be open to the one of the following means: Besides identifying the Federal public up to the seating capacity of the Mail: NARA (NWML), 8601 Adelphi agencies and any subdivisions room. It is imperative that the meeting Road, College Park, MD 20740–6001. requesting disposition authority, this be held on this date to accommodate the E-mail: [email protected]. public notice lists the organizational scheduling priorities of the key FAX: 301–837–3698. unit(s) accumulating the records or participants. Requesters must cite the control indicates agency-wide applicability in number, which appears in parentheses the case of schedules that cover records March 25, 2010. after the name of the agency which that may be accumulated throughout an P. Diane Rausch, submitted the schedule, and must agency. This notice provides the control Advisory Committee Management Officer, provide a mailing address. Those who number assigned to each schedule, the National Aeronautics and Space desire appraisal reports should so total number of schedule items, and the Administration. indicate in their request. number of temporary items (the records [FR Doc. 2010–7156 Filed 3–30–10; 8:45 am] FOR FURTHER INFORMATION CONTACT: proposed for destruction). It also BILLING CODE P Laurence Brewer, Director, Life Cycle includes a brief description of the Management Division (NWML), temporary records. The records National Archives and Records schedule itself contains a full NATIONAL ARCHIVES AND RECORDS Administration, 8601 Adelphi Road, description of the records at the file unit ADMINISTRATION College Park, MD 20740–6001. level as well as their disposition. If Telephone: 301–837–1539. E-mail: NARA staff has prepared an appraisal Records Schedules; Availability and [email protected]. memorandum for the schedule, it too Request for Comments includes information about the records. SUPPLEMENTARY INFORMATION: Each year Further information about the AGENCY: National Archives and Records Federal agencies create billions of Administration (NARA). disposition process is available on records on paper, film, magnetic tape, request. ACTION: Notice of availability of and other media. To control this Schedules Pending: proposed records schedules; request for accumulation, agency records managers 1. Department of Agriculture, Office comments. prepare schedules proposing retention of Procurement and Property (N1–16– periods for records and submit these 09–4, 1 item, 1 temporary item). Master SUMMARY: The National Archives and schedules for NARA’s approval, using files of an electronic information system Records Administration (NARA) the Standard Form (SF) 115, Request for used to track and manage property publishes notice at least once monthly Records Disposition Authority. These assets and related financial information. of certain Federal agency requests for schedules provide for the timely transfer 2. Department of Agriculture, Food records disposition authority (records into the National Archives of and Nutrition Service (N1–462–09–6, 1 schedules). Once approved by NARA, historically valuable records and item, 1 temporary item). Master files of records schedules provide mandatory authorize the disposal of all other an electronic information system that instructions on what happens to records records after the agency no longer needs serves as a central repository of product when no longer needed for current them to conduct its business. Some information relating to the Women, Government business. They authorize schedules are comprehensive and cover Infants, and Children program. the preservation of records of all the records of an agency or one of its 3. Department of Agriculture, Food continuing value in the National major subdivisions. Most schedules, and Nutrition Service (N1–462–09–8, 1 Archives of the United States and the however, cover records of only one item, 1 temporary item). Master files of destruction, after a specified period, of office or program or a few series of an electronic information system that records lacking administrative, legal, records. Many of these update contains information on recipients or research, or other value. Notice is previously approved schedules, and potential recipients of supplemental published for records schedules in some include records proposed as nutrition assistance who have been or which agencies propose to destroy permanent. are disqualified from receiving benefits. records not previously authorized for The schedules listed in this notice are 4. Department of Defense, Defense disposal or reduce the retention period media neutral unless specified Commissary Agency (N1–506–09–2, 2 of records already authorized for otherwise. An item in a schedule is items, 2 temporary items). Master files disposal. NARA invites public media neutral when the disposition and outputs of an electronic information comments on such records schedules, as instructions may be applied to records system that tracks sales and receipts, required by 44 U.S.C. 3303a(a). regardless of the medium in which the products, pricing, ordering, and DATES: Requests for copies must be records are created and maintained. inventories at military commissaries. received in writing on or before April Items included in schedules submitted 5. Department of Defense, Defense 30, 2010. Once the appraisal of the to NARA on or after December 17, 2007, Commissary Agency (N1–506–09–3, 4

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items, 4 temporary items). General records relating to budget matters, snapshots of the entire public Web site correspondence files and informational committee records, and paperwork taken at the end of each Presidential documents relating to communications reduction files. Also included is the administration. and planning. agency web site. Proposed for 20. Department of the Treasury, 6. Department of Defense, Defense permanent retention are such records as Internal Revenue Service (N1–58–09– Commissary Agency (N1–506–09–4, 2 Indian Fiduciary Trust management and 48, 3 items, 3 temporary items). Master items, 2 temporary items). Master files reform records, Freedom of Information files, outputs, and system and outputs of electronic information Act appeals related to the Indian documentation for an electronic systems that maintain data on processed Fiduciary Trust, and executive information system which is used to meat products sold by military committee and board membership store data from estate tax returns and commissaries. records. generate estate tax closing letters. 7. Department of Defense, Defense 15. Department of the Interior, Office 21. Department of the Treasury, Commissary Agency (N1–506–09–6, 2 of Planning and Performance Internal Revenue Service (N1–58–09– items, 2 temporary items). Master files Management (N1–48–09–10, 8 items, 1 90, 2 items, 2 temporary items). Master and outputs of an electronic information temporary item). Records of the office files and system documentation for an system used in connection with the other than those proposed for electronic information system which is pricing and promotion of products at permanent retention. Proposed for used to disclose tax return information military commissaries. permanent retention are such records as to participating state and local 8. Department of Defense, Defense strategic planning files, performance governments. Security Service (N1–446–09–5, 12 and accountability report files, budgets 22. Department of the Treasury, items, 12 temporary items). Records and associated performance information Internal Revenue Service (N1–58–09– relating to contractor facilities involved relating to agency components, and 91, 4 items, 4 temporary items). Master in the National Industrial Security performance management governance files and system documentation for an Program. Records pertain to such files. electronic information system which is matters as security clearance of 16. Department of Justice, Criminal used to monitor upcoming legal actions, facilities, cancellation of clearances, Division (N1–60–07–2, 3 items, 1 media interest, and outreach activities security agreements, and related temporary item). Organized Crime Drug related to criminal investigations. administrative actions. Enforcement Task Force case files that 23. Department of the Treasury, 9. Department of Education, Office of have been incorporated into an Internal Revenue Service (N1–58–09– Management (N1–441–09–21, 2 items, 2 electronic management information 93, 2 items, 2 temporary items). Master temporary items). Case files relating to system. Proposed for permanent files and system documentation for an complaints by borrowers in connection retention are master files of the electronic information system which is with Federal student loans. An electronic information system used to provide account transcripts to electronic case tracking system is also containing case information as well as state tax collection agencies. included. older case files, which have not been 24. Department of the Treasury, 10. Department of Education, Office of incorporated into the system. Internal Revenue Service (N1–58–09– Management (N1–441–09–20, 1 item, 1 17. Department of Justice, Executive 94, 2 items, 2 temporary items). Master temporary item). Master files of an Office for United States Attorneys (N1– files and system documentation for an electronic information system that 60–10–10, 2 items, 2 temporary items). electronic information system which is contains data concerning student loans, Master files and outputs of an electronic used to assist agency employees in including name of recipient, type of information system containing processing taxpayer penalty relief loan, loan period, and loan amount. emergency contact information for requests. 11. Department of Energy, employees. 25. Department of the Treasury, Southwestern Power Administration 18. Department of Justice, United Internal Revenue Service (N1–58–09– (N1–387–10–1, 2 items, 2 temporary States Attorney’s Office for the District 98, 3 items, 3 temporary items). Master items). Records relating to power of South Carolina (N1–118–09–1, 19 files, inputs, and system documentation accounting and billing invoices. items, 8 temporary items). Records for an electronic information system 12. Department of Health and Human relating to a pilot project for intermodal which is used to transmit electronically Services, Centers for Medicare & and maritime security at the Port of filed tax returns to the appropriate tax Medicaid Services (N1–440–09–5, 1 Charleston. Included are such records as processor. item, 1 temporary item). Master files of electronic information systems used for 26. Department of the Treasury, an electronic information system that situational awareness and property asset Internal Revenue Service (N1–58–09– contains information concerning tracking, intelligence working files, 99, 6 items, 6 temporary items). Master appeals of fee-for-service and managed vessel arrival files, and routine reference files, outputs, and system care decisions under the Medicare and research photographs. Proposed for documentation for an electronic program. permanent retention are such records as information system which is used to 13. Department of Homeland Security, organizational records, briefing track remittances that cannot be U.S. Customs and Border Protection materials, operating manuals, public credited to the taxpayer and are (N1–568–09–1, 1 item, 1 temporary relations records, subject files, and considered excess collections. item). Master files of an electronic photographs of significant activities. 27. Department of the Treasury, information system used to manage and 19. Department of State, Bureau of Internal Revenue Service (N1–58–09– track importer compliance audits. Public Affairs (N1–59–09–4, 4 items, 2 100, 6 items, 6 temporary items). Master 14. Department of the Interior, Office temporary items). Web site records that files, outputs, and system of the Secretary (N1–48–08–22, 22 contain information duplicated in other documentation for an electronic items, 17 temporary items). Records agency recordkeeping systems. Also information system which is used to relating to management and included are records that relate to track remittances that cannot be administration, including such records management and operation of the Web immediately credited because the as development files, planning files, site. Proposed for permanent retention taxpayer has not been positively audit records, records inventories, are the agency’s official blog and identified.

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28. Department of the Treasury, NUCLEAR REGULATORY Submit, by June 1, 2010, comments Internal Revenue Service (N1–58–09– COMMISSION that address the following questions: 102, 4 items, 4 temporary items). Master 1. Is the proposed collection of [NRC–2010–0120] files, inputs, outputs, and system information necessary for the NRC to documentation for an electronic Agency Information Collection properly perform its functions? Does the information system which is used to Activities: Submission for the Office of information have practical utility? maintain information concerning Management and Budget (OMB) 2. Is the burden estimate accurate? applicants for and participants in the Review; Comment Request Health Coverage Tax Credit program. 3. Is there a way to enhance the quality, utility, and clarity of the 29. Central Intelligence Agency, AGENCY: U.S. Nuclear Regulatory information to be collected? Agency-wide (N1–263–06–3, 14 items, Commission (NRC). 13 temporary items). Records relating to ACTION: Notice of pending NRC action to 4. How can the burden of the records and information management submit an information collection information collection be minimized, activities. Included are such records as request to the Office of Management and including the use of automated security classified records control and Budget (OMB) and solicitation of public collection techniques or other forms of tracking logs, library services files, comment. information technology? forms files, subject files relating to SUMMARY: The NRC invites public A copy of the draft supporting records management, indexes to comment about our intention to request statement may be viewed free of charge temporary records, and records the OMB’s approval for renewal of an at the NRC Public Document Room, One disposition schedules. Proposed for existing information collection that is White Flint North, 11555 Rockville permanent retention are indexes to summarized below. We are required to Pike, Room O–1 F21, Rockville, records scheduled for permanent publish this notice in the Federal Maryland 20852. OMB clearance retention. Register under the provisions of the requests are available at the NRC 30. Export-Import Bank of the United Paperwork Reduction Act of 1995 (44 worldwide Web site: http:// States, Chief Information Office (N1– U.S.C. Chapter 35). www.nrc.gov/public-involve/doc- 275–09–4, 3 items, 3 temporary items). Information pertaining to the comment/omb/index.html. The Master files of an electronic information requirement to be submitted: document will be available on the NRC system used to facilitate the Bank’s loan 1. The title of the information home page site for 60 days after the collection: The Office of Federal and pre-approval process. signature date of this notice. Comments State Materials and Environmental submitted in writing or in electronic 31. Federal Maritime Commission, Management Programs Requests to form will be made available for public Office of the Secretary (N1–358–09–6, 2 Agreement States for Information. inspection. Because your comments will items, 2 temporary items). Informal 2. Current OMB approval number: not be edited to remove any identifying complaints and dispute resolution case 3150–0029. or contact information, the NRC files relating to shipping disputes. Also 3. How often the collection is cautions you against including any included are master files of an required: One time or as needed. information in your submission that you electronic information system that is 4. Who is required or asked to report: do not want to be publicly disclosed. used to assign cases to staff and monitor Thirty-seven Agreement States who Comments submitted should reference their status. have signed Section 274(b) Agreements Docket No. NRC–2010–0120. You may 32. Federal Maritime Commission, with NRC. 5. The number of annual respondents: submit your comments by any of the Bureau of Certification and Licensing 37. following methods. Electronic (N1–358–09–4, 1 item, 1 temporary 6. The number of hours needed comments: Go to http:// item). Master files of an electronic annually to complete the requirement or www.regulations.gov and search for information system that contains data request: 1,480. Docket No. NRC–2010–0120. Mail about passenger vessels and their 7. Abstract: The Agreement States are comments to NRC Clearance Officer, insurance coverage against potential asked on a one-time or as-needed basis Tremaine Donnell (T–5 F53), U.S. claims. to respond to a specific incident, to Nuclear Regulatory Commission, 33. Federal Maritime Commission, gather information on licensing and Washington, DC 20555–0001. Questions Bureau of Certification and Licensing inspection practices or other technical about the information collection (N1–358–09–5, 1 item, 1 temporary and statistical information. Information requirements may be directed to the item). Master files of an electronic is also exchanged for training purposes, NRC Clearance Officer, Tremaine information system that contains data such as, student travel submissions. In Donnell (T–5 F53), U.S. Nuclear about potentially unlicensed ocean 2007, the NRC policy changed to begin Regulatory Commission, Washington, transportation intermediaries. funding training for Agreement State DC 20555–0001, by telephone at 301– materials licensing and inspection staff Dated: March 25, 2010. 415–6258, or by e-mail to and associated travel to attend courses [email protected]. Michael J. Kurtz, offered through the NRC training Assistant Archivist for Records Services— program. The results of such Dated at Rockville, Maryland, this 22nd Washington, DC. information requests, which are day of March 2010. [FR Doc. 2010–7334 Filed 3–30–10; 8:45 am] authorized under Section 274(b) of the For the Nuclear Regulatory Commission. BILLING CODE 7515–01–P Atomic Energy Act, are utilized in part Tremaine Donnell, by the NRC in preparing responses to NRC Clearance Officer, Office of Information Congressional inquiries. The Agreement Services. State comments are also solicited in the [FR Doc. 2010–7190 Filed 3–30–10; 8:45 am] areas of proposed procedure and policy BILLING CODE 7590–01–P development.

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NUCLEAR REGULATORY related information and, accordingly, fully implement the new requirements. COMMISSION are not available to the public. Redacted This change was incorporated into the versions of the licensee’s exemption final rule. From this, it is clear that the [Docket Nos. 50–266 and 50–301; NRC– requests dated February 26, and March Commission wanted to provide a 2010–0123] 11, 2010, are publicly available in the reasonable timeframe for licensees to FPL Energy Point Beach, LLC; Point Agencywide Documents Access and reach full compliance. Beach Nuclear Plant, Units 1 and 2; Management System (ADAMS) As noted in the final rule, the Exemption Accession Nos. ML100600565 and Commission also anticipated that ML100710739, respectively. The licensees would have to conduct site- 1.0 Background licensee has requested an exemption specific analyses to determine what FPL Energy Point Beach, LLC (FPLE, from the March 31, 2010, compliance changes were necessary to implement the licensee) is the holder of Renewed date stating that it must accommodate the rule’s requirements, and that Facility Operating License Nos. DPR–24 unforeseen delays such as adverse changes could be accomplished through and DPR–27, which authorize operation weather, material delivery delays, and a variety of licensing mechanisms, of the Point Beach Nuclear Plant, Units testing constraints that could result in including exemptions. Since issuance of non-compliance with the March 31, 1 and 2 (PBNP). The licenses provide, the final rule, the Commission has 2010, compliance deadline. Specifically, among other things, that the facility is rejected a request generically to extend the request is for one requirement that subject to all rules, regulations, and the rule’s compliance date for all would be met by May 28, 2010, versus orders of the U.S. Nuclear Regulatory operating nuclear power plants, but the March 31, 2010, deadline. Granting Commission (NRC, the Commission) noted that the Commission’s regulations this exemption for the one item would now or hereafter in effect. provide mechanisms for individual afford the licensee additional time to The facility consists of two licensees, with good cause, to apply for perform necessary upgrades to meet or pressurized water reactors located in relief from the compliance date, as exceed the regulatory requirements. Manitowoc County, Wisconsin. documented in the letter from R. W. 3.0 Discussion of Part 73 Schedule Borchardt (NRC) to M. S. Fertel (Nuclear 2.0 Request/Action Exemptions From the March 31, 2010, Energy Institute) dated June 4, 2009. Title 10 of the Code of Federal Full Implementation Date The licensee’s request for an exemption is therefore consistent with the Regulations (10 CFR) Part 73, ‘‘Physical Pursuant to 10 CFR 73.55(a)(1), ‘‘By protection of plants and materials,’’ March 31, 2010, each nuclear power approach set forth by the Commission Section 73.55, ‘‘Requirements for reactor licensee, licensed under 10 CFR and discussed in the June 4, 2009, letter. physical protection of licensed activities Part 50, shall implement the PBNP Schedule Exemption Request in nuclear power reactors against requirements of this section through its radiological sabotage,’’ published in the Commission-approved Physical Security The licensee provided detailed Federal Register on March 27, 2009, Plan, Training and Qualification Plan, information in Enclosure 1 of its letter effective May 26, 2009, with a full Safeguards Contingency Plan, and Cyber dated March 11, 2010, requesting an implementation date of March 31, 2010, Security Plan referred to collectively exemption. The licensee is requesting requires licensees to protect, with high hereafter as ‘security plans.’ ’’ Pursuant additional time to perform necessary assurance, against radiological sabotage to 10 CFR 73.5, the Commission may, upgrades to the PBNP security system by designing and implementing upon application by any interested due to unforeseen delays such as comprehensive site security plans. The person or upon its own initiative, grant adverse weather, material delivery amendments to 10 CFR 73.55 published exemptions from the requirements of 10 delays, and testing constraints, and on March 27, 2009 establish and update CFR Part 73 when the exemptions are provides a timeline for achieving full generically applicable security authorized by law, and will not compliance with the new regulation. requirements similar to those previously endanger life or property or the common Enclosure 1 to the licensee’s letter imposed by Commission orders issued defense and security, and are otherwise contains security-related information after the terrorist attacks of September in the public interest. regarding the site security plan, details 11, 2001, and implemented by licensees. NRC approval of this exemption, as of the specific requirement of the In addition, the amendments to 10 CFR noted above, would allow an extension regulation for which the site cannot be 73.55 include additional requirements from March 31, 2010, until May 28, in compliance by the March 31, 2010, to further enhance site security based 2010, for the implementation date for deadline, justification for the exemption upon insights gained from one specific requirement of the new request, the required changes to the implementation of the post-September rule. As stated above, 10 CFR 73.5 site’s security configuration, and a 11, 2001, security orders. It is from one allows the NRC to grant exemptions timeline with critical path activities that of these new requirements that PBNP from the requirements of 10 CFR 73. will bring the licensee into full now seeks an exemption from the March The NRC staff has determined that compliance by May 28, 2010. The 31, 2010, implementation date. All other granting of the licensee’s proposed timeline provides dates indicating when physical security requirements exemption would not result in a the critical equipment will be installed, established by this recent rulemaking violation of the Atomic Energy Act of tested, and become operational. have already been or will be 1954, as amended, or the Commission’s Notwithstanding the schedular implemented by the licensee by March regulations. Therefore, the exemption is exemptions for these limited 31, 2010. authorized by law. requirements, the licensee will continue By letter dated February 26, 2010, In the draft final Power Reactor to be in compliance with all other which was superseded by letter dated Security rule sent to the Commission, applicable physical security March 11, 2010, the licensee requested the NRC staff proposed that the requirements as described in 10 CFR an exemption in accordance with 10 requirements of the new regulation be 73.55 and reflected in its current NRC- CFR 73.5, ‘‘Specific exemptions.’’ met within 180 days. The Commission approved physical security program. By Enclosures 1 to the February 26, and directed a change from 180 days to May 28, 2010, PBNP will be in full March 11, 2010, letters contain security- approximately 1 year for licensees to compliance with all the regulatory

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requirements of 10 CFR 73.55, as issued For the Nuclear Regulatory Commission. these comments can be found in on March 27, 2009. Joseph G. Giitter, ADAMS Accession No. ML100570289. Director, Division of Operating Reactor ADDRESSES: The NRC maintains 4.0 Conclusion for Part 73 Schedule Licensing, Office of Nuclear Reactor ADAMS, which provides text and image Exemption Request Regulation. files of NRC’s public documents. These The staff has reviewed the licensee’s [FR Doc. 2010–7189 Filed 3–30–10; 8:45 am] documents may be accessed through the submittals and concludes that the BILLING CODE 7590–01–P NRC’s Public Electronic Reading Room licensee has justified its request for an on the Internet at http://www.nrc.gov/ extension of the compliance date with reading-rm/adams.html. Persons who NUCLEAR REGULATORY do not have access to ADAMS, or who regard to one specified requirement of COMMISSION 10 CFR 73.55 until May 28, 2010. encounter problems in accessing the [DC/COL–ISG–017; NRC–2009–0380] documents located in ADAMS, should Accordingly, the Commission has contact the NRC Public Document Room determined that pursuant to 10 CFR Office of New Reactors; Interim Staff reference staff at 1–800–397–4209, 301– 73.5, ‘‘Specific exemptions,’’ an Guidance on Ensuring Hazard- 415–4737, or by e-mail to exemption from the March 31, 2010, Consistent Seismic Input for Site [email protected]. compliance date is authorized by law Response and Soil Structure FOR FURTHER INFORMATION CONTACT: Dr. Interaction Analyses and will not endanger life or property or Kimberly A. Hawkins, Chief, Structural the common defense and security, and AGENCY: Nuclear Regulatory Engineering Branch 2, Division of is otherwise in the public interest. Commission (NRC). Engineering, Office of the New Reactors, Therefore, the Commission hereby ACTION: Notice of availability. U.S. Nuclear Regulatory Commission, grants the requested exemption. Washington, DC 20555–0001; telephone: The long-term benefits that will be SUMMARY: The NRC staff is issuing its 301–415–0564 or e-mail: realized when the PBNP security Final Interim Staff Guidance (ISG) DC/ [email protected]. COL–ISG–017 titled ‘‘Ensuring Hazard- modifications are complete justifies SUPPLEMENTARY INFORMATION: The exceeding the full compliance date in Consistent Seismic Input for Site Response and Soil Structure Interaction agency posts its issued staff guidance in the case of this particular licensee. The Analyses,’’ (Agencywide Documents the agency external web page (http:// security measure for which PBNP needs Access and Management System www.nrc.gov/reading-rm/doc- additional time to implement is a new (ADAMS) Accession No. collections/isg/). requirement imposed by March 27, ML100570203). This ISG supplements Dated at Rockville, Maryland, this 24th day 2009, amendments to 10 CFR 73.55, and the guidance provided to the NRC staff of March 2010. is in addition to those required by the in Sections 2.5 and 3.7 of NUREG–0800, For the Nuclear Regulatory Commission. security orders issued in response to the ‘‘Standard Review Plan (SRP) for the William F. Burton, events of September 11, 2001. Review of Safety Analysis Reports for Chief, Rulemaking and Guidance Therefore, the NRC concludes that the Nuclear Power Plants,’’ March 2007, and Development Branch, Division of New Reactor licensee’s actions are in the best interest DC/COL–ISG–01, ‘‘Interim Staff Licensing, Office of New Reactor. of protecting the public health and Guidance on Seismic Issues Associated [FR Doc. 2010–7202 Filed 3–30–10; 8:45 am] safety through the security changes that with High Frequency Ground Motion in BILLING CODE 7590–01–P will result from granting this exemption. Design Certification and Combined As per the licensee’s request and the License Applications,’’ issued May 19, NRC’s regulatory authority to grant an 2008 (ADAMS Accession No. NUCLEAR REGULATORY exemption from the March 31, 2010, ML081400293). The NRC staff issues COMMISSION DC/COL–ISGs to facilitate timely deadline for the one item specified in [NRC–2008–0644] Enclosure 1 of PBNP letter dated March implementation of current staff guidance and to facilitate activities 11, 2010, the licensee is required to be Notice of Issuance of Regulatory Guide associated with review of applications in full compliance with 10 CFR 73.55 by for design certifications and combined AGENCY: Nuclear Regulatory May 28, 2010. In achieving compliance, licenses by the Office of New Reactors. Commission. the licensee is reminded that it is The NRC staff intends to incorporate the ACTION: Notice of Issuance and responsible for determining the final approved DC/COL–ISG–017 into Availability of Regulatory Guide (RG) appropriate licensing mechanism (i.e., the next revision of SRP Sections 2.5 1.126, Revision 2, ‘‘An Acceptable 10 CFR 50.54(p) or 10 CFR 50.90) for and 3.7 and Regulatory Guide 1.206, Model and Related Statistical Methods incorporation of all necessary changes ‘‘Combined License Applications for for the Analysis of Fuel Densification.’’ to its security plans. Nuclear Power Plants (LWR Edition),’’ Pursuant to 10 CFR 51.32, ‘‘Finding of June 2007. FOR FURTHER INFORMATION CONTACT: John no significant impact,’’ the Commission Disposition: On August 31, 2009, the C. Voglewede, U.S. Nuclear Regulatory has previously determined that the NRC staff issued the proposed ISG, DC/ Commission, Washington, DC 20555– granting of this exemption will not have COL–ISG–017, ‘‘Ensuring Hazard- 0001, telephone (301) 251–7555 or e- a significant effect on the quality of the Consistent Seismic Input for Site mail [email protected]. human environment [75 FR 14206; Response and Soil Structure Interaction SUPPLEMENTARY INFORMATION: ’’ March 24, 2010]. Analyses, (ADAMS Accession No. ML092230455) to solicit public and I. Introduction This exemption is effective upon industry comment. The NRC staff The U.S. Nuclear Regulatory issuance. received comments on the proposed Commission (NRC) is issuing a revision Dated at Rockville, Maryland, this 24th day guidance. This final issuance to an existing guide in the agency’s of March 2010. incorporates changes from the ‘‘Regulatory Guide’’ series. This series comments. The NRC staff responses to was developed to describe and make

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available to the public information such NUCLEAR REGULATORY participation in ACRS meetings were as methods that are acceptable to the COMMISSION published in the Federal Register on NRC staff for implementing specific October 14, 2009 (74 FR 58268–58269). parts of the agency’s regulations, Advisory Committee on Reactor Detailed meeting agendas and meeting techniques that the staff uses in Safeguards (ACRS); Meeting of the transcripts are available on the NRC evaluating specific problems or ACRS Subcommittee on EPR; Notice Web site at http://www.nrc.gov/ postulated accidents, and data that the of Meeting reading-rm/doc-collections/acrs. Information regarding topics to be staff needs in its review of applications The ACRS Subcommittee on the U.S. discussed, changes to the agenda, for permits and licenses. Evolutionary Power Reactor (EPR) will whether the meeting has been canceled hold a meeting on April 20–21, 2010, at Revision 2 of RG 1.126 was issued or rescheduled, and the time allotted to 11545 Rockville Pike, T2–B1, Rockville, with a temporary identification as Draft present oral statements can be obtained Maryland. Regulatory Guide, DG–1189. This guide from the Web site cited above or by The entire meeting will be open to describes an analytical model and contacting the identified DFO. public attendance, with the exception of related assumptions and procedures that Moreover, in view of the possibility that a portion that may be closed to protect the staff of the NRC considers the schedule for ACRS meetings may be information that is proprietary to acceptable for predicting the effects of adjusted by the Chairman as necessary AREVA NP, pursuant to 5 U.S.C. fuel densification in light-water-cooled to facilitate the conduct of the meeting, 552b(c)(4). nuclear power reactors. To meet these persons planning to attend should check The proposed agenda for the subject with these references if such objectives, the guide describes statistical meeting shall be as follows: methods related to product sampling rescheduling would result in major that will ensure that this and other Tuesday, April 20, 2010, 8:30 a.m.–5 inconvenience. approved analytical models will p.m. Dated: March 25, 2010. adequately describe the effects of The Subcommittee will review Antonio F. Dias, densification for each initial core and Chapters 4, 5 and 17 of the Safety Branch Chief, Reactor Safety Branch B, reload fuel quantity produced. Evaluation Report with Open Items Advisory Committee on Reactor Safeguards. associated with the staff’s review of the II. Further Information [FR Doc. 2010–7224 Filed 3–30–10; 8:45 am] Calvert Cliff’s Unit 3 Combined License BILLING CODE 7590–01–P In December 2008, DG–1189 was Application (COLA). published with a public comment Wednesday, April 21, 2010, 8:30 a.m.– NUCLEAR REGULATORY period of 60 days from the issuance of 5 p.m. the guide. No formal comments were COMMISSION The Subcommittee will review received and the public comment period Chapter 12 of the Safety Evaluation Advisory Committee on Reactor closed on February 9, 2009. Electronic Report with Open Items associated with Safeguards (ACRS); Meeting of the copies of RG 1.126 are available through the staff’s review of the Calvert Cliff’s ACRS Subcommittee on Power the NRC’s public Web site under Unit 3 COLA, and complete review of Uprates; Notice of Meeting ‘‘Regulatory Guides’’ at http:// Chapter 19 of the Safety Evaluation www.nrc.gov/reading-rm/ Report with Open Items associated with The ACRS Subcommittee on Power doc-collections/. the staff’s review of the U.S. EPR Design Uprates will hold a meeting on April 23, 2010, at 11545 Rockville Pike, In addition, regulatory guides are Certification application. Rockville, Maryland, Room T2 B3. available for inspection at the NRC’s The Subcommittee will gather The meeting will be open to public Public Document Room (PDR) located at information, analyze relevant issues and attendance, with the exception of a Room O–1F21, One White Flint North, facts, and formulate proposed positions and actions, as appropriate, for portion that may be closed to protect 11555 Rockville Pike, Rockville, fuel design information that is Maryland 20852–2738. The PDR’s deliberation by the Full Committee. Members of the public desiring to proprietary to General Electric Hitachi mailing address is USNRC PDR, (GEH) and Global Nuclear Fuels (GNF), Washington, DC 20555–0001. The PDR provide oral statements and/or written comments should notify the Designated pursuant to 5 U.S.C. 552b(c)(4). can also be reached by telephone at The agenda for the subject meeting (301) 415–4737 or (800) 397–4209, by Federal Official (DFO), Mr. Derek Widmayer (Telephone 301–415–7366, shall be as follows: fax at (301) 415–3548, and by e-mail to E-mail: [email protected]) five Friday, April 23, 2010,—8:30 a.m.–5 [email protected]. days prior to the meeting, if possible, so p.m. Regulatory guides are not that appropriate arrangements can be The Subcommittee will review copyrighted, and NRC approval is not made. Thirty-five hard copies of each Supplement 3 to Topical Report NEDC– required to reproduce them. presentation or handout should be 33173P–A, ‘‘Applicability of GE Dated at Rockville, Maryland, this 22nd provided to the DFO thirty minutes Methods to Expanded Domains.’’ This day of March 2010. before the meeting. In addition, one supplement extends the GEH/GNF electronic copy of each presentation computational methods to include For the Nuclear Regulatory Commission. should be e-mailed to the DFO one day GNF–2 fuel design. Andrea D. Valentin, before meeting. If an electronic copy The Subcommittee will gather Chief, Regulatory Guide Development Branch, cannot be provided within this information, analyze relevant issues and Division of Engineering, Office of Nuclear timeframe, presenters should provide facts, and formulate proposed positions Regulatory Research. the DFO with a CD containing each and actions, as appropriate, for [FR Doc. 2010–7226 Filed 3–30–10; 8:45 am] presentation at least thirty minutes deliberation by the Full Committee. BILLING CODE 7590–01–P before the meeting. Electronic Members of the public desiring to recordings will be permitted. Detailed provide oral statements and/or written procedures for the conduct of and comments should notify the Designated

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Federal Official (DFO), Zena Abdullahi DATES: Submit comments on or before SBA Form Numbers: SF 269, SF–272, (Telephone: 301–415–8716, E-mail: April 30, 2010. If you intend to SBA Form 2113. [email protected]) five days prior comment but cannot prepare comments Description of Respondents: Eligible to the meeting, if possible, so that promptly, please advise the OMB Dealers associated with the Dealer floor appropriate arrangements can be made. Reviewer and the Agency Clearance plan. Thirty-five hard copies of each Officer before the deadline. Responses: 126. presentation or handout should be Copies: Request for clearance (OMB Annual Burden: 8,568. provided to the DFO thirty minutes 83–1), supporting statement, and other Title: Application for 8(a) Business before the meeting. In addition, one documents submitted to OMB for Development (BD) and Small electronic copy of each presentation review may be obtained from the Disadvantaged Business (SDB) should be emailed to the DFO one day Agency Clearance Officer. Certification. before the meeting. If an electronic copy ADDRESSES: Address all comments Frequency: On occasion. cannot be provided within this concerning this notice to: Agency SBA Form Numbers: 1010, 1010–IND, timeframe, presenters should provide Clearance Officer, Jacqueline White, 1010–AIT, 1010–ANC, 1010–CDC, the DFO with a CD containing each Small Business Administration, 409 3rd 1010–NHO, 1010–REP, 1010–RECERT presentation at least thirty minutes Street, SW., 5th Floor, Washington, DC and 1010C. before the meeting. Electronic 20416; and OMB Reviewer, Office of Description of Respondents: Eligible recordings will be permitted only Information and Regulatory Affairs, Small Disadvantage Businesses and 8(a) during those portions of the meeting Office of Management and Budget, New businesses. that are open to the public. Detailed Executive Office Building, Washington, Responses: 9,971. procedures for the conduct of and DC 20503. Annual Burden: 36,210. participation in ACRS meetings were FOR FURTHER INFORMATION CONTACT: Jacqueline White, published in the Federal Register on October 14, 2009 (74 FR 58268–58269). Jacqueline White, Agency Clearance Chief, Administrative Information Branch. Detailed meeting agendas and meeting Officer, (202) 205–7044. [FR Doc. 2010–7247 Filed 3–30–10; 8:45 am] transcripts are available on the NRC SUPPLEMENTARY INFORMATION: BILLING CODE 8025–01–P Web site at http://www.nrc.gov/reading- Title: SBA Express and Pilot Loan rm/doc-collections/acrs. Information Program Export Express Community regarding topics to be discussed, Express and Patriot Express. SMALL BUSINESS ADMINISTRATION changes to the agenda, whether the Frequency: On occasion. Region II Buffalo District Advisory meeting has been canceled or SBA Form Numbers: 1919, 1920SX, A, Council; Public Meeting rescheduled, and the time allotted to B, C 2237, 2238. present oral statements can be obtained Description of Respondents: Small AGENCY: U.S. Small Business from the Web site cited above or by Business Clients. Administration. contacting the identified DFO. Responses: 98,200. ACTION: Notice of open Federal advisory Moreover, in view of the possibility that Annual Burden: 52,474. committee meeting. the schedule for ACRS meetings may be Title: Lenders Disbursement & adjusted by the Chairman as necessary Collection Report. SUMMARY: The SBA is issuing this notice to facilitate the conduct of the meeting, Frequency: On occasion. to announce the location, date, time, persons planning to attend should check SBA Form Number: 1502R. and agenda for the next meeting of the with these references if such Description of Respondents: Eligible Region II Buffalo District Advisory rescheduling would result in major Dealers associated with the Dealer floor Council. The meeting will be open to inconvenience. plan. the public. Dated: March 25, 2010. Responses: 300. DATES: The meeting will be held on Antonio F. Dias, Annual Burden: 140. April 14, 2010 from approximately 9:30 Branch Chief, Reactor Safety Branch B, Title: Form of Detached assignment a.m. to 11:30 a.m. Eastern Standard Advisory Committee on Reactor Safeguards. for U.S. Small Business Administration Time. [FR Doc. 2010–7188 Filed 3–30–10; 8:45 am] Loan Pool or Guaranteed Interest ADDRESSES: The meeting will be held at BILLING CODE 7590–01–P Certificate. the Canisius College Amherst Frequency: On occasion. Conference Center, 300 Corporate SBA Form Number: 1088. Parkway, Amherst, New York 14226. Description of Respondents: SMALL BUSINESS ADMINISTRATION SUPPLEMENTARY INFORMATION: Pursuant Secondary market participants. to section 10(a)(2) of the Federal Reporting and Recordkeeping Responses: 6,500. Advisory Committee Act (5 U.S.C., Requirements Under OMB Review Annual Burden: 9,750. Appendix 2), SBA announces the Title: Federal Agency Comment AGENCY: Small Business Administration. meeting of the Region II Buffalo District Forms. ACTION: Advisory Council. The Region II Buffalo Notice of reporting requirements Frequency: On occasion. submitted for OMB review. District Advisory Council is tasked with SBA Form Number: 1993. providing information of public interest. SUMMARY: Under the provisions of the Description of Respondents: Small The purpose of the meeting is so the Paperwork Reduction Act (44 U.S.C. business owners and farmers. council can provide advice and Chapter 35), agencies are required to Responses: 350. opinions regarding the effectiveness of submit proposed reporting and Annual Burden: 263. and need for SBA programs, particularly recordkeeping requirements to OMB for Title: Federal Cash Transaction the local districts which members review and approval, and to publish a Report, Financial Status Report, represent. The agenda will include: notice in the Federal Register notifying Program Income Report, Narrative District office, SBA programs and the public that the agency has made Program Report. services, ARRA, government such a submission. Frequency: On occasion. contracting, disaster updates, lending

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activity reports, small business week, Investors’’), MetLife Investors Variable contracts and variable life insurance event announcements, and roundtable Annuity Account One (‘‘VA Account policies issued by the Insurance discussion on small business issues. One’’), MetLife Investors Variable Life Companies (collectively, the FOR FURTHER INFORMATION CONTACT: The Account One (‘‘VL Account One’’), ‘‘Contracts’’). The Section 17 Applicants meeting is open to the public however MetLife Investors Variable Life Account seek an order pursuant to Section 17(b) advance notice of attendance is Eight (‘‘VL Account Eight’’), First of the Act to permit certain in-kind requested. Anyone wishing to attend MetLife Investors Insurance Company transactions in connection with certain and/or make a presentation to the (‘‘First MetLife Investors’’), First MetLife of the Substitutions. Region II Buffalo District Advisory Investors Variable Annuity Account DATES: Filing Date: The application was Council must contact Franklin J. One (‘‘First VA Account One’’), MetLife filed on September 21, 2009, and an Sciortino, District Director, Buffalo Investors USA Insurance Company amended and restated application was District Office by October 8, by fax or (‘‘MetLife Investors USA’’), MetLife filed on March 23, 2010. email in order to be placed on the Investors USA Separate Account A Hearing or Notification of Hearing: An agenda. Franklin J. Sciortino, District (‘‘Separate Account A’’), Metropolitan order granting the application will be Director, Buffalo District Office, U.S. Life Insurance Company (‘‘MetLife’’), issued unless the Commission orders a Small Business Administration, 540 Metropolitan Life Separate Account hearing. Interested persons may request Niagara Center, 130 S. Elmwood DCVL (‘‘Separate Account DCVL’’), a hearing by writing to the Secretary of Avenue, Buffalo, New York 14202; Metropolitan Life Separate Account UL the Commission and serving Applicants telephone (716) 551–4301 or fax (716) (‘‘Separate Account UL’’), Security with a copy of the request personally or 551–4418. Equity Separate Account Twenty-Six by mail. Hearing requests should be Additionally, if you need (‘‘SE Separate Account Twenty-Six’’), received by the Commission by 5:30 accommodations because of a disability Security Equity Separate Account p.m. on April 19, 2010, and should be or require additional information, please Twenty-Seven (‘‘SE Separate Account accompanied by proof of service on contact Kelly Lotempio, BDS/PIO, Twenty-Seven’’), Security Equity Applicants, in the form of an affidavit Buffalo District Office, U.S. Small Separate Account No. 13S (‘‘SE Separate or for lawyers a certificate of service. Business Administration, 540 Niagara Account 13S’’), Security Equity Separate Hearing requests should state the nature Center, 130 S. Elmwood Avenue, Account No. 485 (‘‘SE Separate Account of the writer’s interest, the reason for the Buffalo, New York 14202; telephone 485’’), General American Life Insurance request and the issue contested. Persons (716) 551–4301, [email protected] Company (‘‘General American’’) may request notification of a hearing by or fax (716) 551–4418. (together with MetLife of CT, MetLife writing to the Secretary of the For more information, please visit our Investors, First MetLife Investors, Commission. Web site at http://www.sba.gov/ny/ MetLife Investors USA and MetLife, the ADDRESSES: Secretary, Securities and buffalo. ‘‘Insurance Companies’’), General Exchange Commission, 100 F Street, American Separate Account Twenty- Meghan Burdick, NE., Washington, DC 20549–1090. Eight (‘‘GA Separate Account Twenty- Deputy Chief of Staff/Committee Management Applicants c/o Paul G. Cellupica, Chief Eight’’), General American Separate Officer. Counsel—Securities Regulation and Account Twenty-Nine (‘‘GA Separate [FR Doc. 2010–6816 Filed 3–30–10; 8:45 am] Corporate Services, MetLife Group, 1095 Account Twenty-Nine’’), (together with BILLING CODE P Avenue of the Americas, 40th Floor, Separate Account Eleven, Separate New York, NY 10036 and Robert N. Account QPN, Fund UL, VA Account Hickey, Esq., Sullivan & Worcester LLP, One, VL Account One, VL Account 1666 K Street, NW., Washington, DC SECURITIES AND EXCHANGE Eight, First VA Account One, Separate 20006. COMMISSION Account A, Separate Account DCVL, [Release No. IC–29190; File No. 812–13700] Separate Account UL, SE Separate FOR FURTHER INFORMATION CONTACT: Account Twenty-Six, SE Separate Alison T. White, Senior Counsel, or MetLife Insurance Company of Account Twenty-Seven, SE Separate Joyce M. Pickholz, Branch Chief, Office Connecticut, et al. Account 13S, SE Separate Account 485 of Insurance Products, Division of and GA Separate Account Twenty-Eight, Investment Management, at (202) 551– March 25, 2010. the ‘‘Separate Accounts’’), Met Investors 6795. AGENCY: Securities and Exchange Series Trust (‘‘MIST’’) and Metropolitan Commission (‘‘Commission’’). SUPPLEMENTARY INFORMATION: The Series Fund, Inc. (‘‘Met Series Fund’’), ACTION: following is a summary of the Notice of application for an (together with MIST, the ‘‘Investment order pursuant to Section 26(c) of the application. The complete application Companies’’). may be obtained via the Commission’s Investment Company Act of 1940 (the The Insurance Companies and the ‘‘ ’’ Web site by searching for the file Act ) approving certain substitutions of Separate Accounts are referred to as the securities and an order of exemption number, or for an applicant using the ‘‘Substitution Applicants.’’ The Company name box, at http:// pursuant to Section 17(b) of the Act Insurance Companies, the Separate from Section 17(a) of the Act. www.sec.gov/search/search.htm, or by Accounts and the Investment calling (202) 551–8090. Applicants: MetLife Insurance Companies are referred to as the Company of Connecticut (‘‘MetLife of ‘‘Section 17 Applicants.’’ Applicants’ Representations CT’’), MetLife of CT Separate Account SUMMARY: Summary of Application: 1. MetLife of CT is a stock life Eleven for Variable Annuities (‘‘Separate Applicants seek an order approving the insurance company organized in 1863 Account Eleven’’), MetLife of CT substitution of certain series of the under the laws of Connecticut. MetLife Separate Account QPN for Variable Investment Companies for shares of Investors is a stock life insurance Annuities (‘‘Separate Account QPN’’), series of other unaffiliated registered company organized on August 17, 1981 MetLife of CT Fund UL for Variable Life investment companies held by the under the laws of Missouri. First Insurance (‘‘Fund UL’’), MetLife Separate Accounts to fund certain group MetLife Investors is a stock life Investors Insurance Company (‘‘MetLife and individual variable annuity insurance company organized on

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December 31, 1992 under the laws of 5. Although Separate Account QPN, of its respective Separate Accounts for New York. MetLife Investors USA is a VL Account Eight, Separate Account certain series (the ‘‘Replacement Funds’’) stock life insurance company organized DCVL and Separate Account 485 are of MIST and Met Series Fund. on September 13, 1960 under the laws exempt from registration under the Act, 9. The proposed substitutions are as of Delaware. MetLife is a stock life they would be subject to the investment follows: (a) BlackRock Money Market insurance company organized in 1868 limitations of Section 12 but for the Portfolio for AIM V.I. Money Market under the laws of New York. General exclusion contained in Section Fund and Legg Mason Western Asset American is a stock life insurance 12(d)(1)(E) of the Act. To rely on such Variable Money Market Portfolio; (b) company organized in 1933 under the exclusion, an investment company that RCM Technology Portfolio for AIM V.I. laws of Missouri. is not a registered investment company Technology Fund and DWS Technology 2. Separate Account Eleven, Fund UL, must, among other things, agree to VIP; (c) Oppenheimer Global Equity VA Account One, VL Account One, refrain from substituting a security Portfolio for DWS Global Opportunities First VA Account One, Separate unless the Commission approves the VIP; (d) Met/Artisan Mid Cap Value Account A, Separate Account UL, SE substitution in the manner provided in Portfolio for Janus Aspen Perkins Mid Separate Account Twenty-Six, SE Section 26 of the Act. Cap Value Portfolio; (e) Met/Templeton Separate Account Twenty-Seven, 6. MIST and Met Series Fund are each Growth Portfolio for Legg Mason Separate Account 13S, GA Separate registered under the Act as open-end Batterymarch Variable Global Equity Account Twenty-Eight, and GA Separate management investment companies of Portfolio; (f) MetLife Stock Index Account Twenty-Nine are registered the series type, and their securities are Portfolio for Legg Mason Batterymarch under the Act as unit investment trusts registered under the Securities Act of S&P 500 Index Portfolio; (g) BlackRock for the purpose of funding the Contracts. 1933. Metlife Advisers, LLC serves as High Yield Portfolio for Pioneer High Security interests under the Contracts investment adviser to MIST and Met Yield VCT Portfolio; (h) Lord Abbett have been registered under the Series Fund. Growth and Income Portfolio for Securities Act of 1933. 7. The annuity contracts permit the Putnam VT Growth and Income Fund; 3. Separate Account QPN is exempt Insurance Companies to substitute (i) Met/AIM Small Cap Growth Portfolio from registration under the Act. Security shares of one fund with shares of for UIF Small Company Growth interests under the Contracts have been another, including a fund of a different Portfolio. registered under the Securities Act of registered investment company. The 10. The following is a summary of the 1933. prospectuses for the Contracts and the investment objectives and policies of 4. VL Account Eight, Separate Separate Accounts contain the each Existing Fund and its Account DCVL and Separate Account appropriate disclosures of this right. corresponding Replacement Fund. 485 serve as separate account funding 8. Each Insurance Company, on its Additional information including asset vehicles for certain Contracts that are behalf and on behalf of the Separate sizes, risk factors and comparative exempt from registration under Section Accounts proposes to make certain performance history for each Existing 4(2) of the Securities Act of 1933 and substitutions of shares of 11 funds (the Fund and Replacement Fund can be Regulation D thereunder. ‘‘Existing Funds’’) held in sub-accounts found in the Application.

Existing fund Replacement fund

AIM V.I. Money Market Fund—seeks to provide as high a level of cur- BlackRock Money Market Portfolio—seeks a high level of current in- rent income as is consistent with the preservation of capital and li- come consistent with preservation of capital. The Portfolio invests in quidity. The Fund invests only in high-quality U.S. dollar-denomi- accordance with industry-standard requirements for money market nated short term debt obligations. funds for the quality, maturity and diversification of investments. AIM V.I. Technology Fund—seeks capital growth. The Fund normally RCM Technology Portfolio—seeks capital appreciation; no consider- invests at least 80% of its assets in equity securities (principally com- ation is given to income. The Portfolio normally invests at least 80% mon stocks) of issuers engaged primarily in technology-related in- of its assets in common stocks of companies which utilize new, cre- dustries. ative or different, or ‘‘innovative,’’ technologies to gain a strategic competitive advantage in their industry, as well as companies that provide and service those technologies. DWS Technology VIP—seeks capital growth. Under normal cir- RCM Technology Portfolio—seeks capital appreciation; no consider- cumstances, the Portfolio invests at least 80% of net assets in com- ation is given to income.The Portfolio normally invests at least 80% mon stocks of companies in the technology sector. of its assets in common stocks of companies which utilize new, cre- ative or different, or ‘‘innovative,’’ technologies to gain a strategic competitive advantage in their industry, as well as companies that provide and service those technologies. DWS Global Opportunities VIP—seeks above-average capital apprecia- Oppenheimer Global Equity Portfolio—seeks capital appreciation. The tion over the long term. The Portfolio invests at least 65% of total as- Portfolio invests under normal circumstances at least 80% of its as- sets in common stocks and other equities of small companies sets in equity securities (primarily common stock) of U.S. and for- throughout the world (companies with market values similar to the eign-based companies. The Portfolio can invest without limit in for- smallest 20% of the S&P Developed Small Cap Index). eign securities and can invest in any country, including countries with developed or emerging markets. Janus Aspen Perkins Mid Cap Value Portfolio—seeks capital apprecia- Met/Artisan Mid Cap Value Fund—seeks long term capital growth. The tion. The Portfolio pursues its investment objective by investing pri- Portfolio invests at least 80% of its net assets in the common stocks marily in common stocks selected for their capital appreciation poten- of medium-sized companies. tial. Legg Mason Batterymarch Variable Global Equity Portfolio—seeks Met/Templeton Growth Portfolio—seeks long-term capital growth. long-term capital growth. Dividend income, if any, is a secondary Under normal market conditions, the Portfolio invests primarily in the consideration. The Portfolio invests primarily in the common stock of equity securities of companies with various market capitalizations lo- U.S. and non-U.S. issuers, particularly issuers located in countries cated anywhere in the world, including emerging markets. included in the Morgan Stanley Capital International World Index.

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Existing fund Replacement fund

Legg Mason Batterymarch S&P 500 Index Fund—seeks investment re- MetLife Stock Index Portfolio—seeks to equal the performance of the sults that, before expenses, correspond to the price and yield per- S&P 500 Index (before expenses). formance of the S&P 500 Index. Legg Mason Western Asset Variable Money Market Portfolio—seeks to BlackRock Money Market Portfolio—seeks a high level of current in- maximize current income consistent with preservation of capital. The come consistent with preservation of capital. The Portfolio invests in Portfolio invests exclusively in high quality U.S. dollar denominated accordance with industry-standard requirements for money market short-term debt securities. funds for the quality, maturity and diversification of investments. Pioneer High Yield VCT Portfolio—seeks to maximize total return BlackRock High Yield Portfolio—seeks to maximize total return con- through a combination of income and capital appreciation. Normally, sistent with income generation and prudent investment. The Portfolio the Portfolio invests at least 80% of its total assets in below invest- will invest primarily in non-investment grade bonds with maturities of ment grade high yield debt securities (junk bonds) and preferred ten years or less. The Portfolio will normally invest at least 80% of its stocks. assets in high yield (‘‘junk’’) bonds, including convertible and pre- ferred securities. Putnam VT Growth and Income Fund—seeks capital growth and cur- Lord Abbett Growth and Income Fund—seeks long-term growth of cap- rent income. The Fund invests mainly in common stocks of U.S. ital and income without excessive fluctuation in market value. The companies, with a focus on value stocks that offer the potential for Portfolio primarily purchases equity securities of large, seasoned, capital growth, current income, or both. U.S. and multinational companies that the portfolio manager believes are undervalued. UIF Small Company Growth Portfolio—seeks long-term capital appre- Met/AIM Small Cap Growth Portfolio—seeks long-term growth of cap- ciation. The portfolio manager seeks long-term capital appreciation ital. The Portfolio invests normally at least 80% of its assets in secu- by investing at least 80% of the Portfolio’s assets in growth-oriented rities of small-cap companies. equity securities of small U.S. and foreign companies, including emerging market securities.

11. The management fees, 12b–1 fees operating expenses for each Existing (if applicable), other expenses and total and Replacement Fund are as follows:

Management Other ex- Waiver/Reim- Total ex- fees 12b–1 fees penses bursement penses (Percent) (Percent) (Percent) (Percent) (Percent)

New Fund: BlackRock Money Market Portfolio ...... 32 ...... 02 .01 .33 Old Fund: AIM V.I. Money Market Fund ...... 40 ...... 50 ...... 90 New Fund: RCM Technology Fund ...... 88 ...... 08 ...... 96 Old Fund: AIM V.I. Technology Fund ...... 75 ...... 45 ...... 1.20 New Fund: RCM Technology Fund ...... 88 .15 .08 ...... 1.11 (.25) Old Fund: DWS Technology VIP ...... 67 .25 .26 ...... 1.18 New Fund: Oppenheimer Global Equity Portfolio ...... 53 .25 .11 ...... 89 (.50) Old Fund: DWS Global Opportunities VIP ...... 89 .25 .28 ...... 1.42 New Fund: Met/Artisan Mid Cap Value Portfolio ...... 82 .25 .05 ...... 1.12 (.50) Old Fund: Janus Aspen Perkins Mid Cap Value Portfolio .. .77 .25 .36 .04 1.34 New Fund: Met/Templeton Growth Portfolio ...... 69 .25 .18 .07 1.05 (.50) Old Fund: Legg Mason Batterymarch Variable Global Eq- uity Portfolio...... 75 .25 .39 .39 1.00 New Fund: BlackRock Money Market Portfolio ...... 32 .15 .02 .01 .48 (.25) Old Fund: Legg Mason Western Asset Variable Money Market Portfolio...... 45 ...... 05 ...... 50 New Fund: Met Life Stock Index Portfolio ...... 25 ...... 03 .01 .27 Old Fund: Legg Mason Batterymarch S&P 500 Index Port- folio ...... 25 .20 .16 .02 .59 New Fund: BlackRock High Yield Portfolio ...... 60 .25 .07 ...... 92 (.50) Old Fund: Pioneer High Yield VCT Portfolio ...... 65 .25 .15 ...... 1.05 New Fund: Lord Abbett Growth and Income Portfolio— Class A...... 53 ...... 03 ...... 56 Old Fund: Putnam VT Growth & Income Portfolio—Class IA ...... 48 ...... 10 ...... 58 New Fund: Lord Abbett Growth and Income Portfolio— Class B ...... 53 .25 .03 ...... 81 (.50) Old Fund: Putnam VT Growth & Income Portfolio—Class B ...... 48 .25 .10 ...... 83 New Fund: Met/AIM Small Cap Growth Portfolio ...... 86 .25 .04 ...... 1.15 (.50) Old Fund: UIF Small Company Growth Portfolio ...... 92 .35 .44 ...... 1.71

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12. MetLife Advisers, LLC is the would offset the difference in the Fund will receive from the applicable adviser of each of the Replacement expense ratio between each Existing class of shares held by the Separate Funds. Each Replacement Fund Fund’s net expense ratio and the net Accounts Rule 12b–1 fees in the same currently offers up to four classes of expense ratio for the respective amount or a lesser amount than the shares, three of which, Class A, Class B Replacement Fund. amount paid by the Existing Funds, and Class E are involved in the 19. Except for the Legg Mason except as described above. substitutions. Batterymarch Variable Global Equity 25. Further, in addition to any Rule 13. The Applicants believe the Portfolio/Met/Templeton Growth 12b–1 fees, the investment advisers or substitutions will provide significant Portfolio substitution where there is an distributors of the Existing Funds pay benefits to Contract owners, including increase in net expenses after waivers of the Insurance Companies or one of their improved selection of sub-advisers and 0.05%, the substitutions will result in affiliates from 0 to 43 basis points for simplification of fund offerings through decreased net expense ratios ranging the Existing Funds’ classes of shares the elimination of overlapping offerings. from 2 basis points to 57 basis points. involved in the substitutions. Following 14. As a result of the substitutions, the Moreover, there will be no increase in the substitutions, these payments will number of investment options offered Contract fees and expenses, including not be made on behalf of the under substantially all of the Contracts mortality and expense risk fees and Replacement Funds. Rather, the will not change (currently ranges in administration and distribution fees Insurance Companies or their affiliates number from 3 to 122). For a limited charged to the Separate Accounts as a will have available both the 25 and 15 number of Contracts which currently result of the substitutions. basis points in Rule 12b–1 fees from the have at least 21 investment options 20. The Substitution Applicants Replacement Funds (with respect to available, after the substitutions there believe that the Replacement Funds Class B and Class E shares, respectively) will be available at least 20 investment have investment objectives, policies and and, as owners of the Replacement options. risk profiles that are either substantially Funds’ adviser, profit distributions from 15. Those substitutions which replace the same as, or sufficiently similar to, the adviser. These profits from investment options advised by the corresponding Existing Funds to investment advisory fees may be more investment advisers that are not make those Replacement Funds or less than the fees being paid by the affiliated with the Substitution appropriate candidates as substitutes. Existing Funds. Applicants with funds for which 21. In addition, after the substitutions, MetLife Advisers, LLC acts as neither MetLife Advisers, LLC nor any Applicants’ Legal Analysis and investment adviser will permit each of their affiliates will receive Conditions adviser, under the Multi-Manager Order, compensation from the charges to the 1. The Substitution Applicants [IC–22824 (1997) and IC–23859 (1999)], Separate Accounts related to the request that the Commission issue an to hire, monitor and replace sub- Contracts or from Rule 12b–1 fees or order pursuant to Section 26(c) of the advisers as necessary to achieve optimal revenue sharing from the Replacement Act approving the proposed performance. Funds in excess of the compensation substitutions. 16. Contract owners with sub-account currently received from the investment 2. Applicants represent that the balances invested (through the separate advisers or distributors of the Existing Contracts permit the applicable account) in shares of the Replacement Funds. Insurance Company, subject to Funds, except for the Legg Mason 22. The share classes of the compliance with applicable law, to Batterymarch Variable Global Equity Replacement Funds are either identical substitute shares of another investment Portfolio/Met/Templeton Growth to or less than the share classes of the company for shares of an investment Portfolio, will have lower total expense Existing Funds with respect to the company held by a sub-account of the ratios taking into account fund expenses imposition of Rule 12b–1 fees currently Separate Accounts. The prospectuses for and current fee waivers. imposed, except with respect to the the Contracts and the Separate Accounts 17. In the following substitutions, the substitution of BlackRock Money contain appropriate disclosure of this management fee and/or applicable Rule Market Portfolio for Legg Mason right. 12b–1 fee of the Replacement Fund are Western Asset Variable Money Market 3. By a supplement to the either currently higher, or, at certain Portfolio. prospectuses for the Contracts and the management fee breakpoints, may be 23. Each MIST and Met Series Fund Separate Accounts, each Insurance higher than those of the respective Replacement Fund’s Class B and Class Company has notified all owners of the Existing Fund: Legg Mason Western E Rule 12b–1 fees can be raised to Contracts of its intention to take the Asset Variable Money Market Portfolio/ 0.50% of net assets by the Replacement necessary actions, including seeking the BlackRock Money Market Portfolio; AIM Fund’s Board of Directors/Trustees order requested by this Application, to V. I. Technology Fund/RCM Technology without shareholder approval. However, substitute shares of the funds as Portfolio; DWS Technology VIP/RCM Met Series Fund and MIST represent described herein. The supplement has Technology Portfolio; DWS Global that Rule 12b–1 fees of the Class B and advised Contract owners that from the Opportunities VIP/Oppenheimer Global Class E shares of the Replacement date of the supplement until the date of Equity Portfolio; Putnam VT Growth Funds issued in connection with the the proposed substitution, owners are and Income Portfolio/Lord Abbett proposed substitutions will not be permitted to make one transfer of Growth and Income Portfolio; UIF Small raised above the current rate without Contract value (or annuity unit Company Growth Portfolio/Met/AIM approval of a majority in interest of the exchange) out of the Existing Fund sub- Small Cap Growth Portfolio; and Janus respective Replacement Funds’ account to one or more other sub- Aspen Perkins Mid Cap Value Portfolio/ shareholders after the substitutions. accounts without the transfer (or Met/Artisan Mid Cap Value Portfolio. 24. The distributors of the Existing exchange) being treated as one of a 18. The Substitution Applicants Funds pay to the Insurance Companies, limited number of permitted transfers propose to limit Contract charges or their affiliates, any 12b–1 fees (or exchanges) or a limited number of attributable to Contract value invested associated with the class of shares sold transfers (or exchanges) permitted in the Replacement Funds following the to the Separate Accounts. Similarly, the without a transfer charge. The proposed substitutions to a rate that distributors for MIST and Met Series supplement also has informed Contract

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owners that the Insurance Company will proposed substitutions. No fees will be except with respect to the AIM V.I. not exercise any rights reserved under charged on the transfers made at the Technology Fund/RCM Technology any Contract to impose additional time of the proposed substitutions Portfolio, DWS Technology VIP/RCM restrictions on transfers until at least 30 because the proposed substitutions will Technology Portfolio, DWS Global days after the proposed substitutions. not be treated as a transfer for the Opportunities VIP/Oppenheimer Global The supplement has also advised purpose of assessing transfer charges or Equity Portfolio, Janus Aspen Perkins Contract owners that for at least 30 days for determining the number of Mid Cap Value Portfolio/Met/Artisan following the proposed substitutions, remaining permissible transfers in a Mid Cap Value Portfolio, Legg Mason the Insurance Companies will permit Contract year. Western Asset Variable Money Market Contract owners affected by the 7. In addition to the prospectus Portfolio/BlackRock Money Market substitutions to make one transfer of supplements distributed to owners of Portfolio, Putnam VT Growth and Contract value (or annuity unit Contracts, within five business days Income Portfolio/Lord Abbett Growth exchange) out of the Replacement Fund after the proposed substitutions are and Income Portfolio, and UIF Small sub-account to one or more other sub- completed, Contract owners will be sent Company Growth Portfolio/Met/AIM accounts without the transfer (or a written notice informing them that the Small Cap Growth Portfolio exchange) being treated as one of a substitutions were carried out and that substitutions. limited number of permitted transfers they may make one transfer of all 10. With respect to the AIM V.I. (or exchanges) or a limited number of Contract value or cash value under a Technology Fund/RCM Technology transfers (or exchanges) permitted Contract invested in any one of the sub- Portfolio, DWS Technology VIP/RCM without a transfer charge. accounts on the date of the notice to one Technology Portfolio, DWS Global 4. The proposed substitutions will or more other sub-accounts available Opportunities VIP/Oppenheimer Global take place at relative net asset value under their Contract at no cost and Equity Portfolio, Janus Aspen Perkins with no change in the amount of any without regard to the usual limit on the Mid Cap Value Portfolio/Met/Artisan Contract owner’s Contract value, cash frequency of transfers from the variable Mid Cap Value Portfolio, Legg Mason value, or death benefit or in the dollar account options to the fixed account Western Asset Variable Money Market value of his or her investment in the options. The notice will also reiterate Portfolio/BlackRock Money Market Separate Accounts. that (other than with respect to ‘‘market Portfolio, Putnam VT Growth and 5. The process for accomplishing the timing’’ activity) the Insurance Company Income Portfolio/Lord Abbett Growth transfer of assets from each Existing will not exercise any rights reserved by and Income Portfolio and UIF Small Fund to its corresponding Replacement it under the Contracts to impose Company Growth Portfolio/Met/AIM Fund will be determined on a case-by- additional restrictions on transfers or to Small Cap Growth Portfolio case basis. In most cases, it is expected impose any charges on transfers until at substitutions, the reimbursement that the substitutions will be effected by least 30 days after the proposed agreement with respect to the redeeming shares of an Existing Fund substitutions. The Insurance Companies Replacement Fund’s operating expenses for cash and using the cash to purchase will also send each Contract owner and sub-account expenses, will extend shares of the Replacement Fund. In current prospectuses for the for the life of each Contract outstanding certain other cases, it is expected that Replacement Funds involved to the on the date of the proposed the substitutions will be effected by extent that they have not previously substitutions. redeeming the shares of an Existing received a copy. 11. The Substitution Applicants Fund in-kind; those assets will then be 8. Each Insurance Company also is further agree that, except with respect to contributed in-kind to the seeking approval of the proposed the AIM V.I. Technology Fund/RCM corresponding Replacement Fund to substitutions from any State insurance Technology Portfolio, DWS Technology purchase shares of that Fund. All in- regulators whose approval may be VIP/RCM Technology Portfolio, DWS kind redemptions from an Existing necessary or appropriate. Global Opportunities VIP/Oppenheimer Fund of which any of the Substitution 9. The Substitution Applicants agree Global Equity Portfolio, Janus Aspen Applicants is an affiliated person will that for those who were Contract owners Perkins Mid Cap Value Portfolio/Met/ be effected in accordance with the on the date of the proposed Artisan Mid Cap Value Portfolio, Legg conditions set forth in the Commission’s substitutions, the Insurance Companies Mason Western Asset Variable Money no-action letter issued to Signature will reimburse, on the last business day Market Portfolio/BlackRock Money Financial Group, Inc. (available of each fiscal period (not to exceed a Market Portfolio, Putnam VT Growth December 28, 1999). fiscal quarter) during the twenty-four and Income Portfolio/Lord Abbett 6. Contract owners will not incur any months following the date of the Growth and Income Portfolio, and UIF fees or charges as a result of the proposed substitutions, those Contract Small Company Growth Portfolio/Met/ proposed substitutions, nor will their owners whose sub-account invests in AIM Small Cap Growth Portfolio rights or an Insurance Company’s the Replacement Fund such that the substitutions, the Insurance Companies obligations under the Contracts be sum of the Replacement Fund’s net will not increase total separate account altered in any way. All expenses operating expenses (taking into account charges (net of any reimbursements or incurred in connection with the fee waivers and expense waivers) for any existing owner of the proposed substitutions, including reimbursements) and sub-account Contracts on the date of the brokerage, legal, accounting, and other expenses (asset-based fees and charges substitutions for a period of two years fees and expenses, will be paid by the deducted on a daily basis from sub- from the date of the substitutions. Insurance Companies. In addition, the account assets and reflected in the 12. With respect to the AIM V.I. proposed substitutions will not impose calculation of sub-account unit values) Technology Fund/RCM Technology any tax liability on Contract owners. for such period will not exceed, on an Portfolio, DWS Technology VIP/RCM The proposed substitutions will not annualized basis, the sum of the Technology Portfolio, DWS Global cause the Contract fees and charges Existing Fund’s net operating expenses Opportunities VIP/Oppenheimer Global currently being paid by existing taking into account fee waivers and Equity Portfolio, Janus Aspen Perkins Contract owners to be greater after the expense reimbursements and sub- Mid Cap Value Portfolio/Met/Artisan proposed substitutions than before the account expenses for fiscal year 2009, Mid Cap Value Portfolio, Legg Mason

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Western Asset Variable Money Market owners may be considered the 23. Section 17(b) of the Act provides Portfolio/BlackRock Money Market beneficial owners of those shares held that the Commission may, upon Portfolio, Putnam VT Growth and in the Separate Accounts. If MIST and application, grant an order exempting Income Portfolio/Lord Abbett Growth Met Series Fund and their respective any transaction from the prohibitions of and Income Portfolio and UIF Small funds are under the control of the Section 17(a) if the evidence establishes Company Growth Portfolio/Met/AIM Insurance Companies, then each that: (a) The terms of the proposed Small Cap Growth Portfolio Insurance Company is an affiliated transaction, including the consideration substitutions, the agreement not to person or an affiliated person of an to be paid or received, are reasonable increase the separate account charges affiliated person of MIST and Met Series and fair and do not involve will extend for the life of each Contract Fund and their respective funds. If overreaching on the part of any person outstanding on the date of the proposed MIST and Met Series Fund and their concerned; (b) the proposed transaction substitutions. respective funds are under the control of is consistent with the policy of each 13. In each case, the applicable the Insurance Companies, then MIST registered investment company Insurance Companies believe that it is and Met Series Fund and their concerned, as recited in its registration in the best interests of the Contract respective funds are affiliated persons of statement and records filed under the owners to substitute the Replacement the Insurance Companies. Act; and (c) the proposed transaction is Fund for the Existing Fund. The 20. Regardless of whether or not the consistent with the general purposes of Insurance Companies believe that in Insurance Companies can be considered the Act. cases where the Replacement Fund has to control MIST and Met Series Fund 24. The Section 17 Applicants submit a new sub-adviser, the new sub-adviser and their respective funds, because the that for all the reasons stated above the will, over the long term, be positioned Insurance Companies own of record terms of the proposed in-kind purchases to provide at least comparable more than 5% of the shares of each of of shares of the Replacement Funds by performance to that of the Existing them and are under common control the Insurance Companies, including the Fund’s sub-adviser. with each Replacement Fund’s consideration to be paid and received, 14. The Substitution Applicants investment adviser, the Insurance as described in this Application, are anticipate that Contract owners will be Companies are affiliated persons of both reasonable and fair and do not involve better off with the array of sub-accounts MIST and Met Series Fund and their overreaching on the part of any person offered after the proposed substitutions respective funds. Likewise, their concerned. The Section 17 Applicants than they have been with the array of respective funds are each an affiliated also submit that the proposed in-kind sub-accounts offered prior to the person of the Insurance Companies. purchases by the Insurance Companies substitutions. are consistent with the policies of: (a) 21. The Insurance Companies, 15. The Substitution Applicants MIST and of its RCM Technology, Met/ through their separate accounts in the submit that none of the proposed Templeton Growth, BlackRock High aggregate own more than 5% of the substitutions is of the type that Section Yield, Lord Abbett Growth and Income 26(c) was designed to prevent. outstanding shares of the following and Met/AIM Small Cap Growth 16. The Substitution Applicants Existing Funds: Legg Mason Portfolios; and (b) Met Series Fund and request an order of the Commission Batterymarch Variable Global Equity of its BlackRock Money Market, pursuant to Section 26(c) of the Act Portfolio, Legg Mason Western Asset Oppenheimer Global Equity, Met/ approving the proposed substitutions by Variable Money Market Portfolio, Legg Artisan Mid Cap Value and MetLife the Insurance Companies. Mason Batterymarch S&P 500 Index Stock Index Portfolios, as recited in the 17. The Section 17 Applicants request Portfolio, Pioneer High Yield VCT current registration statements and an order under Section 17(b) exempting Portfolio, UIF Small Company Growth reports filed by each under the Act. them from the provisions of Section Portfolio. Therefore, each Insurance Finally, the Section 17 Applicants 17(a) to the extent necessary to permit Company is an affiliated person of those submit that the proposed substitutions the Insurance Companies to carry out funds. are consistent with the general purposes each of the proposed substitutions. 22. Because the substitutions may be of the Act. 18. Section 17(a)(1) of the Act, in effected, in whole or in part, by means 25. To the extent that the in-kind relevant part, prohibits any affiliated of in-kind redemptions and purchases, purchases by the Insurance Company of person of a registered investment the substitutions may be deemed to the Replacement Funds’ shares are company, or any affiliated person of involve one or more purchases or sales deemed to involve principal such person, acting as principal, from of securities or property between transactions among affiliated persons, knowingly selling any security or other affiliated persons. The proposed the procedures described below should property to that company. Section transactions may involve a transfer of be sufficient to assure that the terms of 17(a)(2) of the Act generally prohibits portfolio securities by the Existing the proposed transactions are reasonable the persons described above, acting as Funds to the Insurance Companies; and fair to all participants. The Section principals, from knowingly purchasing immediately thereafter, the Insurance 17 Applicants maintain that the terms of any security or other property from the Companies would purchase shares of the proposed in-kind purchase registered company. the Replacement Funds with the transactions, including the 19. Because shares held by a separate portfolio securities received from the consideration to be paid and received by account of an insurance company are Existing Funds. Accordingly, as the each fund involved, are reasonable, fair legally owned by the insurance Insurance Companies and certain of the and do not involve overreaching company, the Insurance Companies and Existing Funds listed above, and the principally because the transactions will their affiliates collectively own of record Insurance Companies and the conform with all but one of the substantially all of the shares of MIST Replacement Funds, could be viewed as conditions enumerated in Rule 17a–7. and Met Series Fund. Therefore, MIST affiliated persons of one another under The proposed transactions will take and Met Series Fund and their Section 2(a)(3) of the Act, it is place at relative net asset value in respective funds are arguably under the conceivable that this aspect of the conformity with the requirements of control of the Insurance Companies substitutions could be viewed as being Section 22(c) of the Act and Rule 22c– notwithstanding the fact that Contract prohibited by Section 17(a). 1 thereunder with no change in the

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amount of any Contract owner’s contract 27. The sale of shares of Replacement SECURITIES AND EXCHANGE value or death benefit or in the dollar Funds for investment securities, as COMMISSION value of his or her investment in any of contemplated by the proposed [Investment Company Act Release No. the Separate Accounts. Contract owners Insurance Company in-kind purchases, 29191; File No. 812–13694] will not suffer any adverse tax is consistent with the investment consequences as a result of the policies and restrictions of the MCG Capital Corporation; Notice of substitutions. The fees and charges Investment Companies and the Application under the Contracts will not increase Replacement Funds because (a) the because of the substitutions. Even shares are sold at their net asset value, March 25, 2010. though the Separate Accounts, the and (b) the portfolio securities are of the AGENCY: Securities and Exchange Insurance Companies, MIST and Met type and quality that the Replacement Commission (‘‘Commission’’). Series Fund may not rely on Rule 17a– Funds would each have acquired with ACTION: Notice of an application for an 7, the Section 17 Applicants believe that the proceeds from share sales had the order under section 23(c)(3) of the the Rule’s conditions outline the type of shares been sold for cash. To assure that Investment Company Act of 1940 (the safeguards that result in transactions the second of these conditions is met, ‘‘Act’’) for an exemption from section that are fair and reasonable to registered MetLife Advisers, LLC and the sub- 23(c) of the Act. investment company participants and adviser, as applicable, will examine the preclude overreaching in connection SUMMARY: Summary of the Application: portfolio securities being offered to each with an investment company by its MCG Capital Corporation (the Replacement Fund and accept only affiliated persons. In addition, as stated ‘‘Applicant’’), requests an order to above, the in-kind redemptions will those securities as consideration for amend a prior order (the ‘‘Prior Order’’) 1 only be made in accordance with the shares that it would have acquired for that permits the Applicant to issue conditions set out in the Signature each such fund in a cash transaction. restricted shares of its common stock Financial Group no-action letter 28. The Section 17 Applicants submit (‘‘Restricted Stock’’) to Applicant’s (December 29, 1999). that the proposed Insurance Company employees and non-employee directors ‘‘ ’’ 26. The boards of MIST and Met in-kind purchases are consistent with ( Participants ) pursuant to the MCG Series Fund have adopted procedures, the general purposes of the Act as stated Capital Corporation 2006 Employee as required by paragraph (e)(1) of Rule in the Findings and Declaration of Restricted Stock Plan and the MCG 17a–7, pursuant to which the series of Policy in Section 1 of the Act and that Capital Corporation 2006 Non-Employee each may purchase and sell securities to the proposed transactions do not Director Restricted Stock Plan (together, ‘‘ ’’ 2 and from their affiliates. The Section 17 present any of the conditions or abuses the Plans ). Applicant seeks to amend Applicants will carry out the proposed that the Act was designed to prevent. the Prior Order in order to engage in Insurance Company in-kind purchases certain transactions, provided for in the 29. The Section 17 Applicants MCG Capital Corporation Second in conformity with all of the conditions represent that the proposed in-kind of Rule 17a–7 and each series’ Amended and Restated 2006 Employee purchases meet all of the requirements Restricted Stock Plan and the MCG procedures thereunder, except that the of Section 17(b) of the Act and request consideration paid for the securities Capital Corporation Second Amended that the Commission issue an order and Restated Non-Employee Director being purchased or sold may not be pursuant to Section 17(b) of the Act entirely cash. Nevertheless, the Restricted Stock Plan (together, the exempting the Separate Accounts, the ‘‘Amended Plans’’) that may constitute circumstances surrounding the Insurance Companies, MIST, Met Series proposed substitutions will be such as purchases by the Applicant of its own Fund and each Replacement Fund from securities within the meaning of section to offer the same degree of protection to the provisions of Section 17(a) of the each Replacement Fund from 23(c) of the Act. Act to the extent necessary to permit the overreaching that Rule 17a–7 provides DATES: Filing Dates: The application was Insurance Companies on behalf of the to them generally in connection with filed on September 4, 2009 and Separate Accounts to carry out, as part their purchase and sale of securities amended on January 19, 2010 and of the substitutions, the in-kind under that Rule in the ordinary course March 16, 2010. purchase of shares of the Replacement of their business. In particular, the Hearing or Notification of Hearing: An Insurance Companies (or any of their Funds which may be deemed to be order granting the application will be affiliates) cannot effect the proposed prohibited by Section 17(a) of the Act. issued unless the Commission orders a transactions at a price that is Conclusion hearing. Interested persons may request disadvantageous to any of the a hearing by writing to the Replacement Funds. Although the Applicants assert that for the reasons Commission’s Secretary and serving transactions may not be entirely for summarized above that the proposed applicant with a copy of the request, cash, each will be effected based upon substitutions and related transactions personally or by mail. Hearing requests (1) the independent market price of the meet the standards of Section 26(c) of should be received by the Commission portfolio securities valued as specified the Act and are consistent with the by 5:30 p.m. on April 19, 2010, and in paragraph (b) of Rule 17a–7, and (2) standards of Section 17(b) of the Act should be accompanied by proof of the net asset value per share of each and that the requested orders should be service on applicant, in the form of an fund involved valued in accordance granted. affidavit or, for lawyers, a certificate of service. Hearing requests should state with the procedures disclosed in its For the Commission, by the Division of respective investment company the nature of the writer’s interest, the Investment Management pursuant to reason for the request, and the issues registration statement and as required delegated authority. by Rule 22c–1 under the Act. No brokerage commission, fee, or other Florence E. Harmon, 1 MCG Capital Corporation, Investment Company Deputy Secretary. Act Release Nos. 27258 (Mar. 8, 2006) (notice) and remuneration will be paid to any party 27280 (Apr. 4, 2006) (order). [FR Doc. 2010–7207 Filed 3–30–10; 8:45 am] in connection with the proposed in kind 2 The Plans were each amended and restated on purchase transactions. BILLING CODE 8011–01–P April 23, 2008.

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contested. Persons who wish to be purposes.3 The Amended Plans provide 3. The Applicant states that any such notified of a hearing may request that each Participant must satisfy all purchases will be made in a manner that notification by writing to the applicable Federal, State, and local or does not unfairly discriminate against Commission’s Secretary. other income and employment tax the Applicant’s other stockholders ADDRESSES: Secretary, U.S. Securities withholding obligations before the because any shares that the Participants and Exchange Commission, 100 F Applicant will deliver stock certificates deliver to the Applicant to satisfy tax Street, NE., Washington, DC 20549– or otherwise recognize ownership of withholding obligations will be valued 1090. Applicant, c/o Steven F. Tunney, common stock under an award. at the closing sales price of Applicant’s President and Chief Executive Officer, 3. The Amended Plans will be subject shares of common stock on the MCG Capital Corporation, 1100 Wilson to approval by the Applicant’s board of NASDAQ Global Select Market (or any Boulevard, Suite 3000, Arlington, directors as well as the required other such exchange on which its shares Virginia 22209. majority of the Applicant’s directors of common stock may be traded in the within the meaning of section 57(o) of FOR FURTHER INFORMATION CONTACT: future) as of the date of the transaction. the Act. The Amended Plans explicitly Barbara T. Heussler, Senior Counsel, at Applicant further states that no permit the Applicant to withhold shares (202) 551–6990, or Jennifer L. Sawin, of the Applicant’s common stock or transaction will be conducted pursuant Branch Chief, at (202) 551–6821, purchase shares of the Applicant’s to the requested order on days when (Division of Investment Management, common stock from the Participants to there are no reported market Office of Investment Company satisfy tax withholding obligations transactions involving the Applicant’s Regulation). related to the vesting of Restricted shares. Applicant submits that because SUPPLEMENTARY INFORMATION: The Stock.4 all of the transactions between the following is a summary of the Applicant and the Participants with Applicant’s Legal Analysis application. The complete application respect to the Amended Plans will take may be obtained via the Commission’s 1. Section 23(c) of the Act, which is place at the public market price for the Web site by searching for the file made applicable to BDCs by section 63 Applicant’s common stock, these number, or an applicant using the of the Act, generally prohibits a BDC transactions will not be significantly Company name box, at http:// from purchasing any securities of which different than could be achieved by any www.sec.gov/search/search.htm or by it is the issuer except in the open stockholder selling in a market calling (202) 551–8090. market, pursuant to tender offers or transaction. under other circumstances as the 4. Applicant submits that the Applicant’s Representations Commission may permit to ensure that withholding provisions in the Amended 1. The Applicant is an internally the purchase is made on a basis that Plans do not raise concerns about managed, non-diversified, closed-end does not unfairly discriminate against management investment company that any holders of the class or classes of preferential treatment of the Applicant’s has elected to be regulated as a business securities to be purchased. Applicant insiders because the Amended Plans are development company (‘‘BDC’’) under states that the withholding of the a bona fide compensation plan of the the Act. The Plans authorize the Applicant’s common stock or purchase type that is common among Applicant to issue Restricted Stock to of shares of Applicant’s common stock corporations generally. Further, the the Participants in accordance with the to satisfy tax withholding obligations vesting schedule is determined at the terms and conditions of the Prior Order. related to the vesting of Restricted Stock time of the initial grant of the Restricted The Applicant seeks to amend the Prior might be deemed to be purchases by the Stock. Applicant represents that that the Order to permit the Applicant to Applicant of its own securities within transactions may be made only as withhold shares of the Applicant’s the meaning of section 23(c), and that permitted by the Amended Plans. The common stock or purchase shares of the section 23(c) of the Act may therefore Applicant believes that its request for Applicant’s common stock from the prohibit these transactions. the order is consistent with the policies Participants to satisfy tax withholding 2. Section 23(c)(3) of the Act permits underlying the provisions of the Act obligations related to the vesting of a BDC to purchase securities of which permitting the use of equity Restricted Stock that were or will be it is the issuer ‘‘under such * * * compensation as well as prior granted pursuant to the Plans or the circumstances as the Commission may exemptive relief granted by the Amended Plans. The Applicant will permit by * * * orders for the Commission for relief under section continue to comply with all of the terms protection of investors in order to insure 23(c) of the Act. and conditions of the Prior Order. that such purchases are made in a 2. The Plans and the Amended Plans manner or on a basis which does not For the Commission, by the Division of authorize the Applicant to issue shares unfairly discriminate against any Investment Management, pursuant to of Restricted Stock; at the time of holders of the class or classes of delegated authority. issuance these shares are subject to securities to be purchased.’’ Applicant Florence E. Harmon, certain forfeiture restrictions. On the believes that the requested relief meets Deputy Secretary. date that any Restricted Stock vests, the standards of section 23(c)(3) of the [FR Doc. 2010–7206 Filed 3–30–10; 8:45 am] such vested shares of the Restricted Act. BILLING CODE 8011–01–P Stock are released to the Participant and are available for sale or transfer. For 3 During the restricted period (i.e., prior to the Participants who are employees, the lapse of applicable forfeiture restrictions), the Restricted Stock generally may not be sold, value of the vested shares is deemed to transferred, pledged, hypothecated, margined, or be wage compensation for the employee. otherwise encumbered by a Participant. Applicant states that any compensation 4 The Amended Plans provide that shares income recognized by an employee is withheld from an award to satisfy tax withholding obligations are not returned to the plan reserve, but generally subject to Federal withholding are counted against the number of shares available for income and employment tax under the relevant plan.

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SECURITIES AND EXCHANGE concerning the purpose of and basis for 2. Statutory Basis the proposed rule change and discussed COMMISSION The Exchange believes that the any comments it received on the [Release No. 34–61769; File No. SR–BX– proposed rule change is consistent with proposed rule change. The text of these 2010–020] the provisions of Section 6 of the Act,5 statements may be examined at the in general, and with Sections 6(b)(5) of places specified in Item IV below. The Self-Regulatory Organizations; The the Act,6 in particular, in that the Exchange has prepared summaries, set NASDAQ OMX BX, Inc.; Notice of Filing proposal is designed to prevent forth in Sections A, B, and C below, of and Immediate Effectiveness of fraudulent and manipulative acts and the most significant aspects of such Proposed Rule Change To Amend Rule practices, to promote just and equitable statements. 3121 To Reflect Changes to principles of trade, to foster cooperation Corresponding FINRA Rule A. Self-Regulatory Organization’s and coordination with persons engaged March 24, 2010. Statement of the Purpose of, and in regulating, clearing, settling, Pursuant to Section 19(b)(1) of the Statutory Basis for, the Proposed Rule processing information with respect to, Securities Exchange Act of 1934 Change and facilitating transactions in ‘‘ ’’ 1 2 securities, to remove impediments to ( Act ), and Rule 19b–4 thereunder, 1. Purpose notice is hereby given that on March 19, and perfect the mechanism of a free and 2010, The NASDAQ OMX BX, Inc. (the Many of BX’s rules are based on rules open market and a national market ‘‘Exchange’’ or ‘‘BX’’) filed with the of FINRA (formerly the National system, and, in general, to protect Securities and Exchange Commission Association of Securities Dealers investors and the public interest. The (‘‘Commission’’) the proposed rule (‘‘NASD’’)). During 2008, FINRA proposed changes will conform BX Rule change as described in Items I, II, and embarked on an extended process of 3121 to recent changes made to a III below, which Items have been moving rules formerly designated as corresponding FINRA rule, to promote prepared by the Exchange. The ‘‘NASD Rules’’ into a consolidated application of consistent regulatory Exchange has designated the proposed FINRA rulebook. In most cases, FINRA standards. rule change as constituting a non- has renumbered these rules, and in B. Self-Regulatory Organization’s controversial rule change under Rule some cases has substantively amended Statement on Burden on Competition 19b–4(f)(6) under the Act,3 which them. Accordingly, BX also proposes to renders the proposal effective upon initiate a process of modifying its The Exchange does not believe that filing with the Commission. The rulebook to ensure that BX rules the proposed rule change will result in Commission is publishing this notice to corresponding to FINRA rules continue any burden on competition that is not solicit comments on the proposed rule to mirror them as closely as practicable. necessary or appropriate in furtherance change from interested persons. In some cases, it will not be possible for of the purposes of the Act, as amended. I. Self-Regulatory Organization’s the rule numbers of BX rules to mirror C. Self-Regulatory Organization’s Statement of the Terms of Substance of corresponding FINRA rule numbers, Statement on Comments on the the Proposed Rule Change because existing or planned BX rules Proposed Rule Change Received From make use of those numbers. However, The Exchange is filing this proposed Members, Participants or Others wherever possible, BX plans to update rule change to amend BX Rule 3121 to its rules to reflect changes to Written comments were neither reflect recent changes to a solicited nor received. corresponding rule of the Financial corresponding FINRA rules. Industry Regulatory Authority This filing addresses BX Rule 3121, III. Date of Effectiveness of the (‘‘FINRA’’). The Exchange will which formerly corresponded to NASD Proposed Rule Change and Timing for implement the proposed rule change 3121. In SR–FINRA–2009–080,4 FINRA Commission Action thirty days after the date of the filing. redesignated NASD Rule 3121 as FINRA The foregoing rule change is effective Proposed new language is in italics and Rule 4570 with minor technical upon filing pursuant to Section proposed deletions are in brackets. changes. FINRA Rule 4570 requires a 19(b)(3)(A) of the Act 7 and Rule 19b– * * * * * member to designate, as the custodian of 4(f)(6) 8 thereunder in that it effects a [ 3121]4570. Custodian of [the]Books its required books and records on Form change that: (i) Does not significantly and Records BDW, a person who is associated with affect the protection of investors or the A member who files a [Securities and the firm at the time Form BDW is filed. public interest; (ii) does not impose any Exchange Commission] Form BDW shall The rule is intended to enhance the significant burden on competition; and designate on the Form BDW, as the SRO’s ability to obtain required books (iii) by its terms, does not become custodian of the member’s books and and records from firms that are no operative for 30 days after the date of records, a person associated with the longer conducting business and to the filing, or such shorter time as the member at the time that the Form BDW ensure that the custodian of the books Commission may designate if consistent is filed. and records has been subject to certain background checks. The FINRA Rule * * * * * 5 15 U.S.C. 78f. 4570 text makes minor technical 6 15 U.S.C. 78f(b)(5). II. Self-Regulatory Organization’s changes by adopting terminology 7 15 U.S.C. 78s(b)(3)(A). Statement of the Purpose of, and consistent with that used in Form BDW. 8 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– 4(f)(6)(iii) requires that a self-regulatory Statutory Basis for, the Proposed Rule BX is adopting the new FINRA rule in Change organization submit to the Commission written full, and redesignating BX Rule 3121 to notice of its intent to file the proposed rule change, In its filing with the Commission, the be BX Rule 4570, so as to correspond to along with a brief description and text of the Exchange included statements the new FINRA rule number. proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the 1 15 U.S.C. 78s(b)(1). 4 Securities Exchange Act Release No. 61332 Commission. The Commission notes that the 2 17 CFR 240.19b–4. (January 12, 2010), 75 F.R. 3270 (January 20, 2010) Exchange has satisfied the five-day pre-filing notice 3 17 CFR 240.19b–4(f)(6). (SR–FINRA–2009–080). requirement.

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with the protection of investors and the Commission, and all written publishing this notice to solicit public interest. communications relating to the comments on the rule change from In its guidance on the proposed rules proposed rule change between the interested parties. of Self-Regulatory Organizations Commission and any person, other than I. Self-Regulatory Organization’s (‘‘SROs’’),9 the Commission concluded those that may be withheld from the Statement of the Terms of Substance of that filings based on the rules of another public in accordance with the the Proposed Rule Change SRO already approved by the provisions of 5 U.S.C. 552, will be Commission are eligible for immediate available for Web site viewing and The proposed rule change amends effectiveness under Rule 19b–4(f)(6).10 printing in the Commission’s Public NSCC’s rules regarding the eligibility of The Commission noted that ‘‘a proposed Reference Room, 100 F Street, NE., securities processed through the ID Net rule change appropriately may be filed Washington, DC 20549, on official Service (‘‘ID Net’’). as an immediately effective rule so long business days between the hours of 10 II. Self-Regulatory Organization’s as it is based on and similar to another a.m. and 3 p.m. Copies of such filing Statement of the Purpose of, and SRO’s rule and each policy issue raised also will be available for inspection and Statutory Basis for, the Proposed Rule by the proposed rule (i) has been copying at the principal office of the Change considered previously by the Exchange. All comments received will Commission when the Commission be posted without change; the In its filing with the Commission, NSCC included statements concerning approved another exchange’s rule (that Commission does not edit personal the purpose of and basis for the was subject to notice and comment), identifying information from proposed rule change and discussed any and (ii) the rule change resolves such submissions. comments it received on the proposed policy issue in a manner consistent with You should submit only information rule change. The text of these statements such prior approval.’’11 The Exchange that you wish to make available may be examined at the places specified notes that the change is identical to a publicly. All submissions should refer in Item IV below. NSCC has prepared change by FINRA approved by the to File Number SR–BX–2010–020 and summaries, set forth in sections (A), (B), Commission. should be submitted on or before April 21, 2010. and (C) below, of the most significant IV. Solicitation of Comments aspects of these statements.4 For the Commission, by the Division of Interested persons are invited to Trading and Markets, pursuant to delegated (A) Self-Regulatory Organization’s submit written data, views, and authority.12 Statement of the Purpose of, and arguments concerning the foregoing, Florence E. Harmon, Statutory Basis for, the Proposed Rule including whether the proposed rule Deputy Secretary. Change change, as amended, is consistent with [FR Doc. 2010–7104 Filed 3–30–10; 8:45 am] On June 2, 2008, the Commission the Act. Comments may be submitted by BILLING CODE 8011–01–P approved a rule change that provided any of the following methods: for the settlement of institutional Electronic Comments transactions through a joint service of SECURITIES AND EXCHANGE • Use the Commission’s Internet NSCC and The Depository Trust COMMISSION ‘‘ ’’ comment form (http://www.sec.gov/ Company ( DTC ) called ID Net. ID Net rules/sro.shtml); or [Release No. 34–61783; File No. SR–NSCC– enables subscribers to the service to net 2010–03] • Send an e-mail to rule- all eligible affirmed institutional [email protected]. Please include File transactions at DTC against Continuous Self-Regulatory Organizations; The Net Settlement (‘‘CNS’’) transactions 5 at Number SR–BX–2010–020 on the National Securities Clearing subject line. NSCC. ID Net accepts affirmed Corporation; Notice of Filing and institutional transactions that are Paper Comments Immediate Effectiveness of Proposed eligible for ID Net from clearing Rule Change To Expand the Eligibility • Send paper comments in triplicate agencies,6 entities exempt from clearing of Securities Processed Through the agency registration with the to Elizabeth M. Murphy, Secretary, ID Net Service Securities and Exchange Commission, Commission, and ‘‘qualified vendors’’ 7 100 F Street, NE., Washington, DC March 25, 2010. and nets the broker-dealer’s affirmed 20549–1090. Pursuant to Section 19(b)(1) of the institutional transactions side of such All submissions should refer to File Securities Exchange Act of 1934 transaction with the broker-dealer’s CNS Number SR–BX–2010–020. This file (‘‘Act’’),1 notice is hereby given that on obligations. Participation in ID Net is voluntary. number should be included on the March 5, 2010, the National Securities Eligibility for ID Net requires that a subject line if e-mail is used. To help the Clearing Corporation (‘‘NSCC’’) filed Commission process and review your with the Securities and Exchange 4 The Commission has modified the text of the comments more efficiently, please use Commission (‘‘Commission’’) the summaries prepared by NSCC. only one method. The Commission will proposed rule change described in Items 5 NSCC’s Continuous Net Settlement System post all comments on the Commission’s I, II, and III below, which items have (CNS) is an automated accounting and securities Internet Web site (http://www.sec.gov/ been prepared primarily by NSCC. settlement system that centralizes and nets the NSCC filed the proposal pursuant to settlement of compared and recorded security rules/sro.shtml). Copies of the transactions and maintains an orderly flow of 2 submission, all subsequent Section 19(b)(3)(A)(iii) of the Act and security and money balances. CNS provides amendments, all written statements Rule 19b–4(f)(4) 3 thereunder so that the clearance for equities, corporate bonds, unit with respect to the proposed rule proposal was effective upon filing with investment trusts, and municipal bonds that are change that are filed with the the Commission. The Commission is eligible for book-entry transfer at DTC. 6 The clearing agency must be registered pursuant to Section 17A of the Act or obtain an exemption. 12 9 Securities Exchange Act Release No. 58092 (July 17 CFR 200.30–3(a)(12). 7 The term ‘‘qualified vendor’’ is defined in the 3, 2008), 73 FR 40144 (July 11, 2008). 1 15 U.S.C. 78s(b)(1). rules of the New York Stock Exchange, the National 10 17 CFR 240.19b–4(f)(6). 2 15 U.S.C. 78s(b)(3)(A)(iii). Association of Securities Dealers, and other self- 11 See supra note 9 at 40149. 3 17 CFR 240.19b–4(f)(4). regulatory organizations.

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broker-dealer be a DTC participant and (B) Self-Regulatory Organization’s 100 F Street, NE., Washington, DC an NSCC member eligible for CNS Statement on Burden on Competition 20549–1090. processing. The custodian bank must be NSCC does not believe that the All submissions should refer to File a DTC participant. In addition, proposed rule change will have any Number SR–NSCC–2010–03. This file eligibility for ID Net processing is based impact or impose any burden on number should be included on the on the underlying security being competition. subject line if e-mail is used. To help the processed, the type of transaction Commission process and review your submitted for processing, and the timing (C) Self-Regulatory Organization’s comments more efficiently, please use of affirmation. Most equity securities Statement on Comments on the only one method. The Commission will that are eligible for CNS are eligible for Proposed Rule Change Received From Members, Participants, or Others post all comments on the Commission’s ID Net processing. However, the Internet Web site (http://www.sec.gov/ following securities were initially Written comments relating to the rules/sro.shtml). Copies of the excluded from ID Net eligibility: (1) proposed rule change were not and are submission, all subsequent Corporate and municipal bonds and not intended to be solicited or received. amendments, all written statements unit investment trust issues; (2) new NSCC will notify the Commission of any with respect to the proposed rule issue securities; (3) securities that are written comments received by NSCC. change that are filed with the IPO tracked (because the use of omnibus III. Date of Effectiveness of the Commission, and all written accounts will bypass the tracking Proposed Rule Change and Timing for communications relating to the system); (4) trades in issues that are Commission Action proposed rule change between the currently undergoing a mandatory or The foregoing proposed rule change Commission and any person, other than voluntary reorganization; (5) trades in has become effective upon filing those that may be withheld from the CUSIPs with a CNS buy-in; and (6) pursuant to Section 19(b)(3)(A)(iii) of public in accordance with the trades in securities appearing on the the Act 9 and Rule 19b–4(f)(4) 10 provisions of 5 U.S.C. 552, will be SEC’s Regulation SHO list. At its thereunder because the proposed rule available for inspection and copying in inception, NSCC noted that because ID change effects a change in an existing the Commission’s Public Reference Net was a new service, it was excluding service of NSCC that: (i) Does not Room, 100 F Street, NE., Washington, certain securities that could potentially adversely affect the safeguarding of DC 20549, on official business days have a relatively high rate of delivery securities or funds in the custody or between the hours of 10 a.m. and 3 p.m. failure or disrupt normal processing of control of NSCC or for which it is Copies of such filings also will be transactions in ID Net in order to ensure responsible and (ii) does not available for inspection and copying at that the system ran smoothly. NSCC also significantly affect the respective rights the principal office of NSCC and on noted that as its experience with ID Net or obligations of NSCC or persons using NSCC’s Web site at http:// grew, it would revaluate the exclusion the service. At any time within sixty www.dtcc.com/downloads/legal/ of certain issues. days of the filing of the proposed rule rule_filings/2010/nscc/2010-03.pdf. All change, the Commission may summarily Since the implementation of ID Net, comments received will be posted abrogate such rule change if it appears the service has operated with minimal without change; the Commission does to the Commission that such action is disruption, thus allaying the concerns not edit personal identifying regarding the addition of certain necessary or appropriate in the public interest, for the protection of investors, information from submissions. You securities previously excluded from the or otherwise in furtherance of the should submit only information that service. In order to enhance processing purposes of the Act. you wish to make available publicly. All efficiency and at the request of its submissions should refer to File members, NSCC is expanding ID Net to IV. Solicitation of Comments Number SR–NSCC–2010–03 and should allow NSCC at its discretion from time Interested persons are invited to be submitted on or before April 21, to time to make eligible for ID Net any submit written data, views, and 2010. security that is eligible for CNS arguments concerning the foregoing, processing. For the Commission by the Division of including whether the proposed rule Trading and Markets, pursuant to delegated NSCC will announce by ‘‘Important change is consistent with the Act. authority.11 Comments may be submitted by any of Notice’’ particular securities or classes of Florence E. Harmon, securities are made eligible for the following methods: Deputy Secretary. processing through ID Net. Electronic Comments [FR Doc. 2010–7204 Filed 3–30–10; 8:45 am] The proposed rule change is • BILLING CODE 8011–01–P 8 Use the Commission’s Internet consistent with Section 17A of the Act, comment form (http://www.sec.gov/ as amended, and the rules and rules/sro.shtml); or regulations thereunder applicable to • Send an e-mail to rule- NSCC. The proposed rule change will [email protected]. Please include File promote the prompt and accurate Number SR–NSCC–2010-03 on the clearance and settlement of securities subject line. transactions by leveraging the capabilities of the NSCC system to Paper Comments provide for more streamlined securities • Send paper comments in triplicate deliveries and to extend netting benefits to Elizabeth M. Murphy, Secretary, and efficiencies to more ID Net Securities and Exchange Commission, transactions. 9 15 U.S.C. 78s(b)(3)(A)(iii). 8 15 U.S.C. 78q–1. 10 17 CFR 240.19b–4(f)(4). 11 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE transactions through a service called ID DTC will notify its participants by COMMISSION Net. ID Net enables subscribers to the ‘‘Important Notice’’ of the effective date service to net all eligible affirmed of this change. [Release No. 34–61784; File No. SR–DTC– institutional transactions at DTC against The proposed rule change is 2010–05] Continuous Net Settlement (‘‘CNS’’) consistent with Section 17A of the Act,6 Self-Regulatory Organizations; the transactions at the National Securities as amended, and the rules and Depository Trust Company; Notice of Clearing Corporation (‘‘NSCC’’). ID Net regulations thereunder applicable to Filing and Immediate Effectiveness of accepts affirmed institutional DTC. The proposed rule change will Proposed Rule Change To Update Its transactions from clearing agencies, promote the prompt and accurate Settlement Service Guide as It Relates entities exempt from clearing agency clearance and settlement of securities to the ID Net Service registration with the Commission, and transactions by leveraging the ‘‘qualified vendors,’’ 5 and nets the capabilities of the DTC system to March 25, 2010. broker-dealer’s affirmed institutional provide for more streamlined securities Pursuant to Section 19(b)(1) of the transactions with the broker-dealer’s deliveries and to extend netting benefits Securities Exchange Act of 1934 CNS obligations. and efficiencies to more ID Net (‘‘Act’’),1 notice is hereby given that on transactions. Participation in ID Net is voluntary. March 5, 2010, the Depository Trust Eligibility for ID Net requires that a (B) Self-Regulatory Organization’s Company (‘‘DTC’’) filed with the broker-dealer be a DTC participant and Statement on Burden on Competition Securities and Exchange Commission (‘‘Commission’’) the proposed rule an NSCC member eligible for CNS DTC does not believe that the change described in Items I, II, and III processing. The custodian bank must be proposed rule change will have any below, which items have been prepared a DTC participant. In addition, impact or impose any burden on primarily by DTC. DTC filed the eligibility for ID Net processing is based competition. on the underlying security being proposal pursuant to Section (C) Self-Regulatory Organization’s 19(b)(3)(A)(iii) of the Act 2 and Rule processed, the type of transaction submitted for processing, and the timing Statement on Comments on the 19b–4(f)(4) 3 thereunder so that the Proposed Rule Change Received From of affirmation. Most equity securities proposal was effective upon filing with Members, Participants, or Others the Commission. The Commission is that are eligible for CNS are eligible for publishing this notice to solicit ID Net processing. However, DTC Written comments relating to the comments on the rule change from initially excluded the following proposed rule change were not and are interested parties. securities from ID Net: (1) Corporate and not intended to be solicited or received. municipal bonds and unit investment DTC will notify the Commission of any I. Self-Regulatory Organization’s trust issues; (2) new issue securities; (3) written comments received by DTC. Statement of the Terms of Substance of securities that are IPO tracked (because the Proposed Rule Change III. Date of Effectiveness of the the use of omnibus accounts will bypass Proposed Rule Change and Timing for The proposed rule change amends the tracking system); (4) trades in issues Commission Action DTC’s rules in order to update its that are currently undergoing a Settlement Service Guide as it relates to mandatory or voluntary reorganization; The foregoing proposed rule change has become effective upon filing the ID Net Service (‘‘ID Net’’). (5) trades in CUSIPs with a CNS buy-in; pursuant to Section 19(b)(3)(A)(iii) of and (6) trades in securities appearing on II. Self-Regulatory Organization’s the Act 7 and Rule 19b–4(f)(4) 8 the SEC’s Regulation SHO list. At its Statement of the Purpose of, and thereunder because the proposed rule inception, DTC noted that because ID Statutory Basis for, the Proposed Rule change effects a change in an existing Net was a new service, it was excluding Change service of DTC that: (i) Does not certain securities that could potentially adversely affect the safeguarding of In its filing with the Commission, have a relatively high rate of delivery DTC included statements concerning securities or funds in the custody or failure or disrupt normal processing of control of DTC or for which it is the purpose of and basis for the transactions in ID Net in order to ensure proposed rule change and discussed any responsible and (ii) does not that the system ran smoothly. DTC also significantly affect the respective rights comments it received on the proposed noted that as its experience with ID Net rule change. The text of these statements or obligations of DTC or persons using grew, it would revaluate the exclusion the service. At any time within sixty may be examined at the places specified of certain issues. in Item IV below. DTC has prepared days of the filing of the proposed rule summaries, set forth in sections (A), (B), Since the implementation of ID Net, change, the Commission may summarily and (C) below, of the most significant the service has operated with minimal abrogate such rule change if it appears aspects of these statements.4 disruption, thus allaying the concerns to the Commission that such action is regarding the addition of certain necessary or appropriate in the public (A) Self-Regulatory Organization’s securities previously excluded from the interest, for the protection of investors, Statement of the Purpose of, and service. In order to enhance processing or otherwise in furtherance of the Statutory Basis for, the Proposed Rule efficiency and at the request of its purposes of the Act. Change participants, DTC is expanding ID Net to IV. Solicitation of Comments On June 2, 2008, the Commission allow at DTC’s discretion from time to approved a rule change that provided time to make eligible for ID Net any Interested persons are invited to for the settlement of institutional security that is eligible for CNS submit written data, views, and processing. arguments concerning the foregoing, 1 15 U.S.C. 78s(b)(1). including whether the proposed rule 2 15 U.S.C. 78s(b)(3)(A)(iii). 5 The term ‘‘qualified vendor’’ is defined in the 3 17 CFR 240.19b–4(f)(4). rules of the New York Stock Exchange, the National 6 15 U.S.C. 78q–1. 4 The Commission has modified the text of the Association of Securities Dealers, and other self- 7 15 U.S.C. 78s(b)(3)(A)(iii). summaries prepared by FICC. regulatory organizations. 8 17 CFR 240.19b–4(f)(4).

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change is consistent with the Act. For the Commission by the Division of the places specified in Item IV below. Comments may be submitted by any of Trading and Markets, pursuant to delegated The Exchange has prepared summaries, 9 the following methods: authority. set forth in sections A, B, and C below, Florence E. Harmon, of the most significant parts of such Electronic Comments Deputy Secretary. statements. • Use the Commission’s Internet [FR Doc. 2010–7203 Filed 3–30–10; 8:45 am] A. Self-Regulatory Organization’s comment form (http://www.sec.gov/ BILLING CODE 8011–01–P Statement of the Purpose of, and the rules/sro.shtml); or Statutory Basis for, the Proposed Rule Change • Send an e-mail to rule- SECURITIES AND EXCHANGE [email protected]. Please include File COMMISSION 1. Purpose Number SR–DTC–2010–05 on the [Release No. 34–61775; File No. SR– The Exchange proposes to list and subject line. NYSEArca–2010–17] trade the Shares of the following fund Paper Comments under NYSE Arca Equities Rule 5.2(j)(3), Self-Regulatory Organizations; Notice the Exchange’s listing standards for • Send paper comments in triplicate of Filing and Immediate Effectiveness Investment Company Units (‘‘ICUs’’): 4 to Elizabeth M. Murphy, Secretary, of Proposed Rule Change by NYSE ProShares Ultra MSCI Mexico Investable Securities and Exchange Commission, Arca, Inc. Regarding the Listing of the Market (the ‘‘Fund’’). 100 F Street, NE., Washington, DC ProShares Ultra MSCI Mexico The Fund is an ‘‘index fund’’ that 20549–1090. Investable Market Fund seeks to provide daily investment results that, before fees and expenses, All submissions should refer to File March 24, 2010. correspond to twice (200%) of the daily Number SR–DTC–2010–05. This file Pursuant to Section 19(b)(1) 1 of the performance of the MSCI Mexico number should be included on the Securities Exchange Act of 1934 (the Investable Market Index (‘‘Index’’). The subject line if e-mail is used. To help the ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 Fund does not seek to achieve its stated Commission process and review your notice is hereby given that, on March objective over a period of time greater comments more efficiently, please use 18, 2010, NYSE Arca, Inc. (the than one day. only one method. The Commission will ‘‘Exchange’’ or ‘‘NYSE Arca’’) filed with According to the Trust’s Registration post all comments on the Commission’s the Securities and Exchange Statement,5 the Index measures the ‘‘ ’’ Internet Web site (http://www.sec.gov/ Commission (the Commission ) the performance of the Mexican equity proposed rule change as described in rules/sro.shtml). Copies of the market. The Index is a capitalization- Items I and II below, which Items have submission, all subsequent weighted index that aims to capture been prepared by the self-regulatory 99% of the publicly available total amendments, all written statements organization. The Commission is market capitalization. Component with respect to the proposed rule publishing this notice to solicit companies are adjusted for available change that are filed with the comments on the proposed rule change float and must meet objective criteria for Commission, and all written from interested persons. inclusion in the Index, taking into communications relating to the I. Self-Regulatory Organization’s consideration unavailable strategic proposed rule change between the shareholdings and limitations to foreign Statement of the Terms of Substance of Commission and any person, other than ownership. As of February 26, 2010, the the Proposed Rule Change those that may be withheld from the Index was concentrated in the public in accordance with the The Exchange, through its wholly- telecommunications services industry provisions of 5 U.S.C. 552, will be owned subsidiary NYSE Arca Equities, group, which comprised 35.84% of the available for inspection and copying in Inc. (‘‘NYSE Arca Equities’’), proposes to market capitalization of the Index, and the Commission’s Public Reference list and trade shares (‘‘Shares’’) of the included companies with Room, 100 F Street, NE., Washington, following fund of the ProShares Trust capitalizations between $124.10 million DC 20549, on official business days (‘‘Trust’’): ProShares Ultra MSCI Mexico and 44.68 billion. The average between the hours of 10 a.m. and 3 p.m. Investable Market. The text of the capitalization of the companies Copies of such filings also will be proposed rule change is available at the comprising the Index was available for inspection and copying at Exchange, the Commission’s Public approximately $5.84 billion. the principal office of DTC and on Reference Room, and http:// The Exchange is submitting this DTC’s Web site at http://www.dtcc.com/ www.nyse.com. proposed rule change because the Index for the Fund does not meet all of the downloads/legal/rule_filings/2010/dtc/ II. Self-Regulatory Organization’s ‘‘generic’’ listing requirements of 2010–05.pdf. All comments received Statement of the Purpose of, and Commentary .01(a)(B) to NYSE Arca will be posted without change; the Statutory Basis for, the Proposed Rule Equities Rule 5.2(j)(3) applicable to Commission does not edit personal Change listing of ICUs based on international or identifying information from In its filing with the Commission, the submissions. You should submit only self-regulatory organization included 4 An Investment Company Unit is a security that information that you wish to make statements concerning the purpose of, represents an interest in a registered investment available publicly. All submissions company that holds securities comprising, or and basis for, the proposed rule change otherwise based on or representing an interest in, should refer to File Number SR–DTC– and discussed any comments it received an index or portfolio of securities (or holds 2010–05 and should be submitted on or on the proposed rule change. The text securities in another registered investment before April 21, 2010. of those statements may be examined at company that holds securities comprising, or otherwise based on or representing an interest in, an index or portfolio of securities). See NYSE Arca 9 17 CFR 200.30–3(a)(12). Equities Rule 5.2(j)(3)(A). 1 15 U.S.C.78s(b)(1). 5 See the Trust’s Registration Statement on Form 2 15 U.S.C. 78a et seq. N–1A, dated February 26, 2010 (File Nos. 333– 3 17 CFR 240.19b–4. 89822 and 811–21114) (‘‘Registration Statement’’).

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global indexes. The Index meets all such 2. Statutory Basis A proposed rule change filed under 16 requirements except for those set forth The proposed rule change is Rule 19b–4(f)(6) normally does not 6 in Commentary .01(a)(B)(3). The consistent with Section 6(b) 10 of the become operative prior to 30 days after Exchange represents that (1) except for Act, in general, and furthers the the date of the filing. However, pursuant the requirement under Commentary objectives of Section 6(b)(5),11 in to Rule 19b–4(f)(6)(iii),17 the .01(a)(B)(3) to NYSE Arca Equities Rule particular, in that it is designed to Commission may designate a shorter 5.2(j)(3) that the most heavily weighted prevent fraudulent and manipulative time if such action is consistent with the component stock shall not exceed 25% acts and practices, to promote just and protection of investors and the public of the weight of the Index, the Shares of equitable principles of trade, to foster interest. The Exchange has requested the Fund currently satisfy all of the cooperation and coordination with that the Commission waive the 30-day generic listing standards under NYSE persons engaged in facilitating operative delay so that the proposal may Arca Equities Rule 5.2(j)(3); (2) the transactions in securities, and to remove become operative immediately upon continued listing standards under NYSE impediments to and perfect the filing. The Exchange states that the Arca Equities Rules 5.2(j)(3) and mechanisms of a free and open market proposed rule change does not 5.5(g)(2) applicable to ICUs shall apply and a national market system. The significantly affect the protection of to the Shares; and (3) the Trust is Exchange believes that the proposed investors or the public interest and does 7 required to comply with Rule 10A–3 rule change will facilitate the listing and not impose any significant burden on under the Securities Exchange Act of trading of an additional type of competition. In addition, the Exchange 1934 (the ‘‘Act’’) for the initial and exchange-traded product that will believes that it has developed adequate continued listing of the Shares. In enhance competition among market trading rules, procedures, surveillance addition, the Exchange represents that participants, to the benefit of investors programs, and listing standards for the the Shares will comply with all other and the marketplace. continued listing and trading of the requirements applicable to ICUs Shares. including, but not limited to, B. Self-Regulatory Organization’s The Commission believes that requirements relating to the Statement on Burden on Competition waiving the 30-day operative delay is dissemination of key information such The Exchange does not believe that consistent with the protection of as the Index value and Intraday the proposed rule change will impose investors and the public interest. The Indicative Value, rules governing the any burden on competition that is not Commission notes that the Index fails to trading of equity securities, trading necessary or appropriate in furtherance meet only one of the requirements set hours, trading halts, surveillance,8 and of the purposes of the Act. forth in Commentary .01(a)(B)(3) to Information Bulletin to ETP Holders, as C. Self-Regulatory Organization’s NYSE Arca Equities Rule 5.2(j)(3) by set forth in Exchange rules for ICUs and only a small amount and that the in prior Commission orders approving Statement on Comments on the Proposed Rule Change Received From Exchange has represented that the the generic listing rules applicable to Shares of the Fund currently satisfy all 9 Members, Participants, or Others the listing and trading of ICUs. of the other generic listing standards Detailed descriptions of the Fund, the No written comments were solicited under NYSE Arca Equities Rule 5.2(j)(3) Index, procedures for creating and or received with respect to the proposed and all other requirements applicable to redeeming Shares, transaction fees and rule change. ICUs, as set forth in Exchange rules and expenses, dividends, distributions, prior Commission orders approving the taxes, risks, and reports to be distributed III. Date of Effectiveness of the generic listing rules applicable to the to beneficial owners of the Shares can Proposed Rule Change and Timing for listing and trading of ICUs. Therefore, be found in the Trust’s Registration Commission Action the Commission believes that the listing Statement or on the Web site for the The Exchange has filed the proposed and trading of the Shares do not present Fund (http://www.proshares.com), as rule change pursuant to Section any novel or significant issues or applicable. 19(b)(3)(A)(iii) of the Act 12 and Rule 19b–4(f)(6) thereunder.13 Because the impose any significant burden on competition, and that waiving the 30- 6 Specifically, the Index fails to meet the proposed rule change does not: (i) requirement that the most heavily weighted Significantly affect the protection of day operative delay will benefit the component stock shall not exceed 25% of the market and investors by providing weight of the Index. As of February 26, 2010, the investors or the public interest; (ii) impose any significant burden on market participants with additional most heavily weighted component stock (America investing choices. For these reasons, the Movil S.A.B. de C.V.) represented 27.50% of the competition; and (iii) become operative Index weight. prior to 30 days from the date on which Commission designates the proposed 7 17 CFR 240.10A–3. it was filed, or such shorter time as the rule change as operative under upon 8 18 The Exchange may obtain information for Commission may designate, if filing. surveillance purposes via the Intermarket At any time within 60 days of the Surveillance Group (‘‘ISG’’) from other exchanges consistent with the protection of who are members of ISG. For a list of current investors and the public interest, the filing of the proposed rule change, the members of ISG, see http://www.isgportal.org. proposed rule change has become Commission may summarily abrogate However, the Exchange does not have in place a effective pursuant to Section 19(b)(3)(A) such rule change if it appears to the comprehensive surveillance agreement with the Commission that such action is Bolsa Mexicana de Valores and such exchange is of the Act 14 and Rule 19b–4(f)(6) not an ISG member. thereunder.15 9 See, e.g. Securities Exchange Act Release Nos. description and text of the proposed rule change, at least five business days prior to the date of filing 55621 (April 12, 2007), 72 FR 19571 (April 18, 10 15 U.S.C. 78f(b). 2007) (SR–NYSEArca–2006–86) (order approving of the proposed rule change, or such shorter time 11 15 U.S.C. 78f(b)(5). generic listing standards for ICUs based on as designated by the Commission. The Exchange 12 international or global indexes); 44551 (July 12, 15 U.S.C. 78s(b)(3)(A)(iii). has satisfied this requirement. 2001), 66 FR 37716 (July 19, 2001) (SR–PCX–2001– 13 17 CFR 240.19b–4(f)(6). 16 17 CFR 240.19b–4(f)(6). 14) (order approving generic listing standards for 14 15 U.S.C. 78s(b)(3)(A). 17 17 CFR 240.19b–4(f)(6)(iii). ICUs and Portfolio Depositary Receipts); 41983 15 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– 18 For purposes only of waiving the 30-day (October 6, 1999), 64 FR 56008 (October 15, 1999) 4(f)(6)(iii) requires the Exchange to give the operative delay, the Commission has considered the (SR–PCX–98–29) (order approving rules for listing Commission written notice of the Exchange’s intent proposed rule’s impact on efficiency, competition, and trading of ICUs). to file the proposed rule change along with a brief and capital formation. See 15 U.S.C. 78c(f).

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necessary or appropriate in the public should be submitted on or before statements may be examined at the interest, for the protection of investors, April 21, 2010. places specified in Item IV below. The or otherwise in furtherance of the For the Commission, by the Division of Exchange has prepared summaries, set purposes of the Act. Trading and Markets, pursuant to delegated forth in sections A, B, and C below, of 19 the most significant aspects of such IV. Solicitation of Comments authority. Florence E. Harmon, statements. Interested persons are invited to Deputy Secretary. A. Self-Regulatory Organization’s submit written data, views, and [FR Doc. 2010–7110 Filed 3–30–10; 8:45 am] Statement of the Purpose of, and arguments concerning the foregoing, BILLING CODE 8011–01–P Statutory Basis for, the Proposed Rule including whether the proposed rule Change change is consistent with the Act. Comments may be submitted by any of SECURITIES AND EXCHANGE 1. Purpose the following methods: COMMISSION The purpose of the proposed rule Electronic Comments [Release No. 34–61776; File No. SR–Phlx– change is to attract additional business 2010–44] by extending its sponsored access rule, • Use the Commission’s Internet which is similar to that of other comment form (http://www.sec.gov/ Self-Regulatory Organizations; exchanges. During the previous pilot rules/sro.shtml); or NASDAQ OMX PHLX, Inc.; Notice of program, very few member • Send an e-mail to rule- Filing and Immediate Effectiveness of organizations availed themselves of the [email protected]. Please include File Proposed Rule Change Relating to program, but the Exchange seeks to Number SR–NYSEArca–2010–17 on the Extension of Sponsored Access Pilot make it available for an additional pilot subject line. Program period expiring September 15, 2010. A Sponsored Participant is a non- Paper Comments March 24, 2010. member of the Exchange, such as an Pursuant to Section 19(b)(1) of the • Send paper comments in triplicate institutional investor, that gains access Securities Exchange Act of 1934 to Elizabeth M. Murphy, Secretary, to the Exchange and trades under a (‘‘Act’’),1 and Rule 19b–4 thereunder,2 Securities and Exchange Commission, Sponsoring Member’s execution and notice is hereby given that on March 17, 100 F Street, NE., Washington, DC clearing identity pursuant to a 2010, NASDAQ OMX PHLX, Inc. sponsorship arrangement between such 20549–1090. ‘‘ ’’ ‘‘ ’’ ( Phlx or Exchange ) filed with the non-member and a member All submissions should refer to File Securities and Exchange Commission organization. Specifically, the Exchange Number SR–NYSEArca–2010–17. This ‘‘ ’’ ‘‘ ’’ ( SEC or Commission ) the proposed proposes to permit Sponsored file number should be included on the rule change as described in Items I and Participants to be sponsored by subject line if e-mail is used. To help the II below, which Items have been Sponsoring Member Organizations, and Commission process and review your prepared by the Exchange. The thereby access the Exchange, subject to comments more efficiently, please use Commission is publishing this notice to certain requirements. These only one method. The Commission will solicit comments on the proposed rule requirements are intended to confirm post all comments on the Commission’s change from interested persons. that the Sponsored Participant is Internet Web site (http://www.sec.gov/ required to and had procedures in place rules/sro.shtml). Copies of the I. Self-Regulatory Organization’s to comply with Exchange rules, and that submission, all subsequent Statement of the Terms of Substance of the Sponsoring Member Organization amendments, all written statements the Proposed Rule Change takes responsibility for the Sponsored with respect to the proposed rule The Exchange proposes to extend its Participant’s activity on the Exchange. change that are filed with the sponsored access rule for a pilot period First, the Sponsored Participant and Commission, and all written ending on September 15, 2010. The its Sponsoring Member Organization communications relating to the current pilot expires on March 15, 2010. must have entered into and maintained proposed rule change between the The text of the proposed rule change an Access Agreement with the Commission and any person, other than is available on the Exchange’s Web site Exchange. The Sponsoring Member those that may be withheld from the at http:// Organization must designate the public in accordance with the nasdaqomxphlx.cchwallstreet.com/ Sponsored Participant by name in an provisions of 5 U.S.C. 552, will be NASDAQOMXPHLX/Filings/, at the addendum to the Access Agreement. available for Web site viewing and principal office of the Exchange, and at Second, there must be a Sponsored printing in the Commission’s Public the Commission’s Public Reference Participant Agreement between the Reference Room, 100 F Street, NE., Room. Sponsoring Member Organization and Washington, DC 20549, on official II. Self-Regulatory Organization’s the Sponsored Participant that contains business days between the hours of Statement of the Purpose of, and the following sponsorship provisions, 10 a.m. and 3 p.m. Copies of such filing Statutory Basis for, the Proposed Rule enumerated in full in Rule 1094(b)(ii): also will be available for inspection and Change (i) The orders of the Sponsored copying at the principal office of the Participant are binding in all respects on Exchange. All comments received will In its filing with the Commission, the Exchange included statements the Sponsoring Member Organization; be posted without change; the (ii) The Sponsoring Member Commission does not edit personal concerning the purpose of and basis for the proposed rule change and discussed Organization is responsible for the identifying information from actions of the Sponsored Participant; submissions. You should submit only any comments it received on the proposed rule change. The text of these (iii) In addition to the Sponsoring information that you wish to make Member Organization being required to available publicly. 19 17 CFR 200.30–3(a)(12). comply with the Exchange Certificate of All submissions should refer to File 1 15 U.S.C. 78s(b)(1). Incorporation, By-laws, Rules and Number SR–NYSEArca–2010–17 and 2 17 CFR 240.19b–4. procedures of the Exchange, the

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Sponsored Participant shall do so as if objectives of Section 6(b)(5) of the Act 5 pilot program without delay. such Sponsored Participant were an in particular, in that it is designed to Accordingly, the Commission hereby Exchange member organization; promote just and equitable principles of grants the Exchange’s request and (iv) The Sponsored Participant shall trade, to remove impediments to and designates the proposal operative upon maintain, keep current and provide to perfect the mechanism of a free and filing.10 the Sponsoring Member Organization a open market and a national market list of individuals authorized to obtain system, and, in general to protect IV. Solicitation of Comments access to the Exchange on behalf of the investors and the public interest by Interested persons are invited to Sponsored Participant; helping market participants seeking submit written data, views, and (v) The Sponsored Participant shall access to a marketplace. arguments concerning the foregoing, familiarize its authorized individuals including whether the proposed rule B. Self-Regulatory Organization’s with all of the Sponsored Participant’s change is consistent with the Act. Statement on Burden on Competition obligations under this Rule and will Comments may be submitted by any of assure that they receive appropriate The Exchange does not believe that the following methods: training prior to any use or access to the the proposed rule change will impose Electronic Comments Exchange; any burden on competition not (vi) The Sponsored Participant may necessary or appropriate in furtherance • Use the Commission’s Internet not permit anyone other than authorized of the purposes of the Act. comment form (http://www.sec.gov/ individuals to use or obtain access to C. Self-Regulatory Organization’s rules/sro.shtml); or 3 • the Exchange; Statement on Comments on the Send an e-mail to rule- (vii) The Sponsored Participant shall Proposed Rule Change Received From [email protected]. Please include File take reasonable security precautions to Members, Participants, or Others Number SR–Phlx–2010–44 on the prevent unauthorized use or access to subject line. the Exchange, including unauthorized No written comments were either entry of information into the Exchange, solicited or received. Paper Comments and agrees that it is responsible for any III. Date of Effectiveness of the • Send paper comments in triplicate and all orders, trades and other Proposed Rule Change and Timing for to Elizabeth M. Murphy, Secretary, messages and instructions entered, Commission Action Securities and Exchange Commission, transmitted or received under 100 F Street, NE., Washington, DC Because the foregoing proposed rule identifiers, passwords and security 20549–1090. change does not: (i) Significantly affect codes of authorized individuals, and for the protection of investors or the public All submissions should refer to File the trading and other consequences interest; (ii) impose any significant Number SR–Phlx–2010–44. This file thereof; burden on competition; and (iii) become number should be included on the (viii) The Sponsored Participant operative for 30 days after the date of subject line if e-mail is used. To help the acknowledges its responsibility to the filing, or such shorter time as the Commission process and review your establish adequate procedures and Commission may designate, it has comments more efficiently, please use controls that permit it to effectively become effective pursuant to Section only one method. The Commission will monitor its employees’, agents’ and 19(b)(3)(A) of the Act 6 and Rule 19b– post all comments on the Commission’s Participants’ use and access to the 4(f)(6) 7 thereunder. Internet Web site (http://www.sec.gov/ Exchange for compliance with the terms A proposed rule change filed under rules/sro.shtml). Copies of the of this agreement; 19b–4(f)(6) normally may not become submission, all subsequent (ix) The Sponsored Participant shall operative prior to 30 days after the date amendments, all written statements pay when due all amounts, if any, of filing.8 However, Rule 19b– with respect to the proposed rule payable to Sponsoring Member 4(f)(6)(iii) 9 permits the Commission to change that are filed with the Organization, the Exchange, or any designate a shorter time if such action Commission, and all written other third parties that arise from the is consistent with the protection of communications relating to the Sponsored Participant’s access to and investors and the public interest. The proposed rule change between the use of the Exchange. Such amounts Exchange has requested that the Commission and any person, other than include, but are not limited to Commission waive the 30-day operative those that may be withheld from the applicable exchange and regulatory fees. delay so that the proposal may become public in accordance with the Third, the Sponsoring Member operative upon filing. The Exchange provisions of 5 U.S.C. 552, will be Organization must provide the filed the proposed rule change on March available for Web site viewing and Exchange with a Sponsored Participant 17, 2010. The Commission believes that printing in the Commission’s Public Addendum to its Access Agreement waiving the 30-day operative delay is Reference Room, 100 F Street, NE., acknowledging its responsibility for the consistent with the protection of Washington, DC 20549, on official orders, executions and actions of its investors and the public interest business days between the hours of 10 Sponsored Participant at issue. because such waiver would allow the a.m. and 3 p.m. Copies of such filing 2. Statutory Basis Exchange to extend and continue its also will be available for inspection and The Exchange believes that its copying at the principal office of the 5 15 U.S.C. 78f(b)(5). Exchange. All comments received will proposal is consistent with Section 6(b) 6 15 U.S.C. 78s(b)(3)(A). 4 be posted without change; the of the Act in general, and furthers the 7 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– Commission does not edit personal 4(f)(6) requires a self-regulatory organization to give 3 If the Exchange determines that an authorized the Commission written notice of its intent to file identifying information from individual has caused a Member Organization to the proposed rule change at least five business days submissions. You should submit only violate the Exchange’s Rules, the Exchange could prior to the date of filing of the proposed rule direct the Member Organization to suspend or change, or such shorter time as designated by the 10 For the purposes only of waiving the 30-day withdraw the person’s status as an authorized Commission. Phlx has satisfied this requirement. operative delay, the Commission has considered the individual. 8 17 CFR 240.19b–4(f)(6)(iii). proposed rule’s impact on efficiency, competition, 4 15 U.S.C. 78f(b). 9 Id. and capital formation. See 15 U.S.C. 78c(f).

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information that you wish to make Section 2 (Days and Hours of Business) $1 Strikes for ILS (ETN) Options available publicly. All submissions to establish trading hours for these Prior to the commencement of trading should refer to File Number SR–Phlx– products. The text of the proposed rule options on Index-Linked Securities, the 2010–44 and should be submitted on or change is available on NASDAQ’s Web Exchange is proposing to establish that before April 21, 2010. site at http://nasdaq.cchwallstreet.com/ strike price intervals of $1 will be For the Commission, by the Division of Filings/, on the Commission’s Web site permitted where the strike price is less Trading and Markets, pursuant to delegated at http://www.sec.gov, at NASDAQ, and than $200. Where the strike price is authority.11 at the Commission’s Public Reference greater than $200, $5 strikes will be Florence E. Harmon, Room. permitted. These proposed changes are Deputy Secretary. II. Self-Regulatory Organization’s reflected by the addition of Chapter IV, [FR Doc. 2010–7109 Filed 3–30–10; 8:45 am] Statement of the Purpose of, and Section 6, Supplementary Material BILLING CODE 8011–01–P Statutory Basis for, the Proposed Rule .01(c) to Section 6. Change The Exchange is seeking to establish $1 strikes for ILS (ETN) options where SECURITIES AND EXCHANGE In its filing with the Commission, the the strike price is less than $200 because COMMISSION self-regulatory organization included the Exchange believes the marketplace statements concerning the purpose of, and investors will be expecting these [Release No. 34–61766; File No. SR– and basis for, the proposed rule change NASDAQ–2010–035] types of options to trade in a similar and discussed any comments it received manner to options on exchange-traded Self-Regulatory Organizations; The on the proposed rule change. The text funds (‘‘ETFs’’).6 Strike prices for ETF NASDAQ Stock Market LLC; Notice of of those statements may be examined at options are permitted in $1 or greater Filing of Proposed Rule Change To the places specified in Item IV below. intervals where the strike price is $200 Establish Strike Price Intervals and The Exchange has prepared summaries, or less and $5 or greater where the strike Trading Hours for Options on Index- set forth in sections A, B, and C below, price is greater than $200.7 Accordingly, Linked Securities of the most significant parts of such the Exchange believes that the rationale statements. for permitting $1 strikes for ETF options March 23, 2010. A. Self-Regulatory Organization’s equally applies to permitting $1 strikes Pursuant to Section 19(b)(1) of the Statement of the Purpose of, and for ILS (ETN) options, and that investors Securities Exchange Act of 1934 (‘‘Act’’ will be better served if $1 strike price 1 Statutory Basis for, the Proposed Rule or ‘‘Exchange Act’’) and Rule 19b–4 intervals are available for ILS (ETN) 2 Change thereunder, notice is hereby given that options where the strike price is less on March 11, 2010, The NASDAQ Stock 1. Purpose than $200. The Exchange believes that Market LLC (‘‘NASDAQ’’ or ‘‘Exchange’’) The purpose of this proposal is to $1 strike price intervals for options on filed with the Securities and Exchange amend Chapter IV, Section 6 and Index-Linked Securities will provide Commission (‘‘Commission’’) the Chapter VI, Section 2 to establish strike investors with greater flexibility by proposed rule change as described in price intervals and trading hours for allowing them to establish positions that Items I, II, and III below, which Items options on Index-Linked Securities are better tailored to meet their have been prepared by the Exchange. (‘‘ILS’’), also known as exchange-traded investment objectives. The Commission is publishing this notes (‘‘ETN’’), prior to the Exchange Trading Hours for ILS (ETN) Options notice to solicit comments on the proposing to list and trade these new proposed rule change from interested products. The Exchange proposes to amend persons. The Commission has approved the Chapter VI, Section 2(b) to provide that I. Self-Regulatory Organization’s Exchange’s proposal, as well as the options contracts on exchange-traded Statement of the Terms of Substance of proposals of other options exchanges, to notes including Index-Linked the Proposed Rule Change enable the listing and trading of options Securities, as defined in Chapter IV, on ILS (ETN).4 Options trading has not Section 3(l), may be traded on the NASDAQ is filing with the Securities commenced to date and is contingent Exchange until 4:15 p.m. each business and Exchange Commission (‘‘SEC’’ or upon the Commission’s approval of The day. This will establish similar trading ‘‘Commission’’) a proposal for the Options Clearing Corporation’s (‘‘OCC’’) hours for ILS (ETN) options as the NASDAQ Options Market (‘‘NOM’’ or proposed supplement to the Options currently-established trading hours for ‘‘Exchange’’) to amend: Chapter IV, Disclosure Document (‘‘ODD’’) that will ETF options.8 Section 6 (Series of Options Contracts provide disclosure regarding options on The Exchange has analyzed its Open for Trading) to establish strike- Index-Linked Securities.5 capacity and believes the Exchange and price intervals for options on Index- the Options Price Reporting Authority 3 Linked Securities; and Chapter VI, Act Release No. 59923 (May 14, 2009), 74 FR 23902 (‘‘OPRA’’) have the necessary systems (May 21, 2009) (SR–NASDAQ–2009–046) (notice of capacity to handle the additional traffic 11 17 CFR 200.30–3(a)(12). filing and immediate effectiveness). Other associated with the listing and trading 1 15 U.S.C. 78s(b)(1). exchanges have established similar listing 2 17 CFR 240.19b–4. standards. See Securities Exchange Act Release 3 Index-Linked Securities, also known as Nos. 58571 (September 17, 2008), 73 FR 55188 See Securities Exchange Act Release No. 60872 exchange-traded notes, are long-term notes that are (September 24, 2008) (SR–Phlx–2008–60) (notice of (October 23, 2009), 74 FR 55878 (October 29, 2009) the non-convertible debt of an issuer with a term filing and immediate effectiveness); 58204 (July 22, (SR–OCC–2009–14) (approval order). of at least one year but not greater than thirty years. 2008), 73 FR 43807 (July 28, 2008) (SR–CBOE– 6 ETFs may also be known in the rules as These exchange-traded securities are designed for 2008–64) (approval order); 58203 (July 22, 2008), 73 Exchange Traded Funds or Fund Shares. See, for investors who desire to participate in a specific FR 43812 (July 28, 2008) (SR–NYSEArca–2008–57) example, Chapter IV, Section 6(g) and Chapter 6, market segment by providing exposure to one or (approval order); and 58985 (November 20, 2008), Section 2(b). more identifiable underlying securities, 73 FR 72538 (November 28, 2008) (SR–ISE–2008– 7 See proposed Chapter IV, Section 6, commodities, currencies, derivative instruments or 86) (notice of filing and immediate effectiveness). Supplementary Material .01(b) to Section 6, which, market indexes. The Exchange’s listing standards 4 See supra note 3. like subsection (c), is renumbered for internal for options on Index-Linked Securities were 5 OCC previously received Commission approval consistency. established in May 2009. See Securities Exchange to clear options based on Index-Linked Securities. 8 See Chapter VI, Section 2.

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of $1 strikes where the strike price is IV. Solicitation of Comments For the Commission, by the Division of less than $200 for ILS (ETN) options. Trading and Markets, pursuant to delegated The Exchange expects that other Interested persons are invited to authority.12 option exchanges that have adopted submit written data, views, and Florence E. Harmon, rules providing for the listing and arguments concerning the foregoing, Deputy Secretary. trading of options on Index-Linked including whether the proposed rule [FR Doc. 2010–7105 Filed 3–30–10; 8:45 am] Securities will submit similar change is consistent with the Act. BILLING CODE 8011–01–P proposals.9 Comments may be submitted by any of the following methods: 2. Statutory Basis SECURITIES AND EXCHANGE The Exchange believes that its Electronic Comments COMMISSION proposal is consistent with Section 6(b) • Use the Commission’s Internet of the Act 10 in general, and furthers the [Release No. 34–61774; File No. SR– NYSEAmex–2010–24] objectives of Section 6(b)(5) of the Act 11 comment form (http://www.sec.gov/ in particular, in that it is designed to rules/sro.shtml); or • Self-Regulatory Organizations; Notice prevent fraudulent and manipulative Send an e-mail to rule- of Filing and Immediate Effectiveness acts and practices, to promote just and [email protected]. Please include File of Proposed Rule Change by NYSE equitable principles of trade, to foster No. SR–NASDAQ–2010–035 on the Amex LLC Relating to Exchange cooperation and coordination with subject line. Liability persons engaged in facilitating transactions in securities, and to remove Paper Comments March 24, 2010. impediments to and perfect the • Send paper comments in triplicate Pursuant to Section 19(b)(1) of the mechanisms of a free and open market to Elizabeth M. Murphy, Secretary, Securities Exchange Act of 1934 (the ‘‘ ’’ 1 2 and a national market system, by having Securities and Exchange Commission, Act ) and Rule 19b–4 thereunder, strike price intervals and trading hours notice is hereby given that, on March 5, Station Place, 100 F Street, NE., established prior to the commencement 2010, NYSE Amex LLC (‘‘NYSE Amex’’ Washington, DC 20549–1090. of trading in options on Index-Linked or the ‘‘Exchange’’) filed with the Securities and thereby lessening the All submissions should refer to File Securities and Exchange Commission likelihood for investor confusion. Number SR–NASDAQ–2010–035. This (the ‘‘Commission’’) the proposed rule change as described in Items I and II B. Self-Regulatory Organization’s file number should be included on the below, which Items have been prepared Statement on Burden on Competition subject line if e-mail is used. To help the Commission process and review your by the Exchange. The Exchange has The Exchange does not believe that comments more efficiently, please use designated the proposed rule change as the proposed rule change will impose only one method. The Commission will constituting a ‘‘non-controversial’’ rule any burden on competition not post all comments on the Commission’s change under paragraph (f)(6) of Rule necessary or appropriate in furtherance 3 Internet Web site (http://www.sec.gov/ 19b–4 under the Act, which renders of the purposes of the Act. rules/sro.shtml). Copies of the the proposal effective upon receipt by C. Self-Regulatory Organization’s submission, all subsequent the Commission. The Commission is publishing this notice to solicit Statement on Comments on the amendments, all written statements comments on the proposed rule change Proposed Rule Change Received From with respect to the proposed rule from interested persons. Members, Participants or Others change that are filed with the Written comments were neither Commission, and all written I. Self-Regulatory Organization’s solicited nor received. communications relating to the Statement of the Terms of Substance of proposed rule change between the the Proposed Rule Change III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission and any person, other than The Exchange proposes new Rule Commission Action those that may be withheld from the 905NY regarding the Exchange’s public in accordance with the liability for system outages. The text of Within 35 days of the date of provisions of 5 U.S.C. 552, will be the proposed rule change is attached as publication of this notice in the Federal available for Web site viewing and Exhibit 5 to the 19b–4 form. A copy of Register or within such longer period (i) printing in the Commission’s Public this filing is available on the Exchange’s as the Commission may designate up to Reference Room, on official business Web site at http:www.nyse.com, on the 90 days of such date if it finds such days between the hours of 10 a.m. and Commission’s Web site at http:// longer period to be appropriate and 3 p.m. Copies of such filing also will be www.sec.gov, at the Exchange’s publishes its reasons for so finding or available for inspection and copying at principal office and at the Commission’s (ii) as to which the self-regulatory Public Reference Room. organization consents, the Commission the principal office of the Exchange. All will: comments received will be posted II. Self-Regulatory Organization’s (A) By order approve the proposed without change; the Commission does Statement of the Purpose of, and rule change, or not edit personal identifying Statutory Basis for, the Proposed Rule (B) Institute proceedings to determine information from submissions. You Change should submit only information that whether the proposed rule change In its filing with the Commission, the you wish to make available publicly. All should be disapproved. self-regulatory organization included submissions should refer to File statements concerning the purpose of, 9 See, for example, Securities Exchange Act Number SR–NASDAQ–2010–035 and and basis for, the proposed rule change Release No. 61466 (February 2, 2010), 75 FR 6243 should be submitted on or before April (February 8, 2010) (SR–CBOE–2010–005) (notice of filing). 15, 2010. 1 15 U.S.C.78s(b)(1). 10 15 U.S.C. 78f(b). 2 17 CFR 240.19b–4. 11 15 U.S.C. 78f(b)(5). 12 17 CFR 200.30–3(a)(12). 3 17 CFR 240.19b–4(f)(6).

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and discussed any comments it received 2. Statutory Basis the rule of another self-regulatory 9 on the proposed rule change. The text The Exchange believes the proposed organization, and believes that no of those statements may be examined at rule change is consistent with Section significant purpose is served by the places specified in Item IV below. 6(b) 5 of the Securities Exchange Act of delaying its operative date. The The Exchange has prepared summaries, 1934 (the ‘‘Act’’), in general, and furthers Commission therefore believes that it is set forth in sections A, B, and C below, the objectives of Section 6(b)(5) 6 in consistent with the protection of of the most significant parts of such particular in that it is designed to investors and the public interest to statements. promote just and equitable principles of waive the 30-day operative delay and designates the proposal as operative A. Self-Regulatory Organization’s trade, to prevent fraudulent and upon filing.10 Statement of the Purpose of, and manipulative acts, to remove impediments to and to perfect the At any time within 60 days of the Statutory Basis for, the Proposed Rule filing of the proposed rule change, the Change mechanism for a free and open market and a national market system and, in Commission may summarily abrogate 1. Purpose general, to protect investors and the such rule change if it appears to the The purpose of this filing is to clarify public interest, by clarifying the extent Commission that such action is that that [sic] the Exchange will of the Exchange’s liability for claims necessary or appropriate in the public generally not be held liable for any arising out of the use of its options interest, for the protection of investors, losses, expenses, damages or claims trading platform. Moreover, the or otherwise in furtherance of the arising out of the use of its facilities, proposed rule is based on NYSE Arca purposes of the Act. except to the extent that such losses, Rule 14.2, Liability of Exchange. IV. Solicitation of Comments expenses, damages or claims are B. Self-Regulatory Organization’s Interested persons are invited to attributable to the willful misconduct, Statement on Burden on Competition submit written data, views, and gross negligence, bad faith or fraudulent The Exchange does not believe that arguments concerning the foregoing, or criminal acts of the Exchange or its including whether the proposed rule officers, employees or agents acting the proposed rule change will impose any burden on competition that is not change is consistent with the Act. within the scope of their authority. Comments may be submitted by any of Currently, NYSE Amex Rule 60 limits necessary or appropriate in furtherance the following methods: the liability of the Exchange for claims of the purposes of the Act. arising out of use of NYSE Amex’s Post C. Self-Regulatory Organization’s Electronic Comments Execution Reporting (‘‘PER’’) and NYSE Statement on Comments on the • Use the Commission’s Internet Alternext Options Switch (‘‘AMOS’’) Proposed Rule Change Received from comment form (http://www.sec.gov/ systems. NYSE Amex Rule 63 describes Members, Participants, or Others rules/sro.shtml); or the Exchange’s liability in general. • Send an e-mail to rule- No written comments were solicited These rules were intended to cover both [email protected]. Please include File or received with respect to the proposed the options and equities trading Number SR–NYSEAmex–2010–24 on rule change. platforms of NYSE Amex. However, the subject line. neither of these rules were revised III. Date of Effectiveness of the Paper Comments following adoption of the Section Proposed Rule Change and Timing for 900NY rules governing the trading of Commission Action • Send paper comments in triplicate options contracts. to Elizabeth M. Murphy, Secretary, Because the foregoing proposed rule The Exchange now proposes to adopt Securities and Exchange Commission, change does not: new NYSE Amex Rule 905NY to clarify 100 F Street, NE., Washington, DC (i) Significantly affect the protection that the Exchange (i) is generally not 20549–1090. liable for losses, expenses, damages, or of investors or the public interest; (ii) Impose any significant burden on All submissions should refer to File claims, arising out of the use of its Number SR–NYSEAmex–2010–24. This facilities, but (ii) will assume some competition; and (iii) Become operative for 30 days file number should be included on the limited liability for damages arising out from the date on which it was filed, or subject line if e-mail is used. To help the of the use of the NYSE Amex options such shorter time as the Commission Commission process and review your trading platform under certain may designate, if consistent with the comments more efficiently, please use prescribed circumstances and capped at protection of investors and the public only one method. The Commission will certain prescribed amounts. The post all comments on the Commission’s proposed rule is substantially similar in interest, it has become effective pursuant to Section 19(b)(3)(A) of the Internet Web site (http://www.sec.gov/ scope to NYSE Amex Rules 60 and 63, 7 8 rules/sro.shtml). Copies of the but is modeled off NYSE Arca options Act and Rule 19b–4(f)(6) thereunder. The Exchange requested that the submission, all subsequent Rule 14.2, Liability of Exchange. To the Commission waive the 30-day operative amendments, all written statements extent that a conflict may arise between delay period. The Commission notes with respect to the proposed rule the proposed Rule 905NY and either that the proposal is nearly identical to change that are filed with the Rule 60 or 63, the new rule would take Commission, and all written precedence. The Exchange is in the 5 15 U.S.C. 78f(b). communications relating to the process of reviewing Rules 60 and 63 for 6 15 U.S.C. 78f(b)(5). proposed rule change between the possible revision or deletion. NYSE 7 15 U.S.C. 78s(b)(3)(A). Commission and any person, other than Arca Rule 14.2 offers a comprehensive 8 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– those that may be withheld from the and clear approach regarding liability, 4(f)(6)(iii) requires the Exchange to submit to the public in accordance with the thus the Exchange seeks to harmonize Commission written notice of its intent to file the proposed rule change, along with a brief description its approach regarding liability with that 9 See NYSE Arca Rule 14.2. 4 and text of the proposed rule change, at least five of NYSE Arca. business days prior to the date of filing of the 10 For purposes only of waiving the 30-day proposed rule change, or such shorter time as operative delay, the Commission has considered the 4 This rule, as proposed shall apply only to the designated by the Commission. The Exchange has proposed rule’s impact on efficiency, competition, use of NYSE Amex options systems and facilities. satisfied this requirement. and capital formation. See 15 U.S.C. 78c(f).

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provisions of 5 U.S.C. 552, will be I. Self-Regulatory Organization’s additional time to comply with the new available for Web site viewing and Statement of the Terms of the Substance market access provisions. printing in the Commission’s Public of the Proposed Rule Change B. Self-Regulatory Organization’s Reference Room on official business The Exchange is filing this proposed Statement on Burden on Competition days between the hours of 10 a.m. and rule change to delay the application of 3 p.m. Copies of such filing also will be NASDAQ Rule 4611(d) until 180 days The Exchange does not believe that available for inspection and copying at following its approval. The text of the the proposed rule change will result in the principal office of the Exchange. All proposed rule change is available at any burden on competition that is not comments received will be posted http://nasdaq.cchwallstreet.com/, at the necessary or appropriate in furtherance without change; the Commission does Exchange’s principal office, and at the of the purposes of the Act, as amended. not edit personal identifying Commission’s Public Reference Room. C. Self-Regulatory Organization’s information from submissions. You II. Self-Regulatory Organization’s Statement on Comments on the should submit only information that Statement of the Purpose of, and Proposed Rule Change Received From you wish to make available publicly. All Statutory Basis for, the Proposed Rule Members, Participants, or Others submissions should refer to File Change Number SR–NYSEAmex–2010–24 and Written comments were neither should be submitted on or before April In its filing with the Commission, the solicited nor received. 21, 2010. Exchange included statements concerning the purpose of and basis for III. Date of Effectiveness of the For the Commission, by the Division of the proposed rule change and discussed Proposed Rule Change and Timing for Trading and Markets, pursuant to delegated any comments it received on the Commission Action 11 authority. proposed rule change. The text of these Florence E. Harmon, Because the foregoing proposed rule statements may be examined at the change does not: (i) Significantly affect Deputy Secretary. places specified in Item IV below. The the protection of investors or the public [FR Doc. 2010–7106 Filed 3–30–10; 8:45 am] Exchange has prepared summaries, set interest; (ii) impose any significant forth in Sections A, B, and C below, of BILLING CODE 8011–01–P burden on competition; and (iii) become the most significant aspects of such operative for 30 days from the date on statements. which it was filed, or such shorter time SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s as the Commission may designate, it has COMMISSION Statement of the Purpose of, and become effective pursuant to Section Statutory Basis for, the Proposed Rule 19(b)(3)(A) of the Act 7 and Rule 19b- [Release No. 34–61770; File No. SR– Change 4(f)(6) thereunder.8 At any time within NASDAQ–2010–039] 60 days of the filing of such proposed 1. Purpose rule change, the Commission may Self-Regulatory Organizations; the On January 13, 2010, the Commission summarily abrogate such rule change if NASDAQ Stock Market LLC; Notice of approved SR–NASDAQ–2008–104 it appears to the Commission that such Filing and Immediate Effectiveness of which established new standards for action is necessary or appropriate in the Proposed Rule Change To Delay the sponsored access as set forth in public interest, for the protection of Application of NASDAQ Rule 4611(d) NASDAQ Rule 4611(d), NASDAQ’s investors, or otherwise in furtherance of Market Access Rule.4 Based upon the purposes of the Act. March 24, 2010. conversations with industry IV. Solicitation of Comments Pursuant to Section 19(b)(1) of the participants, NASDAQ believes that Securities Exchange Act of 1934 market participants need additional Interested persons are invited to (‘‘Act’’),1 and Rule 19b–4 thereunder,2 time to implement the Market Access submit written data, views, and notice is hereby given that on March 17, Rule. Accordingly, NASDAQ is arguments concerning the foregoing, 2010, The NASDAQ Stock Market LLC proposing to delay for 180 days from including whether the proposed rule (the ‘‘Exchange’’ or ‘‘NASDAQ’’) filed approval the implementation of new change is consistent with the Act. with the Securities and Exchange NASDAQ Rule 4611(d) as set forth in Comments may be submitted by any of the NASDAQ Market Access Approval Commission (‘‘Commission’’) the the following methods: Order. proposed rule change as described in Electronic Comments Items I, II and III below, which Items 2. Statutory Basis • have been prepared by the Exchange. Nasdaq believes that the proposed Use the Commission’s Internet The Exchange has designated the rule change is consistent with the comment form (http://www.sec.gov/ proposed rule change as constituting a provisions of Section 6 of the Act,5 in rules/sro.shtml); or non-controversial rule change under general and with Section 6(b)(5) of the • Send an e-mail to rule- Rule 19b–4(f)(6) under the Act,3 which Act,6 in particular, in that it is designed [email protected]. Please include File renders the proposal effective upon to promote just and equitable principles Number SR–NASDAQ–2010–039 on the filing with the Commission. The of trade and to protect investors and the subject line. Commission is publishing this notice to public interest. The proposal is solicit comments on the proposed rule consistent with these obligations 7 15 U.S.C. 78s(b)(3)(A). change from interested persons. because market participants require 8 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– 4(f)(6) requires a self-regulatory organization to give the Commission written notice of its intent to file 4 Securities Exchange Act Release No. 61345 (Jan. 11 17 CFR 200.30–3(a)(12). the proposed rule change at least five business days 13, 2010) (‘‘NASDAQ Market Access Approval prior to the date of filing of the proposed rule 1 15 U.S.C. 78s(b)(1). Order’’). change, or such shorter time as designated by the 2 17 CFR 240.19b–4. 5 15 U.S.C. 78f. Commission. NASDAQ has satisfied this 3 17 CFR 240.19b–4(f)(6). 6 15 U.S.C. 78f(b)(5). requirement.

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Paper Comments Mexico’s turtle excluder device (TED) harming sea turtles. Users should check • Send paper comments in triplicate program was not currently comparable boxes 7(A)(1) for aquaculture shrimp to Elizabeth M. Murphy, Secretary, to the United States program as required products or 7(A)(3) for artisanal shrimp Securities and Exchange Commission, by the statute. Withdrawal of Mexican products. Users should note that 100 F Street, NE., Washington, DC certification is primarily a compliance exception 7.A.(2) on the form 20549–1090. and environmental issue, but it does ‘‘Harvested Using TEDs,’’ while a have trade implications. The United currently valid exception to the All submissions should refer to File States government is providing the prohibition on imports from nations not Number SR–NASDAQ–2010–039. This Government of Mexico with detailed certified under Public Law 101–162, is file number should be included on the technical recommendations and only available once the Department of subject line if e-mail is used. To help the capacity-building support with a view State determines in advance that a Commission process and review your to strengthening Mexico’s sea turtle country wishing to use this exception comments more efficiently, please use protection program. Both governments has in place an enforcement and catch only one method. The Commission will will continue to actively seek further segregation system for making such post all comments on the Commission’s engagement opportunities to ensure individual shipment certifications. Internet Web site (http://www.sec.gov/ renewal of Mexican certification within Presently, only Brazil and Australia rules/sro.shtml). Copies of the the shortest period of time consistent have shown that they have a system in submission, all subsequent with the requirements of U.S. law. place for specific fisheries. Exception amendments, all written statements DATES: Effective Date: On publication. 7(A)(4) is for other case-by-case, special with respect to the proposed rule circumstance determinations made by change that are filed with the FOR FURTHER INFORMATION CONTACT: James J. Hogan, III, Office of Marine the Department of State in advance. For Commission, and all written these reasons exceptions 7(A)(2) and communications relating to the Conservation, Bureau of Oceans and International Environmental and 7(A)(4) are not applicable to imports of proposed rule change between the wild-caught shrimp from Mexico. Commission and any person, other than Scientific Affairs, Department of State, those that may be withheld from the Washington, DC 20520–7818; telephone: Dated: March 24, 2010. public in accordance with the (202) 647–2252. David A. Balton, provisions of 5 U.S.C. 552, will be SUPPLEMENTARY INFORMATION: Section Deputy Assistant Secretary for Oceans and available for Web site viewing and 609 of Public Law 101–162 prohibits Fisheries, Department of State. printing in the Commission’s Public imports of certain categories of shrimp [FR Doc. 2010–7221 Filed 3–30–10; 8:45 am] Reference Room, 100 F Street, NE., unless the President certifies to the BILLING CODE 4710–09–P Washington, DC 20549, on official Congress not later than May 1 of each business days between the hours of 10 year either: (1) That the harvesting a.m. and 3 p.m. Copies of such filing nation has adopted a program governing DEPARTMENT OF STATE the incidental capture of sea turtles in also will be available for inspection and [Public Notice 6463] copying at the principal office of the its commercial shrimp fishery Exchange. All comments received will comparable to the program in effect in U.S. Department of State Advisory be posted without change; the the United States and has an incidental Committee on Private International Commission does not edit personal take rate comparable to that of the Law: Organization of American States identifying information from United States; or (2) that the fishing (OAS) Specialized Conference on submissions. You should submit only environment in the harvesting nation Private International Law (CIDIP) Study information that you wish to make does not pose a threat of the incidental Group available publicly. All submissions taking of sea turtles. The President has should refer to File Number SR– delegated the authority to make this The OAS CIDIP Study Group will NASDAQ–2010–039, and should be certification to the Department of State. hold another public meeting to continue submitted on or before April 21, 2010. Revised State Department guidelines for the discussion that began at the making the required certifications were December 15, 2009 and continued at For the Commission, by the Division of published in the Federal Register on two additional meeting. This is not a Trading and Markets, pursuant to delegated meeting of the full Advisory Committee. authority.9 July 2, 1999 (Vol. 64, No. 130, Public Notice 3086). In the context of the Seventh Inter- Florence E. Harmon, The Department of State has American Specialized Conference on Deputy Secretary. communicated this decision under Private International Law (CIDIP–VII), [FR Doc. 2010–7107 Filed 3–30–10; 8:45 am] Section 609 to the Office of Field the Committee on Juridical and Political BILLING CODE 8011–01–P Operations of U.S. Customs and Border Affairs (CJAP) of the Permanent Council Protection. of the OAS is carrying out work on This decision regarding withdrawal of consumer rights as part of its program DEPARTMENT OF STATE Mexico’s certification means that wild- on private international law. Three harvest shrimp from Mexico’s proposals have been put forward: A [Public Notice 6938] commercial trawl fisheries may not be revised Brazilian draft convention on Certifications Pursuant to Section 609 imported into the United States until applicable law that has recently been of Public Law 101–162 Section 609 certification for Mexico can expanded to include jurisdiction, a be reinstated. A Department of State Canadian draft model law on applicable SUMMARY: On March 24, 2010, the DS–2031 form signed by the exporter law and jurisdiction, and a United Department of State notified Congress and importer must accompany all States proposal (with several that it had withdrawn Mexico’s shrimp imports into the United States. components) for legislative guidelines/ certification under United States Public If shrimp products are from a non- model laws/rules to promote consumer Law 101–162, Section 609, because certified country, a government official redress mechanisms such as small of the harvesting nation must also claims tribunals, collective procedures, 9 17 CFR 200.30–3(a)(12). certify the shrimp was caught without on-line dispute resolution, and

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government actions. The U.S. is to Michael Dennis at Docket Number: DOT–OST–2010– considering the possibility of expanding [email protected]. 0067. its existing proposal. Dated: March 25, 2010. Date Filed: March 18, 2010. Due Date for Answers, Conforming The United States is also considering Michael Dennis, Applications, or Motion to Modify whether to pursue ratification of the Attorney-Adviser, Office of Private Inter-American Convention on the Law Scope: April 8, 2010. International Law, Office of the Legal Adviser, Description: Application of Virgin Applicable to International Contracts Department of State. (known as the Mexico City Convention), America Inc. requesting a certificate of [FR Doc. 2010–7218 Filed 3–30–10; 8:45 am] public convenience and necessity to which was adopted at the Fifth Inter- BILLING CODE 4710–08–P American Specialized Conference on engage in foreign scheduled air Private International Law (CIDIP–V). transportation of persons and mail The United States is exploring the DEPARTMENT OF STATE between the United States and Canada. process for obtaining official corrections Docket Number: DOT–OST–2010– to the English text of the Convention to [Public Notice 6937] 0071. conform to the Spanish version. Copies Date Filed: March 19, 2010. Waiver of Restriction on Assistance to Due Date for Answers, Conforming of proposed corrections to the English the Government of Libya text can be obtained through the contact Applications, or Motion to Modify points listed below. Other developments Pursuant to section 7086(c)(2) of the Scope: April 9, 2010. which may be relevant to work at the Department of State, Foreign Description: Application of White ‘‘ ’’ OAS include the proposal at UNCITRAL Operations, and Related Programs Airways, S.A. ( White ) requesting a for future work on on-line dispute Appropriations Act, 2010 (Division F, foreign air carrier permit that will resolution and the establishment by the Pub. L. 111–117) (‘‘the Act’’), and enable White to engage in: (i) Foreign Permanent Bureau of the Hague Department of State Delegation of charter air transportation of persons, Conference on Private International Law Authority Number 245–1, I hereby property and mail from any point or of an experts group to consider determine that it is important to the points behind any Member State of the development of a non-binding national interest of the United States to European Union, via any point or points instrument on choice of law in waive the requirements of section in any Member State and via international commercial contracts. 7086(c)(1) of the Act with respect to the intermediate points to any point or points in the United States and beyond; Time and Place: The public meeting Government of Libya, and I hereby (ii) foreign charter air transportation of of the Study Group will take place in waive such restriction. persons, property and mail between any Room 240, South Building, 2430 E This determination shall be reported point or points in the United States and Street, NW., Washington, DC on April 9, to the Congress, and published in the any point or points in any member of 2010. Visitors should enter by the gate Federal Register. the European Common Aviation Area; at the southwest corner of 23rd and C Dated: March 22, 2010. and (iii) other charters. White also Streets not later than 12:45 p.m. EDT. Jacob J. Lew, requests renewal of its exemption The meeting will begin at 1 p.m. and is Deputy Secretary of State for Management authority to enable White to engage in expected to last no later than 4 p.m. If and Resources. the above-described operations pending you are unable to attend the public [FR Doc. 2010–7222 Filed 3–30–10; 8:45 am] issuance of its foreign air carrier permit. meeting and would like to participate BILLING CODE 4710–31–P from a remote location, teleconferencing Renee V. Wright, will be available. Program Manager, Docket Operations, Public Participation: This Study DEPARTMENT OF TRANSPORTATION Federal Register Liaison. Group meeting is open to the public, [FR Doc. 2010–7176 Filed 3–30–10; 8:45 am] subject to the capacity of the meeting Office of the Secretary BILLING CODE 4910–9X–P room. Access to the meeting building is controlled; persons wishing to attend Notice of Applications for Certificates should contact Tricia Smeltzer or of Public Convenience and Necessity DEPARTMENT OF TRANSPORTATION Niesha Toms of the Department of State and Foreign Air Carrier Permits Filed Legal Adviser’s Office at Under Subpart B (Formerly Subpart Q) Office of the Secretary [email protected] or During the Week Ending March 20, Aviation Proceedings, Agreements [email protected] and provide your 2010 Filed the Week Ending March 20, 2010 name, e-mail address, and mailing The following Applications for address to get admission into the Certificates of Public Convenience and The following Agreements were filed meeting or to get directions to the office. Necessity and Foreign Air Carrier with the Department of Transportation Please contact Ms. Smeltzer for Permits were filed under Subpart B under sections 412 and 414 of the additional meeting information, any of (formerly Subpart Q) of the Department Federal Aviation Act, as amended (49 the documents referenced above, or of Transportation’s Procedural U.S.C. 1382 and 1384) and procedures dial-in information on the conference Regulations (See 14 CFR 301.201 et governing proceedings to enforce these call. A member of the public needing seq.). The due date for Answers, provisions. Answers may be filed within reasonable accommodation should Conforming Applications, or Motions to 21 days after the filing of the advise those same contacts not later Modify Scope are set forth below for application. than April 7th. Requests made after that each application. Following the Answer Docket Number: DOT–OST–2010– date will be considered, but might not period DOT may process the application 0064. be able to be fulfilled. Persons who by expedited procedures. Such Date Filed: March 16, 2010. cannot attend or participate by procedures may consist of the adoption Parties: Members of the International conference call but who wish to of a show-cause order, a tentative order, Air Transport Association. comment on any of the topics referred or in appropriate cases a final order Subject: TC31 North & Central Pacific, to above are welcome to do so by e-mail without further proceedings. Special Passenger Amending Resolution

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from Korea (Rep. of) to Canada, SUPPLEMENTARY INFORMATION: Under the understanding of the motives—as well Caribbean Mexico, Central America, Paperwork Reduction Act of 1995, as attitudes and habits—of these South America (Memo 0509). Intended before an agency submits a proposed subgroups, and explore attitudes and effective date: 1 April 2010. collection of information to OMB for behavioral influences pertinent to Docket Number: DOT–OST–2010– approval, it must publish a document in various countermeasures (e.g., points 0069. the Federal Register providing a 60-day reduction courses, speed awareness Date Filed: March 19, 2010. comment period and otherwise consult courses, engineering countermeasures, Parties: Members of the International with members of the public and affected and automated enforcement) and the Air Transport Association. agencies concerning each proposed acceptance and potential effectiveness Subject: TC31 North & Central Pacific, collection of information. The OMB has of the countermeasures. The focus Special Passenger Amending Resolution promulgated regulations describing groups will include: general discussions from Korea (Rep. of) to USA (Memo what must be included in such a of speed choices and speeding behaviors 0515). Intended effective date: 1 April document. Under OMB’s regulations (at and the factors that influence them, 2010. 5 CFR 1320.8(d)), an agency must ask discussions of beliefs and attitudes Renee V. Wright, for public comment on the following: toward speeding, reactions to and (i) Whether the proposed collection of discussions about specific driving Program Manager, Docket Operations, information is necessary for the proper Federal Register Liaison. scenarios, and individual/group performance of the functions of the responses to various speeding [FR Doc. 2010–7179 Filed 3–30–10; 8:45 am] agency, including whether the countermeasures. The focus groups are BILLING CODE 4910–62–P information will have practical utility; expected to provide data relevant to (ii) The accuracy of the agency’s descriptions of key motivations, estimate of the burden of the proposed DEPARTMENT OF TRANSPORTATION attitudes, normative commitment to collection of information, including the law, driving habits relevant to speeding National Highway Traffic Safety validity of the methodology and and speeding countermeasures; Administration assumptions used; descriptions of countermeasures with (iii) How to enhance the quality, the greatest likely benefits; [U.S. DOT Docket No. NHTSA–2010–0037] utility, and clarity of the information to implementation issues and concerns be collected; and associated with the countermeasures; Reports, Forms, and Record Keeping (iv) How to minimize the burden of Requirements and key advantages and disadvantages the collection of information on those associated with various AGENCY: National Highway Traffic who are to respond, including the use countermeasures. of appropriate automated, electronic, Safety Administration (NHTSA), DOT. Description of the Need for the mechanical, or other technological ACTION: Request for public comment on Information and Proposed Use of the collection techniques or other forms of proposed collection of information. Information—The National Highway information technology, e.g., permitting Traffic Safety Administration (NHTSA) SUMMARY: Before a Federal agency can electronic submission of responses. was established by the Highway Safety collect certain information from the In compliance with these Act of l970 (23 U.S.C. 101) to carry out public, it must receive approval from requirements, NHTSA asks public a Congressional mandate to reduce the the Office of Management and Budget comment on the following proposed mounting number of deaths, injuries, (OMB). Under procedures established collection of information: and economic losses resulting from by the Paperwork Reduction Act of 1995 Title: Motivations for Speeding. motor vehicle crashes on the Nation’s (44 U.S.C. 3501 et seq.), before seeking Type of Request: New information highways. Speeding is one of the OMB approval, Federal agencies must collection request—focus group follow- primary factors leading to vehicle solicit public comment on proposed up with participants from an earlier on- crashes. In 2008, 31% of all fatal crashes collections of information, including road instrumented vehicle study. were speeding-related. The estimated extensions and reinstatements of OMB Clearance Number: N/A. economic cost to society for speeding- previously approved collections. Form Number: This collection of This document describes an information uses no standard forms. related crashes is $40.4 billion per year. Information Collection Request (ICR) for Requested Expiration Date of Driving at higher speeds reduces the which NHTSA intends to seek OMB Approval: September 3, 2011. ability of drivers to avoid obstacles or approval. Summary of the Collection of react to sudden changes in the roadway Information: In Phase 1 of this study, environment and increases crash DATES: Comments must be submitted on the National Highway Traffic Safety severity. The pervasiveness of speeding or before June 1, 2010. Administration (NHTSA) conducted on- behavior is reflected in a recent national ADDRESSES: Direct all written comments road instrumented vehicle data survey that showed that approximately to the U.S. Department of collection in Seattle, WA and College 75% of all drivers reported speeding in Transportation Dockets, 1200 New Station, TX with a total of 167 the past month. Since most drivers often Jersey Ave., SE., Washington, DC 20590. participants to examine driving speed do not see speeding as risky or Docket No. NHTSA–2010–0037. patterns with the goals of understanding dangerous behavior, it is imperative that FOR FURTHER INFORMATION CONTACT: motivations for speeding. Based on NHTSA gain a better understanding of Randolph Atkins, Ph.D., Contracting speeding patterns in the data from the the motivations for speeding behaviors Officer’s Technical Representative, instrumented vehicle phase of this in order to develop and refine effective Office of Behavioral Safety Research study, NHTSA plans to follow-up with interventions and countermeasures. (NTI–131), National Highway Traffic these same subjects in focus groups in These focus groups, directly linked to Safety Administration, 1200 New Jersey Phase 2 of the research to develop a the driving speed patterns of drivers in Ave., SE., W46–500, Washington, DC better understanding of speeding and Phase 1 of the study, will provide 20590. Dr. Atkins’ phone number is speeders, to develop a more accurate important new information on the 202–366–5597 and his e-mail address is taxonomy of high/low speed driver reasons drivers choose to drive at [email protected]. subgroups and to gain a better certain speeds and what

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countermeasures would be most Issued on: March 25, 2010. Federal Railroad Administration, 1200 effective in reducing their speeding Jeff Michael, New Jersey Ave., SE., Mail Stop 17, behaviors. In support of its mission, Associate Administrator, Research and Washington, DC 20590 (telephone: (202) NHTSA will use the findings from these Program Development. 493–6292) or Ms. Kimberly Toone, focus group sessions to improve current [FR Doc. 2010–7130 Filed 3–30–10; 8:45 am] Office of Information Technology, RAD– programs, interventions and BILLING CODE 4910–59–P 20, Federal Railroad Administration, countermeasures for speeding on our 1200 New Jersey Ave., SE., Mail Stop Nation’s highways in order to achieve 35, Washington, DC 20590 (telephone: the greatest benefit in decreasing DEPARTMENT OF TRANSPORTATION (202) 493–6132). (These telephone numbers are not toll-free.) crashes and resulting injuries and Federal Railroad Administration fatalities, and provide informational SUPPLEMENTARY INFORMATION: The [Docket No. FRA 2010–0005–N–6] support to States, localities, and law Paperwork Reduction Act of 1995 enforcement agencies that will aid them Agency Information Collection (PRA), Public Law 104–13, section 2, in their efforts to reduce traffic crashes. Activities; Comment Request 109 Stat. 163 (1995) (codified as revised Description of the Likely Respondents at 44 U.S.C. 3501–3520), and its AGENCY: (Including Estimated Number, and Federal Railroad implementing regulations, 5 CFR part Administration, DOT. Proposed Frequency of Response to the 1320, require Federal agencies to Collection of Information)—A subset of ACTION: Notice. provide 60 days’ notice to the public for comment on information collection the participants who participated in the SUMMARY: In accordance with the activities before seeking approval of Phase 1 on-road study will be asked to Paperwork Reduction Act of 1995 and such activities by OMB. 44 U.S.C. participate in focus groups. Individual its implementing regulations, the focus group sessions will be based on Federal Railroad Administration (FRA) 3506(c)(2)(A); 5 CFR 1320.8(d)(1), specific demographic or behavioral hereby announces that it is seeking re- 1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested respondents to characteristics of the Phase 1 approval of the following information comment on the following summary of participants, with the constraint that the collection activities that were proposed information collection group composition should not be previously approved by OMB under activities regarding (i) Whether the counterproductive to facilitating frank Emergency Clearance Procedures. Before submitting these information information collection activities are and open discussions of the key topics necessary for FRA to properly execute (i.e., combining young males and collection requirements for clearance by the Office of Management and Budget its functions, including whether the females in the same group is not an activities will have practical utility; (ii) effective approach). The selection (OMB), FRA is soliciting public comment on specific aspects of the the accuracy of FRA’s estimates of the strategy will involve three focus groups activities identified below. burden of the information collection at each location, (1) younger male DATES: activities, including the validity of the chronic speeders, (2) younger female Comments must be received no later than June 1, 2010. methodology and assumptions used to chronic speeders, and (3) older male determine the estimates; (iii) ways for and female situational and chronic ADDRESSES: Submit written comments on any or all of the following proposed FRA to enhance the quality, utility, and speeders. These focus groups are activities by mail to either: Mr. Robert clarity of the information being expected to take place in the July/ Brogan, Office of Safety, RRS–21, collected; and (iv) ways for FRA to August 2010 timeframe. Session Federal Railroad Administration, 1200 minimize the burden of information participation would be voluntary and New Jersey Ave., SE., Mail Stop 17, collection activities on the public by compensated with a $75 honorarium. Washington, DC 20590, or Ms. Kimberly automated, electronic, mechanical, or Estimate of the Total Annual Toone, Office of Information other technological collection Reporting and Record Keeping Burden Technology, RAD–20, Federal Railroad techniques or other forms of information Resulting from the Collection of Administration, 1200 New Jersey Ave., technology (e.g., permitting electronic Information—NHTSA will conduct six SE., Mail Stop 35, Washington, DC submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)–(iv); 5 CFR focus group sessions, three in Seattle, 20590. Commenters requesting FRA to 1320.8(d)(1)(I)–(iv). FRA believes that WA and three in College Station TX. acknowledge receipt of their respective comments must include a self-addressed soliciting public comment will promote Each focus group will consist of 8–12 its efforts to reduce the administrative participants and last approximately 80 stamped postcard stating, ‘‘Comments on OMB control number 2130–0587.’’ and paperwork burdens associated with minutes. Participants will be recruited the collection of information mandated by e-mail or telephone based on their Alternatively, comments may be transmitted via facsimile to (202) 493– by Federal regulations. In summary, driving behaviors in Phase 1 of the 6216 or (202) 493–6497, or via e-mail to FRA reasons that comments received study and their demographic Mr. Brogan at [email protected], or will advance three objectives: (i) Reduce characteristics. Therefore, the total to Ms. Toone at reporting burdens; (ii) ensure that it estimated annual burden is between 64 [email protected]. Please refer to organizes information collection and 96 hours, depending on the number the assigned OMB control number and requirements in a ‘‘user friendly’’ format of participants (range 8—12) in each the title of the information collection in to improve the use of such information; group. The respondents would not incur any correspondence submitted. FRA and (iii) accurately assess the resources any reporting cost from the information will summarize comments received in expended to retrieve and produce collection. The respondents also would response to this notice in a subsequent information requested. See 44 U.S.C. not incur any record keeping burden or notice and include them in its 3501. record keeping cost from the information collection submission to Below is a brief summary of the information collection. OMB for approval. information collection activities that Authority: 44 U.S.C. 3506(c)(2)(A). FOR FURTHER INFORMATION CONTACT: Mr. FRA will submit for renewed clearance Robert Brogan, Office of Safety, RRS–21, by OMB as required under the PRA:

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Title: Notice of Funding Availability in one or more grants, to eligible available through grants provided under and Solicitation of Applications for projects by passenger and freight rail this program, together with funding Grants under the Railroad Safety carriers, railroad suppliers, and State from other sources that is committed by Technology Grant Program. and local Governments. Funds will be a grantee as part of a grant agreement, OMB Control Number: 2130–0587. awarded to projects that have a public must be sufficient to complete the Abstract: The Rail Safety Technology benefit of improved railroad safety and funded project and achieve the Program is a newly authorized program efficiency, with priority given to anticipated technology development. under the Rail Safety Improvement Act projects that make PTC technologies FRA will begin accepting grant of 2008 (RSIA) (Pub. L. 110–432; interoperable between railroad systems; applications 10 days after publication of October 16, 2008). The program was projects that accelerate the deployment the separate Notice of Funds directed by Congress and passed into of PTC technology on high-risk Availability, which will be published on law in the aftermath of a series of major corridors, such as those that have high March 29, 2010, in the Federal Register rail accidents that culminated in an volumes of hazardous material detailing the terms of the Railroad accident at Chatsworth, California, in shipments; and for projects over which Safety Technology Grant Program. 2008. Twenty-five people were killed commuter or passenger trains operate, Applications may be submitted until and 135 people were injured in the or that benefit both passenger and July 1, 2010. Selection announcements Chatsworth accident. This event turned freight safety and efficiency. will be made on or around September 3, the Nation’s attention to rail safety and Funds provided under this grant 2010. the possibility that new technologies, program may constitute a maximum of Form Number(s): FRA F 6180.146; such as PTC, could prevent such 80 percent of the total cost of a selected SF–269; SF–270. accidents in the future. The RSIA project, with a minimum of 20 percent Other Instruments: Information ordered installation of PTC by all Class of costs funded from other sources. The Published with the Notice of Funds I railroads on any of their mainlines funding provided under these grants Availability (NOFA) to be published carrying poisonous inhalation hazard will be made available to grantees on a shortly in the Federal Register. (PIH) materials and by all passenger and reimbursement basis. FRA anticipates commuter railroads on their main lines awarding grants to multiple eligible Affected Public: Businesses. not later than December 31, 2015. participants. FRA may choose to award Respondent Universe: 50 railroads. As part of the RSIA, Congress a grant or grants within the available Frequency of Submission: On provided $50 million to FRA to award, funds in any amount. Funding made occasion.

REPORTING BURDEN

Respondent Total annual Average time Total annual Grant program universe responses per response burden hours

Pre-Application Process: —Certification Statements (Form 50 Railroads ...... 50 statements/forms ...... 2 minutes ...... 2 FRA F 6180.146). —Application Process ...... 50 Railroads ...... 50 grant applications ...... 250 hours ...... 12,500 —Meeting requests with FRA Asso- 50 Railroads ...... 25 meeting requests ...... 30 minutes ...... 13 ciate Administrator. —Face to Face Meetings with As- 50 Railroads ...... 25 project meetings ...... 2 hours ...... 50 sociate Admin. —Revisions to Grant Applications .. 50 Railroads ...... 10 grant application revi- 40 hours ...... 400 sions. —Execution Process (Progress Re- 50 Railroads ...... 120 progress reports ...... 1 hour ...... 120 ports). —Close-Out Procedures: —Financial Status Report (SF–269) 50 Railroads ...... 10 forms ...... 30 minutes ...... 5 —Audit (OMB A–133 or 49 CFR 50 Railroads ...... 10 audit documents ...... 34 hours ...... 340 19.26). —Audit Correction Plan ...... 50 Railorads ...... 1 plan ...... 24 hours ...... 24 —Final Progress Report ...... 50 Railroads ...... 10 reports ...... 3 hours ...... 30 —Final Request for Payment (SF– 50 Railroads ...... 10 forms ...... 1 hour ...... 10 270). —Federal Owner Property Report .. 50 Railroads ...... 5 reports ...... 3 hours ...... 15 —Final Technical Report ...... 50 Railroads ...... 10 reports ...... 40 hours ...... 400

Total Responses: 336. displays a currently valid OMB control DEPARTMENT OF TRANSPORTATION Estimated Total Annual Burden number. Federal Transit Administration 13,909 hours. Authority: 44 U.S.C. 3501–3520. Status: Re-Approval under Regular Issued in Washington, DC on March 26, Urbanized Area Formula Program: Clearance Procedures 2010. Notice of Final Circular Pursuant to 44 U.S.C. 3507(a) and 5 Donna Alwine, CFR 1320.5(b), 1320.8(b)(3)(vi), FRA Acting Director, Office of Financial AGENCY: Federal Transit Administration informs all interested parties that it may Management, Federal Railroad (FTA), DOT. Administration. not conduct or sponsor, and a ACTION: Notice of Availability of Final [FR Doc. 2010–7201 Filed 3–30–10; 8:45 am] respondent is not required to respond Circular. to, a collection of information unless it BILLING CODE 4910–06–P

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SUMMARY: The Federal Transit D. Chapter IV—Program Development information about FTA, including Administration (FTA) is issuing Circular E. Chapter V—Coordinated Planning contact information. It briefly addresses 9030.1D to provide comprehensive F. Chapter VI—Program Management and the current authorizing legislation for assistance to grantees in implementing Administrative Requirements the Urbanized Area Formula program G. Chapter VII—Other Provisions the Urbanized Area Formula Program H. Appendices (a.k.a. ‘‘Section 5307 program’’), (Section 5307) for capital, planning, and provides information about Grants.gov, some operating grants in urbanized I. Overview includes definitions applicable to the areas. This notice provides a summary of program and provides a brief program DATES: The effective date of this circular changes to FTA Circular 9030.1C, history. A ‘‘Definitions’’ section has been is May 1, 2010. Urbanized Area Formula Program: added to this circular, defining common terms used in the Section 5307 program. ADDRESSES: A copy of the circular and Program Guidance and Grant Chapter I contains a number of topics comments and material received from Application Instructions and addresses that have been reorganized in the new the public, as well as any documents comments received in response to FTA’s circular. The former section ‘‘Other indicated in the preamble as being September 30, 2009 Federal Register Funds Available for Transit Projects’’ is available in the docket, are part of publication announcing the availability now renamed ‘‘Relationship to Other docket FTA–2009–0010 and are of the proposed circular (74 FR 50273). Programs’’ to be consistent with other available for inspection or copying at The final Circular 9030.1D supersedes FTA circulars, and moved to Chapter II. the Docket Management Facility, U.S. FTA Circular 9030.1C. Readers familiar We have also moved the section titled Department of Transportation, 1200 with the former FTA Circular 9030.1C ‘‘Flexible Funds’’ to the ‘‘Relationship to New Jersey Ave., SE., West Building will notice that FTA is proposing a Other Programs’’ section in Chapter II, Ground Floor, Room W12–140, complete reorganization to make this and transferred information on Washington, DC between 9 a.m. and 5 circular consistent with the style of apportionments and local and Federal p.m., Monday through Friday, except other circulars FTA has updated. share to Chapter III. In addition, we Federal holidays. Substantive changes in content are have incorporated the information in You may also review the circular, discussed in the chapter-by-chapter the section titled ‘‘Grant Application comments, and supporting documents analysis. Process’’ into other sections of the online through the Federal Document Seven commenters responded to the revised circular. Management System (FDMS) at Web notice of availability, including a public Several commenters suggested that site: http://regulations.gov. Enter the transportation trade association, a the term ‘‘direct recipient’’ be deleted in docket number FTA–2009–0010 in the vanpool operator, two large favor of the term ‘‘designated recipient.’’ search field. The FDMS is available 24 metropolitan transit agencies, a member FTA declines to adopt that change, as hours each day, 365 days each year. of the public, and one who wished to the two terms are not identical. A Electronic submission and retrieval help remain anonymous. ‘‘designated recipient’’ is an entity and guidelines are available under the One commenter asked that FTA officially designated by the Governor help section of the Web site. extend the comment period for an through the planning process to receive This notice does not include the final additional 45 to 60 days. FTA declined and apportion funds. A direct recipient, circular. Electronic versions of the final this request, as FTA specified in the in contrast, is any entity that receives circular will be posted on Notice of Availability that ‘‘[l]ate-filed funds directly from FTA. In some cases, http:/regulations.gov as well as on the comments will be considered to the the designated recipient may also be a FTA Web site http://www.fta.dot.gov. extent practicable,’’ and FTA has Paper copies of the final circular may be considered all comments received after direct recipient, although a direct obtained by contacting FTA’s the November 20, 2009, deadline. recipient may not necessarily be the Administrative Services Help Desk, at Several commenters asked that FTA designated recipient. One commenter suggested that 202–366–4865. withhold publication of the circular until new surface transportation content be added to address the FOR FURTHER INFORMATION CONTACT: National Transit Database (NTD) and the Henrika Buchanan-Smith, Office of reauthorization legislation had been enacted. FTA believes that such an Uniform System of Accounts (USOA). Program Management, Federal Transit FTA has accepted and incorporated Administration, 1200 New Jersey Ave., approach is not feasible, given uncertainty concerning the those changes in Chapter I, under the SE., East Building, Fourth Floor, section titled ‘‘Definitions.’’ Another Washington, DC 20590, phone: (202) reauthorization process and the need to implement changes mandated by the suggested that administrative costs be 366–5080, fax: (202) 366–7951, or e- defined and addressed in the Circular, mail, Henrika.Buchanan- 2005 reauthorization bill. One commenter objected to the which FTA has done in Chapter III, [email protected]; or Richard Wong, Office language in section 6 of the title page section 6, ‘‘Eligible Capital Projects.’’ of Chief Counsel, Federal Transit where FTA reserved the right to update One commenter asked FTA to address Administration, 1200 New Jersey Ave., the circular to reflect changes in revised force account plans, which FTA has SE., East Building, Fifth Floor, or new guidance or regulation. FTA done in Appendix E, ‘‘Preventive Washington, DC 20590, phone: (202) disagrees with this objection, noting that Maintenance.’’ 366–0675, fax: (202) 366–3809, or e- FTA is already obligated to include an mail, [email protected]. B. Chapter II—Program Overview opportunity for notice and comment SUPPLEMENTARY INFORMATION: when revising a circular or regulation, Chapter II of the former circular, Table of Contents and there is no need to duplicate that ‘‘Applicant Eligibility’’ has been effort when updating each circular augmented to contain additional detail I. Overview affected by that revision. about the Urbanized Area Formula II. Chapter-by-Chapter Analysis program. Chapter II addresses the A. Chapter I—Introduction and A. Chapter I—Introduction and statutory authority for the Urbanized Background Background B. Chapter II—Program Overview Area Formula program, followed by the C. Chapter III—General Program Chapter I of the revised circular is the goals of the program, recipient Information introductory chapter containing general designation, the respective roles of the

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designated recipient and FTA, a supplemented information about regulations, and FTA policy. We are discussion about transportation ‘‘Preventive Maintenance’’ into a new also streamlining some sections, such as management areas, FTA oversight, and Appendix E due to the length and planning, while expanding others, such the relationship of the Urbanized Area complexity of the topic. FTA has moved as certifications and assurances, to Formula Program to other FTA pre-award authority and letters of no provide more detailed guidance to our programs. This format conforms to prejudice to Chapter IV. Additional recipients. Chapter II in the other circulars FTA has information addressed in Chapter III One commenter noted that the draft recently updated. In discussions includes apportionments, funds circular did not account for the various regarding Transportation Management availability, and local and Federal share. roles of designated recipients vis-a`-vis Areas in Chapter II and Apportionments All of these sections have been updated Metropolitan Planning Organizations in Chapter III, to conform to revisions of to be consistent with the law and with (MPO) throughout the country. Given the joint planning regulation issued in the format of other recently revised FTA the wide variation of these roles among February 2007, we deleted references to circulars. the various urbanized areas (UZA), the the expanded planning areas of a One commenter asked FTA to support commenter stated that the circular must Transportation Management Area when a definition of Mobility Management be flexible. The commenter perceived referring to the Governor authority to that included employer-oriented that Chapter IV of the draft assumes a reallocate funds apportioned to the Transportation Management Metropolitan Planning Organization Governor for urbanized areas under Organizations. FTA has included (MPO) is the sole designated recipient 200,000 in population. The Governor’s language in Chapter III, section 6f(5) to for the UZA. This structure is authority is restricted only in the case implement this request. The same impractical in some communities where of small urbanized areas officially commenter asked that FTA revise the Metropolitan Planning Organization designated as Transportation Chapter III to address eligibility that (MPO) is not staffed sufficiently to Management Areas. takes into account emissions benefits for undertake the duties of a designated One commenter, a large metropolitan purposes of compliance with the Clean recipient or others where the transportation agency, objected to FTA’s Air Act. Emissions benefits, while a independence of local governments is attempt to meet GPRA (Government factor under the Congestion more pronounced and, as a result, a Performance and Results Act) Management and Air Quality (CMAQ) single Metropolitan Planning requirements by setting performance program, are not statutory factors for Organization (MPO) function is targets, using program measures to consideration under the section 5307 primarily to coordinate the activities of determine grant funding levels, or using program. Finally the same commenter multiple designated recipients. FTA those measures in a punitive manner. asked that the circular include stronger agrees with this commenter and has The commenter suggested that FTA provisions to include private providers revised Chapter IV accordingly to clarify provide additional clarification in the and operators in the local planning and the relationship between Metropolitan final circular as to the measurement of programming process. FTA does not get Planning Organization (MPO), fleet condition and specifically involved in the details of the local Designated Recipient and other recommends that FTA require recipients public participation process, and recipients. Chapter IV has also been to report ‘‘average fleet age’’ information. instead defers to the local Metropolitan revised to clarify that the Metropolitan FTA acknowledges the commenter’s Planning Organizations (MPOs) to Planning Organization (MPO) and the concerns, but ridership and condition determine their locally-developed designated recipient can be two separate data are long-standing national data processes and procedures. entities. measures and submitted to the National Another commenter, a large D. Chapter IV—Program Development Transit Database on a regular basis. metropolitan transportation agency With regard to their use as The sections of former Chapter IV, operating across state boundaries, asked determinants, formulas such as the fixed ‘‘Apportionments,’’ describing how that the circular specifically address guideway tier of the 5307 formula are funds are apportioned under the transit agencies that must work with determined by Congress and urbanized area formula program and multi-state Metropolitan Planning implemented by FTA. Finally, FTA apportionments are transferred to other Organization (MPO)s, acknowledging believes that comprehensive fleet age eligible programs, are now in the first them as designated recipients. and condition statistics are necessary for sections of Chapter III. FTA has added Consistent with statute, however, FTA to estimate fleet condition on a a new Chapter IV, ‘‘Program designated recipients are determined by national level with a reasonable degree Development,’’ to address the role of the local officials, not FTA, and FTA of accuracy. designated recipient and the believes language in a circular would metropolitan planning organization have no effect on that process. C. Chapter III—General Program (MPO), applicants other than designated One commenter asked why ‘‘toll Information recipients; pass-through arrangements revenue credits’’ had been renamed Chapter III continues to address (formerly found in Chapter II); subarea ‘‘transportation development credits’’ in eligible capital, operating and planning allocation and transfer of funds for the revised circular. FTA is making this activities, as well as advance capital highway projects (formerly found in change to reflect statutory changes in project authority, reflecting changes Chapter IV); planning requirements the 2005 reauthorization law. made by Safe, Accountable, Flexible, (formerly in Appendix A); program of Several commenters suggested that Efficient Transportation Equity Act: A projects and public participation the planning justification be removed Legacy for users (SAFETEA–LU). requirements; certifications and from the Transportation Electronic Transportation development credits assurances (formerly found in Chapter Award Management (TEAM) system as (formerly referred to as toll revenue V); undertaking projects in advance; a redundant, because by virtue of their credits) have been added to Chapter III catch-all section for pre-award inclusion in a Statewide Transportation to provide a calculation method that is authority; and letters of no prejudice Improvement Plan (STIP), they already consistent with the method used by the (formerly found in Chapter III). have been through the Metropolitan Federal Highway Administration FTA has revised each of these Planning Organization (MPO) planning (FHWA). FTA has moved and sections to reflect changes in statutes, process. FTA does not agree with this

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suggestion, as Transportation Electronic Requirements’’ as the content of that the Presidential Coin Act, are new to Award and Management (TEAM) is the section is already addressed in other this circular. Recipients should use this official administrative record for FTA- chapters. Updated information related chapter, in conjunction with FTA’s funded projects and the data must be to ‘‘Associated Capital Maintenance Master Agreement and the current fiscal included with the Transportation Items,’’ ‘‘New Technology Introduction’’ year Certifications and Assurances to Electronic Award and Management and ‘‘Lease vs. Buy Considerations’’ can assure that they have met all (TEAM) file. The justification to be be found in Chapter III under ‘‘Capital requirements. Recipients may contact included with the application is more Projects;’’ updated information on FTA HQ or Regional Counsel if they project-specific. ‘‘Buses,’’ ‘‘Bus Facilities,’’ and ‘‘Fixed have additional questions concerning Finally, one commenter suggested Guideway Rolling Stock,’’ has been these requirements. that the discussion of joint development consolidated into Chapter IV’s section Once commenter asked FTA to address private investment and provide titled, ‘‘Requirements Related to Rolling include explicit language excluding additional guidance on how retail space Stock and Equipment.’’ The section on vanpool drivers from FTA’s drug and can qualify as incidental space. FTA ‘‘New Starts’’ has been removed because alcohol testing requirements. Consistent believes that FTA’s publication ‘‘Final information on the relationship between with prior legal opinions from FTA’s Agency Guidance on the Eligibility of the New Starts program and the Chief Counsel, FTA has included Joint Development Improvements Under Urbanized Area Formula program is specific language in Chapter VII, section Federal Transit Law’’ (72 FR 5788, Feb. already addressed in Chapter II. Other 7 of the revised circular. 7, 2007) provides adequate direction, provisions in the former Chapter V can H. Appendices but interested parties may contact FTA’s be found in the revised Chapter VII, headquarters or regional offices for ‘‘Other Provisions.’’ The appendices are intended as tools specific questions not addressed by the for developing a grant application. Final Agency Guidance document. F. Chapter VI—Program Management Appendix A specifically addresses steps and Administrative Requirements and instructions for preparing a grant E. Chapter V—Coordinated Planning The content of the former Chapter VI, application, including pre-application The revised Chapter V addresses the ‘‘Application Instructions,’’ has been and application stages. This information coordinated planning process required updated, streamlined, and moved to is comparable to Chapter VI, under the Section 5310, Elderly Appendix A. The revised Chapter VI ‘‘Application Instructions,’’ in the former Individuals and Individuals with contains information on the TEAM circular, although it has been updated Disabilities formula program; the system, Electronic Clearing House and reorganized. Appendix A also Section 5316, Job Access and Reverse Operation (ECHO) system, and, as includes an application checklist. Commute (JARC) program; and the previously discussed, information on Appendix B provides budgetary Section 5317, New Freedom program. the National Transit Database, information, including a sample budget, Often the designated recipient for the requirements related to vehicles and replacing the information formerly Urbanized Area Formula program will equipment, and requirements related to found in Chapter VII, ‘‘Instructions for also be the designated recipient for one facilities. The information in this Preparing a Project Budget.’’ Appendix C or more of these human services chapter is consistent with that found in consists of the content of the former transportation programs. The revised other recently updated FTA circulars. Appendix D, ‘‘Operating Assistance Chapter V contains substantially the Several commenters stated that the Projects.’’ Appendix D contains the same information as that found in FTA estimation of useful service life in content of the former Appendix F, Circular 9040.1F, Nonurbanized Area Chapter VI, section 5, for facilities was ‘‘Forms and Representative Documents,’’ Formula Program Guidance and Grant impractical, given variations in climate, with the exception of documents we Application Instructions. geography, and usage. They claimed have removed that are now readily The information found in the former that such an exercise would result in available online. Appendix E contains a Chapter V, ‘‘Requirements Associated additional investments of time and costs description of the preventive with Urbanized Area Formula Program on transit agencies and FTA alike with maintenance program, and is new to Grants’’ has been reorganized into other no practical benefit. FTA does not agree this circular. Appendix F contains chapters. For example, the section, with these commenters—by establishing updated contact information for FTA’s ‘‘National Transit Database Reporting a standard useful life for facilities, FTA regional and metropolitan offices, which System’’ has been updated and moved to can ensure consistency across projects was previously contained in Chapter the new Chapter VI. We are also and regions. VIII of the former circular. providing a link to the FTA Web site as Several commenters opined that the well as to the TEAM system, where G. Chapter VII—Other Provisions ‘‘Engineering Review’’ required in the applicants can find the instructions. Chapter VII of the former circular revised Appendix A would FTA has moved the section titled contained instructions for preparing a unnecessarily add time and costs ‘‘Certification Procedures’’ to the project budget. This information has without likely improvement of project rewritten Chapter IV. The section titled been updated and moved to Appendix management. One commenter claimed ‘‘FTA Oversight’’ has been updated and B, consistent with other recently revised that this proposal raises the bar for new moved to the new Chapter II. The FTA circulars. The revised Chapter VII projects and will increase the cost of section titled ‘‘Certifications Particular conforms to the ‘‘Other Provisions’’ project development, grant to the Urbanized Area Formula chapters in other FTA circulars, and management, and FTA oversight. Program’’ has been renamed addresses common Federal Another commenter added that state of ‘‘Certifications Required by 49 U.S.C. requirements that FTA grantees are held good repair projects and routine 5307’’ and moved to Chapter IV. to in addition to the program-specific replacement investments should not be Updated information on program of requirements. As previously stated, subjected to more extensive oversight. projects and public participation some of the information has been FTA responds that this is not a new requirements have also been moved to relocated from the former Chapter V’s requirement, but rather, is currently Chapter IV. Finally, FTA is eliminating ‘‘Alphabetical Listing of Other required under Chapter VI, section 9c, the ‘‘Alphabetical List of Other Requirements.’’ Other sections, such as of the outgoing FTA Circular 9030.1C,

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and remains an effective management application about the proposed project Issued in Washington, DC, this 23rd day of tool. The commenter perhaps for FTA to review. In the final circular March 2010. misunderstood that the ‘‘Engineering the review has been renamed Peter Rogoff, Review’’ was performed by FTA in ‘‘Engineering/Technical’’ review to FTA Administrator. reviewing the grant application and that clarify the nature of the review is [FR Doc. 2010–7083 Filed 3–30–10; 8:45 am] the grantee simply had to provide relative to the complexity of the project. BILLING CODE P sufficient information in the grant

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Part II

Department of Justice Drug Enforcement Administration

21 CFR Parts 1300, 1304, 1306, and 1311 Electronic Prescriptions for Controlled Substances; Final Rule

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DEPARTMENT OF JUSTICE 2010. Commenters should be aware that Administration’s public docket. Such the electronic Federal Docket information includes personal Drug Enforcement Administration Management System will not accept identifying information (such as your comments after Midnight Eastern Time name, address, etc.) voluntarily 21 CFR Parts 1300, 1304, 1306, and on the last day of the comment period. submitted by the commenter. 1311 ADDRESSES: To ensure proper handling If you want to submit personal [Docket No. DEA–218I] of comments, please reference ‘‘Docket identifying information (such as your No. DEA–218’’ on all written and name, address, etc.) as part of your RIN 1117–AA61 electronic correspondence. Written comment, but do not want it to be posted online or made available in the Electronic Prescriptions for Controlled comments sent via regular or express public docket, you must include the Substances mail should be sent to the Drug Enforcement Administration, Attention: phrase ‘‘PERSONAL IDENTIFYING AGENCY: Drug Enforcement DEA Federal Register Representative/ INFORMATION’’ in the first paragraph Administration (DEA), Department of ODL, 8701 Morrissette Drive, of your comment. You must also place Justice. Springfield, VA 22152. Comments may all the personal identifying information ACTION: Interim Final Rule with Request be sent to DEA by sending an electronic you do not want posted online or made for Comment. message to available in the public docket in the first [email protected]. paragraph of your comment and identify SUMMARY: The Drug Enforcement Comments may also be sent what information you want redacted. Administration (DEA) is revising its electronically through http:// If you want to submit confidential regulations to provide practitioners with www.regulations.gov using the business information as part of your the option of writing prescriptions for electronic comment form provided on comment, but do not want it to be controlled substances electronically. that site. An electronic copy of this posted online or made available in the The regulations will also permit document is also available at the http:// public docket, you must include the pharmacies to receive, dispense, and www.regulations.gov Web site. DEA will phrase ‘‘CONFIDENTIAL BUSINESS archive these electronic prescriptions. accept attachments to electronic INFORMATION’’ in the first paragraph These regulations are in addition to, not comments in Microsoft Word, of your comment. You must also a replacement of, the existing rules. The WordPerfect, Adobe PDF, or Excel file prominently identify confidential regulations provide pharmacies, formats only. DEA will not accept any business information to be redacted hospitals, and practitioners with the file formats other than those specifically within the comment. If a comment has ability to use modern technology for listed here. so much confidential business controlled substance prescriptions Please note that DEA is requesting information that it cannot be effectively while maintaining the closed system of that electronic comments be submitted redacted, all or part of that comment controls on controlled substances before midnight Eastern Time on the may not be posted online or made dispensing; additionally, the regulations day the comment period closes because available in the public docket. will reduce paperwork for DEA http://www.regulations.gov terminates Personal identifying information and registrants who dispense controlled the public’s ability to submit comments confidential business information substances and have the potential to at midnight Eastern Time on the day the identified and located as set forth above reduce prescription forgery. The comment period closes. Commenters in will be redacted and the comment, in regulations will also have the potential time zones other than Eastern Time may redacted form, will be posted online and to reduce the number of prescription want to consider this so that their placed in the Drug Enforcement errors caused by illegible handwriting electronic comments are received. All Administration’s public docket file. and misunderstood oral prescriptions. comments sent via regular or express Please note that the Freedom of Moreover, they will help both mail will be considered timely if Information Act applies to all comments pharmacies and hospitals to integrate postmarked on the day the comment received. If you wish to inspect the prescription records into other medical period closes. agency’s public docket file in person by records more directly, which may FOR FURTHER INFORMATION CONTACT: appointment, please see the FOR increase efficiency, and potentially Mark W. Caverly, Chief, Liaison and FURTHER INFORMATION paragraph. reduce the amount of time patients Policy Section, Office of Diversion I. Legal Authority spend waiting to have their Control, Drug Enforcement II. Regulatory History prescriptions filled. Administration, 8701 Morrissette Drive, III. Discussion of the Interim Final Rule DATES: This rule has been classified as Springfield, VA 22152, Telephone (202) IV. Discussion of Comments a major rule subject to Congressional 307–7297. A. Introduction review. The effective date is June 1, B. Identity Proofing and Logical Access SUPPLEMENTARY INFORMATION: Control 2010. However, at the conclusion of the Comments: DEA is seeking additional 1. Identity Proofing Congressional review, if the effective comments on the following issues: 2. Access Control date has been changed, the Drug Identity proofing, access control, C. Authentication Protocols Enforcement Administration will authentication, biometric subsystems D. Creating and Signing Electronic publish a document in the Federal and testing of those subsystems, internal Controlled Substance Prescriptions Register to establish the actual effective audit trails for electronic prescription 1. Reviewing Prescriptions date or to terminate the rule. applications, and third-party auditors 2. Timing of Authentication, Lockout, and The incorporation by reference of and certification organizations. Attestation certain publications listed in the rule is Posting of Public Comments: Please 3. Indication That the Prescription Was Signed approved by the Director of the Federal note that all comments received are 4. Other Prescription Content Issues Register as of June 1, 2010. considered part of the public record and 5. Transmission on Signing/Digitally Written comments must be made available for public inspection Signing the Record postmarked and electronic comments online at http://www.regulations.gov 6. PKI and Digital Signatures must be submitted on or before June 1, and in the Drug Enforcement E. Internal Audit Trails

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F. Recordkeeping, Monthly Logs opioids, stimulants, depressants, The Controlled Substances Act is 1. Recordkeeping hallucinogens, anabolic steroids, and unique among criminal laws in that it 2. Monthly Logs drugs that are immediate precursors of stipulates acts pertaining to controlled G. Transmission Issues substances that are permissible. That is, 1. Alteration During Transmission these classes of substances. DEA lists 2. Printing After Transmission and controlled substances in 21 CFR part if the CSA does not explicitly permit an Transmitting After Printing 1308. The substances are divided into action pertaining to a controlled 3. Facsimile Transmission of Prescriptions five schedules: Schedule I substances substance, then by its lack of explicit by Intermediaries have a high potential for abuse and have permissibility the act is prohibited. 4. Other Issues no currently accepted medical use in Violations of the Act can be civil or H. Pharmacy Issues treatment in the United States. These criminal in nature, which may result in 1. Digital Signature substances may only be used for administrative, civil, or criminal 2. Checking the CSA Database proceedings. Remedies under the Act 3. Audit Trails research, chemical analysis, or 4. Offsite Storage manufacture of other drugs. Schedule can range from modification or 5. Transfers II–V substances have currently accepted revocation of DEA registration, to civil 6. Other Pharmacy Issues medical uses in the United States, but monetary penalties or imprisonment, I. Third Party Audits also have potential for abuse and depending on the nature, scope, and J. Risk Assessment psychological and physical dependence extent of the violation. K. Other Issues that necessitate control of the Specifically, it is unlawful for any 1. Definitions substances under the CSA. The vast person knowingly or intentionally to 2. Other Issues manufacture, distribute, or dispense, a 3. Beyond the Scope majority of Schedule II, III, IV, and V L. Summary of Changes From the Proposed controlled substances are available only controlled substance or to possess a Rule pursuant to a prescription issued by a controlled substance with the intent of V. Section-by-Section Discussion of the practitioner licensed by the State and manufacturing, distributing, or Interim Final Rule registered with DEA to dispense the dispensing that controlled substance, VI. Incorporation by Reference substances. Overall, controlled except as authorized by the Controlled VII. Required Analyses substances constitute between 10 Substances Act (21 U.S.C. 841(a)(1)). A. Risk Assessment for Electronic percent and 11 percent of all Further, it is unlawful for any person Prescriptions for Controlled Substances knowingly or intentionally to possess a B. Executive Order 12866 prescriptions written in the United States. controlled substance unless such C. Regulatory Flexibility Act substance was obtained directly, or D. Congressional Review Act E. Paperwork Reduction Act II. Regulatory History pursuant to a valid prescription or order, issued for a legitimate medical F. Executive Order 12988 The Controlled Substances Act and purpose, from a practitioner, while G. Executive Order 13132 Current Regulations. The CSA and acting in the course of the practitioner’s H. Unfunded Mandates Reform Act of 1995 DEA’s regulations were originally professional practice, or except as adopted at a time when most I. Legal Authority otherwise authorized by the CSA (21 transactions and particularly DEA implements the Comprehensive U.S.C. 844(a)). It is unlawful for any prescriptions were done on paper. Drug Abuse Prevention and Control Act person to knowingly or intentionally of 1970, often referred to as the The CSA provides that a controlled acquire or obtain possession of a Controlled Substances Act (CSA) and substance in Schedule II may only be controlled substance by the Controlled Substances Import and dispensed by a pharmacy pursuant to a misrepresentation, fraud, forgery, Export Act (21 U.S.C. 801–971), as ‘‘written prescription,’’ except in deception, or subterfuge (21 U.S.C. amended. DEA publishes the emergency situations (21 U.S.C. 829(a)). 843(a)(3)). implementing regulations for these In contrast, for controlled substances in It is unlawful for any person statutes in Title 21 of the Code of Schedules III and IV, the CSA provides knowingly or intentionally to use a DEA Federal Regulations (CFR), Parts 1300 to that a pharmacy may dispense pursuant registration number that is fictitious, 1399. These regulations are designed to to a ‘‘written or oral prescription.’’ (21 revoked, suspended, expired, or issued ensure an adequate supply of controlled U.S.C. 829(b)). Where an oral to another person in the course of substances for legitimate medical, prescription is permitted by the CSA, dispensing a controlled substance, or for scientific, research, and industrial the DEA regulations further provide that the purpose of acquiring or obtaining a purposes, and to deter the diversion of a practitioner may transmit to the controlled substance (21 U.S.C. controlled substances to illegal pharmacy a facsimile of a written, 843(a)(2)). purposes. The CSA mandates that DEA manually signed prescription in lieu of Beyond these possession and establish a closed system of control for an oral prescription (21 CFR 1306.21(a)). dispensing requirements, it is unlawful manufacturing, distributing, and Under longstanding Federal law, for a for any person to refuse or negligently dispensing controlled substances. Any prescription for a controlled substance fail to make, keep, or furnish any record person who manufactures, distributes, to be valid, it must be issued for a (including any record of dispensing) dispenses, imports, exports, or conducts legitimate medical purpose by a that is required by the CSA (21 U.S.C. research or chemical analysis with practitioner acting in the usual course of 842(a)(5)). It is also unlawful to furnish controlled substances must register with professional practice (United States v. any false or fraudulent material DEA (unless exempt) and comply with Moore, 423 U.S. 122 (1975); 21 CFR information in, or omit any information the applicable requirements for the 1306.04(a)). As the DEA regulations from, any record required to be made or activity. state: ‘‘The responsibility for the proper kept (21 U.S.C. 843(a)(4)(A)). prescribing and dispensing of controlled Within the CSA’s system of controls, Controlled Substances substances is upon the prescribing it is the individual practitioner (e.g., Controlled substances are drugs and practitioner, but a corresponding physician, dentist, veterinarian, nurse other substances that have a potential responsibility rests with the pharmacist practitioner) who issues the prescription for abuse and psychological and who fills the prescription.’’ (21 CFR authorizing the dispensing of the physical dependence; these include 1306.04(a)). controlled substance. This prescription

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must be issued for a legitimate medical ‘‘meaningful EHR users’’ as defined by applications have been available for a purpose and must be issued in the usual the Act and its implementing number of years and are anticipated by course of professional practice. The regulations. Such incentive payments to many to improve healthcare and individual practitioner is responsible for encourage electronic prescribing are possibly reduce costs by increasing ensuring that the prescription conforms allowed, but penalties in any form, by compliance with formularies and the to all legal requirements. The third party payers are prohibited. These use of generic medications. Electronic pharmacist, acting under the authority incentive payments will begin in 2011. prescriptions may reduce medical errors of the DEA-registered pharmacy, has a On January 13, 2010, HHS published caused by illegible handwriting. corresponding responsibility to ensure two rules to implement the provisions Adoption of these applications has been that the prescription is valid and meets of the HITECH ACT. The Centers for relatively slow, primarily because of all legal requirements. The DEA- Medicare and Medicaid Services their cost, the disruption caused during registered pharmacy does not order the published a notice of proposed implementation, and lack of mature dispensing. Rather, the pharmacy, and rulemaking entitled ‘‘Medicare and standards that allow for interoperability the dispensing pharmacist merely rely Medicaid Programs; Electronic Health among applications.2 Some have also on the prescription as written by the Record Incentive Program’’ (75 FR 1844) expressed a concern about the inability DEA-registered individual practitioner [CMS–0033–P, RIN 0938–AP78]. The to use electronic prescription to conduct the dispensing. proposed rule would specify the initial applications for all prescriptions. Thus, a prescription is much more criteria an eligible professional and Electronic prescription applications than the mere method of transmitting eligible hospital must meet to qualify for may be stand-alone applications (i.e., dispensing information from a the incentive payment; calculation of applications that only create practitioner to a pharmacy. The the incentive payment amounts; and prescriptions) or they may be integrated prescription serves both as a record of other payment and program into EHR applications that create and the practitioner’s determination of the participation issues. link all medical records and associated legitimate medical need for the drug to The Office of the National information.3 Either type of application be dispensed, and as a record of the Coordinator for Health Information may be installed on a practitioner’s dispensing, providing the pharmacy Technology published an interim final computers (installed applications) or with the legal justification and authority rule entitled ‘‘Health Information may be an Internet-based application, to dispense the medication prescribed Technology; Initial Set of Standards, where the practitioner accesses the by the practitioner. The prescription Implementation Specifications, and application through the Internet; for also provides a record of the actual Certification Criteria for Electronic these latter applications, the application dispensing of the controlled substance Health Record Technology’’ (75 FR service provider (ASP) retains the to the ultimate user (the patient) and, 2014) [RIN 0991–AB58]. The interim records on its servers. For most therefore, is critical to documenting that final rule became effective February 12, practitioners and pharmacies, the controlled substances held by a 2010. The certification criteria adopted applications are purchased from pharmacy have been dispensed legally. in the interim final rule establish the application providers. Some large The maintenance by pharmacies of capabilities and related standards that healthcare systems and chain complete and accurate prescription certified electronic health record pharmacies, however, may develop and records is an essential part of the overall technology will need to include in order maintain the applications themselves, CSA regulatory scheme established by to, at a minimum, support the serving as both the practitioner or Congress. achievement of the proposed pharmacy and the application provider. American Recovery and Reinvestment meaningful use Stage 1 (beginning in The existing electronic prescription Act. On February 17, 2009, the 2011) by eligible professionals and applications allow practitioners to President signed the American Recovery eligible hospitals under the Medicare create a prescription electronically, but and Reinvestment Act of 2009 (Recovery and Medicaid EHR incentive programs. accommodate different means of Act) (Pub. L. 111–5, 123 STAT. 115). The comment period for both rules transmitting the prescription to the Among its many provisions, the ended March 15, 2010. pharmacy. Practitioners may print the Recovery Act promotes the ‘‘meaningful The Office of the National prescription for manual signature; the use’’ of electronic health records (EHRs) Coordinator for Health Information prescription may then be given to the via incentives. The health information Technology also published a notice of patient or the practitioner’s office may technology provisions of the Recovery proposed rulemaking entitled ‘‘Proposed fax it to a pharmacy. Some applications Act are primarily found in Title XIII, Establishment of Certification Programs will automatically transmit an image of Division A, Health Information for Health Information Technology’’ (75 the prescription as a facsimile. True Technology, and in Title IV of Division FR 11328, March 10, 2010) (RIN 0991– B, Medicare and Medicaid Health AB59) which proposes the 2 California Healthcare Foundation. ‘‘Gauging the Information Technology. These titles establishment of certification programs Progress of the National Health IT Technology together are cited as the Health for purposes of testing and certifying Initiative’’, January 2008; Congressional Budget Information Technology for Economic health information technology. The Office, Evidence on the Costs and Benefits of Health and Clinical Health Act or the HITECH IT, May 2008. proposed rule specifies the processes 3 The National Alliance for Health Information Act. Under Title IV, the Medicare and the National Coordinator for Health Technology has defined the terms ‘‘electronic Medicaid health information technology Information Technology would follow Medical record (EMR),’’ ‘‘electronic health record provisions in the Recovery Act provide to authorize organizations to perform (EHR),’’ and ‘‘personal health record (PHR.’’ Both incentives and support for the adoption EMRs and EHRs are defined to be maintained by the certification of health information practitioners, whereas a PHR is defined to be of certified electronic health record technology. maintained by the individual patient. The main technology. The Recovery Act Electronic Prescription Applications. distinction between an EMR and an EHR is the authorizes incentive payments for Electronic prescription applications 1 EHR’s ability to exchange information eligible professionals and eligible interoperably. DEA’s use of the term EHR in this and electronic health record (EHR) rule relates to those records maintained by hospitals participating in Medicare or practitioners, as opposed to a PHR maintained by Medicaid if they can demonstrate to the 1 ‘‘Application’’ means a software program used to an individual patient, regardless of how those Secretary of HHS that they are perform a set of functions. records are maintained.

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electronic prescriptions, however, are cancellation,), segments (e.g., provider, certification criteria, these criteria do transmitted as electronic data files to the patient), and data fields within not address all elements with which pharmacy, whose applications import segments (e.g., name, date, quantity). DEA has concern, such as the particular the data file into its database. Virtually Each data field has a number and a information required in a prescription. all pharmacies maintain prescription defined format (e.g., DEA number is The CCHIT criteria do address security records electronically; prescriptions that nine characters). The standardization issues, such as access control and audit are not received as electronic data files allows the receiving pharmacy to logs. CCHIT is developing standards for are manually entered into the pharmacy identify and separate the data it receives stand-alone electronic prescription application. and import the information into the applications. DEA has not been able to Because of the large number of correct fields in the pharmacy database. identify any organization that sets electronic prescription and pharmacy SCRIPT does not address other aspects standards for or certifies pharmacy applications and the current lack of a of prescription or pharmacy applications for security issues or even mature standard for the formatting of applications (e.g., what information is for the ability to record and retain prescription data, most electronic displayed and stored at a practice or information such as dispensing data. prescriptions are routed from the pharmacy, logical access controls, audit Proposed Rule. On June 27, 2008, electronic prescription or EHR trails). SCRIPT provides for, but does DEA published a Notice of Proposed application through intermediaries, at not mandate the use of, some fields (e.g., Rulemaking (NPRM) to revise its least one of which determines whether practitioner first name and patient regulations to allow the creation, the prescription file needs to be address) that DEA requires. In addition, signature, transmission, and processing converted from one software version to although the standard mandates that of controlled substance prescriptions another so that the receiving pharmacy applications include certain fields, it electronically (73 FR 36722). The application can correctly import the does not require that those fields be proposed rule followed consultations data. There are generally three to five completed before transmission is with the industry and the Department of intermediaries that route prescriptions allowed. The SCRIPT standard is still Health and Human Services, which is between practitioners and pharmacies. evolving; the most recent is Version 10 responsible for establishing For example, a prescription may be Release 6. The interoperability issues transmission standards for electronic routed to the application provider, then that require intermediaries generally prescriptions and security standards for to a hub that converts the prescription relate to pharmacy and practitioner health information. The proposed rule from one software version to another to applications using different versions of provided two approaches, one for the meet the requirements of the receiving the standard as well as varying private sector and one for Federal pharmacy, then to the pharmacy approaches to providing opening and healthcare providers. The private sector application provider or chain pharmacy reading instructions. approach included identity proofing of server before reaching the dispensing One intermediary, SureScripts/ individual practitioners authorized to pharmacy. Some application providers RxHub, certifies electronic prescription sign controlled substances prescriptions further route prescriptions through and pharmacy applications for prior to granting access to sign such aggregators who direct the prescription compliance with the SCRIPT standard; prescriptions, two-factor authentication to a hub or to a pharmacy. For closed SureScripts/RxHub determines whether including a hard token separate from the healthcare systems, where the the electronic prescription application computer for accessing the signing practitioners and pharmacies are part of creates a prescription that conforms to functions, requirements for the content the same system, intermediaries are not the SCRIPT standard and whether the and review of prescriptions, limited needed. pharmacy application is able to open transmission provisions, requirements Standards. Any electronic data and read a SCRIPT prescription of pharmacy applications processing 5 transfer depends on the ability of the correctly. SureScripts/RxHub controlled substances prescriptions for receiving application to open and read certification does not address aspects of dispensing, third party audits of the the information accurately. To be able to applications unrelated to their ability to application providers, and internal do this, the fields and transactions need produce or read a prescription in audit functions for electronic to be defined and tagged so that the appropriate SCRIPT format. prescription application providers and receiving application knows, for The Certification Commission for pharmacy applications. The Federal example, that a particular set of Healthcare Information Technology healthcare providers told DEA that the characters is a date and that other sets (CCHIT) is a private, nonprofit approach proposed for the private sector are names, etc. The National Council for organization recognized by the Secretary was inconsistent with their existing Prescription Drug Programs (NCPDP) of HHS as a certification body for EHRs practices and did not meet the security has developed a standard for under the exception to the physician requirements imposed on all Federal prescriptions, called SCRIPT, which is self-referral prohibition and safe harbor systems. The approach proposed for Federal healthcare systems was based, generally used by application providers; under the anti-kickback statute, therefore, on the existing Federal hospital-based applications may also respectively, for certain arrangements systems, which rely on public key use Health Level 7 (HL7) standards. involving the donation of interoperable infrastructure (PKI) and digital SCRIPT is a data transmission standard EHR software to physicians and other certificates to address basic security ‘‘intended to facilitate the health care practitioners or entities (71 issues related to non-repudiation, communication of prescription FR 45140 and 71 FR 45110, respectively, August 8, 2006). CCHIT authentication, and record integrity. information between prescribers, DEA’s Concerns. DEA’s proposed rule pharmacies, and payers.’’ 4 It defines develops criteria for electronic medical records (EMRs or EHRs) and certifies was a response to existing and potential transactions (e.g., new prescription, problems that exist when prescriptions refill request, prescription change, applications against these criteria. Although electronic prescribing is are created electronically. It is essential that the rules governing the electronic 4 National Council for Prescription Drug addressed in the CCHIT ambulatory Programs, Prescriber/Pharmacist Interface SCRIPT prescribing of controlled substances do Standard Implementation Guide Version 10.0, 5 http://www.surescripts.com/certification.html, not inadvertently facilitate diversion October 2006. accessed April 29, 2009. and abuse and undermine the ability of

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DEA, State, and local law enforcement perform functions such as approving a responsible for illegitimate prescriptions to identify and prosecute those who prescription or signing it. At medical issued in their name. engage in diversion. In this vein, DEA’s practices and even more so at hospitals Because regulations do not currently primary goals were to ensure that and clinics, many staff members may exist permitting the use of electronic nonregistrants did not gain access to use the same computers. The person prescriptions for controlled substances, electronic prescription applications and who logged onto the application may there is naturally no evidence of generate or alter prescriptions for not be the person entering prescription diversion related to electronic controlled substances and to ensure that information later or the person who prescriptions of these substances. That a prescription record, once created, transmits the prescription. Some there is no evidence that other could not be repudiated. In the case of applications have internal audit trail noncontrolled prescription drugs have at least some existing electronic functions, but whether these are active been diverted through electronic prescription application service and reviewed is at the practitioner’s prescriptions is not relevant for several providers, individuals are allowed to discretion. In addition, with multiple reasons. First, there is a very limited, if enroll online. ASPs may ask for DEA people using computers, it is unclear any, black market for other prescription registration and State authorization that the audit trail can accurately medications. Second, there is no reason numbers, although they are not required identify who is performing actions. for law enforcement to investigate to do so; the degree to which these are Except for those Federal electronic diversion of these medications, if it verified is at the discretion of the prescription applications that require occurs, because such diversion may not application provider. Similarly, practitioners to digitally sign be illegal (this would depend on State application providers that sell installed prescriptions, none of the applications law). Finally, the number of electronic applications may or may not determine transmit any indication that a prescriptions, including refill requests, whether the practitioners have valid prescription was actually signed. has not been great (4 percent in 2008, State and DEA authorizations. Where a With multiple intermediaries moving according to SureScripts/RxHub). In contrast, prescription controlled medical practice purchases an prescriptions between practitioners and substances have always carried a application or service, providers may or pharmacies, there is no assurance that a significant inherent risk of diversion, may not obtain this information for all prescription may not be altered or both because they are addictive and practitioners in the practice. added during transmission. Some because they can be sold for Most of the applications appear to intermediaries have good security, but significantly higher prices than their rely on passwords to identify a user of there is no requirement for them to do retail price. The recent studies showing the application. Passwords are often so and practitioners and pharmacies increasing levels of abuse of these drugs described as the weakest link in security have no control over which because they are easily guessed or, in throughout the United States heightens intermediaries are used. The pharmacy the cause for concern. Accordingly, with healthcare settings, where multiple has no way to verify that the people use the same computers, easily controlled substances there is a prescription was sent by the practitioner considerable incentive for individuals observed. Where longer, more complex whose name is on the prescription or passwords are required by applications and criminal organizations to exploit that if it was, that it was not altered after any vulnerabilities that exist to obtain as a means to increase their the practitioner issued it. The evidence effectiveness, this can actually be these substances illegally. of forgery and alteration that pharmacies The National Survey on Drug Use and counterproductive, as it often causes use to identify illegitimate paper Health (NSDUH) (formerly the National users to write down their passwords, prescriptions do not exist in an Household Survey on Drug Abuse) is an which weakens overall security.6 There electronic record—not only because annual survey of the civilian, non- are, in general, very limited standards electronic prescriptions contain no institutionalized, population of the for security of electronic prescription handwritten signatures, but also because United States aged 12 or older. The applications and no assurance that even electronic prescriptions are typically survey is conducted by the Office of where security capabilities exist, that created from drop-down menus, which Applied Studies, Substance Abuse and they are used. For example, applications prevent or reduce the likelihood of Mental Health Services Administration, may be able to set access controls to misspelled drug names, inappropriate of the Department of Health and Human limit who may sign a prescription, but dosage forms and units, and other Services. Findings from the 2008 unless those controls are set properly, indicators of possible forgery. NSDUH are the latest year for which anyone in a practice might be able to The existing processes used for information is currently available. The sign a prescription in a practitioner’s electronic prescriptions for 2008 NSDUH 7 estimated that 6.2 name. The Certification Commission for noncontrolled substances, therefore, million persons were current users, i.e., Healthcare Information Technology make it easy for every party to repudiate past 30 days, of psychotherapeutic (CCHIT) requires that an application the prescription. A practitioner can drugs—pain relievers, anti-anxiety have logical access controls and audit claim that someone outside the practice medications, stimulants, and trails to gain certification, but there is issued a prescription in his name, that sedatives—taken nonmedically. This no requirement that these functions be someone else in the practice used his represents 2.5 percent of the population used. More than half the electronic password to issue a prescription, or that aged 12 or older. From 2002 to 2008, prescription application providers it was altered after he issued it either in there was an increase among young certified with SureScripts/RxHub (for transmission or at the pharmacy. adults aged 18 to 25 in the rate of transmission) are not certified with Proving or disproving any of these current use of prescription pain CCHIT. claims would be very difficult with the Even if there are logical access existing processes. DEA and other law 7 Substance Abuse and Mental Health Services controls, they may not limit who can enforcement agencies might not be able Administration. (2009). Results from the 2008 to prove a case against someone issuing National Survey on Drug Use and Health: National 6 National Institute of Standards and Technology. Findings (Office of Applied Studies, NSDUH Series Special Publication 800–63–1, Draft Electronic illegitimate prescriptions; equally H–36, DHHS Publication No. SMA 09–4434). Authentication Guideline, December 8, 2008. important, practitioners might have Rockville, MD. http://www.oas.samhsa.gov/nsduh/ Appendix A. trouble proving that they were not 2k8nsduh/2k8Results.pdf.

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relievers, from 4.1 percent to 4.6 controlled substance prescriptions are approach that DEA has adopted in this percent. The survey found that about 52 issued electronically, the process is interim final rule. million people 12 and older had used adequately secure to protect both DEA First, the commenters noted that prescription drugs for non-medical registrants and society. DEA’s proposed approach addressed reasons in their lifetime; about 35 Based on DEA’s concerns, certain primarily one model for electronic million of these had used prescription requirements must exist for any system prescription applications, application painkillers nonmedically in their to be used for the electronic prescribing service providers (ASPs). In this model, lifetime. of controlled substances: the practitioner subscribes to a service The consequences of prescription • Only DEA registrants may be and accesses, usually over the Internet, drug abuse are seen in the data collected granted the authority to sign controlled an electronic prescription application by the Substance Abuse and Mental substance electronic prescriptions. The that is maintained on the ASP’s servers. Health Services Administration on approach must, to the greatest extent The ASP controls access to the emergency room visits. In the latest possible, protect against the theft of application, has access to all of the data, Drug Abuse Warning Network registrants’ identities. records, and maintains security. The (DAWN), 2006: National Estimates of • The method used to authenticate a practitioner does not need to install the Drug-Related Emergency Department practitioner to the electronic prescribing application or maintain servers that 8 Visits, SAMHSA estimates that, during system must ensure to the greatest archive the records. Many electronic that one year, approximately 741,000 extent possible that the practitioner prescription application providers, emergency department visits involved cannot repudiate the prescription. particularly those that develop EHRs nonmedical use of prescription or over- Authentication methods that can be and hospital applications, install their the-counter drugs or dietary compromised without the practitioner software on the practitioner’s supplements, a 38 percent increase over being aware of the compromise are not computers. Once the application is 2004. Of the 741,000 visits, 195,000 acceptable. installed, the electronic prescription involved benzodiazepines (Schedule IV) • The prescription records must be application provider’s role is limited to and 248,000 involved opioids (Schedule reliable enough to be used in legal providing technical assistance when II and III). Overall, controlled actions (enforcing laws relating to needed. Access control, records, and security are handled by the practitioners substances represented 65 percent of the controlled substances) without estimated emergency department visits or their staff. Some of the proposed diminishing the ability to establish the involving prescription drugs or over- provisions did not work when the relevant facts and without requiring the the-counter drugs or dietary electronic prescription application calling of excessive numbers of supplements. Between 2004 and 2006, provider is not involved in logical witnesses to verify records. the number of visits involving opioids access control. • The security systems used by any increased 43 percent and the number Second, many commenters pointed electronic prescription application involving benzodiazepines increased 36 out that the technology continues to percent. Of all visits involving must, to the greatest extent possible, evolve, the EHR applications are still nonmedical use of pharmaceuticals, prevent the possibility of insider changing, and that the standards for about 224,000 resulted in admission to creation or alteration of controlled electronic prescriptions are not mature. the hospital; about 65,000 of those substance prescriptions. A number of commenters indicated that individuals were admitted to critical Comments. DEA received 229 the current transmission system, which care units; 1,574 of the visits ended with comments, 35 of which were copies. relies on a series of intermediaries to the death of the patient. More than half Twenty-one practitioner organizations, provide interoperability, may not be of the visits involved patients 35 and 24 pharmacy organizations, 18 States needed when both technology and the older. (State licensing boards of medicine and standards evolve. These commenters People dependent on the drugs are pharmacy, and three State health wanted DEA to provide more flexibility willing to pay a high premium to obtain departments), and 19 application to be able to adjust to advancements as them, creating a black market for these providers were among the commenters. they occur. Several States supported the rule as drugs. The problem of illegitimate III. Discussion of the Interim Final Rule prescriptions, which exists with paper proposed, expressing concern about the prescriptions, is exacerbated by the security of electronic prescriptions and This section provides an overview of speed of electronic transmissions and stating that the rule should prevent the interim final rule. As noted above, the difficulty of identifying an insider tampering or creation of commenters raised a number of issues electronic prescription as invalid. A controlled substance prescriptions. related to specific proposed provisions. single prescription can be sent to Advocacy groups concerned with drug DEA has revised the rule to address multiple pharmacies; multiple use similarly supported the proposed commenters’ concerns and to recognize practitioners’ identities can be stolen rule as did a few other commenters. A the variations in how electronic and each identity used to issue a limited number of commenters generally prescription applications are number of prescriptions to prevent a supported electronic prescriptions implemented. In arriving at an interim pharmacy or a State prescription without addressing the proposed rule. final rule, DEA has balanced a number monitoring program from noticing an Most commenters, however, raised a of considerations. Chief among these is unusual pattern. DEA’s goal in the substantial number of issues about DEA’s obligation to ensure that the proposed rule was to address these various provisions of the proposed rule; regulations minimize, to the greatest vulnerabilities and ensure that before their comments are addressed in detail extent possible, the potential for in section IV of this preamble. On a diversion of controlled substances 8 Substance Abuse and Mental Health Services general level, they expressed concern resulting from nonregistrants gaining Administration, Office of Applied Studies. Drug that the proposed requirements would access to electronic prescription Abuse Warning Network, 2006: National Estimates prove too burdensome and would create applications and electronic of Drug-Related Emergency Department Visits. DAWN Series D–30, DHHS Publication No. (SMA) a barrier to the adoption of electronic prescriptions. At the same time, DEA 08–4339, Rockville, MD, 2007. http:// prescribing. They also raised two has sought to streamline the rules to dawninfo.samhsa.gov/. overarching issues that have affected the reduce the burden on registrants.

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Another of DEA’s goals has been to physician, nurse), then assign each final rule DEA is allowing the use of a provide flexibility in the rule so that as individual to the appropriate role. biometric as a substitute for a hard technologies and standards mature, Access control will be handled by at token or a password. If a hard token is registrants and application providers least two people within a practice, one used, it must meet FIPS 140–2 Security will be able to take advantage of of whom must be a registrant. Once the Level 1 for cryptographic devices or advances without having to wait for a registrant has been issued the one-time-password devices and must be revision to the regulations. Finally, DEA authentication credential, the stored on a device that is separate from has revised the rules to place individuals who set the logical access the computer being used to access the requirements on either the application controls will verify that the application. The CSPs and CAs may or on registrants so that neither DEA nor practitioner’s DEA registration is valid issue a new hard token or register and registrants are dependent on and set the application’s logical access provide credentials for an existing intermediaries for maintenance of controls to grant the registrant access to token. Regardless of whether a new information. functions that indicate a prescription is token is provided and activated or an In response to commenters’ concerns, ready to be signed and sign controlled existing token is registered for the DEA is adopting an approach to identity substance prescriptions. One person signing of controlled substances proofing (verifying that the user is who will enter the data; a registrant must prescriptions, communications between he claims to be) and logical access approve the entry, using the two-factor the CSP or CA and practitioner control (verifying that the authenticated authentication protocol, before access applicant must occur through two user has the authority to perform the becomes operational. channels (e.g., mail, telephone, e-mail). requested operation) that is different DEA is allowing, but not requiring, However, while DEA is requiring in from the approach that it proposed. The institutional practitioners to conduct this interim final rule that the interim final rule provisions related to identity proofing in-house as part of authentication credential be two-factor, these two steps are based on the concept their credentialing process. At least two DEA is seeking further comments on of separation of duties: No single people within the credentialing office this issue. Specifically, DEA seeks individual will have the ability to grant must sign any list of individuals to be comments in response to the following access to an electronic prescription granted access control. That list must be question: application or pharmacy application. sent to a separate department (probably • Is there an alternative to two-factor For individual practitioners in private the information technology department), authentication that would provide an practice (as opposed to practitioners which will use it to issue authentication equally safe, secure, and closed system associated with an institutional credentials and enter the logical access for electronic prescribing of controlled practitioner registrant), identity proofing control data. As with private practices, substances while better encouraging will be done by an authorized third two individuals will be required to enter adoption of electronic prescriptions for party that will, after verifying the and approve the logical access control controlled substances? If so, please identity, issue the authentication information. Institutional practitioners describe the alternative(s) and indicate credential to a registrant. As some may require registrants and those how, specifically, it would better commenters suggested, DEA is requiring exempted from registration under encourage adoption of electronic registrants to apply to certain Federally § 1301.22 to obtain identity proofing prescriptions for controlled substances approved credential service providers and authentication credentials from the without diminishing the safety and (CSPs) or certification authorities (CAs) same CSPs or CAs that individual security of the system. to obtain their authentication practitioners use. The institutional DEA is establishing standards with credentials or digital certificates. These practitioner may also conduct the which any biometric being used as one CSPs or CAs will be required to conduct identity proofing in-house, then provide factor to sign controlled substance identity proofing at National Institute of the information to these CSPs or CAs to prescriptions must comply; however, Standards and Technology (NIST) SP obtain the authentication credentials. In DEA is not specifying the types of 800–63–1 Assurance Level 3, which this last case, the institutional biometrics that may be used to allow for allows either in-person or remote practitioners would be acting as trusted the greatest flexibility and adaptation to identity proofing. Once a Federally agents for the CSPs or CAs, under rules new technologies in the future. DEA approved CSP or CA has verified the that those organizations set. Because consulted extensively with NIST in the identity of the practitioner, it will issue DEA has made extensive changes to the development of these standards and has the necessary authentication credential. requirements related to identity relied on their recommendations for this The successful issuance of the proofing and logical access control, DEA aspect of the rule. If a biometric is used, authentication credentials will be is seeking further comments on these it may be stored on a computer, a hard necessary to sign electronic controlled issues. token, or the biometric reader. Storage substance prescriptions, but possession As proposed, DEA is requiring in this of biometric data, whether in raw or of the credential will not be sufficient to interim final rule that the authentication template format, has implications for gain access to the signing function. The credential be two-factor. Two-factor data protection and maintenance. These electronic prescription application must authentication (two of the following— are considerations that should be allow the setting of logical access something you know, something you weighed by application providers and controls to ensure that only DEA have, something you are) protects the implementers when choosing where and registrants or persons exempted from practitioner from misuse of his how biometric data may be stored. the requirement of registration are credential by insiders as well as Additionally, application providers and allowed to indicate that prescriptions protecting him from external threats implementers may wish to consider are ready to be signed and sign because the practitioner can retain using open standard biometric data controlled substance prescriptions. control of a biometric or hard token. formats when available, to provide Logical access controls may be by user Authentication based only on interoperability where more than one or role-based; that is, the application knowledge factors is easily subverted application provider may be providing may allow permissions to be assigned to because they can be observed, guessed, biometric capabilities (e.g., a network individual users or it may associate or hacked and used without the that spans multiple entities) and to permissions with particular roles (e.g., practitioner’s knowledge. In the interim protect their interests. Because the use

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of biometrics and the standards related practitioner. The practitioner is not action; and the person taking the action. to their use were not discussed in the required to review the monthly log. The application provider and the notice of proposed rulemaking, DEA is Because the prescription information registrants must develop a list of seeking further comments on these will be digitally signed when the auditable events; auditable events issues. practitioner completes the two-factor should be occurrences that indicate a DEA is requiring that the application authentication protocol, the prescription potential security problem. For display a list of controlled substance need not be transmitted immediately. example, an unauthorized person prescriptions for the practitioner’s Information other than the information attempting to sign or alter a prescription review before the practitioner may that must be digitally signed may be would be an auditable event; a authorize the prescriptions. A separate added to the file (e.g., pharmacy URLs) pharmacist annotating a record to list must be displayed for each patient. or the prescription may be reviewed indicate a change to a generic version of All information that the DEA (e.g., at a long-term care facility) after it a drug would not be. The applications regulations require to be included in a is signed and before it is transmitted to must run the internal audit function prescription for a controlled substance, the pharmacy. After the practitioner daily to identify any auditable events. except the patient’s address, must completes the authentication protocol, When one occurs, the application must appear on the review screen along with the information that the DEA generate a readable report for the a notice that completing the two-factor regulations require to be included in a practitioner or pharmacist. If a authentication protocol is legally prescription for a controlled substance practitioner or pharmacy determines signing the prescription. A separate key may not be modified before or during that there is a potential security stroke will not be required for this transmission. problem, they must report it to DEA DEA has clarified that the application statement. Registrants must indicate that within one business day. may print copies of an electronically each controlled substance prescription Application providers must obtain a transmitted prescription if they are shown is ready to be signed. When the third-party audit before the application clearly labeled as copies, not valid for may be used to create, sign, transmit, or registrant indicates that one or more dispensing. If a practitioner is notified process controlled substance prescriptions are to be signed, the by an intermediary or pharmacy that a prescriptions and whenever a application must prompt him to begin transmission failed, he may print a copy functionality related to controlled the two-factor authentication protocol. of the transmitted prescription and substance prescription requirements is Completion of the two-factor manually sign it. The prescription must altered, or every two years after the authentication protocol legally signs the indicate that it was originally initial audit, whichever occurs first. If prescriptions. When the two-factor transmitted to a specific pharmacy and one or more certification organizations authentication protocol is successfully that the transmission failed. The establish procedures to review completed, the application must pharmacy is responsible for checking to applications and determine whether digitally sign and archive at least the ensure that the prescription was not they meet the requirements set forth in DEA-required information. If the received electronically and no the DEA regulations, DEA may allow practitioner is digitally signing the controlled substances were dispensed 9 this certification to replace the third- prescription with his own private key, pursuant to the electronic prescription party audit. DEA will notify registrants the application need not digitally sign prior to filling the paper prescription. of any such approvals of organizations the record separately, but must archive DEA has also clarified that the to conduct these third-party the digitally signed record. DEA is requirement that the DEA-required certifications through its Web site. At allowing any practitioner to use the contents of the prescription not be this time, no such certification exists for digital signature option proposed for altered during transmission applies only either electronic prescription or Federal healthcare systems. Unless a to changes to the content (not format) by pharmacy applications, but the practitioner has digitally signed a intermediaries, not to changes that may Certification Commission for Healthcare prescription and is transmitting the lawfully be made at a pharmacy after Information Technology (CCHIT) has prescription with the digital signature, receipt. Pharmacy changes to electronic developed a program for electronic the electronic prescription must include prescriptions for controlled substances prescription applications. an indication that the prescription was are governed by the same statutory and All records must be maintained for signed. regulatory limitations that apply to two years from the date on which they The electronic prescription paper prescriptions. Intermediaries may were created or received. Pharmacy application must generate a monthly log not convert an electronic controlled records must be backed up daily; DEA of controlled substance prescriptions substance prescription into a fax. Once is not specifying where back-up files issued by a registrant, archive a record a prescription is created electronically, must be stored. of those logs, and provide the logs to the all records of the prescription must be Because DEA is allowing any retained electronically. registrant to use the public key 9 For technical accuracy, DEA is describing the Unless the prescription is being infrastructure (PKI) option proposed for method of digitally signing as ‘‘applying the private transmitted with a digital signature, Federal healthcare systems, the interim key.’’ The private key is a secret quantity stored on either the last intermediary or the final rule does not include separate the user’s token that is used in the computation of digital signatures. Digital certificates contain a pharmacy must digitally sign the requirements for these systems. related quantity called the public key, which is prescription; the pharmacy must archive When a prescription is transmitted used to verify signatures generated by the the digitally signed prescription. Both (outside of a closed system), it moves corresponding private key. The user is not required the electronic prescription application through three to five intermediaries to know, and does not enter either key. A message digest is computed by the signing software on the and the pharmacy application must between practitioners and pharmacies. user’s computer, and the portion of the signing maintain an internal audit trail that Although prescriptions could be altered, function that involves the private key is records any modifications, annotations, added, or deleted during transmission, automatically performed by the user’s token, once or deletions of an electronic controlled DEA is not regulating transmission. the user has provided the token and a second authentication factor such as a password or PIN. substance prescription or when a Registrants have no control over the From the user’s perspective, the experience is functionality required by the rule is string of intermediaries. A practitioner similar to using an ATM card. interfered with; the time and date of the might be able to determine from his

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application provider which existing electronic prescription issuing paper prescriptions. Several intermediaries it uses to move the application that does not comply with practitioner organizations and a State prescription from the practitioner to the interim final rule to prepare a Board of Pharmacy stated that there was SureScripts/RxHub or a similar service, controlled substance prescription, so no assurance that identity proofing but neither the practitioner nor the that EHR and other electronic would reduce diversion, citing the application provider would find it easy prescribing functionality may be used, vulnerabilities of paper prescriptions. to determine which intermediaries serve and print the prescription for manual One pharmacy chain stated that DEA each of the pharmacies a practitioner’s signature by the practitioner. Such should restrict access to the database of patients may choose. Pharmacies have prescriptions are paper prescriptions DEA registration numbers. the problem in reverse; they may know and subject to the existing requirements DEA Response. DEA continues to which intermediaries send them for paper prescriptions. believe that it is critical to the security prescriptions, but have no way to of electronic prescribing of controlled determine the intermediaries used to IV. Discussion of Comments substances that authentication route prescriptions from perhaps A. Introduction credentials used to sign controlled hundreds of practitioners using different substance prescriptions be issued only This section summarizes the 194 applications to SureScripts/RxHub or a to individuals whose identities have similar service. DEA believes the comments received to the NPRM by been confirmed based on information involvement of intermediaries will not issue and provides DEA’s responses. For presented in, and consistent with, the compromise the integrity of electronic each issue, DEA first summarizes the application (except for institutional prescribing of controlled substances, proposed rule, then presents the practitioners; see discussion below). provided the requirements of the comments and DEA’s responses. The Without this step, nonregistrants—at a interim final rule are satisfied. Among subjects are presented in an order that practitioner’s office, at an application these requirements is that the tracks the process of issuing and provider, or elsewhere—could obtain an prescription record be digitally signed dispensing a prescription from authentication credential in a before and after transmission to avoid practitioner to pharmacy. Issues that registrant’s name and use it to issue the need to address the security of apply to both types of applications (e.g., illegal prescriptions. As DEA discussed intermediaries. DEA realizes that this third-party audits, recordkeeping) are in the NPRM, some existing electronic approach will not prevent problems presented once. General comments and prescription application providers allow during the transmission, but it will at ancillary issues are discussed at the end people to enroll online, with no checks least identify that the problem occurred of this section. on whether the person is who he claims during transmission and protect B. Identity Proofing and Logical Access to be. Although it is true that DEA does practitioners and pharmacies from being Control not require in-person identity proofing held responsible for problems that may for registration and allows applications arise during transmission that are not DEA proposed that practitioners to be filed online, DEA conducts a attributable to them. would be required to undergo in-person number of checks on registration Some commenters on the NPRM identity proofing, with DEA-registered applications before issuing a claimed that the security practices of hospitals, State licensing boards, or law registration. In addition, filing a false intermediaries were sufficient to protect enforcement agencies checking the registration application is a Federal electronic prescriptions. These identification documents. The record of crime punishable by up to four years in practices, which are voluntary, do not the identity proofing would then have prison under 21 U.S.C. 843. Moreover, address the principal threats of been sent to the electronic prescription electronic prescriptions, unlike written diversion, which occur before and after application provider, which would use or oral prescriptions, lack the human transmission. Maintaining the integrity the information to set access controls to elements of handwriting or the spoken of the record during transmission is of ensure that only practitioners eligible to voice, which a pharmacist can take into little value if there is no assurance that issue controlled substance prescriptions account in ascertaining whether the a registrant created and transmitted the were allowed to sign these prescription was issued by the actual prescription or that pharmacy staff did prescriptions. practitioner or an impostor; identity not alter it after receipt. 1. Identity Proofing proofing serves to some degree to fill DEA wishes to emphasize that the this void. electronic prescribing of controlled Comments. Some commenters, In response to comments on whether substances is in addition to, not a including electronic prescription this requirement will reduce diversion, replacement of, existing requirements application providers and practitioner DEA is well aware of the vulnerabilities for written and oral prescriptions for organizations, supported identity of the paper-based prescription system, controlled substances. This rule proofing, but recommended changes to but that such vulnerabilities exist does provides a new option to prescribing the proposed rule. One physician noted not mean that DEA should allow similar practitioners and pharmacies. It does that identity proofing was particularly or greater vulnerabilities with electronic not change existing regulatory important to prevent online enrollment prescriptions for controlled substances. requirements for written and oral without any checks on the veracity of A forged paper prescription provides prescriptions for controlled substances. the information submitted. Other forensic evidence of who committed the Prescribing practitioners will still be commenters, including insurance forgery and can exonerate a practitioner able to write, and manually sign, organizations, some practitioner based on that evidence; an electronic prescriptions for Schedule II, III, IV, and organizations, and some pharmacy prescription issued in a practitioner’s V controlled substances, and organizations, opposed the requirement name provides no such evidence, pharmacies will still be able to dispense for identity proofing, stating that it making it difficult for law enforcement controlled substances based on those would be burdensome to practitioners to identify the person who issued it and written prescriptions and archive those and a barrier to adoption of electronic difficult for the practitioner to prove records of dispensing. Further, nothing prescribing. One electronic prescription that he did not. Restricting access to the in this rule prevents a practitioner or a application provider noted that DEA CSA database would not solve the practitioner’s agent from using an does not conduct identity proofing for problem of patients, medical office staff,

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and pharmacy staff, all of whom have associated with application providers or identity proofing that meets NIST Sp routine access to DEA numbers, issuing information technology organizations 800–63–1 Assurance Level 3 or above. fraudulent prescriptions. asked DEA to consider remote identity For practitioners obtaining a digital DEA recognizes that identity proofing proofing systems. certificate, DEA is requiring that they and logical access controls (discussed DEA Response. In view of the obtain the digital certificate from a below) will not stop all misuse of comments, DEA has revised the certification authority that is cross- electronic prescription applications. requirements for identity proofing to certified with the Federal Bridge Identity proofing will not prevent a adopt an approach that does not involve Certification Authority (FBCA) at a basic registrant from issuing invalid parties discussed in the proposed rule. assurance level or higher and that prescriptions or allowing a staff member As suggested by some commenters, for conducts identity proofing at NIST SP to issue prescriptions in his name, and individual practitioners in private 800–63–1 Assurance Level 3 or above. it is not intended to prevent such practice (i.e., those practitioners not DEA believes that shared service activity. The purpose of identity seeking access to an institutional providers would be too restrictive and proofing is to limit to as great an extent practitioner’s applications), DEA will believes that the approach it is as possible the ability of nonregistrants use existing certification authorities implementing provides greater to obtain an authentication credential (CAs) and similar credential service flexibility for the regulated industry. and issue electronic controlled providers (CSPs) that have been DEA is not dictating how a CSP or CA substance prescriptions under a approved by a Federal authority. These conducts identity proofing. The practitioner’s name. organizations conduct identity proofing standards for identity proofing are set by Comments. A substantial number of and issue digital certificates and other the Federal Bridge Certification commenters raised issues related to who identity credentials as part of their Authority (FBCA) or the General would conduct the identity proofing. existing businesses. The standards they Services Administration in their The State Boards generally objected to use to conduct identity proofing and certificate policies and frameworks and being asked to conduct identity issue credentials are established in in NIST SP 800–63–1. Level 3 requires proofing, asserting that they did not documents (e.g., Certificate Policies, either in-person identity proofing based have the staff or resources to do so. Certificate Practice Statements, and on checking government-issued They noted that they would need to Assurance Frameworks) that are photographic identification or remote train staff and perhaps seek legislative reviewed and approved by Federal identity proofing. For in-person identity authority and funding to carry out this authorities and subject to third-party proofing, Level 3 requires the function. Other commenters doubted audits for their implementation. DEA is examination of a government-issued that hospitals or law enforcement specifying that the identity proofing photographic identification, which must agencies would be willing to conduct must meet NIST SP 800–63–1 be verified with either the issuing the checks or thought that DEA Assurance Level 3 although a CA or CSP agency, credit bureaus, or other similar intended to charge for the process. Some may impose higher standards. databases. The verification must practitioners objected to the idea of DEA’s objective is to ensure that confirm that the name, date of birth, and having law enforcement agencies identity proofing and the provision of address listed in the application for the involved. Many commenters objected to two-factor authentication credentials credential are consistent with the the cost of trips to a third party and will be done by a third party that is not information in other records checked. stated that it would be a barrier to involved in any other part of the The person checking the identification adoption, particularly for practitioners electronic prescribing process. This must compare the person with the who are not affiliated with a hospital, approach is based on the concept of photograph, record the identification such as mid-level practitioners and separation of duties, to ensure that the number, address (if listed), and date of dentists. Some commenters, including ability to sign controlled substance birth. If the identification is valid, the electronic prescription application prescriptions will not depend on the issuing organization may authorize or providers, asked that other entities be action of a single entity or person. A issue the credential and send notice to allowed to conduct identity proofing registrant will need the two-factor the address of record; if the (e.g., notaries, application providers, authentication credential before he will identification or other records checked passport processing agencies, the be able to sign electronic prescriptions do not confirm the address listed in the American Association of Medical for controlled substances, but the application (as may happen if the Colleges). possession of the token or tokens person has recently moved), the A long-term care facility (LTCF) associated with the credential will not, organization must issue credentials in a organization, several information itself, authorize a registrant to access the manner that confirms the address of technology organizations, and an application to sign controlled record (the address of record is the application provider suggested that DEA substances prescriptions. Logical access address listed in the application). use existing certification authorities control will be granted separately. For remote identity proofing, Level 3 (CAs) that issue digital certificates and Without the two-factor authentication requires a valid government-issued routinely conduct identity proofing as credential, a practitioner will not be identification number and a financial part of the enrollment process. An able to sign controlled substance account number. These numbers must information technology firm suggested prescriptions even if granted access. be confirmed via record checks with that DEA establish a set of common For practitioners who are obtaining a either the issuing agency or institution criteria under which credential issuers two-factor authentication credential that or through credit bureaus or similar can become accredited, citing the does not include a digital certificate, databases. The check must confirm that Department of Defense External DEA is requiring that they obtain their the name, address, date of birth, and Certification Authority program as an authentication credential from a other personal information in the example. The commenter also suggested credential service provider (CSP) that records are consistent with the that DEA specify that firms qualified as has been approved by the General application and sufficient to identify a shared service providers by the Federal Services Administration Office of unique individual. The address or Bridge Certification Authority (FBCA) Technology Strategy/Division of telephone number must be confirmed by could serve as CSPs. A few commenters Identity Management to conduct issuing the credential in a manner that

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confirms the ability of the applicant to necessary, but not a sufficient, condition send someone from the credentialing receive communications at the listed for signing a controlled substance office to the other locations to conduct address or number. DEA notes that CAs prescription. It is logical, therefore, to the identity proofing. DEA notes that and CSPs may conduct more extensive require the people who set logical this issue will arise only during the remote identity proofing and may access controls, rather than those who initial enrollment of previously require additional information from conduct identity proofing, to check the credentialed practitioners. After that, applicants. DEA believes that the ability DEA and State authorizations to practice practitioners being newly credentialed to conduct remote identity proofing and, where applicable, authorizations to by an institution can undergo identity allowed for in Level 3 will ensure that dispense controlled substances of proofing when and where they are practitioners in rural areas will be able prescribing practitioners. credentialed. The rule also requires that to obtain an authentication credential Comments. One medical group the credentialing office check the DEA without the need for travel. DEA expects association and a healthcare system and State authorizations to practice and, that application providers will work recommended that the larger practices where applicable, authorizations to with CSPs or CAs to direct practitioners be allowed to conduct the identity dispense controlled substances because to one or more sources of two-factor proofing themselves as they already this check should be part of their authentication credentials that will be conduct Level 4 identity proofing when standard credentialing process. interoperable with their applications. they issue credentials. Under the rule, the institutional DEA is seeking comment on this DEA Response. In view of the practitioner may issue the two-factor approach to identity proofing. comments, DEA has expanded upon the authentication credentials itself or proposed rule to allow institutional obtain them from a third party, which DEA is not requiring the CSP or CA practitioners, which are themselves will have to be a CSP or CA that meets to check DEA registrations or State DEA registrants, to conduct the identity the criteria specified above. In the latter authorizations to practice or dispense proofing for any individual practitioner case, the institutional practitioner could controlled substances as part of the whom the institutional practitioner is have each practitioner apply for the identity-proofing process; these will be granting access to issue prescriptions two-factor credential himself, which checked as part of logical access control, using the institution’s electronic would entail undergoing identity as discussed in the next section. DEA prescribing application. Because proofing by the CSP or CA. decided to have checks for the DEA institutional practitioners have Alternatively, the institutional registration, authorization to practice, credentialing offices, the interim final practitioner can serve as a trusted agent and authorization to dispense controlled rule allows those offices to conduct in- for the third party. Trusted agents substances for individual practitioners person identity proofing, which they conduct part of the identity proofing on handled separately from identity can do as part of their credentialing behalf of the CSP or CA and submit the proofing for three reasons. First, the process. DEA is not requiring information for each person along with information that is used to verify institutional practitioners to meet the a signed agreement that specifies the identity may not be the information requirements of NIST SP 800–63–1 for trusted agent’s responsibilities. DEA associated with a DEA registration. identity proofing. As some commenters emphasizes that institutional Government-issued photographic stated, these institutions already practitioners are allowed, but not identifications and credit cards usually conduct extensive checks before they required, to conduct identity proofing. If are associated with home addresses and, credential a practitioner. The interim an institutional practitioner (e.g., a perhaps, Social Security numbers; DEA final rule simply requires that before small hospital or clinic) decides to have registrations are usually associated with they issue the authentication credential each practitioner obtain identity business locations and, in some cases, they check the person’s government- proofing and the two-factor taxpayer identification numbers. In issued photographic identification authentication credential on his own, as addition, the registration database that against the person presenting it. They other individual practitioners do, that is DEA makes available through the must also check State licensure and permissible under the rule. DEA is National Technical Information Service DEA registrations, where applicable, but seeking comment on this approach to does not include this personal they do this as part of credentialing and identity proofing by institutional information, so that a CA or CSP would do not need to repeat the checks for practitioners. have to contact DEA for each applicant. practitioners whom they have already Comments. An intermediary, a Second, some practices or application credentialed. pharmacist organization, and a State providers may want some or all of the The rule only allows institutional asked whether practitioners would need nonregistrants on the staff to obtain practitioners to conduct in-person to undergo identity proofing more than authentication credentials so that there identity proofing, not remote identity once if they used multiple electronic will be only one method of proofing. There are two reasons for this prescription applications. An authenticating to the application. The limitation. First, the practitioners will application provider and a practitioner possession of a two-factor be visiting the institution on a regular organization asked if the identity authentication credential would not, in basis so the burden should be relatively proofing needed to be revalidated every these cases, distinguish between those low. Second, most institutional year. Several commenters asked about who can sign controlled substance practitioners may not have the ability or the need to obtain separate prescriptions and those who cannot. desire to conduct the credit and other authentication credentials if the Third, the decision to grant access to the background checks that are part of practitioner holds multiple DEA functions that allow a practitioner to remote identity proofing at NIST Levels numbers. indicate that a prescription is ready for 2 and 3. DEA recognizes that in some DEA Response. Identity proofing is signing and to sign controlled substance large systems, the credentialing office required to obtain a two-factor prescriptions is based on whether the may be at a central location and many authentication credential. If a person is a DEA registrant, not on the staff may work at other locations. In practitioner uses multiple applications possession of a two-factor those cases, the institutional (e.g., at his practice and at a hospital), authentication credential. The two- practitioner can decide whether to have he may need to obtain separate factor authentication credential is a the staff visit the central location or authentication credentials, based on the

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following considerations. A practitioner practice, and set access controls. DEA set logical access controls that limit will need to undergo identity proofing also proposed that the application access to the functions for indicating a for each such credential that he needs providers check DEA registration status prescription is ready for signing and for unless the applications he wishes to use weekly and revoke authentication signing the prescription to DEA require authentication credentials from credentials if practitioners’ registrations registrants. The interim final rule will the same CSP or CA; in that case, the had been terminated, revoked, or also limit access to setting these logical CSP or CA will determine whether a suspended. access controls. The application may set single application for identity proofing Comments. A LTCF organization logical access controls on an individual and issuance of the authentication stated that any electronic prescribing basis or on roles. If the logical access credential can serve as a basis for application must have, at its core, controls are role-based, one or more issuing multiple credentials. It may also control over access rights. A practitioner roles will have to be limited to be possible that multiple applications organization also emphasized the need individuals authorized to prescribe will accept the same two-factor to limit access to signing authority controlled substances. This role may be authentication credential. For example, within an application. An electronic labeled ‘‘DEA registrant’’ or physician, if a practitioner obtains a digital prescription application provider stated dentist, nurse practitioner, etc., certificate from an approved CA, he may that it did not set access controls for the provided the role is limited to those be able to use it to digitally sign applications it sells and installs at authorized to issue controlled substance prescriptions on multiple applications, medical practices. Although its prescriptions. For an individual if they accept digital signatures. For applications have logical access practitioner who is an agent or those practitioners who use more than controls, the practice administrator is employee of an institutional one DEA registration to issue controlled responsible for setting the controls. The practitioner, and who has been substance prescriptions, DEA is not application provider is not involved in authorized to prescribe controlled requiring a practitioner to have a the process. substances under the registration of the separate authentication credential based DEA Response. In its proposed rule, institutional practitioner pursuant to 21 solely on the fact that he uses more than DEA did not adequately differentiate CFR 1301.22(c), if logical access one DEA registration. As for the need for between authentication, authorization, controls are role-based, one role will revalidation of identity proofing, those and access. NIST, in its special have to be ‘‘authorized to sign controlled periods will be set by the CSP or CA. publication SP 800–12, provides the substance prescriptions.’’ (Other Comments. Practitioner organizations following description of these three methods of setting logical access asked if practitioners will be charged for steps: controls that NIST cites—location or the identity proofing. Access is the ability to do something with time—do not appear to be relevant, DEA Response. DEA expects that the a computer resource. This usually refers to a although applications or users may add CSP or CA will charge for the issuance technical ability (e.g., read, create, modify, or such limits based on their own of a two-factor authentication delete a file, execute a program, or use an concerns.) credential, which will generally include external connection). Authorization is the the cost of identity proofing. Whether permission to use a computer resource. The application logical access control practitioners will pay directly or Permission is granted, directly or indirectly, capability must require that data entry through the application provider will be by the application or system owner. of authorizations for setting logical a business decision on the part of Authentication is proving (to some access controls and the functions reasonable degree) that users are who they limited to registrants (indicating that a application providers. claim to be. Comments. A practitioner controlled substance prescription is organization expressed concern with the NIST SP 800–12 further states: ready for signing and signing a proposed rule language that referenced Access control is the means by which the controlled substance prescription) ‘‘State licenses’’ because some States do ability is explicitly enabled or restricted in involve two people. The requirement for not issue licenses to mid-level some way (usually through physical and two people to be involved in such data practitioners. system-based controls). Computer-based entry is frequently used to protect DEA Response. DEA agrees with this access controls are called logical access applications from internal security commenter and has revised the language controls. Logical access controls can threats. If a person is able, through the prescribe not only who or what (e.g., in the in the interim final rule to refer to State use of false identity documents, to case of a process) is to have access to a obtain a two-factor authentication authorization to practice and State specific system resource but also the type of authorization to dispense controlled access that is permitted. These controls may credential in a registrant’s name, he will substances.10 be built into the operating system, may be still not be able to sign controlled incorporated into applications programs or substance prescriptions unless he is 2. Access Control major utilities (e.g., database management granted access, by two people (one of In the NPRM, DEA proposed that the systems or communications systems), or may whom is a registrant). The interim final identity proofing document had to be be implemented through add-on security rule does not specify in detail how the submitted to the application provider, packages.11 application must be structured to ensure which would then check the DEA DEA has revised its approach to that two people concur with the data registration and State authorizations to access control to remove the application entry; rather, the rule simply requires provider and its staff from direct that the application must not accept 10 Under the CSA, every person who dispenses a involvement in the process. Instead, the these logical access controls without the controlled substance must have a DEA registration, interim final rule will require that the action of two parties. For example, a and may only dispense controlled substances to the extent authorized by his registration, unless DEA application must have the capability to small practice with two registrants has by regulation, waived the requirement of neither of whom is expecting to leave registration as to such person. 21 U.S.C. 822(a)(2), 11 National Institute of Standards and may decide that only the registrants will 822(b), 822(d). To be eligible to obtain a DEA Technology. Special Publication 800–12 An perform this function, which may occur registration, a practitioner must be licensed or Introduction to Computer Security—The NIST otherwise authorized by the State or jurisdiction in Handbook, Chapter 17; October, 1995. http:// only at the initial installation or upgrade which he practices to dispense controlled csrc.nist.gov/publications/nistpubs/800-12/800-12- of an electronic prescription application substances. 21 U.S.C. 802(21), 823(f), 824(a)(3). html/chapter17-printable.html. to comply with controlled substance

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prescription requirements. In large prescription functions must be defined is responsible for designating and practices, the registrants might find it as auditable events and a record of the documenting individuals or roles that beneficial to allow nonregistrants, such changes retained as part of the internal can perform these functions. Logical as a practice information technology audit trail. DEA is seeking comment on access must be revoked whenever any of administrator, to administer logical this approach to logical access control the following occurs: The institutional access controls in conjunction with a for individual practitioners. practitioner’s or, where applicable, registrant. Logical access must be revoked individual practitioner’s DEA The interim final rule requires that at whenever any of the following occurs: A registration expires without renewal, or least one of the people assigned the role DEA registration expires without is terminated, revoked, or suspended; of administering logical access control renewal, or is terminated, revoked, or the practitioner reports that a token must verify that any registrant granted suspended; the registrant reports that a associated with the two-factor authorization to indicate that a token associated with the two-factor authentication credential has been lost prescription is ready for signing and to authentication credential has been lost or compromised; or the individual sign controlled substance prescriptions or compromised; or the registrant is no practitioner is no longer authorized to has a valid DEA registration, a State longer authorized to use the practice’s use the institutional practitioner’s authorization to practice and, where application. DEA anticipates that for application. DEA is seeking comment on applicable, a State controlled substance most practices, logical access controls this approach to logical access control authorization. In small practices, this will be set and changed infrequently, for institutional practitioners. verification may require nothing more usually when a new registrant joins the Comments. An application provider than checking expiration dates on the practice or a registrant leaves. Even in to a major healthcare system agreed that practitioners’ DEA Certificate of larger practices, changes to access controls were needed, but noted Registration and State authorization(s), authorizations are likely to occur that in a large healthcare system this is unless there is reason to question the relatively infrequently. complex because of the variety of current validity. In larger practices, DEA recognizes that application practitioners involved and will take verification may take more time. service providers (ASPs) may currently time to implement. Individual registrations can be checked set access controls, to the extent that DEA Response. The interim final rule online at DEA’s Web site at http:// they do, at the ASP level and that the does not require applications to www.deadiversion.usdoj.gov/ by interim final rule may require them to distinguish which schedules of clicking on the Registration Validation reprogram some of their security controlled substances a registrant is button on the left side of the Web page. controls. DEA believes these steps are authorized to prescribe. Practitioners are Once DEA registration and State necessary to ensure that a registrant is responsible for knowing which authorization to practice and State involved in the process of setting logical schedules they may prescribe; if a authorization to dispense controlled access controls and that these cannot be practitioner prescribes beyond the substances have been verified, two set or changed without the concurrence extent authorized by his registration, he people must be involved in entering the of a registrant. If registrants submitted a is dispensing in violation of the CSA.12 data to the application to identify those list of people to be authorized to In addition, asking applications to people authorized to indicate that a perform the controlled substance distinguish among all the variations of prescription is ready for signing and to prescription functions to an ASP, there prescribing authority may add sign controlled substance prescriptions; would need to be a process to ensure unnecessary complication to those two people are also involved in that the list was from a legitimate source applications that will mostly be used by entering data to the application to (e.g., notarization), which could be practitioners who are authorized to identify people whose authorization has cumbersome, particularly for larger been revoked. The first person must practices where the list may change prescribe all Schedule II, III, IV, and V enter the data. A registrant must then more frequently than is the case for substances. This approach should use his two-factor authentication small practices. In addition, the reduce some of the complexity in credential to provide the second responsibility for data entry would then programming logical access controls approval. The application must ensure rest with ASP staff, who will not have because the application providers will that until the second approval occurs, the same degree of interest in protecting not need to distinguish among DEA logical access controls for controlled registrants from the misuse of the registrants. DEA also notes that the 2009 substance prescription functions cannot applications as the registrants security survey of the Health be activated or altered. DEA recognizes themselves have. Information and Management Systems that some solo practitioners may not For institutional practitioners, the Society (HIMSS) indicated that all of the have other employees although it seems setting of logical access controls will 196 healthcare systems surveyed have 13 unlikely that they do not have at least necessarily be somewhat different established user access controls. part-time help for office management because the registrant is not an Comments. Several application and back office functions. DEA is not individual. The principle, however, is providers objected to the proposed requiring that the second person be an the same. Identity proofing must be requirement that they check DEA employee, simply that there be two separate from setting logical access registration status weekly. people involved and that the persons controls; two individuals must be DEA Response. Because application involved be specifically designated by involved in each step. The interim final providers are no longer responsible for the practitioner(s). For such solo rule therefore requires that two controlling access, DEA has removed practitioners and for many small individuals from the credentialing office this requirement in the interim final practices, logical access controls may provide the part of the institution that rule. People within a practitioner’s need to be set only once because they controls the computer applications with office or an institutional practitioner will usually be set or changed only with the names of practitioners authorized to 12 staff turnover. issue controlled substance 21 U.S.C. 822(b), 841(a)(1). 13 Healthcare Information and Management All entries and changes to the logical prescriptions. The entry of the data will Systems Society. 2009 HIMSS Security Survey, access controls for setting the controls also require the involvement of two November 3, 2009. http://www.himss.org/content/ and for the controlled substance individuals. The institutional registrant files/HIMSS2009SecuritySurveyReport.pdf.

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will be familiar with any issues related authentication, prescription approval, short[.]’’ 14 This problem is exacerbated to the status of a DEA registration. They transmission of prescription, and in healthcare settings where multiple will have access to the expiration date successful prescription transmittal. people may use the same computers and of the DEA registration and State They suggested that this audit log work in close proximity to each other. authorization(s) to practice and, where should be in the form defined by Even if other staff cannot guess the applicable, to dispense controlled Healthcare Information Technology password, they may have many substances and be able to check with the Standards Panel (HITSP) T15 ‘‘Collect opportunities to observe a practitioner practitioner to ensure that the and Communicate Security Audit Trail entering the password. Strong registration has been renewed. If a Transaction.’’ Other commenters noted passwords (combinations of 8 or more practitioner is subject to suspension or that the Certification Commission for letters, numbers, and special characters) revocation, other registrants in the Healthcare Information Technology are hard to remember and are often practice or the institutional practitioner (CCHIT) does not require two-factor written down. None of these strategies are likely to be aware of the legal authentication and has only listed it as alters the ability of others in a problems and can revoke access control. a possibility for its 2010 standard. A healthcare setting to observe the DEA recognizes that this approach State Board of Pharmacy supported two- password. NIST, in its draft guidance on will not prevent a registrant in solo factor authentication, stating that enterprise password management (SP practice from continuing to issue concerns expressed by some members of 800–118) states the following: controlled substances prescriptions industry about the added time to Organizations should be aware of the under an expired, terminated, complete two-factor authentication are drawbacks of using password-based suspended, or revoked registration. misplaced. It said that the two-factor authentication. There are many types of However, it is already clear under authentication will take a minimal threats against passwords, and most of these existing law and regulations that a amount of time compared to the time it threats can only be partially mitigated. Also, practitioner who prescribes or otherwise takes to move through the multiple users are burdened with memorizing and dispenses controlled substances beyond screens used to create a prescription in managing an ever-increasing number of the scope of his registration is passwords. However, although the existing most applications. mechanisms for enterprise password committing a violation of the CSA and DEA Response. DEA agrees that management can somewhat alleviate this subject to potential criminal CCHIT does not yet require two-factor burden, they each have significant usability prosecution, civil fine, and loss of authentication. Two-factor disadvantages and can also cause more registration. Any practitioner who authentication is roadmapped by CCHIT serious security incidents because they would use his two-factor authentication in 2010 and beyond. DEA emphasizes, permit access to many systems through a credential to issue prescriptions after he however, that an audit log will not single authenticator. Therefore, organizations is legally barred from doing so would be provide any assurance of who issued a should make long-term plans for replacing or creating evidence of such criminal prescription. The commenters appear to supplementing password-based authentication with stronger forms of activity. As discussed above, the have confused logical access control authentication for resources with higher purpose of identity proofing and access with authentication. The problem DEA security needs.15 control is to prevent nonregistrants from is addressing with the requirement for gaining the ability to issue controlled two-factor authentication credentials is DEA remains convinced that single- substance prescriptions. not that someone may use their own factor authentication is insufficient to authentication credential to alter or ensure that a practitioner will not be C. Authentication Protocols create a prescription, but that a able to repudiate a prescription he Authentication protocols are nonregistrant will use a registrant’s signed. Comments. Although only a few classified by the number of factors they authentication credential to create and commenters opposed two-factor require. NIST and others recognize three sign a prescription. If a nonregistrant authentication, believing that passwords factors: something you know, something has been able to use a registrant’s were sufficient, most comments DEA you have, and something you are. authentication credential, the audit trail Combinations of user IDs and passwords will incorrectly indicate that the received on the issue raised substantial are one-factor because they require only registrant was responsible for the concerns about the details of the information that you know. A standard prescription. DEA believes that use of proposed rule on this subject. These ATM uses two-factor—something you two-factor authentication limits this concerns focused on the requirement for know (a personal identification number possibility. a hard token and the security levels (PIN)) and something you have (bank As commenters indicated, single- proposed. card). DEA proposed that practitioners factor authentication usually means A practitioner organization, a hospital be required to use a two-factor passwords alone or in combination with organization, a pharmacy association, a authentication protocol to access the user IDs. NIST states in its special health information technology electronic prescription application to publication SP 800–63–1: ‘‘* * * the organization, a healthcare system, other sign controlled substance prescriptions. ability of humans to remember long, medical associations, and a number of DEA proposed that one factor would arbitrary passwords is limited, so application providers asked DEA to have to be a hard token that met NIST passwords are often vulnerable to a allow the use of biometrics as an SP 800–63 Level 4 and that the variety of attacks including guessing, alternative to a hard token. The cryptographic module would have to be use of dictionaries of common practitioner organization stated that a validated at Federal Information passwords, and brute force attacks of all 14 Processing Standard (FIPS) 140–2 possible password combinations. * * * National Institute of Standards and Technology. Special Publication 800–63–1, Draft Security Level 2 overall and Level 3 all password authentication Electronic Authentication Guideline, December 8, security. mechanisms are vulnerable to keyboard 2008, Appendix A. http://csrc.nist.gov/ Comments. Three information loggers and observation of the password Publications/PubsSPs.html. technology firms asserted that two- when it is entered.’’ NIST also states that 15 National Institute of Standards and ‘‘ Technology. Special Publication 800–118, Guide to factor authentication is not common. * * * many users, left to choose their Enterprise Password Management (draft), April They suggested that a clear ‘audit log’ be own passwords will choose passwords 2009; http://csrc.nist.gov/publications/drafts/800- generated upon the provider that are easily guessed and even fairly 118/draft-sp800-118.pdf.

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second authentication at the time of and for the testing of the software used 1 17 describes technical acquisition and transmission is reasonable given the to read the biometrics. DEA is formatting specifications for the potential for unintentional or establishing these standards after biometric credentials of the PIV system. intentional failure to have only extensive consultation with NIST, and Section 4.2 covers sensor specifications authorized prescribers actually transmit based on NIST recommendations. A for fingerprint acquisition for the the prescription. That commenter discussion of these requirements purpose of authentication; Section 8.6 asserted that the key is to view follows. covers conformance to this authentication as having many highly • The biometric subsystem must specification. Section 5.2 covers both acceptable approaches and requiring operate at a false match rate of 0.001 or format and acquisition specifications for that a certain strength of authentication lower. facial images. While the format be the outcome, but not prescribe the The term ‘‘false match rate’’ is similar requirements for PIV will not be exact method by which that to the term ‘‘false accept rate’’—it is the required by DEA here, the normative authentication is generated. A health rate at which an impostor’s biometric is requirements for facial image information technology organization falsely accepted as being that of an acquisition establish minimum criteria asserted that the Association of authorized user. DEA is not establishing for automated face recognition, American Medical Colleges uses a a false non-match (rejection) rate; while specifically the ‘‘Normative Notes,’’ fingerprint biometric strategy to users may be interested in this criterion, numbers 4 through 8 under Table 6. permanently identity proof all future DEA does not have an interest in setting DEA also recommends using the physicians at the time they take their a requirement for a tolerance level for normative values for PIV conformance Medical College Admission Test false rejections for electronic in Table 6 rows 36 through 58 for frontal (MCAT). An application provider noted prescription applications. facial image acquisition. Currently, that biometric identifiers will limit • The biometric subsystem must use specifications exist only for fingerprint unauthorized access to electronic matching software that has and face acquisitions. prescription applications and ensure demonstrated performance at the DEA wishes to emphasize that the use non-repudiation with absolute certainty; operating point corresponding with the of SP 800–76–1 does not imply that all the commenter asserted that these required false match rate specified requirements related to Federally applications cannot be compromised (0.001) or a lower false match rate. This mandated Personal Identity Verification without the practitioner’s knowledge. testing must be performed by the cards apply in this context, only those The commenter noted that biometric National Institute of Standards and specified for biometric acquisition for identifiers cannot be misplaced, loaned Technology (NIST) or another DEA- the purposes of authentication. PIV goes to others or stored in a central location approved (government or non- beyond this application, in that it has for use by other persons. The government) laboratory. additional requirements for fingerprint commenter noted, however, that the This criterion is designed to ensure registration (or enrollment) suitable for technology may not be ready to deploy that an independent third-party has a Federal Bureau of Investigation in a scalable, cost-effective way at this tested the software and has determined background check, and the PIV time. its effectiveness on a sequestered data credential has interoperability DEA Response. DEA agrees with these set that is large enough for high requirements that will not necessarily commenters and has revised the interim confidence in the results, which will be apply to users of controlled substance final rule to allow the use of a biometric made publicly available for consumers. electronic prescription applications. as a second factor; thus, two of the three DEA believes that the requirement to • The biometric subsystem must factors must be used: a biometric, a have the biometric software tested by an either be co-located with a computer or knowledge factor (e.g., password), or a independent third party, as discussed PDA that the practitioner uses to issue hard token. While DEA is uncertain further below, will provide greater electronic prescriptions for controlled about the extent to which existing assurance to electronic prescription substances, where the computer or PDA biometric readers will be used in application providers and practitioners is located in a known, controlled healthcare settings, DEA believes it is that the biometric subsystem being location, or be built directly into the reasonable to allow for such technology used, in fact, meets DEA’s requirements. practitioner’s computer or PDA that he because the technology is likely to NIST currently lists technologies which uses to issue electronic prescriptions for improve. The HIMSS 2009 security it has tested and their rates of controlled substances. survey indicated that 19 percent of the performance at the following URLs: This criterion is intended to add to 196 healthcare systems surveyed use http://fingerprint.nist.gov for fingerprint the security of the biometric factor by biometric technologies as a tool to testing, http://face.nist.gov for facial physically controlling access to the provide security for electronic patient testing, and http://iris.nist.gov for iris biometric device to reduce the potential data; the HIMSS 2009 leadership survey testing. for spoofing. of larger healthcare systems found that • The biometric subsystem must • The biometric subsystem must store 18 percent used biometrics as a tool to conform to Personal Identity device ID data at enrollment (i.e., provide security for electronic patient Verification authentication biometric biometric registration) with the data, but 36 percent indicated that they acquisition specifications, pursuant to biometric data and verify the device ID intended to do so.16 The 2009 security NIST Special Publication 800–76–1, if at the time of authentication. survey also found that 33 percent of the they exist for the biometric modality of Within this context, enrollment is the systems already use two-factor choice. process of collecting a biometric sample authentication for security. This requirement specifies minimum from a new user and storing it (in some DEA is establishing several requirements for the performance of the format) locally, on a network, and/or on requirements for the use of biometrics, device that is used to acquire biometric a token. These enrolled data are stored data (usually an image), whereas the 16 Healthcare Information and Management prior requirements relate to the software 17 National Institute of Standards and Systems Society. 2008 HIMSS Security Survey, used to compare biometric samples to Technology. Special publication 800–76–1, October 28, 2008. HIMSS, 20th Annual 2009 HIMSS Biometric Data Specification for Personal Identity Leadership Survey, April 6, 2009. http:// determine if a user is who he claims to Verification, January 2007. http://csrc.nist.gov/ www.himss.org. be. NIST Special Publication 800–76– publications/PubsSPs.html.

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for the purpose of future comparisons testing is similar to the third-party application providers to find the when someone (whether the genuine audits or certifications of the electronic biometric application that best meets user or an impostor) attempts to log in. prescription and pharmacy applications their needs. To help ensure that log-in attempts are DEA is also requiring. Testing of the DEA recognizes the need for being initiated by the genuine user (as biometric subsystem must have the assurance that a captured biometric opposed to a spoofed biometric), this following characteristics: sample is obtained from a genuine requirement in combination with the • The test is conducted by a user—and not a spoofed copy, above requirement increase the laboratory that does not have an interest particularly in unattended applications difficulty for an impostor to spoof a in the outcome (positive or negative) of such as electronic prescriptions for biometric and remotely issue an performance of a submission or controlled substances, where many unlawful prescription. biometric. users may have access to computers that • The biometric subsystem must DEA wishes to ensure that the testing contain electronic prescription protect the biometric data (raw data or body is independent and neutral. As applications. Liveness detection is a tool templates), match results, and/or non- noted previously, tests may be that some biometric vendors have match results when authentication is conducted by NIST, or DEA may developed to address this issue. not local. approve other government or However, since this is an active area of • If sent over an open network, nongovernment laboratories to conduct research that has not been standardized, biometric data (raw data or templates), these tests. DEA is not setting a specific match results, and/or non-match results • Test data are sequestered. requirement for liveness detection at must be: • Algorithms are provided to the this time, but will reconsider this tool Æ Cryptographically source testing laboratory (as opposed to scores). in the future as industry standards and authenticated; To the extent possible, independent specifications are developed. Æ Combined with a random testing should provide an unbiased DEA emphasizes that the use of challenge, a nonce, or a timestamp to evaluation of its object of study, which biometrics as one factor in the two- prevent replay; should yield repeatable, generalizable factor authentication protocol is strictly Æ Cryptographically protected for results. The above two requirements voluntary, as is all electronic integrity and confidentiality; reflect the principle behind prescribing of controlled substances. As Æ Sent only to authorized systems. independent testing. If test participants noted previously, DEA wishes to The above requirements are to ensure had access to the test data used in an emphasize that these standards do not the security and integrity for this evaluation, they would have the specify the types of biometrics that may authentication factor (a biometric), opportunity to tune or augment their be acceptable. Any biometric that meets ensuring any data related to the algorithms to maximize accuracy on that the criteria specified above may be used biometric subsystem (biometric patterns data set, but would likely fail to give a as the biometric factor in a two-factor and results of comparisons) are sent fair assessment of the algorithm’s authentication credential used to from an authorized source to an performance. Therefore, test data should indicate that prescriptions are ready to authorized destination and that the not be made public before the testing be signed and sign controlled substance message was not tampered with in period closes, and if test data are prescriptions. DEA, after extensive transit. Additionally, cryptographic sequestered, algorithms must be consultation with NIST, has written protection of the biometric data provided to the independent testing these criteria to be as flexible as possible addresses an aspect of the user’s laboratory for the experiment(s) to be to emerging technologies, allowing new interests in confidentiality of personal conducted. Additionally, the latter biometrics systems to develop in the data. requirement permits the independent future that meet these criteria. The easiest way to meet the above testing laboratory to produce the results Because the use of biometrics and the requirements when authentication is not itself that are ultimately used to standards related to their use were not local is to run a client authenticated characterize performance. discussed in the notice of proposed TLS connection or a similar protocol • The operating point(s) rulemaking, DEA is seeking further between the endpoints of any remote corresponding with the false match rate comment on these issues. Specifically, communication carrying data subject to specified (0.001), or a lower false match DEA is seeking comments in response to the above requirements. Another rate, is tested so that there is at least the following questions: possible solution that may be used is 95% confidence that the false match • What effect will the inclusion of server authenticated TLS in and non-match rates are equal to or less biometrics as an option for meeting the combination with a secure HTTP cookie than the observed value. two-factor authentication requirement at the client that contains at least 64 bits As discussed above, testing should have on the adoption rate of electronic of entropy. yield results that are repeatable. The prescriptions for controlled substances, DEA also recognizes that biometrics resulting measurements of an evaluation using the proposed requirements of a application providers have a vested should have a reasonably high degree of password and hard token as a baseline? interest in either selling their reliability. A confidence level of 95% or Do you expect the adoption rate to applications directly to practitioners or greater will characterize the values from significantly increase, slightly increase, electronic prescription application an evaluation as reliable for this context. or be about the same? Please also providers, or partnering with those • Results are made publicly available. indicate why. electronic prescription application The provision of testing results to the • Is there an alternative to the option providers to market their applications. public, either through a Web site or of biometrics which could result in Therefore, as discussed above, to other means, will help to ensure greater adoption by medical provide practitioners and electronic transparency of the testing process and practitioners of electronic prescriptions prescription application providers with of the results. Such transparency will for controlled substances while also an objective appraisal of the biometrics provide greater opportunity for providing a safe, secure, and closed applications they may purchase and interested electronic prescription system for prescribing controlled use, DEA is requiring independent application providers and others to substances electronically? If so, please testing of those applications. This compare results between biometrics describe the alternative(s) and indicate

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how, specifically, it would be an • What other benefits have been believed, the requirements according to improvement on the authentication realized? this new draft SP 800–63–1 could be requirements in this interim rule. Comments. A practitioner implemented more easily. Also, based on the comments organization recommended that the DEA Response. DEA has revised this received, it appears that a number of second factor be eliminated when a rule to allow the use of a hard token that commenters may have already biometric authentication device is used. is separate from the computer being implemented biometrics as an DEA Response. DEA believes that any accessed and that meets FIPS 140–2 authentication credential to electronic authentication protocol that uses only Security Level 1 security or higher. applications. DEA is seeking one factor entails greater risk than a Proximity cards that are smart cards information from commenters on their two-factor authentication protocol. with cryptographic modules could serve experiences implementing biometric While DEA recognizes the strength that as hard tokens. The FIPS 140–2 authentication. DEA seeks the following biometrics provide, biometric readers requirements for higher security levels information: themselves are not infallible. They can generally relate to the packaging of the • Why was the decision made to falsely accept a biometric, or purported token (tamper-evident coatings and adopt biometrics as an authentication biometric, that does not correspond to seals, tamper-resistant circuitry). DEA credential? Why was the decision made the biometric associated with a does not consider this level of physical to adopt biometrics as opposed to particular user. Requiring two-factor security necessary for a hard token. another option? What other options authentication, regardless of the factors Contrary to the intermediary’s were considered? used (Something you know, something statement, NIST SP 800–63–1 does • What are biometrics as an you have, and something you are), require that cryptographic modules be authentication credential used for (e.g., ensures a strong authentication method, FIPS 140–2 validated. NIST SP 800–63– access to a computer, access to which DEA believes is necessary to sign 1 requires the following for one-time- particular records, such as patient electronic prescriptions for controlled password devices: ‘‘Must use approved records, or applications)? substances. block cipher or hash function to • How many people in the practice/ Comments. Some physician and combine a symmetric key stored on institution use biometric authentication pharmacy organizations objected to hard device with a nonce to generate a one- (number and percentage, type of tokens, asserting that they are time password. The cryptographic employee—practitioners, nurses, office inconvenient, impractical, easily lost or module performing this operation shall staff, etc.)? shared, and generally not secure be validated at FIPS 140–2 Level 1 or • What types of biometric enough. They suggested tap-and-go higher.’’ For single-factor and multi- authentication credentials are used (e.g., proximity cards because, they asserted, factor cryptographic tokens at fingerprint, iris scan, hand print)? such cards would be more cost effective. Assurance Level 2 or 3, NIST SP 800– • How are the biometrics read, and These physician organizations further 63–1 requires: ‘‘The cryptographic what hardware is necessary (e.g., noted that hospital security systems module shall be validated at FIPS 140– fingerprint readers built into keyboards may bar the use of certain hard tokens. 2 Level 1 or higher.’’ or mouses, on-screen biometric readers, One application provider indicated that DEA believes that NIST 800–63–1 external readers attached to computers)? it had tried one-time-password devices Assurance Level 3 as described will • Is biometric authentication used by in an application used for electronically meet its security concerns. As discussed itself or in combination with a user ID prescribing noncontrolled substances above, DEA continues to believe that or password? and found they discouraged use of the reliance on passwords alone, as a few • How are biometric readers application. Two large healthcare commenters suggested, would not distributed (e.g., at every computer systems suggested alternative challenge- provide sufficient security in healthcare workstation, at certain workstations response methods as well as biometrics settings where computers are accessed based on location, allocated based on as another approach for closed systems. and shared by staff. Many staff may be number of staff)? Other commenters objected to the able to watch passwords being entered, • Was the adoption of biometrics part requirement for Level 4 security for the and computers may be accessible to of installation of a new system or an hard token. They noted that relatively patients or other outsiders. In addition, addition to existing applications? few devices that are validated by DEA notes that practitioners might find • How long did the implementation Federal Information Processing strong passwords more burdensome process take? Was the time related to Standards (FIPS) meet Level 4. One than a biometric or token over the long implementing biometrics or other application provider stated that DEA’s run. Strong passwords generally need to application installation issues? description in the proposed rule is more be long (e.g., 8–12 characters) with a • Which parts of the biometric like Level 3 with a hard token. It mix of characters, to maintain security. implementation were completed asserted that Level 4 would mean that They also need to be changed frequently without difficulty? any user of the application, not just (e.g., every 60 to 90 days). However, • What challenges were encountered practitioners signing controlled imposing these password requirements and how were they overcome? substance prescriptions, would need would make it more likely that • Were workflows affected during or Level 4 tokens. Some commenters practitioners would simply write down after implementation and, if so, how further asserted that few devices meet passwords, thereby rendering them were they affected and for how long? FIPS 140–2 Security Level 3 for physical useless for purposes of security. In • How do the users feel about the use security. An intermediary stated the contrast to the time limits typically of biometrics as an authentication current NIST SP 800–63–1 draft required for strong passwords, a token credential? definition is different from the original and biometrics can last for years. • Has the use of biometric SP 800–63 definition; the commenter Although initially simpler to authentication improved or slowed indicated that SP 800–63–1 does not implement, passwords impose a burden workflows? If so, how? require that approved cryptographic on the user, who has to remember and • Has the use of biometric algorithms must be implemented in a key in the password, and on the authentication improved data and/or cryptographic module validated under application, which has to reset network security? FIPS 140–2. Thus, the commenter passwords when the user forgets them.

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DEA is not allowing the use of some • Which parts of the implementation organizations. He stated that two-factor combinations. For example, were completed without difficulty? consideration should be given to look-up secret tokens or out-of-band • What challenges were encountered allowing some exemptions for small tokens are not acceptable. Look-up and how were they overcome? practices or physicians who are willing secret tokens, which are something you • Were workflows affected during or to accept some risk from less than ideal have, are often printed on paper or after implementation and, if so, how authentication such as the use of plastic; the user is asked to provide a were they affected and for how long? biometrics as a substitute for • subset of characters printed on the card. How do the users feel about the use cryptographic two-factor authentication Unlike a hard token, these tokens can be of hard tokens as an authentication or use of private keys or other copied and used without the credential? cryptographic secrets protected by • practitioner’s knowledge, undermining Has the use of hard tokens as an software installed on computers in a non-repudiation. Out-of-band tokens authentication credential improved or limited controlled office environment slowed workflows? If so, how? that would allow operation with only send the user a message over a separate • channel (e.g., to a cell phone); the Has the use of hard tokens as an the PIN from a defined set of computers message is then entered with the authentication credential improved data that were shared in a small practice. The password. Although DEA recognizes and/or network security? commenter asserted that the cost of • What other benefits have been that these tokens might work, DEA cryptographic tokens is not large, but a realized? potential barrier nonetheless. doubts if they are practical because they Comments. Practitioner organizations require more time for each DEA Response. As discussed above, asked who will create and distribute DEA is allowing the use of biometrics as authentication than the other options. hard tokens, and how losses, Based on the comments received, it an alternative to hard tokens, as one malfunctions, and application appears that a number of commenters factor in the two-factor authentication downtime will be handled. A physician have already implemented a variety of protocol. DEA disagrees, however, with stated that tokens should be able to hard tokens (e.g., proximity cards, USB allowing an exception from two-factor create keys on the token immediately devices) as an authentication credential authentication for small practices. DEA under user control to speed distribution to electronic applications. DEA is recognizes the constraints on small and replacement that has been such a seeking information from commenters practices, but believes that the interim barrier in pilot work. final rule, which allows Level 3 tokens on their experiences implementing hard DEA Response. Who distributes the tokens as authentication credentials. and biometrics, will make it easier for hard tokens will depend on the small practices. One-factor DEA seeks the following information: application being used. In some cases, • Why was the decision made to authentication, such as a PIN, will not the credential service provider, working adopt hard token(s) as an authentication provide adequate security, particularly in conjunction with the electronic credential? Why was the decision made in a small practice where passwords prescription application provider, may to adopt hard tokens as opposed to may be more easily guessed than in a distribute the hard tokens; in other another option? What other options large practice because the office staff cases, the credential service provider, were considered? will be familiar with the words a • What are hard token(s) as an working in conjunction with the practitioner is most likely to use (e.g., authentication credential used for (e.g., electronic prescription application nickname, favorite team, child’s or pet’s access to a computer, access to provider, may tell the practitioners what name). particular records, such as patient type of token is required (e.g., a smart Comments. A State agency reported records, or applications)? card, thumb drive, PDA), then securely on a vendor that uses a security matrix • How many people in the practice/ register or activate the token. DEA card; prescribers log on using a institution use hard tokens for agrees with the commenter that the password and user ID and then have to authentication (number and percentage, latter scenario would make replacement respond to a challenge that corresponds type of employee—practitioners, nurses, easier because the practitioner could to three interstices on the card. The office staff, etc.)? purchase a new token locally and obtain commenter asserted that the challenge is • What types of hard tokens are used a new credential without having to wait unique to the provider, different every (e.g., proximity cards, USB drives, OTP for the application provider to send a time, and only the card will provide the devices, smart cards)? new token. DEA, however, believes it is correct response. The commenter • Are the hard tokens used by better to provide flexibility and allow asserted that although there are some themselves or in combination with user credential service providers, electronic vulnerabilities, it is simple and IDs or passwords? prescription application providers, and inexpensive. • How are the hard tokens read practitioners to determine how to DEA Response. DEA believes that (where applicable), and what hardware provide and replace tokens when they such devices can be vulnerable as they is necessary (e.g., card readers built into are lost or malfunction. may be physically reproduced and keyboards, external readers attached to Electronic prescription application provided to others, or reproduced and computers)? downtime is not specific to tokens; any used by others without the practitioner’s • How are hard token readers electronic prescription application may knowledge. For that reason, DEA does distributed (e.g., at every computer experience downtime regardless of the not believe that these types of workstation, at certain workstations authentication method used. authentication tokens address DEA’s based on location, allocated based on Practitioners will always have the concerns. Hard tokens are tangible, number of staff)? option of writing controlled substance physical, objects, possessed by a • Was the adoption of hard tokens prescriptions manually. practitioner. Giving this tangible, part of installation of a new system or Comments. A physician stated that physical object to another person takes an addition to existing applications? there are special problems for a specific physical act on the part of the • How long did the implementation physicians in small practices who do practitioner. That act is difficult for the process take? Was the time related to not normally wear institutional practitioner to deny, and thus implementing hard tokens or other identification badges and have tighter strengthens the value of hard tokens as application installation issues? time and budget constraints than large a method of security.

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Comments. A pharmacy association DEA proposed allowing practitioners § 1306.12(b), these dates will also have and an application provider asked to indicate that prescriptions for to appear, consistent with the current whether practitioners would need multiple patients were ready for signing requirement for paper prescriptions. multiple tokens if they used multiple and allow a single signing to cover all DEA emphasizes that although this rule applications. approved prescriptions. allows for one element of the required DEA Response. The number of tokens Comments. A number of commenters controlled substance prescription that a practitioner will need will depend were concerned about the data elements information (the patient’s address) not on the applications and their that must be presented to practitioners to appear on the review screen, the for review. Two application providers requirements. It is possible that multiple controlled substance prescription that is stated that the data elements should be authentication credentials could be digitally signed by either the application stored on a single token (e.g., on a smart limited because too much data will be confusing. They asserted that the or the practitioner and that is card or thumb drive). If a practitioner transmitted must include all of the accesses two applications that require patient’s address is unlikely to be useful to practitioners as patients are usually information that has always been him to have a digital certificate, it is required under 21 CFR part 1306. possible that a single digital certificate identified by name and date of birth; it could be used for both. is unlikely that most practitioners DEA realizes that many application would recognize an address as incorrect. providers will have to update their D. Creating and Signing Electronic They also expressed their view that the applications, but it notes that most Controlled Substance Prescriptions practitioner did not need to see the DEA perform regular updates and upgrades. DEA proposed that controlled registration number associated with the They may choose to incorporate the substance prescriptions must contain prescription. changes required by these regulations as A practitioner organization expressed the same data elements required for part of a regular revision cycle. agreement with the requirement in the paper prescriptions. DEA proposed that, proposed rule that prior to the Comments. A few application as with paper prescriptions, transmission of the electronic providers objected to requiring a review practitioners or their agents would be prescription, the application should of the prescription information by the able to create a prescription. When the show a summary of the prescription. It practitioner prior to signing, stating that prescription was complete, DEA noted that while National Council for this is not required for paper proposed that the application require Prescription Drug Programs (NCPDP) prescriptions. the practitioner to complete the two- SCRIPT provides fields and codes for all factor authentication protocol. The DEA Response. DEA recognizes that it required data, not all are mandatory. In is possible that some applications application would then present at least addition, this commenter indicated the DEA-required elements for review currently in use for the prescribing of some applications do not show all of the noncontrolled substances might not for each controlled substance DEA-required prescription information. require the practitioner to review prescription and the practitioner would The commenter asked how applications prescription data prior to signing. have to positively indicate his approval will be updated and/or modified to meet of each prescription. Prior to signing, the specifications required in the Nonetheless, with respect to the the proposed rule would have required proposed rule. Another commenter, an prescribing of controlled substances, a the practitioner to indicate, with application provider, stated that practitioner has the same responsibility another keystroke, agreement with an developers will have to redesign the when issuing an electronic prescription attestation that he had reviewed the applications at the screen level and at as when issuing a paper prescription to prescription information and the user permission level, which will ensure that the prescription conforms in understood that he was signing the add costs. An insurance organization all respects with the requirements of the prescription. The practitioner would stated that the current NCPDP standards CSA and DEA regulations. This then have signed the prescription for do not accommodate the described responsibility applies with equal force immediate transmission. If there was no process and will have to be revised to regardless of whether the prescription activity for more than two minutes after conform next generation electronic information is entered by the two-factor authentication, the prescribing software to the DEA practitioner himself or a member of his application would have been required to requirements. The commenter believed staff. Whether the prescription for a lock out the practitioner and require that this would create another delay in controlled substance is on paper or in reauthentication to the signing function. the eventual use of electronic electronic format, it would be The first intermediary that received the prescribing for controlled substances. irresponsible for a practitioner to sign prescription would have been required DEA Response. DEA has revised the the prescription without carefully to digitally sign and archive the rule to limit the required data displayed reviewing it, particularly where the prescription. for the practitioner on the screen where prescription information has been 1. Reviewing Prescriptions the practitioner signs the controlled entered by someone other than the substance prescription to the patient’s practitioner. Careful review by the DEA proposed that the application name, drug information, refill/fill practitioner of the prescription present to the practitioner certain information, and the practitioner information ensures that staff or the prescription information including the information. If there are multiple patient’s name and address, the drug prescriptions for a particular patient, the practitioner himself has entered the data name, strength, dosage form, quantity practitioner information and the patient correctly. Doing so is therefore in the prescribed, directions for use, and the name could appear only once on the interest of both the practitioner and DEA registration number under which screen. The refill information, if patient. Electronic prescriptions are the prescription would be authorized. applicable, will be a single number. For expected to reduce prescription errors DEA further proposed to require the Schedule II substances, if a practitioner that result from poor handwriting, but practitioner to indicate those is writing prescriptions indicating the as reports by Rand Health have stated, prescriptions that were ready to be earliest date on which a pharmacy may the applications create the potential for signed. fill each prescription under new errors that result from keystroke

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mistakes.18 Rand Health reported many indicated as being ready to be signed. electronic prescribing applications is electronic prescribing applications are DEA notes that many patients who are variable, and many applications already designed to create a prescription using prescribed controlled substances receive clearly show the user which a series of drop down menus; some of only one controlled substance prescriptions are awaiting signature and the applications do not display the prescription at a time. transmittal (for instance, by displaying information after it is selected so that them in a different frame on the screen 2. Timing of Authentication, Lockout, keystroke errors (e.g., selecting the or in a different color). The commenter and Attestation wrong patient or drug) may be difficult asserted that a requirement that the user to catch. Comments on the proposed DEA proposed that the practitioner take further action to specify the rule from a State Pharmacy Board would use his two-factor authentication prescriptions he/she will sign would be indicate that such keystroke errors do credential to access the review screen. superfluous. occur in electronic prescriptions. Recent The practitioner would indicate those Commenters generally expressed research on electronic prescribing in the prescriptions ready to be signed. Prior to concern about the additional keystrokes United States and Sweden also found signing, DEA proposed that the required to take these steps, stating that that electronic prescriptions have practitioner indicate agreement with the each new keystroke adds to the burden problems with missing and incorrect following statement: ‘‘I, the prescribing of creating an electronic prescription information, which indicates that the practitioner whose name and DEA and discourages use of electronic applications allow prescriptions to be registration number appear on the prescriptions. An insurance transmitted without information in the controlled substance prescription(s) organization stated that the process DEA standard prescription fields.19 A review being transmitted, have reviewed all of proposed would require at least three screen should alert practitioners to these the prescription information listed practitioner confirmations of the problems. DEA notes that a number of above and have confirmed that the electronic prescription. The commenter electronic prescription application information for each prescription is asserted that the more steps in the providers indicated that their accurate. I further declare that by process, the less the workflow applications already meet this transmitting the prescription(s) integration with current electronic practitioner review requirement. information, I am indicating my intent prescribing workflow, and the increased Comments. Practitioner organizations to sign and legally authorize the potential for the reversion to written expressed the view that checking an prescription(s).’’ If there was no activity prescriptions. Another insurance ‘‘all’’ box should be sufficient if a for two or more minutes, the application organization stated the process of practitioner approves all of the would have to lock him out; he would reviewing and signing should be prescriptions displayed, as opposed to have to reauthenticate to the application streamlined. The commenter believed indicating each prescription approved before being able to continue reviewing the process proposed by DEA seemed to individually. Two State agencies, an or signing prescriptions. have five steps with three information technology organization, Comments. DEA received a confirmations. and application providers objected to substantial number of comments on the Commenters were particularly DEA’s proposal to allow signing of timing of authentication and signing, concerned about the 2-minute lockout prescriptions for multiple patients at lockout, and attestation. An application period. They were unsure whether it one time. Some commenters believed provider organization stated that applied to the initial access to the that allowing practitioners to sign delegating prescription-related tasks application or to access to the signing prescriptions for multiple patients at (e.g., adding pharmacy information) to function. A number of application one time posed health and safety risks practitioner staff is a vital step in the providers stated that requiring two- for the patients. Others stated that the prescribing process. The commenter factor authentication to sign the prescriber might not notice fraudulent believed that requiring all such tasks to prescription would be more effective prescriptions in a long list. occur before the practitioner approves and eliminate the need for a lockout; DEA Response. DEA agrees that and signs the prescription would change that is, they advocated making the use allowing practitioners to simultaneously the workflow in practitioners’ offices. of the two-factor authentication issue multiple prescriptions for multiple The application provider recommended synonymous with signing a controlled patients with a single signature that DEA allow for variable workflows substance prescription. One practitioner increases the likelihood of the potential in which ancillary information organization stated that the detrimental consequences listed by the regarding the prescription, such as authentication and lockout could commenters. Accordingly, DEA has which destination pharmacy to send to, interrupt work flows; access to other revised the rule to allow signing of may be completed by the nurse after functions of the electronic medical multiple prescriptions for only a single signing, but all other data specific to the record must be available with the patient at one time. Each controlled medication dispensed be locked down authentication. The application substance prescription will have to be and only editable by the prescribing providers also noted that lockouts are indicated as ready for signing, but a practitioner. Another application easy to implement. single two-factor authentication can provider suggested revising the Those commenters who addressed the then sign all prescriptions for a given requirement for reviewing and attestation statement expressed patient that the practitioner has indicating that a prescription is ready to opposition to it. They emphasized that sign to read: ‘‘* * * where more than a practitioner must comply with the 18 Bell, D.S., et al., ‘‘A Conceptual Framework for one prescription has been prepared at Controlled Substances Act and its Electronic Prescribing,’’ J Am Med Inform Assoc. any one time[,] * * * prior to the time implementing regulations in the 2004; 11:60–70. the practitioner authenticates to the prescribing of any controlled substance. 19 Warholak, T.L. and M.T. Mudd. ‘‘Analysis of community chain pharmacists’ interventions on application, the application must make Some were of the view that the electronic prescriptions.’’ J. Am. Pharm. Assoc. it clear which prescriptions are to be statement did not serve any new 2009 Jan–Feb; 49(1): 59–64. signed and transmitted.’’ This purpose or address any new Astrand, B. et al. ‘‘Assessment of ePrescription commenter expressed the view that requirement. They emphasized that Quality: an observational study at three mail-order pharmacies.’’ BMC Med Inform Decis Mak. 2009 Jan although this may seem like a subtle such a statement is not required for 26; 9:8. distinction, the user interface design of written prescriptions. Commenters

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further stated that they believed it patient’s address must be included in prescription was signed. When a would be an annoyance, and that the prescription data transmitted to the practitioner sends the prescription, the practitioners would not read it, but pharmacy.) Because DEA is requiring prescription is associated with the would simply click it and move on. that the application digitally sign the practitioner. One electronic prescription They also asserted that each additional information required by the DEA application provider objected to the step DEA added to the creation of an regulations at the time the practitioner addition of a field indicating that the electronic prescription made it more signs the prescription, additional non- prescription has been signed and asked likely that practitioners would decide to DEA-required information (e.g., whether the pharmacy could fill the revert to paper prescriptions. Many pharmacy URL) could also be added prescription if the field was not individual practitioners indicated they after signing. (See discussion below.) completed. A standards development found the statement unnecessary and Using two-factor authentication as the organization stated that DEA would demeaning. A few commenters stated signing function eliminates the need for have to request the addition of the field that if DEA believed this was essential, the lockout requirement and, therefore, to NCPDP SCRIPT. Two application it should be a one-time notice, similar this rule contains no such requirement. providers stated that without a to licensing agreements that appear on DEA has revised the rule to eliminate prescription and signature format, there first use of a new application. a separate keystroke for an attestation is no way to verify the signature. A number of organizations stated that statement and adopted the suggestion of DEA Response. DEA is not specifying they believed a better approach would some of the commenters that the by regulation how the field indicating be to present a simple dialog box with statement be included on the screen that a prescription has been signed a clear and short warning that a with the prescription review list. could be formatted, only that such a prescription for a controlled substance Further, DEA has revised the statement field must exist and that electronic is about to be signed. Some suggested displayed. The statement will read: ‘‘By prescription applications must indicate this dialog could have three buttons: completing the two-factor that the prescription has been signed Agree, Cancel, and Check Record. Some authentication protocol at this time, you using that particular field. As DEA commenters also noted that when are legally signing the prescription(s) noted in the NPRM, the field indicating prescribers get prescription renewal and authorizing the transmission of the that the prescription was signed could requests (for noncontrolled substances) above information to the pharmacy for be a single character field that populates in their electronic medical record dispensing. The two-factor automatically when the practitioner applications now they have to minimize authentication protocol may only be ‘‘signs’’ the prescription. DEA is not or temporarily ‘‘cancel’’ the request, completed by the practitioner whose requiring that a signature be check the chart for appropriateness, and name and DEA registration number transmitted. The field is needed to then click yes or no. Commenters appear above.’’ The practitioner will not provide the pharmacy assurance that the believed that the proposed rule does not be required to take any action with practitioner in fact authorized the seem to include this necessary regard to the statement. Rather, the prescription. Although most existing capability. statement is meant to be informative applications may not transmit the DEA Response. DEA has revised the and thereby eliminate the possibility of prescription unless the prescription is rule to limit the number of steps any uncertainty as to the significance of approved or signed, and DEA is making necessary to sign an electronic completing the two-factor that an application requirement, the controlled substance prescription to authentication protocol at that time and pharmacy has no way to determine two. Practitioners will not have to use the limitation on who may do so. The whether the electronic prescription two-factor authentication to access the only keystrokes that the practitioner application the practitioner used to list of prescriptions prior to signing. will have to take will be to indicate write the prescription meets the When they review prescriptions, they approval of the prescription and affix a requirement absent an indication that will have to indicate that each legal signature to the prescription by the prescription was signed. The controlled substance prescription is execution of the two-factor prescription application’s internal audit ready for signing, then, as some authentication protocol. DEA notes that trail is not available to the pharmacist commenters recommended, use their some applications already present who has to determine whether he can two-factor authentication credential to practitioners with a list of prescriptions legally dispense the medication. If a sign the prescriptions. If the information ready to be signed and require their pharmacy receives an electronic required by part 1306 is altered after the approval. For these applications, only prescription for a controlled substance practitioner indicated the prescription the two-factor authentication will be a in which the field indicates that the was ready for signing, a second new step. prescription has not been signed, the indication of readiness for signing will pharmacy must treat this as it would be required before the prescription can 3. Indication That the Prescription Was any written prescription that does not be signed. Signed contain a manual signature as required As discussed previously, DEA has Because the National Council for by DEA regulations. revised the rule to limit the required Prescription Drug Programs SCRIPT The required contents for an data displayed for the practitioner on standard does not currently contain a electronic prescription for a controlled the screen where the practitioner signs field for the signature of a prescription, substance set forth in the interim final the controlled substance prescription to DEA proposed that the prescription rule are the same contents that have the patient’s name, drug information, record transmitted to the pharmacy long been required under the DEA refill/fill information, and the must include an indication that the regulations for all paper and oral practitioner information. The practitioner signed the prescription. prescriptions for controlled substances. requirement in the proposed rule that This indication could be a single As with all regulations issued by any the patient’s address be displayed on character. agency, the DEA regulations are the screen at this step of the process has Comments. An application provider publicly available, every standards been eliminated. (However, consistent organization stated that existing logic in organization and application provider with longstanding requirements for audit trails should cover the has access to them, and all persons controlled substance prescriptions, the requirement for an indication that the subject to the regulations are legally

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obligated to abide by them. If any prescription is based on a need to be assigned by an institutional practitioner organization or application provider able to identify the prescribing to individual practitioners permitted to wants its standard or application to be practitioner. The interim final rule prescribe controlled substances using compliant with the regulations and, allows multiple DEA numbers to appear the institution’s DEA registration, DEA therefore, usable for controlled on a single prescription, if required by notes that the ‘‘validation’’ that some substance prescriptions, they need only State law or regulations, provided that pharmacy applications conduct simply read the regulations and make any the electronic prescription application confirms that the DEA number is in the necessary changes. clearly identifies which practitioner is standard format and conforms to the Comments. A standards organization the prescriber and which is the formula used to generate the DEA asked how the signature field affected supervisor. NCPDP SCRIPT already registration numbers. The validation nurses that act as agents for provides such differentiation. does not confirm that the number is practitioners and nurses at LTCFs who DEA is aware of the issue of internal associated with the prescriber listed on are given oral prescription orders. code numbers held by individual the prescription or that the registration DEA Response. Longstanding DEA practitioners prescribing controlled is current and in good standing. To regulations allow agents of a substances as agents or employees of confirm the actual validity of the DEA practitioner to enter information on a hospitals or other institutions under number, the pharmacy would have to prescription for a practitioner’s manual those institutions’ registrations pursuant check the DEA registration database signature and also permit practitioners to § 1301.22(c). DEA published an using the Registration Validation tool to provide oral prescriptions to Advance Notice of Proposed available at the Office of Diversion pharmacies for Schedule III, IV, and V Rulemaking (74 FR 46396, September 9, Control Web site (http:// controlled substances. Nurses, who are 2009) to seek information that can be www.DEAdiversion.usdoj.gov). If a not DEA registrants, are not allowed to used to standardize these data and to pharmacy has reason to question any sign controlled substances prescriptions require institutions to provide their lists prescription containing special on behalf of practitioners regardless of of practitioners eligible to prescribe identification codes for individual whether the prescription is on paper or controlled substances under the practitioners, it must contact the electronic. Accordingly, whether in the registration of the hospital or other institutional practitioner. LTCF setting or otherwise, nurses may institution to pharmacies on request. DEA recognizes that revisions to the not be given access to, or use, the The problem with special codes for SCRIPT standard to accommodate practitioner’s two-factor authentication individual practitioners prescribing identification codes for individual credential to sign electronic controlled substances using the practitioners prescribing controlled prescriptions for controlled substances. institutional practitioner’s registration substances using the institutional and the DEA-issued identification 4. Other Prescription Content Issues practitioner’s registration, identification number for certain substances used for numbers for maintenance or DEA proposed that only one DEA detoxification and maintenance detoxification treatment, and dates number should be associated with a treatment is that SCRIPT does not before which a Schedule II prescription controlled substance prescription. currently have a code to identify them. may not be filled may not occur Comments. A number of commenters Codes exist that identify DEA numbers immediately as they have to be associated with mid-level practitioners and State authorization numbers; the incorporated into a revision to the stated that some State laws require that fields are then defined to limit them to standard that is subject to the standards a controlled substance prescription from the acceptable number of characters. development process. Application a mid-level practitioner must contain The general standard for the providers will then have to incorporate the practitioner’s supervisor’s DEA identification number field, however, is the new codes into their applications. registration number as well as the mid- 35 characters. It should, therefore, be Because DEA does not want to delay level practitioner’s DEA registration possible for NCPDP to add a code for an implementation of electronic number. Other commenters noted that institution-based DEA number that prescribing of controlled substances for under § 1301.28 a DEA identification allows up to 35 characters, with the first any longer than is necessary to number is required in addition to the nine characters in the standard DEA accommodate the main provisions of the DEA registration number on format; the remaining characters should rule, DEA has added provisions to prescriptions written by practitioners be sufficient to accommodate most §§ 1311.102 (‘‘Practitioner prescribing approved narcotic institutional coding systems until DEA responsibilities.’’), 1311.200 (‘‘Pharmacy controlled substances in Schedules III, and the industry can standardize the responsibilities.’’), and 1311.300 IV, or V for maintenance or format. Similarly, NCPDP should be (‘‘Third-party audits.’’) to address the detoxification treatment. Other able to add a code for the identification short-term inability of applications to commenters stated that the DEA number for maintenance of handle information such as this requirements for paper prescriptions detoxification treatment. Free text fields accurately and consistently. DEA is include, for practitioners prescribing may also need to be used to incorporate requiring that third-party auditors or under an institutional practitioner’s other information required on certain certification organizations determine registration, the special internal code prescriptions; for example, part 1306 whether the application being tested can assigned by the institutional practitioner requires that prescriptions for gamma record, store, and transmit (for an under §§ 1301.22 and 1306.05. These hydroxybutyric acid the practitioner electronic prescription application) or commenters stated that NCPDP SCRIPT must indicate the medical need for the import, store, and display (for a does not accommodate the special prescription; for certain medications pharmacy application) the basic internal codes, which do not have a being used for maintenance or information required under § 1306.05(a) standard format, nor do most pharmacy detoxification treatment, the for every controlled substance computer applications. They also noted practitioner must include an prescription, the indication that the that a pharmacy has no way to validate identification number in addition to his prescription was signed, and the the special internal codes. DEA number. number of refills. Any application that DEA Response. DEA’s concern with On the issue of the inability of cannot perform these functions must not multiple DEA numbers on a single pharmacies to validate the special code be approved, certified, or used for

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controlled substance prescriptions. The association asked DEA to require that should remove the requirement for third-party auditors or certification the prescription include the instant transmission of prescription organizations must also determine practitioner’s phone number and data: Many electronic prescribing whether the applications can perform authorized schedules. applications use processes where these functions for the additional DEA Response. Only a practitioner pending messages are stored and, with information required for a subset of who has issued the prescription to the a fixed periodicity of 10 seconds, prescriptions; currently this information patient for a legitimate medical purpose transmitted to electronic prescribing includes the extension data, the special in the usual course of professional networks. The commenter believed that DEA identification number, the dates practice may sign a prescription. As this requirement might require complete before which a prescription may not be stated above, the requirements for the re-architecting of these processes, which filled, and notes required for certain information on an electronic would create a substantial burden on prescriptions. If a third-party auditor or prescription are the same as those for a electronic prescribing application certification organization reports that an paper prescription. DEA notes that the developers. A chain pharmacy stated application cannot record, store, and NCPDP SCRIPT standard includes a that DEA should allow the prescriber transmit, or import, store, and display field for telephone number, but DEA is the option to put the prescription in a one or more of these data fields, the not requiring its use. If a pharmacist has queue or to immediately transmit. The practitioner or pharmacy must not use questions about a practitioner’s commenter suggested that if opting to the application to create, sign and registration and schedules, the hold in a queue, the prescriber would transmit or accept and process pharmacist can check the registration have to approve prior to sending. If, electronic prescriptions for controlled through DEA’s Web site. however, the prescription is substances that require this information. Comments. One company automatically held in a queue due to Comments. Some commenters stated recommended registering actual written connectivity problems, the prescriber that the requirement that the signatures and associating them with should not be required to re-approve the prescription be dated would remove the electronic prescriptions. A State asked prescription. ability to create several Schedule II that digital ink signatures be recognized A standards organization prescriptions for future filling. and be allowed on faxes; this would DEA Response. DEA does not allow allow people to avoid using recommended extending to long-term practitioners to post-date paper SureScripts/RxHub, which the care facilities (LTCFs) the option prescriptions as some commenters commenter indicated is expensive. allowed to Federal health care agencies seemed to think. Under § 1306.05(a), all DEA Response. DEA does not believe where the prescription may be digitally prescriptions for controlled substances there is any way to allow the foregoing signed and ‘‘locked’’ after being signed must be dated as of, and signed on, the signature methods while providing an by the practitioner, while allowing other day when issued. Under § 1306.12(b), adequate level of assurance of non- facility-determined information, such as practitioners are allowed to issue repudiation. Verification of a manually resident unit/room/bed, times of multiple prescriptions authorizing the written signature depends on more than administration, and pharmacy routing patient to receive up to a 90-day supply the image of the signature. information to be added prior to of a Schedule II controlled substance transmission. The commenter noted that 5. Transmission on Signing/Digitally provided, among other things, the these additional data elements are Signing the Record practitioner indicates the earliest date distinct from the prescription data on which a pharmacy may fill each DEA proposed that the electronic required by § 1306.05(a). The prescription. These prescriptions must prescription would have to be commenter explained that this digitally be dated on the day they are signed and transmitted immediately upon signing. signed version would be archived and marked to indicate the earliest date on DEA proposed that the first recipient of available for audit. The organization which they may be filled. All of these the electronic prescription would have stated that its recommended process requirements can (and must) be satisfied to digitally sign the record as received matches a key aspect of the accepted when a practitioner elects to issue and archive the digitally signed copy. LTCF order workflow, where the multiple prescriptions for Schedule II The digital signature would not be nursing facility reviews each physician controlled substances by means of transmitted to the other intermediaries order in the context of the resident’s full electronic prescriptions. At present, it is or the pharmacy. treatment regimen and adds related not clear that the SCRIPT standard Comments. Some commenters nursing and administration notes. The accommodates the inclusion of these disagreed with the requirement that commenter explained that after review dates or that pharmacy applications can prescriptions be transmitted on signing. and nursing annotation, the prescription accurately import the data. As noted in A practitioner organization and a health is forwarded to the appropriate LTC the previous response, until information technology group supported pharmacy. By requiring that the applications accurately and consistently the requirement, but stated that DEA prescription be digitally signed record and import these data, should word this so the intent is clear immediately after the physician’s applications must not be used to handle that the electronic prescription signature (or upon receipt if the facility these prescriptions. application is to be configured to system is the first recipient of the Comments. One application provider electronically transmit the prescription electronic prescription), this rule could stated that DEA should not include the as soon as it has been signed by the appropriately be extended to non- practitioner’s name, address, and DEA prescriber. They stated that DEA must Federal nursing facilities, enabling them number on the review screen because, make it clear that an electronic to meet existing regulations requiring in some cases, prescriptions are written prescription is not considered to be review of resident medication orders by for one of several practitioners in a ‘‘transmitted’’ unless it has been facility nursing staff prior to practice to sign. This commenter stated successfully received by the pharmacist transmission to the pharmacy. A that with paper prescriptions, there is who will fill the prescription, and an pharmacist organization, whose no indication other than the signature as acknowledgment has been returned to members work in LTCFs and similar to which practitioner signed the the prescriber’s application. An facilities, stated that the rule may be prescription. A State pharmacist application provider stated that DEA impossible to put into operation without

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fundamental changes to pharmacy also. Some commenters thought that record. Unless the record is digitally practice and workflow. Other every intermediary would be required to signed before it moves through the commenters also stated that the digitally sign and archive a copy. A transmission system, practitioners workflow at LTCFs mean that nurses State board of pharmacy said the first would be able to repudiate prescriptions generally enter information about recipient should not have to digitally by claiming that they had been altered prescriptions into records and transmit sign the prescription unless the first during transmission (inadvertently or them to pharmacies. The standards recipient is the pharmacy. The purposefully). The only way to prove organization recommended a responsible pharmacist should have to otherwise would be to obtain (by modification to allow nursing staff at digitally sign the prescription. subpoena or otherwise) all of the audit LTCFs to review, but not change, the An application provider stated that log trails from the intermediaries, prescription before transmission. The the combination of authentication assuming that they retained them. As commenter asserted that this mechanisms, combined with reasonable DEA is not requiring the intermediaries modification would enable consultation security measures by the practice (e.g., to retain records or audit trails, it might with the prescriber regarding potential at a minimum, not sharing or writing not be possible to obtain them. In conflicts in the care of the resident, and down passwords), is sufficient to addition, unless a practitioner was could prevent dispensing of duplicate or prevent abuse. Additionally, this transmitting prescriptions to a single unnecessary controlled medications. commenter indicated, the audit logs pharmacy, the number of intermediaries Further, the commenter asserted that should be sufficient to recognize and involved could be substantial; although this change would resolve a conflict document fraud or forgery. The the practitioner’s application might use between the proposed rule and existing commenter stated that the requirement the same routers to reach SureScripts/ nursing home regulations, which call for for digitally signing the record should RxHub or its equivalent, each of the review of resident medication orders by be dropped. recipient pharmacies may rely on facility nursing staff prior to their DEA Response. DEA has revised the different intermediaries. transmission to the pharmacy. rule to eliminate the need for signing On the issue of having the first and transmission to occur at the same 6. PKI and Digital Signatures recipient digitally sign the DEA- time. Under the proposed rule, the DEA proposed an alternative required information, some commenters application of the digital signature to approach, limited to Federal healthcare asked about the identity of the first the information required under part facilities, that would be based on public recipient. One application provider 1306 would have occurred after key infrastructure (PKI) and digital expressed the view that unless the transmission. Hence, under the signature technology. Under this application provider is the first proposed rule, it was critical that the approach, practitioners would obtain a recipient, it cannot be held responsible information be transmitted immediately digital certificate from a certification for the digital signing and archiving. so that the DEA-required information authority (CA) cross-certified with the Where the first processor is a third-party could not be altered after signature but Federal Bridge CA (FBCA) and use the aggregator, this commenter asserted, it before transmission. Under the interim associated private key to digitally sign should be responsible for complying. final rule, however, the application will prescriptions for controlled substances. An application provider organization apply a digital signature to and archive DEA proposed this approach based on stated that adding a digital signature the controlled substance prescription requests from Federal health care will greatly increase the storage cost of information required under part 1306 agencies that have implemented PKI transaction data. when the practitioner completes the systems. Those agencies noted that the One application provider stated that if two-factor authentication protocol. option DEA proposed for all health care the prescription is created on an Alternatively, the practitioner may sign practitioners did not meet the security Internet-based application, such as one the controlled substance prescription needs of Federal health care agencies. on which the prescriber uses an Internet with his own private key. Because of the Comments. A number of commenters, browser to access the application, the digital signature at the time of signing, including practitioner associations, one prescription would actually be digitally the timing of transmission is less large chain drug store, several electronic signed on the Internet-based application critical. DEA expects that most prescription application providers, and provider’s servers by the prescriber. prescriptions will be transmitted as organizations representing computer Therefore, the initial digital signature soon as possible after signing, but security interests asked DEA to allow archived on the Internet-based recognizes that practitioners may prefer any practitioner or provider to use the prescribing application would be that of to sign prescriptions before office staff digital signature approach, as an option. the prescriber, created using the add pharmacy or insurance information. A pharmacist organization and a hardware cryptographic key, rather than In long-term care facilities, nurses may standards development organization that of the application provider. The need to transfer information to their stated that long-term care facilities commenter indicated that in this case, records before transmitting. By having should be able to use this approach. A the application network provider, rather the application digitally sign and practitioner organization and a than the electronic prescription archive at the point of two-factor healthcare management organization application provider, should digitally authentication, practitioners and stated that the system would be more sign the prescription with its own applications will have more flexibility secure, and prescribers’ liability would digital signature and archive the in issuing and transmitting electronic be reduced, if prescribers could digitally digitally signed version of the prescriptions. sign prescriptions. Three application prescription as received. The DEA does not believe that the security providers preferred applying a commenter asserted that for true ASP mechanisms that the application practitioner’s digital signature rather applications (Web-based applications), provider cited at a practitioner’s office than a provider’s. They stated that the the prescriber is actually digitally would sufficiently provide for non- added burden to the electronic health signing the prescription at the server. It repudiation. DEA disagrees with the record is authentication using smart- is not necessary, this commenter State Board of Pharmacy that the first cards (of a well known format), and that indicated, for the Web-based electronic recipient or the electronic prescription it can wrap the NCPDP SCRIPT prescription application provider to sign application need not digitally sign the prescription in XML-Digital signature

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envelop with a signature using the it was not altered after receipt by the according to PKCS#1 version 2.1 identity of the authenticated user. The pharmacist. (RSASSA–PKCS1-v1_5 and RSASSA– commenters stated that the added An information technology provider PSS) should also be considered as burden to the healthcare provider is the suggested the application allow the end appropriate for electronic prescriptions issuance of a digital certificate that users to choose credential types, for controlled substances. This same chains to the Federal PKI, possibly including PKI and/or One Time commenter asserted that the minimum SAFE Biopharma or possibly extending Password (OTP) credentials, and key sizes for digital signatures should the Federal PIV card. A State pharmacist recommended end users be permitted to meet the requirements specified in NIST organization asked why DEA is in favor use their existing PKI credentials if their SP 800–57 Part 1. of a system that is less secure than the digital certificates met Federal Medium DEA Response. DEA agrees with the one Federal health agencies use. Assurance requirements and are issued practitioner organizations and other Some commenters noted that from a CA that is cross-certified with the commenters that the digital signature although the current system, based on Federal Bridge. The commenter asserted option should be available to any intermediaries, makes use of digital that it is expected that there will be a practitioner or group that wants to adopt signatures difficult, changes in number of service providers who will it and has revised the interim final rule technology may make it feasible in the offer a turnkey PKI service to issue to provide this option to any group. future. In addition, for healthcare digital certificates for non-Federal DEA believes it is important to provide systems with their own pharmacies, a entities that meet these requirements. as much flexibility as possible in the PKI-based approach would be feasible This would lower costs for the overall regulation and accommodate alternative now. An intermediary stated that system and would foster a stronger approaches even if they are unlikely to NCPDP SCRIPT could not accommodate adoption curve for end users because be widely used in the short-term. DEA a digital signature, but other IT they may be able to use a device they notes that a number of commenters, organizations argued that this is not already possess to secure online including a major pharmacy chain, necessarily true. One information accounts. anticipate that once the SCRIPT technology security firm stated that A PKI system designer noted that standard is mature, the intermediaries companion standards to NCPDP SCRIPT digital signatures can be used for any will no longer be needed and standard in XML and HL7, which ought data. Once prescription and pharmacy prescriptions will then move directly to be considered, include the W3C’s applications are using the same version from practitioner to pharmacy as they XML digital signature standard (XML– of SCRIPT the commenter believed there do in closed systems. At that point, the DSig) and the Document Digital will be no need for conversion of PKI/digital signature approach may be Signature (DSG) Profile. Several prescriptions from one software version more efficient and provide security application providers stated: to another. The commenter further benefits. In the short-term, some closed asserted that: systems may find this approach The prescription should be digitally signed * * * prescriptions need not be sent in a advantageous. DEA emphasizes that the using encapsulated XML Digital Signature use of a practitioner digital signature is with XADES profile. The specific profile is format that can be immediately interpreted recognized for optional use by CCHIT [the by a pharmacy computer. It would be optional. DEA is including the option to Certification Commission for Healthcare efficient, but it is not necessary. Free text accommodate the requirements of Information Technology] in S28. This is fully messages can be digitally signed, too. * * * existing Federal systems and to provide specified in HITSP C26 for documents, Free text messages may not be as efficient as flexibility for other systems to adopt the which points at the IHE DSG profile. HITSP NCPDP SCRIPT messages, but they do the approach in the future if they decide C26 and IHE DSG profile uses detached job, just as the scores of faxes or paper-based that it would provide benefits for them. prescriptions do, only better and faster. signatures on managed documents. This Under the interim final rule, using a might be preferred as it would have the least Another information technology firm private key to sign controlled substance impact on the existing data flow, or further noted that digital signatures work for prescriptions will be an option provided profiling could support encapsulation if systems as simple as email and PDF. that the associated digital certificate is necessary. CCHIT S28 is not fully clear and The commenter stated that Adobe obtained from a certification authority has not yet been tested. Acrobat is capable of performing that is cross-certified with the Federal An information technology signature validation and checking for PKI Policy Authority at a basic organization stated that DEA should certificate revocation using either a assurance level or above. The electronic require PKI. The government has a Certificate Revocation List (CRL) or an prescription application will have to highly secure, interoperable digital Online Certificate Status Protocol support the use of digital signatures, identity system for Federal agencies and (OCSP) request. applying the same criteria as proposed cross-certified entities through FBCA. An intermediary further stated that for Federal systems. The private key The commenter asserted that this the FIPS 186–2 Digital Signature associated with the digital certificate system should provide the framework Standard published in January 2000 has will have to be stored on a hard token for DEA’s rule for electronic prescribing some shortcomings that are addressed in (separate from the computer being of controlled substances. The the current draft version FIPS 186–3 of accessed) that meets the requirements commenter believed that it is a widely the standard. The commenter believed for FIPS 140–2 Security Level 1 or available and supported system that these shortcomings relate to the higher. If a practitioner digitally signs a provides the level of security, non- signature schemas. The commenter prescription with his own private key repudiability, interoperability, and asserted that FIPS 186–2 does not and transmits the prescription with the auditability required by legislation support RSA signature schemes digital signature attached, the pharmacy covering the prescribing of controlled according to Public Key Cryptography will have to validate the prescription, substances. The commenter stated that Standard (PKCS) #1 version 2.1, which but no other digital signatures will need such a system would provide strong is a widely used industry standard. The to be applied. (If the practitioner uses evidence that the original prescription commenter indicated that PKCS#1 is his own private key to sign a was signed by a DEA-registered added to the FIPS 186–3 draft for the prescription, the electronic prescribing practitioner, that it was not altered after Digital Signature Standard. Therefore, application will not have to apply an it was signed and transmitted, and that the commenter asserted, signatures application digital signature.) If the

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digital signature is not transmitted, the procedures to guard against theft and long periods and make it difficult to pharmacy or last intermediary will have diversion of controlled substances.21 collect evidence. DEA believes that one to digitally sign the prescription. DEA Accordingly, there is a certain level of business day is sufficient. DEA notes emphasizes that Federal systems will be responsibility that comes with holding a that this is the same length of time free to impose more stringent DEA registration. With that required under the regulations for requirements on their users, as they responsibility comes an expectation of reporting of thefts or significant losses have indicated that they do. due diligence on the part of the of controlled substances.22 As noted in other parts of this practitioner to ensure that information rulemaking, DEA has updated the regarding potential diversion is F. Recordkeeping, Monthly Logs incorporation by reference to FIPS 186– provided to law enforcement 1. Recordkeeping 3, June 2009. authorities, where circumstances so DEA proposed that all records related warrant. This requirement is no less E. Internal Audit Trails to controlled substance electronic applicable in the electronic prescribing prescriptions be maintained for five DEA proposed that an application context than in the paper or oral years. DEA also proposed that the provider must audit its records and prescribing context. In fact, this concern electronic records must be easily applications daily to identify if any might be heightened in the electronic readable or easily rendered into a format security incidents had occurred and context, due to the potential for large- that a person can read. report such incidents to DEA. scale diversion of controlled substances Comments. One application provider Comments. Pharmacy commenters that might occur when a practitioner’s generally objected to the five-year stated that daily audit log checks would electronic prescribing authority has not be feasible and objected to reporting record retention requirement, noting fallen into unauthorized hands or is that they are required to retain paper incidents as no parallel requirement otherwise being used inappropriately. prescriptions for only two years. exists for paper prescriptions. The Comments. An application provider Commenters believed that the added application provider stated that organization and two application SureScripts/RxHub transmission providers asked how security incidents retention time conflicted with many standards should address all security should be reported. A healthcare system State pharmacy laws and regulations. concerns. had concerns about reporting an They also believed there would be DEA Response. DEA disagrees with incident before it could be investigated. additional costs for purchase of added this commenter. At the July 2006 public Another healthcare system requested storage capacity. Some electronic hearing,20 application providers stated further clarification and detail prescription application providers that their applications had internal surrounding the documentation expressed their view that 21 U.S.C. 827 audit trails and they suggested that the requirements for findings and reporting limits the applicability of DEA audit function provided security and of suspicious activity. A number of recordkeeping requirements solely to documentation. In the HIMSS 2009 commenters recommended differing registrants. Accordingly, they believed Security Survey 83 percent of reporting periods from the end of the that DEA has no statutory authority to respondents reported having audit logs business day to 72 hours. impose recordkeeping requirements on for access to patient records. The DEA Response. At this time, DEA is application providers or intermediaries. requirement for an internal audit trail not specifying by rule how a security Some of the commenters also stated should, therefore, not impose any incident should be reported. they believed that 21 U.S.C. 827(b) does additional burden on most application Accordingly, practitioners have several not give DEA statutory authority to providers. DEA is requiring the options, including providing the require registrants to maintain records application provider to define auditable information to DEA by telephone or for more than two years. Finally, with events and run a daily check for such email. If DEA finds over time that respect to the statutory recordkeeping events. DEA does not expect that many enough of these reports are being requirements for practitioners, some such auditable events should occur. submitted to merit a standard format, commenters stated they believed that When they do occur, the application DEA may develop a reporting form in the recordkeeping provisions are limited must generate a report for the the future. As DEA and registrants gain to the two sets of circumstances set forth practitioner, who must determine experience with these incidents, DEA at 21 U.S.C. 827(c)(1)(A) and (B). They whether the event represented a security will be able to provide guidance on the stated that if they were required to problem. DEA notes that only one specific information that must be electronically store other data, such as application provider who commented included in the reports. In general, the that relating to identity proofing and on the NPRM had concerns regarding security incidents that should be transmissions with the digital signature this requirement. The SureScripts/ reported are those that represent and the monthly reports, this would RxHub transmission standards provide successful attacks on the application or result in overhead costs that application no protection for attempts to access a other incidents in which someone gains providers might not find relevant to the practitioner’s application. unauthorized access. These should be delivery of patient care and thus Although practitioners are not reported to both DEA and the spending time developing such expressly required under the DEA application provider because a databases would have no value to the regulations to report suspected successful attack may indicate a delivery of patient care. Commenters diversion of controlled substances to problem with the application. noted that these requirements are not DEA, all DEA registrants have a duty to DEA recognizes the concern about part of the paper process and questioned provide effective controls and reporting incidents before the why DEA would introduce it here. practitioner or application provider has Commenters indicated that if five years 20 Transcripts, written comments, and other had a chance to investigate. DEA’s of transactional data must be stored information regarding DEA’s public meeting to experience with theft and loss reporting, electronically for immediate retrieval, discuss electronic prescriptions for controlled however, indicates that waiting for the cost to the application provider will substances, held in conjunction with the Department of Health and Human Services, may be investigation may delay reporting for be prohibitive. If offline or slower found at http://www.DEAdiversion.usdoj.gov/ ecomm/e_rx/mtgs/july2006/index.html. 21 21 CFR 1301.71(a). 22 21 CFR 1301.76(b).

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means of data storage retrieval are issue controlled substance prescriptions should allow noncontrolled prescription required, the cost to the application electronically. drug activity to be reviewed and provider will be drastically reduced Although DEA had proposed having archived in the same manner so as not while still providing data to the the first intermediary store the record, to duplicate work for the physician. after taking into consideration the Administration in a timely manner. Other practitioner groups and comments received to the NPRM, DEA Finally, a State health care agency asked application providers opposed the that all records handled by decided that this approach risked losing the records. The practitioner can requirement that the practitioner review intermediaries should be easily sorted, the monthly log check because such should provide a clear audit trail, and determine, through audit or certification review is not required for paper should be available to law enforcement. reports, whether an electronic prescriptions and because, these DEA Response. In response to the prescribing application meets DEA’s requirements, but it may be difficult for commenters asserted, it would be comments, DEA has in the interim final difficult to do without cross-checking rule changed the record retention period the prescribing practitioner to ensure patient records. An application provider from that set forth in the proposed rule that an intermediary meets DEA’s stated that DEA does not have the to two years, which is parallel to the requirements if the first intermediary is authority to require the monthly log as requirement for paper prescriptions. a different firm, as it often is. 21 U.S.C. 827(c)(1) exempts Although DEA has revised the Intermediaries may change or go out of practitioners from keeping prescription requirement, it should be noted that if business, destroying any records stored; the State in which the activity occurs intermediaries may also subcontract out records. Some commenters mistakenly requires a longer retention period, the some of the functions, further assumed that pharmacies would be State law must be complied with in attenuating controls. generating the logs and that practitioners would have to review addition to, and not in lieu of, the 2. Monthly Logs requirements of the Controlled multiple logs each month; they opposed DEA proposed that the electronic Substances Act. the requirement on that basis. An prescription application would have to application provider and a State agency With respect to the issue of placing generate, on a monthly basis, a log of all certain recordkeeping responsibilities expressed doubt about the benefits of controlled substance prescriptions the requirement given the number of on application providers, which are issued by a practitioner and provide the nonregistrants, the following prescriptions that might be in an log to the practitioner for his review. individual practitioner’s monthly log. A considerations should be noted. While DEA further proposed that the the express recordkeeping requirements few commenters suggested that DEA practitioner would be required to review should enhance the log requirement to of the CSA (set forth in 21 U.S.C. 827) the log, but would not be expected to apply only to registrants, DEA has require the electronic prescription cross-check it with other records. As application to generate the logs every authority under the Act to promulgate DEA explained in the NPRM, the ‘‘any rules, regulations, and procedures week (rather than every month, as was purpose of the log review was to proposed). One application provider [that the agency] may deem necessary provide a chance for the practitioner to said that any log requirement would and appropriate for the efficient spot obvious anomalies, such as discourage electronic prescribing. execution of [the Act].’’ (21 U.S.C. prescriptions for patients he did not see, Several commenters stated that the 871(b)). DEA also has authority under for controlled substances he did not check would not enhance non- the Act ‘‘to promulgate rules and prescribe, unusual numbers of regulations * * * relating to the * * * prescriptions, or high quantity of drugs. repudiation. A practitioner organization control of the * * * dispensing of The practitioner would have to indicate and a practitioner said that many controlled substances.’’ (21 U.S.C. 821). that he had reviewed the log. providers would be worried about their The requirements set forth in the Comments. Commenters were divided liability if they fail to detect fraud. interim final rule relating to on the viability and necessity of the log These commenters suggested that the recordkeeping by nonregistrant provision. Several practitioner regulations should protect unintentional application providers are being issued organizations and one application failure to detect fraud and the purpose pursuant to this statutory authority. As provider stated that logs should be of the logs should be exclusively to help stated in the interim final rule, for the available for review, but opposed the physicians recognize fraud if they are purpose of electronic prescribing of requirement that practitioners confirm able to do so, but without penalty for controlled substances, DEA registrants the monthly logs. A long-term care failures to catch errors if a good faith may only use those applications that facility organization stated the log review and signature were performed. comply fully with the requirements of would be useful for detecting increased Another practitioner organization stated the interim final rule. prescribing patterns. It, however, said that DEA did not detail the It should also be noted that DEA is the brief review proposed was too short practitioner’s ultimate responsibility to not requiring practitioners to create a and that the review should be review and approve the information in copy of a prescription or a new record; reimbursable under Medicare. Other the logs, the manner and timeframe in it is requiring the practitioner to use an commenters stated that without which the review must be completed, or application that stores a copy of the checking the patients’ records, it is the practitioner’s liability for failing to digitally signed record and retains the unclear how this would increase the review the log. The commenter asserted record for two years. These records will likelihood of identifying diversion. The that this obligation, as well as the other be stored on an application service State agency said the rule did not requirements, seems to create a new provider’s servers if the practitioner is definitively state the mechanism for the practice standard that places more using an application service provider to review. A healthcare system stated that responsibility, and thus increased prescribe or on the practitioner’s it would be helpful if DEA would liability, for proper implementation of computers for installed applications. provide further clarification the law on practitioners. In addition, DEA further notes that the electronic surrounding the type of information that this commenter expressed the view that prescribing of controlled substances is would need to be maintained. This there is a need to specify the voluntary; no practitioner is required to commenter further asserted that DEA confidentiality of all such records,

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including who has access and under log, as well as the monthly logs, be requirement not to alter prescription what circumstances. sortable at least by patient name, drug information during transmission applies A State board of pharmacy said that name, and date of issuance. to actions by intermediaries. It does not a review of prescription monitoring With respect to 21 U.S.C. 827, it is apply to changes that occur after receipt records should be accepted as a true that this provision sets forth the at the pharmacy. Changes made by the substitute. Several commenters asked statutorily mandated recordkeeping pharmacy are governed by the same that the review be done electronically. requirements for DEA registrants. laws and regulations that apply to paper A State agency stated that DEA should However, this provision does not prescriptions. Again, any applicable prohibit the practitioner from delegating preclude DEA from requiring that State laws must also be complied with. the review to members of his staff. practitioners who elect to prescribe As for changes by intermediaries during DEA Response. DEA continues to controlled substances electronically use transmission, DEA is limiting only believe that the monthly log applications that meet certain standards changes to the DEA-required elements requirement serves an important designed to reduce the likelihood of (those set forth in 21 CFR part 1306). An function in preventing diversion of diversion. In this same vein, nothing in intermediary could add information controlled substances. In view of the 21 U.S.C. 827 precludes DEA from about the practitioner other than his comments, however, DEA has modified requiring that practitioners, when name, address, and DEA registration the requirement to lessen the burden on electronically prescribing controlled number or about the patient, other than practitioners. Specifically, under the substances, use applications that, among name and address. Alteration during interim final rule, as in the proposed other things, maintain records that the transmission would be identified by rule, the electronic prescription agency reasonably concludes are comparing the digitally signed application will be required to generate, necessary to ensure proper prescription retained by the electronic on a monthly basis, a log of all accountability. As stated at the outset of prescription application and the controlled substance prescriptions this preamble, DEA has broad statutory digitally signed prescription retained by issued by a practitioner and authority to promulgate any rules and the pharmacy. automatically provide the log to the regulations that the agency deems practitioner for his review. However, necessary and appropriate to controlled 2. Printing After Transmission and DEA has eliminated from the interim against diversion of controlled Transmitting After Printing final rule the requirement that the substances or to otherwise efficiently DEA proposed that if a prescription is practitioner mandatorily review each of execute the agency’s functions under transmitted electronically, it could not the monthly logs. DEA believes this 23 the CSA. be printed. If it was printed, it could not strikes a fair balance in the following be transmitted electronically. respects. Maintaining in the rule the G. Transmission Issues requirement that the application supply DEA proposed that the information Comments. A number of commenters the practitioner with the monthly log required under part 1306 including the raised issues related to this requirement. will ensure that all practitioners receive full name and address of the patient, A standards development organization the logs on a regular basis without drug name, strength, dosage form, noted that in some cases electronic requiring practitioners to expend extra quantity prescribed, directions for use, prescriptions may be cancelled, for time and effort to request the logs. As a and the name, address, and registration example when a transmission fails. In practical matter, this will result in more number of the practitioner must not be such cases, the commenter believed practitioners actually receiving the logs altered during transmission; it could be retransmission should be allowed. and, in all likelihood, more practitioners reformatted. Pharmacies and pharmacy organizations actually reviewing logs than would be stated that if transmission fails, the the case if practitioners had to 1. Alteration During Transmission practitioner should be able to print the affirmatively request each time that the Comments. Many commenters prescription. Practitioner organizations application send the log. The more misinterpreted this requirement to mean suggested the following language: ‘‘If practitioners review the logs, the more pharmacies would not be able to electronic transmission is prevented by likely it will be that they will detect, substitute generic versions for brand weather, power loss, or equipment without excessive delay, any instances name versions as is allowed under many failure, or other similar system failure, of fraud or misappropriation of their State laws. One application provider prescriptions may be faxed to the two-factor authentication credentials. organization suggested that the rule pharmacy or printed.’’ A healthcare Such early detection will allow for state that no changes are allowed on the organization stated that the rule does earlier reporting by the practitioner of medication segment and an application not define processes for transmission these transgressions and thereby more provider could only augment the failures. The commenter asked if a quickly cut off the unauthorized user’s segments of the prescription pertaining second prescription is issued because access to electronic prescribing of to transaction, transaction source, the first was not received, how it would controlled substances. Ultimately, this patient, or physician. Further, this be clear that the first was cancelled. is likely to result in fewer instances of commenter suggested, the application Many commenters, including pharmacy diversion of controlled substances and provider would not be able to edit any organizations, practitioner less resulting harm to the public health existing data. A healthcare organization organizations, and electronic and safety. asked how alteration of content is prescription application providers, DEA is also maintaining in the identified (e.g., according to FIPS 180– stated that DEA should allow printing of interim final rule the requirement that 2). a copy of the electronically transmitted the application be able to generate a log, DEA Response. DEA has revised the prescription if it is clearly labeled as a upon request by the practitioner, of all rule to clarify that the content of the copy. They noted that copies are often electronic prescriptions for controlled required information must not be needed for insurance files and medical substances the practitioner issued using altered ‘‘during transmission between records; patients may be given a receipt the application over at least the the practitioner and pharmacy.’’ The listing all prescriptions written. Long- preceding two years. As was proposed, term care organizations also stated that the interim final rule requires that this 23 21 U.S.C. 821, 871(b). these printed prescriptions were

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necessary for medication administration through these regulations to dictate to containing the ID tags of the script records. intermediaries that certify electronic message. Those ID tags could then be DEA Response. DEA had noted in the prescription applications and pharmacy later confirmed against the SCRIPT preamble of the NPRM that transmitted applications for interoperability what to transaction when connectivity is prescriptions could be printed for cover in their certification requirements. resumed. The commenter believed that medical records and other similar DEA does not consider it advisable to if DEA does not allow faxing by the needs. DEA agrees with the commenters include, as part of its regulations, intermediary, a unique workflow will be that such a statement should appear in references to particular functions in the necessary for controlled substance the regulatory text and has revised the SCRIPT standard, or any other standard, transaction errors not required for interim final rule to allow printing of a as these standards are constantly legend drugs. copy of a transmitted prescription, evolving. One State Board of Pharmacy stated receipt, or other record, provided that Comments. A healthcare organization that it had found many problems with the copy is clearly labeled as a copy that suggested a requirement for the electronic prescriptions. Among the is not valid for dispensing. The copy receiving pharmacy to provide problems this State Board reported was should state, as recommended by confirmation back to the prescriber’s that even when pharmacies are able to commenters, that the original application. The commenter suggested receive electronic prescriptions, their prescription was sent to [pharmacy that the confirmation may then be applications do not necessarily read name] on [date/time] and that the copy printed and given to the patient, thereby electronic prescriptions accurately. Data may not be used for dispensing. Printed providing documentation to entered by a practitioner may be copies of transmitted prescriptions may demonstrate that the patient’s truncated in the pharmacy application not be signed. prescription has been successfully or moved to another field. These DEA has also added a provision that transmitted to the patient’s pharmacy. statements were echoed by a State the application may print a prescription DEA Response. Based on the pharmacist association. for signing and dispensing if comments, DEA does not believe that a One application provider asked if transmission fails. DEA will require that requirement for a return receipt that faxed electronic prescriptions can these original prescriptions include a would be provided to the patient would continue to be treated as oral note to the pharmacy that the be reasonable because it would reduce prescriptions. prescription was originally transmitted the flexibility of the system. It would DEA Response. A faxed prescription to a specific pharmacy, but that the force the practitioner to write and is a paper prescription and, therefore, transmission failed. DEA considers this transmit the prescription while the must be manually signed by the warning necessary because it is possible patient was still in the office. DEA does prescribing practitioner registered with that the practitioner will be notified of not have a similar requirement for oral DEA to prescribe controlled substances. a failure while the application is still or facsimile transmissions of paper If an intermediary cannot complete a attempting to transmit the prescription. Schedule III, IV, and V prescriptions transmission of a controlled substance The warning will alert the pharmacy to and does not believe that this is prescription, it must notify the check its records to be certain a later warranted or necessary. In addition, as practitioner in the manner discussed transmission attempt had not commenters made clear, it is not always above. Under such circumstances, if the succeeded. If the printed prescription is possible to access a transmission system prescription is for a Schedule III, IV, or to be used for dispensing, it must be at a particular point in time. V controlled substance, the practitioner manually signed by the prescribing can print the prescription, manually 3. Facsimile Transmission of practitioner pursuant to § 1306.05(a). As sign it, and fax the prescription directly Prescriptions by Intermediaries the printed prescription contains to the pharmacy. DEA recognizes that information regarding the prior DEA proposed that intermediaries not all pharmacies are currently capable transmission, this information will be could not convert an electronic of receiving fully electronic retained by the pharmacy. prescription into a fax if transmission prescriptions and that there may be Comments. A commenter failed. They would be required to notify other transmission issues; however, it recommended retaining the proposed the practitioner, who would then have would be incompatible with effective language, but allowing the use of the to print and manually sign the controls against diversion to allow SCRIPT CANCEL transaction. The prescription. unsigned faxes of controlled substance commenter believed this would allow Comments. A standards development prescriptions to be generated by the application to either print the organization, several electronic intermediaries. As the commenters prescription or transmit it to another prescription application providers, and indicated, most of the reported pharmacy. It noted that most vendors a pharmacy chain stated that transmission problems have to do with have not implemented support of this intermediaries should be able to convert the lack of a mature standard for transaction. The commenter electronic prescriptions to faxes if the electronic prescriptions and the number recommended that intermediaries that intermediaries cannot complete the of pharmacies that are not accepting certify electronic prescription transmission. One electronic electronic prescriptions. A number of applications and pharmacy applications prescription application provider stated commenters indicated that they for interoperability should have to test that 20 percent of its transmissions need anticipate that the need for and verify that vendors support the to be converted to facsimile because of intermediaries will disappear once the message before they are certified to pharmacy technology problems. An standard is mature. At that point, the accept controlled substances application provider organization stated issue of faxes will also be eliminated. As prescriptions. that DEA is requiring that the for the comment about treating faxed DEA Response. DEA agrees that if a prescription be digitally signed, so the electronic prescriptions as oral transmission fails or is canceled, the prescription would have been signed. In prescriptions, this practice is not practitioner will be able to print the the case of a temporary communication allowed under DEA’s regulations as the prescription or transmit it to another outage between physician and commenter seemed to believe. To pharmacy. DEA, however, does not pharmacy, the commenter suggested reiterate, the regulations have always believe it is appropriate to attempt that the pharmacy could receive a fax required that a facsimile of a Schedule

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III, IV, or V prescription be manually and the dispensing pharmacy. and the pharmacy would archive the signed by the prescribing practitioner. Practitioners and pharmacies have no digitally signed record as proof of the Comments. A State Board of way to determine which intermediaries prescription as received. Pharmacy and a healthcare organization will be used and, therefore, no way to Comments. State pharmacist stated that under New Mexico and avoid intermediaries that do not employ associations and some pharmacy California law it was permissible to good security practices. As a practical application providers asked DEA to electronically generate a prescription matter, once a practitioner purchases an analyze the cost of this requirement. and fax it. One commenter indicated electronic prescription application, the One retail association stated that DEA that New Mexico allows electronic practitioner must accept whatever had not considered that the software prescriptions to be sent ‘‘by electronic transmission routing the application used to create the prescription might not means including, but not limited to, provider employs. Neither the be compatible with digital signatures. A telephone, fax machine, routers, practitioner nor electronic prescription number of pharmacy chains and computer, computer modem or any application provider has any way of pharmacy associations asked DEA to other electronic device or authorized knowing which intermediaries are used explain what regulatory requirements means.’’ A commenter noted that by each of the pharmacies that patients’ would apply to those electronic California, among others, allows for the may designate. prescriptions that occur through direct faxing of controlled substances None of the security measures that are exchanges between practitioners and prescriptions with the text used for transmission address the threat pharmacies (i.e., transmission without ‘‘electronically signed by’’ on the fax. of someone stealing a practitioner’s intermediaries). A chain pharmacy DEA Response. As discussed above, identity to issue prescriptions or of noted that the intermediaries may be under DEA’s regulations, a faxed office staff being able to issue phased out, leaving pharmacies with no prescription is a paper prescription and prescriptions in a practitioner’s name choice but to add digital signature must be manually signed. It is not because of inadequate access controls or functionality. A State Board of permissible to electronically generate authentication protocols. None of the Pharmacy stated that the digital and fax a controlled substance measures address the threat of signature should be validated to ensure prescription without the practitioner pharmacy staff altering records to hide that the record had not been altered. An manually signing it. diversion. Some commenters indicated electronic prescription application 4. Other Issues that they anticipate the elimination of provider stated that it will be very intermediaries once the SCRIPT difficult for the pharmacies to digitally Comments. Several electronic standard is mature and interoperability sign prescriptions in the short run and prescription application providers exists without the need for converting a will require more time. It suggested that stated that DEA had not specified the data file from one software version to the rule include the following characteristics of the transmission statement: ‘‘Until 1/1/2011 pharmacies system between the practitioner and the another so that it can be read correctly. Although DEA is concerned about the can print out and wet sign controlled pharmacy, which could be insecure. possibility that controlled substances drug prescriptions as they arrive, and They recommended that a clear prescriptions could be altered or created archive those paper records for an ‘‘secured’’ communication be used during transmission, it has chosen to acceptable period.’’ A standards between the electronic prescription address those issues by requiring that organization stated that the requirement application and the pharmacy. the controlled substance prescription is would require a major revision of its Commenters recommended that the standard. A healthcare system communications should meet HITSP digitally signed when the practitioner executes the two-factor authentication recommended that DEA include T17 ‘‘Secured Communications reasonable alternatives to proposed Channel’’ requirements. They stated that protocol and when the pharmacy receives the prescription. The only requirements to address record integrity. this is already required, though not This commenter asserted that DEA tested, by the Certification Commission transmission issues that DEA is addressing in the interim final rule should allow flexibility regarding the for Healthcare Information Technology use of digital signatures in systems with today (S28, S29). One State agency concern one common practice—the conversion of prescriptions from one no intermediate processing. recommended requiring end-to-end DEA Response. DEA did analyze the encryption. An electronic prescription software version to another—and one possible practice—the facsimile cost of this requirement in the Initial and pharmacy application provider and Economic Impact Analysis associated an intermediary described their network transmission of prescriptions by intermediaries to pharmacies. As with the notice of proposed security. A practitioner organization rulemaking 24 and included estimates stated that DEA should not over-specify discussed above, DEA will permit intermediaries to convert controlled for the time and costs required to add requirements because other digital signature functionality to specifications exist with which DEA’s substances prescriptions from one software version to another; DEA will existing applications. DEA disagrees requirements must coexist. with the commenters that asserted that DEA Response. DEA has not not allow intermediaries to transform an electronic prescription for a controlled electronic prescribing applications or addressed the security of the the SCRIPT standard are incompatible transmission systems used to transmit substance into a facsimile as many of them do. DEA is also explicitly stating with digital signatures. As a number of electronic prescriptions from commenters noted, any data file can be practitioners to pharmacies, although that any DEA-required information may not be altered during transmission. digitally signed and can be digitally some commenters asked DEA to do so signed without affecting the formatting and others claimed that the security of H. Pharmacy Issues of the file. these systems provided sufficient 1. Digital Signature The interim final rule requires the protection against misuse of electronic pharmacy or the last intermediary to prescriptions. As noted previously, the DEA proposed that either the digitally sign the prescription and the existing transmission system routes pharmacy or the last intermediary prescriptions through three to five routing an electronic prescription 24 http://www.deadiversion.usdoj.gov/fed_regs/ intermediaries between a practitioner should digitally sign the prescription 2008/index.gtml.

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pharmacy to archive the digitally signed would be required unless the receives an electronic prescription for a record. These steps do not alter the data practitioner’s digital signature is controlled substance to check the CSA record that the pharmacy application transmitted to the pharmacy and database in every instance to confirm will read. If the last intermediary validated. Even when intermediaries are that the prescribing practitioner is digitally signs the record, the digital not involved, there is the possibility that properly registered with DEA. signature will be attached to the data an electronic prescription could be Accordingly, DEA has removed this record. Digital signatures, which under intercepted and altered during requirement from the interim final rule. current NIST standards range from 160 transmission. When it becomes feasible It should be made clear that a to 512 bits (which generally equates to for practitioners to transmit electronic pharmacist continues to have a 20 to 64 bytes), would fit within the prescriptions directly to pharmacies, corresponding responsibility to fill only free-text fields that the SCRIPT standard without conversion from one software those prescriptions that conform in all provides (70 characters), or the digital version to another, the PKI option that respects with the requirements of the signature could be linked to the DEA is making available under the Controlled Substances Act and DEA prescription record rather than interim final rule may be an alternative regulations, including the requirement incorporated into the record. If the that more applications and practitioners that the prescribing practitioner be pharmacy digitally signs the choose to use. The primary barrier to properly registered. Pharmacists also prescription record, the issue of this option is the current need to have an obligation to ensure that potential problems with the format will convert prescription information from controlled substance prescriptions not apply. The digitally signed one software version to another during contain all requisite elements, including prescription-as-received record ensures transmission because of interoperability (but not limited to) the valid DEA that DEA can determine whether a issues; conversion of the prescription registration of the prescribing prescription was altered during information from one software version practitioner. If a pharmacy has doubts transmission or after receipt at the to another makes it impossible to about a particular DEA registration, it pharmacy. If the contents of the digitally validate the digital signature on receipt. can now check the registration through signed record at the pharmacy do not When interoperability issues have been DEA’s Registration Validation Tool on match the contents of the digitally resolved, transmitting a digital signature its Web site rather than having to signed record held by the practitioner’s and validating the digital signature may purchase the CSA database.25 electronic prescription application, the be more cost-effective for some prescription was altered during pharmacies. Because of the alternatives 3. Audit Trails transmission. If the record of the DEA is providing for practitioner DEA proposed that pharmacy prescription in the pharmacy database issuance of electronic prescriptions for applications have an internal electronic does not match the digitally signed controlled substances, DEA does not audit trail that recorded each time a record of the prescription as received, believe it is necessary to develop controlled substance prescription was the prescription was altered after alternative approaches that would apply opened, annotated, altered, or deleted receipt. only to those few truly closed systems. and the identity of the person taking the About a third of registered pharmacies DEA notes that it has also made a action. The pharmacy or the application already have the ability to digitally sign number of changes to the proposed rule provider would establish and electronic controlled substance orders that are consistent with the practices implement a list of auditable events through DEA’s Controlled Substances described by the commenters from that, at a minimum, would include Ordering System; the private key used closed systems; for example, DEA is attempted or successful unauthorized for these electronic orders could be used allowing institutional practitioners to access, use, disclosure, modification, or to sign prescriptions upon receipt. conduct identity proofing in-house. destruction of information or Similarly, most applications that move 2. Checking the CSA Database interference with application operations files through virtual private networks or in the pharmacy application. The DEA proposed that pharmacies would that conduct business over the Internet application would have to analyze the be required to check the CSA database have digital signature capabilities. DEA audit logs at least once every 24 hours to confirm that the DEA registration of has not imposed any requirements for and generate an incident report that the prescriber was valid at the time of the source of the digital signatures identifies each auditable event. Security signing. because pharmacies and intermediaries incidents would need to be reported may already have signing modules that Comments. Several commenters within one business day. can be used. Pharmacies that have a objected to this requirement, stating that Comments. A substantial number of Controlled Substance Ordering System pharmacies are not required to check commenters representing pharmacies digital certificate obtained it from DEA. DEA registrations for paper and pharmacy associations objected to In response to the comment on prescriptions unless they suspect the requirement that the audit trail validating the digital signature, the something is wrong with a prescription. document any time a prescription pharmacy or intermediary will be They also stated that the requirement record was viewed, asserting that signing the record; DEA sees no need to would be costly and probably not current applications do not have the ask them to validate their own feasible because the CSA database must capability to track this as opposed to certificate. DEA does not believe that it be purchased and is not up-to-date. is necessary to provide an alternative to Some commenters expressed the view tracking annotations, modifications, and the digital signature because it should that since DEA proposed to have deletions. be possible for either the intermediary electronic prescription application 25 DEA provides a ‘‘Registration Validation’’ tool or pharmacy to apply a digital signature providers check the registration, on its Web site, through which DEA registrants may within a reasonable time. requiring the pharmacy to do so would query DEA’s registration database regarding another On the issue of direct exchanges be redundant. DEA registrant to gather specific information about between a practitioner and a pharmacy, DEA Response. DEA agrees with those that registrant. Information available includes: The registrant’s name, address, and DEA registration two digital signatures (the electronic commenters that expressed the view number; the date of expiration of the registration; prescription application’s or that, when filling a paper prescription, business activity; and the schedules of controlled practitioner’s and the pharmacy’s) it is not necessary for a pharmacist who substances the registrant is authorized to handle.

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DEA Response. In view of the for all pharmacies. The extent to which unless they result in a report to DEA of comments, DEA agrees that the audit a particular event might raise concern at a potential security incident. function does not need to document one pharmacy is not necessarily the Comments. A chain pharmacy every instance in which a prescription same at other pharmacies. For example, asserted that as the record as received record is opened or viewed and has a community pharmacy may want to set will be digitally signed, only a revised the rule accordingly. The different triggers for changes to opioid compromise of the encryption key pharmacy application will only be prescriptions than a pharmacy that should be an auditable event. required to document those instances in serves a large cancer center or a DEA Response. The digital signature which a controlled substance pharmacy that services LTCFs would. A on a record as received does not address prescription is received, annotated, community pharmacy that is closed the concerns that the audit trail and modified, or deleted. In such overnight may want to identify any review are intended to document. The circumstances, the application must change that occurs during the hours digitally signed prescription as received record when the annotation, when it is closed—an event that is not documents the information content of modification, or deletion occurred and a consideration for a pharmacy that is the prescription on receipt. It does not who took the action. open 24 hours a day. The auditable help identify later alterations of the Comments. Several commenters events must, at a minimum, include record; it can show that the record was stated that standards for the automation attempted or successful unauthorized altered later, but not who did it or of capturing auditable events and access, modification, or destruction of when. interpretation of the resulting reports information or interference with Comments. A State asked if have not been published. Commenters application operations in the pharmacy pharmacies should discontinue asserted that many pharmacy application. DEA has dropped the accepting electronic prescriptions if a applications have the ability to track unauthorized ‘‘use or disclosure’’ from security incident occurs. auditable events, but not all have the its list of auditable events. These events DEA Response. In general, it would be ability to generate the reports desired by are included in the CCHIT standards for advisable to discontinue accepting DEA. A number of commenters asked electronic health records and may be electronic prescriptions for controlled DEA to define auditable event and important to pharmacies, but are not substances until the security concerns explain what level of security incident directly relevant to DEA’s concerns. were resolved. However, if, despite the would need to be reported. A chain DEA expects that application security concerns associated with the pharmacy asked DEA to define what providers and developers will work application, the pharmacy is able to constituted an alteration of the record with pharmacies to identify other verify that a prescription has been and to clarify that a generic substitution auditable events. DEA emphasizes that issued lawfully, the pharmacy may fill is not an auditable event. An application providers should define the prescription. application provider asked if auditable auditable events to capture potential events are limited to information security threats or diversion. Changes 4. Offsite Storage changed at the order level (e.g., from brand name drug to a generic DEA proposed that back-up records be administration instructions) or at version of the same drug, for example, stored at a separate offsite location. DEA dispensing (e.g., NDC changed due to do not represent potential security proposed that the electronic record be insufficient quantity). A number of issues. easily readable or easily rendered into a commenters suggested that reporting of Comments. One State recommended format that a person could read and security incidents should be within 2 to that audit trails and event logs should must be readily retrievable. 3 business days. be in a standard format. Comments. Most pharmacy DEA Response. The audit trail and the DEA Response. DEA understands the commenters objected to offsite storage internal auditing of auditable events State’s desire for a uniform format for as costly and not required for paper serve somewhat different purposes. The audit trails and event logs, but in the prescriptions. A pharmacy organization audit trail provides a record of all absence of a single industry-wide stated that back-up copies should be modifications to the prescription record. standard being utilized by pharmacies, transferred off-site weekly, not daily. For example, the audit trail will note DEA does not believe it would be DEA Response. DEA has removed the when the prescription was dispensed appropriate at this time to mandate one requirement for storage of back-up and by whom; it will indicate particular format over others. records at another location. DEA, modifications (e.g., partial dispensing Comments. A pharmacy organization however, recommends as a best practice when the full amount is not available, and pharmacist associations asked if that pharmacies store their back-up changes to generic version). The audit trails and daily audits could be copies at another location to prevent the auditable events, in contrast, are automated. One commenter asked DEA loss of the records in the event of intended to identify potential security to clarify that the records could be kept natural disasters, fires, or system concerns, such as attempts to alter the on existing systems. Another asked if a failures. record by someone not authorized to do pharmacy had to document that the DEA believes that daily backup of so or significant increases in the dosage record had been reviewed. prescription records is an acceptable unit or quantity dispensed without an DEA Response. Audit trails and daily length of time to ensure the integrity of additional annotation (e.g., indicating audits are automated functions that pharmacy records. practitioner authorization). DEA points occur on the pharmacy’s computers and Comments. Several pharmacy chains out that during hearings on electronic that should not require actions on the asked that the functionality for prescriptions, representatives of the part of pharmacists or other pharmacy retrieving records be at the headquarters pharmacy and electronic prescription employees except when a security threat rather than the pharmacy level; they application industries uniformly is identified, which DEA expects to supported the standard of ‘‘readily stressed the audit trails as the basis for occur relatively rarely. The internal retrievable,’’ as DEA proposed, which is the security of their applications. audit trail records must be maintained the same standard that applies to paper DEA does not believe it is feasible to for two years, but DEA is not requiring prescriptions. One State board of define or list every conceivable event that the pharmacy retain a record of its pharmacy stated that the provision for that would constitute an auditable event review of reports of auditable events making the data available in a readable

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format may require extensive to another. Commenters requested that security measures demanded by DEA, it reprogramming. A pharmacist DEA revise the rule to address this was concerned about the ability of association asked DEA to define readily industry practice. independent pharmacies, especially retrievable. One commenter objected to DEA Response. DEA has never those that rely almost exclusively on storing information at pharmacies permitted the transfer of a controlled prescription revenues and not ‘‘front-of- because it could be exposed. substance prescription without the the-store’’ revenues, to cope with the DEA Response. Under the interim involvement of two licensed proposed rule’s added requirements. final rule, it is permissible for a pharmacists, regardless of whether the DEA Response. DEA has revised some pharmacy to have records stored on two pharmacies share a common of the requirements to reduce the headquarters’ computers, but the database. DEA emphasizes that this has burden imposed by this rulemaking, dispensing pharmacy must be able to been a longstanding requirement, one where DEA believes that doing so does retrieve them if requested as they do for which was not proposed to be changed not compromise effective controls computerized refill records allowed as part of this rulemaking. DEA believes against diversion. DEA has also clarified under § 1306.22. DEA does not believe that it is important that two licensed that the third-party audit applies to the that the requirement for readable pharmacists be involved in the transfer application provider, not to the records will impose significant burdens. of controlled substances prescriptions individual pharmacy unless the Similar requirements exist for between pharmacies so that the pharmacy has developed and computerized refill records. In addition, pharmacists are aware that the implemented its own application, a it is unlikely that pharmacy applications prescription is actually being circumstance which, at the present time, would be useable by pharmacists unless transferred. As the dispensing of the is likely limited to chain pharmacies. the data can be provided in an easily prescription is the responsibility of the The audit trail is something that readable form. ‘‘Readily retrievable’’ is pharmacist, DEA believes that it is members of industry stated, prior to the already defined in § 1300.01. Finally, critical that those pharmacists have proposed rule, was the basis for their requirements currently exist for knowledge of prescriptions entering security controls. The pharmacy pharmacies to retain and store their pharmacy for dispensing. Without applications should, therefore, have the prescription records in compliance with this requirement, it would be quite capability to implement this HIPAA requirements to protect feasible for other pharmacy employees requirement. DEA is simply requiring individuals’ personal information. to move prescriptions between that the application identify security pharmacies, thereby increasing the incidents, which should be infrequent, 5. Transfers potential for diversion by pharmacy and that the pharmacy be notified and In the NPRM, DEA confirmed existing employees. take action to determine if the regulations regarding the transfer of Comments. One commenter, a large application’s security was prescriptions for Schedule III, IV, and V pharmacy, believed that while the compromised. This should not be an controlled substances. Specifically, NPRM addressed the transfer of insurmountable burden for a small under § 1306.25(a) a pharmacy is prescription refill information for pharmacy. The other functions required allowed to transfer an original unfilled Schedule III, IV, and V controlled are automated and do not require action electronic prescription to another substance prescriptions, it did not on the part of the pharmacy staff. Most pharmacy if the first pharmacy is unable address the transfer of original of the burden of the pharmacy to or chooses not to fill the prescription. prescriptions that have not been filled. requirements fall on the pharmacy Further, a pharmacy is also allowed to DEA Response. As DEA explained in application provider, not on the transfer an electronic prescription for a the NPRM, the existing requirements for pharmacy. Schedule III, IV, or V controlled transfers of Schedule III, IV, and V Comments. Some commenters stated substance with remaining refills to controlled substances prescriptions that the requirements for paper another pharmacy for filling provided remain unchanged. DEA currently prescriptions include, for practitioners the transfer is communicated between permits the transfer of original prescribing under an institutional two licensed pharmacists. The prescription information for a practitioner’s registration, the specific pharmacy transferring the prescription prescription in Schedules III, IV, and V internal code number assigned by the would have to void the remaining refills on a one-time basis. This allowance institutional practitioner under in its records and note in its records to does not change. DEA wishes to § 1301.22. These commenters stated that which pharmacy the prescription was emphasize that the only changes made NCPDP SCRIPT does not accommodate transferred. The notations may occur to § 1306.25 as part of the NPRM were the extensions, which do not have a electronically. The pharmacy receiving to revise the text to include separate standard format, nor do most pharmacy the transferred prescription would have requirements for transfers of electronic computer applications. They also noted to note from whom the prescription was prescriptions. These revisions were that a pharmacy has no way to validate received and the number of remaining needed because an electronic the extension numbers. refills. prescription could be transferred DEA Response. DEA is aware of the Comments. Several commenters, without a telephone call between issue with extension data and published including three pharmacy chains and an pharmacists. Consequently, the an Advance Notice of Proposed association representing chain drug transferring pharmacist must provide, Rulemaking (74 FR 46396, September 9, stores, all indicated their belief that if a with the electronic transfer, the 2009) to seek information that can be prescription transfer occurs within the information that the recipient used to standardize these data and to same pharmacy chain, only one licensed transcribes when accepting an oral require institutional practitioners to pharmacist is necessary to complete the transfer. provide their lists to pharmacies on transfer if that pharmacy chain uses a request. As discussed above, DEA common database among its 6. Other Pharmacy Issues believes that SCRIPT can be modified to pharmacies. One pharmacy chain noted Comments. An advocacy group stated accept extensions by adding a code that that in many cases, pharmacists do not that although it expects the chain drug indicates that the DEA number is for an call each other to effectuate the transfer stores to be able to handle the institutional practitioner and allowing of the prescription from one pharmacy administrative burden and expense of the field to accept up to 35 characters.

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Pharmacy applications will need to be prescriptions and annually thereafter to assurance to registrants as non- revised to accept the longer numbers; ensure that the application met the compliant application providers would without the extension data, there is no requirements of the rule. DEA sought have an incentive to misrepresent their way to determine who issued the comments on whether alternative audit compliance with DEA regulatory prescription if individual practitioners types were available and appropriate. requirements, and registrants would with the same name are associated with Comments. An application provider have few ways to determine the truth. the institutional practitioner. DEA is not organization stated annual security For example, an application provider requiring pharmacies to validate the audits are unrealistic and will not be could claim that its application required extension numbers unless the performed or enforced. The commenter the setting of logical access controls pharmacist has reason to suspect that asserted that a better use of both DEA when the application, in fact, allowed the prescription or prescribing and application provider resources anyone access regardless of the logical practitioner are not legitimate. would be to write and enforce a set of access controls. Until a practitioner or Comments. A pharmacy organization standards around systems writing. pharmacy discovered that prescriptions asked if a pharmacy that services a DEA Response. Even if DEA had the were being written or altered by Federal healthcare facility would need technical expertise to develop unauthorized persons there would be no to operate separate systems, one for standards, DEA does not believe that reason to suspect a problem with the Federal facilities and one for other imposing an inflexible regulatory application. facilities it serves. It also asked what standard on applications is a reasonable DEA does not have the expertise or facilities were considered Federal approach. Security technologies are the resources to conduct technical healthcare facilities. evolving. Locking applications into a reviews of electronic prescription or DEA Response. As discussed above, specific format that would then have to pharmacy applications. Even if DEA DEA is allowing any application to use be used until the regulation was revised, elected to obtain such expertise, the the digital certificate option proposed a time-consuming process, could delay time required for it to do so and then to for Federal healthcare systems. DEA is implementation of more user-friendly review all of the existing applications not, therefore, imposing any different and efficient applications that may be would delay adoption. requirements on Federal facilities. developed. In addition, most pharmacy DEA believes that a third-party audit Pharmacies may decide whether they applications have been in use for years; approach allows application providers will accept and verify digital signatures forcing them to reprogram in a specified to seek a review as soon as their transmitted with a prescription, whether way could be more costly and applications are compliant, which it was signed by a practitioner at a disruptive than letting each application should make applications available for Federal facility or in private practice. If provider tailor a solution that works for electronic prescribing of controlled a pharmacy does not accept controlled a particular application. DEA is substances sooner than relying on DEA. substance prescriptions digitally signed interested in the end result (a secure Third-party audits, while perhaps new with the individual practitioner’s system that can reasonably be to some prescription and pharmacy private key, it will have to ensure that implemented and is consistent with application providers, are a common it has a digitally signed record of the maintenance of effective controls approach used by the private sector to prescription as received. The rest of the against diversion of controlled ensure compliance with both requirements for annotating and substances), not in the details of how government regulations and private dispensing a controlled substance they are achieved. sector standards. For example, the DEA proposed third-party audits as a prescription are the same for all International Standards Organization way to provide registrants with an electronic prescriptions for controlled (ISO) frequently requires companies to objective appraisal of the applications substances. The determination of obtain a third-party audit to gain they purchase and use. As a number of whether a particular facility is a Federal certification for compliance with its commenters stated, except for 28 facility is not affected by this standards (e.g., ISO 9001, ISO 14001). registrants associated with very large rulemaking. The fourth approach would be to rely practices, large healthcare systems, or on an independent certification I. Third Party Audits chain pharmacies, any of which may organization, such as CCHIT, to test and DEA proposed that both electronic have their own information technology certify electronic prescription and prescription applications and the departments, the majority of registrants pharmacy applications. Under the prescription processing module in cannot be expected to determine, on interim final rule, DEA will allow the their own, whether an application meets pharmacy applications should be certifications of such independent DEA’s requirements. If they are to have subject to a third-party audit that met organizations to substitute for a third- assurance that the application they are the requirements of SysTrust or party audit if the certification process using is in compliance with DEA WebTrust audits (or for pharmacies, clearly determines that the application regulatory requirements, that assurance SAS 70). The standards for these audits being tested is compliant with DEA must come from another source. are established and maintained by the regulatory requirements and clearly As commenters noted, DEA American Institute of Certified Public distinguishes between applications that essentially had to choose among four Accountants.26 27 The audits are are compliant with part 1311 and those possibilities for determining whether an that are not. DEA notes, for example, conducted by CPAs. DEA proposed that application meets the requirements of the application provider would have to that CCHIT currently tests and certifies part 1311: The application provider EHRs against a set of published have the third-party audit for processing could self-certify the application; DEA integrity and physical security before standards and plans to test and certify could review and certify applications; stand-alone electronic prescribing the initial use of the application for an independent certification electronic controlled substance applications. However, at this time, organization could take on that role; or CCHIT does not evaluate pharmacy the application provider could obtain a 26 http://www.ffiec.gov/ffiecinfobase/booklets/ applications. Once any certification audit/audit_06_3_party.html. third-party audit from a qualified 27 http://www.ffiec.gov/ffiecinfobase/booklets/ independent auditor. DEA believes that 28 http://www.iso.org/iso/iso_catalogue/ audit/audit_06_3_party.html. self-certification would not provide any management_standards/certification.htm.

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organization has incorporated tests for logistically. These commenters noted the FBCA for third-party auditors and part 1311 compliance, DEA will work that some clinics that serve as both by the Federal Reserve Bank for its with the organization to determine practitioners and pharmacies will bear examiners and is approved by the whether the process and certification the costs of both sides of the transaction. Department of Defense. DEA believes are sufficient so that a registrant DEA Response. DEA emphasizes that that allowing other certified IT auditors purchasing an application can rely on the requirement for a third-party audit will provide application providers with the certification to ensure that the applies to the application provider, not more options and potentially reduce the application is compliant. Because many to the practitioner or pharmacy that uses cost of the audit. DEA is seeking application providers seek certification, the application. Unless a healthcare comments on the addition of CISA to this approach will reduce costs. DEA system or a pharmacy has developed its the list of permissible auditors. notes, however, that it has not been able own application, it would not be subject Comments. A mail-order pharmacy to identify any independent to the requirement. Healthcare systems said the rule should state that the organization that certifies pharmacy that serve as both practitioner and annual SysTrust or SAS 70 audit meets applications or any that certifies pharmacy may obtain a single third- DEA’s regulatory requirements so that prescription modules at the level of party audit that addresses part 1311 pharmacies passing their most recent detail DEA requires. compliance of the integrated system. audit can begin accepting electronic Comments. Two commenters asserted DEA has taken a number of steps to controlled substance prescriptions. that third-party audits are not a common reduce the cost of the third-party audit. DEA Response. The SysTrust or SAS practice and not required for paper First, recognizing that the electronic 70 audit will be sufficient if the audit prescriptions. prescribing and prescription processing has determined that the application DEA Response. Third-party audits, in functions DEA is requiring may not meets the applicable requirements of this context, address the ability of the change every year, DEA has revised the part 1311. Because the pharmacy electronic prescription application or rule to require an audit whenever an requirements address internal audit pharmacy application to handle application is altered in a way that trails, logical access controls, and the controlled substance prescriptions could affect the functionalities within ability to annotate and retain securely. It is difficult to understand the electronic prescription or pharmacy prescription records, which may be how that concept could be applied to application related to controlled standard functions in existing pharmacy paper prescriptions, where the only substance prescription requirements or applications, it is possible that the issues are whether they are written in every two years, whichever occurs first. existing audit has covered these compliance with the law and Second, DEA has clarified that the functions. The pharmacy and the regulations, properly filed, and whether purpose of the third-party audit is to auditor should review the requirements they have been altered. On a paper determine whether the application of part 1311 and determine whether prescription, the alteration creates meets DEA’s requirements, that is, that compliance has been addressed by the forensic evidence of the change, which the application is capable of performing existing audit. is not necessarily the case with a the functions DEA requires and does so Comments. An intermediary prescription generated using an consistently. Where the application is suggested that certifying organizations electronic application, where the lack of installed on practice or pharmacy such as itself and CCHIT could make the an audit trail or an audit function that computers, the audit will not need to presentation of the audit a condition of has been disabled may eliminate any address the application provider’s certification. An information technology evidence of alterations. physical security nor will it need to organization suggested that DEA might Comments. Many of the commenters address physical security at the practice consider the North American Security on this issue focused on the costs or pharmacy because that will vary with Products Organization (NASPO) associated with third-party audits. One each installation and is beyond the certification as a recognized standard for electronic prescription application control of the application provider. For security products since, the commenter provider that currently obtains a application service providers, the asserted, NASPO certification is SysTrust audit stated that the cost of the physical security of the ASP will need sponsored by the FBI and Secret Service audit for the proposed requirements to be audited. through the Document Security would be considerably less than DEA Third, as discussed above, if Alliance. had estimated. This commenter independent certification organizations DEA Response. DEA notes that the estimated the cost to be ‘‘in the lower develop programs that certify commenter’s existing certification tens of thousands of dollars range’’ applications for part 1311 compliance, process does not address the functions rather than the range of $100,000 to DEA will review their processes to that DEA is requiring, but rather focuses $125,000 that DEA mentioned in the determine whether such certifications on compliance with the SCRIPT NPRM. Another electronic prescription can substitute for a third-party audit. standard. The commenter, as it stated, application provider asserted that the Finally, DEA has expanded the kinds would rely on third-party audits to cost was underestimated and said the of third-party auditors beyond those determine whether the applications requirement would place a burden on who perform SysTrust, WebTrust, or meet DEA’s requirements. Although the application providers. SAS 70 audits to include certified commenter may choose to impose this A pharmacy organization stated information system auditors (CISA) who requirement on entities it certifies, application vulnerabilities should be perform compliance audits as a regular making the third-party audit a condition addressed through technology and that ongoing business activity. The CISA of certification by this intermediary they should not create extra paperwork. certification is sponsored by the would not reduce the cost for the It also stated that DEA should ensure Information Systems Audit and Control application providers because they that the cost of these audits is Association (ISACA) 29 and is would still need to obtain a third-party reasonable for small practices and recognized by the American National audit. Further, DEA cannot rely on one pharmacies. A pharmacy organization Standards Institute under ISO/IEC third party’s certification of another and an information technology 17024. The certification is required by third party’s audit or certification of a organization stated that the audit particular application’s compliance requirement is a burden financially and 29 http://www.isaca.org. with DEA regulatory requirements. In

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this regard, DEA must look to its own system or pharmacy-specific changes do DEA Response. SureScripts/RxHub regulatory authority and regulatory not affect the functions specified in part certifies pharmacy and electronic requirements, not those of other entities. 1311, a single audit may be able to prescription applications for This is particularly true as DEA is not address the multiple tailored versions of interoperability and compliance with mandating the use of intermediaries. its application. DEA expects that, except NCPDP SCRIPT, but not for their As discussed above, if a certification for very large healthcare systems or internal security or other functionalities; organization decides to incorporate, as practices, applications will not be as commenters noted, SCRIPT supports, part of its certification, a determination tailored in ways that will affect but does not mandate, the inclusion of that the application meets the compliance with part 1311. all the DEA-required information. In requirements of part 1311, DEA will Comments. One application provider addition, SureScripts/RxHub is not a review the process used to determine stated that some of the controls that neutral third party, but was established whether the certification can be used as DEA wants addressed in the audit are and is run by the pharmacy industry a substitute for a third-party audit. not under the application provider’s and may have a vested interest in Based on a review of the information control when the application has been promoting the existing model of available on its Web site,30 NASPO does installed on a practice or pharmacy transmission over others. Thus, DEA not appear to address applications such computer. believes that SureScripts/RxHub as those used to create electronic DEA Response. DEA recognizes that certification, while beneficial from an prescriptions, but rather certifies the proposed rule failed to address industry perspective, is not suitable to organizations. Thus, DEA does not adequately the different roles played by address DEA’s requirement for a neutral believe that NASPO is currently a application providers that install unbiased third-party audit of electronic suitable alternative to the third-party applications and those that serve as prescription and pharmacy applications. audits or certifications DEA is requiring application service providers. To DEA also notes that assertions in this rule. address the differences, DEA has revised (especially self-assertions, which are Comments. Some commenters stated the rule to clarify that a third-party typically not verified by an outside that there are multiple versions of audit does not need to address physical party) of compliance with the HIPAA applications in use and that third-party security of an application provider if its Security Rule provide limited assurance audits would not be feasible in these application is installed on practitioner of security. The HIPAA Security Rule, cases. office or pharmacy computers and which is focused on protecting personal DEA Response. The existing servers. The audit for applications that health information from disclosure, is certification programs test and certify will be installed on practice or risk-based and designed to be flexible multiple versions of applications. The pharmacy computers is limited to the and scalable because the risks may vary application providers should, therefore, application’s ability to meet the part with the number of patients. In contrast, be familiar with the process of gaining 1311 application requirements. The DEA has based its requirements on its approval for new versions. DEA notes application provider, in this case, has statutory obligations and must require that it is requiring a new audit more no control over physical security of the all pharmacies to implement the defined frequently than once every two years application installed at the practice or security controls. As discussed above, only when one of the functions required pharmacy location and the security of application provider self-certification by part 1311 is affected by an update or its own operations is not of concern to would not provide registrants with upgrade to the application. If an DEA because the prescription records reasonable assurance of compliance. application provider has multiple are not created or stored on computers DEA would be willing to evaluate a versions of the application, all of which that the application provider controls. A request from a pharmacy board to carry use the same code and controls for the third-party audit for an application out a third-party audit or review of an functions that DEA is requiring, a single service provider, whose servers and audit, but as no State Board offered to audit may be able to address multiple Web sites host the files of practices or take on this role in its comments to the versions if other changes could not pharmacies, must, however, address NPRM, DEA doubts that this approach impact these functions. physical security because the ability of is feasible. Comments. Some commenters the ASP to prevent insider and outsider Comments. An application provider thought that individual practitioners or attacks is critical to the security of stated that the SysTrust and WebTrust pharmacies would have to obtain an prescription processing. audits are intended for e-commerce Web audit of their applications. Comments. Pharmacy commenters sites. The commenter asserted that a DEA Response. As discussed above, a stated that SureScripts/RxHub healthcare information application is practice or pharmacy will be required to certification and HIPAA compliance considerably more complex than an e- obtain an audit only if it developed the should be sufficient to meet DEA commerce Web site, as an EMR may application itself. Although there may regulatory requirements. One pharmacy provide thousands of features/functions. be some pharmacy chains that chain asserted that it should be allowed The commenter asked what the auditor developed their own applications, it to self-certify that its pharmacy would examine and test during an audit appears that even large hospital systems application was compliant with DEA of such a complex application. The usually obtain applications from requirements for electronic commenter asked whether CPA firms application providers. If the application prescriptions. Two retail pharmacy are qualified to audit such complex provider has tailored its application to associations stated that the rule was not applications in a consistent manner. meet the specific needs of a healthcare needed for pharmacies because State With the overall complexity and the system or a pharmacy chain, the pharmacy boards may inspect their number of organizations that would be application provider will have to computer applications. They stated that required to obtain the audits, it asked determine whether the changes it made their applications must comply with whether DEA had considered the impact for a particular client affect the HIPAA and the SCRIPT standard. A of such a requirement if organizations capability of the application to meet State agency stated that these audits for are not able to get an audit performed DEA’s requirements. If the healthcare pharmacies may not be needed and due to overall demand. would impose additional costs on DEA Response. The WebTrust audit is 30 http://www.naspo.info. pharmacies. intended for Web sites, but the SysTrust

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audit and the SAS 70 audits are not. related to creating and signing or to five intermediaries involved in some DEA stated in the NPRM that the only processing of controlled substance electronic prescription transmissions. A aspects of the applications that are prescriptions are altered, whichever practitioner might be able to determine subject to the audit are processing occurs first. Application providers will from his application provider which integrity and, for ASPs, physical be required to keep their most recent intermediaries it uses to move the security as they relate to the creation audit report and any other reports prescription from the practitioner to and processing of controlled substance obtained in the previous two years. DEA SureScripts/RxHub or a similar prescriptions. DEA is not requiring an notes that CCHIT now requires conversion service, but neither the application provider to have all aspects recertification every two year. practitioner nor the application provider and functions of their applications Comments. Practitioner organizations, would find it easy to determine which audited. Although a provider may want healthcare organizations, and an intermediaries serve each of the an auditor to determine whether its intermediary stated that prescribers are pharmacies a practitioner’s patients may application accurately moves data from not competent to review audits and that choose. Pharmacies have the problem in one part of an EHR to another (e.g., DEA should publish a list of qualifying reverse; they may know which diagnosis codes from the patient record applications. One association stated that intermediaries send them prescriptions, to an insurance form), DEA is not the onus should be on the application but have no way to determine the requiring that such functions be audited provider to meet the requirements and intermediaries used to route unless they directly affect the creation, fix any deficiencies so that practitioners prescriptions from perhaps hundreds of signing, transmitting, or, for pharmacies, do not need to stop using an practitioners using different the processing of controlled substance application. applications to SureScripts/RxHub or a prescriptions. DEA Response. SysTrust and similar service. Despite these As discussed above, if an organization WebTrust audit reports are intended for considerations, DEA believes the develops a program to certify electronic the public. It should not be difficult for involvement of intermediaries will not prescription or pharmacy applications, an application provider to insist that the compromise the integrity of electronic DEA will review the processes for report include a summary that clearly prescribing of controlled substances, certification of applications proposed by states whether the application meets provided the requirements of the that organization to determine if the DEA requirements. If certification interim final rule are satisfied. Among certification standards adequately bodies take on the role of certifying these requirements is that the evaluate compliance with part 1311. applications for compliance with part prescription record be digitally signed DEA will provide a list of those 1311, the existence of the certification before and after transmission to avoid organizations whose certification will be enough to meet the requirement the need to address the security of processes adequately address to use a compliant application. DEA intermediaries. DEA realizes that this compliance with DEA’s requirements expects that application providers will approach will not prevent problems and allow such certifications to take the have an incentive to address any during the transmission, but it will at place of third-party audits. This should shortcomings quickly to ensure least identify that the problem occurred reduce the cost to application providers. customer satisfaction. during transmission and protect As for the concern about the availability Comments. Another commenter asked practitioners and pharmacies from being of third-party auditors, DEA notes that why the intermediaries are not required held responsible for problems that may there are a limited number of to be audited. A State agency asserted arise during transmission that are not applications, which are unlikely all to that intermediaries should be attributable to them. be ready for audits at the same time. independently certified and audited DEA, however, has expanded the range annually. That commenter suggested J. Risk Assessment of potential auditors by including those that transmission should be limited to who have CISA credentials. wired networks. In the NPRM, DEA provided a Comments. A number of commenters DEA Response. DEA’s rule does not detailed risk assessment, applying the objected to the annual audit, stating that address the use of intermediaries in the criteria of OMB M–04–04, a guidance the applications do not change transmission of electronic prescriptions document for assessing risks for Federal annually. They suggested a two- or for controlled substances. Rather, it agencies. (See 73 FR 36731–36739; June three-year period would be more addresses requirements for applications 27, 2008.) Under M–04–04, risks are appropriate. used to write electronic prescriptions assessed for four assurance levels (1— DEA Response. DEA agrees with for controlled substances and process little or no confidence in asserted commenters on the issue of annual them at pharmacies, and requirements identity—to 4—very high certainty in audits and has revised the rule to for the registrants who use those the asserted identity) across six require an initial audit prior to use of applications. DEA requires registrants to potential impacts. M–04–04 classifies the application for electronic use only applications that meet certain risks as low, medium, and high as prescriptions for controlled substances, requirements because the registrants described in Table 1 and associates risk and to require subsequent audits once choose the applications. Registrants levels with assurance levels as shown in every two years or whenever functions have no control over the string of three Table 2.

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TABLE 1—M–04–04 POTENTIAL IMPACTS OF AUTHENTICATION ERRORS 31

Low impact Moderate impact High impact

Potential Impact of Inconven- At worst, limited short-term incon- At worst, serious short-term or lim- Severe or serious long-term incon- ience, Distress or Damage venience, distress or embarrass- ited long-term inconvenience or venience, distress or damage to to Standing or Reputation. ment to any party. damage to the standing or rep- the standing or reputation to the utation of any party. party (ordinarily reserved for situ- ations with particularly severe ef- fects or which may affect many individuals). Potential Impact of Financial At worst, an insignificant or incon- At worst, a serious unrecoverable fi- Severe or catastrophic unrecover- Loss. sequential unrecoverable financial nancial loss to any party, or a se- able financial loss to any party; or loss to any party, or at worst, an rious agency liability. severe or catastrophic agency li- insignificant or inconsequential ability. agency liability. Potential impact of harm to At worst, a limited adverse effect on At worst, a serious adverse effect A severe or catastrophic adverse agency programs or public organizational operations, assets, on organizational operations or effect on organizational oper- interests. or public interests. Examples of assets, or public interests. Exam- ations or assets, or public inter- limited adverse effects are: (i) ples of serious adverse effects ests. Examples of severe or cata- Mission capability degradation to are: (i) Significant mission capa- strophic effects are: (i) Severe the extent and duration that the bility degradation to the extent mission capability degradation or organization is able to perform its and duration that the organization loss of [sic] to the extent and du- primary functions with noticeably is able to perform its primary ration that the organization is un- reduced effectiveness; or (ii) functions with significantly re- able to perform one or more of its minor damage to organizational duced effectiveness; or (ii) signifi- primary functions; or (ii) major assets or public interests. cant damage to organizational as- damage to organizational assets sets or public interests. or public interests. Potential Impact of unauthor- At worst, a limited release of per- At worst, a release of personal, At worst, a release of personal, ized release of sensitive sonal, U.S. government sensitive, U.S. government sensitive, or U.S. government sensitive, or information. or commercially sensitive informa- commercially sensitive informa- commercially sensitive informa- tion to unauthorized parties re- tion to unauthorized parties re- tion to unauthorized parties re- sulting in a loss of confidentiality sulting in a loss of confidentiality sulting in a loss of confidentiality with a low impact, as defined in with a moderate impact, as de- with a high impact, as defined in FIPS PUB 199. fined in FIPS PUB 199. FIPS PUB 199. Potential Impact to Personal At worst, minor injury not requiring At worst, moderate risk of minor in- A risk of serious injury or death. Safety. medical treatment. jury or limited risk of injury requir- ing medical treatment. Potential impact of civil or At worst, a risk of civil or criminal At worst, a risk of civil or criminal A risk of civil or criminal violations criminal violations. violations of a nature that would violations that may be subject to that are of special importance to not ordinarily be subject to en- enforcement efforts. enforcement programs. forcement efforts.

TABLE 2—MAXIMUM POTENTIAL IMPACTS FOR EACH ASSURANCE LEVEL

Level 1 Level 2 Level 3 Level 4

Potential Impact of Inconvenience, Distress, or Dam- Low Impact ...... Moderate Impact ..... Moderate Impact ..... High Impact. age to Standing or Reputation. Potential Impact of Financial Loss ...... Low Impact ...... Moderate Impact ..... Moderate Impact ..... High Impact. Potential impact of harm to agency programs or public n/a ...... Low Impact ...... Moderate Impact ..... High Impact. interests. Potential Impact of unauthorized release of sensitive n/a ...... Low Impact ...... Moderate Impact ..... High Impact. information. Potential Impact to Personal Safety ...... n/a ...... n/a ...... Low Impact ...... Moderate Impact. Potential impact of civil or criminal violations ...... n/a ...... Low Impact ...... Moderate Impact ..... High Impact.

In the risk assessment conducted as associated with Level 4. As DEA imprisonment and/or fines. (See 73 FR part of the NPRM, DEA determined that discussed in the NPRM, inadequate 36733–36734, June 27, 2009, for a full the potential impact of financial loss requirements for authentication description of the reasons for DEA’s and the potential impact of protocols would make it difficult to ratings.) Because the highest risk level unauthorized release of sensitive detect diversion and to enforce the rated for any element determines the information were not applicable to the statutory mandates of the Controlled overall assurance level, DEA proposed rule; the risk related to the potential Substances Act; DEA’s ability to carry using Level 4 for the authentication impact of inconvenience, damage, or out its statutory mandate would be protocols although it did not apply any distress to standing or reputation was seriously undermined. As DEA assurance level to identity proofing. rated as moderate. DEA rated the other discussed extensively in the NPRM, the Comments. Only four commenters three factors as high risk, which is consequences of diversion and abuse of directly addressed the risk assessment. controlled substances are clearly severe An application provider and an 31 Office of Management and Budget. ‘‘E-Authentication Guidance for Federal Agencies’’ to the users. The criminal penalties information technology firm addressed M–04–04. associated with diversion involve the requirements for a hard token and

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asserted that Level 4 would be very hard access the application. Contrary to the frequently, are more likely to be written to implement and that Level 3 would be commenter’s claim, NIST SP 800–63–1 down. DEA also notes that maintenance sufficient. requires both OTP devices and of password systems imposes The information technology firm cryptographic tokens to be validated at considerable costs. stated that Level 4 token technology is FIPS 140–2 Security Level 1 or higher.33 DEA also disagrees with the significantly more costly to distribute, The primary purpose of the higher commenter’s suggestion for different manage, and operate than multi-token level of physical security for Level 4 is requirements for Schedule II Level 3 technologies. The commenter to prevent tampering with the device. prescriptions. As DEA has discussed, asserted that cell phone-based multi- Given the technical expertise needed to electronic prescriptions are written factor one-time-password devices tamper with a device without making it prescriptions. Requirements for written require the distribution of code that is nonfunctional, DEA does not consider prescriptions are uniform, regardless of unique to each cell phone platform. that such tampering is enough of a risk the schedule of the controlled Consequently, the commenter asserted, in healthcare settings to justify imposing substance. Further, to establish differing the cost and complexity for the end- the higher costs associated with such requirements for Schedule II controlled users is significant. The logistical devices. DEA believes that the other substance prescriptions as compared management of the software and steps it is implementing regarding with Schedule III, IV, and V cryptographic solutions for multi-factor identity proofing and logical access prescriptions would add unnecessary cryptographic hardware devices make control are sufficient to mitigate the risk complexity to the electronic their cost untenable in a large scale, to allow for Level 3 rather than Level 4 prescription application. The heterogeneous deployment. The tokens. By requiring that two factors are commenter’s suggestion appears to be application provider asserted that Level used to access the controlled substance based on the assumption that Schedule 4 requires that every system user use a functions in the application, DEA is II substances, and their related Level 4 token to access the system, not limiting the threat from stolen or prescriptions, are more likely to be just practitioners accessing select tampered-with tokens. diverted; however, DEA notes that both functions in a single application. Both Comments. Another application Schedule III and Schedule IV commenters suggested that DEA require provider objected to DEA’s assessment substances, and their related Level 3 tokens that are stored on a and argued that Level 2 protections prescriptions, are regularly diverted for device ‘‘separate from the computer (single-factor) were adequate. The nonlegitimate use. DEA believes that a gaining access,’’ citing OMB application provider stated that Level 2, single approach more accurately reflects memorandum M–07–16 on safeguarding with the use of a strong password in the statutory and regulatory personal information.32 These addition to a known Internet Protocol requirements for written prescriptions, commenters asserted that this approach address or out-of-band token, would be is more appropriate, and will be easier would eliminate the risk that DEA cited sufficient. The application provider also for application providers and with NIST Level 3, which allows storage suggested that DEA should adopt a practitioners to implement. on the computer gaining access. They tiered approach, with lesser DEA has adopted some of the second stated that ‘‘the use of such multi-token requirements for Schedule III, IV, and V factors that the commenter suggested, level 3 two-factor authentication substances (just a strong password). For specifically the biometric and any hard solutions has been proven successful in Schedule II, it suggested a combination token that meets NIST Level 3, which mass scale deployments with of a strong password and other could include proximity cards and heterogeneous user populations since ‘‘something you know’’ (e.g., out-of-band thumb drives that contain a no hardware or software is required by message, challenge response questions) cryptographic module. DEA does not believe that associating a prescription the end-user specific to the plus a printout of every prescription, with a particular IP address will provide authentication transaction. This has with the printout manually signed to a pharmacy any assurance of the been done with no provisioning create an audit trail. As an alternative identity of the person who signed the complexity and a variety of integrated the application provider suggested that prescription; any prescription generated identity proofing capabilities including if DEA requires two-factor on a practice’s computers may have the face-to-face and remote knowledge- authentication, DEA should allow a same IP address. This suggestion also based identity proofing.’’ An variety of second factors including assumes that every pharmacy to which intermediary stated that most PDAs or whitelisted IP address, biometrics, soft a practitioner may transmit would have other handheld devices typically do not tokens, and hard tokens, such as meet a FIPS 140–2 validation with the ability to determine whether the proximity badges, barcode readers, source IP address was whitelisted. physical security at Level 3 or higher. It thumb drives, etc. also said that SP 800–63–1 does not Comments. An intermediary asserted DEA Response. DEA disagrees with that DEA should implement electronic require that approved cryptographic this commenter. DEA does not believe algorithms must be implemented in a prescriptions for controlled substances that one-factor authentication is with Level 2 and increase the cryptographic module validated under adequate. As discussed at length above, FIPS 140–2. requirements only if needed. The passwords are not secure, particularly in commenter asserted that the existing DEA Response. DEA agrees with some healthcare settings where people work of the comments and has revised the system includes authentication of the in close proximity to each other and clinician and the connections, access interim final rule to allow many people may use the same authentication protocols that meet NIST controls, audit trails, and pharmacist as computers. Even without the possibility a gatekeeper. It stated that electronic Level 3; if the protocols involve a hard of shoulder-surfing in such settings, token, they must be either one-time- prescribing could not increase the speed strong passwords, because of their of diversion because the pharmacist acts password devices or cryptographic complexity and the need to change them modules that are not stored on the as a gatekeeper. The commenter claimed that electronic prescribing would have a computer the practitioner is using to 33 National Institute of Standards and Technology. Special Publication 800–63–1, Draft low impact on harm to the agency and 32 http://www.whitehouse.gov/omb/assets/omb/ Electronic Authentication Guideline, December 8, public interest. The commenter asserted memoranda/fy2007/m07-16.pdf. 2008, pages 40–41. that the ability to breach the electronic

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prescribing infrastructure would take far fraudulent prescriptions issued to electronic prescribing applications are greater expertise than today’s paper multiple patients. Unlike paper widely deployed, as the commenter system. The commenter further claimed prescriptions, electronic prescriptions suggested, could be done, would be far that electronic prescribing would reduce lack many of the indications of a forged more difficult and more disruptive than the risk of injury and death by reducing prescription that pharmacists use to implementing reasonable controls in the undetectable diversion and abuse. The identify a forged paper prescription. early stages of the applications’ use. commenter asserted that personal safety Electronic prescribing applications Because of DEA’s statutory should be considered low risk. Stronger make it difficult for the person diverting responsibilities and the magnitude of authentication of the clinician to misspell a drug name or to select the harm to the public health and safety minimally reduces the risk of alteration dosage forms that do not exist; they that would result if an insufficiently of the prescription; existing processes provide no indication of alterations. secure system were to cause an increase and controls audited by third parties The commenter assumes that such in diversion of controlled substances, reduce the overall risk more problems will be discovered through any regulations authorizing the use of significantly. The commenter believed data mining and that data mining will electronic prescriptions for controlled that existing electronic prescribing reduce diversion. DEA, however, has no substances must contain adequate infrastructure and systems will authority to collect data on all security measures from the outset. DEA dramatically reduce the chance of prescriptions issued and, therefore, no cannot, consistent with its obligations, diversion and abuse seen in the existing ability to conduct data mining. Even if set the bar lower than it believes paper process; thus, the commenter DEA had the authority to collect necessary with an eye toward increasing asserted, the risk of civil or criminal prescription data, data mining would the security requirements at some later violations is actually reduced with only work if all prescription data were date should the vulnerabilities be electronic prescribing and should be available (electronic prescriptions, exploited. Regulatory changes take considered low. The commenter stated paper, fax, and oral) and in a common significant time—time during which that data mining would effectively electronic format. If the per-prescription there could be continuing harm to the address diversion concerns. transaction fee charged by the public health and safety. DEA Response. DEA strongly commenter for transmission is any Comment. One application provider disagrees with this commenter’s claims. indication of the cost of that one step in stated that the use of the government The existing system, where some data mining, the cost of data mining for guidelines for risk assessment was applications allow individuals to enroll controlled substance prescriptions to inappropriate because those guidelines online with no identity proofing, DEA could be high. were developed to analyze people provides no assurance that the person Data mining, were it legally possible remotely accessing open networks. issuing a prescription is a practitioner. and economically feasible, is based on DEA Response. DEA recognizes that It takes no technical expertise to steal an being able to identify patterns of the guidelines were developed for identity, particularly for office staff who unusual activities. Data mining might government systems, but believes that have access to DEA registration detect individuals diverting controlled the basic principles can be applied to certificates and State authorizations. substances for themselves or registrants the security of both Federal and private Applications that do not have logical issuing large numbers of prescriptions applications. Although practitioners access controls or do not implement potentially other than for legitimate may write most of their prescriptions them may allow any person with access medical purposes. It would not identify while at their offices, they will probably to a practitioner’s computers to write the organized diverters who would want the ability to access their office and issue prescriptions. Passwords, as easily determine what patterns would applications when they are away from discussed previously, are the most trigger investigation and avoid those the office so they can issue prescriptions common form of authentication patterns. One problem with poorly remotely when needed; such access will credential and provide no proof that the controlled or uncontrolled electronic frequently be through the Internet and person entering the password is the prescription issuance is that it would be may use wireless connections. In person associated with the password. easy for criminals to steal practitioner addition, practitioners using application The security of the prescription as it identities, issue a limited number of service providers access the electronic prescriptions under each identity to a moves through intermediaries is of prescription application over the limited number of patients, and move limited value if there is no evidence of Internet, which they may do from any on to the next set of stolen identities. who issued the prescription. Strong computer or location. Security concerns Nothing in the pattern would trigger authentication is needed, not simply to must address both of these situations. prevent alteration, but to prevent investigation, regardless of whether data nonregistrants from issuing controlled mining was being conducted. K. Other Issues Finally, data mining, even in real time substance prescriptions. The risk of 1. Definitions diversion without strong authentication if that were to be possible, would not is high. The practitioners could be prevent many of the injuries and deaths In the NPRM, DEA proposed to move subject to civil and criminal prosecution diversion causes because the drugs all of the existing definitions in part if their applications are misused and would have been obtained and used or 1311 to a new section in part 1300 prescriptions are written in their names, sold before law enforcement could act. (§ 1300.03) and to add new definitions or if their identity is stolen. To claim that the risk to personal safety to that section. The proposed definitions As to the claim that pharmacists will is low is to ignore the reality of the included ‘‘audit,’’ ‘‘audit trail,’’ prevent wide-spread diversion, it is consequences of drug diversion. DEA ‘‘authentication,’’ ‘‘authentication difficult to see how this could be the considers it critical that electronic protocol,’’ ‘‘electronic prescription,’’ case. If someone issues multiple prescribing applications for controlled ‘‘hard token,’’ ‘‘identity proofing,’’ prescriptions to a patient and transmits substance prescriptions be designed to ‘‘intermediary,’’ ‘‘NIST SP 800–63,’’ them to multiple pharmacies, the limit the possibility of diversion to as ‘‘paper prescription,’’ ‘‘PDA,’’ ‘‘SAS 70 pharmacists will have no ability to great an extent as possible rather than audit,’’ ‘‘service provider,’’ ‘‘SysTrust,’’ identify the problem, just as a single assume that the problems will not ‘‘token,’’ ‘‘valid prescription,’’ and pharmacist will not be able to identify occur. Fixing the problem after ‘‘WebTrust.’’

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Definition of ‘‘Service provider.’’ In the terms to use the more accurate word source of the message and indicates the the NPRM, DEA proposed to define a ‘‘application,’’ rather than service or person’s approval of the information service provider as follows: system. In computer terminology, an contained in the message.’’ As DEA Service provider means a trusted entity that application is software that performs explained in the NPRM, this definition does one or more of the following: specific tasks (e.g., word processing, of electronic signature is taken directly (1) Issues or registers practitioner tokens EHRs); a system is the underlying from 21 CFR 1311.02, and was merely and issues electronic credentials to operating program. DEA has, therefore, being merged into the definitions practitioners. revised the rule to add the following section for electronic ordering and (2) Provides the technology system definitions. prescribing activities. (software or service) used to create and send Electronic prescription application Comments. Several commenters electronic prescriptions. provider means an entity that develops stated that DEA should adopt the (3) Provides the technology system or markets electronic prescription E-Sign definition of electronic signature: (software or service) used to receive and process electronic prescriptions at a software either as a stand-alone ‘‘Electronic Signature means an pharmacy. application or as a module in an electronic sound, symbol, or process electronic health record application. attached to or logically associated with Comments. Practitioner and pharmacy Pharmacy application provider means a record and executed or adopted by a organizations requested that DEA define an entity that develops or markets person with the intent to sign the service providers and intermediaries. A software that manages the receipt and record.’’ practitioner organization stated that processing of electronic prescriptions. DEA Response. DEA disagrees. The DEA had used ‘‘service provider’’ for any Application service provider means definition of ‘‘electronic signature’’ in third party (vendor or intermediary). It an entity that sells electronic the proposed rule is the existing believed that these should have separate prescription or pharmacy applications definition in § 1311.02 that was adopted names. A standards organization asked as a hosted service, where the entity in 2005 when DEA promulgated its who the service provider is in the case controls access to the application and ‘‘Electronic Orders for Controlled where the software is loaded to the maintains the software and records on Substances’’ Final Rule (70 FR 16901, practitioners’ computers. A pharmacy its servers. April 1, 2005). DEA is simply moving organization also asked for clarification Installed electronic prescription the definitions codified in that final rule of the term ‘‘service provider’’ and application means software that is used to a new section. DEA believes that the whether their functions can be to create electronic prescriptions and E-Sign definition is too general to delegated. that is installed on a practitioner’s provide the necessary clarity in the An intermediary recommended computers and servers, where access context of this interim final rule. modifying the definition of service and records are controlled by the Comments. A healthcare group asked provider to recognize that some practitioner. DEA to further define ‘‘manually prescribers and the entities for which Installed pharmacy application signed.’’ It asked whether the act of a they work have created their own means software that is used to process practitioner signing with an electronic electronic prescribing applications. The prescription information and that is signature would suffice or is a intermediary noted that some installed on the pharmacy’s computers handwritten signature on the computer- prescribers, as well as some pharmacies, or servers and is controlled by the generated prescription that is printed or have their own proprietary applications pharmacy. faxed required. and do not connect to intermediaries The definition of ‘‘intermediary’’ is DEA Response. DEA does not believe through third-party service providers, unchanged from the NPRM: that ‘‘manually signed’’ requires further but rather connect directly. ‘‘Intermediary means any technology definition. The phrase ‘‘manually Accordingly, some entities in fact act as system that receives and transmits an signed’’ has been a part of the DEA both a prescriber or pharmacy, on the electronic prescription between the regulations since the inception of the one hand, and an application provider, practitioner and pharmacy.’’ CSA (and is currently found in on the other hand. The intermediary DEA believes that these revisions will § 1306.05(a)) without the need for also noted that the addition of the word clarify the rule and allow DEA to make elaboration. It has a plain language ‘‘trusted’’ to the definition of service the distinction between application meaning that is clear: The practitioner provider adds a subjective element that service providers, who host and manage must use a pen, indelible pencil, or is not defined anywhere in the NPRM. the electronic prescription applications other writing instrument to sign by hand While the word ‘‘trusted’’ is a term of art on an ongoing basis, and those the paper prescription. used in the industry, since it is not providers that develop, market, or Comments. An application provider defined in the NPRM, the intermediary install software, but do not manage the organization stated that the word stated that DEA should delete the word application once it is installed. In the ‘‘signing’’ is imprecise; instead it should ‘‘trusted’’ from the definition of service case of a closed system, a single entity say ‘‘approve’’ and/or ‘‘transmit.’’ provider to avoid any ambiguity in the may manage both the electronic DEA Response. DEA has revised the future. The intermediary argued that if prescription application and the proposed rule, as discussed, to require an entity complies with the pharmacy application and, therefore, that two-factor authentication act as requirements as imposed by the rule, would be considered to be the provider signing and that the application must then that entity is and should be of both. Based on the inclusion of these label the function as signing as well as considered a trusted entity, and there is new definitions, DEA has removed the presenting a statement on the screen no need to introduce an undefined and term ‘‘service provider’’ from the interim that informs the practitioner that subjective word such as ‘‘trusted’’ into final rule. executing the two-factor authentication the definition. Definition of ‘‘electronic signature.’’ In protocol is signing the prescription. DEA Response. DEA agrees that the NPRM, DEA proposed to define the Signing is the practitioner’s final further delineation among the various term electronic signature as follows: authorization for the transmission and entities involved in electronic ‘‘Electronic signature means a method of dispensing of a controlled substance prescribing of controlled substances is signing an electronic message that prescription, issued for a legitimate needed. In addition, DEA has changed identifies a particular person as the medical purpose in the usual course of

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professional practice, and indicating the Comments. An information DEA Response. DEA has revised the practitioner’s intent to be legally technology organization recommended incorporation of NIST SP 800–63 to responsible for such authorization. that DEA add a USB fob to the list of cover the current version. Federal Comments. A State Board of hardware devices described in the agencies are not permitted to Pharmacy provided definitions it uses definition of hard token. It also incorporate by reference future versions for electronic prescriptions to define recommended the use of the term Key of documents. ‘‘point of care vendors,’’ ‘‘network Storage Mechanism instead of hard Definitions of SysTrust and WebTrust. vendors,’’ ‘‘prescribers,’’ and token as this is the more standard In the NPRM, DEA separately defined ‘‘contracted.’’ industry term in current use. the terms SysTrust and WebTrust. DEA Response. DEA considered these DEA Response. DEA has added USB Comments. A healthcare organization definitions in developing its definitions fob to the list of devices described in the believed that SysTrust and WebTrust for the interim final rule. The definition of ‘‘hard token.’’ DEA notes have converged under the reference of definitions offered by the Board of that this list merely provides examples Trust Services for business to business Pharmacy commenter include and is not all-encompassing. If another commerce. The commenter believed requirements, which are not generally hardware device meets DEA’s that a new definition for Trust Services part of Federal definitions. The requirements for security it can be used should be introduced and language commenter’s definitions appear to rely to meet the requirements of this interim within the rule modified accordingly for on contracts among the various vendors final rule. such references. DEA Response. Although SysTrust for security, but it is not clear how these Definitions related to digital and WebTrust are considered part of contracts would be enforced or how a signatures. DEA did not propose any Trust Services, they are still separate practitioner or pharmacy would be able definitions in the NPRM related to services and identified as such by the to determine that they were in place. digital signatures other than those it was American Institute of Certified Public DEA also notes that the network vendor transferring from 21 CFR 1311.02. definition fails to consider that many Accountants. Therefore, DEA has not Comments. An information revised these terms in this interim final intermediaries connect only to other technology organization recommended intermediaries, not to practitioners and rule. adding definitions for registration agent Other Definition Issues: pharmacies. A definition of prescriber is and trusted agent. A security firm Comment. One commenter stated that not needed as DEA’s rules limit who can suggested the inclusion of several other DEA should adopt the NIST SP 800–63 prescribe controlled substances. Thus, definitions related to digital signatures. definition of ‘‘possession and control of while DEA appreciates the Board of DEA Response. DEA does not believe a token’’ and recommended that DEA Pharmacy’s suggestions, it did not adopt that definitions of registration agent and define ‘‘sole possession.’’ any of the definitions specifically other certification authority terms are DEA Response. DEA does not believe included in the comment. needed. DEA has, however, added a that these definitions are necessary. Definition of ‘‘closed system.’’ DEA definition of ‘‘trusted agent,’’ because Both phrases consist of plainly did not propose to define the term institutional practitioners may fill this understood terms that have well- ‘‘closed system.’’ This phrase would role if they elect to obtain established legal meanings. refer to situations in which both the authentication credentials from a 2. Other Issues electronic prescription application and certification authority or credential the pharmacy application were service provider for practitioners using Comments. A number of commenters controlled by the same entity and where their electronic prescription application asked DEA to provide a list of practitioners and pharmacies outside of to write controlled substances application providers that met DEA’s the closed system could not access or be prescriptions. The definition is based on requirements. A practitioner accessed by users of the closed system. NIST’s definition and describes the organization, a pharmacy organization, Comments. An insurance industry trusted agent as an entity authorized to and a physician suggested that DEA organization suggested that DEA add a act as a representative of a certification make available to prescribers and definition of ‘‘closed system’’ to address authority or credential Service provider application providers a database of healthcare systems that employ both the in confirming practitioner identification pharmacies that accept electronic practitioner and pharmacists and handle as part of the identity proofing prescriptions. The physician suggested the prescriptions within a single system. process.34 that DEA require all pharmacies to DEA Response. DEA does not believe Definition of NIST SP 800–63. In the register their ability to accept electronic that a definition of closed system is NPRM, DEA proposed to define the term prescriptions for controlled substances needed at this time because DEA is not NIST SP 800–63 as follows: ‘‘NIST SP with DEA and for DEA to provide an imposing any additional or different 800–63, as incorporated by reference in online automatic directory that enables requirements on closed systems. Closed § 1311.08 of this chapter, means a all electronic health record application systems are subject to the same rules as Federal standard for electronic providers and electronic prescription open systems. As discussed above, DEA authentication.’’ While this term application providers to query for all is allowing non-Federal systems to use appeared in the definitions, DEA also pharmacies and determine immediately the rules proposed for Federal systems. notes that the Special Publication itself if an electronic prescription for a Some closed systems may find it was also proposed to be incorporated by controlled substance can be sent to a advantageous to adopt this approach, reference in proposed § 1311.08. particular pharmacy. The commenter but they are not required to do so. Comments. A healthcare organization suggested that, if it was determined that Definition of ‘‘hard token.’’ In the stated that the definition of NIST SP a particular pharmacy did not accept NPRM, DEA proposed to define the term 800–63 should be modified to cover electronic prescriptions, the electronic hard token as follows: ‘‘Hard token future revisions. health record application or electronic means a cryptographic key stored on a prescription application could then special hardware device (e.g., a PDA, 34 National Institute of Standards and automatically switch to print and notify cell phone, smart card) rather than on a Technology. IR–7298 Glossary of Key Information the prescribing physician of the change general purpose computer.’’ Security Terms, April 25, 2006. and requirement for wet signature and

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providing the prescription to the that application providers and/or reports, actually ‘‘shuffled’’ prescriptions patient. This commenter asserted that intermediaries are better suited to the in the application, such that the drug physicians have had considerable task of maintaining these listings. This intended for one patient appeared on difficulty with the current is particularly necessary as, due to screen for another patient. The noncontrolled substance electronic potential interoperability issues, a organization asserted that errors have prescribing systems because they could pharmacy that can process prescriptions been caused by practitioner software not rely on pharmacy participation or from one application provider may not and pharmacy software, as well as have a reliable means of locating be able to process prescriptions from practitioner keying errors. pharmacies. A practitioner organization other application providers. DEA Response. DEA shares the suggested that DEA could require Comments. A number of commenters concern about prescription errors pharmacies to indicate whether they urged DEA to adopt a particular version created by the SCRIPT standard, which accept electronic prescriptions as part of of the National Council for Prescription is not yet fully functional. DEA, DEA’s registration process. Drug Programs SCRIPT standard and however, does not believe that DEA Response. DEA does not believe cite particular SCRIPT functions. mandating one version of the standard that it is in a position to develop and Several State pharmacist associations or particular functions would be useful. maintain complete and accurate lists of asserted that DEA should require the The standard continues to evolve; if either application providers that full support of all transaction types of DEA incorporated by reference one provide applications meeting DEA’s the approved Centers for Medicare and version, it would need to go through requirements for electronic Medicaid Services standards including rulemaking to update the reference, prescriptions for controlled substances, fill status notification (RXFILL), cancel which could delay implementation of or of pharmacies that accept electronic prescription notification (CANRX) improvements. DEA believes that the prescriptions. Whether an application transactions, and prescription change best approach is to set minimum provider chooses to develop transactions (RXCHG), throughout the requirements to ensure the integrity, applications that comply with DEA’s prescribing process for controlled authentication, and non-repudiation for regulatory requirements and, thus, be in substances. The commenters asserted controlled substance prescriptions (and a position to supply applications that that using these transactions supports in a manner consistent with maintaining may lawfully be used by practitioners to medication adherence monitoring and effective controls against diversion) and create, sign, and transmit electronic decreases opportunities for diversion. leave the industry to develop all other prescriptions for controlled substances These transactions are already present aspects of electronic prescriptions. This and by pharmacies to receive and in the NCPDP SCRIPT standard. A will provide the maximum flexibility process electronic prescriptions for pharmacy Application provider stated while ensuring that DEA’s statutory controlled substances, is a business that DEA should clarify which SCRIPT obligations are addressed. decision on the part of that provider. As transactions must be covered and Comments. A few commenters all providers will be required to undergo recommended NEWRX, REFRES, and suggested that DEA apply different third-party audits of their applications, CHGRES. Pharmacy organizations noted DEA believes that these audit reports, that the SCRIPT standard does not standards for Schedule II prescriptions. which will be available to interested provide explicit standards for some data One application provider suggested that practitioners, will provide notice of elements in prescriptions (drug names, Schedule II prescriptions should remain application providers’ compliance with dosing, route, and frequency); without permissible only as paper prescriptions DEA regulations. If certification standards for these elements, and that a single-factor authentication organizations develop programs to interoperability between pharmacies protocol be allowed for Schedule III, IV certify compliance with DEA’s and practitioners cannot be assured. A and V prescriptions. requirements and DEA approves the pharmacy organization urged DEA to DEA Response. It is true that programs, the certification will also encourage the development of discrete prescriptions for Schedule II controlled provide practitioners with the standards for these elements. substances are subject to greater information. Practitioner organizations also noted statutory and regulatory controls than Similarly, DEA does not believe it that the SCRIPT standard for sig prescriptions for controlled substances appropriate for DEA itself to maintain a (directions for use) has not been in Schedules III, IV, and V. These list of pharmacies that accept electronic approved or accepted. differences in controls are prescriptions for controlled substances. A pharmacy organization stated that it commensurate with the differences Again, whether a pharmacy chooses to is receiving many reports of errors among these drugs in relative potential accept such prescriptions is a business occurring in electronic prescriptions. for abuse and likelihood of causing decision left to that pharmacy. DEA is The commenter indicated that the dependence when abused. Along not in a position to proactively and prescriptions are quite legible, but, similar lines, it is accurate to state that, continually monitor pharmacies’ occasionally, quite wrong. Pharmacists among the pharmaceutical controlled involvement in this arena, nor is DEA in are reporting that many prescriptions substances, drugs in Schedule II are a position to continually receive are being received by the pharmacy with subject to the most stringent controls updates from its approximately 65,000 the drug names and directions for use because abuse of these drugs tends to be pharmacy registrants regarding their truncated. In other cases, the directions more harmful to the public health and involvement. The electronic prescribing are incorrect in the space allocated for welfare than abuse of pharmaceutical of controlled substances by prescribing directions, while the intended drugs in lower schedules. Nonetheless, practitioners, and the dispensing of instructions are placed in the DEA does not believe it is necessary or those electronic prescriptions by DEA- ‘‘comments’’ section. In other situations, appropriate to disallow altogether the registered pharmacies, is strictly the wrong drug, wrong strength, or electronic prescribing of Schedule II voluntary. DEA notes that electronic totally incorrect directions are controlled substances. Given the prescription application providers transmitted. Occasionally, the quantity carefully crafted requirements contained maintain databases of pharmacies that of drug is incorrect. There have been a in this interim final rule, DEA believes accept electronic prescriptions for few instances where a computer that electronic prescribing of all routing or other purposes. DEA believes application, according to anecdotal pharmaceutical controlled substances in

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all schedules can take place without subject to potential administrative were cost-effective, particularly for adversely affecting diversion control. action that may result in suspension or small practices. It should also be noted that the revocation of his DEA registration. DEA Response. DEA believes that the required elements of a prescription for Comments. A pharmacy organization interim final rule will impose even a controlled substance (those set forth in and an intermediary stated that DEA lower costs on registrants than the 21 CFR 1306.05(a)) are the same for all should revise proposed § 1306.11(a) proposed rule. DEA also notes that the prescriptions for controlled substances, (‘‘Requirement of prescription [for incremental cost of its requirements is and this same approach is followed in controlled substances listed in Schedule relatively small compared to the costs of the interim final rule with respect to II].’’) to read ‘‘pursuant to a written or adopting and installing new electronic prescriptions. Further, DEA electronic prescription.’’ applications. A full discussion of the believes that disallowing the electronic DEA Response. DEA has defined costs and benefits associated with this prescribing of Schedule II controlled paper prescription in § 1300.03. A rule is provided in the required analyses substances could significantly hinder written prescription includes both paper section of this document. adoption of electronic prescribing of and electronic prescriptions issued in Comments. One advocacy controlled substances in other conformity with the DEA regulations. organization asserted that DEA is schedules, as it would potentially create Thus, the suggested revision is not placing much of the responsibility for separate application requirements for necessary. application security on practitioners separate schedules, causing confusion Comments. A number of pharmacist and pharmacies, and asked if DEA has among practitioners, pharmacies, and organizations submitted the same sufficient statutory authority to do so. application providers as to which comment, listing the following as The commenter asked whether such requirements should be followed for objectives DEA should pursue in authority to require this new which substances. developing the final rule: responsibility lies within the Controlled Comments. An application provider • Promoting scalability and Substances Act authority to register practitioners. believed that proposed § 1311.100 is nationwide adoption of electronic redundant in view of current § 1306.03 DEA Response. As set forth at the prescribing by enabling all prescribers, and should be deleted. outset of this preamble, DEA has broad regardless of the volume of controlled DEA Response. Current § 1306.03 statutory authority under the Controlled (‘‘Persons entitled to issue substances prescribed, to create and Substances Act to issue rules and prescriptions.’’) provides general transmit prescriptions for controlled regulations relating to, among other requirements for the issuance of all substances via the same electronic things, the control of the dispensing of prescriptions, written and oral. While media as prescriptions for controlled substances, and to issue and noncontrolled substances; the requirements of proposed § 1311.100 • enforce rules and regulations that the (‘‘Eligibility to issue electronic Reducing and eliminating agency deems necessary to effectuate prescriptions.’’) restated principles from additional costs and administrative the CSA.35 Also, the structure of the burden on pharmacists and prescribers; § 1306.03, DEA believes it appropriate • CSA is unlike most statutory schemes in to restate those important concepts Ensuring compliance and that it prohibits all transactions specifically in regard to electronic consistency with the uniform standards involving controlled substances except prescriptions. Therefore, DEA is relating to the requirements for those specifically allowed by the Act retaining the concepts proposed in electronic prescription drug programs; and its implementing regulations.36 The • § 1311.100. Improving patient safety and interim final rule is consistent with Comments. A healthcare system asked quality of care; and these aspects of the CSA. It is also worth DEA to clarify the specific consequences • Allowing for the expeditious reiterating here that DEA is not of non-compliance with each adoption of technological advances and requiring any practitioner to issue requirement. innovation. electronic prescriptions for controlled DEA Response. The potential DEA Response. DEA has attempted to substances or any pharmacy to accept consequences of failing to comply with reduce the burden to practitioners, them; it is simply setting the the requirements in this interim final pharmacies, and others with changes in requirements that must be met before a rule regarding the electronic prescribing the interim final rule based on the practitioner may lawfully issue, and a of controlled substances are the same as comments received, providing pharmacy may lawfully process, the potential consequences of failing to flexibility to adopt other technologies as electronic prescriptions for controlled comply with longstanding requirements they become feasible, and facilitating substances. regarding the general prescribing and adoption of electronic prescriptions for As has been discussed previously, dispensing of controlled substances. Just controlled substances. Although nothing in this rule prevents a as one cannot list all the potential admirable goals, uniform standards and practitioner or a practitioner’s agent scenarios in which the existing improved quality of care are not within from using an existing electronic prescription requirements might be DEA’s statutory authority, other prescription application that does not violated, one cannot list all the possible government agencies are responsible for comply with the interim final rule to ways in which the various requirements these issues. DEA recognizes the prepare a controlled substance of this interim final rule might be benefits to pharmacies of uniform prescription, so that EHR and other violated. However, as a general matter, standards, but a variety of methods of electronic prescribing functionality may if a person fails to comply with the signing and transmitting electronic be used, and print the prescription for requirements of this interim final rule in prescriptions may satisfy the manual signature by the practitioner. a manner that constitutes a criminal or requirements of the interim final rule Such prescriptions are paper civil violation of the CSA, that person and should be allowed for those that is subject to potential criminal wish to use them. 35 21 U.S.C. 821 & 871(b). prosecution or civil action as Comments. A number of practitioner 36 21 U.S.C. 841(a)(1). See United States v. Moore, 423 U.S. 122, 131 (1975) (‘‘only the lawful acts of contemplated by the Act. In addition, a organizations urged DEA to ensure that registrants are exempted’’ from the prohibition on DEA registrant who fails to comply with the requirements for electronic distribution and dispensing of controlled the requirements of the regulations is prescriptions for controlled substances substances set forth in 21 U.S.C. 841(a)(1)).

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prescriptions and subject to the existing from that statutory prohibition in the that prescription would have to be requirements for paper prescriptions. context of paper or electronic printed and signed manually, then given Comments. Some commenters urged prescriptions. If a patient is seeking to the patient or, for Schedule III, IV, DEA to help tighten the security additional medication not authorized by and V prescriptions, faxed to the standards imposed under the Health the original prescription, the pharmacy. Insurance Portability and practitioner must issue a new Similarly, DEA does not believe it Accountability Act. Others cited HIPAA prescription regardless of the Schedule. prudent to delay the effective date of as sufficient to protect the security of If a pharmacy electronically requests this rule for any length of time. DEA electronic prescriptions. that a practitioner authorize the wishes to encourage adoption of DEA Response. The Department of dispensing of medication not originally electronic prescriptions for controlled Health and Human Services is authorized on a prescription, or substances as rapidly as industry is responsible for the HIPAA standards; authorize a new prescription based on a willing and able to comply with the questions or comments about these previously dispensed prescription, DEA requirements of this rule. DEA standards should be addressed to HHS. would view any prescriptions issued recognizes that some health care The HIPAA security standards are pursuant to those requests as new entities, particularly Federal healthcare general, leaving many details on prescriptions. If they are written, facilities, may be more prepared to implementation to individual healthcare regardless of whether they are electronic begin electronically prescribing providers; many of the specifications to or on paper, they must be signed by the controlled substances in compliance implement the security standards are practitioner. Thus, a manual signature with this rule than others. To delay the addressable and not mandatory. HIPAA would be required for a paper effective date of this rule may generally focuses on protecting the prescription pursuant to § 1306.05, or a unnecessarily hinder those privacy of the individual patient’s practitioner could follow the signature organizations from electronically information rather than on the requirements for electronic prescribing controlled substances as possibility of alteration of records or the prescriptions discussed in this quickly as they are able. creation of fraudulent records. As rulemaking. Alternatively, for a Comments. A State pharmacy HIPAA was not designed to prevent the Schedule III, IV, or V prescription, the organization asserted that if it is diversion of controlled substances, pharmacy may receive an oral required to use an intermediary in the compliance with HIPAA standards prescription for that controlled transmission of a controlled substance alone will not result in the substance, but the pharmacy must prescription from a practitioner to a implementation of the types of measures immediately reduce that oral, unsigned, pharmacy, the only way to verify a contained in this interim final rule that prescription to writing pursuant to prescription would be to call the are specifically tailored to safeguard current regulatory requirements. practitioner. against diversion. Comments. A number of commenters DEA Response. DEA does not require Comments. A practitioner asked that DEA postpone the effective the use of any intermediaries in the organization noted that the rule did not date of the final rule, i.e., grant what transmission of electronic prescriptions specify requirements for what the some commenters characterized as an between prescribing practitioners and commenter termed ‘‘pharmacy- ‘‘extended compliance date.’’ Among pharmacies. There is nothing in the rule generated electronic refill requests.’’ The these commenters, the range of that bars the direct transmission of an commenter stated that existing suggested effective dates was from 18 electronic prescription from a electronic prescription applications months to four years after issuance of practitioner to a pharmacy. Until the allow physicians to quickly review and the final rule. SCRIPT standard is mature, however, a approve electronic refill requests from DEA Response. DEA believes it is practitioner whose patients use multiple pharmacies. The commenter asserted unnecessary to postpone the effective pharmacies may have to use that the efficiency of electronic refills is date of the interim final rule because intermediaries to ensure that the one of the major incentives for use of electronic prescriptions for pharmacy will read the data file physicians to electronically prescribe. controlled substances is voluntary. The correctly. DEA believes that the The commenter suggested that the final interim final rule does not mandate that requirements of the interim final rule rule should explicitly state whether practitioners switch to electronic will provide adequate protections. electronic refill requests will require prescribing of controlled substances. As Comments. A number of commenters physicians to take additional steps soon as electronic prescription believed that DEA would, could, or when authorizing refills of controlled applications can come into compliance should conduct data mining of substance prescriptions. with the requirements of these electronic controlled substance DEA Response. The interim final rule regulations they may be used for prescriptions. One commenter saw this allows for a practitioner to authorize the controlled substance prescriptions. as a potential threat to civil liberties. refilling of an electronic prescription for Conversely, practitioners may not use Others saw it as a benefit. A pharmacy a controlled substance in the same existing electronic prescription organization and a chain pharmacy circumstances that the regulations applications to transmit electronic stated that adding requirements for currently allow a practitioner to prescriptions for controlled substances electronic prescriptions will not authorize the refilling of a paper or oral until those applications are in improve DEA’s ability to reduce abuse, prescription for a controlled substance. compliance with the interim final rule. but that data mining could. One In this context, the following aspects of Pharmacy applications may also be used commenter stated that the benefits to be existing law and regulations should be to process electronic prescriptions for gained from data mining would allow noted. Part 1306 allows practitioners to controlled substances once they are in DEA to impose fewer requirements on authorize refills for controlled compliance with the interim final rule, electronic prescriptions. substances in Schedules III, IV, and V but not before. DEA notes that existing DEA Response. DEA does not conduct when the original prescription is electronic prescription applications may a prescription monitoring program (as written. Schedule II prescriptions may be used to create a prescription for some States do) or otherwise engage in not be refilled, as set forth in the CSA, controlled substances, but until the the generalized collection or analysis of and DEA has no authority to depart application is compliant with the rule, controlled substance prescription data;

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nor is it the intent of this rule to provide DEA Response. DEA recognizes the diversion was with the patient, not the a mechanism for such an activity. The value of pilot testing, but does not doctor. real-time data mining that some believe that waiting for pilot testing is DEA Response. DEA notes that there commenters feared and others saw as an necessary or appropriate. Many of the is no substantial regulatory experience advantage of electronic prescribing is provisions DEA proposed in its NPRM on which State Boards of Pharmacy or not contemplated as part of this have been revised based on comments other regulating bodies may draw when rulemaking. This rule permits received; DEA has provided options for it comes to electronic prescriptions for practitioners to write electronic some key items to give registrants and controlled substances as such method of prescriptions for controlled substances application providers alternatives. DEA prescribing has not, prior to the and pharmacies to process those also notes that with so many issuance of this interim final rule, been electronically written prescriptions. applications available, what may be authorized by the DEA regulations. Those applications work independently feasible for one system may be While there has been electronic of DEA and do not directly report burdensome for others, so that pilot prescribing of noncontrolled substances, prescription information to DEA. This testing would not necessarily prove it is not surprising that there may be rule merely establishes requirements whether a particular approach was little evidence of fraud with those applications must meet to be used feasible or difficult for any specific prescriptions for such drugs as they are for electronic prescriptions for application provider. This is far less likely to be abused and diverted controlled substances. particularly true as electronic than controlled substances. One State DEA notes that 38 States have prescription applications can be either Board of Pharmacy seems to have implemented prescription monitoring stand-alone applications or can be misunderstood the purpose of the rule programs that are based on the integrated into more robust or the issues of establishing who altered submission of data from pharmacies applications, such as electronic health a prescription when there is no forensic after the prescriptions have been filled. record applications. evidence. It is true that with a paper These programs may be used to identify Comments. A pharmacy organization prescription, it may, depending on the patients who are obtaining prescriptions asked if the statement in proposed circumstances, be unnecessary to from multiple practitioners at one time § 1311.200(d) is imposing a strict establish when and where a prescription or practitioners who are issuing an liability standard. was altered because the alteration itself unusual number of controlled substance DEA Response. The statement the can provide evidence of who did it. prescriptions. commenter references appeared in both With electronic prescriptions, however, Comments. A State Board of proposed § 1311.100(c) (‘‘Eligibility to there may be no effective means of Pharmacy asserted that there should be issue electronic prescriptions.’’) and proving who made the alteration absent a requirement for application proposed § 1311.200(d) (‘‘Eligibility to evidence of when the change occurred. integration with all electronic medical digitally sign controlled substances Likewise, without such evidence, it is record applications and State prescriptions.’’) It reads: ‘‘The difficult, if not impossible, to achieve prescription data banks so that practitioner issuing an electronic non-repudiation, and thus the persons controlled substance prescriptions are controlled substance prescription is actually responsible for the prescription readily identifiable. responsible if a prescription does not may be able to disclaim responsibility. DEA Response. DEA understands the conform in all essential respects to the As for the practitioner commenter who Board’s concern, but believes what the law and regulations.’’ The statement in attributed the problem to the patient, Board seeks is not feasible or proposed § 1311.100(c) and DEA agrees that patients can be sources appropriate as a DEA regulatory § 1311.200(d) is simply a repetition of of diversion of controlled substances, requirement at this time for two reasons. the existing requirement in current but a considerable amount of diversion First, electronic prescription § 1306.05. This statement has been a also occurs from within practitioners’ applications and electronic health part of the regulations implementing the offices and pharmacies as well. record applications may be installed in CSA since the regulations were first Comments. One application provider many States. Unless all State data banks issued in 1971 following the enactment stated that the evidence that DEA will be configured in exactly the same of the CSA. In the ensuing 38 years, presented on insider threats in the way, it would not be possible for an there has never been an occasion in NPRM would not have been available if application provider to ensure its which a court has declared the these threats had not been identified. application would be integrated with provision to be legally problematic or in The commenter asserted that the ability any particular State system. DEA notes need of elaboration. Accordingly, it is of the Secret Service/Carnegie Mellon that the electronic prescription and appropriate to retain the concept in the study 37 to identify the character of the electronic health record applications context of electronic prescriptions for employees as well as their ‘‘technical’’ will have to be able to identify controlled substances, which DEA is status indicates that existing industry controlled substance prescriptions and doing by incorporating the provision in standards are sufficient to detect and generate logs of those prescriptions. § 1311.100 and § 1311.200. investigate the nature of violations. Second, State systems have generally Comments. Several commenters DEA Response. That studies have obtained data from pharmacies rather questioned DEA’s concern about been able to identify the kinds of people than practitioners. Pharmacy diversion. A State Board of Pharmacy who commit insider crimes does not applications have to be able to identify asserted that it had found less risk of support an argument that insider crimes controlled substance prescriptions. fraud with electronic prescriptions. are, therefore, not a problem or are Comments. A number of commenters Another State Board of Pharmacy easily identified or prosecuted. Further, representing practitioner organizations disagreed that record integrity was most of the insider attacks mentioned in and one application provider stated that needed to prosecute individuals forging the study to which this commenter DEA should not impose any prescriptions, asserting that it did not 37 Insider Threat Study: Illicit Cyber Activity in requirements until those requirements need to prove when and where a the Banking and Financial Sector, August 2004; have been tested and shown ready for prescription was forged or altered. One Insider Threat Study: Computer System Sabotage in use. physician stated that the problem with Critical Infrastructure Sectors, May 2005.

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referred were identified because the DEA Response. Section 1306.05 states logical outgrowths of the proposed rule insiders or former insiders intended the that the practitioner is responsible for and comments. In some instances, attack to be obvious and destructive; ensuring that a prescription conforms in however, DEA has determined that the these were usually revenge attacks by all essential respects with the law and changes from the proposed rule warrant disgruntled employees or former regulation; it also places a additional public comment. To assist employees. With financial insider corresponding liability on pharmacies to the reader in understanding the attacks, the victim has reason to identify ensure that only prescriptions that changes, this section summarizes the the attack because the attack results in conform with the regulations are major revisions. Commenters made a financial losses. If insider attacks occur dispensed. The interim final rule variety of recommendations on each with electronic prescription requires that the electronic prescription issue. Where DEA determined that it applications, the application providers application be capable of capturing all could accept recommendations without will not be the target or suffer financial of the information and that the lessening the security and integrity of losses; their applications will simply be practitioner review the prescription controlled substance prescriptions, it used to commit a crime. In any event, before signing it. This requirement, has done so to provide more flexibility regardless of what studies might purport however, does not relieve a pharmacy of and lessen the burden on practitioners to show with respect to insider attacks its responsibility to ensure that the and pharmacies. of computer-based systems, DEA has an prescription it receives conforms to the Identity proofing. DEA has adopted in obligation in this rulemaking to law and regulations. the interim final rule an approach that establish requirements that are As this interim final rule is a DEA is different from the approach it particularly crafted to maintain effective rule, it is, of course, focused on Federal, proposed. As some commenters controls against diversion of controlled not State, requirements. In view of this recommended, the interim final rule substances in the context of electronic comment, however, it should be noted requires individual practitioners to prescribing. DEA is aware of no study that the CSA has long provided that a obtain NIST SP 800–63–1 Assurance that refutes DEA’s determination about practitioner who fails to comply with Level 3 identity proofing from entities the need for the controls contained in applicable State laws relating to that are Federally approved to conduct this interim final rule. controlled substances is subject to loss such identity proofing; NIST SP 800– 38 Comments. One commenter, a of DEA registration. Similarly, it has 63–1 Assurance Level 3 allows either in- physician, suggested that DEA and the always been the case that compliance person or remote identity proofing, Centers for Medicare and Medicaid with the CSA or DEA regulations does subject to the NIST requirements. The Services go back to the electronic not relieve anyone of the additional federally approved entities will provide prescribing and electronic health record obligation to comply with any State the two-factor authentication credentials for individual practitioners. As industries and tell them to incorporate requirements that pertain to the same 39 commenters suggested, institutional DEA’s proposed system upgrades, that activity. Thus, it is both the practitioners have the option to conduct these be operational in any CCHIT- practitioner’s and the pharmacy’s identity proofing in-house through their approved system before moving ahead responsibility to ensure that the credentialing offices and may issue the with these standards, and that DEA tell prescription complies with all two-factor authentication credentials Congress that no penalties should be applicable laws and regulations. DEA themselves. applied to any non-adopting physician does not limit where a prescription may be filled, nor does it limit where a Access control. In contrast to the before the system has been upgraded to proposed rule, the interim final rule the satisfaction of DEA. prescription may be transferred, provided such transfers take place in a places the responsibility for checking DEA Response. Consistent with the the DEA and State authorities and Administrative Procedure Act, DEA will manner authorized by the DEA regulations. setting logical access on the individual articulate through this interim final rule practice or institution rather than on the those regulatory requirements regarding 3. Beyond the Scope application provider. Commenters electronic prescriptions for controlled A number of commenters raised indicated that many application substances. DEA does not believe it issues that are beyond the scope of this providers were not involved in these would be legally sound or consistent rulemaking (e.g., requirements on the actions. Under the interim final rule, with the public health and safety to number of registrations that a two individuals are required to enter or declare that physicians or any other practitioner must hold, penalties and change logical access controls. The persons may disregard, without legal incentives for electronic prescribing, the applications must limit access for consequence, the standards established inability to set an indefinite quantity in indicating that a controlled substance by this interim final rule. prescriptions for LTCF patients). prescription is ready for signing and Comment. A State said that checks for Consistent with sound APA practice, signing to individuals authorized under the validity and completeness of a and to avoid unnecessary discussion, DEA regulations to do so. prescription should occur at the DEA will not address in this interim Two-factor authentication. The prescriber’s office. A pharmacy final rule such comments that are not interim final rule retains the proposed employee stated that prescribers should directly related to the electronic requirement of two-factor not be able to transmit prescriptions prescribing of controlled substances. authentication, but as commenters unless the prescription meets all requested, allows the option of using a regulations of the State where the L. Summary of Changes From the biometric to replace the hard token or prescription will be filled. This Proposed Rule the knowledge factor. DEA has also individual further believed that In view of the comments that DEA revised the rule to allow the hard token, prescriptions should be allowed to be received, the interim final rule contains when used, to be compliant with FIPS filled anywhere in the country. Finally, a number of changes to the proposed 140–2 Security Level 1 or higher, this individual recommended that there rule. For the most part, the changes are provided that the token is separate from be provisions to permit the transfer of the computer being accessed. DEA has the prescription to another pharmacy 38 21 U.S.C. 823(f)(4). revised the rule to allow practitioners even if it is out of State. 39 See 21 U.S.C. 903. with multiple DEA numbers to use a

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single two-factor authentication Transmission issues. The interim final by the pharmacy. However, as credential per practitioner; the rule adopts the suggestion of some commenters suggested, the interim final application must require these commenters that printing of a rule revises the requirement for practitioners to select the appropriate transmitted electronic prescription be checking the DEA registration of the DEA number for the prescription being permissible provided the printed practitioner to make it consistent with issued. As commenters requested, the prescription is clearly marked as a copy other prescriptions: the pharmacy must interim final rule also includes an not for dispensing. The interim final check the DEA registration when it has application requirement that will allow rule specifies the conditions for printing reason to suspect the validity of the a supervisor’s DEA number to appear on a prescription when transmission fails, registration or the prescription. the prescription provided it is clear as commenters asked. DEA has also Although DEA recommends as a best which DEA number is associated with clarified in the interim final rule that practice offsite storage of backup copies, the prescribing practitioner. the prohibition on alteration of content it is not requiring it in the interim final Creating the prescription. As during transmission applies to the rule as was proposed. proposed, the interim final rule requires actions of intermediaries; changes made that practitioners indicate that each by pharmacies are subject to the same Third-party audits. As commenters controlled substance prescription is rules that apply to all prescriptions for recommended, the interim final rule ready to be signed. As commenters controlled substances. As proposed, allows certification of electronic recommended, however, the patient’s intermediaries are not allowed under prescription applications and pharmacy address need not appear on the review the interim final rule to transform an applications by a DEA-approved screen, but it must still be included on electronic prescription into a facsimile; certification organization to replace a the transmitted prescription, consistent facsimiles of prescriptions are paper third-party audit. The interim final rule with longstanding regulations prescriptions that must be manually also expands beyond the proposed rule applicable to all prescriptions for signed. the list of potential auditors to include controlled substances. The proposed Monthly logs. As some commenters certified information system auditors. attestation statement has been shortened recommended, DEA has retained in the As commenters suggested, the interim and must appear on the screen at the interim final rule the requirement that final rule extends the time frame for time of the review, but, as some the application automatically provide periodic audits from one year to two commenters recommended, does not the practitioner with a monthly log of years, or whenever a functionality require a separate keystroke. Also under the practitioner’s electronic prescribing related to controlled substance the interim final rule, authentication to of controlled substances. However, the prescriptions is altered, whichever the application must occur at signing, interim final rule eliminates the occurred first. eliminating the need for the proposed proposed requirement that the lock-out provision. practitioner indicate his review of the Recordkeeping. Based on the Signing and transmitting the log. DEA has also maintained in the comments received, the interim final prescription. As some commenters interim final rule the proposed rule reduces the recordkeeping period to recommended, the interim final rule requirement that the application two years from the proposed five years. requires two-factor authentication to be provide practitioners a log on request. DEA wishes to emphasize that the synonymous with signing. In fact, the The interim final rule goes somewhat electronic prescribing of controlled interim final rule expressly states that further than the proposed rule in this substances is in addition to, not a the completion of the two-factor respect by requiring that the application replacement of, existing requirements authentication protocol by the allow the practitioner to specify the for written and oral prescriptions for practitioner legally constitutes that time period for log review, and to allow controlled substances. This rule practitioner’s signature of the the practitioner to request and obtain a provides a new option to prescribing prescription. When the practitioner display of up to a minimum of two years practitioners and pharmacies. It does completes the two-factor authentication of prior electronic prescribing of not change existing regulatory protocol, the application must apply its controlled substances and to request a requirements for written and oral (or the practitioner’s) private key to display for particular patients or drugs. prescriptions for controlled substances. digitally sign at least the information Internal audit trails. DEA has Prescribing practitioners will still be required under part 1306. That digitally provided in the interim final rule more able to write, and manually sign, signed record must be electronically detail on the requirements for the prescriptions for Schedule II, III, IV, and archived. As commenters suggested, this internal audit trails required for both V controlled substances, and revision allows other staff members to prescription and pharmacy applications. pharmacies will still be able to dispense add information not required by DEA The interim final rule does not provide regulations after signature, such as a comprehensive list of auditable events controlled substances based on those pharmacy URLs, and at LTCFs, allows as some commenters requested, but written prescriptions and archive those staff to review and annotate records clarifies that auditable events should be records of dispensing. Further, nothing before transmission, so that current limited to potential security problems. in this rule prevents a practitioner or a workflows can be maintained. The For pharmacy applications, the interim practitioner’s agent from using an interim final rule retains the proposed final rule eliminates the proposed existing electronic prescription requirement that the electronic requirement that the audit trail log each application that does not comply with prescription application include an time a prescription is opened, as the interim final rule to prepare a indication that the prescription was commenters suggested. controlled substance prescription signed in the information transmitted to Other pharmacy issues. DEA has electronically, so that EHR and other the pharmacy. retained in the interim final rule the electronic prescribing functionality may PKI. At the suggestion of many proposed requirement that either the be used, and print the prescription for commenters, the interim final rule last intermediary or the pharmacy manual signature by the practitioner. allows any practitioner to use the digital digitally sign the prescription as Such prescriptions are paper signature option proposed for Federal received unless a practitioner’s digital prescriptions and subject to the existing healthcare systems. signature is attached and can be verified requirements for paper prescriptions.

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V. Section-by-Section Discussion of the requirements. To ensure that terms used include the items DEA requires on a Interim Final Rule regarding recordkeeping are understood, prescription. Records are required to be In Part 1300, DEA is adding a new DEA has repeated the definition of capable of being printed upon request. DEA is adding a new § 1304.06 § 1300.03 (‘‘Definitions relating to ‘‘readily retrievable’’ from 21 CFR (‘‘Records and reports for electronic electronic orders for controlled 1300.01(b)(38). This definition is prescriptions.’’) This section does not substances and electronic prescriptions longstanding and is well understood by create new recordkeeping requirements, for controlled substances.’’) The the regulated industry. DEA does not but rather simply consolidates and definitions currently in § 1311.02 are believe that this definition will cause references in one section requirements moved to § 1300.03. Definitions of the the regulated industry any difficulty. that exist in other parts of the rule. This following are established without Since the inception of the CSA, the DEA regulations have defined the term as new section is intended to make it revision from the NPRM: ‘‘audit trail,’’ follows: ‘‘Readily retrievable means that easier for registrants and application ‘‘authentication,’’ ‘‘electronic certain records are kept by automatic providers to understand the records and prescription,’’ ‘‘identity proofing,’’ data processing systems or other reports they are required to maintain. ‘‘intermediary,’’ ‘‘paper prescription,’’ electronic or mechanized recordkeeping Practitioners who issue electronic ‘‘PDA,’’ ‘‘SAS 70,’’ ‘‘SysTrust,’’ ‘‘token,’’ systems in such a manner that they can prescriptions for controlled substances ‘‘valid prescription,’’ and ‘‘WebTrust.’’ be separated out from all other records must use electronic prescription Based on comments received, DEA is in a reasonable time and/or records are applications that retain the record of the establishing the definition of ‘‘hard kept on which certain items are digitally signed prescription token,’’ with changes as discussed asterisked, redlined, or in some other information and the internal audit trail above. Based on comments received, manner visually identifiable apart from and any auditable event identified by DEA is adding definitions of the terms other items appearing on the records.’’ the internal audit trail. Institutional ‘‘application service provider,’’ In its NPRM, DEA proposed to define practitioners must retain a record of ‘‘electronic prescription application the term ‘‘audit’’ as follows: ‘‘audit identity proofing and issuance of the provider,’’ ‘‘installed electronic means an independent review and two-factor authentication credential, prescription application,’’ ‘‘installed examination of records and activities to where applicable, as required by pharmacy application,’’ ‘‘pharmacy assess the adequacy of system controls, § 1311.110. Pharmacies that process application provider,’’ and ‘‘signing to ensure compliance with established electronic prescriptions for controlled function.’’ DEA is updating the proposed policies and operational procedures, substances must use a pharmacy definition of ‘‘NIST SP 800–63’’ to reflect and to recommend necessary changes in application that retains all prescription the most current version of this controls, policies, or procedures.’’ To and dispensing information required by document. provide greater specificity to this term, DEA regulations, the digitally signed Other changes to definitions. Beyond DEA has revised the term to be ‘‘third- record of the prescription as received by the revisions discussed above, DEA has party audit’’ rather than simply ‘‘audit.’’ the pharmacy, and the internal audit made several changes to the definitions The definition remains unchanged from trail and any auditable event identified section established in this rulemaking. the NPRM in all other respects. by the internal audit trail. Registrants Although not specifically discussed by DEA has added definitions of and application service providers must commenters, DEA has made other credential and credential service retain a copy of any security incident changes to certain definitions to provide provider based on the NIST definitions report filed with the Administration. greater clarity, specificity, or precision. in NIST SP 800–63–1. Application providers must retain third- Changes are discussed below. DEA has added definitions for the party audit or certification reports and To address the use of a biometric as updated NIST FIPS standards. Finally, any adverse audit or certification reports one possible factor in a two-factor DEA is defining the term ‘‘trusted agent’’ filed with the Administration regarding authentication credential, DEA is to provide greater specificity regarding problems identified by the third-party adding definitions specific to that identity proofing conducted by audit or certification. All records must subject. Specifically, DEA is adding institutional practitioners. be retained for two years unless definitions of ‘‘biometric subsystem,’’ In Part 1304, § 1304.04 is revised to otherwise specified. DEA is not ‘‘false match rate,’’ ‘‘false non-match limit records that cannot be maintained establishing any recordkeeping rate,’’ ‘‘NIST SP 800–76–1,’’ and at a central location to paper order requirements for credential service ‘‘operating point.’’ While DEA is adding forms for Schedule I and II controlled providers or certification authorities a definition of ‘‘password’’ to mean ‘‘a substances and paper prescriptions. In because they are already subject to such secret, typically a character string paragraph (b)(1), DEA is removing the requirements under the terms of (letters, numbers, and other symbols), reference to prescriptions; all certificate policies or frameworks they that a person memorizes and uses to prescription requirements are moved to must meet to gain Federal approval. authenticate his identity,’’ DEA is not paragraph (h). Paragraph (h), which In Part 1306 (‘‘Prescriptions’’) establishing any regulations regarding details pharmacy recordkeeping, is § 1306.05 is amended to state that password strength, length, format, or revised to limit the current requirements electronic prescriptions must be created character usage. to paper prescriptions and to state that and signed using an application that In the definition of authentication electronic prescriptions must be meets the requirements of part 1311 and protocol, DEA revised the language retrievable by prescriber’s name, patient to limit some requirements to paper slightly to read: ‘‘Authentication name, drug dispensed, and date filled. prescriptions (e.g., the requirement that protocol means a well specified message The electronic records must be in a paper prescriptions have the exchange process that verifies format that will allow DEA or other law practitioner’s name stamped or hand- possession of a token to remotely enforcement agencies to read the printed on the prescriptions). The authenticate a person to an application.’’ records and manipulate them; section also adds ‘‘computer printer’’ to The proposed language had read ‘‘to preferably the data should be the list of methods for creating a paper remotely authenticate a prescriber.’’ downloadable to a spreadsheet or prescription and clarifies that a As discussed elsewhere in this rule, database format that allows DEA to sort computer-generated prescription that is DEA is revising certain recordkeeping the data. The data extracted should only printed out or faxed must be manually

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signed. DEA is aware that in some cases, prescriptions are consistent with those lost, stolen, or compromised, or the an intermediary transferring an for paper and oral prescriptions. authentication protocol has otherwise electronic prescription to a pharmacy Finally, DEA notes that it had been compromised. may convert a prescription to a proposed a new § 1306.28 to state the If the practitioner is notified by an facsimile if the intermediary cannot basic recordkeeping requirements for intermediary or pharmacy that an complete the transmission pharmacies for all controlled substance electronic prescription was not electronically. As discussed previously prescriptions. Those requirements are successfully delivered, he must ensure in this rule, for controlled substance present in § 1304.22. Although DEA that any paper or oral prescription prescriptions, transformation to initially believed that including these (where permitted) issued as a facsimile by an intermediary is not an requirements in part 1306 would be replacement of the original electronic acceptable solution. The section, as beneficial, after further consideration prescription indicates that the proposed, is also revised to divide DEA believes that they would be prescription was originally transmitted paragraph (a) into shorter units. redundant and could, in fact, create electronically to a particular pharmacy Section 1306.08 is added to state that confusion. Therefore, DEA is not and that the transmission failed. practitioners may sign and transmit finalizing proposed 21 CFR 1306.28. As discussed previously, if the third- controlled substance prescriptions DEA is revising the title of part 1311 party auditor or certification electronically if the applications used as proposed. organization finds that an electronic are in compliance with part 1311 and all Section 1311.08 is revised to include prescription application does not other requirements of part 1306 are met. the incorporations by reference of FIPS accurately and consistently record, Pharmacies are allowed to handle 180–3, Secure Hash Standard; FIPS store, and transmit the information 186–3, Digital Signature Standard; and electronic prescriptions if the pharmacy related to the name, address, and NIST SP 800–63–1 Draft Electronic application complies with part 1311 and registration number of the practitioner, Authentication Guideline. patient name and address, and the pharmacy meets all other applicable Subpart C is being added by this requirements of parts 1306 and 1311. prescription information (drug name, interim final rule. DEA has revised the strength, quantity, directions for use), As proposed, §§ 1306.11, 1306.13, and content of proposed subpart C, as the indication of signing, and the 1306.15 are revised to clarify how the discussed above, and has reorganized number of refills, the practitioner must requirements for Schedule II the subpart. The following describes not use the application to sign and prescriptions apply to electronic each of the sections in the interim final transmit electronic prescriptions for the prescriptions. subpart C. controlled substances. As proposed, § 1306.21 is revised to Section 1311.100 provides the general Further, if the third-party auditor or clarify how the requirements for requirements for issuing electronic certification organization finds that an Schedule III, IV, and V prescriptions controlled substance prescriptions. It electronic prescription application does apply to electronic prescriptions. clarifies that the rules apply to all not accurately and consistently record, As proposed, § 1306.22 is revised to controlled substance prescriptions; the store, and transmit other information clarify how the requirements for same electronic prescription required for prescriptions, the Schedule III and IV refills apply to requirements apply to Schedule II practitioner must not sign and transmit electronic prescriptions and to clarify prescriptions as apply to other electronic prescriptions for controlled that requirements for electronic refill controlled substance prescriptions. DEA substances that are subject to the records for paper, fax, or oral notes that the statutory prohibition on additional information requirements. prescriptions do not apply to electronic refilling Schedule II prescriptions In most cases, this will not be an issue refill records for electronic remains in effect regardless of whether as the SCRIPT standard supports the prescriptions. Pharmacy applications the prescription is issued electronically standard information required for a used to process and retain electronic or on paper (21 U.S.C. 829(a), 21 CFR prescription. A limited number of controlled substance prescriptions are 1306.12(a)). Only a practitioner prescriptions, however, require special required to comply with the registered or exempt from registration information. Prescriptions for GHB requirements in part 1311. In addition, and authorized to issue the prescription require a note on medical need; DEA is breaking up the text of the may do so; the prescription must be prescriptions for drugs used for existing section into shorter paragraphs created on an application that meets all detoxification and maintenance to make it easier to read. of the requirements of part 1311 subpart treatment require an additional DEA As proposed, § 1306.25 is revised to C. A prescription is not valid if the identification number. Schedule II include separate requirements for application does not meet the prescriptions may be issued with transfers of electronic prescriptions. requirements of the subpart or if any of written instructions indicating the These revisions are needed because an the required application functions were earliest date that the prescription may electronic prescription could be disabled when it was created. A be filled. DEA is not certain that the transferred without a telephone call pharmacy may process electronic existing SCRIPT standard between pharmacists. Consequently, the controlled substance prescriptions only accommodates the additional transferring pharmacist must provide, if its application meets the requirements information or that existing pharmacy with the electronic transfer, the of the subpart. applications accurately and consistently information that the recipient Section 1311.102 specifies the capture and display such information. transcribes when accepting an oral practitioner’s responsibilities. A Because there are relatively few transfer. DEA notes that the NPRM practitioner must retain sole control of prescriptions with these requirements, contained language proposing to permit the hard token, where applicable, and DEA decided to place the onus on the an electronic prescription to be must not share the password or other third-party auditors or certification transferred more than once, in conflict knowledge factor or biometric organizations to determine whether with the requirements for paper and oral information. The practitioner must applications can create, transmit, prescriptions. DEA has removed this notify the individuals designated to set import, display, and store all of the proposed requirement; all transfer logical access controls within one information needed for these requirements for electronic business day if the hard token has been prescriptions. If an electronic

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prescription application does not allow the requirements that hard tokens must from automatically filling in the DEA the entry of this additional information, meet. number field when a practitioner uses the practitioner must not issue the Section 1311.116 specifies the more than one number. prescriptions electronically. DEA requirements that biometric subsystems Section 1311.120(b)(8) states that the decided that this approach was must meet. electronic prescription application must preferable to making it an application Section 1311.120 provides the have a time application that is within requirement that all applications would electronic prescription application five minutes of the official National have to meet before they could be used requirements. Institute of Standards and Technology to issue or process any controlled Section 1311.120(b)(1) requires an time source. substance prescriptions electronically. electronic prescription application to Section 1311.120(b)(9) specifies the DEA believes that there may be a link each registrant, by name, with a information that must appear on the difference between adding a single- DEA registration number. For review screen. As explained above, if a character field to the SCRIPT standard, practitioners exempt from the practitioner has written several indicating that the prescription was requirement of registration under prescriptions for a single patient, the signed, which would be transmitted § 1301.22(c), the application must link practitioner’s and patient’s information with almost all prescriptions, and each practitioner to the institutional may appear only once on the review adding a set of additional fields, some practitioner’s DEA registration number screen. of which could be defined in multiple and the specific internal code number Section 1311.120(b)(10) states that the ways. For example, future fill dates required under § 1301.22(c)(5). application must require the could be placed in fields defined as Section 1311.120(b)(2) requires an practitioner to indicate that each future fill dates and presented as dates electronic prescription application to controlled substance prescription is or they could be presented as text. allow setting of logical access controls ready for signing. If any of the NCPDP may need time to decide how to for indicating that prescriptions are information required under part 1306 is add fields to capture this information; ready to be signed and signing altered after the practitioner has application providers cannot begin to controlled substance prescriptions. It indicated that it is ready for signing, the reprogram until decisions on the also requires the application to allow application must remove the indication standard are reached. DEA does not the setting and changing of logical that it is ready for signing and require believe it is necessary or appropriate to access controls. another indication before allowing it to delay adoption of electronic controlled Section 1311.120(b)(3) states that be signed. The application must not substance prescriptions until these logical access controls must be set by allow the signing or transmission of a issues are resolved. user name or role. If the application prescription that was not indicated as Section 1311.102 also states that a uses role-based access controls, it must ready to be signed. practitioner must not use the not allow an individual to be assigned Section 1311.120(b)(11) provides the application for controlled substance the role of registrant unless the requirement that the practitioner use the prescriptions if any of the functions individual is linked to a DEA two-factor authentication protocol to have been disabled or is not working registration number. sign the prescription. properly. Finally, if the application Section 1311.120(b)(4) requires that Section 1311.120(b)(12) states that the provider notifies him that the third- setting and changing of logical access application must not allow a party audit indicated that the controls must take the actions of two practitioner to sign a prescription if his application does not meet the individuals, as discussed above. two-factor authentication credential is requirements of part 1311, or that the Section 1311.120(b)(5) states that the not associated with the prescribing application provider has identified a application must accept two-factor practitioner’s DEA number listed on the problem that makes the application non- authentication credentials and require prescription (or an institutional compliant, the practitioner must their use for approving logical access practitioner’s DEA number and the immediately cease to issue controlled controls and signing prescriptions. prescriber’s extension data). The substance prescriptions using the Section 1311.120(b)(6) states that an application will have to associate each application and must ensure that access electronic controlled substance two-factor authentication credential for signing controlled substance prescription must contain all of the with the registrant’s DEA number(s) (or prescriptions is terminated. The information required under part 1306. institutional practitioner’s DEA number practitioner must not use the As commenters pointed out, although plus the individual practitioner’s application to issue controlled the SCRIPT standard has fields for most extension data) and ensure that only the substance prescriptions until it is of this information, the use of these authentication credentials associated notified that the application is again fields is not always mandated. Some of with the number on the prescription can compliant and all relevant updates to the required information may have to be indicate the prescription as ready for the application have been installed. put in free text fields (e.g., internal signing and sign it. This provision is Sections 1311.105 and 1311.110 institutional code data or service needed to prevent one registrant in a specify the requirements for obtaining identification numbers for practitioners practice from reviewing and signing an authentication credential for exempt from registration, the medical prescriptions written by other individual practitioners and need for GHB prescriptions, a separate registrants. DEA recognizes that with practitioners using an institutional identification number for certain paper prescriptions, DEA numbers for practitioner’s application, as discussed prescriptions). every member of a practice may be above. Section 1311.120(b)(7) states that the printed on a prescription pad; only the Section 1311.115 specifies the application must require the signature indicates which practitioner requirements for two-factor practitioner or his agent to select the issued the prescription. For electronic authentication. It allows the DEA number to be used for the prescriptions, however, only one authentication protocol to use any two prescription where the practitioner prescribing practitioner’s name will of the three authentication factors issues prescriptions under more than appear and one DEA number. Although (something you know, something you one DEA number. This provision is the authentication credential will be are, and something you have) and sets intended to prevent the application associated with only one practitioner, it

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may be associated with more than one Section 1311.120(b)(19) states that the Section 1311.140 provides the DEA number. If a practitioner needs to information required under part 1306 application requirements for signing an sign a prescription originally created must not be altered after the electronic prescription for a controlled and indicated as ready for signing by prescription is digitally signed. If any of substance. It requires that the screen another practitioner in a practice, he the required information is altered, the displaying the prescription information must change the practitioner name and prescription must be canceled. for review include the statement that DEA number to his own, then indicate Section 1311.120(b)(20) through (22) completing the two-factor that the prescription is ready to sign and specify the requirements for printing authentication protocol signs the execute the two-factor authentication transmitted prescriptions. prescription and that only the protocol to sign it. Section 1311.120(b)(23) states that the practitioner whose name and DEA Section 1311.120(b)(13) states that application must maintain an audit trail number are on the prescription may sign where a practitioner seeks to prescribe related to the following: The creation, it. After the practitioner has indicated more than one controlled substance at alteration, indication of readiness for that one or more controlled substance one time for a particular patient, the signing, signing, transmission, or prescriptions for a single patient are electronic prescription application may deletion of a controlled substance ready for signing, the application must allow the practitioner to sign multiple prescription; the setting or changing of prompt the practitioner to execute the prescriptions for a single patient at one logical access controls related to two-factor authentication protocol. The time using a single invocation of the controlled substance prescriptions; and completion of the two-factor two-factor authentication protocol any notification of failed transmission. authentication protocol must apply the provided that the practitioner has Section 1311.120(b)(24) specifies the application’s (or practitioner’s) digital individually indicated that each information that must be maintained in signature to the DEA-required controlled substance prescription is the audit trail: Date and time of the information and electronically archive ready to be signed while all the action, type of action, identity of the the digitally signed record. The prescription information and the person taking the action, and outcome. application must clearly label as the statement described in § 1311.140 are Section 1311.120(b)(25) states that the signing function the function that displayed. application must be capable of applies the digital signature. Any Section 1311.120(b)(14) states that the conducting an internal audit and controlled substance prescription not application must time and date stamp generating a report on auditable events. signed in this manner must not be the prescription on signing. Section 1311.120(b)(26) states that the transmitted. Section 1311.145 specifies the Section 1311.120(b)(15) states that application must protect audit trail requirements for the use of a when the practitioner executes the two- records from unauthorized deletion, and practitioner’s digital certificate and the factor authentication protocol, the must prevent modifications to the associated private key. The digital application must digitally sign and records. certificate must have been obtained in electronically archive at least the Section 1311.120(b)(27) specifies the accordance with the requirements of information required by DEA. If the requirements for the monthly log. § 1311.105. The digitally signed record practitioner is signing the prescription Section 1311.120(b)(28) specifies that must be electronically archived. The with his own private key, the all records that the application is section specifies that if the prescription application must electronically archive required to generate and archive must is transmitted without the digital the digitally signed prescription, but be retained electronically for at least signature attached, the application must need not digitally sign the prescription two years. check the Certificate Revocation List to a second time. Sections 1311.125 and 1311.130 ensure that the certificate is valid and Section 1311.120(b)(16) specifies the specify the requirements for setting and must not transmit the prescription if the requirements for a digital signature. The changing logical access controls at an certificate has expired. The section also cryptographic module must be validated individual practitioner’s practice and at clarifies that if a practitioner uses his at FIPS 140–2 Security Level 1. The an institutional practitioner, own private key, the application need digital signature application and hash respectively. not apply its private key to sign the function must comply with FIPS 186–3 Section 1311.135 sets the basic record. and FIPS 180–3. The electronic application requirements for creating an Section 1311.150 specifies the prescription application’s private key electronic controlled substance requirements for auditable events for must be stored encrypted on a FIPS prescription. It states that either a electronic prescription applications. 140–2 Security Level 1 validated practitioner or his agent may enter Auditable events must include at least cryptographic module using a FIPS- prescription information. If a DEA the following: attempted or successful approved encryption algorithm. For registrant holds more than one unauthorized access to the application; software implementations, when the registration that he uses to issue attempted or successful unauthorized signing module is deactivated, the prescriptions, the application must deletion or modification of any records application must clear the plain text require him to select the registration required by part 1311; interference with password from the application memory number for each prescription. The application operations related to to prevent the unauthorized access to, or application cannot set a default or pre- prescriptions; any setting of or changes use of, the private key. fill the field if the practitioner has more to logical access controls related to Section 1311.120(b)(17) states that the than one registration. If a practitioner controlled substance prescriptions; prescription transmitted to the has only one registration, as most attempted or successful interference pharmacy must include an indication practitioners do, the application could with audit trail functions; and, for that the prescription was signed unless automatically fill that field. If required application service providers, attempted the prescription is being transmitted by State law, a supervisor’s name and or successful creation, modification, or with the practitioner’s digital signature. DEA number may be listed on a destruction of controlled substance Section 1311.120(b)(18) states that a prescription, provided the prescription prescriptions or logical access controls prescription must not be transmitted clearly indicates who is the supervisor related to controlled substance unless the signing function was used. and who is the prescribing practitioner. prescriptions by any agent or employee

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of the application service provider. The prescription data file to another form that digitally sign prescription records application must run the internal audit (e.g., facsimile) for transmission. upon receipt. once every calendar day and generate a Section 1311.200 specifies the Section 1311.205(b)(5) states that the report that identifies any auditable pharmacy’s responsibility to process pharmacy application must validate a event. This report must be reviewed by controlled substance electronic practitioner’s digital signature if the an individual authorized to set access prescriptions only if the application pharmacy accepts prescriptions digitally controls. If the auditable event meets the requirements of part 1311. signed by the practitioner and compromised or could have The section also requires the pharmacy transmitted with the digital signature. compromised the integrity of the to determine which employees may Section 1311.205(b)(6) states that if a records, this must be reported to DEA access functions for annotating, altering, practitioner’s digital signature is not and the application provider within one and deleting prescription information sent with the prescription, either the business day of discovery. (to the extent such alteration is application must check for the Section 1311.170 requires that the permitted by the CSA and its indication that the prescription was application transmit the prescription as implementing regulations) and for signed or the application must display soon as possible after signature by the implementing those logical access the indication for the pharmacist to practitioner. The section requires that controls. As discussed previously, if the check. the electronic prescription application third-party auditor or certification Section 1311.205(b)(7) states that the not allow the printing of an electronic organization finds that a pharmacy application must read and retain the prescription that has been transmitted application does not accurately and entire DEA number including the unless the pharmacy or intermediary consistently import, store, and display specific internal code number assigned notifies the practitioner that the the information related to the name, to an individual practitioner prescribing electronic prescription could not be address, and registration number of the controlled substances using the delivered to the pharmacy designated as practitioner, patient name and address, registration of the institutional the recipient or was otherwise rejected. and prescription information (drug practitioner. If a practitioner is notified that an name, strength, quantity, directions for Section 1311.205(b)(8) states that the electronic prescription was not use), the indication of signing, and the application must read and store, and be successfully delivered to the designated number of refills, the pharmacy must capable of displaying, all of the pharmacy, the application may print the not accept electronic prescriptions for prescription information required under prescription for the practitioner’s the controlled substance. If the third- part 1306. manual signature. The prescription party auditor or certification Section 1311.205(b)(9) states that the must include information noting that organization finds that a pharmacy pharmacy application must read and the prescription was originally application does not accurately and store in full the information required transmitted electronically to [name of consistently import, store, and display under § 1306.05(a). Either the specific pharmacy] on [date/time], and other information required for pharmacist or the application must that transmission failed. prescriptions, the pharmacy must not verify all the information is present. Section 1311.205(b)(10) states that the accept electronic prescriptions for The section indicates that the application must allow the pharmacy to controlled substances that are subject to application may print copies of the add information on the number/volume the additional information transmitted prescription if they are of the drug dispensed, the date requirements. clearly labeled as copies not valid for dispensed, and the name of the The section specifies that if a dispensing. Data on the prescription dispenser. may be electronically transferred to prescription is received electronically, Section 1311.205(b)(11) specifies that medical records and a list of all annotations and recordkeeping the application must be capable of prescriptions written may be printed for related to that prescription must be retrieving prescription information by patients if the list indicates that it is for retained electronically. The section practitioner name, patient name, drug informational purposes only. The reiterates the responsibility of the name, and date dispensed. section clarifies that the electronic pharmacy to dispense controlled Section 1311.205(b)(12) states that the prescription application must not allow substances only in response to application must allow downloading of the transmission of an electronic legitimate prescriptions. prescription data into a form that is prescription if a prescription was Section 1311.205 provides the readable and sortable. printed for signature prior to attempted requirements for pharmacy applications. Section 1311.205(b)(13) states that the transmission. Section 1311.205(b)(1) states that the application must maintain an audit trail Finally, the section specifies that the application must allow the pharmacy to related to the following: The receipt, contents of the prescription required set access controls to limit access to annotation, alteration, or deletion of a under part 1306 must not be altered functions that annotate, alter, or delete controlled substance prescription; and during transmission between the prescription information, and to the the setting or changing of logical access practitioner and pharmacy. Any change setting or changing of logical access controls related to controlled substance to this required content during controls. prescriptions. transmission, including truncation or Section 1311.205(b)(2) states that Section 1311.205(b)(14) specifies the removal of data, will render the logical access controls must be set by information that must be maintained in prescription invalid. The contents may name or role. the audit trail: Date and time of the be converted from one software version Section 1311.205(b)(3) specifies that action, type of action, identity of the to another; conversion includes altering the application must digitally sign and person taking the action, and outcome. the structure of fields or machine archive an electronic prescription upon Section 1311.205(b)(15) states that the language so that the receiving pharmacy receipt or be capable of receiving and application must generate a daily report application can read the prescription archiving a digitally signed record. of auditable events (if they have and import the data into its application. Section 1311.205(b)(4) specifies the occurred). At no time may an intermediary convert requirements for the digital signature Section 1311.205(b)(16) states that the an electronic controlled substance functionality for pharmacy applications application must protect the audit trail

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from unauthorized deletion and shall Application providers must make of assurance.40 The guidance describes prevent modification of the audit trail. audit reports available to any four levels of identity assurance for Section 1311.205(b)(17) states that the practitioner or pharmacy that uses or is electronic transactions and provides application must back up files daily. considering using the application to standards to be used to determine the Section 1311.205(b)(18) states that the handle controlled substance level of risk associated with a application must retain records for two prescriptions. The rule also requires transaction and, therefore, the level of years from the date of their receipt or application providers to notify both assurance needed. Assurance is the creation. their users and DEA of adverse audit degree of confidence in the vetting Section 1311.210 sets the reports or certification decisions. Users process used to establish the identity of requirements for digitally signing the must be notified within five business an individual to whom a credential was prescription as received and archiving days; DEA must be notified within one issued, the degree of confidence that the the record. It also sets the requirements business day. individual who uses the credential is for validating a prescription that has the Section 1311.302 requires application the individual to whom the credential practitioner’s digital signature attached. was issued, and the degree of Section 1311.215 specifies the providers to notify practitioners or pharmacies, as applicable, of any confidence that a message when sent is requirements for auditable events for secure. OMB established four levels of pharmacy applications. Auditable problem that they identify that makes the application noncompliant with part assurance: events must include at least the Assurance Level 1: Little or no following: Attempted or successful 1311. When providing patches and updates to the application to address confidence in the asserted identity’s unauthorized access to the application; validity. attempted or successful unauthorized these problems, the application provider must inform the users that the Assurance Level 2: Some confidence deletion or modification of any records in the asserted identity’s validity. required by part 1311; interference with application may not be used to issue or process electronic controlled substance Assurance Level 3: High confidence in application operations related to the asserted identity’s validity. prescriptions; any setting of or changes prescriptions until the patches or updates have been installed. DEA is Assurance Level 4: Very high to logical access controls related to confidence in the asserted identity’s controlled substance prescriptions; requiring that practitioners and pharmacies be notified as quickly as validity. attempted or successful interference M–04–04 states that to determine the with audit trail functions; and, for possible, but no later than five business days after the problem is identified. appropriate level of assurance in the application service providers, attempted user’s asserted identity, agencies must or successful annotation, alteration, or Section 1311.305 specifies assess the potential risks and identify destruction of controlled substance recordkeeping requirements for records measures to minimize their impact. The prescriptions or logical access controls required by part 1311. document states that the risk from an related to controlled substance VI. Incorporation by Reference authentication error is a function of two prescriptions by any agent or employee factors: (a) Potential harm or impact and of the application service provider. The The following standards are (b) the likelihood of such harm or application must run the internal audit incorporated by reference: impact. NIST SP 800–63–1 supplements once every calendar day and generate a • FIPS Pub 180–3, Secure Hash M–04–04 and defines the steps report that identifies any auditable Standard (SHS), October 2008. necessary to reach each assurance level event. This report must be reviewed by • FIPS Pub 186–3, Digital Signature for identity proofing that precedes the the pharmacy. If the auditable event Standard (DSS), June 2009. issuance of the credential; the use of compromised or could have • credential once issued; and the compromised the integrity of the Draft NIST Special Publication 800– transmission of any document ‘‘signed’’ records, this must be reported to DEA 63–1, Electronic Authentication with the credential. In plain language, and the application service provider, if Guideline, December 8, 2008; Burr, W. an e-authentication risk assessment applicable, within one business day of et al. considers two issues: discovery. • NIST Special Publication 800–76–1, • How important is it to know that Section 1311.300 specifies the Biometric Data Specification for the person who is issued a credential is, requirements for third-party audits Personal Identity Verification, January in fact, the person whose identity is discussed above and includes the option 2007. of substituting a certification from an associated with the credential. These standards are available from the • How important is it to be certain organization and certification program National Institute of Standards and that the person who uses the credential, approved by DEA. Audits or Technology, Computer Security once it is issued, is the person to whom certifications must occur before the Division, Information Technology it was issued. application may be used to create, sign, Laboratory, National Institute of This risk assessment addresses the transmit, or process electronic Standards and Technology, 100 Bureau level of assurance needed to allow the controlled substance prescriptions, and Drive, Gaithersburg, MD 20899–8930 use of electronic prescriptions for whenever a functionality related to and are available at http://csrc.nist.gov/ controlled substances. This section controlled substance prescription . summarizes the assessment that DEA requirements is altered or every two conducted for the interim final rule. The years, whichever occurs first. Audits VII. Required Analyses full risk assessment is available in the must be conducted by a person qualified A. Risk Assessment for Electronic docket. to conduct a SysTrust, WebTrust, or Prescriptions for Controlled Substances As discussed in Section IV J of this SAS 70 audit, or a Certified Information The Office of Management and preamble, M–04–04 requires that an System Auditor who performs Agency assess risks as low, moderate, or compliance audits as a regular ongoing Budget’s E-Authentication Guidance for Federal Agencies (M–04–04) requires business activity. DEA is seeking 40 Office of Management and Budget. ‘‘E- comment regarding the use of Certified agencies to ensure that authentication Authentication Guidance for Federal Agencies’’ M– Information System Auditors. processes provide the appropriate level 04–04. December 16, 2003.

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high for six factors (see Table 1), then the ratings DEA developed in its risk the rationale for each (for the full determines the Assurance Level needed assessment for the proposed rule and discussion, see 73 FR 36731–36739). based on the ratings. Table 3 presents

TABLE 3—INITIAL RATING OF POTENTIAL IMPACTS FOR AUTHENTICATION ERRORS FOR ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES

Potential impact Initial rating Rationale

Inconvenience, Distress, or Damage to Stand- Moderate—At worst, serious short-term or lim- Identity theft, issuance of illegitimate prescrip- ing or Reputation. ited long-term inconvenience, distress, or tions in a practitioner’s name, or alteration damage to the standing or reputation of any of prescriptions could expose practitioners party. to legal difficulties and force them to prove that they had not used an electronic pre- scription application or issued specific pre- scriptions. Financial Loss ...... N/A. Harm to Agency Programs or Public Interests .. High—A severe or catastrophic adverse effect Were there identity theft or the misuse of a on organizational operations or assets, or credential issued to a registrant, the poten- public interests. Examples of severe or cat- tial exists for widespread and rapid diver- astrophic effects are: (i) severe mission ca- sion of controlled substances. Such diver- pability degradation or loss of (sic) to the sion would undermine the effectiveness of extent and duration that the organization is prescription laws and regulations of the unable to perform one or more of its pri- United States. This diversion would, by its mary functions; or (ii) major damage to or- very nature, harm the public health and ganizational assets or public interests. safety, as any illicit drug use does. Such di- version would undermine the effectiveness of the entire United States closed system of distribution created by the CSA and would, for the same reason, be incompatible with United States obligations under inter- national drug control treaties. Unauthorized release of Sensitive Information .. N/A. Personal Safety ...... High—A risk of serious injury or death ...... Failure to limit the potential for diversion could result in an increase in drug abuse and in the associated deaths and illnesses as well as other social harms. Civil or Criminal Violations ...... High—A risk of civil or criminal violations that A practitioner whose identity was stolen to are of special importance to enforcement gain a credential or whose credential was programs. used by someone else to issue a prescrip- tion for a controlled substance could be subject to legal action in which the practi- tioner would have to prove that he was not responsible for the prescriptions. Such legal action against the practitioner could include criminal prosecution, civil fine proceedings, and administrative proceedings to revoke the practitioner’s DEA registration.

Under M–04–04, the overall rating is substances rests on the principle of Access control. The possession of a driven by the highest rating assigned. separation of duties. The interim final credential by the practitioner, while Therefore, the potential impact of not rule requires that practitioners wishing necessary to legally sign controlled being able to limit authentication to prescribe controlled substances substance prescriptions, is not sufficient credentials to DEA registrants is rated as undergo identity proofing by an to do so. After the practitioner has high, which means that without independent third-party credential obtained the credential, a person in the mitigating factors, DEA should impose service provider (CSP) or certification practitioner’s office (assuming that the requirements that meet Assurance Level authority (CA) that is recognized by a practitioner is in private practice in an 4 under NIST SP 800–63–1. Federal agency as conducting identity office setting) must enter information Mitigating Factors: proofing at the basic assurance level into the electronic prescription DEA included a number of elements (Assurance Level 3 for CAs) or greater. application identifying the practitioner in the interim final rule that mitigate the The CSP or CA will then issue the as a person authorized to prescribe risks of unauthorized access to the credential. This approach removes the controlled substances. A second person electronic prescription application and electronic prescription application in that office, who must be a DEA reduce the potential for diversion. provider from the process of issuing the registrant, must approve the information While some of these relate to entered and grant the practitioner access credential, which limits the ability of authentication to the application, others to the electronic prescription individuals at the application provider relate to use of the application itself. application for the purpose of signing to steal identities and ensures, to as Separation of duties. DEA’s premise controlled substance prescriptions using great an extent as possible, that a person for its requirements regarding the access the practitioner’s credential. (Note that to any electronic prescription will not be issued a credential using a similar system involving separation of application to prescribe controlled someone else’s identity. duties is being implemented for

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institutional practitioners, i.e., hospitals This step ensures that there is a record requirements on the security of the and clinics. That system has similar of the prescription as signed and allows transmission.) conceptual requirements, but involves other people in the practice or facility As has been discussed previously, it different people in the physical to add information not required by DEA, is important to note that the electronic processes.) (e.g., pharmacy URLs) or review the prescribing of controlled substances is This separation of duties ensures that prescription before transmission. voluntary—practitioners may still even if someone is able to impersonate • The application must not allow a dispense controlled substances through a practitioner and obtain a credential practitioner to sign a prescription if his the use of written prescriptions, from an independent third-party CSP or credential is not linked to the DEA regardless of whether they choose to CA, that impersonator will not be able number listed on the prescription. write controlled substances • to gain access to the electronic The application must undergo a prescriptions electronically. Also, the prescription application to sign third-party audit to determine whether compromise of an authentication controlled substance prescriptions it complies with the requirements of the protocol through loss, credential unless the impersonator also has the interim final rule. invalidation, or other cause, does not assistance of two persons (one of whom In addition, as part of their approval invalidate the practitioner’s authority to is a DEA registrant) within a by the Federal Government, CSPs and write controlled substances practitioner’s office. In this way, it will CAs issuing credentials undergo third- prescriptions. Practitioners may be significantly more difficult for party audits to ensure compliance with continue to write controlled substances impersonators to gain access to sign Federal Government standards. prescriptions on paper or generate a controlled substance prescriptions, Conclusion: Consistent with M–04–04, DEA prescription electronically to be printed reducing the possibility of and signed manually even if their authentication errors and lessening the believes that it is appropriate for the agency to accept lower level credentials authentication credential has been potential for diversion. compromised, so long as the Use of two-factor authentication. DEA in view of the mitigating factors discussed above. M–04–04 states, in practitioner continues to possess a DEA is requiring the use of two-factor registration. authentication. Assurance Level 4 pertinent part (in Section 2.5): requires a hard token that is separate Agencies may also decrease reliance on B. Executive Order 12866 from the computer to which the person identity credentials through increased risk- Under Executive Order 12866 (58 FR mitigation controls. For example, an agency is gaining access, but also imposes more 51735, October 4, 1993), DEA must stringent requirements on the business process rated for Level 3 identity assertion assurance may lower its profile to determine whether a regulatory action is cryptographic module and the token. ‘‘significant’’ and, therefore, subject to DEA has determined that combining the accept Level 2 credentials by increasing system controls or ‘second level Office of Management and Budget requirements for Assurance Level 3 authentication’ activities. review and the requirements of the tokens (i.e., FIPS 140–2 Security Level Executive Order. The Order defines 1 tokens used in combination with Following this approach, DEA has ‘‘significant regulatory action’’ as one another factor to reach Assurance Level concluded that, even though the agency that is likely to result in a rule that may: 3) with the requirement that the token rates overall identity assurance for (1) Have an annual effect on the be separate from the computer will electronic prescribing of controlled economy of $100 million or more or provide sufficient security to mitigate substances at Assurance Level 4, the adversely affect in a material way the the risk of misuse. Keeping the token agency believes that Level 3 credentials separate from the computer being are acceptable in view of the system economy, a sector of the economy, accessed makes it much easier for the controls that are mandated by this productivity, competition, jobs, the practitioner to control access to his interim final rule. Specifically, DEA environment, public health or safety, or credential. A person would have to believes that the requirements that the State, local, or tribal government or obtain both the token and the second interim final rule imposes for identity communities. factor to gain access. (Note that DEA is proofing, logical access controls, the (2) Create a serious inconsistency or also permitting the use of biometrics as separation of the hard token from the otherwise interfere with an action taken one of the factors that may be used for computer being accessed, and the or planned by another agency. authentication; the biometric could application requirements lower the (3) Materially alter the budgetary replace either the hard token or the potential for a nonregistrant to steal an impact of entitlements, grants, user fees, knowledge factor.) identity or gain access to a registrant’s or loan programs or the rights and Application requirements. In addition credential and issue illegal prescriptions obligations of recipients thereof. to the requirements discussed above, sufficiently to render acceptable remote (4) Raise novel legal or policy issues DEA is also imposing the following identity proofing, consistent with NIST arising out of legal mandates, the requirements on the electronic SP 800–63–1 Assurance Level 3 President’s priorities, or the principles prescription application that will requirements, and the use of FIPS 140– set forth in the Executive Order. mitigate the risks: 2 Security Level 1 hard tokens that in A copy of the Economic Impact • The application must have the combination with a second factor Analysis of the Electronic Prescriptions ability to set logical access controls as provided that the token is not stored on for Controlled Substances Rule can be discussed above and limit access to the computer to which the person is obtained by contacting the Liaison and indicating that prescriptions are ready gaining access. With these requirements Policy Section, Office of Diversion for signing and signing prescriptions to in place, the potential for diversion Control, Drug Enforcement DEA registrants or those exempted from through misuse of a credential will be Administration, 8701 Morrissette Drive, registration. limited, which supports the closed Springfield, VA 22152, Telephone (202) • The application must require the system of control DEA is mandated to 307–7297. The initial analysis is also use of the two-factor credential to sign maintain, protect practitioners from available on DEA’s Diversion Control the prescription and digitally sign and misuse of their identity, and protects the Program Web site at http:// archive the record when the two-factor public from the harm of drug abuse. www.deadiversion.usdoj.gov. authentication protocol is executed. (Note that DEA is not imposing any Comments:

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DEA conducted an initial economic examined the impacts of electronic their customers, the incremental costs analysis of the proposed rule and sought prescribing have found that the primary for any single customer will be low, comments. DEA received several benefit is improved formulary particularly when compared to the cost comments regarding the estimates compliance. DEA has not found any of an electronic health record provided in the NPRM. studies that quantify the number of application. DEA has revised the rule to Comments. A practitioner adverse drug events associated with reduce the costs to application organization stated that DEA illegible prescriptions. The data often providers by both lengthening the time underestimated the costs for cited regarding medication errors are between audits/certifications and registration, hard token hardware and based primarily on inpatient hospital allowing them to substitute certification software, software upgrades, annual and long-term care facility adverse drug by an approved organization, where one system audits, and, especially, for events and include ‘‘errors’’ that are exists, for a third-party audit. Because separate prescribing workflows for unrelated to legibility (e.g., the American Recovery and controlled drugs. The commenter administering a drug to the wrong Reinvestment Act requires that an asserted that the analysis did not patient, dispensing the wrong drug); application be certified before a include the added costs for each some of the errors cited may not result practitioner will be eligible for an prescriber every time a controlled in adverse drug events (e.g., failing to incentive payment, it is reasonable to substance prescription is written. The include all of the label information or assume that all electronic prescription commenter believed that the the insert). In addition, as discussed application providers will be seeking comparison should not be with the below in the Benefits section, studies of certification and incurring those costs current system where controlled pharmacy experiences with electronic regardless of DEA’s rules. On the substance prescriptions require a prescriptions have found that there may pharmacy application side, the third- separate workflow, but rather with a be an increase in errors with these party audit will only need to address commenter-preferred system where all prescriptions. DEA notes that although compliance with DEA’s requirements, prescribing takes place in a single illegible handwritten prescriptions are most of which existing pharmacy workflow. The commenter asserted that unquestionably a problem, in most cases applications already meet. the costs of prosecutions are dwarfed by the pharmacists resolve the problem by DEA has removed the requirement for the potential benefits offered by a single, calling the practitioner to clarify the offsite storage. As for the costs for manageable electronic prescribing prescription rather than risk dispensing technology, staff resources, and system. The commenter stated that DEA the wrong drug. oversight, these apply to acquisition of acknowledged in the analysis it did not Comments. A pharmacy organization the application, not to DEA’s have valid data on all costs to society asserted that unless there is a requirements. DEA is not requiring any from diversion of controlled substances. compelling law enforcement need, DEA registrant to issue or accept electronic Without valid estimates of the cost of must eliminate provisions that increase prescriptions for controlled substances. the problem, the commenter asserted, it the burden and costs on prescribers and Any registrant that purchases an is impossible to justify the expense of pharmacies. The commenter claimed application will incur these costs the proposed solution. that these burdens and costs will fall whether they use the application for DEA Response. DEA disagrees with disproportionately on independent, controlled substance prescriptions or this comment, but notes that the rural and small primary care and not. revisions to the interim final rule reduce physician practices, pharmacies and Comments. An organization the costs and the additional keystrokes. health care facilities and programs. State representing dentists stated that the The only change to the usual workflow pharmacy associations stated that DEA number of dentists used in the will be the use of the two-factor should perform an economic analysis calculations in the economic analysis authentication credential to sign the that details the financial impact on was high; the commenter noted that the prescription. Wherever possible, in the safety-net clinics using appropriate Bureau of Labor Statistics lists 161,000 economic analysis of the interim final metrics (net revenue) and actual fees, dentists as opposed to DEA’s estimate of rule, DEA has used estimates based on and that DEA should consider options 170,969. The commenter also asserted current prices. that reduce these identified costs. One that DEA did not include potential DEA’s concern is not simply or organization indicated that the analysis practitioner reprogramming cost(s) in primarily with the costs of prosecutions, did not adequately address the cost of this figure. The commenter believed that but with the diversion of controlled storage, technology, staff resources, and the addition of any reprogramming costs substances and the societal harm caused oversight. will make this figure much greater and by abuse of these drugs. The cost of DEA Response. DEA disagrees that the create additional burden for practicing emergency room treatment alone for costs fall disproportionately on small or dentists who wish to transmit people using prescription controlled rural practices. Most of the costs of the prescriptions for controlled substances substances for nonmedical reasons is far rule will be borne by practitioners, to electronically. higher than the cost of this rule. obtain identity proofing, and the DEA Response. In the interim final Without appropriate security measures, application providers. DEA has revised Economic Impact Analysis, DEA used electronic prescriptions could facilitate the process for identity proofing to the organization’s estimate for the increased drug abuse, with a reduce the burden on rural number of dentists, adjusted to account concomitant increase in deaths, medical practitioners. The primary cost will be for growth. DEA has estimated the cost treatment, and other societal costs to complete an application for a for reprogramming, but notes that this associated with drug dependency. credential or digital certificate and to will be done by the application Although DEA supports electronic pay for the credential. The frequency provider, not at the practice level. prescribing and shares the hope that it with which a practitioner must do this Unless an individual practice decides to will reduce adverse drug events and will be determined by the credential implement biometrics as part of their improve the efficiency of the healthcare service provider or certification two-factor authentication credentials, system, there is little, if any, evidence authority. there should not be additional hardware that electronic prescribing is achieving Although the application providers or software needed; the software needed this goal. The limited studies that have will have to recover their costs from to use a biometric can be relatively

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inexpensive. DEA expects that there commenters stated they are paying their costs are likely to be borne by the will be considerable variation in the intermediaries. institutional practitioner. extent of reprogramming an application Comments. A healthcare system Comments. An application provider provider needs to do based on the stated that PDAs may not be able to estimated that cost per unit for two- degree to which an application already function as tokens and thumb drives factor authentication at $329 to $349, meets the requirements being would require software changes and comprising a hand-held reader at $300, implemented in this rule. Application take too much time to connect. The a desktop reader at $20, and a smart providers, however, routinely reprogram commenter believed that other solutions card ($29). The commenter estimated their software to add new features, would be more expensive. The support costs between $300 to $400 a upgrade functions, and fix problems. commenter also noted that mid-level year per prescriber to deal with Reprogramming to meet the interim practitioners would be likely to use the malfunctions. The commenter asserted final rule is likely to occur as part of this same kind of tokens as practitioners, that it would take 3 to 7 days to replace routine process. which differed from the assumptions the smart card. The commenter further Comments. A pharmacy organization DEA made in its initial analysis. That indicated that its current support asserted that the cost of dispensing for commenter and a second healthcare metrics indicate 7 trouble tickets per the average independent community system also stated that the initial year per prescriber, 10 percent of which pharmacy is already high. The Economic Impact Analysis did not require an office visit. The commenter commenter believed that the regulation include staff time for audits. claimed that the average prescriber would necessitate the purchase of new DEA Response. DEA has not included writes six controlled substance technology, generating more reports at PDAs in its cost analysis of the interim prescriptions a week and would not pay the end of the day, and then storing final rule although some practitioners as much as DEA indicated the costs those corresponding reports for five may use them. The range of possible would be to write controlled substances years. The commenter claimed that tokens is considerable and the costs prescriptions electronically. It noted these processes will only add to the associated with them wide. For that these costs would monetary costs and time constraints that example, one-time-password (OTP) disproportionately burden stand-alone pharmacists have to abide by to devices are slightly more expensive than electronic prescription applications smart cards or tap-and-go cards, but do responsibly consult with and serve their because they represent a higher not require a separate reader. Where patients. The commenter asserted that proportion of the annual fee. The readers are needed, they may exist on such gains from electronic prescribing commenter indicated that the first year keyboards, or can be separate devices. are relatively minimal when compared cost of $629–749 would be a 35 percent Because it has no basis for estimating to such costs, considering that increase in the $2000 first year fee. how many computers would need independent community pharmacies Subsequent year costs ($300–400) readers, DEA has based its cost already connected for electronic would be a 58% increase in the $600 estimates on OTP devices, recognizing charge. The costs represent a much prescribing only receive around 2 that practices may find other options smaller percentage of EHR costs. The percent of their prescriptions through more suitable. commenter asserted that these costs such technology. DEA has not estimated staff time for would deter practitioners from adopting DEA Response. DEA is not requiring application providers for audits in part electronic prescribing. any pharmacy to accept electronic because the interim final rule limits the DEA Response. DEA notes that most prescriptions for controlled substances. audit to determining whether the of the costs the commenter estimated Based on industry comments, the application meets DEA’s requirements. relate to a hand-held reader, but the existing pharmacy applications already An auditor will usually make this commenter failed to explain why this have most, if not all, of the functions determination by testing the was needed. It also failed to explain that DEA is requiring. It is unlikely, application, which will not involve why the smart card would cost so much, therefore, that any pharmacy will have provider staff time. In addition, DEA when many are available for a tenth the to replace its existing application. assumes that once a certification amount listed, and why it would take Where additional functionality is organization is ready to make this days to replace the card. If the needed, it can be added as an upgrade determination as part of its certification practitioner acquires the card locally, or patch, as occurs routinely with most process, application providers will not then registers or activates the credential, widely used software applications. The need audits. They will obtain the replacement would take little time. The only reports that will be generated are certification for reasons other than commenter appears to be incurring the on security incidents, which should be compliance with DEA rules. support costs for problems already. It is rare events. Pharmacies should not have Comments. An application provider unclear to DEA, based on the daily reports to review. DEA has revised stated that financial incentives may commenter’s comments, why the the record retention period to two years. speed adoption more quickly than commenter believes this would change DEA also notes that in allowing assumed in the initial Economic Impact or increase. Under the interim final rule, electronic prescriptions, it is relieving Analysis. It further stated that the the application provider is not involved pharmacies of the burden of storing average salary of a primary care in providing the authentication paper prescriptions. physician is $104,000, but provided no credential. If its application has Comments. A pharmacy organization sourcing for this assertion. problems after it has been programmed, asserted that costs of several cents per DEA Response. DEA has increased that is not a cost that accrues to the prescription will be significant to some (i.e., shortened) the implementation rate interim final rule. DEA recognizes that pharmacies. to account for the financial incentives any incremental costs will represent a DEA Response. DEA estimates that that may be available to practitioners. higher proportion of the annual fee for the average cost of the rule will be less According to the Bureau of Labor stand-alone electronic prescription than one cent per controlled substance Statistics the average salary rate for a applications. DEA notes, however, that prescription, which as some physician in family practice is $167,970 the Federal incentive payments commenters noted is far less than the (May of 2008). Some hospital-based available under the American Recovery $0.30 per prescription fee some physicians have lower salary rates, but and Reinvestment Act are for EHR

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applications, not electronic prescription Option 2: The interim final rule with them to create or process controlled applications. It is likely, therefore, that the requirement that one of the factors substance prescriptions. The the trend toward EHRs rather than used to authenticate to the application practitioners who prescribe controlled stand-alone electronic prescription must be a biometric. substances are primarily physicians, applications will accelerate. Option 3: No additional requirements dentists, and mid-level practitioners. The Interim Final Rule Analysis: for electronic prescription or pharmacy Hospitals and clinics will be affected if DEA has determined that this interim applications, but a callback for each practitioners working for or affiliated final rule is an economically significant controlled substance electronic with the hospital or clinic use the regulatory action; therefore, DEA has prescription. institutional practitioner’s application conducted an analysis of the options. Universe of Affected Entities: to issue prescriptions for persons The following sections summarize the The entities directly affected by this leaving the institution (inpatient economic analysis conducted in support rule are the following: medical orders are not subject to these of this rule. DEA is seeking further • DEA individual practitioner rules). Several thousand institutional comments on the assumptions used in registrants who issue controlled practitioner registrants (e.g., prisons, this revised economic analysis and is substance prescriptions or individual jails, veterinarians, medical practices, especially interested in any data or practitioners who are exempt from and Federal facilities) are not included information that commenters can registration and who are authorized to either because they are unlikely to have provide that would reduce the many issue controlled substance prescriptions staff issuing prescriptions, are already uncertainties in the estimates as under an institutional practitioner’s counted in the practitioner total, or, in discussed below and improve the registration. the case of Federal facilities, already options considered in the analysis of a • Hospitals and clinics where comply with more stringent standards. final rule. practitioners may issue controlled Table 4 presents the estimates of entities Options Considered: substance prescriptions. directly affected and estimated growth DEA considered three options for the • Pharmacies. rates, which are based on recent trends. electronic prescribing of controlled In addition, application providers are As the number of hospitals and retail substances: indirectly affected because their pharmacies have been declining, DEA Option 1: The interim final rule as applications must meet DEA’s did not project growth (or decline) for described in this preamble. requirements before a registrant may use these sectors.

TABLE 4—UNIVERSE OF DIRECTLY AFFECTED ENTITIES

In offices/ in hospitals Growth rate

Physicians ...... 328,772 169,337 2.1 percent.1 Mid-levels ...... 82,579 48,841 2.2 percent. Dentists ...... 171,328 (2) 1.3 percent. Total Practitioner ...... 582,729/ 218,178 1.9 percent. Hospitals and Clinics ...... 12,412 DEA assumes no future growth. Pharmacies ...... 65,421 DEA assumes no future growth. 1 This rate does not include physicians in hospitals. 2 Not applicable.

The number of application providers prescriptions.41 According to data from estimating public wait time as long-term is based on the number of providers SDI/Verispan, in 2008, controlled care prescriptions and mail order currently certified by SureScripts/ substances represented about 12 percent prescriptions will not be affected. RxHub or CCHIT. For practitioners, that of prescriptions for the top 400 drugs.42 Previous DEA analysis has indicated number is about 170, which DEA IMS Health data reported a total of that 75 percent of controlled substance assumes will increase to 200 by the 3.8431 billion prescriptions in 2008.43 prescriptions are original prescriptions third year and then begin declining. Based on these data, DEA estimates that, or 356 million prescriptions in Year 1. Pharmacy application providers are with a three percent growth rate for DEA has previously estimated that estimated to be about 40; the actual prescriptions, there will be about 475 about 19 percent of prescriptions are number is lower but DEA increased the million controlled substance currently faxed or phoned into number to account for pharmacy chains prescriptions in Year 1 of the analysis. pharmacies. Applying both the 86 that may have developed their own IMS Health data indicate that about 86 percent and 19 percent to the number of applications. percent of prescriptions are filled at original prescriptions results in an The number of controlled substance retail outlets, which is relevant to estimate of 247 million prescriptions prescriptions written is relevant to the that may have reduced public wait time estimate of cost-savings. DEA estimates 41 The top 400 drugs represent about 87% of all as electronic prescriptions for controlled the number of prescriptions based on prescriptions dispensed at retail. substances is implemented. the assumption that the percentage of 42 See http://www.drugtopics.com for the top 200 controlled substance prescriptions in generic and top 200 brand name drugs. Unit Costs 43 See http://www.imshealth.com. IMS Health the top 200 brand name and top 200 data are used for total prescriptions because the For the interim final Economic Impact generic drug prescriptions is the same as data include prescriptions for long-term care and Analysis, DEA based all labor costs on it is for the remainder of the mail order. May 2008 BLS data, inflated to 2009

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dollars and loaded with fringe and at offices, it should not be a cost because System rule.44 The requirements for overhead. Using BLS data provides a credentials should be checked before a pharmacy applications are simpler and consistent source of data. For the person is hired. include functionalities that the industry NPRM, DEA used other estimates for Prior to granting access, those who has indicated it already has, so DEA physician and dentist costs, but these will be given this responsibility will assumes an average of 1,000 hours of were based on salary surveys that may need to be trained to do so. DEA reprogramming for pharmacy be weighted toward larger practices and estimates the time at one hour per applications. were not clearly wage as opposed to person at practices. This estimate may To estimate the cost of obtaining compensation figures. The effect of the be high, particularly for smaller offices. identity proofing from a credential change is to lower the wage rates for It may also be the case that in some service provider, DEA used the fee these practitioners. larger practices, people already perform SAFE BioPharma charges for a three- Practitioners will have to complete an this task for other reasons and training year digital certificate and a hard token application to apply for identity may be unnecessary. Because it is likely using remote identity proofing ($110). proofing and a credential. As these that in larger pharmacies, access This figure may be high because it applications generally ask for standard controls are already being set, DEA assumes a medium rather than the basic information that practitioners will be estimates that the training time will be assurance level that DEA is requiring. able to fill in without needing to collect five minutes. Based on standard industry practice for documents that they would not carry DEA estimates that it will take, on digital certificates, DEA estimates that with them (e.g., credit cards, driver’s average, five minutes to enter the data the credential will need to be renewed licenses), DEA estimates that it will take to grant access for the first time at a every three years, but that a complete them 10 minutes to complete the form. practice or a pharmacy. The approval of reapplication will not be required until Credential providers generally require the data entry is estimated to take one the ninth year. These assumptions are subscribers to renew the credential minute. The actual approval may take based on the standards incorporated in periodically. This renewal can take the only a few seconds, but the approver the Federal PKI Policy Authority form of an e-mail request that is signed may take time away from some other Common Policy. The cost for the three- with the credential. To be conservative, work, but would presumably do it when year renewal is estimated to be $35.00, DEA estimates that it will take 5 using the computer for other tasks. which is what SAFE charges for a three- minutes to renew. DEA has not estimated the cost of year digital certificate at the basic For hospitals and clinics, DEA setting logical access controls at assurance level. Hospitals and clinics estimates that practitioners and hospitals because hospital applications are assumed to use or adapt their someone at the credentialing office will should already do this. The CCHIT existing access cards to store the spend 2 minutes to verify the identity criteria for in-patient applications credential and, therefore, incur no document presented. Practitioners are include logical access controls; the HL7 additional costs for the credential. assumed to take 30 minutes total for this standard used by most hospitals In the initial years, application process because they will need to go to includes logical access controls. In providers may have to obtain a third- the credentialing office. This review addition, an application used by as party audit to determine whether the will occur only when the hospital or many different departments as exist at application meets the requirements of clinic first implements controlled hospitals necessarily will impose limits the rule. DEA estimates the cost of this substance electronic prescribing and on who can carry out certain functions. audit at $15,000. This estimated cost is will involve only those practitioners Consequently, DEA’s requirements about 50 percent of the application fee that already work at or have privileges should not entail any actions not for CCHIT testing and certification of a at the hospital or clinic. All already being performed. full ambulatory electronic health record practitioners that are hired or gain Auditable events reported on security application ($29,000). DEA chose to use privileges later will have this step done incident logs should be rare once the the CCHIT fees as a basis because the as part of their regular initial application has been implemented and interim final rule narrows the scope of credentialing. staff understand their permission levels. the third-party audit and allows a larger Prior to granting access, someone at Because of the size of hospitals and number of auditors to conduct the audit. each office must verify that each clinics and the volume of controlled The higher cost estimates in the NPRM practitioner has a valid DEA registration substance prescriptions at pharmacies, were based on obtaining particular types and State authorization to practice and, DEA estimates that each of them will of audits and having the audits cover where applicable, dispense controlled review security incident logs monthly; functions that will not be subject to substances. As this requires nothing DEA estimates that the review will take auditing for installed applications. In more than checking the expiration dates hospitals ten minutes per month and addition, the one commenter that of these documents, which are often pharmacies five minutes per month. already obtained the third-party audits visibly displayed, DEA estimates that Because of the smaller size of private specified in the NPRM stated that the this will take an average of one minute. practices and the much lower volume of costs were much lower than DEA had In small practices, which are the controlled substance prescriptions estimated. DEA estimates that within majority of offices, it may take no time issued, DEA estimates that a review will five years, all electronic prescription because the registrant will be one of the be needed only once a quarter. The application providers will obtain people granting access and the status of review time remains at 5 minutes. certification from an approved every registrant will be known. DEA estimates that reprogramming for certification organization; because the Checking registrations and State electronic prescription applications will providers already seek these authorizations is done as part of take, on average, 2,000 hours, an certifications for other reasons, the cost credentialing at hospitals and clinics estimate based on industry information of continuing to obtain certifications and is, therefore, not a cost of the rule. obtained during the development of will not accrue to the rule after that Similarly, once the rule is implemented DEA’s Controlled Substances Ordering point.

44 ‘‘Electronic Orders for Controlled Substances’’ Analysis of the Electronic Orders Rule available at http://www.DEAdiversion.usdoj.gov/fed_regs/rules/ 70 FR 16901, April 1, 2005; Economic Impact 2005/index.html

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Table 5 presents the unit costs for both labor-based costs and fees.

TABLE 5—UNIT COSTS

Requirement Item, or labor, required Unit cost

Non-Labor Costs

Identity proofing and credential ...... Remote identity proofing and downloadable code for registrant (includes hard $110.00 token). Renewal of credential ...... Three-year renewal ...... 35.00 Nine-year renewal ...... 110.00 Initial audit of application ...... Certification that application meets DEA requirements ...... 15,000.00 Reaudit of application ...... Certification that application still meets DEA requirements ...... 15,000.00

Labor Costs

Application for identity proofing and credential ...... Registrant must fill out form; 10 minutes required ...... 28.23 Renewal application for credential ...... Registrant must only fill out parts where information has changed; 5 minutes 14.12 needed. Registration check ...... Requires one minute for a non-registrant. Physician office—nurse ...... 1.12 Dental office—dental assistant ...... 0.57 Access control—training (practice office) ...... One hour per person; one is a registrant ...... Physician plus nurse ...... 259.35 Mid-level plus nurse ...... 151.49 Dentist plus dental assistant ...... 201.01 Access control—granting (practice office) ...... Requires one minute for registrant, five minutes for non-registrant (nurse). Physician plus nurse ...... 8.66 Mid-level plus nurse ...... 7.00 Dentist plus dental assistant ...... 5.64 Access control—training (pharmacy) ...... Requires five minutes for pharmacy technician ...... 2.33 Access control—granting (pharmacy) ...... Requires five minutes for pharmacy technician ...... 2.33 Review of security logs (practice office) ...... Requires five minutes per quarter; 20 minutes per year for nurse ...... 22.39 Review of security logs (pharmacy) ...... Requires five minutes per quarter; 20 minutes per year for pharmacy tech ...... 11.43 Review of security logs (hospital) ...... Requires ten minutes per month per year for system administrator ...... 136.64 ID check, face to face (hospital only) ...... Requires two minutes for HR person AND ...... 1.20 30 minutes per hospital practitioner OR ...... 55.22 30 minutes per private physician ...... 96.08 Reprogramming applications for practices ...... Requires 2,000 hours of application provider engineer’s time ...... 184,197 Reprogramming pharmacy applications ...... Requires 1,000 hours of application provider engineer’s time ...... 92,099

Total Costs over seven years; after that point TABLE 6—IMPLEMENTATION RATES implementation for practitioners FOR PRACTITIONERS—Continued To proceed from unit costs to total basically covers new practitioners and costs, it is necessary to establish the offices as well as ongoing costs. Implementation Cumulative frequency of occurrence of cost items Practitioners incur ongoing costs for rate (percentage) percentage and the distribution of those renewal of the credential, reviewing occurrences, and thus of costs, over security incident logs, and adding new YEAR 8 ..... 2.0 93.0 time. DEA assumes that all application staff to the access list. DEA estimates YEAR 9 ..... 1.0 94.0 providers will reprogram their costs for 15 years. Table 6 presents the YEAR 10 ... 1.0 95.0 applications in the first year and that implementation rate for practitioners. YEAR 11 ... 1.0 96.0 after the fifth year they will be able to YEAR 12 ... 1.0 97.0 YEAR 13 ... 1.0 98.0 substitute certification for the third- TABLE 6—IMPLEMENTATION RATES YEAR 14 ... 1.0 99.0 party audit. DEA assumes that FOR PRACTITIONERS pharmacies will be able to accept YEAR 15 ... 1.0 100.0 electronic prescriptions in the first year Implementation Cumulative and set initial access controls in that rate (percentage) percentage Total costs are calculated by year, but that they will incur ongoing multiplying the unit cost for an item or costs for checking security incident logs. YEAR 1 ..... 6.0 6.0 activity by the number of entities that YEAR 2 ..... 10.0 16.0 will incur the cost in each year. Tables Hospitals and clinics are assumed to YEAR 3 ..... 20.0 36.0 adopt applications within five years; YEAR 4 ..... 20.0 56.0 7 and 8 present the Option 1 annualized identity proofing costs occur only in the YEAR 5 ..... 20.0 76.0 costs by item and regulated entity at first year of adoption. Practitioners are YEAR 6 ..... 10.0 86.0 both a 7 percent and 3 percent discount assumed to adopt electronic prescribing YEAR 7 ..... 5.0 91.0 rate.

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TABLE 7—OPTION 1 ANNUALIZED COSTS BY ITEM AND BY SECTOR—7.0 PERCENT

Practitioners’ Application offices Hospitals Pharmacies providers Totals

Credential ...... $14,669,488 ...... $14,669,488 Credential application ...... 3,844,882 ...... 3,844,882 Registration check ...... 30,405 ...... 30,405 Granting access ...... 303,086 ...... $16,752 ...... 319,838 Training for granting ...... 7,147,886 ...... 50,255 ...... 7,198,142 Review security logs ...... 4,248,868 $1,524,079 1,959,040 ...... 7,731,986 ID verification ...... 4,717,580 ...... 4,717,580 Reprogram applications ...... $3,842,530 3,842,530 Obtain certification ...... 391,021 391,021 Audit of applications ...... 583,957 583,957

Totals ...... 30,244,615 6,241,658 2,026,046 4,817,509 43,329,829

TABLE 8—OPTION 1 ANNUALIZED COSTS BY ITEM AND BY SECTOR—3.0 PERCENT

Practitioners’ Application offices Hospitals Pharmacies providers Totals

Credential ...... $14,761,504 ...... $14,761,504 Credential application ...... 3,817,785 ...... 3,817,785 Registration check ...... 27,259 ...... 27,259 Granting access ...... 281,572 ...... $12,781 ...... 294,353 Training for granting ...... 6,315,405 ...... 38,342 ...... 6,353,747 Review security logs ...... 4,399,243 $1,518,215 1,885,804 ...... 7,803,262 ID verification ...... 3,834,522 ...... 3,834,522 Reprogram applications ...... $3,842,530 3,842,530 Obtain certification ...... 393,356 393,356 Audit of applications ...... 650,592 650,592

Totals ...... 29,602,769 5,352,737 1,936,927 4,886,478 41,778,910

Option 2 substances. Hospital beds and clinics applications for hospitals would require Option 2 is the same as Option 1, are phased in as shown in Table 9. 200 hours for an application provider’s except that the two-factor authentication engineer at $92.10 per hour. Cost is credential requires a biometric identifier TABLE 9—PHASE-IN OF HOSPITAL $18,420 per application provider. Table and a hard token. Passwords would not BEDS AND CLINICS 10 presents the annualized costs of be permitted as an authentication factor. adding the biometric. The cost items are: Beds Clinics • TABLE 10—COST OF OPTION 2 Biometric readers for practitioners’ YEAR 1 ...... 200,665 1,871 offices, hospitals, and clinics. • YEAR 2 ...... 200,665 1,871 7.0 percent 3.0 percent Software packages for practitioners’ YEAR 3 ...... 160,532 1,497 offices and clinics. YEAR 4 ...... 160,532 1,497 YEAR 1 ..... $8,037,011 $8,037,011 • Reprogramming of applications for YEAR 5 ...... 80,266 749 hospitals. YEAR 2 ..... 10,862,145 11,283,976 A biometric reader would be needed YEAR 3 ..... 18,424,735 19,883,569 There are no costs for hospitals and YEAR 4 ..... 17,750,891 19,900,309 for every practitioner’s computer. DEA clinics after YEAR 5. All reprogramming estimates that hospitals would need one YEAR 5 ..... 16,454,640 19,163,490 costs are in YEAR 1. Costs for YEAR 6 ..... 8,085,656 9,782,458 for every 15 beds, and each clinic would practitioners’ offices and registrants YEAR 7 ..... 4,387,114 5,513,892 need an average of two readers. Based extend over 15 years following the YEAR 8 ..... 2,278,677 2,975,149 on American Hospital Association data, projected start-up of electronic YEAR 9 ..... 1,570,416 2,130,037 DEA estimates the number of prescriptions for controlled substances YEAR 10 ... 1,502,772 2,117,445 community hospital beds to be 802,658. in practitioners’ offices and number of YEAR 11 ... 1,437,996 2,104,861 The number of clinics is estimated to be registrants in practitioners’ offices YEAR 12 ... 1,375,970 2,092,286 7,485. There are 20 firms providing starting electronic prescriptions for YEAR 13 ... 1,316,578 2,079,722 applications to hospitals, and their controlled substances. YEAR 14 ... 1,259,712 2,067,171 45 number is not expected to change. All A biometric reader that meets the YEAR 15 ... 1,205,265 2,054,634 of these firms would reprogram their requirements costs $114.00.46 The applications in YEAR 1. Costs of readers software package for clinics and offices Total ... 95,949,579 111,186,009 and software packages would be is $86.00. Reprogramming of incurred as hospitals and clinics adopt electronic prescriptions for controlled 46 Based on the cost of BioTouch 500, which is a separate reader. Where the reader is part of a 45 The estimate is based on the number of keyboard, the bundled reader and software is 7.0 percent 3.0 percent application providers that have obtained CCHIT available for $200. The software cost was derived certification for inpatient EHRs. from this price. Annualized .... $10,534,748 $9,313,672

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reprogramming to incorporate the The callback rate for controlled requirements for annotations. The costs substance prescriptions is likely to be 7.0 percent 3.0 percent of reprogramming, however, will be lower than 30 percent because more relatively small compared with the than 85 percent of controlled substance Annualized primary cost of this option. prescriptions are for generic drugs. plus Option 1 ...... 53,864,576 51,092,582 The cost of this option depends on the Adjusting for a lower number of calls number of prescriptions to be verified. related to generic drugs, DEA estimates The cost of the biometrics There were 461,172,000 controlled that currently 22 percent of controlled 47 requirement is additive to the interim substance prescriptions in 2008. substance prescriptions require final rule cost, since no other Annual growth rate has been 3.0 callbacks. The callback option applies requirements are eliminated. percent. Therefore, DEA expects only to new calls that would need to be 475,007,160 prescriptions in YEAR 1 placed, or 78 percent of the original Option 3 and growth thereafter at 3.0 percent prescriptions: 277,879,189 (0.78 × 0.75 × Under this option the security annually. Of these prescriptions, 75.0 475,007,160). For the 22 percent of requirements of the interim final rule percent will be original prescriptions, prescriptions that already require are set aside and sole reliance for requiring verification if electronic; the callbacks, the confirmation would security is placed on a requirement that, remainder are refills that are authorized simply be part of a call that is being on receipt of an electronic prescription on the original prescription and require made anyway and, therefore, is not an for a controlled substance, a pharmacy no contact between the pharmacy and additional cost. The number of must call the practitioner’s office for practitioner. electronic prescriptions each year verification of the prescription. For the Industry estimates indicate that 30 requiring calls will be determined by sake of simplicity, DEA has not percent of original prescriptions the rate of adoption of electronic included in this option estimates of the generate callbacks to deal with prescriptions for controlled substances. time that will be required to reprogram formulary issues, requests to change to Because these are callbacks simply to existing applications to conform to the generic forms of the prescribed drug, confirm the legitimacy of the basic information included on every illegibility, and other problems. Based prescription, DEA assumes that each controlled substance prescription. DEA on data from a 2004 Medical Group call would require three minutes of a has no basis for determining how many Management Association survey, 34 pharmacy technician’s time, three existing applications do not include or percent of callbacks on original minutes of a medical assistant’s time, do not transmit all of this information. prescriptions were for formulary issues, and one minute of the practitioner’s Similarly, there may be some pharmacy 31 percent were about generic drugs, time. Table 11 presents the present applications that will require and 35 percent were on other issues.48 value and annualized costs of Option 3.

TABLE 11—PRESENT VALUE AND ANNUALIZED COST OPTION 3

7.0 percent 3.0 percent

YEAR 1 ...... $100,904,733 $100,904,733 YEAR 2 ...... 259,020,250 269,079,289 YEAR 3 ...... 561,008,812 605,428,399 YEAR 4 ...... 840,056,809 941,777,510 YEAR 5 ...... 1,097,457,393 1,278,126,621 YEAR 6 ...... 1,195,435,021 1,446,301,176 YEAR 7 ...... 1,217,649,690 1,530,388,454 YEAR 8 ...... 1,197,891,176 1,564,023,365 YEAR 9 ...... 1,165,509,232 1,580,840,821 YEAR 10 ...... 1,133,874,313 1,597,658,276 YEAR 11 ...... 1,102,975,819 1,614,475,732 YEAR 12 ...... 1,072,802,902 1,631,293,187 YEAR 13 ...... 1,043,344,493 1,648,110,643 YEAR 14 ...... 1,014,589,338 1,664,928,098 YEAR 15 ...... 986,526,025 1,681,745,554

Total ...... 13,989,046,006 19,155,081,859 Annualized ...... 1,535,922,056 1,604,555,706

TABLE 12—TOTAL ANNUALIZED COSTS OF OPTIONS

7.0 percent 3.0 percent

Option 1 ...... $43,329,829 $41,778,910 Option 2—Required Use of Biometrics ...... 53,864,576 51,092,582 Option 3—Callbacks ...... 1,535,922,056 1,604,555,706

47 In 2008, controlled substances represented assumption that 12% of all prescriptions (3.8431 48 http://www.mgma.com/WorkArea/ 12.15% of the top 400 brand name and generic billion according to IMS Health data) are for DownloadAsset.aspx?id=19248, accessed 08/06/09. drugs sold at retail. The estimated number of controlled substances. controlled substance prescriptions is based on the

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Benefits: reacts with other medications the $420 million (at 7% discount) or $439 Electronic prescriptions are widely patient is taking or because it negatively million (at 3% discount). expected to reduce errors in medication affects other conditions from which the Electronic prescriptions could also dispensing because they will eliminate patient suffers. Each callback involves reduce the patient’s wait time at the illegible written prescriptions and the pharmacy staff and one or more staff pharmacy. The number of original misunderstood oral prescriptions. They at the practitioner’s office, often controlled substance prescriptions that are also expected to reduce the number including the practitioner. Electronic could require public wait time is based of callbacks from pharmacy to prescriptions will eliminate illegible on the estimated number of original practitioner to address legibility, prescriptions and could eliminate those prescriptions (approximately 356 formulary, and contraindication issues. with missing information or unavailable million in 2009), reduced by 19 percent, Electronic prescriptions may also dosage units or forms. The recent to account for those prescriptions reduce processing time at the pharmacy studies cited above indicate that at least phoned to the pharmacy 55 plus another and wait time for patients. These some prescription applications do not 14 percent to remove those that are benefits are likely to be mitigated to prevent practitioners from transmitting currently filled by mail order some extent. As a Rand study suggested, electronic prescriptions that are pharmacies or long-term care practitioners may fail to review the incomplete. At present, the field for facilities.56 Assuming the average wait prescription and notice errors that occur directions for use in the NCPDP SCRIPT time is 15 minutes for the 81 percent of when the wrong item is selected from has not been standardized; when it is, original prescriptions that are presented one or more drop-down menus; the issues cited in the studies related to on paper to retail pharmacies (not mail pharmacists may be less likely to these directions may be resolved. order or long-term care prescriptions), if question a legible electronic Whether formulary and contraindication those waiting times are eliminated, at prescription.49 The formulary and callbacks are eliminated will depend on the current United States average hourly contraindication checks are functions the functions of the electronic wage ($20.49), the annualized savings that practitioners sometimes disable prescription applications and the over 15 years would be $1 billion (at 7% because they do not work as they should accuracy of the drug databases that they discount) or $1.03 billion (at 3% or take too much time.50 In addition, use. discount). recent studies indicate that electronic The public is also affected by the The estimate for public wait time is prescriptions sometimes are missing current system. For the majority of an upper bound, as such it is not information, particularly directions for controlled substance prescriptions, the included in the primary estimate for the use and dosing errors.51 52 Nonetheless, patient (or someone acting for the benefits of this interim final rule. It electronic prescriptions may provide patient) presents a paper prescription to assumes that the practitioner will benefits in avoided medication errors, the pharmacy and then waits for the transmit the prescription and that the reduced processing time, and reduced pharmacy to fill it. The time between pharmacist will open the record and fill callbacks. These benefits of electronic the point when the prescription is it before the patient arrives at the prescriptions are not directly handed to the pharmacist and the point attributable to this rule because they when it is ready for pick-up is a cost to pharmacy. Recent research on electronic accrue to electronic prescribing, not the the public. prescriptions found that 28 percent of incremental changes being required in The percentage of callbacks that will electronic prescriptions transmitted this rule. be eliminated by electronic prescribing were never picked up by patients; for DEA has quantified three types of is unclear. The Centers for Medicare and painkillers, more than 50 percent were 57 benefits: reduced number of callbacks to Medicaid Services, in its November 16, not picked up. If pharmacies prepared clarify prescriptions, the reduction in 2007, proposed rule on formulary and electronic prescriptions before the wait time for patients picking up generic transactions, estimated a 25 patient arrives, the pharmacy will have prescriptions, and the cost-savings percent reduction in time spent on spent time for which it will not be pharmacies will realize from callbacks.53 DEA similarly assumes that reimbursed if the patient does not pick eliminating storage of paper records. callbacks will be reduced by 25 percent. up the prescription and will spend One of the greatest burdens in the paper For these callbacks, which require more further time returning the drugs to stock system is the need for callbacks to effort than the simple confirmation and correcting records. It is possible, clarify prescriptions. Clarifications and required for Option 3, DEA used the therefore, that pharmacies will not be changes may be required for several time estimates from the MGMA survey willing to fill electronic prescriptions reasons: the prescription is not legible; (6.9 minutes of staff time per call and for controlled substances until they are required information is not included on 4.2 minutes of practitioner time).54 certain that the patient wants to fill the the prescription; the prescribed dosage Assuming that electronic controlled prescription. The primary estimate for unit does not exist; the particular substance prescriptions phase in over 15 public wait time, therefore, is zero. medication is not approved by the years, as described above, the Table 13 presents the annualized patient’s health insurance; and the drug annualized time-saving for eliminating gross benefits at a 7.0 percent and 3.0 prescribed is contraindicated because it 25 percent of these callbacks would be percent discount rate.

49 Bell, D.S. et al., ‘‘Recommendations for 52 Astrand, B. et al., ‘‘Assessment of ePrescription prescription and do not require second calls, and Comparing Electronic Prescribing Systems: Results Quality: an observational study at three mail order slightly less than half of prescriptions are refills, the of An Expert Consensus Process,’’ Health Affairs, pharmacies.’’ BMC Med Inform Decis Mak, 2009 Jan analysis uses 19% for phoned in prescriptions. May 25, 2004, W4–305–317. 26; 9:8. 56 Based on IMS Health 2008 channel distribution 50 Grossman, J.M. et al., ‘‘Physicians’ Experiences 53 72 FR 64900, November 16, 2007. by U.S. dispensed prescriptions. http:// Using Commercial E-Prescribing Systems,’’ Health 54 Affairs, 26, no. 3 (2007), w393–w404. http://www.mgma.com/WorkArea/ imshealth.com, accessed June 16, 2009. 57 51 Warholak, T.L. and M.T. Rupp. ‘‘Analysis of DownloadAsset.aspx?id=19248, accessed 08/06/09. Solomon, M., and S.R. Majumdar. ‘‘Primary community chain pharmacists’ interventions on 55 A 1999 Drugtopics.com survey indicated that Non-Adherence of Medications: Lifting the Veil on electronic prescriptions.’’ Journal of American 36% of all prescriptions were phoned in; because Prescription-filling Behavior’’ Journal of General Pharm Association, 2009, Jan–Feb; 49(1): 59–64. refills are usually authorized on the original Internal Medicine, March 2, 2010.

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TABLE 13—ANNUALIZED GROSS BENEFITS

7% 3%

Callbacks Avoided ...... $419,745,516 $438,502,110

These benefits are gross rather than able to issue electronic prescriptions for emergency care the benefits will far net benefits, but it is not possible to controlled substances and because any exceed the costs. compare these cost-savings to the costs alteration of the prescription at the These costs also do not represent all of the rule or to estimate net benefits. pharmacy will be discernible from the of the costs of drug abuse to society. These savings will accrue to any audit log and a comparison of the Drug abuse is associated with crime and electronic prescription application. The digitally signed records. DEA expects lost productivity. Crime imposes costs only way to assess net benefits is to that over time, as electronic prescribing on the victims as well as on compare them with the costs of the full becomes the norm, practitioners issuing government. DEA does not track application and its implementation, not paper prescriptions for controlled information on controlled substance the incremental costs of DEA’s substances may find that their prescription drug diversion because requirements. prescriptions are examined more enforcement is generally handled by Pharmacies are required to retain all closely. State and local authorities. The cost of original controlled substance The Substance Abuse and Mental enforcement is, however, considerable. prescriptions, including oral Health Services Administration In 2007, DEA spent between $2,700 for prescriptions that the pharmacist (SAMHSA) runs the Drug Abuse a small case and $147,000 for a large reduces to writing, on paper for two Warning Network (DAWN), a public diversion case just for the primary years. As electronic prescriptions health surveillance system that monitors investigators; adjudication costs and replace paper records, pharmacies will drug-related visits to hospital support staff are additional. It is be able to eliminate file cabinets, freeing emergency departments and drug- reasonable to assume that State and up space for other uses. The annualized related deaths investigated by medical local law enforcement agencies are cost of a prescription file cabinet is examiners and coroners. SAMHSA spending similar sums per case. Some $78.50 ($715 annualized over 15 years reported that in 2003, in six States cases involve multiple jurisdictions, all at 7%); the cost of the floor space is (Maine, Maryland, New Hampshire, of which bear costs for collecting data $55.34 per cabinet (2.77 square feet New Mexico, Utah, and Vermont) there and deposing witnesses. The rule could times $20/square feet rental price for were 352 deaths from misuse of reduce the number of cases and, retail space). The annualized cost- oxycodone and hydrocodone, both therefore, reduce the costs to savings for pharmacies are $1.38 million prescription controlled substances. governments at all levels. A reduction in at 7 percent and $1.4 million at 3 SAMHSA data for 2006 show that forgeries will also benefit practitioners percent. 195,000 emergency department visits who will be less likely to be at risk of Other Benefits involved nonmedical use of being accused of diverting controlled benzodiazepines (Schedule IV) and substances and of then having to prove DEA has not attempted to quantify or 248,000 involved nonmedical use of that they were not responsible. monetize the benefits of the rule that opioids (Schedule II and III). Of all Adverse drug events that result from relate to diversion because of a lack of visits involving nonmedical use of medication errors are frequently cited as data on the extent of diversion of pharmaceuticals, about 224,000 resulted a benefit of electronic prescriptions. controlled substances through forged or in admission to the hospital; about Illegible prescriptions and altered prescriptions and alteration of 65,000 of those individuals were misunderstood oral prescriptions can pharmacy records. Electronic admitted to critical care units; 1,574 of result in the dispensing of the wrong prescriptions for controlled substances the visits ended with the death of the drug, which may cause medical will directly affect the following types patient. More than half of the visits problems and, at the very least, fail to of diversion: provide the treatment a practitioner has • Stealing prescription pads or involved patients 35 and older. Using a determined is necessary. Once a printing them, and writing non- value per life of $5.8 million, the costs practitioner has access to a patient’s legitimate prescriptions. of the 2003 deaths from misuse of • Altering a legitimate prescription to prescription controlled substances in complete medication list, electronic 58 obtain a higher dose or more dosage the six States is more than $2 billion. prescription applications hold the units (e.g., changing a ‘‘10’’ to a ‘‘40’’). The cost of the 2006 emergency room promise of identifying contraindication • Phoning in non-legitimate visits is above $350 million (at $1,000 problems so that a patient is not prescriptions late in the day when it is per visit), not including the cost of prescribed drugs that taken together difficult for a pharmacy to complete a further in-patient care for those cause health problems or cancel the confirmation call to the practitioner’s admitted. These costs are some fraction benefits. Allergy alerts will also warn office. of the total cost to the Nation. DEA has practitioners of potential medication • Altering a prescription record at the no basis for estimating what percentage concerns. pharmacy to hide diversion from of these costs could be addressed by the DEA has not attempted to estimate the pharmacy stock. rule. If, however, the rule prevents even extent of these benefits for two reasons. These are examples of prescription a small fraction of the deaths and First, there are few data that indicate the forgery that contribute significantly to extent of the problem as it relates to the overall problem of drug diversion. 58 The DAWN mortality data from 2005 indicate prescriptions. The data most frequently DEA expects this rule to reduce that almost 4,900 people died with prescription cited on medication errors and adverse opioids in their bloodstream; about 600 were not drug events (1.5 million preventable significantly these types of forgeries using any other drug or alcohol. These numbers, because only practitioners with secure however, do not indicate how many of the people adverse drug events) are from two prescription-writing applications will be were using the drugs for nonmedical purposes. literature reviews conducted by the

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Institute of Medicine.59 These reviews names to diagnostic codes and dosage the high cost of the applications, which and the estimate are based on studies units to age and weight, the applications may be greater than the subsidies; the that looked at medication errors that will have no way to prevent a disruption that implementation creates occur in hospitals, nursing homes, practitioner from issuing a prescription in a practice; and uncertainty about the clinics, and ambulatory settings. with an inappropriate drug name or applications themselves.63 The pattern Similarly, a 2008 review of studies dosage. with software applications is that a large found fewer errors with electronic Second, the use of electronic number of firms enter a market, but the medication orders, but at least 24 of the prescription applications and vast majority of them fail, leaving a very 27 studies reviewed covered only transmission systems may introduce few dominant providers.64 The health IT inpatient medication orders, which DEA errors. Keystroke and data entry errors market is still in the early phases of this does not regulate.60 61 Many of the may replace some of the errors that process. DEA has no basis for estimating studies cover errors that will not be occur with illegible handwriting. A when dominant players will emerge. addressed by electronic prescribing, comment on the proposed rule from a The 7-year implementation period such as inpatient administration errors State pharmacy board indicated that, at projected may be too conservative or too (i.e., either the chart was incorrect or the least at this early stage of optimistic. chart was correct, but the wrong drug or implementation, the translation of the The time for reprogramming existing dosage was administered or the drug electronic data file to the pharmacies applications is estimated to be between was given to the wrong patient), has caused data to be placed in the 1,000 hours and 2,000 hours. DEA based pharmacy dispensing errors (i.e., the wrong fields and, in some cases, in the the upper estimate on information prescription was correct, but the wrong wrong patient’s file. Similarly, a 2006 provided by the industry for DEA’s drug was given to the patient), failure to survey of chain pharmacy experience rulemaking regarding electronic orders include the dosage or other information with electronic prescribing noted both for controlled substances. The actual on the label, and failure to include positive experiences (improved clarity cost to existing application providers is informational inserts with the dispensed and speed) and negative, prescribing likely to vary widely. Some providers drug. All of these may cause adverse errors, particularly those with wrong may meet all or virtually all of the drug events, but will not be addressed drugs or directions.62 requirements and need little by electronic prescribing. Other errors, DEA believes that electronic reprogramming. Many of the such as the practitioner’s selection of prescribing will reduce the number of requirements are standard practice for the wrong dose, wrong drug, or wrong prescription errors, but it has no basis software (e.g., logical access controls for frequency of use, may or may not be for estimating the scope of the problem hospitals) and should need minimal addressed by electronic prescribing. or the extent of reduction that will occur adjustments. Most electronic DEA has no basis to determine what and the speed at which it will occur. prescription applications appear to number of adverse drug events could be Some of the problems will not be solved present the data DEA will require on prevented by the use of an electronic until EHRs are common and linked; prescriptions. Any software firm that prescription application. Although others could be addressed more easily uses the Internet for any transaction will illegible prescriptions have caused by programming applications to require have digital signature capability. adverse drug events when the wrong all of the fields to be completed before Electronic health record applications drug or dosage was dispensed, most transmission. Even the best system is must control access to gain Certification often pharmacies contact the unlikely to be able to eliminate human Commission for Healthcare Information Technology certification. Nonetheless, practitioner to decipher prescriptions errors. DEA expects that for some existing rather than guess at the drug or dosage Uncertainties: providers, the requirements may take intended. In addition, the assumption Any economic analysis involves some more than the estimated time. The that the use of electronic prescription level of uncertainty about elements of extent to which this requires additional applications will alert practitioners to the analysis. This is particularly true for time will also depend on whether the contraindications and allergies is based this analysis, which must estimate costs changes are incorporated into other on the assumption that the patient’s for implementation of a new technology updates to the application or are done medical record will be complete. and project voluntary adoption rates. This section discusses the elements that on a different schedule. Although this may be the case when Another uncertainty of application have the greatest level of uncertainty every patient has an EHR and all of the provider costs relates to the third-party associated with them. applications are interoperable so that a audit and the time that will elapse The American Recovery and practitioner can access pharmacy before a certification organization is able Reinvestment Act (Pub. L. 111–5) records, until that time the medical to certify compliance with DEA’s provides incentives for practitioners to record will be only as complete as the requirements. If the Certification adopt electronic health record patient is willing or able to make it, Commission for Healthcare Information applications; the incentives are which will limit the ability of the Technology includes DEA’s scheduled to end after 2016. The application to alert the practitioner to requirements in its criteria, the costs for analysis assumes that practitioners will potential problems. Similarly, until third-party audits may be eliminated adopt electronic prescribing by that EHRs have databases that link drug sooner than estimated. The interim final time; after that point all of the rule provides more options for obtaining 59 implementation occurs with new ‘‘To Err is Human: Building a Safer Health a third-party audit, which should System,’’ IOM 2000; ‘‘Preventing Medication Errors,’’ entrants. Whether adoption is, in fact, reduce its cost. DEA has not assumed IOM 2007. http://www.nap.edu. that rapid will depend on a number of 60 Ammenwerth, E. et al. ‘‘The Effect of Electronic factors unrelated to this rulemaking. Prescribing on Medication Errors and Adverse Drug 63 California HealthCare Foundation, Snapshot: Events: A Systematic Review.’’ Jour. Am. Medical The barriers to adoption continue to be The State of Health Information Technology in Informatics Assn., June 25, 2008. California, 2008. 61 Most of the studies label all medical orders as 62 Rupp, M.T. and T.L. Warholack. ‘‘Evaluation of 64 Bergin, T.J., ‘‘The Proliferation and prescriptions, whether they are included on a e-prescribing in chain community pharmacy: best- Consolidation of Word Processing Software: 1985– patient’s chart in a hospital or LTCF or are written practice recommendations.’’ J. Am. Pharm. Assoc. 1995.’’ IEEE Annals of the History of Computing. and given to a patient to fill at a pharmacy. 2008 May–Jun; 48(3):364–370. Volume 28, Issue 4, Oct.–Dec. 2006 Page(s):48–63.

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that any organization will certify represent about 0.3 percent of the substance prescription. It also pharmacy applications because no annual income of the lowest paid represents a far lower cost than the organization currently does so except practitioner and 0.1 percent of average pharmacy will pay its application for determining whether the pharmacy revenues. The ongoing costs are provider to cover the fee charged by application can read a SCRIPT format. considerably lower. For practices with a SureScripts/RxHub or another The single largest cost for physician and a mid-level practitioner, intermediary for processing the practitioners is obtaining identity the costs would be lower because access prescriptions. According to comments proofing and an authentication control training would not need to DEA received to its notice of proposed credential. DEA used the cost of a three- involve the physician. (Mid-level rulemaking, the application provider year digital certificate at a medium practitioners, because they are generally charges a transaction fee of $0.30 per assurance level from the SAFE employees, are not small entities under electronic prescription to cover BioPharma Certification Authority for the Regulatory Flexibility Act.) intermediary charges for routing and, the cost estimate. SAFE meets the Determining the incremental cost of where necessary converting, criteria set in the rule. Other firms that the application requirements per prescriptions to ensure that the meet the criteria provide digital practitioner is difficult because it pharmacy system will be able to capture certificates and other credentials for depends on the number of application the data electronically. Based on more and for less. The actual cost will providers, the number of customers, the National Association of Chain Drug not be known until the rule is number of application requirements that Stores data on the average price of implemented and practitioners and an application provider does not already prescriptions ($71.69) and the average providers decide on the type of meet, and how costs are recovered (in value of prescription sales, an credential they will use. Some the year in which the money is spent or independent pharmacy processes about commenters on the proposed rule stated over time). For example, an electronic 36,000 prescriptions a year and will that remote identity proofing, which is health record application that had to have to pay about $10,800 to cover the allowable, can be done very quickly, reprogram to the full extent will have transaction fee.65 which could lower the cost. The firms incremental application costs of The average annualized cost to providing the service, however, may $199,000 ($15,000 for the third-party hospitals and clinics is about $180, impose other requirements beyond audit and $184,000 for reprogramming). which does not represent a significant those of DEA, which could increase the If the provider recovered the costs from economic impact. Most of the hospital cost. 1,000 practitioners (charges are usually tasks are part of their routine business There will also be costs associated on a per practitioner, not per practice practices related to credentialing. with lost or compromised credentials. basis), the incremental cost to those Application providers are not directly DEA has not attempted to estimate those customers will be $199 or about $17 a regulated by the rule and, therefore, are costs because the frequency with which month. The costs for the application not covered by the requirements of the this will occur and the requirements provider in the out years will be much RFA. DEA notes, however, that the costs that credential providers will impose is lower ($15,000 every two years) because of the rule are not so high that any of not known. Some practitioners will no further programming is needed. Even these firms will not be able to recover never incur these costs while others if the application provider did not add them from their customers. may incur them multiple times. practitioners and continued to obtain a Reprogramming is a routine practice in Credential providers may require a third-party audit rather than rely on the software industry; applications are practitioner to go through identity certification, the incremental cost to updated with some frequency to add proofing or may impose lesser practitioners will be less than a dollar features and fix problems. The requirements. If one of the two factors a month. additional requirements of the rule can is a password, credential providers may For pharmacies, the costs will be the be incorporated during the update cycle. deal with password resets as they do incremental cost that their application Many of these firms are already now; password resets do not usually provider charges to cover the costs of spending more than DEA has estimated involve issuing a new token or a fee. reprogramming and audits ($92,000 plus to obtain CCHIT certification; in time, $15,000) plus the cost of reviewing the C. Regulatory Flexibility Act DEA expects that this certification (or a security log ($11.43 per year) and initial similar certification) will replace the Under the Regulatory Flexibility Act access control training and initial access third-party audit, further reducing their of 1980 (5 U.S.C. 601–612) (RFA), control setting ($4.66). In the first year, costs. Federal agencies must evaluate the if the application providers recover the Based on the above analysis, DEA has impact of rules on small entities and programming costs and initial audit determined that although the rule will consider less burdensome alternatives. costs in a single year, the average impact a substantial number of small In its Economic Impact Analysis, DEA incremental cost to a pharmacy for these entities, it will not impose a significant has evaluated the cost of the rule on two activities will be $65 ($4,284,900 economic impact on any small entity individual practitioners and small first year cost divided by 65,421 directly subject to the rule. pharmacies. The initial costs to the pharmacies). The total first year cost smallest practitioner office will be about will, therefore, be less than $100. After D. Congressional Review Act $400 ($110 for identity proofing that, the incremental charge to recover It has been determined that this rule including the authentication credential, the cost of the third-party audit will be is a major rule as defined by Section 804 and $290 in labor costs to complete the $9 per pharmacy every two years, of the Small Business Regulatory application, receive access control assuming the cost is evenly distributed Enforcement Fairness Act of 1996 training, and set logical access controls). across all pharmacies. The pharmacy (Congressional Review Act). This rule is The main ongoing costs for the rule will will have continuing labor costs for voluntary and could result in a net be the renewal of the credential ($49 reviewing security logs ($11.43). The reduction in costs. This rule will not every three years) and checking security first year charge represents less than result in a major increase in costs or logs ($22 per year) plus any incremental 0.01 percent of an independent cost of the software or application. The pharmacy’s annual sales. The annual 65 http://www.nacds.org/ initial costs for the basic rule elements cost is less than $0.01 per controlled wmspage.cfm?parm1=507, accessed 6/17/09.

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prices; or significant adverse effects on (1) Type of Information Collection: practitioner offices, two people will competition, employment, investment, New collection. need to enter logical access control data productivity, innovation, or on the (2) Title of the Form/Collection: into the electronic prescription ability of United States-based Recordkeeping for electronic application to grant permissions for companies to compete with foreign- prescriptions for controlled substances. individual practitioner registrants to based companies in domestic and (3) Agency form number, if any, and approve and sign controlled substance export markets. the applicable component of the prescriptions. For larger offices (more Department of Justice sponsoring the than two registrants), DEA registrations E. Paperwork Reduction Act collection: will be checked prior to granting access. As part of its NPRM, DEA included a Form number: None. Similarly pharmacies will have to enter discussion of the hour burdens Office of Diversion Control, Drug permissions for access to prescription associated with the proposed rule. DEA Enforcement Administration, records. Finally, practitioners, did not receive any comments specific Department of Justice. hospitals/clinics, and pharmacies will to the information collection aspects of (4) Affected public who will be asked have to check security logs periodically the NPRM. or required to respond, as well as a brief to determine if security incidents have The Department of Justice, Drug abstract: occurred. Enforcement Administration, has Primary: business or other for-profit. submitted the following information Other: non-profit healthcare facilities. (5) An estimate of the total number of collection request to the Office of Abstract: DEA is requiring that each respondents and the amount of time Management and Budget for review and registered practitioner apply to a estimated for an average respondent to clearance in accordance with review credential service provider approved by respond: procedures of the Paperwork Reduction the Federal government to obtain DEA estimates in the first three years Act of 1995. identity proofing and a credential. of implementation 217,740 All suggestions or questions regarding Hospitals and other institutional practitioners, 8,688 hospitals and additional information, to include practitioners may conduct this process clinics, and 65,421 pharmacies will obtaining a copy of the information in-house as part of their credentialing. adopt electronic prescribing for a total collection instrument with instructions, For practitioners currently working at or of 291,849 respondents. The average should be directed to Mark W. Caverly, affiliated with a registered hospital or practitioner is expected to spend 0.17 Chief, Liaison and Policy Section, Office clinic, the hospital/clinic will have to hours, the average hospital or clinic, of Diversion Control, Drug Enforcement check a government-issued 2.23 hours, and the average pharmacy Administration, 8701 Morrissette Drive, photographic identification. In the 0.36 hours annually or an average across Springfield, VA 22152. future, this will be done when the all respondents of 0.27 hours per year. Overview of information collection hospital/clinic issues credentials to new Table 14 presents the burden hours by 1117–0049: hires or newly affiliated physicians. At activity, registrant type, and year.

TABLE 14—BURDEN HOURS BY ACTIVITY, REGISTRANT TYPE, AND YEAR

Year 1 Practitioner Hospitals Pharmacies Total hours

Application ...... 5,827 ...... 5,827 Registration check ...... 264 ...... 264 Access control ...... 1,826 ...... 5,452 7,277 Security log ...... 6,086 6,206 21,807 34,099 ID check ...... 27,712 ...... 27,712

Total ...... 14,003 33,918 27,259 75,180

Year 2 Practitioner Hospitals Pharmacies Total hours

Application ...... 10,004 ...... 10,004 Registration check ...... 454 ...... 454 Access control ...... 3,101 ...... 3,101 Security log ...... 16,423 12,412 21,807 50,642 ID check ...... 28,887 ...... 28,887

Total ...... 29,983 41,299 21,807 93,089

Year 3 Practitioner Hospitals Pharmacies Total hours

Application ...... 20,459 ...... 20,459 Registration check ...... 931 ...... 931 Access control ...... 6,292 ...... 0 6,292 Security log ...... 37,395 9,120 21,807 68,322 ID check ...... 24,319 ...... 24,319

Total ...... 65,076 41,696 21,807 128,579

(6) An estimate of the total public The three year burden hours are If additional information is required burden (in hours) associated with the estimated to be 296,848 or 98,949 hours contact: Lynn Bryant, Department collection: annually. Clearance Officer, Information Management and Security Staff, Justice

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Management Division, Department of Authority: 21 U.S.C. 802, 821, 829, 871(b), Certificate revocation list (CRL) means Justice, Patrick Henry Building, Suite 951, 958(f). a list of revoked, but unexpired 1600, 601 D Street NW., Washington, ■ 2. Section 1300.03 is added to read as certificates issued by a certification DC 20530. follows: authority. Certification authority (CA) means an F. Executive Order 12988 § 1300.03 Definitions relating to electronic organization that is responsible for This regulation meets the applicable orders for controlled substances and verifying the identity of applicants, standards set forth in Sections 3(a) and electronic prescriptions for controlled authorizing and issuing a digital 3(b)(2) of Executive Order 12988 Civil substances. certificate, maintaining a directory of Justice Reform. For the purposes of this chapter, the public keys, and maintaining a following terms shall have the meanings Certificate Revocation List. G. Executive Order 13132 specified: Certified information systems auditor This rulemaking does not preempt or Application service provider means (CISA) means an individual who has modify any provision of State law; nor an entity that sells electronic been certified by the Information does it impose enforcement prescription or pharmacy applications Systems Audit and Control Association responsibilities on any State; nor does it as a hosted service, where the entity as qualified to audit information diminish the power of any State to controls access to the application and systems and who performs compliance enforce its own laws. Accordingly, this maintains the software and records on audits as a regular ongoing business rulemaking does not have federalism its servers. activity. implications warranting the application Audit trail means a record showing Credential means an object or data of Executive Order 13132. who has accessed an information structure that authoritatively binds an technology application and what identity (and optionally, additional H. Unfunded Mandates Reform Act of operations the user performed during a attributes) to a token possessed and 1995 given period. controlled by a person. Credential service provider (CSP) This rule will not result in the net Authentication means verifying the means a trusted entity that issues or expenditure by State, local, and tribal identity of the user as a prerequisite to registers tokens and issues electronic governments, in the aggregate, or by the allowing access to the information credentials to individuals. The CSP may private sector, of $120,000,000 or more application. be an independent third party or may (adjusted for inflation) in any one year Authentication protocol means a well specified message exchange process that issue credentials for its own use. and will not significantly or uniquely CSOS means controlled substance affect small governments. Because this verifies possession of a token to remotely authenticate a person to an ordering system. rule will not affect other governments, Digital certificate means a data record no actions were deemed necessary application. Biometric authentication means that, at a minimum— under the provisions of the Unfunded (1) Identifies the certification Mandates Reform Act of 1995. The authentication based on measurement of the individual’s physical features or authority issuing it; economic impact on private entities is (2) Names or otherwise identifies the repeatable actions where those features analyzed in the Economic Impact certificate holder; Analysis of the Electronic Prescription or actions are both distinctive to the (3) Contains a public key that Rule. individual and measurable. corresponds to a private key under the Biometric subsystem means the sole control of the certificate holder; List of Subjects hardware and software used to capture, (4) Identifies the operational period; store, and compare biometric data. The 21 CFR Part 1300 and biometric subsystem may be part of a (5) Contains a serial number and is Chemicals, Drug traffic control. larger application. The biometric digitally signed by the certification subsystem is an automated system 21 CFR Part 1304 authority issuing it. capable of: Digital signature means a record Drug traffic control, Reporting and (1) Capturing a biometric sample from created when a file is algorithmically recordkeeping requirements an end user. transformed into a fixed length digest (2) Extracting and processing the 21 CFR Part 1306 that is then encrypted using an biometric data from that sample. asymmetric cryptographic private key Drug traffic control, Prescription (3) Storing the extracted information associated with a digital certificate. The drugs. in a database. combination of the encryption and (4) Comparing the biometric data with 21 CFR Part 1311 algorithm transformation ensure that the data contained in one or more reference signer’s identity and the integrity of the Administrative practice and databases. file can be confirmed. procedure, Certification authorities, (5) Determining how well the stored Digitally sign means to affix a digital Controlled substances, Digital data matches the newly captured data signature to a data file. certificates, Drug traffic control, and indicating whether an identification Electronic prescription means a Electronic signatures, Incorporation by or verification of identity has been prescription that is generated on an reference, Prescription drugs, Reporting achieved. electronic application and transmitted and recordkeeping requirements. Cache means to download and store as an electronic data file. information on a local server or hard ■ For the reasons set out above, 21 CFR Electronic prescription application drive. parts 1300, 1304, 1306, and 1311 are provider means an entity that develops Certificate policy means a named set amended as follows: or markets electronic prescription of rules that sets forth the applicability software either as a stand-alone PART 1300—DEFINITIONS of the specific digital certificate to a application or as a module in an particular community or class of electronic health record application. ■ 1. The authority citation for part 1300 application with common security Electronic signature means a method continues to read as follows: requirements. of signing an electronic message that

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identifies a particular person as the applications used to generate and rely specific algorithm on a specific set of source of the message and indicates the upon digital signatures. data. person’s approval of the information Hard token means a cryptographic Paper prescription means a contained in the message. key stored on a special hardware device prescription created on paper or False match rate means the rate at (e.g., a PDA, cell phone, smart card, computer generated to be printed or which an impostor’s biometric is falsely USB drive, one-time password device) transmitted via facsimile that meets the accepted as being that of an authorized rather than on a general purpose requirements of part 1306 of this user. It is one of the statistics used to computer. chapter including a manual signature. measure biometric performance when Identity proofing means the process Password means a secret, typically a operating in the verification or by which a credential service provider character string (letters, numbers, and authentication task. The false match rate or certification authority validates other symbols), that a person memorizes is similar to the false accept (or sufficient information to uniquely and uses to authenticate his identity. acceptance) rate. identify a person. PDA means a Personal Digital False non-match rate means the rate Installed electronic prescription Assistant, a handheld computer used to at which a genuine user’s biometric is application means software that is used manage contacts, appointments, and falsely rejected when the user’s to create electronic prescriptions and tasks. biometric data fail to match the enrolled that is installed on a practitioner’s Pharmacy application provider means data for the user. It is one of the computers and servers, where access an entity that develops or markets statistics used to measure biometric and records are controlled by the software that manages the receipt and performance when operating in the practitioner. processing of electronic prescriptions. verification or authentication task. The Installed pharmacy application Private key means the key of a key false match rate is similar to the false means software that is used to process pair that is used to create a digital reject (or rejection) rate, except that it prescription information and that is signature. does not include the rate at which a installed on a pharmacy’s computers or Public key means the key of a key pair biometric system fails to acquire a servers and is controlled by the that is used to verify a digital signature. biometric sample from a genuine user. pharmacy. The public key is made available to FIPS means Federal Information Intermediary means any technology anyone who will receive digitally signed Processing Standards. These Federal system that receives and transmits an messages from the holder of the key standards, as incorporated by reference electronic prescription between the pair. in § 1311.08 of this chapter, prescribe practitioner and pharmacy. Public Key Infrastructure (PKI) means specific performance requirements, Key pair means two mathematically a structure under which a certification practices, formats, communications related keys having the properties that: authority verifies the identity of protocols, etc., for hardware, software, (1) One key can be used to encrypt a applicants; issues, renews, and revokes data, etc. message that can only be decrypted digital certificates; maintains a registry FIPS 140–2, as incorporated by using the other key; and of public keys; and maintains an up-to- reference in § 1311.08 of this chapter, (2) Even knowing one key, it is date certificate revocation list. means the National Institute of computationally infeasible to discover Readily retrievable means that certain Standards and Technology publication the other key. records are kept by automatic data entitled ‘‘Security Requirements for NIST means the National Institute of processing applications or other Cryptographic Modules,’’ a Federal Standards and Technology. electronic or mechanized recordkeeping standard for security requirements for NIST SP 800–63–1, as incorporated by systems in such a manner that they can cryptographic modules. reference in § 1311.08 of this chapter, be separated out from all other records FIPS 180–2, as incorporated by means the National Institute of in a reasonable time and/or records are reference in § 1311.08 of this chapter, Standards and Technology publication kept on which certain items are means the National Institute of entitled ‘‘Electronic Authentication asterisked, redlined, or in some other Standards and Technology publication Guideline,’’ a Federal standard for manner visually identifiable apart from entitled ‘‘Secure Hash Standard,’’ a electronic authentication. other items appearing on the records. Federal secure hash standard. NIST SP 800–76–1, as incorporated by SAS 70 Audit means a third-party FIPS 180–3, as incorporated by reference in § 1311.08 of this chapter, audit of a technology provider that reference in § 1311.08 of this chapter, means the National Institute of meets the American Institute of means the National Institute of Standards and Technology publication Certified Public Accountants (AICPA) Standards and Technology publication entitled ‘‘Biometric Data Specification Statement of Auditing Standards (SAS) entitled ‘‘Secure Hash Standard (SHS),’’ for Personal Identity Verification,’’ a 70 criteria. a Federal secure hash standard. Federal standard for biometric data Signing function means any keystroke FIPS 186–2, as incorporated by specifications for personal identity or other action used to indicate that the reference in § 1311.08 of this chapter, verification. practitioner has authorized for means the National Institute of Operating point means a point chosen transmission and dispensing a Standards and Technology publication on a receiver operating characteristic controlled substance prescription. The entitled ‘‘Digital Signature Standard,’’ a (ROC) curve for a specific algorithm at signing function may occur Federal standard for applications used which the biometric system is set to simultaneously with or after the to generate and rely upon digital function. It is defined by its completion of the two-factor signatures. corresponding coordinates—a false authentication protocol that meets the FIPS 186–3, as incorporated by match rate and a false non-match rate. requirements of part 1311 of this reference in § 1311.08 of this chapter, An ROC curve shows graphically the chapter. The signing function may have means the National Institute of trade-off between the principal two different names (e.g., approve, sign, Standards and Technology publication types of errors (false match rate and transmit), but it serves as the entitled ‘‘Digital Signature Standard false non-match rate) of a biometric practitioner’s final authorization that he (DSS),’’ a Federal standard for system by plotting the performance of a intends to issue the prescription for a

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legitimate medical reason in the normal ■ 5. Section 1304.04 is amended by chapter. The computers on which the course of his professional practice. revising paragraph (b) introductory text, records are maintained may be located SysTrust means a professional service paragraph (b)(1), and paragraph (h) to at another location, but the records must performed by a qualified certified public read as follows: be readily retrievable at the registered accountant to evaluate one or more location if requested by the aspects of electronic systems. § 1304.04 Maintenance of records and Administration or other law inventories. Third-party audit means an enforcement agent. The electronic independent review and examination of * * * * * application must be capable of printing records and activities to assess the (b) All registrants that are authorized out or transferring the records in a adequacy of system controls, to ensure to maintain a central recordkeeping format that is readily understandable to compliance with established policies system under paragraph (a) of this an Administration or other law and operational procedures, and to section shall be subject to the following enforcement agent at the registered recommend necessary changes in conditions: location. Electronic copies of (1) The records to be maintained at controls, policies, or procedures. prescription records must be sortable by the central record location shall not Token means something a person prescriber name, patient name, drug include executed order forms and possesses and controls (typically a key dispensed, and date filled. or password) used to authenticate the inventories, which shall be maintained person’s identity. at each registered location. ■ 6. Section 1304.06 is added to read as Trusted agent means an entity * * * * * follows: authorized to act as a representative of (h) Each registered pharmacy shall maintain the inventories and records of § 1304.06 Records and reports for a certification authority or credential electronic prescriptions. service provider in confirming controlled substances as follows: practitioner identification during the (1) Inventories and records of all (a) As required by § 1311.120 of this enrollment process. controlled substances listed in Schedule chapter, a practitioner who issues Valid prescription means a I and II shall be maintained separately electronic prescriptions for controlled prescription that is issued for a from all other records of the pharmacy. substances must use an electronic legitimate medical purpose by an (2) Paper prescriptions for Schedule II prescription application that retains the individual practitioner licensed by law controlled substances shall be following information: to administer and prescribe the drugs maintained at the registered location in (1) The digitally signed record of the concerned and acting in the usual a separate prescription file. information specified in part 1306 of course of the practitioner’s professional (3) Inventories and records of this chapter. practice. Schedules III, IV, and V controlled (2) The internal audit trail and any WebTrust means a professional substances shall be maintained either auditable event identified by the service performed by a qualified separately from all other records of the internal audit as required by § 1311.150 certified public accountant to evaluate pharmacy or in such form that the of this chapter. one or more aspects of Web sites. information required is readily (b) An institutional practitioner must retrievable from ordinary business retain a record of identity proofing and PART 1304—RECORDS AND records of the pharmacy. issuance of the two-factor REPORTS OF REGISTRANTS (4) Paper prescriptions for Schedules authentication credential, where III, IV, and V controlled substances shall applicable, as required by § 1311.110 of ■ 3. The authority citation for part 1304 be maintained at the registered location this chapter. continues to read as follows: either in a separate prescription file for (c) As required by § 1311.205 of this Authority: 21 U.S.C. 821, 827, 831, 871(b), Schedules III, IV, and V controlled chapter, a pharmacy that processes 958(e), 965, unless otherwise noted. substances only or in such form that electronic prescriptions for controlled ■ 4. Section 1304.03 is amended by they are readily retrievable from the substances must use an application that revising paragraph (c) and adding other prescription records of the retains the following: (1) All of the information required paragraph (h) to read as follows: pharmacy. Prescriptions will be deemed readily retrievable if, at the time they under § 1304.22(c) and part 1306 of this § 1304.03 Persons required to keep are initially filed, the face of the chapter. records and file reports. prescription is stamped in red ink in the (2) The digitally signed record of the * * * * * lower right corner with the letter ‘‘C’’ no prescription as received as required by (c) Except as provided in § 1304.06, a less than 1 inch high and filed either in § 1311.210 of this chapter. registered individual practitioner is not the prescription file for controlled (3) The internal audit trail and any required to keep records of controlled substances listed in Schedules I and II auditable event identified by the substances in Schedules II, III, IV, and or in the usual consecutively numbered internal audit as required by § 1311.215 V that are prescribed in the lawful prescription file for noncontrolled of this chapter. course of professional practice, unless substances. However, if a pharmacy (d) A registrant and application such substances are prescribed in the employs a computer application for service provider must retain a copy of course of maintenance or detoxification prescriptions that permits identification any security incident report filed with treatment of an individual. by prescription number and retrieval of the Administration pursuant to * * * * * original documents by prescriber name, §§ 1311.150 and 1311.215 of this (h) A person is required to keep the patient’s name, drug dispensed, and chapter. records and file the reports specified in date filled, then the requirement to mark (e) An electronic prescription or § 1304.06 and part 1311 of this chapter the hard copy prescription with a red pharmacy application provider must if they are either of the following: ‘‘C’’ is waived. retain third party audit or certification (1) An electronic prescription (5) Records of electronic prescriptions reports as required by § 1311.300 of this application provider. for controlled substances shall be chapter. (2) An electronic pharmacy maintained in an application that meets (f) An application provider must application provider. the requirements of part 1311 of this retain a copy of any notification to the

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Administration regarding an adverse rests upon the pharmacist, including a for a controlled substance prescription audit or certification report filed with pharmacist employed by a central fill is altered during the transmission, the the Administration on problems pharmacy, who fills a prescription not prescription is deemed to be invalid and identified by the third-party audit or prepared in the form prescribed by DEA the pharmacy may not dispense the certification as required by § 1311.300 of regulations. controlled substance. this chapter. (g) An individual practitioner ■ 10. In § 1306.11, paragraphs (a), (c), (g) Unless otherwise specified, exempted from registration under (d)(1), and (d)(4) are revised to read as records and reports must be retained for § 1301.22(c) of this chapter shall include follows: two years. on all prescriptions issued by him the registration number of the hospital or § 1306.11 Requirement of prescription. PART 1306—PRESCRIPTIONS other institution and the special internal (a) A pharmacist may dispense ■ code number assigned to him by the directly a controlled substance listed in 7. The authority citation for part 1306 hospital or other institution as provided Schedule II that is a prescription drug continues to read as follows: in § 1301.22(c) of this chapter, in lieu of as determined under section 503 of the Authority: 21 U.S.C. 821, 829, 831, 871(b), the registration number of the Federal Food, Drug, and Cosmetic Act unless otherwise noted. practitioner required by this section. (21 U.S.C. 353(b)) only pursuant to a ■ 8. Section 1306.05 is revised to read Each paper prescription shall have the written prescription signed by the as follows: name of the practitioner stamped, typed, practitioner, except as provided in or handprinted on it, as well as the paragraph (d) of this section. A paper § 1306.05 Manner of issuance of prescriptions. signature of the practitioner. prescription for a Schedule II controlled (h) An official exempted from substance may be transmitted by the (a) All prescriptions for controlled registration under § 1301.23(a) of this practitioner or the practitioner’s agent to substances shall be dated as of, and chapter must include on all a pharmacy via facsimile equipment, signed on, the day when issued and prescriptions issued by him his branch provided that the original manually shall bear the full name and address of of service or agency (e.g., ‘‘U.S. Army’’ signed prescription is presented to the the patient, the drug name, strength, or ‘‘Public Health Service’’) and his pharmacist for review prior to the actual dosage form, quantity prescribed, service identification number, in lieu of dispensing of the controlled substance, directions for use, and the name, the registration number of the except as noted in paragraph (e), (f), or address and registration number of the practitioner required by this section. (g) of this section. The original practitioner. The service identification number for a prescription shall be maintained in (b) A prescription for a Schedule III, Public Health Service employee is his accordance with § 1304.04(h) of this IV, or V narcotic drug approved by FDA Social Security identification number. ‘‘ chapter. specifically for detoxification Each paper prescription shall have the treatment’’ or ‘‘maintenance treatment’’ * * * * * name of the officer stamped, typed, or (c) An institutional practitioner may must include the identification number handprinted on it, as well as the issued by the Administrator under administer or dispense directly (but not signature of the officer. prescribe) a controlled substance listed § 1301.28(d) of this chapter or a written ■ notice stating that the practitioner is 9. Section 1306.08 is added to read as in Schedule II only pursuant to a acting under the good faith exception of follows: written prescription signed by the prescribing individual practitioner or to § 1301.28(e) of this chapter. § 1306.08 Electronic prescriptions. (c) Where a prescription is for gamma- an order for medication made by an (a) An individual practitioner may individual practitioner that is dispensed hydroxybutyric acid, the practitioner sign and transmit electronic shall note on the face of the prescription for immediate administration to the prescriptions for controlled substances ultimate user. the medical need of the patient for the provided the practitioner meets all of prescription. (d) * * * the following requirements: (1) The quantity prescribed and (d) A practitioner may sign a paper (1) The practitioner must comply with prescription in the same manner as he dispensed is limited to the amount all other requirements for issuing adequate to treat the patient during the would sign a check or legal document controlled substance prescriptions in (e.g., J.H. Smith or John H. Smith). emergency period (dispensing beyond this part; the emergency period must be pursuant Where an oral order is not permitted, (2) The practitioner must use an to a paper or electronic prescription paper prescriptions shall be written application that meets the requirements signed by the prescribing individual with ink or indelible pencil, typewriter, of part 1311 of this chapter; and or printed on a computer printer and (3) The practitioner must comply with practitioner); shall be manually signed by the the requirements for practitioners in * * * * * practitioner. A computer-generated part 1311 of this chapter. (4) Within 7 days after authorizing an prescription that is printed out or faxed (b) A pharmacy may fill an emergency oral prescription, the by the practitioner must be manually electronically transmitted prescription prescribing individual practitioner shall signed. for a controlled substance provided the cause a written prescription for the (e) Electronic prescriptions shall be pharmacy complies with all other emergency quantity prescribed to be created and signed using an application requirements for filling controlled delivered to the dispensing pharmacist. that meets the requirements of part 1311 substance prescriptions in this part and In addition to conforming to the of this chapter. with the requirements of part 1311 of requirements of § 1306.05, the (f) A prescription may be prepared by this chapter. prescription shall have written on its the secretary or agent for the signature (c) To annotate an electronic face ‘‘Authorization for Emergency of a practitioner, but the prescribing prescription, a pharmacist must include Dispensing,’’ and the date of the oral practitioner is responsible in case the all of the information that this part order. The paper prescription may be prescription does not conform in all requires in the prescription record. delivered to the pharmacist in person or essential respects to the law and (d) If the content of any of the by mail, but if delivered by mail it must regulations. A corresponding liability information required under § 1306.05 be postmarked within the 7-day period.

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Upon receipt, the dispensing pharmacist transmittal must be added to the such as a medication record, or must attach this paper prescription to electronic prescription record. electronic prescription record, the the oral emergency prescription that had * * * * * document or record must be uniformly earlier been reduced to writing. For ■ 13. In § 1306.21, paragraphs (a) and (c) maintained and readily retrievable. electronic prescriptions, the pharmacist are revised to read as follows: (c) The following information must be must annotate the record of the retrievable by the prescription number: electronic prescription with the original § 1306.21 Requirement of prescription. (1) The name and dosage form of the authorization and date of the oral order. (a) A pharmacist may dispense controlled substance. The pharmacist must notify the nearest directly a controlled substance listed in (2) The date filled or refilled. office of the Administration if the Schedule III, IV, or V that is a (3) The quantity dispensed. prescribing individual practitioner fails prescription drug as determined under (4) The initials of the dispensing to deliver a written prescription to him; section 503(b) of the Federal Food, pharmacist for each refill. (5) The total number of refills for that failure of the pharmacist to do so shall Drug, and Cosmetic Act (21 U.S.C. prescription. void the authority conferred by this 353(b)) only pursuant to either a paper (d) If the pharmacist merely initials paragraph to dispense without a written prescription signed by a practitioner, a and dates the back of the prescription or prescription of a prescribing individual facsimile of a signed paper prescription annotates the electronic prescription practitioner. transmitted by the practitioner or the record, it shall be deemed that the full practitioner’s agent to the pharmacy, an * * * * * face amount of the prescription has been electronic prescription that meets the ■ 11. In § 1306.13, paragraph (a) is dispensed. requirements of this part and part 1311 revised to read as follows: (e) The prescribing practitioner may of this chapter, or an oral prescription authorize additional refills of Schedule § 1306.13 Partial filling of prescriptions. made by an individual practitioner and III or IV controlled substances on the promptly reduced to writing by the (a) The partial filling of a prescription original prescription through an oral pharmacist containing all information for a controlled substance listed in refill authorization transmitted to the required in § 1306.05, except for the Schedule II is permissible if the pharmacist provided the following signature of the practitioner. pharmacist is unable to supply the full conditions are met: quantity called for in a written or * * * * * (1) The total quantity authorized, emergency oral prescription and he (c) An institutional practitioner may including the amount of the original makes a notation of the quantity administer or dispense directly (but not prescription, does not exceed five refills supplied on the face of the written prescribe) a controlled substance listed nor extend beyond six months from the prescription, written record of the in Schedule III, IV, or V only pursuant date of issue of the original prescription. emergency oral prescription, or in the to a paper prescription signed by an (2) The pharmacist obtaining the oral electronic prescription record. The individual practitioner, a facsimile of a authorization records on the reverse of remaining portion of the prescription paper prescription or order for the original paper prescription or may be filled within 72 hours of the first medication transmitted by the annotates the electronic prescription partial filling; however, if the remaining practitioner or the practitioner’s agent to record with the date, quantity of refill, portion is not or cannot be filled within the institutional practitioner- number of additional refills authorized, the 72-hour period, the pharmacist shall pharmacist, an electronic prescription and initials the paper prescription or notify the prescribing individual that meets the requirements of this part annotates the electronic prescription practitioner. No further quantity may be and part 1311 of this chapter, or an oral record showing who received the supplied beyond 72 hours without a prescription made by an individual authorization from the prescribing new prescription. practitioner and promptly reduced to practitioner who issued the original writing by the pharmacist (containing * * * * * prescription. all information required in § 1306.05 (3) The quantity of each additional ■ 12. In § 1306.15, paragraph (a)(1) is except for the signature of the refill authorized is equal to or less than revised to read as follows: individual practitioner), or pursuant to the quantity authorized for the initial an order for medication made by an filling of the original prescription. § 1306.15 Provision of prescription individual practitioner that is dispensed information between retail pharmacies and (4) The prescribing practitioner must central fill pharmacies for prescriptions of for immediate administration to the execute a new and separate prescription Schedule II controlled substances. ultimate user, subject to § 1306.07. for any additional quantities beyond the ■ five-refill, six-month limitation. * * * * * 14. Section 1306.22 is revised to read as follows: (f) As an alternative to the procedures (a) * * * provided by paragraphs (a) through (e) (1) Write the words ‘‘CENTRAL FILL’’ § 1306.22 Refilling of prescriptions. of this section, a computer application on the face of the original paper (a) No prescription for a controlled may be used for the storage and retrieval prescription and record the name, substance listed in Schedule III or IV of refill information for original paper address, and DEA registration number of shall be filled or refilled more than six prescription orders for controlled the central fill pharmacy to which the months after the date on which such substances in Schedule III and IV, prescription has been transmitted, the prescription was issued. No prescription subject to the following conditions: name of the retail pharmacy pharmacist for a controlled substance listed in (1) Any such proposed computerized transmitting the prescription, and the Schedule III or IV authorized to be application must provide online date of transmittal. For electronic refilled may be refilled more than five retrieval (via computer monitor or hard- prescriptions the name, address, and times. copy printout) of original prescription DEA registration number of the central (b) Each refilling of a prescription order information for those prescription fill pharmacy to which the prescription shall be entered on the back of the orders that are currently authorized for has been transmitted, the name of the prescription or on another appropriate refilling. This shall include, but is not retail pharmacy pharmacist transmitting document or electronic prescription limited to, data such as the original the prescription, and the date of record. If entered on another document, prescription number; date of issuance of

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the original prescription order by the employing such an application for a § 1306.25 Transfer between pharmacies of practitioner; full name and address of period of two years after the date of prescription information for Schedules III, the patient; name, address, and DEA dispensing the appropriately authorized IV, and V controlled substances for refill purposes. registration number of the practitioner; refill. and the name, strength, dosage form, (a) The transfer of original (4) Any such computerized quantity of the controlled substance prescription information for a controlled application shall have the capability of prescribed (and quantity dispensed if substance listed in Schedule III, IV, or different from the quantity prescribed), producing a printout of any refill data V for the purpose of refill dispensing is and the total number of refills that the user pharmacy is responsible permissible between pharmacies on a authorized by the prescribing for maintaining under the Act and its one-time basis only. However, practitioner. implementing regulations. For example, pharmacies electronically sharing a real- (2) Any such proposed computerized this would include a refill-by-refill audit time, online database may transfer up to application must also provide online trail for any specified strength and the maximum refills permitted by law retrieval (via computer monitor or hard- dosage form of any controlled substance and the prescriber’s authorization. copy printout) of the current refill (by either brand or generic name or (b) Transfers are subject to the history for Schedule III or IV controlled both). Such a printout must include following requirements: substance prescription orders (those name of the prescribing practitioner, (1) The transfer must be communicated directly between two authorized for refill during the past six name and address of the patient, months). This refill history shall licensed pharmacists. quantity dispensed on each refill, date (2) The transferring pharmacist must include, but is not limited to, the name of dispensing for each refill, name or of the controlled substance, the date of do the following: identification code of the dispensing (i) Write the word ‘‘VOID’’ on the face refill, the quantity dispensed, the pharmacist, and the number of the of the invalidated prescription; for identification code, or name or initials original prescription order. In any electronic prescriptions, information of the dispensing pharmacist for each computerized application employed by that the prescription has been refill and the total number of refills a user pharmacy the central transferred must be added to the dispensed to date for that prescription recordkeeping location must be capable prescription record. order. (ii) Record on the reverse of the (3) Documentation of the fact that the of sending the printout to the pharmacy invalidated prescription the name, refill information entered into the within 48 hours, and if a DEA Special address, and DEA registration number of computer each time a pharmacist refills Agent or Diversion Investigator requests the pharmacy to which it was an original paper, fax, or oral a copy of such printout from the user transferred and the name of the prescription order for a Schedule III or pharmacy, it must, if requested to do so pharmacist receiving the prescription IV controlled substance is correct must by the Agent or Investigator, verify the information; for electronic be provided by the individual printout transmittal capability of its prescriptions, such information must be pharmacist who makes use of such an application by documentation (e.g., added to the prescription record. application. If such an application postmark). (iii) Record the date of the transfer provides a hard-copy printout of each (5) In the event that a pharmacy and the name of the pharmacist day’s controlled substance prescription which employs such a computerized transferring the information. order refill data, that printout shall be application experiences system down- (3) For paper prescriptions and verified, dated, and signed by the time, the pharmacy must have an prescriptions received orally and individual pharmacist who refilled such reduced to writing by the pharmacist a prescription order. The individual auxiliary procedure which will be used for documentation of refills of Schedule pursuant to § 1306.21(a), the pharmacist pharmacist must verify that the data receiving the transferred prescription indicated are correct and then sign this III and IV controlled substance prescription orders. This auxiliary information must write the word document in the same manner as he ‘‘transfer’’ on the face of the transferred would sign a check or legal document procedure must ensure that refills are authorized by the original prescription prescription and reduce to writing all (e.g., J.H. Smith, or John H. Smith). This information required to be on a order, that the maximum number of document shall be maintained in a prescription pursuant to § 1306.05 and separate file at that pharmacy for a refills has not been exceeded, and that include: period of two years from the dispensing all of the appropriate data are retained (i) Date of issuance of original date. This printout of the day’s for online data entry as soon as the prescription. controlled substance prescription order computer system is available for use (ii) Original number of refills refill data must be provided to each again. authorized on original prescription. pharmacy using such a computerized (g) When filing refill information for (iii) Date of original dispensing. application within 72 hours of the date original paper, fax, or oral prescription (iv) Number of valid refills remaining on which the refill was dispensed. It and date(s) and locations of previous must be verified and signed by each orders for Schedule III or IV controlled substances, a pharmacy may use only refill(s). pharmacist who is involved with such (v) Pharmacy’s name, address, DEA dispensing. In lieu of such a printout, one of the two applications described in registration number, and prescription the pharmacy shall maintain a bound paragraphs (a) through (e) or (f) of this number from which the prescription log book, or separate file, in which each section. information was transferred. individual pharmacist involved in such (h) When filing refill information for (vi) Name of pharmacist who dispensing shall sign a statement (in the electronic prescriptions, a pharmacy transferred the prescription. manner previously described) each day, must use an application that meets the (vii) Pharmacy’s name, address, DEA attesting to the fact that the refill requirements of part 1311 of this registration number, and prescription information entered into the computer chapter. number from which the prescription that day has been reviewed by him and was originally filled. is correct as shown. Such a book or file ■ 15. Section 1306.25 is revised to read (4) For electronic prescriptions being must be maintained at the pharmacy as follows: transferred electronically, the

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transferring pharmacist must provide ■ 20. Section 1311.08 is revised to read Secure Hash Standard (SHS), October the receiving pharmacist with the as follows: 2008 (FIPS 180–3); incorporation by following information in addition to the reference approved for §§ 1311.120(b) original electronic prescription data: § 1311.08 Incorporation by reference. and 1311.205(b). (a) These incorporations by reference (i) The date of the original dispensing. (4) Federal Information Processing were approved by the Director of the (ii) The number of refills remaining Standard Publication (FIPS PUB) 186–2, Federal Register in accordance with 5 and the date(s) and locations of previous Digital Signature Standard, January 27, U.S.C. 552(a) and 1 CFR part 51. Copies refills. 2000, as amended by Change Notice 1, may be inspected at the Drug (iii) The transferring pharmacy’s October 5, 2001 (FIPS 186–2); Enforcement Administration, 600 Army name, address, DEA registration incorporation by reference approved for Navy Drive, Arlington, VA 22202 or at number, and prescription number for §§ 1311.30(b) and 1311.55(b). each dispensing. the National Archives and Records (5) Federal Information Processing (iv) The name of the pharmacist Administration (NARA). For Standard Publication (FIPS PUB) 186–3, transferring the prescription. information on the availability of this Digital Signature Standard (DSS), June (v) The name, address, DEA material at the Drug Enforcement 2009 (FIPS 186–3); incorporation by registration number, and prescription Administration, call (202) 307–1000. reference approved for §§ 1311.120(b), number from the pharmacy that For information on the availability of 1311.205(b), and 1311.210(c). originally filled the prescription, if this material at NARA, call (202) 741– different. 6030 or go to: http://www.archives.gov/ (6) Draft NIST Special Publication (5) The pharmacist receiving a federal_register/ 800–63–1, Electronic Authentication transferred electronic prescription must code_of_federal_regulations/ Guideline, December 8, 2008 (NIST SP create an electronic record for the ibr_locations.html. 800–63–1); Burr, W. et al.; incorporation prescription that includes the receiving (b) These standards are available from by reference approved for § 1311.105(a). pharmacist’s name and all of the the National Institute of Standards and (7) NIST Special Publication 800–76– information transferred with the Technology, Computer Security 1, Biometric Data Specification for prescription under paragraph (b)(4) of Division, Information Technology Personal Identity Verification, January this section. Laboratory, National Institute of 2007 (NIST SP 800–76–1); Wilson, C. et (c) The original and transferred Standards and Technology, 100 Bureau al.; incorporation by reference approved prescription(s) must be maintained for a Drive, Gaithersburg, MD 20899–8930, for § 1311.116(d). (301) 975–6478 or TTY (301) 975–8295, period of two years from the date of last ■ 21. Subpart C, consisting of refill. [email protected], and are available at http://csrc.nist.gov/. The following §§ 1311.100 through 1311.305, is added (d) Pharmacies electronically to read as follows: accessing the same prescription record standards are incorporated by reference: must satisfy all information (1) Federal Information Processing Subpart C—Electronic Prescriptions requirements of a manual mode for Standard Publication (FIPS PUB) 140–2, Sec. prescription transferal. Change Notices (12–03–2002), Security 1311.100 General. (e) The procedure allowing the Requirements for Cryptographic 1311.102 Practitioner responsibilities. transfer of prescription information for Modules, May 25, 2001 (FIPS 140–2) 1311.105 Requirements for obtaining an refill purposes is permissible only if including Annexes A through D; authentication credential—Individual allowable under existing State or other incorporation by reference approved for practitioners. 1311.110 Requirements for obtaining an applicable law. §§ 1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b). authentication credential—Individual (i) Annex A: Approved Security practitioners eligible to use an electronic PART 1311—REQUIREMENTS FOR prescription application of an ELECTRONIC ORDERS AND Functions for FIPS PUB 140–2, Security institutional practitioner. PRESCRIPTIONS Requirements for Cryptographic 1311.115 Additional requirements for two- Modules, September 23, 2004. factor authentication. ■ 16. The authority citation for part (ii) Annex B: Approved Protection 1311.116 Additional requirements for 1311 continues to read as follows: Profiles for FIPS PUB 140–2, Security biometrics. Authority: 21 U.S.C. 821, 828, 829, 871(b), Requirements for Cryptographic 1311.120 Electronic prescription 958(e), 965, unless otherwise noted. Modules, November 4, 2004. application requirements. (iii) Annex C: Approved Random 1311.125 Requirements for establishing ■ 17. The heading for part 1311 is Number Generators for FIPS PUB 140– logical access control—Individual revised to read as set forth above. 2, Security Requirements for practitioner. ■ 1311.130 Requirements for establishing 18. Section 1311.01 is revised to read Cryptographic Modules, January 31, logical access control—Institutional as follows: 2005. practitioner. (iv) Annex D: Approved Key § 1311.01 Scope. 1311.135 Requirements for creating a Establishment Techniques for FIPS PUB controlled substance prescription. This part sets forth the rules 140–2, Security Requirements for 1311.140 Requirements for signing a governing the creation, transmission, Cryptographic Modules, February 23, controlled substance prescription. and storage of electronic orders and 2004. 1311.145 Digitally signing the prescription prescriptions. (2) Federal Information Processing with the individual practitioner’s private ■ 19. Section 1311.02 is revised to read Standard Publication (FIPS PUB) 180–2, key. 1311.150 Additional requirements for as follows: Secure Hash Standard, August 1, 2002, as amended by change notice 1, internal application audits. § 1311.02 Definitions. 1311.170 Transmission requirements. February 25, 2004 (FIPS 180–2); 1311.200 Pharmacy responsibilities. Any term contained in this part shall incorporation by reference approved for 1311.205 Pharmacy application have the definition set forth in section §§ 1311.30(b) and 1311.55(b). requirements. 102 of the Act (21 U.S.C. 802) or part (3) Federal Information Processing 1311.210 Archiving the initial record. 1300 of this chapter. Standard Publication (FIPS PUB) 180–3, 1311.215 Internal audit trail.

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1311.300 Application provider password or other knowledge factor, or substance prescriptions if any of the requirements—Third-party audits or biometric information, with any other functions of the application required by certifications. person. The practitioner must not allow this subpart have been disabled or 1311.302 Additional application provider any other person to use the token or appear to be functioning improperly. requirements. enter the knowledge factor or other (g) If an electronic prescription 1311.305 Recordkeeping. identification means to sign application provider notifies an Subpart C—Electronic Prescriptions prescriptions for controlled substances. individual practitioner that a third-party Failure by the practitioner to secure the audit or certification report indicates § 1311.100 General. hard token, knowledge factor, or that the application or the application (a) This subpart addresses the biometric information may provide a provider no longer meets the requirements that must be met to issue basis for revocation or suspension of requirements of this part or notifies him and process Schedule II, III, IV, and V registration pursuant to section 304(a)(4) that the application provider has controlled substance prescriptions of the Act (21 U.S.C. 824(a)(4)). identified an issue that makes the electronically. (b) The practitioner must notify the application non-compliant, the (b) A practitioner may issue a individuals designated under § 1311.125 practitioner must do the following: prescription for a Schedule II, III, IV, or or § 1311.130 within one business day (1) Immediately cease to issue V controlled substance electronically if of discovery that the hard token has electronic controlled substance all of the following conditions are met: been lost, stolen, or compromised or the prescriptions using the application. (1) The practitioner is registered as an authentication protocol has been (2) Ensure, for an installed electronic individual practitioner or exempt from otherwise compromised. A practitioner prescription application at an the requirement of registration under who fails to comply with this provision individual practitioner’s practice, that part 1301 of this chapter and is may be held responsible for any the individuals designated under authorized under the registration or controlled substance prescriptions § 1311.125 terminate access for signing exemption to dispense the controlled written using his two-factor controlled substance prescriptions. substance; authentication credential. (h) If an electronic prescription (2) The practitioner uses an electronic (c) If the practitioner is notified by an application provider notifies an prescription application that meets all intermediary or pharmacy that an institutional practitioner that a third- of the applicable requirements of this electronic prescription was not party audit or certification report subpart; and successfully delivered, as provided in indicates that the application or the (3) The prescription is otherwise in § 1311.170, he must ensure that any application provider no longer meets conformity with the requirements of the paper or oral prescription (where the requirements of this part or notifies Act and this chapter. permitted) issued as a replacement of it that the application provider has (c) An electronic prescription for a the original electronic prescription identified an issue that makes the Schedule II, III, IV, or V controlled indicates that the prescription was application non-compliant, the substance created using an electronic originally transmitted electronically to a institutional practitioner must ensure prescription application that does not particular pharmacy and that the that the individuals designated under meet the requirements of this subpart is transmission failed. § 1311.130 terminate access for signing not a valid prescription, as that term is (d) Before initially using an electronic controlled substance prescriptions. defined in § 1300.03 of this chapter. prescription application to sign and (i) An individual practitioner or (d) A controlled substance transmit controlled substance institutional practitioner that receives a prescription created using an electronic prescriptions, the practitioner must notification that the electronic prescription application that meets the determine that the third-party auditor or prescription application is not in requirements of this subpart is not a certification organization has found that compliance with the requirements of valid prescription if any of the functions the electronic prescription application this part must not use the application to required under this subpart were records, stores, and transmits the issue electronic controlled substance disabled when the prescription was following accurately and consistently: prescriptions until it is notified that the indicated as ready for signature and (1) The information required for a application is again compliant and all signed. prescription under § 1306.05(a) of this relevant updates to the application have (e) A registered pharmacy may chapter. been installed. process electronic prescriptions for (2) The indication of signing as (j) The practitioner must notify both controlled substances only if all of the required by § 1311.120(b)(17) or the the individuals designated under following conditions are met: digital signature created by the § 1311.125 or § 1311.130 and the (1) The pharmacy uses a pharmacy practitioner’s private key. Administration within one business day application that meets all of the (3) The number of refills as required of discovery that one or more applicable requirements of this subpart; by § 1306.22 of this chapter. prescriptions that were issued under a and (e) If the third-party auditor or DEA registration held by that (2) The prescription is otherwise in certification organization has found that practitioner were prescriptions the conformity with the requirements of the an electronic prescription application practitioner had not signed or were not Act and this chapter. does not accurately and consistently consistent with the prescriptions he (f) Nothing in this part alters the record, store, and transmit other signed. responsibilities of the practitioner and information required for prescriptions (k) The practitioner has the same pharmacy, specified in part 1306 of this under this chapter, the practitioner must responsibilities when issuing chapter, to ensure the validity of a not create, sign, and transmit electronic prescriptions for controlled substances controlled substance prescription. prescriptions for controlled substances via electronic means as when issuing a that are subject to the additional paper or oral prescription. Nothing in § 1311.102 Practitioner responsibilities. information requirements. this subpart relieves a practitioner of his (a) The practitioner must retain sole (f) The practitioner must not use the responsibility to dispense controlled possession of the hard token, where electronic prescription application to substances only for a legitimate medical applicable, and must not share the sign and transmit electronic controlled purpose while acting in the usual course

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of his professional practice. If an agent institutional practitioner (e.g., a hospital authorize the issuance of the enters information at the practitioner’s credentialing office) may conduct authentication credential as provided in direction prior to the practitioner identity proofing and authorize the paragraphs (a) through (c) of this section reviewing and approving the issuance of the authentication must do so in a manner consistent with information and signing and authorizing credential. That entity must do the the institutional practitioner’s general the transmission of that information, the following: obligation to maintain effective controls practitioner is responsible in case the (1) Ensure that photographic against diversion. Failure to meet this prescription does not conform in all identification issued by the Federal obligation may result in remedial action essential respects to the law and Government or a State government consistent with § 1301.36 of this regulations. matches the person presenting the chapter. identification. (e) An institutional practitioner that § 1311.105 Requirements for obtaining an (2) Ensure that the individual elects to conduct identity proofing must authentication credential—Individual practitioner’s State authorization to practitioners. retain a record of the identity-proofing. practice and, where applicable, State (a) An individual practitioner must An institutional practitioner that elects authorization to prescribe controlled to issue the two-factor authentication obtain a two-factor authentication substances, is current and in good credential from one of the following: credential must retain a record of the standing. issuance of the credential. (1) A credential service provider that (3) Either ensure that the individual has been approved by the General practitioner’s DEA registration is current § 1311.115 Additional requirements for Services Administration Office of and in good standing or ensure that the two-factor authentication. Technology Strategy/Division of institutional practitioner has granted the (a) To sign a controlled substance Identity Management to conduct individual practitioner exempt from the prescription, the electronic prescription identity proofing that meets the requirement of registration under application must require the requirements of Assurance Level 3 or § 1301.22 of this chapter privileges to practitioner to authenticate to the above as specified in NIST SP 800–63– prescribe controlled substances using application using an authentication 1 as incorporated by reference in the institutional practitioner’s DEA protocol that uses two of the following § 1311.08. registration number. three factors: (2) For digital certificates, a (4) If the individual practitioner is an (1) Something only the practitioner certification authority that is cross- employee of a health care facility that is knows, such as a password or response certified with the Federal Bridge operated by the Department of Veterans to a challenge question. certification authority and that operates Affairs, confirm that the individual (2) Something the practitioner is, at a Federal Bridge Certification practitioner has been duly appointed to biometric data such as a fingerprint or Authority basic assurance level or practice at that facility by the Secretary above. iris scan. of the Department of Veterans Affairs (b) The practitioner must submit (3) Something the practitioner has, a pursuant to 38 U.S.C. 7401–7408. identity proofing information to the device (hard token) separate from the (5) If the individual practitioner is credential service provider or computer to which the practitioner is working at a health care facility certification authority as specified by gaining access. operated by the Department of Veterans the credential service provider or (b) If one factor is a hard token, it Affairs on a contractual basis pursuant certification authority. must be separate from the computer to to 38 U.S.C. 8153 and, in the (c) The credential service provider or which it is gaining access and must performance of his duties, prescribes certification authority must issue the meet at least the criteria of FIPS 140–2 controlled substances, confirm that the authentication credential using two Security Level 1, as incorporated by individual practitioner meets the channels (e.g., e-mail, mail, or telephone reference in § 1311.08, for cryptographic criteria for eligibility for appointment call). If one of the factors used in the modules or one-time-password devices. under 38 U.S.C. 7401–7408 and is authentication protocol is a biometric, (c) If one factor is a biometric, the prescribing controlled substances under or if the practitioner has a hard token biometric subsystem must comply with the registration of such facility. that is being enabled to sign controlled the requirements of § 1311.116. (b) An institutional practitioner that substances prescriptions, the credential elects to conduct identity proofing must § 1311.116 Additional requirements for service provider or certification provide authorization to issue the biometrics. authority must issue two pieces of authentication credentials to a separate (a) If one of the factors used to information used to generate or activate entity within the institutional authenticate to the electronic the authentication credential using two practitioner or to an outside credential prescription application is a biometric channels. Service provider or certification as described in § 1311.115, it must § 1311.110 Requirements for obtaining an authority that meets the requirements of comply with the following authentication credential—Individual § 1311.105(a). requirements. practitioners eligible to use an electronic (c) When an institutional practitioner (b) The biometric subsystem must prescription application of an institutional is conducting identity proofing and operate at a false match rate of 0.001 or practitioner. submitting information to a credential lower. (a) For any registrant or person service provider or certification (c) The biometric subsystem must use exempted from the requirement of authority to authorize the issuance of matching software that has registration under § 1301.22(c) of this authentication credentials, the demonstrated performance at the chapter who is eligible to use the institutional practitioner must meet any operating point corresponding with the institutional practitioner’s electronic requirements that the credential service false match rate described in paragraph prescription application to sign provider or certification authority (b) of this section, or a lower false match prescriptions for controlled substances, imposes on entities that serve as trusted rate. Testing to demonstrate the entity within a DEA-registered agents. performance must be conducted by the institutional practitioner that grants that (d) An institutional practitioner that National Institute of Standards and individual practitioner privileges at the elects to conduct identity proofing and Technology or another DEA-approved

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government or nongovernment meets the requirements in paragraph (b) application that is within five minutes laboratory. Such testing must comply of this section to issue electronic of the official National Institute of with the requirements of paragraph (h) controlled substance prescriptions. Standards and Technology time source. of this section. (b) The electronic prescription (9) The electronic prescription (d) The biometric subsystem must application must meet the requirements application must present for the conform to Personal Identity of this subpart including the following: practitioner’s review and approval all of Verification authentication biometric (1) The electronic prescription the following data for each controlled acquisition specifications, pursuant to application must do the following: substance prescription: NIST SP 800–76–1 as incorporated by (i) Link each registrant, by name, to at (i) The date of issuance. reference in § 1311.08, if they exist for least one DEA registration number. (ii) The full name of the patient. the biometric modality of choice. (ii) Link each practitioner exempt (iii) The drug name. (e) The biometric subsystem must from registration under § 1301.22(c) of (iv) The dosage strength and form, either be co-located with a computer or this chapter to the institutional quantity prescribed, and directions for PDA that the practitioner uses to issue practitioner’s DEA registration number use. electronic prescriptions for controlled and the specific internal code number (v) The number of refills authorized, substances, where the computer or PDA required under § 1301.22(c)(5) of this if applicable, for prescriptions for is located in a known, controlled chapter. Schedule III, IV, and V controlled location, or be built directly into the (2) The electronic prescription substances. practitioner’s computer or PDA that he application must be capable of the (vi) For prescriptions written in uses to issue electronic prescriptions for setting of logical access controls to limit accordance with the requirements of controlled substances. permissions for the following functions: § 1306.12(b) of this chapter, the earliest (f) The biometric subsystem must (i) Indication that a prescription is date on which a pharmacy may fill each store device ID data at enrollment (i.e., ready for signing and signing controlled prescription. biometric registration) with the substance prescriptions. (vii) The name, address, and DEA biometric data and verify the device ID (ii) Creating, updating, and executing registration number of the prescribing at the time of authentication to the the logical access controls for the practitioner. electronic prescription application. functions specified in paragraph (b)(2)(i) (viii) The statement required under (g) The biometric subsystem must of this section. § 1311.140(a)(3). (10) The electronic prescription protect the biometric data (raw data or (3) Logical access controls must be set application must require the prescribing templates), match results, and/or non- by individual user name or role. If the practitioner to indicate that each match results when authentication is application sets logical access control by controlled substance prescription is not local. If sent over an open network, role, it must not allow an individual to ready for signing. The electronic biometric data (raw data or templates), be assigned the role of registrant unless prescription application must not match results, and/or non-match results that individual is linked to at least one permit alteration of the DEA elements must be: DEA registration number as provided in (1) Cryptographically source paragraph (b)(1) of this section. after the practitioner has indicated that authenticated; (4) The application must require that a controlled substance prescription is (2) Combined with a random the setting and changing of logical ready to be signed without requiring challenge, a nonce, or a time stamp to access controls specified under another review and indication of prevent replay; paragraph (b)(2) of this section involve readiness for signing. Any controlled (3) Cryptographically protected for the actions of two individuals as substance prescription not indicated as integrity and confidentiality; and specified in §§ 1311.125 or 1311.130. ready to be signed shall not be signed (4) Sent only to authorized systems. Except for institutional practitioners, a or transmitted. (h) Testing of the biometric subsystem practitioner authorized to sign (11) While the information required must have the following characteristics: controlled substance prescriptions must by paragraph (b)(9) of this section and (1) The test is conducted by a approve logical access control entries. the statement required by laboratory that does not have an interest (5) The electronic prescription § 1311.140(a)(3) remain displayed, the in the outcome (positive or negative) of application must accept two-factor electronic prescription application must performance of a submission or authentication that meets the prompt the prescribing practitioner to biometric. requirements of § 1311.115 and require authenticate to the application, using (2) Test data are sequestered. its use for signing controlled substance two-factor authentication, as specified (3) Algorithms are provided to the prescriptions and for approving data in § 1311.140(a)(4), which will testing laboratory (as opposed to scores that set or change logical access controls constitute the signing of the prescription or other information). related to reviewing and signing by the practitioner for purposes of (4) The operating point(s) controlled substance prescriptions. § 1306.05(a) and (e) of this chapter. corresponding with the false match rate (6) The electronic prescription (12) The electronic prescription described in paragraph (b) of this application must be capable of application must not permit a section, or a lower false match rate, is recording all of the applicable practitioner other than the prescribing tested so that there is at least 95% information required in part 1306 of this practitioner whose DEA number (or confidence that the false match and chapter for the controlled substance institutional practitioner DEA number non-match rates are equal to or less than prescription. and extension data for the individual the observed value. (7) If a practitioner has more than one practitioner) is listed on the prescription (5) Results of the testing are made DEA registration number, the electronic as the prescribing practitioner and who publicly available. prescription application must require has indicated that the prescription is the practitioner or his agent to select the ready to be signed to sign the § 1311.120 Electronic prescription DEA registration number to be included prescription. application requirements. on the prescription. (13) Where a practitioner seeks to (a) A practitioner may only use an (8) The electronic prescription prescribe more than one controlled electronic prescription application that application must have a time substance at one time for a particular

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patient, the electronic prescription (18) The electronic prescription be automated and need not require application may allow the practitioner application must not transmit a human intervention to be conducted. to sign multiple prescriptions for a controlled substance prescription unless (26) The electronic prescription single patient at one time using a single the signing function described in application must protect the stored invocation of the two-factor § 1311.140(a)(4) has been used. audit records from unauthorized authentication protocol provided the (19) The electronic prescription deletion. The electronic prescription following has occurred: The practitioner application must not allow alteration of application shall prevent modifications has individually indicated that each any of the information required by part to the audit records. controlled substance prescription is 1306 of this chapter after the (27) The electronic prescription ready to be signed while the information prescription has been digitally signed. application must do the following: required by paragraph (b)(9) of this Any alteration of the information (i) Generate a log of all controlled section for each such prescription is required by part 1306 of this chapter substance prescriptions issued by a displayed along with the statement after the prescription is digitally signed practitioner during the previous required by § 1311.140(a)(3). must cancel the prescription. calendar month and provide the log to (14) The electronic prescription (20) The electronic prescription the practitioner no later than seven application must time and date stamp application must not allow transmission calendar days after that month. the prescription when the signing of a prescription that has been printed. (ii) Be capable of generating a log of function is used. (21) The electronic prescription all controlled substance prescriptions (15) When the practitioner uses his application must allow printing of a issued by a practitioner for a period two-factor authentication credential as prescription after transmission only if specified by the practitioner upon specified in § 1311.140(a)(4), the the printed prescription is clearly request. Prescription information electronic prescription application must labeled as a copy not for dispensing. available from which to generate the log digitally sign at least the information The electronic prescription application must span at least the previous two required by part 1306 of this chapter may allow printing of prescription years. and electronically archive the digitally information if clearly labeled as being (iii) Archive all logs generated. signed record. If the practitioner signs for informational purposes. The (iv) Ensure that all logs are easily the prescription with his own private electronic prescription application may readable or easily rendered into a format key, as provided in § 1311.145, the transfer such prescription information that a person can read. electronic prescription application must to medical records. (v) Ensure that all logs are sortable by electronically archive a copy of the (22) If the transmission of an patient name, drug name, and date of digitally signed record, but need not electronic prescription fails, the issuance of the prescription. apply the application’s digital signature electronic prescription application may (28) Where the electronic prescription to the record. print the prescription. The prescription application is required by this part to (16) The digital signature must indicate that it was originally archive or otherwise maintain records, it functionality must meet the following transmitted electronically to, and must retain such records electronically requirements: provide the name of, a specific for two years from the date of the (i) The cryptographic module used to pharmacy, the date and time of record’s creation and comply with all digitally sign the data elements required transmission, and that the electronic other requirements of § 1311.305. by part 1306 of this chapter must be at transmission failed. (23) The electronic prescription § 1311.125 Requirements for establishing least FIPS 140–2 Security Level 1 logical access control—Individual validated. FIPS 140–2 is incorporated by application must maintain an audit trail practitioner. reference in § 1311.08. of all actions related to the following: (i) The creation, alteration, indication (a) At each registered location where (ii) The digital signature application of readiness for signing, signing, one or more individual practitioners and hash function must comply with transmission, or deletion of a controlled wish to use an electronic prescription FIPS 186–3 and FIPS 180–3, as substance prescription. application meeting the requirements of incorporated by reference in § 1311.08. (ii) Any setting or changing of logical this subpart to issue controlled (iii) The electronic prescription access control permissions related to the substance prescriptions, the registrant(s) application’s private key must be stored issuance of controlled substance must designate at least two individuals encrypted on a FIPS 140–2 Security prescriptions. to manage access control to the Level 1 or higher validated (iii) Notification of a failed application. At least one of the cryptographic module using a FIPS- transmission. designated individuals must be a approved encryption algorithm. FIPS (iv) Auditable events as specified in registrant who is authorized to issue 140–2 is incorporated by reference in § 1311.150. controlled substance prescriptions and § 1311.08. (24) The electronic prescription who has obtained a two-factor (iv) For software implementations, application must record within each authentication credential as provided in when the signing module is deactivated, audit record the following information: § 1311.105. the application must clear the plain text (i) The date and time of the event. (b) At least one of the individuals password from the application memory (ii) The type of event. designated under paragraph (a) of this to prevent the unauthorized access to, or (iii) The identity of the person taking section must verify that the DEA use of, the private key. the action, where applicable. registration and State authorization(s) to (17) Unless the digital signature (iv) The outcome of the event (success practice and, where applicable, State created by an individual practitioner’s or failure). authorization(s) to dispense controlled private key is being transmitted to the (25) The electronic prescription substances of each registrant being pharmacy with the prescription, the application must conduct internal granted permission to sign electronic electronic prescription application must audits and generate reports on any of prescriptions for controlled substances include in the data file transmitted an the events specified in § 1311.150 in a are current and in good standing. indication that the prescription was format that is readable by the (c) After one individual designated signed by the prescribing practitioner. practitioner. Such internal audits may under paragraph (a) of this section

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enters data that grants permission for (c) The institutional practitioner must (2) The practitioner must indicate the individual practitioners to have access retain a record of the individuals or prescriptions that are ready to be signed. to the prescription functions that roles that are authorized to conduct (3) While the prescription information indicate readiness for signature and identity proofing and logical access required in § 1311.120(b)(9) is signing or revokes such authorization, a control data entry and execution. displayed, the following statement or its second individual designated under (d) Permission to indicate that substantial equivalent is displayed: ‘‘By paragraph (a) of this section must use controlled substances prescriptions are completing the two-factor his two-factor authentication credential ready to be signed and to sign controlled authentication protocol at this time, you to satisfy the logical access controls. The substance prescriptions must be revoked are legally signing the prescription(s) second individual must be a DEA whenever any of the following occurs, and authorizing the transmission of the registrant. on the date the occurrence is above information to the pharmacy for (d) A registrant’s permission to discovered: dispensing. The two-factor indicate that controlled substances (1) An individual practitioner’s hard authentication protocol may only be prescriptions are ready to be signed and token or any other authentication factor completed by the practitioner whose to sign controlled substance required by the practitioner’s two-factor name and DEA registration number prescriptions must be revoked whenever authentication protocol is lost, stolen, or appear above.’’ any of the following occurs, on the date compromised. Such access must be (4) While the prescription information the occurrence is discovered: terminated immediately upon receiving required in § 1311.120(b)(9) and the (1) A hard token or any other notification from the individual statement required by paragraph (a)(3) authentication factor required by the practitioner. of this section remain displayed, the two-factor authentication protocol is (2) The institutional practitioner’s or, practitioner must be prompted to lost, stolen, or compromised. Such where applicable, individual complete the two-factor authentication access must be terminated immediately practitioner’s DEA registration expires, protocol. upon receiving notification from the unless the registration has been (5) The completion by the practitioner individual practitioner. renewed. of the two-factor authentication protocol (2) The individual practitioner’s DEA (3) The institutional practitioner’s or, in the manner provided in paragraph registration expires, unless the where applicable, individual (a)(4) of this section will constitute the registration has been renewed. practitioner’s DEA registration is signing of the prescription by the (3) The individual practitioner’s DEA terminated, revoked, or suspended. practitioner for purposes of § 1306.05(a) registration is terminated, revoked, or (4) An individual practitioner is no and (e) of this chapter. suspended. longer authorized to use the (6) Except as provided under (4) The individual practitioner is no institutional practitioner’s electronic § 1311.145, the practitioner’s longer authorized to use the electronic prescription application (e.g., when the completion of the two-factor prescription application (e.g., when the individual practitioner is no longer authentication protocol must cause the individual practitioner leaves the associated with the institutional application to digitally sign and practice). practitioner.) electronically archive the information required under part 1306 of this chapter. § 1311.135 Requirements for creating a § 1311.130 Requirements for establishing (b) The electronic prescription controlled substance prescription. logical access control—Institutional application must clearly label as the practitioner. (a) The electronic prescription signing function the function that (a) The entity within an institutional application may allow the registrant or prompts the practitioner to execute the practitioner that conducts the identity his agent to enter data for a controlled two-factor authentication protocol using proofing under § 1311.110 must develop substance prescription, provided that his credential. a list of individual practitioners who are only the registrant may sign the (c) Any prescription not signed in the permitted to use the institutional prescription in accordance with manner required by this section shall practitioner’s electronic prescription §§ 1311.120(b)(11) and 1311.140. not be transmitted. (b) If a practitioner holds multiple application to indicate that controlled DEA registrations, the practitioner or his § 1311.145 Digitally signing the substances prescriptions are ready to be agent must select the appropriate prescription with the individual signed and to sign controlled substance registration number for the prescription practitioner’s private key. prescriptions. The list must be approved being issued in accordance with the (a) An individual practitioner who by two individuals. requirements of § 1301.12 of this has obtained a digital certificate as (b) After the list is approved, it must provided in § 1311.105 may digitally be sent to a separate entity within the chapter. (c) If required by State law, a sign a controlled substance prescription institutional practitioner that enters supervisor’s name and DEA number using the private key associated with his permissions for logical access controls may be listed on a prescription, digital certificate. into the application. The institutional provided the prescription clearly (b) The electronic prescription practitioner must authorize at least two indicates who is the supervisor and who application must require the individual individuals or a role filled by at least is the prescribing practitioner. practitioner to complete a two-factor two individuals to enter the logical authentication protocol as specified in access control data. One individual in § 1311.140 Requirements for signing a § 1311.140(a)(4) to use his private key. the separate entity must authenticate to controlled substance prescription. (c) The electronic prescription the application and enter the data to (a) For a practitioner to sign an application must digitally sign at least grant permissions to individual electronic prescription for a controlled all information required under part 1306 practitioners to indicate that controlled substance the following must occur: of this chapter. substances prescriptions are ready to be (1) The practitioner must access a list (d) The electronic prescription signed and to sign controlled substance of one or more controlled substance application must electronically archive prescriptions. A second individual must prescriptions for a single patient. The the digitally signed record. authenticate to the application to list must display the information (e) A prescription that is digitally execute the logical access controls. required by § 1311.120(b)(9). signed with a practitioner’s private key

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may be transmitted to a pharmacy compromised or could have electronic prescription to another form without the digital signature. compromised the integrity of the (e.g., facsimile) for transmission. (f) If the electronic prescription is prescription records. Any such transmitted without the digital incidents must be reported to the § 1311.200 Pharmacy responsibilities. signature, the electronic prescription electronic prescription application (a) Before initially using a pharmacy application must check the certificate provider and the Administration within application to process controlled revocation list of the certification one business day. substance prescriptions, the pharmacy authority that issued the practitioner’s must determine that the third-party digital certificate. If the digital § 1311.170 Transmission requirements. auditor or certification organization has certificate is not valid, the electronic (a) The electronic prescription found that the pharmacy application prescription application must not application must transmit the electronic does the following accurately and transmit the prescription. The certificate prescription as soon as possible after consistently: revocation list may be cached until the signature by the practitioner. (1) Import, store, and display the certification authority issues a new (b) The electronic prescription information required for prescriptions certificate revocation list. application may print a prescription under § 1306.05(a) of this chapter. (g) When the individual practitioner that has been transmitted only if an (2) Import, store, and display the digitally signs a controlled substance intermediary or the designated indication of signing as required by prescription with the private key pharmacy notifies a practitioner that an § 1311.120(b)(17). associated with his own digital electronic prescription was not (3) Import, store, and display the certificate obtained as provided under successfully delivered to the designated number of refills as required by § 1311.105, the electronic prescription pharmacy. If this occurs, the electronic § 1306.22 of this chapter. application is not required to digitally prescription application may print the (4) Import, store, and verify the sign the prescription using the prescription for the practitioner’s practitioner’s digital signature, as application’s private key. manual signature. The printed provided in § 1311.210(c), where prescription must include information § 1311.150 Additional requirements for applicable. internal application audits. noting that the prescription was (b) If the third-party auditor or originally transmitted electronically to certification organization has found that (a) The application provider must [name of the specific pharmacy] on a pharmacy application does not establish and implement a list of [date/time] and that transmission failed. accurately and consistently import, auditable events. Auditable events must, (c) The electronic prescription store, and display other information at a minimum, include the following: application may print copies of the (1) Attempted unauthorized access to required for prescriptions under this transmitted prescription if they are the electronic prescription application, chapter, the pharmacy must not process clearly labeled: ‘‘Copy only—not valid or successful unauthorized access where electronic prescriptions for controlled for dispensing.’’ Data on the prescription the determination of such is feasible. substances that are subject to the (2) Attempted unauthorized may be electronically transferred to additional information requirements. modification or destruction of any medical records, and a list of (c) If a pharmacy application provider information or records required by this prescriptions written may be printed for notifies a pharmacy that a third-party part, or successful unauthorized patients if the list indicates that it is for audit or certification report indicates modification or destruction of any informational purposes only and not for that the application or the application information or records required by this dispensing. provider no longer meets the part where the determination of such is (d) The electronic prescription requirements of this part or notifies it feasible. application must not allow the that the application provider has (3) Interference with application transmission of an electronic identified an issue that makes the operations of the prescription prescription if an original prescription application non-compliant, the application. was printed prior to attempted pharmacy must immediately cease to (4) Any setting of or change to logical transmission. process controlled substance access controls related to the issuance of (e) The contents of the prescription prescriptions using the application. controlled substance prescriptions. required by part 1306 of this chapter (d) A pharmacy that receives a (5) Attempted or successful must not be altered during transmission notification that the pharmacy interference with audit trail functions. between the practitioner and pharmacy. application is not in compliance with (6) For application service providers, Any change to the content during the requirements of this part must not attempted or successful creation, transmission, including truncation or use the application to process controlled modification, or destruction of removal of data, will render the substance prescriptions until it is controlled substance prescriptions or electronic prescription invalid. The notified that the application is again logical access controls related to electronic prescription data may be compliant and all relevant updates to controlled substance prescriptions by converted from one software version to the application have been installed. any agent or employee of the another between the electronic (e) The pharmacy must determine application service provider. prescription application and the which employees are authorized to (b) The electronic prescription pharmacy application; conversion enter information regarding the application must analyze the audit trail includes altering the structure of fields dispensing of controlled substance at least once every calendar day and or machine language so that the prescriptions and annotate or alter generate an incident report that receiving pharmacy application can records of these prescriptions (to the identifies each auditable event. read the prescription and import the extent such alterations are permitted (c) Any person designated to set data. under this chapter). The pharmacy must logical access controls under (f) An electronic prescription must be ensure that logical access controls in the §§ 1311.125 or 1311.130 must determine transmitted from the practitioner to the pharmacy application are set so that whether any identified auditable event pharmacy in its electronic form. At no only such employees are granted access represents a security incident that time may an intermediary convert an to perform these functions.

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(f) When a pharmacist fills a (2) Logical access controls must be set displaying, all information required by prescription in a manner that would by individual user name or role. part 1306 of this chapter. require, under part 1306 of this chapter, (3) The pharmacy application must (9) The pharmacy application must the pharmacist to make a notation on digitally sign and archive a prescription read and store in full the information the prescription if the prescription were on receipt or be capable of receiving and required under § 1306.05(a) of this a paper prescription, the pharmacist archiving a digitally signed record. chapter. The pharmacy application must must make the same notation (4) For pharmacy applications that either verify that such information is electronically when filling an electronic digitally sign prescription records upon present or must display the information prescription and retain the annotation receipt, the digital signature for the pharmacist’s verification. electronically in the prescription record functionality must meet the following (10) The pharmacy application must or in linked files. When a prescription requirements: provide for the following information to is received electronically, the (i) The cryptographic module used to be added or linked to each electronic prescription and all required digitally sign the data elements required controlled substance prescription record annotations must be retained by part 1306 of this chapter must be at for each dispensing: electronically. least FIPS 140–2 Security Level 1 (i) Number of units or volume of drug (g) When a pharmacist receives a validated. FIPS 140–2 is incorporated by dispensed. paper or oral prescription that indicates reference in § 1311.08. (ii) Date dispensed. that it was originally transmitted (ii) The digital signature application (iii) Name or initials of the person electronically to the pharmacy, the and hash function must comply with who dispensed the prescription. pharmacist must check its records to FIPS 186–3 and FIPS 180–3, as (11) The pharmacy application must ensure that the electronic version was incorporated by reference in § 1311.08. be capable of retrieving controlled not received and the prescription (iii) The pharmacy application’s substance prescriptions by practitioner dispensed. If both prescriptions were private key must be stored encrypted on name, patient name, drug name, and received, the pharmacist must mark one a FIPS 140–2 Security Level 1 or higher date dispensed. as void. validated cryptographic module using a (12) The pharmacy application must (h) When a pharmacist receives a FIPS-approved encryption algorithm. allow downloading of prescription data paper or oral prescription that indicates FIPS 140–2 is incorporated by reference into a database or spreadsheet that is that it was originally transmitted in § 1311.08. readable and sortable. electronically to another pharmacy, the (iv) For software implementations, (13) The pharmacy application must pharmacist must check with that when the signing module is deactivated, maintain an audit trail of all actions pharmacy to determine whether the the pharmacy application must clear the related to the following: (i) The receipt, annotation, alteration, prescription was received and plain text password from the or deletion of a controlled substance dispensed. If the pharmacy that received application memory to prevent the prescription. the original electronic prescription had unauthorized access to, or use of, the (ii) Any setting or changing of logical not dispensed the prescription, that private key. access control permissions related to the pharmacy must mark the electronic (v) The pharmacy application must dispensing of controlled substance version as void or canceled. If the have a time application that is within prescriptions. pharmacy that received the original five minutes of the official National electronic prescription dispensed the (iii) Auditable events as specified in Institute of Standards and Technology § 1311.215. prescription, the pharmacy with the time source. paper version must not dispense the (14) The pharmacy application must (5) The pharmacy application must record within each audit record the paper prescription and must mark the verify a practitioner’s digital signature prescription as void. following information: (if the pharmacy application accepts (i) The date and time of the event. (i) Nothing in this part relieves a prescriptions that were digitally signed pharmacy and pharmacist of the (ii) The type of event. with an individual practitioner’s private (iii) The identity of the person taking responsibility to dispense controlled key and transmitted with the digital substances only pursuant to a the action, where applicable. signature). (iv) The outcome of the event (success prescription issued for a legitimate (6) If the prescription received by the medical purpose by a practitioner acting or failure). pharmacy application has not been (15) The pharmacy application must in the usual course of professional digitally signed by the practitioner and conduct internal audits and generate practice. transmitted with the digital signature, reports on any of the events specified in § 1311.205 Pharmacy application the pharmacy application must either: § 1311.215 in a format that is readable requirements. (i) Verify that the practitioner signed by the pharmacist. Such an internal (a) The pharmacy may only use a the prescription by checking the data audit may be automated and need not pharmacy application that meets the field that indicates the prescription was require human intervention to be requirements in paragraph (b) of this signed; or conducted. section to process electronic controlled (ii) Display the field for the (16) The pharmacy application must substance prescriptions. pharmacist’s verification. protect the stored audit records from (b) The pharmacy application must (7) The pharmacy application must unauthorized deletion. The pharmacy meet the following requirements: read and retain the full DEA number application shall prevent modifications (1) The pharmacy application must be including the specific internal code to the audit records. capable of setting logical access controls number assigned to individual (17) The pharmacy application must to limit access for the following practitioners authorized to prescribe back up the controlled substance functions: controlled substances by the hospital or prescription records daily. (i) Annotation, alteration, or deletion other institution as provided in (18) The pharmacy application must of prescription information. § 1301.22(c) of this chapter. retain all archived records electronically (ii) Setting and changing the logical (8) The pharmacy application must for at least two years from the date of access controls. read and store, and be capable of their receipt or creation and comply

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with all other requirements of alteration, or destruction of controlled (1) Before the application may be used § 1311.305. substance prescriptions or logical access to create, sign, transmit, or process controls related to controlled substance controlled substance prescriptions. § 1311.210 Archiving the initial record. prescriptions by any agent or employee (2) Whenever a functionality related (a) Except as provided in paragraph of the application service provider. to controlled substance prescription (c) of this section, a copy of each (b) The pharmacy application must requirements is altered or every two electronic controlled substance analyze the audit trail at least once years, whichever occurs first. prescription record that a pharmacy every calendar day and generate an (f) The application provider must receives must be digitally signed by one incident report that identifies each make the audit or certification report of the following: auditable event. available to any practitioner or (1) The last intermediary transmitting (c) The pharmacy must determine pharmacy that uses the application or is the record to the pharmacy must whether any identified auditable event considering use of the application. The digitally sign the prescription represents a security incident that electronic prescription or pharmacy immediately prior to transmission to the compromised or could have application provider must retain the pharmacy. compromised the integrity of the most recent audit or certification results (2) The first pharmacy application prescription records. Any such and retain the results of any other audits that receives the electronic prescription incidents must be reported to the or certifications of the application must digitally sign the prescription pharmacy application service provider, completed within the previous two immediately on receipt. years. (b) If the last intermediary digitally if applicable, and the Administration within one business day. (g) Except as provided in paragraphs signs the record, it must forward the (h) and (i) of this section, if the third- digitally signed copy to the pharmacy. § 1311.300 Application provider party auditor or certification (c) If a pharmacy receives a digitally requirements—Third-party audits or organization finds that the application signed prescription that includes the certifications. does not meet one or more of the individual practitioner’s digital (a) Except as provided in paragraph requirements of this part, the signature, the pharmacy application (e) of this section, the application application must not be used to create, must do the following: provider of an electronic prescription sign, transmit, or process electronic (1) Verify the digital signature as application or a pharmacy application controlled substance prescriptions. The provided in FIPS 186–3, as incorporated must have a third-party audit of the application provider must notify by reference in § 1311.08. application that determines that the registrants within five business days of (2) Check the validity of the certificate application meets the requirements of the issuance of the audit or certification holder’s digital certificate by checking this part at each of the following times: report that they should not use the the certificate revocation list. The (1) Before the application may be used application for controlled substance pharmacy may cache the CRL until it to create, sign, transmit, or process prescriptions. The application provider expires. controlled substance prescriptions. must also notify the Administration of (3) Archive the digitally signed (2) Whenever a functionality related the adverse audit or certification report record. The pharmacy record must to controlled substance prescription and provide the report to the retain an indication that the requirements is altered or every two Administration within one business day prescription was verified upon receipt. years, whichever occurs first. of issuance. No additional digital signature is (b) The third-party audit must be (h) For electronic prescription required. conducted by one of the following: applications, the third-party auditor or § 1311.215 Internal audit trail. (1) A person qualified to conduct a certification organization must make the (a) The pharmacy application SysTrust, WebTrust, or SAS 70 audit. following determinations: provider must establish and implement (2) A Certified Information System (1) If the information required in a list of auditable events. The auditable Auditor who performs compliance § 1306.05(a) of this chapter, the events must, at a minimum, include the audits as a regular ongoing business indication that the prescription was following: activity. signed as required by § 1311.120(b)(17) (1) Attempted unauthorized access to (c) An audit for installed applications or the digital signature created by the the pharmacy application, or successful must address processing integrity and practitioner’s private key, if transmitted, unauthorized access to the pharmacy determine that the application meets the and the number of refills as required by application where the determination of requirements of this part. § 1306.22 of this chapter, cannot be such is feasible. (d) An audit for application service consistently and accurately recorded, (2) Attempted or successful providers must address processing stored, and transmitted, the third-party unauthorized modification or integrity and physical security and auditor or certification organization destruction of any information or determine that the application meets the must indicate that the application does records required by this part, or requirements of this part. not meet the requirements of this part. successful unauthorized modification or (e) If a certifying organization whose (2) If other information required destruction of any information or certification process has been approved under this chapter cannot be records required by this part where the by DEA verifies and certifies that an consistently and accurately recorded, determination of such is feasible. electronic prescription or pharmacy stored, and transmitted, the third-party (3) Interference with application application meets the requirements of auditor or certification organization operations of the pharmacy application. this part, certification by that must indicate that the application has (4) Any setting of or change to logical organization may be used as an failed to meet the requirements for the access controls related to the dispensing alternative to the audit requirements of specific information and should not be of controlled substance prescriptions. paragraphs (b) through (d) of this used to create, sign, and transmit (5) Attempted or successful section, provided that the certification prescriptions that require the additional interference with audit trail functions. that determines that the application information. (6) For application service providers, meets the requirements of this part (i) For pharmacy applications, the attempted or successful annotation, occurs at each of the following times: third-party auditor or certification

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organization must make the following requirements of this part, the readable or easily rendered into a format determinations: application provider must notify that a person can read. (1) If the information required in practitioners or pharmacies that use the (d) Records required by this part must § 1306.05(a) of this chapter, the application as soon as feasible, but no be made available to the Administration indication that the prescription was later than five business days after upon request. signed as required by § 1311.205(b)(6), discovery, that the application should (e) If an application service provider and the number of refills as required by not be used to issue or process ceases to provide an electronic § 1306.22 of this chapter, cannot be electronic controlled substance prescription application or an electronic consistently and accurately imported, prescriptions. pharmacy application or if a registrant stored, and displayed, the third-party (b) When providing practitioners or ceases to use an application service auditor or certification organization pharmacies with updates to any issue provider, the application service must indicate that the application does that makes the application non- provider must transfer any records not meet the requirements of this part. compliant with the requirements of this subject to this part to the registrant in (2) If the pharmacy application part, the application provider must a format that the registrant’s accepts prescriptions with the indicate that the updates must be applications are capable of retrieving, practitioner’s digital signature, the installed before the practitioner or displaying, and printing in a readable third-party auditor or certification pharmacy may use the application to format. organization must indicate that the issue or process electronic controlled (f) If a registrant changes application application does not meet the substance prescriptions. providers, the registrant must ensure requirements of this part if the that any records subject to this part are application does not consistently and § 1311.305 Recordkeeping. migrated to the new application or are accurately import, store, and verify the (a) If a prescription is created, signed, stored in a format that can be retrieved, digital signature. transmitted, and received electronically, displayed, and printed in a readable (3) If other information required all records related to that prescription format. under this chapter cannot be must be retained electronically. (g) If a registrant transfers its consistently and accurately imported, electronic prescription files to another (b) Records required by this subpart stored, and displayed, the third-party registrant, both registrants must ensure must be maintained electronically for auditor or certification organization that the records are migrated to the new two years from the date of their creation must indicate that the application has application or are stored in a format that or receipt. This record retention failed to meet the requirements for the can be retrieved, displayed, and printed requirement shall not pre-empt any specific information and should not be in a readable format. longer period of retention which may be used to process electronic prescriptions (h) Digitally signed prescription required now or in the future, by any that require the additional information. records must be transferred or migrated other Federal or State law or regulation, with the digital signature. § 1311.302 Additional application provider applicable to practitioners, pharmacists, requirements. or pharmacies. Dated: March 22, 2010. (a) If an application provider (c) Records regarding controlled Michele M. Leonhart, identifies or is made aware of any issue substances prescriptions must be readily Deputy Administrator. with its application that make the retrievable from all other records. [FR Doc. 2010–6687 Filed 3–24–10; 4:15 pm] application non-compliant with the Electronic records must be easily BILLING CODE 4410–09–P

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Part III

Reader Aids Cumulative List of Public Laws 111th Congress, First Session

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CUMULATIVE LIST OF PUBLIC LAWS This is the cumulative list of public laws for the 111th Congress, First Session. Other cumulative lists (1993– 2009) are available online at http://www.archives.gov/federal-register/laws/past/index.html. Comments may be addressed to the Director, Office of the Federal Register, Washington, DC 20408 or send e-mail to [email protected].

The text of laws may be ordered in individual pamphlet form (referred to as ‘‘slip laws’’) from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402 (phone, 202–512–2470). The text will also be made available on the Internet from GPO Access at http://www.gpoaccess.gov/plaws/index.html.

123 Public Law Title Approved Stat.

111–1 ...... Ensuring that the compensation and other emoluments attached to the office of Secretary of Jan. 16, 2009 ...... 3 the Interior are those which were in effect on January 1, 2005. 111–2 ...... Lilly Ledbetter Fair Pay Act of 2009 ...... Jan. 29, 2009 ...... 5 111–3 ...... Children’s Health Insurance Program Reauthorization Act of 2009 ...... Feb. 4, 2009 ...... 8 111–4 ...... DTV Delay Act ...... Feb. 11, 2009 ..... 112 111–5 ...... American Recovery and Reinvestment Act of 2009 ...... Feb. 17, 2009 ..... 115 111–6 ...... Making further continuing appropriations for fiscal year 2009, and for other purposes ...... Mar. 6, 2009 ...... 522 111–7 ...... To designate the facility of the United States Postal Service located at 2105 East Cook Street in Mar. 9, 2009 ...... 523 Springfield, Illinois, as the ‘‘Colonel John H. Wilson, Jr. Post Office Building’’. 111–8 ...... Omnibus Appropriations Act, 2009 ...... Mar. 11, 2009 ..... 524 111–9 ...... To extend certain immigration programs ...... Mar. 20, 2009 ..... 989 111–10 ...... To provide for an additional temporary extension of programs under the Small Business Act Mar. 20, 2009 ..... 990 and the Small Business Investment Act of 1958, and for other purposes. 111–11 ...... Omnibus Public Land Management Act of 2009 ...... Mar. 30, 2009 ..... 991 111–12 ...... Federal Aviation Administration Extension Act of 2009 ...... Mar. 30, 2009 ..... 1457 111–13 ...... Serve America Act ...... Apr. 21, 2009 ..... 1460 111–14 ...... To designate the United States courthouse under construction at 327 South Church Street, Apr. 23, 2009 ..... 1602 Rockford, Illinois, as the ‘‘Stanley J. Roszkowski United States Courthouse’’. 111–15 ...... Special Inspector General for the Troubled Asset Relief Program Act of 2009 ...... Apr. 24, 2009 ..... 1603 111–16 ...... Statutory Time-Periods Technical Amendments Act of 2009 ...... May 7, 2009 ...... 1607 111–17 ...... Providing for the appointment of David M. Rubenstein as a citizen regent of the Board of Re- May 7, 2009 ...... 1610 gents of the Smithsonian Institution. 111–18 ...... To repeal section 10(f) of Public Law 93-531, commonly known as the ‘‘Bennett Freeze’’ ...... May 8, 2009 ...... 1611 111–19 ...... Civil Rights History Project Act of 2009 ...... May 12, 2009 ..... 1612 111–20 ...... Protecting Incentives for the Adoption of Children with Special Needs Act of 2009 ...... May 15, 2009 ..... 1616 111–21 ...... Fraud Enforcement and Recovery Act of 2009 ...... May 20, 2009 ..... 1617 111–22 ...... To prevent mortgage foreclosures and enhance mortgage credit availability ...... May 20, 2009 ..... 1632 111–23 ...... Weapon Systems Acquisition Reform Act of 2009 ...... May 22, 2009 ..... 1704 111–24 ...... Credit Card Accountability Responsibility and Disclosure Act of 2009 ...... May 22, 2009 ..... 1734 111–25 ...... Ronald Reagan Centennial Commission Act ...... June 2, 2009 ...... 1767 111–26 ...... To designate the facility of the United States Postal Service located at 12877 Broad Street in June 19, 2009 ..... 1771 Sparta, Georgia, as the ‘‘Yvonne Ingram-Ephraim Post Office Building’’. 111–27 ...... To designate the facility of the United States Postal Service located at 300 East 3rd Street in June 19, 2009 ..... 1772 Jamestown, New York, as the ‘‘Stan Lundine Post Office Building’’. 111–28 ...... To designate the facility of the United States Postal Service located at 103 West Main Street in June 19, 2009 ..... 1773 McLain, Mississippi, as the ‘‘Major Ed W. Freeman Post Office’’. 111–29 ...... To designate the facility of the United States Postal Service located at 3245 Latta Road in June 19, 2009 ..... 1774 Rochester, New York, as the ‘‘Brian K. Schramm Post Office Building’’. 111–30 ...... Antitrust Criminal Penalty Enhancement and Reform Act of 2004 Extension Act ...... June 19, 2009 ..... 1775 111–31 ...... To protect the public health by providing the Food and Drug Administration with certain au- June 22, 2009 ..... 1776 thority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Fed- eral Employees’ Retirement System, and for other purposes. 111–32 ...... Supplemental Appropriations Act, 2009 ...... June 24, 2009 ..... 1859 111–33 ...... Native American Heritage Day Act of 2009 ...... June 26, 2009 ..... 1922 111–34 ...... To designate the Federal building and United States courthouse located at 306 East Main June 30, 2009 ..... 1924 Street in Elizabeth City, North Carolina, as the ‘‘J. Herbert W. Small Federal Building and United States Courthouse’’. 111–35 ...... To designate the Federal building located at 799 United Nations Plaza in New York, New June 30, 2009 ..... 1925 York, as the ‘‘Ronald H. Brown United States Mission to the United Nations Building’’.. 111–36 ...... Webcaster Settlement Act of 2009 ...... June 30, 2009 ..... 1926 111–37 ...... Veterans’ Compensation Cost-of-Living Adjustment Act of 2009 ...... June 30, 2009 ..... 1927 111–38 ...... To provide additional personnel authorities for the Special Inspector General for Afghanistan June 30, 2009 ..... 1932 Reconstruction. 111–39 ...... To make technical corrections to the Higher Education Act of 1965, and for other purposes ..... July 1, 2009 ...... 1934 111–40 ...... To award a Congressional Gold Medal to the Women Airforce Service Pilots (‘‘WASP’’) ...... July 1, 2009 ...... 1958 111–41 ...... Korean War Veterans Recognition Act ...... July 27, 2009 ...... 1962 111–42 ...... Approving the renewal of import restrictions contained in the Burmese Freedom and Democ- July 28, 2009 ...... 1963 racy Act of 2003, and for other purposes. 111–43 ...... To provide for an additional temporary extension of programs under the Small Business Act July 31, 2009 ...... 1965 and the Small Business Investment Act of 1958, and for other purposes. 111–44 ...... New Frontier Congressional Gold Medal Act ...... Aug. 7, 2009 ...... 1966 111–45 ...... To authorize the Director of the United States Patent and Trademark Office to use funds made Aug. 7, 2009 ...... 1968 available under the Trademark Act of 1946 for patent operations in order to avoid furloughs and reductions-in-force, and for other purposes. 111–46 ...... To restore sums to the Highway Trust Fund and for other purposes ...... Aug. 7, 2009 ...... 1970 111–47 ...... Making supplemental appropriations for fiscal year 2009 for the Consumer Assistance to Recy- Aug. 7, 2009 ...... 1972 cle and Save Program. 111–48 ...... Miami Dade College Land Conveyance Act ...... Aug. 12, 2009 .... 1974 111–49 ...... Judicial Survivors Protection Act of 2009 ...... Aug. 12, 2009 .... 1976

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123 Public Law Title Approved Stat.

111–50 ...... To designate the facility of the United States Postal Service located at 46-02 21st Street in Aug. 19, 2009 .... 1979 Long Island City, New York, as the ‘‘Geraldine Ferraro Post Office Building’’. 111–51 ...... To designate the facility of the United States Postal Service located at 601 8th Street in Free- Aug. 19, 2009 .... 1980 dom, Pennsylvania, as the ‘‘John Scott Challis, Jr. Post Office’’. 111–52 ...... To designate the facility of the United States Postal Service located at 2351 West Atlantic Bou- Aug. 19, 2009 .... 1981 levard in Pompano Beach, Florida, as the ‘‘Elijah Pat Larkins Post Office Building’’. 111–53 ...... Utah Recreational Land Exchange Act of 2009 ...... Aug. 19, 2009 .... 1982 111–54 ...... To designate the facility of the United States Postal Service located at 41 Purdy Avenue in Aug. 19, 2009 .... 1989 Rye, New York, as the ‘‘Caroline O’Day Post Office Building’’. 111–55 ...... To designate the facility of the United States Postal Service located at 431 State Street in Aug. 19, 2009 .... 1990 Ogdensburg, New York, as the ‘‘Frederic Remington Post Office Building’’. 111–56 ...... To designate the facility of the United States Postal Service located at 123 11th Avenue South Aug. 19, 2009 .... 1991 in Nampa, Idaho, as the ‘‘Herbert A Littleton Postal Station’’. 111–57 ...... To designate the facility of the United States Postal Service located at 1300 Matamoros Street Aug. 19, 2009 .... 1992 in Laredo, Texas, as the ‘‘Laredo Veterans Post Office’’. 111–58 ...... To designate the facility of the United States Postal Service located at 2300 Scenic Drive in Aug. 19, 2009 .... 1993 Georgetown, Texas, as the ‘‘Kile G. West Post Office Building’’. 111–59 ...... To designate the facility of the United States Postal Service located at 19190 Cochran Boule- Aug. 19, 2009 .... 1994 vard FRNT in Port Charlotte, Florida, as the ‘‘Lieutenant Commander Roy H. Boehm Post Office Building’’. 111–60 ...... To extend the deadline for commencement of construction of a hydroelectric project ...... Aug. 19, 2009 .... 1995 111–61 ...... Recognizing the service, sacrifice, honor, and professionalism of the Noncommissioned Offi- Aug. 19, 2009 .... 1996 cers of the United States Army. 111–62 ...... Granting the consent and approval of Congress to amendments made by the State of Maryland, Aug. 19, 2009 .... 1998 the Commonwealth of Virginia, and the District of Columbia to the Washington Metropoli- tan Area Transit Regulation Compact. 111–63 ...... WIPA and PABSS Reauthorization Act of 2009 ...... Sept. 18, 2009 .... 2001 111–64 ...... Providing for the appointment of France A. Cordova as a citizen regent of the Board of Regents Sept. 18, 2009 .... 2002 of the Smithsonian Institution. 111–65 ...... To provide for the award of a gold medal on behalf of Congress to Arnold Palmer in recogni- Sept. 30, 2009 .... 2003 tion of his service to the Nation in promoting excellence and good sportsmanship in golf. 111–66 ...... To provide for an additional temporary extension of programs under the Small Business Act Sept. 30, 2009 .... 2005 and the Small Business Investment Act of 1958, and for other purposes. 111–67 ...... Defense Production Act Reauthorization of 2009 ...... Sept. 30, 2009 .... 2006 111–68 ...... Making appropriations for the Legislative Branch for the fiscal year ending September 30, Oct. 1, 2009 ...... 2023 2010, and for other purposes. 111–69 ...... Fiscal Year 2010 Federal Aviation Administration Extension Act ...... Oct. 1, 2009 ...... 2054 111–70 ...... To amend the Foreign Affairs Reform and Restructuring Act of 1998 to reauthorize the United Oct. 9, 2009 ...... 2057 States Advisory Commission on Public Diplomacy. 111–71 ...... To amend the United States International Broadcasting Act of 1994 to extend by one year the Oct. 9, 2009 ...... 2058 operation of Radio Free Asia, and for other purposes. 111–72 ...... To amend title XVIII of the Social Security Act to delay the date on which the accreditation Oct. 13, 2009 ..... 2059 requirement under the Medicare Program applies to suppliers of durable medical equipment that are pharmacies. 111–73 ...... Enhanced Partnership with Pakistan Act of 2009 ...... Oct. 15, 2009 ..... 2060 111–74 ...... To designate the federally occupied building located at McKinley Avenue and Third Street, Oct. 19, 2009 ..... 2080 SW., Canton, Ohio, as the ‘‘Ralph Regula Federal Building and United States Courthouse’’. 111–75 ...... To designate the United States courthouse located at 525 Magoffin Avenue in El Paso, Texas, Oct. 19, 2009 ..... 2081 as the ‘‘Albert Armendariz, Sr., United States Courthouse’’. 111–76 ...... To authorize the Administrator of General Services to convey a parcel of real property in Gal- Oct. 19, 2009 ..... 2082 veston, Texas, to the Galveston Historical Foundation. 111–77 ...... To designate the Federal building located at 844 North Rush Street in Chicago, Illinois, as the Oct. 19, 2009 ..... 2084 ‘‘William O. Lipinski Federal Building’’. 111–78 ...... To designate the United States courthouse located at 301 Simonton Street in Key West, Flor- Oct. 19, 2009 ..... 2085 ida, as the ‘‘Sidney M. Aronovitz United States Courthouse’’. 111–79 ...... Foreign Evidence Request Efficiency Act of 2009 ...... Oct. 19, 2009 ..... 2086 111–80 ...... Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appro- Oct. 21, 2009 ..... 2090 priations Act, 2010. 111–81 ...... Veterans Health Care Budget Reform and Transparency Act of 2009 ...... Oct. 22, 2009 ..... 2137 111–82 ...... To authorize major medical facility leases for the Department of Veterans Affairs for fiscal year Oct. 26, 2009 ..... 2140 2010, and for other purposes. 111–83 ...... Department of Homeland Security Appropriations Act, 2010 ...... Oct. 28, 2009 ..... 2142 111–84 ...... National Defense Authorization Act for Fiscal Year 2010 ...... Oct. 28, 2009 ..... 2190 111–85 ...... Energy and Water Development and Related Agencies Appropriations Act, 2010 ...... Oct. 28, 2009 ..... 2845 111–86 ...... Girl Scouts USA Centennial Commemorative Coin Act ...... Oct. 29, 2009 ..... 2881 111–87 ...... Ryan White HIV/AIDS Treatment Extension Act of 2009 ...... Oct. 30, 2009 ..... 2885 111–88 ...... Making appropriations for the Department of the Interior, environment, and related agencies Oct. 30, 2009 ..... 2904 for the fiscal year ending September 30, 2010, and for other purposes. 111–89 ...... To provide for an additional temporary extension of programs under the Small Business Act Oct. 30, 2009 ..... 2975 and the Small Business Investment Act of 1958, and for other purposes. 111–90 ...... Morris K. Udall Scholarship and Excellence in National Environmental Policy Amendments Nov. 3, 2009 ...... 2976 Act of 2009. 111–91 ...... Medal of Honor Commemorative Coin Act of 2009 ...... Nov. 6, 2009 ...... 2980 111–92 ...... Worker, Homeownership, and Business Assistance Act of 2009 ...... Nov. 6, 2009 ...... 2984 111–93 ...... Credit CARD Technical Corrections Act of 2009 ...... Nov. 6, 2009 ...... 2998 111–94 ...... Proclaiming Casimir Pulaski to be an honorary citizen of the United States posthumously ...... Nov. 6, 2009 ...... 2999 111–95 ...... To amend title 36, United States Code, to grant a Federal charter to the Military Officers Asso- Nov. 6, 2009 ...... 3001 ciation of America, and for other purposes. 111–96 ...... To allow the funding for the interoperable emergency communications grant program estab- Nov. 6, 2009 ...... 3005 lished under the Digital Television Transition and Public Safety Act of 2005 to remain avail- able until expended through fiscal year 2012, and for other purposes. 111–97 ...... Military Spouses Residency Relief Act ...... Nov. 11, 2009 .... 3007

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123 Public Law Title Approved Stat.

111–98 ...... To authorize a major medical facility project at the Department of Veterans Affairs Medical Nov. 11, 2009 .... 3010 Center, Walla Walla, Washington, and for other purposes. 111–99 ...... To designate the facility of the United States Postal Service located at 10355 Northeast Valley Nov. 30, 2009 .... 3011 Road in Rollingbay, Washington, as the ‘‘John ‘Bud’ Hawk Post Office’’. 111–100 ...... To designate the facility of the United States Postal Service located at 37926 Church Street in Nov. 30, 2009 .... 3012 Dade City, Florida, as the ‘‘Sergeant Marcus Mathes Post Office’’. 111–101 ...... To name the South Central Agricultural Research Laboratory of the Department of Agriculture Nov. 30, 2009 .... 3013 in Lane, Oklahoma, and the facility of the United States Postal Service located at 310 North Perry Street in Bennington, Oklahoma, in honor of former Congressman Wesley ‘‘Wes’’ Wat- kins. 111–102 ...... To designate the facility of the United States Postal Service located at 4282 Beach Street in Nov. 30, 2009 .... 3014 Akron, Michigan, as the ‘‘Akron Veterans Memorial Post Office’’. 111–103 ...... To designate the facility of the United States Postal Service located at 140 Merriman Road in Nov. 30, 2009 .... 3015 Garden City, Michigan, as the ‘‘John J. Shivnen Post Office Building’’. 111–104 ...... To designate the facility of the United States Postal Service located at 1615 North Wilcox Ave- Nov. 30, 2009 .... 3016 nue in Los Angeles, California, as the ‘‘Johnny Grant Hollywood Post Office Building’’. 111–105 ...... To designate the facility of the United States Postal Service located at 115 West Edward Street Nov. 30, 2009 .... 3017 in Erath, Louisiana, as the ‘‘Conrad DeRouen, Jr. Post Office’’. 111–106 ...... To designate the facility of the United States Postal Service located at 867 Stockton Street in Nov. 30, 2009 .... 3018 San Francisco, California, as the ‘‘Lim Poon Lee Post Office’’. 111–107 ...... To designate the facility of the United States Postal Service located at 1165 2nd Avenue in Des Nov. 30, 2009 .... 3019 Moines, Iowa, as the ‘‘Iraq and Afghanistan Veterans Memorial Post Office’’. 111–108 ...... To designate the facility of the United States Postal Service located at 936 South 250 East in Nov. 30, 2009 .... 3020 Provo, Utah, as the ‘‘Rex E. Lee Post Office Building’’. 111–109 ...... To redesignate the facility of the United States Postal Service located at 2777 Logan Avenue in Nov. 30, 2009 .... 3021 San Diego, California, as the ‘‘Cesar E. Chavez Post Office’’. 111–110 ...... To designate the facility of the United States Postal Service located at 60 School Street, Or- Nov. 30, 2009 .... 3022 chard Park, New York, as the ‘‘Jack F. Kemp Post Office Building’’. 111–111 ...... To designate the facility of the United States Postal Service located at 630 Northeast Nov. 30, 2009 .... 3023 Killingsworth Avenue in Portland, Oregon, as the ‘‘Dr. Martin Luther King, Jr. Post Office’’. 111–112 ...... To extend the authority for relocation expenses test programs for Federal employees, and for Nov. 30, 2009 .... 3024 other purposes. 111–113 ...... Reserve Officers Association Modernization Act of 2009 ...... Dec. 14, 2009 ..... 3026 111–114 ...... To permit each current member of the Board of Directors of the Office of Compliance to serve Dec. 14, 2009 ..... 3028 for 3 terms. 111–115 ...... No Social Security Benefits for Prisoners Act of 2009 ...... Dec. 15, 2009 ..... 3029 111–116 ...... Fiscal Year 2010 Federal Aviation Administration Extension Act, Part II ...... Dec. 16, 2009 ..... 3031 111–117 ...... Consolidated Appropriations Act, 2010 ...... Dec. 16, 2009 ..... 3034 111–118 ...... Department of Defense Appropriations Act, 2010 ...... Dec. 19, 2009 ..... 3409 111–119 ...... Airline Flight Crew Technical Corrections Act ...... Dec. 21, 2009 ..... 3476 111–120 ...... To extend through December 31, 2010, the authority of the Secretary of the Army to accept Dec. 22, 2009 ..... 3478 and expend funds contributed by non-Federal public entities to expedite the processing of permits. 111–121 ...... Appointing the day for the convening of the second session of the One Hundred Eleventh Dec. 22, 2009 ..... 3479 Congress. 111–122 ...... Human Rights Enforcement Act of 2009 ...... Dec. 22, 2009 ..... 3480 111–123 ...... To permit continued financing of Government operations ...... Dec. 28, 2009 ..... 3483 111–124 ...... To extend the Generalized System of Preferences and the Andean Trade Preference Act, and Dec. 28, 2009 ..... 3484 for other purposes. 111–125* .... To extend the commercial space transportation liability regime ...... Dec. 28, 2009 ..... 3486 111–128 ...... To designate the facility of the United States Postal Service located at 116 North West Street Jan. 29, 2010 ...... 3487 in Somerville, Tennessee, as the ‘‘John S. Wilder Post Office Building’’. 111–129 ...... To designate the facility of the United States Postal Service located at 76 Brookside Avenue in Jan. 29, 2010 ...... 3488 Chester, New York, as the ‘‘1st Lieutenant Louis Allen Post Office’’. 111–130 ...... To designate the facility of the United States Postal Service located at 9810 Halls Ferry Road Jan. 29, 2010 ...... 3489 in St. Louis, Missouri, as the ‘‘Coach Jodie Bailey Post Office Building’’. 111–131 ...... To designate the facility of the United States Postal Service located at 440 South Gulling Street Jan. 29, 2010 ...... 3490 in Portola, California, as the ‘‘Army Specialist Jeremiah Paul McCleery Post Office Building’’. 111–132 ...... To designate the facility of the United States Postal Service located at 427 Harrison Avenue in Jan. 29, 2010 ...... 3491 Harrison, New Jersey, as the ‘‘Patricia D. McGinty-Juhl Post Office Building’’. 111–133 ...... To designate the facility of the United States Postal Service located at 16555 Springs Street in Jan. 29, 2010 ...... 3492 White Springs, Florida, as the ‘‘Clyde L. Hillhouse Post Office Building’’. 111–134 ...... To designate the facility of the United States Postal Service located at 170 North Main Street Jan. 29, 2010 ...... 3493 in Smithfield, Utah, as the ‘‘W. Hazen Hillyard Post Office Building’’. 111–135* .... To designate the facility of the United States Postal Service located at 3900 Darrow Road in Jan. 29, 2010 ...... 3494 Stow, Ohio, as the ‘‘Corporal Joseph A. Tomci Post Office Building’’. 111–137 ...... To amend title 38, United States Code, to expand veteran eligibility for reimbursement by the Feb. 1, 2010 ...... 3495 Secretary of Veterans Affairs for emergency treatment furnished in a non-Department facil- ity, and for other purposes. ———————— *Note: Public Laws 111–126, 127, and 136 will appear in the Cumulative List of Public Laws for the 111th Congress, Second Session.

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Reader Aids Federal Register Vol. 75, No. 61 Wednesday, March 31, 2010

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MARCH

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. Presidential Documents 2 CFR 930...... 12702 932...... 9536 Executive orders and proclamations 741–6000 176...... 14323 The United States Government Manual 741–6000 985...... 13445 3 CFR 1208...... 13238 Other Services 1218...... 12707 Electronic and on-line services (voice) 741–6020 Proclamations: 3550...... 10194 Privacy Act Compilation 741–6064 8478...... 9325 Public Laws Update Service (numbers, dates, etc.) 741–6043 8479...... 10159 8 CFR 8480...... 10161 TTY for the deaf-and-hard-of-hearing 741–6086 217...... 15991 8481...... 10631 8482...... 10991 ELECTRONIC RESEARCH 9 CFR 8483...... 10993 53...... 10645 World Wide Web 8484...... 13215 56...... 10645 Full text of the daily Federal Register, CFR and other publications 8485...... 15601 145...... 10645 is located at: http://www.gpoaccess.gov/nara/index.html 8486...... 15989 Federal Register information and research tools, including Public 146...... 10645 Executive Orders: 147...... 10645 Inspection List, indexes, and links to GPO Access are located at: 13394 (revoked by http://www.archives.gov/federallregister 13533) ...... 10163 Proposed Rules: 417...... 14361 E-mail 13532...... 9749 418...... 14361 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 13533...... 10163 an open e-mail service that provides subscribers with a digital 13534...... 12433 10 CFR form of the Federal Register Table of Contents. The digital form 13535...... 15599 50...... 10410 of the Federal Register Table of Contents includes HTML and Administrative Orders: 430...... 13217 PDF links to the full text of each document. Notices: 431...... 10874, 10950 To join or leave, go to http://listserv.access.gpo.gov and select Notice of February 26, 440...... 11419 Online mailing list archives, FEDREGTOC-L, Join or leave the list 2010 ...... 10157 (or change settings); then follow the instructions. Notice of March 10, Proposed Rules: PENS (Public Law Electronic Notification Service) is an e-mail 2010 ...... 12117 73...... 10444 service that notifies subscribers of recently enacted laws. Memorandums: 170...... 11376 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html Memorandums of 171...... 11376 and select Join or leave the list (or change settings); then follow March 10, 2010...... 12119, 430 ...... 12144, 14288, 14319 the instructions. 13427 431...... 9120, 14368 FEDREGTOC-L and PENS are mailing lists only. We cannot 11 CFR respond to specific inquiries. 5 CFR Reference questions. Send questions and comments about the 2423...... 13429 100...... 13223 Federal Register system to: [email protected] 106...... 13223 6 CFR The Federal Register staff cannot interpret specific documents or 12 CFR regulations. 5 ...... 9085, 10633, 12437 Reminders. Effective January 1, 2009, the Reminders, including 201...... 9093 7 CFR Rules Going Into Effect and Comments Due Next Week, no longer 360...... 12962, 14330 appear in the Reader Aids section of the Federal Register. This 246...... 15603 617...... 10411 information can be found online at http://www.regulations.gov. 301...... 12961 Proposed Rules: CFR Checklist. Effective January 1, 2009, the CFR Checklist no 354...... 10634 205...... 9120 longer appears in the Federal Register. This information can be 457...... 15603, 15778 226...... 12334 found online at http://bookstore.gpo.gov/. 966...... 10409 230...... 9126 1000...... 10122 652...... 13682 701...... 14372, 15574 FEDERAL REGISTER PAGES AND DATE, MARCH 1001...... 10122 1005...... 10122 708a...... 15574 9085–9326...... 1 13427–13666...... 22 1006...... 10122 708b...... 15574 9327–9514...... 2 13667–14068...... 23 1007...... 10122 723...... 14372 9515–9752...... 3 14069–14322...... 24 1030...... 10122 742...... 14372 9753–10158...... 4 14323–14490...... 25 1032...... 10122 906...... 10446 1033...... 10122 1207...... 10446 10159–10408...... 5 14491–15320...... 26 1124...... 10122 1807...... 12408 10409–10630...... 8 15321–15600...... 29 10631–10990...... 9 1126...... 10122 15601–15990...... 30 13 CFR 10991–11418...... 10 1131...... 10122 11419–11732...... 11 15991–16324...... 31 1207...... 14491 123...... 14330 11733–12118...... 12 1580...... 9087 301...... 11733 12119–12432...... 15 Proposed Rules: Proposed Rules: 12433–12656...... 16 46...... 11472 121...... 9129, 10030 12657–12960...... 17 205...... 14500 124...... 9129 12961–13214...... 18 319...... 11071 125...... 9129 13215–13426...... 19 923...... 10442 126...... 9129

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127...... 10030 270...... 10060 22 CFR 117...... 9557 134...... 9129, 10030 274...... 10060 Proposed Rules: 165 ...... 9370, 10195, 10446, Proposed Rules: 13707 14 CFR 22...... 14111 38...... 15635 124...... 15388 334...... 12718 1...... 9095 140...... 15635 126...... 15388 34 CFR 21...... 9095 129...... 15388 25...... 12965 18 CFR Ch. II ...... 12004 26...... 11734 35...... 14342 24 CFR 280...... 9777 39 ...... 9515, 9753, 9756, 9760, 131...... 15950 Proposed Rules: Proposed Rules: 10658, 10664, 10667, 10669, 157...... 15336 1000...... 13243, 14390 206...... 13814 11422, 11428, 11433, 11435, 292...... 15950 642...... 13814 11439, 12438, 12439, 12441, 1301...... 11735 25 CFR 643...... 13814 12657, 12659, 12661, 12663, Proposed Rules: Proposed Rules: 644...... 13814 12665, 12667, 12670, 12968, 35...... 15362 Ch. VI...... 15389 645...... 13814 12971, 13225, 14333, 15321, 40 ...... 14097, 14103, 14386, 646...... 13814 15322, 15326, 15328, 15331 15371 26 CFR 647...... 13814 43...... 9095 410...... 11502 1 ....9101, 10172, 13679, 15610 694...... 13814 45...... 9095 31...... 15610 61...... 9763, 15609 19 CFR 36 CFR 63...... 9763 Proposed Rules: Ch. I ...... 12445 1 ...... 9141, 9142, 14539 251...... 14495 65...... 9763 1254...... 10414 71 ...... 12674, 12675, 12676, 12...... 10411, 13676 31...... 9142 12677, 12678, 12679, 12680, 163...... 13676 301...... 9142 Proposed Rules: 1191...... 13457 12972, 12973, 12974, 12975, Ch. IV...... 12445 27 CFR 1193...... 13457 13667, 13368, 13669, 13670, Proposed Rules: 1194...... 13457 13671 111...... 13699 Proposed Rules: 113...... 9359 9...... 9827, 9831 73 ...... 12976, 14069, 15992 37 CFR 91...... 9327 159...... 12483 28...... 9359 95...... 10995 163...... 13699 44...... 9359 383...... 14074 191...... 9359 Proposed Rules: 97 ....9095, 9098, 12977, 12979 28 CFR 121...... 12121 201...... 15390 20 CFR 0...... 14070 Proposed Rules: 38 CFR 29...... 11799 655...... 10396, 16000 2...... 9516 35...... 13238 Proposed Rules: 43...... 9102 Proposed Rules: 39 ...... 9137, 9140, 9809, 9811, 404...... 9821 571...... 13680 3...... 13051, 14391 9814, 9816, 10694, 10696, 416...... 9821 Proposed Rules: 39 CFR 10701, 11072, 12148, 12150, 115...... 11077 12152, 12154, 12158, 12464, 21 CFR 513...... 13705 111 ...... 9343, 12981, 14076 12466, 12468, 12710, 12713, 3...... 13678 545...... 9544 121...... 9343 310...... 12123 13045, 13046, 13239, 13451, 14...... 15342 29 CFR 13682, 13684, 13686, 13689, 73...... 14491 320...... 12123 13695, 14375, 14377, 14379, 333...... 9767 1910...... 12681 3020 ...... 9523, 11452, 12445 15353, 15357, 15627, 15629, 514...... 10413 1915...... 12681 16022 520...... 10165, 12981 1926...... 12681 40 CFR 71 ...... 9538, 11475, 11476, 522 ...... 9333, 10165, 13225 2520...... 9334 49...... 10174 11477, 11479, 11480, 11481, 524...... 10165 4022...... 12121 51...... 16012 12161, 12162, 12163, 12165, 526...... 10165 4044...... 12121 52 ...... 9103, 10182, 10415, 12166, 13049, 13453, 13697, 558 ...... 9334, 11451, 15610, Proposed Rules: 10416, 10420, 10690, 11461, 13698, 14381, 14382, 14383, 16001 9...... 13382 11464, 11738, 12088, 12449, 14385, 15360, 15361, 16024 1140...... 13225 1904...... 10738 13436, 14077, 14352, 15348, 73...... 15632 1300...... 16236 1910 ...... 10739, 12485, 12718 16012 234...... 11075 1301...... 10671 1915...... 12485, 12718 55...... 9780 1303...... 10671 1926...... 12485, 12718 63 ...... 9648, 10184, 12988 15 CFR 1304...... 10671, 16236 2550...... 9360 70...... 9106 740...... 14335 1306...... 16236 80...... 9107, 14670 31 CFR 742...... 14335 1307...... 10671 81 ...... 9781, 13436, 14077 748...... 14335 1308...... 10671, 13678 515...... 10996, 10997 93...... 14260 774 ...... 13672, 13674, 14335 1309...... 10671 538...... 10997 98...... 12451, 14081 902...... 11441 1310...... 10671 560...... 10997 180 ...... 9527, 10186, 11740, 1311...... 16236 12691, 12695, 14082, 14086, Proposed Rules: 32 CFR 801...... 10704 1312...... 10671 16017 904...... 13050 1313...... 10168, 10671 706...... 10413 260...... 12989 1314...... 10671 Proposed Rules: 261...... 11002, 12989 16 CFR 1315...... 10671 157...... 9548 262...... 12989 610...... 9726 1316...... 10671 240...... 9142 263...... 12989 1119...... 15993 1321...... 10671 264...... 12989 33 CFR Proposed Rules: Proposed Rules: 265...... 12989 Ch. I ...... 12715 202...... 15376 117 ...... 9521, 10172, 12686, 266...... 12989 305...... 11483 510...... 15387 12688, 16002, 16004, 16005, 268...... 12989 306...... 12470 514...... 15387 16006, 16007, 16009 270...... 12989 322...... 10707 558...... 15387 165 ...... 10687, 11000, 12688, 271...... 9345 1450...... 12167 610...... 15639 13232, 13433, 14072, 14493, 300...... 9782, 9790 807...... 14510 15343, 15611, 16010 450...... 10438 17 CFR 1140...... 13241 401...... 10688 Proposed Rules: 242...... 11232 1308...... 14538, 15642 Proposed Rules: 52 .....9146, 9373, 9834, 10198, 249...... 9100 1314...... 13702 100...... 13454 10449, 11503, 12090, 12168,

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13058, 13468, 13710, 14116, 46 CFR 13...... 13413 175...... 9147 14401, 14545, 15391, 15645, Proposed Rules: 14...... 13425 389...... 12720 15648, 16026, 16032 10...... 13715 15...... 13414, 13415 395...... 9376 63...... 15655 11...... 13715 16...... 13416 575...... 10740, 11806 70...... 9147 12...... 13715 25...... 13421 81...... 12090, 13710 42...... 14059 15...... 13715 50 CFR 98...... 12489 52 ...... 13421, 13422, 14059 131...... 11079 47 CFR 53...... 13415 10...... 9282 260...... 13066 1...... 9797 Ch. 2 ...... 14095 17 ...... 11010, 12816, 14496 261...... 13066, 16037 2...... 10439 217...... 9114, 10190 21...... 9314, 9316 262...... 13066 15...... 9113 237...... 10191 223...... 13012 263...... 13066 25...... 14094 252...... 10191 229...... 12698 264...... 13066 54...... 15352 Ch. 13 ...... 10568 300...... 13024 265...... 13066 63...... 13235 1352...... 14496 600...... 9531 266...... 13066 73 .....9114, 9530, 9797, 10692, Proposed Rules: 622 ...... 9116, 10693, 11068 268...... 13066 13235, 13236, 13681, 14359 204...... 9563 635...... 12700 270...... 13066 74...... 9113 252...... 9563 648 ...... 11441, 12141, 12462, 300...... 9843 76...... 9692, 12458 Ch. 14 ...... 14547 15625 1809...... 9860 660...... 11068 43 CFR 80...... 10692 Proposed Rules: 1827...... 9860 679 ...... 9358, 9534, 10441, 10...... 12378 0...... 14401 1837...... 9860 11471, 11749, 11778, 12463, 1852...... 9860 13237, 13444, 14359, 14498, 44 CFR 1...... 14401, 14409 15...... 9850 15626, 16021 49 CFR 64 ...... 9111, 14356, 15613 25...... 15392 Proposed Rules: 65...... 11744 54...... 10199 40...... 13009 16...... 11808 67...... 11468, 14091 64...... 13471 107...... 15613 17 ...... 9377, 11081, 12598, Proposed Rules: 68...... 13471 172...... 10974 13068, 13715, 13717, 13720, 67...... 9561 73...... 9856, 9859 395...... 13441 13910, 16046, 16050 541...... 11005 223...... 12598 45 CFR 48 CFR 571 ...... 12123, 15620, 15621 224...... 12598 Proposed Rules: Ch. 1...... 14058, 14067 575...... 15894 622 ...... 9864, 12169, 14548, 170...... 11328 1...... 13412, 13425 Proposed Rules: 15665 2527...... 15664 2...... 14059 71...... 9568 648...... 10450 2551...... 15664 9...... 14059 172...... 9147 660...... 11829 2552...... 15664 12...... 14059 173...... 9147 679...... 14016

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pamphlet) form from the S. 3186/P.L. 111–151 enacted public laws. To Superintendent of Documents, subscribe, go to http:// LIST OF PUBLIC LAWS Satellite Television Extension U.S. Government Printing Act of 2010 (Mar. 26, 2010; listserv.gsa.gov/archives/ Office, Washington, DC 20402 This is a continuing list of 124 Stat. 1027) publaws-l.html (phone, 202–512–1808). The public bills from the current A Cumulative List of Public session of Congress which text will also be made Laws for the first session of available on the Internet from Note: This service is strictly have become Federal laws. It the 111th Congress appears for E-mail notification of new may be used in conjunction GPO Access at http:// in Part III of this issue. www.gpoaccess.gov/plaws/ laws. The text of laws is not with ‘‘P L U S’’ (Public Laws Last List March 30, 2010 Update Service) on 202–741– index.html. Some laws may available through this service. 6043. This list is also not yet be available. PENS cannot respond to specific inquiries sent to this available online at http:// H.R. 4938/P.L. 111–150 Public Laws Electronic address. www.archives.gov/federal- To permit the use of register/laws.html. Notification Service previously appropriated funds (PENS) The text of laws is not to extend the Small Business published in the Federal Loan Guarantee Program, and Register but may be ordered for other purposes. (Mar. 26, PENS is a free electronic mail in ‘‘slip law’’ (individual 2010; 124 Stat. 1026) notification service of newly

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