6–24–10 Thursday Vol. 75 No. 121 June 24, 2010

Pages 35957–36256

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Contents Federal Register Vol. 75, No. 121

Thursday, June 24, 2010

Agricultural Marketing Service Education Department RULES NOTICES Final Free and Reserve Percentages for 2009–10 Crop Agency Information Collection Activities; Proposals, Natural (Sun-dried) Seedless Raisins: Submissions, and Approvals, 36065–36066 Raisins Produced from Grapes Grown in California, Applications for New Awards for Fiscal Year (FY) 2010: 35959–35962 Improved Outcomes for Individuals with Serious Mental PROPOSED RULES Illness and Co-Occurring Conditions, 36239–36243 Milk in the Northeast and Other Marketing Areas; Final Priority: Correction, 36015 Improved Outcomes for Individuals with Serious Mental NOTICES Illness and Co-Occurring Conditions, 36238–36239 Agency Information Collection Activities; Proposals, Promise Neighborhoods Program, 36066 Submissions, and Approvals, 36058–36060 Election Assistance Commission Agriculture Department NOTICES See Agricultural Marketing Service Meetings; Sunshine Act, 36066–36067 See Animal and Plant Health Inspection Service See Forest Service Environmental Protection Agency See Rural Utilities Service RULES Significant New Use Rules on Certain Chemical Substances, Animal and Plant Health Inspection Service 35977–35989 NOTICES PROPOSED RULES Agency Information Collection Activities; Proposals, Approval and Promulgation of Implementation Plans; Submissions, and Approvals: Designation of Areas for Air Quality Planning Blood and Tissue Collection at Slaughtering and Purposes: Rendering Establishments, 36060–36061 California; PM–10; Redesignation of the Coso Junction Planning Area to Attainment, etc., 36023–36034 Centers for Disease Control and Prevention Lead Emissions From Piston-Engine Aircraft Using Leaded NOTICES Aviation Gasoline: Establishment: Extension of Comment Period, 36034–36035 Advisory Committee on Breast Cancer in Young Women, NOTICES 36098–36099 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Civil Rights Commission Chemical-Specific Rules, TSCA Section 8(a), 36067– NOTICES 36068 Meetings: Clean Air Act Operating Permit Program; Petition for North Carolina Advisory Committee, 36061–36062 Objection to a Federal Operating Permit: Waste Management of Louisiana L.L.C., Woodside Coast Guard Landfill and Recycling Center, Walker, Livingston RULES Parish, LA, 36069 Safety Zones: Regional Project Waiver of Section 1605 (Buy American) of Fireworks Display in Stevenson, WA, 35968–35970 American Recovery and Reinvestment Act of 2009, North Jetty, Named the Barview Jetty, Tillamook Bay, OR, Newport, RI, 36069–36071 35970–35973 NOTICES Farm Credit Administration Certificate of Alternative Compliance for the Offshore RULES Supply Vessel: Farm Credit Administration Board Meetings; Assessment SOUTHERN CROSS, 36106–36107 and Apportionment of Administrative Expenses; etc.; Technical Changes, 35966–35968 Commerce Department See National Oceanic and Atmospheric Administration Federal Communications Commission See Patent and Trademark Office RULES Facilitating Provision of Fixed and Mobile Broadband Comptroller of the Currency Access, Educational and Other Advanced Services PROPOSED RULES (2150–2162 and 2500–2690 MHz Bands), 35989–35990 Community Reinvestment Act Regulations, 36016–36022 NOTICES Framework for Broadband Internet Service, 36071–36088 Consumer Product Safety Commission NOTICES Federal Deposit Insurance Corporation Meetings; Sunshine Act, 36065 PROPOSED RULES Community Reinvestment Act Regulations, 36016–36022 Defense Department NOTICES See Navy Department Meetings; Sunshine Act, 36088

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Federal Financial Institutions Examination Council General and Plastic Surgery Devices Panel of the Medical NOTICES Devices Advisory Committee, 36102 Appraisal Subcommittee; Rules of Operation; Amendment, 36088–36089 Forest Service NOTICES Federal Highway Administration Meetings: NOTICES Humboldt Resource Advisory Committee, 36061 Final Federal Agency Action on Proposed Transportation Snohomish County Resource Advisory Committee, 36061 Project in Illinois, 36150–36151 Final Federal Agency Actions on Proposed Highway in General Services Administration California, 36151–36152 NOTICES Environmental Impact Statements; Availability, etc.: Federal Reserve System Improvements to the Calexico West Port of Entry, PROPOSED RULES Calexico, CA, 36091 Community Reinvestment Act Regulations, 36016–36022 NOTICES Health and Human Services Department Change in Bank Control Notices; Acquisition of Shares of See Centers for Disease Control and Prevention Bank or Bank Holding Companies, 36089 See Food and Drug Administration Formations of, Acquisitions by, and Mergers of Bank See Health Resources and Services Administration Holding Companies, 36089 See National Institutes of Health Payment System Risk Policy; Daylight Overdraft Posting RULES Rules, 36089–36091 Establishment of the Temporary Certification Program for Health Information Technology, 36158–36209 Federal Retirement Thrift Investment Board PROPOSED RULES Health Resources and Services Administration Uniformed Services Accounts and Death Benefits; NOTICES Correction, 36015 Legislative Changes to Primary Care Loan Program Authorized Under Title VII of the Public Health Fiscal Service Service Act, 36099 NOTICES Recruitment of Sites for Assignment of National Health Surety Companies Acceptable on Federal Bonds – Change Service Corps Personnel Obligated under NHSC in Business Address and Redomestication: Scholarship Program, 36102–36104 First Liberty Insurance Corp. et al., 36153 Statement of Organization, Functions and Delegations of Surety Companies Acceptable on Federal Bonds – Change Authority, 36104–36105 in Business Address: American Economy Insurance Co. et al., 36153 Homeland Security Department Surety Companies Acceptable on Federal Bonds – See Coast Guard Terminations: See U.S. Customs and Border Protection Victore Insurance Co., 36153–36154 Housing and Urban Development Department Fish and Wildlife Service PROPOSED RULES RULES Native American Housing Assistance and Self- Endangered and Threatened Wildlife and Plants: Determination Reauthorization Act of 2008: Listing the Flying Earwig Hawaiian Damselfly and Pacific Negotiated Rulemaking Committee Meeting, 36022–36023 Hawaiian Damselfly, 35990–36012 NOTICES PROPOSED RULES Funding Availability: Endangered and Threatened Wildlife and Plants: Department of Housing and Urban Development’s Listing the Cumberland Darter, Rush Darter, Yellowcheek Community Challenge Planning Grants and Darter, Chucky Madtom, and Laurel Dace as Department of Transportation’s TIGER II Planning Endangered, 36035–36057 Grants, 36246–36255

Food and Drug Administration Indian Affairs Bureau NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals: No Child Left Behind School Facilities and Construction Adoption of Food and Drug Administration Food Code Negotiated Rulemaking Committee, 36117–36118 by Local, State, and Tribal Governments, 36097– 36098 Interior Department Medical Devices; Current Good Manufacturing Practice See Fish and Wildlife Service Quality System Regulations, 36092–36097 See Indian Affairs Bureau Threshold of Regulation for Substances Used in Food– See Land Management Bureau Contact Articles, 36091–36092 See National Park Service Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, International Trade Commission 36099–36100 NOTICES Meetings: Investigations: Dermatologic and Ophthalmic Drugs Advisory Certain Cold Cathode Fluorescent Lamp Inverter Circuits Committee; Cancellation, 36101–36102 and Products Containing the Same, 36119

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Meetings; Sunshine Act, 36119 U.S. Department of Defense, Army Corps of Engineers, Walla Walla District, Walla Walla, WA, etc., 36114– Labor Department 36117 See Mine Safety and Health Administration National Science Foundation Land Management Bureau NOTICES NOTICES Agency Information Collection Activities; Proposals, Public Land Order No. 7743: Submissions, and Approvals, 36123–36124 Partial Revocation of Five Secretarial Orders for Reclamation Project Purposes on the Colorado River, Navy Department CA, 36118–36119 NOTICES Meetings: Mine Safety and Health Administration Ocean Research and Resources Advisory Panel, 36065 NOTICES Agency Information Collection Activities; Proposals, Nuclear Regulatory Commission Submissions, and Approvals: PROPOSED RULES Operations Under Water (pertains to underground coal Requirements for Distribution of Byproduct Material, mines), 36122 36212–36236 Program to Prevent Smoking Underground and in NOTICES Hazardous Surface Areas (pertains to underground Construction Reactor Oversight Process; Request for Public coal mines), 36120 Comment, 36124–36125 Safety Standards for Underground Coal Mine Ventilation, Proposed Revision to Standard Review Plan: etc., 36121–36122 Section 13.6.1, Revision 1 on Physical Security— Combined License and Operating Reactors, 36126– National Archives and Records Administration 36127 NOTICES Section 13.6.2, Revision 1 on Physical Security—Design Agency Information Collection Activities; Proposals, Certification, 36125–36126 Submissions, and Approvals, 36122–36123 Section 13.6.3, Revision 1 on Physical Security—Early Site Permit, 36126 National Highway Traffic Safety Administration NOTICES Patent and Trademark Office Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals, 36150 Trademark Technical and Conforming Amendments, 35973–35977 National Institutes of Health NOTICES NOTICES Enforcement Policy Symposium on Combating Meetings: Counterfeiting in the 21st Century, 36062–36063 Center for Scientific Review, 36101–36102 Expansion and Extension of the Patent Application Backlog Eunice Kennedy Shriver National Institute of Child Reduction Stimulus Plan, 36063–36064 Health and Human Development, 36100–36101 Pension Benefit Guaranty Corporation National Oceanic and Atmospheric Administration NOTICES RULES Agency Information Collection Activities; Proposals, Fisheries of the Northeastern United States: Submissions, and Approvals: 2010 Specifications for the Spiny Dogfish Fishery, Annual Reporting and Disclosure, 36127–36128 36012–36014 NOTICES Public Debt Bureau Availability of Conservation Seat and Diving Operations See Fiscal Service Seat: Flower Garden Banks National Marine Sanctuary Rural Utilities Service Advisory Council, 36062 RULES Marine Mammals (File No. 14186), 36064 Special Evaluation Assistance for Rural Communities and Stellwagen Bank National Marine Sanctuary Final Revised Households Program, 35962–35966 Management Plan; Availability, 36064–36065 Securities and Exchange Commission National Park Service NOTICES NOTICES Order of Suspension of Trading: Intent to Repatriate Cultural Items: Green Energy Resources, Inc., 36128 Army Corps of Engineers, Walla Walla, WA and Museum Self-Regulatory Organizations; Proposed Rule Changes: of Anthropology, Washington State University, C2 Options Exchange, Inc., 36144–36147 Pullman, WA, 36107–36109 Chicago Board Options Exchange, Inc., 36147–36148 California Department of Parks and Recreation, International Securities Exchange, LLC, 36134–36136, Sacramento, CA, 36109–36110 36143–36144 Inventory Completion: Municipal Securities Rulemaking Board, 36148–36149 Cranbrook Institute of Science, Bloomfield Hills, MI, NASDAQ OMX PHLX, Inc., 36132–36134 36111–36114 NASDAQ Stock Market LLC, 36128–36130 New York University College of Dentistry, New York, NY, New York Stock Exchange LLC, 36138–36140 36110–36111 NYSE Amex LLC, 36140–36143

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NYSE Arca, Inc., 36130–36132, 36136–36138 Veterans Affairs Department NOTICES Special Inspector General For Iraq Reconstruction Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals: Supplemental Standards of Ethical Conduct for Employees Request to Employer for Employment Information in of the Special Inspector General for Iraq Connection with Claim for Disability Benefits, Reconstruction, 35957–35959 36154–36155 Surface Transportation Board Statement of Heirs for Payment of Credits Due Estate of NOTICES Deceased Veteran, 36154 Abandonment Exemptions: Union Pacific Railroad Co., Kane County, IL, 36149– 36150 Separate Parts In This Issue Thrift Supervision Office PROPOSED RULES Part II Community Reinvestment Act Regulations, 36016–36022 NOTICES Health and Human Services Department, 36158–36209 Savings Association Holding Company Report (H–(b)11), 36152 Part III Nuclear Regulatory Commission, 36212–36236 Transportation Department See Federal Highway Administration See National Highway Traffic Safety Administration Part IV See Surface Transportation Board Education Department, 36238–36243 NOTICES Funding Availability: Department of Housing and Urban Development’s Part V Community Challenge Planning Grants and Housing and Urban Development Department, 36246–36255 Department of Transportation’s TIGER II Planning Transportation Department, 36246–36255 Grants, 36246–36255 Treasury Department See Comptroller of the Currency Reader Aids See Fiscal Service Consult the Reader Aids section at the end of this page for See Thrift Supervision Office phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. U.S. Customs and Border Protection NOTICES To subscribe to the Federal Register Table of Contents Agency Information Collection Activities; Proposals, LISTSERV electronic mailing list, go to http:// Submissions, and Approvals: listserv.access.gpo.gov and select Online mailing list Distribution of Continued Dumping and Subsidy Offset to archives, FEDREGTOC-L, Join or leave the list (or change Affected Domestic Producers, 36106 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.

5 CFR Ch. LXXXII...... 35957 Proposed Rules: 1604...... 36015 1651...... 36015 7 CFR 989...... 35959 1774...... 35962 Proposed Rules: 1000...... 36015 10 CFR Proposed Rules: 30...... 36212 31...... 36212 32...... 36212 40...... 36212 70...... 36212 12 CFR 604...... 35966 607...... 35966 612...... 35966 614...... 35966 615...... 35966 618...... 35966 627...... 35966 Proposed Rules: 25...... 36016 228...... 36016 345...... 36016 563e...... 36016 24 CFR Proposed Rules: 1000...... 36022 33 CFR 165 (2 documents) ...... 35968, 35970 37 CFR 2...... 35973 7...... 35973 40 CFR 9...... 35977 721...... 35977 Proposed Rules: 52...... 36023 81...... 36023 87...... 36034 45 CFR 170...... 36158 47 CFR 27...... 35989 50 CFR 17...... 35990 648...... 36012 Proposed Rules: 17...... 36035

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Rules and Regulations Federal Register Vol. 75, No. 121

Thursday, June 24, 2010

This section of the FEDERAL REGISTER SUPPLEMENTARY INFORMATION: employment except to the extent that contains regulatory documents having general the SIGIR DAEO or alternate DAEO has Background applicability and legal effect, most of which issued an instruction or manual are keyed to and codified in the Code of In 1992, OGE published Standards of pursuant to paragraph (e) of this section Federal Regulations, which is published under Ethical Conduct for Employees of the exempting an activity or class of 50 titles pursuant to 44 U.S.C. 1510. Executive Branch (Standards) which activities from this requirement. The Code of Federal Regulations is sold by became effective on February 3, 1993. Section 9201.102(b) broadly defines the Superintendent of Documents. Prices of The Standards, as corrected and outside employment to cover any form new books are listed in the first FEDERAL amended, are codified at 5 CFR part of non-Federal employment or business REGISTER issue of each week. 2635. The Standards set uniform ethical relationship involving the provision of conduct standards applicable to all personal services, whether or not for executive branch personnel. Section compensation, other than the discharge SPECIAL INSPECTOR GENERAL FOR 2635.105 of the Standards authorizes of official duties. It includes writing IRAQ RECONSTRUCTION agencies, with the concurrence of OGE, when done under an arrangement with to publish agency-specific supplemental another person or entry for production 5 CFR Chapter LXXXII regulations that are necessary to or publication of the written product. It properly implement their respective Supplemental Standards of Ethical does not, however, include participation ethics programs. The SIGIR, with OGE’s Conduct for Employees of the Special in the activities of non-profit charitable, concurrence, has determined that the Inspector General for Iraq religious, professional, social, fraternal, following interim supplemental rule is Reconstruction educational, recreational, public service, necessary for successful implementation or civic organizations, unless such AGENCY: Special Inspector General for of its ethics program. activities are for compensation other Iraq Reconstruction. Analysis of the Regulations than reimbursement of expense, the ACTION: Interim rule with request for organization’s activities are devoted comments. Section 9201.101 General substantially to matters relating to the Section 9201.101 explains that the employee’s official duties as defined in SUMMARY: The Special Inspector General regulations in part 9201 apply to 5 CFR 2635.807(a)(2)(i)(B) through (E) for Iraq Reconstruction (SIGIR), with the employees of the SIGIR and supplement and the employee will serve as an concurrence of the Office of the OGE Standards. This section also officer or director of the organization, or Government Ethics (OGE), is issuing an includes cross-references to other the activities will involve the provision interim regulation for employees of the issuances applicable to SIGIR of consultative or professional services. SIGIR that supplement the executive- employees, including the regulations Consultative services means the branch-wide Standards of Ethical concerning executive branch financial provision of personal services by an Conduct (Standards) issued by OGE. disclosure, financial interests, and employee, including the rendering of With certain exceptions, this employee responsibilities and conduct, advice or consultation, which requires supplemental regulation requires SIGIR as well as implementing SIGIR guidance advanced knowledge in a field of employees, except special Government and procedures issued in accordance science or learning customarily acquired employees, to obtain approval before with OGE Standards. by a course of specialized instruction engaging in outside employment. and study in an institution of higher DATES: This interim rule is effective Section 9201.102 Prior Approval for education, hospital, or similar facility. June 24, 2010. Written comments must Outside Employment and Other Outside Professional services means the be received by August 23, 2010. Activities provision of personal services by an ADDRESSES: Send or deliver comments In accordance with 5 CFR 2635.803, employee, including the rendering of to Michael H. Mobbs, Deputy General the SIGIR has determined it is necessary advice or consultation, which involves Counsel and Designated Agency Ethics for the purpose of administering its application of the skills of a profession Official, by any of the following ethics program to require its employees as defined in 5 CFR 2636.305(b)(1) or methods: to obtain approval before engaging in involves a fiduciary relationship as • E-mail: [email protected] outside employment or activities. This defined in 5 CFR 2636.305(b)(2). A note Include the reference ‘‘SIGIR approval requirement will help to following paragraph (b) of § 9201.102 Supplemental Standards’’ in the subject ensure that potential ethical problems pertains to the special approval line of the message. are resolved before employees begin requirement set out in both 18 U.S.C. • Fax: 703–428–0817. 203(d) and 205(e) respectively, for • outside employment or activities that Mail/Hand Delivery/Courier: SIGIR, could involve a violation of applicable certain representational activities 400 Army Navy Drive, Arlington, VA statutes and standards of conduct. otherwise covered by the conflict of 22202–4704, Attention: Michael H. Section 9201.102(a) provides that a interest restrictions on compensation Mobbs, Deputy General Counsel and SIGIR employee, other than a special and activities of employees in claims Designated Agency Ethics Official Government employee, must obtain against and other matters affecting the (DAEO). advance written approval from the Government. The note explains that an FOR FURTHER INFORMATION CONTACT: employee’s supervisor and the employee who wishes to act as agent or Michael H. Mobbs, Deputy General concurrence of the Designated Agency attorney for, or otherwise represent his Counsel, Telephone 703–604–0429; e- Ethics Official (DAEO) or alternate parents, spouse, child, or any person for mail: [email protected]. DAEO before engaging in any outside whom, or any estate for which, he is

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serving as guardian, executor, Regulatory Flexibility Act CFR 2635.105(c). SIGIR employees are administrator, trustee or other personal SIGIR has determined, pursuant to the also subject to the regulations fiduciary in such matters must obtain Regulatory Flexibility Act, 5 U.S.C. concerning executive branch financial the approval required by law of the chapter 6, that this rulemaking will not disclosure contained in 5 CFR part Government official responsible for the have a significant economic impact on 2634, the regulations concerning employee’s appointment in addition to a substantial number of small entities executive branch financial interests the regulatory approval required in because it primarily affects SIGIR contained in 5 CFR part 2640, and the § 9201.102. employees. regulations concerning executive branch employee responsibilities and conduct Section 9201.102(c) sets out the Paperwork Reduction Act contained in 5 CFR part 735. procedures for requesting prior approval to engage in outside employment The Paperwork Reduction Act, 44 § 9201.102 Prior approval for outside initially, or within seven calendar days U.S.C. chapter 35, does not apply employment and other outside activities. of a significant change in the nature or because this rulemaking does not (a) General requirement. Before scope of the outside employment or the contain information collection engaging in any outside employment, employee’s official position. requirements subject to the approval of with or without compensation, an the Office of Management and Budget. Section 9201.102(d) sets out the employee of the SIGIR, other than a standard to be applied by the Congressional Review Act special Government employee, must employee’s supervisor and the DAEO or obtain written approval from the SIGIR has determined that this rule is employee’s supervisor and the alternate DAEO in acting on requests for not a rule as defined in 5 U.S.C. 804, prior approval of outside employment concurrence of the Designated Agency and thus, does not require review by Ethics Official (DAEO) or the alternate as broadly defined by 9201.102(b). Congress. Approval shall be granted only upon a DAEO, except to the extent that the determination that the outside List of Subjects in 5 CFR Part 9201 SIGIR DAEO or alternate DAEO has issued an instruction or manual employment is not expected to involve Conflict of interest, Government pursuant to paragraph (e) of this section conduct prohibited by statute or Federal employees. regulation, including 5 CFR part 2635. exempting an activity or class of ■ Accordingly, for the reasons set forth activities from this requirement. Section 9201.102(e) provides that the in the preamble, the Special Inspector Nonetheless, special Government SIGIR DAEO or alternate DAEO can General for Iraq Reconstruction, with employees remain subject to other issue instructions or manual issuances the concurrence of the Office of statutory and regulatory provisions governing the submission of requests for Government Ethics, is amending title 5 governing their outside activities, approval of outside employment, which of the Code of Federal Regulations by including 18 U.S.C. 203(c) and 205(c), may exempt categories of employment adding a new chapter LXXXII, as well as applicable provisions of 5 from the prior approval requirement of consisting of part 9201, to read as CFR part 2635. this section based on a determination follows: (b) Definition of employment. For that employment within those Chapter LXXXII—Special Inspector General purposes of this section, employment categories would generally be approved for Iraq Reconstruction means any form of non-Federal and is not likely to involve conduct employment or business relationship prohibited by statute or Federal PART 9201—SUPPLEMENTAL involving the provision of personal regulation, including 5 CFR part 2635. STANDARDS OF ETHICAL CONDUCT services, whether or not for The instructions or issuances may FOR EMPLOYEES OF THE SPECIAL compensation. It includes, but is not include examples of outside INSPECTOR GENERAL FOR IRAQ limited to, services as an officer, employment that are permissible or RECONSTRUCTION director, employee, agent, advisor, impermissible consistent with this part attorney, consultant, contractor, general and 5 CFR part 2635. Sec. 9201.101 General. partner, trustee, teacher, or speaker. It Administrative Procedure Act 9201.102 Prior approval for outside includes writing when done under an employment and other outside activities. arrangement with another person for production or publication of the written Pursuant to 5 U.S.C. 553(b) the SIGIR Authority: 5 U.S.C. 7301; 5 U.S.C. App. finds good cause exists for waiving the (Ethics in Government Act of 1978); E.O. product. The definition does not general notice of proposed rulemaking 12674, 54 FR 15159; 3 CFR, 1989 Comp., p. include participation in the activities of and opportunity for public comment as 215, as modified by E.O. 12731, 55 FR 42547; a nonprofit charitable, religious, to this interim rule. 3 CFR, 1990 Comp., p. 306; 5 CFR 2635.105, professional, social, fraternal, 2635.802, 2635.803, 2635.807. educational, recreational, public service, Notice and comment before the or civic organization, unless: effective date are being waived because § 9201.101 General. (1) The employee will receive this rule concerns matters of agency (a) Purpose. In accordance with 5 CFR compensation other than reimbursement organization, practice and procedure. 2635.105, the regulations in this part of expenses; However, written comments, which apply to employees of the Special (2) The organization’s activities are must be received by August 23, 2010, Inspector General for Iraq devoted substantially to matters relating can be submitted on this interim rule; Reconstruction (SIGIR) and supplement to the employee’s official duties as any such comments will be considered the Standards of Ethical Conduct for defined in 5 CFR 2635.807(a)(2)(i)(B) before this rule is adopted as final. Employees of the Executive Branch through (E) and the employee will serve Executive Orders 12866 and 12988 contained in 5 CFR part 2635. as officer or director of the organization; (b) Cross-references. In addition to 5 or Because this rule relates to SIGIR CFR part 2635 and this part, SIGIR (3) The activities will involve the personnel, it is exempt from the employees are required to comply with provision of consultative or professional provisions of Executive Orders Nos. implementing guidance and procedures services. Consultative services means 12866 and 12988. issued by SIGIR in accordance with 5 the provision of personal services by an

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employee, including the rendering of or manual issuances may exempt AMS, USDA; Telephone: (559) 487– advice or consultation, which requires categories of employment from the prior 5901; Fax: (559) 487–5906; or E-mail: advanced knowledge in a field of approval requirement of this section [email protected] or science or learning customarily acquired based on a determination that [email protected]. by a course of specialized instruction employment within those categories of Small businesses may obtain and study in an institution of higher employment would generally be information on complying with this and education, hospital or similar facility. approved and is not likely to involve other marketing order regulations by Professional services means the conduct prohibited by statute or Federal viewing a guide at the following Web provision of personal service by an regulation, including 5 CFR part 2635. site: http://www.ams.usda.gov/ employee, including the rendering of The DAEO or alternate DAEO may AMSv1.0/ams.fetchTemplate advice or consultation, which involves include in these instructions or Data.do?template=TemplateN&page= application of the skills of a profession issuances examples of outside MarketingOrdersSmallBusinessGuide; as defined in 5 CFR 2636.305(b)(1) or employment that are permissible or or by contacting Antoinette Carter, involves a fiduciary relationship as impermissible consistent with this part Marketing Order Administration defined in 5 CFR 2636.305(b)(2). and 5 CFR 2635. Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Note to § 9201.102(b): There is a special Stuart W. Bowen, Jr., approval requirement set out in both 18 Avenue, SW., STOP 0237, Washington, Special Inspector General for Iraq U.S.C. 203(d) and 205(e) respectively, for DC 20250–0237; Telephone: (202) 720– Reconstruction. certain representational activities otherwise 2491; Fax: (202) 720–8938; or E-mail: covered by the conflict of interest restrictions Approved: June 10, 2010. [email protected]. on compensation and activities of employees Robert I. Cusick, SUPPLEMENTARY INFORMATION: This rule in claims against and other matters affecting Director, Office of Government Ethics. is issued under Marketing Agreement the Government. Thus, an employee who [FR Doc. 2010–15103 Filed 6–23–10; 8:45 am] and Order No. 989, both as amended (7 wishes to act as agent or attorney for, or CFR part 989), regulating the handling otherwise represent his parents, spouse, BILLING CODE 3710–8N–P child, or any person for whom, or any estate of raisins produced from grapes grown for which, he is serving as guardian, in California, hereinafter referred to as executor, administrator, trustee, or other DEPARTMENT OF AGRICULTURE the ‘‘order.’’ The order is effective under personal fiduciary in such matters must the Agricultural Marketing Agreement obtain the approval required by law of the Agricultural Marketing Service Act of 1937, as amended (7 U.S.C. 601– Government official responsible for the 674), hereinafter referred to as the ‘‘Act.’’ employee’s appointment in addition to the 7 CFR Part 989 The Department of Agriculture regulatory approval required by this section. (USDA) is issuing this rule in (c) Procedure for requesting approval. [Doc. No. AMS–FV–09–0075; FV10–989–1 conformance with Executive Order (1) The approval required by paragraph FIR] 12866. (a) of this section shall be requested by The handling of California raisins is Raisins Produced From Grapes Grown regulated by 7 CFR part 989. The order e-mail or other form of written in California; Final Free and Reserve correspondence at least 30 calendar authorizes the establishment of volume Percentages for 2009–10 Crop Natural regulations, when warranted, for each days in advance of engaging in outside (Sun-Dried) Seedless Raisins employment as defined in paragraph (b) crop. Volume regulations: (1) Help the of this section. AGENCY: Agricultural Marketing Service, industry address its marketing problems (2) The request for approval to engage USDA. by keeping supplies in balance with demand; (2) strengthen market in outside employment or certain other ACTION: Affirmation of interim rule as conditions; (3) fully supply both the activities shall set forth, at a minimum: final rule. (i) The name of the employer or domestic and export markets without organization; SUMMARY: The Department of overburdening them; and (4) provide for (ii) The nature of the legal activity or Agriculture (USDA) is adopting, as a market expansion. other work to be performed; final rule, without change, an interim Volume regulation is warranted for (iii) The title of the position; and rule that established final volume the 2009–10 crop of NS raisins because (iv) The estimated duration of the regulation percentages of 85 percent free the crop estimate (supply) exceeded the outside employment. and 15 percent reserve for the 2009–10 trade demand (demand). In an interim (3) Upon a significant change in the crop of Natural (sun-dried) Seedless rule published in the Federal Register nature or scope of the outside (NS) raisins covered under the Federal on April 22, 2010, and effective on April employment or in the employee’s marketing order for California raisins 23, 2010 (75 FR 20897; Doc No. AMS– official position within the SIGIR, the (order). The percentages are intended to FV–09–0075, FV10–989–1 IFR), employee must, within 7 calendar days help stabilize raisin supplies and prices, § 989.257 was amended by of the change, submit a revised request and strengthen market conditions. incorporating the 2009–10 crop year for approval. final free and reserve percentages. This (d) Standard for approval. Approval DATES: Effective June 25, 2010. The rule continues in effect the rule that shall be granted only upon a volume regulation percentages apply to established a final free percentage of 85 determination that the outside acquisitions of NS raisins from the percent, and a final reserve percentage employment is not expected to involve 2009–10 crop until the reserve raisins of 15 percent, of NS raisins acquired by conduct prohibited by statute or Federal from that crop are disposed of under the handlers during the crop year, which regulation, including 5 CFR part 2635. marketing order. began August 1, 2009, and ends July 31, (e) DAEO’s and alternate DAEO’s FOR FURTHER INFORMATION CONTACT: 2010. responsibilities. The SIGIR DAEO or Terry Vawter, Senior Marketing alternate DAEO may issue instructions Specialist, or Kurt J. Kimmel, Regional Final Regulatory Flexibility Analysis or manual issuances governing the Manager, California Marketing Field Pursuant to requirements set forth in submission of requests for approval for Office, Marketing Order Administration the Regulatory Flexibility Act (RFA) (5 outside employment. The instructions Branch, Fruit and Vegetable Programs, U.S.C. 601–612), the Agricultural

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Marketing Service (AMS) has crop year for NS raisins. The volume California’s grapes are classified into considered the economic impact of this regulation percentages are 85 percent three groups—table grapes, wine grapes, action on small entities. Accordingly, free and 15 percent reserve. Free and raisin-variety grapes. Raisin-variety AMS has prepared this final regulatory tonnage raisins may be sold by handlers grapes are the most versatile of the three flexibility analysis. to any market. Reserve raisins must be types. They can be marketed as fresh The purpose of the RFA is to fit held in a pool for the account of the grapes, crushed for juice in the regulatory actions to the scale of committee and are disposed of through production of wine or juice concentrate, business subject to such actions in order certain programs authorized under the or dried into raisins. Annual that small businesses will not be unduly order. Volume regulation is warranted fluctuations in the fresh grape, wine, or disproportionately burdened. this season because the crop estimate of and concentrate markets, as well as Marketing orders issued pursuant to the 275,000 tons is significantly higher than weather-related factors, cause Act, and rules issued thereunder, are the 234,769 ton trade demand. fluctuations in raisin supply. This type unique in that they are brought about The volume regulation procedures of situation introduces a certain amount through group action of essentially have helped the industry address its of variability into the raisin market. small entities acting on their own marketing problems by keeping supplies These fluctuations can result in behalf. Thus, both statutes have small in balance with domestic and export producer price instability and entity orientation and compatibility. market needs, and strengthening market disorderly market conditions. There are approximately 26 handlers conditions. The volume regulation Volume regulation is helpful to the of California raisins who are subject to procedures fully supply the domestic raisin industry because it lessens the regulation under the order and and export markets, provide for market impact of such fluctuations and approximately 3,000 raisin producers in expansion, and help reduce the burden contributes to orderly marketing. For the regulated area. Small agricultural of oversupplies in the domestic market. example, producer prices for NS raisins service firms are defined by the Small remained fairly steady between the Business Administration (SBA) (13 CFR Raisin grapes are a perennial crop, so 121.201) as those having annual receipts production in any year is dependent 1993–94 and 1997–98 crop years, of less than $7,000,000, and small upon plantings made in earlier years. although production varied. As shown agricultural producers as those having The sun-drying method of producing in the table below, during those years, annual receipts of less than $750,000. raisins involves considerable risk production varied from a low of 272,063 Approximately 18 handlers and a because of variable weather patterns. tons in 1996–97 to a high of 387,007 majority of producers of California Even though the product and the tons in 1993–94. raisins may be classified as small industry are viewed as mature, the According to committee data, the total entities. industry has experienced considerable producer return per ton during those Since 1949, the California raisin change over the last several decades. years, which includes proceeds from industry has operated under a Federal Before the 1975–76 crop year, more than both free tonnage plus reserve pool marketing order. The order contains 50 percent of the raisins were packed raisins, has varied from a low of $904.60 authority to limit the portion of a given and sold directly to consumers. Now, in 1993–94 to a high of $1,049.20 in year’s crop that can be marketed freely about 63 percent of the raisins are sold 1996–97. Producer prices for the 1998– in any outlet by raisin handlers. This in bulk. This means that raisins are now 99 and 1999–2000 crop years increased volume regulation mechanism is used to sold to consumers mostly as an significantly due to back-to-back short stabilize supplies and prices, and to ingredient in another product such as crops during those years. Record large strengthen market conditions. If the cereal and baked goods. In addition, for crops followed, and producer prices primary market (the normal domestic a few years in the early 1970s, over 50 dropped dramatically for the 2000–01 market) is over-supplied with raisins, percent of the raisin grapes were sold through 2003–04 crop years, as grower prices decline substantially. fresh to the wine market for crushing. inventories grew while demand Pursuant to § 989.54(d) of the order, Since then, the percent of raisin-variety stagnated. However, as noted below, this rule establishes final volume grapes sold to the wine industry has producer prices were higher for the regulation percentages for the 2009–10 decreased. 2004–05 through 2008–09 crop years:

NATURAL SEEDLESS (NATURAL CONDITION) DELIVERIES, FIELD PRICES AND PRODUCER PRICES

Crop year Deliveries (tons) Field prices Producer prices (per ton)1 (per ton)

2008–09 ...... 364,268 $1,310.00 2 $1,139.70 2007–08 ...... 329,288 1,210.00 2 1,028.50 2006–07 ...... 282,999 1,210.00 1 1,089.00 2005–06 ...... 319,126 1,210.00 1 998.25 2004–05 ...... 265,262 1,210.00 3 1,210.00 2003–04 ...... 296,864 810.00 567.00 2002–03 ...... 388,010 745.00 491.20 2001–02 ...... 377,328 880.00 650.94 2000–01 ...... 432,616 877.50 603.36 1999–2000 ...... 299,910 1,425.00 1,211.25 1998–99 ...... 240,469 1,290.00 3 1,290.00 1997–98 ...... 382,448 1,250.00 946.52 1996–97 ...... 272,063 1,220.00 1,049.20 1995–96 ...... 325,911 1,160.00 1,007.19 1994–95 ...... 378,427 1,160.00 928.27 1993–94 ...... 387,007 1,155.00 904.60 1 Field prices for NS raisins are established by the Raisin Bargaining Association, and are also referred to in the industry as the ‘‘free tonnage price’’ for raisins.

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2 Return-to-date, reserve pool still open. 3 No volume regulation.

There are essentially two broad deliveries increased in 2005–06 crop large enough margin that the committee markets for raisins—domestic and year to 319,126 tons, this may have been believes volume regulation is necessary export. Domestic shipments generally because fewer growers opted to contract to maintain market stability. increased over the years. Although with wineries, as raisin variety grapes Accordingly, in assessing whether to domestic shipments decreased from a crushed in 2005–06 crop year decreased apply volume regulation or, as an high of 204,805 packed tons during the by 161,000 green tons, the equivalent of alternative, not to apply such regulation, 1990–91 crop year to a low of 156,325 over 40,000 tons of raisins. In the 2006– the committee determined that volume packed tons in 1999–2000, they 07 crop year, raisin deliveries were regulation was warranted for the 2009– increased from 174,117 packed tons again less than 300,000 tons at 282,999 10 crop for only one of the nine raisin during the 2000–01 crop year to 193,609 tons and increased to 329,288 tons in varietal types defined under the order. packed tons during the 2007–08 crop 2007–08 crop year. The 2008–09 crop The free and reserve percentages year and decreased to 191,929 packed year was considered to be a good crop established in the interim rule release tons during the 2008–09 crop year. and the quality of the crop has a direct the full trade demand and apply Export shipments ranged from a high of bearing on the overall production with uniformly to all handlers in the 107,931 packed tons in the 1991–92 364,268 tons of NS raisins delivered. industry, regardless of size. For NS crop year to a low of 91,599 packed tons The order permits the industry to raisins, with the exception of the 1998– in the 1999–2000 crop year. Since that exercise volume regulation provisions, 99 and 2004–05 crop years, small and time, export shipments increased to which allow for the establishment of large raisin producers and handlers 106,755 tons of raisins during the 2004– free and reserve percentages, and have been operating under volume 05 crop year, fell to 101,684 tons in the establishment of a reserve pool. One of regulation percentages every year since 2006–07 crop year, and again increased the primary purposes of establishing the 1983–84 crop year. There are no to 142,541 tons in the 2007–08 crop free and reserve percentages is to known additional costs incurred by year. This significant increase was due balance supply and demand. If raisin small handlers that are not incurred by to a short crop in Turkey. Export markets are over-supplied with product, large handlers. While the level of shipments remained relatively high in producer prices will decline. benefits of this rulemaking are difficult 2008–09 at 125,789 tons. Raisins are generally marketed at to quantify, the stabilizing effects of the The per capita consumption of raisins relatively lower price levels in the more volume regulations impact small and has declined from 2.07 pounds in 1988 elastic export market than in the more large handlers positively by helping to 1.46 pounds in 2007. This decrease inelastic domestic market. This results them maintain and expand markets is consistent with the decrease in the in a larger volume of raisins being even though raisin supplies fluctuate per capita consumption of dried fruits marketed and enhances producer widely from season to season. Likewise, in general, which may be due to the returns. In addition, this system allows price stability positively impacts small increasing year-round availability of the U.S. raisin industry to be more and large producers by allowing them to most types of fresh fruit. competitive in export markets. better anticipate the revenues their While the overall demand for raisins The reserve percentage limits raisins will generate. has increased in four of the last five provides for raisins that handlers can This rule continues in effect the years (as reflected in increased market as free tonnage. Based on the action that established final volume commercial shipments), production has 2009–10 crop year estimate of 275,000 regulation percentages for the 2009–10 been decreasing. Deliveries of NS dried tons, the 15 percent reserve would limit crop year for NS raisins at 85 percent raisins from producers to handlers the total free tonnage to 233,750 natural free and 15 percent reserve. The volume reached an all-time high of 432,616 tons condition tons (0.85 x the 275,000 ton regulation percentages are intended to in the 2000–01 crop year. This large crop). Adding the estimated figure of help stabilize raisin supplies and prices, crop was preceded by two short crop 41,250 tons of raisins offered to meet the needs of the domestic and years; deliveries were 240,469 tons in handlers through the 10 + 10 program export markets, strengthen market the 1998–99 crop year and 299,910 tons to the 233,750 tons of free tonnage, plus conditions, and expand marketing in the 1999–2000 crop year. Deliveries 126,824 tons of carry-in inventory, plus opportunities. for the 2000–01 crop year soared to a 12,137 tons of 2008–09 NS reserve pool This rule will not impose any record level because of increased raisins released during the 2009–10 crop additional reporting or recordkeeping bearing acreage and yields. Deliveries year, results in a total supply of 413,961 requirements on either small or large for the 2001–02 crop year were at tons of natural condition raisins. raisin handlers. As with all Federal 377,328 tons, 388,010 tons for the 2002– With volume regulation, producer marketing order programs, reports and 03 crop year, 296,864 tons for the 2003– prices are expected to be higher than forms are periodically reviewed to 04 crop year, and 265,262 tons for the without volume regulation. This price reduce information requirements and 2004–05 crop year. increase is beneficial to all producers duplication by industry and public After three crop years of high regardless of size, and enhances sector agencies. In addition, USDA has production and a large 2001–02 carry-in producers’ total revenues in comparison not identified any relevant Federal rules inventory, the industry diverted raisin to no volume regulation. Establishing a that duplicate, overlap, or conflict with production to other uses or removed reserve allows the industry to help this rule. bearing vines. Diversions/removals stabilize supplies in both domestic and Further, the committee meeting on totaled 38,000 acres in 2001; 27,000 export markets, while improving returns October 6, 2009, at which this acres in 2002; and 8,000 acres of vines to producers. recommendation was made, was widely in 2003. These actions resulted in Free and reserve percentages are publicized throughout the raisin declining deliveries of 296,864 tons for established by varietal type; and are industry, and all interested persons the 2003–04 crop year and 265,262 tons generally established in years when the were invited to attend the meeting and for the 2004–05 crop year. Although supply exceeds the trade demand by a encouraged to participate in the

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committee’s deliberations. Like all Farm and Rural Development Act direct economic costs associated with committee meetings, the meeting was a (CONACT) (7 U.S.C. 1926(a)(2)). The complying with RUS regulations and public meeting; and all entities, both amendment added the new SEARCH requirements. large and small, were able to express grant program under which the Information Collection and their views on this issue. Secretary is authorized to make Recordkeeping Requirements Comments on the interim rule were predevelopment planning grants for required to be received by May 24, 2010. feasibility studies, design assistance, The information collection and One comment supporting the rule was and technical assistance to financially recordkeeping requirements contained received. Therefore, for the reasons distressed communities in rural areas in this final rule are pending approval given in the interim rule, we are with populations of 2,500 or fewer by OMB pursuant to the Paperwork adopting the interim rule as a final rule, inhabitants for water and waste disposal Reduction Act 1995 (44 U.S.C. Chapter without change. projects. 35) under control number 0572—New. To view the interim rule, go to: DATES: This rule is effective June 24, The paperwork contained in this rule http://www.regulations.gov/search/ 2010. will not be effective until approved by Regs/home.html#documentDetail?R= OMB. FOR FURTHER INFORMATION CONTACT: 0900006480add0ad. E-Government Act Compliance This action also affirms information Anita O’Brien, Loan Specialist, Water contained in the interim rule concerning and Environmental Programs, U.S. The Rural Utilities Service is Executive Orders 12866 and 12988, the Department of Agriculture, Rural committed to the E-Government Act, Paperwork Reduction Act (44 U.S.C. Utilities Service, Room 2230 South which requires Government agencies in Chapter 35), and the E–Gov Act (44 Building, Stop 1570, 1400 general to provide the public the option U.S.C. 101). Independence Ave., SW., Washington, of submitting information or transacting After consideration of all relevant DC 20250–1570. Telephone: (202) 690– business electronically to the maximum material presented, it is found that 3789, FAX: (202) 690–0649, E-mail: extent possible. [email protected]. finalizing the interim rule without National Environmental Policy Act change, as published in the Federal SUPPLEMENTARY INFORMATION: Certification Register (75 FR 20897, April 22, 2010), will tend to effectuate the declared Classification The Administrator of RUS has policy of the Act. Executive Order 12866 determined that this final rule will not significantly affect the quality of the List of Subjects in 7 CFR Part 989 This final rule has been determined to human environment as defined by the Grapes, Marketing agreements, be not significant for purposes of National Environmental Policy Act of Raisins, Reporting and recordkeeping Executive Order 12866 and, therefore, 1969 (42 U.S.C. 4321 et seq.). Therefore, requirements. has not been reviewed by the Office of this action does not require an Management and Budget (OMB). environmental impact statement or PART 989—[AMENDED] Executive Order 12988 assessment. ■ Accordingly, the interim rule that This final rule has been reviewed in Catalog of Federal Domestic Assistance amended 7 CFR part 989 and that was accordance with Executive Order 12988, The program described by this final published at 75 FR 20897 on April 22, Civil Justice Reform. RUS has rule is listed in the Catalog of Federal 2010, is adopted as a final rule, without determined that this final rule meets the Domestic Assistance Programs under change. applicable standards provided in number 10.759—Special Evaluation Dated: June 18, 2010. section 3 of the Executive Order. In Assistance for Rural Communities and Robert C. Keeney, addition, all State and local laws and Households Program (SEARCH). This regulations that are in conflict with this Acting Administrator, Agricultural Marketing catalog is available on a subscription Service. rule will be pre-empted; no retroactive basis from the Superintendent of effect will be given to the rule; and in [FR Doc. 2010–15298 Filed 6–23–10; 8:45 am] Documents, the United States accordance with sec. 212(e) of the BILLING CODE 3410–02–P Government Printing Office, Department of Agriculture Washington, DC, 20402–9325, telephone Reorganization Act of 1994 (7 U.S.C. number (202) 512–1800 and at https:// DEPARTMENT OF AGRICULTURE sec. 6912(e)), appeal procedures must be www.cfda.gov. exhausted before an action against the Executive Order 12372 Rural Utilities Service Department or its agencies may be initiated. This program is not subject to the requirements of Executive Order 12372, 7 CFR Part 1774 Regulatory Flexibility Act Certification ‘‘Intergovernmental Review of Federal RIN 0572–AC14 RUS has determined that this final Programs,’’ as implemented under rule will not have a significant Special Evaluation Assistance for USDA’s regulations at 7 CFR part 3015. economic impact on a substantial Rural Communities and Households number of small entities, as defined in Unfunded Mandates Program the Regulatory Flexibility Act (5 U.S.C. This final rule contains no Federal ACTION: Final rule. 601 et seq.). The RUS Water and mandates (under the regulatory Environmental Programs provide loans provision of title II of the Unfunded SUMMARY: The Rural Utilities Service to borrowers at interest rates and terms Mandates Reform Act of 1995) for State, (RUS) is issuing a regulation to establish that are more favorable than those local, and Tribal governments or the the Special Evaluation Assistance for generally available from the private private sector. Therefore, this final rule Rural Communities and Households sector. RUS borrowers, as a result of is not subject to the requirements of (SEARCH) Program as authorized by obtaining Federal financing, receive section 202 and 205 of the Unfunded Section 306(a)(2) of the Consolidated economic benefits that exceed any Mandates Reform Act.

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Executive Order 13132, Federalism cost of the grant may be funded and may services; reporting the status of The policies contained in this final not exceed $30,000. The grant recipients applicable Federal property rule do not have any substantial direct shall use the grant funds for feasibility management specifications on the RUS effect on States, on the relationship studies, design assistance, and Web site; adding available water between the national government and development of an application for management references to the RUS Web the States, or on the distribution of financial assistance to financially site as a component of the design and power and responsibilities among the distressed communities in rural areas technical assistance object; and various levels of government. Nor does with populations of 2,500 or fewer expounding upon the definition of rural. this final rule impose substantial direct inhabitants for water and waste disposal Response: The Agency will take under compliance costs on State and local projects as authorized in Sections advisement the suggestion to provide governments. Therefore, consultation 306(a)(1), 306(a)(2) and 306(a)(24) of the additional information on RUS Web with States is not required. Consolidated Farm and Rural site. For the purpose of water and waste Development Act (CONACT) (7 U.S.C. disposal grants and direct and Executive Order 13175, Consultation 1926(a)(1), (a)(2) and (a)(24). guaranteed loans, the terms ‘‘rural’’ and and Coordination With Indian Tribal Eligible entities for the SEARCH ‘‘rural area’’ mean a city, town, or Governments grants will be the same entities eligible unicorporated area that has a population USDA will undertake, within 6 to obtain a loan, grant, or loan guarantee of no more than 10,000 inhabitants (7 months after this rule becomes effective, from the Rural Utilities Service Water U.S.C. 1991(a)(13). The SEARCH grant a series of regulation Tribal consultation and Waste Disposal and Wastewater amendment (7 U.S.C. (a)(2)(c)) restricts sessions to gain input by Tribal officials loan and grant programs. However, as eligibility, for the purposes of SEARCH, concerning the impact of this rule on applied to the SEARCH program, rural to communities of 2,500 or less within Tribal governments, communities, and area is specified as one with a such rural areas. individuals. These sessions will population of 2,500 or less. The Agency Issue 4: Commentor suggested the establish a baseline of consultation for will define financially distressed areas collection burden can be minimized by future actions, should any become as those where the median household adding two rural support offices directly necessary, regarding this rule. Reports income of the areas to be served is either to the Web pages. from these sessions for consultation will below the poverty line or below 80 Response: The Agency believes that be made part of the USDA annual percent of the statewide non- there is minimal burden with the reporting on Tribal Consultation and metropolitan median household current Web site in obtaining States’ Collaboration. USDA will respond in a income. local office information. The Secretary may use not more than timely and meaningful manner to all List of Subjects four percent of the total amount of funds Tribal government requests for made available for a fiscal year for water Community development, Grant consultation concerning this rule and and waste disposal to carry out the programs, Reporting and recordkeeping will provide additional venues, such as SEARCH program. requirements, Rural areas, Waste webinars and teleconferences, to The Administrator of the RUS is treatment and disposal, Water supply. periodically host collaborative required to prescribe regulations to ■ conversations with Tribal leaders and Therefore for the reasons discussed in implement the provisions of the their representatives concerning ways to the preamble, RUS amends chapter XVII SEARCH grant program and does so improve this rule in Indian country. of title 7 of the Code of Federal through this final rule. In developing Regulations by adding a new part 1774 Background the SEARCH program regulation, the to read as follows: On January 22, 2010, RUS published Agency relied heavily on existing Rural PART 1774—SPECIAL EVALUATION a proposed rule in the Federal Register Development regulations relative to ASSISTANCE FOR RURAL (75 FR 3642) to establish the Special water and waste disposal loans and COMMUNITIES AND HOUSEHOLDS Evaluation Assistance for Rural grants. PROGRAM (SEARCH) Communities and Households Comments (SEARCH) Program as authorized by RUS published a proposed Subpart A—General Provisions Section 306(a)(2) of the Consolidated rulemaking in the Federal Register on 1774.1 General. Farm and Rural Development Act January 22, 2010 at 75 FR 3642. No 1774.2 Definitions. (CONACT) (7 U.S.C. 1926(a)(2)). The comments were received from outside 1774.3 Availability of forms and amendment added a grant program to Federal agencies, however, one public regulations. 1774.4 Allocation of funds. make Special Evaluation Assistance for submission was received with regard to Rural Communities and Households 1774.5–1774.6 [Reserved] the information collection and 1774.6 Equal opportunity requirements. (SEARCH) Program grants. SEARCH recordkeeping requirements contained grants are intended to assist financially 1774.7 Environmental requirements. in the rule. The commentor’s responses 1774.8 Other Federal Statutes. distressed, eligible communities to pay are summarized below with the 1774.9 [Reserved] for feasibility studies, design assistance Agency’s response as follows: Subpart B—Grant Application Processing and technical assistance associated with Issue 1: Commentor agreed that the water and waste disposal infrastructure collection is necessary for performance 1774.10 Applications. needs. and practical utility. 1774.11 [Reserved] Under the SEARCH program, the Response: Agency concurs. 1774.12 Eligibility. Secretary may make predevelopment Issue 2: Commentor agreed that the 1774.13 Limitations. and planning grants to public or quasi- 1774.14 Eligible grant purposes. burden estimate is accurate. 1774.15 Selection criteria. public agencies, organizations operated Response: Agency concurs. 1774.16 Grant application processing and on a not-for-profit basis or Indian Tribes Issue 3: Commentor suggested that the approval. on Federal and State reservations and information quality, utility and clarity 1774.17 Grant closing and disbursement. other Federally recognized Indian could be enhanced by allowing extra 1774.18 Reporting requirements, Tribes. Up to 100 percent of the eligible application credit for professional accounting methods and audits.

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1774.19 Applications determined ineligible. median household income of the area to this part. These include but are not 1774.20 Conflict of Interest. be served is either below the poverty limited to: 1774.21–1774.23 [Reserved] line or below 80 percent of the (a) 7 CFR part 1, subpart A—USDA 1774.24 Exception Authority. statewide non-metropolitan median implementation of Freedom of 1774.25–1774.99 [Reserved] 1774.100 OMB Control Number. household income based on available Information Act. historic statistical information from the (b) 7 CFR part 3—USDA Authority: 7 U.S.C. 1926(a)(2)(C). latest decennial census. implementation of OMB Circular No. A– Subpart A—General Provisions Grantee. The applicant receiving 129 regarding debt collection. financial assistance directly from the (c) 7 CFR part 15, subpart A—USDA § 1774.1 General. RUS to carry out the project or program implementation of Title VI of the Civil The purpose of the Special Evaluation under this program. Rights Act of 1964, as amended. Assistance for Rural Communities and Poverty line. The level of income for (d) 7 CFR part 1794, RUS Household (SEARCH) Grant program is a family of four, as defined in section Implementation of the National to provide financial assistance to the 673(2) of the Community Services Block Environmental Policy Act. neediest, eligible communities, who Grant Act (42 U.S.C. 9902(2)). (e) 7 CFR part 1901, subpart E—Civil lack financial resources to pay for Processing Official. The Agency Rights Compliance Requirements. feasibility studies, design assistance and official designated by the approval (f) 7 CFR part 3015—Uniform Federal technical assistance. This subpart sets official as having the authority to accept Assistance Regulations. forth the general policies and and process applications for water and (g) 7 CFR part 3016—USDA procedures for making and processing waste disposal assistance. Implementation of OMB Circular Nos. predevelopment planning SEARCH Rural area. For the purposes of this A–102 and A–97, Uniform grants for water and waste projects. SEARCH program, any area not in a city Administrative Requirements for Grants or town with a population of 2,500 or and Cooperative Agreements to State § 1774.2 Definitions. fewer, according to the latest decennial and Local Governments. The following definitions apply to census of the United States. (h) 7 CFR part 3018—Restrictions on subparts A and B of this part. State. Any of the 50 States, the Lobbying, prohibiting the use of Agency. The Rural Utilities Service of District of Columbia, the appropriated funds to influence the United States Department of Commonwealth of Puerto Rico, the Congress or a Federal agency in Agriculture (USDA) within the Rural Territory of Guam, the Commonwealth connection with the making of any Development mission area of the Under of the Northern Mariana Islands, the Federal grant and other Federal Secretary for Rural Development. The Republic of the Marshall Islands, the contracting and financial transactions. Processing Official will administer this Federated States of Micronesia, the (i) 7 CFR part 3019—USDA water and waste program on behalf of Republic of Palau, and the U.S. Virgin implementation of OMB Circular A– the Rural Utilities Service. Islands. 110, Uniform Administrative Approval official. The Agency official Requirements for Grants and at the State level who has been Technical Assistance. Supervision, oversight, or training by an organization Agreements With Institutions of Higher delegated the authority to approve Education, Hospitals, and Other grants. for the development of an application for financial assistance. Nonprofit Organizations. ConAct. Consolidated Farm and Rural (j) 7 CFR part 3021, as amended— Development Act (7 U.S.C. 1926(a)(2)). § 1774.3 Availability of forms and Government-wide Debarment and Design assistance. Preliminary design regulations. Suspension (Non-procurement); and engineering analysis necessary for Information about the forms, Government-wide Requirements for an application for funding. Design instructions, regulations, bulletins, Drug-Free Workplace (Grants), assistance does not include financial OMB Circulars, Treasury Circulars, implementing Executive Order 12549 on assistance for development of plans, standards, documents and publications debarment and suspension and the specifications, or bidding documents. DUNS Number. Data Universal cited in this part is available from any Drug-Free Workplace Act of 1988 (41 Numbering System number obtained UDSA/Rural Development Office or the U.S.C. 701). from Dun and Bradstreet and used when United States Department of (k) 7 CFR part 3052—USDA applying for Federal grants or Agriculture, Washington, DC 20250– implementation of OMB Circular No. A– cooperative agreements. A DUNS 1500 and at http://www.grants.gov. 133 regarding audits of institutions of higher education and other nonprofit number may be obtained at no cost, by § 1774.4 Allocation of funds. calling 1–866–705–5711. institutions. The Secretary may use not more than Eligible entity. Entity that meets (l) 29 U.S.C. 794, section 504— four percent of the total amount of funds eligibility requirements to obtain a loan, Rehabilitation Act of 1973, and 7 CFR made available for a fiscal year for water loan guarantee or grant under part 15B (USDA implementation of and waste disposal activities for Paragraphs 1, 2 or 24 of Section 306(a) statute), prohibiting discrimination SEARCH grants. of the ConAct (codified at 7 U.S.C. based upon physical or mental handicap in Federally assisted programs. Section 1926(a)(1)(2) and (24)). §§ 1774.5–1774.6 [Reserved] Feasibility study. Documentation § 1774.9 [Reserved] associated with an objective analysis of § 1774.7 Environmental requirements. project-related technical engineering or The policies and regulations Subpart B—Grant Application environmental impact analyses required contained in 7 CFR part 1794 of this Processing to support applications for funding title apply to grants made in accordance water or waste disposal projects through with this part. § 1774.10 Applications. USDA, Rural Utilities Service or other (a) To file an application, an agencies. § 1774.8 Other Federal Statutes. organization must provide their DUNS Financially distressed area. An area is Other Federal statutes and regulations number. An organization may obtain a considered financially distressed if the are applicable to grants awarded under DUNS number from Dun and Bradstreet

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by calling (1–866–705–5711). To file a § 1774.11 [Reserved] assistance as each is defined in § 1774.2. complete application, the following The eligible predevelopment activities § 1774.12 Eligibility. information should be submitted: funded with these grant funds must be (1) Standard Form 424, ‘‘Application The following eligibility requirements agreed to and accepted by the Agency for Federal Assistance (For Non- must be met: prior to the disbursement of the Construction).’’ (a) The applicant must be: SEARCH grant. The predevelopment (2) Standard Form 424A & B, ‘‘Budget (1) A public body, such as a planning costs must be related to a Information—Non-Construction municipality, county, district, authority, proposed project that meets the Programs.’’ or other political subdivision or a State, following requirements: (3) Supporting documentation territory or commonwealth, or (1) To construct, enlarge, extend, or necessary to make an eligibility (2) An organization operated on a not- otherwise improve rural water, sanitary determination such as financial for-profit basis, such as an association, sewage, solid waste disposal, and storm statements, audits, organizational cooperative, or private corporation. The wastewater disposal facilities. documents, or existing debt organization must be an association (2) To construct or relocate public instruments. The Processing Official controlled by a local public body or buildings, roads, bridges, fences, or will advise applicants regarding the bodies, or have a broadly based utilities, and to make other public required documents. Applicants that are ownership by or membership of people improvements necessary for the indebted to RUS will not need to submit of the local community, or successful operation or protection of documents already on file with the (3) Indian Tribes on Federal and State facilities authorized in paragraph (a)(1) Processing Official as long as such reservations and other Federally of this section. documents are current and valid. recognized Indian Tribes. (3) To relocate private buildings, (4) Project narrative detailing the (b) The area to be served must be roads, bridges, fences, or utilities, and project to be financed with the SEARCH financially distressed and rural as other private improvements necessary grant funds. The narrative will also defined in § 1774.2 of this part. for the successful operation or provide details on the activities or tasks protection of facilities authorized in § 1774.13 Limitations. to be accomplished, objectives, paragraph (a)(1) of this section. timetables for task completion, and Grant funds may not be used to: (b) The Secretary, subject to the anticipated results. (a) Fund political or lobbying limitation in § 1774.4 of this part, may (5) The applicant’s Internal Revenue activities. fund up to 100 percent of the eligible Service Taxpayer Identification Number (b) Pay for work already completed. grant costs, not to exceed $30,000. (c) Purchase real estate or vehicles, (TIN). § 1774.15 Selection Criteria. (6) Other Forms and certifications. improve or renovate office space, or Projects will be selected based Applicants will be required to submit repair and maintain privately owned primarily on the funding priorities in 7 the following items to the Processing property. CFR 1780.17. The Program Official Official, upon notification from the (d) Construct or furnish a building. discretionary points stated in 7 Processing Official to proceed with (e) Intervene in the Federal regulatory or adjudicatory proceedings. CFR1780.17 (e) can also include further development of the full consideration of the following criteria: application: (f) Sue the Federal Government or any other government entities. (a) Systems with limited resources. (i) Form RD 442–7, ‘‘Operating (b) Smallest systems with lowest (g) Pay for any other costs that are not Budget’’; incomes. (ii) Form RD 400–1, ‘‘Equal allowable under OMB Circular A–87, (c) Funds availability. Opportunity Agreement’’; OMB Circular A–110, OMB Circular A– (iii) Form RD 400–4, ‘‘Assurance 102 or OMB Circular A–122. § 1774.16 Grant application processing Agreement’’; (h) Make contributions or donations and approval. (iv) Form AD–1047, ‘‘Certification to others. (a) Before starting to assemble the full Regarding Debarment, Suspension and (i) Fund projects that duplicate application, the applicant should other Responsibility Matters’’; technical assistance given to implement arrange through the Processing Official (v) Form AD–1049, Certification action plans under the National Forest- an application conference to provide a regarding Drug-Free Workplace Dependent Rural Communities basis for orderly application assembly. Requirements (Grants) Alternative I For Economic Diversification Act of 1990 (7 The processing office will explain Grantees Other Than Individuals; U.S.C. 6613). Applicants cannot receive program requirements, public (vi) Certifications for Contracts, both grants made under this part and information requirements and provide Grants, and Loans (Regarding Lobbying); grants that the Forest Service makes to guidance on preparation of items and implement the action plans for five necessary for final determination. (vii) Certification regarding prohibited continuous years from the date of grant (b) The Processing Official will tying arrangements. Applicants that approval by the Forest Service. determine if the application is properly provide electric service must provide (j) To pay an outstanding judgment assembled. If not, the applicant will be the Agency a certification that they will obtained by the United States in a notified within fifteen Federal working not require users of a water or waste Federal Court (other than in the United days as to what additional submittal facility financed under this part to States Tax Court), which has been items are needed. accept electric service as a condition of recorded. An applicant will be ineligible (c) The Processing Official and receiving assistance. to receive a loan or grant until the Approval Official will coordinate their (b) Applicants are encouraged to judgment is paid in full or otherwise reviews to ensure that the applicant is contact the State Office or the satisfied. advised about eligibility and anticipated Processing Official to find out how to fund availability within 45 days of the file electronically. The application and § 1774.14 Eligible grant purposes. receipt of a completed application. supporting documentation must be sent (a) Eligible predevelopment planning (d) The Processing Official will or delivered to the Processing Official, costs are feasibility studies, preliminary submit the following to the Approval unless it is filed electronically. design assistance, and technical Official:

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(1) ‘‘Water and Waste Project § 1774.19 Applications determined FARM CREDIT ADMINISTRATION Information Summary’’; ineligible. 12 CFR Parts 604, 607, 612, 614, 615, (2) Form RD 442–3, ‘‘Balance Sheet’’ If at any time an application is 618, and 627 or a financial statement or audit that determined ineligible, the processing includes a balance sheet; office will notify the applicant in (3) Letter of Conditions; writing of the reasons. The notification RIN 3052–AC63 ‘‘ (4) Form RD 1942–46, Letter of Intent to the applicant will state that an appeal Farm Credit Administration Board ’’ to Meet Conditions ; of this decision may be made by the Meetings; Assessment and (5) Form RD 1940–1, ‘‘Request for applicant under 7 CFR part 11. Apportionment of Administrative Obligation of Funds’’; § 1774.20 Conflict of Interest. Expenses; Standards of Conduct and § 1774.17 Grant closing and disbursement. Referral of Known or Suspected Any processing or servicing activity Criminal Violations; Loan Policies and (a) Grant closing. RUS Bulletin 1780– conducted pursuant to this part Operations; Funding and Fiscal 12 ‘‘Water or Waste System Grant involving authorized assistance to Rural Affairs, Loan Policies and Operations, Agreement’’ will be completed and Development employees with Water and and Funding Operations; General executed in accordance with the Environmental Programs responsibility, Provisions; and Title IV Conservators, requirements of grant approval. The members of their families, known close Receivers, and Voluntary Liquidations; grant will be considered closed when relatives, or business or close personal Technical Changes RUS Bulletin 1780–12 has been associates, is subject to the provisions of properly executed. Processing officials AGENCY: subpart D of part 1900 of this title. Farm Credit Administration. or Approval officials are authorized to ACTION: Direct final rule. sign the grant agreement on behalf of Applicants of this assistance are RUS. required to identify any known relationship or association with an RUS SUMMARY: The Farm Credit (b) Grant disbursements. Agency employee. Administration (FCA or Agency) policy is not to disburse grant funds amends the current regulations in parts from the Treasury until they are actually §§ 1774.21–1774.23 [Reserved] 604, 607, 612, 614, 615, 618, and 627 to needed by the applicant. If an approved eliminate unnecessary, redundant or grant includes applicant or other § 1774.24 Exception authority. outdated regulations, to correct cross- contributions, then these funds will be The Administrator may, in individual reference errors, and to clarify the intent disbursed before the disbursal of any cases, make an exception to any of a regulatory provision. This direct Agency grant funds. requirement or provision of this part final rule covers issues that are (c) Payment for project costs. Project which is not inconsistent with the technical in nature. costs will be monitored by the RUS authorizing statute or other applicable DATES: If no significant adverse processing office. Invoices will be law and is determined to be in the comment is received on or before July approved by the borrower and Government’s interest. Requests for 26, 2010, these regulations shall be submitted to the Processing Official for exceptions must be made in writing by effective upon the expiration of 30 days concurrence. The review and after publication in the Federal Register acceptance of project costs by the the State Director and supported with documentation to explain the adverse during which either or both Houses of Agency does not attest to the correctness Congress are in session. We will publish of the amounts, the quantities shown or effect on the Government’s interest, propose alternative course(s) of action, notice of the effective date in the that the work has been performed under Federal Register. If we receive the terms of the agreements or contracts. and show how the adverse affect will be eliminated or minimized if the significant adverse comment on an (d) Use of remaining funds. Funds amendment, paragraph, or section of exception is granted. The exception remaining after all costs incident to the this rule, and that provision may be decision will be documented in writing, basic project have been paid or provided addressed separately from the for will not include applicant signed by the Administrator, and remainder of the rule, we will withdraw contributions if SEARCH grants funds retained in the files. that amendment, paragraph, or section are financing less than 100 percent of § 1774.25–1774.99 [Reserved] and adopt as final those provisions of the project. Funds remaining may be the rule that are not the subject of a considered in direct proportion to the § 1774.100 OMB Control Number. significant comment. In such a case, we amounts obtained from each source. would then inform you of how we The information collection Remaining funds will be handled as expect to continue further rulemaking requirements in this part will not be follows: on the provisions that were the subject (1) Remaining funds may be used for effective until approved by the Office of of significant adverse comment. Management and Budget (OMB), subject eligible grant purposes as described in FOR FURTHER INFORMATION CONTACT: 1774.14 of this subpart, or to the submission of a paperwork Jacqueline R. Melvin, Policy Analyst, (2) Grant funds not expended will be package to OMB and assigned an OMB Control Number. Office of Regulatory Policy, Farm canceled. Prior to the actual Credit Administration, McLean, VA cancellation, the borrower, its attorney Dated: May 10, 2010. 22102–5090, (703) 883–4498, TTY and its engineer will be notified of RUS’ Jonathan Adelstein, (703) 883–4434, or intent to cancel the remaining funds. Administrator, Rural Utilities Service. Mary Alice Donner, Senior Attorney, § 1774.18 Reporting requirements, [FR Doc. 2010–15265 Filed 6–23–10; 8:45 am] Office of General Counsel, Farm accounting methods and audits. BILLING CODE 3410–15–P Credit Administration, McLean, VA All Agency grantees will follow the 22102–5090, (703) 883–4020, TTY reporting requirements as outlined in 7 (703) 883–4020. CFR 1780.47. SUPPLEMENTARY INFORMATION:

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I. Objective relocation.2 Therefore, this direct final raise an issue serious enough to warrant The objective of this direct final rule rule redesignates the remaining a substantive response from the Agency is to carry out the FCA Board’s regulations, § 614.4510 and § 614.4513 in a notice-and-comment proceeding. commitment to the principles contained of subpart N, part 614, to § 614.4170 and We believe that a direct final in the Board’s Policy Statement on § 614.4175 of subpart D, part 614. In rulemaking is the appropriate method Regulatory Philosophy,1 which includes addition, the definitions in subpart N, for amending the regulations in Section the elimination of outdated regulations part 614, in § 614.4512 are redundant II above because the changes are and technical amendments to ensure and are removed. technical in nature and do not substantively alter the rights or that regulations are accurate. In D. Section 618.8320 (Subpart G)— furtherance of this objective, the Agency Releasing Information responsibilities of any party. We do not anticipate there will be significant is making a number of technical changes The direct final rule amends to its regulations. adverse comments. If, however, we § 618.8320(b)(4) by inserting the phrase receive a significant adverse comment II. Section-by-Section Analysis ‘‘, administration of credit,’’ after during the comment period, we will ‘‘extension of credit’’. This is a technical publish a notice of withdrawal of the A. Section 604.420(i)(1)—Farm Credit change that does not alter the intended Administration Board Meetings; relevant provisions of this rule that will meaning of the provision but clarifies also indicate how further rulemaking § 607.2(j)—Assessment and that borrower information that is shared Apportionment of Administrative will proceed. If we receive no in connection with the extension of significant adverse comments, we will Expenses; § 612.2300(a)—Standards of credit and the collection of loans would Conduct and Referral of Known or publish notice of the effective date of also necessarily include the the rule following the required Suspected Criminal Violations; administration of credit for the §§ 615.5030(b) and 615.5560—Funding Congressional waiting period under confidential use of Farm Credit System section 5.17(c)(1) of the Farm Credit Act and Fiscal Affairs, Loan Policies and (System) institutions. Operations, and Funding Operations; of 1971, as amended. and § 627.2705(b)—Title IV E. Section 627.2735 (Subpart B)—Notice IV. Regulatory Flexibility Act Conservators, Receivers, and Voluntary to Holders of Uninsured Accounts and Pursuant to section 605(b) of the Liquidations Stockholders Regulatory Flexibility Act (5 U.S.C. 601 In each of the above-listed sections, The direct final rule amends et seq.), the FCA hereby certifies that the the direct final rule eliminates obsolete § 627.2735(a) by deleting the reference direct final rule will not have a to § 614.4513 and replacing it with references or deletes obsolete significant economic impact on a § 614.4175 to conform to the regulations that directly or indirectly substantial number of small entities. redesignation of that provision relate to either the Farm Credit System Each of the banks in the System, described in part C of this preamble. Assistance Board (Assistance Board) or considered together with its affiliated the Farm Credit System Financial III. Direct Final Rule associations, has assets and annual Assistance Corporation (Financial We are amending regulations income in excess of the amounts that Assistance Corporation or FAC). The described in the ‘‘Section-by-Section would qualify them as small entities. Assistance Board’s charter was Analysis’’ above by a direct final Therefore, System institutions are not cancelled by the FCA Board, effective rulemaking. The Administrative ‘‘small entities’’ as defined in the December 31, 1992, as required by Conference of the United States Regulatory Flexibility Act. section 6.12 of the Farm Credit Act of recommends direct final rulemaking for 1971, as amended (Act). In addition, the List of Subjects in 12 CFR Parts 604, Federal agencies to enact 607, 612, 614, 615, 618, and 627 Financial Assistance Corporation’s noncontroversial regulations on an charter was cancelled by the FCA Board expedited basis, without the usual Accounting, Agriculture, Archives on December 31, 2006. notice and comment period.3 This and records, Banks, Banking, Claims, B. Section 614.4265(d)(Subpart F)— process enables us to reduce the time Conflict of interest, Credit, Crime, Collateral Evaluation Requirements and resources we need to develop, Foreign trade, Government securities, review, and publish a final rule while Insurance, Investigations, Investments, The direct final rule amends Organization and functions § 614.4265(d) to correctly reference still affording the public an adequate opportunity to comment or object to the (Government agencies), Reporting and paragraph (c) of that section regarding recordkeeping requirements, Rural the evaluation of the income-earning rule. In a direct final rulemaking, we notify areas, Sunshine Act, Technical and debt-servicing capacity for real the public that the rule will become assistance. property. final on a specified date unless we ■ For the reasons stated in the preamble, C. Sections 614.4510, 614.4512, and receive a significant adverse comment parts 604, 607, 612, 614, 615, 618, and 614.4513 (Subpart N)—Loan Servicing during the comment period. A 627 of chapter VI, title 12 of the Code Requirements; State Agricultural Loan significant adverse comment is one of Federal Regulations are amended as Mediation Programs; Right of First where the commenter explains why the follows: Refusal rule would be inappropriate (including We previously removed §§ 614.4514 challenges to its underlying premise or PART 604—FARM CREDIT through 614.4522 of subpart N, part 614, approach), ineffective, or unacceptable ADMINISTRATION BOARD MEETINGS without a change. In general, a and redesignated them to the newly ■ 1. The authority citation for part 604 significant adverse comment would created part 617 to make the borrower continues to read as follows: rights rules more readily identifiable; 2 Authority: Secs. 5.9, 5.17 of the Farm however, we overlooked §§ 614.4510, See 69 FR 10901, March 9, 2004. 3 Recommendation 95–4, referencing the Credit Act (12 U.S.C. 2243, 2252). 614.4512 and 614.4513 in the Administrative Procedure Act ‘‘good cause’’ ■ exemption at 5 U.S.C. 553(b)(B), adopted June 15, 2. Amend § 604.420 by revising 1 See 70 FR 71142, November 25, 2005. 1995. paragraph (i)(1) to read as follows:

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§ 604.420 Exemptive provisions. Subpart F—Collateral Evaluation the phrase ‘‘extension of credit’’ in * * * * * Requirements paragraph (b)(4). (i) * * * § 614.4265 [Amended] PART 627—TITLE IV CONSERVATORS, (1) Significantly endanger the stability ■ 8. Section 614.4265(d) is amended by RECEIVERS, AND VOLUNTARY of any Farm Credit System institution, removing the reference to ‘‘paragraph LIQUIDATIONS including banks, associations, service (d)’’ and adding in its place, a reference ■ organizations, or the Funding to ‘‘paragraph (c).’’ 16. The authority citation for part 627 Corporation; or continues to read as follows: * * * * * Subpart I—Loss-Sharing Agreements Authority: Secs. 4.2, 5.9, 5.10, 5.17, 5.51, 5.58, 5.61 of the Farm Credit Act (12 U.S.C. PART 607—ASSESSMENT AND § 614.4341 [Removed] 2183, 2243, 2244, 2252, 2277a, 2277a–7, APPORTIONMENT OF ■ 9. Section 614.4341 is removed. 2277a–10). ADMINISTRATIVE EXPENSES Subpart N—[Removed and Reserved] Subpart A—General ■ 3. The authority citation for part 607 §§ 614.4510 and 614.4513 [Redesignated ■ 17. Section 627.2705 is amended by continues to read as follows: as §§ 614.4170 and 614.4175 of subpart D] revising paragraph (b) to read as follows: Authority: Secs. 5.15, 5.17 of the Farm ■ 10. Subpart N is amended by § 627.2705 Definitions. Credit Act (12 U.S.C. 2250, 2252) and 12 redesignating §§ 614.4510 and 614.4513 U.S.C. 3025. as newly designated §§ 614.4170 and * * * * * (b) Farm Credit institution(s) or § 607.2 [Amended] 614.4175 in subpart D of part 614, removing § 614.4512, and reserving institution(s) means all associations, ■ 4. Amend § 607.2 by removing the subpart N. banks, service corporations chartered words ‘‘the Farm Credit System under title IV of the Act, and the Federal Financial Assistance Corporation,’’ in PART 615—FUNDING AND FISCAL Farm Credit Banks Funding paragraph (j). AFFAIRS, LOAN POLICIES AND Corporation. OPERATIONS, AND FUNDING * * * * * PART 612—STANDARDS OF OPERATIONS CONDUCT AND REFERRAL OF Subpart B—Receivers and KNOWN OR SUSPECTED CRIMINAL ■ 11. The authority citation for part 615 Receiverships VIOLATIONS continues to read as follows: § 627.2735 [Amended] Authority: Secs. 1.5, 1.7, 1.10, 1.11, 1.12, ■ 5. The authority citation for part 612 2.2, 2.3, 2.4, 2.5, 2.12, 3.1, 3.7, 3.11, 3.25, 4.3, ■ 18. Section 627.2735(a) is amended by continues to read as follows: 4.3A, 4.9, 4.14B, 4.25, 5.9, 5.17, 6.20, 6.26, removing the reference ‘‘§ 614.4513’’ and 8.0, 8.3, 8.4, 8.6, 8.8, 8.10, 8.12 of the Farm adding in its place, the reference Authority: Secs. 5.9, 5.17, 5.19 of the Farm Credit Act (12 U.S.C. 2013, 2015, 2018, 2019, ‘‘§ 614.4175’’. Credit Act (12 U.S.C. 2243, 2252, 2254). 2020, 2073, 2074, 2075, 2076, 2093, 2122, 2128, 2132, 2146, 2154, 2154a, 2160, 2202b, Dated: June 18, 2010. Subpart B—Referral of Known or 2211, 2243, 2252, 2278b, 2278b–6, 2279aa, Roland E. Smith, Suspected Criminal Violations 2279aa–3, 2279aa–4, 2279aa–6, 2279aa–8, Secretary, Farm Credit Administration Board. 2279aa–10, 2279aa–12); sec. 301(a) of Pub. L. § 612.2300 [Amended] 100–233, 101 Stat. 1568, 1608. [FR Doc. 2010–15327 Filed 6–23–10; 8:45 am] BILLING CODE 6705–01–P ■ 6. Amend § 612.2300 by removing the Subpart A—Funding words ‘‘the Farm Credit System § 615.5030 [Amended] Financial Assistance Corporation,’’ in DEPARTMENT OF HOMELAND the first sentence of paragraph (a). ■ 12. Amend § 615.5030 by removing SECURITY paragraph (b) and the designation for PART 614—LOAN POLICIES AND paragraph (a). Coast Guard OPERATIONS Subpart R—[Removed and Reserved] 33 CFR Part 165 ■ 7. The authority citation for part 614 continues to read as follows: ■ 13. Subpart R, consisting of [Docket No. USCG–2010–0332] § 615.5560, is removed and reserved. Authority: 42 U.S.C. 4012a, 4104a, 4104b, RIN 1625–AA00 4106, and 4128; secs. 1.3, 1.5, 1.6, 1.7, 1.9, PART 618—GENERAL PROVISIONS 1.10, 1.11, 2.0, 2.2, 2.3, 2.4, 2.10, 2.12, 2.13, Safety Zone; Fireworks Display in 2.15, 3.0, 3.1, 3.3, 3.7, 3.8, 3.10, 3.20, 3.28, ■ 14. The authority citation for part 618 Stevenson, WA 4.12, 4.12A, 4.13B, 4.14, 4.14A, 4.14C, 4.14D, continues to read as follows: 4.14E, 4.18, 4.18A, 4.19, 4.25, 4.26, 4.27, AGENCY: Coast Guard, DHS. Authority: Secs. 1.5, 1.11, 1.12, 2.2, 2.4, 4.28, 4.36, 4.37, 5.9, 5.10, 5.17, 7.0, 7.2, 7.6, ACTION: Temporary final rule. 7.8, 7.12, 7.13, 8.0, 8.5 of the Farm Credit Act 2.5, 2.12, 3.1, 3.7, 4.12, 4.13A, 4.25, 4.29, 5.9, 5.10, 5.17 of the Farm Credit Act (12 U.S.C. (12 U.S.C. 2011, 2013, 2014, 2015, 2017, SUMMARY: The U.S. Coast Guard is 2013, 2019, 2020, 2073, 2075, 2076, 2093, 2018, 2019, 2071, 2073, 2074, 2075, 2091, establishing a temporary safety zone 2093, 2094, 2097, 2121, 2122, 2124, 2128, 2122, 2128, 2183, 2200, 2211, 2218, 2243, 2244, and 2252). covering the waters of the Columbia 2129, 2131, 2141, 2149, 2183, 2184, 2201, River in the vicinity of Stevenson, 2202, 2202a, 2202c, 2202d, 2202e, 2206, 2206a, 2207, 2211, 2212, 2213, 2214, 2219a, Subpart G—Releasing Information Washington. The safety zone is necessary to help ensure the safety of 2219b, 2243, 2244, 2252, 2279a, 2279a-2, § 618.8320 [Amended] 2279b, 2279c–1, 2279f, 2279f–1, 2279aa, the maritime public during the 2279aa–5); sec. 413 of Pub. L. 100–233, 101 ■ 15. Amend § 618.8320 by adding the fireworks display and will do so by Stat. 1568, 1639. phrase ‘‘, administration of credit,’’ after prohibiting all persons and vessels from

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entering the safety zone unless that good cause exists for not publishing and benefits under section 6(a)(3) of that authorized by the Captain of the Port or an NPRM. Order. The Office of Management and his designated representative. Under 5 U.S.C. 553(d)(3), the Coast Budget has not reviewed it under that DATES: This rule is effective from 8 p.m. Guard finds that good cause exists for Order. Although this temporary rule until 11 p.m. on July 4, 2010. making this rule effective less than 30 restricts access to the safety zone, the days after publication in the Federal effect of the rule will not be significant DATES: Documents indicated in this Register because due to the need for because: (i) The safety zone will only be preamble as being available in the immediate action, the restriction of in effect for three hours on one day, and docket are part of docket USCG–2010– vessel traffic is necessary to protect life, (ii) the zone is of a limited size. 0332 and are available online by going property and the environment; Small Entities to http://www.regulations.gov, inserting therefore, a 30-day notice is USCG–2010–0332 in the ‘‘Keyword’’ impracticable. Delaying the effective Under the Regulatory Flexibility Act box, and then clicking ‘‘Search.’’ They date would be contrary to the safety (5 U.S.C. 601–612), we have considered are also available for inspection or zone’s intended objectives of protecting whether this rule would have a copying at the Docket Management persons and vessels involved in the significant economic impact on a Facility (M–30), U.S. Department of event, and enhancing public and substantial number of small entities. Transportation, West Building Ground maritime safety. The term ‘‘small entities’’ comprises Floor, Room W12–140, 1200 New Jersey small businesses, not-for-profit Avenue SE., Washington, DC 20590, Basis and Purpose organizations that are independently between 9 a.m. and 5 p.m., Monday Fireworks displays create a hazardous owned and operated and are not through Friday, except Federal holidays. condition for the maritime public dominant in their fields, and FOR FURTHER INFORMATION CONTACT: If because of the large number of vessels governmental jurisdictions with you have questions on this temporary that congregate near the displays as well populations of less than 50,000. rule, call or e-mail MST1 Jaime Sayers, as the noise, falling debris, and The Coast Guard certifies under 5 Waterways Management Division, explosions that occur during the event. U.S.C. 605(b) that this rule will not have Sector Portland, Coast Guard; telephone The establishment of a safety zone a significant economic impact on a 503–240–9319, e-mail D13–SG– around the display helps to ensure the substantial number of small entities [email protected]. If you have safety of the maritime public by because the zone will be in effect for questions on viewing the docket, call prohibiting all persons and vessels from only be in effect for three hours on one Renee V. Wright, Program Manager, coming too close to the fireworks day. This rule may affect the following Docket Operations, telephone 202–366– display and the associated hazards. entities some of which may be small 9826. entities: The owners or operators of Discussion of Rule vessels wishing to transit or anchor in SUPPLEMENTARY INFORMATION: The Coast Guard is establishing a that portion of the Columbia River Regulatory Information temporary safety zone on specified between 8 p.m. and 11 p.m. on July 4, waters of the Columbia River in the 2010. The Coast Guard is issuing this vicinity of Stevenson, Washington. temporary final rule without prior Specifically, the safety zone would Assistance for Small Entities notice and opportunity to comment include all waters within an area whose Under section 213(a) of the Small pursuant to authority under section 4(a) boundary is defined by connecting the Business Regulatory Enforcement of the Administrative Procedure Act following points: starting from the shore Fairness Act of 1996 (Public Law 104– (APA) (5 U.S.C. 553(b)). This provision at 45°41′26.70″ N/121°53′36.80″ W; 121), we offer to assist small entities in authorizes an agency to issue a rule thence continuing to 45°41′24.62″ N/ understanding the rule so that they can without prior notice and opportunity to 121°53′40.85″ W; thence continuing to better evaluate its effects on them and comment when the agency for good 45°41′18.10″ N/121°53′27.86″ W; thence participate in the rulemaking process. cause finds that those procedures are continuing to 45°41′ 25.32″ N/ Small businesses may send comments ‘‘impracticable, unnecessary, or contrary 121°53′19.42″ W; thence continuing to on the actions of Federal employees to the public interest.’’ Under 5 U.S.C. 45° 41′30.32″ N/121°53′27.14″ W; who enforce, or otherwise determine 553(b)(B), the Coast Guard finds that thence continuing back to the starting compliance with, Federal regulations to good cause exists for not publishing a point at 45°41′26.70″ N/121°53′36.80″ the Small Business and Agriculture notice of proposed rulemaking (NPRM) W. All persons and vessels will be Regulatory Enforcement Ombudsman with respect to this rule because it is prohibited from entering the safety zone and the Regional Small Business contrary to the public interest to delay unless authorized by the Captain of the Regulatory Fairness Boards. The the effective date of this rule. Delaying Port or his designated representative. Ombudsman evaluates these actions the effective date by first publishing an annually and rates each agency’s NPRM would be contrary to the safety Regulatory Analyses responsiveness to small business. If you zone’s intended objective since We developed this rule after wish to comment on actions by immediate action is needed to protect considering numerous statutes and employees of the Coast Guard, call person’s and vessels against the hazards executive orders related to rulemaking. 1–888–REG–FAIR (1–888–734–3247). associated with fireworks displays on Below we summarize our analyses The Coast Guard will not retaliate navigable waters. Such hazards include based on 13 of these statutes or against small entities that question or premature detonations, dangerous executive orders. complain about this rule or any policy detonations, dangerous projectiles and or action of the Coast Guard. falling or burning debris. Additionally, Regulatory Planning and Review the zone should have negligible impact This rule is not a significant Collection of Information on vessel transits due to the fact that regulatory action under section 3(f) of This rule calls for no new collection vessels will be limited from the area for Executive Order 12866, Regulatory of information under the Paperwork only three hours. Accordingly, under 5 Planning and Review, and does not Reduction Act of 1995 (44 U.S.C. 3501– U.S.C. 553(b)(B), the Coast Guard finds require an assessment of potential costs 3520).

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Federalism Significantly Affect Energy Supply, ■ For the reasons discussed in the A rule has implications for federalism Distribution, or Use. We have preamble, the Coast Guard amends 33 under Executive Order 13132, determined that it is not a ‘‘significant CFR part 165 as follows: Federalism, if it has a substantial direct energy action’’ under that order because it is not a ‘‘significant regulatory action’’ PART 165—REGULATED NAVIGATION effect on State or local governments and AREAS AND LIMITED ACCESS AREAS would either preempt State law or under Executive Order 12866 and is not impose a substantial direct cost of likely to have a significant adverse effect ■ 1. The authority citation for part 165 compliance on them. We have analyzed on the supply, distribution, or use of continues to read as follows: energy. The Administrator of the Office this rule under that Order and have Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. determined that it does not have of Information and Regulatory Affairs has not designated it as a significant Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; implications for federalism. 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. energy action. Therefore, it does not Unfunded Mandates Reform Act 107–295, 116 Stat. 2064; Department of require a Statement of Energy Effects Homeland Security Delegation No. 0170.1. The Unfunded Mandates Reform Act under Executive Order 13211. ■ 2. Add § 165.T13–143 to read as of 1995 (2 U.S.C. 1531–1538) requires Technical Standards Federal agencies to assess the effects of follows: their discretionary regulatory actions. In The National Technology Transfer § 165.T13–143 Safety Zone; Fireworks particular, the Act addresses actions and Advancement Act (NTTAA) (15 Display in Stevenson, WA that may result in the expenditure by a U.S.C. 272 note) directs agencies to use (a) Location. The following area is a State, local, or tribal government, in the voluntary consensus standards in their safety zone: all waters within an area aggregate, or by the private sector of regulatory activities unless the agency whose boundary is defined by $100,000,000 (adjusted for inflation) or provides Congress, through the Office of connecting the following points: starting more in any one year. Though this rule Management and Budget, with an from the shore at 45°41′26.70″ will not result in such an expenditure, explanation of why using these N/121°53′36.80″ W; thence continuing we do discuss the effects of this rule standards would be inconsistent with to 45°41′24.62″ N/121°53′40.85″ W; elsewhere in this preamble. applicable law or otherwise impractical. thence continuing to 45°41′18.10″ N/ Taking of Private Property Voluntary consensus standards are 121°53′27.86″ W; thence continuing to technical standards (e.g., specifications 45°41′25.32″ N/121°53′19.42″ W; thence This rule will not cause a taking of of materials, performance, design, or ° ′ ″ private property or otherwise have continuing to 45 41 30.32 N/ operation; test methods; sampling 121°53′27.14″ W; thence continuing taking implications under Executive procedures; and related management ° ′ ″ Order 12630, Governmental Actions and back to the starting point at 45 41 26.70 systems practices) that are developed or N/121°53′36.80″ W. Interference with Constitutionally adopted by voluntary consensus Protected Property Rights. (b) Regulations. In accordance with standards bodies. the general regulations in § 165.23 of Civil Justice Reform This rule does not use technical this part, no person or vessel may enter This rule meets applicable standards standards. Therefore, we did not or remain in the safety zone created by in sections 3(a) and 3(b)(2) of Executive consider the use of voluntary consensus paragraph (a) of this section without the Order 12988, Civil Justice Reform, to standards. permission of the Captain of the Port, Sector Portland or his designated minimize litigation, eliminate Environment ambiguity, and reduce burden. representative. (c) Enforcement Period. The safety Protection of Children We have analyzed this rule under Department of Homeland Security zone created in paragraph (a) of this We have analyzed this rule under Management Directive 023–01 and section will be in effect from 8 p.m. Executive Order 13045, Protection of Commandant Instruction M16475.lD, until 11 p.m. on July 4, 2010. Children from Environmental Health which guide the Coast Guard in Dated: May 14, 2010. Risks and Safety Risks. This rule is not complying with the National F.G. Myer, an economically significant rule and Environmental Policy Act of 1969 does not create an environmental risk to Captain, U.S. Coast Guard, Captain of the (NEPA) (42 U.S.C. 4321–4370f), and Port, Portland. health or risk to safety that may have concluded this action is one of a disproportionately affect children. [FR Doc. 2010–15274 Filed 6–23–10; 8:45 am] category of actions that do not BILLING CODE 9110–04–P Indian Tribal Governments individually or cumulatively have a significant effect on the human This rule does not have tribal environment. This rule is categorically implications under Executive Order DEPARTMENT OF HOMELAND excluded, under figure 2–1, paragraph 13175, Consultation and Coordination SECURITY (34)(g), of the Instruction. This rule with Indian Tribal Governments, involves the establishment of a safety Coast Guard because it does not have a substantial zone. An environmental analysis direct effect on one or more Indian checklist and a categorical exclusion 33 CFR Part 165 tribes, on the relationship between the determination are available in the Federal Government and Indian tribes, [Docket No. USCG–2010–0214] docket where indicated under or on the distribution of power and ADDRESSES. responsibilities between the Federal RIN 1625–AA00 Government and Indian tribes. List of Subjects in 33 CFR Part 165 Safety Zone; North Jetty, Named the Energy Effects Harbors, Marine safety, Navigation Barview Jetty, Tillamook Bay, OR We have analyzed this rule under (water), Reporting and recordkeeping AGENCY: Coast Guard, DHS. Executive Order 13211, Actions requirements, Security measures, ACTION: Temporary final rule. Concerning Regulations That Waterways.

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SUMMARY: The Coast Guard is safety zone’s intended objectives of the jetty to latitude 45°34′17.5″ N, establishing a temporary safety zone protecting persons and vessels involved longitude 123°57′58″ W; thence back surrounding the north jetty, named the in the event, and enhancing public and inland to latitude 45°34′15″ N, longitude Barview Jetty near Tillamook Bay, maritime safety. 123°57′31″ W. All persons and vessels will be prohibited from entering or Oregon. The safety zone is necessary to Basis and Purpose help ensure the safety of work crews remaining in the zone unless and the maritime public while the jetty The north jetty, named the Barview specifically authorized by the Captain of is being repaired and will do so by Jetty, near Tillamook Bay, Oregon has the Port or his designated prohibiting all persons and vessels from deteriorated to the point that the United representative. States Army Corps of Engineers has entering or remaining within 250 feet of Regulatory Analyses the jetty unless specifically authorized contracted Kiewit Corporation to repair by the Captain of the Port or his the jetty. The repairs will begin on June We developed this rule after designated representative. 15, 2010 and will involve the use of a considering numerous statutes and track mounted Manitowoc 18,000 lb executive orders related to rulemaking. DATES: Effective Date: This rule is effective in the CFR from June 24, 2010 crane with as much as 200 feet of boom. Below we summarize our analyses until 11:59 p.m. on September 30, 2010. The crane will be used to move large based on 13 of these statutes or This rule is effective with actual notice granite boulders weighing executive orders. approximately 20 to 50 tons each by for purposes of enforcement beginning Regulatory Planning and Review 12:01 a.m. on June 15, 2010. lifting them up, circling them out over the waterway on either side of the north This rule is not a significant ADDRESSES: Comments and material jetty, and placing them into the jetty. regulatory action under section 3(f) of received from the public, as well as Due to the inherent dangers Executive Order 12866, Regulatory documents mentioned in this preamble associated with such operations, the Planning and Review, and does not as being available in the docket, are part safety zone created by this rule is require an assessment of potential costs of docket USCG–2010–0214 and are necessary to help ensure the safety of and benefits under section 6(a)(3) of that available online by going to http:// work crews and the maritime public Order. The Office of Management and www.regulations.gov, inserting USCG– while the jetty is being repaired. It will Budget has not reviewed it under that 2010–0214 in the ‘‘Keyword’’ box, and do so by prohibiting all persons and Order. Although this regulation restricts then clicking ‘‘Search.’’ This material is vessels from entering or remaining in access to the safety zone, the effect of also available for inspection or copying the zone when work is being conducted the rule will not be significant because: at the Docket Management Facility (M– on the jetty unless specifically (i) The safety zone will only be in effect 30), U.S. Department of Transportation, authorized by the Captain of the Port or during the 31⁄2 months repairs are being West Building Ground Floor, Room his designated representative. made to the north jetty, named the W12–140, 1200 New Jersey Avenue, SE., Barview Jetty; (ii) the zone is of limited Washington, DC 20590, between 9 a.m. Discussion of Comments and Changes size; and (iii) maritime traffic will be and 5 p.m., Monday through Friday, The Coast Guard received one able to transit the zone with the except Federal holidays. comment on this safety zone regarding permission of the Captain of the Port or FOR FURTHER INFORMATION CONTACT: If the ability of surfers to use the ‘‘rip his designated representative. you have questions on this rule, call or adjacent to the jetty to get out to the e-mail MST1 Jaime Sayers, Waterways breaking waves.’’ The Coast Guard Small Entities Management Branch, Coast Guard agrees the temporary safety zone will Under the Regulatory Flexibility Act Sector Portland; telephone 503–240– restrict access to the area, and we have (5 U.S.C. 601–612), we have considered 9319, e-mail [email protected]. made a change to the rule in light of this whether this rule would have a If you have questions on viewing the comment by adding language that the significant economic impact on a docket, call Renee V. Wright, Program safety zone will be enforced when work substantial number of small entities. Manager, Docket Operations, telephone is being conducted on the jetty, between The term ‘‘small entities’’ comprises 202–366–9826. the hours of 5:30 a.m. and 7:30 p.m. small businesses, not-for-profit SUPPLEMENTARY INFORMATION: Monday through Saturday, unless organizations that are independently otherwise required. The purpose of the owned and operated and are not Regulatory Information safety zone is to protect the public from dominant in their fields, and On April 28, 2010, we published a the dangers associated with the governmental jurisdictions with notice of proposed rulemaking (NPRM) construction project and due to safety populations of less than 50,000. entitled ‘‘Safety Zone; North Jetty, concerns the area may be closed to The Coast Guard certifies under 5 Named the Barview Jetty, Tillamook public access by the company working U.S.C. 605(b) that this rule will not have Bay, OR’’ in the Federal Register (75 FR on the jetty. The public will be notified a significant economic impact on a 22336). We received one comment on of the enforcement and suspension of substantial number of small entities. the proposed rule. There were no enforcement of the safety zone by This rule may affect the following requests for a public meeting and none Broadcast Notice to Mariners in entities some of which may be small was held. accordance with the procedures entities: The owners or operators of Under 5 U.S.C. 553(d)(3), the Coast outlined in this regulation. vessels wishing to transit the safety zone Guard finds that good cause exists for established by this rule. The rule will making this rule effective less than 30 Discussion of Rule not have a significant economic impact days after publication in the Federal The safety zone created by this rule on a substantial number of small Register. Due to the need for immediate will cover all waters surrounding the entities, however, because the safety action, the restriction of vessel traffic is Barview jetty within 250 feet starting at zone will only be in effect during the necessary to protect life, property and latitude 45°34′12″ N, longitude 31⁄2 months repairs are being made to the environment; therefore, a 30-day 123°57′31″ W; thence heading offshore the north jetty, named the Barview Jetty, notice is impracticable. Delaying the to latitude 45°34′12″ N, longitude and maritime traffic will be able to effective date would be contrary to the 123°57′58″ W; thence across the tip of transit the zone with the permission of

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the Captain of the Port or his designated Interference with Constitutionally adopted by voluntary consensus representative. Protected Property Rights. standards bodies. This rule does not use technical Assistance for Small Entities Civil Justice Reform standards. Therefore, we did not Under section 213(a) of the Small This rule meets applicable standards consider the use of voluntary consensus Business Regulatory Enforcement in sections 3(a) and 3(b)(2) of Executive standards. Fairness Act of 1996 (Pub. L. 104–121), Order 12988, Civil Justice Reform, to in the NPRM we offered to assist small minimize litigation, eliminate Environment entities in understanding the rule so ambiguity, and reduce burden. We have analyzed this rule under that they could better evaluate its effects Department of Homeland Security Protection of Children on them and participate in the Management Directive 023–01 and 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 the Small Business and Agriculture does not create an environmental risk to have concluded this action is one of a Regulatory Enforcement Ombudsman health or risk to safety that may category of actions that do not and the Regional Small Business disproportionately affect children. individually or cumulatively have a Regulatory Fairness Boards. The Indian Tribal Governments significant effect on the human Ombudsman evaluates these actions environment. This rule is categorically annually and rates each agency’s This rule does not have tribal excluded, under figure 2–1, paragraph responsiveness to small business. If you implications under Executive Order (34)(g) of the Instruction. This rule wish to comment on actions by 13175, Consultation and Coordination involves the establishment of a safety employees of the Coast Guard, call 1– with Indian Tribal Governments, zone. An environmental analysis 888–REG–FAIR (1–888–734–3247). The because it does not have a substantial checklist and a categorical exclusion Coast Guard will not retaliate against direct effect on one or more Indian determination are available in the small entities that question or complain tribes, on the relationship between the docket where indicated under about this rule or any policy or action Federal Government and Indian tribes, ADDRESSES. of the Coast Guard. or on the distribution of power and responsibilities between the Federal List of Subjects in 33 CFR Part 165 Collection of Information Government and Indian tribes. Harbors, Marine safety, Navigation This rule calls for no new collection Energy Effects (water), Reporting and recordkeeping of information under the Paperwork requirements, Security measures, Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under Waterways. Executive Order 13211, Actions 3520). ■ For the reasons discussed in the Concerning Regulations That preamble, the Coast Guard amends 33 Federalism Significantly Affect Energy Supply, CFR part 165 as follows: A rule has implications for federalism Distribution, or Use. We have under Executive Order 13132, determined that it is not a ‘‘significant PART 165—REGULATED NAVIGATION Federalism, if it has a substantial direct energy action’’ under that order because AREAS AND LIMITED ACCESS AREAS effect on State or local governments and it is not a ‘‘significant regulatory action’’ would either preempt State law or under Executive Order 12866 and is not ■ 1. The authority citation for part 165 impose a substantial direct cost of likely to have a significant adverse effect continues to read as follows: compliance on them. We have analyzed on the supply, distribution, or use of Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. this rule under that Order and have energy. The Administrator of the Office Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; determined that it does not have of Information and Regulatory Affairs 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. implications for federalism. has not designated it as a significant 107–295, 116 Stat. 2064; Department of energy action. Therefore, it does not Homeland Security Delegation No. 0170.1. Unfunded Mandates Reform Act require a Statement of Energy Effects ■ 2. Add § 165.T13–137 to read as The Unfunded Mandates Reform Act under Executive Order 13211. follows: of 1995 (2 U.S.C. 1531–1538) requires Technical Standards Federal agencies to assess the effects of § 165.T13–137 Safety Zone; North Jetty, their discretionary regulatory actions. In The National Technology Transfer Named the Barview Jetty, Tillamook Bay, particular, the Act addresses actions and Advancement Act (NTTAA) (15 OR. that may result in the expenditure by a U.S.C. 272 note) directs agencies to use (a) Location. The following area is a State, local, or tribal government, in the voluntary consensus standards in their safety zone: All waters within a 250 feet aggregate, or by the private sector of regulatory activities unless the agency radius of the north jetty, named the $100,000,000 (adjusted for inflation) or provides Congress, through the Office of Barview Jetty, near Tillamook Bay, more in any one year. Though this rule Management and Budget, with an Oregon starting at latitude 45°34′12″ N, will not result in such an expenditure, explanation of why using these longitude 123°57′31″ W; thence heading we do discuss the effects of this rule standards would be inconsistent with offshore to latitude 45°34′12″ N, elsewhere in this preamble. applicable law or otherwise impractical. longitude 123°57′58″ W; thence across Voluntary consensus standards are the tip of the jetty to latitude 45°34′17.5″ Taking of Private Property technical standards (e.g., specifications N, longitude 123°57′58″ W; thence back This rule will not cause a taking of of materials, performance, design, or inland to latitude 45° 34′ 15″ N, private property or otherwise have operation; test methods; sampling longitude 123°57′31″ W. taking implications under Executive procedures; and related management (b) Regulations. In accordance with Order 12630, Governmental Actions and systems practices) that are developed or the general regulations in § 165.23, no

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person may enter or remain in the safety registrants’’) to file Affidavits or grace period existed at the end of the zone created in paragraph (a) of this Declarations of Use or Excusable six-year period following the date of section or bring, cause to be brought, or Nonuse at intervals identical to those for registration in the U.S., and only a allow to remain in the safety zone nationally issued registrations. The three-month grace period existed created in paragraph (a) of this section changes additionally allow all following the expiration of each any vehicle, vessel or object unless trademark owners to cure deficiencies successive 10-year period following authorized by the Captain of the Port or in their maintenance filings, including registration. The new grace periods his designated representative. when the affidavit or declaration is not match those already provided to all (c) Enforcement. The safety zone will filed in the name of the owner of the other trademark owners for submitting be enforced daily June 15, 2010 through registration. maintenance filings to the USPTO. September 31, 2010 between the hours DATES: This rule is effective on June 24, In addition, the legislation allows all of 5:30 a.m. and 7:30 p.m. 2010. Comments must be received by trademark owners to cure deficiencies (1) The Captain of the Port, Sector August 23, 2010 to ensure in their post-registration maintenance Portland, will notify the public of the consideration. filings outside of the statutory filing enforcement and suspension of period upon payment of a deficiency enforcement of the safety zone ADDRESSES: The Office prefers that surcharge, specifically including when established by this section via any comments be submitted via electronic affidavits or declarations are not filed in means that will provide as much notice mail message to the name of the owner of the as possible to the public. These means [email protected]. Written registration. Previously, the statute did might include some or all of those listed comments may also be submitted by not provide Madrid Protocol registrants in 33 CFR 165.7(a). The primary method mail to Commissioner for Trademarks, with the opportunity to correct of notification, however, will be through P.O. Box 1451, Alexandria, VA 22313– deficiencies in their maintenance filings Broadcast Notice to Mariners and local 1451, attention Cynthia Lynch; by hand- and allowed all other trademark owners Notice to Mariners. delivery to the Trademark Assistance to correct deficiencies outside of the (d) Effective Period. The safety zone Center, Concourse Level, James Madison statutory filing period upon payment of created in paragraph (a) of this section Building-East Wing, 600 Dulany Street, the surcharge, except when an affidavit will be in effect from 12:01 a.m. June 15, Alexandria, Virginia, attention Cynthia or declaration was not filed in the name 2010 until 11:59 p.m. September 30, Lynch; or by electronic mail message via of the owner. 2010 while work is being conducted on the Federal eRulemaking Portal. See the The interim final rule revises 37 CFR the jetty. Federal eRulemaking Portal Web site parts 2 and 7 to implement the (http://www.regulations.gov) for Trademark Technical and Conforming Dated: June 11, 2010. additional instructions on providing Amendment Act of 2010, as referenced F.G. Myer, comments via the Federal eRulemaking above. It applies to all maintenance Captain, U.S. Coast Guard, Captain of the Portal. The comments will be available filings pending with the USPTO as of Port, Portland. for public inspection on the Office’s March 17, 2010, the effective date of the [FR Doc. 2010–15273 Filed 6–23–10; 8:45 am] Web site at http://www.uspto.gov, and legislation. BILLING CODE 9110–04–P will also be available at the Trademark References to ‘‘the Act,’’ ‘‘the Lanham Legal Policy Office, Madison East, Act,’’ ‘‘the Trademark Act,’’ or ‘‘the Fourth Floor, 600 Dulany Street, statute’’ refer to the Trademark Act of DEPARTMENT OF COMMERCE Alexandria, Virginia. 1946, 15 U.S.C. 1051 et seq., as FOR FURTHER INFORMATION CONTACT: amended. United States Patent and Trademark Cynthia C. Lynch, Office of the Deputy Rule Making Considerations Office Commissioner for Trademark Examination Policy, by telephone at The changes made in this interim 37 CFR Parts 2 and 7 (571) 272–8742. final rule constitute interpretative rules or rules of agency practice and [Docket No. PTO–T–2010–0014] SUPPLEMENTARY INFORMATION: procedure and are not subject to the RIN 0651–AC39 Statutory Background requirement for the publication of prior The Trademark Technical and notice of proposed rule making. See The Trademark Technical and Conforming Conforming Amendment Act of 2010 Administrative Procedure Act (‘‘APA’’), Amendments became effective on March 17, 2010. 5 U.S.C. 553(b)(3)(A). The rule changes AGENCY: United States Patent and Public Law 111–146, 124 Stat. 66 relate solely to the procedures for Trademark Office, Commerce. (2010). In addition to making small maintaining a Federal trademark ACTION: Interim final rule with request technical and conforming corrections in registration, and merely implement the for comments. Sections 7, 15, and 21 of the Lanham Trademark Technical and Conforming Act, 15 U.S.C. 1057, 1065, and 1071, the Amendment Act of 2010, so that the SUMMARY: The United States Patent and legislation makes other more Rules of Practice in Trademark Cases are Trademark Office (‘‘USPTO’’) is noteworthy changes to Sections 8 and consistent with the statutory revisions. amending the Rules of Practice in 71, 15 U.S.C. 1058 and 1141k, regarding Thus, they qualify as interpretative rules Trademark Cases to implement the filing Affidavits or Declarations of Use or rules of agency practice and Trademark Technical and Conforming or Excusable Nonuse to maintain a procedure under 5 U.S.C. 553(b)(A), and Amendment Act of 2010. The rule registration. prior notice and an opportunity for changes harmonize the framework for Specifically, the legislation gives public comment are not required submitting trademark registration Madrid Protocol registrants the benefit pursuant to 5 U.S.C. 553(b)(A) (or any maintenance filings to the USPTO by of six-month grace periods immediately other law). See Cooper Techs. Co. v. permitting holders of international following the statutory time periods for Dudas, 536 F.3d 1330, 1336–37, 87 registrations with an extension of filing their trademark registration U.S.P.Q.2d 1705, 1710 (Fed. Cir. 2008) protection to the United States under maintenance documents under Section (stating that 5 U.S.C. 553, and thus 35 the Madrid Protocol (‘‘Madrid Protocol 71, 15 U.S.C. 1141k. Previously, no U.S.C. 2(b)(2)(B), does not require notice

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and comment rule making for particular injustice no longer occurs.’’) public the opportunity to comment on ‘‘ ‘interpretative rules, general statements and 156 Cong. Rec. H1081 (daily ed. the rule changes. of policy, or rules of agency Mar. 3, 2010) (statement of Rep. Coble) The USPTO is interested in the organization, procedure, or practice.’ ’’ (‘‘The main purpose of the bill is to public’s input and requests public (quoting 5 U.S.C. 553(b)(A)), Bachow bring provisions for maintaining comments regarding these amendments. Communications Inc. v. FCC, 237 F.3d extensions of protection under Madrid Therefore, although the interim final 683, 690 (DC Cir. 2001) (rules governing in conformity with provisions for rule is effective upon publication, the an application process are ‘‘rules of maintaining registrations.’’). Thus, even USPTO will publish in the Federal agency organization, procedure, or the establishment of the $100 deficiency Register a response to any significant practice’’ and are exempt from the surcharge for Madrid Protocol adverse comments received along with APA’s notice and comment registrants constitutes an interpretative modifications to the rule, if any. rule. requirement); see also Merck & Co., Inc. Discussion of Specific Rules v. Kessler, 80 F.3d 1543, 1549–50, 38 In the alternative, in the event these USPQ2d 1347, 1351 (Fed. Cir. 1996) (the rule changes were deemed to require The following amendments bring the rules of practice promulgated under the notice and comment, the USPTO has Rules of Practice in Trademark Cases authority of former 35 U.S.C. 6(a) (now concluded that it has good cause, under into conformity with the Trademark in 35 U.S.C. 2(b)(2)) are not substantive 5 U.S.C. 553(b)(B), to adopt the changes Act, as amended by the Trademark rules (to which the notice and comment made in this interim final rule without Technical and Conforming Amendment requirements of the APA apply)), and prior notice and opportunity for public Act of 2010. Fressola v. Manbeck, 36 USPQ2d 1211, comment, as such prior notice and The Office is amending 37 CFR 1215 (D.D.C. 1995) (‘‘[i]t is extremely comment procedures would be 2.160(a)(3), 2.161(d)(2), and 2.163(c) to doubtful whether any of the rules impracticable, unnecessary, and replace the references to ‘‘section 8(c)(1) formulated to govern patent or trade- contrary to the public interest. The of the Act’’ with ‘‘section 8(a)(3) of the mark practice are other than amendments made to the Trademark Act.’’ In addition, the Office is amending 37 ‘interpretive rules, general statements of Act by the Trademark Technical and CFR 2.160(a)(3) to add the wording ‘‘per policy, * * * procedure, or practice.’ ’’) Conforming Amendment Act of 2010 class’’ to be consistent with the (quoting C.W. Ooms, The United States became effective on March 17, 2010, requirements stated in 37 CFR Patent Office and the Administrative and thus apply to maintenance filings 2.161(d)(2). Similarly, the Office is Procedure Act, 38 Trademark Rep. 149, for registrations currently pending amending 37 CFR 2.161(d)(2) to replace 153 (1948)). Accordingly, prior notice before the USPTO. The Rules of Practice ‘‘late fee’’ with ‘‘grace period surcharge’’ and an opportunity for public comment in Trademark Cases, however, are to be consistent with the language used are not required pursuant to 5 U.S.C. currently inconsistent with, and do not in 37 CFR 2.160(a)(3) and 37 CFR 553(b)(A) (or any other law), and thirty- reflect the benefits provided by, the new 7.37(d)(2). day advance publication is not required legislation. To delay the conforming rule changes for prior notice and The Office is amending 37 CFR pursuant to 5 U.S.C. 553(d) (or any other 2.163(a) to replace ‘‘[i]f the owner of the law). comment, and leave the inconsistency in place, is impracticable. In order to registration filed the affidavit or The establishment of a statutory rectify the inconsistency as quickly and declaration’’ with ‘‘[i]f the affidavit or deficiency surcharge in the amount of efficiently as possible, an interim final declaration is filed.’’ Similarly, the $100 for Madrid Protocol registrants, rule is issued to eliminate the Office is amending 37 CFR 2.164(a) to who under the new legislation are now inconsistency between the statute and replace ‘‘[i]f the owner of the registration afforded the opportunity to correct a the rules, while still affording the public files the affidavit or declaration’’ with deficiency outside the statutory time the opportunity to comment on the rule ‘‘[i]f the affidavit or declaration is filed.’’ period, comes in the context of making changes. These revisions reflect the amendment the treatment of Madrid Protocol In addition, delaying the rule changes to the Act providing that when an registrants’ maintenance filing for prior notice and comment is affidavit or declaration is not filed in the deficiencies consistent with those of unnecessary because of the nature of the name of the owner of the registration, it non-Madrid Protocol registrants. The rule changes. As described above, the is a correctable deficiency. legislative history reflects that, with full rule changes merely track the statutory The Office is amending 37 CFR awareness of the maintenance filing changes, negating the need to consider 2.163(b) to replace the reference to framework, including the $100 public input on the substance of the rule ‘‘section 8(a) or section 8(b) of the Act’’ deficiency surcharge already in changes prior to a final agency with ‘‘section 8(a) of the Act.’’ existence for non-Madrid Protocol determination. The Office is amending 37 CFR registrants, Congress sought to establish Finally, delaying the rule changes for 2.164(a)(1) to replace the reference to that same framework for Madrid prior notice and comment would be ‘‘sections 8(a) and 8(b) of the Act’’ with Protocol registrants. See, e.g., 156 Cong. contrary to the public interest, as it ‘‘sections 8(a)(1) and 8(a)(2) of the Act,’’ Rec. H1080 (daily ed. Mar. 3, 2010) could delay the implementation of the replace the reference to ‘‘section 8(a) or (statement of Rep. Johnson) (‘‘However, benefits established by the legislation or section 8(b) of the Act’’ with ‘‘section due to a technical mistake in the lead to public confusion caused by the 8(a)(1) or section 8(a)(2) of the Act,’’ and Lanham Act, our trademark laws inconsistency between the statute and replace the reference to ‘‘the deficiency unintentionally prevent trademark the rules. This interim final rule, surcharge required by section 8(c)(2) of owners who file these affidavits for making conforming rule changes and the Act’’ with ‘‘the deficiency surcharge registering extensions under the Madrid establishing the amount of the statutory required by section 8(c) of the Act.’’ Protocol from having the same rights as deficiency surcharge for Madrid In addition, the Office is amending 37 other U.S. trademark owners. Protocol registrants who wish to correct CFR 2.164(a)(1) to replace ‘‘[i]f the Compliance with regulations should not a deficiency after the statutory deadline, owner timely files the affidavit or reduce the rights of trademark owners. serves the public interest by quickly and declaration’’ with ‘‘[i]f the affidavit or Today, we will harmonize our laws with efficiently implementing the new declaration is timely filed.’’ This the Madrid Protocol so that this legislation, while still affording the revision reflects the amendment to the

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Act providing that when an affidavit or periods provided by the Act for filing Rule Making Requirements declaration is not filed in the name of the affidavits or declarations due each Executive Order 13132: This rule the owner of the registration, it is a successive ten-year period following making does not contain policies with correctable deficiency. registration. Previously, Madrid federalism implications sufficient to The Office is amending 37 CFR Protocol registrants had a six-month warrant preparation of a Federalism 2.164(a)(2) to replace the reference to window in which to make such filings. Assessment under Executive Order ‘‘grace period provided by section 8(c)(1) They now have the benefit of a full year 13132 (Aug. 4, 1999). of the Act’’ with ‘‘grace period provided to make such filings, not including the Executive Order 12866: This rule by section 8(a)(3) of the Act’’ and replace grace period. The new time periods making has been determined to be not the reference to ‘‘deficiency surcharge match those given to other trademark significant for purposes of Executive required by section 8(c)(2) of the Act’’ owners. Order 12866 (Sept. 30, 1993). with ‘‘deficiency surcharge required by The Office is adding 37 CFR 7.36(b)(3) Regulatory Flexibility Act: As prior section 8(c) of the Act.’’ to account for the new grace periods notice and an opportunity for public The Office is amending 37 CFR provided by the Act. Previously, for 2.164(b) to remove ‘‘or if it is filed comment are not required pursuant to 5 Madrid Protocol registrants, no grace U.S.C. 553 (or any other law), neither a within that period by someone other period existed at the end of the six-year ’’ ‘‘ regulatory flexibility analysis nor a than the owner, and These period following the date of registration ’’ certification under the Regulatory deficiencies cannot be cured. The and only a three-month grace period deletions reflect the amendment to the Flexibility Act (5 U.S.C. 601 et seq.) is existed following the expiration of each Act providing that when an affidavit or required for this interim final rule. See successive ten-year period following declaration is not filed in the name of 5 U.S.C. 603. Nevertheless, the Deputy registration. Now, Madrid Protocol the owner of the registration, it is a General Counsel for General Law of the registrants have the benefit of six-month correctable deficiency. United States Patent and Trademark The Office is amending the heading grace periods immediately following the Office certifies to the Chief Counsel for for 37 CFR 2.168 to account for the statutory time periods. The newly Advocacy of the Small Business rule’s applicability to affidavits or enacted grace periods match those given Administration that this interim final declarations under section 71 of the Act. to other trademark owners. rule will not have a significant The Office is amending 37 CFR The Office is adding 37 CFR 7.36(c) to economic impact on a substantial 2.168(a) to add ‘‘[t]he affidavit or be analogous to 37 CFR 2.160(b). number of small entities. See 5 U.S.C. declaration filed under section 15 of the The Office is amending 37 CFR 605(b). Act may also be used as the affidavit or 7.37(d)(2) to replace the reference to The principal impact of this rule declaration required by section 71, if the ‘‘section 71(a)(2)(B) of the Act’’ with making is to ensure that holders of affidavit or declaration meets the ‘‘section 71(a)(3) of the Act.’’ international registrations are provided requirements of both sections 71 and The Office is amending the heading with greater flexibility to maintain their 15.’’ By allowing Madrid Protocol for 37 CFR 7.39 to account for the ability marks. Furthermore, this increased registrants to combine their filings, the of Madrid Protocol registrants to correct flexibility harmonizes the requirements Office is providing them with the same deficiencies in their maintenance filings between international registrations and filing options available to all other as provided by the Act. nationally issued registrations. The only trademark owners. The Office is adding introductory text fee ($100.00) associated with this rule The Office is adding 37 CFR 7.6(a)(8) to 37 CFR 7.39 that is analogous to the making is to enable international to provide for the deficiency surcharge introductory text for 37 CFR 2.163 and registrants to receive the benefit of for Madrid Protocol registrants now includes text previously in 37 CFR correcting a deficiency in their provided by the Act. Previously, the Act 7.39(a). maintenance filings outside the statutory time period. Of the did not confer authority on the USPTO The Office is amending 37 CFR to allow Madrid Protocol registrants to approximately 126,000 affidavits filed 7.39(a) to include text previously in 37 under the national registration process, correct deficiencies in their CFR 7.39(b) and to state who must sign maintenance filings, but did confer such less than 800 (or less than two-thirds of an Office action response. This is one percent) paid the $100.00 authority with respect to the analogous to 37 CFR 2.163(b) and is maintenance filings of other trademark deficiency surcharge. In 2010, the Office consistent with the requirements of 37 estimates approximately 2,700 affidavits owners. The amendment of the Act CFR 2.193(e)(2). eliminated this disparity, and permits will be filed under the international the USPTO to allow the correction of The Office is amending 37 CFR registration process. Assuming that a deficiencies in Madrid Protocol 7.39(b) to account for the grace period similar percentage of international registrants’ maintenance filings after the provided by the Act and a Madrid registrants would pay the deficiency statutory period with payment of the Protocol registrant’s option of filing a surcharge, the Office estimates only a deficiency surcharge. This surcharge is new affidavit or declaration if time small number of registrants would be provided in order to give Madrid remains in the grace period. This is subject to the fee. For these reasons, the Protocol registrants the same benefit analogous to 37 CFR 2.163(c) as applied Office has concluded that this interim available to all other trademark owners, to all other trademark owners. final rule will not have a significant and the amount is the same as the The Office is adding 37 CFR 7.39(c), economic impact on a substantial deficiency surcharge applicable to other (c)(1), and (c)(2) to account for the number of small entities. trademark owners, provided in 37 CFR ability of Madrid Protocol registrants to Paperwork Reduction Act: This 2.6(a)(20). correct deficiencies in their proposed rule involves information The Office is amending 37 CFR maintenance filings as provided by the collection requirements which are 7.25(a) to remove the reference to Act. This is analogous to 37 CFR 2.164 subject to review by the Office of § 2.168 since § 2.168 now applies to as applied to all other trademark Management and Budget (OMB) under registered extensions of protection. owners. the Paperwork Reduction Act of 1995 The Office is amending 37 CFR The Office is adding § 7.39(d) to be (44 U.S.C. 3501 et seq.). The collection 7.36(b)(2) to account for the new time analogous to § 2.164(b). of information involved in this

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proposed rule has been reviewed and action is not a major rule as defined by issuance of the Office action, or before previously approved by OMB under 5 U.S.C. 804(2). the end of the filing period set forth in control number 0651–0051. The United section 8(a) of the Act, whichever is List of Subjects States Patent and Trademark Office is later. The response must be signed by not resubmitting an information 37 CFR Part 2 the owner, someone with legal authority collection request to OMB for its review Administrative practice and to bind the owner (e.g., a corporate and approval because the changes in procedure, Trademarks. officer or general partner of a this proposed rule would not affect the partnership), or a practitioner qualified information collection requirements 37 CFR Part 7 to practice under § 11.14 of this chapter, associated with the information Administrative practice and in accordance with the requirements of collection under OMB control number procedure, Trademarks, International § 2.193(e)(2). 0651–0051. registration. (c) If no response is filed within this Comments are invited on: (1) Whether time period, the registration will be ■ For the reasons stated in the preamble the collection of information is cancelled, unless time remains in the and under the authority contained in 15 necessary for proper performance of the grace period under section 8(a)(3) of the U.S.C. 1123 and 35 U.S.C. 2, as functions of the agency; (2) the accuracy Act. If time remains in the grace period, amended, the Office is amending parts of the agency’s estimate of the burden; the owner may file a complete, new 2 and 7 of title 37 as follows: (3) ways to enhance the quality, utility, affidavit. and clarity of the information to be PART 2—RULES OF PRACTICE IN ■ 5. Revise § 2.164 to read as follows: collected; and (4) ways to minimize the TRADEMARK CASES burden of the collection of information § 2.164 Correcting deficiencies in affidavit to respondents. ■ 1. The authority citation for 37 CFR or declaration. Interested persons are requested to part 2 continues to read as follows: (a) If the affidavit or declaration is send comments regarding these Authority: 15 U.S.C. 1123, 35 U.S.C. 2, filed within the time periods set forth in information collections, including unless otherwise noted. section 8 of the Act, deficiencies may be suggestions for reduction of this burden, corrected, as follows: to: (1) The Office of Information and ■ 2. Revise § 2.160(a)(3) to read as (1) Correcting deficiencies in Regulatory Affairs, Office of follows: affidavits or declarations timely filed Management and Budget, New § 2.160 Affidavit or declaration of within the periods set forth in sections Executive Office Building, Room 10202, continued use or excusable nonuse 8(a)(1) and 8(a)(2) of the Act. If the 725 17th Street, NW., Washington, DC required to avoid cancellation of affidavit or declaration is timely filed 20503, Attention: Desk Officer for the registration. within the relevant filing period set Patent and Trademark Office; and (2) (a) * * * forth in section 8(a)(1) or section 8(a)(2) Commissioner for Trademarks, P.O. Box (3) The affidavit or declaration may be of the Act, deficiencies may be corrected 1451, Alexandria, VA 22313–1451 filed within a grace period of six months before the end of this filing period (Attn: Cynthia Lynch). after the end of the deadline set forth in without paying a deficiency surcharge. Notwithstanding any other provision paragraphs (a)(1) and (a)(2) of this Deficiencies may be corrected after the of law, no person is required to respond section, with payment of the grace end of this filing period with payment to nor shall a person be subject to a period surcharge per class required by of the deficiency surcharge required by penalty for failure to comply with a section 8(a)(3) of the Act and § 2.6. section 8(c) of the Act and § 2.6. collection of information subject to the * * * * * (2) Correcting deficiencies in requirements of the Paperwork ■ affidavits or declarations filed during Reduction Act unless that collection of 3. Revise § 2.161(d)(2) to read as follows: the grace period. If the affidavit or information displays a currently valid declaration is filed during the six-month OMB control number. § 2.161 Requirements for a complete grace period provided by section 8(a)(3) Unfunded Mandates: The Unfunded affidavit or declaration of continued use or of the Act, deficiencies may be corrected Mandates Reform Act, at 2 U.S.C. 1532, excusable nonuse. before the expiration of the grace period requires that agencies prepare an * * * * * without paying a deficiency surcharge. assessment of anticipated costs and (d) * * * Deficiencies may be corrected after the benefits before issuing any rule that may (2) If the affidavit or declaration is expiration of the grace period with result in expenditure by State, local, and filed during the grace period under payment of the deficiency surcharge Tribal governments, in the aggregate, or section 8(a)(3) of the Act, include the required by section 8(c) of the Act and by the private sector, of $100 million or grace period surcharge per class § 2.6. more (adjusted annually for inflation) in required by § 2.6; (b) If the affidavit or declaration is not any given year. This rule would have no * * * * * filed within the time periods set forth in such effect on State, local, and Tribal ■ 4. Revise § 2.163 to read as follows: section 8 of the Act, the registration will governments or the private sector. be cancelled. Congressional Review Act: Under the § 2.163 Acknowledgment of receipt of ■ 6. In § 2.168, revise the heading and Congressional Review Act provisions of affidavit or declaration. paragraph (a) to read as follows: the Small Business Regulatory The Office will issue a notice as to Enforcement Fairness Act of 1996 (5 whether an affidavit or declaration is § 2.168 Affidavit or declaration under U.S.C. 801 et seq.), prior to issuing any acceptable, or the reasons for refusal. section 15 combined with affidavit or final rule, the USPTO will submit a (a) If the affidavit or declaration is declaration under sections 8 or 71, or with report containing the final rule and filed within the time periods set forth in renewal application. other required information to the United section 8 of the Act, deficiencies may be (a) The affidavit or declaration filed States Senate, the United States House corrected if the requirements of § 2.164 under section 15 of the Act may also be of Representatives, and the Comptroller are met. used as the affidavit or declaration General of the Government (b) A response to the refusal must be required by section 8, if the affidavit or Accountability Office. However, this filed within six months of the date of declaration meets the requirements of

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both sections 8 and 15. The affidavit or § 7.37 Requirements for a complete grace period with payment of the declaration filed under section 15 of the affidavit or declaration of use in commerce deficiency surcharge required by section Act may also be used as the affidavit or or excusable nonuse. 71(c) of the Act and § 7.6. declaration required by section 71, if the * * * * * (d) If the affidavit or declaration is not affidavit or declaration meets the (d) * * * filed within the time periods set forth in requirements of both sections 71 and 15. (2) If the affidavit or declaration is section 71 of the Act, the registration * * * * * filed during the grace period under will be cancelled. section 71(a)(3) of the Act, include the Dated: June 18, 2010. grace period surcharge per class PART 7—RULES OF PRACTICE IN David J. Kappos, required by § 7.6; FILINGS PURSUANT TO THE Under Secretary of Commerce for Intellectual PROTOCOL RELATING TO THE * * * * * Property and Director of the United States MADRID AGREEMENT CONCERNING ■ 12. Revise § 7.39 to read as follows: Patent and Trademark Office. THE INTERNATIONAL REGISTRATION [FR Doc. 2010–15305 Filed 6–23–10; 8:45 am] OF MARKS § 7.39 Acknowledgment of receipt of and correcting deficiencies in affidavit or BILLING CODE 3510–16–P ■ declaration of use in commerce or 7. The authority citation for 37 CFR excusable nonuse. part 7 continues to read as follows: The Office will issue a notice as to ENVIRONMENTAL PROTECTION Authority: 15 U.S.C. 1123, 35 U.S.C. 2, whether an affidavit or declaration is AGENCY unless otherwise noted. acceptable, or the reasons for refusal. 40 CFR Parts 9 and 721 ■ 8. In § 7.6, add paragraph (a)(8) to read (a) A response to the refusal must be as follows: filed within six months of the date of [EPA–HQ–OPPT–2008–0920; FRL–8824–6] issuance of the Office action, or before RIN 2070–AB27 § 7.6 Schedule of U.S. process fees. the end of the filing period set forth in (a) * * * section 71(a) of the Act, whichever is Significant New Use Rules on Certain (8) For correcting a deficiency in a later. The response must be signed by Chemical Substances section 71 affidavit—$100.00 the holder, someone with legal authority to bind the holder (e.g., a corporate AGENCY: Environmental Protection * * * * * officer or general partner of a Agency (EPA). ■ 9. Revise § 7.25(a) to read as follows: partnership), or a practitioner qualified ACTION: Direct final rule. to practice under § 11.14 of this chapter, § 7.25 Sections of part 2 applicable to SUMMARY: EPA is promulgating extension of protection. in accordance with the requirements of § 2.193(e)(2). significant new use rules (SNURs) under (a) Except for §§ 2.22–2.23, 2.130– (b) If no response is filed within this section 5(a)(2) of the Toxic Substances 2.131, 2.160–2.166, 2.173, and 2.181– time period, the extension of protection Control Act (TSCA) for 17 chemical 2.186, all sections in parts 2, 10, and 11 will be cancelled, unless time remains substances which were the subject of of this chapter shall apply to an in the grace period under section premanufacture notices (PMNs). Two of extension of protection of an 71(a)(3) of the Act. If time remains in these chemical substances are subject to international registration to the United the grace period, the holder may file a TSCA section 5(e) consent orders issued States, including sections related to complete, new affidavit. by EPA. This action requires persons proceedings before the Trademark Trial (c) If the affidavit or declaration is who intend to manufacture, import, or and Appeal Board, unless otherwise filed within the time periods set forth in process any of these 17 chemical stated. section 71 of the Act, deficiencies may substances for an activity that is designated as a significant new use by * * * * * be corrected, as follows: (1) Correcting deficiencies in this rule to notify EPA at least 90 days ■ 10. In § 7.36, revise paragraph (b)(2) affidavits or declarations timely filed before commencing that activity. The and add paragraphs (b)(3) and (c) to read within the periods set forth in sections required notification will provide EPA as follows: 71(a)(1) and 71(a)(2) of the Act. If the with the opportunity to evaluate the § 7.36 Affidavit or declaration of use in affidavit or declaration is timely filed intended use and, if necessary, to commerce or excusable nonuse required to within the relevant filing period set prohibit or limit that activity before it avoid cancellation of an extension of forth in section 71(a)(1) or section occurs. protection to the United States. 71(a)(2) of the Act, deficiencies may be DATES: This rule is effective on August * * * * * corrected before the end of this filing 23, 2010. For purposes of judicial (b) * * * period without paying a deficiency review, this rule shall be promulgated at (2) Within the year before the end of surcharge. Deficiencies may be 1 p.m. (e.s.t.) on July 8, 2010. every ten-year period after the date of corrected after the end of this filing Written adverse or critical comments, registration in the United States. period with payment of the deficiency or notice of intent to submit adverse or critical comments, on one or more of (3) The affidavit or declaration may be surcharge required by section 71(c) of these SNURs must be received on or filed within a grace period of six months the Act and § 7.6. (2) Correcting deficiencies in before July 26, 2010 (see Unit VI. of the after the end of the deadline set forth in affidavits or declarations filed during SUPPLEMENTARY INFORMATION). paragraphs (b)(1) and (b)(2) of this the grace period. If the affidavit or For additional information on related section, with payment of the grace declaration is filed during the six-month reporting requirement dates, see Units period surcharge per class required by grace period provided by section I.A., VI., and VII. of the SUPPLEMENTARY section 71(a)(3) of the Act and § 7.6. 71(a)(3) of the Act, deficiencies may be INFORMATION. (c) For the requirements for the corrected before the expiration of the ADDRESSES: Submit your comments, affidavit or declaration, see § 7.37. grace period without paying a identified by docket identification (ID) ■ 11. Revise § 7.37(d)(2) to read as deficiency surcharge. Deficiencies may number EPA–HQ–OPPT–2008–0920, by follows: be corrected after the expiration of the one of the following methods:

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• Federal eRulemaking Portal: http:// will be publicly available only in hard examine the applicability provisions in www.regulations.gov. Follow the on-line copy. Publicly available docket § 721.5. If you have any questions instructions for submitting comments. materials are available electronically at regarding the applicability of this action • Mail: Document Control Office http://www.regulations.gov, or, if only to a particular entity, consult the (7407M), Office of Pollution Prevention available in hard copy, at the OPPT technical person listed under FOR and Toxics (OPPT), Environmental Docket. The OPPT Docket is located in FURTHER INFORMATION CONTACT. Protection Agency, 1200 Pennsylvania the EPA Docket Center (EPA/DC) at Rm. This action may also affect certain Ave., NW., Washington, DC 20460– 3334, EPA West Bldg., 1301 entities through pre-existing import 0001. Constitution Ave., NW., Washington, certification and export notification • Hand Delivery: OPPT Document DC. The EPA/DC Public Reading Room rules under TSCA. Chemical importers Control Office (DCO), EPA East, Rm. hours of operation are 8:30 a.m. to 4:30 are subject to the TSCA section 13 (15 6428, 1201 Constitution Ave., NW., p.m., Monday through Friday, excluding U.S.C. 2612) import certification Washington, DC. Attention: Docket ID legal holidays. The telephone number of requirements promulgated at 19 CFR Number EPA–HQ–OPPT–2008–0920. the EPA/DC Public Reading Room is 12.118 through 12.127 and 19 CFR The DCO is open from 8 a.m. to 4 p.m., (202) 566–1744, and the telephone 127.28 (the corresponding EPA policy Monday through Friday, excluding legal number for the OPPT Docket is (202) holidays. The telephone number for the appears at 40 CFR part 707, subpart B). 566–0280. Docket visitors are required Chemical importers must certify that the DCO is (202) 564–8930. Such deliveries to show photographic identification, are only accepted during the DCO’s shipment of the chemical substance pass through a metal detector, and sign complies with all applicable rules and normal hours of operation, and special the EPA visitor log. All visitor bags are orders under TSCA. Importers of arrangements should be made for processed through an X-ray machine chemicals subject to these SNURs must deliveries of boxed information. and subject to search. Visitors will be certify their compliance with the SNUR Instructions: Direct your comments to provided an EPA/DC badge that must be requirements. In addition, any persons docket ID number EPA–HQ–OPPT– visible at all times in the building and who export or intend to export a 2008–0920. EPA’s policy is that all returned upon departure. comments received will be included in chemical substance that is the subject of FOR FURTHER INFORMATION CONTACT: For this rule on or after July 26, 2010 are the docket without change and may be technical information contact: Tracey made available on-line at http:// subject to the export notification Klosterman, Chemical Control Division provisions of TSCA section 12(b) (15 www.regulations.gov, including any (7405M), Office of Pollution Prevention personal information provided, unless U.S.C. 2611(b)) (see § 721.20), and must and Toxics, Environmental Protection comply with the export notification the comment includes information Agency, 1200 Pennsylvania Ave., NW., claimed to be Confidential Business requirements in 40 CFR part 707, Washington, DC 20460–0001; telephone subpart D. Information (CBI) or other information number: (202) 564–2209; e-mail address: whose disclosure is restricted by statute. [email protected]. B. What Should I Consider as I Prepare Do not submit information that you For general information contact: The My Comments for EPA? consider to be CBI or otherwise TSCA-Hotline, ABVI-Goodwill, 422 protected through regulations.gov or e- South Clinton Ave., Rochester, NY 1. Submitting CBI. Do not submit this mail. The regulations.gov website is an 14620; telephone number: (202) 554– information to EPA through ‘‘anonymous access’’ system, which 1404; e-mail address: TSCA- regulations.gov or e-mail. Clearly mark means EPA will not know your identity [email protected]. the part or all of the information that or contact information unless you you claim to be CBI. For CBI provide it in the body of your comment. SUPPLEMENTARY INFORMATION: information in a disk or CD-ROM that If you send an e-mail comment directly I. General Information you mail to EPA, mark the outside of the to EPA without going through disk or CD-ROM as CBI and then regulations.gov, your e-mail address A. Does this Action Apply to Me? identify electronically within the disk or will be automatically captured and You may be potentially affected by CD-ROM the specific information that is included as part of the comment that is this action if you manufacture, import, claimed as CBI. In addition to one placed in the docket and made available process, or use the chemical substances complete version of the comment that on the Internet. If you submit an contained in this rule. Potentially includes information claimed as CBI, a electronic comment, EPA recommends affected entities may include, but are copy of the comment that does not that you include your name and other not limited to: contain the information claimed as CBI contact information in the body of your • Manufacturers, importers, or must be submitted for inclusion in the comment and with any disk or CD-ROM processors of one or more subject public docket. Information so marked you submit. If EPA cannot read your chemical substances (NAICS codes 325 will not be disclosed except in comment due to technical difficulties and 324110), e.g., chemical accordance with procedures set forth in and cannot contact you for clarification, manufacturing and petroleum refineries. 40 CFR part 2. This listing is not intended to be EPA may not be able to consider your 2. Tips for preparing your comments. exhaustive, but rather provides a guide comment. Electronic files should avoid When submitting comments, remember for readers regarding entities likely to be the use of special characters, any form to: of encryption, and be free of any defects affected by this action. Other types of or viruses. entities not listed in this unit could also i. Identify the document by docket ID Docket: All documents in the docket be affected. The North American number and other identifying are listed in the docket index available Industrial Classification System information (subject heading, Federal at http://www.regulations.gov. Although (NAICS) codes have been provided to Register date and page number). listed in the index, some information is assist you and others in determining ii. Follow directions. The Agency may not publicly available, e.g., CBI or other whether this action might apply to ask you to respond to specific questions information whose disclosure is certain entities. To determine whether or organize comments by referencing a restricted by statute. Certain other you or your business may be affected by Code of Federal Regulations (CFR) part material, such as copyrighted material, this action, you should carefully or section number.

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iii. Explain why you agree or disagree; C. Applicability of General Provisions • The reasonably anticipated manner suggest alternatives and substitute General provisions for SNURs appear and methods of manufacturing, language for your requested changes. in 40 CFR part 721, subpart A. These processing, distribution in commerce, iv. Describe any assumptions and provisions describe persons subject to and disposal of a chemical substance. provide any technical information and/ the rule, recordkeeping requirements, In addition to these factors or data that you used. exemptions to reporting requirements, enumerated in TSCA section 5(a)(2), the and applicability of the rule to uses statute authorized EPA to consider any v. If you estimate potential costs or other relevant factors. burdens, explain how you arrived at occurring before the effective date of the rule. Provisions relating to user fees To determine what would constitute a your estimate in sufficient detail to significant new use for the 17 chemical allow for it to be reproduced. appear at 40 CFR part 700. According to § 721.1(c), persons subject to these substances that are the subject of these vi. Provide specific examples to SNURs must comply with the same SNURs, EPA considered relevant illustrate your concerns and suggest notice requirements and EPA regulatory information about the toxicity of the alternatives. procedures as submitters of PMNs under chemical substances, likely human vii. Explain your views as clearly as TSCA section 5(a)(1)(A). In particular, exposures and environmental releases possible, avoiding the use of profanity these requirements include the associated with possible uses, and the or personal threats. information submission requirements of four bulleted TSCA section 5(a)(2) factors listed in this unit. viii. Make sure to submit your TSCA section 5(b) and 5(d)(1), the comments by the comment period exemptions authorized by TSCA section IV. Substances Subject to this Rule deadline identified. 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA is establishing significant new II. Background EPA receives a SNUN, EPA may take use and recordkeeping requirements for 17 chemical substances in 40 CFR part A. What Action is the Agency Taking? regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities 721, subpart E. In this unit, EPA EPA is promulgating these SNURs for which it has received the SNUN. If provides the following information for each chemical substance: using direct final procedures. These EPA does not take action, EPA is • SNURs will require persons to notify required under TSCA section 5(g) to PMN number. • Chemical name (generic name, if EPA at least 90 days before commencing explain in the Federal Register its the specific name is claimed as CBI). the manufacture, import, or processing reasons for not taking action. • CAS number (if assigned for non- of a chemical substance for any activity Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) confidential chemical identities). designated by these SNURs as a • Basis for the TSCA section 5(e) import certification requirements significant new use. Receipt of such consent order or, for non-section 5(e) codified at 19 CFR 12.118 through notices allows EPA to assess risks that SNURs, the basis for the SNUR (i.e., 12.127, and 19 CFR 127.28 (the may be presented by the intended uses SNURs without TSCA section 5(e) and, if appropriate, to regulate the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical consent orders). proposed use before it occurs. • Toxicity concerns. importers must certify that the shipment Additional rationale and background to • Tests recommended by EPA to of the chemical substance complies with these rules are more fully set out in the provide sufficient information to all applicable rules and orders under preamble to EPA’s first direct final evaluate the chemical substance (see TSCA. Importers of chemical substances SNUR published in the Federal Register Unit VIII. for more information). of April 24, 1990 (55 FR 17376). Consult subject to a final SNUR must certify • CFR citation assigned in the that preamble for further information on their compliance with the SNUR regulatory text section of this rule. the objectives, rationale, and procedures requirements. In addition, any persons The regulatory text section of this rule for SNURs and on the basis for who export or intend to export a specifies the activities designated as significant new use designations, chemical substance identified in a final significant new uses. Certain new uses, including provisions for developing test SNUR are subject to the export including production volume limits data. notification provisions of TSCA section (i.e., limits on manufacture and 12(b) (15 U.S.C. 2611 (b)) (see § 721.20), importation volume) and other uses B. What is the Agency’s Authority for and must comply with the export designated in this rule, may be claimed Taking this Action? notification requirements in 40 CFR part as CBI. Unit IX. discusses a procedure 707, subpart D. Section 5(a)(2) of TSCA (15 U.S.C. companies may use to ascertain whether 2604(a)(2)) authorizes EPA to determine III. Significant New Use Determination a proposed use constitutes a significant that a use of a chemical substance is a Section 5(a)(2) of TSCA states that new use. ‘‘significant new use.’’ EPA must make EPA’s determination that a use of a This rule includes 2 PMN substances this determination by rule after chemical substance is a significant new that are subject to ‘‘risk-based’’ consent considering all relevant factors, use must be made after consideration of orders under TSCA section including those listed in TSCA section all relevant factors, including: 5(e)(1)(A)(ii)(I) where EPA determined 5(a)(2) (see Unit III.). Once EPA • The projected volume of that activities associated with the PMN determines that a use of a chemical manufacturing and processing of a substances may present unreasonable substance is a significant new use, chemical substance. risk to human health or the TSCA section 5(a)(1)(B) requires persons • The extent to which a use changes environment. Those consent orders to submit a significant new use notice the type or form of exposure of human require protective measures to limit (SNUN) to EPA at least 90 days before beings or the environment to a chemical exposures or otherwise mitigate the they manufacture, import, or process the substance. potential unreasonable risk. The so- chemical substance for that use. The • The extent to which a use increases called ‘‘5(e) SNURs’’ on these PMN mechanism for reporting under this the magnitude and duration of exposure substances are promulgated pursuant to requirement is established under of human beings or the environment to § 721.160, and are based on and § 721.5. a chemical substance. consistent with the provisions in the

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underlying consent orders. The 5(e) premanufacture notice for the Development (OECD) 412 test SNURs designate as a ‘‘significant new substance, including any amendments, guideline); a prenatal developmental use’’ the absence of the protective deletions, and additions of activities to toxicity study (OCSPP Harmonized Test measures required in the corresponding the premanufacture notice, and (ii) may Guideline 870.3700) via the oral route; consent orders. be accompanied by changes in exposure a reproduction and fertility study Where EPA determined that the PMN or release levels that are significant in (OCSPP Harmonized Test Guideline substance may present an unreasonable relation to the health or environmental 870.3800) via the oral route; an risk of injury to human health via concerns identified’’ for the PMN immunotoxicity test (OCSPP inhalation exposure, the underlying substance. Harmonized Test Guideline 870.7800) TSCA section 5(e) consent order usually PMN Number P–02–996 via the oral route; a fish chronic toxicity requires, among other things, that Chemical name: Aliphatic triamine test (OCSPP Harmonized Test Guideline potentially exposed employees wear (generic). 850.1400); and a daphnid chronic specified respirators unless actual CAS number: Not available. toxicity test (OCSPP Harmonized Test measurements of the workplace air Basis for action: The PMN states that the Guideline 850.1300). All recommended show that air-borne concentrations of chemical substance will be used as a tests should be performed on the PMN the PMN substance are below a New monomer for polymers with amide or substance neutralized with HCl to a pH Chemical Exposure Limit (NCEL) that is imide links; a crosslinker for epoxy type of 7.0. Further, a certificate of analysis established by EPA to provide adequate coatings, adhesives and sealants; a should be included for the test protection to human health. In addition crosslinker for epoxy type composites; a substance. to the actual NCEL concentration, the monomer for urea and urethane urea comprehensive NCELs provisions in polymers used in coatings; a chemical CFR citation: 40 CFR 721.10184. TSCA section 5(e) consent orders, intermediate for functional chemicals: PMN Number P–03–106 which are modeled after Occupational amides, imides; a chemical intermediate Chemical name: 1,2-Propanediol, 3- Safety and Health Administration for functional chemicals: isocyanates, (diethylamino)-, polymers with 5- (OSHA) Permissible Exposure Limits salts; and a chemical intermediate for isocyanato-1- (isocyanatomethyl)-1,3,3- (PELs) provisions, include requirements functional chemicals: cyclic amines, etc. trimethylcyclohexane, propylene glycol addressing performance criteria for Based on test data on the PMN and reduced Me esters of reduced sampling and analytical methods, substance and analogous substances, polymd. oxidized tetrafluoroethylene, 2- periodic monitoring, respiratory ethyl-1-hexanol-blocked, acetates (salts). protection, and recordkeeping. EPA identified concerns for corrosion of the skin, eyes, mucous membranes and CAS number: 328389–90–8. However, no comparable NCEL Basis for action: The PMN states that the provisions currently exist in 40 CFR lungs; respiratory tract irritation; immunotoxicity; developmental generic (non-confidential) use of the part 721, subpart B, for SNURs. substance will be as a surface treatment Therefore, for these cases, the toxicity; and reproductive toxicity from exposure to the PMN substance. In agent. Based on test data on analogous individual SNURs in 40 CFR part 721, substances, EPA believes this substance subpart E, will state that persons subject addition, based on test data on the PMN substance, EPA predicts toxicity to could cause lung toxicity to workers if to the SNUR who wish to pursue NCELs inhaled, via irritation to mucous as an alternative to the § 721.63 aquatic organisms may occur at concentrations that exceed 48 parts per membranes and cationic binding with respirator requirements may request to membranes. For the use described in the do so under § 721.30. EPA expects that billion (ppb) of the PMN substance in PMN, significant worker dermal or persons whose § 721.30 requests to use surface waters. For the use described in inhalation exposure is not expected. the NCELs approach for SNURs are the PMN, worker inhalation and dermal Therefore, EPA has not determined that approved by EPA will be required to exposures are not expected and releases the proposed manufacturing, comply with NCELs provisions that are to water are not expected. Therefore, processing, or use of the substance may comparable to those contained in the EPA has not determined that the present an unreasonable risk. EPA has corresponding TSCA section 5(e) proposed manufacturing, processing, or determined, however, that use of the consent order for the same chemical use of the substance may present an substance involving an application substance. unreasonable risk. EPA has determined, This rule also includes SNURs on 15 however, that any use of the substance method which generates a vapor, mist, PMN substances that are not subject to involving an application method which or aerosol may result in serious health consent orders under TSCA section 5(e). generates a vapor, mist, or aerosol may effects. Based on this information, the In these cases, for a variety of reasons, cause serious health effects and any use PMN substance meets the concern EPA did not find that the use scenario of the substance resulting in release to criteria at § 721.170(b)(3)(ii). described in the PMN triggered the surface waters may cause significant Recommended testing: EPA has determinations set forth under TSCA adverse environmental effects. Based on determined that the results of a 90–day section 5(e). However, EPA does believe this information, the PMN substance inhalation toxicity study (OCSPP that certain changes from the use meets the concern criteria at § 721.170 Harmonized Test Guideline 870.3465) scenario described in the PMN could (b)(3)(i), (b)(3)(ii), and (b)(4)(i). would help characterize the human result in increased exposures, thereby Recommended testing: EPA has health effects of the PMN substance. constituting a ‘‘significant new use.’’ determined that the results of the CFR citation: 40 CFR 721.10185. These so-called ‘‘non-5(e) SNURs’’ are following testing would help PMN Number P–04–132 promulgated pursuant to § 721.170. EPA characterize the human health and Chemical name: Ethylhexyl oxetane has determined that every activity environmental effects of the PMN (generic). designated as a ‘‘significant new use’’ in substance: Either a 90–day inhalation CAS number: Not available. all non-5(e) SNURs issued under toxicity test (OCSPP Harmonized Test Effective date of TSCA section 5(e) § 721.170 satisfies the two requirements Guideline 870.3465) in rodents, consent order: March 7, 2007. stipulated in § 721.170(c)(2), i.e., these modified for a 28–day exposure, or a Basis for TSCA section 5(e) consent significant new use activities, ‘‘(i) are repeated dose inhalation toxicity study order: The PMN states that the generic different from those described in the (Organization for Co-Operation and (non-confidential) use of the substance

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will be as an additive for industrial derivs (generic); and (Chemical D) Chemical names: (P–06–262) Amides, applications. The order was issued Formaldehyde, polymer with aliphatic coco, N-[3-(dibutylamino)propyl]; (P– under sections 5(e)(1)(A)(i) and diamine and phenol, reaction products 06–263, Chemical A) Amides, coco, N- 5(e)(1)(A)(ii)(I) of TSCA based on with 4-methyl-2-pentanone (generic). [3-(dibutylamino)propyl], acrylates; (P– findings that this substance may present CAS numbers: (Chemical A) 1003863– 06–263, Chemical B) 1-Butanaminium, an unreasonable risk of injury to human 30–6; (Chemical B) not available; N-(3-aminopropyl)-N-butyl-N-(2- health and the environment. To protect (Chemical C) not available; and carboxyethyl)-, N-coco acyl derivs., against these risks, the consent order (Chemical D) not available. inner salts; and (P–06–264) requires use of dermal personal Basis for action: The PMN states that the Dialkylcocoamidoalkylpropionate protective equipment, including gloves substances will be used as curing agents (generic). demonstrated by testing to be for epoxy coating systems. Based on test CAS numbers: (P–06–262) 851544–20– impervious (Polyvinyl Alcohol gloves data on analogous aliphatic amines, 2; (P–06–263, Chemical A) 851545–09– with a thickness of no less than 31.3 EPA predicts toxicity to aquatic 0; (P–06–263, Chemical B) 851545–17– mils or Silvershield/4H sleeves with a organisms may occur at concentrations 0; and (P–06–264) not available. thickness of no less than 2.7 mils have that exceed 10 ppb of the PMN in Basis for action: The consolidated PMN been shown to satisfy this requirement surface waters. For the uses described in states that the substances will be used for up to 8 hours), requires the the PMN, releases of the substances are as intermediates for hydrate inhibitors establishment of a hazard not expected to result in surface waters for oil and gas wells, production communication program, and limits concentrations that exceed 10 ppb. pipelines and flowlines (P–06–262); and uses to those listed in the consent order. Therefore, EPA has not determined that hydrate inhibitors for oil and gas wells, The SNUR designates as a ‘‘significant the proposed manufacturing, production pipelines and flowlines (P– new use’’ the absence of these protective processing, or use of the substances may 06–263 and P–06–264). Based on test measures. present an unreasonable risk. EPA has data on analogous aliphatic amines, Toxicity concern: Based on test data on determined, however, that any use of EPA predicts toxicity to aquatic the PMN substance, EPA identified the substances resulting in surface water organisms may occur at concentrations concerns for liver toxicity, thyroid concentrations exceeding 10 ppb may that exceed 20 ppb of the PMN toxicity, and systemic toxicity. Further, cause significant adverse environmental substances in surface waters. For the based on test data on the PMN effects. Based on this information, the uses described in the PMNs, these substance, EPA predicts toxicity to PMN substances meet the concern substances will not be released to aquatic organisms may occur at criteria at § 721.170(b)(4)(ii). surface waters. Therefore, EPA has not concentrations that exceed 20 ppb of the Recommended testing: EPA has determined that the proposed manufacturing, processing, or use of the PMN substance in surface waters. determined that the results of the substances may present an unreasonable Recommended testing: EPA has following tests would help characterize risk. EPA has determined, however, that determined that the following tests the environmental effects of the PMN any use of the substances resulting in would help characterize the human substances: A fish acute toxicity test, release to surface waters may cause health and environmental effects of the freshwater and marine (OCSPP significant adverse environmental PMN substance: A 90–day oral toxicity Harmonized Test Guideline 850.1075) effects. Based on this information, the test (OCSPP Harmonized Test Guideline using the static method with 24–hour PMN substances meet the concern 870.3100) in rodents; a fish early-life renewal intervals; a fish acute toxicity criteria at § 721.170(b)(4)(ii). stage toxicity test (OCSPP Harmonized test mitigated by humic acid (OCSPP Recommended testing: EPA has Test Guideline 850.1400) with rainbow Harmonized Test Guideline 850.1085) determined that the results of the trout; and a daphnid chronic toxicity using the static method with 24–hour following tests would help characterize test (OCSPP Harmonized Test Guideline renewal intervals; an aquatic the environmental effects of the PMN 850.1300). The order does not require invertebrate acute toxicity test, substance: A fish acute toxicity test, submission of the aforementioned freshwater daphnids (OCSPP freshwater and marine (OCSPP information at any specified time or Harmonized Test Guideline 850.1010) Harmonized Test Guideline 850.1075); production volume. However, the using the static method with 24–hour an aquatic invertebrate acute toxicity order’s restrictions on manufacturing, renewal intervals; and an algal toxicity test, freshwater daphnids (OCSPP import, processing, distribution in test, tiers I and II (OCSPP Harmonized Harmonized Test Guideline 850.1010); commerce, use and disposal of the PMN Test Guideline 850.5400) using the an algal toxicity test, tiers I and II substance will remain in effect until the static method. For all fish and daphnid (OCSPP Harmonized Test Guideline order is modified or revoked by EPA testing, the dilution water must have a 850.5400); a ready biodegradability test based on submission of that or other water hardness of less than 180 mg/L (OCSPP Harmonized Test Guideline relevant information. calcium carbonate and a total organic 835.3110); and an activated sludge CFR citation: 40 CFR 721.10186. carbon (TOC) level of less than 2.0 mg/ sorption isotherm (OCSPP Harmonized PMN Number P–05–186 L. Further, the stock solution should be Test Guideline 835.1110) would help Chemical names: (Chemical A) 4- adjusted to a pH of 7 at study initiation characterize the environmental effects of Morpholinepropanamine, N-(1,3- prior to the introduction of test the PMN substances. Testing should be dimethylbutylidene)-; (Chemical B) organisms. Study reports must include performed on P–06–264. Further, a Fatty acids, tall-oil, reaction products chemical names, CAS numbers, and certificate of analysis should be with 4-methyl-2-pentanone and composition of the test substance. included for the test substances. aliphatic polyamine (generic); CFR citations: 40 CFR 721.10187 (P–05– CFR citations: 40 CFR 721.10191 (P–06– (Chemical C) Fatty acids, tall-oil, 186, Chemical A); 40 CFR 721.10188 (P– 262); 40 CFR 721.10192 (P–06–263, reaction products with (butoxymethyl) 05–186, Chemical B); 40 CFR 721.10189 Chemical A); 40 CFR 721.10193 (P–06– oxirane formaldehyde-phenol polymer (P–05–186, Chemical C); and 40 CFR 263, Chemical B); and 40 CFR glycidyl ether, morpholinepropanamine, 721.10190 (P–05–186, Chemical D). 721.10194 (P–06–264). propylene glycol diamine and aliphatic PMN Numbers P–06–262, P–06–263, PMN Numbers P–06–265, P–06–266, polyamine, N-(1,3 -dimethylbutylidene) and P–06–264 and P–06–267

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Chemical names: (P–06–265) CAS number: Not available. toxicity test and the daphnid chronic Dialkylcornoilamidoalkylamine Effective date of TSCA section 5(e) toxicity test at any specified time or (generic); (P–06–266, Chemical A) consent order: May 26, 2009. production volume. However, the Dialkylcornoilamidoacrylate (generic); Basis for TSCA section 5(e) consent order’s restrictions on manufacturing, (P–06–266, Chemical B) order: The PMN states that the generic import, processing, distribution in Dialkycornoilamidoalkylbetaine (non-confidential) use of the substance commerce, use and disposal of the PMN (generic); and (P–06–267) will be as a polymer curative. The order substance will remain in effect until the Dialkylcornoilamidopropionate was issued under sections 5(e)(1)(A)(i) order is modified or revoked by EPA (generic). and 5(e)(1)(A)(ii)(I) of TSCA based on based on submission of that or other CAS numbers: (P–06–265) Not available; findings that this substance may present relevant information. (P–06–266, Chemical A) not available; an unreasonable risk of injury to the CFR citation: 40 CFR 721.10199. (P–06–266, Chemical B) not available; environment and human health. To PMN Number P–09–75 and (P–06–267) not available. protect against these risks, the consent Chemical name: Benzenacetonitrile, Basis for action: The consolidated PMN order requires use of dermal personal cyclohexylidene-alkyl substituted states that the substances will be used protective equipment, including gloves (generic). as intermediates for hydrate inhibitors demonstrated by testing to be CAS number: Not available. for oil and gas wells, production impervious (Ansell NEOX style 9–912 Basis for action: The PMN states that the pipelines and flowlines (P–06–265); and gloves have been shown to satisfy this generic (non-confidential) use of the hydrate inhibitors for oil and gas wells, requirement for up to 110 minutes), use PMN substance will be as a component production pipelines and flowlines (P– of respiratory personal protective of odorant compositions for highly- 06–266 and P–06–267). Based on test equipment, including a National dispersive applications. Based on test data on analogous aliphatic amines, Institute of Occupational Safety and data on the PMN substance, EPA EPA predicts toxicity to aquatic Health (NIOSH)-approved respiratory predicts chronic toxicity to aquatic organisms may occur at concentrations protection with an APF of at least 50 or organisms at concentrations that exceed that exceed 20 ppb of the PMN compliance with a New Chemical 123 ppb of the PMN substance in substances in surface waters. For the Exposure Limit (NCEL) of 0.14 mg/m3 as surface waters. For the processing and uses described in the PMNs, these an 8–hour time-weighted average, use scenario and production volume in substances will not be released to establishment of a hazard the amended PMN, releases of the surface waters. Therefore, EPA has not communication program, and restricts substance are not expected to result in determined that the proposed releases to water. The SNUR designates surface water concentrations that exceed manufacturing, processing, or use of the as a ‘‘significant new use’’ the absence of 123 ppb. Therefore, EPA has not substances may present an unreasonable these protective measures. determined that the proposed risk. EPA has determined, however, that Toxicity concern: Based on test data on manufacturing, processing, or use of the any use of the substances resulting in analogous substances, EPA identified substance may present an unreasonable release to surface waters may cause concerns for chronic liver toxicity, acute risk. EPA has determined, however, that significant adverse environmental oral toxicity and corrosion to any use of the substance resulting in effects. Based on this information, the membranes, dermal toxicity, inhalation surface water concentrations that exceed PMN substances meet the concern toxicity, dermal and eye irritation to 123 ppb, or exceedance of the annual criteria at § 721.170(b)(4)(ii). workers exposed to the PMN substance. maximum manufacturing and Recommended testing: EPA has EPA set the NCEL at 0.14 mg/m3 as an importation limit of 10,000 kg, may determined that the results of the 8–hour time-weighted average. In cause significant adverse environmental following tests would help characterize addition, based on test data on the PMN effects. Based on this information, the the environmental effects of the PMN substance, EPA predicts toxicity to PMN substance meets the concern substance: A fish acute toxicity test, aquatic organisms may occur at criteria at § 721.170(b)(4)(I). freshwater and marine (OCSPP concentrations that exceed 1 ppb of the Recommended testing: EPA has Harmonized Test Guideline 850.1075); PMN substance in surface waters. determined that the results of the an aquatic invertebrate acute toxicity Recommended testing: EPA has following tests would help characterize test, freshwater daphnids (OCSPP determined that the results of the the environmental effects of the PMN Harmonized Test Guideline 850.1010); following tests would help characterize substance: A fish early life stage toxicity an algal toxicity test, tiers I and II the health and environmental effects of test (OCSPP Harmonized Test Guideline (OCSPP Harmonized Test Guideline the PMN substance: A primary skin 850.5400); a ready biodegradability test irritation test (OECD 404 test guideline); 850.1400) and a field testing for aquatic (OCSPP Harmonized Test Guideline a primary eye irritation test (OECD 405 organisms test (OCSPP Harmonized Test 835.3110); and an activated sludge test guideline); a 28–day repeated dose Guideline 850.1950). The fish early-life sorption isotherm (OCSPP Harmonized (OECD 407 test guideline) gavage in rats, stage test should be performed using the Test Guideline 835.1110) would help a fish early life stage toxicity test flow-through method with measured characterize the environmental effects of (OCSPP Harmonized Test Guideline concentrations. Further, a certificate of the PMN substances. Testing should be 850.1400); and a daphnid chronic analysis should be provided for the test performed on P–06–267. Further, a toxicity test (OCSPP Harmonized Test substance. EPA recommends conducting certificate of analysis should be Guideline 850.1300). The PMN the early life stage fish test first, as the included for the test substances. submitter has agreed not to exceed the results of this test may affect the choice of species for subsequent field testing. CFR citations: 40 CFR 721.10195 (P–06– production volume limit without CFR citation: 40 CFR 721.10200. 265); 40 CFR 721.10196 (P–06–266, performing the primary skin irritation Chemical A); 40 CFR 721.10197 (P–06– test (OECD 404 test guideline); primary V. Rationale and Objectives of the Rule 266, Chemical B); and 40 CFR eye irritation test (OECD 405 test A. Rationale 721.10198 (P–06–267). guideline); and 28–day repeated dose PMN Number P–06–702 test (OECD 407 test guideline) gavage in During review of the PMNs submitted Chemical name: Substituted aliphatic rats. The order does not require for the chemical substances that are the amine (generic). submission of the fish early life-stage subjects of these SNURs, EPA

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concluded that for 2 of the 17 chemical § 721.160(c)(3) and § 721.170(d)(4). In PMN bona fide submissions (per substances, regulation was warranted accordance with § 721.160(c)(3)(ii) and §§ 720.25 and 721.11), the Agency under TSCA section 5(e), pending the § 721.170(d)(4)(i)(B), the effective date believes that it is highly unlikely that development of information sufficient to of this rule is August 23, 2010 without any of the significant new uses make reasoned evaluations of the health further notice, unless EPA receives described in the regulatory text of this or environmental effects of the chemical written adverse or critical comments, or rule are ongoing. substances. The basis for such findings notice of intent to submit adverse or As discussed in the Federal Register is outlined in Unit IV. Based on these critical comments before July 26, 2010. of April 24, 1990, EPA has decided that findings, TSCA section 5(e) consent If EPA receives written adverse or the intent of TSCA section 5(a)(1)(B) is orders requiring the use of appropriate critical comments, or notice of intent to best served by designating a use as a exposure controls were negotiated with submit adverse or critical comments, on significant new use as of the date of the PMN submitters. The SNUR one or more of these SNURs before July publication of this direct final rule provisions for these chemical 26, 2010, EPA will withdraw the rather than as of the effective date of the substances are consistent with the relevant sections of this direct final rule rule. If uses begun after publication provisions of the TSCA section 5(e) before its effective date. EPA will then were considered ongoing rather than consent orders. These SNURs are issue a proposed SNUR for the chemical new, it would be difficult for EPA to promulgated pursuant to § 721.160. substance(s) on which adverse or establish SNUR notice requirements In the other 15 cases, where the uses critical comments were received, because a person could defeat the SNUR are not regulated under a TSCA section providing a 30–day period for public by initiating the significant new use 5(e) consent order, EPA determined that comment. before the rule became effective, and one or more of the criteria of concern This rule establishes SNURs for a then argue that the use was ongoing established at § 721.170 were met, as number of chemical substances. Any before the effective date of the rule. discussed in Unit IV. person who submits adverse or critical Thus, persons who begin commercial comments, or notice of intent to submit manufacture, import, or processing of B. Objectives adverse or critical comments, must the chemical substances regulated EPA is issuing these SNURs for identify the chemical substance and the through this SNUR will have to cease specific chemical substances which new use to which it applies. EPA will any such activity before the effective have undergone premanufacture review not withdraw a SNUR for a chemical date of this rule. To resume their because the Agency wants to achieve substance not identified in the activities, these persons would have to the following objectives with regard to comment. comply with all applicable SNUR notice the significant new uses designated in VII. Applicability of Rule to Uses requirements and wait until the notice this rule: review period, including all extensions, • Occurring Before Effective Date of the EPA will receive notice of any Rule expires (see Unit III.). person’s intent to manufacture, import, EPA has promulgated provisions to or process a listed chemical substance Significant new use designations for a allow persons to comply with this for the described significant new use chemical substance are legally SNUR before the effective date. If a before that activity begins. established as of the date of publication person meets the conditions of advance • EPA will have an opportunity to of this direct final rule June 24, 2010. compliance under § 721.45(h), the review and evaluate data submitted in a To establish a significant ‘‘new’’ use, person is considered exempt from the SNUN before the notice submitter EPA must determine that the use is not requirements of the SNUR. ongoing. The chemical substances begins manufacturing, importing, or VIII. Test Data and Other Information processing a listed chemical substance subject to this rule have undergone for the described significant new use. premanufacture review. TSCA section EPA recognizes that TSCA section 5 • EPA will be able to regulate 5(e) consent orders have been issued for does not require developing any prospective manufacturers, importers, 2 chemical substances and the PMN particular test data before submission of or processors of a listed chemical submitters are prohibited by the TSCA a SNUN, except where the chemical substance before the described section 5(e) consent orders from substance subject to the SNUR is also significant new use of that chemical undertaking activities which EPA is subject to a test rule under TSCA substance occurs, provided that designating as significant new uses. In section 4 (see TSCA section 5(b)). regulation is warranted pursuant to cases where EPA has not received a Persons are required only to submit test TSCA sections 5(e), 5(f), 6, or 7. notice of commencement (NOC) and the data in their possession or control and • EPA will ensure that all chemical substance has not been added to describe any other data known to or manufacturers, importers, and to the TSCA Inventory, no other person reasonably ascertainable by them (see processors of the same chemical may commence such activities without § 720.50). However, upon review of substance that is subject to a TSCA first submitting a PMN. For chemical PMNs and SNUNs, the Agency has the section 5(e) consent order are subject to substances for which an NOC has not authority to require appropriate testing. similar requirements. been submitted at this time, EPA In cases where EPA issued a TSCA Issuance of a SNUR for a chemical concludes that the uses are not ongoing. section 5(e) consent order that requires substance does not signify that the However, EPA recognizes that prior to or recommends certain testing, Unit IV. chemical substance is listed on the the effective date of the rule, when lists those tests. Unit IV. also lists TSCA Inventory. Guidance on how to chemical substances identified in this recommended testing for non-5(e) determine if a chemical substance is on SNUR are added to the TSCA Inventory, SNURs. Descriptions of tests are the TSCA Inventory is available on the other persons may engage in a provided for informational purposes. Internet at http://www.epa.gov/opptintr/ significant new use as defined in this EPA strongly encourages persons, before newchems/pubs/invntory.htm. rule before the effective date of the rule. performing any testing, to consult with However, 12 of the 17 chemical the Agency pertaining to protocol VI. Direct Final Procedures substances contained in this rule have selection. To access the Harmonized EPA is issuing these SNURs as a CBI chemical identities, and since EPA Test Guidelines referenced in this direct final rule, as described in has received a limited number of post- document electronically, please go to

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http://www.epa.gov/ocspp and select IX. Procedural Determinations whether that higher volume would be a ‘‘Test Methods and Guidelines.’’ The significant new use. Organisation for Economic Co-operation By this rule, EPA is establishing X. SNUN Submissions and Development (OECD) test certain significant new uses which have guidelines are available from the OECD been claimed as CBI subject to Agency As stated in Unit II.C., according to Bookshop at http:// confidentiality regulations at 40 CFR § 721.1(c), persons submitting a SNUN www.oecdbookshop.org or SourceOECD part 2 and 40 CFR part 720, subpart E. must comply with the same notice at http://www.sourceoecd.org. Absent a final determination or other requirements and EPA regulatory In the TSCA section 5(e) consent disposition of the confidentiality claim procedures as persons submitting a orders for several of the chemical under 40 CFR part 2 procedures, EPA is PMN, including submission of test data substances regulated under this rule, required to keep this information on health and environmental effects as EPA has established production volume confidential. EPA promulgated a described in § 720.50. SNUNs must be limits in view of the lack of data on the procedure to deal with the situation submitted to EPA, on EPA Form No. potential health and environmental where a specific significant new use is 7710–25 in accordance with the risks that may be posed by the CBI. This rule cross-references procedures set forth in §§ 721.25 and significant new uses or increased § 721.1725(b)(1) and is similar to that in 720.40. This form is available from the exposure to the chemical substances. § 721.11 for situations where the Environmental Assistance Division These limits cannot be exceeded unless chemical identity of the chemical (7408M), 1200 Pennsylvania Ave., NW., the PMN submitter first submits the substance subject to a SNUR is CBI. This Washington, DC 20460–0001. Forms results of toxicity tests that would procedure is cross-referenced in each and information are also available permit a reasoned evaluation of the SNUR that includes specific significant electronically at http://www.epa.gov/ potential risks posed by these chemical new uses that are CBI. opptintr/newchems. substances. Under recent TSCA section Under these procedures a XI. Economic Analysis 5(e) consent orders, each PMN submitter manufacturer, importer, or processor EPA has evaluated the potential costs is required to submit each study at least may request EPA to determine whether of establishing SNUN requirements for 14 weeks (earlier TSCA section 5(e) a proposed use would be a significant potential manufacturers, importers, and consent orders required submissions at new use under the rule. The least 12 weeks) before reaching the processors of the chemical substances manufacturer, importer, or processor subject to this rule. EPA’s complete specified production limit. Listings of must show that it has a bona fide intent the tests specified in the TSCA section economic analysis is available in the to manufacture, import, or process the docket. 5(e) consent orders are included in Unit chemical substance and must identify IV. The SNURs contain the same the specific use for which it intends to XII. Statutory and Executive Order production volume limits as the TSCA manufacture, import, or process the Reviews section 5(e) consent orders. Exceeding chemical substance. If EPA concludes A. Executive Order 12866 these production limits is defined as a that the person has shown a bona fide significant new use. Persons who intend intent to manufacture, import, or This rule establishes SNURs for to exceed the production limit must process the chemical substance, EPA several new chemical substances that notify the Agency by submitting a will tell the person whether the use were the subject of PMNs, or TSCA SNUN at least 90 days in advance of identified in the bona fide submission section 5(e) consent orders. The Office commencement of non-exempt would be a significant new use under of Management and Budget (OMB) has commercial manufacture, import, or the rule. Since most of the chemical exempted these types of actions from processing. identities of the chemical substances review under Executive Order 12866, The recommended tests may not be subject to these SNURs are also CBI, entitled Regulatory Planning and the only means of addressing the manufacturers, importers, and Review (58 FR 51735, October 4, 1993). potential risks of the chemical processors can combine the bona fide B. Paperwork Reduction Act substance. However, SNUN submitting submission under the procedure in for significant new use without any test According to the Paperwork § 721.1725(b)(1) with that under Reduction Act (PRA), 44 U.S.C. 3501 et data may increase the likelihood that § 721.11 into a single step. EPA will take action under TSCA seq., an Agency may not conduct or section 5(e), particularly if satisfactory If EPA determines that the use sponsor, and a person is not required to test results have not been obtained from identified in the bona fide submission respond to a collection of information a prior PMN or SNUN submitter. EPA would not be a significant new use, i.e., that requires OMB approval under the recommends that potential SNUN the use does not meet the criteria PRA, unless it has been approved by submitters contact EPA early enough so specified in the rule for a significant OMB and displays a currently valid that they will be able to conduct the new use, that person can manufacture, OMB control number. The OMB control appropriate tests. import, or process the chemical numbers for EPA’s regulations in title 40 SNUN submitters should be aware substance so long as the significant new of the CFR, after appearing in the that EPA will be better able to evaluate use trigger is not met. In the case of a Federal Register, are listed in 40 CFR SNUNs which provide detailed production volume trigger, this means part 9, and included on the related information on the following: that the aggregate annual production collection instrument or form, if • Human exposure and volume does not exceed that identified applicable. EPA is amending the table in environmental release that may result in the bona fide submission to EPA. 40 CFR part 9 to list the OMB approval from the significant new use of the Because of confidentiality concerns, number for the information collection chemical substances. EPA does not typically disclose the requirements contained in this rule. • Potential benefits of the chemical actual production volume that This listing of the OMB control numbers substances. constitutes the use trigger. Thus, if the and their subsequent codification in the • Information on risks posed by the person later intends to exceed that CFR satisfies the display requirements chemical substances compared to risks volume, a new bona fide submission of PRA and OMB’s implementing posed by potential substitutes. would be necessary to determine regulations at 5 CFR part 1320. This

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Information Collection Request (ICR) is that, in response to the promulgation G. Executive Order 13045 was previously subject to public notice of over 1,400 SNURs, the Agency and comment prior to OMB approval, receives on average only 5 notices per This action is not subject to Executive and given the technical nature of the year. Of those SNUNs submitted from Order 13045, entitled Protection of table, EPA finds that further notice and 2006–2008, only one appears to be from Children from Environmental Health comment to amend it is unnecessary. As a small entity. In addition, the estimated Risks and Safety Risks (62 FR 19885, a result, EPA finds that there is ‘‘good reporting cost for submission of a SNUN April 23, 1997), because this is not an cause’’ under section 553(b)(3)(B) of the (see Unit XI.) is minimal regardless of economically significant regulatory Administrative Procedure Act, 5 U.S.C. the size of the firm. Therefore, EPA action as defined by Executive Order 553(b)(3)(B), to amend this table without believes that the potential economic 12866, and this action does not address further notice and comment. impacts of complying with these SNURs environmental health or safety risks The information collection are not expected to be significant or disproportionately affecting children. requirements related to this action have adversely impact a substantial number H. Executive Order 13211 already been approved by OMB of small entities. In a SNUR that pursuant to PRA under OMB control published in the Federal Register of This action is not subject to Executive number 2070–0012 (EPA ICR No. 574). June 2, 1997 (62 FR 29684) (FRL–5597– Order 13211, entitled Actions This action does not impose any burden 1), the Agency presented its general Concerning Regulations That requiring additional OMB approval. If determination that final SNURs are not Significantly Affect Energy Supply, an entity were to submit a SNUN to the expected to have a significant economic Distribution, or Use (66 FR 28355, May Agency, the annual burden is estimated impact on a substantial number of small 22, 2001), because this action is not to average between 30 and 170 hours entities, which was provided to the expected to affect energy supply, per response. This burden estimate Chief Counsel for Advocacy of the Small distribution, or use and because this includes the time needed to review Business Administration. action is not a significant regulatory instructions, search existing data action under Executive Order 12866. D. Unfunded Mandates Reform Act sources, gather and maintain the data I. National Technology Transfer and needed, and complete, review, and Based on EPA’s experience with Advancement Act submit the required SNUN. proposing and finalizing SNURs, State, Send any comments about the local, and Tribal governments have not In addition, since this action does not accuracy of the burden estimate, and been impacted by these rulemakings, involve any technical standards, section any suggested methods for minimizing and EPA does not have any reasons to 12(d) of the National Technology respondent burden, including through believe that any State, local, or Tribal Transfer and Advancement Act of 1995 the use of automated collection government will be impacted by this (NTTAA), Public Law 104–113, section techniques, to the Director, Collection rule. As such, EPA has determined that 12(d) (15 U.S.C. 272 note), does not Strategies Division, Office of this rule does not impose any apply to this action. Environmental Information (2822T), enforceable duty, contain any unfunded Environmental Protection Agency, 1200 mandate, or otherwise have any affect J. Executive Order 12898 Pennsylvania Ave., NW., Washington, on small governments subject to the This action does not entail special DC 20460–0001. Please remember to requirements of sections 202, 203, 204, considerations of environmental justice include the OMB control number in any or 205 of the Unfunded Mandates related issues as delineated by correspondence, but do not submit any Reform Act of 1995 (UMRA) (Public Executive Order 12898, entitled Federal completed forms to this address. Law 104–4). Actions to Address Environmental C. Regulatory Flexibility Act E. Executive Order 13132 Justice in Minority Populations and Low-Income Populations (59 FR 7629, Pursuant to section 605(b) of the This action will not have a substantial February 16, 1994). Regulatory Flexibility Act (RFA) (5 direct effect on States, on the U.S.C. 601 et seq.), the Agency hereby relationship between the national XIII. Congressional Review Act certifies that promulgation of these government and the States, or on the SNURs will not have a significant The Congressional Review Act, 5 distribution of power and U.S.C. 801 et seq., generally provides adverse economic impact on a responsibilities among the various substantial number of small entities. that before a rule may take effect, the levels of government, as specified in agency promulgating the rule must The rationale supporting this Executive Order 13132, entitled conclusion is discussed in this unit. The submit a rule report, which includes a Federalism (64 FR 43255, August 10, copy of the rule, to each House of the requirement to submit a SNUN applies 1999). to any person (including small or large Congress and to the Comptroller General entities) who intends to engage in any F. Executive Order 13175 of the United States. EPA will submit a activity described in the rule as a This rule does not have Tribal report containing this rule and other ‘‘significant new use.’’ Because these implications because it is not expected required information to the U.S. Senate, uses are ‘‘new,’’ based on all information to have substantial direct effects on the U.S. House of Representatives, and currently available to EPA, it appears Indian Tribes. This does not the Comptroller General of the United that no small or large entities presently significantly or uniquely affect the States prior to publication of the rule in engage in such activities. A SNUR communities of Indian Tribal the Federal Register. This rule is not a requires that any person who intends to governments, nor does it involve or ‘‘major rule’’ as defined by 5 U.S.C. engage in such activity in the future impose any requirements that affect 804(2). must first notify EPA by submitting a Indian Tribes. Accordingly, the List of Subjects SNUN. Although some small entities requirements of Executive Order 13175, may decide to pursue a significant new entitled Consultation and Coordination 40 CFR Part 9 use in the future, EPA cannot presently with Indian Tribal Governments (65 FR Environmental protection, Reporting determine how many, if any, there may 67249, November 9, 2000), do not apply and recordkeeping requirements. be. However, EPA’s experience to date to this rule. 40 CFR Part 721

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Environmental protection, Chemicals, PART 721—[AMENDED] apply to this section except as modified Hazardous substances, Reporting and by this paragraph. recordkeeping requirements. ■ 3. The authority citation for part 721 (1) Recordkeeping. Recordkeeping continues to read as follows: requirements as specified in § 721.125 Dated: June 17, 2010. Authority: 15 U.S.C. 2604, 2607, and (a), (b), (c), and (i) are applicable to Wendy C. Hamnett, 2625(c). manufacturers, importers, and Director, Office of Pollution Prevention and ■ processors of this substance. Toxics. 4. Add § 721.10184 to subpart E to (2) Limitations or revocation of read as follows: certain notification requirements. The ■ Therefore, 40 CFR parts 9 and 721 are provisions of § 721.185 apply to this amended as follows: § 721.10184 Aliphatic triamine (generic). (a) Chemical substance and section. PART 9—[AMENDED] significant new uses subject to reporting. ■ 6. Add § 721.10186 to subpart E to (1) The chemical substance identified read as follows: ■ 1. The authority citation for part 9 generically as aliphatic triamine (PMN § 721.10186 Ethylhexyl oxetane (generic). continues to read as follows: P–02–996) is subject to reporting under (a) Chemical substance and this section for the significant new uses Authority: 7 U.S.C. 135 et seq., 136–136y; significant new uses subject to reporting. described in paragraph (a)(2) of this 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; (1) The chemical substance identified 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 section. (2) The significant new uses are: generically as ethylhexyl oxetane (PMN U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, P–04–132) is subject to reporting under 1321, 1326, 1330, 1342, 1344, 1345 (d) and (i) Industrial, commercial, and consumer activities. Requirements as this section for the significant new uses (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, described in paragraph (a)(2) of this 1971–1975 Comp. p. 973; 42 U.S.C. 241, specified in § 721.80(y)(1). 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, (ii) Release to water. Requirements as section. The requirements of this rule do 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, specified in § 721.90 (a)(1), (b)(1), and not apply to quantities of the PMN 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., (c)(1). substance after it has been completely 6901–6992k, 7401–7671q, 7542, 9601–9657, (b) Specific requirements. The reacted (cured). 11023, 11048. provisions of subpart A of this part (2) The significant new uses are: apply to this section except as modified (i) Protection in the workplace. ■ 2. The table in § 9.1 is amended by by this paragraph. Requirements as specified in § 721.63 adding the following sections in (1) Recordkeeping. Recordkeeping (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3)(i), (b) numerical order under the undesignated requirements as specified in § 721.125 (concentration set at 1.0 percent), and center heading ‘‘Significant New Uses of (a), (b), (c), (i), and (k) are applicable to (c). Polyvinyl Alcohol gloves with a Chemical Substances’’ to read as manufacturers, importers, and thickness of no less than 31.3 mils or follows: processors of this substance. Silvershield/4H sleeves with a thickness (2) Limitations or revocation of of no less than 2.7 mils have been § 9.1 OMB approvals under the Paperwork shown to satisfy the requirements of Reduction Act. certain notification requirements. The provisions of § 721.185 apply to this § 721.63(a)(3)(i) for up to 8 hours. * * * * * section. (ii) Hazard communication program. ■ Requirements as specified in § 721.72 40 CFR citation OMB control No. 5. Add § 721.10185 to subpart E to (a), (b), (c), (d), (e) (concentration set at read as follows: 1.0 percent), (f), (g)(1)(iii), (g)(1)(iv), *** * * § 721.10185 1,2-Propanediol, 3- (g)(2)(i), (g)(2)(v), (g)(3)(ii), and (g)(5). (diethylamino)-, polymers with 5- (iii) Industrial, commercial, and . isocyanato-1- (isocyanatomethyl)-1,3,3- consumer activities. Requirements as Significant New Uses of Chemical trimethylcyclohexane, propylene glycol and specified in § 721.80(k). Substances reduced Me esters of reduced polymd. (b) Specific requirements. The oxidized tetrafluoroethylene, 2-ethyl-1- provisions of subpart A of this part *** * * hexanol-blocked, acetates (salts). apply to this section except as modified (a) Chemical substance and by this paragraph. 721.10184 ...... 2070–0012 significant new uses subject to reporting. (1) Recordkeeping. Recordkeeping 721.10185 ...... 2070–0012 (1) The chemical substance identified as requirements as specified in § 721.125 721.10186 ...... 2070–0012 1,2-propanediol, 3-(diethylamino)-, (a), (b), (c), (d), (e), (f), (g), (h), and (i) 721.10187 ...... 2070–0012 polymers with 5-isocyanato-1- are applicable to manufacturers, 721.10188 ...... 2070–0012 (isocyanatomethyl)-1,3,3- importers, and processors of this 721.10189 ...... 2070–0012 trimethylcyclohexane, propylene glycol substance. 721.10190 ...... 2070–0012 and reduced Me esters of reduced (2) Limitations or revocation of 721.10191 ...... 2070–0012 polymd. oxidized tetrafluoroethylene, 2- 721.10192 ...... 2070–0012 certain notification requirements. The 721.10193 ...... 2070–0012 ethyl-1-hexanol-blocked, acetates (salts) provisions of § 721.185 apply to this 721.10194 ...... 2070–0012 (PMN P–03–106; CAS No. 328389–90–8) section. 721.10195 ...... 2070–0012 is subject to reporting under this section (3) Determining whether a specific use 721.10196 ...... 2070–0012 for the significant new uses described in is subject to this section. The provisions 721.10197 ...... 2070–0012 paragraph (a)(2) of this section. of § 721.1725(b)(1) apply to this section. 721.10198 ...... 2070–0012 (2) The significant new uses are: ■ 7. Add § 721.10187 to subpart E to 721.10199 ...... 2070–0012 (i) Industrial, commercial, and read as follows: 721.10200 ...... 2070–0012 consumer activities. Requirements as *** * * specified in § 721.80(y)(l). § 721.10187 4-Morpholinepropanamine, N- (ii) [Reserved] (1,3-dimethylbutylidene)-. (b) Specific requirements. The (a) Chemical substance and * * * * * provisions of subpart A of this part significant new uses subject to reporting.

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(1) The chemical substance identified as [(N1 x Release1) + (N2 x Release2) + (ii) [Reserved] 4-morpholinepropanamine, N-(1,3- (N3 x Release3) + (N4 x Release4)] / (b) Specific requirements. The dimethylbutylidene)- (PMN P–05–186, (Release1 + Release2 + Release3 + provisions of subpart A of this part Chemical A; CAS No. 1003863–30–6) is Release4) = Adjusted N apply to this section except as modified subject to reporting under this section Where the ‘‘N’’ variables are the N by this paragraph. for the significant new uses described in values for each of the four substances as (1) Recordkeeping. Recordkeeping paragraph (a)(2) of this section. specified in this section and requirements as specified in § 721.125 (2) The significant new uses are: § 721.10187, § 721.10189, § 721.10190 (a), (b), (c), and (k) are applicable to (i) Release to water. Requirements as and the ‘‘Release’’ variables are the manufacturers, importers, and specified in § 721.90 (a)(4), (b)(4), and number of kilograms released of the processors of this substance. (c)(4) (N=10). However, when this respective four substances (in units of (2) Limitations or revocation of chemical substance is released in kg/site/day) per § 721.91(a). certain notification requirements. The combination with any of the substances (ii) [Reserved] provisions of § 721.185 apply to this (b) Specific requirements. The in § 721.10188, § 721.10189, or section. § 721.10190, then the value of N shall provisions of subpart A of this part ■ 10. Add § 721.10190 to subpart E to instead be adjusted according to the apply to this section except as modified read as follows: following formula: by this paragraph. [(N1 x Release1) + (N2 x Release2) + (1) Recordkeeping. Recordkeeping § 721.10190 Formaldehyde, polymer with (N3 x Release3) + (N4 x Release4)] / requirements as specified in § 721.125 aliphatic diamine and phenol, reaction (Release1 + Release2 + Release3 + (a), (b), (c), and (k) are applicable to products with 4-methyl-2-pentanone Release4) = Adjusted N manufacturers, importers, and (generic). Where the ‘‘N’’ variables are the N processors of this substance. (a) Chemical substance and (2) Limitations or revocation of values for each of the four substances as significant new uses subject to reporting. certain notification requirements. The specified in this section and (1) The chemical substance identified provisions of § 721.185 apply to this § 721.10188, § 721.10189, § 721.10190 generically as formaldehyde, polymer section. and the ‘‘Release’’ variables are the with aliphatic diamine and phenol, ■ number of kilograms released of the 9. Add § 721.10189 to subpart E to reaction products with 4-methyl-2- respective four substances (in units of read as follows: pentanone (PMN P–05–186; Chemical kg/site/day) per § 721.91(a). § 721.10189 Fatty acids, tall-oil, reaction D) is subject to reporting under this (ii) [Reserved] products with (butoxymethyl) oxirane section for the significant new uses (b) Specific requirements. The formaldehyde-phenol polymer glycidyl described in paragraph (a)(2) of this provisions of subpart A of this part ether, morpholinepropanamine, propylene section. apply to this section except as modified glycol diamine and aliphatic polyamine, N- (2) The significant new uses are: (1,3 -dimethylbutylidene) derivs (generic). by this paragraph. (i) Release to water. Requirements as (1) Recordkeeping. Recordkeeping (a) Chemical substance and specified in § 721.90 (a)(4), (b)(4), and requirements as specified in § 721.125 significant new uses subject to reporting. (c)(4) (N=10). However, when this (a), (b), (c), and (k) are applicable to (1) The chemical substance identified chemical substance is released in manufacturers, importers, and generically as fatty acids, tall-oil, combination with any of the substances processors of this substance. reaction products with (butoxymethyl) in § 721.10187, § 721.10188, or (2) Limitations or revocation of oxirane formaldehyde-phenol polymer § 721.10189, then the value of N shall certain notification requirements. The glycidyl ether, morpholinepropanamine, instead be adjusted according to the provisions of § 721.185 apply to this propylene glycol diamine and aliphatic following formula: section. polyamine, N-(1,3 -dimethylbutylidene) [(N1 x Release1) + (N2 x Release2) + ■ 8. Add § 721.10188 to subpart E to derivs (PMN P–05–186, Chemical C) is (N3 x Release3) + (N4 x Release4)] / subject to reporting under this section read as follows: (Release1 + Release2 + Release3 + for the significant new uses described in Release4) = Adjusted N § 721.10188 Fatty acids, tall-oil, reaction paragraph (a)(2) of this section. products with 4-methyl-2-pentanone and (2) The significant new uses are: Where the ‘‘N’’ variables are the N aliphatic polyamine (generic). (i) Release to water. Requirements as values for each of the four substances as (a) Chemical substance and specified in § 721.90 (a)(4), (b)(4), and specified in this section and significant new uses subject to reporting. (c)(4) (N=10). However, when this § 721.10187, § 721.10188, § 721.10189 (1) The chemical substance identified chemical substance is released in and the ‘‘Release’’ variables are the generically as fatty acids, tall-oil, combination with any of the substances number of kilograms released of the reaction products with 4-methyl-2- in § 721.10187, § 721.10188, or respective four substances (in units of pentanone and aliphatic polyamine § 721.10190, then the value of N shall kg/site/day) per § 721.91(a). (PMN P–05–186, Chemical B) is subject instead be adjusted according to the (ii) [Reserved] to reporting under this section for the following formula: (b) Specific requirements. The significant new uses described in [(N1 x Release1) + (N2 x Release2) + provisions of subpart A of this part paragraph (a)(2) of this section. (N3 x Release3) + (N4 x Release4)] / apply to this section except as modified (2) The significant new uses are: (Release1 + Release2 + Release3 + by this paragraph. (i) Release to water. Requirements as Release4) = Adjusted N (1) Recordkeeping. Recordkeeping specified in § 721.90 (a)(4), (b)(4), and Where the ‘‘N’’ variables are the N requirements as specified in § 721.125 (c)(4) (N=10). However, when this values for each of the four substances as (a), (b), (c), and (k) are applicable to chemical substance is released in specified in this section and manufacturers, importers, and combination with any of the substances § 721.10187, § 721.10188, § 721.10190 processors of this substance. in § 721.10187, § 721.10189, or and the ‘‘Release’’ variables are the (2) Limitations or revocation of § 721.10190, then the value of N shall number of kilograms released of the certain notification requirements. The instead be adjusted according to the respective four substances (in units of provisions of § 721.185 apply to this following formula: kg/site/day) per § 721.91(a). section.

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■ 11. Add § 721.10191 to subpart E to § 721.10193 1-Butanaminium, N-(3- (1) The chemical substance identified read as follows: aminopropyl)-N-butyl-N-(2-carboxyethyl)-, generically as N-coco acyl derivs., inner salts. dialkylcornoilamidoalkylamine (PMN § 721.10191 Amides, coco, N-[3- (a) Chemical substance and P–06–265) is subject to reporting under (dibutylamino)propyl]. significant new uses subject to reporting. this section for the significant new uses (a) Chemical substance and (1) The chemical substance identified as described in paragraph (a)(2) of this significant new uses subject to reporting. 1-butanaminium, N-(3-aminopropyl)-N- section. (1) The chemical substance identified as butyl-N-(2-carboxyethyl)-, N-coco acyl (2) The significant new uses are: amides, coco, N-[3- derivs., inner salts (PMN P–06–263, (i) Release to water. Requirements as (dibutylamino)propyl] (PMN P–06–262; Chemical B; CAS No. 851545–17–0) is specified in § 721.90 (a)(1), (b)(1), and CAS No. 851544–20–2) is subject to subject to reporting under this section (c)(1). reporting under this section for the for the significant new uses described in (ii) [Reserved] significant new uses described in paragraph (a)(2) of this section. (b) Specific requirements. The paragraph (a)(2) of this section. (2) The significant new uses are: provisions of subpart A of this part (2) The significant new uses are: (i) Release to water. Requirements as apply to this section except as modified (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and by this paragraph. specified in § 721.90 (a)(1), (b)(1), and (c)(1). (1) Recordkeeping. Recordkeeping (ii) [Reserved] requirements as specified in § 721.125 (c)(1). (b) Specific requirements. The (ii) [Reserved] (a), (b), (c), and (k) are applicable to provisions of subpart A of this part manufacturers, importers, and (b) Specific requirements. The apply to this section except as modified provisions of subpart A of this part processors of this substance. by this paragraph. (2) Limitations or revocation of apply to this section except as modified (1) Recordkeeping. Recordkeeping by this paragraph. certain notification requirements. The requirements as specified in § 721.125 provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping (a), (b), (c), and (k) are applicable to section. requirements as specified in § 721.125 manufacturers, importers, and ■ (a), (b), (c), and (k) are applicable to processors of this substance. 16. Add § 721.10196 to subpart E to manufacturers, importers, and (2) Limitations or revocation of read as follows: processors of this substance. certain notification requirements. The § 721.10196 Dialkylcornoilamidoacrylate (2) Limitations or revocation of provisions of § 721.185 apply to this (generic). certain notification requirements. The section. (a) Chemical substance and provisions of § 721.185 apply to this ■ 14. Add § 721.10194 to subpart E to significant new uses subject to reporting. section. read as follows: (1) The chemical substance identified ■ 12. Add § 721.10192 to subpart E to § 721.10194 generically as read as follows[U1]: Dialkylcocoamidoalkylpropionate (generic). dialkylcornoilamidoacrylate (PMN P– (a) Chemical substance and 06–266, Chemical A) is subject to § 721.10192 Amides, coco, N-[3- reporting under this section for the (dibutylamino)propyl], acrylates. significant new uses subject to reporting. (1) The chemical substance identified significant new uses described in (a) Chemical substance and generically as paragraph (a)(2) of this section. significant new uses subject to reporting. dialkylcocoamidoalkylpropionate (PMN (2) The significant new uses are: (1) The chemical substance identified as (i) Release to water. Requirements as P–06–264) is subject to reporting under amides, coco, N-[3- specified in § 721.90 (a)(1), (b)(1), and this section for the significant new uses (dibutylamino)propyl], acrylates (PMN (c)(1). described in paragraph (a)(2) of this P–06–263, Chemical A; CAS No. (ii) [Reserved] section. 851545–09–0) is subject to reporting (b) Specific requirements. The (2) The significant new uses are: under this section for the significant (i) Release to water. Requirements as provisions of subpart A of this part new uses described in paragraph (a)(2) specified in § 721.90 (a)(1), (b)(1), and apply to this section except as modified of this section. (c)(1). by this paragraph. (2) The significant new uses are: (ii) [Reserved] (1) Recordkeeping. Recordkeeping (i) Release to water. Requirements as (b) Specific requirements. The requirements as specified in § 721.125 specified in § 721.90 (a)(1), (b)(1), and provisions of subpart A of this part (a), (b), (c), and (k) are applicable to (c)(1). apply to this section except as modified manufacturers, importers, and (ii) [Reserved] by this paragraph. processors of this substance. (b) Specific requirements. The (1) Recordkeeping. Recordkeeping (2) Limitations or revocation of provisions of subpart A of this part requirements as specified in § 721.125 certain notification requirements. The apply to this section except as modified (a), (b), (c), and (k) are applicable to provisions of § 721.185 apply to this by this paragraph. manufacturers, importers, and section. (1) Recordkeeping. Recordkeeping processors of this substance. ■ 17. Add § 721.10197 to subpart E to requirements as specified in § 721.125 (2) Limitations or revocation of read as follows: (a), (b), (c), and (k) are applicable to certain notification requirements. The provisions of § 721.185 apply to this § 721.10197 manufacturers, importers, and Dialkycornoilamidoalkylbetaine (generic). section. processors of this substance. (a) Chemical substance and (2) Limitations or revocation of ■ 15. Add § 721.10195 to subpart E to read as follows: significant new uses subject to reporting. certain notification requirements. The (1) The chemical substance identified provisions of § 721.185 apply to this § 721.10195 generically as section. Dialkylcornoilamidoalkylamine (generic). dialkycornoilamidoalkylbetaine (PMN ■ 13. Add § 721.10193 to subpart E to (a) Chemical substance and P–06–266, Chemical B) is subject to read as follows: significant new uses subject to reporting. reporting under this section for the

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significant new uses described in (i) Protection in the workplace. apply to this section except as modified paragraph (a)(2) of this section. Requirements as specified in § 721.63 by this paragraph. (2) The significant new uses are: (a)(1), (a)(2), (a)(3)(i), (a)(4), (a)(5), (a)(6), (1) Recordkeeping. Recordkeeping (i) Release to water. Requirements as (b) (concentration set at 1.0 percent), requirements as specified in § 721.125 specified in § 721.90 (a)(1), (b)(1), and and (c). Ansell NEOX style 9–912 gloves (a), (b), (c), (d), (e), (f), (g), (h), (i), and (c)(1). have been shown to satisfy the (k) are applicable to manufacturers, (ii) [Reserved] requirements of § 721.63(a)(3)(i) for up importers, and processors of this (b) Specific requirements. The to 110 minutes. Respirators must substance. provisions of subpart A of this part provide a National Institute for (2) Limitations or revocation of apply to this section except as modified Occupational Safety and Health certain notification requirements. The by this paragraph. (NIOSH) assigned protection factor provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping (APF) of at least 50. The following section. requirements as specified in § 721.125 NIOSH-approved respirators meet the (3) Determining whether a specific use (a), (b), (c), and (k) are applicable to requirements for § 721.63(a)(4): Air is subject to this section. The provisions manufacturers, importers, and purifying, tight-fitting full-face of § 721.1725(b)(1) apply to this section. processors of this substance. respirator equipped with the ■ 20. Add § 721.10200 to subpart E to (2) Limitations or revocation of appropriate combination cartridges, read as follows: certain notification requirements. The cartridges should be tested and provisions of § 721.185 apply to this § 721.10200 Benzenacetonitrile, approved for the gas/vapor substance cyclohexylidene-alkyl substituted (generic). section. (i.e., organic vapor, acid gas, or (a) Chemical substance and ■ substance-specific cartridge) and should 18. Add § 721.10198 to subpart E to significant new uses subject to reporting. read as follows: include a particulate filter (N100 if oil aerosols are absent, R100, or P100); (1) The chemical substance identified § 721.10198 powered air-purifying respirator generically as benzenacetonitrile, Dialkylcornoilamidopropionate (generic). equipped with a tight-fitting facepiece cyclohexylidene-alkyl substituted (PMN (a) Chemical substance and (full-face) and the appropriate P–09–75) is subject to reporting under significant new uses subject to reporting. combination cartridges, cartridges this section for the significant new uses (1) The chemical substance identified should be tested and approved for the described in paragraph (a)(2) of this generically as gas/vapor substance (i.e., organic vapor, section. (2) The significant new uses are: dialkylcornoilamidopropionate (PMN acid gas, or substance-specific P–06–267) is subject to reporting under (i) Industrial, commercial, and cartridges) and should include High consumer activities. Requirements as this section for the significant new uses Efficiency Particulate Air (HEPA) filters; described in paragraph (a)(2) of this specified in § 721.80(s) (10,000 kg). supplied-air respirator operated in (ii) Release to water. Requirements as section. pressure demand or continuous flow specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: mode and equipped with a tight-fitting (c)(4) (N=123). (i) Release to water. Requirements as face piece (full-face). As an alternative (b) Specific requirements. The specified in § 721.90 (a)(1), (b)(1), and to the respiratory requirements listed provisions of subpart A of this part (c)(1). here, a manufacturer, importer, or apply to this section except as modified (ii) [Reserved] processor may choose to follow the new by this paragraph. (b) Specific requirements. The chemical exposure limit (NCEL) (1) Recordkeeping. Recordkeeping provisions of subpart A of this part provisions listed in the Toxic requirements as specified in § 721.125 apply to this section except as modified Substances Control Act (TSCA) section (a), (b), (c), (i), and (k) are applicable to by this paragraph. 5(e) consent order for this substance. manufacturers, importers, and (1) Recordkeeping. Recordkeeping 3 The NCEL is 0.14 mg/m as an 8–hour processors of this substance. requirements as specified in § 721.125 time-weighted average. Persons who (2) Limitations or revocation of (a), (b), (c), and (k) are applicable to wish to pursue NCELs as an alternative certain notification requirements. The manufacturers, importers, and to the § 721.63 respirator requirements provisions of § 721.185 apply to this processors of this substance. may request to do so under § 721.30. section. (2) Limitations or revocation of Persons whose § 721.30 requests to use [FR Doc. 2010–15334 Filed 6–23–10; 8:45 am] certain notification requirements. The the NCELs approach are approved by provisions of § 721.185 apply to this EPA will receive NCELs provisions BILLING CODE 6560–50–S section. comparable to those contained in the ■ 19. Add § 721.10199 to subpart E to corresponding section 5(e) consent read as follows: order. FEDERAL COMMUNICATIONS (ii) Hazard communication program. COMMISSION § 721.10199 Substituted aliphatic amine Requirements as specified in § 721.72 47 CFR Part 27 (generic). (a), (b), (c), (d), (e) (concentration set at (a) Chemical substance and 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), [WT Docket No. 03–66; RM–10586; FCC 10– significant new uses subject to reporting. (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 107] (1) The chemical substance identified (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), generically as substituted aliphatic (g)(4)(iii), and (g)(5). Facilitating the Provision of Fixed and amine (PMN P–06–702) is subject to (iii) Industrial, commercial, and Mobile Broadband Access, reporting under this section for the consumer activities. Requirements as Educational and Other Advanced significant new uses described in specified in § 721.80(r). Services in the 2150–2162 and 2500– paragraph (a)(2) of this section. The (iv) Release to water. Requirements as 2690 MHz Bands requirements of this rule do not apply specified in § 721.90 (a)(1), (b)(1), and AGENCY: Federal Communications to quantities of the PMN substance after (c)(1). Commission. it has been completely reacted (cured). (b) Specific requirements. The ACTION: Correction. (2) The significant new uses are: provisions of subpart A of this part

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SUMMARY: The FCC published a pacificum) on the islands of Hawaii, group, which began its evolution document in the Federal Register of Maui, and Molokai. This final rule perhaps as long as 10 million years ago June 15, 2010, (75 FR 33729), clarifying implements the Federal protections (Jordan et al. 2003, p. 89), is the narrow- the requirements necessary for provided by the Act for these species. winged Hawaiian damselfly genus Broadband Radio Service (BRS) and We also determine that critical habitat Megalagrion. This genus appears to be Educational Broadband Service (EBS) for these two Hawaiian damselflies is most closely related to species of licensees to demonstrate substantial prudent, but not determinable at this Pseudagrion elsewhere in the Indo- service and ensure that BRS licensees of time. Pacific (Zimmerman 1948a, pp. 341, new initial licenses are given a DATES: This rule becomes effective July 345). The Megalagrion species of the reasonable period of time to deploy 26, 2010. Hawaiian Islands have evolved to occupy as many larval breeding niches service, while ensuring that spectrum is ADDRESSES: This final rule is available (different adaptations and ecological rapidly placed in use. The document on the Internet at http:// conditions for breeding and contained an incorrect page number in www.regulations.gov and http:// development of larvae, including reference to the BRS/EBS Third Further www.fws.gov/pacificislands. Comments chemical, physical, spatial, and Notice of Proposed Rulemaking citation. and materials received, as well as temporal factors) as all the rest of the DATES: Effective July 15, 2010. supporting documentation used in the world’s damselfly species combined, FOR FURTHER INFORMATION CONTACT: preparation of this rule, will be and in terms of the number of insular- available for public inspection, by Nancy M. Zaczek, Wireless endemic (native to only one island) appointment, during normal business Telecommunications Bureau, species, are exceeded only by the hours at: U.S. Fish and Wildlife Service, Broadband Division, Federal radiation of damselfly species of Fiji in Pacific Islands Fish and Wildlife Office, Communications Commission, 445 12th the Pacific (Jordan et al. 2003, p. 91). Street, SW., Washington, DC 20554, at 300 Ala Moana Boulevard, Room 3-122, Native Hawaiians apparently did not (202) 418–0274 or via the Internet to Box 50088, Honolulu, HI 96850; differentiate the various species, but [email protected]. telephone, 808-792-9400; facsimile, 808- referred to the native damselflies (and 792-9581. Correction dragonflies) collectively as ‘‘pinao,’’ and FOR FURTHER INFORMATION CONTACT: to the red-colored damselflies In the Federal Register 75 FR 33729 Loyal Mehrhoff, Field Supervisor, specifically as ‘‘pinao ula.’’ There has published on Tuesday, June 15, 2010, Pacific Islands Fish and Wildlife Office been no traditional European use of a the following correction is made: On (see ADDRESSES). If you use a common name for species in the genus page 33730, second column, paragraph telecommunications device for the deaf Megalagrion. In his 1994 taxonomic 3, first sentence, remove the phrase ‘‘74 (TDD), call the Federal Information review of the candidate species of FR 49335’’ and insert ‘‘74 FR 49356.’’ Relay Service (FIRS) at 800-877-8339. insects of the Hawaiian Islands, Nishida Marlene H. Dortch, SUPPLEMENTARY INFORMATION: (1994, pp. 4-7) proposed the name ‘‘Hawaiian damselflies’’ as the common Secretary, Federal Communications Background Commission. name for species in the genus Damselflies are insects in the order [FR Doc. 2010–15348 Filed 6–23–10; 8:45 am] Megalagrion. Because this name reflects Odonata, and are close relatives of the restricted distribution of these BILLING CODE 6712–01–P dragonflies, which they resemble in insects and is nontechnical, the appearance. Damselflies, however, are common name ‘‘Hawaiian damselflies’’ slender-bodied and fold their wings is adopted for general use here, and we DEPARTMENT OF THE INTERIOR parallel to the body while at rest, which use the common names flying earwig readily distinguishes them from their Fish and Wildlife Service Hawaiian damselfly and Pacific dragonfly relatives, which hold their Hawaiian damselfly to identify the two wings out perpendicular to the body 50 CFR Part 17 species addressed in this final rule. while not in flight. The general biology of Hawaiian [Docket No. FWS-R1-ES-2009-0036] The flying earwig Hawaiian damselfly damselflies is typical of other narrow- [MO 92210-0-0008] and the Pacific Hawaiian damselfly are winged damselflies (Polhemus and unique, endemic insects found only in Asquith 1996, pp. 2-7). The males of RIN 1018-AV47 the Hawaiian Islands. Historically found most species are territorial, guarding Endangered and Threatened Wildlife on the islands of Hawaii and Maui, the areas of habitat where females lay eggs and Plants; Listing the Flying Earwig flying earwig Hawaiian damselfly has (Moore 1983a, p. 89). During copulation, Hawaiian Damselfly and Pacific not been seen on the island of Hawaii and often while the female lays eggs, the Hawaiian Damselfly As Endangered for over 80 years. Currently, the species male grasps the female behind the head Throughout Their Ranges is known only from one location on with terminal abdominal appendages to Maui. The Pacific Hawaiian damselfly guard the female against rival males; AGENCY: Fish and Wildlife Service, was historically found on all of the main thus males and females are frequently Interior. Hawaiian Islands except Kahoolawe and seen flying in tandem. ACTION: Final rule. Niihau. Currently, the Pacific Hawaiian Female damselflies lay eggs in damselfly is known only from the submerged aquatic vegetation or in mats SUMMARY: We, the U.S. Fish and islands of Hawaii, Maui and Molokai. of moss or algae on submerged rocks, Wildlife Service (Service), determine The Hawaiian Islands are well known and hatching occurs in about 10 days endangered status under the for several spectacular evolutionary (Williams 1936, pp. 303, 306, 318; Endangered Species Act of 1973, as radiations (the rapid evolution of new Evenhuis et al. 1995, p. 18). In most amended (Act), for two species of species from a single ancestral type, as species of Hawaiian damselflies, the Hawaiian damselflies, the flying earwig a result of adaptation and divergence in immature larval stages (naiads) are Hawaiian damselfly (Megalagrion response to new ecological conditions) aquatic, breathing through three nesiotes) on the island of Maui and the resulting in unique insect fauna found flattened abdominal gills, and are Pacific Hawaiian damselfly (M. nowhere else in the world. One such predaceous, feeding on small aquatic

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invertebrates or fish (Williams 1936, p. Previous Federal Actions In fiscal year 2007, we determined 303). Naiads may take up to 4 months that funding was available to initiate to mature (Williams 1936, p. 309), after Both the flying earwig Hawaiian work on listing determinations for these which they crawl out of the water onto damselfly and the Pacific Hawaiian two species. On July 8, 2009, we rocks or vegetation to molt into winged damselfly were first designated as published a proposed rule to list the adults, typically remaining close to the candidate species on May 22, 1984 (49 flying earwig Hawaiian damselfly and aquatic habitat from which they FR 21664). Candidate species are those the Pacific Hawaiian damselfly as emerged. The Pacific Hawaiian taxa for which the Service has sufficient endangered (74 FR 32490). We solicited damselfly exhibits this typical aquatic information on their biological status data and comments from the public on life history. and threats to propose them for listing the proposed rule for 60 days, ending under the Act (16 U.S.C. 1531 et seq.), September 8, 2009. To allow the public In contrast, the naiads of a few species but for which the development of a of Hawaiian damselflies are terrestrial or and interested parties additional time to listing regulation has been precluded by submit comments on the proposed rule, semiterrestrial, living on wet rock faces other higher-priority listing activities. or in damp terrestrial conditions, we reopened the comment period on The flying earwig Hawaiian damselfly November 19, 2009 (74 FR 59956), and inhabiting wet leaf litter or moist leaf was removed from the candidate list on accepted comments until December 21, axils (the angled juncture of the leaf and November 21, 1991 (56 FR 58804), 2009. stem) of native plants up to several feet whereas the Pacific Hawaiian damselfly above ground (Zimmerman 1970, p. 33; retained its status as a candidate Species Information Simon et al. 1984, p. 13; Polhemus and species. On November 15, 1994 (59 FR Flying Earwig Hawaiian Damselfly Asquith 1996, p. 17). The naiads of 58982), the flying earwig Hawaiian The flying earwig Hawaiian damselfly these terrestrial and semiterrestrial damselfly was added back onto the species have evolved short, thick, hairy was first described from specimens candidate list. In the Candidate Notice collected in the 1890s in Puna on gills and in many species are unable to of Review (CNOR) published on swim (Polhemus and Asquith 1996, p. Hawaii Island by R.C.L. Perkins (1899, February 28, 1996 (61 FR 7595), we p. 72). Kennedy (1934, pp. 343-345) 75). The flying earwig Hawaiian announced a revised list of plant and damselfly is believed to exhibit this described what was believed at the time animal taxa that we regarded as to be a new species of damselfly based terrestrial or semiterrestrial naiad life candidates for possible addition to the history. on specimens from Maui; these were Lists of Threatened and Endangered later determined to be synonymous with The Hawaiian damselflies are Wildlife and Plants. This revision also the specimens collected by Perkins. The represented by 23 species and 5 included a new ranking system, flying earwig Hawaiian damselfly is a subspecies, and are currently found on whereby each candidate species was comparatively large and elongated 6 of the Hawaiian Islands (Kauai, Oahu, assigned a Listing Priority Number species. The males are blue and black in Molokai, Maui, Lanai, and Hawaii). (LPN) from 1 to 12. Both the flying color and exhibit distinctive, greatly There are more species of Megalagrion earwig Hawaiian damselfly and the enlarged, pincer-like cerci (paired on the geologically older islands (12 Pacific Hawaiian damselfly were appendages on the rearmost segment of species on Kauai) than on the assigned an LPN of 2 on February 28, the abdomen used to clasp the female geologically youngest island (8 species 1996 (61 FR 7595). during mating). It is for the males’ on Hawaii), and there are more single- On May 4, 2004, the Center for elongated abdominal appendages and island endemic species on the older Biological Diversity petitioned the their resemblance to those found on islands (10 on Kauai) than on the Secretary of the Interior to list 225 earwigs (order Dermaptera) that the youngest island (none on Hawaii) species of plants and animals that were species is named. Females are (Jordan et al. 2003, p. 91). Historically, already candidates, including these two predominantly brownish in color. The Megalagrion damselflies were among Hawaiian damselfly species, as adults measure from 1.8 to 1.9 inches the most common and conspicuous endangered or threatened under the (in) (46 to 50 millimeters (mm)) in native Hawaiian insects. Some species provisions of the Act. In our annual length and have a wingspan of 1.9 to 2.1 commonly inhabited water gardens in CNOR, dated May 11, 2005 (70 FR in (50 to 53 mm). The wings of both residential areas, artificial reservoirs, 24870), we retained a listing priority sexes are clear except for the tips, which and watercress farms, and were even number of 2 for both of these species in are narrowly darkened along the front abundant in the city of Honolulu, as accordance with our listing priority margins. Naiads of this species have noted by early collectors of this group guidance published on September 21, never been collected or found (Perkins 1899, p. 76; Perkins 1913, p. 1983 (48 FR 43098). A listing priority (Polhemus and Asquith 1996, p. 69), but clxxviii; Williams 1936, p. 304). number of 2 reflects threats that are both they are believed to be terrestrial or Beginning with the extensive stream imminent and high in magnitude, as semiterrestrial in habit (Kennedy 1934, and wetland conversion, alteration, and well as the taxonomic classification of p. 345; Preston 2007a). modification, and degradation of native each of these two Hawaiian damselflies The biology of the flying earwig forests through the 20th century, as distinct species. At the time, we Hawaiian damselfly is not well Hawaii’s native damselflies, including determined that publication of a understood, and it is unknown if this the two species that are the subject of proposed rule to list these species was species is more likely to be associated this final listing action, experienced a precluded by our work on higher with standing water or flowing water tremendous reduction in available priority listing actions. Since then, we (Kennedy 1934, p. 345; Polhemus 1994, habitat. In addition, predation by a have published our annual findings on p. 40). The only confirmed population number of nonnative species that have the May 4, 2004, petition (including our found in the last 6 years occurs along a been both intentionally and, in some findings on these two candidate species) single East Maui stream and the cases, inadvertently introduced into the in the CNORs dated September 12, 2006 adjacent steep, moist, riparian talus Hawaiian Islands is a significant and (71 FR 53756), December 6, 2007 (72 FR slope (a slope formed by an ongoing threat to all native Hawaiian 69034), and December 10, 2008 (73 FR accumulation of rock debris), which is damselflies. 75176). densely covered with Dicranopteris

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linearis (uluhe), a native fern. Adults of uluhe habitat located upslope, where of the breeding pools, perching on the flying earwig Hawaiian damselfly the habitat is predominantly native bordering vegetation and flying only have been observed to perch on shrubs and matted fern understory short distances when disturbed vegetation and boulders, and to fly (Foote 2007; Hawaii Biodiversity and (Polhemus and Asquith 1996, p. 83). slowly for short distances above this Mapping Program (HBMP) 2006). This species is rarely seen along main particular stream within the one known Unsurveyed areas containing potentially stream channels, and its ability to remaining habitat site. When disturbed, suitable habitat for this species include disperse long distances over land or the adults fly downward within nearby the Hana coast of east Maui, and the east water is suspected to be poor compared vegetation or between rocks, rather than rift zone of Kilauea and the Kona area to other Hawaiian damselflies (Jordan et up and away as is usually observed with on the island of Hawaii (Foote 2007). al. 2007, p. 254). aquatic Hawaiian damselfly species. Pacific Hawaiian Damselfly The Pacific Hawaiian damselfly is Although immature individuals have now believed to be extirpated from the not been located, based on the habitat The Pacific Hawaiian damselfly was islands of Oahu, Kauai, and Lanai and the behavior of the adults, it is first described by McLachlan (1883, p. (Polhemus and Asquith 1996, p. 83). On believed that the naiads may be 234), based on specimens collected by the island of Oahu, due to its terrestrial or semiterrestrial, occurring R.C.L. Perkins from streams on the occupation of particularly vulnerable among damp leaflitter (Kennedy 1934, islands of Lanai and Maui. This habitat within sidepools of lowland p. 345) or possibly within moist soil or damselfly is a relatively small, dark- streams, the Pacific Hawaiian damselfly seeps between boulders in suitable colored species, with adults measuring was rare by the 1890s and appears to habitat (Preston 2007a). The highest 1.3 to 1.4 in (34 to 37 mm) in length and have been extirpated from this island by elevation at which this species has been having a wingspan of 1.3 to 1.6 in (33 1910 (Liebherr and Polhemus 1997, p. recorded is 3,000 feet (ft) (914 meters to 42 mm). Both adult males and 494). It is unknown when the Kauai and females are mostly black in color. Males (m)), but its close association with uluhe Lanai populations of the Pacific exhibit brick-red striping and patterns, habitat suggests that its range may Hawaiian damselfly disappeared. Until while females exhibit light-green extend upward to close to 4,000 ft 1998, it was believed that the species striping and patterns. The only (1,212 m) (Foote 2007). was extirpated from the island of immature individuals of this species Historically, the flying earwig Hawaii. That year, one population was that have been collected were early- Hawaiian damselfly was known from discovered within a small stream instar (an intermoult stage of the islands of Hawaii and Maui. On located just above, but isolated from, development) individuals, and they Hawaii, it was originally known from Maili Stream, which is known to be exhibit flattened, leaf-like gills seven or more general localities. The occupied by nonnative fish (Englund (Polhemus and Asquith 1996, p. 83). species has not been seen on Hawaii for 1998, pp. 15-16). On Maui and Molokai, over 80 years, although extensive This species is most easily fewer than six populations of the Pacific surveys within apparently suitable distinguished from other Hawaiian Hawaiian damselfly could be located by habitat in the Kau and Olaa areas were damselflies by the extremely long lower the 1970s (Harwood 1976, pp. 251-253; conducted from 1997 to 2008 (Polhemus abdominal appendages of the male, Gagne 1980, pp. 119, 125; Moore and 2008). On Maui, the flying earwig which greatly exceed the length of the Gagne 1982, p. 1). The conservation of damselfly was historically reported from upper appendages. this species was identified as a priority five general locations on the windward Historically, the Pacific Hawaiian by the International Union for the side of the island (Kennedy 1934, p. damselfly was known from lower Conservation of Nature and Natural 345). Since the 1930s, however, the elevations (below 2,000 ft (600 m)) on Resources (Moore 1982, p. 209). flying earwig Hawaiian damselfly has all of the main Hawaiian Islands except only been observed in a single area Kahoolawe and Niihau (Perkins 1899, p. The Pacific Hawaiian damselfly is along a particular stream on the 64). This species was known to breed currently found in at least seven streams windward side of east Maui, despite primarily in lentic (standing water) on Molokai and may possibly be extant surveys from 1993 through 2008 at systems such as marshes, seepage-fed in other unsurveyed streams on several of its historically occupied sites. pools, large ponds at higher elevations, Molokai’s northern coast that have not Although presumed extant, the last and small, quiet pools in gulches that been invaded by nonnative fish observation of the species was in 2005 have been cut off from the main stream (Englund 2008). On the island of Maui, (Foote 2008); the species was not channel (Moore and Gagne 1982, p. 4; the species is currently known from 14 observed during the last survey at this Polhemus and Asquith 1996, p. 83). The streams. The Pacific Hawaiian damselfly location in 2008. No quantitative Pacific Hawaiian damselfly is no longer is no longer found along the entire estimate of the size of this remaining found in most lentic habitats in Hawaii, reaches of these Maui streams, but only population is available. such as ponds and taro (Colocasia in restricted areas along each stream It is hypothesized that the flying esculenta) fields, due to predation by where steep terrain prevents access by earwig Hawaiian damselfly may now be nonnative fish that now occur in these nonnative fish, which inhabit degraded, restricted to what is perhaps suboptimal systems (Moore and Gagne 1982, p. 4; lower stream reaches (Polhemus and habitat, where periodic absences of the Englund et al. 2007, p. 215). Asquith 1996, p. 13; Englund et al. species due to drought may be expected Observations have confirmed that the 2007, p. 215). The species is known and might explain the lack of Pacific Hawaiian damselfly is now from a single population on the island observations of the species (Foote 2007). restricted almost exclusively to seepage- of Hawaii, last observed in 1998. Some researchers also believe that fed pools along overflow channels in the No quantitative estimates of the size overcollection of this species by terminal reaches of perennial streams, of the extant populations are available. enthusiasts may have impacted some usually in areas surrounded by thick Howarth (1991, p. 490) described the populations in the past (Polhemus vegetation (Moore and Gagne 1982, pp. Pacific Hawaiian damselfly as the most 2008). It is further possible that the 3-4; Polhemus 1994, p. 54; Englund common and most widespread of the individuals observed in this area are 1999, p. 236; Englund et al. 2007, p. native damselfly species at the end of actually part of a larger population that 216; Polhemus 2007, p. 238). Adults the 19th century, and yet a decline in may be located in the extensive belt of usually do not stray far from the vicinity this species was observed as early as

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1905 due to the effects of nonnative fish two damselflies as endangered (Conry Our response: In preparing both the introduced for control of mosquitoes. 2009, pers. comm.; Namu’o 2009, pers. proposed and final rules for these comm.). species, we reviewed the best scientific Summary of Comments and and commercial data available, Recommendations Public Comments including technical reports, published In our proposed rule published on (1) Comment: One commenter stated journal articles, and numerous other July 8, 2009 (74 FR 32490), we that there appears to be little, if any, documents, including unpublished requested that all interested parties empirical data indicating water reports and surveys. In addition, we submit written comments on the diversions have any potential impact on consulted with several species experts. proposal by September 8, 2009. We also the flying earwig Hawaiian damselfly. We based our listing determination for contacted appropriate Federal and State Our response: While we acknowledge the flying earwig Hawaiian damselfly agencies, scientific experts and that the larval stage of the flying earwig and the Pacific Hawaiian damselfly on organizations, and other interested Hawaiian damselfly has never been the best available information regarding parties and invited them to comment on observed within stream water, repeated the species’ current known population the proposal. Newspaper notices observations of the adults along the status, the known condition of their inviting general public comment were stream adjacent to its only known habitat, and the current factors affecting published on the islands of Hawaii, population site on east Maui indicate a the species, along with ongoing Maui, Molokai, and Oahu. On strong biological association of an conservation efforts, as described in the November 19, 2009 (74 FR 59956), we unknown nature with flowing stream Summary of Factors Affecting the reopened the comment period for an water. This association is likely related Species (below) in this final rule. The additional 30 days, ending December to the species’ natural history and may Act neither provides for, nor requires, 21, 2009. include the need for sufficient space or additional research effort prior to a We received a total of five written a stream setting for mating adults and listing decision. We acknowledge that comments and no requests for public territorial behavior of males. uncertainties exist; however, under hearings. Three comments were from Additionally, the species’ larval habitat section 4 of the Act, we must make a State of Hawaii agencies and two were is undoubtedly dependent on localized listing determination based on the best from the same nongovernmental area hydrology. For example, should a scientific and commercial available at organization. We received three stream experience either reduced flow the time of our determination. comments supporting the listing of the or complete dewatering for an extended (4) Comment: One commenter two Hawaiian damselflies. Two period of time, it is expected that the disagreed with our analysis that stream comments neither supported nor impact to surrounding soils and diversions for agriculture have reduced opposed the listings, and one of these associated vegetation, including the stream habitat available to the Pacific comments provided additional uluhe ferns that are believed to be the Hawaiian damselfly, and currently pose information on the two damselflies. We species’ likely larval-stage habitat, will a threat to this species. Our response: Historically, the also requested peer review from be soil desiccation and concomitant impacts of the plantation-era sugarcane potential peer reviewers. prolonged vegetation dieback, resulting irrigation system reduced stream habitat in degraded habitat conditions for the Peer Review Comments available to this species. The Pacific flying earwig Hawaiian damselfly. In accordance with our peer review Hawaiian damselfly was once among policy published on July 1, 1994 (59 FR (2) Comment: One commenter stated the most commonly observed aquatic 34270), we solicited expert opinion the reduction or modification of water insects in the islands (Zimmerman from seven knowledgeable individuals flow in a stream should not be 1948, p. 377). Because this species with scientific expertise that included identified as an activity that could breeds in lentic habitats or stream familiarity with the two Hawaiian potentially result in violation of section terminal reaches, which experienced damselflies and their habitat, biological 9 of the Act pertaining to the flying significant modification for agriculture needs, and threats. We received no earwig Hawaiian damselfly. beginning as early as the 19th century, written comments from any of the seven Our response: As discussed in the the Pacific Hawaiian damselfly was peer reviewers, although several offered previous response (see Comment 1), we extirpated from many of its historical their opinion that the two Hawaiian believe there is a strong association with habitat sites (Polhemus 2007, p. 236). By damselfly species meet the definition of stream water flow and the species’ life the 1930s, water diversions had been an endangered species (A. Asquith, history requirements. Stream flow is developed on all of the main Hawaiian Hawaii Sea Grant, pers. comm. 2009; F. likely essential to the adult damselfly’s Islands, and by 1978, the stream flow in Howarth, Bishop Museum, pers. comm. breeding requirements and is also over one-half of all of the 366 perennial 2009; K. Magnacca, University of essential to maintaining localized soil streams in Hawaii had been altered in Hawaii at Hilo, pers. comm. 2009; D. hydrology necessary for persistence of some manner (Brasher 2003, p. 1055). Polhemus, State of Hawaii Division of uluhe ferns, which are known foraging All or most of the low or average flow Aquatic Resources, pers. comm. 2009; and mating sites for the adults and may of the stream was, and often still is, D. Preston, Bishop Museum, pers. provide habitat for the larval stage. diverted into fields or reservoirs, leaving comm. 2009). Therefore, any permanent or prolonged many stream channels completely dry reduction or modification of stream flow (Takasaki et al. 1969, pp. 27-28; Harris Comments from the State of Hawaii in a stream utilized by this species may et al. 1993, p. 12; Wilcox 1996, p. 56). The State of Hawaii’s State Historic result in a violation of section 9 of the With the nearly complete cessation of Preservation Division concurred that no Act. this industry in the Hawaiian Islands, it historic properties would be affected by (3) Comment: One commenter stated is unlikely that new irrigation-related the listing of the two Hawaiian that distribution of both species is not water diversion activities will be damselflies (McMahon 2009, pers. fully known and recommended that the initiated in the remaining streams that comm.). The State’s Division of Forestry Service conduct additional surveys for currently provide habitat for the Pacific and Wildlife (DOFAW) and Office of both species prior to proceeding with Hawaiian damselfly. However, most of Hawaiian Affairs supported listing the listing. the historical water diversions remain in

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place. The historical loss of stream proposal to list the Pacific Hawaiian as current. Because the new standards habitat, resulting in the present damselfly (1984), and elevated it to have not yet been implemented, we are curtailment of habitat available to the candidate status, it had been extirpated unable to determine their effectiveness Pacific Hawaiian damselfly, combined from Kauai, Oahu, and Lanai, and was in enhancing damselfly habitat. with the threat of predation by also considered extirpated from the Should the proposed IIFS be nonnative fish in the remaining stream island of Hawaii. Subsequently in 1998, approved as the new standard, we will habitat, continues to restrict and reduce a single population was discovered on strongly support a collaborative the amount of habitat potentially an isolated portion of a Hilo stream on conservation effort between our agency; available to this species. Should some of the island of Hawaii. However, since the State; the CWRM; and affected this water be returned to stream then, the Pacific Hawaiian damselfly landowners, leaseholders, and other systems, the amount of habitat available has not been reobserved on Kauai, entities, to analyze the potential return to this species may increase if the water Lanai, or Oahu, and remains only on of water flow into currently diverted return were to be implemented carefully Molokai and Maui, and one location on streams on a case-by-case basis, to to prevent the spread of nonnative fish Hawaii Island. We do not consider the ensure the protection of the Pacific species upstream. discovery of a single population on the Hawaiian and the flying earwig (5) Comment: One commenter noted island of Hawaii to represent a Hawaiian damselflies and their stream the Pacific Hawaiian damselfly, significant broadening of the range of or stream-associated habitat. although historically known from lower the species. (9) Comment: One commenter elevations, is now known to have (7) Comment: One commenter disagreed with our assessment that the established successfully breeding observed that water diversions may damselflies were threatened by populations at higher elevations above enhance the damselflies’ chances for inadequate regulatory protections. The existing stream diversions. survival by isolating them from commenter stated that the State Water Our response: Prior to the predatory, nonnative fish species. Code requires that the economic establishment of widespread stream Our response: We agree that existing benefits of stream water removal be diversions, the Pacific Hawaiian diversions on some streams function as balanced against in-stream benefits, damselfly was considered one of the a manmade barrier and prevent the including benefits to aquatic fish and most abundant and frequently observed egress of nonnative, predatory fish into wildlife. The commenter further stated insects in Hawaii and was known from currently isolated, upstream damselfly that the CWRM’s IIFS standards provide all of the main Hawaiian Islands, except habitat sites. However, existing adequate protection for aquatic wildlife, Kahoolawe and Niihau. Previously diversions also alter the historical and the CWRM has, in the past, given known from suitable portions of many amount and flow rate of water within considerable deference to in-stream streams and water bodies from sea level many lower stream sections because the benefits over stream water removal in to some higher elevation sites diversions either reduce the amount of setting IIFS. (Zimmerman 1948, p. 377), the Pacific water flow at the point of diversion or Our response: We believe that the Hawaiian damselfly is now extirpated capture all stream water during times of CWRM’s stated requirements to provide from at least 18 known population sites drier weather or drought. Therefore, the protection for aquatic wildlife are on the islands of Hawaii, Kauai, Lanai, net impact of stream diversions in the insufficiently specific to adequately Oahu, Maui, and Molokai. Diversions Hawaiian Islands has been and protect the damselflies or their habitat. changed the amount and flow rate of continues to be an overall reduction in The CWRM’s IIFS standards do not water within many lower stream the amount of suitable stream habitat include provisions that address the sections, because the diversions either available to both the Pacific Hawaiian needs of the species. Additionally, we reduced the amount of water flow at the damselfly and the flying earwig lack specific examples of past CWRM point of diversion, or captured all Hawaiian damselfly. deference to in-stream benefits, and are stream water (as they were designed to (8) Comment: One commenter noted thus unable to determine whether do) during times of drier weather or that the recently mandated interim in- CWRM’s IIFS standards have drought. The Pacific Hawaiian stream flow standards (IIFS) established specifically benefited these damselflies. damselfly is currently found in by the Commission for Water Resource (10) Comment: One commenter approximately 22 streams on the islands Management (CWRM) for 10 east Maui explained that several of the State’s of Hawaii, Maui, and Molokai, across a streams diverted by the East Maui existing hydroelectric plants do not variety of elevations. All known Irrigation Company (EMI) may either operate directly on streams but are populations are located within streams benefit existing damselfly populations located some distance away and are or bodies of water free of nonnative, or allow entry of nonnative fish species powered by water diverted from predatory fish. We lack sufficient into currently fish-isolated damselfly streams. information to determine whether all habitat. The commenter further stated Our response: In this final rule, we stream reaches occupied by this that the proposed rule incorrectly have clarified that water is diverted to damselfly species are now above identifies the 1988 IIFS as current while power hydroelectric facilities regardless manmade diversions, but we know the newer standards have been mandated. of their location. species is largely absent from areas Our response: We agree that the (11) Comment: One commenter noted below manmade diversions. potential release of additional water into that some of the hydroelectric projects (6) Comment: One commenter stated streams that are currently being diverted identified as proposed may be that the current known range of the is a complex issue, and that the outcome developed without diverting additional Pacific Hawaiian damselfly appears to may be beneficial to damselflies or may water from streams. be broader than the species’ known increase the threat from nonnative Our response: We have modified the range at the time it became a candidate predatory fish. As of the date of appropriate section of this final rule to for listing. publication of this final rule, it is our clarify that in some cases, for some of Our response: We acknowledged in understanding that the recently the State’s proposed hydroelectric our proposed rule that at the time we proposed IIFS have yet to be approved facilities, no additional water might be determined we had sufficient and implemented by the CWRM, and we diverted beyond what is currently information on file to support a therefore recognize the 1988 standards removed for agriculture or other

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purposes. However, the threats to the that the sites have been identified as economically developable, and that damselflies below the point of diversion economically developable for none of the 10 proposed sites includes within a given stream remain the same hydroelectric use. Populations of the streams with Pacific Hawaiian due to the existing diversion, and we Pacific Hawaiian damselfly are located damselfly populations. We have added believe that any additional increased upon three of these streams identified the information regarding the proposed water diversion for hydroelectric power only as potentially economically hydroelectric development on the could possibly impact damselfly developable for hydroelectric use. stream site associated with the only populations. Our response: We have modified the known location of the flying earwig (12) Comment: One commenter noted appropriate section of this final rule to Hawaiian damselfly to our threats that water currently being diverted from correct the information that 28, not 38, analysis (see Factor A). streams to generate power for some sites have been identified as potentially Summary of Factors Affecting the hydroelectric projects is often returned economically developable for Species downstream within the same stream hydroelectric use and that three of the system. Therefore, the potential to streams harboring Pacific Hawaiian Section 4 of the Act (16 U.S.C. 1531 impact damselfly habitat will vary damselfly populations are not proposed et seq.) and its implementing depending on location of the diversion for development but rather are regulations (50 CFR part 424) set forth and location of damselfly habitat within identified as only potentially the procedures for adding species to the the respective stream system. developable. Federal Lists of Endangered and Our response: We have modified the (14) Comment: One commenter Threatened Wildlife and Plants. A appropriate section of this final rule to observed that the HSA identifies 10 sites species may be determined to be an clarify that, in some streams, water where hydropower developments have endangered or threatened species due to diverted for the generation of power is been proposed, several of which overlap one or more of the five factors described returned to the same stream system. with sites identified as potentially in section 4(a)(1) of the Act. These five However, the threats to the damselflies developable (see Comment 13). The listing factors are: (A) The present or below the point of diversion remain, commenter further noted that the list of threatened destruction, modification, or and may depend upon the difference (if 10 sites actually proposed for curtailment of its habitat or range; (B) any) of the volume and quality of water hydroelectric development does not overutilization for commercial, returned and the point at which the include streams known to be occupied recreational, scientific, or educational water is returned to the stream system. by the Pacific Hawaiian damselfly; purposes; (C) disease or predation; (D) The commenter did not provide specific therefore, future hydropower the inadequacy of existing regulatory examples or elaborate upon specific development is unlikely to impact this mechanisms; and (E) other natural or streams. species. However, one proposed site manmade factors affecting its continued (13) Comment: One commenter does include the only known existence. Listing actions may be clarified that the Hawaii Stream population of the flying earwig warranted based on any of the above Assessment (HSA) (CWRM 1990) Hawaiian damselfly. threat factors, singly or in combination. identifies 28, not 38, sites that have Our response: We have modified the The threats to the flying earwig and potential to be developed for appropriate section of this final rule to Pacific Hawaiian damselfly species are hydropower. The commenter further clarify that some of the 10 sites summarized according to the five listing noted that these sites have not been proposed for development in the HSA factors in Table 1, and discussed in proposed for development, but rather overlap with those sites identified as detail below. TABLE 1. SUMMARY OF THREATS TO THE FLYING EARWING HAWAIIAN DAMSELFLY AND PACIFIC HAWAIIAN DAMSELFLY.

SPECIES 5 FACTORS CATEGORY THREATS Flying Earwig Pacific Hawaiian Hawaiian Damselfly Damselfly

FACTOR A Agriculture/urban development X X

Stream alteration P X

Habitat modification by pigs X —

Habitat modification by nonnative plants X X

Stochastic events X X

Climate change P P

FACTOR B Overcollection P —

FACTOR C Predation A, BF (P) A, B, F, BF

FACTOR D Inadequate habitat protection X X

Inadequate protection from nonnative aquatic species X X

FACTOR E Limited populations X X A = ants

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B = backswimmers F = fish BF = bullfrogs P = potential threat X = known threat

Factor A. The Present or Threatened and connectivity, resulting in an through the year, rather than Destruction, Modification, or increased probability of local continuously flood them (Handy and Curtailment of Its Habitat or Range extirpation or even extinction of the two Handy 1972, pp. 58-59). The advent of Hawaiian damselfly species. plantation sugarcane cultivation led to Freshwater habitats used by the flying Although extensive filling of far more extensive stream diversions, earwig and Pacific Hawaiian damselflies freshwater wetlands is rarely permitted with the first diversion built in 1856 on on all of the main Hawaiian Islands are today, loss of riparian or wetland Kauai (Wilcox 1996, p. 54). These severely altered and degraded because habitats utilized by the Pacific and systems were designed to tap water at of past and present land and water flying earwig Hawaiian damselflies, upper elevations (above 984 ft (300 m)) management practices, including: such as smaller areas of moist slopes, by means of a concrete weir in the agriculture and urban development; emergent vegetation, and narrow strips stream (Wilcox 1996, p. 54). All or most development of groundwater, perched of freshwater seeps within anchialine of the low or average flow of the stream aquifer (aquifer sitting above main water pool complexes (landlocked bodies of was, and often still is, diverted into table), and surface water resources; and water with a subterranean connection to fields or reservoirs, leaving many stream the deliberate and accidental the ocean), still occurs. In addition, channels completely dry (Takasaki et al. introductions of nonnative animals marshes have been, and continue to be, 1969, pp. 27-28; Harris et al. 1993, p. 12; (Harris et al. 1993, pp. 12-13; Meier et slowly filled and converted to meadow Wilcox 1996, p. 56). al. 1993, pp. 181-183). habitat due to increased sedimentation As noted above, by the 1930s, water Habitat Destruction and Modification by resulting from increased storm water diversions had been developed on all of Agriculture and Urban Development runoff from upslope development, the the main Hawaiian Islands, and by accumulation of uncontrolled growth of 1978, the stream flow in over one-half Although there has not been a invasive vegetation, and blockage of of all of the 366 perennial streams in comprehensive, site-by-site assessment downslope drainage (Wilson Okamoto & Hawaii had been altered in some of wetland loss in Hawaii (Erikson and Associates, Inc. 1993, pp. 3-4 to 3-5). manner (Brasher 2003, p. 1055). Some Puttock 2006, p. 40), Dahl (1990, p. 7) The effects of future conversion of stream diversion systems are extensive, estimated that at least 12 percent of wetland and other aquatic habitat for such as the Waiahole Ditch, which lowland to upper-elevation wetlands in agriculture and urban development are diverts water from 37 streams within the Hawaii had been converted to non- immediate and significant for the range of the Pacific Hawaiian damselfly wetland habitat by the 1980s. If only following reason: As noted above, an on the windward side of Oahu to the coastal plain (below 1,000 ft (305 m) estimated 30 percent of all coastal plain dry plains on the leeward side of the elevation) wetlands are considered, it is wetlands in Hawaii have already been island via a tunnel cut through the estimated that 30 percent have been lost to agriculture and urban Koolau mountain range (Stearns and converted for agricultural and urban development, while the loss of lowland Vaksvik 1935, pp. 399-403). On west development (Kosaka l990, p. 1). These freshwater habitat in Hawaii already Maui, as of 1978, over 49 miles (mi) (78 marshlands and wetlands provided approaches 80 to 90 percent (Kosaka kilometers (km)) of stream habitat in 12 habitat for several damselfly species, 1990, p. 1). Lacking the aquatic habitat streams had been lost due to diversions, including the Pacific Hawaiian features that the damselflies require for and all of the 17 perennial streams on damselfly. essential life history needs, such as west Maui are dewatered to some extent By the 1930s, water diversions had marshes, ponds, and sidepools along (Maciolek 1979, p. 605). This loss of been developed on all of the main streams (Pacific Hawaiian damselfly) stream habitat may have contributed to Hawaiian Islands, and by 1978, the and riparian habitat (flying earwig the extirpation of the Pacific Hawaiian stream flow in over one-half of all of the Hawaiian damselfly), these modified damselfly population on west Maui. 366 perennial streams in Hawaii had areas no longer support populations of Given the affiliation of the flying earwig been altered in some manner (Brasher these two Hawaiian damselflies. Hawaiian damselfly with riparian 2003, p. 1055). All or most of the low Agriculture and urban development habitats, this loss of stream habitat may or average flow of the stream was, and have thus contributed to the present also potentially account for its absence often still is, diverted into fields or curtailment of the habitat of these two on west Maui. Most lower-elevation reservoirs, leaving many stream Hawaiian damselflies, and we have no stream segments on west Maui are now channels completely dry (Takasaki et al. indication that this threat is likely to be completely dry, except during storm- 1969, pp. 27-28; Harris et al. 1993, p. 12; significantly ameliorated in the influenced flows (Maciolek 1979, p. Wilcox 1996, p. 56). The historical foreseeable future. 605). destruction and modification of habitat The maintenance of natural hydrology continues to impact the two Hawaiian Habitat Destruction and Modification by is closely tied to the life history damselflies, by restricting them to Stream Diversion requirements of the Hawaiian curtailed or isolated habitat areas that Stream modifications began with the damselflies, as the presence of standing are often degraded in quality (for early Hawaiians, who diverted water to or running water is essential to example, by the presence of predatory irrigate taro. However, unlike modern reproduction of the two species. In nonnative fishes). The present stream diversions which often addition to providing breeding habitat curtailment of the habitat or range of the completely dewater streams all year for the adults, the aquatic larval stage of flying earwig Hawaiian damselfly and around, early diversions often took no the Pacific Hawaiian damselfly is Pacific Hawaiian damselfly due to past more than half the stream flow, and entirely dependent on water, and the habitat destruction or modification in typically were periodic to occasionally maintenance of local soil hydrology is turn limits population size, distribution, flood taro ponds at different times necessary for the persistence of uluhe

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ferns, which provide habitat for the Stream on Molokai has reduced flow (Stearns 1940, p. 88). This allows water larval stage of the flying earwig due in part to groundwater withdrawal in aquifers normally feeding the stream Hawaiian damselfly. The reduced flow (Brasher 2003, p. 1,056), which may to be diverted elsewhere underground. or complete dewatering of streams thus have reduced stream habitat available to Dewatering of the streams by tunneling results in the destruction or degradation the Pacific Hawaiian damselfly. and earlier, less-informed well of habitat conditions for both the Pacific Likewise, on Maui, streams in the west placement near or in streams was a and flying earwig Hawaiian damselflies. Maui Mountains that flow into the significant cause of habitat loss, and The extensive diversion of streams on Lahaina District are fed by groundwater these effects continue today. Maui island-wide has reduced the leaking from breached high-elevation Historically, for example, there was amount of stream habitat available to dikes. Downstream of the dike sufficient surface flow in Makaha and the Pacific Hawaiian damselfly, and compartments, stream diversions are Nanakuli streams on Oahu to support potentially to the flying earwig designed to capture all of the low stream taro loi in their lower reaches, but this Hawaiian damselfly as well. flow, causing the streams downstream flow disappeared subsequent to In addition to diverting water for to be frequently dry (U.S. Geological construction of vertical wells upstream agriculture and domestic water supply, Survey 2008a, p. 1), likely impacting (Devick 1995, p. 1). The inadvertent streams in Hawaii have also been available habitat for the Pacific dewatering of streams through the diverted for use in hydroelectric power. Hawaiian damselfly, and potentially for piercing of their aquifers (which are In some cases, the water used for power the flying earwig Hawaiian damselfly, in normally separated from adjacent water- generation is already being diverted for the Honolua and Honokohau streams. another use; in other cases the water is The island of Lanai lies within the bearing layers by an impermeable layer), returned to the stream of origin. There rain shadow of the west Maui by tunneling or through placement of are a total of 18 active hydroelectric Mountains, which reach 5,788 ft (1,764 vertical wells, caused the loss of Pacific plants operating on Hawaiian streams m) in elevation. Lower in elevation than Hawaiian damselfly habitat, and on the islands of Hawaii, Kauai, and Maui, annual rainfall on Lanai’s summit contributed to the Pacific Hawaiian Maui, only one of which is located on is 30 to 40 in (760 to 1,015 mm), but is damselfly’s extirpation on the islands of a stream where a historical population much less over the rest of the island Oahu, Kauai, and Lanai (Polhemus and of the Pacific Hawaiian damselfly was (University of Hawaii Department of Asquith 1996, pp. 23-24). Such known on Kauai (Waimea). Another 28 Geography 1998, p. 13). Flows of almost activities also reduced the extent of sites have been identified as feasible for every spring and seep on Lanai have stream habitat for the Pacific Hawaiian hydroelectric development on the been diverted (Stearns 1940, pp. 73-74, damselfly on the islands of Maui, islands of Hawaii, Kauai, Maui, and 85, 88, 95). Surface waters in streams Molokai, and Hawaii. Most lower- Molokai (Hawaii Stream Assessment have also been diverted by tunnels in elevation stream segments on west Maui 1990, pp. xxi, 96-97). Three of the sites stream beds. Historically, Maunalei and leeward east Maui are now identified as developable include Stream was the only perennial stream completely dry, except during storm- current populations of the Pacific on Lanai, and Hawaiians constructed influenced flows (Maciolek 1979, p. Hawaiian damselfly. A total of 10 taro loi (ponds for cultivation of taro) in 605). The flow of nearly every seep and streams have actually been proposed for the lower portions of this stream system. spring on Lanai has been captured or development, with some overlap In 1911, a tunnel was constructed at bored with wells (Stearns 1940, pp. 73- between the 28 streams identified as 1,100 ft (330 m) elevation that undercuts 74, 85, 88, 95). The inadvertent drying feasible. Notably, the stream adjacent to the stream bed, diverting both the of streams from earlier, uninformed well the single current remaining population surface and subsurface flows and placement and other activities has site for the flying earwig Hawaiian dewatering the stream from this point to contributed to the decline of the Pacific damselfly on Maui is included among its mouth (Stearns 1940, pp. 86-88). The Hawaiian damselfly by reducing its those proposed for hydroelectric Pacific Hawaiian damselfly, which habitat on all of the islands from which development. Any additional diversion depends on stream habitat, was it was historically known. It should be of stream flow for use in hydroelectric historically known from Lanai but is no noted that the Pacific Hawaiian power could contribute to further loss of longer extant on this island. The Pacific damselfly was once among the most stream habitat for the Pacific Hawaiian Hawaiian damselfly was most likely commonly observed aquatic insects in damselfly and for the flying earwig impacted by the dewatering of this the islands (Howarth 1991, p. 40). The Hawaiian damselfly. stream because it was the only dewatering of streams on Maui and permanent stream on Lanai prior to its Habitat Modification and Destruction by Hawaii may also have impacted habitat dewatering. This example of the Dewatering of Aquifers of the flying earwig Hawaiian damselfly. negative impact of dewatering leads us In addition to the diversion of stream to conclude that dewatering poses a Although the State of Hawaii’s water and the resultant downstream threat to the Pacific Hawaiian damselfly Commission on Water Resource dewatering, many streams in Hawaii and the flying earwig Hawaiian Management is now more cognizant of have experienced reduced or zero damselfly on the remaining islands the effects that groundwater removal has surface flow as a result of the where the species persist. on streams via injudicious placement of dewatering of their source aquifers. wells, the Commission still routinely Often these aquifers, which previously Habitat Modification and Destruction by reviews new permit applications for fed the streams, were tapped by Vertical Wells wells (Hardy 2009, p. 1). Thus, the tunneling or the injudicious placement Surface flow of streams has also been potential for additional well-drilling of wells (Stearns and Vaksvik 1935, pp. affected by vertical wells drilled in the continues to be a threat (see further 386-434; Stearns 1985, pp. 291-305). past, because the basal aquifer (lowest discussion under Factor D, The These groundwater sources were groundwater layer) and alluvial caprock Inadequacy of Existing Regulatory captured for both domestic and (sediment-deposited harder rock layer) Mechanisms, below), and the ongoing agricultural use and in some areas have through which the lower sections of effects of previously constructed vertical completely depleted nearby stream and streams flow can be pierced and wells continue to be an ongoing threat spring flows. For example, the Waikolu hydraulically connected by wells to the Hawaiian dragonflies.

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Habitat Modification and Destruction by during storms, or leaving many streams spread through the excrement of the Channelization completely dry year-round, thus pigs and by transport in their hair In addition to the destruction of most reducing or eliminating stream habitat; (Stone 1985, p. 263). In nitrogen-poor of the stream habitat of the Pacific and (3) they indirectly lead to an soils, feral pig excrement increases Hawaiian damselfly and the flying increase in water temperature that leads nutrient availability, enhancing earwig Hawaiian damselfly, much of the to the loss of Pacific Hawaiian damselfly establishment of nonnative weeds that remaining stream habitat has been, and naiads due to direct physiological stress. are more adapted to richer soils than are continues to be, seriously degraded Because the probability of species native plants (Cuddihy and Stone 1990, throughout the Hawaiian Islands. extinction increases when ranges are p. 65). In this manner, largely nonnative Stream degradation has been restricted, habitat decreases, and forests replace native forest habitat particularly severe on the island of population numbers decline, the Pacific (Cuddihy and Stone 1990, p. 65). In Oahu where, by 1978, 58 percent of all Hawaiian damselfly is particularly addition, feral pigs will root and dig for vulnerable to extinction due to such plant tubers and worms in wetlands, the perennial streams had been changes in its stream habitats. including marshes, on all of the main channelized (lined, partially lined, or In addition, stream diversion, Hawaiian Islands (Erikson and Puttock altered) to control flooding (Brasher dewatering, and vertical wells have the 2006, p. 42). 2003, p. 1055; Polhemus and Asquith potential to negatively impact, and in In a study conducted in the 1980s on 1996, p. 24), and 89 percent of the total some cases may have impacted, the feral pig populations in Kipahulu Valley length of these streams had been flying earwig Hawaiian damselfly. on Maui, the deleterious effects of feral channelized (Parrish et al. 1984, p. 83). Stream flow is essential to the adult pig rooting on native forest ecosystems The channelization of streams creates flying earwig damselfly’s breeding was documented (Diong 1982, pp. 150, artificial, wide-bottomed stream beds requirements and is also essential to 160-167). Rooting by feral pigs was and often results in removal of riparian maintaining localized soil hydrology observed to be related to the search for vegetation, increased substrate necessary for persistence of uluhe ferns, earthworms, with rooting depths homogeneity, increased temporal water which are known foraging and mating averaging 8 in (20 cm), and rooting was velocity (increased water flow speed sites for the adults and may provide found to greatly disrupt the leaf litter during times of higher precipitation, habitat for the larval stage. Should the and topsoil layers, and contribute to including minor and major flooding), species’ population site stream erosion and changes in ground increased illumination, and higher experience either reduced flow or topography. The feeding habits of pigs water temperatures (Parrish et al. 1984, complete dewatering for an extended were observed to create seed beds, p. 83; Brasher 2003, p. 1052). Natural period of time, it is expected that the enabling the establishment and spread streams meander and are lined with impact to surrounding soils and of invasive weedy species such as rocks, trees, and natural debris, and associated vegetation, including the Clidemia hirta (Koster’s curse). The during times of flooding, jump their uluhe ferns that are believed to be the study concluded that all aspects of the banks. Channelized streams are species’ likely larval-stage habitat, will feeding habits of pigs are damaging to straightened and often lack natural be soil desiccation and prolonged the structure and function of the obstructions, and during times of higher vegetation dieback, respectively. Hawaiian forest ecosystem (Diong 1982, precipitation or flooding, facilitate a pp. 160-167). higher water flow velocity. Hawaiian Habitat Destruction and Modification by It is likely that pigs similarly impact damselflies are largely absent from Feral Pigs the native vegetation used for perching channelized portions of streams One of the primary threats to the by adult flying earwig Hawaiian (Polhemus and Asquith 1996, p. 24). In flying earwig Hawaiian damselfly is the damselflies. On Maui, feral pigs inhabit contrast, undisturbed Hawaiian stream ongoing destruction and degradation of the uluhe-dominated riparian habitat of systems exhibit a greater amount of its riparian habitat by nonnative the flying earwig Hawaiian damselfly. riffle habitat, canopy closure, higher animals, particularly feral pigs (Sus Through their rooting and digging consistent flow velocity, and lower scrofa) (Polhemus and Asquith 1996, p. activities, they have significantly water temperatures that are 22; Erickson and Puttock 2006, p. 42). degraded and destroyed the habitat of characteristic of streams to which the Pigs of Asian descent were first the adult flying earwig Hawaiian Hawaiian damselflies, in general, are introduced to Hawaii by the Polynesian damselfly (Foote 2008, p. 1). adapted (Brasher 2003, pp. 1054-1057). ancestors of Hawaiians around 400 A.D. In addition to creating conditions that Channelization of streams has not (Kirch 1982, pp. 3-4). Western enable the spread of nonnative plant been restricted to lower stream reaches. immigrants, beginning with Captain species, Mountainspring (1986, p. 98) For example, there is extensive Cook in 1778, repeatedly introduced surmised that rooting by pigs depresses channelization of the Kalihi Stream, on European strains (Tomich 1986, pp. insect populations that depend upon the the island of Oahu, above 1,000-ft (300- 120-121). The pigs escaped ground layer at some life stage or that m) elevation. Extensive stream domestication and successfully invaded exhibit diel (day and night) movements. channelization has contributed to the all areas, including wet and mesic As a result, it is likely that the presumed extirpation of the Pacific Hawaiian forests and grasslands, on all of the habitat (seeps or damp leaf litter) of the damselfly on Oahu (Englund 1999, p. main Hawaiian Islands. naiads of the flying earwig Hawaiian 236; Polhemus 2008, pp. 45-46). High pig densities and expansion of damselfly is negatively impacted by Stream diversion, channelization, and their distribution have caused feral pig activity, including the dewatering represent significant and indisputable widespread damage to uprooting and denuding of native immediate threats to the Pacific native vegetation on the Hawaiian vegetation (Foote 2008, p. 1; Polhemus Hawaiian damselfly for the following Islands (Cuddihy and Stone 1990, p. 2008, p. 48). reasons: (1) They reduce the amount 63). Feral pigs create open areas within Feral pigs are managed as a game and distribution of stream habitat forest habitat by digging up, eating, and animal for public hunting in the more available to this species; (2) they reduce trampling native plant species (Stone accessible regions of the east Maui stream flow, leaving lower elevation 1985, p. 263). These open areas become watershed (Jokiel 2008, p. 1). This stream segments completely dry except fertile ground for nonnative plant seeds management makes it likely that feral

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pigs will continue to exist on Maui, and replace the native plant community Hawaiian damselfly. These threats are thus likely that pigs will continue to (Cuddihy and Stone 1990, p. 74; expected to continue or increase destroy and degrade habitat of the flying Vitousek 1992, pp. 33-35). As C. hirta without control or elimination of earwig Hawaiian damselfly on the can outcompete the native uluhe fern, invasive nonnative plants in these island of Maui. this invasive nonnative species poses a habitats. The effects from introduced feral pigs threat by altering and degrading the Habitat Destruction and Modification by are immediate and ongoing because pigs native plant community utilized by the Hurricanes, Landslides, and Drought currently occur in the uluhe-dominated flying earwig Hawaiian damselfly. riparian habitat of the flying earwig Presently, the most significant threat Stochastic (random, naturally Hawaiian damselfly. The threat of to natural ponds and marshes in Hawaii occurring) events, such as hurricanes, habitat destruction or modification from is the nonnative species Urochloa landslides, and drought, alter or degrade feral pigs is significant for the following mutica (California grass). This the habitat of Hawaiian damselflies reasons: (1) Trampling and grazing sprawling perennial grass is likely from directly by modifying and destroying directly impact the vegetation used by Africa (Erickson and Puttock 2006, p. native riparian, wetland, and stream adult flying earwig Hawaiian 270). It was first noted on Oahu in 1924 habitats (e.g., rocks and debris falling in damselflies for perching and by the and now occurs on all of the main a stream, by mechanical damage to terrestrial or semiterrestrial naiads; (2) Hawaiian Islands (O’Connor 1999, p. riparian and wetland vegetation), and by increased soil disturbance leads to 1,504), where it is considered an indirectly by creating disturbed areas mechanical damage to plants used by aggressive invasive weed of marshes conducive to invasion by nonnative adults for perching and by the terrestrial and wetlands (Erickson and Puttock plants that outcompete the native plants or semiterrestrial naiads; (3) creation of 2006, p. 270). Found from sea level to used by damselflies for perching. We open, disturbed areas, conducive to 3,610 ft (1,100 m) in elevation (Erickson presume these events also alter weedy plant invasion and establishment and Puttock 2006, p. 270), this plant microclimatic conditions (e.g., opening of alien plants from dispersed fruits and forms dense, monotypic stands that can the tree canopy, leading to an increase seeds, results over time in the completely eliminate any open water by in streamwater temperature; increasing conversion of a community dominated layering trailing stems (Smith 1985, p. stream sedimentation) so that the by native vegetation to one dominated 186). Marshlands eventually convert to habitat no longer supports damselfly by nonnative vegetation (leading to all meadowland when invaded by U. populations. Both the flying earwig of the negative impacts associated with mutica (Polhemus and Asquith 1996, p. Hawaiian damselfly and the Pacific nonnative plants, detailed below); and 23). At Kawainui Marsh, the most Hawaiian damselfly may also be (4) increased watershed erosion and extensive marsh system remaining on affected by temporary habitat loss (e.g., sedimentation upstream may degrade Oahu, control of U. mutica to prevent desiccation of streams, die-off of uluhe) adult breeding habitat for the flying conversion of the marsh to meadowland associated with droughts, which are not earwig Hawaiian damselfly. These is an ongoing management activity uncommon on the Hawaiian Islands. threats are expected to continue or (Wilson, Okamoto and Associates, Inc. With populations that have already been increase without control or elimination 1993, pp. 3-4; Hawaii Ecosystems at severely reduced in both abundance and of pig populations in these habitats. Risk (HEAR) 2008, p. 1). The preferred geographic distribution, and particularly habitat of the Pacific Hawaiian in the case of the flying earwig Habitat Destruction and Modification by damselfly (primarily lowland, stagnant Hawaiian damselfly, with only one Nonnative Plants water, large ponds, and small pools) on known population, even such a The invasion of nonnative plants, all of the Hawaiian Islands has likely temporary loss of habitat can have a including Clidemia hirta (Koster’s declined and continues to decline due severe negative impact on the species. curse), further contributes to the to the spread of U. mutica (Polhemus Natural disasters such as hurricanes degradation of Hawaii’s native forests, and Asquith 1996, p. 23). and drought, and local, random including the riparian habitat of the In conclusion, nonnative plants environmental events (such as flying earwig Hawaiian damselfly on represent a significant and immediate landslides), represent a significant Maui (Foote 2008, p. 1). Clidemia hirta and ongoing threat to the flying earwig threat to native riparian, wetland, and is the most serious nonnative plant Hawaiian damselfly through habitat stream habitat and the two damselfly invader within the uluhe-dominated destruction and modification for the species addressed in this final rule. riparian habitat where the flying earwig following reasons: (1) They adversely These types of events are known to Hawaiian damselfly occurs on Maui and impact microhabitat by modifying the cause significant habitat damage where it formerly occurred on the island availability of light; (2) they alter soil- (Polhemus 1993, p. 86). Because the two of Hawaii (Foote 2008, p. 1). A noxious water regimes; (3) they modify nutrient species addressed in this final rule now shrub first cultivated in Wahiawa on cycling processes; and (4) they persist in low numbers or occur in Oahu before 1941, this plant is now outcompete, and possibly directly restricted ranges, they are more found on all of the main Hawaiian inhibit the growth of, native plant vulnerable to these events and less Islands (Wagner et al. 1985, p. 41). species; ultimately, native-dominated resilient to such habitat disturbances. Clidemia hirta forms a dense plant communities are converted to Hurricanes, drought, and landslides, understory, shading out native plants nonnative plant communities (Cuddihy even though unpredictable as to exact and hindering their regeneration; it is and Stone 1990, p. 74; Vitousek 1992, timing, have been and are expected to considered a major nonnative plant pp. 33-35). This conversion negatively continue to be threats to the Hawaiian threat in wet forest areas because it impacts and threatens the flying earwig damselflies. Therefore, they pose inhibits and eventually replaces native Hawaiian damselfly, which depends immediate and ongoing threats to the plants (Wagner et al. 1985, p. 41; Smith upon native plant species, particularly two damselfly species and their habitat. 1989, p. 64). Invasive nonnatives such uluhe, for essential life history needs. In as C. hirta are capable of modifying the addition, conversion of habitat from Habitat Destruction and Modification by natural environment at the microhabitat marshlands to meadowlands caused by Climate Change level by altering light availability and the encroachment of the nonnative Currently available information on soil-water regimes, and may eventually Urochloa mutica threatens the Pacific global climate change is not sufficiently

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precise to predict detailed changes in Pounds et al. 1999, pp. 611-612; Still et each of these species especially the habitats and ecosystems upon which al. 1999, p. 610; Benning et al. 2002, pp. vulnerable to extinction. Thus we these species rely. Consequently, the 14,246 and 14,248). We believe changes consider the present or threatened exact nature of the impacts of climate in environmental conditions that may destruction, modification, or change on the aquatic and riparian result from climate change will likely curtailment of the habitat and range of habitats of the flying earwig Hawaiian impact these two species and, according the flying earwig Hawaiian damselfly damselfly and the Pacific Hawaiian to current climate projections, we do not and the Pacific Hawaiian damselfly to damselfly, are unknown. However, anticipate a reduction in this threat any pose an immediate and significant increasing temperatures and altered time in the near future; however, the threat to these species. patterns of precipitation may affect magnitude of this potential threat Factor B. Overutilization for aquatic habitats through reduced stream cannot be determined at this time. Commercial, Recreational, Scientific, or flow, evaporation of standing water, Summary of Factor A Educational Purposes increased streamwater temperature, and the loss of native riparian and wetland The effects of past, present, and Individuals from what may be the plants that comprise the habitat in potential future destruction, single remaining population of the which these two species occur (Pounds modification, and degradation of native flying earwig Hawaiian damselfly were et al. 1999, pp. 611-612; Still et al. 1999, riparian, wetland, and stream habitats collected by amateur collectors as p. 610; Benning et al. 2002, pp. 14,246 threaten the continued existence of the recently as the mid-1990s (Polhemus and 14,248). flying earwig Hawaiian damselfly and 2008, pp. 14-15). Although it is not Oki (2004, p. 4) noted long-term the Pacific Hawaiian damselfly, which known how many individuals were evidence of decreased precipitation and depend on these habitats throughout collected at that time, Polhemus (2008, stream flow in the Hawaiian Islands, their respective ranges. These effects pp. 14-15) inferred that this collection based upon evidence collected by have been or continue to be caused by: resulted in a noticeable decrease in the stream gauging stations. This long-term Agriculture and urban development; population size. Furthermore, if there is drying trend, coupled with existing stream diversion, well-drilling, only one population of the species left, ditch diversions and periodic El Nin˜ o– channelization, and dewatering; the decreased reproduction that would caused drying events, has created a introduced feral pigs; introduced plants; result from the removal of potential pattern of severe and persistent stream and hurricanes, landslides, and drought. breeding adults would have a significant dewatering events (Polhemus 2008, p. The ongoing and likely increasing negative impact on the species. 52). Future changes in precipitation and effects of global climate change, while There is a market for damselflies that the forecast of those changes are highly currently unquantifiable, are also likely may serve as an incentive to collect uncertain because they depend, in part, to adversely impact, directly or them. There are internet websites that on how the El Nin˜ o–La Nin˜ a weather indirectly, the habitat of these two offer damselfly specimens or parts (e.g., cycle (a disruption of the ocean species. wings) for sale. In addition, the internet atmospheric system in the tropical Agriculture and urban development, abounds with ‘‘how to’’ guides for Pacific having important global to date, have caused the loss of 30 collecting and preserving damselfly consequences for weather and climate) percent of Hawaii’s coastal plain specimens (e.g., Abbott 2000, pp. 1-3; might change (Hawaii Climate Change wetlands and 80 to 90 percent of van der Heijden 2005). After butterflies Action Plan 1998, pp. 2-10). lowland freshwater habitat in Hawaii. and large beetles, dragonflies and The flying earwig Hawaiian damselfly Extensive stream diversions and the damselflies are probably the most and the Pacific Hawaiian damselfly may ongoing dewatering of remaining frequently collected insects in the world be especially vulnerable to extinction wetland habitats continue to degrade (Polhemus 2008, pp. 14-15). A rare due to anticipated environmental the quality of Pacific Hawaiian specimen such as the flying earwig change that may result from global damselfly habitat and its capability to Hawaiian damselfly may be particularly climate change. Environmental changes support viable populations of this attractive to potential collectors that may affect these species are species and may also negatively affect (Polhemus 2008, pp. 14-15)). Based on expected to include habitat loss or the habitat of the flying earwig the history of collection of the flying alteration and changes in disturbance Hawaiian damselfly. Ongoing habitat earwig Hawaiian damselfly, the market regimes (e.g., storms and hurricanes), in destruction and degradation caused by for damselfly specimens or parts, and addition to direct physiological stress feral pigs in remaining tracts of uluhe- the vulnerability of this small caused by increased streamwater dominated riparian habitat promote the population to the negative impacts of temperatures to which the native establishment and spread of nonnative any collection, we consider the Hawaiian damselfly fauna are not plants which, in turn, lower or destroy potential overutilization of the flying adapted. The probability of a species the capability of the habitat to support earwig Hawaiian damselfly to pose an going extinct as a result of these factors viable populations of the flying earwig immediate and significant threat to this increases when its range is restricted, Hawaiian damselfly. The invasive species. habitat decreases, and population nonnative grass Urochloa mutica Unlike the flying earwig Hawaiian numbers decline (Intergovernmental threatens to destroy the habitat of the damselfly, which is restricted to one Panel on Climate Change 2007, p. 8). Pacific Hawaiian damselfly through remaining population site and which is Both of these damselfly species have conversion of marshlands to known to have previously been of limited environmental tolerance ranges, meadowlands. interest to odonata enthusiasts restricted habitat requirements, small The above threats have caused the (collectors of insects in the order population size, and a low number of extirpation of many flying earwig Odonata, including damselflies) individuals. Therefore, we would expect Hawaiian damselfly and Pacific (Polhemus 2008, pp. 14-15), we do not these species to be particularly Hawaiian damselfly populations; as a believe overcollection is currently a vulnerable to projected environmental result, their current ranges are very threat to the Pacific Hawaiian damselfly, impacts that may result from changes in restricted. The combination of restricted because it is comparatively more climate, and subsequent impacts to their range, limited habitat quantity and widespread across several population aquatic and riparian habitats (e.g., quality, and low population size makes sites on three islands and we are

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unaware of hobbyist collection of this Hawaiian damselfly and the Pacific Hardy (1979, p. 34) documented the species. Hawaiian damselfly is amplified by the apparent eradication of native insects fact that most ant species have winged within the Kipahulu area on Maui after Factor C. Disease or Predation reproductive adults (Borror et al. 1989, this area was invaded by the long-legged The geographic isolation of the p. 738) and can quickly establish new ant. Although only cursory observations Hawaiian Islands restricted the number colonies in suitable habitats (Staples exist, long-legged ants are thought to be of original successful colonizing and Cowie 2001, p. 55). These attributes a threat to populations of the Pacific arthropods and resulted in the allow some ants to destroy otherwise Hawaiian damselfly in mesic areas development of Hawaii’s unusual fauna. geographically isolated populations of within its elevation range due to their Only 15 percent of the known families native arthropods (Nafus 1993, pp. 19, particularly aggressive nature and large of insects are represented by native 22-23). colony sizes (Foote 2008, p. 1). Hawaiian species (Howarth 1990, p. 11). At least 47 species of ants are known Solenopsis papuana is the only Some groups of insects that often to be established in the Hawaiian abundant, aggressive ant that has dominate continental arthropod fauna, Islands (Hawaii Ants 2008, pp. 1-11), invaded intact mesic to wet forest from including social Hymenoptera (e.g., ants and at least 4 particularly aggressive sea level to over 2,000-ft (600-m) and wasps), were absent during the species have severely impacted the elevation on all of the main Hawaiian evolution of Hawaii’s unique arthropod native insect fauna, likely including Islands, and is still expanding its range fauna. Commercial shipping and air native damselflies (Zimmerman 1948b, (Reimer 1993, p. 14). Gillespie and cargo, as well as biological p. 173; Reimer et al. 1990, pp. 40-43; Reimer (1993, p. 30) found a negative introductions to Hawaii, have resulted HEAR database 2005, pp. 1-2): The big- correlation between native spider in the establishment of over 3,372 headed ant (Pheidole megacephala), the diversity and areas invaded by this ant species of nonnative insects (Howarth long-legged ant (also known as the species. It is likely, based on our 1990, p. 18; Staples and Cowie 2001, p. yellow crazy ant) (Anoplolepis knowledge of the expanding range of 52), with an estimated continuing gracilipes), Solenopsis papuana (no this invasive ant, its aggressive nature, establishment rate of 20 to 30 new common name), and Solenopsis and dense populations (Reimer 1993, p. species per year (Beardsley 1962, p. 101; geminata (no common name). 14), that it may threaten populations of Beardsley 1979, p. 36; Staples and Numerous other species of ants are the Pacific Hawaiian damselfly in mesic Cowie 2001, p. 52). recognized as threats to Hawaii’s native areas up to 2,000-ft (600-m) elevation as Nonnative arthropod predators and invertebrates, with a trend of new well (Foote 2008, p. 1). parasites have also been intentionally species of ants being established every The rarity or disappearance of native imported and released by individuals few years (Staples and Cowie 2001, pp. damselfly species, including the two and governmental agencies for 53). Due to their preference for drier species in this final rule, from historical biological control of insect pests. habitat sites, ants are less likely to occur observation sites over the past 100 Between 1890 and 1985, 243 nonnative in high densities in the riparian and years, is likely due to a variety of species were introduced, sometimes aquatic habitat currently occupied by factors. There is no documentation that with the specific intent of reducing the flying earwig Hawaiian damselfly conclusively ties the decrease in populations of native Hawaiian insects and the Pacific Hawaiian damselfly. damselfly observations to the (Funasaki et al. 1988, p. 105; Lai 1988, However, some species of ants (e.g., the establishment of nonnative ants in low pp. 186-187). Nonnative arthropods, long-legged ant and Solenopsis to montane, and mesic to wet, habitats whether purposefully or accidentally papuana) have increased their range on the Hawaiian Islands. However, we introduced, pose a serious threat to into these areas. do have evidence that introduced ants Hawaii’s native insects, including the The presence of ants in nearly all of prey on Hawaiian damselflies. In 1998, flying earwig Hawaiian damselfly and the lower elevation habitat sites during a survey of an Oahu stream, the Pacific Hawaiian damselfly, through historically occupied by the flying researchers observed predation by ants direct predation (Howarth and Medeiros earwig Hawaiian damselfly and the upon another damselfly species, the 1989, pp. 82-83; Howarth and Ramsay Pacific Hawaiian damselfly may orangeblack Hawaiian damselfly 1991, pp. 81-84; Staples and Cowie preclude the future recolonization of (Megalagrion xanthomelas) (Englund 2001, pp. 54-57). these areas by these two species. 2008, pp. 56-57). The presence of In addition to the problems posed by Damselfly naiads may be particularly nonnative ants in these habitats and nonnative arthropods, the establishment susceptible to ant predation when they parallel decline of damselfly of various nonnative fish, frogs, and crawl out of the water or seek a observations in these habitats suggest toads that act as predators on native terrestrial location for their that nonnative ants may have played a Hawaiian damselflies has also had a metamorphosis into the adult stage. role in the decline of some populations serious negative impact on the Pacific Likewise, newly emerged adult of the flying earwig Hawaiian damselfly Hawaiian damselfly and flying earwig damselflies are susceptible to predation and Pacific Hawaiian damselfly. Hawaiian damselfly, as discussed until their wings have sufficiently In summary, observations and reports below. hardened to permit flight, or when the have documented that ants are adults are simply resting on vegetation particularly destructive predators Predation by Nonnative Ants at night (Polhemus 2008, p. 59). because of their high densities, broad Ants are not a natural component of The long-legged ant appeared in range of diet, and ability to establish Hawaii’s arthropod fauna, and the Hawaii in 1952, and now occurs on new colonies in otherwise native species of the islands evolved in Kauai, Oahu, Maui, and Hawaii (Reimer geographically isolated locations, the absence of predation pressure from et al. 1990, p. 42). It inhabits low to because the reproductive adult ants are ants. Ants can be particularly mid-elevation (less than 2,000 ft (600 able to fly. Damselfly naiads are destructive predators because of their m)) rocky areas of moderate rainfall (less particularly vulnerable to ant predation high densities, recruitment behavior, than 100 in (250 cm) annually) (Reimer when they crawl out of water or seek a aggressiveness, and broad range of diet et al. 1990, p. 42). Direct observations terrestrial location for metamorphosis (Reimer 1993, pp. 17-18). The threat of indicate that Hawaiian arthropods are into adults, and newly emerged adults ant predation on the flying earwig susceptible to predation by this species. are susceptible to predation until they

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can fly. In particular, the long-legged ant expect this threat to continue or habitats of Hawaii (Freshwater Fishes of and Solenopsis papuana are two increase over time. Hawaii 2008, p. 1). The initial aggressive species reported from sea introduction of nonnative fish to Hawaii Predation by Nonnative Fish level to 2,000-ft (610-m) elevation on all began with the release of food stock of the main Hawaiian Islands. Since Predation by nonnative fish is a species by Asian immigrants at the turn their range overlaps that of both the significant threat to Hawaiian damselfly of the 20th century; however, the impact flying earwig and Pacific Hawaiian species with aquatic life stages, such as of these first introductions to Hawaiian damselfly species, we consider these the Pacific Hawaiian damselfly. The damselflies cannot be assessed because introduced ants to pose an immediate aquatic naiads tend to rest and feed near they predated the initial collection of and significant threat to both damselfly or on the surface of the water, or on damselflies in Hawaii (Perkins 1899, pp. species. Unless these aggressive rocks where they are exposed and 64-76). nonnative ant predators are eliminated vulnerable to predation by nonnative In 1905, three species of fish within or controlled, we expect this threat to fish. Hawaii has only five native the Poeciliidae family, including the continue or increase. freshwater fish species, comprised of mosquito fish (Gambusia affinis) and gobies (Gobiidae) and sleepers the sailfin molly (Poecilia latipinna), Predation by Nonnative Backswimmers (Eleotridae), that occur on all of the were introduced for biological control of Backswimmers, so called because major islands. Because these native fish mosquitoes (Van Dine 1907, p. 9; they swim upside down, are aquatic are benthic (bottom) feeders (Kido et al. Englund 1999, p. 225; Brasher 2003, p. ‘‘true bugs’’ (Heteroptera). 1993, pp. 43-44; Ego 1956, p. 24; 1054). In 1922, several additional Backswimmers are voracious predators Englund 1999, pp. 236-237), Hawaii’s species were introduced for mosquito and frequently feed on prey much larger stream-dwelling damselfly species control, including the green swordtail than themselves, such as tadpoles, small probably experienced limited natural (Xiphophorus helleri), the moonfish fish, and other aquatic insects, predation pressure due to their (Xiphophorus maculatus), and the avoidance of benthic areas in preference including damselfly naiads (Heads guppy (Poecilia reticulata). By 1935, for shallow side channels, sidepools, 1985, p. 559; Heads 1986, p. 369). some Oahu damselfly species, including and higher velocity riffles and seeps Backswimmers are not native to Hawaii, the orangeblack Hawaiian damselfly, (Englund 1999, pp. 236-237). While fish but several species have been were becoming less common, and fish predation has been an important factor introduced. Notonecta indica (no introduced for mosquito control were in the evolution of behavior in common name) was first collected on the suspected cause of their decline damselfly naiads in continental systems Oahu in the mid-1980s and is presently (Williams 1936, p. 313; Zimmerman (Johnson 1991, pp. 8), it is speculated known from Oahu, Maui, and Hawaii. 1948b, p. 341). The literature clearly that Hawaii’s stream-dwelling Species of Notonecta are known to prey indicates that the extirpation of the damselflies adapted behaviors to avoid on damselfly naiads and the mere Pacific Hawaiian damselfly from the the benthic feeding habits of native fish majority of its historical habitat sites on presence of this predator in the water species. Additionally, some species of the main Hawaiian Islands is the result can cause naiads to reduce foraging damselflies, including some of the of predation by nonnative fish (Moore (which can reduce naiad growth, native Hawaiian species, are not and Gagne 1982, p. 4; Liebherr and development, and survival) (Heads adapted to cohabitate with some fish Polhemus 1997, p. 502; Englund 1999, 1985, p. 559; Heads 1986, p. 369). While species, and are found only in bodies of pp. 235-237; Brasher 2003, p. 1,055; there is no documentation that water without fish (Henrikson 1988, p. Englund et al. 2007, p. 215; Polhemus conclusively ties the decrease in 179; McPeek 1990a, p. 83). The naiads 2007, pp. 238-239). From 1946 through damselfly observations to the of the aquatic Pacific Hawaiian 1961, several additional nonnative fish establishment of nonnative damselfly tend to occupy more exposed were introduced for the purpose of backswimmers in Hawaiian streams and positions and engage in conspicuous controlling nonnative aquatic plants, other aquatic habitat, the presence of foraging behavior, thereby increasing and for angling (Brasher 2003, p. 1,054). backswimmers in these habitats, the their susceptibility to fish predation In the early 1980s, several additional documented predation of (Englund 1999, p. 232), unlike species of nonnative fish began backswimmers on the naiads of other damselflies that coevolved with appearing in stream systems, likely damselfly species, and the concurrent predaceous fish (Macan 1977, p. 48; originating from the aquarium fish trade decline of damselfly observations in McPeek 1990b, p. 1,714). In laboratory (Devick 1991, p. 189; Brasher 2003, p. some areas suggest that these nonnative studies, Englund (1999, p. 232) found 1,054). By 1990, there were an aquatic insects may have played a role that naiads of the orangeblack Hawaiian additional 14 species of nonnative fish in the decline of some damselfly damselfly and the Pacific Hawaiian established in waters on Hawaii, Maui, populations, including those of the damselfly invariably were eaten due to and Molokai. By 2008, there were at Pacific Hawaiian damselfly. their behavior of swimming to the water least 17 nonnative freshwater fish We consider predation by nonnative surface when exposed to two nonnative established on one or more of these backswimmers to pose a significant and freshwater fish. In the same study, islands, including several aggressive immediate threat to the Pacific naiads of nonnative damselfly species predators and habitat-altering species Hawaiian damselfly, because this avoided predation by the same fish such as the channel catfish (Ictalurus species has an aquatic naiad life stage. species by remaining still and avoiding punctatus) and cichlids (Tilapia sp.) In addition, the presence of these surface waters (Englund 1999, p. 232). (Devick 1991, pp. 191-192; FishBase predators in damselfly aquatic habitat Over 70 species of nonnative fish 2008). causes naiads to reduce foraging, which have been introduced into Hawaiian The Pacific Hawaiian damselfly is in turn reduces their growth, freshwater habitats (Devick 1991, p. 190; currently found only in portions of development, and survival. Englund 1999, p. 226; Staples and stream systems without nonnative fish Backswimmers are reported on all of the Cowie 2001, p. 32; Brasher 2003, p. (Liebherr and Polhemus 1997, pp. 493- main Hawaiian Islands except 1,054; Englund 2004, p.27; Englund et 494; Englund 1999, p. 228; Englund Kahoolawe. Without elimination or al. 2007, p. 232); at least 53 species are 2004, p. 27; Englund et al. 2007, p. 215). control of nonnative backswimmers, we now established in the freshwater There is a strong correlation between

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the absence of nonnative fish species damselfly remains extant are not secure Geological Survey 2008b, p. 8). This and the presence of Hawaiian from the threat of predation by species is flexible in both habitat and damselflies in streams on all of the main introduced fish species. There are many food requirements (Bury and Whelan Hawaiian Islands (Englund 1999, p. 225; documented cases of people moving 1985 in Earlham College 2002, p. 11), Englund et al. 2007, p. 215), suggesting nonnative fish from one area to another and can utilize any water source within that the damselflies cannot coexist with (Brock 1995, pp. 3-4; Englund 1999, p. its temperature range (60 to 75 degrees nonnative fish. The distribution of some 237). Once nonnative fish species are Fahrenheit (°F)) (16 to 24 degrees Hawaiian damselfly species is now introduced to aquatic habitats Celsius (°C)) (DesertUSA 2008). reduced to stream reaches less than 312 previously free of nonnative fish, they Introduced to areas outside its native ft (95 m) in length where invasive fish often become permanently established range, the bullfrog’s primary impact is species do not occur (Englund 1999, p. (Englund and Filbert 1999, p. 151; typically the elimination of native frog 229; Englund 2004, p. 27). In 2007, a Englund 1999, pp. 232-233; Englund et species (Moyle 1973, p. 21). In Hawaii, Statewide survey including 15 streams al. 2007). An example of facilitated fish where there are no native frogs, the on the islands of Hawaii, Maui, and movement occurred in 2000, when an bullfrog has not been definitively Molokai found the flying earwig uninformed maintenance worker implicated in the extirpation of any Hawaiian damselfly was not observed in introduced Tilapia sp. into pools particular native aquatic invertebrate streams where the introduced Mexican located on the grounds of Tripler species, but Englund et al. (2007, pp. molly (Poecilia mexicana) was present Hospital that were maintained for the 215, 219) found a strong correlation (Englund et al. 2007, pp. 214-216, 228). benefit of the remaining Oahu between the presence of bullfrogs and On Oahu, researchers found that the population of the orangeblack Hawaiian the absence of Hawaiian damselflies in Oahu-endemic Hawaiian damselflies damselfly (Englund 2000). their 2006 study of streams on all of the only occupied habitat sites without The continued introduction and main Hawaiian Islands. As the bullfrog nonnative fish. For two of these species, establishment of new species of prefers habitats with dense vegetation a geologic or manmade barrier (e.g., predatory nonnative fish in Hawaiian and relatively calm water (Moyle 1973, waterfalls, steep gradient, dry stream waters, and the possible movement of p. 19; Bury and Whelan 1985 in midreaches, or constructed diversions) these nonnative species to new streams Earlham College 2002, p. 9), it is likely appears to prevent access by the and other aquatic habitat, is an of particular threat to the Pacific nonnative fish species. For this reason, immediate and significant threat to the Hawaiian damselfly because this species researchers have recommended that survival of the aquatic Pacific Hawaiian also prefers calm water habitat that is geologically isolated sites inaccessible damselfly. Unless nonnative predatory surrounded by dense vegetation. to nonnative fishes, such as isolated fish are eradicated or effectively Capable of breeding within small pools anchialine ponds, high-gradient streams controlled in the habitats utilized by the of water, bullfrogs are also a potential interrupted by manmade diversions, Pacific Hawaiian damselfly, we have no threat to the flying earwig Hawaiian and streams entering the coast as reason to believe that there will be any damselfly within its uluhe-covered, waterfalls, be used as restoration sites significant reduction in this threat at steep, riparian, and moist talus-slope for damselflies on all of the Hawaiian any time in the near future. The flying habitat on Maui. Islands (Englund 2004, p. 27). earwig Hawaiian damselfly is not Because the effects of possible Of the two damselfly species known to be threatened by predation predation by the cane toad and the considered in this final rule, the aquatic from nonnative fish species, due to the Japanese wrinkled frog on the flying Pacific Hawaiian damselfly appears to apparent absence of the larval stage earwig Hawaiian damselfly and the have had the greatest range contraction within stream habitats. Pacific Hawaiian damselfly are due to predation by nonnative fish unknown at this time, the magnitude or Predation by Introduced Frogs and (Englund 1999, p. 235; Polhemus 2007, significance of this potential threat Toads p. 234, 238-240). Once found on all of cannot be determined. the main Hawaiian Islands, it is now Currently, there are three species of We consider predation by bullfrogs to found only on Molokai, Maui, and one introduced aquatic amphibians known pose a significant and immediate threat stream on the island of Hawaii below in the Hawaiian Islands: The North to the Pacific Hawaiian damselfly, since 2,000 ft (600 m) in elevation; all are in American bullfrog (Rana catesbeiana), Englund et al. (2007, pp. 215, 219) stream reaches free of nonnative fish. the cane toad (Bufo marinus), and the found a strong correlation between the The Pacific Hawaiian damselfly was Japanese wrinkled frog (Rana rugosa). presence of predatory nonnative extirpated from Oahu by 1910 (Liebherr The bullfrog is native to the eastern bullfrogs and the absence of Hawaiian and Polhemus 1997, p. 502), although United States and the Great Plains damselflies, and the preferred habitat of Englund (1999, p. 235) found that Oahu region (Moyle 1973, p. 18; Bury and the bullfrog overlaps with that of the still has abundant and otherwise Whelan 1985 in Earlham College 2002, Pacific Hawaiian damselfly. Within its suitable lowland and coastal water p. 10), and was first introduced into riparian habitat, the flying earwig habitat to support this species. Hawaii in 1899 (Bryan 1931, p. 63) to Hawaiian damselfly may also be However, this aquatic habitat is infested help control insects, specifically the threatened by the bullfrog, which is with nonnative fish, with some nonnative Japanese beetle (Popillia capable of breeding within small pools nonnative species occurring up to 1,300- japonica), a significant pest of of water. In the absence of the ft (400-m) elevation. In contrast, ornamental plants (Bryan 1931, p. 62). elimination or control of nonnative Englund (1999, p. 236) found that even Bullfrogs were first released and quickly bullfrogs, we expect that this threat will at sea level, artificial wetlands (resulting became established in the Hilo region continue or increase in the future. from taro cultivation) on the island of on the island of Hawaii (Bryan 1931, p. Molokai can support populations of the 63). Bullfrogs have demonstrated great Summary of Factor C Pacific Hawaiian damselfly because success in establishing new populations Predation by nonnative animal nonnative fish are absent. wherever they have been introduced species (ants, backswimmers, fish, and Even the geographically isolated (Moyle 1973, p. 19), and now occur on bullfrogs) poses an immediate and stream headwaters and other aquatic the islands of Hawaii, Kauai, Lanai, significant threat to the Pacific and habitats where the Pacific Hawaiian Maui, Molokai, and Oahu (U.S. flying earwig Hawaiian damselflies

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throughout their ranges for the threatened within its riparian permit to drill a well within proximity following reasons: habitat by the bullfrog, which is of streams or dike rock located at the • Damselfly naiads are vulnerable to capable of breeding within small headwaters of streams automatically predation by ants, and the ranges of pools of water. triggers additional review (Hardy 2009). both the Pacific and flying earwig Permits to drill wells near streams or Factor D. The Inadequacy of Existing Hawaiian damselflies overlap that within dike complexes are now unlikely Regulatory Mechanisms of particularly aggressive, to be granted because a new well would nonnative, predatory ant species Inadequate Habitat Protection require the amendment of in-stream that currently occur from sea level Currently, there are no Federal, State, flow standards for the impacted stream. to 2,000 ft (610 m) elevation on all or local laws, treaties, or regulations that However, such amendments are of the main Hawaiian Islands. We specifically conserve or protect the sometimes approved. One example is consider both the Pacific and flying flying earwig Hawaiian damselfly or the the long-contested case involving the earwig Hawaiian damselflies to be Pacific Hawaiian damselfly from the Waiahole Ditch on the island of Oahu threatened by predation by these threats described in this final rule. The (Hawaii Department of Agriculture nonnative ants. 2002, p. 3). In that case, the Commission • Nonnative backswimmers prey on State of Hawaii considers all natural flowing surface water (streams, springs, supports the removal of several million damselfly naiads in streams and gallons of water daily from windward other aquatic habitat, and are and seeps) as State property (Hawaii Revised Statutes 174c 1987), and the Oahu streams (Hawaii Department of considered a threat to the Pacific Agriculture 2002). Although a Hawaiian damselfly since this Hawaii Department of Land and Natural Resources (DLNR), Division of Aquatic regulatory process is in place that can species has an aquatic naiad life potentially address the effects of new stage. In addition, the presence of Resources has management responsibility for the aquatic organisms requests for groundwater removal on backswimmers inhibits the foraging streams, this process includes behavior of damselfly naiads, with in these waters (Hawaii Revised Statutes Annotated, 1988, Title 12; 1992 provisions for amendments that would negative consequences for result in adverse effects to groundwater development and survival. Cumulative Supplement). Thus, damselfly populations associated with that supports streamside habitat for the Backswimmers are reported on all Pacific Hawaiian damselfly, and of the main Hawaiian Islands streams, seeps, and springs are under the jurisdiction of the State of Hawaii, potentially for the flying earwig except Kahoolawe. Hawaiian damselfly. • The absence of Hawaiian damselflies, regardless of the ownership of the including the aquatic Pacific property across which the stream flows. The maintenance of instream flow, Hawaiian damselfly, in streams and This includes all populations of the which is needed to protect the habitat other aquatic habitat on the main Pacific Hawaiian damselfly and the of damselflies and other aquatic Hawaiian Islands, is strongly flying earwig Hawaiian damselfly. wildlife, is regulated by the correlated with the presence of The State of Hawaii manages the use establishment of standards on a stream- predatory nonnative fish as of surface and groundwater resources by-stream basis (State Water Code, documented in numerous through the Commission on Water Hawaii Revised Statutes Chapter 174C- observations and reports (Englund Resource Management (Water 71, and Administrative Rules of the 1999, p. 237; Englund 2004, p. 27; Commission), as mandated by the 1987 State Water Code, Title 13, Chapter Englund et al. 2007, p. 215), thereby State Water Code (State Water Code, 169). Currently, the interim instream suggesting that nonnative predatory Hawaii Revised Statutes Chapter 174C- flow standards represent the existing fishes eliminated native Hawaiian 71, 174C-81-87, and 174C-9195, and flow conditions in streams in the State damselflies from these aquatic Administrative Rules of the State Water (as of June 15, 1988, for Molokai, habitats. There are over 51 species Code, Title 13, Chapters 168 and 169). Hawaii, Kauai and east Maui; and of nonnative fishes established in In the State Water Code, there are no October 19, 1988, for west Maui and freshwater habitats on the Hawaiian formal requirements that project leeward Oahu) (Administrative Rules of Islands from sea level to over 3,800- proponents or the Water Commission the State Water Code, Title 13, Chapter ft (1,152-m) elevation (Devick 1991, protect the habitats of fish and wildlife 169-44-49). However, the State Water p. 190; Staples and Cowie 2001, p. prior to issuance of a permit to modify Code does not provide permanent or 32; Brasher 2003, p. 1054; Englund surface or groundwater resources. minimal instream flow standards for the 1999, p. 226; Englund and As noted above in Factor A, the Water protection of aquatic wildlife. Instead, Polhemus 2001; Englund 2004, p. Commission is now more cognizant of modification of instream flow standards 27; Englund et al. 2007, p. 232). the effects that groundwater removal has and stream channels can be undertaken Predation by nonnative fishes is on streams via injudicious placement of at any time by the Water Commission or considered to pose a significant and wells. The Commission routinely via public petitions to revise flow immediate threat to the Pacific reviews new permit applications for standards or modify stream channels in Hawaiian damselfly. wells (Hardy 2009, p. 1). All requests for a specified stream (Administrative Rules • Englund et al. (2007, pp. 215, 219) new wells require a drilling permit, and, of the State Water Code, Title 13, found a strong correlation between in some cases, a use permit is Chapter 169-36). Additionally, the the presence of nonnative bullfrogs additionally required, depending upon Water Commission must consider and the absence of Hawaiian the intended allocation and anticipated economic benefits gained from out-of- damselflies. Bullfrogs are reported amount of water to be pumped from the stream water uses, but is not required to on all of the main Hawaiian Islands, well. Water Management Areas have balance these benefits against instream except Kahoolawe and Niihau. The been designated over much of Oahu and benefits or impacts to aquatic fish and Pacific Hawaiian damselfly is likely in some areas on other neighboring wildlife. Consequently, any stabilization threatened by bullfrogs, due to their islands. Within these areas, a use permit of stream flow for the protection of any shared preference for similar for a new well is also required, which native Hawaiian damselfly species habitat, and the flying earwig automatically triggers a greater review of habitat is subject to modification at a Hawaiian damselfly may also be the potential impacts. Any request for a future date.

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The natural value of Hawaii’s stream complexity of the impacts on Hawaiian or regulations that adequately conserve systems has been recognized under the damselflies from stream modifications or protect habitat of the flying earwig State of Hawaii Instream Use Protection and surface water diversions, the Hawaiian damselfly or the Pacific Program (Administrative Rules of the remoteness of project sites, and the Hawaiian damselfly from the threats State Water Code, Title 13, Chapter 169- types of studies necessary to determine described in this final rule, and the 20(2)). In the Hawaii Stream Assessment project impacts and mitigation, this regulations currently in place are Report (1990), prepared in coordination limited comment period does not allow inadequate to maintain stream and with the National Park Service, the State time for an adequate assessment of riparian habitats and protect the two Water Commission identified high- impacts. This regulation is inadequate damselfly species from stream quality rivers or streams, or portions of to protect the damselflies because the modifications and surface water rivers or streams, that may be placed Corps is under no obligation to modify diversions, all of these threats remain within the Federal Wild and Scenic the project based upon comments immediate and significant. The habitat River system. This report recommended received. of both species continues to be reduced, that streams meeting certain criteria be However, if the stream is degraded, and altered by past and protected from further development. jurisdictional and impacts are expected present manmade alterations to streams However, there is no formal or to exceed the thresholds for a and riparian zones. institutional mechanism within the nationwide permit, the Corps can issue Inadequate Protection from Introduction State’s Water Code to designate and set individual permits under section 404 of of Nonnative Species aside these streams, or to identify and the Clean Water Act (33 U.S.C. 1251 et protect stream habitat for Hawaiian seq.). These permits are subject to As discussed above (see Factor C. damselflies. Furthermore, the setting of public review, and must comply with Disease or Predation), predation by instream flow standards sufficient to the Environmental Protection Agency’s nonnative species (fish, insects, and conserve Hawaiian damselflies is 404(b)(1) guidelines and public bullfrogs) is one of the most significant currently not a condition that would be comment requirements under the Clean threats to the survival of the flying considered or included in a Hawaii Water Act. Compensatory mitigation earwig Hawaiian damselfly and the Department of Agriculture individual may also be required to offset lost Pacific Hawaiian damselfly. permit (DLNR, Commission on Water stream functions. However, in issuing Based on historical and current rates Resource Management 2006, p. 2). these permits, the Corps does not of aquatic species introductions (both Existing Federal regulatory establish instream flow standards as a purposeful and accidental), existing mechanisms that may protect Hawaiian matter of policy. The Corps normally State and Federal regulatory damselflies and their habitat are also considers that the public interest for mechanisms are not adequately inadequate. The Federal Energy instream flow is represented by the preventing the spread of nonnative Regulatory Commission (FERC) has very State water allocation rights or species between islands and watersheds limited jurisdiction in Hawaii. Hawaii’s preferences (U.S. Army Corp of in Hawaii. The Hawaii Department of streams are isolated on individual Engineers’ Regulatory Guidance Letter Agriculture has administrative rules in islands and run quickly down steep No 85-6), and project alternatives that place that address importation of volcanic slopes. There are no interstate supersede, abrogate, or otherwise impair nonnative species and establish a permit rivers in Hawaii, few if any streams the State water quantity allocations are process for such activities (Hawaii crossing Federal land, and no Federal not normally addressed as alternatives Administrative Rules sec. 4-71). The dams. Many of Hawaii’s streams are during permit review. Division of Aquatic Resources within generally intermittent, or if perennial, In cases where the Corps district the Hawaii Department of Land and not navigable. Thus, licensing of engineer does propose to impose Natural Resources (HDLNR) has hydroelectric projects in Hawaii instream flow standards on an authority to seize, confiscate, or destroy generally does not come under the individual permit, this flow standard as a public nuisance, any fish or other purview of FERC, although hydropower must reflect a substantial national aquatic life found in any waters of the developers in Hawaii may voluntarily interest. Additionally, if this instream State and whose importation is seek licensing under FERC. flow standard is in conflict with a State prohibited or restricted under rules of In contrast, the U.S. Army Corps of water quantity allocation, then it must the Department of Agriculture (Section Engineers (Corps) has some regulatory be reviewed and approved by the Office 187A-2(4 H.R.S. sec. 187A-6.5)). control over modifications of freshwater of the Chief Engineer in Washington, Although State and Federal regulations streams in the United States, yet may D.C. (Regulatory Guidance Letter No 85- are now firmly in place to prevent the assert discretion relative to 6). unauthorized entry of nonnative aquatic jurisdictional determinations depending One population of the Pacific species into the State of Hawaii, on the surface water connection of the Hawaiian damselfly occurs in Palikea movement of species between islands stream to a tangible water of the United Stream on Maui, which flows through and from one watershed to the next States. If the Corps finds the stream to Haleakala National Park. On Molokai, remains problematic even while be jurisdictional, certain activities such populations of this damselfly species prohibited (HDAR 2003, pp. 2/12 – 2/ as road crossings for streams and bank occur at the mouth of Pelekunu Stream, 14). For example, while unauthorized stabilization can be subject to a which flows through a preserve movement of an aquatic species from streamlined permitting process (33 CFR managed by The Nature Conservancy, one watershed to the next may be 330). This process, called the and in lower Waikolu Stream, which prohibited, there simply is not enough nationwide permits program, can flows through Kalaupapa National government funding to adequately involve only limited public review if Historic Park. However, the landowners enforce such regulation or to provide for impacts are anticipated to be minimal, do not own the water rights to any of the sufficient inspection services and both individually and cumulatively. streams, and thus cannot fully manage monitoring, although this priority need The Service and the Hawaii DLNR the conservation of any of these is recognized (Cravalho 2009, p. 1). have 15 days to provide substantive site- damselfly populations. Furthermore, due to the complexity of specific comments prior to the issuance Because there are currently no the pathways of invasion by aquatic of a nationwide permit. Given the Federal, State, or local laws or treaties species (i.e., intentional, inadvertent,

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and by forces of nature), many for the damselflies and to regulate the historical processes responsible for components contributing to the problem spread of nonnative species, the genetic divergence within a species) of may be better addressed through greater inadequacy of existing regulatory four Megalagrion species that the Pacific public outreach and education mechanisms is considered to be a Hawaiian damselfly may be more (Montgomery 2009, p. 1). significant and immediate threat. susceptible to problems linked to low On the basis of the above information, genetic diversity compared to other we find that existing regulatory Factor E. Other Natural or Manmade Hawaiian damselfly species. Both Maui mechanisms do not adequately protect Factors Affecting the Species’ Continued and Molokai populations of this species the flying earwig Hawaiian damselfly or Existence were analyzed, and results suggested the Pacific Hawaiian damselfly from the Small Numbers of Populations and that the Pacific Hawaiian damselfly may threat of established nonnative species Individuals not disperse well across both land and (particularly fish and insect species) Species that are endemic to single water, which may have led to the low spreading between islands and genetic diversity observed in the two islands or known from few, widely watersheds, where they may prey upon populations sampled. The authors dispersed locations are inherently more or directly compete with the two proposed that populations of the Pacific vulnerable to extinction than damselfly species for food and space. Hawaiian damselfly be monitored and widespread species because of the Because current Federal, State, and local managed to help understand the higher risks from genetic bottlenecks, laws and treaties and regulations are conservation needs of this species and random demographic fluctuations, inadequate to prevent the spread of the threat of population bottlenecks climate change, and localized nonnative aquatic animals between (Jordan et al. 2007, p. 258). This study catastrophes such as hurricanes, islands and watersheds, the impacts did not include an analysis of the flying landslides, and drought (Lande 1988, p. from these introduced threats remain earwig Hawaiian damselfly. However, immediate and significant. From 1,455; Mangel and Tier 1994, p. 607; given that this species may now be habitat-altering, nonnative plant species Pimm et al. 1988, p. 757). These reduced to a single population, the to predation or competition caused by problems are further magnified when potential loss of genetic diversity and introduced frogs, nonnative fish, and populations are few and restricted to a threat of inbreeding depression is a insect species, the Pacific Hawaiian limited geographic area, and the number concern for the flying earwig Hawaiian damselfly and the flying earwig of individuals is very small. Populations damselfly as well. Hawaiian damselfly are immediately with these characteristics face an The small number of remaining and significantly threatened by former increased likelihood of stochastic populations of the flying earwig and new plant and animal introductions extinction due to changes in Hawaiian damselfly (now possibly within the damselflies’ remaining demography, the environment, genetics, reduced to a single remaining habitat. or other factors, in a process described population) puts this species at as an ‘‘extinction vortex’’ by Gilpin and significant risk of extinction from Summary of Factor D Soul´e (1986, pp. 24-25). Small, isolated stochastic events, such as hurricanes, The aquatic habitat of the flying populations often exhibit a reduced landslides, or prolonged drought (Jones earwig and the Pacific Hawaiian level of genetic variability or genetic et al. 1984, p. 209). For example, damselflies is under the jurisdiction of depression due to inbreeding, which Polhemus (1993, p. 87) documented the the State of Hawaii, which also has diminishes the species’ capacity to extirpation of a related damselfly management responsibility for aquatic adapt and respond to environmental species, Megalagrion vagabundum, from organisms. However, the State Water changes, thereby lessening the the entire Hanakapiai Stream system on Code has no regulatory mechanism in probability of long-term persistence Kauai as a result of the impacts from place to protect these species or their (Soul´e 1987, pp. 4-7). The problems Hurricane Iniki in 1992. Such stochastic habitat. The State Water Code does not associated with small population size events thus pose the threat of immediate currently provide for permanent or and vulnerability to random extinction of a species with a very small minimum instream flow standards for demographic fluctuations or natural and geographically restricted the protection of aquatic ecosystems catastrophes are further magnified by distribution, as in the case of the flying upon which these damselfly species synergistic interactions with other earwig Hawaiian damselfly. depend, and does not contain a threats, such as those discussed above regulatory mechanism for identifying (Factors A–C). Summary of Factor E and protecting damselfly habitat under Historically, the two damselfly The threat to the flying earwig and a Wild and Scenic River designation. species were more widespread, present Pacific Hawaiian damselflies from To date, administration of the Clean on several Hawaiian islands. An limited numbers of populations and Water Act permitting program by the important benefit of this greater individuals is significant and immediate U.S. Army Corps of Engineers has not historical range, especially the fact they for the following reasons: provided substantive protection of were on several islands from which they • Each of these species is subject to damselfly habitat, including any are now extirpated, resulted in an potentially reduced reproductive requirements for retention of adequate advantage of redundancy: Additional vigor due to inbreeding depression, instream flows. populations separated by some distance particularly the flying earwig Existing State and Federal regulatory likely allowed some populations to be Hawaiian damselfly, which is now mechanisms are not adequately spared the impacts of localized or more apparently restricted to one regulating the spread of nonnative discrete catastrophic events, such as population; animal species between islands and narrow-track hurricanes or mud slides. • Each of these species is subject to watersheds. Predation by nonnative However, this advantage of redundancy reduced levels of genetic variability animal species poses a major ongoing has been lost with the great reduction in that may diminish their capacity to threat to the flying earwig and the the damselflies’ ranges. adapt and respond to Pacific Hawaiian damselflies. Because Jordan et al. (2007, p. 247) showed in environmental changes, thereby existing regulatory mechanisms are their genetic and comparative lessening the probability of their inadequate to maintain aquatic habitat phylogeography analysis (study of long-term persistence;

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• The potential benefits of redundancy temperatures) are also likely to listing if it is endangered or threatened resulting from the wider historical threaten these two damselfly throughout all or a significant portion of distribution of the species, in which species (compounded because of its range. Each of the two endemic some populations might survive the two species’ small population damselfly species designated as stochastic events that impact other sizes and limited distributions), endangered in this final rule is highly populations of the damselflies, has although currently there is limited restricted in its range, and the threats to been lost as a result of the extreme information on the exact nature of its survival occur throughout its range reduction in the ranges of the two these impacts (see discussion under and are not restricted to any particular species; Factor A). significant portion of that range. • As there may be only one remaining • The only known population of the Therefore, we assessed the status of population of the flying earwig flying earwig Hawaiian damselfly is each species throughout its entire range. Hawaiian damselfly that occurs in a immediately and significantly Accordingly, our assessment and final relatively restricted geographic threatened by potential recreational determination apply to each species location, a single catastrophic collection (see Factor B). throughout its entire range. event, such as a hurricane or • Both the flying earwig Hawaiian landslide, could result in the damselfly and the Pacific Hawaiian Available Conservation Measures extinction of the species. Likewise, damselfly are subject to an Conservation measures provided to the Pacific Hawaiian damselfly, immediate and significant threat of species listed as endangered or with several small, widely predation by nonnative insects threatened under the Act include dispersed populations, would be (ants) and bullfrogs. The Pacific recognition, recovery actions, vulnerable to the extirpation of Hawaiian damselfly is also requirements for Federal protection, and remaining populations; and similarly threatened by prohibitions against certain activities. • Species with few populations and a backswimmers and nonnative fish Recognition through listing results in small number of individuals, such (see Factor C). public awareness and conservation by as the Pacific Hawaiian damselfly • The inadequacy of existing regulatory Federal, State, Tribal, and local and flying earwig Hawaiian mechanisms (e.g., inadequate agencies, private organizations, and damselfly, are less resilient to protection of stream habitat and individuals. The Act encourages threats that might otherwise have a inadequate protection from the cooperation with the States and requires relatively minor impact on a larger introduction of nonnative species) that recovery actions be carried out for population. For example, the poses a threat to both species of all listed species. The protection reduced availability of breeding Hawaiian damselfly, as discussed required by Federal agencies, and the habitat or an increase in predation under Factor D above. prohibitions against certain activities of naiads, which might be absorbed • Both of these species face an are discussed, in part, below. in a relatively large population, immediate and significant threat The primary purpose of the Act is the could result in a significant from extinction due to factors conservation of endangered and decrease in survivorship or associated with small numbers of threatened species and the ecosystems reproduction of a relatively small, populations and individuals as upon which they depend. The ultimate isolated population. The small discussed under Factor E above. goal of such conservation efforts is the population size of these two species All of the above threats are recovery of these listed species, so that thus magnifies the severity of the exacerbated by the inherent they no longer need the protective impact of the other threats vulnerability of the flying earwig measures of the Act. Subsection 4(f) of discussed in this final rule. Hawaiian damselfly and the Pacific the Act requires the Service to develop Hawaiian damselfly to extinction from and implement recovery plans for the Determination stochastic events at any time because of conservation of endangered and We have carefully assessed the best their endemism (indigenousness), small threatened species. The recovery scientific and commercial information numbers of individuals and planning process involves the available regarding the past, present, populations, and restricted habitats. identification of actions that are and future threats to the flying earwig The Act defines an endangered necessary to halt or reverse the species’ Hawaiian damselfly and the Pacific species as any species that is ‘‘in danger decline by addressing the threats to its Hawaiian damselfly. We find that both of extinction throughout all or a survival and recovery. The goal of this of these species face immediate and significant portion of its range’’ and a process is to restore listed species to a significant threats throughout their threatened species as any species ‘‘that point where they are secure, self- ranges: is likely to become endangered sustaining, and functioning components • Both the Pacific Hawaiian damselfly throughout all or a significant portion of of their ecosystems. and the flying earwig Hawaiian its range within the foreseeable future.’’ Recovery planning includes the damselfly face threats from past, We find that each of these two species development of a recovery outline present, and potential future endemic to Hawaii is presently in shortly after a species is listed, destruction, modification, and danger of extinction throughout its preparation of a draft and final recovery curtailment of their habitats, entire range, based on the immediacy, plan, and revisions to the plan as primarily from: Agriculture and severity, and scope of the threats significant new information becomes urban development; stream described above. Therefore, on the basis available. The recovery outline guides diversion, well-drilling, of the best available scientific and the immediate implementation of urgent channelization, and dewatering; commercial information, we are listing recovery actions and describes the feral pigs and nonnative plants; and the flying earwig Hawaiian damselfly process to be used to develop a recovery from stochastic events like and the Pacific Hawaiian damselfly as plan. The recovery plan identifies site- hurricanes, landslides, and drought. endangered in accordance with sections specific management actions that will The changing environmental 3(6) and 4(a)(1) of the Act. achieve recovery of the species, conditions that may result from Under the Act and our implementing measurable criteria that determine when climate change (particularly rising regulations, a species may warrant a species may be downlisted or delisted,

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and methods for monitoring recovery Act are codified at 50 CFR part 402. scientific purposes, to enhance the progress. Recovery plans also establish Section 7(a)(2) of the Act requires propagation or survival of the species, a framework for agencies to coordinate Federal agencies to ensure that activities and for incidental take in connection their recovery efforts and provide they authorize, fund, or carry out are not with otherwise lawful activities. estimates of the cost of implementing likely to jeopardize the continued It is our policy, as published in the recovery tasks. Recovery teams existence of a listed species or destroy Federal Register on July 1, 1994 (59 FR (comprised of species experts, Federal or adversely modify its critical habitat. 34272), to identify to the maximum and State agencies, nongovernment If a Federal action may affect a listed extent practicable at the time a species organizations, and stakeholders) are species or its critical habitat, the is listed, those activities that would or often established to develop recovery responsible Federal agency must enter would not constitute a violation of plans. When completed, the recovery into consultation with the Service. section 9 of the Act. The intent of this outline, draft recovery plan, and the Federal agency actions within the policy is to increase public awareness of final recovery plan will be available species’ habitat that may require the effect of a proposed listing on from our website (http://www.fws.gov/ consultation as described in the proposed and ongoing activities within endangered), or from our Pacific Islands preceding paragraph include, but are the range of species proposed for listing. Fish and Wildlife Office (see not limited to: Army Corps of Engineers The following activities could ADDRESSES). involvement in projects, such as the potentially result in a violation of Implementation of recovery actions construction of roads, bridges, and section 9 of the Act; this list is not generally benefits from the participation dredging projects, subject to section 404 comprehensive: of a broad range of partners, including of the Clean Water Act (33 U.S.C. 1251 (1) Unauthorized collecting, handling, other Federal agencies, States, et seq.) and section 10 of the Rivers and possessing, selling, delivering, carrying, nongovernmental organizations, Harbors Act of 1899 (33 U.S.C. 401 et or transporting of the species, including businesses, and private landowners. seq.); U.S. Environmental Protection import or export across State lines and Examples of recovery actions include Agency–authorized discharges under international boundaries, except for habitat restoration (e.g., restoration of the National Pollutant Discharge properly documented antique native vegetation), research, captive Elimination System (NPDES); U.S. specimens of these taxa at least 100 propagation and reintroduction, and Department of Agriculture involvement years old, as defined by section 10(h)(1) outreach and education. The recovery of in the release or permitting of the of the Act; many listed species cannot be release of biological control agents (2) Introduction of nonnative species accomplished solely on Federal lands under the Federal Plant Pest Act (7 that compete with or prey upon the two because their range may occur primarily U.S.C. 150aa-150jj); military training damselflies, such as the introduction of or solely on non-Federal lands. To and related activity carried out by the competing nonnative insects or achieve recovery of these species U.S. Department of Defense; and predatory fish to the State of Hawaii; requires cooperative conservation efforts projects by the Natural Resources (3) The unauthorized release of on private and State lands. Conservation Service, National Park biological control agents that attack any Upon listing, funding for recovery Service, U.S. Fish and Wildlife Service, life stage of these species; actions will be available from a variety Federal Highways Administration, and (4) Unauthorized modification of the of sources, including Federal budgets, the U.S. Department of Housing and channel or water flow of any stream or State programs, and cost-share grants for Urban Development. removal or destruction of emergent non-Federal landowners, the academic The Act and its implementing aquatic vegetation in any body of water community, and nongovernmental regulations set forth a series of general in which the flying earwig Hawaiian organizations. In addition, under section prohibitions and exceptions that apply damselfly and the Pacific Hawaiian 6 of the Act, the State of Hawaii is to all endangered and threatened damselfly are known to occur; and eligible for Federal funds to implement wildlife. The prohibitions of section (5) Unauthorized discharge of management actions that promote the 9(a)(2) of the Act, codified at 50 CFR chemicals or fill material into any protection and recovery of the flying 17.21 for endangered wildlife, in part, waters in which the flying earwig earwig Hawaiian damselfly and the make it illegal for any person subject to Hawaiian damselfly and the Pacific Pacific Hawaiian damselfly. Information the jurisdiction of the United States to Hawaiian damselfly are known to occur. on our grant programs that are available take (includes harass, harm, pursue, Questions regarding whether specific to aid species recovery can be found at: hunt, shoot, wound, kill, trap, capture, activities would constitute a violation of http://www.fws.gov/grants. or collect, or attempt any of these), section 9 of the Act should be directed Please let us know if you are import, export, ship in interstate to the Pacific Islands Fish and Wildlife interested in participating in recovery commerce in the course of a commercial Office (see ADDRESSES). Requests for efforts for the flying earwig Hawaiian activity, or sell or offer for sale in copies of the regulations concerning damselfly and the Pacific Hawaiian interstate or foreign commerce any listed animals and general inquiries damselfly. Additionally, we invite you listed species. It is also illegal to regarding prohibitions and permits may to submit any new information on these possess, sell, deliver, carry, transport, or be addressed to the U.S. Fish and species whenever it becomes available ship any such wildlife that has been Wildlife Service, Endangered Species and any information you may have for taken illegally. Certain exceptions apply Permits, 911 N.E. 11th Avenue, recovery planning purposes (see to our agents and State conservation Portland, OR 97232-4181 (telephone ADDRESSES). agencies. 503-231-2063; facsimile 503-231-6243). Section 7(a) of the Act, as amended, We may issue permits to carry out Upon listing under the Act, the State requires Federal agencies to evaluate otherwise-prohibited activities of Hawaii’s Endangered Species Act their actions with respect to any species involving endangered and threatened (HRS, Sect. 195D–4(a)) is automatically that is proposed or listed as endangered wildlife species under certain invoked, which would also prohibit take or threatened and with respect to its circumstances. Regulations governing of these species and encourage critical habitat, if any is designated. permits are codified at 50 CFR 17.22 for conservation by State government Regulations implementing this endangered species. A permit must be agencies. Further, the State may enter interagency cooperation provision of the issued for the following purposes: For into agreements with Federal agencies

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to administer and manage any area lands. Such designation does not generally the information developed required for the conservation, require implementation of restoration, during the listing process for the management, enhancement, or recovery, or enhancement measures by species. Additional information sources protection of endangered species (HRS, the landowner. Where a landowner may include the recovery plan for the Sect. 195D–5(c)). Funds for these seeks or requests Federal agency species, if available; articles in peer- activities could be made available under funding or authorization that may affect reviewed journals; conservation plans section 6 of the Act (Cooperation with a listed species or critical habitat, the developed by States and counties; the States). Thus, the Federal protection consultation requirements of section scientific status surveys and studies; afforded to these species by listing them 7(a)(2) of the Act would apply, but even biological assessments; or other as endangered species will be reinforced in the event of a destruction or adverse unpublished materials and expert and supplemented by protection under modification finding, the Federal action opinion or personal knowledge. State law. agency’s and landowner’s obligation is Habitat is often dynamic, and species not to restore or recover the species, but Critical Habitat may move from one area to another over to implement reasonable and prudent time. Furthermore, we recognize that Background alternatives to avoid destruction or critical habitat designated at a particular adverse modification of the critical Critical habitat is defined in section 3 point in time may not include all of the habitat. of the Act as: habitat areas that we may later For inclusion in a critical habitat determine are necessary for the recovery (1) The specific areas within the designation, the habitat within the geographical area occupied by the of the species. For these reasons, a geographical area occupied by the critical habitat designation does not species, at the time it is listed in species at the time of listing must accordance with the provisions of signal that habitat outside the contain the physical and biological designated area is unimportant or may section 4 of the Act, on which are found features essential to the conservation of those physical or biological features not be required for recovery of the the species, and be included only if species. (a) Essential to the conservation of the those features may require special Areas that are important to the species; and management considerations or conservation of the species, but are (b) Which may require special protection. Critical habitat designations outside the critical habitat designation, management considerations or identify, to the extent known using the will continue to be subject to protections; and best scientific data available, habitat (2) Specific areas outside the areas that provide essential life cycle conservation actions we implement geographical area occupied by a species needs of the species (i.e., areas on which under section 7(a)(1) of the Act. Areas at the time it is listed in accordance are found the primary constituent that support populations are also subject with the provisions of section 4 of the elements (PCEs) laid out in the to the regulatory protections afforded by Act, upon a determination by the appropriate quantity and spatial section 9 prohibitions and the section Secretary of the Interior that such areas arrangement for the conservation of the 7(a)(2) jeopardy standard, as determined are essential for the conservation of the species). Under the Act, we can on the basis of the best available species. designate critical habitat in areas scientific information at the time of the Conservation, as defined under outside the geographical area occupied agency action. Federally funded or section 3 of the Act, means to use and by the species at the time it is listed permitted projects affecting listed the use of all methods and procedures only when we determine that those species outside their designated critical that are necessary to bring an areas are essential for the conservation habitat areas may still result in jeopardy endangered or threatened species to the of the species. findings in some cases. Similarly, point at which the measures provided Section 4 of the Act requires that we critical habitat designations made on the under the Act are no longer necessary. designate critical habitat on the basis of basis of the best available information at Such methods and procedures include, the best scientific and commercial data the time of designation will not control but are not limited to, all activities available. Further, our Policy on the direction and substance of future associated with scientific resources Information Standards Under the recovery plans, habitat conservation management such as research, census, Endangered Species Act (published in plans, or other species conservation law enforcement, habitat acquisition the Federal Register on July 1, 1994 (59 planning efforts if new information and maintenance, propagation, live FR 34271)), the Information Quality Act available at the time of these planning trapping, and transplantation, and, in (section 515 of the Treasury and General efforts warrants otherwise. the extraordinary case where population Government Appropriations Act for Prudency Determination pressures within a given ecosystem Fiscal Year 2001 (Pub. L. 106-554; H.R. cannot be otherwise relieved, may 5658)), and our associated Information Section 4(a)(3) of the Act, as include regulated taking. Quality Guidelines issued by the amended, and implementing regulations Critical habitat receives protection Service, provide criteria, establish (50 CFR 424.12) require that, to the under section 7 of the Act through the procedures, and provide guidance to maximum extent prudent and prohibition against Federal agencies ensure that our decisions are based on determinable, the Secretary designate carrying out, funding, or authorizing the the best scientific data available. They critical habitat at the time a species is destruction or adverse modification of require our biologists, to the extent determined to be endangered or critical habitat. Section 7(a)(2) of the Act consistent with the Act and with the use threatened. Our regulations (50 CFR requires consultation on Federal actions of the best scientific data available, to 424.12(a)(1)) state that designation of that may affect critical habitat. The use primary and original sources of critical habitat is not prudent when one designation of critical habitat does not information as the basis for or both of the following situations exist: affect land ownership or establish a recommendations to designate critical (1) The species is threatened by taking refuge, wilderness, reserve, preserve, or habitat. or other human activity, and other conservation area. Such When we are determining which areas identification of critical habitat can be designation does not allow the should be designated as critical habitat, expected to increase the degree of threat government or public access to private our primary source of information is to the species, or (2) such designation of

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critical habitat would not be beneficial essential to the survival and recovery of (1) Space for individual and to the species. the species, they may be proposed for population growth, and for normal In the absence of finding that the designation of critical habitat. This behavior; designation of critical habitat would would alert the public that these areas (2) Food, water, air, light, minerals, or increase threats to a species, if there are are important for the future recovery of other nutritional or physiological any benefits to a critical habitat the species, as well as invoke the requirements; designation, then we would determine protection of these areas under section (3) Cover or shelter; that the designation of critical habitat is 7 of the Act with regard to any possible (4) Sites for breeding, reproduction, prudent. We find that the designation of Federal actions in that area. rearing (or development) of offspring; critical habitat for the two damselfly These aspects of critical habitat and species addressed in this rule will designation would potentially benefit (5) Habitats that are protected from benefit them by: (1) Triggering the conservation of both the flying disturbance or are representative of the consultation under section 7 of the Act earwig Hawaiian damselfly and the historical geographical and ecological for Federal actions where consultation Pacific Hawaiian damselfly. Although distributions of a species. would not otherwise occur because, for collection has been identified as a threat We are currently unable to identify example, the affected area has become to the flying earwig Hawaiian damselfly, the physical and biological features that unoccupied by the species or the we believe that collection poses a are considered essential to the occupancy is in question; (2) focusing potential threat to this rare species conservation of either damselfly species, conservation efforts on the most regardless of the designation of critical because necessary information is not essential habitat features and areas; (3) habitat. Therefore, since we have available at this time. Key features of the providing educational benefits about the determined that the identification of life histories of these damselfly species, species to State or County governments critical habitat will not increase the such as longevity, larval stage or private entities; and (4) preventing degree of threats to these species and requirements, and fecundity, remain people from causing inadvertent harm because the designation may provide unknown. The aquatic and associated to the species. some measure of benefit, we find that upland habitats where the populations The primary regulatory effect of designation of critical habitat is prudent of the Pacific Hawaiian damselfly are critical habitat is the section 7(a)(2) for both the flying earwig Hawaiian found have been modified and altered requirement that Federal agencies damselfly and the Pacific Hawaiian by development and agriculture; stream refrain from taking any action that damselfly. diversions, channelization, and destroys or adversely modifies critical dewatering; and nonnative plants. In habitat. On the island of Maui, one Critical Habitat Determinability addition, introduced ants, population of the Pacific Hawaiian As stated above, section 4(a)(3) of the backswimmers, bullfrogs, and predatory damselfly occurs in a stream that flows Act requires the designation of critical nonnative fish have altered and through Haleakala National Park, and on habitat concurrently with the species’ degraded the habitat for the Pacific the island of Molokai, one population of listing ‘‘to the maximum extent prudent Hawaiian damselfly. Likewise, the this species occurs in the lower section and determinable.’’ Our regulations at 50 uluhe-dominated, moist talus-slope of a stream that flows through CFR 424.12(a)(2) state that critical habitats where populations of the flying Kalaupapa National Historical Park. The habitat is not determinable when one or earwig Hawaiian damselfly once National Park Service regulations and both of the following situations exist: occurred have been modified and Federal laws protect native animals in (i) Information sufficient to perform altered by agriculture; stream National Parks from harassment or required analyses of the impacts of the diversions, channelization, and destruction. Nevertheless, lands that designation is lacking, or dewatering; and the presence of feral may be designated as critical habitat in (ii) The biological needs of the species pigs, nonnative plants, and introduced the future for this species may be are not sufficiently well known to ants and bullfrogs. Historically, both of subject to Federal actions that trigger the permit identification of an area as these damselfly species were much section 7 consultation requirement, critical habitat. more widespread and occurred in such as the granting of Federal monies When critical habitat is not habitats found on several different for conservation projects or the need for determinable, the Act provides for an islands. Because over a century has Federal permits for projects, such as the additional year to publish a critical elapsed since these species were construction and maintenance of habitat designation (16 U.S.C. observed in an unaltered environment, aqueducts and bridges subject to section 1533(b)(6)(C)(ii)). the optimal natural conditions that 404 of the Clean Water Act (33 U.S.C. In accordance with section 3(5)(A)(i) provide the biological or ecological 1251 et seq.). of the Act and regulations at 50 CFR requisites of these species are not There may also be some educational 424.12, in determining which areas known. As described above, we can or informational benefits from the occupied by the species at the time of surmise that habitat degradation from a designation of critical habitat. listing to designate as critical habitat, variety of factors and predation by a Educational benefits include the we consider those physical and number of nonnative species has notification of landowners, land biological features essential to the contributed to the decline of these managers, and the general public of the conservation of the species that may species; however, we do not know the importance of protecting the habitat of require special management physical or biological features that are these species. considerations or protection. We essential for either of the two Critical habitat may play a role in consider the physical or biological damselflies addressed in this final rule. protecting habitat for future features essential to the species’ As we are unable to identify the reintroductions of a species as well. For conservation to be the primary physical and biological features example, although the flying earwig constituent elements laid out in the essential to the conservation of these Hawaiian damselfly formerly inhabited appropriate quantity and spatial species, we are unable to identify areas areas that are not currently occupied by arrangement for the conservation of the that contain these features. the species, if those currently species. The primary constituent Although we have determined that unoccupied areas are determined to be elements include, but are not limited to: the designation of critical habitat is

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prudent for the flying earwig Hawaiian approval by Office of Management and Authors damselfly and the Pacific Hawaiian Budget (OMB) under the Paperwork damselfly, the biological needs of these Reduction Act. This rule will not The primary authors of this document species are not sufficiently well known impose recordkeeping or reporting are the staff members of the Pacific to permit identification of the physical requirements on State or local Islands Fish and Wildlife Office. and biological features that may be governments, individuals, businesses, or List of Subjects in 50 CFR Part 17 essential for the conservation of the organizations. An agency may not species, or those areas essential to the conduct or sponsor, and a person is not Endangered and threatened species, conservation of the species. Therefore, required to respond to, a collection of Exports, Imports, Reporting and we find that critical habitat for the information unless it displays a recordkeeping requirements, flying earwig Hawaiian damselfly and currently valid OMB control number. Transportation. the Pacific Hawaiian damselfly is not determinable at this time. Over the next National Environmental Policy Act (42 Regulation Promulgation year, we intend to continue gathering U.S.C. 4321 et seq.) information regarding the essential life ■ Accordingly, we amend part 17, history requirements of the flying We have determined that subchapter B of chapter I, title 50 of the earwig Hawaiian damselfly and the environmental assessments and Code of Federal Regulations, as follows: Pacific Hawaiian damselfly to facilitate environmental impact statements, as identification of essential features and defined under the authority of the PART 17—[AMENDED] areas. We also will evaluate the needs National Environmental Policy Act of of the flying earwig Hawaiian damselfly 1969, need not be prepared in ■ 1. The authority citation for part 17 and the Pacific Hawaiian damselfly connection with regulations adopted continues to read as follows: within the ecological context of the under section 4(a) of the Act. We Authority: 16 U.S.C. 1361-1407; 16 U.S.C. broader ecosystems in which they published a notice outlining our reasons 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99- occur, similar to the approach that we for this determination in the Federal 625, 100 Stat. 3500; unless otherwise noted. recently used in our designation of Register on October 25, 1983 (48 FR ■ critical habitat for 47 species endemic to 49244). 2. Amend § 17.11(h) by adding entries the island of Kauai (April 13, 2010; 75 for ‘‘Damselfly, flying earwig Hawaiian’’ FR 18959), and will consider the utility References Cited and ‘‘Damselfly, Pacific Hawaiian’’ in of using this approach for these alphabetical order under Insects to the damselfly species as well. A complete list of all references cited List of Endangered and Threatened in this rule is available on the Internet Wildlife to read as follows: Required Determinations at http://www.regulations.gov or upon Paperwork Reduction Act of 1995 (44 request from the Field Supervisor, §17.11 Endangered and threatened U.S.C. 3501 et seq.) Pacific Islands Fish and Wildlife Office wildlife. This rule does not contain any new (see ADDRESSES). * * * * * collections of information that require (h) * * *

Species Vertebrate population Historic range where endangered or Status When listed Critical Special Common name Scientific name threatened habitat rules

*******

INSECTS

*******

Damselfly, flying Megalagrion U.S.A. (HI) NA E 271 NA NA earwig nesiotes Hawaiian

Damselfly, Megalagrion U.S.A. (HI) NA E 271 NA NA Pacific pacificum Hawaiian

*******

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* * * * * Compliance Guide are available from dogfish stock can be considered rebuilt Dated: June 11, 2010 the Regional Administrator, Northeast for the purposes of U.S. management. In Jeffrey L. Underwood, Regional Office, NMFS, 55 Great addition, the peer reviewers agreed on Republic Drive, Gloucester, MA 01930– a new fishing mortality rate target Acting Director, U.S. Fish and Wildlife Service. 2276, and are also available via the (Ftarget) of 0.207 (previously 0.28), which internet at http://www.nero.nmfs.gov. allows 1.5 pups per recruit, and a [FR Doc. 2010–15237 Filed 6–23– 10; 8:45 am] fishing mortality rate threshold BILLING CODE 4310–55–S FOR FURTHER INFORMATION CONTACT: Lindsey Feldman, Fisheries (Fthreshold) of 0.325 (previously 0.39). Management Specialist, phone: 978– Based on the updated stock status DEPARTMENT OF COMMERCE 675–2179, fax: 978–281–9135. determination criteria, NMFS sent a letter to the Councils that the spiny SUPPLEMENTARY INFORMATION: National Oceanic and Atmospheric dogfish stock is rebuilt. Administration Background The Ftarget of 0.207 could allow the 2010 quota to be specified as high as A proposed rule for this action was 21.5 million lb (9,752.24 mt). However, 50 CFR Part 648 published in the Federal Register on the Mid-Atlantic and New England April 2, 2010 (75 FR 16716), with public [Docket No. 100201058–0260–02] Fishery Management Councils’ Joint comment accepted through May 3, 2010. RIN 0648–AY50 Spiny Dogfish Committee (Committee) NMFS proposed to establish a submitted a comment on the proposed Fisheries of the Northeastern United commercial quota of 12 million lb rule that supported increasing the FY States; 2010 Specifications for the (5,443.11 mt), the level calculated to 2010 commercial quota to a level that Spiny Dogfish Fishery achieve the fishing mortality rate (F) employs a constant catch management that would rebuild the stock (Frebuild) approach and avoids dramatic AGENCY: National Marine Fisheries after accounting for other sources of fluctuations in annual quota levels. In Service (NMFS), National Oceanic and fishing mortality. NMFS also proposed addition, there are still a number of Atmospheric Administration (NOAA), maintaining the possession limit of concerns about the spiny dogfish stock Commerce. 3,000 lb (1.36 mt) for FY 2010. As noted condition. The 2009 updated stock ACTION: Final rule. in the preamble to the proposed rule, assessment shows evidence of strong the proposed commercial quota of 12 SUMMARY: NMFS announces recruitment; however, low pup million lb (5,443.11 mt) was consistent production from 1997 through 2003 has specifications and management with the rebuilding F level (Frebuild = measures for the spiny dogfish fishery been implicated by survey catches of 0.11) in existence at that time. As also pups and is further supported by for the 2010 fishing year (FY) (May 1, noted, the Transboundary Resource 2010, through April 30, 2011). NMFS is subsequent low survey catches of the Assessment Committee (TRAC) size categories these age classes have implementing a spiny dogfish quota of conducted a benchmark stock 15 million lb (6,803.89 mt) for FY 2010, grown into. As such, a decline in the assessment for spiny dogfish in stock is expected when these small and maintaining the possession limit of February 2010, and planned to re- 1997–2003 year-classes recruit into the 3,000 lb (1.36 mt). These measures are examine biological reference points. The SSB (in approximately 2015). In consistent with the Spiny Dogfish proposed rule explained that the FMP addition, the current survival rate of Fishery Management Plan (FMP) and provides a mechanism to allow updated pups may be lower than historic levels based on new biological reference stock status determination criteria to be due to reduced maternal size and a points announced by peer reviewers of used in setting final specifications. skewed male-to-female sex ratio in the the Transboundary Resource Details about the proposed measures population. A harvest scenario of 21.6 Assessment Committee (TRAC), which were included in the preamble of the million lb (9,797.6 mt) over the next 5 indicated the stock is rebuilt. proposed rule and are not repeated here. years has only a 27 percent chance of DATES: Effective July 26, 2010 through 1 The TRAC met in early February exceeding the biomass target ( ⁄2 Bmsy) April 30, 2011. 2010, and determined that additional when the small year classes from years ADDRESSES: Copies of supporting analysis would be conducted by a group of low pup production recruit into the documents used by the Mid-Atlantic of selected peer reviewers to further fishery. Fishery Management Council (MAFMC), define biological reference points, in including the Environmental particular to determine the status of the 2010 Specifications and Management Assessment (EA) and Regulatory Impact spiny dogfish stock for the purposes of Measures Review (RIR)/Initial Regulatory U.S. management. The commercial spiny dogfish quota Flexibility Analysis (IRFA), are for FY 2010 is 15 million lb (6,803.89 Revised Stock Status Determination available from: Richard Seagraves, mt), the level that equates to an F of Criteria Acting Deputy Director, Mid–Atlantic 0.167 when discard mortality and Fishery Management Council, Room On April 6, 2010, the group of peer Canadian harvest estimates are 2115, Federal Building, 300 South New reviewers selected by the TRAC accounted for. In setting the FY 2010 Street, Dover, DE 19904–6790. The accepted a newly defined biomass target commercial quota at 15 million lb revised EA/RIR/IRFA updated after the of 159,288 mt, based on analysis of (6,803.89 mt), there is a 98–percent announcement of new biological information in the TRAC assessment. chance that the stock will not decline to reference points is also accessible via The reviewers concluded that the the level where it would once again be the Internet at http:// updated stochastic estimate of spawning deemed overfished, and a significant www.nero.noaa.gov. stock biomass (SSB) for 2009 (163,256 decrease in annual quota levels will not NMFS prepared a Final Regulatory mt) exceeded the newly defined be necessary when the small year- Flexibility Analysis (FRFA), which is biomass target, and that estimates of classes from years of low pup contained in the Classification section SSB have been above the new biomass production recruit into the fishery. of the preamble of this rule. Copies of target since 2008, consistent with a As specified in the FMP, quota Period the FRFA and the Small Entity rebuilt stock. Therefore, the spiny 1 (May 1 through October 31) would be

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allocated 57.9–percent of the 15– pups may be lower than historic levels harvest estimates are incorporated into million-lb quota (8,685,000 lb), and due to reduced maternal size and a total catch. Projections also indicate that quota Period 2 (November 1 through skewed male-to-female sex ratio in the this harvest level could be held constant April 30) would be allocated 42.1– population. Therefore, the FY 2010 for 5 years, with a 98–percent percent of the quota (6,315,000 lb). The commercial quota is being increased to probability the stock would not decline possession limit of 3,000 lb (1.36 mt) is a level where F is equal to 0.167 after to the level where it would once again maintained for FY 2010. other sources of fishing mortality are be deemed overfished. accounted for. NMFS does monitor state landings on Comments and Responses NMFS does not agree that the a weekly basis and closes the fishery NMFS received six comments on the possession limit should be increased for when it is anticipated that the proposed measures from: The Maine FY 2010. The FMP was developed in commercial quota is met for that quota Department of Marine Resources (ME 1998 and implemented in 2000 in order period; however NMFS and the DMR); the Mid-Atlantic and New to halt large-scale depletion of Commission differ in their quota England Fishery Management Councils’ reproductively mature female spiny allocation schemes, which can cause Joint Spiny Dogfish Committee dogfish and to allow the stock to confusion among different parties. (Committee); Shark Advocates rebuild. Because the commercial fishery NMFS manages the spiny dogfish stock International, on behalf of nine concentrated primarily on mature by allocating the quota into two periods, conservation organizations including females, the FMP established possession where Period 1 (May 1 through October itself; and three individuals. limits to control the directed fishery for 31) is allocated 57.9–percent of the Comment 1: The Committee spiny dogfish and allow for the commercial quota (8,685,000 lb), and supported an increase in the FY 2010 reproductively mature portion of the quota Period 2 (November 1 through spiny dogfish quota from the 12– population to recover. April 30), which is allocated 42.1– million-lb level in the proposed rule, Neither the Councils nor the Atlantic percent of the quota (6,315,000 lb). The based on analysis of the TRAC results. States Marine Fisheries Commission Commission allocates the commercial It specifically supported a commercial (Commission) considered alternatives quota by region; the Northern region is quota greater than in the proposed rule that would have increased the FY 2010 allocated 58–percent of the quota, the (12 million lb) but less than the possession limits. In fact, the Southern region is allocated 26–percent maximum quota analyzed by the Commission plan specifies that spiny of the quota, and North Carolina is Councils (29.5 million lb), in order to dogfish possession limits may be allocated 16–percent of the quota. While ensure stability in future landings of established by the states at a maximum the Federal fishery is closed when the spiny dogfish. of 3,000 lb (1.36 mt), and many states commercial quota is project to be Response: NMFS considered the have set possession limits that are harvested, it is the responsibility of the Committee recommendation along with considerably lower than that for some or individual states to close their fishery at the results from the peer reviewed all of the year. It is for these reasons that the recommendation of the Commission analysis of the TRAC assessment in the possession limit is maintained at when the regional allocation is setting the FY 2010 specifications. 3,000 lb (1.36 mt) for the FY 2010. projected to be harvested. Implementing NMFS understands the desirability of a Comment 3: Shark Advocacy a commercial quota of 15 million lb constant catch management approach International, on behalf of nine (6,803.89 mt) ensures consistency with and anticipates that the 15–million-lb conservation groups, including itself, the Commission. However, there are (6,803.89 mt) quota for FY 2010 will supported maintaining the commercial still inconsistencies in the quota avoid the need for significant quota quota at 12–million-lb (5,443.11 mt) and allocation scenario between the state fluctuations in future years. the possession limit at 3,000–lb (1.36 and Federal FMPs, which is sometimes Comment 2: ME DMR suggested mt) to ensure the spiny dogfish fishery confusing for fishermen and creates NMFS take the TRAC analysis results is fully rebuilt. They state that a administrative burden. The issue of into account in preparing the final significant increase in quota would quota allocation will be reconsidered by specifications for FY 2010 and increase encourage fishing on already stressed the Councils in upcoming Amendment the commercial quota and possession populations of mature females. They 3 to the FMP, and is not the subject of limit as high as possible. The three also expressed concern about the this rulemaking. individuals, all from Maine, opposed Commission setting a 15–million-lb maintaining the 3,000–lb (1.36 mt) (6,803.89 mt) quota because it is Classification possession limit, and suggested it be inconsistent, in their view, with the best Pursuant to section 304 (b)(1)(A) of increased to 6,000 lb. One individual scientific information available. They the Magnuson–Stevens Act, the NMFS suggested the possession limit increase encouraged NMFS to track state Assistant Administrator has determined to either 6,000 lb per day, or 12,000 lb landings, anticipate when catch limits that this rule is consistent with the per trip. are met, and close Federal fisheries to Spiny Dogfish FMP, other provisions of Response: NMFS utilized the results avoid overages. the Magnuson–Stevens Act, and other from the peer-reviewed analysis of the Response: NMFS’s decision to specify applicable law. TRAC when setting the FY 2010 the FY 2010 commercial quota at 15 This action is authorized by 50 CFR specifications for the spiny dogfish million lb (6,803.89 mt) is based on new part 648 and has been determined to be fishery. Although recruitment to the biological reference points established not significant for purposes of Executive fishery increased in 2009, due to for the spiny dogfish stock, and the Order 12866 (E.O. 12866). estimated low pup production from determination that the stock is rebuilt. NMFS, pursuant to section 604 of the 1997–2003 implicated by survey catches NMFS concluded that that the Regulatory Flexibility Act, has prepared of pups and low survey catches of size commercial quota could be increased to a final regulatory flexibility analysis categories for those year classes, a 15 million lb (6,803.89 mt) without (FRFA), included in this final rule, in decline in the stock is expected when negative effects on reproductively support of the FY 2010 spiny dogfish these small 1997–2003 year-classes mature females. Analysis indicates this specifications and management recruit to the SSB (approximately 2015). quota level equates to an F of 0.167, measures. The FRFA describes the In addition, the current survival rate of when discard mortality and Canadian economic impact that this final rule,

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along with other non-preferred recordkeeping, or other compliance Revenue would be expected to increase alternatives, will have on small entities. requirements. It does not duplicate, to $5.191 million under Alternative 2, The FRFA incorporates the economic overlap, or conflict with any other and $7.070 million under Alternative 3. impacts and analysis summarized in the Federal rules. The economic benefits would be IRFA, a summary of the significant greatest under Alternative 3, and to a Minimizing Significant Economic issues raised by the public, and a Impacts on Small Entities lesser extent Alternatives 2 and 4, but summary of analyses prepared to fishermen would still benefit compared support the action (i.e., the EA and the The IRFA was revised from the to the maintained revenue levels under RIR). The contents of these documents original submitted by the Councils after Alternative 1. Although Alternatives 2 are not repeated in detail here. A copy the results of the TRAC review were and 3 would provide the greatest of the IRFA, the RIR, and the EA are announced. The revised IRFA economic benefits, the quota proposed available upon request (see ADDRESSES). considered four distinct alternatives. under Alternative 4 is the action being A complete description of the reasons Alternative 1, which was the preferred implemented due to concerns about the why this action is being considered, and alternative in the proposed rule, is stock condition and the desire to avoid the objectives of and legal basis for this equivalent to No Action, and was dramatic fluctuations in annual quota action, is contained in the preamble to proposed to achieve Frebuild = 0.11 levels, as explained earlier in this the proposed rule and this final rule, with a commercial quota of 12.0– preamble. Implementing a commercial and is not repeated here. million-lb (5,443.11 mt). Alternative 2 is quota that employs a constant catch based on an Ftarget of 0.20, with a management strategy and that takes into Statement of Objective and Need resultant commercial quota of 21.6 account potential future declines in SSB A description of the reasons why this million lb (9,797.60 mt). Alternative 3 is will provide the industry with a more action is being considered, and the based on the target F of 0.28 with a stable and economically beneficial objectives of and legal basis for this resultant quota of 29.5–million-lb fishery in the future. action, is contained in the preamble to (13,380.97 mt). Alternative 4, the action the proposed rule and is not repeated being implemented, is based on an F Small Entity Compliance Guide here. below the revised Ftarget, and is equal Section 212 of the Small Business to an F of 0.167 after other sources of Regulatory Enforcement Fairness Act of Summary of Public Comment on IRFA fishing mortality are accounted for. 1996 states that, for each rule or group and Agency Response Alternative 4 results in a commercial of related rules for which an agency is NMFS received six comments on this quota of 15.0–million-lb (6,803.89 mt). required to prepare a FRFA, the agency rule but none of them concerned the None of the alternatives proposed to shall publish one or more guides to IRFA or the economic impacts of the modify the current 3,000–lb (1.36 mt) assist small entities in complying with proposed action. possession limit. the rule, and shall designate such None of the alternatives under Description and Estimate of Number of publications as ‘‘small entity compliance consideration are expected to result in guides.’’ The agency shall explain the Small Entities to Which the Rule Will negative economic impacts. Higher Apply actions a small entity is required to take quotas (Alternatives 2, 3, and 4) are to comply with a rule or group of rules. All of the potentially affected expected to increase revenue from the As part of this rulemaking process, a businesses are considered small entities dogfish fishery, assuming that the quota letter to permit holders that also serves under the standards described in NMFS implemented would be attained. In as small entity compliance guide (guide) guidelines because their gross receipts general, no negative economic impacts was prepared and will be sent to all do not exceed $3.5 million annually. are expected because the alternatives are holders of permits issued for the spiny Information from FY 2008 was used to consistent with the goals of the FMP dogfish fishery. In addition, copies of evaluate impacts of this action, as that and are unlikely to result in significant this final rule and guide (i.e., permit is the most recent year for which data (negative) deviation from the status quo. holder letter) are available from the are complete. According to unpublished Total spiny dogfish revenue from the Northeast Regional Administrator (see NMFS permit file data, 3,142 vessels last FY for which data are complete (FY ADDRESSES) and may be found at the were issued Federal spiny dogfish 2008) was reported as $2.157 million. following web site: http:// permits in FY 2008, while 229 of these Using the average FY 2008 price/lb www.nero.noaa.gov/nero/. vessels contributed to overall landings. ($0.24), landing the full FY 2009 quota (and therefore also the quota under Dated: June 18, 2010 Description of Projected Reporting, Alternative 1) corresponds to $2.880 Eric C. Schwaab, Recordkeeping, and Other Compliance million. Using the same approach, Assistant Administrator For Fisheries, Requirements landing the 15–million-lb (6,803.89 mt) National Marine Fisheries Service. This action does not contain any new quota under Alternative 4 would [FR Doc. 2010–15324 Filed 6–23–10; 8:45 am] collection–of–information, reporting, increase revenue to $3.600 million. BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 75, No. 121

Thursday, June 24, 2010

This section of the FEDERAL REGISTER of SSNs, profanities, et cetera) on product that contains less than 6.5 contains notices to the public of the proposed http://www.regulations.gov.’’ percent nonfat milk solids and contains issuance of rules and regulations. The Dated: June 21, 2010. less than 2.25 percent true milk purpose of these notices is to give interested protein;’’. persons an opportunity to participate in the Megan Graziano Grumbine, rule making prior to the adoption of the final Assistant General Counsel. Further, in consideration of this rules. [FR Doc. 2010–15366 Filed 6–23–10; 8:45 am] correction, the Referendum Order to BILLING CODE 6760–01–P Determine Producer Approval; Determination of Representative Period; FEDERAL RETIREMENT THRIFT and Designation of Referendum Agency INVESTMENT BOARD DEPARTMENT OF AGRICULTURE on page 33551 of the final decision is 5 CFR Parts 1604 and 1651 superseded by the following order: Agricultural Marketing Service Referendum Order To Determine Uniformed Services Accounts and Producer Approval; Determination of Death Benefits; Correction 7 CFR Part 1000 Representative Period; and Designation AGENCY: Federal Retirement Thrift [Doc. No. AMS–DA–09–0062; AO–14–A73, et of Referendum Agent Investment Board. al.; DA–03–10] ACTION: Proposed rule; correction. It is hereby directed that a referenda Milk in the Northeast and Other be conducted and completed on or SUMMARY: This proposed rule corrects Marketing Areas; Correction. before the 30th day from the date this the ADDRESSES section of a proposed AGENCY: Agricultural Marketing Service, correction is published in the Federal rule published in the Federal Register USDA. Register, in accordance with the on June 18, 2010, regarding uniformed ACTION: Proposed rule; correction. procedures for the conduct of referenda services accounts and death benefits. [7 CFR 900.300–311], to determine This correction clarifies that comments SUMMARY: This document contains a whether the issuance of the orders as may be submitted at http:// correction to the proposed rule that was amended and hereby proposed to be www.regulations.gov, by mail, by hand published in the June 14, 2010, Federal amended, regulating the handling of deliver/courier, or by facsimile. Register (75 FR 33534). The proposed milk in the Northeast, Appalachian, FOR FURTHER INFORMATION CONTACT: rule inadvertently used the word ‘‘or’’ Florida, Southeast, Upper Midwest, Megan G. Grumbine at (202) 942–1644 rather than ‘‘and’’ in the proposed Central, Mideast, Pacific Northwest, or Laurissa Stokes at (202) 942–1645. amendment to § 1000.15 paragraph Southwest and Arizona marketing areas Correction (b)(1) that provides exceptions to the is approved or favored by producers, as fluid milk product definition. This defined under the terms of the order, as In proposed rule FR Doc. 2010–14741 document corrects the proposed rule by amended and as hereby proposed to be beginning on page 34654 in the issue of revising that section and directs that a amended, who during such June 18, 2010, correct the ADDRESSES referendum be conducted on the representative period were engaged in section to read as follows: ‘‘ADDRESSES: proposed amendments in the corrected the production of milk for sale within You may submit comments using one of proposed rule. the aforesaid marketing areas. the following methods: DATES: Effective Date: June 24, 2010. • Federal Rulemaking Portal: http:// The representative period for the FOR FURTHER INFORMATION CONTACT: www.regulations.gov. Follow the conduct of such referenda is hereby William Francis, Associate Deputy instructions for submitting comments. determined to be June 2009. • Mail: Office of General Counsel, Administrator, USDA/AMS/Dairy The agents of the Secretary of Attn: Thomas Emswiler, Federal Programs, Order Formulation and Agriculture to conduct such referenda Retirement Thrift Investment Board, Enforcement Branches, STOP 0231– 1250 H Street, NW., Washington, DC Room 2971, 1400 Independence are hereby designated to be the 20005. Avenue, SW., Washington, DC 20250– respective market administrators of the • Hand Delivery/Courier: The address 0231, (202) 720–6274, e-mail address: aforesaid orders. for sending comments by hand delivery [email protected]. Authority: 7 U.S.C. 601–674 and 7253. or courier is the same as that for SUPPLEMENTARY INFORMATION: In FR Doc. Dated: June 18, 2010. submitting comments by mail. No. AMS–DA–09–0062 appearing in the David R. Shipman, • Facsimile: Comments may be Federal Register of Monday, June 14, Associate Administrator, Agricultural submitted by facsimile at (202) 942– 2010 [75 FR 33534], the following Marketing Service. 1676. correction is made: The most helpful comments explain [FR Doc. 2010–15296 Filed 6–23–10; 8:45 am] the reason for any recommended change § 1000.15 [Corrected] BILLING CODE P and include data, information, and the On page 33552, in the second column, authority that supports the in paragraph (b)(1) of § 1000.15, the recommended change. We will post all phrase ‘‘Any product that contains less substantive comments (including any than 6.5 percent nonfat milk solids or personal information provided) without contains less than 2.25 percent true milk change (with the exception of redaction protein;’’ is corrected to read ‘‘Any

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DEPARTMENT OF THE TREASURY middle-income individuals and OCC–2010–0010’’ in your comment. In geographies in designated target areas. general, OCC will enter all comments Office of the Comptroller of the Such consideration would include received into the docket and publish Currency covered activities within an institution’s them on the Regulations.gov Web site assessment area(s) and outside of its without change, including any business 12 CFR Part 25 assessment area(s), as long as the or personal information that you [Docket ID OCC–2010–0010] institution has adequately addressed the provide such as name and address community development needs of its information, e-mail addresses, or phone RIN 1557–AD34 assessment area(s). As proposed, numbers. Comments received, including favorable consideration under the new attachments and other supporting FEDERAL RESERVE SYSTEM rule would only be available until no materials, are part of the public record later than two years after the last date and subject to public disclosure. Do not 12 CFR Part 228 appropriated funds for the program are enclose any information in your [Docket No. R–1387] required to be spent by the grantees. The comment or supporting materials that agencies will provide reasonable you consider confidential or RIN 7100–AD50 advance notice to institutions in the inappropriate for public disclosure. Federal Register regarding termination You may review comments and other FEDERAL DEPOSIT INSURANCE of the rule once a date certain has been related materials that pertain to this CORPORATION identified. proposed rule by any of the following methods: 12 CFR Part 345 DATES: Comments must be received by: July 26, 2010. • Viewing Comments Electronically: RIN 3064–AD60 ADDRESSES: Comments should be Go to http://www.regulations.gov. Select ‘‘Document Type’’ of ‘‘Public DEPARTMENT OF THE TREASURY directed to: Because paper mail in the Washington, Submissions,’’ in ‘‘Enter Keyword or ID DC area and at the agencies is subject to Box,’’ enter Docket ID ‘‘OCC–2010– Office of Thrift Supervision delay, commenters are encouraged to 0010,’’ and click ‘‘Search.’’ Comments submit comments by the Federal will be listed under ‘‘View By 12 CFR Part 563e eRulemaking Portal or e-mail, if Relevance’’ tab at bottom of screen. If [Docket ID OTS–2010–0017] possible. Please use the title comments from more than one agency ‘‘Community Reinvestment Act are listed, the ‘‘Agency’’ column will RIN 1550–AC42 Regulation’’ to facilitate the organization indicate which comments were received and distribution of the comments. by the OCC. Community Reinvestment Act • Viewing Comments Personally: You Regulations OCC: You may submit comments by any of the following methods: may personally inspect and photocopy AGENCIES: Office of the Comptroller of • Federal eRulemaking Portal— comments at the OCC, 250 E Street, the Currency, Treasury (OCC); Board of ‘‘regulations.gov’’: Go to http:// SW., Washington, DC. For security Governors of the Federal Reserve www.regulations.gov. Select ‘‘Document reasons, the OCC requires that visitors System (Board); Federal Deposit Type’’ of ‘‘Proposed Rules,’’ and in make an appointment to inspect Insurance Corporation (FDIC); Office of ‘‘Enter Keyword or ID Box,’’ enter Docket comments. You may do so by calling Thrift Supervision, Treasury (OTS). ID ‘‘OCC–2010–0010,’’ and click (202) 874–4700. Upon arrival, visitors will be required to present valid ACTION: Notice of proposed rulemaking. ‘‘Search.’’ On ‘‘View By Relevance’’ tab at bottom of screen, in the ‘‘Agency’’ government-issued photo identification SUMMARY: The OCC, the Board, the column, locate the proposed rule for and to submit to security screening in FDIC, and the OTS (collectively, ‘‘the OCC, in the ‘‘Action’’ column, click on order to inspect and photocopy agencies’’) are issuing this proposed rule ‘‘Submit a Comment’’ or ‘‘Open Docket comments. to revise provisions of our rules Folder’’ to submit or view public • Docket: You may also view or implementing the Community comments and to view supporting and request available background Reinvestment Act (CRA). The agencies related materials for this rulemaking documents and project summaries using propose to revise the term ‘‘community action. the methods described above. development’’ to include loans, • Click on the ‘‘Help’’ tab on the Board: You may submit comments, investments, and services by financial Regulations.gov home page to get identified by Docket No. R–1387, by any institutions that support, enable, or information on using Regulations.gov, of the following methods: facilitate projects or activities that meet including instructions for submitting or • Agency Web site: http:// the criteria described in Section viewing public comments, viewing www.federalreserve.gov. Follow the 2301(c)(3) of the Housing and Economic other supporting and related materials, instructions for submitting comments at Recovery Act of 2008 (HERA) and are and viewing the docket after the close http://www.federalreserve.gov/ conducted in designated target areas of the comment period. generalinfo/foia/Regs.cfm. identified in plans approved by the • E-mail: • Federal eRulemaking Portal: http:// United States Department of Housing [email protected]. www.regulations.gov. Follow the and Urban Development (HUD) under • Mail: Office of the Comptroller of instructions for submitting comments. the Neighborhood Stabilization the Currency, 250 E Street, SW., Mail • E-mail: regs.comments@federal Program, established pursuant to the Stop 2–3, Washington, DC 20219. reserve.gov. Include docket number in HERA and the American Recovery and • Fax: (202) 874–5274. the subject line of the message. Reinvestment Act of 2009. The • Hand Delivery/Courier: 250 E • Fax: 202/452–3819 or 202/452– proposed rule would provide favorable Street, SW., Mail Stop 2–3, Washington, 3102. CRA consideration to such activities DC 20219. • Mail: Jennifer J. Johnson, Secretary, that, pursuant to the requirements of the Instructions: You must include ‘‘OCC’’ Board of Governors of the Federal program, benefit low-, moderate-, and as the agency name and ‘‘Docket ID Reserve System, 20th Street and

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Constitution Avenue, NW., Washington, attachments and other supporting institution in meeting the credit needs DC 20551. materials received are part of the public of its entire community, including low- All public comments are available record and subject to public disclosure. and moderate-income neighborhoods, from the Board’s Web site at http:// Do not enclose any information in your consistent with the safe and sound www.federalreserve.gov/generalinfo/ comment or supporting materials that operation of the institution, and to take foia/Regs.cfm as submitted, unless you consider confidential or that record into account when the modified for technical reasons. inappropriate for public disclosure. agency evaluates an application by the • Accordingly, your comments will not be Viewing Comments Electronically: institution for a deposit facility.1 The edited to remove any identifying or Go to http://www.regulations.gov and agencies have promulgated substantially contact information. Public comments follow the instructions for reading similar regulations to implement the may also be viewed electronically or in comments. requirements of the CRA.2 paper in Room MP–500 of the Board’s • Viewing Comments On-Site: You Martin Building (20th and C Streets, may inspect comments at the Public Regulatory Revision NW.) between 9 a.m. and 5 p.m. on Reading Room, 1700 G Street, NW., by weekdays. appointment. To make an appointment Today, there is a pressing need to FDIC: You may submit comments, for access, call (202) 906–5922, send an provide housing-related assistance to identified by RIN 3064–AD60 by any of e-mail to [email protected], or stabilize communities affected by high the following methods: send a facsimile transmission to (202) levels of foreclosures. High levels of • Agency Web site: http:// 906–6518. (Prior notice identifying the foreclosures have devastated www.fdic.gov/regulations/laws/ materials you will be requesting will communities and are projected to federal.html. Follow instructions for assist us in serving you.) We schedule continue into 2012 and beyond with submitting comments on the Agency appointments on business days between damaging spillover effects for low- and Web site. 10 a.m. and 4 p.m. In most cases, moderate-income census tracts, as well • E-mail: [email protected]. appointments will be available the next as middle-income census tracts affected Include the RIN number in the subject business day following the date we by high levels of loan delinquencies and line of the message. receive a request. foreclosures. Among the many • Mail: Robert E. Feldman, Executive FOR FURTHER INFORMATION CONTACT: consequences of high levels of Secretary, Attention: Comments, Federal OCC: Michael S. Bylsma, Director, or foreclosures are growing inventories of Deposit Insurance Corporation, 550 17th Margaret Hesse, Special Counsel, Street, NW., Washington, DC 20429. vacant foreclosed properties and Community and Consumer Law • Hand Delivery/Courier: Guard institution ‘‘other real estate owned’’ Division, (202) 874–5750; Greg Nagel or station at the rear of the 550 17th Street (OREO) properties, depreciating home Brian Borkowicz, National Bank Building (located on F Street) on values, declining property tax bases, Examiner, Compliance Policy, (202) business days between 7 a.m. and 5 p.m. and destabilization of communities Instructions: All submissions received 874–4428, Office of the Comptroller of directly affected by high levels of must include the agency name and RIN the Currency, 250 E Street, SW., foreclosures and of adjacent and number. All comments received will be Washington, DC 20219. surrounding neighborhoods. posted without change to http:// Board: Paul J. Robin, Manager, www.fdic.gov/regulations/laws/ Reserve Bank Oversight and Policy, Neighborhood Stabilization Program federal.html, including any personal (202) 452–3140; or Jamie Z. Goodson, (NSP) information provided. Attorney, (202) 452–3667; Division of Consumer and Community Affairs, Congress recognized the need to OTS: You may submit comments provide emergency assistance to address identified by OTS–2010–0017, by any of Board of Governors of the Federal these problems with the establishment the following methods: Reserve System, 20th Street and • Federal eRulemaking Portal- Constitution Avenue, NW., Washington, of the Neighborhood Stabilization ‘‘Regulations.gov’’: Go to http:// DC 20551. Program (NSP) through Division B, Title www.regulations.gov, and follow the FDIC: Janet Gordon, Senior Policy III, of the Housing and Economic instructions for submitting or viewing Analyst, Division of Supervision and Recovery Act of 2008 (HERA), Public public comments. Consumer Protection, (202) 898–3850 or Law 110–289 (2008). Under HERA, • Mail: Regulation Comments, Chief Richard Schwartz, Counsel, Legal emergency funds (‘‘NSP1’’), totaling Counsel’s Office, Office of Thrift Division, (202) 898–7424; Federal nearly $4 billion, for the redevelopment Supervision, 1700 G Street, NW., Deposit Insurance Corporation, 550 17th of abandoned and foreclosed properties Washington, DC 20552, Attention: OTS– Street, NW., Washington, DC 20429. were distributed to States and localities 2010–0017. OTS: Stephanie M. Caputo, Senior with the greatest need for such funds • Fax: (202) 906–6518. Compliance Program Analyst, according to a formula based on the • Hand Delivery/Courier: Guard’s Compliance and Consumer Protection, number and percentage of home Desk, East Lobby Entrance, 1700 G (202) 906–6549; or Richard Bennett, foreclosures, the number and percentage Street, NW., from 9 a.m. to 4 p.m. on Senior Compliance Counsel, of homes financed by a subprime business days, Attention: Regulation Regulations and Legislation Division, mortgage-related loan, and the number (202) 906–7409; Office of Thrift Comments, Chief Counsel’s Office, and percentage of homes in default or Supervision, 1700 G Street, NW., Attention: OTS–2010–0017. delinquency in each State or unit of • Instructions: All submissions Washington, DC 20552. general local government. Under NSP1, received must include the agency name SUPPLEMENTARY INFORMATION: each of the 50 States and Puerto Rico and docket number for this proposed rulemaking. All comments received will Background received a minimum award of $19.6 be entered into the docket and posted The Community Reinvestment Act million and 254 local areas received on Regulations.gov without change, (CRA) requires the Federal banking and including any personal information thrift regulatory agencies to assess the 1 12 U.S.C. 2903. provided. Comments including record of each insured depository 2 See 12 CFR parts 25, 228, 345, and 563e.

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grants totaling $1.86 billion ranging Revision of ‘‘Community Development’’ NSP-targeted geographies in HUD- from $2.0 million to $62.2 million.3 under CRA approved State NSP1 plans that are not Using similar criteria, the American The definition of ‘‘community identified in the HUD census tract Recovery and Reinvestment Act of 2009 development’’ is a key definition in the database. Information about these targeted areas may be found in the (ARRA), Public Law 111–5 (2009), agencies’ CRA regulations. Financial institutions receive positive individual plans. provided supplementary NSP funding Although the CRA rules expressly consideration in their CRA (‘‘NSP2’’) to be awarded as grants, encourage activities that benefit low- or examinations for community through a competitive bidding process, moderate-income individuals or development loans, qualified to State and local governments as well geographies, the agencies have created investments, and community as to non-profit organizations and limited exceptions to cover certain development services, all of which must consortia of non-profit entities. On exigencies that may include middle- have a primary purpose of ‘‘community January 14, 2010, HUD awarded a income individuals and geographies.7 development.’’ combined total of nearly $2 billion in The agencies believe that the purposes The agencies are proposing to revise NSP2 grants.4 To receive NSP funding, of CRA can be served by providing CRA the interagency CRA regulations by each grantee was required to submit an incentives to institutions to engage in adding to the definition of ‘‘community action plan or application, including community development loans, development’’ loans, investments, and any amendments thereto, to HUD investments and services that meet the services that support, enable, or according to specific alternative narrowly tailored requirements of the facilitate NSP-eligible activities in requirements set out by HUD in 2008 NSP. First, HUD has stated that its designated target areas identified in and 2009.5 funding of these programs was designed plans approved by HUD under the NSP. to satisfy Congressional intent that the Section 2301(c)(3) of HERA For example, under the proposed funds have maximum impact and be establishes five activities that are ‘‘ revised definition of community targeted to States and local communities ‘‘eligible uses’’ of NSP funds (for ’’ development, a financial institution with the greatest needs.8 In addition, purposes of this proposed rule, would receive favorable CRA while, by its statutory terms, the NSP designated as ‘‘NSP-eligible activities’’). consideration for a donation of OREO may include some middle-income NSP-eligible activities are projects or properties to non-profit housing individuals, the program must use 25 activities that use the NSP funds to: (1) organizations in eligible middle-income, percent of its funds on low-income Establish financing mechanisms for as well as low- and moderate-income, individuals and may, in some cases, purchase and redevelopment of geographies. In addition, institutions cover higher percentages of low- and foreclosed upon homes and residential would receive favorable CRA moderate-income individuals. properties, including such mechanisms consideration if they provide financing Under the current CRA rules, an as soft-seconds, loan loss reserves, and for the purchase and rehabilitation of institution is evaluated primarily on shared equity loans for low- and foreclosed, abandoned, or vacant how it helps meet the credit and moderate-income homebuyers; (2) properties. Other examples of activities community development needs of its purchase and rehabilitate homes and that would receive favorable CRA CRA assessment area(s). However, the residential properties that have been consideration under the proposal agencies note that many foreclosed abandoned or foreclosed upon, in order include loans, investments, and services properties owned by an institution may to sell, rent, or redevelop such homes that support the redevelopment of be located in areas that are outside of and properties; (3) establish and operate demolished or vacant properties in such the institution’s CRA assessment area(s). land banks for homes and residential areas, consistent with eligible uses for Restricting CRA consideration of NSP- properties that have been foreclosed NSP funds. eligible activities to an institution’s upon; (4) demolish blighted structures; Allowing institutions to receive CRA assessment area(s) may not fully help to and (5) redevelop demolished or vacant consideration for NSP-eligible activities promote Congress’s objectives for the properties.6 In addition, Section in NSP-targeted areas creates an NSP. Therefore, the proposed rule 2301(f)(3)(A) of HERA provides that all opportunity to leverage government provides that an institution that has NSP funds must be used with respect to funding targeted to areas with high adequately addressed the community individuals and families whose income foreclosure or vacancy rates. HUD development needs of its assessment does not exceed 120 percent of the area approves NSP action plans and area(s) may receive favorable applications, including amendments median income and not less than 25% consideration for NSP-eligible activities thereto (hereinafter referred to as ‘‘NSP of funds must be used for the purchase under this provision that are outside of plans’’ or ‘‘plans’’), for all NSP grantees. and redevelopment of abandoned or its assessment area(s). These public documents must designate foreclosed homes and residential There is precedent for allowing ‘‘areas of greatest need’’ for targeting properties that will be used to house greater flexibility concerning the CRA NSP-eligible activities, consistent with individuals and families whose incomes focus on assessment area(s) in certain statutory criteria. Therefore, the temporary and exigent circumstances. do not exceed 50 percent of area median agencies propose to provide institutions income. For example, in 2006, the agencies CRA consideration for supporting NSP- issued a supervisory policy statement eligible activities, subject to the providing that an institution would 3 See Neighborhood Stabilization Grants, http:// requirements in Section 2301(c)(3) and www.hud.gov/offices/cpd/communitydevelopment/ receive favorable CRA consideration for programs/neighborhoodspg/nsp1.cfm. the limitations set forth in Section engaging in activities that helped 4 See Neighborhood Stabilization Program 2, 2301(d)(1)–(3) of HERA, in the http://www.hud.gov/offices/cpd/ geographies identified under these 7 70 FR 44256 (Aug. 2, 2005), and 71 FR 18614 communitydevelopment/programs/ HUD-approved NSP plans. The vast (Apr. 12, 2006). neighborhoodspg/arrafactsheet.cfm. majority of NSP–targeted areas will be 8 See HUD, NSP Frequently Asked Questions, 5 74 FR 21377 (May 7, 2009); 73 FR 58330 (Oct. http://www.hud.gov/offices/cpd/ 6, 2008). listed on a database located on HUD’s communitydevelopment/programs/ 6 NSP2 funds for redevelopment of demolished or Web site at: http://www.hud.gov/ neighborhoodspg/pdf/ vacant properties may only be used for housing. nspmaps. However, there may be a few nsp_faq_formula_allocation.pdf.

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revitalize or stabilize areas affected by • Whether the agencies should agency reviewed its proposed rule and Hurricanes Katrina and Rita, even if specify a date certain for the rule to determined that there are no collections such areas were not in the institution’s ‘‘sunset’’ and, if so, what that date of information. The proposed rule assessment area(s), provided the should be; would expand the types of activities institution had adequately met the CRA- • Whether CRA consideration should that qualify for CRA consideration, if an related needs of its assessment area(s). be limited to those NSP-eligible institution chooses to engage in them, Finally, the agencies intend for this activities reflected in HUD-approved but it would not impose any new proposed rule to be generally tied to the NSP plans or to activities undertaken by requirements, including paperwork duration of the NSP. The NSP does not financial institutions that support requirements. The overall cost of this have a ‘‘sunset’’ date. Under NSP1, activities that have been funded by the proposed rule is expected to negligible, grantees must expend NSP funds within NSP; at most. The amendments could have a four years of the date the grant is • Recognition of NSP-eligible negligible effect on burden estimates for awarded. Under NSP2, grantees have activities outside of an institution’s existing information collections, three years from that date to fully spend assessment area(s); including recordkeeping requirements • the grant, and HUD was required to The potential costs and benefits of for community development loans. obligate all funds appropriated for NSP2 the proposed rule if adopted; and • Regulatory Flexibility Act in February 2010. As noted above, the Whether and the extent to which NSP does not have a termination date the proposed rule if adopted will affect The Regulatory Flexibility Act (RFA) generally requires agencies that are and Congress could appropriate an institution’s decisions about the issuing a proposed rule to prepare and additional funds for the program. amount and type of community make available for public comment an Therefore, a specific termination date development loans, investments, and initial regulatory flexibility analysis that for the regulatory provision has not been services it will provide or the describes the impact of the proposed chosen. Instead, the proposed rule geographies it will target in doing so. rule on small entities.9 The RFA provides that NSP-eligible activities In addition, smaller financial provides that agencies are not required would receive favorable consideration institutions are invited to comment on to prepare and publish an initial under the new rule if conducted no later whether any aspects of the proposed regulatory flexibility act analysis if the than two years after the last date rule should be modified to address any agencies certify that the proposed rule appropriated funds for the program are implementation issues unique to their will not, if promulgated, have a required to be spent by the grantees. The lines of business or to provide additional flexibility. significant economic impact on a agencies will provide reasonable substantial number of small entities.10 advance notice to institutions in the Regulatory Analysis The Small Business Administration Federal Register regarding termination (SBA) has defined ‘‘small entities’’ for of the rule once a date certain has been Request for Comments Regarding the Use of ‘‘Plain Language’’ banking purposes as a bank or savings identified. association with $175 million or less in The proposed rule imposes no new Section 722 of the Gramm-Leach- assets.11 13 CFR 121.201. Each agency requirements on institutions. It simply Bliley Act, Public Law 106–102, sec. has reviewed the impact of this expands the categories of activities that 722, 133 Stat. 1338, 1471 (Nov. 12, proposed rule on the small entities qualify for CRA considerations as 1999), requires the OCC, Board, FDIC, subject to its regulation and supervision ‘‘community development.’’ No and OTS to use plain language in all and certifies that it will not have a institution will be required to provide proposed and final rules published after significant economic impact on a loans, investments, or services pursuant January 1, 2000. Therefore, these substantial number of the small entities to the proposed expanded definition. In agencies specifically invite your that it regulates and supervises. addition, any community development comments on how to make this OCC: The OCC has reviewed the loans that are made by large institutions proposed rule easier to understand. For proposed amendments to Part 25. The under the proposed new provision example, proposed rule would expand the • would be covered under existing loan Have we organized the material to definition of the term ‘‘community reporting requirements. As such, no suit your needs? If not, how could this development,’’ which is applied in the new reporting requirements and material be better organized? CRA regulations’ performance tests. • negligible, if any, administrative costs Are the requirements clearly stated? However, the proposed rule does not will result from the proposed rule. The If not, how could the regulations be impose new requirements on small agencies anticipate that the proposal, if more clearly stated? entities because the CRA performance • finalized, would provide an incentive Do the regulations contain language test for small entities (as defined above) for institutions to engage in activities or jargon that is not clear? If so, which does not require community that stabilize foreclosure affected language requires clarification? development activities. Rather, the • communities approved for NSP projects Would a different format (grouping proposed rule reduces burden by and, thus, will create an opportunity to and order of sections, use of headings, expanding the types of community leverage government funded projects paragraphing) make the regulations development activities for which with complementary private financing easier to understand? If so, what institutions may receive CRA in areas targeted for assistance. The changes to the format would make them consideration. Only 617 national banks easier to understand? are small entities based on the SBA’s likely benefits of the proposed rule are • of uncertain magnitude, however, What else could we do to make the general principles of affiliation (13 CFR because they cannot be quantified at regulations easier to understand? 121.103(a)) and the size threshold for this time. Regulatory Analysis 9 See 5 U.S.C. 603(a). Request for Comments Paperwork Reduction Act 10 See 5 U.S.C. 605(b). The agencies request comment on all In accordance with the Paperwork 11 A financial institution’s assets are determined by averaging the assets reported on its four aspects of the proposed rule, and Reduction Act of 1995 (44 U.S.C. Ch. immediately preceding full quarterly financial particularly seek comment on: 3506; 5 CFR 1320 Appendix A.1), each statements.

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commercial banks and trust companies. size criteria, with assets of less than the Board does not believe any other The OCC reviewed national banks with $175 million, totaled 2,872. However, alternatives would accomplish the assets of less than $175 million that are also as of that date, only 3 of those stated objectives while minimizing evaluated under the lending, banks that are small entities would be burden of the proposed rule. The Board investment, and service tests, which are required to engage in community welcomes comment on any significant normally applicable to large banks, the development activities under the alternatives that would minimize the community development test, which is examination types that include such impact of the proposal on small entities. applicable to wholesale and limited consideration. Therefore, the FDIC has OCC Executive Order 12866 purpose banks, and the community determined that the proposal does not Consideration development performance factor affect a substantial number of small applicable to intermediate small banks. entities. Pursuant to Executive Order 12866, As of March 31, 2010, only 17 of the 617 Board: In accordance with Section OMB’s Office of Information and national banks that are small entities 3(a) of the Regulatory Flexibility Act, 5 Regulatory Affairs (OIRA) has would be required to engage in U.S.C. 601 et seq., the Board has designated the proposed rule to be community development activities reviewed the proposed amendments to significant. It has not yet been under these examination types. The rest Regulation BB. A final regulatory determined whether the proposal would would be evaluated under the small flexibility analysis will be conducted have an annual effect on the economy bank examination procedures, which do after consideration of comments of $100 million or more. OCC solicits not require consideration of community received during the public comment comment on the likely increase in development activities. Therefore, the period. The Small Business lending and costs incurred by banks as OCC has determined that the proposal Administration (SBA) has defined a result of this proposed rule. For the does not affect a substantial number of ‘‘small entities’’ for banking purposes as final rule, OCC will conduct additional small entities. a banking organization with $175 analysis based on information provided OTS: The OTS has reviewed the million or less in assets. See 13 CFR by commenters or otherwise obtained proposed amendments to Part 563e. The 121.201. The Board invites comment on during the comment period. proposed rule would expand the the effect of the proposed rule on small OTS Executive Order 12866 ‘‘ definition of the term community entities. Consideration development,’’ which is applied in the 1. Description of rule. The proposed CRA regulations’ performance tests. rule expands the definition of the term Pursuant to Executive Order 12866, However, the proposed rule does not ‘‘community development,’’ which is OMB’s Office of Information and impose new requirements on small applied in the CRA regulations’ Regulatory Affairs (OIRA) has entities because the CRA performance performance tests. However, it does not designated the proposed rule to be test for small entities (as defined above) impose new requirements on small significant. It has not yet been does not include evaluation of entities because the CRA performance determined whether the proposal would community development activities. test for small entities does not require have an annual effect on the economy Rather, the proposed rule reduces community development activities. of $100 million or more. OTS solicits burden by expanding the types of Rather, the proposed rule expands the comment on the likely increase in community development activities for types of community development lending and costs incurred by savings which institutions may receive CRA activities for which institutions may associations as a result of this proposed consideration. The Small Business receive CRA consideration. rule. For the final rule, OTS will Administration (SBA) has defined 2. Reasons for agency action and conduct additional analysis based on ‘‘small entities’’ for banking purposes as statement of the objectives/legal basis information provided by commenters or a savings association with $175 million for the proposal. As explained above in otherwise obtained during the comment or less in assets. See 13 CFR 121.201. As the supplementary information, the period. of March 31, 2010, only 369 OTS- Board believes that it is desirable to OCC and OTS Unfunded Mandates regulated thrifts are small entities with expand CRA eligibility to include NSP- Reform Act of 1995 Determination assets of $175 million or less. However, eligible activities and areas in order also as of that date, only two of those provide financial institutions incentives Section 202 of the Unfunded small savings associations are wholesale to leverage NSP funding by providing Mandates Reform Act of 1995 or limited purpose savings associations loans, investments, and services in areas (Unfunded Mandates Act) (2 U.S.C. whose community development with high foreclosure or vacancy rates. 1532) requires that covered agencies activities would be evaluated as part of The legal basis of the proposed rule is prepare a budgetary impact statement the CRA examination process. in CRA Section 806, 12 U.S.C. 2905. before promulgating a rule that includes Therefore, the OTS has determined that 3. Small entities affected by proposal. any Federal mandate that may result in the proposal does not affect a As of December 2009, the Board the expenditure by State, local, and substantial number of small entities. supervised 403 banking organizations Tribal governments, in the aggregate, or FDIC: The FDIC has reviewed the that meet the definition of small by the private sector, of $100 million or proposed amendments to Part 345. The entities, all of which are subject to the more in any one year. If a budgetary proposal does not impose new proposed rule. impact statement is required, section requirements on small entities because 4. Other Federal rules. The Board is 205 of the Unfunded Mandates Act also the CRA performance test for small not aware of any other Federal rules requires covered agencies to identify entities (as defined above) does not which may duplicate, overlap or and consider a reasonable number of require community development conflict with the proposed rule. regulatory alternatives before activities. Rather, the proposed rule 5. Significant alternatives to the promulgating a rule. The OCC and the reduces burden by expanding the types proposed revisions. Given that the OTS have determined that this proposed of community development activities proposed rule does not require rule will not result in expenditures by for which institutions may receive CRA institutions to fund NSP-eligible State, local, and Tribal governments, or consideration. As of March 31, 2010, activities and reduces burdens and by the private sector, of $100 million or FDIC regulated entities under the SBA’s restrictions on CRA funding in general, more in any one year. Accordingly,

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neither agency has prepared a budgetary PART 25—COMMUNITY PART 228—COMMUNITY impact statement or specifically REINVESTMENT ACT AND REINVESTMENT (REGULATION BB) addressed the regulatory alternatives INTERSTATE DEPOSIT PRODUCTION 3. The authority citation for part 228 considered. REGULATIONS continues to read as follows: The Treasury and General Government 1. The authority citation for part 25 Authority: 12 U.S.C. 321, 325, 1828(c), Appropriations Act, 1999—Assessment continues to read as follows: 1842, 1843, 1844, and 2901 et seq. of Impact of Federal Regulation on Authority: 12 U.S.C. 21, 22, 26, 27, 30, 36, 4. In § 228.12: Families 93a, 161, 215, 215a, 481, 1814, 1816, 1828(c), a. Republish the introductory text of 1835a, 2901 through 2907, and 3101 through paragraph (g): The FDIC has determined that this 3111. b. Remove the word ‘‘or’’ at the end of proposed rule will not affect family 2. In § 25.12: paragraph (g)(3); well-being within the meaning of a. Republish the introductory text of c. Remove the period at the end of section 654 of the Treasury and General paragraph (g): paragraph (g)(4)(iii)(B) and add in its Government Appropriations Act, b. Remove the word ‘‘or’’ at the end of place ‘‘; or’’; and enacted as part of the Omnibus paragraph (g)(3); d. Add a new paragraph (g)(5). The republication and addition read Consolidated and Emergency c. Remove the period at the end of as follows: Supplemental Appropriations Act of paragraph (g)(4)(iii)(B) and add in its 1999, Public Law 105–277 (5 U.S.C. 601 place ‘‘; or’’; and § 228.12 Definitions. note). d. Add a new paragraph (g)(5). * * * * * OCC and OTS Executive Order 13132 The republication and addition read (g) Community development means: Determination as follows: * * * * * § 25.12 Definitions. (5) Loans, investments, and services The OCC and the OTS have each that— determined that its portion of this * * * * * (i) Support, enable or facilitate proposed rule does not have any (g) Community development means: projects or activities that meet the Federalism implications, as required by * * * * * criteria described in Section 2301(c)(3) Executive Order 13132. (5) Loans, investments, and services of the Housing and Economic Recovery that— Act of 2008 (HERA), Public Law 110– List of Subjects (i) Support, enable or facilitate 289, 122 Stat. 2654, and are conducted 12 CFR Part 25 projects or activities that meet the in designated target areas identified in criteria described in Section 2301(c)(3) plans approved by the United States Community development, Credit, of the Housing and Economic Recovery Department of Housing and Urban Investments, National banks, Reporting Act of 2008 (HERA), Public Law 110– Development in accordance with the and recordkeeping requirements. 289, 122 Stat. 2654, and are conducted Neighborhood Stabilization Program in designated target areas identified in (NSP) established by the HERA and the 12 CFR Part 228 plans approved by the United States American Recovery and Reinvestment Department of Housing and Urban Banks, banking, Community Act of 2009, Public Law 111–5, 123 Stat. Development in accordance with the 115; development, Credit, Investments, Neighborhood Stabilization Program (ii) Are provided no later than two Reporting and recordkeeping (NSP) established by the HERA and the years after the last date funds requirements. American Recovery and Reinvestment appropriated for the NSP are required to 12 CFR Part 345 Act of 2009, Public Law 111–5, 123 Stat. be spent by grantees; and 115; (iii) Benefit low-, moderate-, and Banks, banking, Community (ii) Are provided no later than two middle-income individuals and development, Credit, Investments, years after the last date funds geographies in the bank’s assessment Reporting and recordkeeping appropriated for the NSP are required to area(s) or areas outside the bank’s requirements. be spent by grantees; and assessment area(s) provided the bank (iii) Benefit low-, moderate-, and has adequately addressed the 12 CFR Part 563e middle-income individuals and community development needs of its Community development, Credit, geographies in the bank’s assessment assessment area(s). Investments, Reporting and area(s) or areas outside the bank’s * * * * * assessment area(s) provided the bank recordkeeping requirements, Savings Federal Deposit Insurance Corporation associations. has adequately addressed the community development needs of its 12 CFR Chapter III Department of the Treasury assessment area(s). Authority and Issuance * * * * * Office of the Comptroller of the For the reasons set forth in the joint Currency Federal Reserve System preamble, the Board of Directors of the 12 CFR Chapter I 12 CFR Chapter II Federal Deposit Insurance Corporation proposes to amend part 345 of chapter Authority and Issuance Authority and Issuance III of title 12 of the Code of Federal Regulations as follows: For the reasons discussed in the joint For the reasons set forth in the joint preamble, the Office of the Comptroller preamble, the Board of Governors of the PART 345—COMMUNITY Federal Reserve System proposes to of the Currency proposes to amend part REINVESTMENT amend part 228 of chapter II of title 12 25 of chapter I of title 12 of the Code of the Code of Federal Regulations as 5. The authority citation for part 345 of Federal Regulations as follows: follows: continues to read as follows:

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Authority: 12 U.S.C. 1814–1817, 1819– b. Remove the word ‘‘or’’ at the end of DEPARTMENT OF HOUSING AND 1920, 1828, 1831u and 2901–2907, 3103– paragraph (g)(3); URBAN DEVELOPMENT 3104, and 3108(a). c. Remove the period at the end of 6. In § 345.12: paragraph (g)(4)(iii)(B) and add in its 24 CFR Part 1000 a. Republish the introductory text of place ‘‘; or’’; and [Docket No. FR–5275–N–10] paragraph (g): d. Add a new paragraph (g)(5). ‘‘ ’’ b. Remove the word or at the end of The republication and addition read Native American Housing Assistance paragraph (g)(3); as follows: and Self-Determination c. Remove the period at the end of Reauthorization Act of 2008: paragraph (g)(4)(iii)(B) and add in its § 563e.12 Definitions. Negotiated Rulemaking Committee place ‘‘; or’’; and * * * * * Meeting d. Add a new paragraph (g)(5). (g) Community development means: The republication and addition read AGENCY: Office of the Assistant as follows: * * * * * Secretary for Public and Indian (5) Loans, investments, and services Housing, HUD. § 345.12 Definitions. that— ACTION: Notice of negotiated rulemaking * * * * * (i) Support, enable or facilitate committee meeting. (g) Community development means: projects or activities that meet the * * * * * criteria described in Section 2301(c)(3) SUMMARY: This document announces the (5) Loans, investments, and services of the Housing and Economic Recovery sixth meeting of the negotiated that— Act of 2008 (HERA), Public Law 110– rulemaking committee that was (i) Support, enable or facilitate 289, 122 Stat. 2654, and are conducted established pursuant to the Native projects or activities that meet the in designated target areas identified in American Housing Assistance and Self- criteria described in Section 2301(c)(3) plans approved by the United States Determination Reauthorization Act of of the Housing and Economic Recovery Department of Housing and Urban 2008. The primary purpose of the Act of 2008 (HERA), Public Law 110– Development in accordance with the committee is to discuss and negotiate a 289, 122 Stat. 2654, and are conducted Neighborhood Stabilization Program proposed rule that would change the in designated target areas identified in (NSP) established by the HERA and the regulations for the Indian Housing Block plans approved by the United States American Recovery and Reinvestment Grant (IHBG) program and the Title VI Department of Housing and Urban Act of 2009, Public Law 111–5, 123 Stat. Loan Guarantee program. Development in accordance with the 115; DATES: The committee meeting will be Neighborhood Stabilization Program (ii) Are provided no later than two held on Tuesday, August 17, 2010, (NSP) established by the HERA and the years after the last date funds Wednesday, August 18, 2010, and American Recovery and Reinvestment appropriated for the NSP are required to Thursday, August 19, 2010. The meeting Act of 2009, Public Law 111–5, 123 Stat. be spent by grantees; and will begin at 8 a.m. and is scheduled to 115; (iii) Benefit low-, moderate-, and end at 5 p.m. on each day. (ii) Are provided no later than two middle-income individuals and ADDRESSES: The meeting will take place years after the last date funds geographies in the savings association’s appropriated for the NSP are required to at the Crowne Plaza St. Paul Hotel— assessment area(s) or areas outside the Riverfront, 11 East Kellogg Boulevard, be spent by grantees; and savings association’s assessment area(s) (iii) Benefit low-, moderate-, and St. Paul, Minnesota 55101; telephone provided the savings association has middle-income individuals and number 651–292–1900 (this is not a toll- adequately addressed the community geographies in the bank’s assessment free number). development needs of its assessment area(s) or areas outside the bank’s FOR FURTHER INFORMATION CONTACT: area(s). assessment area(s) provided the bank Rodger J. Boyd, Deputy Assistant has adequately addressed the * * * * * Secretary for Native American community development needs of its Dated: June 16, 2010. Programs, Office of Public and Indian assessment area(s). John C. Dugan, Housing, Department of Housing and * * * * * Comptroller of the Currency. Urban Development, 451 Seventh Street, SW., Room 4126, Washington, DC Office of Thrift Supervision By order of the Board of Governors of the Federal Reserve System, acting through the 20410; telephone number 202–401–7914 12 CFR Chapter V Secretary of the Board under delegated (this is not a toll-free number). Hearing For the reasons set forth in the joint authority. or speech-impaired individuals may preamble, the Office of Thrift Dated: June 15, 2010. access this number via TTY by calling Supervision proposes to amend part Jennifer J. Johnson, the toll-free Federal Information Relay Service at 1–800–877–8339. 563e of chapter V of title 12 of the Code Secretary of the Board. of Federal Regulations as follows: Dated at Washington, DC, this 16th day of SUPPLEMENTARY INFORMATION: June 2010. PART 563e—COMMUNITY I. Background Valerie J. Best, REINVESTMENT The Native American Housing Assistant Executive Secretary, Federal Assistance and Self-Determination Deposit Insurance Corporation. 7. The authority citation for part 563e Reauthorization Act of 2008 (Pub. L. continues to read as follows: Dated: May 26, 2010. 110–411, approved October 14, 2008) Authority: 12 U.S.C. 1462a, 1463, 1464, By the Office of Thrift Supervision. (NAHASDA Reauthorization Act) 1467a, 1814, 1816, 1828(c), and 2901 through John E. Bowman, reauthorizes the Native American 2907. Acting Director. Housing Assistance and Self- 8. In § 563e.12: [FR Doc. 2010–15119 Filed 6–23–10; 8:45 am] Determination Act of 1996 (25 U.S.C. a. Republish the introductory text of BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P; 4101 et seq.) (NAHASDA) through paragraph (g): 6720–01–P September 30, 2013, and makes a

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number of amendments to the statutory ENVIRONMENTAL PROTECTION restricted by statute. Information that requirements governing the Indian AGENCY you consider CBI or otherwise protected Housing Block Grant Program (IHBG) should be clearly identified as such and and Title VI Loan Guarantee programs. 40 CFR Parts 52 and 81 should not be submitted through http://www.regulations.gov or e-mail. For more information on the IHBG and [EPA–R09–OAR–2010–0336; FRL–9168–1] Title VI of NAHASDA, please see the http://www.regulations.gov is an background section of the Notice of Approval and Promulgation of ‘‘anonymous access’’ system, and EPA Negotiated Rulemaking Committee Implementation Plans; Designation of will not know your identity or contact Meeting published on February 22, 2010 Areas for Air Quality Planning information unless you provide it in the body of your comment. If you send e- at 75 FR 7579. Purposes; State of California; PM–10; Redesignation of the Coso Junction mail directly to EPA, your e-mail The NAHASDA Reauthorization Act Planning Area to Attainment; Approval address will be automatically captured amends section 106 of NAHASDA to of PM–10 Maintenance Plan for the and included as part of the public provide that HUD shall initiate a Coso Junction Planning Area comment. If EPA cannot read your negotiated rulemaking in order to comment due to technical difficulties implement aspects of NAHASDA that AGENCY: Environmental Protection and cannot contact you for clarification, require rulemaking. On January 5, 2010 Agency (EPA). EPA may not be able to consider your (75 FR 423), HUD published a Federal ACTION: Proposed rule. comment. Register notice announcing the final list Docket: The index to the docket for of members of the Native American SUMMARY: EPA is proposing to approve this action is available electronically at Housing Assistance & Self- the State of California’s request to www.regulations.gov and in hard copy Determination Negotiated Rulemaking redesignate to attainment the Coso at EPA Region IX, 75 Hawthorne Street, Committee. Junction planning area (CJPA), which is San Francisco, California. While all currently designated moderate documents in the docket are listed in II. Negotiated Rulemaking Committee nonattainment for the particulate matter the index, some information may be Meeting of ten microns or less (PM–10) national publicly available only at the hard copy ambient air quality standard (NAAQS). location (e.g., copyrighted material), and This document announces the sixth EPA is also proposing to approve the some may not be publicly available in meeting of the Native American PM–10 emissions inventory and the either location (e.g., CBI). To inspect the Housing Assistance & Self- maintenance plan for the CJPA area, hard copy materials, please schedule an Determination Negotiated Rulemaking which includes control measures for appointment during normal business Committee. The committee meeting will Owens Lake, the primary cause of PM– hours with the contact listed in the FOR take place as described in the DATES and 10 nonattainment for the CJPA. The FURTHER INFORMATION CONTACT section. ADDRESSES sections of this document. California Air Resources Board (CARB) FOR FURTHER INFORMATION CONTACT: The meeting will be open to the public has requested that EPA ‘‘parallel Doris Lo, EPA Region IX, (415) 972– without advance registration. Public process’’ the redesignation submittal, 3959, [email protected]. attendance may be limited to the space maintenance plan, and related SIP SUPPLEMENTARY INFORMATION: available. Members of the public may be submissions. Finally, EPA is proposing Throughout this document, ‘‘we,’’ ‘‘us’’ allowed to make statements during the to find the contribution of motor and ‘‘our’’ refer to EPA. meeting, to the extent time permits, and vehicles to the area’s PM–10 problem Table of Contents to file written statements with the insignificant. If this insignificance committee for its consideration. Written finding is finalized, the area would not I. Background statements should be submitted to the have to complete a regional emissions II. The State’s Submittal III. Proposed Redesignation of the CJPA to address listed in the FOR FURTHER analysis for any transportation conformity determinations necessary in Attainment for the PM–10 Standard INFORMATION CONTACT section of this A. EPA Has Determined That the Area has document. the CJPA. Attained the NAAQS DATES: Any comments must arrive by B. The Area Has Met All Applicable Dated: June 18, 2010. July 26, 2010. Requirements for Purposes of Rodger J. Boyd, ADDRESSES: Submit comments, Redesignation Under Section 110 and Part D of the CAA and the Area Has a Deputy Assistant Secretary for Native identified by docket number EPA–R09– American Programs. Fully Approved Applicable OAR–2010–0336, by one of the Implementation Plan Under Section [FR Doc. 2010–15364 Filed 6–23–10; 8:45 am] following methods: 110(K) of the CAA BILLING CODE 4210–67–P 1. Federal eRulemaking Portal: 1. Basic SIP Requirements Under CAA http://www.regulations.gov. Follow the Section 110 on-line instructions. 2. SIP Requirements Under Part D 2. E-mail: [email protected]. C. EPA Has Determined That the 3. Mail or Deliver: Doris Lo (Air-2), Improvement in Air Quality Is Due to Permanent and Enforceable Reductions U.S. Environmental Protection Agency in Emissions Region IX, 75 Hawthorne Street, San D. EPA Has Fully Approved a Maintenance Francisco, CA 94105–3901. Plan, Including a Contingency Plan, for Instructions: All comments will be the Area Under Section 175a of the CAA included in the public docket without 1. An Attainment Emissions Inventory to change and may be made available Identify the Level of Emissions in the online at http://www.regulations.gov, Area Sufficient to Attain the NAAQS 2. A Demonstration Of Maintenance of the including any personal information NAAQS for 10 Years After Redesignation provided, unless the comment includes 3. Verification of Continued Attainment Confidential Business Information (CBI) Through Operation of an Appropriate or other information whose disclosure is Air Quality Monitoring Network

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4. Contingency Provisions That EPA Deems drained Owens Lake almost completely The 2010 Plan addresses the PM–10 Necessary to Promptly Correct Any dry. Strong winds over the dry, alkaline maintenance plan and the CAA Violation of the NAAQS That Occurs bed of Owens Lake have produced redesignation requirements for the After Redesignation of the Area among the highest measured CJPA. E. Transportation Conformity And Motor concentrations of PM–10 ever recorded Vehicle Emissions Budgets II. The State’s Submittal IV. Proposed Actions and can have impacts as far as 150 miles V. Statutory and Executive Order Reviews away. See 64 FR 34173, June 25, 1999. EPA has granted CARB’s request that The CJPA is anywhere from 10 to 30 EPA ‘‘parallel process’’ 1 our review and I. Background miles from the southern end of Owens proposed action on the 2010 Plan’s The CJPA was originally part of the Lake. maintenance plan and redesignation Searles Valley PM–10 nonattainment The impact of Owens Lake dust on request for the CJPA. (See May 28, 2010 area which was designated Coso Junction and other downwind sites letter to Jared Blumenfeld, Regional nonattainment and classified as was documented in a special purpose Administrator, EPA Region 9, from moderate by operation of law in 1990. monitoring network that was operated James N. Goldstene, Executive Officer, See 56 FR 11101 (March 15, 1991) and from 1993 to 1996. The monitoring CARB) EPA thus is parallel processing 40 CFR 81.305. In 2002, EPA revised the network measured Owens Lake dust the 2010 Plan, including proposed SIP boundaries of the Searles Valley area, impacts at five downwind sites and approvals of the maintenance plan, dividing it into three separate found exceedances of the standard as far emissions inventory, and Owens Valley nonattainment areas: The CJPA, Indian as 50 miles from Owens Lake. The five control measures, concurrently with the Wells and Trona. 67 FR 50805 (August downwind sites included Coso Junction, CARB’s adoption process. 40 CFR part 6, 2002). Our recent notices of proposed Navy 1, Pearsonville, Inyokern and 51, appendix V.2 and final determination of attainment Ridgecrest. Navy 1 and Pearsonville are The Great Basin Unified Air Pollution for the CJPA provide more background no longer in operation and Inyokern and Control District (GBUAPCD or District) information on the designation and Ridgecrest are outside the CJPA. See the adopted the 2010 Plan on May 17, 2010 classification of the area. 75 FR 13710 2010 Plan. and has forwarded it to CARB. CARB (March 23, 2010) and 75 FR 27944 (May The process for developing controls has scheduled a Board Hearing on June 19, 2010). and a plan for the unique situation at 24, 2010 where it will consider approval The CJPA is located in eastern Owens Lake area has been ongoing for of the 2010 Plan. All public comments California in the southern portion of decades. The GBUAPCD has developed to CARB concerning their proposed Inyo County. It is an arid desert area the controls and plans for the Owens action on the 2010 Plan are also due by that receives less than 5 inches of rain Valley Planning Area with many that date. per year. The area is rural in nature and participants including the California Air III. Proposed Redesignation of the CJPA sparsely populated with only 0.5% of Resources Board (CARB), LADWP, the to Attainment for the PM–10 Standard the population of Inyo County (2000 City of Los Angeles, tribal governments, U.S. Census shows 102 people living in Federal land managers, the Navy, the Section 107(d)(3)(E) of the CAA sets the area). The Great Basin Unified Air State Lands Commission, and members forth the following criteria for Pollution Control Agency (GBUAPCD or of the public. These efforts resulted in redesignating an area from District) operates the one PM–10 a unique Board Order by the GBUAPCD nonattainment to attainment: monitoring site for the CJPA which is which requires the City of Los Angeles, (1) EPA determines that the area has located in the Coso Junction rest area in by certain timeframes, to implement attained the NAAQS. the Rose Valley. The Rose Valley is dust control measures including (2) EPA has fully approved the flanked by the Sierra Nevada and Coso shallow flooding, managed vegetation applicable implementation plan under mountain ranges. The China Lake Naval and application of gravel on designated section 110(k) of the CAA. Air Weapons Station (China Lake areas of Owens Lake. 64 FR 34173, June NAWS) covers most of the CJPA and is 25, 1999. The original Board Order, 1 Parallel processing is used for expediting the review of a plan. Parallel processing allows a State generally restricted from public access. which serves as the enforceable to submit the plan prior to actual adoption by the Air pollution in the CJPA is dominated mechanism for the dust control State and provides an opportunity for the State to by windblown dust transported from measures, has been revised on several consider EPA comments prior to submittal of the Owens Lake which has been estimated occasions and implementation of the final plan for final review and action. 2 dust control measures has led to a 90% CARB’s parallel processing request and SIP to be as much as 1.55 million pounds submittal includes the following documents: (1) per day and is overwhelming when decrease in emissions from Owens Lake May 28, 2010 letter to Jared Blumenfeld, Regional compared to the daily emissions and to significant improvement in the Administrator, U.S. EPA Region 9, from James N. estimate of 1,478 pounds per day for all air quality in CJPA. 2010 Plan. Goldstene, Executive Officer, CARB, requesting of the sources within the CJPA. ‘‘2010 On May 19, 2010, EPA published a parallel processing; (2) May 19, 2000 transmittal letter to James N. Goldstene, Executive Officer, PM10 Maintenance Plan and final determination that the CJPA has CARB, from Theodore D. Schade, Air Pollution Redesignation Request for the Coso attained the PM–10 NAAQS and that Control Officer, GBUAPCD; (3) Proof of Publication Junction Planning Area,’’ adopted May the area’s obligation to submit certain of Public Notice for ‘‘2010 Maintenance Plan and 17, 2010 (the 2010 Plan). CAA requirements (i.e., demonstration Redesignation Request for the Coso Junction Planning Area’’ (2010 Plan) and the May 17, 2010 Owens Lake, which is also located in of attainment, demonstration of GBUAPCD Board Hearing; (4) Certification by the Inyo County and also under the reasonable further progress, reasonably Clerk of the GBUAPCD Board regarding adoption of jurisdiction of the GBUAPCD, is located available control measures, and the 2010 Plan; (5) GBUAPCD Board Resolution of in the Owens Valley Planning Area contingency measures) no longer Adoption 2010–1 approving and adopting the 2010 Plan; (6) the California Environmental Quality Act which is to the north and adjacent to the applies for so long as the area continues Notice of Exemption for the 2010 Plan; (6) the CJPA. In 1913, the Los Angeles to attain prior to final redesignation. Id. Notice of Public Hearing for consideration of the Department of Water and Power On May 28, 2010, CARB submitted to adoption and approval of the 2010 Plan; and (7) The (LADWP) completed an aqueduct EPA a request for parallel processing of 2010 PM–10 Maintenance Plan and Redesignation ‘‘ Request for the Coso Junction Planning Area, May system and began diverting the waters the 2010 PM10 Maintenance Plan and 17, 2010, GBUAPCD, with Appendices A–D. All of of the Owens River to the City of Los Redesignation Request for the Coso these documents are available for review in the Angeles. By 1930, these diversions had Junction Planning Area’’ (the 2010 Plan). docket for today’s proposed rule.

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(3) EPA determines that the cover, exposing friable soils that could EPA agrees with the GBUAPCD’s improvement in air quality is due to be lofted by the wind to impact monitor assessment of the monitoring site for the permanent and enforceable reductions readings. In addition, they found a period since January 2010 and that the in emissions. deterioration in the condition of the data collected during the first two (4) EPA has fully approved a unpaved access road to the station, quarters of 2010 should not be used for maintenance plan for the area as which was located adjacent to the regulatory purposes.5 None of the meeting the requirements of section monitor and which had previously been recorded values have been entered into 175A of the CAA. covered with gravel. According to the the AQS database, and, instead, the (5) The State has met all applicable Coso Operating Company, beginning in District has entered codes for the first requirements for the area under section January 2010, a contractor working quarter 2010 data which indicate that 110 and Part D of the CAA. onsite to install an equipment trailer the data are invalid due to temporary These requirements are discussed in near the monitoring station drove along construction/repair activity in the area. more detail in a September 4, 1992 EPA See AQS raw data report for Coso Memorandum, ‘‘Procedures for the access road several times each day in order to collect equipment from the Junction, June 4, 2010. 40 CFR part 58 Processing Request to Redesignate Areas establishes criteria and requirements for to Attainment, John Calcagni, Director, trailer. The lack of vegetation and the contractor activity and increased vehicle ambient air monitoring and appendix E Air Quality Management Division’’ sets forth the probe and monitoring path trips that forced the gravel deeper into (Calcagni memo). Below, we discuss siting criteria for ambient air quality the ground combined to expose soils how these requirements are met for the monitoring. 71 FR 61236 (October 17, that could be lofted in close proximity CJPA. 2006). These include both binding to the monitor. The District staff requirements and goals. Section 1(b) of A. EPA Has Determined That the Area therefore concluded that beginning in Has Attained the NAAQS appendix E, the Introduction, provides January, 2010, this resulted in the that ‘‘[t]he probe and monitoring path In our May 19, 2010 final monitoring site’s failure to meet EPA siting criteria discussed in this determination of attainment, EPA siting criteria for a PM–10 monitor. See appendix must be followed to the determined that the CJPA attained the June 2, 2010 GBUAPCD Memorandum, maximum extent possible.’’ Under the PM–10 standard, based on data Subject: Coso Junction PM10 principles established in part 58, available to date through 2010.3 See 75 Monitoring Station Siting Review. The appendix E, EPA believes that it is not FR 13710 and 75 FR 27944. Since our District promptly set to work with the a reasonable monitoring practice to May 19, 2010 determination of Coso Operating Company to resolve the locate a PM–10 monitor, intended for attainment, the GBUAPCD requested siting problems by re-vegetating the area purposes of characterizing large-scale certification of the 2009 data (see letter and adding another layer of gravel to pollution, so close to a dust source such to Jared Blumenfeld, Regional areas with vehicular travel. The Coso as the case with the Coso Junction Administrator, EPA Region 9, from Operating Company has also restricted monitor since January 2010. The Theodore D. Schade, Air Pollution traffic on the unpaved access road objective of the Coso Junction Control Officer, GBUAPCD). The adjacent to the monitor, limiting it to monitoring site is to capture transport GBUAPCD recently determined, only the monitoring station operators from Owens Lake which is 15 to 20 however, that the monitoring site in and station support personnel as miles to the north. Coso Junction has violated siting criteria needed. Furthermore, the Company has Section 3(a) of appendix E, Spacing since January 2010. Following the moved the contractors’ trailer, which from Minor Sources, addresses the occurrence of two preliminary had previously been parked close to the siting of monitors, including PM–10 exceedances monitored in March 2010, monitor, to a gravel parking lot monitors. It states that close spacing District staff began to investigate the approximately 100 meters east of the between a monitor and a minor source cause of the exceedances. On May 27, station. They are developing a plan to may be proper if the purpose of that 2010, the GBUAPCD’s monitoring staff apply water to the soil surfaces near the monitoring site is to investigate met with the Coso Operating Company’s monitor to re-vegetate the area and emissions from that source and other Compliance Officer 4 to assess the facilitate development of a ground local sources. However, if, as is the case situation at the Coso Junction surface crust that will help minimize with the Coso Junction monitor here, monitoring site. During that meeting the site is to be used to determine air and site visit it was determined that the localized PM–10 emissions. The GBUAPCD is committed to resolving the quality over a larger area representative vegetation surrounding the monitor site of many kilometers across, it should not had not been watered for several years monitor siting problem, but believes that until the problem is resolved, the be placed near local, minor sources, and had died off. As a result, it was no because the plume from the local minor longer providing sufficient ground data collected since January 2010 should not be used for regulatory source would inappropriately impact the air quality data collected at this site. 3 As discussed in our May 19, 2010 determination purposes. See June 2, 2010 GBUAPCD of attainment, the GBUAPCD provided preliminary Memorandum, Subject: Coso Junction It is plain that this occurred at the Coso data for 2010 which indicated that there were 2 PM10 Monitoring Station Siting Review. Junction situation, where the monitor, exceedances in March 2010, but expressed concern The GBUAPCD has advised EPA that since January 2010, has been operating about the validity of the data and also noted that in an unvegetated area with exposed the status of these preliminary exceedances could adequate application of water to the change after the data validation process was surrounding soils will begin on July 1, soils and with unprecedented contractor concluded and relevant issues addressed. 75 FR 2010 and that the District expects that, activity and vehicle traffic traveling 27944. As set forth in the discussion in this section, frequently on an unpaved access road the GBUAPCD determined that these exceedances, as a result of the efforts outlined above to limit contractor activities near the site adjacent to the monitoring site. along with the other data for the first quarter of EPA will continue to work with the 2010, were invalid due to problems at the and improve the conditions near the GBUACPD to ensure that the issues with monitoring site, and therefore should not be monitor, they will be able to rectify the included in the AQS database. siting problems so that they can once 4 The Coso Operating Company is a power 5 The District advised EPA that among the invalid generating company and the owner of the property again start collecting valid data data monitored during this period was an upon which the Coso Junction monitor is located. subsequently in July. additional exceedance monitored on May 9.

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the monitoring site are resolved as soon operation of appropriate procedures linked to a particular area’s designation as possible. The recent siting problem needed to monitor ambient air quality; and classification, are the relevant affects only data collected for the period implementation of a source permit measures to evaluate in reviewing a after January, 2010, and does not have program; provisions for the redesignation request. This policy is any impact on EPA’s determination that implementation of part C requirement consistent with EPA’s existing policy on the CJPA attained the PM–10 standard for Prevention of Significant applicability of the conformity SIP based on the two most recent, Deterioration (PSD); provisions for the requirement for redesignations. See consecutive three-year periods with implementation of part D requirements Reading, Pennsylvania propose and quality-assured data. (2006–2008 and for New Source Review (NSR) permit final rulemakings at 61 FR 53174–53176 2007–2009). In view of the recent programs; provisions for air pollution (October 10, 1996), 62 FR 24816 (May 7, history of continuous attainment in the modeling; and provisions for public and 1997); Cleveland-Akron-Lorain, Ohio CJPA and the ongoing expansion of and local agency participation in planning final rulemaking at 61 FR 20458 (May 7, implementation of controls discussed and emission control rule development. 1996); and Tampa, Florida final elsewhere, EPA finds nothing to On numerous occasions over the past rulemaking at 60 FR 62748 (December 7, contradict EPA’s belief that the area has 35 years, CARB and the GBUAPCD have 1995). See also the discussion of this attained the PM–10 standard through submitted and we have approved issue in the Cincinnati redesignation at 2009 and continues to attain to date. provisions addressing the basic CAA 65 FR 37890 (June 19, 2000), and in the Therefore EPA believes that the section section 110 provisions. There are no Pittsburgh redesignation at 66 FR 50399 107(d)(3)(E)(i) requirement for outstanding or disapproved applicable (October 19, 2001). See also 73 FR attainment has been met.6 section 110 SIP submittals with respect 22307, 22312–22313 (April 25, 2008) 7 (San Joaquin PM–10 proposed B. The Area Has Met All Applicable to the State and the GBUAPCD. We redesignation). EPA believes that Requirements for Purposes of propose to conclude that CARB and the section 110 elements not linked to the Redesignation Under Section 110 and GBUAPCD have met all SIP area’s nonattainment status are not Part D of the CAA and the Area Has a requirements for the CJPA applicable for applicable for purposes of Fully Approved Applicable purposes of redesignation under section redesignation. Implementation Plan Under Section 110 of the CAA (General SIP 110(K) of the CAA Requirements). 2. SIP Requirements Under Part D Moreover, we note that SIPs must be Section 107(d)(3)(E), as interpreted by fully approved only with respect to Subparts 1 and 4 of part D, title 1 of EPA, provides that the SIP for the area applicable requirements for purposes of the CAA contain air quality planning must be fully approved under section redesignation in accordance with CAA requirements for PM–10 nonattainment 110(k) of the CAA for all requirements section 107(d)(3)(E)(ii). Thus, for areas. Subpart 1 of part D, sections that apply to the area for purposes of example, CAA section 110(a)(2)(D) 172(c) and 176 contains general redesignation. Section 107(d)(3)(E)(ii) requires that SIPs contain certain requirements for areas designated as and (v). measures to prevent sources in a state nonattainment. Subpart 4 of part D EPA may rely on prior SIP approvals from significantly contributing to air contains specific planning and in approving a redesignation request. quality problems in another state. scheduling requirements for PM–10 Calcagni Memo, p. 3, Wall v. EPA F.3d However, the section 110(a)(2)(D) nonattainment areas. 416 (6th Cir. 2001), Southwestern The subpart 1 requirements include, requirements for a state are not linked Pennsylvania Growth Alliance v. among other things, provisions for the with a particular nonattainment area’s Browner, 144 F.3d 984, 989–90 (6th Cir. reasonable available control measures designation and classification in that 1998), as well as any additional measure (RACM), reasonable further progress state. EPA believes that the it may approve in conjunction with a (RFP), emissions inventories, requirements linked with a particular redesignation action. See 68 FR 25426 contingency measures and conformity. (May 12, 2003), and citations therein. nonattainment area’s designation and Subpart 4 of part D, section 189(a), (c) The Calcagni memo states that a state classifications are the relevant measures and (e) requirements apply specifically must meet those requirements of section to evaluate in reviewing a redesignation to moderate PM–10 nonattainment 110 and part D of the CAA that were request. The transport SIP submittal areas. These requirements include: (1) applicable prior to the submittal of the requirements, where applicable, An approved permit program for redesignation request. CAA section continue to apply to a state regardless of construction of new and modified major 107(d)(3)(E)(v). the designation of any one particular stationary sources; (2) an attainment area in the state. Thus, we do not demonstration; (3) provisions for 1. Basic SIP Requirements Under CAA believe that these requirements should Section 110 RACM; (4) quantitative milestones be construed to be applicable demonstrating RFP toward attainment The general SIP elements and requirements for purposes of by the applicable attainment date; and requirements set forth in section redesignation. (5) provisions to ensure that the control 110(a)(2) include, but are not limited to, In addition, EPA believes that the requirements applicable to major the following: Submittal of a SIP that other section 110 elements not stationary sources of PM–10 also apply has been adopted by the state after connected with nonattainment plan to major stationary sources of PM–10 reasonable public notice and hearing; area’s attainment status are not precursors except where the provisions for establishment and applicable requirements for purposes of Administrator has determined that such redesignation. The State will still be sources do not contribute significantly 6 EPA notes that the 2010 Plan also includes air subject to these requirements after the to PM–10 levels which exceed the quality modeling to demonstrate that the CJPA is CJPA is redesignated. The section 110 attaining the PM–10 NAAQS. See 2010 Plan, NAAQS in the area. section 6 Air Quality Modeling and Attainment and part D requirements, which are In addition to these subpart 4 Demonstration and Appendix D. While we do not requirements, general planning 7 believe air quality modeling is required to The applicable California SIP for all requirements in subpart 1, section substantiate attainment for this purpose, EPA has nonattainment areas can be found at: http:// reviewed the modeling and believes that it is yosemite.epa.gov/r9/r9sips.nsf/ 172(c) and section 176 include supportive of the attainment determination. Casips?readform&count=100&state=California. requirements for emissions inventories,

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reasonably available control measures, Club v. EPA, 375 F.3d 537 (7th Cir. EPA or, assuming that the GBUAPCD contingency measures and conformity. 2004). makes necessary modifications to its For the CJPA, we have determined After application of the Clean Data NSR rules and EPA approves the that the requirements for an attainment Policy, the remaining applicable Part D modifications, under a SIP-approved demonstration 189(a)(1)(B), section requirements for moderate PM–10 rule. 172(c) and section 189(a)(1)(c) RACM nonattainment areas include an With respect to the conformity determination, a reasonable further emissions inventory under section requirement, section 176(c) of the CAA progress demonstration under 189(c)(1) 172(c)(3). In this notice, EPA is requires states to establish criteria and and section 172(c)(9) contingency proposing to approve the attainment procedures to ensure that federally measures no longer apply for so long as inventories submitted in the 2010 Plan supported or funded projects ‘‘conform’’ the area continues to attain the PM–10 as meeting the requirements for a to the air quality planning goals in the standard in accordance with EPA’s section 172(c) emissions inventory. See applicable SIP. The requirement to Clean Data Policy. 75 FR 27944. See also discussion below in section D.1. In determine conformity applies to San Joaquin proposed and final addition, EPA has previously approved transportation plans, programs and determination of attainment 71 FR numerous PM–10 measures into the projects developed, funded or approved 40952, 40954–5 (July 19, 2006) and 71 CJPA SIP. See footnote 11, below, and under Title 23 U.S.C. and the Federal ‘‘ FR 63641, 63643–7 (October 30, 2006). Table 5 of the 2010 Plan. Transit Act ( transportation With respect to the Part D ’’ Moreover, in the context of evaluating conformity ) as well as to other federally requirements for a NSR permit program supported or funded projects (‘‘general the area’s eligibility for redesignation, for construction of new and modified conformity’’). State conformity revisions there is a separate and additional major stationary sources, EPA has must be consistent with Federal justification for finding that the previously approved new source review conformity regulations relating to requirements associated with attainment rules (Rules 209–A and 216) for the consultation, enforcement and are not applicable for purposes of GBUACPD which cover the CJPA. See enforceability that the CAA required redesignation. Prior to and 47 FR 26380 (June 18, 1982) and 41 FR EPA to promulgate. independently of the Clean Data Policy, 53661 (December 8, 1976). EPA believes it is reasonable to and specifically in the context of Final approval of the NSR program, interpret the conformity SIP redesignations, EPA interpreted however, is not a prerequisite to requirements as not applying for attainment-linked requirements as not finalizing our proposed approval of the purposes of a redesignation request applicable for purposes of State’s redesignation request. EPA has under section 107(d) because state redesignation. In the General Preamble, determined in past redesignations that a conformity rules are still required after ‘‘General Preamble for the Interpretation NSR program does not have to be redesignation and Federal conformity of Title I of the Clean Air Act approved prior to redesignation, rules apply where state rules have not Amendments of 1990,’’ (General provided that the area demonstrates been approved. See Wall v. EPA, 265 F. Preamble) 57 FR 13498, 13564 (April 16, maintenance of the standard without 3d 426 (6th Cir. 2001), upholding this 1992). part D NSR requirements in effect. The interpretation. See also, 60 FR 62748 EPA stated that: rationale for this position is described in (December 7, 1995). a memorandum from Mary Nichols, Finally, given the extensive [t]he section 172(c)(9) requirements are directed at ensuring RFP and attainment by Assistant Administrator for Air and documentation throughout the 2010 the applicable date. These requirements no Radiation, dated October 14, 1994, Plan and today’s proposed rule that the longer apply when an area has attained the entitled ‘‘Part D NSR Requirements or primary cause of the PM–10 problem in standard and is eligible for redesignation. Areas Requesting Redesignation to the CJPA is windblown dust from Furthermore, section 175A for maintenance Attainment.’’ See the more detailed Owens Lake, EPA is proposing to plans * * * provides specific requirements explanations in the following determine that major stationary sources for contingency measures that effectively redesignation rulemakings: Detroit, MI of PM–10 precursors do not contribute supersede the requirements of section (60 FR 12467–12468, March 7, 1996); significantly to PM–10 levels that 172(c)(9) for these areas. Cleveland-Akron-Lorrain, OH (61 FR exceed the standard in the CJPA. Thus, See also Calcagni memorandum at 6 20458, 20469–20470, May 7, 1996); EPA proposes to determine that, if EPA (‘‘The requirements for reasonable Louisville, KY (66 FR 53665, 53669, finalizes today’s proposal and finally further progress and other measures October 23, 2001); Grand Rapids, MI (61 approves the emissions inventory for needed for attainment will not apply for FR 31831, 31836–31837, June 21, 1996); CJPA, the State has met and EPA has redesignations because they only have and San Joaquin Valley, CA (73 FR fully approved all requirements meaning for areas not attaining the 22307, 22313, April 25, 2008 and 73 FR applicable under section 110 and part D standard.’’). Thus, even if the 66759, 66766–7, November 12, 2008). for the CJPA for purposes of requirements associated with attainment The requirements of the PSD program redesignation. CAA Section had not previously been suspended, will apply to PM–10 once the area has 107(d)(3)(E)(v). they would not apply for purposes of been redesignated. Thus, new major evaluating whether an area that has sources with significant PM–10 C. EPA Has Determined That the attained the standard qualifies for emissions and major modifications of Improvement in Air Quality Is Due to redesignation. EPA has enunciated this PM–10 at major sources as defined Permanent and Enforceable Reductions position since the General Preamble was under 40 CFR 52.21 will be required to in Emissions published more than eighteen years ago, obtain a PSD permit or include PM–10 Section 107(d)(3)(E)(iii) requires EPA, and it represents the Agency’s emissions in their existing PSD permit. in order to approve a redesignation to interpretation of what constitutes Currently, EPA is the PSD permitting attainment, to determine that the applicable requirements under section authority in the CJPA under a Federal improvement in air quality is due to 107(d)(3)(E). The Courts have implementation plan. See 40 CFR emission reductions which are recognized the scope of EPA’s authority 52.270(a)(3). However, the GBUAPCD permanent and enforceable. to interpret ‘‘applicable requirements’’ in can implement the Federal PSD program Improvement should not be a result of the redesignation context. See Sierra through a delegation agreement with temporary reductions (e.g., economic

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downturns or shutdowns) or unusually SUMMARY OF 24-HOUR PM–10 MAX- the CJPA relies in large part on the favorable meteorology. Calcagni IMUM EXCEEDANCES (μG/M3) IN THE control measures in place for the Owens memorandum, p. 4. CJPA (1985 THROUGH 2009)*— Valley Planning Area through 2008. As discussed above in the Continued Thus, the GBUAPCD has included in its ‘‘Background’’ section, the PM–10 maintenance plan submission for the problem in the CJPA is caused primarily Exceedance Conc. Primary cause of CJPA area all of the control measures in by transport of windblown dust from date (μg/m3) exceedance the 1998 Owens Valley SIP, as well as the Owens Lake. Between 1985 and the 2003 and 2008 SIP revisions for 6/5/2007 ...... 217 Coso Junction 2009, there have been 22 exceedances of Owens Valley that the District and Parking Area CARB have submitted to EPA. These the PM–10 standard, 18 of which were Dust. caused by windblown dust from the control measures are contained in the 12/6/2007 ...... 283 Coso Junction CJPA 2010 Plan, Appendix C, Owens Lake. The remaining 4 Parking Area exceedances were caused by windblown Dust. GBUAPCD Board Order #080128–01, dust from agricultural land (1 12/22/2009 ..... 168 Owens Lake January 28, 2008/February 1, 2008 89 exceedance in 1990), wildfire smoke (1 Dust. (Board Order). The 2010 Plan exceedance in 2002) and an unpaved indicates that all of the controls * All values were recorded at the Coso Junc- required by the 1998 Owens Valley SIP truck parking area (2 exceedances in tion monitor site with the following exceptions: 2007). 2010 Plan, section 3, pp. 4–8. 4/9/1995 at Navy, 4/27/1996 at Pearsonville and the District’s 2003 Owens Valley Since 1985, the frequency of and 3/6/1998 at Navy. See 2010 Plan, Tables SIP revision submission (i.e., dust 1 and 2. exceedances has decreased with the controls for 29.8 square miles of the expected number of exceedances per Control Measures for Owens Lake Owens lakebed) have been successfully year at in the CJPA ranging from zero to implemented and that the controls have As discussed above, the Owens Valley led to a decline in the level of frequency two (prior to 2004 there were many Planning Area is located to the north of PM–10 exceedances of the 24-hour years with six to twelve expected and adjacent to CJPA and is classified as standard in the CJPA. 2010 Plan, section exceedances per year). See 2010 Plan, a serious PM–10 nonattainment area. 5, p. 12 and Table 3.10 The additional Table 3. Attainment in the CJPA depends on controls required by the 2008 SIP controls on and emissions reductions revision (for a total of 43.0 square miles SUMMARY OF 24-HOUR PM–10 MAX- from Owens Lake which is the primary of controls on Owens Lake) are μ 3 IMUM EXCEEDANCES ( G/M ) IN THE source of emissions in the Owens Valley scheduled for implementation by CJPA (1985 THROUGH 2009)* Planning area. The GBUAPCD has October 2010. jurisdiction over air quality planning Prior to the adoption of the 1998 Exceedance Conc. Primary cause of requirements for Inyo, Mono and Alpine Owens Valley PM–10 SIP, the peak 24- date (μg/m3) exceedance Counties. The GBUAPCD has adopted hour PM–10 concentration levels 4/25/1985 ...... 307 Owens Lake the following plan and revisions for the recorded in the CJPA were as high as Dust. Owens Valley Planning Area, in order to 1175 micrograms per cubic meter (μg/ 4/2/1986 ...... 1175 Owens Lake reduce the PM–10 emissions from m3) with many years recording levels Dust. Owens Lake: over 300 μg/m3, and there were several • 6/7/1986 ...... 157 Owens Lake In 1998 the GBUAPCD adopted and years where the expected number of Dust. CARB submitted the Owens Valley SIP exceedances were as high as 6 or 12 1/15/1987 ...... 196 Owens Lake requiring dust controls on 16.5 square days. See 2010 Plan, Table 3 and Dust. miles of the Owens lakebed. (1998 Summary of 24-hour PM–10 Maximum 2/3/1989 ...... 227 Owens Lake Owens Valley SIP). Exceedances table above. Following the Dust. • In 2003 the GBUAPCD adopted and 4/23/1990 ...... 866 Abandoned Ag adoption of the 1998 Owens Valley SIP CARB submitted a SIP revision to and the 2003 Owens Valley SIP Land Dust. expand dust controls to cover a total 10/26/1993 ..... 254 Owens Lake Dust. 29.8 square miles of the Owens lakebed. 8 Adopted on February 1, 2008, the GBUAPCD (2003 Owens Valley SIP revision). Board Order #080128–01 provides for the 12/23/1993 ..... 188 Owens Lake • Dust. In 2008 the GBUAPCD adopted and enforcement and implementation of 43.0 square CARB submitted a SIP revision to miles of BACM level controls on the Owens Lake 1/5/1994 ...... 388 Owens Lake bed found in the 1998 Owens Valley SIP and Dust. expand dust control requirements to subsequent SIP revisions. Board Order #080128–01 4/8/1995 ...... 692 Owens Lake apply to a total of 43.1 square miles of specifies the timing, implementation, placement, Dust. the Owens lakebed. (2008 Owens Valley and management of lake bed controls such as 4/9/1995 ...... 567* Owens Lake SIP revision). shallow flooding, managed vegetation, gravel blanketing, and ‘‘moat and row’’ controls. Also, Dust. See 2010 Plan, section 5, pp. 11–12. 4/21/1995 ...... 337 Owens Lake Board Order #080128–01 provides for contingency Dust. EPA has approved the 1998 Owens procedures for supplemental controls, maintenance of existing controls, and a ‘‘performance monitoring 4/27/1996 ...... 176* Owens Lake Valley SIP (64 FR 48305, September 3, 1999), but has not acted on the State’s plan.’’ Dust. 9 proposed 2003 and 2008 Owens Valley We note that there is a slight difference between 5/23/1996 ...... 309 Owens Lake the discussion in the 2010 Plan (p. 12) and the Dust. SIP revisions. In the meantime, the Board Order (paragraph 5) for the total square miles 3/6/1998 ...... 246* Owens Lake GBUAPCD has implemented the 2003 controlled. Page 12 of the 2010 Plan states the total Dust. Owens Valley SIP revision submission is 43.1 square miles while the Board Order states 3/18/1998 ...... 409 Owens Lake measures and has begun the total is 43.0 square miles. Since the Board Order is the enforceable mechanism, we believe the Dust. implementation of the 2008 Owens 7/25/2002 ...... 175 Wildland Fire enforceable controls are for 43.0 square miles. Valley SIP submission measures. 10 Smoke. Table 3 of the 2010 Plan shows a decline in level and frequency of the 24-hour PM–10 standard. 2/2/2003 ...... 484 Owens Lake The GBUAPCD, which exercises joint jurisdiction over CJPA and Owens Table 3 also provides information on the annual Dust. PM–10 standard, however, EPA revoked this 12/28/2006 ..... 296 Owens Lake Valley, has shown that attainment and standard on October 17, 2006, effective on Dust. maintenance of the PM–10 standard in December 18, 2006 (71 FR 61144).

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revision, which have led to which is included as Appendix C of the the NAAQS that occurs after implementation of 29.8 square miles of 2010 Plan. As discussed above, this redesignation of the area. We discuss dust controls on Owens Lake by the end Board Order is the enforceable below how these requirements are met of 2006, the peak 24-hour PM–10 levels mechanism by which the GBUAPCD can for the SJVAB. and expected number of exceedances require the City of Los Angeles to have declined. Id. Figure 4 of the 2010 implement, in phases, a total of 43 1. An Attainment Emissions Inventory plan also documents the dramatic square miles of dust control measures To Identify the Level of Emissions in the decrease in emissions in Owens Valley. for Owens Lake. The successful Area Sufficient To Attain the NAAQS EPA believes that the data in Table 3 implementation of 29.8 square miles of Section 172(c)(3) of the CAA requires and Figure 4 of the 2010 plan show controls by December 2006 has resulted plan submittals to include a there is a direct air quality benefit in the in significantly improved air quality in comprehensive, accurate, and current CJPA from the dust controls the CJPA. 2010 Plan, Table 3, Figure 4, implemented for Owens Lake. section 5. Thus, EPA believes that the inventory of actual emissions from all improvement in PM–10 air quality for sources in the nonattainment area. In Control Measures in the CJPA the CJPA is the result of permanent and demonstrating maintenance in As mentioned above, 4 of the 22 PM– enforceable reductions in emissions accordance with CAA section 175A and 10 exceedances in the CJPA between from Owens Lake, and that this the Calcagni memo, the State should 1985 and 2009 were caused by sources improvement will continue if our provide an attainment emissions other than Owens Lake emission proposal is finalized. Because of the inventory to identify the level of including windblown dust from an clear correlation between the reductions emissions in the area sufficient to attain agricultural field, smoke from a wildfire in emissions from Owens Lake and the NAAQS. Where the State has made and windblown dust from an unpaved declining PM–10 exceedances in the an adequate demonstration that air truck parking area. 2010 Plan, section 3, CJPA, EPA believes that the quality has improved as a result of the p. 4. These types of exceedances are not improvement in air quality is not the SIP, the attainment inventory will generally a problem in the CJPA and are result of temporary reductions (e.g., generally be an inventory of actual not expected to recur. The agricultural economic downturns or shutdowns) or emissions at the time the area attained land just north of the monitor site was unusually favorable meteorology. Thus, the standard. EPA’s primary guidance in stabilized by natural vegetation cover in EPA proposes to determine that the evaluating these inventories is the 1991 after the land was fallowed. Since improvement in air quality in CJPA is document entitled, ‘‘PM–10 Emissions that time no agricultural activities have due to permanent and enforceable Inventory Requirements,’’ EPA, OAQPS, taken place in the CJPA. Dust from the emissions reductions 107(d)(3)(E)(iii). EPA–454/R–94–033 (September 1994) unpaved truck parking area, located which can be found at: http:// D. EPA Has Fully Approved a adjacent to the PM–10 monitor site was www.epa.gov/ttn/chief/eidocs/ Maintenance Plan for the Area Under mitigated by covering it with gravel in pm10eir.pdf. 2008 and then asphalt pavement in Section 175A of the CAA The 2010 Plan provides an estimated 2009. 2010 Plan, section 1. The 2010 Section 175A of the CAA provides the daily PM–10 emissions inventory for Plan also provides a summary of the requirements for maintenance plans that 2008 through 2025. The year 2008 was District rules and regulations that apply must be fully approved under section chosen as the attainment year because it to sources of PM–10 within the CJPA. 107(d)(3)(E) for purposes of is one of the attainment years in the 2010 Plan, Table 5. While the focus of redesignation to attainment. The most recent three-year periods (2006– attaining and maintaining the PM–10 provisons to be included in a 2008, 2007–2009) in which compliance standard in the CJPA is on the controls maintenance plan are further addressed with the PM–10 NAAQS was for Owens Lake, these measures, many in the Calcagni memo. They include: of which have been SIP-approved, will (1) An attainment emissions inventory monitored. The 2010 Plan projects the also benefit air quality.11 Those to identify the level of emissions in the emissions attainment inventory to measures that EPA has already area sufficient to attain the NAAQS; remain constant from 2008 through approved into the CJPA SIP contribute (2) A demonstration of maintenance 2025, at an estimated 1,478 pounds per to attainment and maintenance of the of the NAAQS for 10 years after day. See 2010 Plan, section 4, pp. 9–10. PM–10 NAAQS. redesignation; In contrast, as noted in the Background (3) Verification of continued discussion in section I above, the EPA Proposal for Approval of attainment through operation of an emissions generated within the CJPA are GBUAPCD Board Order Maintenance appropriate air quality monitoring less than 0.1% of the emissions caused Plan Control network; and by windblown dust from the Owens EPA is proposing to approve the (4) Contingency provisions that EPA Lake area, which were estimated to be GBUAPCD Board Order #080128–01, deems necessary to assure that the State 1.55 million pounds per day for the January 28, 2008/February 1, 2008, will promptly correct any violation of CJPA design day (January 5, 2007). Id.

DAILY PM–10 EMISSIONS FOR 2008 THROUGH 2025 FOR PM–10 SOURCES IN THE CJPA

Pounds per day

Stationary Sources: —California Lightweight Pumice ...... 167 —China Lake Naval Air Weapons Station ...... 84

11 There are thirteen measures listed in Table 5 these rules into the SIP: Rule 209–A, 47 FR 26380, 8471, January 27, 1981; Rule 409, 42 FR 28883, June of the 2010 Plan including New Source Review and June 18, 1982; Rule 216, 41 FR 53661, December 8, 6, 1977; Rule 410, 42 FR 28883, June 6, 1977; and, permitting rules and rules to control fugitive dust 1976; Rule 400, 42 FR 28883, June 6, 1977; Rule Regulation XIII (Rules 1301–1311), 64 FR 19916, and controlled burning. We have approved nine of 401, 42 FR 28883, June 6, 1977; Rule 408, 46 FR April 23, 1999.

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DAILY PM–10 EMISSIONS FOR 2008 THROUGH 2025 FOR PM–10 SOURCES IN THE CJPA—Continued

Pounds per day

—Coso Operating Company ...... 953 —Halliburton Services ...... 20 —Twin Mountain Rock ...... 58 —Total Stationary ...... 1282 Area Sources: —Unpaved Roads ...... 83 —Paved Roads ...... 101 —Total Area Sources ...... 184 Mobile Sources: —On-Road Motor Vehicles ...... 12 Total PM–10 for CJPA ...... 1478 Source: 2010 Plan, Table 4.

The 2010 Plan’s inventory for sources industrial operations for the area, a staying constant or decreasing from within the CJPA is subdivided into three constant inventory of 1,478 pounds per 2007 through 2026. EPA believes the subcategories: Stationary sources; area day from 2008 through 2025 is also forecasted decreases in emissions in sources; and mobile sources. Id. In the appropriate for the CJPA. We have 2010 from Owens Lake are consistent CJPA, the majority of daily PM–10 reviewed the 2010 Plan’s estimated with the additional control measures emissions are estimated to come from attainment year emission inventory and (discussed above) that are scheduled for stationary sources. Five sources account determined that it is current, accurate implementation. for 1,282 pounds or 86.7% of estimated and comprehensive, and meets EPA In addition, we believe that, while not total daily PM–10 emissions. The largest guidance and the CAA. Therefore we are nearly as significant as the emissions stationary source contributor is Coso proposing to approve the 2008 reductions from Owens Lake, as Operating Company, a geothermal, wind inventory, which also serves as the discussed in the Inventory section above and solar energy company, with an maintenance plan’s attainment year the total daily emissions of PM–10 from estimated 953 pounds per day of PM– inventory, under section 172(c) of the sources within CJPA will remain 10 emissions. These emissions estimates CAA. constant at 1,478 pounds per day from are derived from GBUAPCD source 2008 through 2025. 2010 Plan, section 4. 2. A Demonstration of Maintenance of permits and include unpaved road and Sources within the CJPA are also subject the NAAQS for 10 Years After haul road PM–10 emissions for these to SIP-approved measures. See footnote Redesignation sources. Id. 11. The plan estimates daily area source Section 175A of the CAA requires a Based on our review of the emissions for unpaved and paved roads demonstration of maintenance of the information presented in the 2010 Plan, at 184 pounds per day (12.4% of total). NAAQS for 10 years after redesignation. we believe that the State has shown that CJPA on-road mobile source A state generally may demonstrate attainment of the PM–10 standard will emissions are estimated to be 12 pounds maintenance of the NAAQS by either be maintained in the CJPA for at least per day (0.8% of total) and are based on showing that future emissions of a ten years after redesignation. CARB’s 2008 PM–10 emission estimates pollutant or its precursors will not for Inyo County. CJPA estimates were exceed the level of the attainment 3. Verification of Continued Attainment derived from Inyo County estimates by inventory, or by modeling to show that Through Operation of an Appropriate pro-rating the amount of traffic (5.1%) the future anticipated mix of sources Air Quality Monitoring Network in the CJPA. 2010 Plan, section 4, p. 10. and emission rates will not cause a In demonstrating maintenance, GBUAPCD projects that PM–10 violation of the NAAQS. continued attainment of the NAAQS can emissions will not grow from 2008 to As discussed above, the emissions be verified through operation of an 2025 because of the CJPA’s continued reductions from Owens Lake provided appropriate air quality monitoring sparse population and lack of the path to attainment for the CJPA and network. The Calcagni memo states that population growth, and relative stability is also the paramount source of the maintenance plan should contain of the area’s industrial activities. The emissions that must be addressed in provisions for continued operation of air CJPA has only 0.5% of Inyo County’s ensuring maintenance for the area. The quality monitors that will provide such population and, according to U.S. emissions estimates and projections for verification. Census Bureau figures, Inyo County the Owens Lake and the Owens Valley The GBUAPCD has committed to population declined from 18,281 in area have decreased significantly since continue daily monitoring of PM–10 at 1990 to 17,945 in 2000, and further 2000 and are expected to continue to the Coso Junction monitoring site and is declined to 17,136 in 2008, a population decrease until 2011 and then remain authorized to do so under the California decrease of 4.5% over this 18-year constant through 2025. 2010 Plan, Health and Safety Code section 40001. period. 2010 Plan, section 4, p. 9–10. section 5, pp. 11–13 and Figure 4. 2010 Plan, section 5.1, p. 13 and section In conclusion, EPA believes that the Figure 4 of the 2010 Plan shows actual 10, p. 23. The Coso Junction monitor is selection of 2008 as the attainment year and forecasted emissions from Owens part of an EPA-approved air quality inventory and 2025 for the maintenance Lake and from all sources in the Owens monitoring network. See December 1, year inventory is appropriate since the Valley area. Since 2000, the actual 2009 letter to Ted Schade, Air Pollution area was determined to have attained by emissions have decreased by 90% as a Control Officer, GBUAPCD, from Joseph 2008, and that given the sparse result of dust control measures and the Lapka, Acting Manager, Air Quality population, the lack of population forecasts show emission from Owens Analysis Section, EPA Region 9. As growth and the lack of changes to Lake and the Owens Valley Area either noted above, EPA and the District have

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recently learned that changed Lake dust controls as part of the Valley Planning Area that are intended conditions in the area adjacent to the maintenance plan for the CJPA. The to address the CAA section 172(c)(9) Coso Junction monitor have resulted in Board Order is the enforceable contingency measure requirement for the monitor not meeting EPA siting mechanism by which the GBUAPCD nonattainment area plans. The process criteria since January 2010. As a result, requires the City of Los Angeles to for developing these contingency data from the monitor during this period implement, in phases, a total of 43 measures for Owens Lake is triggered by are not representative of the area for square miles of dust control measures a determination by the GBUAPCD Air which the monitor is designed, and for Owens Lake. EPA believes that the Pollution Control Officer (APCO) as cannot be relied upon for regulatory successful implementation of 29.8 described in paragraphs 10 through 13 purposes. GBUAPCD has already taken square miles of controls by December of the Board Order. As paragraph 10 steps to correct the problems identified, 2006 has let to significantly improved explains, these are annual which are linked to the operations of a air quality in the CJPA and in fact has determinations made by the GBUAPCD nearby contractor. These include plans resulted in attainment of the PM–10 APCO beginning in 2011. Paragraph 11 and actions to promote regrowth of standard in the CJPA, beginning in of the Board Order provides criteria and vegetation in the area surrounding the 2008. Thus, EPA also believes that procedures for determining the need for monitor, and development of a additional dust controls beyond the 29.8 contingency measures and competent crustal surface to reduce square miles of control, and supplemental control measures. emissions. The GBUAPCD has already implemented after attainment, can serve Paragraph 13 ensures that the rerouted and restricted traffic from an as contingency measures for the CJPA. GBUAPCD can require the City of Los unpaved access road near the monitor, The additional controls included in the Angeles to take added reasonable and has directed the contractor to 2008 Board Order which EPA is today measures not specifically addressed remove its equipment trailer from a proposing to approve, include within paragraphs 10 or 12. EPA location near the monitor. Additional application of another 13.2 square miles believes these procedures for additional gravel placement on the access road and of dust controls to Owens Lake by measures at Owens Lake, which EPA is areas on which vehicles will travel and October 31, 2010. 2010 Plan, section 5. today proposing to approve, will also the application of water will also reduce Since the primary source of PM–10 help to ensure continued attainment in dust emissions near the monitor. The emissions is from Owens Lake, EPA is the CJPA. GBUAPCD is committed to resolving the proposing to approve the 13.2 square Although local emissions within CJPA siting issues and expects that the miles of dust controls for Owens Lake play a very minor role in maintenance monitor will be collecting valid data for as meeting the requirement for 175A of the PM–10 standard in CJPA, EPA the area after July 1, 2010. Thus EPA maintenance plan contingency measures notes that in addition to the 175A believes that all these circumstances for the CJPA. These dust controls for an maintenance plan contingency measures demonstrate that the District’s additional 13.2 square miles of Owens directed at Owens Valley that we are commitment to continued verification Lake are already adopted controls and proposing to approve, the GBUAPCD through operation of its monitor is do not require a trigger for has also made a commitment to address credible and sufficient. implementation. local emissions in CJPA. GBUAPCD EPA has long approved contingency commits to investigate the cause of any 4. Contingency Provisions That EPA provisions that rely on reductions from such exceedance within 60 days from Deems Necessary To Promptly Correct measures that are already in place but the end of the calendar quarter in which Any Violation of the NAAQS That are over and above those relied on for the exceedance occurs, and to address Occurs After Redesignation of the Area attainment and RFP under CAA section and correct exceedances found to be Contingency provisions are required 172(c)(9). See, e.g., 62 FR 15844 (April caused by local sources within 18 for maintenance plans under section 3, 1997); 62 FR 66279 (December 18, months of identifying the cause of the 175A of the CAA. These contingency 1997); 66 FR 30811 (June 8, 2001); 66 FR exceedance. See 2010 Plan, sections 5.1 measures are distinguished from those 586 and 66 FR 634 (January 3, 2001). and 10 and June 10, 2010 letter to generally required for nonattainment See discussion in our final PM–2.5 Deborah Jordan, Director, Air Division, areas under section 172(c)(9) in that implementation rule. 72 FR 20586, EPA Region 9, from Theodore D. they are not required to be fully adopted 20642–20643 (April 25, 2007). This Schade, Air Pollution Control Officer, measures that will take effect without interpretation has also been upheld in GBUAPCD. EPA believes this further action by the state in order for LEAN v. EPA, 382 F.3d 575 (5th Cir. commitment will also help to ensure the maintenance plan to be approved. 2004), where the court in that case set maintenance in the CJPA. The Calcagni memo states that the forth its reasoning for accepting excess Finally, GBUAPCD is not proposing to contingency provisions of the reductions from already adopted remove or cease implementing any maintenance plan should identify the measures as contingency measures. approved SIP measures. Thus, for the measures to be adopted, a schedule and Our interpretation that excess reasons set forth above, EPA is procedure for adoption and emission reductions can appropriately proposing to approve the contingency implementation, and a time limit for serve as section 172(c)(9) contingency measures under section 175A(d). action by the state. The memo also measures is equally applicable to In light of the discussion set forth states that the contingency provisions section 175A(d) contingency measures. above, EPA is proposing to approve the should identify indicators or triggers EPA has approved maintenance plans maintenance plan for CJPA as meeting which will be used to determine when under section 175A that included the requirements of CAA section 175A. the contingency measures need to be contingency provisions relying on implemented. While the memo suggests measures to be implemented prior to E. Transportation Conformity and Motor inventory or monitoring indicators, it any post-redesignation NAAQS Vehicle Emissions Budgets states that contingency provisions will violation. See 60 FR 27028, 27029 (May Under section 176(c) of the CAA, be evaluated on a case-by-case basis. 22, 1995); 73 FR 66759, 66,769 transportation plans, programs and As discussed in section C above, EPA (November 12, 2008). projects in the nonattainment or is proposing to approve the GBUAPCD The Board Order also includes maintenance areas that are funded or Board Order #080128–01 for Owens contingency measures for the Owens approved under title 23 U.S.C. and the

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Federal Transit Laws (49 U.S.C. chapter projected annual PM–10 emissions PM–10 emissions problem in Owens 53) must conform to the applicable SIP. levels for the Owens Valley, 8,000 tons Valley itself, where the primary source In short, a transportation plan and per year, CJPA motor vehicle related of PM–10 emissions is located, then it program are deemed to conform to the PM–10 emissions are insignificant at is reasonable to conclude that motor applicable SIP if the emissions resulting 196 pounds per day (35.8 tons per year), vehicle emissions are also not a from the implementation of that which means that on-road motor vehicle significant contributor to the PM–10 transportation plan and program are less emissions represent just 0.4% of the emissions problem in neighboring CJPA. than or equal to the motor vehicle inventory when emissions from Owens In the context of these unique factual emissions budget (MVEB) established in Valley are considered.12 EPA further circumstances, EPA is proposing to find the SIP for the attainment year, notes that the four exceedances that motor vehicle emissions are an maintenance year and other analysis attributed to CJPA sources were caused insignificant contributor to the PM–10 years. See, generally, 40 CFR part 93. by windblown dust from fallow problem in the CJPA. Consideration of Section 93.109(m) of EPA’s agricultural land, wildfire smoke and an the other factors specified in EPA’s regulations implementing the unpaved truck parking area. See 2010 regulations supports this proposed transportation conformity requirement Plan, section 3, pp. 4–9. As discussed finding and is described below. (40 CFR part 93) states that an area is above and in the 2010 Plan, Current Air Quality as Determined by not required to satisfy a regional exceedances due to these sources are PM–10 Monitoring Data emissions analysis for a pollutant if EPA not expected to recur because the finds that motor vehicle emissions of agricultural land has been re-vegetated Current air quality as determined by that pollutant are an insignificant and the truck parking lot has been PM–10 monitoring data show that the contributor to the area’s air quality paved. CJPA attains the PM–10 standard. As problem. To make this demonstration, While EPA indicated in its discussed in section A above, for PM– the SIP would have to show that it Transportation Conformity final rule 10 in the CJPA, EPA has reviewed the would be unreasonable to expect that that mobile source emissions of ambient air quality data and determined the area would experience enough approximately 10% or less may be that the CJPA has attained the PM–10 motor vehicle emissions growth in that considered insignificant, EPA further standard through 2009 and continues to pollutant/precursor for a NAAQS noted that ten percent should be viewed attain to date. See 75 FR 13710 and 75 violation to occur. Factors to consider in as a general guideline only, and that FR 27944. such a demonstration include the mobile source emissions that are above Absence of SIP Motor Vehicle Control following: the percentage of motor 10% of total emissions could still be Measures vehicle emissions in the context of the found to be insignificant, depending on total SIP inventory; the current state of the circumstances. Given the unique There are no local PM–10 motor air quality as determined by monitoring circumstances of the CJPA, EPA believes vehicle control measures for the CJPA. data for that NAAQS; the absence of SIP that the motor vehicle emissions With the exception of GBUAPCD Rule motor vehicle control measures; and contribution to the CJPA is insignificant. 401—Fugitive Dust, that may apply to historical trends and future projections In addition to the overwhelming area sources such as unpaved roads, of the growth of motor vehicle contribution of Owens Valley to the there are no specific CJPA only PM–10 emissions. CJPA PM–10 problem, EPA considered motor vehicle control measures. Of Today, we are proposing to find that the control measures adopted for Owens course, national and state-wide motor motor vehicle-related PM–10 emissions Valley as one of the relevant factual vehicle emission controls may apply, (i.e., tailpipe emissions, brake and tire circumstances. The GBUAPCD exercises but they are not GBUAPCD adopted and wear emissions, and re-entrained dust joint jurisdiction over Owens Valley and CJPA specific motor vehicle control emissions from paved and unpaved the CJPA and therefore has authority to measures. Furthermore, these state-wide roads) are insignificant contributors to adopt and implement controls in both and national emission control measures the CJPA’s PM–10 nonattainment areas. Pursuant to this authority, the would contribute to reductions in motor problem, based on our consideration of GBUAPCD has in fact adopted and vehicle related PM–10 emissions in the the factors identified in EPA’s implemented control measures to CJPA. transportation conformity regulations address the PM–10 contribution to the Historical Trends and Future and on the unique circumstances of the CJPA from Owens Valley. See section C Projections of the Growth of Motor PM–10 CJPA. above for a detailed discussion of these Vehicle Related PM–10 Emissions As discussed in section 4 of the 2010 control measures. Plan, at 196 pounds per day, the total Finally, EPA notes that in 1999 (See Finally, historical trends and future on-road-related PM–10 emissions from 64 FR 34173 and 64 FR 48305), EPA projections of the growth of motor motor vehicles are 13.3% of the 1,478 found that the motor vehicle emissions vehicle related PM–10 emissions pounds per day attainment inventory for contribution in Owens Valley itself was suggest that motor vehicle related PM– the CJPA. However, as explained insignificant. This earlier finding for 10 emissions are not likely to increase, elsewhere in this notice, air pollution in Owens Valley supports the proposed and therefore not likely to cause or the CJPA is dominated by windblown finding for the CJPA—if motor vehicles contribute to violations of the PM–10 dust transported from Owens Lake, are not a significant contributor to the standard. The CJPA is within a sparsely which has been estimated to be as much populated area of Inyo County, as 1.55 million pounds per day. The 12 Depending on the year, the emissions from the California. An estimated 102 people live contribution of Owens Lake to the CJPA Owens Valley area are estimated to be anywhere in two communities of Pearsonville and from approximately 8,000 to 47,000 tons per year is overwhelming when compared to the (past actual estimates are anywhere from 10,000 to Homewood Canyon. These two daily emissions estimate of 1,478 86,000 tons per year). See 2010 Plan, Figure 4. The communities are located at the southern pounds per day for all of the sources CJPA PM–10 emissions of 269.74 tons per year end of the CJPA, approximately 25 miles within the CJPA, and is even more (converted from the 1,478 pounds per day estimate apart and separated by the China Lake found in the 2010 Plan, Table 4) are approximately overwhelming when compared to the 3% when compared to the lowest estimate NAWS. Commuters from these on-road PM–10 emissions of 196 lbs/ emissions level (8,000 tons per year) for the Owens communities most likely travel south day. In comparison with the lowest Valley area. out of the CJPA to Ridgecrest, a small

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community of approximately 27,600 the CJPA to attainment, pursuant to Executive Order 12866 (58 FR 51735, people.13 According to US Census CAA sections 107(d)(3)(E) and 175A. October 4, 1993); figures, in the period 1990 to 2008, Inyo Assuming that California adopts the • Do not impose an information County population did not increase, but maintenance plan and associated collection burden under the provisions dropped 4.5%. (See 2010 Plan, Section controls as they are currently drafted, of the Paperwork Reduction Act (44 4.4, pages 10–11.) Within the CJPA, EPA is therefore proposing to U.S.C. 3501 et seq.); almost all of the land, 98.5%, is redesignate the CJPA to attainment for • controlled by the federal government: the PM–10 NAAQS. EPA also proposes Are certified as not having a the Department of Defense through the to approve the maintenance plan for significant economic impact on a China Lake NAWS controls 63%; the CJPA which includes the GBUAPCD substantial number of small entities Department of the Interior through the Board Order #080128–01 as a SIP under the Regulatory Flexibility Act (5 Bureau of Land Management (BLM) and revision. As discussed above the Board U.S.C. 601 et seq.); the Forest Service controls 32.6% and Order includes all of the control • Do not contain any unfunded 2.9%, respectively, with just over measures in the 1998 Owens Valley SIP, mandate or significantly or uniquely twelve percent (12.2%) of BLM land and the 2003 and 2008 SIP revisions for affect small governments, as described designated as wilderness.14 All of these Owens Valley. EPA is also proposing to in the Unfunded Mandates Reform Act entities restrict access, development, or approve the emissions inventory of 1995 (Pub. L. 104–4); both within the lands they control. In submitted with the maintenance plan as • Do not have Federalism summary, given a sparse population, meeting the requirements of section implications as specified in Executive historically declining or no population 172(c)(3). If the State substantially Order 13132 (64 FR 43255, August 10, growth, the absence of any significant revises the submitted control measures 1999); commutershed in the CJPA, limited land or maintenance plan from the versions • ownership, and restricted access or proposed by the State and reviewed Are not an economically significant development, PM–10 related motor here, this will result in the need for regulatory action based on health or vehicle emissions are not expected to additional proposed rulemaking on the safety risks subject to Executive Order increase in the CJPA to the point where maintenance plan and redesignation. 13045 (62 FR 19885, April 23, 1997); a violation would occur. Finally, EPA is proposing to find the • Are not a significant regulatory EPA Proposal for Transportation contribution of motor vehicles to the action subject to Executive Order 13211 Conformity and MVEBs in the CJPA area’s PM–10 problem insignificant, and (66 FR 28355, May 22, 2001); if this insignificance finding is finalized, • Given the factors discussed above, we Are not subject to requirements of the area would not have to complete a are proposing to find that motor vehicle- Section 12(d) of the National regional emissions analysis for any related PM–10 emissions are Technology Transfer and Advancement transportation conformity insignificant contributors to the CJPA’s Act of 1995 (15 U.S.C. 272 note) because determinations necessary in the CJPA. PM–10 nonattainment problem and that application of those requirements would it would be unreasonable to expect that V. Statutory and Executive Order be inconsistent with the Clean Air Act; motor vehicle related PM–10 emissions Reviews and would grow enough within the CJPA to • Do not provide EPA with the Under the CAA, redesignation of an threaten the PM–10 standard. If this discretionary authority to address, as area to attainment and the proposal is finalized, a regional appropriate, disproportionate human accompanying approval of a emissions analysis would not be health or environmental effects, using maintenance plan under section required for PM–10 in any future practicable and legally permissible 107(d)(3)(E) are actions that affect the conformity determination in the CJPA. methods, under Executive Order 12898 status of a geographical area and do not Given that the CJPA is an isolated (59 FR 7629, February 16, 1994). rural area, if EPA takes final action impose any additional regulatory finding the motor vehicle emissions requirements on sources beyond those In addition, this rule does not have PM–10 contribution is insignificant, a imposed by State law. A redesignation tribal implications as specified by conformity determination would be to attainment does not in and of itself Executive Order 13175 (65 FR 67249, necessary only in the case where a create any new requirements, but rather November 9, 2000), because the SIP is transportation project needs federal results in the applicability of not approved to apply in Indian country funding or approval. Even with an requirements contained in the CAA for located in the State, and EPA notes that insignificance finding, such a areas that have been redesignated to it will not impose substantial direct conformity determination would need attainment. Moreover, the Administrator costs on tribal governments or preempt to include a hot-spot analysis, if the is required to approve a SIP submission tribal law. project is one of the types found in 40 that complies with the provisions of the List of Subjects CFR 93.123(b). Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). 40 CFR Part 52 IV. Proposed Actions Thus, in reviewing SIP submissions, Based on our review of the 2010 Plan EPA’s role is to approve State choices, Environmental protection, Air submitted by the State, air quality provided that they meet the criteria of pollution control, Incorporation by monitoring data, and other relevant the Clean Air Act. Accordingly, this reference, Intergovernmental relations, materials, EPA believes the State has action merely approves State law as Particulate matter, Reporting and addressed all the necessary meeting Federal requirements and does recordkeeping requirements. requirements for the redesignation of not impose additional requirements 40 CFR Part 81 beyond those imposed by State law. For 13 U.S. Census Bureau, 2006–2008 American these reasons, these actions: Environmental protection, Air Community Survey. • Are not ‘‘significant regulatory pollution control, National parks, 14 Data source is http://www.nationalatlas.gov; Wilderness areas. http://nationalatlas.gov/mld/fedlandp.html; shape actions’’ subject to review by the Office file from Federal Lands of the United States map. of Management and Budget under Authority: 42 U.S.C. 7401 et seq.

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Dated: June 18, 2010. DC. Such deliveries are only accepted Avenue, NW., Washington, DC. The Jared Blumenfeld, during the Docket’s normal hours of Public Reading Room is open from 8:30 Regional Administrator, Region IX. operation, and special arrangements a.m. to 4:30 p.m., Monday through [FR Doc. 2010–15453 Filed 6–23–10; 8:45 am] should be made for deliveries of boxed Friday, excluding legal holidays. The BILLING CODE 6560–50–P information. telephone number for the Public Instructions: Direct your comments to Reading Room is (202) 566–1744, and Docket ID No. EPA–HQ–OAR–2007– the telephone number for the Air Docket ENVIRONMENTAL PROTECTION 0294. EPA’s policy is that all comments is (202) 566–1742. AGENCY received will be included in the public docket without change and may be How can I get copies of this document, 40 CFR Part 87 made available online at http:// the advance notice of proposed www.regulations.gov, including any rulemaking, and other related [EPA–HQ–OAR–2007–0294; FRL–9167–4] personal information provided, unless information? RIN 2060–AP79 the comment includes information The EPA has established a docket for claimed to be Confidential Business this action under Docket ID No. EPA– Advance Notice of Proposed Information (CBI) or other information HQ–OAR–2007–0294. The EPA has also Rulemaking on Lead Emissions From whose disclosure is restricted by statute. developed a Web site for aviation, Piston-Engine Aircraft Using Leaded Do not submit information that you including the ANPR, at: http:// Aviation Gasoline; Extension of consider to be CBI or otherwise www.epa.gov/otaq/aviation.htm. Please Comment Period protected through http:// refer to the ANPR for detailed www.regulations.gov or e-mail. The AGENCY: Environmental Protection information on accessing information http://www.regulations.gov Web site is Agency (EPA). related to this notice. an ‘‘anonymous access’’ system, which ACTION: Advance notice of proposed means EPA will not know your identity FOR FURTHER INFORMATION CONTACT: rulemaking; extension of comment or contact information unless you Marion Hoyer, Assessment and period. provide it in the body of your comment. Standards Division, Office of Transportation and Air Quality, 2000 SUMMARY: EPA is announcing a 60-day If you send an e-mail comment directly to EPA without going through http:// Traverwood Drive, Ann Arbor, MI extension of the public comment period 48105; telephone number: (734) 214– for the Advance Notice of Proposed www.regulations.gov your e-mail address will be automatically captured 4513; fax number: (734) 214–4821; e- Rulemaking on Lead Emissions From mail address: [email protected]. Piston-Engine Aircraft Using Leaded and included as part of the comment Aviation Gasoline (hereinafter referred that is placed in the public docket and SUPPLEMENTARY INFORMATION: to as the ANPR). EPA published this made available on the Internet. If you Background: In the ANPR, EPA ANPR, which included a request for submit an electronic comment, EPA described and invited comment from all comment, in the Federal Register on recommends that you include your interested parties on the data available April 28, 2010. The public comment name and other contact information in for evaluating lead emissions, ambient the body of your comment and with any period was to end on June 28, 2010 (60 concentrations and potential exposure disk or CD–ROM you submit. If EPA days after its publication in the Federal to lead from the use of leaded aviation cannot read your comment due to Register). This document extends the gasoline (avgas) in piston-engine technical difficulties and cannot contact comment period an additional 60 days powered aircraft. The ANPR is one of you for clarification, EPA may not be until August 27, 2010. This extension of the steps EPA has taken in response to able to consider your comment. the comment period is provided to a petition submitted by Friends of the Electronic files should avoid the use of allow the public additional time to Earth (FOE) requesting that EPA find special characters, any form of provide comment on the ANPR. endangerment from and regulate lead encryption, and be free of any defects or emitted by piston-engine aircraft, or if DATES: The comment period for the viruses. For additional information insufficient information exists, to ANPR published April 28, 2010 (75 FR about EPA’s public docket visit the EPA 22440) is extended. Written comments Docket Center homepage at http://www. commence a study. In addition to must be received on or before August epa.gov/epahome/dockets.htm. For describing and inviting comment on the 27, 2010. additional instructions on submitting current data, the ANPR also describes ADDRESSES: Submit your comments, comments, please refer to the considerations regarding emission identified by Docket ID No. EPA–HQ– SUPPLEMENTARY INFORMATION section of engine standards and requests comment OAR–2007–0294, by one of the the advance notice of proposed on approaches for transitioning the following methods: rulemaking document. piston-engine fleet to unleaded avgas. • http://www.regulations.gov: Follow Docket: All documents in the docket Extension of Comment Period: EPA the on-line instructions for submitting are listed in the http:// received requests for an extension of the comments. www.regulations.gov index. Although ANPR comment period that are • E-mail: [email protected]. listed in the index, some information is available in the docket for this rule • Fax: (202) 566–9744. not publicly available, e.g., CBI or other (EPA–HQ–OAR–2007–0294). After • Mail: Environmental Protection information whose disclosure is considering the requests, EPA has Agency, Mail Code: 6102T, 1200 restricted by statute. Certain other determined that a 60-day extension of Pennsylvania Avenue, NW., material, such as copyrighted material, the comment period would provide the Washington, DC 20460. Please include will be publicly available only in hard public adequate time to provide two copies. copy. Publicly available docket meaningful comment on the ANPR. • Hand Delivery: EPA Docket Center materials are available either Accordingly, the public comment (Air Docket), U.S. Environmental electronically in http:// period for the ANPR is extended until Protection Agency, EPA West Building, www.regulations.gov or in hard copy at August 27, 2010. EPA does not 1301 Constitution Avenue, NW., Room: the EPA Docket Center, EPA/DC, EPA anticipate any further extension of the 3334 Mail Code: 2822T, Washington, West, Room 3334, 1301 Constitution comment period at this time.

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Dated: June 18, 2010. We will not accept e-mail or faxes. We size of these species, including the Gina McCarthy, will post all comments on http:// locations of any additional populations Assistant Administrator, Office of Air and www.regulations.gov. This generally of the species; Radiation. means that we will post any personal (3) Any additional information on the [FR Doc. 2010–15340 Filed 6–23–10; 8:45 am] information you provide us (see the biological or ecological requirements of BILLING CODE 6560–50–P Request for Public Comments section the species; below for more information). (4) Current or planned activities in the FOR FURTHER INFORMATION CONTACT: For areas occupied by the species and possible impacts of these activities on DEPARTMENT OF THE INTERIOR information regarding the Cumberland darter, contact Lee Andrews, Field the species and their habitat; (5) Potential effects of climate change Fish and Wildlife Service Supervisor, U.S. Fish and Wildlife on the species and their habitats; Service, Kentucky Ecological Services (6) The reasons why areas should or 50 CFR Part 17 Field Office, J.C. Watts Federal should not be designated as critical Building, 330 W. Broadway Rm. 265, habitat as provided by section 4 of the [Docket No. FWS-R4-ES-2010-0027] Frankfort, KY 40601; telephone 502- [MO 92210-0-0008-B2] Act (16 U.S.C. 1531, et seq.), including 695-0468; facsimile 502-695-1024. For whether the benefits of designation RIN 1018-AV85 information regarding the rush darter, would outweigh threats to the species contact Stephen Ricks, Field Supervisor, that designation could cause (e.g., Endangered and Threatened Wildlife U.S. Fish and Wildlife Service, exacerbation of existing threats, such as and Plants; Listing the Cumberland Mississippi Ecological Services Field overcollection), such that the Darter, Rush Darter, Yellowcheek Office, 6578 Dogwood View Parkway, designation of critical habitat is Darter, Chucky Madtom, and Laurel Suite A, Jackson, MI 39213; telephone prudent; and . Dace as Endangered Throughout Their 601-965-4900; facsimile 601-965-4340 or (7) Specific information on: Ranges Bill Pearson, Field Supervisor, U.S. Fish • What areas contain physical and and Wildlife Service, Alabama biological features essential for the AGENCY: Fish and Wildlife Service, Ecological Services Field Office, 1208-B Interior. conservation of the species; Main Street, Daphne AL 36526; • What areas are essential to the ACTION: Proposed rule; request for telephone 251-441-5181; fax 251-441- conservation of the species; and public comments. 6222. For information regarding the • Special management considerations or yellowcheek darter, contact Mark protection that proposed critical SUMMARY: We, the U.S. Fish and Sattelberg, Field Supervisor, U.S. Fish habitat may require. Wildlife Service (Service), propose to and Wildlife Service, Arkansas list the Cumberland darter (Etheostoma Please note that submissions merely Ecological Services Field Office, 110 stating support for or opposition to the susanae), rush darter (Etheostoma South Amity Road, Suite 300, Conway, phytophilum), yellowcheek darter action under consideration without AR 72032; telephone 501-513-4470; providing supporting information, (Etheostoma moorei), chucky madtom facsimile 501-513-4480. For information (Noturus crypticus), and laurel dace although noted, will not be considered regarding the chucky madtom or laurel in making a determination, as section (Phoxinus saylori) as endangered under dace, contact Mary Jennings, Field the Endangered Species Act of 1973, as 4(b)(1)(A) of the Act directs that Supervisor, U.S. Fish and Wildlife determinations as to whether any amended (Act). If we finalize this rule Service, Tennessee Ecological Services as proposed, it would extend the Act’s species is a threatened or endangered Field Office, 446 Neal Street, species mush be made ‘‘solely on the protections to these species throughout Cookeville, TN 38501; telephone 931- their ranges, including, Cumberland basis of the best scientific and 528-6481; facsimile 931-528-7075. If you ’’ darter in Kentucky and Tennessee, rush commercial data available. use a telecommunications device for the You may submit your comments and darter in Alabama, yellowcheek darter deaf (TDD), call the Federal Information materials concerning this proposed rule in Arkansas, and chucky madtom and Relay Service (FIRS) at 800-877-8339. by one of the methods listed in the laurel dace in Tennessee. We have SUPPLEMENTARY INFORMATION: ADDRESSES section. We will not accept determined that critical habitat for these comments sent by e-mail or fax or to an species is prudent, but not determinable Request for Public Comments address not listed in the ADDRESSES at this time. We intend that any final action section. DATES: We will consider comments we resulting from this proposed rule will be We will post your entire comment, receive on or before August 23, 2010. based on the best scientific and including your personal identifying We must receive requests for public commercial data available and as information, on http:// hearings, in writing, at the address accurate and effective as possible. www.regulations.gov. If you provide shown in the ADDRESSES section by Therefore, we request comments or personal identifying information in your August 9, 2010. information from the public, other hard copy comments, such as your ADDRESSES: You may submit comments concerned governmental agencies, the street address, phone number, or e-mail by one of the following methods: scientific community, industry, or any address, you may request at the top of Federal eRulemaking Portal: http:// other interested party concerning this your document that we withhold this www.regulations.gov. Follow the proposed rule. We particularly seek information from public review. instructions for submitting comments. comments concerning: However, we cannot guarantee that we U.S. mail or hand-delivery: Public (1) Biological, commercial trade, or will be able to do so. We will post all Comments Processing, Attn: [Docket No. other relevant data concerning any hardcopy submissions on http:// FWS-R4-ES-2010-0027]; Division of threats (or lack thereof) to these species www.regulations.gov. Please include Policy and Directives Management, U.S. and regulations that may be addressing sufficient information with your Fish and Wildlife Service, 4401 N. those threats; comments to allow us to verify any Fairfax Drive, Suite 222, Arlington, VA (2) Additional information concerning scientific or commercial information 22203. the ranges, distribution, and population you include.

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Comments and materials we receive, Thomas (2007, p. 4) did not encounter (Strange 1998, p. 101). Thomas (2007, p. as well as supporting documentation we the species in high-gradient sections of 3) provided the most recent information used in preparing this proposed rule, streams or areas dominated by cobble or on status and distribution of the species will be available for public inspection boulder substrates. Thomas (2007, p. 4) through completion of a range-wide on http://www.regulations.gov, or by reported that streams inhabited by status assessment in the upper appointment, during normal business Cumberland darters were second to Cumberland River drainage in hours, at the U.S. Fish and Wildlife fourth order, with widths ranging from Kentucky. Between June 2005 and April Service, Tennessee Ecological Services 4 to 9 meters (m) (11 to 30 feet (ft)) and 2007, a total of 47 sites were sampled Field Office (see FOR FURTHER depths ranging from 20 to 76 cm (8 to qualitatively in the upper Cumberland INFORMATION CONTACT section). 30 in). River drainage. All Kentucky sites with Little is known regarding the historic records were surveyed (20 Background reproductive habits of the Cumberland sites), as well as 27 others having Species Information darter. Thomas (2007, p. 4) reported the potentially suitable habitat. Surveys by collection of males in breeding Thomas (2007, p. 3) produced a total of Cumberland darter condition in April and May, with water 51 specimens from 13 localities (12 The Cumberland darter, Etheostoma temperatures ranging from 15 to 18o streams). Only one of the localities susanae (Jordan and Swain), is a Celsius (C) (59 to 64o Fahrenheit (F)). represented a new occurrence record for medium-sized member of the fish tribe Extensive searches by Thomas (2007, p. the species. Etheostomatini (Family Percidae) that 4) produced no evidence of nests or eggs Currently, the Cumberland darter is reaches over 5.5 centimeters (cm) (2 at these sites. Species commonly known from 14 localities in a total of 12 inches (in)) standard length (SL) (SL, associated with the Cumberland darter streams in Kentucky (McCreary and length from tip of snout to start of the during surveys by Thomas (2007, pp. 4– Whitley Counties) and Tennessee caudal peduncle (slender region 5) were creek chub (Semotilus (Campbell and Scott Counties). All 14 extending from behind the anal fin to atromaculatus), northern hogsucker extant occurrences of the Cumberland the base of the caudal fin)) (Etnier and (Hypentelium nigricans), stripetail darter are restricted to short stream Starnes 1993, pp. 512). The species has darter (Etheostoma kennicotti), and reaches, with the majority believed to be a straw-yellow background body color Cumberland arrow darter (Etheostoma restricted to less than 1.6 kilometers with brown markings that form six sagitta sagitta). Thomas (2007, p. 5) (km) (1 mile (mi)) of stream (O’Bara evenly spaced dorsal (back) saddles and collected individuals of the Federally 1991, pp. 9–10; Thomas 2007, p. 3). a series of X-, C-, or W-shaped markings threatened blackside dace, Phoxinus These occurrences are thought to form on its sides (Etnier and Starnes 1993, p. cumberlandensis, from three streams six population clusters (Bunches Creek, 510). During spawning season, the that also supported Cumberland darters. Indian Creek, Marsh Creek, Jellico overall body color of breeding males The Cumberland darter is endemic to Creek, Clear Fork, and Youngs Creek), darkens, and the side markings become the upper Cumberland River system which are geographically separated from obscure or appear as a series of blotches above Cumberland Falls in Kentucky one another by an average distance of (Etnier and Starnes 1993, p. 510). and Tennessee (O’Bara 1988, p. 1; 30.5 stream km (19 mi) (O’Bara 1988, p. The Cumberland darter was first O’Bara 1991, p. 9; Etnier and Starnes 12; O’Bara 1991, p. 10; Thomas 2007, p. reported as Boleosoma susanae by 1993, p. 511). The earliest known 3). Based on collection efforts by O’Bara Jordan and Swain (1883, pp. 249–250) collections of the species were made by (1991, pp. 9–10), Laudermilk and from tributaries of the Clear Fork of the Jordan and Swain (1883, pp. 249–250), Cicerello (1998, pp. 83–233, 303–408), Cumberland River, Kentucky. who recorded it as abundant in and Thomas (2007, p. 3), the species Subsequent studies by Kuhne (1939, p. tributaries of Clear Fork of the appears to be extirpated from 11 historic 92) and Cole (1967, p. 29) formerly Cumberland River, Kentucky. The collection sites and a total of 9 streams: recognized the taxon as a subspecies species was later reported from Gum Cumberland River mainstem, near (Etheostoma nigrum susanae) of E. n. Fork, Scott County, Tennessee, by mouth of Bunches Creek and nigrum (Johnny darter). Starnes and Shoup and Peyton (1940, p. 11), and Cumberland Falls (Whitley County); Starnes (1979, p. 427) clarified the seven additional tributaries of the Sanders Creek (Whitley County); Brier subspecific status of the Cumberland Cumberland River by Burr and Warren Creek (Whitley County); Kilburn Fork of darter, differentiating it from the Johnny (1986, p. 310). More exhaustive surveys Indian Creek (McCreary County); Bridge darter by several diagnostic by O’Bara (1988, p. 6; 1991, pp. 9–10) Fork (McCreary County); Marsh Creek, characteristics. Strange (1994, p. 14; and Laudermilk and Cicerello (1998; pp. near mouth of Big Branch and Caddell 1998, p. 101) recommended that E. n. 83–233, 303–408) determined that the Branch (McCreary County); Cal Creek susanae be elevated to specific status Cumberland darter was restricted to (McCreary County), Little Wolf Creek based on the results of mitochondrial short reaches of 20 small streams (23 (Whitley County); and Gum Fork (Scott DNA analyses of E. n. susanae and E. n. sites) in the upper Cumberland River County). No population estimates or nigrum. The Cumberland darter was system in Whitley and McCreary status trends are available for the recognized as a valid species, E. susanae Counties, Kentucky, and Campbell and Cumberland darter; however, survey (Cumberland darter), by Nelson et al. Scott Counties, Tennessee. These results by Thomas (2007, p. 3) suggest (2004, p. 233) based on the work of studies suggested the extirpation of the that the species is uncommon or occurs Strange (1994, p. 14; 1998, p. 101) and species from Little Wolf Creek, Whitley in low densities across its range a personal communication with W. C. County, Kentucky, and Gum Fork, Scott (Thomas (2007, p. 3). Starnes (May 2000), who suggested the County, Tennessee. Preliminary reports The Cumberland darter is ranked by common name. of disjunct populations in the Poor Fork the Kentucky State Nature Preserves The Cumberland darter inhabits pools Cumberland River and Martins Fork in Commission (2009, p. 38) as a G1G2S1 or shallow runs of low to moderate Letcher and Harlan Counties, Kentucky species: critically imperiled or gradient sections of streams with stable (Starnes and Starnes 1979, p. 427; imperiled globally and critically sand, silt, or sand-covered bedrock O’Bara 1988, p. 6; O’Bara 1991, pp. 9– imperiled in Kentucky. The Kentucky substrates (O’Bara 1988, pp. 10–11; 10), were evaluated genetically and Department of Fish and Wildlife O’Bara 1991, p. 10; Thomas 2007, p. 4). determined to be the Johnny darter Resources State Wildlife Action Plan

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identified the Cumberland darter as a from 3.0 cm to 0.5 m ( 0.1 ft to 1.6 ft), drainage in Winston County; an species of Greatest Conservation Need with moderate water velocity in riffles unnamed spring run of Beaver Creek (KDFWR 2005, p. 2.2.2). The plan and no flow or low flow in pools. Rush and from Penny Springs of the Turkey identified several top conservation darters have not been found in higher Creek drainage in Jefferson County; and actions for the Cumberland darter and gradient streams with bedrock Cove Spring (Little Cove Creek system) other species in its Aquatic Guild substrates and sparse vegetation (Stiles and Bristow Creek of the Locust Fork (Upland Headwater Streams in Pools): and Mills 2008, pp. 1–4; Bart 2002, p. drainage in Etowah County. acquisition or conservation easements 1; Johnston and Kleiner 2001, pp. 3–4; Currently, the three rush darter for critical habitat, development of Stiles and Blanchard 2001, pp. 1–4; Bart populations occur in the same financial incentives to protect riparian and Taylor 1999, p. 32). watersheds but in a more limited corridors, development and Stiles and Mills (2008, p. 2) found distribution. One population is located implementation of best management gravid rush darter females in February in Wildcat Branch and Mill Creek in the practices, and restoration of degraded and fry (newly hatched larval fish) in Clear Creek drainage in Winston County habitats through various State and late April from a wetland pool in the (Johnston and Kleiner 2001, p. 4); the Federal programs. Mill Creek watershed (Winston County, second is located in an unnamed spring Alabama). These pools act as nursery run to Beaver Creek and in Penny Rush Darter areas for the fry (Stiles and Mills 2008, Springs in the Turkey Creek drainage in The rush darter (Etheostoma p. 5). Even though the life history of the Jefferson County (Stiles and Blanchard phytophilum), a medium-sized darter in rush darter is poorly known, it is likely 2001, p. 2); and the third is in the Little the subgenus Fuscatelum, was described similar to the closely related goldstripe Cove Creek drainage population. The by Bart and Taylor in 1999 (pp. 27–33). darter. Spawning of the goldstripe darter Little Cove Creek population in Etowah The average size of the rush darter is 5 in Alabama occurs from mid March County was known from only a single cm (2 in) SL (Bart and Taylor 1999, p. through June (Mettee et al. 1996, p. 655). specimen collected in Cove Spring in 28; Johnston and Kleiner 2001, p. 3). Goldstripe larvae reared in captivity 1975 (Bart and Taylor 1999, p. 28) and The rush darter is closely related to the avoid downstream drift (Conservation one specimen from Bristow Creek goldstripe darter (Etheostoma Fisheries, Inc., 2005, p. 7). This collected in 1997 (Bart 2002, p. 7). parvipinne), a drab-colored species with behavior alteration may inhibit Kuhajda (2008, pers. comm.) discovered a thin golden stripe along the lateral line dispersal capabilities between isolated a single specimen of the species in 2005, (canal along the side of a fish with suitable habitat patches, and may at the confluence of the Cove Spring run sensory capabilities) that is surrounded reduce the success of captively bred where it drains into an unnamed by heavily mottled or stippled sides individuals in the wild. Preferred food swamp. (Shaw 1996, p. 85). However, the items for the goldstripe darter include Rush darter populations are separated distinct golden stripe characteristic of midges, mayflies, blackflies, beetles, and from each other geographically, and goldstripe darters is not well developed microcrustaceans (Mettee et al. 1996, p. individual rush darters are only in rush darters (Bart and Taylor 1999, p. 655). The life span of the goldstripe sporadically collected at a particular site 29). Also, the brown pigment on the darter is estimated to be 2 to 3 years. within their range. Where it occurs, the sides of the rush darter is usually not as The rush darter currently has a rush darter is apparently an uncommon intense as in the goldstripe darter. Other restricted distribution (Johnston and species that is usually collected in low characteristics of the rush darter are Kleiner 2001, p. 1). All rush darter numbers (Bart and Taylor 1999, p. 32). described in Bart and Taylor (1999, p. populations are located above the Fall Since 1969, approximately 100 rush 28). Line (the inland boundary of the Coastal darters have been collected or captured Rush darters have been collected from Plain physiographic region) and other and released within the species’ range various habitats (Stiles and Mills 2008, ‘‘highland regions’’ where topography (compiled from Bart and Taylor 1999, pp. 1–4; Bart 2002, p. 1; Johnston and and elevation changes are observed pp. 31–32; Johnston and Kleiner 2001, Kleiner 2001, pp. 3–4; Stiles and presenting a barrier for fish movement pp. 2–4; Stiles and Blanchard 2001, pp. Blanchard 2001, pp. 1–4; Bart and (Boshung and Mayden 2004, p. 18)) in 1–4; Johnston 2003, pp.1-3; P. Rakes Taylor 1999, p. 32), including root the Tombigbee–Black Warrior drainage 2010, pers.comm.); however, there are masses of emergent vegetation along the (Warren et al. 2000, pp. 9, 10, 24), in no population estimates at this time. margins of spring-fed streams in very portions of the Appalachian Plateau, Cumulatively, the rush darter is only shallow, clear, cool, and flowing water; and Valley and Ridge physiographic known from localized collection sites and from both small clumps and dense provinces of Alabama. The closely within approximately 14 km (9 mi ) of stands of bur reed (Sparganium sp.), related goldstripe darter in Alabama streams in the Clear Creek, Little Cove coontail (Ceratophyllum sp.), watercress occurs essentially below the Fall Line in and Bristow Creek, and Turkey Creek (Nasturtium officinale), and rush all major systems except the Coosa drainages in Winston, Etowah, and (Juncus sp.) in streams with substrates system (Boshung and Mayden 2004, p. Jefferson Counties, respectively. of silt, sand, sand and silt, muck and 550). Reports of goldstripe darters from Currently, about 3 km (2 mi) of stream, sand or some gravel with sand, and the 1960s and 1970s in Winston and or about 22 percent of the rush darter’s bedrock. Rush darters appear to prefer Jefferson Counties, Alabama (Caldwell known range, is not occupied, which springs and spring-fed reaches of 1965, pp. 13–14; Barclay 1971, p. 38; may be due to non-point source relatively low-gradient small streams Dycus and Howell 1974, pp. 21–24; pollution (e.g., sedimentation and which are generally influenced by Mettee et al. 1989, pp. 13, 61, 64), which chemicals) from agriculture, springs (Stiles and Mills 2008, pp. 1–4; are above the Fall Line, were made prior urbanization, and road construction and Fluker et al. 2007, p. 1; Bart 2002, p. 1; to the description of the rush darter, but maintenance. Johnston and Kleiner 2001, pp. 3–4; are now considered to be rush darters Within the Clear Creek drainage, the Stiles and Blanchard 2001, pp. 1–4; Bart (Kuhajda 2008, pers. comm.). rush darter has been collected in and Taylor 1999, p. 32). Rush darters Historically, rush darters have been Wildcat Branch, Mill Creek, and Doe have also been collected in wetland found in three distinct watersheds in Creek, which represents about 13 km (8 pools (Stiles and Mills 2008; pp. 2–3). Alabama: Doe Branch, Wildcat Branch, mi) of stream or about 94 percent of the Water depth at collection sites ranged and Mill Creek of the Clear Creek species’ total cumulative range. Recent

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surveys (Stiles and Mills 2008, pp. 1–4; females possess orange and red-orange substrates (often behind large cobble or Johnston and Kleiner 2001, p. 3) have spots but are not brightly colored boulders) with only their heads and documented the absence of the rush (Robison and Buchanan 1988, pp. 427– caudal fin exposed. A male yellowcheek darter in Doe Creek, possibly indicating 429). First collected in 1959 from the darter will then position upstream of the a reduction of the species’ known range Devils Fork Little Red River, Cleburne buried female and fertilize her eggs as within the Clear Creek drainage by County, Arkansas, this species was she releases them in a vibrating motion. about 3 km (2 mi) of stream or 22 eventually described by Raney and Clutch size and nest defense behavior percent. Rush darters were collected in Suttkus in 1964, using 228 specimens were not observed. October 2005 and again in June 2008 from the Middle, South, and Devils The yellowcheek darter is endemic to and 2009 in the Little Cove Creek Forks of the Little Red River (Devils the Devils, Middle, South, and Archey drainage (Cove Spring run), a first since Fork, Turkey Fork, and Beech Fork Forks of the Little Red River and main 1975, despite sporadic surveys over the represent one stream with three stem Little Red River in Cleburne, last 30 years. This rediscovery of the different names and are subsequently Searcy, Stone, and Van Buren Counties, species confirms the continued referred to in this proposed rule as Arkansas (Robison and Buchanan 1988, existence of the species in Etowah ‘‘Devils Fork’’). Wood (1996, p. 305) p. 429). In 1962, the construction of a County and Cove Spring. However, the verified the taxonomic status of the dam on the Little Red River to create Little Cove Creek drainage constitutes yellowcheek darter within the subgenus Greers Ferry Reservoir impounded an increase of only 0.05 km (0.02 mi) of Nothonotus. The yellowcheek darter is much of the range of this species, occupied stream habitat or a 1.6 percent one of only two members of the including the lower reaches of Devils addition to the total range of the species. subgenus Nothonotus known to occur Fork, Middle Fork, South Fork, and No collections of the species have west of the Mississippi River. portions of the main stem Little Red occurred at Bristow Creek since 1997. The yellowcheek darter inhabits high- River, thus extirpating the species from Bristow Creek has since been gradient headwater tributaries with these reaches. Yellowcheek darter was channelized (straightened and deepened clear water; permanent flow; moderate also extirpated from the Little Red River to increase water velocity). In the to strong riffles; and gravel, rubble, and downstream of Greers Ferry Reservoir Turkey Creek drainage, rush darters boulder substrates (Robison and due to cold tailwater releases. The lake have been collected sporadically within Buchanan 1988, p. 429). Yellowcheek flooded optimal habitat for the species, Penny Springs and at the type locality darter prey items include aquatic and caused the genetic isolation of for the species (an unnamed spring run dipteran larvae, stoneflies, mayflies, and populations (McDaniel 1984, p. 1). The in Jefferson County, Alabama) (Bart and caddisflies (McDaniel 1984, p. 56). yellowcheek darter was known to Taylor 1999, pp. 28, 33). This area Male and female yellowcheek darters historically occur in portions of these contains about 0.5 km (0.3 mi) of reach sexual maturity at one year of age, streams that maintained permanent occupied stream habitat or and maximum life span is around five year-round flows. approximately 4 percent of the rush years (McDaniel 1984, pp. 25, 76). In the 1978-81 study by Robison and darter’s total range. Spawning occurs from late May through Harp (1981, pp. 15–16), yellowcheek The rush darter is ranked by the June in the swift to moderately swift darter occurred in greatest numbers in Alabama Department of Conservation portions of riffles, often around or under the Middle and South Forks of the Little and Natural Resources (2005) as a the largest substrate particles (McDaniel Red River, with populations estimated P1G1S1 species signifying its rarity in 1984, p. 82), although brooding females at 36,000 and 13,500 individuals, Alabama and its status as critically have been found at the head of riffles in respectively, while populations in both imperiled globally. It is also considered smaller gravel substrate (Wine et al. Devils Fork and Archey Fork were a species of Greatest Conservation Need 2000, p. 3). During non-spawning estimated at approximately 10,000 (GCN) by the State. The rush darter has months, there is a general movement to individuals (Robison and Harp 1981, a High Priority Conservation Actions portions of the riffle with smaller pp. 5–11). During this study, the four Needed and Key Partnership substrate, such as gravel or cobble, and forks of the Little Red River supported Opportunities ranking of ‘‘CA 6,’’ the less turbulence (Robison and Harp 1981, an estimated yellowcheek darter highest of any fish species listed. The p. 3). Weston and Johnson (2005, p. 24) population of 60,000 individuals, and plan states that the species consists of observed that the yellowcheek darter the species was considered the most disjoint populations and information is moved very little during a 1–year abundant riffle fish present (Robison needed to determine genetic structuring migration study. It was noted that the and Harp 1981, p. 14). Extensive within the populations. Conservation yellowcheek darter appears to be a sampling of the first two tributaries of Actions for the species may require relatively non-mobile species, with 19 the Little Red River below Greers Ferry population augmentation and/or of 22 recaptured darters found within 9 Dam (both named Big Creek) failed to reintroduction of the species to suitable meters (29.5 feet) of their original find any yellowcheek darters, and no habitats to maintain viability. capture position after periods of several darters were found in immediately months. A number of life history adjacent watersheds (Robison and Harp Yellowcheek Darter characteristics, including courtship 1981, p. 5). The yellowcheek darter (Etheostoma patterns, specific spawning behaviors, Two subsequent studies have failed to moorei) is a small and compressed fish egg deposition sites, number of eggs per observe specimens of yellowcheek which attains a maximum SL of about nest, degree of nest protection by males, darter in the Turkey Fork reach of the 64 mm (2.5 in), and has a moderately and degree of territoriality are unknown Devils Fork Little Red River (Wine et al. sharp snout, deep body, and deep at this time; however, researchers have 2000, p. 9; Wine and Blumenshine 2002, caudal peduncle (Raney and Suttkus suggested that the yellowcheek darter p. 11), since four individuals were last 1964, p. 130). The back and sides are deposit eggs on the undersides of larger collected by Arkansas State University grayish brown, often with darker brown rubble in swift water (McDaniel 1984, p. (ASU) researchers in 1999 (Mitchell et saddles and lateral bars. Breeding males 82). Wine and Blumenshine (2002, p. al. 2002, p. 129). They have been are brightly colored with a bright blue 10) noted that during laboratory observed downstream within that or brilliant turquoise breast, and throat spawning, female yellowcheek darters system in the Beech Fork reach, where and light green belly, while breeding bury themselves in fine gravel/sand flows are more permanent. The reach

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downstream of Raccoon Creek is than community phenomenon (Wine et individuals have been encountered influenced by inundation from Greers al. 2000, p. 11). since 2000, 1 in 2000 (Lang et al. 2001, Ferry Reservoir and no longer supports Weston and Johnson (2005, p. 22) p. 2) and 2 in 2004 (Conservation yellowcheek darter. The U.S. Army estimated yellowcheek darter Fisheries, Inc. 2008, unpublished data), Corps of Engineers channelized populations within the Middle Fork to despite surveys that have been approximately 5.6-km (3.5 mi) of the be between 15,000 and 40,000 conducted in both historic localities at lower Archey and South Forks Little individuals, and between 13,000 and least twice a year since 2000 (Rakes and Red River located within the city limits 17,000 individuals in the South Fork. Shute 2004 pp. 2-3; Weber and Layzer of Clinton, Arkansas, in 1985 for flood Such increases since the status survey 2007, p. 4 Conservation Fisheries, Inc. control purposes. Yellowcheek darter done in 2000 would indicate remarkable 2008, unpublished data). In addition, has not been collected within this 5.6- adaptability to changing environmental several streams in the Nolichucky, km (3.5-mi) reach since channelization. conditions. However, it should be noted Holston, and French Broad River The yellowcheek darter otherwise that estimates were based upon mark/ watersheds of the upper Tennessee recapture estimates using the Jolly-Seber inhabits most of its historical range, River basin, which are similar in size method which requires high numbers of although in greatly reduced numbers in and character to Little Chucky Creek, recaptured specimens for accurate have been surveyed with no success the Middle, South, Archey, and Devils estimations. Recaptures were extremely (Burr and Eisenhour 1994 pp. 1-2; Shute Forks of the Little Red River. low during that study; therefore, et al. 1997 p. 5; Lang et al. 2001, pp. 2- While collecting specimens for the population estimates were highly 3; Rakes and Shute 2004 p.1). 1999 genetic study, ASU researchers variable and confidence in the resulting Conservation Fisheries, Inc., did not discovered that the yellowcheek darter estimates is low. find chucky madtoms in 2007 after was no longer the most abundant riffle The yellowcheek darter is ranked by attempting new sampling techniques fish and was more difficult to find the Arkansas Natural Heritage (e.g., PVC ‘‘jug’’ traps) (Conservation (Wine et al. 2000, p. 2). Because optimal Commission (ANHC) (2007, pp. 2–118) Fisheries, Inc. 2008, unpublished data). habitat had been destroyed by the as an S1G1 species: extremely rare in Originally, museum specimens creation of Greers Ferry Lake, Arkansas, and critically imperiled collected from the Roaring River yellowcheek darters were confined to globally. The Arkansas Game and Fish (Cumberland River drainage) and from upper stream reaches with lower Commission’s Arkansas Wildlife Action the Paint Rock River system in Alabama summer flow, smaller substrate particle Plan assigns the yellowcheek darter a (a Tennessee River tributary well size, and reduced gradient. A thorough score of 100 out of 100, representing a downstream of the Nolichucky and status survey conducted in 2000 found critically imperiled species with Little Pigeon River sites) were first the yellowcheek darter in three of four declining populations (AGFC 2005, pp. identified and catalogued as Noturus historic forks in greatly reduced 452–454). elegans and thought to be chucky numbers (Wine et al. 2000, p. 9). Chucky Madtom madtoms. The Roaring River specimens Populations in the Middle Fork were are now considered to be a member of The chucky madtom (Noturus the N. elegans group, but have not been estimated at approximately 6,000 crypticus) is a small catfish, with the individuals, the South Fork at 2,300, assigned to a species. While the largest specimen measuring 6.47 cm specimens from the Paint Rock River and the Archey Fork at 2,000. (2.55 in) SL (Burr et al. 2005, p. 795). Yellowcheek darter was not collected system share typical anal ray counts Burr et al. (2005) described the chucky with the chucky madtom, they lack the from the Devils Fork. Yellowcheek madtom, confirming previous analyses darter was the fifth most abundant riffle distinctive cheek characteristics, differ (Burr and Eisenhour 1994), which in pelvic ray counts, and are fish rangewide, while historically it was indicated that the chucky madtom is a the most abundant riffle fish. Fish intermediately shaped between the unique species, a member of the Rabida chucky and saddled madtoms, Noturus community composition was similar subgenus (i.e., the ‘‘mottled’’ or fasciatus, with respect to body width as from 1978-1981 and 2000 studies, but ‘‘saddled’’ madtoms), and a member of a proportion of SL (Burr et al. 2005, p. the proportion of yellowcheek darter the Noturus elegans species complex 796). Thus, the Little Chucky and Dunn declined from approximately 28 percent (i.e., N. elegans, N. albater, and N. Creek forms are the only forms that are to 6 percent of the overall composition. trautmani) ascribed by Taylor (1969 in recognized as chucky madtoms. Fish known to co-exist with Grady and LeGrande 1992). A robust All of the specimens collected in yellowcheek darter include the rainbow madtom, the chucky madtom body is Little Chucky Creek have been found in darter (E. caeruleum) and greenside wide at the pectoral fin origins, greater stream runs with slow to moderate darter (E. blennioides), which can use than 23 percent of the SL. The dorsum current over pea gravel, cobble, or slab- pool habitats during periods of low (back) contains three dark, nearly black rock substrates (Burr and Eisenhour flow, as evidenced by the collection of blotches ending abruptly above the 1994, p. 2). Habitat of these types is these two species from pools during lateral midline of the body, with a sparse in Little Chucky Creek, and the electroshocking activities. moderately contrasting, oval, pale stream affords little loose, rocky cover Electroshocking has not revealed saddle anterior to each blotch (Burr et suitable for madtoms (Shute et al. 1997, yellowcheek darter in pools, suggesting al. 2005, p. 795). p. 8). It is notable that intact riparian perhaps that they are unable to tolerate The chucky madtom is a rare catfish buffers are present in the locations pool conditions (deep, slow-moving known from only 15 specimens where chucky madtoms have been water usually devoid of cobble collected from two Tennessee streams. found (Shute et al. 1997, p. 9). substrate). An inability to use pools A lone individual was collected in 1940 No studies to determine the life during low flows would make them from Dunn Creek (a Little Pigeon River history and behavior of this species much more vulnerable to seasonal tributary) in Sevier County, and 14 have been conducted. While nothing is fluctuations in flows that reduce riffle specimens have been encountered since known specifically about chucky habitat. As a result, researchers have 1991 in Little Chucky Creek (a madtom reproductive biology, suggested that yellowcheek darter Nolichucky River tributary) in Greene recruitment, growth and longevity, food declines are more likely a species rather County. Only 3 chucky madtom habits, or mobility, available

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information for other similar members information from other members of this of the surveys, but no chucky madtoms of the Noturus group are known. N. genus for which longevity data are were found. There are no population hildebrandi may reach sexual maturity available, Noturus hildebrandi and N. size estimates or status trends for the at one or more years of age (i.e., during baileyi, it is unlikely that chucky chucky madtom due to low numbers their second summer) (Mayden and madtoms can survive this long in the and only sporadic collections of Walsh 1984, p. 351). Only the largest wild. The shorter lived of these, N. specimens. females of N. albater were found to be hildebrandi reached a maximum age of The chucky madtom is ranked by the sexually mature, and males were found 18 months, though most individuals Tennessee Natural Heritage Program to be sexually mature primarily within lived little more than 12 months, dying (Withers 2009, p. 58) as an S1G1 the second age class (Mayden et al. soon after reproducing (Mayden and species: extremely rare in Tennessee, 1980, p. 339). Though, a single large Walsh 1984, p. 351). Based on length- and critically imperiled globally. In the male of the first age class showed frequency distributions, N. baileyi Tennessee Comprehensive Wildlife evidence of sexual maturity (Mayden et exhibited a lifespan of 2 years, with two Conservation Strategy (CWCS), species al. 1980, p. 339). The breeding season in cohorts present in a given year (Dinkins of Greatest Conservation Need (GCN) N. hildebrandi and N. baileyi was and Shute 1996, p. 53). Collection of were selected based on their Global primarily during June through July, two age classes together provided imperilment (G1-G3; critically imperiled though development of breeding evidence that life expectancy exceeds 1 globally—very rare or restricted condition was initiated as early as April year in N. stanauli (Etnier and Jenkins throughout their range), knowledge of in N. hildebrandi and May in N. baileyi 1980, p. 20). Noturus albater lives as declining trends or vulnerability, or due (Mayden and Walsh 1984, p. 353; long as 3 years (Mayden et al. 1980, p. to significance of an otherwise wide- Dinkins and Shute 1996, p. 56). 337). ranging species (TWRA 2005, p. 36). Fecundity varied among the species for Invertebrate taxa form the primary Species of GCN were further prioritized which data were available; however, it food base for madtoms. Chironomid into three different tiers to distinguish should be noted that fecundity in (midge), trichopteran (caddisfly), their status within the State and to madtoms is generally lower in plecopteran (stonefly), and determine conservation funding comparison to other North American ephemeropteran (mayfly) larvae were availability. The CWCS designated the freshwater fishes (Breder and Rosen frequently encountered in stomach chucky madtom as a Tier 1 GCN species 1966 in Dinkins and Shute 1996, p. 58). contents of Noturus hildebrandi in the State, representing species Dinkins and Shute (1996, p. 58) (Mayden and Walsh 1984, p. 339). In N. defined as wildlife (amphibians, birds, commented that for N. baileyi the baileyi, ephemeropteran nymphs fish, mammals, reptiles, crustaceans, combination of relatively large egg size comprised 70.7 percent of stomach and mollusks) under Tennessee Code and high level of parental care given to contents analyzed, dipterans (flies, Annotated 70-8-101, and excluding the fertilized eggs and larvae reduce mosquitoes, midges, and gnats) 2.4 Federally listed species (TWRA 2005, p. early mortality and therefore the need to percent, trichopterans 4.4 percent, and 44, 49). Tier 1 species were the primary produce a large number of young. plecopterans 1.0 percent (Dinkins and focus of the Tennessee CWCS (TWRA Sexual dimorphism (two different forms Shute 1996, p. 61). Significant daytime 2005, p. 44). feeding was observed in N. baileyi. for male and female individuals) has Laurel Dace been observed only in a single pair of The only data on mobility were for specimens of N. baileyi collected during Noturus baileyi, which were found The laurel dace (Phoxinus saylori) has the month of May; the male of this pair underneath slabrocks in swift to two continuous black lateral stripes and had swollen lips and enlarged moderate current during May to early black pigment covering the breast and mandibulae (lower jaw) muscles behind November. Habitat use shifted to underside of the head of nuptial the eyes, and the female had a distended shallow pools over the course of a 1– (breeding) males (Skelton 2001, p. 120). abdomen (Burr et al. 2005, p. 795). week period, coinciding with a drop in While the belly, breast, and lower half Both Noturus baileyi and N. elegans water temperature to 7 or 8° C (45 to 46 of the head are typically a whitish- were found to nest under flat rocks at or ° F), and persisted from early November silvery color, at any time of the year near the head of riffles (Dinkins and to May (Dinkins and Shute 1996, p. 50). laurel dace may develop red coloration Shute 1996, p. 56; Burr and Dimmick The current range of the chucky below the lateral stripe that extends 1981, p. 116). Shallow pools were also madtom is believed to be restricted to an from the base of the pectoral fins to the used by N. baileyi, which was observed approximately 3-km (1.8-mi) reach of base of the caudal fin (Skelton 2001, p. to select rocks of larger dimension for Little Chucky Creek in Greene County, 121). nesting than were used for shelter Tennessee. Because this species was Nuptial males often acquire brilliant during other times of year (Dinkins and also collected from Dunn Creek, a coloration during the breeding season, Shute 1996, p. 56). Single madtoms stream that is in a different watershed as the two lateral stripes, breast, and were found to guard nests in N. baileyi and physiographic province than Little underside of head turn intensely black and N. elegans, behavior also exhibited Chucky Creek, it is likely that the and the entire ventral (lower/ by N. albater and N. hildebrandi historic range of the chucky madtom abdominal) portion of the body, (Dinkins and Shute 1996, p. 56; Burr encompassed a wider area in the Ridge contiguous with the lower black stripe and Dimmick 1981, p. 116; Mayden et and Valley and the Blue Ridge and black breast, becomes an intense al. 1980, p. 337; Mayden and Walsh physiographic provinces in Tennessee scarlet color. All of the fins acquire a 1984, p. 357). Males of these species than is demonstrated by its current yellow color, which is most intense in were the nest guardians and many were distribution. A survey for the chucky the paired fins and less intense in the found to have empty stomachs madtom in Dunn Creek in 1996 was not dorsal, anal, and caudal fins. Females suggesting that they do not feed during successful at locating the species (Shute also develop most of these colors, nest guarding, which can last as long as et al. 1997, p. 8). The Dunn Creek though of lesser intensity (Skelton 2001, 3 weeks. population may be extirpated (Shute et p. 121). Broadly rounded pectoral fins of Conservation Fisheries, Inc., had one al. 1997, p. 6; Burr et al. 2005, p. 797), males are easily discerned from the male chucky madtom in captivity from because adequate habitat and a diverse broadly pointed fins of females at any 2004 through 2008. However, based on fish community were present at the time time during the year. The maximum SL

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observed is 5.1 cm (2 in) (Skelton 2001, during a rotenone survey of Laurel (Strange and Skelton 2005, p. 7). p. 124). Branch in 1976 to represent laurel dace Nuptial males are easily identified from Laurel dace have been most often that were misidentified as southern other species present in Bumbee Creek collected from pools or slow runs from redbelly dace, as was found to be true due to their brilliant coloration during undercut banks or beneath slab for specimens collected by TVA from the breeding season, as the two lateral boulders, typically in first or second Horn Branch in 1976, but no specimens stripes, breast, and underside of head order, clear, cool (maximum are available for confirmation. In 1991, turn intensely black and the entire temperature 26° C or 78.8° F) streams. and in four other surveys (in 1995, 1996 ventral (lower/abdominal) portion of the Substrates in streams where laurel dace and 2004), laurel dace were not body, contiguous with the lower black are found typically consist of a mixture collected in Laurel Branch, leading stripe and black breast, becomes an of cobble, rubble, and boulders, and the Skelton to the conclusion that laurel intense scarlet color. This brilliant streams tend to have a dense riparian dace have been extirpated from this coloration is easily seen through zone consisting largely of mountain stream (Skelton 1997, p. 13; 2001, p. binoculars at short distances by trained laurel (Skelton 2001, pp. 125–126). 126, Skelton 2009, pers. comm.). individuals. Skelton (2001, p. 126) reported having Skelton (2009, pers. comm.) also noted No population estimates are available collected nuptial individuals from late that the site was impacted by silt. for laurel dace. However, based on March until mid-June, though Call (Call The current distribution of laurel dace trends observed in surveys and 2004, pers. obs.) observed males in comprises six of the seven streams that collections since 1991, Strange and waning nuptial color during surveys on were historically occupied; the species Skelton (2005, p. 8) concluded that this July 22, 2004. Laurel dace may be a is considered extirpated from Laurel species is persisting in Young’s, spawning nest associate where syntopic Branch (see above). In these six streams, Moccasin, and Bumbee creeks in the (sharing the same habitat) with nest- they are known to occupy reaches of Piney River watershed, but is at risk of building minnow species, as has been approximately 0.3 to 8 km (0.2 to 5 mi) extirpation from the southern part of documented in Phoxinus in length. The laurel dace is known Walden Ridge in Soddy Creek, and in cumberlandensis (Starnes and Starnes from a single reach in Soddy Creek, and the Horn Branch and Cupp Creek areas 1981, p. 366). Soddy Creek is the only surveys in 2004 produced only a single, that are tributaries to Sale Creek. As location in which Skelton (2001, p. 126) juvenile laurel dace (Strange and noted above, the species is considered has collected a nest-building minnow Skelton 2005, pp. 5–6 and Appendices to be extirpated from Laurel Branch, with laurel dace. Skelton (2001, p. 126) 1 and 2). In Horn Branch, laurel dace are which is part of the Sale Creek system. reports finding as many as three year known from approximately 900 m The laurel dace is ranked by the classes in some collections of laurel (2,953 ft), but have become increasingly Tennessee Natural Heritage Program dace, though young-of-year fish are difficult to collect (Skelton 1997, pp. (Withers 2009, p. 60) as an S1G1 uncommon in collections. Observations 13–14). Skelton (1997, p. 14) reports species: extremely rare in Tennessee, of three year classes indicate that laurel that minnow traps have been the most and critically imperiled globally. dace live as long as 3 years. successful method for collecting live In the Tennessee CWCS, species of Skelton (2001, p. 126) qualitatively laurel dace from Horn Branch, as it is GCN were selected based on their analyzed stomach contents of 12 laurel difficult to electroshock due to in- Global imperilment (G1-G3; critically dace and found the species eats a stream rock formations and fallen trees. imperiled globally—very rare or mixture of food items, dominantly Only a single juvenile was caught in restricted throughout their range), benthic invertebrates, including 2004 (Strange and Skelton 2005, p. 6). knowledge of declining trends or Trichopteran, Plecopteran, and Dipteran A total of 19 laurel dace were collected vulnerability, or due to significance of larva. Some intestines contained plant from Cupp Creek during 1995 and 1996 an otherwise wide-ranging species material and sand grains. Skelton using an electroshocker (Skelton 1996, (TWRA 2005, p. 36). Species of GCN observed that the morphological feeding p. 14). However, Skelton found no were further prioritized into three traits of laurel dace, including large laurel dace in this stream in 2004, different tiers to distinguish their status mouth, short digestive tract, reduced despite attempts to collect throughout within the State and to determine number of pharyngeal (located within an approximately 700-m (2,297-ft) reach conservation funding availability. The the throat) teeth, and primitively shaped (Strange and Skelton 2005, p. 6). CWCS designated the laurel dace as a basioccipital bone (bone that articulates Laurel dace were initially found in Tier-1 GCN species in the State, the vertebra) are consistent with a diet Young’s, Moccasin, and Bumbee creeks representing species defined as wildlife consisting largely of animal material. in the Piney River system in 1996 (amphibians, birds, fish, mammals, Laurel dace are known historically (Skelton 1997, pp. 14–15). Sampling in reptiles, crustaceans, and mollusks) from seven streams on the Walden 2004 led to the discovery of additional under Tennessee Code Annotated 70-8- Ridge portion of the Cumberland laurel dace localities in Young’s and 101, and excluding federally listed Plateau, where drainages generally Moccasin creeks, but the locality where species (TWRA 2005, p. 44, 49). Tier 1 meander eastward before dropping laurel dace were found in Young’s Creek species were the primary focus of the abruptly down the plateau escarpment in 1996 was inaccessible due to the and draining into the Tennessee River. presence of a locked gate (Strange and Tennessee CWCS(TWRA 2005, p. 44). Specifically, these seven streams occur Skelton 2005, p. 6–7). The new Previous Federal Action in three independent systems: Soddy localities were in the headwaters of Creek; three streams that are part of the these two streams. Persistence of laurel Cumberland Darter Sale Creek system (the Horn and Laurel dace at the Bumbee Creek locality was On September 18, 1985, the Service branch tributaries to Rock Creek, and confirmed in 2004 by surveying from a announced that the Cumberland darter the Cupp Creek tributary to Roaring nearby road using binoculars. Direct was being considered for possible Creek); and three streams that are part surveys were not possible because the addition to the List of Endangered and of the Piney River system (Young’s, land had been leased to a hunt club for Threatened Wildlife (50 FR 37958). It Moccasin, and Bumbee creeks). Skelton which contact information was not was assigned a Category 2 status, which (2001, p. 126) considered collections by available, and therefore survey was given to those species for which the the Tennessee Valley Authority (TVA) permission could not be obtained Service possessed information

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indicating that proposing to list as In 2006, we changed the listing Laurel Dace endangered or threatened was possibly priority number of the rush darter from We first identified the laurel dace as appropriate, but for which conclusive 5 to 2 based on the imminent threat of a new candidate for listing in the 2007 data on biological vulnerability and water quality deterioration (i.e., Candidate Notice of Review (72 FR threat was not currently available to increased sedimentation due to 69036). New candidates are those taxa support proposed rules. In the 1989, urbanization, road maintenance, and for which we have sufficient 1991, and 1994 Candidate Notices of silviculture practices) (71 FR 53755). In information on biological vulnerability Review, the Cumberland darter was the 2009 Candidate Notice of Review and threats to support preparation of a again assigned a Category 2 status (54 (74 FR 57869), the rush darter retained listing proposal, but for which FR 554, 56 FR 58804, 59 FR 58982). a listing priority of 2. development of a listing regulation is Assigning categories to candidate Yellowcheek Darter precluded by other higher priority species was discontinued in 1996, and listing activities. only species for which the Service had We first identified the yellowcheek In the 2007 Candidate Notice of sufficient information on biological darter as a candidate for listing in the Review, we assigned the laurel dace a vulnerability and threats to support 2001 Candidate Notice of Review (66 FR listing priority of 5 (72 FR 69036), and issuance of a proposed rule were 54807). The yellowcheek darter was it was again identified as a listing regarded as candidate species (61 FR assigned a listing priority number of 2 priority 5 candidate species in the 2008 7596). Candidate species were also and has retained that status in the 2002, and 2009 Candidate Notices of Review assigned listing priority numbers based 2004, 2005, 2006, 2007, 2008, and 2009 (73 FR 75236, 74 FR 57869). This on immediacy and the magnitude of Candidate Notices of Review (67 FR number reflects the high magnitude and threat, as well as their taxonomic status. 40657, 69 FR 24875, 70 FR 24869, 71 FR non-imminence of threats to the species. In the 1999, 2001, 2002, and 2004 53755, 72 FR 69073, 73 FR 75175). We Candidate Notices of Review, the published a petition finding for Summary of Factors Affecting the Cumberland darter was identified as a yellowcheek darter in the 2005 Species listing priority 6 candidate species (64 Candidate Notice of Review in response Section 4 of the Act (16 U.S.C 1533), FR 57533, 66 FR 54807, 67 FR 40657, to a petition received on May 11, 2004 and its implementing regulations (50 69 FR 24875). We published a petition (70 FR 24869). The yellowcheek darter CFR Part 424), set forth the procedures finding for Cumberland darter in the is covered by a 2007 programmatic for adding species to the Federal Lists 2005 Candidate Notice of Review (70 FR Candidate Conservation Agreement with of Endangered and Threatened Wildlife 24869) in response to a petition received Assurances (71 FR 53129) that covers and Plants. We may determine a species on May 11, 2004. We continued to the entire range of the species. to be endangered or threatened due to assign the Cumberland darter a listing Chucky Madtom one or more of the five factors described priority number of 6, reflecting a threat in section 4(a)(1) of the Act. The five magnitude and immediacy of high and We first identified the chucky listing factors are: (A) The present or non-imminent, respectively. In the 2006 madtom as a possible candidate for threatened destruction, modification, or Candidate Notice of Review, we listing in the 1994 Candidate Notice of curtailment of its habitat or range; (B) changed the listing priority number for Review (59 FR 58982). It was assigned overutilization for commercial, Cumberland darter from 6 to 5, because a Category 2 status, which was given to recreational, scientific, or educational it was formally described as a distinct those species for which the Service purposes; (C) disease or predation; (D) species (71 FR 53755). Based on new possessed information indicating that the inadequacy of existing regulatory molecular evidence, the subspecies proposing to list as endangered or mechanisms; and (E) other natural or Etheostoma nigrum susanae was threatened was possibly appropriate, manmade factors affecting its continued elevated to specific status, Etheostoma but for which persuasive data on existence. Listing actions may be susanae. The Cumberland darter biological vulnerability and threat was warranted based on any of the above continued to be recognized as a listing not currently available to support threat factors, singly or in combination. priority 5 candidate in the 2009 proposed rules. In the 2002, 2004, 2005, Each of these factors is discussed below. Candidate Notice of Review (74 FR 2006, 2007, 2008, and 2009 Candidate 57869). Notices of Review, the chucky madtom A. The Present or Threatened was again identified as a listing priority Destruction, Modification, or Rush Darter 2 candidate species (67 FR 40657, 69 FR Curtailment of Its Habitat or Range We first identified the rush darter as 24875, 70 FR 24869, 71 FR 53755, 72 FR The primary threat to the Cumberland a candidate for listing in the 2002 69033, 73 FR 75236, 74 FR 57869). darter, rush darter, yellowcheek darter, Candidate Notice of Review (67 FR We published a petition finding for chucky madtom, and laurel dace is 40657). The rush darter was assigned a chucky madtom in the 2005 Candidate physical habitat destruction/ listing priority number of 5. In the 2004 Notice of Review (70 FR 24869) in modification resulting from a variety of (69 FR 24875) and 2005 (70 FR 24869) response to a petition received on May human-induced impacts such as Candidate Notice of Review, the rush 11, 2004, stating the chucky madtom siltation, disturbance of riparian darter retained a listing priority number would retain a listing priority of 2. corridors, and changes in channel of 5. We published a petition finding for In 1994, the chucky madtom was first morphology (Waters 1995, pp. 2–3; rush darter in the 2005 Candidate added to the candidate list as Noturus Skelton 1997, pp. 17, 19; Thomas 2007, Notice of Review (70 FR 24869) in sp. (59 FR 58982). Subsequently, and p. 5). The most significant of these response to a petition received on May based on morphological and molecular impacts is siltation (excess sediments 11, 2004. The rush darter retained a evidence, the chucky madtom was suspended or deposited in a stream) listing priority number of 5 in the 2005 formally described as a distinct species, caused by excessive releases of Candidate Notice of Review (70 FR Noturus crypticus (Burr et al. 2005). We sediment from activities such as 24869), in accordance with our priority included this new information in the resource extraction (e.g., coal mining, guidance published on September 21, 2006 Candidate Notice of Review (71 FR silviculture, natural gas development), 1983 (48 FR 43098). 53755). agriculture, road construction, and

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urban development (Waters 1995, pp. 2– degrading habitats used by fishes for habitat degradation in the Barren Fork 3; KDOW 2006, pp. 178–185; Skelton both feeding and reproduction mainstem and ‘‘adverse effects’’ on the 1997, pp. 17, 19; Thomas 2007, p. 5). (Mattingly et al. 2005, p. 5). blackside dace. Several smaller Land use practices that affect Undisturbed riparian corridors are sediment events have occurred despite sediment and water discharges into a important because they prevent elevated Federal and State attempts to resolve the stream can also increase the erosion or stream temperatures due to solar issue, and on July 31, 2008, another sedimentation pattern of the stream, heating, serve as buffers against non- large rainfall event resulted in excessive which can lead to the destruction or point source pollutants, provide sedimentation in two Barren Fork modification of in-stream habitat and submerged root materials for cover and watershed streams. riparian vegetation, stream bank feeding, and help to stabilize stream Another significant threat to the collapse, and increased water turbidity banks (Mattingly et al. 2005, p. 5). Cumberland darter is water quality and temperature. Sediment has been degradation caused by a variety of non- shown to abrade and or suffocate Cumberland Darter point source pollutants. Coal mining bottom-dwelling algae and other The Cumberland darter’s preferred represents a major source of these organisms by clogging gills; reducing habitat characteristics (i.e., low- to pollutants (O’Bara 1991, p. 11; Thomas aquatic insect diversity and abundance; moderate-gradient, low current velocity, 2007, p. 5), because it has the potential impairing fish feeding behavior by backwater nature) make it extremely to contribute high concentrations of altering prey base and reducing susceptible to the effects of siltation dissolved metals and other solids that visibility of prey; impairing (O’Bara 1991, p. 11). Sediment lower stream pH or lead to elevated reproduction due to burial of nests; and, (siltation) has been listed repeatedly by levels of stream conductivity (Pond ultimately, negatively impacting fish the Kentucky Natural Resources and 2004, pp. 6–7, 38–41; Mattingly et al. growth, survival, and reproduction Environmental Protection Cabinet 2005, p. 59). These impacts have been (Waters 1995, pp. 5–7, 55–62; Knight (Division of Water) as the most common shown to negatively affect fish species, and Welch 2001, pp. 134–136). Wood stressor of aquatic communities in the including listed species, in the Clear and Armitage (1997, pp. 211–212) upper Cumberland River basin (KDOW Fork system of the Cumberland basin identified at least five impacts of 1996, pp. 50–53, 71–75; 2002, pp. 39– (Weaver 1997, pp. 29; Hartowicz 2008, sedimentation on fish, including (1) 40; 2006, pp. 178–185). The primary pers. comm.). The direct effect of reduction of growth rate, disease source of sediment was identified as elevated stream conductivity on fishes, tolerance, and gill function; (2) resource extraction (e.g., coal mining, including the Cumberland darter, is reduction of spawning habitat and egg, logging). The streams within the poorly understood, but some species, larvae, and juvenile development; (3) Cumberland darter’s current range that such as blackside dace, have shown modification of migration patterns; (4) are identified as impaired (due to declines in abundance over time as reduction of food availability through siltation from mining, logging, and conductivity increased in streams the blockage of primary production; and agricultural activities) and have been affected by mining (Hartowicz 2008, (5) reduction of foraging efficiency. The included on Kentucky’s 303(d) list of pers. comm.). Studies indicate that effects of these types of threats will impaired waters (KDOW 2007, pp. 155– blackside dace are generally absent likely increase as development increases 166) include Jenneys Branch (Indian when conductivity values exceed 240 in these watersheds. Creek basin), an unnamed tributary of microSiemens (μS) (Mattingly et al. Non-point source pollution from land Jenneys Branch (Indian Creek basin), 2005, p. 59; Black and Mattingly 2007, surface runoff can originate from Ryans Creek (Jellico Creek basin), Marsh p. 12). virtually any land use activity and may Creek, and Wolf Creek (Clear Fork Other non-point source pollutants be correlated with impervious surfaces basin). that affect the Cumberland darter and storm water runoff. Pollutants may Siltation can also occur in the include domestic sewage (through include sediments, fertilizers, Cumberland darter’s known habitat as a septic tank leakage or straight pipe herbicides, pesticides, animal wastes, result of construction activities for discharges); agricultural pollutants such septic tank and gray water leakage, human development. For example, as fertilizers, pesticides, herbicides, and pharmaceuticals, and petroleum during the fall of 2007, an 8.4-km (5.2- animal waste; and other chemicals products. These pollutants tend to mi) reach of Barren Fork in McCreary associated with oil and gas increase concentrations of nutrients and County, Kentucky, was subjected to a development. Non-point source toxins in the water and alter the severe sedimentation event (Floyd 2008, pollutants can cause excess nutrification chemistry of affected streams such that pers. obs.). This event occurred despite (increased levels of nitrogen and the habitat and food sources for species the fact that approximately 95 percent of phosphorus), excessive algal growth, like the Cumberland darter, rush darter, the Barren Fork watershed is under instream oxygen deficiencies, increased yellowcheek darter, chucky madtom, Federal ownership within the Daniel acidity and conductivity, and other and laurel dace are negatively impacted. Boone National Forest (DBNF). changes in water chemistry that can Construction and road maintenance Construction activities associated with seriously impact aquatic species (KDOW activities associated with urban the development of a 40.47-hectare 1996, pp. 48–50; KDOW 2006, pp. 70– development typically involve earth- (100-acre) park site caused excessive 73). moving activities that increase sediment sedimentation of two unnamed In summary, habitat loss and loads into nearby streams. Other headwater tributaries of Barren Fork. modification represent significant siltation sources, including timber Successive, large rainfall events in threats to the Cumberland darter. Severe harvesting, natural gas development September and October carried degradation from sedimentation, activities, clearing of riparian sediment off site and impacted physical habitat disturbance, and vegetation, mining, and agricultural downstream areas of Barren Fork known contaminants threatens the habitat and practices, allow exposed earth to enter to support Cumberland darters and the water quality on which the Cumberland streams during or after precipitation Federally threatened blackside dace. darter depends. Sedimentation from events. These activities result in canopy Our initial site visit on September 7, coal mining, silviculture, agriculture, removal, elevated stream temperatures, 2007, confirmed that sediment had been and development sites within the upper and increased siltation, thereby carried off site, resulting in significant Cumberland basin negatively affect the

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Cumberland darter by reducing growth deepening of roadside ditches, and surrounding the streams and springs, rates, disease tolerance, and gill erosion of the gravel County Road 329 road maintenance and silviculture function; reducing spawning habitat, at Doe and Wildcat branches, practices. This threat is ongoing and reproductive success, and egg, larvae, contributing to the sediment in these thus considered imminent. The and juvenile development; modifying streams. magnitude of the threat is high due to migration patterns; reducing food Blanco (2001, p. 68) identified the small population and high levels of availability through reductions in prey; siltation from development projects as siltation in the springs and streams. We and reducing foraging efficiency. the greatest threat to the fauna of Turkey have no information indicating that the Contaminants associated with coal Creek. Point source siltation sites have magnitude or imminence of this threat mining (metals, other dissolved solids), impacted the Turkey Creek watershed, is likely to be appreciably reduced in domestic sewage (bacteria, nutrients), including four sites affecting Beaver the foreseeable future. and agriculture (fertilizers, pesticides, Creek, a major tributary to Turkey Yellowcheek Darter herbicides, and animal waste) cause Creek. These sites included bridge, road, degradation of water quality and and sewer line construction sites and a Robison and Harp (1981, p. 17), habitats through increased acidity and wood pallet plant (Drennen 1999, pers. McDaniel (1984, p. 92), and Robison conductivity, instream oxygen obs.). In addition, Turkey Creek at the and Buchanan (1988, p. 429) have deficiencies, excess nutrification, and confluence of Tapawingo and Penny attributed the decline in populations of excessive algal growths. Furthermore, Springs is often sediment laden and yellowcheek darters in the four forks of these threats faced by the Cumberland completely turbid after medium to the Little Red River and main stem darter from sources of sedimentation heavy rainfall. Rapid urbanization in Little Red River to habitat alteration and and contaminants are imminent; the this area renders this population degradation. The suspected primary result of ongoing projects that are extremely vulnerable during the cause of the species’ decline is the expected to continue indefinitely. As a breeding season when rush darters impoundment of the Little Red River result of the imminence of these threats concentrate in wetland pools and and lower reaches of the Devils, Middle, combined with the vulnerability of the shallow pools with aquatic vegetation in and South Forks, areas that in the past remaining small populations to headwater streams (Stiles and Mills provided optimal habitat for this extirpation from natural and manmade 2008, p. 5; Fluker et al. 2007, p. 10). species. The creation of Greers Ferry threats, we have determined that the Four major soil types occur within the Lake in 1962 converted optimal present or threatened destruction, Turkey Creek watershed, and all are yellowcheek darter habitat (clear, cool, modification, or curtailment of the considered highly erodible due to the perennial flow with large substrate Cumberland darter habitat and range steep topography (Spivey 1982, pp. 5, 7, particle size (Robison and Buchanan represents a significant threat of high 8, 14). Therefore, any activity that 1988, p. 429)), to a deep, standing water magnitude. We have no information removes native vegetation on these soils environment. This dramatic change in indicating that the magnitude or can be expected to lead to increased habitat flooded spawning sites, altered imminence of this threat is likely to be sediment loads in Turkey Creek habitat radically, and changed chemical appreciably reduced in the foreseeable (USFWS 2001, p. 59370), including the and physical characteristics in the future. areas near Penny and Tapawingo streams which provide optimal habitat Springs. Industrialization is extensive for this species. Impoundments Rush Darter and expanding throughout the profoundly alter channel characteristics, Sediment is the most abundant watershed, particularly near the type habitat availability, and flow regime pollutant in the Mobile River Basin locality for the rush darter (Bart and with serious consequences for biota (Alabama Department of Environmental Taylor 1999, p. 33; Drennen 2007, pers. (Allan and Flecker 1993, p. 36, Ward Management 1996, pp. 14–15). Within obs.). and Stanford 1995, pp. 105–119). Some the Clear Creek drainage, Johnston and Abundant water from springs of these include converting flowing to Kleiner (2001, p. 4) reported that during throughout the rush darter’s range, still waters, increasing depths and August 2001, land uses in the Doe especially in Pinson Valley, Alabama, is sedimentation, decreasing dissolved Branch and Mill Creek area appeared to needed as a flushing effect to provide oxygen, drastically altering resident fish be dominated by forests, and that there constant cleansing of the streams with populations (Neves et al. 1997, p. 63), were no obvious threats to water cool, fresh water. However, ongoing disrupting fish migration, and quality. However, Johnston and Kleiner destruction of spring heads and destroying spawning habitat (Ligon et (2001, p. 4) reported that clear cutting wetlands has significantly reduced the al. 1995, pp. 185–86). Channelization of in the Wildcat Branch watershed may species’ movement and colonization. the lower 5.6 km (3.5 miles) of Archey have increased sedimentation into the Little Cove Creek and Bristow Creek and South Forks in 1985 and stream. Approximately 84 percent (i.e., spring heads have been channelized, subsequent channel maintenance to this 5 km or 3 mi) of Wildcat Branch is and the head of Cove Spring has a day by the U.S. Army Corps of privately owned, and recent land pumping facility built on it (Fluker et al. Engineers and City of Clinton, Arkansas, exchanges within the Bankhead 2007, p. 1). Spring water in these degraded habitat in this reach as well as National Forest have taken about 0.9 km systems may be more impacted by site- segments upstream of the project area. (0.6 mi) of stream west of Clear Creek specific spring head disturbances rather Based upon current knowledge and a out of U.S. Forest Service (USFS) than overall spring drainage 2004-2005 threats assessment (Davidson management and protection. In 2001, disturbances (Drennen 2005, per. obs.). and Wine 2004, pp. 6–13; Davidson Service and USFS personnel noted Alteration of spring head habitats has 2005, pp. 1–4), gravel mining, heavy siltation at the County Road 329 reduced water quality and increased unrestricted cattle access into streams, Bridge over Doe Branch during a modest sediment loads into spring-fed tributary water withdrawal for agricultural and spring rain and also noted heavy streams throughout the range of the rush recreational purposes (i.e., golf courses), siltation at several other road crossings darter. lack of adequate riparian buffers, and in other tributary streams in the In summary, the most significant construction and maintenance of county immediate area. Drennen (2005, pers. threat to rush darters is siltation, caused roads, and non-point source pollution obs.) noted increasing erosion and by an increase in urbanization arising from a broad array of activities

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also appear to be degrading suitable rivers. Neves et al. (1997, p. 65) suggest The chuck wagon race event draws habitat for the species. The threats that agriculture affects 72 percent of approximately 20,000 to 30,000 people assessment documented occurrences of impaired river reaches in the United per year to the South Fork Little Red the aforementioned activities and found States. Nutrients, bacteria, pesticides, River for a 1–week period around Labor 52 sites on the Middle Fork, 28 sites on and other organic compounds generally Day. Horses and wagons traverse the the South Fork, 8 sites on Archey Fork are found in higher concentrations in river and its tributaries for miles leading (Davidson 2005, pp. 1–4), and 1 site in agricultural areas than forested areas. to increased habitat disturbance, the Turkey/Beech/Devils Fork system Nutrient concentrations in streams may sedimentation, and trampling. The that are adversely affected by these result in increased algal growth in chuck wagon races continue to grow activities and likely contributors to the streams, and a related alteration in fish annually and pose a significant threat to decline of the species. community composition (Petersen et al. the continued existence of yellowcheek Yellowcheek darter numbers have 1999, p. 16). Major agricultural activities darters in the South Fork Little Red declined by 83 percent in both the within the Little Red River watershed River. Middle Fork and South Fork of the include poultry, dairy, swine, and beef Timber harvesting activities involving Upper Little Red River watershed, and cattle operations. clear-cutting entire steep hillsides were 60 percent in the Archey Fork in the The Arkansas Natural Resources observed during 1999-2000 in the Devils past 20 years. Yellowcheek darter was Conservation Service has identified Fork watershed (Wine 2008, pers. not found in the Turkey Fork reach of animal wastes, nutrients, excessive comm.). The failure to implement the Devils Fork during the 2000 status erosion, loss of plant diversity, and voluntary State best management survey, and is presumed to be extirpated declining species as water quality practices (BMPs) for intermittent and in this reach. A comparison of inhabited concerns associated with agricultural perennial streams during timber stream reaches in the 1981 survey land use activities in the upper Little harvests has resulted in water quality versus the 2000 survey reveals that the Red River watershed (NRCS 1999). degradation and habitat alteration in largest decline occurred in the South Large poultry and dairy operations stream reaches adjacent to harvesting Fork, where reaches formerly inhabited increase nutrient inputs to streams operations. When timber harvests by the yellowcheek darter declined by when producers apply animal waste to involve clear cutting to the water’s edge, 70 percent. The second largest decline pastures to stimulate vegetation growth without leaving a riparian buffer, silt occurred in the Archey Fork, where for grazing and hay production. and sediment enter streams lying at the there was a 60 percent reduction in Continuous grazing methods in the bottom of steep slopes. The lack of inhabited stream reach. The Middle watershed allow unrestricted animal stream side vegetation also promotes Fork showed the least decline in access to grazing areas, and on steeper bank erosion that alters stream courses inhabited stream reach, at 22 percent. slopes this results in increased runoff and introduces large quantities of Ozark headwater streams typically and erosion (NRCS 1999). Since sediment into the channel (Allan 1995, exhibit seasonal fluctuations in flows, pastures often extend directly to the p. 321). Timber harvest operations that with flow rates highest in spring, and edge of the stream, and lack a riparian use roads on steep slopes to transport lowest in late summer and fall. The zone with native vegetation, runoff from timber can carry silt and sediment from upper reaches of these small streams are pastures carries pollutants directly into the road into the stream at the bottom most affected by seasonally fluctuating streams. Eroding stream banks also of the slope. Logging impacts on water levels (Robison and Harp 1981, p. result in alterations to stream hydrology sediment production are considerable, 17). As a result, they often lack and geomorphology, degrading habitat. but often erosion of access and haul consistent and adequate flows, and by Livestock spend a disproportionate roads produces more sediment than the late summer or fall are reduced to a amount of time in riparian areas during land harvested for timber (Brim Box and series of isolated pools (Wine 2008, hot summer months. Trampling and Mossa 1999, p. 102). These activities pers. comm.). Expanding natural gas grazing can change and reduce have occurred historically and continue development activities that began in the vegetation and eliminate riparian areas to occur in the upper Little Red River upper Little Red River watershed in by channel widening, channel watershed. 2006 require large quantities of water aggradation, or lowering of the water Natural gas exploration and and pose an imminent threat to the table (Armour et al. 1991, pp. 7–11). development is a newly emerging threat continued existence of yellowcheek Additionally, earthen dams were to yellowcheek darter populations. darter as these activities rapidly expand constructed across a riffle in the lower Significant erosion and sedimentation and increase in the watersheds of all South Fork to create a pool for annual issues associated with natural gas four forks (Davidson 2008, pers. comm.). chuck wagon races for many years development activities, particularly Because the yellowcheek darter requires leading up to 2003. The Service and pipelines (herein defined as all flow permanent flows with moderate to U.S. Army Corps of Engineers met with lines, gathering lines, and non-interstate strong current (Robison and Buchanan the responsible landowner in 2004 and pipelines), were first documented by 1988, p. 429), and because downstream suggested an alternative to dam Service biologists during 2007 in the refugia have been lost, seasonal construction that would minimize South Fork Little Red River watershed. fluctuations in stream flows that reduce impacts to the yellowcheek darter. In June 2008, the Service began moving water (lotic habitat) to a series These recommendations were followed documenting significant erosion and of isolated pool habitats are a serious for several years; however, another sedimentation issues associated with threat. earthen dam was constructed in 2008 natural gas pipeline construction and Additional contributors to using material from the South Fork to maintenance as natural gas development yellowcheek declines and continuing facilitate events associated with the activities expanded into the watershed. threats include habitat degradation from annual chuck wagon races. This dam, Service biologists documented land use activities in the watershed, like its predecessors, was unpermitted significant erosion and sedimentation at including agriculture and forestry. and resulted in significant habitat almost every new pipeline stream Traditional farming practices, feed-lot degradation and alteration for several crossing in the South Fork and Middle operations, and associated poor land use miles upstream and downstream of the Fork Little Red River watersheds, practices contribute many pollutants to site. regardless of the diameter of the pipe.

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Channel incision was documented at rivers. Neves et al. (1997, p. 65) suggest sedimentation, physical habitat numerous stream crossings that are that agriculture affects 72 percent of disturbance, and contaminants threaten tributaries to the South Fork Little Red impaired river reaches in the United the habitat and water quality on which River. The incision increased erosion States. These practices erode stream the chucky madtom depends. and sedimentation, as well as altering banks and result in alterations to stream Sedimentation from agricultural lands the hydrology and geomorphology hydrology and geomorphology, could negatively affect the chucky characteristics of the streams. Pipeline degrading habitat. Nutrients, bacteria, madtom by reducing growth rates, rights-of-way were found to have one of pesticides, and other organic disease tolerance, and gill function; the following conditions: (1) no BMPs compounds generally are found in reducing spawning habitat, reproductive (i.e., silt fences, grade breaks, non- higher concentrations in agricultural success, and egg, larvae, and juvenile erodible stream crossing materials) areas than forested areas. Nutrient development; reducing food availability installed to prevent erosion and concentrations in streams may result in through reductions in prey; and sedimentation, (2) ineffective erosion increased algal growth in streams, and reducing foraging efficiency. minimization practices in place, (3) a related alteration in fish community Contaminants associated with effective erosion minimization practices composition (Petersen et al. 1999, p. agriculture (e.g., fertilizers, pesticides, that had not been maintained and, thus, 16). herbicides, and animal waste) can cause had become ineffective, or (4) final The TVA Index of Biological Integrity degradation of water quality and reclamation of the pipeline right-of-way results indicate that Little Chucky Creek habitats through instream oxygen had not occured for months and in some is biologically impaired (Middle deficiencies, excess nutrification, and cases greater than a year after Nolichucky Watershed Alliance 2006, p. excessive algal growths. Furthermore, construction activities ceased leading to 13). Given the predominantly these threats faced by the chucky prolonged periods of erosion and agricultural land use within the Little madtom from sources of sedimentation sedimentation. The magnitude of the Chucky Creek watershed, non-point and contaminants are imminent; the impacts to the South Fork and Middle source sediment and agrochemical result of ongoing agricultural practices Fork Little Red River from 2007-2008 discharges may pose a threat to the that are expected to continue also was exacerbated due to above chucky madtom by altering the physical indefinitely. As a result of the average rainfall, which led to more characteristics of its habitat, thus imminence of these threats combined frequent and larger pipeline erosion potentially impeding its ability to feed, with the vulnerability of the remaining events. seek shelter from predators, and small population to extirpation from In summary, threats to the successfully reproduce. The Little natural and manmade threats, we have yellowcheek darter from the present Chucky Creek watershed also contains a determined that the present or destruction, modification, or portion of the city of Greeneville, threatened destruction, modification, or curtailment of its habitat or range providing an additional source for input curtailment of the chucky madtom negatively impact the species. Threats of sediments and contaminants into the habitat and range represents a include such activities as creek and threatening the chucky significant threat of high magnitude. We impoundment, sedimentation (from a madtom. Wood and Armitage (1997, pp. have no information indicating that the broad array of activities), nutrient 211–212) identify at least five impacts of magnitude or imminence of these enrichment, gravel mining, sedimentation on fish, including (1) threats is likely to be appreciably channelization/channel instability, and reduction of growth rate, disease reduced in the foreseeable future. natural gas development. These threats tolerance, and gill function; (2) are considered imminent and of high reduction of spawning habitat and egg, Laurel Dace magnitude throughout the species’ larvae, and juvenile development; (3) Skelton (2001, p. 127) concluded that entire range. We have no information modification of migration patterns; (4) the laurel dace is ‘‘presumably tolerant indicating that the magnitude or reduction of food availability through of some siltation.’’ However, Strange and imminence of these threats is likely to the blockage of primary production; and Skelton (2005, p. 7 and Appendix 2) be appreciably reduced in the (5) reduction of foraging efficiency. observed levels of siltation they foreseeable future, and in the case of The chucky madtom is a bottom- considered problematic during later pipeline disturbance, we expect this dwelling species. Bottom-dwelling fish surveys for the laurel dace and threat to become more problematic over species are especially susceptible to concluded this posed a threat in several the next several years as natural gas sedimentation and other pollutants that localities throughout the range of the development continues to intensify. degrade or eliminate habitat and food species. Sediment has been shown to sources (Berkman and Rabeni 1987, pp. abrade and or suffocate bottom-dwelling Chucky Madtom 290–292; Richter et al. 1997, p. 1091; fish and other organisms by clogging The current range of the chucky Waters 1995, p. 72). Etnier and Jenkins gills; reducing aquatic insect diversity madtom is believed to be restricted to an (1980, p. 20) suggested that madtoms, and abundance; impairing fish feeding approximately 1.8-mi (3-km) reach of which are heavily dependent on behavior by altering prey base and Little Chucky Creek in Greene County, chemoreception (detection of chemicals) reducing visibility of prey; impairing Tennessee. Land use data from the for survival, are susceptible to human- reproduction due to burial of nests; and, Southeast GAP Analysis Program (SE- induced disturbances, such as chemical ultimately, negatively impacting fish GAP) show that land use within the and sediment inputs, because the growth, survival, and reproduction Little Chucky Creek watershed is olfactory (sense of smell) ‘‘noise’’ they (Waters 1995, pp. 5–7, 55–62; Knight predominantly dominated by produce could interfere with a and Welch 2001, pp. 134–136). agricultural use, with the vast majority madtom’s ability to obtain food and However, we do not currently know of agricultural land being devoted to otherwise monitor its environment. what levels of siltation laurel dace are production of livestock and their forage In summary, threats to the chucky able to withstand before populations base (USGS 2008). madtom from the present destruction, begin to decline due to these siltation- Traditional farming practices, feed-lot modification, or curtailment of its related stressors. The apparent stability operations, and associated land use habitat or range negatively impact the of the northern population of laurel practices contribute many pollutants to species. Degradation from dace in the Piney River system suggests

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that this species is at least moderately but also for the potential thermal sources of sedimentation and tolerant of siltation-related stressors. We alteration of these small headwater contaminants are imminent; the result do not know the extent to which other streams. Skelton (2001, p. 125) reported of ongoing agriculture and forestry factors might have driven the decline of that laurel dace occupy cool streams practices that are expected to continue. the southern populations in Sale and with a maximum recorded temperature As a result of the imminence of these Soddy Creeks. of 26° C (78.8° F). The removal of threats, we have determined that the Of the streams inhabited by the riparian vegetation could potentially present or threatened destruction, southern populations recognized by increase temperatures above the laurel modification, or curtailment of the Strange and Skelton (2005, p. Appendix dace’s maximum tolerable limit. laurel dace habitat and range represents 2), the reaches from which laurel dace Water temperature may be a limiting a significant threat of high magnitude. have been collected in Soddy Creek and factor in the distribution of this species We have no information indicating that Horn Branch approach 0.6 mi (1 km) in (Skelton 1997, pp. 17, 19). Canopy cover the magnitude or imminence of these length. In Cupp Creek, collections of of laurel dace streams often consists of threats is likely to be appreciably this species are restricted to less than eastern hemlock, mixed hardwoods, reduced in the foreseeable future. 984 ft (300 m) of stream, in spite of pine, and mountain laurel. The hemlock surveys well beyond the reach known to woolly adelgid (Adelges tsugae) is a B. Overutilization for Commercial, be inhabited. In each of the streams nonnative insect that infests hemlocks, Recreational, Scientific, or Educational occupied by the southern populations, causing damage or death to trees. The Purposes Strange and Skelton (2005, Appendix 2) woolly adelgid was recently found in The Cumberland darter, rush darter, identified siltation as a factor that could Hamilton County, Tennessee, and could yellowcheek darter, chucky madtom, alter the habitat and render it unsuitable impact eastern hemlock in floodplains and laurel dace are not commercially for laurel dace. The restricted and riparian buffers (land adjacent to utilized. Individuals have been taken for distribution of laurel dace in streams stream channels) along laurel dace scientific and private collections in the inhabited by the southern populations streams in the future (Simmons 2008, past, but collecting is not considered a leaves them highly vulnerable to pers. comm.). Riparian buffers filter factor in the decline of these species and potential deleterious effects of excessive sediment and nutrients from overland is not expected to be so in the future. siltation or other localized disturbances. runoff, allow water to soak into the The available information does not A newly emerging threat to laurel ground, protect stream banks and indicate that overutilization is likely to dace in Soddy Creek is the conversion lakeshores, and provide shade for become a threat to any of these five of pine plantations to row crop streams. Because eastern hemlock is fishes in the foreseeable future. agriculture. Two large plantations primarily found in riparian areas, the within the Soddy Creek Watershed were loss of this species adjacent to laurel C. Disease or Predation harvested and then converted to tomato dace streams would be detrimental to Disease is not considered to be a farms. An irrigation impoundment was fish habitat. factor in the decline of the Cumberland built on one Soddy Creek tributary and Habitat destruction and modification darter, rush darter, yellowcheek darter, another is under construction. As a also stem from existing or proposed chucky madtom, or laurel dace. result of these activities, a large silt infrastructure development in Although the Cumberland darter, rush source was introduced into the Soddy association with timber harvesting. The darter, yellowcheek darter, and laurel Creek headwaters. In addition to presence of culverts at one or more road dace are undoubtedly consumed by contributing sediment, crop fields often crossings in most of the streams predators, the available information allow runoff from irrigation water to inhabited by laurel dace may disrupt suggests that this predation is naturally flow directly into the creek. This water upstream dispersal within those systems occurring, or a normal aspect of the contains fungicides, herbicides, and (Chance 2008, pers. obs.). Such population dynamics. As a result, we do fertilizers (Thurman 2010, pers. comm.). dispersal barriers could prevent re- not believe that predation is considered Strange and Skelton (2005, p. 7 and establishment of laurel dace populations to currently pose a threat to these Appendix 2) identified siltation as a in reaches where they suffer localized species. Furthermore, the information threat in all of the occupied Piney River extinctions due to natural or human- we do have, does not indicate that tributaries (Young’s, Moccasin, and caused events. disease or predation is likely to become Bumbee Creeks). The Bumbee Creek In summary, the primary threat to a threat to any of these five fishes in the type locality for the laurel dace is laurel dace throughout its range is foreseeable future. located within industrial forest that has excessive siltation resulting from been subjected to extensive clear-cutting agriculture and extensive timber D. The Inadequacy of Existing and road construction in close harvesting involving both inadequate Regulatory Mechanisms proximity to the stream. Strange and riparian buffers in harvest areas and the Cumberland Darter Skelton (2005, p. 7) noted a heavy failure to use best management practices sediment load at this locality and in road construction. Severe degradation The Cumberland darter and its commented that conditions there in from sedimentation, physical habitat habitats are afforded some protection 2005 had deteriorated since the site was disturbance, and contaminants threatens from water quality and habitat visited by Skelton in 2002. Strange and the habitat and water quality on which degradation under the Clean Water Act Skelton (2005, pp. 7 and 8 and the laurel dace depends. Sedimentation of 1977 (33 U.S.C. 1251 et seq.), Appendix 2) also commented on from negatively affects the laurel dace Kentucky’s Forest Conservation Act of excessive siltation in localities they by reducing growth rates, disease 1998 (KRS 149.330-355), Kentucky’s sampled on Young’s and Moccasin tolerance, and gill function; reducing Agriculture Water Quality Act of 1994 Creeks, and observed localized removal spawning habitat, reproductive success, (KRS 224.71-140), additional Kentucky of riparian vegetation around residences and egg, larvae, and juvenile laws and regulations regarding natural in the headwaters of each of these development; reducing food availability resources and environmental protection streams. They considered the removal of through reductions in prey; and (KRS 146.200-360; KRS 224; 401 KAR riparian vegetation problematic not only reducing foraging efficiency. These 5:026, 5:031), and Tennessee’s Water for the potential for increased siltation, threats faced by the laurel dace from Quality Control Act of 1977 (T.C.A. 69-

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3-101). However, as demonstrated under species listed in (1) of this environmental laws within Alabama to Factor A, population declines and proclamation, or (2) the United States specifically consider the rush darter or degradation of habitat for this species list of Endangered fauna.’’ Under these ensure that a project will not jeopardize are ongoing despite the protection regulations, potential collectors of this its continued existence. afforded by these laws and species are required to have a State The State of Alabama maintains corresponding regulations. While these collection permit. However, in terms of water-use classifications through laws have resulted in some project management, this regulation issuance of NPDES permits to improvements in water quality and only provides for the consideration of industries, municipalities, and others stream habitat for aquatic life, including alternatives, and does not require the that set maximum limits on certain the Cumberland darter, they alone have level of project review afforded by the pollutants or pollutant parameters. For not been adequate to fully protect this Act. water bodies on the 303(d) list, States species; sedimentation and non-point In 7 of 12 streams where the are required under the Clean Water Act source pollutants continue to be a Cumberland darter still occurs, the to establish a TMDL for the pollutants significant problem. species is indirectly provided some of concern that will bring water quality States maintain water-use protection from Federal actions and into the applicable standard. The State classifications through issuance of activities through the Endangered of Alabama has not identified any National Pollutant Discharge Species Act of 1973, as amended (16 impaired water bodies in Jefferson, Elimination System (NPDES) permits to U.S.C. 1531 et seq.), because these Winston, and Etowah Counties in the industries, municipalities, and others streams (or basins) also support the immediate or upstream portion of the that set maximum limits on certain Federally threatened blackside dace and rush darter range or watersheds in pollutants or pollutant parameters. For occupy watersheds that are at least Winston or Etowah County. However, water bodies on the 303(d) list, States partially owned by the Federal sedimentation events are usually related are required under the Clean Water Act government (Daniel Boone National to the stormwater runoff episodes, and to establish a total maximum daily load Forest). The five remaining streams are usually not captured by routine (TMDL) for the pollutants of concern supporting populations of the water quality sampling. Although that will bring water quality into the Cumberland darter are not afforded this stormwater events are temporary, they applicable standard. Three Cumberland protection. are still very significant and destructive darter streams, Jenneys Branch, Marsh In summary, population declines and to the species, habitat, vegetation and Creek, and Wolf Creek, have been degradation of habitat for the food sources, as previously mentioned. identified as impaired by the Kentucky Cumberland darter are ongoing despite When the stormwater water events Division of Water and placed on the the protection afforded by State and abate, the water becomes more State’s 303(d) list (KDOW 2008). Causes Federal laws and corresponding hospitable to the species, due to the of impairment were listed as siltation/ regulations. Because of the vulnerability spring influences and constant flushing sedimentation from agriculture, coal of the small remaining populations of from spring water. Thus, there is no mining, land development, and the Cumberland darter and the listing or label for these bodies as silviculture and organic enrichment/ imminence of these threats, we find the impaired and are generally considered eutrophication from residential areas. inadequacy of existing regulatory satisfactory for the species when TMDLs have not yet been developed for mechanisms to be a significant threat of stormwater is not involved. these pollutants. high magnitude. Further, the In summary, population declines and The Cumberland darter has been information available to us at this time degradation of habitat for the rush darter designated as an endangered species by does not indicate that the magnitude or are ongoing despite the protection Tennessee (TWRA 2005, p. 240) and imminence of this threat is likely to be afforded by State and Federal laws and Kentucky (KSNPC 2005, p. 11), but the appreciably reduced in the foreseeable corresponding regulations. Despite these designation in Kentucky conveys no future. laws, sedimentation and non-point legal protection. Under the Tennessee source pollution continue to adversely Rush Darter Nongame and Endangered or affect the species. Because of the Threatened Wildlife Species The rush darter and its habitats are vulnerability of the small remaining Conservation Act of 1974 (Tennessee afforded some protection from water populations of the rush darter and the Code Annotated §§ 70-8-101-112), ‘‘[I]t quality and habitat degradation under imminence of these threats, we find the is unlawful for any person to take, the Clean Water Act and the Alabama inadequacy of existing regulatory attempt to take, possess, transport, Water Pollution Control Act, as mechanisms to be a significant threat of export, process, sell or offer for sale or amended, 1975 (Code of Alabama, §§ high magnitude. Further, the ship nongame wildlife, or for any 22-22-1 to 22-22-14). However, as information available to us at this time common or contract carrier knowingly demonstrated under Factor A, does not indicate that the magnitude or to transport or receive for shipment population declines and degradation of imminence of this threat is likely to be nongame wildlife.’’ Further, regulations habitat for this species are ongoing appreciably reduced in the foreseeable included in the Tennessee Wildlife despite the protection afforded by these future. Resources Commission Proclamation laws. While these laws have resulted in 00-15 Endangered Or Threatened some improvement in water quality and Yellowcheek Darter Species state the following: ‘‘Except as stream habitat for aquatic life, including The Arkansas Department of provided for in Tennessee Code the rush darter, they alone have not Environmental Quality (ADEQ) has Annotated, Section 70-8-106 (d) and (e), been adequate to fully protect this established water quality standards for it shall be unlawful for any person to species; sedimentation and non-point surface waters in Arkansas, including take, harass, or destroy wildlife listed as source pollutants continue to be a specific standards for those streams threatened or endangered or otherwise significant problem. Sediment is the designated as ‘‘extraordinary resource to violate terms of Section 70-8-105 (c) most abundant pollutant in the Mobile waters’’ (ERW) based on ‘‘a combination or to destroy knowingly the habitat of River Basin and the greatest threat to the of the chemical, physical, and biological such species without due consideration rush darter. There are currently no characteristics of a waterbody and its of alternatives for the welfare of the requirements within the scope of other watershed, which is characterized by

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scenic beauty, aesthetics, scientific U.S. Army Corps of Engineers regulates mining, agriculture, and channelization values, broad scope recreation potential, instream activities under the Clean (Tennessee Department of Environment and intangible social values’’ (ADEQ Water Act. Their policy to date has been and Conservation (TDEC) 2008, pp. 62– Regulation 2, November 25, 2007). As to issue permits for instream activities 70). However, Little Chucky Creek is not described in ADEQ’s Regulation 2, associated with pipeline construction listed as ‘‘an impaired water’’ by the Section 2.203, ERW ‘‘shall be protected and maintenance under Nationwide State of Tennessee (TDEC 2008, pp. 62– by (1) water quality controls, (2) Permits rather than Individual Permits 70). For water bodies on the 303(d) maintenance of natural flow regime, (3) that require more public involvement. (impaired) list, States are required under protection of in stream habitat, and (4) ADEQ lacks resources necessary to the Clean Water Act to establish a pursuit of land management protective enforce existing regulations under the TMDL for the pollutants of concern that of the watershed.’’ This regulatory Clean Water Act and Arkansas Water will bring water quality into the mechanism has precluded most large and Air Pollution Act for activities applicable standard. The Tennessee scale commercial gravel mining in the associated with natural gas Department of Environment and watershed; however, illegal gravel development. Conservation has developed TMDLs for mining is still considered a cause of The yellowcheek darter receives the Nolichucky River watershed to habitat degradation and a threat in the incidental protection under the Act due address the problems of fecal coliform Little Red River watershed. The Middle, to the coexistence of the federally loads, siltation, and habitat alteration by Archey, and Devils (and its major endangered speckled pocketbook agriculture. tributaries) forks are designated as ERW. mussel (Lampsilis streckeri), which The chucky madtom receives The South Fork has not been designated occurs throughout the upper Little Red incidental protection under the Act due as an ERW. The applicable water quality River drainage. to the coexistence of the Federally standards have not protected In summary, the threats of inadequacy endangered Cumberland bean (Villosa yellowcheek darter habitat from the of existing regulatory mechanisms are trabalis), which is still thought to occur damaging habitat alterations and water imminent and considered high in in Little Chucky Creek, Greene County, quality degradation from traditional magnitude. This is of particular concern Tennessee (Ahlstedt 2008, pers. comm.). land use and expanding natural gas in regard to the vulnerability of the The chucky madtom was listed as development activities. species to threats from natural gas Endangered by the State of Tennessee in The Arkansas Forestry Commission is development which is already September of 2000. Under the the State agency responsible for impacting populations in the South and Tennessee Nongame and Endangered or establishing Best Management Practices Middle forks of the Little Red River and Threatened Wildlife Species (BMPs) for timber harvests in Arkansas. is expected to intensify in the next Conservation Act of 1974 (Tennessee BMPs for timber harvests in Arkansas several years throughout the range of the Code Annotated §§ 70-8-101-112), ‘‘[I]t are only recommendations. There is no species. Further, the information is unlawful for any person to take, requirement that timber harvesters available to us at this time does not attempt to take, possess, transport, include BMPs in timber operations. The indicate that the magnitude or export, process, sell or offer for sale or BMPs are currently under revision, but imminence of this threat is likely to be ship nongame wildlife, or for any the Service does not know what effect appreciably reduced in the foreseeable common or contract carrier knowingly these revisions will have on aquatic future. to transport or receive for shipment nongame wildlife.’’ Further, regulations habitats within the range of the species. Chucky Madtom Natural gas production in the upper included in the Tennessee Wildlife Little Red River watershed presents a The chucky madtom and its habitats Resources Commission Proclamation unique problem for yellowcheek darter are afforded some protection from water 00-15 Endangered Or Threatened conservation. In Arkansas, mineral quality and habitat degradation under Species state the following: ‘‘Except as rights for properties supersede the the Clean Water Act and TDEC’s provided for in Tennessee Code surface rights. Even where private Division of Water Pollution Control Annotated, Section 70-8-106 (d) and (e), landowners agree to implement certain under the TWQCA. However, as it shall be unlawful for any person to BMPs or conservation measures on their demonstrated under Factor A, take, harass, or destroy wildlife listed as lands for yellowcheek darter population declines and degradation of threatened or endangered or otherwise conservation, there is no guarantee that habitat for this species are ongoing to violate terms of Section 70-8-105 (c) these BMPs or conservation measures despite the protection afforded by these or to destroy knowingly the habitat of will be implemented by natural gas laws. While these laws have resulted in such species without due consideration companies, their subsidiaries, or improved water quality and stream of alternatives for the welfare of the contractors that lease and develop the habitat for aquatic life, including the species listed in (1) of this mineral rights for landowners. For this Chucky madtom, they alone have not proclamation, or (2) the United States reason, the intended benefits of been adequate to fully protect this list of Endangered fauna.’’ Under these conservation measures agreed to by species; sedimentation and non-point regulations, potential collectors of this landowners in agreements such as source pollutants continue to be a species are required to have a State Candidate Conservation Agreements significant problem. Sediment is the collection permit. However, in terms of with Assurances may never be realized. most abundant pollutant in the Little project management, this regulation Additionally, natural gas projects often Chucky Creek watershed and is the only provides for the consideration of do not contain a Federal nexus that greatest threat to the Chucky madtom. alternatives, and does not require the would allow the Service to comment on Portions of the Nolichucky River and level of project review afforded by the proposed or ongoing projects. its tributaries in Greene County, Act. The Arkansas Natural Resources Tennessee, are listed as impaired (303d) In summary, population declines and Commission regulates water withdrawal by the State of Tennessee due to pasture degradation of habitat for the chucky in Arkansas streams. To date, they have grazing, irrigated crop production, madtom are ongoing despite the not precluded water withdrawal for unrestricted cattle access, land protection afforded by State and Federal natural gas development activities in the development, municipal point source laws and corresponding regulations. upper Little Red River watershed. The discharges, septic tank failures, gravel Despite these laws, sedimentation and

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non-point source pollution continue to Annotated, Section 70-8-106 (d) and (e), Species that are restricted in range adversely affect the species. Because of it shall be unlawful for any person to and population size are more likely to the vulnerability of the small remaining take, harass, or destroy wildlife listed as suffer loss of genetic diversity due to populations of the chucky madtom and threatened or endangered or otherwise genetic drift, potentially increasing their the imminence of these threats, we find to violate terms of Section 70-8-105 (c) susceptibility to inbreeding depression, the inadequacy of existing regulatory or to destroy knowingly the habitat of decreasing their ability to adapt to mechanisms to be a significant threat of such species without due consideration environmental changes, and reducing high magnitude. Further, the of alternatives for the welfare of the the fitness of individuals (Soule 1980, information available to us at this time species listed in (1) of this pp. 157–158; Hunter 2002, pp. 97–101; does not indicate that the magnitude or proclamation, or (2) the United States Allendorf and Luikart 2007, pp. 117– imminence of this threat is likely to be list of Endangered fauna.’’ Under these 146). It is likely that some of the appreciably reduced in the foreseeable regulations, potential collectors of this Cumberland darter, rush darter, future. species are required to have a State yellowcheek darter, chucky madtom, and laurel dace populations are below Laurel Dace collection permit. However, in terms of project management, this regulation the effective population size required to The laurel dace and its habitats are only provides for the consideration of maintain long-term genetic and afforded some protection from water alternatives, and does not require the population viability (Soule 1980, pp. quality and habitat degradation under level of project review afforded by the 162–164; Hunter 2002, pp. 105–107). the Clean Water Act and by TDEC’s Act. The long-term viability of a species is Division of Water Pollution Control In summary, population declines and founded on the conservation of under the TWQCA. However, as degradation of habitat for the laurel dace numerous local populations throughout demonstrated under Factor A, are ongoing despite the protection its geographic range (Harris 1984, pp. population declines and degradation of afforded by State and Federal water 93–104). These separate populations are habitat for this species are ongoing quality laws. While these laws have essential for the species to recover and despite the protection afforded by these adapt to environmental change (Noss laws. While these laws have resulted in resulted in improved water quality and stream habitat for aquatic life, including and Cooperrider 1994, pp. 264–297; improved water quality and stream Harris 1984, pp. 93–104). The level of habitat for aquatic life, including the the laurel dace, they alone have not been adequate to fully protect this isolation seen in these five species laurel dace, they alone have not been makes natural repopulation following adequate to fully protect this species; species; sedimentation and non-point source pollutants continue to be a localized extirpations virtually sedimentation and non-point source impossible without human intervention. significant problem. Non-point pollutants continue to be a significant Climate change has the potential to pollution is not regulated by the Clean problem. Sediment is the most abundant increase the vulnerability of the pollutant in the watershed and one of Water Act. Due to the vulnerability of Cumberland darter, rush darter, the greatest threat to the laurel dace. the laurel dace, we find the threat of yellowcheek darter, chucky madtom, The State of Tennessee maintains inadequate regulatory mechanisms to be and laurel dace to random catastrophic water-use classifications through imminent and of high magnitude. events (e.g., McLaughlin et al. 2002; issuance of NPDES permits to Further, the information available to us Thomas et al. 2004). Climate change is industries, municipalities, and others at this time does not indicate that the expected to result in increased that set maximum limits on certain magnitude or imminence of this threat frequency and duration of droughts and pollutants or pollutant parameters. For is likely to be appreciably reduced in the strength of storms (e.g., Cook et al. water bodies on the 303(d) list, States the foreseeable future. 2004). During 2007, a severe drought are required under the Clean Water Act E. Other Natural or Manmade Factors affected the upper Cumberland River to establish a TMDL for the pollutants Affecting Its Continued Existence basin in Kentucky and Tennessee. of concern that will bring water quality Streamflow values for the Cumberland into the applicable standard. The The Cumberland darter, rush darter, River at Williamsburg, Kentucky (USGS Tennessee Department of Environment yellowcheek darter, chucky madtom, Station Number 03404000), in and Conservation has not identified any and laurel dace have limited geographic September and October of 2007 were impaired water bodies in the Soddy ranges and small population sizes. Their among the lowest recorded monthly Creek, the Sale Creek system, or the existing populations are extremely values (99th percentile for low-flow Piney River system (TDEC 2008). localized, and geographically isolated periods) during the last 67 years The TWRA lists the laurel dace as from one another, leaving them (Cinotto 2008, pers. comm.). Climate endangered. Under the Tennessee vulnerable to localized extinctions from change could intensify or increase the Nongame and Endangered or intentional or accidental toxic chemical frequency of drought events, such as the Threatened Wildlife Species spills, habitat modification, progressive one that occurred in 2007. Thomas et al. Conservation Act of 1974 (Tennessee degradation from runoff (non-point (2009, p. 112) report that the frequency, Code Annotated §§ 70-8-101-112), ‘‘[I]t source pollutants), natural catastrophic duration, and intensity of droughts are is unlawful for any person to take, changes to their habitat (e.g., flood likely to increase in the southeast as a attempt to take, possess, transport, scour, drought), other stochastic result of global climate change. export, process, sell or offer for sale or disturbances, and to decreased fitness Fluker et al. (2007, p. 10) reported ship nongame wildlife, or for any from reduced genetic diversity. that drought conditions, coupled with common or contract carrier knowingly Potential sources of unintentional spills rapid urbanization in watersheds that to transport or receive for shipment include accidents involving vehicles contain rush darters, render the nongame wildlife.’’ Further, regulations transporting chemicals over road populations vulnerable, especially included in the Tennessee Wildlife crossings of streams inhabited by one of during the breeding season when they Resources Commission Proclamation these five fish, or the accidental or concentrate in wetland pools and 00-15 Endangered Or Threatened intentional release into streams of shallow pools of headwater streams. Species state the following: ‘‘Except as chemicals used in agricultural or Drought conditions from 2006 to 2007 provided for in Tennessee Code residential applications. greatly reduced spawning habitat for

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rush darter in Jefferson County p. 58) could limit the potential for during the most recent surveys by (Drennen 2007, pers. obs.). Survey populations to rebound from Thomas (2007, p. 3)). Rush darter numbers for the rush darter within the disturbance events. The short life span populations are isolated from each spring-fed headwaters for the unnamed exhibited by members of the N. other, and individual rush darters are tributary to Turkey Creek during 2007 hildebrandi clade (a taxonomic group of only sporadically collected within their were reduced due to a lack of water organisms classified together on the range. Where it occurs, the rush darter (Kuhajda 2008, pers. comm.). In basis of homologous features traced to a is an uncommon species that is usually Winston County, Stiles and Mills (2008, common ancestor) of madtoms, if also collected in low numbers. Yellowcheek pp. 5–6) noted that Doe Branch almost true of chucky madtoms, would further darter populations are restricted to completely dried up during the summer limit the species’ viability by rendering portions of four headwater streams, of 2007. (Stiles 2008, pers. comm.). it vulnerable to severe demographic have declined drastically over the last The federally endangered watercress shifts from disturbances that prevent 30 years and are effectively isolated as darter (Etheostoma nuchale) was reproduction in even a single year, and a result of reservoir construction. Only translocated outside of its native range could be devastating to the population three specimens of the chucky madtom by the Service into Tapawingo Springs if the disturbance persists for successive have been encountered since 2000 (one in 1988 in order to assist in the species, years. in 2000 and two in 2004), despite recovery by expanding its range (Moss In summary, because the Cumberland several surveys that have been 1995, p. 5). The watercress darter is now darter, rush darter, yellowcheek darter, conducted in Little Chucky Creek and reproducing and may be competing with chucky madtom, and laurel dace all several streams in the Nolichucky, rush darters in Tapawingo Springs have limited geographic ranges and Holston, and French Broad River (USFWS 1993, p. 1; Drennen 2004, pers. small population sizes, they are subject watersheds of the upper Tennessee obs.). More recently, a population of to several ongoing natural and manmade River basin, which are similar in size watercress darters was found in the threats. Since these threats are ongoing, and character to Little Chucky Creek. Penny Springs site (Stiles and they are considered to be imminent. The laurel dace is restricted to six Blanchard 2001, p. 3). We require Exacerbation of natural drought cycles streams, where they are only known to further investigation to determine as a result of global climate change occupy reaches of approximately 0.3 to whether interspecific competition is could have detrimental effects on these 8 km (0.2 to 5 mi) in length. These occurring between the watercress darter five species which is expected to isolated species have a limited ability to and the rush darter at this site. (Stiles continue or increase in the future. The recolonize historically occupied stream 2008, pers. comm.). magnitude of these threats is high for and river reaches and are vulnerable to The Little Red River watershed in each of these species because of their natural or human-caused changes in Arkansas experienced moderate drought reduced ranges and population sizes their stream and river habitats. Their conditions during 1997-2000 (Southern which result in a reduced ability to range curtailment, small population Regional Climate Center 2000), which adapt to environmental change. Further, size, and isolation make these five reduced flows in its tributaries and the information available to us at this species more vulnerable to threats such affected yellowcheek darter time does not indicate that the as sedimentation, disturbance of populations. Stage height was 1 foot magnitude or imminence of this threat riparian corridors, changes in channel lower during the sampling period for is likely to be appreciably reduced in morphology, point and non-point source the 2000 status survey than during the the foreseeable future. pollutants, urbanization, and introduced 1979–1980 study (Wine et al. 2000, p. Proposed Determination species. 7). Stream flow is strongly correlated Therefore, as described above, these with important physical and chemical We have carefully assessed the best five species are in danger of extinction parameters that limit the distribution scientific and commercial information throughout their highly localized ranges and abundance of riverine species available regarding the past, present, due to their reduction of habitat and (Power et al. 1995, p. 159, Resh et al. and future threats to the Cumberland ranges, small population sizes, current 1988, p. 437) and regulates the darter, rush darter, yellowcheek darter, habitat threats, and resulting ecological integrity of flowing water chucky madtom, and laurel dace. Based vulnerability due to lack of regulatory systems (Poff et al. 1997, p. 769). on the immediate and ongoing mechanisms and natural or human Yellowcheek darter was not found in significant threats to these species induced catastrophic events. Efforts to the upper reaches of any study streams throughout their entire ranges, as control excessive sedimentation and or in the Turkey/Beech Fork reach of described above in the five-factor improve general water quality Devils Fork, a likely result of drought analyses, we consider these species to throughout their ranges coupled with conditions, and indicates a contraction be in danger of extinction throughout all efforts to increase population levels will of yellowcheek darter range to stream of their ranges. The Endangered Species be essential for these species’ survival. reaches lower in the watershed where Act (Sec. 3(5)(C)(6)) defines an flows are maintained for a greater endangered species as ‘‘any species Available Conservation Measures portion of the year (Wine et al. 2000, p. which is in danger of extinction Conservation measures provided to 11). The threat immediacy and throughout all or a significant portion of species listed as endangered or magnitude of drought is imminent and its range.’’ Therefore, on the basis of the threatened under the Act include moderate to high, respectively, in all best available scientific and commercial recognition, recovery actions, four watersheds for the yellowcheek information, we are proposing to list requirements for Federal protection, and darter. Exacerbation of natural drought these five fishes as endangered species, prohibitions against certain practices. cycles as a result of global climate in accordance with Section 4(a)(1) of the Recognition through listing encourages change could have detrimental effects Act. and results in public awareness and on the species which could continue for The Cumberland darter is threatened conservation by Federal, State, and local the foreseeable future. with range curtailment, specifically its agencies, private organizations, and The low fecundity rates exhibited by disappearance from 9 streams and 11 individuals. The Act encourages many madtom catfishes (Breder and historic sites, and its small population cooperation with the States and requires Rosen 1966 in Dinkins and Shute 1996, size (only 51 individuals observed that recovery actions be carried out for

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all listed species. The protection accomplished solely on Federal lands the survival and recovery of the species. required of Federal agencies and the because their range may occur primarily The section 7(a)(2) analysis is focused prohibitions against take and harm are or solely on non-Federal lands. To not only on these populations but also discussed, in part, below. achieve recovery of these species on the habitat conditions necessary to The primary purpose of the Act is the requires cooperative conservation efforts support them. conservation of endangered and on private, State, and Tribal lands. The jeopardy analysis usually threatened species and the ecosystems Listing will also require the Service to expresses the survival and recovery upon which they depend. The ultimate review any actions on Federal lands and needs of the species in a qualitative goal of such conservation efforts is the activities under Federal jurisdiction that fashion without making distinctions recovery of these listed species, so that may adversely affect the five species; between what is necessary for survival they no longer need the protective allow State plans to be developed under and what is necessary for recovery. measures of the Act. Subsection 4(f) of section 6 of the Act; encourage scientific Generally, if a proposed Federal action the Act requires the Service to develop investigations of efforts to enhance the is incompatible with the viability of the and implement recovery plans for the propagation or survival of the animals affected core area populations(s), conservation of endangered and under section 10(a)(1)(A) of the Act; and inclusive of associated habitat threatened species. The recovery promote habitat conservation plans on conditions, a jeopardy finding is planning process involves the non-Federal lands and activities under considered to be warranted, because of identification of actions that are section 10(a)(1)(B) of the Act. the relationship of each core area necessary to halt or reverse the species’ Section 7(a) of the Act, as amended, population to the survival and recovery decline by addressing the threats to its requires Federal agencies to evaluate of the species as a whole. survival and recovery. The goal of this their actions with respect to any species Section 9 Take process is to restore listed species to a that is proposed or listed as endangered point where they are secure, self- or threatened and with respect to its Section 9(a)(2) of the Act, and its sustaining, and functioning components critical habitat, if any is designated. implementing regulations found at 50 of their ecosystems. Regulations implementing this CFR 17.21, set forth a series of general Recovery planning includes the interagency cooperation provision of the prohibitions and exceptions that apply development of a recovery outline Act are codified at 50 CFR part 402. to all endangered wildlife. These shortly after a species is listed, Federal agencies are required to confer prohibitions, in part, make it illegal for preparation of a draft and final recovery with us informally on any action that is any person subject to the jurisdiction of plan, and revisions to the plan as likely to jeopardize the continued the United States to take (includes significant new information becomes existence of a proposed species. Section harass, harm, pursue, hunt, shoot, available. The recovery outline guides 7(a)(4) requires Federal agencies to wound, kill, trap, or collect, or to the immediate implementation of urgent confer with the Service on any action attempt any of these), import or export, recovery actions and describes the that is likely to jeopardize the continued ship in interstate commerce in the process to be used to develop a recovery existence of a species proposed for course of commercial activity, or sell or plan. The recovery plan identifies site- listing or result in destruction or offer for sale in interstate or foreign specific management actions that will adverse modification of proposed commerce any listed species. It also is achieve recovery of the species, critical habitat. If a species is listed illegal to knowingly possess, sell, measurable criteria that determine when subsequently, section 7(a)(2) requires deliver, carry, transport, or ship any a species may be downlisted or delisted, Federal agencies to ensure that activities wildlife that has been taken illegally. and methods for monitoring recovery they authorize, fund, or carry out are not Certain exceptions apply to agents of the progress. Recovery plans also establish likely to jeopardize the continued Service and State conservation agencies. a framework for agencies to coordinate existence of the species or destroy or We may issue permits to carry out their recovery efforts and provide adversely modify its critical habitat. If a otherwise prohibited activities estimates of the cost of implementing Federal action may adversely affect a involving endangered wildlife species recovery tasks. Recovery teams listed species or its critical habitat, the under certain circumstances. (comprised of species experts, Federal responsible Federal agency must enter Regulations governing permits are at 50 and State agencies, non-government into formal consultation with the CFR 17.22 for endangered species. Such organizations, and stakeholders) are Service. permits are available for scientific often established to develop recovery Federal activities that may affect the purposes, to enhance the propagation or plans. When completed, the recovery Cumberland darter, rush darter, survival of the species or for incidental outline, draft recovery plan, and the yellowcheek darter, chucky madtom, take in connection with otherwise final recovery plan will be available on and laurel dace include, but are not lawful activities. The yellowcheek our website (http://www.fws.gov/ limited to, the funding, carrying out, or darter is currently covered under a joint endangered), or from our Fish and the issuance of permits for reservoir Safe Harbor/Candidate Conservation Wildlife Service Field Office (see FOR construction, natural gas extraction, Agreement with Assurances (SHA/ FURTHER INFORMATION CONTACT). stream alterations, discharges, CCAA) in the upper Little Red River Implementation of recovery actions wastewater facility development, water watershed in Arkansas along with the generally requires the participation of a withdrawal projects, pesticide endangered speckled pocketbook broad range of partners, including other registration, mining, and road and mussel. Seven landowners have Federal agencies, States, Tribal, bridge construction. enrolled 3,845 hectares (9,500 acres) in nongovernmental organizations, the program since its inception in mid- businesses, and private landowners. Jeopardy Standard 2007 and 10 more landowners with Examples of recovery actions include Prior to and following listing and approximately 19, 420 hectares (48,000 habitat restoration (e.g., restoration of designation of critical habitat, if prudent acres) are pending with draft native vegetation), research, captive and determinable, the Service applies agreements. The CCAA would convert propagation and reintroduction, and an analytical framework for jeopardy to a SHA if the species becomes listed outreach and education. The recovery of analyses that relies heavily on the as threatened or endangered and would many listed species cannot be importance of core area populations to be covered by an enhancement of

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survival permit, which expires January including interstate and foreign (ii) specific areas outside the 1, 2044. commerce, or harming, or attempting geographic area occupied by a species at Under the Interagency Cooperative any of these actions, of the Cumberland the time it is listed, upon a Policy for Endangered Species Act darter, rush darter, yellowcheek darter, determination that such areas are Section 9 Prohibitions, published in the chucky madtom, and laurel dace; essential for the conservation of the Federal Register on July 1, 1994 (59 FR (2) Unlawful destruction or alteration species. 34272), we identify to the maximum of their habitats (e.g., unpermitted Conservation, as defined under extent practicable those activities that instream dredging, impoundment, section 3 of the Act, means to use and would or would not constitute a channelization, discharge of fill the use of all methods and procedures violation of section 9 of the Act if the material) that impairs essential that are necessary to bring an Cumberland darter, rush darter, behaviors such as breeding, feeding, or endangered or threatened species to the yellowcheek darter, chucky madtom, sheltering, or results in killing or point at which the measures provided and laurel dace are listed. The intent of injuring any of these species; pursuant to the Act are no longer this policy is to increase public (3) Violation of any discharge or water necessary. awareness as to the effects of these withdrawal permit that results in harm Critical habitat receives protection proposed listings on future and ongoing or death to any of these species or that under section 7 of the Act through the activities within a species’ range. We results in degradation of their occupied prohibition against Federal agencies believe, based on the best available habitat to an extent that essential carrying out, funding, or authorizing the information, that the following actions behaviors such as breeding, feeding and destruction or adverse modification of will not result in a violation of the sheltering are impaired; and critical habitat. Section 7(a)(2) requires provisions of section 9 of the Act, (4) Unauthorized discharges or consultation on Federal actions that provided these actions are carried out in dumping of toxic chemicals or other may affect critical habitat. The accordance with existing regulations pollutants into waters supporting the designation of critical habitat does not and permit requirements: Cumberland darter, rush darter, affect land ownership or establish a (1) Possession, delivery, or movement, yellowcheek darter, chucky madtom, refuge, wilderness, reserve, preserve, or including interstate transport that does and laurel dace that kills or injures other conservation area. Such not involve commercial activity, of these species, or otherwise impairs designation does not allow the specimens of these species that were essential life-sustaining requirements government or public to access private legally acquired prior to the publication such as breeding, feeding, or shelter. lands. Such designation does not in the Federal Register of the Federal Other activities not identified above require implementation of restoration, List of Endangered or Threatened will be reviewed on a case-by-case basis recovery, or enhancement measures by Wildlife and Plants; to determine if a violation of section 9 non-Federal landowners. Where a (2) Discharges into waters supporting of the Act may be likely to result from landowner seeks or requests Federal the Cumberland darter, rush darter, such activity should these fishes agency funding or authorization for an yellowcheek darter, chucky madtom, become listed. The Service does not action that may affect a listed species or and laurel dace, provided these consider these lists to be exhaustive and critical habitat, the consultation activities are carried out in accordance provides them as information to the requirements of section 7(a)(2) of the with existing regulations and permit public. Act would apply, but even in the event requirements (e.g., activities subject to If you have questions regarding of a destruction or adverse modification section 404 of the Clean Water Act and whether specific activities will likely finding, the obligation of the Federal discharges regulated under the National violate the provisions of section 9 of the action agency and the applicant is not Pollutant Discharge Elimination System Act, contact the Alabama, Arkansas, to restore or recover the species, but to (NPDES)); Tennessee, Kentucky, or Mississippi implement reasonable and prudent (3) Development and construction Ecological Services Field Office (see FOR alternatives to avoid destruction or activities designed and implemented FURTHER INFORMATION CONTACT section). adverse modification of critical habitat. under State and local water quality Requests for copies of regulations Prudency Determination regulations and implemented using regarding listed species and inquiries approved Best Management Practices; Section 4(a)(3) of the Act, as about prohibitions and permits should amended, and implementing regulations and be addressed to the U.S. Fish and (4) Any actions that may affect the (50 CFR 424.12), require that, to the Wildlife Service, Ecological Services Cumberland darter, rush darter, maximum extent prudent and Division, 1875 Century Boulevard, yellowcheek darter, chucky madtom, determinable, we designate critical Atlanta, GA 30345 (Phone 404/679- and laurel dace that are authorized, habitat at the time the species is 7313; Fax 404/679-7081). funded, or carried out by a Federal determined to be endangered or agency (e.g., bridge and highway Critical Habitat threatened. Our regulations (50 CFR construction, pipeline construction, 424.12(a)(1)) state that the designation Background hydropower licensing, etc.), when the of critical habitat is not prudent when action is conducted in accordance with Critical habitat is defined in section 3 one or both of the following situations the consultation and planning of the Act as: exist: (1) The species is threatened by requirements for listed species pursuant (i) the specific areas within the taking or other human activity, and to sections 7 and 10 of the Act. geographical area occupied by a species, identification of critical habitat can be Potential activities that we believe at the time it is listed in accordance expected to increase the degree of threat will likely be considered a violation of with the Act, on which are found those to the species, or (2) such designation of section 9 if these species become listed, physical or biological features critical habitat would not be beneficial include, but are not limited to, the (I) essential to the conservation of the to the species. following: species, and There is no documentation that the (1) Unauthorized possession, (II) that may require special Cumberland darter, rush darter, collecting, trapping, capturing, killing, management considerations or yellowcheek darter, chucky madtom, or harassing, sale, delivery, or movement, protection; and laurel dace are threatened by taking or

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other human activity such that future for these species may be subject (3) Cover or shelter; identification of critical habitat for each to Federal actions that trigger the (4) Sites for breeding, reproduction, of these species could be expected to section 7 consultation requirement, and rearing (or development) of increase the degree of threat to them. In such as the granting of Federal monies offspring; and the absence of finding that the for conservation projects and/or the (5) Habitats that are protected from designation of critical habitat would need for Federal permits for projects disturbance or are representative of the increase threats to a species, if there are (e.g., construction and maintenance of historical geographical and ecological any benefits to a critical habitat roads and bridges subject to section 404 distributions of a species. designation, then we would determine of the Clean Water Act). We are currently unable to identify that the designation of critical habitat is There may also be some educational the physical and biological features for prident. For these species, the potential or informational benefits to the the Cumberland darter, rush darter, benefits include: (1) Triggering designation of critical habitat. yellowcheek darter, chucky madtom, consultation under section 7 of the Act, Educational benefits include the and laurel dace, because information on in new areas for actions in which there notification of land owners, land the physical and biological features that may be a Federal nexus where it would managers, and the general public of the are considered essential to the not otherwise occur because, for importance of protecting the habitat of conservation of these species is not example, it is or has become these species. In the case of these known at this time. As discussed in the unoccupied or the occupancy is in species, this aspect of critical habitat ‘‘Species Information’’ section of this question; (2) focusing conservation designation would potentially benefit proposed rule, the life histories of these activities on the most essential features the conservation of these species. species are poorly known. Although, as and areas; (3) providing educational Therefore, since we have determined described above, we can surmise that benefits to State or county governments, that the designation of critical habitat habitat degradation from a variety of private entities, and the public as a will not likely increase the degree of factors has contributed to the decline of whole; and (4) preventing people from threat to the species and may provide these species, we do not know specifically the essential physical or causing inadvertent harm to the species. some measure of benefit, we find that biological features the habitat is The primary regulatory effect of designation of critical habitat is prudent for the Cumberland darter, rush darter, currently lacking. As we are unable to critical habitat is the section 7(a)(2) identify the physical and biological requirement that Federal agencies yellowcheek darter, chucky madtom, and laurel dace. features essential to the conservation of refrain from taking any action that these species, we are unable to identify destroys or adversely affects critical Critical Habitat Determinability areas that contain these features. habitat. Extant populations of the As stated above, section 4(a)(3) of the Therefore, although we have determined Cumberland darter occur in watersheds Act requires the designation of critical that the designation of critical habitat is that are roughly 60 percent privately habitat concurrently with the species’ prudent for the Cumberland darter, rush owned and 40 percent publicly-owned listing ‘‘to the maximum extent prudent darter, yellowcheek darter, chucky (U.S. Forest Service (USFS), DBNF). The and determinable.’’ Our regulations at 50 madtom, and laurel dace, since the U.S. Forest Service’s ownership is CFR 424.12(a)(2) state that critical biological requirements of these species typically fragmented and often occurs habitat is not determinable when one or are not sufficiently known, we find that on only one side of the stream. The rush both of the following situations exist: critical habitat for these species is not darter occupies streams that are (i) Information sufficient to perform determinable at this time. approximately 96 percent privately required analyses of the impacts of the How the Service Intends to Proceed owned industrial, forestry, agricultural, designation is lacking, or and urbanized lands. The State of (ii) The biological needs of the species We intend to begin preparation of Alabama, Jefferson County, and the are not sufficiently well known to proposed rulemaking in Fiscal Year Freshwater Land Trust own and permit identification of an area as 2011 and publish a proposed critical maintain about two percent of the rush critical habitat. habitat designation for Cumberland darter’s habitat; and the USFS manages When critical habitat is not darter, rush darter, yellowcheek darter, approximately two percent of habitat in determinable, the Act provides for an chucky madtom, and laurel dace in June the Bankhead National Forest. The U.S. additional year to publish a critical 2011. We will take the following steps Forest Service owns two percent of habitat designation (16 U.S.C. to develop a proposal of critical habitat yellowcheek darter habitat in Arkansas, 1533(b)(6)(C)(ii)). for the Cumberland darter, rush darter, while the Arkansas Game and Fish In accordance with section 3(5)(A)(i) yellowcheek darter, chucky madtom, Commission owns one percent. The and 4(b)(1)(A) of the Act and the and laurel dace: (1) Determine the remaining 97 percent is privately regulations at 50 CFR 424.12, in geographical area occupied by the owned. In the Little Chucky Creek determining which areas occupied by species at the time of listing; (2) identify watershed, the chucky madtom the species at the time of listing to the physical or biological features occupies habitat that is primarily designate as critical habitat, we consider essential to the conservation of the privately owned. Approximately five the physical and biological features species; (3) delineate areas within the percent of the Dunn Creek watershed is essential to the conservation of the geographical area occupied by the owned by the National Park Service species which may require special species that contain these features, and (i.e., portions of the Great Smoky management considerations or identify the special management Mountains National Park and Foothills protection. These include, but are not considerations or protections the Parkway), but the majority of the limited to: features may require; (4) delineate any watershed is privately owned habitat for (1) Space for individual and areas outside of the geographical area the madtom. The laurel dace is only population growth and for normal occupied by the species at the time of known to occur in waters within behavior; listing that are essential for the privately owned lands. Any of the (2) Food, water, air, light, minerals, or conservation of the species; and (5) abovementioned lands that may be other nutritional or physiological conduct appropriate analyses under designated as critical habitat in the requirements; section 4(b)(2) of the Act.

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To aid us in completing these steps, • Special management considerations or that are the basis for our conclusions we will use the best science available. protection that proposed critical regarding the proposal to list We also solicit the public for additional habitat may require; Cumberland darter (Etheostoma information (see Request for Public • Conservation programs and plans that susanae), rush darter (Etheostoma Information section below) and will protect these species and their phytophilum), yellowcheek darter consult experts on the Cumberland habitat; and; (Etheostoma moorei), chucky madtom darter, rush darter, yellowcheek darter, • Whether we could improve or modify (Noturus crypticus), and laurel dace chucky madtom, and laurel dace. our approach to designating critical (Phoxinus saylori) as endangered and While the proposed designation of habitat in any way to provide for our proposal regarding critical habitat critical habitat for these fishes is under greater public participation and for this species. preparation, the areas occupied by these understanding, or to better We will consider all comments and species in the United States will accommodate public concerns and information we receive during the continue to be subject to conservation comments. comment period on this proposed rule actions implemented under section Public Comment Procedures during preparation of a final 7(a)(1) of the Act, as well as rulemaking. Accordingly, our final consultation pursuant to section 7(a)(2) To ensure that any final action decision may differ from this proposal. resulting from this finding will be as of the Act for Federal activities that may Public Hearings affect any of these species, as accurate and as effective as possible, we determined on the basis of the best request that you send relevant The Act provides for one or more available scientific information at the information for our consideration. The public hearings on this proposal, if time of the action. In addition, the comments that will be most useful and requested. Requests must be received prohibition of taking Cumberland likely to influence our decisions are within 45 days after the date of darter, rush darter, yellowcheek darter, those that you support by quantitative publication of this proposal in the chucky madtom, and laurel dace under information or studies and those that Federal Register. Such requests must be section 9 of the Act (e.g., prohibitions include citations to, and analyses of, the made in writing and be addressed to the against killing, harming, harassing, and applicable laws and regulations. Please Field Supervisor at the address in the capturing endangered species) make your comments as specific as FOR FURTHER INFORMATION CONTACT continues to apply. possible and explain the bases for them. section. We will schedule public In addition, please include sufficient We will also continue to use our hearings on this proposal, if any are information with your comments to authorities to work with agencies and requested, and announce the dates, allow us to authenticate any scientific or other partners in the to conserve and times, and places of those hearings, as commercial data you include. For recover these species. We are working well as how to obtain reasonable instructions on how to submit with the partners to develop and accommodations, in the Federal comments, please see the Request for implement a framework for the Register and local newspapers at least Public Comments conservation of the Cumberland darter, 15 days before the hearing. Section. rush darter, yellowcheek darter, chucky Persons needing reasonable madtom, and laurel dace. Public Availability of Comments accommodations to attend and participate in a public hearing should As stated above in more detail, before Request for Public Information contact the Tennessee Ecological including your address, phone number, Services Field Office by telephone at We intend that any designation of e-mail address, or other personal 931-528-6481, as soon as possible. To critical habitat for the Cumberland identifying information in your allow sufficient time to process darter, rush darter, yellowcheek darter, comment, you should be aware that requests, please call no later than one chucky madtom, and laurel dace be as your entire comment—including your week before the hearing date. accurate as possible. Therefore, we will personal identifying information—may Information regarding this proposed continue to accept additional be made publicly available at any time. rule is available in alternative formats information and comments from all While you can ask us in your comment upon request. concerned governmental agencies, the to withhold your personal identifying scientific community, industry, or any information from public review, we Required Determinations other interested party concerning this cannot guarantee that we will be able to Clarity of the Rule finding. We are particularly interested do so. in information concerning: We are required by Executive Orders (1)The reasons why areas should or Peer Review 12866 and 12988 and by the should not be designated as critical In accordance with our joint policy Presidential Memorandum of June 1, habitat as provided by section 4 of the published in the Federal Register on 1998, to write all rules in plain Act (16 U.S.C. 1531, et seq.), including July 1, 1994 (59 FR 34270), we will seek language. This means that each rule we whether the benefits of designation the expert opinions of at least three publish must: would outweigh threats to the species appropriate and independent specialists (a) Be logically organized; that designation could cause (e.g., regarding this proposed rule. The (b) Use the active voice to address exacerbation of existing threats, such as purpose of such review is to ensure that readers directly; overcollection), such that the our proposed rule is based on (c) Use clear language rather than designation of critical habitat is scientifically sound data, assumptions, jargon; prudent; and and analyses. We will send these peer (d) Be divided into short sections and (2)Specific information on: reviewers copies of this proposed rule sentences; and • What areas contain physical and immediately following publication in (e) Use lists and tables wherever biological features essential for the the Federal Register. We will invite possible. conservation of the species; these peer reviewers to comment, If you feel that we have not met these • What areas are essential to the during the public comment period, on requirements, send us comments by one conservation of the species; and the specific assumptions and the data of the methods listed in the ADDRESSES

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section. To better help us revise the defined under the authority of the List of Subjects in 50 CFR Part 17 rule, your comments should be as National Environmental Policy Act of Endangered and threatened species, specific as possible. For example, you 1969, need not be prepared in Exports, Imports, Reporting and should tell us the names of the sections connection with regulations adopted recordkeeping requirements, or paragraphs that are unclearly written, pursuant to section 4(a) of the Act. We Transportation. which sections or sentences are too published a notice outlining our reasons long, the sections where you feel lists or for this determination in the Federal Proposed Regulation Promulgation tables would be useful, etc. Register on October 25, 1983 (48 FR Accordingly, we propose to amend 49244). Paperwork Reduction Act of 1995 (44 part 17, subchapter B of chapter I, title U.S.C. 3501, et seq.) References Cited 50 of the Code of Federal Regulations, as set forth below: This rule does not contain any new A complete list of all references cited collections of information that require in this rule is available on the Internet PART 17—[AMENDED] approval by Office of Management and at http://www.regulations.govor upon Budget (OMB) under the Paperwork 1. The authority citation for part 17 request from the Field Supervisor, Reduction Act. This rule will not continues to read as follows: impose recordkeeping or reporting Tennessee Ecological Services Field Office (see FOR FURTHER INFORMATION Authority: 16 U.S.C. 1361-1407; 16 U.S.C. requirements on State or local 1531-1544; 16 U.S.C. 4201-4245; Public Law CONTACT section). governments, individuals, businesses, or 99-625, 100 Stat. 3500; unless otherwise organizations. An agency may not Author(s) noted. conduct or sponsor, and a person is not 2. In §17.11(h) add the following to The primary authors of this document required to respond to, a collection of the List of Endangered and Threatened information unless it displays a are staff members of the U.S. Fish and Wildlife in alphabetical order under currently valid OMB control number. Wildlife Service’s Tennessee Ecological Fishes: Services Field Office, Kentucky National Environmental Policy Act Ecological Services Field Office, §17.11 Endangered and threatened We have determined that Arkansas Ecological Services Office, and wildlife. environmental assessments and the Mississippi Ecological Services * * * * * environmental impact statements, as Field Office. (h) * * *

Species Vertebrate population Historic range where Status When listed Critical habitat Special rules Common name Scientific name endangered or threatened

*******

FISHES

*******

Dace, laurel Phoxinus U.S.A (TN) Entire E TBD NA NA saylori

*******

Darter, Etheostoma U.S.A. (KY, Entire E TBD NA NA Cumberland susanae TN)

*******

Darter, rush Etheostoma U.S.A. (AL) Entire E TBD NA NA phytophilum

*******

Darter, Etheostoma U.S.A. (AR) Entire E TBD NA NA yellowcheek moorei

******* Madtom, chucky Noturus U.S.A. (TN) Entire E TBD NA NA crypticus

*******

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* * * * * Dated: June 2, 2010 Jeffrey L. Underwood, Acting Director, U.S. Fish and Wildlife Service. [FR Doc. 2010–15240 Filed 6–23– 10; 8:45 am] BILLING CODE 4310–55–S

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Notices Federal Register Vol. 75, No. 121

Thursday, June 24, 2010

This section of the FEDERAL REGISTER Programs, AMS, USDA, 1400 allotments, container regulations, and contains documents other than rules or Independence Avenue, SW., Room quality control. Assessments are levied proposed rules that are applicable to the 1406–S, Washington, DC 20250–0237; on handlers regulated under the public. Notices of hearings and investigations, Fax: (202) 720–8938); or submitted marketing orders. Also pursuant to committee meetings, agency decisions and through the Internet at http:// Section 8e of the Act, importers of rulings, delegations of authority, filing of petitions and applications and agency www.regulations.gov. raisins, dates, and dried prunes are statements of organization and functions are SUPPLEMENTARY INFORMATION: required to submit certain information. examples of documents appearing in this Title: Vegetable and Specialty Crop USDA requires several forms to be section. Marketing Orders. filed in order to enable the OMB Number: 0581–0178. administration of each marketing order Expiration Date of Approval: February program. These include forms covering DEPARTMENT OF AGRICULTURE 28, 2011. the selection process for industry Type of Request: Extension and members to serve on a marketing order’s Agricultural Marketing Service revision of a currently approved committee or board and ballots used in [Doc. No. AMS–FV–10–0034; FV10–901– information collection. referenda to amend or continue 1NC] Abstract: Marketing order programs marketing order programs. provide an opportunity for producers of Under Federal marketing orders, Notice of Request for Extension and fresh fruit, vegetables, and specialty producers and handlers are nominated Revision of a Currently Approved crops, in specified production areas, to by their peers to serve as representatives Information Collection work together to solve marketing on a committee or board which AGENCY: Agricultural Marketing Service, problems that cannot be solved administers each program. Nominees USDA. individually. This notice covers the must provide information on their following marketing order program qualifications to serve on the committee ACTION: Notice and request for or board. Nominees are selected by the comments. citations: 7 CFR parts 932 (California olives), 945 (Idaho/Oregon potatoes), Secretary. Formal rulemaking SUMMARY: In accordance with the 946 (Washington potatoes), 947 amendments must be approved in Paperwork Reduction Act of 1995 (44 (Oregon/California potatoes), 948 referenda conducted by USDA and the U.S.C. Chapter 35), this notice (Colorado potatoes), 953 (North Secretary. For the purposes of this announces the Agricultural Marketing Carolina/Virginia potatoes), 955 (Vidalia action, ballots are considered Service’s (AMS) intention to request an onions), 956 (Walla Walla onions), 958 information collections and are subject extension for and revision to a currently (Idaho/Oregon onions), 959 (South to the Paperwork Reduction Act. If an approved generic information collection Texas onions), 966 (Florida tomatoes), order is amended, handlers are asked to for vegetables and specialty crop 981 (California almonds), 982 (Oregon/ sign an agreement indicating their marketing order programs. Washington hazelnuts), 984 (California willingness to abide by the provisions of DATES: Comments on this notice must be walnuts), 985 (Northwest spearmint oil), the amended order. received by August 23, 2010 to be 987 (California dates), 989 (California Some forms are required to be filed assured of consideration. raisins), 993 (California prunes), and with the committee or board. The orders Additional Information or Comments: 999 (Specialty Crop Import Regulation). and their rules and regulations Contact Andrew Hatch, Supervisory Order regulations help ensure adequate authorize the respective commodities’ Marketing Specialist, Marketing Order supplies of high quality products for committees and boards, the agencies Administration Branch, Fruit and consumers and adequate returns to responsible for local administration of Vegetable Programs, AMS, USDA, 1400 producers. Under the Agricultural the orders, to require handlers and Independence Avenue, SW., STOP Marketing Agreement Act of 1937 (Act), producers to submit certain information. 0237, Room 1406–S, Washington, DC as amended (7 U.S.C. 601–674), Much of the information is compiled in 20250–0237; Telephone: (202) 720– industries enter into marketing order aggregate and provided to the respective 6862, Fax: (202) 720–8938, or E-mail: programs. The Secretary of Agriculture industries to assist in marketing [email protected]. (Secretary) is authorized to oversee the decisions. The committees and boards Small businesses may request order operations and issue regulations have developed forms as a means for information on this notice by contacting recommended by a committee or board persons to file required information Antoinette Carter, Marketing Order of representatives from each commodity relating to supplies, shipments, and Administration Branch, Fruit and industry. dispositions of their respective Vegetable Programs, AMS, USDA, 1400 The information collection commodities, and other information Independence Avenue, SW., STOP requirements in this request are needed to effectively carry out the 0237, Room 1406–S, Washington, DC essential to carry out the intent of the purpose of the Act and their respective 20250–0237; Telephone (202) 690–3919, Act, to provide the respondents the type orders, and these forms are utilized Fax: (202) 720–8938, or E-mail: of service they request, and to accordingly. [email protected]. administer the marketing order The forms covered under this Comments: Comments should programs. Under the Act, orders may information collection require the reference the document number and the authorize the following: Production and minimum information necessary to date and page number of this issue of marketing research including paid effectively carry out the requirements of the Federal Register, and be mailed to advertising, volume regulations, the orders, and their use is necessary to the Docket Clerk, Fruit and Vegetable reserves, including pools and producer fulfill the intent of the Act as expressed

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in the orders, and the rules and DEPARTMENT OF AGRICULTURE fresh fruits, vegetables and specialty regulations issued under the orders. crops, in specified production areas, to Agricultural Marketing Service The information collected is used work together to solve marketing only by authorized employees of the [Doc. No. AMS–FV–10–0033; FV10–902– problems that cannot be solved individually. This notice covers the committees and boards and authorized 1NC] following marketing order program representatives of the USDA, including Notice of Request for Extension and citations 7 CFR parts 905 (Florida AMS, Fruit and Vegetable Programs’ Revision of a Currently Approved citrus), 906 (Texas citrus), 915 (Florida regional and headquarters’ staff. Information Collection avocados), 916 (California nectarines), Authorized committee/board employees 917 (California peaches and pears), 920 AGENCY: are the primary users of the information Agricultural Marketing Service, (California kiwifruit), 922 (Washington and AMS is the secondary user. USDA. apricots), 923 (Washington cherries), ACTION: Estimate of Burden: Public reporting Notice and request for 924 (Oregon/Washington prunes), 925 comments. burden for this collection of information (California table grapes), 927 (Oregon/ is estimated to average 0.10 hours per SUMMARY: In accordance with the Washington pears), and 929 (Cranberries response. Paperwork Reduction Act of 1995 (44 grown in 10 States). Order regulations U.S.C. Chapter 35), this notice help ensure adequate supplies of high Respondents: Producers, handlers, quality product and adequate returns to processors, dehydrators, cooperatives, announces the Agricultural Marketing Service’s (AMS) intention to request an producers. Under the Agricultural manufacturers, importers, and public Marketing Agreement Act of 1937 (Act), members. extension and revision to a currently approved generic information collection as amended (7 U.S.C. 601–674) Estimated Number of Respondents: for marketing orders covering fruit industries enter into marketing order 20,626. crops. programs. The Secretary of Agriculture is authorized to oversee the order Estimated Number of Total Annual DATES: Comments on this notice must be operations and issue regulations Responses: 174,142. received by August 23, 2010 to be recommended by a committee of Estimated Number of Responses per assured of consideration. representatives from each commodity Respondent: 8.47 Additional Information: Contact industry. Andrew Hatch, Supervisory Marketing Estimated Total Annual Burden on The information collection Specialist, Marketing Order Respondents: 17,498.50 hours. requirements in this request are Administration Branch, Fruit and essential to carry out the intent of the Comments are invited on: (1) Whether Vegetable Programs, AMS, USDA, 1400 Act, to provide the respondents the type the proposed collection of information Independence Avenue, SW., STOP of service they request, and to is necessary for the proper performance 0237, Room 1406–S, Washington, DC administer the marketing order of the functions of the agency, including 20250–0237; Telephone: (202) 720– programs. Under the Act, orders may whether the information will have 6862, Fax: (202) 720–8938, E-mail: authorize the following: Production and practical utility; (2) the accuracy of the [email protected]. marketing research, including paid agency’s estimate of the burden of the Small businesses may request advertising; volume regulations; proposed collection of information information on this notice by contacting reserves, including pools and producer including the validity of the Antoinette Carter, Marketing Order allotments; container regulations; and methodology and assumptions used; (3) Administration Branch, Fruit and quality control. Assessments are levied ways to enhance the quality, utility and Vegetable Programs, AMS, USDA, 1400 on handlers regulated under the clarity of the information to be Independence Avenue, SW., STOP marketing orders. collected; and (4) ways to minimize the 0237, Room 1406–S, Washington, DC USDA requires several forms to be 20250–0237; Telephone (202) 690–3919, burden of the collection of information filed to enable the administration of Fax: (202) 720–8938, or e-mail: each marketing order program. These on those who are to respond, including [email protected]. include forms covering the selection through the use of appropriate Comments: Comments should process for industry members to serve automated, electronic, mechanical, or reference the document number and the on a marketing order’s committee or other technological collection date and page number of this issue of board and ballots used in referenda to techniques or other forms of information the Federal Register, and be mailed to amend or continue marketing order technology. the Docket Clerk, Fruit and Vegetable programs. All responses to this notice will be Programs, AMS, USDA, 1400 Under Federal marketing orders, summarized and included in the request Independence Avenue, SW., Room producers and handlers are nominated for OMB approval. All comments will 1406–S, Washington, DC 20250–0237; by their peers to serve as representatives also become a matter of public record. Fax: (202) 720–8938); or submitted on a committee or board which All comments received will be available through the Internet at http:// administers each program. Nominees for public inspection at the street www.regulations.gov. must provide information on their qualifications to serve on the committee address in the ‘‘Comment’’ section and SUPPLEMENTARY INFORMATION: or board. Nominees are appointed by can be viewed at: http:// Title: Marketing Orders for Fruit the Secretary. Formal rulemaking www.regulations.gov. Crops. OMB Number: 0581–0189. amendments must be approved in Dated: June 18, 2010. Expiration Date of Approval: referenda conducted by USDA and the David R. Shipman, November 30, 2010. Secretary. For the purposes of this Acting Administrator, Agricultural Marketing Type of Request: Extension and action, ballots are considered Service. Revision of a currently approved information collections and are subject [FR Doc. 2010–15297 Filed 6–23–10; 8:45 am] information collection. to the Paperwork Reduction Act. If an Abstract: Marketing order programs order is amended, handlers are asked to BILLING CODE 3410–02–P provide an opportunity for producers of sign an agreement indicating their

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willingness to abide by the provisions of on those who are to respond, including River Road Unit 118, Riverdale, MD the amended order. through the use of appropriate 20737-1238. Please state that your Some forms are required to be filed automated, electronic, mechanical, or comment refers to Docket No. APHIS- with the committee or board. The orders other technological collection 2010-0044. and their rules and regulations techniques or other forms of information Reading Room: You may read any authorize the respective commodities’ technology. comments that we receive on this committees and boards, the agencies All responses to this notice will be docket in our reading room. The reading responsible for local administration of summarized and included in the request room is located in room 1141 of the the orders, to require handlers and for OMB approval. All comments will USDA South Building, 14th Street and producers to submit certain information. also become a matter of public record. Independence Avenue SW., Much of the information is compiled in All comments received will be available Washington, DC. Normal reading room aggregate and provided to the respective for public inspection at the street hours are 8 a.m. to 4:30 p.m., Monday industries to assist in marketing address in the ‘‘Comment’’ section and through Friday, except holidays. To be decisions. The committees and boards can be viewed at: http:// sure someone is there to help you, have developed forms as a means for www.regulations.gov. please call (202) 690-2817 before persons to file required information Dated: June 18, 2010. coming. relating to supplies, shipments, and Other Information: Additional David R. Shipman, dispositions of their respective information about APHIS and its commodities, and other information Acting Administrator, Agricultural Marketing programs is available on the Internet at Service. needed to effectively carry out the (http://www.aphis.usda.gov). [FR Doc. 2010–15300 Filed 6–23–10; 8:45 am] purpose of the Act and their respective FOR FURTHER INFORMATION CONTACT: For orders, and these forms are utilized BILLING CODE 3410–02–P information on regulations for blood accordingly. and tissue collection at slaughtering and The forms covered under this DEPARTMENT OF AGRICULTURE rendering establishments, contact Dr. information collection require the Debra Cox, Senior Staff Veterinarian, minimum information necessary to Animal and Plant Health Inspection Surveillance and Identification effectively carry out the requirements of Service Programs, NCAHP, VS, APHIS, 4700 the orders, and their use is necessary to River Road Unit 200, Riverdale MD fulfill the intent of the Act as expressed [Docket No. APHIS-2010-0044] 20737; (301) 734-6954. For copies of in the orders rules and regulations. more detailed information on the The information collected is used Notice of Request for Extension of Approval of an Information Collection; information collection, contact Mrs. only by authorized employees of the Celeste Sickles, APHIS’ Information committees and authorized Blood and Tissue Collection at Slaughtering and Rendering Collection Coordinator, at (301) 851- representatives of the USDA, including 2908. AMS, Fruit and Vegetable Programs’ Establishments regional and headquarters’ staff. SUPPLEMENTARY INFORMATION: AGENCY: Animal and Plant Health Title: Blood and Tissue Collection at Authorized committee or board Inspection Service, USDA. employees are the primary users of the Slaughtering and Rendering ACTION: Extension of approval of an information and AMS is the secondary Establishments. information collection; comment OMB Number: 0579-0212. user. request. Estimate of Burden: Public reporting Type of Request: Extension of burden for this collection of information approval of an information collection. SUMMARY: In accordance with the Abstract: Under the Animal Health is estimated to average .28 hours per Paperwork Reduction Act of 1995, this response. Protection Act (7 U.S.C. 8301 et seq.), notice announces the Animal and Plant the Animal and Plant Health Inspection Respondents: Producers, handlers, Health Inspection Service’s intention to processors, cooperatives, and public Service (APHIS), U.S. Department of request an extension of approval of an Agriculture, is authorized to prevent the members. information collection associated with Estimated Number of Respondents: interstate spread of livestock diseases regulations for blood and tissue and for eradicating such diseases from 16,043. collection at slaughtering and rendering Estimated Number of Responses: the United States when feasible. In establishments to enhance animal connection with this mission, the 30,604. disease surveillance. Estimated Number of Responses per Veterinary Services (VS) program, Respondent: 1.91. DATES: We will consider all comments APHIS, conducts animal disease Estimated Total Annual Burden on that we receive on or before August 23, surveillance programs, including Respondents: 8,419 hours. 2010. diagnostic testing. Comments are invited on: (1) Whether ADDRESSES: You may submit comments The regulations in 9 CFR, subchapter the proposed collection of the by either of the following methods: C, part 71, ‘‘General Provisions,’’ provide information is necessary for the proper ∑ Federal eRulemaking Portal: Go to for the collection of blood and tissue performance of the functions of the (http://www.regulations.gov/ samples from livestock (horses, cattle, agency, including whether the fdmspublic/component/ bison, captive cervids, sheep and goats, information will have practical utility; main?main=DocketDetail&d=APHIS- swine, and other farmed animals) and (2) the accuracy of the agency’s estimate 2010-0044) to submit or view comments poultry at slaughter. Persons moving of the burden of the proposed collection and to view supporting and related livestock and poultry interstate for of information including the validity of materials available electronically. slaughter may only move the animals to the methodology and assumptions used; ∑ Postal Mail/Commercial Delivery: slaughtering or rendering (3) ways to enhance the quality, utility Please send one copy of your comment establishments that have been listed by and clarity of the information to be to Docket No. APHIS-2010-0044, the Administrator of APHIS. Federal collected; and (4) ways to minimize the Regulatory Analysis and Development, personnel, in conjunction with burden of the collection of information PPD, APHIS, Station 3A-03.8, 4700 establishment personnel, are required to

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complete a listing agreement and a Done in Washington, DC, this 17th day ACTION: Notice of meeting. facility inspection report (VS Form 10- of June 2010. 5). At APHIS’ discretion, slaughtering or SUMMARY: The Snohomish County Kevin Shea rendering establishment personnel will Resource Advisory Committee (RAC) collect blood and tissue samples to Acting Administrator, Animal and Plant will meet in Everett, Washington on July Health Inspection Service. assess the prevalence of disease and to 7, 2010. The committee is meeting to identify sources of disease. The test-at- [FR Doc. 2010–15301 Filed 6–23–10: 8:45 am] review and prioritize 2009/2010 slaughter program necessitates the use BILLING CODE 3410–34–S Snohomish County RAC Project of specimen submission and Proposals for funding. DATES: The meeting will be held on supplemental forms (VS Forms 10-4/10- DEPARTMENT OF AGRICULTURE 4A). If APHIS denies or withdraws an Wednesday, July 7, 2010, from 9 a.m. to establishment’s listing, the Forest Service 5 p.m. establishment may appeal the denial or ADDRESSES: The meeting will be held at withdrawal in writing to APHIS. Humboldt Resource Advisory the Snohomish County Administration We are asking the Office of Committee (RAC) Building West in the 6th floor Executive Management and Budget (OMB) to Conference Room, located at 3000 AGENCY: Forest Service, USDA. Rockefeller Ave., Everett, Washington approve our use of these information ACTION: Notice of meeting. collection activities for an additional 3 98201. years. SUMMARY: The Humboldt Resource FOR FURTHER INFORMATION CONTACT: The purpose of this notice is to solicit Advisory Committee (RAC) will meet in Peter Forbes, District Ranger, Darrington comments from the public (as well as Eureka, California. The committee Ranger District, phone (360) 436–2301, affected agencies) concerning our meeting is authorized under the Secure e-mail [email protected]. information collection. These comments Rural Schools and Community Self- Individuals who use will help us: Determination Act (Pub. L. 110–343) telecommunication devices for the deaf and in compliance with the Federal (TDD) may call the Federal Information (1) Evaluate whether the collection of Advisory Committee Act. The purpose Relay Service (FIRS) at 1–800–877–8339 information is necessary for the proper of the meeting is to orientate new between 8 a.m. and 8 p.m., Eastern performance of the functions of the committee members to the Secure Rural Standard Time, Monday through Friday. Agency, including whether the Schools Act, guidelines for Title II, and SUPPLEMENTARY INFORMATION: The information will have practical utility; Federal Advisory Committees Act and meeting is open to the public. More (2) Evaluate the accuracy of our receive public comment on the meeting information will be posted on the Mt. estimate of the burden of the collection subjects and proceedings. Baker-Snoqualmie National Forest Web of information, including the validity of DATES: The meeting will be held July 13, site at http://www.fs.fed.us/r6/mbs/ the methodology and assumptions used; 2010, from 5 p.m. to 7 p.m. projects/rac.shtml. (3) Enhance the quality, utility, and ADDRESSES: The meeting will be held at Comments may be sent via e-mail to clarity of the information to be the Six Rivers National Forest Office, [email protected] or via facsimile to collected; and 1330 Bayshore Way, Eureka, CA 95501. (360) 436–1309. All comments, including names and addresses when (4) Minimize the burden of the FOR FURTHER INFORMATION CONTACT: Julie collection of information on those who Ranieri, Committee Coordinator, Six provided, are placed in the record and are to respond, through use, as Rivers National Forest, 1330 Bayshore are available for public inspection and appropriate, of automated, electronic, Way, Eureka, CA 95503 (707) 441–3673; copying. The public may inspect mechanical, and other collection e-mail [email protected]. comments received at the Darrington Ranger District office at 1405 Emens technologies; e.g., permitting electronic SUPPLEMENTARY INFORMATION: The Avenue, Darrington, Washington, submission of responses. meeting is open to the public. Agenda during regular office hours (Monday items to be covered include: (1) Develop Estimate of burden: The public through Friday 8 a.m.–4:30 p.m.). reporting burden for this collection of and approve operational guidelines and information is estimated to average ground rules; (2) presentation on the Dated: June 16, 2010. 0.250395 hours per response. National Environmental Policy Act; (3) Y. Robert Iwamoto, Respondents: Slaughtering and Title II projects; (4) project solicitation Forest Supervisor. rendering establishment personnel. process and timeline; and (5) receive [FR Doc. 2010–15102 Filed 6–23–10; 8:45 am] public comment. An opportunity will be Estimated annual number of BILLING CODE 3410–11–M provided for the public to address the respondents: 66. Committee. Estimated annual number of Dated: June 18, 2010. COMMISSION ON CIVIL RIGHTS responses per respondent: 162.8333. Tyrone Kelley, Agenda and Notice of Public Meeting Estimated annual number of Forest Supervisor. responses: 10,747. of the North Carolina Advisory [FR Doc. 2010–15308 Filed 6–23–10; 8:45 am] Committee Estimated total annual burden on BILLING CODE P respondents: 2,691 hours. (Due to Notice is hereby given, pursuant to averaging, the total annual burden hours the provisions of the rules and may not equal the product of the annual DEPARTMENT OF AGRICULTURE regulations of the U.S. Commission on number of responses multiplied by the Civil Rights (Commission), and the reporting burden per response.) Forest Service Federal Advisory Committee Act All responses to this notice will be Snohomish County Resource Advisory (FACA), that a meeting of the North summarized and included in the request Committee Carolina Advisory Committee for OMB approval. All comments will (Committee) to the Commission will also become a matter of public record. AGENCY: Forest Service, USDA. convene on Wednesday, July 14, 2010,

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at 1 p.m. and adjourn at approximately SUMMARY: The ONMS is seeking DEPARTMENT OF COMMERCE 4 p.m. (EST) at the International Civil applications for the following vacant Rights Center, 134 S. Elm Street, seats on the Flower Garden Banks Patent and Trademark Office Greensboro, NC, 27401. The purpose of National Marine Sanctuary Advisory [Docket No. PTO–C–2010–0053] the meeting is for the Committee to Council: Conservation and Diving discuss its report on disparate discipline Operations. Applicants are chosen Notice of Enforcement Policy of minority youth by public school based upon their particular expertise Symposium on Combating districts. and experience in relation to the seat for Counterfeiting in the 21st Century Members of the public are entitled to which they are applying; community submit written comments. The and professional affiliations; philosophy AGENCY: United States Patent and comments must be received in the regarding the protection and Trademark Office, Department of Southern Regional Office by August 14, management of marine resources; and Commerce. 2010. The mailing address is Southern possibly the length of residence in the ACTION: Notice of public symposium. Regional Office, U.S. Commission on area affected by the sanctuary. Civil Rights, 61 Forsyth Street, Suite SUMMARY: To focus on the United States Applicants who are chosen as Government enforcement policy 18T40, Atlanta, GA 30301. Persons members should expect to serve three- wishing to e-mail their comments may regarding counterfeit goods involving year terms, pursuant to the council’s health and safety concerns and the do so to [email protected]. Persons Charter. that desire additional information United States Patent and Trademark Office’s (USPTO) efforts at home and should contact Peter Minarik, Regional DATES: Applications are due by August abroad combating counterfeiting, the Director, Southern Regional Office, at 2, 2010. (404) 562–7000 (or for hearing impaired USPTO and the National Intellectual ADDRESSES: TDD 913–551–1414). Application kits may be Property Rights Coordination Center Hearing-impaired persons who will obtained from Jennifer Morgan, (IPR Center) are co-hosting an attend the meeting and require the NOAA—Flower Garden Banks National enforcement policy symposium on services of a sign language interpreter Marine Sanctuary, 4700 Avenue U, combating counterfeiting in the 21st should contact the Regional Office at Bldg. 216, Galveston, TX 77551 or century. A three panel program is least ten (10) working days before the downloaded from the sanctuary Web planned for the symposium addressing scheduled date of the meeting. site http://flowergarden.noaa.gov. counterfeiting through regulatory Records generated from this meeting Completed applications should be sent procedures, criminal procedures, and may be inspected and reproduced at the to the same address. training/public awareness. There are a limited number of seats allocated for Southern Regional Office, as they FOR FURTHER INFORMATION CONTACT: members of the public who wish to become available, both before and after Jennifer Morgan, NOAA—Flower attend and observe the symposium. the meeting. Persons interested in the Garden Banks National Marine Requests to attend the symposium are work of this advisory committee are Sanctuary, 4700 Avenue U, Bldg. 216, required and must be submitted by advised to go to the Commission’s Web Galveston, TX 77551, 409–621–5151 electronic mail through the Internet to: site, http://www.usccr.gov, or to contact ext. 103, [email protected]. the Southern Regional Office at the [email protected]. Requests to above e-mail or street address. SUPPLEMENTARY INFORMATION: Located in attend the symposium should indicate The meeting will be conducted the northwestern Gulf of Mexico, the the following information: (1) The name pursuant to the provisions of the rules Flower Garden Banks National Marine of the person desiring to attend; (2) the and regulations of the Commission and Sanctuary includes three separate areas, person’s contact information (telephone FACA. known as East Flower Garden, West number and electronic mail address); Flower Garden, and Stetson Banks. The and (3) the organization(s) the person Dated in Washington, DC, June 18, 2010. Sanctuary was designated on January represents, if any. Peter Minarik, 17, 1992. Stetson Bank was added to the Dates and Times: The symposium Acting Chief, Regional Programs Sanctuary in 1996. The Sanctuary will be held on Wednesday, July 14, Coordination Unit. Advisory Council will consist of no 2010, from 1 p.m. to 4 p.m. The [FR Doc. 2010–15262 Filed 6–23–10; 8:45 am] more than 21 members; 16 non- deadline for receipt of requests to BILLING CODE 6335–01–P governmental voting members and 5 observe the symposium is 5 p.m. on governmental non-voting members. The Wednesday, July 7, 2010. Council may serve as a forum for ADDRESSES: The symposium will be DEPARTMENT OF COMMERCE consultation and deliberation among its held at the USPTO, Madison members and as a source of advice to Auditorium, Concourse Level, 600 National Oceanic and Atmospheric the Sanctuary manager regarding the Dulany Street, Alexandria, Virginia, Administration management of the Flower Garden 22314. Banks National Marine Sanctuary. Availability of Conservation Seat and FOR FURTHER INFORMATION CONTACT: Diving Operations Seat for the Flower Authority: 16 U.S.C. 1431, et seq. Elizabeth Shaw, Office of External Garden Banks National Marine (Federal Domestic Assistance Catalog Affairs, by phone 571–272–8494, by Sanctuary Advisory Council Number 11.429 Marine Sanctuary Program) facsimile to 571–273–0121, by e-mail at Dated: June 14, 2010. [email protected] or by mail AGENCY: Office of National Marine addressed to: Mail Stop OIPPE, United Sanctuaries (ONMS), National Ocean Daniel J. Basta, States Patent and Trademark Office, Service (NOS), National Oceanic and Director, Office of National Marine P.O. Box 1450, Alexandria, Virginia Atmospheric Administration (NOAA), Sanctuaries, National Ocean Service, 22313–1450, ATTN: Elizabeth Shaw. Department of Commerce (DOC). National Oceanic and Atmospheric Administration. SUPPLEMENTARY INFORMATION: The ACTION: Notice and request for [FR Doc. 2010–15095 Filed 6–23–10; 8:45 am] Enforcement Policy Symposium on applications. BILLING CODE 3510–22–M Combating Counterfeiting in the 21st

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Century will consist of three panel with which their applications are Extension of the Patent Application discussions focused on the challenges examined while also stimulating a Backlog Reduction Stimulus Plan, 75 FR and opportunities presented, changes in reduction of the backlog of unexamined 5041 (Feb. 1, 2010), 1351 Off. Gaz. Pat. the intellectual property enforcement patent applications pending before the Off. 202 (Feb. 23, 2010). The notice landscape, and interagency cooperation. USPTO. The USPTO is expanding the stated that the USPTO may further A panel on regulatory authority will Patent Application Backlog Reduction extend the procedures set forth in this address enforcement policy involving Stimulus Plan to permit all applicants to notice to all applicants (on either a counterfeiting and the regulatory participate by eliminating the small temporary or permanent basis), or may response. A second panel on criminal entity status requirement and adding a also discontinue the procedures set procedure will involve a discussion of few new requirements in view of the forth in this notice after June 30, 2010, enforcement policy involving the expansion. The program is also being depending upon the results of the Patent investigation and prosecution of extended until December 31, 2010, or Application Backlog Reduction counterfeit goods involving health and the date that 10,000 applications have Stimulus Plan. safety concerns. A third panel on the been accorded special status for The Backlog Reduction Notice United States Government’s domestic examination under the Patent required inter alia that the application and international training efforts Application Backlog Reduction for which special status is sought is a relating to counterfeiting and public Stimulus Plan, whichever occurs earlier. nonprovisional application that has an awareness is the final panel. These changes allow more applicants to actual filing date earlier than October 1, Government agencies that provide take advantage of the program. 2009, in which the applicant has enforcement training and public DATES: Effective Date: The changes in established small entity status under 37 awareness programs will be featured. this notice are effective on June 24, CFR 1.27. The program is being Should there be time during the 2010. The Patent Application Backlog expanded to permit all applicants to symposium, questions from members of Reduction Stimulus Plan became participate by eliminating the small the public in attendance may be effective on November 27, 2009. entity status requirement and adding a addressed. FOR FURTHER INFORMATION CONTACT: few new requirements in view of the The USPTO plans to make the Pinchus M. Laufer, Office of the expansion. The modifications set forth symposium available via Web cast. Web Associate Commissioner for Patent in this notice will apply to any petitions cast information will be available on the Examination Policy, by telephone at that are filed on or after the publication USPTO’s Internet Web site, http:// 571–272–7726; or via e-mail addressed date of this notice. This will permit www.uspto.gov, before the symposium. to [email protected]; or by mail more applications to qualify for the program and result in a greater Dated: June 18, 2010. addressed to: Box Comments Patents, reduction of the patent application David J. Kappos, Commissioner for Patents, P.O. Box backlog. Applicants may obtain special 1450, Alexandria, VA 22313–1450. Under Secretary of Commerce for Intellectual status for examination for as many as Property and Director of the United States SUPPLEMENTARY INFORMATION: The Patent and Trademark Office. fifteen applications under this program. USPTO published a notice in the Effective immediately, the USPTO [FR Doc. 2010–15307 Filed 6–23–10; 8:45 am] Federal Register providing an will accord special status for BILLING CODE 3510–16–P additional temporary basis (the Patent examination to a patent application that Application Backlog Reduction has an actual filing date earlier than Stimulus Plan) under which a small DEPARTMENT OF COMMERCE October 1, 2009, if the new entity applicant may have an requirements set forth in this notice are application accorded special status for United States Patent and Trademark satisfied, and the conditions set forth in examination if the applicant expressly Office the Backlog Reduction Notice published abandons another copending on November 27, 2009, other than the [Docket No.: PTO–P–2010–0048] unexamined application. See Patent small entity status requirement, are also Application Backlog Reduction satisfied. In view of the expansion, the Expansion and Extension of the Patent Stimulus Plan, 74 FR 62285 (Nov. 27, following new requirements are added Application Backlog Reduction 2009), 1349 Off. Gaz. Pat. Off. 304 (Dec. to the program: (1) The letter of express Stimulus Plan 22, 2009) (hereinafter ‘‘Backlog abandonment filed in the copending AGENCY: United States Patent and Reduction Notice’’). The Patent nonprovisional application must also Trademark Office, Commerce. Application Backlog Reduction include a statement that the applicant ACTION: Notice. Stimulus Plan allows small entity has not and will not file a new applicants having multiple applications application that claims the same SUMMARY: The United States Patent and currently pending before the USPTO to invention claimed in the expressly Trademark Office (USPTO) published a have greater control over the priority abandoned application (the phrase notice in the Federal Register providing with which their applications are ‘‘same invention’’ has the same meaning an additional temporary basis (the examined while also stimulating a as used in the context of statutory Patent Application Backlog Reduction reduction of the backlog of unexamined double patenting under 35 U.S.C. 101); Stimulus Plan) under which a small patent applications pending before the (2) the applicant has not received entity applicant may have an USPTO. The USPTO indicated that the special status for more than fourteen application accorded special status for program would last for a period ending other applications under this program; examination if the applicant expressly on February 28, 2010, but may be and (3) the petition under 37 CFR 1.102 abandons another copending extended for an additional time period must also: (i) Include a specific unexamined application. The Patent thereafter. See Patent Application identification of the relationship Application Backlog Reduction Backlog Reduction Stimulus Plan, 74 FR between the applications that qualifies Stimulus Plan allows small entity at 62287, 1349 Off. Gaz. Pat. Off. at 306. the application for special status (e.g., applicants having multiple applications The USPTO extended the Patent identifying, by name, a common currently pending before the USPTO to Application Backlog Reduction inventor, assignee or owner); (ii) have greater control over the priority Stimulus Plan until June 30, 2010. See identify, by application number if

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available, the application that is being Applicants are cautioned to exercise CA 90802–4213; phone (562)980–4001; expressly abandoned; (iii) provide a care in filing a letter of express fax (562)980–4018. statement certifying that applicant has abandonment in an application. The FOR FURTHER INFORMATION CONTACT: not filed petitions in more than fourteen USPTO cannot revive an application Jennifer Skidmore or Amy Sloan, other applications requesting special once the letter of express abandonment (301)713–2289. status under this program; and (iv) is recognized by the USPTO because the SUPPLEMENTARY INFORMATION: On provide a statement that applicant application was expressly and December 19, 2008, notice was agrees to make an election without intentionally abandoned by the published in the Federal Register (73 traverse in a telephonic interview if the applicant. See MPEP §§ 711.01 and FR 77630) that a request for a permit to Office determines that the claims of the 711.03(c). conduct enhancement on the species application to be made special are The procedure for petition under 37 identified above had been submitted by directed to two or more independent CFR 1.102 to make an application the above-named applicant. The special specified in the Backlog and distinct inventions (see 35 U.S.C. requested permit has been issued under Reduction Notice and this notice is 121, 37 CFR 1.141–142). If the examiner the authority of the Endangered Species being adopted on a temporary basis cannot reach the applicant after a Act of 1973, as amended (ESA; 16 until December 31, 2010. For a petition reasonable effort or applicant refuses to U.S.C. 1531 et seq.), and the regulations under 37 CFR 1.102 to be granted under make an election in a telephonic governing the taking, importing, and the procedure specified in this notice, interview, the examiner will treat the exporting of endangered and threatened the petition under 37 CFR 1.102 and the first claimed invention as constructively species (50 CFR parts 222–226). letter of express abandonment and its elected without traverse for Additional authorization is provided examination. In addition, the USPTO accompanying statement must be filed pursuant to sections 109(h) and 112(c) will accord special status for on or before December 31, 2010, and of the Marine Mammal Protection Act of examination under the Patent must be among the first 10,000 1972 as amended (MMPA; 16 U.S.C. Application Backlog Reduction applications accorded special status for examination under the Patent 1361 et seq.). Stimulus Plan to only the first 10,000 Permit No. 14186 authorizes Sea Application Backlog Reduction applications that meet the requirements World LLC to maintain up to six (6) Stimulus Plan. of the Patent Application Backlog non-releasable stranded Guadalupe fur Reduction Stimulus Plan. Dated: June 18, 2010. seals over a five-year period. For the purpose of the certification David J. Kappos, In compliance with the National that applicant has not filed petitions in Under Secretary of Commerce for Intellectual Environmental Policy Act of 1969 (42 more than fourteen other applications Property and Director of the United States U.S.C. 4321 et seq.), a final requesting special status under this Patent and Trademark Office. determination has been made that the program, any application that is [FR Doc. 2010–15306 Filed 6–23–10; 8:45 am] activity proposed is categorically assigned to or subject to an obligation to BILLING CODE 3510–16–P excluded from the requirement to assign to an entity or is owned by that prepare an environmental assessment or entity for which a petition under this environmental impact statement. program has been filed is considered to DEPARTMENT OF COMMERCE Issuance of this permit, as required by be a petition filed by applicant. Thus, the ESA, was based on a finding that the certification that applicant has not National Oceanic and Atmospheric such permit: (1) was applied for in good filed petitions in more than fourteen Administration faith; (2) will not operate to the other applications requesting special RIN 0648–XM26 disadvantage of such endangered status under this program is based upon species; and (3) is consistent with the ownership. Marine Mammals; File No. 14186 The procedure specified in the purposes and policies set forth in Backlog Reduction Notice and this AGENCY: National Marine Fisheries section 2 of the ESA. notice is applicable to applicants having Service (NMFS), National Oceanic and Dated: June 18, 2010. multiple applications currently pending Atmospheric Administration (NOAA), P. Michael Payne, before the USPTO and who are willing Commerce. Chief, Permits, Conservation and Education to expressly abandon one application to ACTION: Notice; issuance of permit. Division, Office of Protected Resources, have another application accorded National Marine Fisheries Service. SUMMARY special status for examination. The : Notice is hereby given that [FR Doc. 2010–15322 Filed 6–23–10; 8:45 am] Sea World LLC, 9205 South Park Center USPTO appreciates that there are BILLING CODE 3510–22–S applicants who are willing to expressly Loop, Suite 400, Orlando, FL 32819 abandon an application, but who have [Brad Andrews, Responsible Party] has only a single application pending before been issued an enhancement permit to DEPARTMENT OF COMMERCE the USPTO or no application for which maintain non-releasable stranded special status for examination is Guadalupe fur seals (Arctocephalus National Oceanic and Atmospheric desired. Applicants are reminded that townsendi). Administration 37 CFR 1.138(d) provides a procedure ADDRESSES: The permit and related by which an applicant may obtain a documents are available for review Stellwagen Bank National Marine refund of the search fee and excess upon written request or by appointment Sanctuary Final Revised Management claims fee paid in an application by in the following office(s): Plan: Notice of Availability submitting a petition (requires no fee) Permits, Conservation and Education AGENCY: Office of National Marine and letter of express abandonment. See Division, Office of Protected Resources, Sanctuaries (ONMS), National Ocean MPEP § 711. 01. The procedure set forth NMFS, 1315 East-West Highway, Room Service (NOS), National Oceanic and in 37 CFR 1.138(d), however, is 13705, Silver Spring, MD 20910; phone Atmospheric Administration (NOAA), applicable only to applications filed (301)713–2289; fax (301)713–0376; and Department of Commerce (DOC). under 35 U.S.C. 111(a) on or after Southwest Region, NMFS, 501 West ACTION: Notice of availability. December 8, 2004. Ocean Blvd., Suite 4200, Long Beach,

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SUMMARY: The final revised management DEPARTMENT OF DEFENSE Federal agencies and the public an early plan for the Stellwagen Bank National opportunity to comment on information Marine Sanctuary (SBNMS) has been Department of the Navy collection requests. OMB may amend or approved and is now available. This waive the requirement for public Meeting of the Ocean Research and plan is the result of a multi-year review consultation to the extent that public Resources Advisory Panel at the SBNMS and ONMS, and included participation in the approval process extensive public, as well as state, local AGENCY: Department of the Navy, DoD. would defeat the purpose of the information collection, violate State or and other Federal agency involvement. ACTION: Notice of Open Meeting. The plan is available for download on Federal law, or substantially interfere the Web site: http://stellwagen.noaa.gov. SUMMARY: The Ocean Research and with any agency’s ability to perform its For a hard copy or data CD of the plan Resources Advisory Panel (ORRAP) will statutory obligations. The Acting contact the sanctuary office at the hold a regularly scheduled meeting. The Director, Information Collection Clearance Division, Regulatory contact number identified below. meeting will be open to the public. DATES: The meeting will be held on Information Management Services, DATES: The final revised management Tuesday, July 27, 2010, from 8:30 a.m. Office of Management, publishes that plan is available to the public on June to 5:30 p.m. and on Wednesday, July 28, notice containing proposed information 17, 2010. 2010, from 8:30 a.m. to 2 p.m. Members collection requests prior to submission of the public should submit their of these requests to OMB. Each FOR FURTHER INFORMATION CONTACT: proposed information collection, Anne Smrcina, Stellwagen Bank comments in advance of the meeting to the meeting Point of Contact. grouped by office, contains the National Marine Sanctuary, 175 Edward following: (1) Type of review requested, ADDRESSES: The meeting will be held at Foster Road, Scituate, MA 02066; 781– e.g. new, revision, extension, existing or the Alaska SeaLife Center, 301 Railway 545–8026; anne.smrcinanoaa.gov. reinstatement; (2) Title; (3) Summary of Ave., Seward, AK 99664. Dated: June 14, 2010. the collection; (4) Description of the FOR FURTHER INFORMATION CONTACT: Dr. Daniel J. Basta, need for, and proposed use of, the Charles L. Vincent, Office of Naval information; (5) Respondents and Director, Office of National Marine Research, 875 North Randolph Street, frequency of collection; and (6) Sanctuaries. Suite 1425, Arlington, VA 22203–1995, Reporting and/or Recordkeeping [FR Doc. 2010–15097 Filed 6–23–10; 8:45 am] telephone 703–696–4118. burden. OMB invites public comment. BILLING CODE 3510–22–M SUPPLEMENTARY INFORMATION: This The Department of Education is notice of open meeting is provided in especially interested in public comment accordance with the Federal Advisory addressing the following issues: (1) Is Committee Act (5 U.S.C. App. 2). The this collection necessary to the proper CONSUMER PRODUCT SAFETY meeting will include discussions on functions of the Department; (2) will COMMISSION ocean research, resource management, this information be processed and used and other current issues in the ocean in a timely manner; (3) is the estimate Sunshine Act; Notice of Meeting science and management communities. of burden accurate; (4) how might the Dated: June 17, 2010. Department enhance the quality, utility, TIME AND DATE: Wednesday, June 30, H.E. Higgins, and clarity of the information to be 2010; 11 a.m.–12 Noon. Lieutenant, Judge Advocate Generals Corps, collected; and (5) how might the PLACE: Hearing Room 420, Bethesda U.S. Navy, Alternate Federal Register Liaison Department minimize the burden of this Towers, 4330 East West Highway, Officer. collection on the respondents, including Bethesda, Maryland. [FR Doc. 2010–15294 Filed 6–23–10; 8:45 am] through the use of information BILLING CODE 3810–FF–P technology. STATUS: Closed to the public. Dated: June 21, 2010. MATTERS TO BE CONSIDERED: James Hyler, DEPARTMENT OF EDUCATION Acting Director, Information Collection Compliance Status Report Clearance Division, Regulatory Information Notice of Proposed Information The Commission staff will brief the Management Services, Office of Management. Collection Requests Commission on the status of compliance Federal Student Aid matters. AGENCY: Department of Education. Type of Review: New. For a recorded message containing the SUMMARY: The Acting Director, OMB Number: Pending. latest agenda information, call (301) Information Collection Clearance Title: Student Assistance General 504–7948. Division, Regulatory Information Provisions—Satisfactory Academic Management Services, Office of Progress Policy. CONTACT PERSON FOR MORE INFORMATION: Management, invites comments on the Frequency: On Occasion. Todd A. Stevenson, Office of the proposed information collection Affected Public: Individuals or Secretary, U.S. Consumer Product requests as required by the Paperwork household; Not-for-profit institutions; Safety Commission, 4330 East West Reduction Act of 1995. State, Local, or Tribal Gov’t, State Highway, Bethesda, MD 20814, (301) DATES: Interested persons are invited to Educational Agencies (SEAs) or Local 504–7923. submit comments on or before August Educational Agencies (LEAs). Dated: June 21, 2010. 23, 2010. Reporting and Recordkeeping Hour Todd A. Stevenson, SUPPLEMENTARY INFORMATION: Section Burden: 3506 of the Paperwork Reduction Act of Responses: 21,672,244. Secretary. 1995 (44 U.S.C. Chapter 35) requires Burden Hours: 977,033. [FR Doc. 2010–15512 Filed 6–22–10; 4:15 pm] that the Office of Management and Abstract: These regulations identify BILLING CODE 6355–01–P Budget (OMB) provide interested the policies and procedures to ensure

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that students are making satisfactory established for the application narrative PLACE: Sheraton Chicago Hotel and academic progress in their program at a was an administrative error and unduly Towers, 301 East North Water Street, pace and a level to receive or continue restricts applicant flexibility. To correct Chicago, IL 60611, (312) 464–1000. to receive Title IV Higher Education Act this error, the Department makes the MEETING AGENDA: The Commission will of 1965, as amended (HEA) program following correction to the May 5 hold a public meeting to hold a funds. notice: discussion on a clearinghouse policy. Requests for copies of the proposed On page 24680, second column, the Commissioners will act on the following information collection request may be last paragraph, the word ‘‘must’’ is matters: (1) Consider and vote on a accessed from http://edicsweb.ed.gov, replaced with the words ‘‘are strongly Maintenance of Expenditure (MOE) by selecting the ‘‘Browse Pending encouraged to’’. policy; (2) consider and vote on the Collections’’ link and by clicking on link Extension. In light of this error, we are publication of proposed draft National number 4267. When you access the extending the deadline for the Voter Registration Act (NVRA) information collection, click on transmittal of applications to June 28, regulations for public comment. ‘‘Download Attachments’’ to view. 2010, and the deadline for Commissioners will consider other Written requests for information should intergovernmental review to August 27, administrative matters. be addressed to U.S. Department of 2010. The updated dates are as follows: HEARING AGENDA: The Commission will Education, 400 Maryland Avenue, SW., Deadline for Transmittal of conduct a public hearing to receive LBJ, Washington, DC 20202–4537. Applications: June 28, 2010. presentations on the following topic: Requests may also be electronically Deadline for Intergovernmental Voting System Pre-Election Logic and mailed to [email protected] or faxed Review: August 27, 2010. Accuracy Testing and Post-Election to 202–401–0920. Please specify the FOR FURTHER INFORMATION CONTACT: Audit Grants. Members of the public complete title of the information Larkin Tackett, U.S. Department of who wish to speak at the hearing, collection when making your request. Education, 400 Maryland Avenue, SW., regarding voting system pre-election Comments regarding burden and/or Room 4W338, Washington, DC 20202– logic and accuracy testing and post- the collection activity requirements 5970. Telephone: (202) 453–6615 or by election audit grants may send a request should be electronically mailed to e-mail: [email protected]. to participate to the EAC by 12 Noon [email protected]. Individuals who If you use a telecommunications CDT June 28, 2010. Due to time use a telecommunications device for the device for the deaf, call the Federal constraints, the EAC can select no more deaf (TDD) may call the Federal Relay Service, toll free, at 1–800–877– than ten participants amongst the Information Relay Service (FIRS) at 1– 8339. volunteers who request to participate. 800–877–8339. Electronic Access to This Document: The selected volunteers will be allotted [FR Doc. 2010–15341 Filed 6–23–10; 8:45 am] You can view this document, as well as three-minutes each to share their BILLING CODE 4000–01–P all other documents of this Department viewpoint. Participants will be selected published in the Federal Register, in on a first-come, first-served basis. text or Adobe Portable Document However, to maximize diversity of DEPARTMENT OF EDUCATION Format (PDF) on the Internet at the input, only one participant per [CFDA Number 84.215P] following site: http://www.ed.gov/news/ organization or entity will be chosen if fedregister. To use PDF you must have necessary. Participants may also submit Promise Neighborhoods Program Adobe Acrobat Reader, which is written testimony to be published at available free at this site. http://www.eac.gov. Requests to speak AGENCY: Office of Innovation and may be sent to the EAC via e-mail at Improvement, Department of Education. Note: The official version of this document [email protected], via mail addressed is the document published in the Federal ACTION: Notice inviting applications for Register. Free Internet access to the official to the U.S. Election Assistance new awards for fiscal year (FY) 2010; edition of the Federal Register and the Code Commission, 1201 New York Avenue, correction; extension of application of Federal Regulations is available on GPO NW., Suite 300, Washington, DC 20005, deadline. Access at: http://www.gpoaccess.gov/nara/ or by fax at 202–566–1392. All requests index.html. must include a description of what will SUMMARY: On May 5, 2010, we be said, contact information which will published in the Federal Register (75 Dated: June 21, 2010. be used to notify the requestor with FR 10492) a notice inviting applications James H. Shelton, III, status of request (phone number on for new awards for FY 2010 for the Assistant Deputy Secretary for Innovation and which a message may be left or e-mail), Promise Neighborhoods Program (May 5 Improvement. and include the subject/attention line notice). The May 5 notice established a [FR Doc. 2010–15346 Filed 6–23–10; 8:45 am] (or on the envelope if by mail): Grants: deadline of June 25, 2010, for the BILLING CODE 4000–01–P Logic/Accuracy/Audits. Please note that submission of applications under this these comments will be made available competition. Through this notice, we to the public at http://www.eac.gov. are correcting the May 5 notice and are Written comments from members of extending the deadline for transmittal of ELECTION ASSISTANCE COMMISSION the public, regarding voting system pre- applications and the deadline for election logic and accuracy testing and intergovernmental review. Sunshine Act Notice post-election audit grants will also be SUPPLEMENTARY INFORMATION: accepted. This testimony will be AGENCY: U.S. Election Assistance Correction. This notice corrects the included as part of the written record of Commission. May 5 notice by removing language that the hearing, and available on our Web established a maximum page limit for ACTION: Notice of Public Meeting and site. Written testimony must be received the application narrative for Hearing Agenda. by 5 pm. CDT June 28, 2010, and should applications submitted under this DATE & TIME: Monday, June 28, 2010, 10 be submitted via e-mail at competition. We are taking this action a.m.—12 p.m. CDT (Morning Session), [email protected], via mail addressed because the maximum page limit 1–4 p.m. CDT (Afternoon Session). to the U.S. Election Assistance

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Commission, 1201 New York Avenue, number EPA–HQ–OPPT–2010–0488 by restricted by statute. Certain other NW., Suite 300, Washington, DC 20005, one of the following methods: material, such as copyrighted material, or by fax at 202–566–1392. All • Federal eRulemaking Portal: http:// will be publicly available only in hard correspondence that contains written www.regulations.gov. Follow the on-line copy. Publicly available docket testimony must have in the subject/ instructions for submitting comments. materials are available electronically at attention line (or on the envelope if by • Mail: Document Control Office http://www.regulations.gov, or, if only mail): Written Submission for Grants: (7407M), Office of Pollution Prevention available in hard copy, at the OPPT Logic/Accuracy/Audits. and Toxics (OPPT), Environmental Docket. The OPPT Docket is located in Members of the public may observe Protection Agency, 1200 Pennsylvania the EPA Docket Center (EPA/DC) at Rm. but not participate in EAC meetings Ave., NW., Washington, DC 20460– 3334, EPA West Bldg., 1301 unless this notice provides otherwise. 0001. Constitution Ave., NW., Washington, • Members of the public may use small Hand Delivery: OPPT Document DC. The EPA/DC Public Reading Room electronic audio recording devices to Control Office (DCO), EPA East, Rm. hours of operation are 8:30 a.m. to 4:30 record the proceedings. The use of other 6428, 1201 Constitution Ave., NW., p.m., Monday through Friday, excluding recording equipment and cameras Washington, DC. Attention: Docket ID legal holidays. The telephone number of requires advance notice to and Number EPA–HQ–OPPT–2010–0488. the EPA/DC Public Reading Room is coordination with the Commission’s The DCO is open from 8 a.m. to 4 p.m., (202) 566–1744, and the telephone Communications Office.* Monday through Friday, excluding legal number for the OPPT Docket is (202) * View EAC Regulations holidays. The telephone number for the 566–0280. Docket visitors are required Implementing Government in the DCO is (202) 564–8930. Such deliveries to show photographic identification, Sunshine Act. are only accepted during the DCO’s pass through a metal detector, and sign This Meeting and Hearing Will Be normal hours of operation, and special the EPA visitor log. All visitor bags are Open to the Public. arrangements should be made for processed through an X-ray machine PERSON TO CONTACT FOR INFORMATION: deliveries of boxed information. and subject to search. Visitors will be Instructions: Direct your comments to Bryan Whitener, Telephone: (202) 566– provided an EPA/DC badge that must be docket ID number EPA–HQ–OPPT– 3100. visible at all times in the building and 2010–0488. EPA’s policy is that all Signed: llllllllllllll returned upon departure. comments received will be included in Donetta Davidson, the docket without change and may be FOR FURTHER INFORMATION CONTACT: For Chair, U.S. Election Assistance Commission. made available on-line at http:// technical information contact: Karen [FR Doc. 2010–15535 Filed 6–22–10; 4:15 pm] www.regulations.gov, including any Chu, Chemical Control Division BILLING CODE 6820–KF–P personal information provided, unless (7405M), Office of Pollution Prevention the comment includes information and Toxics, Environmental Protection claimed to be Confidential Business Agency, 1200 Pennsylvania Ave., NW., ENVIRONMENTAL PROTECTION Information (CBI) or other information Washington, DC 20460–0001; telephone AGENCY whose disclosure is restricted by statute. number: (202) 564–8773; fax number: Do not submit information that you (202) 564–9490; e-mail address: [EPA–HQ–OPPT–2010–0488 FRL–8830–2] consider to be CBI or otherwise [email protected]. For general information contact: The Agency Information Collection protected through regulations.gov or e- TSCA-Hotline, ABVI-Goodwill, 422 Activities; Proposed Collection; mail. The regulations.gov website is an South Clinton Ave., Rochester, NY Comment Request; Chemical-Specific ‘‘anonymous access’’ system, which 14620; telephone number: (202) 554– Rules, TSCA Section 8(a); EPA ICR No. means EPA will not know your identity 1404; e-mail address: TSCA- 1198.09, OMB Control No. 2070–0067 or contact information unless you provide it in the body of your comment. [email protected]. AGENCY: Environmental Protection If you send an e-mail comment directly SUPPLEMENTARY INFORMATION: Agency (EPA). to EPA without going through ACTION: Notice. regulations.gov, your e-mail address I. What Information is EPA Particularly will be automatically captured and Interested In? SUMMARY: In compliance with the included as part of the comment that is Pursuant to section 3506(c)(2)(A) of Paperwork Reduction Act (PRA) (44 placed in the docket and made available PRA, EPA specifically solicits U.S.C. 3501 et seq.), this document on the Internet. If you submit an comments and information to enable it announces that EPA is planning to electronic comment, EPA recommends to: submit a request to renew an existing that you include your name and other 1. Evaluate whether the proposed approved Information Collection contact information in the body of your collection of information is necessary Request (ICR) to the Office of comment and with any disk or CD-ROM for the proper performance of the Management and Budget (OMB). This you submit. If EPA cannot read your functions of the Agency, including ICR, entitled: ‘‘Chemical-Specific Rules, comment due to technical difficulties whether the information will have TSCA Section 8(a)’’ and identified by and cannot contact you for clarification, practical utility. EPA ICR No. 1198.09 and OMB Control EPA may not be able to consider your 2. Evaluate the accuracy of the No. 2070–0067, is scheduled to expire comment. Electronic files should avoid Agency’s estimates of the burden of the on January 31, 2011. Before submitting the use of special characters, any form proposed collection of information, the ICR to OMB for review and of encryption, and be free of any defects including the validity of the approval, EPA is soliciting comments on or viruses. methodology and assumptions used. specific aspects of the proposed Docket: All documents in the docket 3. Enhance the quality, utility, and information collection. are listed in the docket index available clarity of the information to be DATES: Comments must be received on at http://www.regulations.gov. Although collected. or before August 23, 2010. listed in the index, some information is 4. Minimize the burden of the ADDRESSES: Submit your comments, not publicly available, e.g., CBI or other collection of information on those who identified by docket identification (ID) information whose disclosure is are to respond, including through the

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use of appropriate automated electronic, by other appropriate means, such as on technology and systems for the purposes mechanical, or other technological the related collection instrument or of collecting, validating, and verifying collection techniques or other forms of form, if applicable. The display of OMB information, processing and information technology, e.g., permitting control numbers for certain EPA maintaining information, and disclosing electronic submission of responses. In regulations is consolidated in 40 CFR and providing information; adjust the particular, EPA is requesting comments part 9. existing ways to comply with any from very small businesses (those that Abstract: The Toxic Substances previously applicable instructions and employ less than 25) on examples of Control Act (TSCA) section 8(a) requirements which have subsequently specific additional efforts that EPA authorizes the Administrator of EPA to changed; train personnel to be able to could make to reduce the paperwork promulgate rules that require persons respond to a collection of information; burden for very small businesses who manufacture, import, or process search data sources; complete and affected by this collection. chemical substances and mixtures, or review the collection of information; who propose to manufacture, import, or and transmit or otherwise disclose the II. What Should I Consider when I process chemical substances and information. Prepare My Comments for EPA? mixtures, to maintain such records and The ICR provides a detailed You may find the following submit such reports to EPA as may be explanation of this estimate, which is suggestions helpful for preparing your reasonably required. Any chemical only briefly summarized here: comments: covered by TSCA for which EPA or 1. Explain your views as clearly as another Federal agency has a reasonable Estimated total number of potential possible and provide specific examples. need for information and which cannot respondents: 4. 2. Describe any assumptions that you be satisfied via other sources is a proper Frequency of response: On occasion. used. potential subject for a chemical-specific 3. Provide copies of any technical TSCA section 8(a) rulemaking. Estimated total average number of information and/or data you used that Information that may be collected under responses for each respondent: 1. support your views. TSCA section 8(a) includes, but is not Estimated total annual burden hours: 4. If you estimate potential burden or limited to, chemical names, categories 275 hours. costs, explain how you arrived at the of use, production volume, byproducts Estimated total annual costs: $14,080. estimate that you provide. of chemical production, existing data on This includes an estimated burden cost 5. Provide specific examples to deaths and environmental effects, of $14,080 and an estimated cost of $0 illustrate your concerns. exposure data, and disposal for capital investment or maintenance 6. Offer alternative ways to improve information. Generally, EPA uses and operational costs. the collection activity. chemical-specific information under 7. Make sure to submit your TSCA section 8(a) to evaluate the IV. Are There Changes in the Estimates comments by the deadline identified potential for adverse human health and from the Last Approval? under DATES. environmental effects caused by the 8. To ensure proper receipt by EPA, manufacture, importation, processing, There is no change in the total be sure to identify the docket ID number use or disposal of identified chemical estimated respondent burden compared assigned to this action in the subject substances and mixtures. Additionally, with that identified in the ICR currently line on the first page of your response. EPA may use TSCA section 8(a) approved by OMB. You may also provide the name, date, information to assess the need or set V. What is the Next Step in the Process and Federal Register citation. priorities for testing and/or further for this ICR? III. What Information Collection regulatory action. To the extent that reported information is not considered EPA will consider the comments Activity or ICR Does this Action Apply confidential, environmental groups, received and amend the ICR as to? environmental justice advocates, state appropriate. The final ICR package will Affected entities: Entities potentially and local government entities and other then be submitted to OMB for review affected by this ICR are those businesses members of the public will also have and approval pursuant to 5 CFR that fall under the North American access to this information for their own 1320.12. EPA will issue another Federal Industrial Classification System use. Register notice pursuant to 5 CFR (NAICS) codes 325, chemical Responses to the collection of 1320.5(a)(1)(iv) to announce the manufacturers and processors, and information are mandatory (see 40 CFR submission of the ICR to OMB and the 324110, petroleum refineries. part 704). Respondents may claim all or opportunity to submit additional Title: Chemical-Specific Rules, TSCA part of a notice confidential. EPA will comments to OMB. If you have any Section 8(a). disclose information that is covered by questions about this ICR or the approval ICR numbers: EPA ICR No. 1198.09, a claim of confidentiality only to the process, please contact the technical OMB Control No. 2070–0067. extent permitted by, and in accordance person listed under FOR FURTHER ICR status: This ICR is currently with, the procedures in TSCA section 14 INFORMATION CONTACT. scheduled to expire on January 31, and 40 CFR part 2. 2011. An Agency may not conduct or Burden statement: The annual public List of Subjects sponsor, and a person is not required to reporting and recordkeeping burden for Environmental protection, Reporting respond to, a collection of information, this collection of information is and recordkeeping requirements. unless it displays a currently valid OMB estimated to average 68.8 hours per control number. The OMB control response. Burden means the total time, Dated: June 17, 2010. numbers for EPA’s regulations in title 40 effort, or financial resources expended Stephen A. Owens, of the Code of Federal Regulations by persons to generate, maintain, retain, (CFR), after appearing in the Federal or disclose or provide information to or Assistant Administrator, Office of Chemical Safety and Pollution Prevention. Register when approved, are listed in 40 for a Federal agency. This includes the CFR part 9, are displayed either by time needed to review instructions; [FR Doc. 2010–15330 Filed 6–23–10; 8:45 am] publication in the Federal Register or develop, acquire, install, and utilize BILLING CODE 6560–50–S

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ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: The Act requirements of ARRA Section 1605 AGENCY affords EPA a 45-day period to review, under the authority of Section and, as appropriate, object to operating 1605(b)(2) [manufactured goods are not [FRL–9167–5] permits proposed by State permitting produced in the United States in Clean Air Act Operating Permit authorities under Title V of the Act. sufficient and reasonably available Program; Petition for Objection to a Section 505(b)(2) of the Act authorizes quantities and of a satisfactory quality] Federal Operating Permit for Waste any person to petition the EPA to the City of Newport, RI (‘‘City’’) for the Management of Louisiana L.L.C., Administrator within 60 days after the purchase of a foreign manufactured Woodside Landfill and Recycling expiration of this review period to ultraviolet (UV) light disinfection Center (WLRC), Walker, Livingston object to title V operating permits if EPA treatment system for the Easton Beach Parish, LA has not done so. Petitions must be based Project in Newport, Rhode Island. This only on objections to the permit that is a project specific waiver and only AGENCY: Environmental Protection were raised with reasonable specificity applies to the use of the specified Agency (EPA). during the public comment period product for the ARRA project being ACTION: Notice of final action. provided by the State, unless the proposed. Any other ARRA recipient petitioner demonstrates that it was that wishes to use the same product SUMMARY: This document announces impracticable to raise these issues must apply for a separate waiver based that the EPA Administrator has during the comment period or the on project specific circumstances. Based responded to a citizen petition asking grounds for the issues arose after this upon information submitted by the City EPA to object to the part 70 Operating period. and its consulting engineer, it has been Permit for WLRC, Walker, Livingston On January 2, 2009, EPA received a determined that there are currently no Parish, Louisiana, issued by the petition from the Petitioners requesting domestically manufactured UV Louisiana Department of Environmental that EPA object to the issuance of the disinfection treatment systems available Quality. Specifically, the Administrator title V operating permit to WLRC for the to meet the City’s project specifications has partially granted and partially operation of the landfill in Walker, and construction schedule. The denied the petition submitted by Tulane Livingston Parish, Louisiana. The Regional Administrator is making this Environmental Law Clinic on behalf of petitioners claim that: (1) The title V determination based on the review and the Louisiana Environmental Action permit fails to include monitoring recommendations of the Municipal Network, Concerned Citizens of requirements sufficient to assure Assistance Unit. The Assistant Livingston Parish, Mr. O’Neil compliance with permit limits; (2) Administrator of the Office of Couvillion, and Mr. Harold Wayne LDEQ erred in determining the amount Administration and Resources Breaud (Petitioners), to object to the part of carbon monoxide emissions for Management has concurred on this 70 operating permit for WLRC in purposes of assessing the applicability decision to make an exception to Livingston Parish, Louisiana of Prevention of Significant Section 1605 of ARRA. This action Pursuant to section 505(b)(2) of the Deterioration requirements; (3) the title permits the purchase of a foreign Clean Air Act (Act), the petitioner may V permit fails to include nonattainment manufactured UV light disinfection seek judicial review of those portions of new source review; and (4) LDEQ failed treatment system by the City, as the petition which EPA denied in the to meet the public notice requirements specified in its February 4, 2010 request. United States Court of Appeals for the before issuing the title V permit. DATES: Effective Date: June 15, 2010. appropriate circuit. Any petition for On May 27, 2010, the Administrator review shall be filed within 60 days issued an order partially granting and FOR FURTHER INFORMATION CONTACT: from the date this notice appears in the partially denying the petition. The order Katie Connors, Environmental Engineer, Federal Register, pursuant to section explains the reasons behind EPA’s (617) 918–1658, or David Chin, 307 of the Act. conclusion to partially grant and Environmental Engineer, (617) 918– ADDRESSES: You may review copies of partially deny the petition for objection. 1764, Municipal Assistance Unit (CMU), Office of Ecosystem Protection (OEP), the final order, the petition, and other Dated: June 11, 2010. supporting information at EPA Region 6, U.S. EPA, 5 Post Office Square, Suite Al Armendariz, 1445 Ross Avenue, Dallas, Texas 75202– 100, Boston, MA 02109–3912. Regional Administrator, Region 6. 2733. EPA requests that if at all SUPPLEMENTARY INFORMATION: [FR Doc. 2010–15331 Filed 6–23–10; 8:45 am] In possible, you contact the individual accordance with ARRA Section 1605(c), BILLING CODE 6560–50–P listed in the FOR FURTHER INFORMATION the EPA hereby provides notice that it CONTACT section to view copies of the is granting a project waiver of the final order, petition, and other requirements of Section 1605(b)(2) of supporting information. If you wish to ENVIRONMENTAL PROTECTION AGENCY Public Law 111–5, Buy American examine these documents, you should requirements, to the City of Newport, RI make an appointment at least 24 hours [FRL–9167–9] (‘‘City’’) for the purchase of a non- before visiting day. The final order is domestically manufactured medium- Notice of a Regional Project Waiver of also available electronically at: http:// pressure UV light disinfection treatment Section 1605 (Buy American) of the www.epa.gov/region07/air/title5/ system from Trojan Technologies, American Recovery and Reinvestment petitiondb/petitions/ manufactured in Canada, to meet the _ Act of 2009 (ARRA) to the City of woodside decision2009.pdf. City’s design and performance Newport, RI FOR FURTHER INFORMATION CONTACT: specifications and construction Bonnie Braganza, Air Permits Section, AGENCY: Environmental Protection schedule as part of its proposed Easton Multimedia Planning and Permitting Agency (EPA). Beach Project in Newport, RI. Trojan Division, EPA Region 6, 1445 Ross ACTION: Notice. Technologies has a U.S. manufacturing Avenue, Dallas, Texas 75202–2733, facility in Ontario, California, but that telephone (214) 665–7340, or email at SUMMARY: The EPA is hereby granting a site is not currently equipped to [email protected]. waiver of the Buy American conduct a specific product test

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procedure required for this project’s guarantee for the UV system, the construction of the project by at least 2– specifications. product will be subject to a device test 3 months. An independent review of the Section 1605 of the ARRA requires cell procedure. Trojan’s California site is submitted documentation by EPA’s that none of the appropriated funds may not equipped for this test procedure at national contractor confirmed this be used for the construction, alteration, this time. However, the Canadian site is evidence. maintenance, or repair of a public currently equipped for the test. The test Furthermore, the purpose of the building or a public works project is performed at the site of manufacture ARRA is to stimulate economic recovery unless all of the iron, steel, and in Canada, according to the City’s by funding current infrastructure manufactured goods used in the project design engineer. construction, not to delay projects that is produced in the United States, or The supporting documentation and are ‘‘shovel ready’’ by requiring potential unless a waiver is provided to the independent research and SRF eligible recipients, such as the City recipient by the head of the appropriate communication with select of Newport, RI, to revise their design agency, here the EPA. A waiver may be manufacturers of medium pressure UV standards and specifications as well as provided if EPA determines that (1) disinfection systems conducted by their construction schedule. The Applying these requirements would be EPA’s national contractor demonstrate imposition of ARRA Buy American inconsistent with the public interest; (2) that there are no U.S. manufacturers requirements in this case would result iron, steel, and the relevant able to meet all the project in unreasonable delay for this project. manufactured goods are not produced in specifications and the construction To delay this construction would directly conflict with a fundamental the United States in sufficient and schedule. The design engineer for the reasonably available quantities and of a economic purpose of ARRA, which is to City had identified one domestic satisfactory quality; or (3) inclusion of create or retain jobs. In addition, the manufacturer in the United States. iron, steel, and the relevant timely construction of the new According to the City’s design engineer, manufactured goods produced in the stormwater disinfection system would although the domestic manufacturer United States will increase the cost of allow further protection of Easton Beach could meet most of the project the overall project by more than 25 and its users. The project delays are of specifications and performance criteria, percent. particular concern for implementation if the City used the domestic UV The City is proposing a disinfection of the system within the recreation disinfection system, a redesign of the system to treat storm water discharging season of 2010. into Easton Beach, a recreational area. system would be required before The April 28, 2009 EPA HQ The UV disinfection system is designed construction could take place. The Memorandum, ‘‘Implementation of Buy to treat as much as 62 MGD of storm domestic system is larger than the American provisions of P.L. 111–5, the water that has historically been the proposed Trojan system and an increase ‘American Recovery and Reinvestment source of elevated concentration levels in the size of the structure housing for Act of 2009’ ’’ (‘‘Memorandum’’), defines of bacterial contamination sufficient to the UV system would be necessary. reasonably available quantity as ‘‘the cause health officials to close the Easton Additionally, the electrical system of quantity of iron, steel, or relevant Beach area for recreational purposes the UV system would also need to be manufactured good is available or will during certain weather/runoff events. redesigned if the domestic system was be available at the time needed and The project specifications are for a used. Project permits that have been place needed, and in the proper form or medium pressure UV light disinfection approved for the proposed Trojan specification as specified in the project system capable of treating up to 62 MGD system would likely have to be modified plans and design.’’ The same with the following parameters: (1) and/or new permits would need to be Memorandum defines ‘‘satisfactory Minimum 55% UV transmittance in secured because of the increase in the quality’’ as ‘‘the quality of steel, iron or storm water runoff, with a minimum of size of the structure. EPA confirmed that manufactured good specified in the 30 mg/L total suspended solids (TSS) the footprint would increase by 50 project plans and designs.’’ concentration, (2) 40 mW-sec/cm2 percent for the domestic system. There The Municipal Assistance Unit (CMU) applied UV dose, (3) The Rhode Island has already been considerable public has reviewed this waiver request and Department of Health beach closure concern regarding the size of the actual has determined that the supporting standard is that each sample shall be proposed stormwater disinfection documentation provided by the City less than or equal to 104 Enterococci structure being located in a popular and establishes both a proper basis to colonies/100 mL; a 20 year lifetime busy recreational section of Newport. specify a particular manufactured good, process performance guarantee will be There is a great deal of local and tourist and that the domestic manufactured required of the disinfection system traffic in the area. In addition, there are good that is currently available does not supplier, (4) Allowable headloss at Peak a number of site constraints involved meet all of the design specifications and Flow 18 inches, maximum from the with the proposed project. For example, the construction schedule for the controlling weir to the discharge pumps one of the design requirements noted by proposed project. The information outlet, (5) Requisite UV dose at 254 nm the City of Newport was that the amount provided is sufficient to meet the wavelength: 40 mW-sec/cm2, (6) of land that may be disturbed is less following criteria listed under Section Ultraviolet transmittance at 253.7 nm: than 25,000 square feet in order to 1605(b) of the ARRA and in the April 55%, and (7) effluent to be able to meet minimize impacts to existing buried 28, 2009 Memorandum: Iron, steel, and 30 mg/L of Total Suspended Solids utilities, the existing street or right-of- the manufactured goods are not (TSS). way, as well as the nearby stream and produced in the United States in Trojan Technologies (‘‘Trojan’’) dam. The City is concerned that sufficient and reasonably available manufactures the applicable 3000+ UV significantly increasing the size of the quantities and of a satisfactory quality. disinfection treatment unit domestically structure will raise additional public The March 31, 2009 Delegation of in the Ontario, California plant as well concern and would indefinitely delay Authority Memorandum provided as outside the U.S. in Canada. However, the project. The redesign of the structure Regional Administrators with the due to the beach closure standard by the would take months to complete and that temporary authority to issue exceptions RIDOH and the specification of a 20 along with the expected permitting to Section 1605 of the ARRA within the year lifetime process performance process would ultimately delay the geographic boundaries of their

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respective regions and with respect to • People with Disabilities: Contact the • Commercial overnight mail (other requests by individual grant recipients. FCC to request reasonable than U.S. Postal Service Express Mail Having established both a proper accommodations (accessible format and Priority Mail) must be sent to 9300 basis to specify the particular good documents, sign language interpreters, East Hampton Drive, Capitol Heights, required for this project and that this CART, etc.) by e-mail: [email protected] MD 20743. manufactured good was not available or phone: 202–418–0530 or TTY: 202– • U.S. Postal Service first-class, from a producer in the United States, 418–0432. Express, and Priority mail must be the City is hereby granted a waiver from For detailed instructions for addressed to 445 12th Street, SW., the Buy American requirements of submitting comments and additional Washington, DC 20554. Section 1605(a) of Public Law 111–5. information on the rulemaking process, Parties shall also serve one copy with This waiver permits use of ARRA funds see the SUPPLEMENTARY INFORMATION the Commission’s copy contractor, Best for the purchase of a non-domestic section of this document. Copy and Printing, Inc. (BCPI), Portals manufactured ultraviolet light II, 445 12th Street, SW., Room CY–B402, FOR FURTHER INFORMATION CONTACT: disinfection treatment system Washington, DC 20554, (202) 488–5300, documented in City’s waiver request Chris Killion or David Tannenbaum, or via e-mail to [email protected]. submittal dated February 4, 2010. This Office of General Counsel, 202–418– The inquiry this Notice initiates shall supplementary information constitutes 1700. be treated as a ‘‘permit-but-disclose’’ the detailed written justification SUPPLEMENTARY INFORMATION: This is a proceeding in accordance with the required by Section 1605(c) for waivers summary of the Commission’s Notice of Commission’s ex parte rules. Persons based on a finding under subsection (b). Inquiry (Notice), FCC 10–114, adopted making oral ex parte presentations are reminded that memoranda summarizing Authority: Pub. L. 111–5, section 1605. on June 17, 2010, and released on June 17, 2010. Interested parties may file the presentations must contain Dated June 15, 2010. comments on or before July 15, 2010, summaries of the substance of the Ira W. Leighton, and reply comments on or before presentations and not merely a listing of Acting Regional Administrator, EPA Region August 12, 2010. Comments and reply the subjects discussed. More than a one 1—New England. comments may be filed: (1) Using the or two sentence description of the views [FR Doc. 2010–15342 Filed 6–23–10; 8:45 am] Commission’s Electronic Comment and arguments presented generally is BILLING CODE 6560–50–P Filing System (ECFS), (2) using the required. Other requirements pertaining Federal Government’s eRulemaking to oral and written presentations are set Portal, or (3) by filing paper copies. See forth in section 1.1206(b) of the FEDERAL COMMUNICATIONS Electronic Filing of Documents in Commission’s rules. Ex parte comments COMMISSION Rulemaking Proceedings, 63 FR 24121, may be filed at any time except during the Sunshine Period. Ex parte comments [GN Docket No. 10–127; FCC 10–114] May 1, 1998. All filings related to this Notice should refer to GN Docket No. may be filed: (1) Using the Framework for Broadband Internet 10–127. Further, we strongly encourage Commission’s Electronic Comment Service parties to develop responses to this Filing System (ECFS), (2) using the Notice that adhere to the organization Federal Government’s eRulemaking AGENCY: Federal Communications Portal, (3) by filing paper copies, or (4) and structure of this Notice. Commission. by posting comments and ideas on the • Electronic Filers: Comments may be ACTION: Notice. Broadband.gov blog at http:// filed electronically using the Internet by blog.broadband.gov/?categoryId=494971 SUMMARY: This document begins an accessing the ECFS: http:// or on http://broadband.ideascale.com/ open, public process to consider the fjallfoss.fcc.gov/ecfs2/. • a/ideafactory.do?discussionID=11271. adequacy of the current legal framework Paper Filers: Parties who choose to In addition to the usual methods for within which the Commission promotes file by paper must file an original and filing ex parte comments, the investment and innovation in, and four copies of each filing. If more than Commission is allowing ex parte protects consumers of, broadband one docket or rulemaking number comments in this proceeding to be filed Internet service. Recent developments— appears in the caption of this by posting comments on http:// including a decision of the United proceeding, filers must submit two blog.broadband.gov/?categoryId=494971 States Court of Appeals for the District additional copies for each additional and on http://broadband.ideascale.com/ of Columbia Circuit and affirmation docket or rulemaking number. a/ideafactory.do?discussionID=11271. from Congress that the Commission Filings can be sent by hand or Accordingly, persons wishing to plays a vital role with respect to messenger delivery, by commercial examine the record in this proceeding broadband—lead the Commission to overnight courier, or by first-class or should examine the record on ECFS, seek comment on our legal framework overnight U.S. Postal Service mail. All http://blog.broadband.gov/ for broadband Internet service. filings must be addressed to the ?categoryId=494971 and http:// DATES: Comments must be submitted by Commission’s Secretary, Office of the broadband.ideascale.com/a/ July 15, 2010, and reply comments must Secretary, Federal Communications ideafactory.do?discussionID=11271. be submitted by August 12, 2010. Commission. Although those posting comments on ADDRESSES: You may submit comments, • All hand-delivered or messenger- the blog may choose to provide identified by GN Docket No. 10–127, by delivered paper filings for the identifying information or may any of the following methods: Commission’s Secretary must be comment anonymously, anonymous • Federal eRulemaking Portal: http:// delivered to FCC Headquarters at 445 comments will not be part of the record www.regulations.gov. Follow the 12th St., SW., Room TW–A325, in this proceeding and accordingly will instructions for submitting comments. Washington, DC 20554. The filing hours not be relied on by the Commission in • Federal Communications are 8 a.m. to 7 p.m. All hand deliveries reaching its conclusions in this Commission’s Web Site: http:// must be held together with rubber bands rulemaking. The Commission will not fjallfoss.fcc.gov/ecfs2/. Follow the or fasteners. Any envelopes must be rely on anonymous postings in reaching instructions for submitting comments. disposed of before entering the building. conclusions in this matter because of

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the difficulty in verifying the accuracy of Columbia Circuit, there was a settled Communications Act from applying all of information in anonymous postings. approach to facilities-based broadband provisions of Title II other than the Should posters provide identifying Internet service, which combined small number that are needed to information, they should be aware that minimal regulation with meaningful implement the fundamental universal although such information will not be Commission oversight. The Comcast service, competition and small business posted on the blog, it will be publicly opinion, however, held that the opportunity, and consumer protection available for inspection upon request. Commission went too far when it relied policies that have received broad Documents in GN Docket No. 10–127 on its ‘‘ancillary authority’’ to enjoin a support. We seek comment on the same will be available for public inspection cable operator from secretly degrading issues as they relate to terrestrial and copying during business hours at its customers’ lawful Internet traffic. wireless and satellite broadband the FCC Reference Information Center, Comcast appears to undermine prior Internet services, as well as on other Portals II, 445 12th Street, SW., Room understandings about the Commission’s factual and legal issues specific to these CY–A257, Washington, DC 20554. The ability under the current framework to wireless services that bear on their documents may also be purchased from provide consumers basic protections appropriate classification. We further BCPI, telephone (202) 488–5300, when they use today’s broadband seek comment on discrete issues, facsimile (202) 488–5563, TTY (202) Internet services. Moreover, the current including the states’ proper role with 488–5562, e-mail [email protected]. legal classification of broadband respect to broadband Internet service. People with Disabilities: To request Internet service is based on a record that Introduction materials in accessible formats for was gathered a decade ago. Congress, people with disabilities (Braille, large meanwhile, has reaffirmed the 3. This Commission exists ‘‘[f]or the print, electronic files, audio format), Commission’s vital role with respect to purpose of regulating interstate and send an e-mail to [email protected] or call broadband, and the Commission has foreign commerce in communication by the Consumer & Governmental Affairs developed a National Broadband Plan wire and radio so as to make available, Bureau at 202–418–0530 (voice), 202– recommending specific agency actions so far as possible, to all people of the 418–0432 (tty). to encourage deployment and adoption. United States * * * a rapid, efficient, 1. This Notice begins an open, public The Plan contains dozens of Nation-wide, and world-wide wire and process to consider the adequacy of the recommendations to fulfill the radio communication service with current legal framework within which congressional aims articulated in the adequate facilities at reasonable charges, the Commission promotes investment for the purpose of the national defense, Recovery Act, including specific and innovation in, and protects [and] for the purpose of promoting proposals to increase access and consumers of, broadband Internet safety of life and property through the affordability; maximize utilization of service. In this Notice we use the term use of wire and radio communications.’’ broadband Internet services; and ‘‘broadband Internet service’’ to refer to During more than 75 years of enhance public safety, consumer the bundle of services that facilities- technological progress—from the time of welfare and education throughout the based providers sell to end users in the tube radios and telephone switchboards United States. Roughly half of the Plan’s retail market. This bundle allows end to the modern era of converged digital recommendations are directed to the users to connect to the Internet, and services—the Commission has promoted Commission itself. often includes other services such as e- innovation and investment in new mail and online storage. In prior orders 2. These developments lead us to seek communications services and protected we have referred to this bundle as comment on our legal framework for and empowered the businesses and ‘‘broadband Internet access service.’’ We broadband Internet service. In addition consumers who depend on them. use the term ‘‘wired,’’ as in ‘‘wired to seeking original suggestions from 4. We have held to our pro- broadband Internet service,’’ to commenters, we ask questions about competition and pro-consumer mission distinguish platforms such as digital three specific approaches. First in the Internet Age. Indeed, for at least subscriber line (DSL), fiber, cable addressing the wired service offered by the last decade the Commission has modem, and broadband over power telephone and cable companies and taken a consistent approach to Internet lines (BPL), from platforms that rely on other providers, we seek comment on services—one that industry has wireless connections to provide Internet whether our ‘‘information service’’ endorsed and Congress and the United connectivity and other services in the classification of broadband Internet States Supreme Court have approved. last mile. We refer to the service that service remains adequate to support This approach consists of three may constitute a telecommunications effective performance of the elements: The Commission generally service as ‘‘Internet connectivity service’’ Commission’s responsibilities. We then does not regulate Internet content and or ‘‘broadband Internet connectivity ask for comment on the legal and applications; access to an Internet service.’’ As discussed below, Internet practical consequences of classifying service provider via a dial-up connectivity service allows users to Internet connectivity service as a connection is subject to the regulatory communicate with others who have ‘‘telecommunications service’’ to which rules for telephone service; and for the Internet connections, send and receive all the requirements of Title II of the broadband Internet services that most content, and run applications online. Communications Act would apply. consumers now use to reach the For administrative simplicity we Finally, we identify and invite comment Internet, the Commission has refrained incorporate the same distinction on a third way under which the from regulation when possible, but has between broadband and narrowband Commission would: (i) Reaffirm that the authority to step in when necessary that the Commission applied in the Internet information services should to protect consumers and fair classification orders we revisit here. remain generally unregulated; (ii) competition. That is, services with over 200 kbps identify the Internet connectivity 5. The first element of our consistent capability in at least one direction will service that is offered as part of wired approach, preserving the Internet’s be considered ‘‘broadband’’ for the broadband Internet service (and only capacity to enable a free and open forum particular purposes of these Notices. this connectivity service) as a for innovation, speech, education, and Until a recent decision of the United telecommunications service; and (iii) job creation, finds expression in (among States Court of Appeals for the District forbear under section 10 of the other provisions) section 230 of the

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Communications Act, which states communications service providers— telephony services. Our questions Congress’s conclusion that ‘‘[t]he shared the Commission’s view that the instead are directed toward addressing Internet and other interactive computer information service classification broadband Internet service in a way that services have flourished, to the benefit allowed the Commission to exercise is consistent with the Communications of all Americans, with a minimum of jurisdiction over broadband Internet Act, reduces uncertainty that may chill government regulation.’’ services when required. But the D.C. investment and innovation if allowed to 6. The second element, oversight of Circuit concluded that the Commission continue, and accomplishes Congress’s dial-up access to the Internet under the lacked authority to prohibit practices of pro-consumer, pro-competition goals for common carriage framework of Title II a major cable modem Internet service broadband. of the Communications Act, is a facet of provider that involved secret traditional telephone regulation. interruption of lawful Internet Discussion Although Internet users increasingly transmissions, which the Commission Background depend on broadband communications found were unjustified and 11. The Commission has long sought connections for Internet access, discriminatory and denied users the to ensure that communications approximately 5.6 million American ability to access the Internet content and networks support a robust marketplace households still use a dial-up telephone applications of their choice. Today, in for computer services operated over connection. the wake of the Comcast decision, the publicly accessible networks, from the 7. The third element of the Commission faces serious questions early database lookup services to today’s framework, restrained oversight of about the legal framework that will best social networking sites. To provide broadband Internet service, was enable it to carry out, with respect to expressed clearly on September 23, broadband Internet service, the context for the later discussion of the 2005, for example, when the purposes for which Congress Commission’s options for a suitable Commission released two companion established the agency. Meanwhile, framework for broadband Internet decisions. The first ‘‘establishe[d] a Congress has highlighted the service, we briefly describe this minimal regulatory environment for importance of broadband networks and historical backdrop. wireline broadband Internet access Internet-based content and services for The Commission’s Classification services.’’ It reclassified telephone economic growth and development and Decisions companies’ broadband Internet service has directed the Commission to develop 12. In 1966, the Commission initiated offerings as indivisible ‘‘information policies to address concerns about the its Computer Inquiries ‘‘to ascertain services’’ subject only to potential pace of deployment, adoption, and whether the services and facilities regulation under Title I of the utilization of broadband Internet offered by common carriers are Communications Act and the doctrine services in the United States. of ancillary authority. In that decision, 9. Comcast makes unavoidable the compatible with the present and the Commission articulated its belief question whether the Commission’s anticipated communications that ‘‘the predicates for ancillary current legal approach is adequate to requirements of computer users.’’ In jurisdiction are likely satisfied for any implement Congress’s directives. In this Computer I, the Commission required consumer protection, network Notice, we seek comment on the best ‘‘maximum separation’’ between large reliability, or national security way for the Commission to fulfill its carriers that offered data transmission obligation that we may subsequently statutory mission with respect to services subject to common carrier decide to impose on wireline broadband broadband Internet service in light of requirements and their affiliates that Internet access service providers.’’ The the legal and factual circumstances that sold data processing services. Refining second decision that day adopted exist today. We do so while standing this approach, in Computer II and principles for an open Internet, again ready to serve as a resource to Congress Computer III the Commission required expressing confidence that the as it considers additional legislation in facilities-based providers of ‘‘enhanced Commission had the ‘‘jurisdiction this area. Commenters may wish to services’’ to separate out and offer on a necessary to ensure that providers of address how the Commission should common carrier basis the ‘‘basic service’’ telecommunications for Internet access proceed on these issues in light of transmission component underlying * * * are operated in a neutral Congressional developments. their enhanced services. manner.’’ Earlier this year, the 10. We emphasize that the purpose of 13. In the Telecommunications Act of Commission unanimously reaffirmed in this proceeding is to ensure that the 1996, Congress built upon the Computer a Joint Statement on Broadband that Commission can act within the scope of Inquiries by codifying the Commission’s ‘‘[e]very American should have a its delegated authority to implement distinction between meaningful opportunity to benefit from Congress’s directives with regard to the ‘‘telecommunications services’’ used to the broadband communications era,’’ broadband communications networks transmit information (akin to offerings and that ‘‘[w]orking to make sure that used for Internet access. These networks of ‘‘basic services’’) and ‘‘information America has world-leading high-speed are within the Commission’s subject- services’’ that run over the network (akin broadband networks—both wired and matter jurisdiction over communication to ‘‘enhanced services’’). In a 1998 report wireless—lies at the very core of the by wire and radio and historically have to Congress, the Commission attempted FCC’s mission in the 21st Century.’’ been supervised by the Commission. We to indicate how it might apply the new Together, these and other agency do not suggest regulating Internet law in the Internet context. decisions show the Commission’s applications, much less the content of Approximately 98 percent of commitment to restrained oversight of Internet communications. We also will households with Internet connections broadband Internet service, and its not address in this proceeding other then used traditional telephone service equally strong resolve to ensure Internet facilities or services that to ‘‘dial up’’ their Internet access service universal service and protect consumers currently are lightly regulated or provider, which was typically a separate and fair competition in this area when unregulated, such as the Internet entity from their telephone company. In necessary. backbone, content delivery networks the report to Congress—widely known 8. Before the Comcast case, most (CDNs), over-the-top video services, or as the ‘‘Stevens Report,’’ after Senator stakeholders—including major voice-over-Internet-Protocol (VoIP) Ted Stevens—the Commission stated

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that Internet access service as it was connection to the Internet and writing for the six-Justice majority, then being provided was an interconnecting with the Internet recited that ‘‘ambiguities in statutes ‘‘information service.’’ The Stevens backbone, and sometimes including within an agency’s jurisdiction to Report declined to address whether protocol conversion, Internet Protocol administer are delegations of authority entities that provided Internet (IP) address number assignment, to the agency to fill the statutory gap in connectivity over their own network domain name resolution through a reasonable fashion. Filling these gaps facilities were offering a separate domain name system (DNS), network * * * involves difficult policy choices telecommunications component. The security, caching, network monitoring, that agencies are better equipped to courts, rather than the Commission, first capacity engineering and management, make than courts.’’ Furthermore, ‘‘[a]n answered that question. fault management, and troubleshooting. initial agency interpretation is not 14. In 2000 the United States Court of The Ruling also noted that ‘‘[n]etwork instantly carved in stone. On the Appeals for the Ninth Circuit held that monitoring, capacity engineering and contrary, the agency * * * must cable modem Internet service is a management, fault management, and consider varying interpretations and the telecommunications service to the troubleshooting are Internet access wisdom of its policy on a continuing extent that the cable operator ‘‘provides service functions that are generally basis.’’ its subscribers Internet transmission performed at an ISP or cable operator’s 19. Turning specifically to the over its cable broadband facility’’ and an Network Operations Center (NOC) or Communications Act, Justice Thomas information service to the extent the back office and serve to provide a steady wrote: ‘‘[T]he statute fails operator acts as a ‘‘conventional and accurate flow of information unambiguously to classify the [Internet Service Provider (ISP)].’’ At the between the cable system to which the telecommunications component of cable time, the Commission’s Computer subscriber is connected and the modem service as a distinct offering. Inquiry rules required telephone Internet.’’ The Commission This leaves federal telecommunications companies to offer their digital distinguished these functions from policy in this technical and complex subscriber line (DSL) transmission ‘‘Internet applications [also] provided area to be set by the Commission.’’ ‘‘The services as telecommunications through cable modem services,’’ questions the Commission resolved in services. The Ninth Circuit’s decision including ‘‘e-mail, access to online the order under review,’’ Justice Thomas thus put cable companies’ broadband newsgroups, and creating or obtaining summed up, ‘‘involve a subject matter transmission service on a regulatory par and aggregating content,’’ ‘‘home pages,’’ [that] is technical, complex, and with DSL transmission service. and ‘‘the ability to create a personal Web dynamic. The Commission is in a far 15. In 2002, the Commission page.’’ better position to address these exercised its authority to interpret the 17. The Commission found that cable questions than we are.’’ Justice Breyer Act and disagreed with the Ninth modem service was ‘‘an offering . . . concurred with Justice Thomas, stating Circuit. Addressing the classification of which combines the transmission of that he ‘‘believe[d] that the Federal cable modem service, the Commission data with computer processing, Communications Commission’s observed that ‘‘[t]he Communications information provision, and computer decision falls within the scope of its Act does not clearly indicate how cable interactivity, enabling end users to run statutorily delegated authority,’’ modem service should be classified or a variety of applications.’’ The although ‘‘perhaps just barely.’’ regulated.’’ Based on a factual record Commission further concluded that, ‘‘as 20. In dissent, Justice Scalia, joined by that had been compiled largely in 2000, it [was] currently offered,’’ cable modem Justices Souter and Ginsburg, expressed the Commission’s Cable Modem service as a whole met the statutory the view that the Commission had Declaratory Ruling described cable definition of ‘‘information service’’ adopted ‘‘an implausible reading of the modem service as ‘‘typically includ[ing] because its components were best statute[,] * * * thus exceed[ing] the many and sometimes all of the functions viewed as a ‘‘single, integrated service authority given it by Congress.’’ Justice made available through dial-up Internet that enables the subscriber to utilize Scalia reasoned that ‘‘the access service, including content, e-mail Internet access service,’’ with a telecommunications component of accounts, access to news groups, the telecommunications component that cable-modem service retains such ample ability to create a personal Web page, was ‘‘not . . . separable from the data independent identity that it must be and the ability to retrieve information processing capabilities of the service.’’ regarded as being on offer—especially from the Internet, including access to The Commission thus concluded that when seen from the perspective of the the World Wide Web.’’ The Commission cable modem service ‘‘does not include consumer or end user.’’ noted that cable modem providers often an offering of telecommunications 21. After the Supreme Court affirmed consolidated these functions ‘‘so that service to subscribers.’’ the Commission’s authority to classify subscribers usually do not need to 18. When the United States Supreme cable modem service, the Commission contract separately with another Court considered the Cable Modem eliminated the resulting regulatory Internet access provider to obtain Declaratory Ruling in the Brand X case, asymmetry between cable companies discrete services or applications, such as all parties agreed that cable modem and other broadband Internet service an e-mail account or connectivity to the service either is or includes an providers by issuing follow-on orders Internet, including access to the World information service. The Court therefore that extended the information service Wide Web.’’ The Commission defined focused, in pertinent part, on whether classification to broadband Internet cable modem service as ‘‘a service that the Commission permissibly interpreted services offered over DSL and other uses cable system facilities to provide the Communications Act in concluding wireline facilities, power lines, and residential subscribers with high-speed that cable modem service providers wireless facilities. The Commission Internet access, as well as many offer only an information service, rather nevertheless allowed these providers, at applications or functions that can be than a separate telecommunications their own discretion, to offer the used with high-speed Internet access.’’ service and information service. The broadband transmission component of 16. The Commission identified a Court’s opinion reaffirms that courts their Internet service as a separate portion of the cable modem service it must defer to the implementing agency’s telecommunications service. Exercising called ‘‘Internet connectivity,’’ which it reasonable interpretation of an that flexibility, providers—including described as establishing a physical ambiguous statute. Justice Thomas, more than 840 incumbent local

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telephone companies—currently offer and Broadband Consumer Protection goal.’’ In the Recovery Act, Congress broadband transmission as a Notice, moreover, the Commission further directed the Commission to telecommunications service expressly unanimously adopted the Internet produce a ‘‘detailed strategy for separate from their Internet information Policy Statement. In this Statement, the achieving affordability of such service service. Commission articulated four principles and maximum utilization of broadband ‘‘[t]o encourage broadband deployment infrastructure and service by the The Commission’s Established Policy and preserve and promote the open and public,’’ and a ‘‘plan for [the] use of Goals interconnected nature of the public broadband structure and services’’ to 22. In the 1996 Act, Congress made Internet,’’ and to ‘‘foster creation advance national goals such as public clear its desire that the Commission adoption and use of Internet broadband safety, consumer welfare, and promote the widespread availability of content, applications, services and education. These three pieces of affordable Internet connectivity attachments, and to insure consumers legislation, passed within a span of nine services, directing the Commission to benefit from the innovation that comes months, make clear that the adopt universal service mechanisms to from competition.’’ The principles are: Commission must retain its focus on ensure that ‘‘[a]ccess to advanced • consumers are entitled to access the implementing broadband policies that telecommunications and information lawful Internet content of their choice; encourage investment, innovation, and services * * * [is] provided in all • consumers are entitled to run competition, and promote the interests regions of the Nation.’’ Congress also applications and use services of their of consumers. instructed the Commission to choice, subject to the needs of law 26. Even more recently, the D.C. ‘‘encourage the deployment on a enforcement; Circuit’s rejection of the Commission’s reasonable and timely basis of advanced • consumers are entitled to connect attempt to address a broadband Internet telecommunications capability to all their choice of legal devices that do not service provider’s unreasonable traffic Americans.’’ The Commission’s harm the network; and disruption practices has cast a shadow classification decisions in the Cable • consumers are entitled to over the Commission’s prior Modem Declaratory Ruling and the later competition among network providers, understanding of its authority over follow-on orders were intended to application and service providers, and broadband Internet services. In late support the policy goal of encouraging content providers. All principles are 2007, the Commission received a widespread deployment of broadband. subject to reasonable network complaint alleging that Comcast was The Commission’s hypothesis was that management. blocking peer-to-peer traffic in violation classifying all of broadband Internet The Commission expressed of the Internet Policy Statement. In service as an information service, confidence that it had the ‘‘jurisdiction 2008, the Commission granted the outside the scope of any specific necessary to ensure that providers of complaint and directed Comcast to regulatory duty in the Act, would help telecommunications for Internet access disclose specific information about its achieve Congress’ aims. * * * are operated in a neutral network management practices to the 23. At the same time, the Commission manner.’’ Commission, submit a compliance plan acted with the express understanding Legal Developments detailing how it would transition away that its information service from unreasonable network classifications would not impair the 25. Recent legislative and judicial management practices, and disclose to agency’s ability to protect the public developments suggest a need to revisit the public the network management interest. For example, when the the Commission’s approach to practices it intends to use going Commission permitted telephone broadband Internet service. Since 2008, forward. Comcast challenged that companies to offer broadband Internet Congress has passed three significant decision in the D.C. Circuit, arguing service as solely an information service, pieces of legislation that reflect its (among other things) that the it emphasized that this new strong interest in ubiquitous Commission lacks authority to prohibit classification would not remove the deployment of high speed broadband a broadband Internet service provider agency’s ‘‘ample’’ Title I authority to communications networks and bear on from engaging in discriminatory accomplish policy objectives related to the Commission’s policy goals for practices that violate the four principles consumer protection, network broadband: the 2008 Farm Bill directing the Commission announced in 2005. reliability, and national security. The the Chairman to submit to Congress ‘‘a 27. On April 6, 2010, the D.C. Circuit Wireline Broadband Report and Order comprehensive rural broadband granted Comcast’s petition for review thus was accompanied by a Broadband strategy,’’ including recommendations and vacated the Commission’s Consumer Protection Notice, in which for the rapid buildout of broadband in enforcement decision, holding that the the Commission sought comment on ‘‘a rural areas and for how federal Commission had ‘‘failed to tie its framework that ensures that consumer resources can ‘‘best * * * overcome assertion of ancillary authority over protection needs are met by all obstacles that impede broadband Comcast’s Internet service to any providers of broadband Internet access deployment’’; the Broadband Data ‘statutorily mandated responsibility.’’’ service, regardless of the underlying Improvement Act, to improve data The Commission had argued that ending technology.’’ The Commission stressed collection and ‘‘promote the deployment Comcast’s secret practices was ancillary that its ancillary jurisdiction was ‘‘ample of affordable broadband services to all to the statutory objectives Congress to accomplish the consumer protection parts of the Nation’’; and the Recovery established for the Commission in goals we identify.’’ The Commission Act, which, among other things, sections 1 and 230(b) of the Act. The similarly referenced the Broadband appropriated up to $7.2 billion to court rejected that argument on the Consumer Protection Notice when it evaluate, develop, and expand access to ground that those sections are merely extended the information service and use of broadband services, and statements of policy by Congress—as classification to broadband Internet required the Commission to develop the opposed to grants of regulatory services offered over power lines and National Broadband Plan to ensure that authority—and thus were not sufficient wireless facilities. every American has ‘‘access to to support Commission action against 24. On the same day it adopted the broadband capability and * * * Comcast. The court also rejected the Wireline Broadband Report and Order establish benchmarks for meeting that Commission’s position that various

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other statutory provisions supported greatest possible opportunity for public Commission’s universal service ancillary authority. As to section 706 of comment, however, we are soliciting programs ‘‘shall’’ be based on this and the Telecommunications Act of 1996, initial and reply comments via the other enumerated principles. AT&T the court noted that the agency had traditional filing mechanisms, as well as notes that the Commission’s information previously interpreted section 706 as input through our recently expanded service classification for broadband not constituting a grant of authority and online participation tools. Internet service creates ‘‘tension’’ with held that the Commission was bound by ‘‘the text of Section 254(c)(1), which Continued Information Service that interpretation for purposes of the states that ‘[u]niversal service is an Classification and Reliance on Ancillary case. The court also rejected the evolving level of telecommunications Authority agency’s reliance on sections 201, 256, services that the Commission shall 257, and 623 of the Communications 30. In this part, we seek comment on establish periodically under this Act. maintaining the current classification of section.’ ’’ But, AT&T suggests, ‘‘[o]ther wired broadband Internet service as a evidence in the statutory text makes Approaches to Classification unitary information service. Under this clear that Congress did not intend to 28. In light of the legislative and approach, we would rely primarily on disable the Commission from using judicial developments described above, our ancillary authority to implement the universal service to support information we seek comment on whether our Commission’s broadband policies. We services.’’ For example, existing legal framework adequately seek comment on whether our ancillary • ‘‘Section 254(b) requires the supports the Commission’s previously authority continues to provide an Commission to use universal service to stated policy goals for broadband. First, adequate legal foundation. Throughout promote access to ‘advanced we ask whether the current information the last decade, the Commission has telecommunications and information service classification of broadband stated its consistent understanding that services,’ ’’ Internet service can still support Title I provided the Commission • ‘‘Section 254(c) * * * [refers] to an effective performance of the adequate authority to support effective ‘evolving level of telecommunications Commission’s core responsibilities. performance of its core responsibilities. services that the Commission shall Second, we ask for comment on the Commissioners, including the two establish periodically under this legal and practical consequences of former Chairmen who urged the section[,]’ ’’ and classifying the Internet connectivity information service approach, as well as • Section 254(c)(2) ‘‘expressly component of broadband Internet cable and telephone companies and authoriz[es] the Joint Board and the service as a ‘‘telecommunications other interested parties, individually Commission to ‘modif[y] * * * the service’’ to which the full weight of Title expressed this understanding. In Brand definition of the services that are II requirements would apply, and X, the Supreme Court appeared to supported by Federal universal support whether such a classification would confirm this widely held view, stating mechanisms.’ ’’ The reference to accurately reflect the current market that ‘‘the Commission remains free to ‘‘services’’ in section 254(c)(2) may facts. Finally, we identify and invite impose special regulatory duties on suggest that Congress intended comment on a third way, under which facilities-based ISPs under its Title I universal service policies to support the Commission would classify the ancillary jurisdiction.’’ The Comcast information services, even though the Internet connectivity portion of decision, however, causes us to definition of universal service in section broadband Internet service as a reexamine our ability to rely on Title I 254(c)(1) is explicitly limited to telecommunications service but would as the legal basis for implementing ‘‘telecommunications services.’’ simultaneously forbear, using the broadband policies. AT&T explains that section 254 section 10 authority Congress delegated 31. Some have suggested that ‘‘contains competing directives,’’ but to us, from all but a small handful of although the D.C. Circuit rejected the asserts that ‘‘the schizophrenic nature of provisions necessary for effective Commission’s theory of ancillary Section 254 is simply another example implementation of universal service, authority in Comcast, the Commission of the many ways in which the 1996 Act competition and small business can still accomplish many of its most is not a ‘model of clarity.’ ’’ opportunity, and consumer protection important broadband-related goals 33. We seek comment on whether we policies. without changing its classification of may interpret section 254 to give the 29. The Commission has frequently broadband Internet service as a unitary Commission authority to provide expressed its commitment to protecting information service. We seek comment universal service support for broadband consumers and promoting innovation, on the overall scope of the Internet service if that service is investment, and competition in the Commission’s authority regarding classified as a unitary information broadband context. We reaffirm that broadband Internet service in the wake service. Could we provide support to commitment here and ask commenters of the Comcast decision. Below we information service providers consistent to address—in general terms, as well as identify and seek comment on several with section 254(e), which says that in response to the specific questions particular concerns. ‘‘only an eligible telecommunications posed below—which of the three carrier designated under section 214(e) alternative regulatory frameworks for Universal Service shall be eligible to receive specific broadband Internet service (or what 32. Can the Commission reform its Federal universal service support,’’ and other framework) will best position the universal service program to support 214(e), which sets forth the framework Commission to advance these broadband Internet service by asserting for designating ‘‘telecommunications fundamental goals. We note that direct authority under section 254, carrier[s] * * * eligible to receive because the broadband Internet service combined with ancillary authority universal service support’’? classification questions posed in this under Title I? AT&T, for example, 34. AT&T posits that even after the part II.B involve an interpretation of the observes that section 254 provides that Comcast decision, the Commission Communications Act, the notice and ‘‘[a]ccess to advanced could bolster its reliance on section 254 comment procedures we follow here are telecommunications and information by also relying on several other not required under the Administrative services should be provided in all provisions of the Act. First, the Procedure Act. In order to provide the regions of the nation,’’ and that the ‘‘necessary and proper clause’’ in section

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4(i) of the Act allows the Commission to the Commission ‘‘shall encourage the of broadband deployment authorizes the ‘‘perform any and all acts, make such deployment on a reasonable and timely Commission to provide universal rules and regulations, and issue such basis of advanced telecommunications service support to spur that deployment. orders, not inconsistent with this capability to all Americans * * * by Would any such support be contingent chapter, as may be necessary in the utilizing, in a manner consistent with on continued negative findings in the execution of its functions.’’ Second, the the public interest, convenience, and annual broadband availability inquiry? Act makes clear that the Commission’s necessity, price cap regulation, Under section 706(b), would universal ‘‘core statutory mission’’ is to ‘‘make regulatory forbearance, measures that service programs have to be tailored to available, so far as possible, to all the promote competition in the local particular geographic areas where people of the United States * * * a telecommunications market, or other deployment is lagging, or could the rapid, efficient, Nation-wide and world- regulating methods that remove barriers Commission implement the program on wide wire and radio communication to infrastructure investment.’’ Section a national basis? Would the Commission service with adequate facilities at 706(c) defines ‘‘advanced be limited to direct support for reasonable charges.’’ Third, the text of telecommunications capability’’ as deployment, or could the Commission 254, as described above, suggests that ‘‘high-speed, switched, broadband interpret section 706(b) also to support Congress intended the Commission to telecommunications capability that broadband Internet services to low- support universal broadband Internet enables users to originate and receive income populations, such as is the case service. Finally, the policy directive in high-quality voice, data, graphics, and with our support for voice services in section 706 of the 1996 Act instructs the video telecommunications using any the Lifeline and Link Up programs? Commission to encourage the technology.’’ The D.C. Circuit rejected 38. For each of these legal theories, deployment on a reasonable and timely section 706(a) as a basis for the the Commission seeks comment on the basis of advanced telecommunications Commission’s Comcast order because administrative record that would be capability to all Americans. AT&T ‘‘[i]n an earlier, still-binding order * * * needed to successfully defend against a contends that section 706’s directive the Commission ruled that section 706 legal challenge to implementation of the supports the view that section 254 ‘does not constitute an independent theory. Would adopting these theories provides authority for supporting grant of authority,’ ’’ and ‘‘agencies ‘may be consistent with the federal Anti- broadband Internet services with not * * * depart from a prior policy sub Deficiency Act and Miscellaneous monies from the Universal Service silentio.’ ’’ We seek comment on whether Receipts Act? What other issues should Fund. We seek comment on AT&T’s the Commission should revisit and the Commission consider in evaluating analysis. change its conclusion that section 706(a) these legal theories? Are there other 35. The National Cable and is not an independent grant of authority. legal frameworks that would allow us to Telecommunications Association What findings would be necessary to promote universal service in the (NCTA) has put forward a similar legal reverse that interpretation? If the broadband context without revisiting theory rooted in section 254(h)(2) of the Commission were to find that section our classification decisions? Communications Act. That section gives 706(a) is an independent grant of Privacy the Commission authority ‘‘to enhance authority, would that subsection, read 39. The Commission has long * * * access to advanced in conjunction with sections 4(i) and telecommunications and information supported protecting the privacy of 254, provide a firm basis for the users of broadband Internet services. In services for all public and non-profit Commission to provide universal elementary and secondary school 2005, the Commission emphasized in service support for broadband Internet classrooms, health care providers, and the Wireline Broadband Report and services? ’’ Order that ‘‘[c]onsumers’ privacy needs libraries. NCTA contends that because 37. Some parties have suggested that ‘‘the use of broadband in the home has are no less important when consumers the Commission could rely on section communicate over and use broadband become a critical component of the 706(b) as a source of authority to American education system * * * it is Internet access than when they rely on support broadband Internet service with entirely reasonable to read the statutory [telephone] services.’’ The Commission Universal Service Fund money. That directive to support Internet access for believed at the time that it had section provides that: classrooms to include support for jurisdiction to enforce privacy residential broadband service to [t]he Commission shall * * * annually requirements, and ‘‘note[d] that long households where it is reasonably likely * * * initiate a notice of inquiry concerning before Congress enacted section 222 of that such service would be used for the availability of advanced the Act,’’ which requires providers of educational purposes.’’ Could the telecommunications capability to all telecommunications services to protect Americans * * * . In the inquiry, the confidential information, ‘‘the Commission interpret section 254(h)(2) Commission shall determine whether to permit this type of support for advanced telecommunications capability is Commission had recognized the need broadband Internet service? Is this being deployed to all Americans in a for privacy requirements associated approach a permissible extension of the reasonable and timely fashion. If the with the provision of enhanced Commission’s existing E–Rate program? Commission’s determination is negative, it services.’’ In 2007, the Commission Would this approach enable the shall take immediate action to accelerate extended the privacy protections of Commission to provide support for deployment of such capability by removing section 222 to interconnected VoIP broadband Internet service only to barriers to infrastructure investment and by services without resolving whether households with school-aged children, promoting competition in the interconnected VoIP services are or could the Commission provide telecommunications market. telecommunications services or support for adult education as well? We seek comment on whether we information services. More recently, the 36. Another legal theory for could interpret section 706(b) as an National Broadband Plan recommended promoting broadband deployment independent grant of authority. that the Commission work with the under the Commission’s current Specifically, we ask whether Congress’s Federal Trade Commission (FTC) to classification of broadband Internet direction that the Commission take protect consumers’ privacy in the service rests directly on section 706 of ‘‘immediate action’’ if it makes a broadband context. Indeed, we fully the 1996 Act. Section 706(a) states that negative determination about the state intend that our efforts with regard to

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privacy complement those of the FTC. for the purpose of promoting safety of address interconnection by We seek comment on the best approach life and property through the use of wire telecommunications carriers. Although for ensuring privacy for broadband and radio communications.’’ Comcast these provisions apply specifically to Internet service users under the did not address questions of national telecommunications carriers, the Commission’s current information defense, public safety, homeland proposal asserts that they are not service classification, and any legal security, or national security. Are there explicitly limited to the obstacles to protecting privacy that may bases for asserting ancillary authority telecommunications services provided exist if the Commission retains that over broadband Internet service by such carriers. classification. providers for purposes of advancing 43. Section 251(a) requires each such vital and clearly enumerated carrier ‘‘to interconnect directly or Access for Individuals With Disabilities Congressional purposes? Could the indirectly with the facilities and 40. Section 255 requires Commission use its ancillary authority equipment of other telecommunications telecommunications service providers as a legal foundation for protecting carriers.’’ Reading section 251(a) as and equipment manufacturers to make cyber security and other public safety limited to telecommunication services, their services and equipment accessible initiatives, such as 911 emergency and it has been suggested, ‘‘would make [the to individuals with disabilities, unless public warning and alerting services, Commission’s] rules promoting not readily achievable. Section 251(a)(2) with respect to broadband Internet interconnection irrelevant’’ as the major requires telecommunications carriers service? Specifically, could the carriers move increasingly toward ‘‘not to install network features, Commission rely on provisions in Title providing services over broadband functions, or capabilities that do not I either alone or in combination with Internet networks. Likewise, ‘‘[i]n a comply with the guidelines and provisions in Title II or Title III to world where traditional public standards established pursuant to support these public safety purposes, as telecommunications networks and section 255.’’ In the 2005 Wireline well as data reporting and/or network newer Internet-data-transmission Broadband Report and Order, the reliability and resiliency standards with networks are pervasively Commission committed to exercise its respect to broadband Internet services? interconnected,’’ it has been asserted, ‘‘it authority ‘‘to ensure achievement of As noted below, Title III contains makes no sense to preclude the FCC’s important policy goals of section 255’’ in several provisions that enable the interoperability efforts [pursuant to the broadband context. In 2007, the Commission to impose on spectrum section 256] from affecting information Commission exercised its ancillary licensees obligations that are in the services.’’ authority to extend section 255 to public interest. With the convergence of 44. We seek comment on this interconnected VoIP providers, and in the various modes of communications reasoning. What factual findings would 1999 the Commission similarly relied networks, many broadband Internet the Commission have to make to on ancillary authority to extend services incorporate wireline and support reliance on sections 251(a) and/ disability-related requirements to wireless elements. What would be the or 256 with respect to broadband voicemail and interactive menu effect if the Commission employed its Internet service? Would those facts services. The Commission also Title III authority to achieve public support exercise of authority sufficient exercised ancillary authority to extend safety goals with respect to wireless to implement the Commission’s section 225 telecommunications relay elements of such converged services? broadband policies in full, or in part? service obligations under the Could the Commission also regulate Under this approach, could the Commission’s rules to providers of wireline elements of such services Commission address conduct by interconnected VoIP. More recently, a through its Title III and Title I authority broadband Internet service providers unanimous Commission stated its belief because of the wireless elements that are not also telecommunications that disabilities should not stand in the incorporated into these services, or in carriers? Does reliance on sections way of Americans’ ‘‘opportunity to the interests of ensuring regulatory 251(a) and 256 limit Commission benefit from the broadband parity and predictability? Could the authority to protect competition and communications era.’’ The Commission Commission rely on the mandate in consumers to only those networks that has also announced its intent to section 706(a) to ‘‘encourage the are interconnected with the public consider how ‘‘[t]o better enable deployment on a reasonable and timely telephone network? If so, what are the Americans with disabilities to basis of advanced telecommunications practical implications of this limitation? experience the benefits of broadband.’’ capability to all Americans’’ to ensure What is the significance of the Comcast We seek comment on the best legal the security, reliability and resiliency of decision, which held that ‘‘[t]he approaches to extending disability- wired broadband Internet services, or to Commission’s attempt to tether its related protections to broadband advance other public safety and assertion of ancillary authority to Internet service users under the homeland security initiatives? section 256’’ was flawed in that context Commission’s current information because section 256 states that Addressing Harmful Practices by service classification. Could we exercise ‘‘[n]othing in this section shall be Internet Service Providers ancillary authority to ensure access for construed as expanding or limiting any people with disabilities? Could the 42. Although the D.C. Circuit rejected authority that the Commission’’ Commission rely on the mandate in the legal theory the Commission relied otherwise has under law? What else section 706(a) to ‘‘encourage the on to address Comcast’s interference should the Commission consider as it deployment on a reasonable and timely with its customers’ peer-to-peer evaluates the significance of sections basis of advanced telecommunications transmissions, some have suggested that 251(a) and 256 in this proceeding? capability to all Americans,’’ or the other theories of ancillary authority 45. Section 202(a) of the similar directive in section 706(b)? could support Commission action to Communications Act makes it unlawful protect against harmful practices of this for any common carrier to make any Public Safety and Homeland Security sort. For example, one commentator has unjust or unreasonable discrimination 41. As noted above, Congress created proposed that the Commission assert in charges, practices, classifications, the Commission, in part, ‘‘for the ancillary authority pursuant to sections regulations, facilities, or services for or purpose of the national defense, [and] 251(a) and 256 of the Act, which in connection with like communication

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service, directly or indirectly, by any covert blocking of online gaming or e- authorities to prevent harm to means or device, or to make or give any commerce services, perhaps—that does competition and consumers if or when undue or unreasonable preference or not obviously affect services clearly bad actors emerge anywhere in the advantage to any particular person, class addressed by Titles II, III, or VI? Could Internet space, and * * * agree that of persons, or locality, or to subject any the Commission rely on sections 624 or involvement should occur only where particular person, class of persons, or 629 of the Act to establish broadband necessary on a case-by-case base basis.’’ locality to any undue or unreasonable policy related to cable modem service? Commenters in other proceedings have prejudice or disadvantage. 48. We also invite comment on suggested similar approaches. We ask It has been suggested that ‘‘[i]f whether the portions of section 214(a) commenters to address whether the network operators are allowed the addressing discontinuance, reduction, Commission should pursue a regime in option of offering broadband Internet and impairment of service provide a which one or more third parties play a access services on a completely potential basis for an assertion of major role in setting standards and best unregulated basis, that option could ancillary authority regarding harmful practices relative to maintaining our enable them to end run Section 202(a)’’ Internet service provider practices. That policy goals for broadband Internet as carriers move toward providing provision mandates that a common service. Pursuant to what authority services over broadband Internet carrier may not ‘‘impair service to a could the Commission create a third networks, ‘‘and render that provision a community’’ without prior Commission party advisory group? What authority dead letter.’’ We seek comment on the approval. Impairment, in the section could the Commission delegate to such factual and legal assumptions 214(a) context, refers to both ‘‘the a third party or third parties? Would it underlying this argument, and whether adequacy’’ and ‘‘quality’’ of the service be appropriate for other federal this reasoning provides the Commission provided. governmental entities, such as the FTC, authority to address practices of 49. Are there other statutory to have a role in such an approach? broadband Internet service providers provisions that could support the Would the Commission have sufficient that endanger competition or consumer Commission’s exercise of ancillary ancillary authority under its information welfare. authority in this area? Do any statutory service framework to serve as a backstop 46. As the Commission argued to the provisions preclude such action if the if the third party is unable to resolve a D.C. Circuit in the Comcast case, section Commission retains its information dispute or implement a necessary 706(a) might also provide a basis for service classification? policy? prohibiting harmful practices of Internet 50. Other harmful practices by service providers. As noted above, the broadband Internet service providers Application of All Title II Provisions D.C. Circuit gave no weight to section may involve a failure to disclose 52. Title II of the Communications Act 706(a) because the Commission had practices to consumers. For instance, provides the Commission express determined in a prior order that section one problem identified by the authority to implement, for 706(a) is not an independent grant of Commission in the Comcast case was telecommunications services, rules authority. We seek comment on the best Comcast’s failure to identify to furthering universal service, privacy, reading of section 706(a). We also seek customers its practice of degrading peer- access for persons with disabilities, and comment on whether section 706(b) to-peer traffic. If the Commission basic consumer protection, among other could provide a legal foundation for maintains its information services federal policies. We seek comment on rules addressing harmful practices by framework for broadband Internet whether the legal and policy Internet service providers. If so, could services, will it have sufficient authority developments discussed above and the the Commission adopt such rules on a to address these concerns? facts of today’s broadband marketplace suggest a need to classify Internet national basis, or would it have to tailor Other Approaches to Oversight its rules to particular geographic areas? connectivity as a telecommunications Would its rules depend on continued 51. Finally, we ask for public input on service, so as to trigger this clear negative determinations in the annual whether there are other approaches to authority. We also ask whether that broadband availability report? fulfilling our role for broadband Internet approach would be consistent with our 47. The Comcast opinion also rejected services that would provide meaningful goals of promoting innovation and arguments that other provisions of Titles oversight consistent with maintaining investment in broadband, or would II, III, and VI of the Communications robust incentives for innovation and result in overregulation of a service that Act supported the Commission’s action investment. For instance, in a number of has undergone rapid and generally against Comcast because Internet- proceedings commenters have suggested beneficial development under our enabled communications services that that the Commission should pursue deregulatory approach. depend on broadband Internet service— policies based on standards set by third such as VoIP and Internet video parties and enforced by the Current Facts in the Broadband services—may affect the regulated Commission. In the Open Internet Marketplace operations of telephony common proceeding, Verizon and Google suggest 53. In the Cable Modem Declaratory carriers, broadcasters, and cable that the Commission could create Ruling, the Commission observed that operators. The court did not address the technical advisory groups ‘‘comprised of ‘‘the cable modem service business is merits of these theories, but rather a range of stakeholders with technical still nascent, and the shape of rejected them because they were not expertise’’ to develop best practices, broadband deployment is not yet clear,’’ sufficiently articulated in the resolve disputes, issue advisory and nearly a decade has passed since underlying Commission order. Could opinions, and coordinate with the Commission examined the facts such theories provide sufficient support standards-setting bodies. Although surrounding broadband Internet service for the Commission to address harmful Verizon and Google ‘‘may not in the Cable Modem Declaratory Ruling. practices of Internet service providers? necessarily agree on which federal In this part we therefore ask whether or What type of factual record would be agency does or should have authority not the facts of today’s broadband required to support such theories? If the over these matters,’’ they ‘‘do recognize marketplace support a conclusion that Commission relied on these theories, as a policy matter that there should be providers now offer Internet could it prohibit behavior—such as the some backstop role for federal connectivity as a separate

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telecommunications service. In addition classification orders, broadband Internet spam filtering? To what extent do to the specific questions we ask below, service was offered with various consumers rely on their Internet service we seek comment on what facts are services—such as e-mail, newsgroups, provider, as opposed to alternative most relevant to this inquiry. The and the ability to create and maintain a providers, for content such as news and Commission has explained that because web page—that we described as medical advice? To the extent the Act defines ‘‘telecommunications ‘‘Internet applications.’’ The broadband Internet service providers service’’ as ‘‘ ‘the offering of Commission understood that offer applications to consumers, do telecommunications for a fee directly to subscribers to broadband Internet consumers view them as an integrated the public[,]’ * * * whether a services ‘‘usually d[id] not need to part of the Internet connectivity telecommunications service is being contract separately’’ for ‘‘discrete offering? To what extent do consumers provided turns on what the entity is services or applications’’ such as e-mail. today use ‘‘the high-speed wire always ‘offering * * * to the public,’ and We seek comment on whether this in connection with the information- customers’ understanding of that remains the case. To what extent are processing capabilities provided by service.’’ Similarly, in Brand X, the these and other applications and Internet access’’? majority opinion noted that ‘‘[i]t is services sold with wired broadband 57. Marketing Practices. We also seek common usage to describe what a Internet service today? Are providers comment on how broadband Internet company ‘offers’ to a consumer as what offering the same applications and service providers market their services. the consumer perceives to be the services that they did when the What do broadband Internet service integrated finished product.’’ The Brand Commission began building the record providers’ marketing practices suggest X dissent asserted that ‘‘[t]he relevant in 2000, or have their offerings changed? they are offering to the public? What question is whether the individual Are these applications and services features do broadband Internet service components in a package being offered always packaged with Internet providers highlight in their still possess sufficient identity to be connectivity, or can consumers choose advertisements to consumers? How do described as separate objects of the not to purchase them? What test(s) the companies describe their services? offer, or whether they have been so should the Commission use to evaluate What are the primary dimensions of changed by their combination with the whether particular features are today competition among broadband Internet other components that it is no longer integrated with the underlying Internet service providers? Are cable modem and reasonable to describe them in that connectivity? other wired services marketed or way.’’ The Brand X majority opinion understood differently from each other, 56. Consumer Use and Perception. and the dissent examined consumers’ or in a generally similar way? Next, we seek comment on how understanding of the services, analogies 58. Technical and Functional consumers use and perceive broadband to other services, and technical Characteristics. In addition, to aid our Internet service. Do customers today characteristics of the services being understanding of what carriers offer to perceive that they are receiving one provided. What factors should the consumers, we seek to develop a current unitary service comprising Internet Commission consider in order to assess record on the technical and functional connectivity as well as features and the proper classification of broadband characteristics of broadband Internet Internet connectivity service? functionalities, or Internet connectivity service, and whether those 54. Status of Current Offerings. Is as the main service, with additional characteristics have changed materially wired broadband Internet service (or features and functionalities in the last decade. For example, DNS any telecommunications component simultaneously offered and provided? lookup is now offered to consumers on thereof) held out ‘‘for a fee directly to We note that under Commission a standalone basis, and web page the public, or to such classes of users as precedent, services composing a single caching is offered by third party content to be effectively available directly to the bundle at the point of sale—for instance, delivery networks. Web browsers, for public,’’ for instance through a tariff local telephone service packaged with example, are often installed separately such as the NECA DSL Access Service voice mail—can retain distinct by users. We ask commenters to Tariff or through facilities-based identities as separate offerings for describe the technical characteristics of Internet service providers’ public Web classification purposes. To what extent broadband Internet service, including sites? A provider is engaged in common do consumers continue to rely on the identifying those functions that are carriage if it ‘‘make[s] capacity available features and applications that are essential for web browsing and other to the public indifferently’’; it can be provided as part of their broadband basic consumer Internet activities. What compelled to offer a common carriage Internet service package, and to what are the necessary components of web service if ‘‘the public interest requires extent have they increased their use of browsing? How is caching provided to common carrier operation of the applications and services offered by end users, and how have caching proposed facility.’’ If so, we seek specific third party providers? For instance, services changed over time? How do examples of such offerings. If not, does some users now rely on free e-mail routing functions and DNS directory the Commission have legal authority to services provided by companies such as lookup enable users to access compel the offering of a broadband Yahoo and Microsoft, social networking information online? Internet telecommunications service sites including Facebook and MySpace, 59. In classifying services, the that is not currently offered? If legal public message boards like those found Commission has taken into account the authority exists, would it be appropriate in the Google Groups service, web purpose of the feature or service at for the Commission to exercise such portals like Netvibes, web hosting issue. For example, some features and authority? Are there First Amendment services like Go Daddy, and blog hosting services that meet the literal definition constraints on the Commission’s ability services like TypePad. How does the use of ‘‘enhanced service,’’ but do not alter to compel the offering of such a service? of these third party services compare the fundamental character of the Would such a compulsion raise any with the use of similar services offered associated basic transmission service, concerns under the Takings Clause of by broadband Internet service are ‘‘adjunct-to-basic’’ and are treated as the Fifth Amendment? providers? To what extent do consumers basic (i.e., telecommunications) services 55. Services Offered Today. When the rely on their Internet service provider or even though they go beyond mere Commission gathered the record for its other providers for security features and transmission. Do any of the features and

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functionalities offered by broadband necessary to define what is being so customer-provided modem to be Internet service providers have relevant classified. Here we ask commenters to transported to a DSL Access Service similarities to or differences from those propose approaches to defining the Connection Point using the Telephone that resemble an information service but telecommunications service offered as Company’s local exchange service are treated differently under part of wired broadband Internet facilities.’’ The Access Service Commission precedent? Similarly, service, assuming that the Commission Connection Point is a point designated which, if any, of the ‘‘Internet finds a separate telecommunications by the telephone company that connectivity’’ functions listed in the service is being offered today, or must ‘‘aggregates ADSL Access Service and/or Cable Modem Declaratory Ruling fall be offered. wireline broadband Internet within the management exceptions to 64. We have previously defined transmission service data traffic from the information services category, and ‘‘Internet connectivity’’ to include the and to suitably equipped Telephone why? functions that ‘‘enable [broadband Company Serving Wire Centers.’’ 60. Some have suggested that the Internet service subscribers] to transmit Commission should take account of the data communications to and from the Consequences of Classifying Internet different network ‘‘layers’’ that compose rest of the Internet.’’ Identifying a Connectivity as a Telecommunications the Internet. Are distinctions between telecommunications service at a Service the functional ‘‘layers’’ that compose the similarly high level—for instance, as the 66. If we were to classify Internet Internet relevant and useful for service that provides Internet connectivity service as a classifying broadband Internet service? connectivity—may be appropriate for telecommunications service and take no For example, the Commission could this proceeding if a telecommunications further action, that service would be distinguish between physical, logical, service is classified. Is this approach or subject to all requirements of Title II and content and application layers, and some other mechanism appropriate to that apply to telecommunications identify some of those layers as give the Internet service provider service or common carrier service. If the elements of a telecommunications latitude to define its own Commission chose, it could provide service and others as elements of an telecommunications service? For support for Internet connectivity information service. (As discussed instance, would it be desirable for the services through the Universal Service above, the Commission historically has Commission to identify only bare Fund under section 254. Under section distinguished between Internet minimum characteristics of an Internet 222, the Commission could ensure that connectivity functions and Internet connectivity service? Or is it necessary consumers of Internet connectivity applications.) If the Commission for the Commission to define the enjoy protections for their private adopted this approach, which of the functionality, elements, or endpoints of information. Consumers with services offered by wired broadband Internet connectivity service? What are disabilities would see greater Internet service providers should be the pros and cons of these and other accessibility of broadband services and included in each category? Are the approaches? Would use of the term equipment under section 255. And the boundaries of each layer sufficiently ‘‘Internet connectivity service’’ in this Commission could protect consumers clear that such an approach would be context be unduly confusing because and fair competition through workable in practice? Would such an the Commission has previously defined application of sections 201, 202, and approach have implications for services that term to include the function of 208. Would application of all Title II other than broadband Internet service? ‘‘operating or interconnecting with requirements to the wired broadband 61. Competition. We also seek Internet backbone facilities’’ in order to Internet connectivity service be comment on the level of competition ‘‘enable cable modem service consistent with the approach to among broadband Internet service subscribers to transmit data broadband Internet service described in providers. The Commission adopted the communications to and from the rest of part II.A.2, above? We seek comment on unitary information service the Internet’’? whether these benefits to classifying classification for broadband Internet 65. Commenters should also identify Internet connectivity as a services in part ‘‘to encourage facilities- the particular aspects of broadband telecommunications service would based competition.’’ The Commission Internet service that do and do not outweigh the costs of doing so, envisioned competition among cable constitute ‘‘transmission, between or including the application of numerous operators, telephone companies, among points specified by the user, of regulatory provisions that the satellite providers, terrestrial wireless information of the user’s choosing, Commission, in its information service providers, and broadband-over- without change in the form or content classification orders, determined should powerline (BPL) providers. Has the of the information as sent and received.’’ not apply. Are there any elements of our market for broadband Internet services Does the catalog of Internet connectivity framework that the Commission could developed as expected, and, if not, what functions provided in the Cable Modem not pursue if it adopted a Title II is the significance for this proceeding of Declaratory Ruling include all the classification? Under Title II the market’s actual development? functions an end user would need from classification what role, if any, might be 62. Are there other relevant facts or its broadband Internet service provider played by third party standard setting circumstances that bear on the in order to use the Internet? Are there bodies? Commission’s application of the other connectivity functions the Telecommunications Service statutory definition of Commission should consider? Can the Classification and Forbearance ‘‘telecommunications service’’ to wired Commission draw guidance from other broadband Internet service? attempts to define the functionality of 67. In addition to the traditional an Internet connectivity service, such as information service and Defining the Telecommunications the definition in NECA’s DSL Access telecommunications service approaches Service Service Tariff? In its tariff, NECA offers discussed above, we identify and seek 63. If the Commission were to classify a DSL data telecommunications service comment on a third option for a service provided as part of the to end user and Internet service establishing a suitable legal foundation broadband Internet service bundle as a provider customers. The service for broadband Internet and Internet telecommunications service, it would be ‘‘enables data traffic generated by a connectivity services. This third way

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would involve classifying wired (c) forbearance from applying such 72. In this proceeding, however, we broadband Internet connectivity as a provision or regulation is consistent do not intend to disrupt the status quo telecommunications service (as with the public interest. for incumbent local exchange carriers or suggested above), but simultaneously In ordinary forbearance proceedings, other common carriers that choose to forbearing from applying most therefore, the Commission must make a offer their Internet transmission services requirements of Title II to that predictive judgment whether, without as telecommunications services. Nor do connectivity service, save for a small enforcement of the provisions or we propose to alter the status quo with number of provisions. regulations in question, charges and regard to the application of section practices will be just and reasonable, 68. Specifically, if the Commission 254(k) and related cost-allocation rules consumers will be protected, and the decided, after appropriate analysis, to to these carriers. We therefore seek public interest will be served. classify wired broadband Internet comment on excepting from forbearance 70. The forbearance analysis here has any carrier that elects to be subject to connectivity (and no other component a different posture. The Commission of wired broadband Internet service) as the full range of Title II requirements, would not be responding to a carrier’s and on the mechanism that would be a telecommunications service, it could request to change the legal and most suitable for a carrier to make such simultaneously forbear from applying regulatory framework that currently an election. all but a handful of core statutory applies. Rather, it would be assessing provisions—sections 201, 202, 208, and whether to forbear from provisions of Defining the Geographic Scope for 254—to the service. Two other the Act that, because of our information Analysis provisions that have attracted service classification, do not apply at 73. Section 10 requires the longstanding and broad support in the the time of the analysis. Under section Commission to forbear from broadband context—sections 222 and 10, the Commission may forbear on its unnecessary requirements ‘‘in any or 255—might also be implemented for the own motion. If the statutory criteria are some of [carriers’] geographic markets.’’ connectivity service, perhaps after the met, the Commission is compelled to By its terms section 10 requires no Commission provides guidance in forbear just as if it were responding to ‘‘particular * * * level of geographic subsequent proceedings as to how they a carrier’s petition. In this situation, rigor,’’ and the Commission has will apply in this context. We seek could the Commission simply observe flexibility to adopt an approach suited comment on this third approach, and the current marketplace for broadband to the circumstances. The Commission whether it would constitute a Internet services to determine whether decisions classifying broadband Internet framework for broadband Internet enforcing the currently inapplicable service did not rely on any particular, service that is fundamentally consistent requirements is or is not necessary to defined geographic area. Instead, where with what the Commission, Congress, ensure that charges and practices are those decisions evaluated the state of consumer groups, and industry believed just and reasonable and not unjustly or the marketplace, they did so ‘‘in view of the Commission could pursue under unreasonably discriminatory, whether larger trends.’’ The 2005 Wireline Title I before the Comcast decision. application of the requirements is or is Broadband Report and Order granted Forbearing To Maintain the not necessary for the protection of forbearance on a nationwide basis. The Deregulatory Status Quo consumers, and whether applying the Commission has adopted a similar requirements is or is not in the public approach to evaluating the broadband 69. In recognition of the need to tailor interest? Section 10 allows the marketplace in other forbearance the Commission’s policies to evolving Commission to consider forbearance decisions. Given that backdrop, and the markets and technologies, Congress gave from requirements that do not currently fact that the forbearance discussed here the Commission in 1996 the authority apply or may not apply even in the would be designed to maintain a and responsibility to forbear from absence of forbearance. deregulatory status quo for wired broadband Internet service that applies applying provisions of the Identifying the Relevant across the nation, the same approach Communications Act when certain Telecommunications Service and may be warranted here, with the effect criteria are met, and specifically Telecommunications Carriers directed the Commission to use this that forbearance would be granted or new power to ‘‘encourage the 71. In this part of the Notice we denied on a nationwide basis. We seek deployment on a reasonable and timely assume, solely for purposes of framing comment on this approach. If basis of advanced telecommunications the forbearance option, that the commenters suggest a more granular capability to all Americans.’’ In typical Commission has decided to classify the geographic market as is sometimes used forbearance proceedings, a petitioner— Internet connectivity service underlying in other forbearance proceedings, we usually a telecommunications service broadband Internet service as a ask them to address whether such an provider—files a petition seeking relief telecommunications service. Section 10 approach would be legally required. from a provision of the Act that applies provides that ‘‘the Commission shall forbear from applying any regulation or Identifying the Provisions of Title II to it. The Commission ‘‘shall’’ grant the From Which the Commission Would requested relief if: any provision of this chapter to a telecommunications carrier or Forbear (a) Enforcement of such regulation or telecommunications service, or class of 74. The forbearance option provision is not necessary to ensure that telecommunications carriers or contemplates a determination not to the charges, practices, classifications, or telecommunications services’’ if certain apply all but the small number of regulations by, for, or in connection criteria are met. The relevant provisions of Title II that provide a solid with that telecommunications carrier or ‘‘telecommunications service’’ would be legal foundation for the Commission to telecommunications service are just and Internet connectivity service as the implement its established broadband reasonable and are not unjustly or Commission defines it. The ‘‘class of policies. In this part, we seek comment unreasonably discriminatory; telecommunications carriers’’ at issue on declining to forbear from the three (b) enforcement of such regulation or would comprise the providers of the core provisions of Title II—sections 201, provision is not necessary for the Internet connectivity service identified 202, and 208. We also seek comment on protection of consumers; and as a telecommunications service. whether we should decline to forbear

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from section 254 in order to ensure that (damages awards)? Would forbearance ‘‘contribute[] on an equitable and the Commission has clear authority to from these additional provisions render nondiscriminatory basis,’’ possibly as pursue universal service goals for enforcement under section 208 part of comprehensive Universal Service broadband services. And we seek procedurally or substantively deficient, Fund reform? comment on whether we should decline or would section 208 (together with 81. If commenters suggest that we to forbear from two other provisions— Title V of the Act) provide the should forbear from applying the sections 222 and 255—that speak to two Commission adequate authority to support provisions of section 254 in the other broadband issues the Commission identify and address unlawful practices context of broadband Internet has believed it can address (customer involving broadband Internet service? connectivity service, we ask them to privacy and access by persons with 78. Exclusion from Forbearance: provide alternative proposals to ensure disabilities). We further seek comment Section 254. Section 254, the statutory universal availability of broadband on whether forbearing from any of the foundation of our universal service Internet connectivity services, and to remaining provisions of Title II is programs, requires the Commission to assess the legal sustainability of beyond our forbearance authority or promote universal service goals, proposed alternatives. If commenters otherwise should be rejected. including ‘‘[a]ccess to advanced suggest that we forbear from (or delay) 75. Exclusions from Forbearance: telecommunications and information applying the mandatory contribution Sections 201, 202, and 208. The services * * * in all regions of the provisions of section 254, what would Commission has never exercised its Nation.’’ In March 2010, a unanimous be the consequences for the Universal authority under section 10 to forbear Commission endorsed reform of Service Fund? The Commission has from these three fundamental provisions universal service programs to statutory authority to assess any of the Act, although it has been asked ‘‘encourage targeted investment in provider of interstate to do so on many occasions. In addition broadband infrastructure and emphasize telecommunications if that would serve to being consistent with our precedent, the importance of broadband to the the public interest. Nothing in this a determination not to forbear from future of these programs.’’ Reforming Notice should be understood to limit the these core provisions would comport universal service to encompass Commission’s ability to exercise this with Congress’s approach to commercial broadband is also a keystone of the authority during the pendency of this mobile radio services (CMRS), such as National Broadband Plan. Our current proceeding. cell phone services. In 1993, CMRS universal service support programs, 82. Possible Exclusion from services were still nascent, and Congress including our high-cost program and Forbearance: Section 222. Section 222 specified in a new section 332(c)(1)(A) our low-income programs, address of the Communications Act requires of the Communications Act that deployment and income-related providers of telecommunications although Title II applies to CMRS, the adoption barriers for voice. The Plan services to protect their customers’ Commission may forbear from enforcing recommends that the Commission confidential information, as well as any provision of the title other than provide high-cost and low-income proprietary information of other sections 201, 202, and 208. After support that ensures that all households telecommunications service providers Congress gave the Commission broader have the ability to subscribe to a high- and equipment manufacturers. As forbearance authority in the quality broadband connection that discussed above, the Commission has Telecommunications Act of 1996, the provides both broadband and voice supported applying this provision in the Commission considered a petition to services. broadband context. Section 222 would forbear from sections 201 and 202 as 79. Two subsections of section 254 appear to provide the Commission clear applied to certain CMRS services. The bear particularly on whether to forbear authority to implement appropriate Commission rejected that forbearance from this universal service provision. privacy requirements for broadband request, finding that even in a First, section 254(c) defines universal Internet connectivity. We question, competitive market those provisions are service as ‘‘an evolving level of however, whether it would be in the critical to protecting consumers. telecommunications service.’’ By not public interest to apply section 222 to 76. Applying sections 201 and 202 forbearing from section 254(c), the broadband Internet connectivity service could provide the Commission direct Commission would retain clear immediately. It might be more effective statutory authority to protect consumers authority to support the availability and for the Commission to interpret the and promote fair competition, yet allow adoption of broadband Internet specific provisions of section 222, the Commission to avoid burdensome connectivity service through reformed including the definition of ‘‘customer regulation. For example, while CMRS high-cost and low-income programs in proprietary network information,’’ in the providers are subject to sections 201 and the Universal Service Fund. broadband context before requiring 202, they do not file tariffs because the 80. Second, section 254(d) requires all broadband Internet connectivity Commission forbore from section 203. providers of telecommunications service providers to comply. Proceeding We seek comment on these issues as to contribute to the Universal Service otherwise could cause confusion and well as how to address in any Fund on an equitable and disparity among broadband Internet forbearance analysis the existing agency nondiscriminatory basis. Should the connectivity providers, and confusion rules that have been promulgated under Commission apply the mandatory for consumers. Compliance with section sections 201 and 202. contribution requirement to broadband 222 could also be more expensive if the 77. In addition, we seek comment on Internet connectivity providers? If so, provision took effect immediately, and not forbearing from section 208 and the should we delay implementation of the we later adopted specific rules. On the associated procedural rules. Would the contribution obligation, through other hand, most providers are already enforcement regime that would apply if temporary forbearance or other means, subject to privacy requirements, at least we enforce only section 208 be until the Commission adopts rules for other services they provide; their sufficient if we decide to forbear from governing specifically how broadband costs of immediate compliance with the damages and jurisdictional Internet connectivity providers should section 222 may not outweigh the provisions of sections 206 (carrier calculate their contribution consistent benefit to consumers of quick assurance liability for damages), 207 (recovery of with the requirement that all of their privacy while using broadband damages and forum election), and 209 telecommunications carriers Internet connectivity services. In

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addition, section 631 of the disabilities, unless not reasonably necessary for the protection of Communications Act requires cable achievable. As discussed above, the consumers;’’ and forbearance is operators to fulfill certain obligations Commission has repeatedly expressed consistent with the public interest. We with respect to consumer privacy for its intent to apply this requirement in ask whether section 10 provides cable or ‘‘other service[s]’’ to which a the broadband context. authority to forbear from provisions of consumer subscribes. The term ‘‘other 85. We seek comment on the the statute that do not directly impose service’’ includes ‘‘any wire or radio appropriateness of implementing obligations on carriers. For example, communications service provided using section 255 to ensure that Americans section 224 provides the framework for any of the facilities of the cable operator with disabilities have access to the Commission’s regulation of pole that are used in the provision of cable broadband Internet connectivity attachments, including the rates service.’’ How should the obligations of services. As with section 222, might it therefor. Does section 10 provide the sections 222 and 631 be reconciled for be appropriate to apply section 255 only Commission authority to forbear from cable operators offering broadband after a separate notice-and-comment section 224 insofar as it imposes rate- Internet service? More broadly, we seek proceeding that allows detailed related obligations on the Commission comment on the application of section consideration of disabilities-access and utilities that own poles, rather than 222 to any wired broadband Internet issues in the broadband context? We on telecommunications carriers or connectivity service that may be seek comment on implementation telecommunications services? classified as a telecommunications questions and other issues related to the 88. Similarly, section 253 permits the service, and on whether the public application of section 255. Commission to preempt state interest would be served by permitting 86. Scope of Forbearance Generally. regulations that prohibit the provision section 222 to apply in the absence of We believe that the six sections we have of telecommunications services. Does new implementing rules. The just discussed—sections 201, 202, 208, section 10 provide the Commission Commission has previously forborne 222, 254, and 255—could compose a authority to forbear from section 253, temporarily from applying a statutory sufficient set of tools for effecting the which does not impose obligations on provision or regulation. In 1994, soon established policy approach and telecommunications carriers? If the after Congress authorized the implementing the Commission’s goals Commission were to forbear from Commission to deregulate wireless for 21st Century communications. Are section 253, how would the services, the Commission forbore there others that should be added to this Commission’s general authority to temporarily from requiring or permitting list? Some provisions of Title II relate preempt inconsistent state requirements CMRS providers to file tariffs for directly or indirectly to the effective be affected? interstate access service. And in 2005, application and enforcement of the six 89. Congress created the Commission the Commission temporarily forbore provisions we have identified. Section in part ‘‘for the purpose of the national from carrier eligibility requirements for 214, for example, deals primarily with defense, [and] for the purpose of universal service support, to provide ‘‘Extension of Lines’’ yet contains promoting safety of life and property victims of Hurricane Katrina access to section 214(e), which provides the through the use of wire and radio wireless phone service. framework for determining which communication.’’ Would it be consistent 83. One aspect of retaining the carriers are eligible to participate in with the Commission’s mission with information service classification for universal service support programs. respect to promoting safety of life and broadband Internet service (other than Similarly, section 251(a)(2) directs property, and consumer protection for the Internet connectivity telecommunications carriers ‘‘not to generally, to forbear from the portions of telecommunications service that may be install network features, functions, or section 214(a) that address offered separately with broadband capabilities that do not comply with the discontinuance, reduction, or Internet service) is that it minimizes guidelines and standards established impairment of service? Would it be interference with the FTC’s ability to pursuant to section 255,’’ and section consistent with our mission to forbear enforce the Federal Trade Commission 225 establishes the telecommunications from section 214(d), which allows the Act’s prohibition of unfair, deceptive, or relay services program. Is application of Commission to require a carrier ‘‘to anticompetitive practices by broadband these or any other provisions of Title II provide itself with adequate facilities for Internet service providers. Section required to allow effective the expeditious and efficient 5(a)(1) of the FTC Act declares to be implementation and enforcement of the performance of its service’’; or section unlawful all ‘‘[u]nfair methods of six provisions identified above? If so, 218, which permits the Commission to competition in or affecting commerce, should the Commission exempt such ‘‘inquire into the management of the and unfair or deceptive acts or practices provisions from forbearance for business of all carriers subject to this in or affecting commerce,’’ but section administrative reasons, if this third Act’’? Does section 10 provide authority 5(a)(2) of the FTC Act restricts the FTC’s approach to classification is adopted? to forbear from these provisions? Should ability to enforce this prohibition with 87. Are there provisions of Title II the Commission exclude them from respect to common carrier activities. We from which we lack authority to forbearance so it may proceed with, for seek comment on how the Commission forbear? Section 10(a) directs the example, cybersecurity or data gathering might use its authority under section Commission to forbear from applying initiatives, or would authority under 222 to ensure privacy for users of regulations or provisions of the sections 201 and 202 (or other Internet connectivity without Communications Act to provisions) be sufficient? How would significantly compromising the FTC’s telecommunications carriers or services forbearance from these provisions affect ability to address privacy issues in those instances where the the Commission’s ability to promote involving broadband Internet services Commission determines that the adequate service to underserved and applications. particular provision is unnecessary to communities? 84. Possible Exclusion from ensure that carrier ‘‘charges, practices, 90. Also with regard to our national Forbearance: Section 255. Section 255 classifications, or regulations * * * are defense and homeland security mission, requires telecommunications service just and reasonable and are not unjustly we note that section 229 directs the providers to make their services or unreasonably discriminatory;’’ Commission to implement the accessible to individuals with enforcement of such regulation is ‘‘not provisions of the Communications

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Assistance for Law Enforcement Act circumstance in which it would be disruption of its customers’ peer-to-peer (CALEA). CALEA is a separate statute sound policy to cease making the communications, which the that requires ‘‘telecommunications reports. We seek comment on these Commission determined to be carriers’’ to meet certain assistance issues and on how best to ensure that unjustified, is one example. There have capability requirements in support of the obligation of section 257(c) is been recent reports involving: AT&T’s electronic surveillance. The preserved in this context. alleged failure to deliver DSL service at Commission has previously found that 92. We further seek comment on the speeds promised; allegations that CALEA’s definition of whether there are provisions of Title II although RCN promised subscribers ‘‘telecommunications carrier’’ is broader that would require interpretation even ‘‘fast and uncapped’’ broadband, it than the definition of after forbearance. For example, would delayed or blocked peer-to-peer file ‘‘telecommunications carrier’’ in the forbearance from section 203 mean that transfers without users’ knowledge or Communications Act. All service carriers may not file tariffs even if they consent; and Windstream’s redirection providers that are ‘‘telecommunications want to, or just that they are not of subscribers who used the default carriers’’ under the Communications Act required to do so? Would the search function in the Firefox web are also ‘‘telecommunications carriers’’ Commission’s review of transactions browser to a Windstream ‘‘landing subject to CALEA, and some involving providers of broadband page.’’ Furthermore, legislative providers—including facilities-based Internet connectivity service be affected developments described above suggest broadband Internet access providers— if the Commission forbore from that Congress is not satisfied with the are subject to CALEA even if they are applying section 214? pace of broadband deployment, not ‘‘telecommunications carriers’’ as 93. We also seek comment on whether adoption, and utilization. defined in the Communications Act. there are approaches superior or 97. We seek comment on whether, in Specifically, the Commission held in complementary to forbearance that the light of the current charges, practices, 2005 that ‘‘facilities-based providers of Commission should consider as means classifications, and regulations of any type of broadband Internet access of easing regulatory burdens. For broadband Internet connectivity service service, including but not limited to example, in the past the Commission providers, it would be consistent with wireline, cable modem, satellite, has ‘‘streamlined’’ the statutory section 10(a)(1) for the Commission to wireless, fixed wireless, and broadband procedures that apply to non-dominant forbear from all provisions of Title II access via powerline are subject to carriers, and has granted blanket except the six identified provisions. If CALEA.’’ Thus, it appears that authority to all carriers under section we found on the record developed in regardless of whether we maintain the 214 to provide domestic interstate response to this Notice that the current statutory classification for services and to construct, acquire, or marketplace for broadband Internet broadband Internet service or classify operate any domestic transmission line. connectivity services is operating Internet connectivity (or some other Is any similar approach appropriate sufficiently well with regard to service) as a telecommunications here? competition and consumers’ interests, 94. Finally, we seek comment on the service, CALEA will continue to apply then retaining only the authority in role of third party standard setting to these providers. We seek comment on sections 201, 202, and 208; reforming bodies if the Commission were to adopt this analysis. In addition, as we do with universal service under section 254; and one of the deregulatory approaches regard to the sections described just continuing to enforce the privacy and described here. access provisions of sections 222 and above, we seek comment on whether 255 could be sufficient to address section 10 would provide authority to Application of the Statutory Forbearance Criteria current and foreseeable future concerns. forbear from section 229, and on 98. Protection of Consumers and the whether forbearance from application of 95. Charges, Practices, Classifications, Public Interest. Section 10(b) directs the section 229 would be consistent with and Regulations. In 2002, when the Commission, in making its public the purposes for which CALEA was Commission decided to classify cable interest analysis, to ‘‘consider whether enacted and the public interest. Finally, modem service as an information forbearance from enforcing the we emphasize that section 10 does not service, only 12 percent of American provision or regulation will promote provide the Commission authority to adults had broadband at home. Now competitive market conditions.’’ As forbear from provisions of CALEA or nearly two-thirds of American adults discussed above, the goals of any action any other statute other than the use broadband at home. In just the last to classify broadband Internet Communications Act. two years, home broadband use has connectivity as a telecommunications 91. Section 257(c) requires the grown more than 25 percent. The service would include preserving the Commission to make periodic reports to quality and availability of broadband Commission’s ability to step in when Congress concerning the elimination of services continue to improve, with cable necessary to protect consumers and fair previously identified barriers to market and telephone companies investing competition, while generally refraining entry by entrepreneurs and other small about $20 billion in wireline broadband from regulation where possible. Further, businesses. This obligation applies to capital expenditures in 2008 and about the Commission has tools to promote ‘‘the provision and ownership of $18 billion in 2009. As described in the competition for broadband Internet telecommunications and information National Broadband Plan, ‘‘[t]op services that would be unaffected by the services’’ and thus applies regardless of advertised speeds available from forbearance proposal discussed here. the legal classification of broadband broadband providers have increased in We seek comment on this element of the Internet service and broadband Internet the past few years. Additionally, typical forbearance test. connectivity service. It thus would advertised download speeds to which appear that none of the three alternative consumers subscribe have grown Maintaining Forbearance Decisions approaches suggested here would affect approximately 20% annually for the last 99. We seek comment on whether, if the Commission’s duty to make the 10 years.’’ we forbore from applying those mandated reports. Nor, given the 96. Still, a number of reported provisions of Title II that go beyond importance of lowering barriers to incidents suggest there is a role for the minimally intrusive Commission market entry, do we contemplate any Commission. Comcast’s secret oversight, that decision would likely

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endure. Section 10 allows the classification option) could be utilized and satellite Internet services Commission to revisit a decision to to address this theoretical situation, purchased, provided, and perceived? forbear. Normally, to depart from a prior even if that means the Commission 104. Several provisions of Title III of decision, an agency may simply would not, in the post-litigation the Communications Act provide the acknowledge that it is doing so and situation just described, ultimately Commission authority to impose on provide a rational explanation for the maintain the classification of Internet spectrum licensees obligations that are change, which may or may not need to connectivity as a telecommunications in the public interest. For example, be more detailed than the explanation service. section 301 provides the Commission for the original decision. The agency authority to regulate ‘‘radio Effective Dates ‘‘need not demonstrate to a court’s communications’’ and ‘‘transmission of satisfaction that the reasons for the new 101. If the Commission decided to energy by radio.’’ Under section 303, the policy are better than the reasons for the alter its current approach to Internet Commission has the authority to old one.’’ Section 10, though, requires connectivity service, affected providers establish operational obligations for the Commission to forbear if the might need time to adjust to any new licensees that further the goals and statutory criteria are met. Thus, to requirements. To reflect this, the requirements of the Act if the reverse a forbearance decision, the Commission could delay the effective obligations are in the ‘‘public Commission must find that at least one date of a classification (or classification convenience, interest, or necessity’’ and of the criteria is no longer met with and forbearance) decision for 180 days not inconsistent with other provisions regard to a particular statutory after release, or another suitable period. of law. Section 303 also authorizes the provision. That determination would be Moreover, as discussed above, certain Commission, subject to what the ‘‘public subject to judicial review, and the provisions of Title II, such as sections interest, convenience, or necessity Supreme Court has stated that an agency 222, 254(d), and 255, could be phased- requires,’’ to ‘‘[p]rescribe the nature of must ‘‘provide a more detailed in on an even longer timetable. We seek the service to be rendered by each class justification than what would suffice for comment on the effective date the of licensed stations and each station a new policy created on a blank slate’’ Commission should adopt for a within any class.’’ Section 307(a) in instances where, for example, ‘‘its classification decision under one of the likewise authorizes the issuance of new policy rests upon factual findings approaches proposed here, or an licenses ‘‘if public convenience, interest, that contradict those which underlay its alternative approach identified by the or necessity will be served thereby.’’ prior policy; or when its prior policy commenter. Section 316 provides a similar test for has engendered serious reliance new conditions on existing licenses, Terrestrial Wireless and Satellite interests that must be taken into authorizing such modifications if ‘‘in the Services account.’’ Reversal of forbearance also judgment of the Commission such action will promote the public interest, might be in arguable tension with 102. The Commission currently convenience, and necessity.’’ On the section 706(a) of the 1996 Act, which classifies broadband Internet service other hand, Title III provides the directs the Commission to ‘‘encourage solely as an information service Commission no express authority to the deployment on a reasonable and regardless of whether it is provided over extend universal service to wireless timely basis of advanced cable facilities, wireline facilities, broadband Internet services. We seek telecommunications capability to all wireless facilities, or power lines. At the comment on whether these or other Americans * * * by utilizing, in a same time, the Commission has in the technical, market, or legal manner consistent with the public past taken a deliberate approach to considerations justify different interest, convenience, and necessity, extending its classification framework. classification of wireless and wired * * * regulatory forbearance.’’ We seek In particular, though the Commission broadband Internet services. We also comment on the Commission’s authority had classified all cable modem and seek comment on whether our approach to reverse a forbearance decision wireline Internet access services as to classification of non-facilities-based concerning broadband Internet information services by 2005, it was not Internet service providers should be connectivity service. We also seek until 2007 that it extended that different in the wireless context, or the comment on what provisions, if any, classification to wireless broadband same as in the wired context. could appropriately be included in a Internet services, even though the first 105. In addition, section 332 sets forth forbearance order to establish a 3G networks went into service in 2003. various provisions concerning the heightened standard for justifying future 103. We seek comment on which of regulatory treatment of mobile wireless ‘‘unforbearance.’’ the three legal frameworks specifically service. Sections 332(c)(1) and (c)(3), in 100. If the Commission were to elect discussed in this Notice, or what particular, require that CMRS providers the option of classifying Internet alternate framework, would best support be regulated as common carriers under connectivity as a telecommunications the Commission’s policy goals for Title II of the Act. To what extent service but forbearing from most of Title wireless broadband. In addition, as the should section 332 of the Act affect our II, then a reviewing court could in Commission recently noted in the Open classification of wireless broadband theory uphold the classification Internet NPRM, ‘‘there are technological, Internet services? Section 332(c)(1) gives determination but vacate the structural, consumer usage, and the Commission the authority to specify accompanying forbearance in whole or historical differences between mobile certain provisions of Title II as in part. In that situation, the wireless and wireline/cable networks.’’ inapplicable to CMRS providers. If the Commission could maintain the We seek comment on whether these Commission were to take the third way classification of broadband Internet differences are relevant to the described above in the wireless connectivity service as Commission’s statutory approach to broadband context, could it and should telecommunications service and allow terrestrial wireless and satellite-based it apply section 332(c)(1) as well as the relevant provisions of Title II, which broadband Internet services. Do section 10 in its forbearance analysis? the court restored, to apply. We seek consumers today view wireless We also seek comment on whether the comment on any lawful mechanisms broadband as a substitute for wired Commission would have reason to that (assuming adoption of the third services? How are terrestrial wireless apply sections 201 and 202 differently

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to wireless and wired broadband disturb our treatment of services that are addition, section 10(e) provides that ‘‘[a] Internet services. not sold by facilities-based Internet State commission may not continue to 106. We also ask commenters to service providers to end users in the apply or enforce any provision of this address whether, if the Commission retail market, including, for example, Act that the Commission has were to alter its present approach to Internet backbone connectivity determined to forbear from applying.’’ broadband Internet service, it would be arrangements. In short, the Commission We seek comment on the application of preferable for the Commission to proposes not to change its treatment of these provisions in the context of address wireless services at the same services that fall outside a broadband Internet service and time that it addresses wired services, or commonsense definition of broadband broadband Internet connectivity service, whether there are reasons for the Internet service. We seek comment on the states’ role in the broadband Commission to defer a decision on whether any of the three legal marketplace, and how our decision to classification of non-wired broadband approaches described in this Notice apply or not apply section 253 could Internet services (and any associated would affect these services directly or relate to this authority. forbearance if a wireless broadband indirectly, and how we should factor telecommunications service is that into our decision-making about the Related Actions identified). treatment of broadband Internet service. 109. In a separate proceeding, the 112. We seek comment on whether Non-Facilities-Based Internet Service Commission has asked for public there are actions we can and should take Providers comment on the treatment of other outside the proceeding this Notice 107. In 1998, the Commission services (including Internet-Protocol- initiates to implement the established addressed non-facilities-based Internet based voice and subscription video policy approach to broadband Internet service providers and concluded that services) that may be provided over the service. As one example, the they provided only information same facilities used to provide Commission could decline to pursue the services. In Brand X, Justice Scalia broadband Internet service to ‘‘open access’’ policies for cable modem stated in his dissent that non-facilities- consumers, but that have not been service on which the Commission based Internet service providers using classified by the Commission. The sought comment in 2002 when it telephone lines to provide DSL service Commission has described these as decided to classify cable modem service stand in a different position in the eyes ‘‘managed’’ or ‘‘specialized’’ services, and as a single information service. We seek of the consumer than the provider of the recognized ‘‘that these managed or comment on terminating the docket physical connection. Some industry specialized services may differ from initiated by the notice of proposed members have suggested, however, that broadband Internet services in ways that rulemaking that accompanied the Cable providers of Internet connectivity could recommend a different policy approach, Modem Declaratory Ruling, and we avoid compliance with consumer and it may be inappropriate to apply the invite additional proposals. protection measures by relying on non- rules proposed here to managed or facilities-based affiliates to offer retail specialized services.’’ We do not intend Procedural Matters broadband Internet service. We seek to address the classification or treatment Paperwork Reduction Act comment on what policy goals we of these services in this proceeding. We should have for non-facilities-based seek comment on whether any of the 113. This document does not contain Internet service providers, and what three legal approaches identified in this proposed information collection(s) legal foundation for non-facilities-based Notice would affect these services subject to the Paperwork Reduction Act Internet service providers can best directly or indirectly, and how we of 1995 (PRA), Public Law 104–13. In support effective implementation of should factor that into our decision- addition, therefore, it does not contain those goals. making about the treatment of Internet any new or modified ‘‘information Internet Backbone Services, Content connectivity service. collection burden for small business Delivery Networks, and Other Services State and Local Regulation of concerns with fewer than 25 employees,’’ pursuant to the Small 108. The focus of this proceeding is Broadband Internet and Internet Business Paperwork Relief Act of 2002, limited to the classification of Connectivity Services Public Law 107–198, see 47 U.S.C. broadband Internet service. We remain 110. We also ask commenters to 3506(c)(4). cognizant that, under the Act, all address the implications for state and information services are provided ‘‘via local regulation that would arise from Ex Parte Presentations telecommunications,’’ and therefore the the three proposals described above. use of telecommunications does not, on Under each of the three approaches, 114. The inquiry this Notice initiates its own, warrant the identification of a what would be the limits on the states’ shall be treated as a ‘‘permit-but- separate telecommunications service or localities’ authority to impose disclose’’ proceeding in accordance with component. For example, we do not requirements on broadband Internet the Commission’s ex parte rules. intend to address in this proceeding the service and broadband Internet Persons making oral ex parte classification of information services connectivity service? presentations are reminded that such as e-mail hosting, web-based 111. We anticipate that if a state were memoranda summarizing the content and applications, voicemail, to impose requirements on broadband presentations must contain summaries interactive menu services, video Internet connectivity service or of the substance of the presentations conferencing, cloud computing, or any broadband Internet service that are and not merely a listing of the subjects other offering aside from broadband contrary to a Commission decision not discussed. More than a one or two Internet service. Services that utilize to apply similar requirements, we sentence description of the views and telecommunications to afford access to would have authority under the arguments presented generally is particular stored content, such as Communications Act and the required. Other requirements pertaining content delivery networks, also are Supremacy Clause of the United States to oral and written presentations are set outside the scope of this proceeding. Constitution (Article III, section 2) to forth in § 1.1206(b) of the Commission’s Nor do we intend here to address or preempt those state requirements. In rules.

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Ordering Clause FEDERAL FINANCIAL INSTITUTIONS agency rules of operation in the Federal EXAMINATION COUNCIL Register. The notice and publication 115. Accordingly, it is ordered that, requirements of 5 U.S.C. 553 do not pursuant to the authority contained in [Docket No. AS10–2] apply to the adoption of Sections 3.04 sections 4(i), 4(j), 10, 218, 303(b), 303(r), Appraisal Subcommittee; Rules of and 3.06 because it is a ‘‘rule of agency and 403 of the Communications Act of Operation; Amendment organization, procedure, or practice’’ 1934, as amended, 47 U.S.C. 154(i), exempt from the public notice and 154(j), 160, 218, 303(b), 303(r), and 403, AGENCY: Appraisal Subcommittee of the comment process under 5 U.S.C. this Notice of Inquiry is adopted. Federal Financial Institutions 553(b)(3)(A). Federal Communications Commission. Examination Council. Based on the foregoing, the Subcommittee adopts new Sections Marlene H. Dortch, ACTION: Notice of amendment to rules governing the Chairperson and Vice 3.04, 3.04.a and 3.06 of the Rules of Secretary. Chairperson of the Appraisal Operation, as follows, effective [FR Doc. 2010–15349 Filed 6–23–10; 8:45 am] Subcommittee. immediately: BILLING CODE 6712–01–P Rules of Operation SUMMARY: The Appraisal Subcommittee (Subcommittee) of the Federal Financial * * * * * Institutions Examination Council is Article III Members of the Subcommittee FEDERAL DEPOSIT INSURANCE amending the following sections: CORPORATION Section 3.04 of the Rules of * * * * * Operation, which sets forth the term of Section 3.04. Chairperson of the Sunshine Act Meeting the Chairperson and designation of a Subcommittee. The Council shall elect a person to act in the absence of the Chairperson of the Subcommittee. The Pursuant to the provisions of the Chairperson, as amended will define the term of office of the Chairperson shall ‘‘Government in the Sunshine Act’’ (5 Chairperson’s term to expire on March be for a two-year term. Section U.S.C. 552b), notice is hereby given that 31 every even-numbered year. The 1104(a)(12 U.S.C. 3333(a)). The at 10:23 a.m. on Tuesday, June 22, 2010, language to designate a person to act in Chairperson’s term shall expire on the Board of Directors of the Federal the Chairperson’s absence will be March 31 every even-numbered year. Deposit Insurance Corporation met in deleted due to the proposed amendment The Chairperson shall carry out all duties required by the Act and these closed session to consider matters for selection of a Vice Chairperson. A Rules and shall perform such other related to the Corporation’s supervision subsection 3.04.a will be added which duties as from time to time may be and resolution activities. sets forth the selection process of the Vice Chairperson, and describes the assigned by the Subcommittee In calling the meeting, the Board Section 3.04.a. Vice Chairperson of Vice Chairperson’s term and duties. determined, on motion of Director the Subcommittee. The outgoing Section 3.06 of the Rules of Operation Thomas J. Curry (Appointive), seconded Chairperson shall serve as the Vice designates the Vice Chairperson to by Vice Chairman Martin J. Gruenberg, Chairperson for a period of one year, preside over Subcommittee meetings in concurred in by Director John E. with the term ending March 31. During the Chairperson’s absence. Bowman (Acting Director, Office of the March meeting, the Subcommittee Thrift Supervision), Director John C. DATES: Effective Date: Immediately. shall vote upon a Vice Chairperson to Dugan (Comptroller of the Currency), FOR FURTHER INFORMATION CONTACT: serve for the next one-year term, which and Chairman Sheila C. Bair, that James R. Park, Executive Director, at shall coincide with the second year of Corporation business required its (202) 595–7575, or Alice M. Ritter, the Chairperson’s two-year term. It is consideration of the matters which were General Counsel, at (202) 595–7577, via anticipated that the Vice Chairperson to be the subject of this meeting on less Internet e-mail at [email protected] and could serve as the next Chairperson, if than seven days’ notice to the public; [email protected], respectively, or by U.S. so elected by the Council. The Vice that no earlier notice of the meeting was Mail at Appraisal Subcommittee, 1401 Chairperson shall assist the Chairperson practicable; that the public interest did H Street, NW., Suite 760, Washington, as needed, and shall act on behalf of the not require consideration of the matters DC 20005. Subcommittee in the absence or in a meeting open to public observation; SUPPLEMENTARY INFORMATION: The incapacity of the Chairperson. and that the matters could be Subcommittee, on May 29, 1991, * * * * * considered in a closed meeting by adopted Rules of Operation, which were Section 3.06. Organization of authority of subsections (c)(2), (c)(4), published at 56 FR 28561 (June 21, Subcommittee Meetings. (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and 1991). The Rules of Operation describe, (a) The Chairperson of the (c)(10) of the ‘‘Government in the among other things, the organization of Subcommittee shall preside at Sunshine Act’’ (5 U.S.C. 552b(c)(2), Subcommittee meetings, notice Subcommittee meetings. In his or her (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), requirements for meetings, quorum absence, the Vice Chairperson shall and (c)(10)). requirements and certain practices preside at such Subcommittee meeting. regarding the disclosure of information. (b) The Secretary, or in the absence of The meeting was held in the Board The Subcommittee approved by the Secretary, any person designated by Room of the FDIC Building located at notation vote on May 5, 2010, the Chairperson, shall draft and transmit 550–17th Street, NW., Washington, DC. substantive revisions to Sections 3.04 the minutes of the meeting to each Dated: June 22, 2010. and 3.06 of the Rules of Operation to member. The Executive Director is Federal Deposit Insurance Corporation. address the appointment of a Vice appointed to serve as Secretary, and Chairperson for the Subcommittee. shall be responsible for recording the Robert E. Feldman, The Subcommittee is publishing new minutes, including the full text of each Executive Secretary. Sections 3.04, 3.04.a and 3.06 to resolution voted on by the [FR Doc. 2010–15496 Filed 6–22–10; 4:15 pm] conform with 5 U.S.C. 552(a)(1)(C), Subcommittee and the substance of each BILLING CODE P which requires the publication of action voted on by the Subcommittee as

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well as the vote. The Secretary will also 1. Richard Earl Williams, Jr., Unless otherwise noted, comments be responsible for certifying or attesting Cameron, Texas, individually and as regarding each of these applications to true copies, minutes, or other Trustee of the Richard E. Williams must be received at the Reserve Bank documents stating that actions were in Exempt Trust; Debora Evans, Belton, indicated or the offices of the Board of fact taken by the Subcommittee. The Texas, individually and as Trustee of Governors not later than July 19, 2010. Secretary will also be responsible for the Debora Evans Exempt Trust; Richard A. Federal Reserve Bank of Cleveland maintaining and preserving at a single Earl Williams, Jr. and Debora Evans as (Nadine Wallman, Vice President) 1455 place, available for inspection at co–Trustees of (i) the Williams Family East Sixth Street, Cleveland, Ohio reasonable times by any member of the Exempt Trust, (ii) the Victoria Grace 44101–2566: Subcommittee or any person designated Williams Special Trust, (iii) the Thomas 1. Standard Financial Corp., by any member, the complete minutes Joseph Evans 2002 Trust and (iv) the Murrysville, Pennsylvania; to become a of the proceedings of the Subcommittee. Elizabeth Ashton Williams 2002 Trust, bank holding company by acquiring 100 The Executive Director may delegate the all of Cameron, Texas; and Richard E. percent of the voting shares of Standard ministerial duties of Secretary to Williams, Jr., Debora Evans and the Bank, PaSB, Murrysville, Pennsylvania. above named trusts, collectively (the Subcommittee staff. Board of Governors of the Federal Reserve (c) Regular meetings of the ‘‘Williams Family Group’’), to retain System, June 21, 2010. voting shares of Cameron Financial Subcommittee shall be held in Robert deV. Frierson, Corporation and thereby indirectly Washington, DC, at a location Deputy Secretary of the Board. designated by the Chairperson, or in retain voting shares of Classic Bank, such other place as the Subcommittee N.A., both of Cameron, Texas. [FR Doc. 2010–15284 Filed 6–23–10; 8:45 am] BILLING CODE 6210–01–S may designate. Special meetings shall Board of Governors of the Federal Reserve be held in such place and at such System, June 21, 2010. location as designated by the calling Robert deV. Frierson, FEDERAL RESERVE SYSTEM party or parties. Deputy Secretary of the Board. (d) Regular meetings of the [FR Doc. 2010–15283 Filed 6–23–10; 8:45 am] [OP–1385] Subcommittee shall be held at least BILLING CODE 6210–01–S monthly at the call of the Chairperson. Payment System Risk Policy; Daylight Special meetings shall be held as Overdraft Posting Rules provided in section 3.07(b) below. FEDERAL RESERVE SYSTEM AGENCY: Board of Governors of the * * * * * Formations of, Acquisitions by, and Federal Reserve System. By the Appraisal Subcommittee, Mergers of Bank Holding Companies ACTION: Announcement. June 16, 2010. Deborah S. Merkle, The companies listed in this notice SUMMARY: As part of its Payment System Chairman. have applied to the Board for approval, Risk Policy, the Board is announcing [FR Doc. 2010–15320 Filed 6–23–10; 8:45 am] pursuant to the Bank Holding Company posting rules for a new same-day BILLING CODE P Act of 1956 (12 U.S.C. 1841 et seq.) automated clearing house (ACH) (BHC Act), Regulation Y (12 CFR Part service. The Reserve Banks’ FedACH 225), and all other applicable statutes SameDay service, which will include and regulations to become a bank FEDERAL RESERVE SYSTEM certain debit transactions, will be holding company and/or to acquire the available only to customers who elect to Change in Bank Control Notices; assets or the ownership of, control of, or participate. Acquisition of Shares of Bank or Bank the power to vote shares of a bank or DATES: Effective Date: August 2, 2010. bank holding company and all of the Holding Companies FOR FURTHER INFORMATION CONTACT: banks and nonbanking companies Susan Foley, Deputy Associate Director The notificants listed below have owned by the bank holding company, (202–452–3596), Holly Kirkpatrick, applied under the Change in Bank including the companies listed below. Senior Financial Services Analyst, Control Act (12 U.S.C. 1817(j)) and The applications listed below, as well Payment System Risk (202–452–2796), § 225.41 of the Board’s Regulation Y (12 as other related filings required by the or Jennifer Davidson, Senior Financial CFR 225.41) to acquire a bank or bank Board, are available for immediate Services Analyst, Retail Payments (202– holding company. The factors that are inspection at the Federal Reserve Bank 452–2446), Division of Reserve Bank considered in acting on the notices are indicated. The applications also will be Operations and Payment Systems, Board set forth in paragraph 7 of the Act (12 available for inspection at the offices of of Governors of the Federal Reserve U.S.C. 1817(j)(7)). the Board of Governors. Interested System; for users of The notices are available for persons may express their views in Telecommunications Device for the Deaf immediate inspection at the Federal writing on the standards enumerated in (‘‘TDD’’) only, contact (202) 263–4869. Reserve Bank indicated. The notices the BHC Act (12 U.S.C. 1842(c)). If the also will be available for inspection at proposal also involves the acquisition of SUPPLEMENTARY INFORMATION: the office of the Board of Governors. a nonbanking company, the review also I. Background Interested persons may express their includes whether the acquisition of the views in writing to the Reserve Bank nonbanking company complies with the The Reserve Banks will be offering an indicated for that notice or to the offices standards in section 4 of the BHC Act opt-in, same-day settlement service for of the Board of Governors. Comments (12 U.S.C. 1843). Unless otherwise certain ACH debit payments through the must be received not later than July 9, noted, nonbanking activities will be FedACH service effective August 2, 1 2010. conducted throughout the United States. 2010. FedACH customers may opt-in to A. Federal Reserve Bank of Dallas (E. Additional information on all bank 1 For additional information on the FedACH Ann Worthy, Vice President) 2200 holding companies may be obtained SameDay service, please contact your Federal North Pearl Street, Dallas, Texas 75201– from the National Information Center Reserve Account Executive or visit http:// 2272: website at www.ffiec.gov/nic/. www.frbservices.org.

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this service by completing a debit transfers initiated over the Internet Reserve Banks offer new financial participation agreement. As part of the and phone.2 services, the Board determines when the agreement, depository institutions may Institutions that choose to use this payments will post to an institution’s choose the extent of their participation: service should be aware of the posting Federal Reserve account so it may They may send only, receive only, or times and associated settlement times manage and appropriately fund its send and receive same-day debit items. established for same-day forward and account.4 The following table outlines This service will be limited to return transfers, as these times could the transmission deadlines and transactions arising from consumer influence how participating institutions associated posting times for the FedACH checks converted to ACH and consumer manage their Federal Reserve accounts, SameDay service.5 especially late in the day.3 When the

FedACH SameDay opt-in service Transmission deadline to FedACH Posting time

Forward same-day debit transfers ...... 2 p.m ...... 5 p.m. Return same-day debit transfers ...... 4:30 p.m ...... 5:30 p.m.

In considering these transmission settlement transactions. Immediate- position deriving from such legal deadlines and posting times, the Board settlement transactions include ACH differences.7 The Board believes that sought to provide receiving institutions return items and check-truncation there are no adverse effects to other with enough time to process same-day items. The posting time for these items service providers resulting from the new transactions. Depository institutions is 5 p.m. While customers will not be posting rules. While FedACH is the only may send a same-day forward item to able to request an extension to the ACH operator that is currently offering FedACH until 2 p.m. FedACH will FedACH SameDay service, the a same-day service, if the other ACH process these forward items and send transmission deadline for this service operator elects to offer a same-day them to the receiving institutions by may be minimally affected by service, FedACH would support inter- approximately 4 p.m., and these items extensions granted for the immediate- operator transfers to enable customers to will settle the same day at 5 p.m. The settlement transactions. If a customer is benefit from both operators’ same-day Board also wanted to ensure that granted an extension, FedACH would service offerings. institutions have sufficient time to extend both the transmission deadline III. Paperwork Reduction Act manage their Federal Reserve account if to send immediate-settlement return they receive a returned debit transfer payments and the transmission deadline In accordance with the Paperwork late in the day. Depository institutions to send same-day forward items past 2 Reduction Act of 1995 (44 U.S.C. 3506; will have until 4:30 p.m. to return same- p.m. While this extension would grant 5 CFR 1320 Appendix A.1), the Board day debit items for same-day all FedACH customers more time to reviewed the new posting rules under settlement.6 FedACH will process and send these items, it would not delay the the authority delegated to the Board by send the returned items to the posting times as FedACH would absorb the Office of Management and Budget. originating institutions by the extension by shortening its No collections of information pursuant approximately 5 p.m., and these items processing window. Depository to the Paperwork Reduction Act are will settle the same day at 5:30 p.m. The institutions interested in learning more contained in these new posting rules. Board believes that because these detailed information about the FedACH IV. Federal Reserve Policy on Payment processing and posting times provide SameDay service should contact their System Risk institutions with information local Reserve Bank or visit http:// sufficiently in advance of the close of www.frbservices.org. The Federal Reserve Policy on Fedwire, participants in the FedACH Payment System Risk, Section II.A. SameDay service will be able to react II. Competitive Impact Analysis under the subheading ‘‘Procedures for appropriately to any debit transfers they Measuring Daylight Overdrafts,’’ is The Board conducts a competitive amended with changes as follows in may receive in their Federal Reserve impact analysis when it considers a accounts. italics. change, such as introducing posting Procedures for Measuring Daylight The Board also considered the rules for a new service. Specifically, the Overdrafts 8 possibility of how extensions to the Board determines whether there would Post at 5 p.m. Eastern Time: FedACH service may affect the FedACH be a direct and material adverse effect +/¥ FedACH SameDay service SameDay service. Today, under certain on the ability of other service providers transactions. circumstances, FedACH customers may to compete with the Federal Reserve + Treasury checks, postal money request an extension to the transmission due to differing legal powers or due to orders, and EZ–Clear savings bond deadline of 2 p.m. for immediate- the Federal Reserve’s dominant market redemptions in separately sorted

2 This service is limited to the origination of non- Institutions may view their real-time account settlement at 5:30 p.m. If a same-day item is not government debit payments and includes only balance and daylight overdraft balance in Account returned by the same-day return deadline, Accounts Receivable Entry (ARC), Back Office Management Information (AMI), which is a service institutions have until the generally applicable Conversion Entry (BOC), Point-of-Purchase Entry offered by the Reserve Banks. return deadline specified in the National (POP), Telephone-Initiated Entry (TEL), 4 Under the current posting times, government Automated Clearing House Association (NACHA) Represented Check Entry (RCK), and Internet- and commercial ACH credit transactions post at Initiated Entry (WEB). rules to return items. 8:30 a.m. Eastern Time and debit transactions post 3 The posting time is the time by which a 7 Federal Reserve Regulatory Service, 7–145.2. at 11 a.m. Eastern Time. ACH return transactions transaction will be recorded for daylight overdraft 8 These posting times do not affect the overdraft post at 5 p.m. Eastern Time. purposes and reflected in an institution’s daylight restrictions and overdraft-measurement provisions 5 All times associated with the deadlines and overdraft balance. Settlement for the transaction for nonbank banks established by the Competitive posting rules are Eastern Time. will occur approximately fifteen to thirty minutes Equality Banking Act of 1987 and the Board’s before the associated posting time and will be 6 Institutions have the option of returning same- Regulation Y (12 CFR 225.52). reflected in the institution’s account balance. day items by 4:30 p.m. for same-day return

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deposits; these items must be deposited considered in preparation of the Final improvements at the Calexico West Port by 4 p.m. Eastern Time. Environmental Impact Statement. of Entry. + Local Federal Reserve Bank checks; FOR FURTHER INFORMATION CONTACT: Mr. ADDRESSES: Comments may be these items must be presented before Greg Smith, GSA Regional submitted in writing to: Mr. Greg Smith, 3:00 p.m. Eastern Time. Environmental Quality Advisor, Regional Environmental Quality +/¥ Immediate-settlement ACH Portfolio Management Division, Capital Advisor, Portfolio Management transactions; these transactions include Investment Branch (9P2PTC), U.S. Division, Capital Investment Branch ACH return items and check-truncation General Services Administration, 880 (9P2PTC), U.S. General Services items. Front Street, Room 4236, San Diego, Administration, 880 Front Street, Room Post at 5:30 p.m. Eastern Time: California 92101, (619) 557–6169 or via 4236, San Diego, California 92101, or +/¥ FedACH SameDay service return e-mail to [email protected]. Oral and via e-mail to [email protected]. Oral transactions. written comments may also be and written comments may also be By order of the Board of Governors of the submitted at the public hearing submitted at the public meetings Federal Reserve System, acting through the described in the DATES section. Requests described in the DATES section. Copies Director of the Division of Reserve Bank for copies of the Draft Calexico West of the Draft Calexico Environmental Operations and Payment Systems under Port of Entry EIS or other matters Impact Statement may be downloaded delegated authority, June 16, 2010. regarding this environmental review from http://www.gsa.gov/nepalibrary. Jennifer J. Johnson, should be referred to Greg Smith at the Other matters regarding this Secretary of the Board. address above. environmental review should be [FR Doc. 2010–15276 Filed 6–23–10; 8:45 am] SUPPLEMENTARY INFORMATION: A notice referred to Greg Smith at the address BILLING CODE 6210–01–P of availability will be mailed to all above. agencies, organizations, and individuals Dated: June 10, 2010. who participated in the scoping process Samuel R. Mazzola, GENERAL SERVICES or were identified during the EIS Director, Portfolio Management Division, ADMINISTRATION process. GSA has distributed copies of Public Building Service, Pacific Rim Region. the Draft Calexico West Port of Entry [FR Doc. 2010–15299 Filed 6–23–10; 8:45 am] EIS to appropriate Congressional Notice of Availability of the Draft BILLING CODE 6820–YF–P Environmental Impact Statement for members and committees, the state of Improvements to the Calexico West California, American Indian tribal Port of Entry, Calexico, CA governments, local county governments, other Federal agencies, and other DEPARTMENT OF HEALTH AND AGENCY: Public Buildings Service, GSA. interested parties who have already HUMAN SERVICES ACTION: Notice of Availability and requested copies. Food and Drug Administration public hearing for the Draft The Draft EIS was prepared pursuant Environmental Impact Statement. to the National Environmental Policy [Docket No. FDA–2010–N–0181] Act of 1969 (NEPA) [42 U.S.C. 4321 et SUMMARY: The General Services seq.] and the Council on Environmental Agency Information Collection Administration (GSA) announces the Quality NEPA regulations [40 CFR part Activities; Submission for Office of availability of the Draft Environmental 1500]. GSA proposes to continue Management and Budget Review; Impact Statement (EIS) for operating the Calexico West Port of Comment Request; Threshold of Improvements to the Calexico West Port Entry, which is located in Calexico in Regulation for Substances Used in of Entry, Calexico, California, for public south-central California. GSA has Food-Contact Articles review and comment. The EIS provides identified and assessed several design GSA and its stakeholders an analysis of AGENCY: Food and Drug Administration, options for the renovation, replacement, HHS. the environmental impacts resulting and continued operation of the Calexico ACTION: from ongoing operations as well as West Port of Entry. In addition, GSA Notice. reasonable alternatives for renovation, analyzed the No Action Alternative in replacement, and continued operation SUMMARY: The Food and Drug which GSA would continue the status Administration (FDA) is announcing of the Calexico West Port of Entry, quo, that is, operate the port of entry in located in south-central California. that a proposed collection of its current configuration, with only information has been submitted to the DATES: Comments on the Draft minor planned upgrades. Office of Management and Budget Environmental Impact Statement may The Draft Calexico Port of Entry EIS (OMB) for review and clearance under be submitted during the public identifies the expected environmental the Paperwork Reduction Act of 1995. comment period, which will commence impacts from facility operations for each DATES: with the U.S. Environmental Protection alternative. For each alternative, impact Fax written comments on the Agency’s publication of the Federal discussions are presented by resource collection of information by July 26, Register Notice of Availability for this area (e.g., land use, geology and soils) or 2010. document and end on August 18, 2010. topic area (e.g., traffic, environmental ADDRESSES: To ensure that comments on Comments may be submitted in writing, justice). the information collection are received, orally, or by electronic mail to the After the public comment period, OMB recommends that written General Services Administration at the which ends August 18, 2010, GSA will comments be faxed to the Office of address, phone number, or e-mail listed consider the comments received, revise Information and Regulatory Affairs, below. Oral or written comments may the Draft EIS, select a preferred OMB, Attn: FDA Desk Officer, FAX: also be submitted at public meetings to alternative, and issue a Final EIS. GSA 202–395–7285, or e-mailed to be held on June 22 and July 14, 2010, will consider the Final EIS, along with [email protected]. All between 3 and 7 p.m., at the Calexico other economic and technical comments should be identified with the City Hall, 608 Heber Avenue, Calexico, considerations, to make a decision on OMB control number 0910–0298. Also California. Comments submitted will be the appropriate course for include the FDA docket number found

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in brackets in the heading of this an effective notification in accordance composition of the substance for which document. with section 409(a)(3)(B). the request is made, (2) detailed FOR FURTHER INFORMATION CONTACT: The regulations in § 170.39 (21 CFR information on the conditions of use of Denver Presley Jr., Office of Information 170.39) established a process that the substance, (3) a clear statement of Management, Food and Drug provides the manufacturer with an the basis for the request for exemption Administration, 1350 Piccard Dr., PI50– opportunity to demonstrate that the from regulation as a food additive, (4) 400B, Rockville, MD 20850, 301–796– likelihood or extent of migration to food data that will enable FDA to estimate 3793. of a substance used in a food-contact the daily dietary concentration resulting article is so trivial that the use need not from the proposed use of the substance, SUPPLEMENTARY INFORMATION: In be the subject of a food additive listing (5) results of a literature search for compliance with 44 U.S.C. 3507, FDA toxicological data on the substance and has submitted the following proposed regulation or an effective notification. The agency has established two its impurities, and (6) information on collection of information to OMB for the environmental impact that would review and clearance. thresholds for the regulation of substances used in food-contact articles. result from the proposed use. Threshold of Regulation for Substances The first exempts those substances used FDA uses this information to Used in Food-Contact Articles—(OMB in food-contact articles where the determine whether the food-contact Control Number 0910–0298)—Extension resulting dietary concentration would article meets the threshold criteria. Under section 409(a) of the Federal be at or below 0.5 part per billion (ppb). Respondents to this information Food, Drug, and Cosmetic Act (the act) The second exempts regulated direct collection are individual manufacturers (21 U.S.C. 348(a)), the use of a food food additives for use in food-contact and suppliers of substances used in additive is deemed unsafe unless one of articles where the resulting dietary food-contact articles (i.e., food the following is applicable: (1) It exposure is 1 percent or less of the packaging and food processing conforms to an exemption for acceptable daily intake for these equipment) or of the articles themselves. investigational use under section 409(j), substances. In the Federal Register of April 9, (2) it conforms to the terms of a In order to determine whether the 2010 (75 FR 18209), FDA published a regulation prescribing its use, or (3) in intended use of a substance in a food- 60-day notice requesting public the case of a food additive that meets contact article meets the threshold comment on the proposed collection of the definition of a food-contact criteria, certain information specified in information. No comments were substance in section 409(h)(6), there is § 170.39(c) must be submitted to FDA. received. either a regulation authorizing its use in This information includes the following FDA estimates the burden of this accordance with section 409(a)(3)(A) or components: (1) The chemical collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Annual Frequency Total Annual Hours 21 CFR Section Respondents per Response Responses per Response Total Hours

170.39 7 1 7 48 336 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

In compiling these estimates, FDA food contacted, etc.) are those for which Dated: June 16, 2010. consulted its records of the number of the exemption was issued. As a result, David Dorsey, regulation exemption requests received the overall burden on both the agency Acting Deputy Commissioner for Policy, in the past 3 years. The annual hours and the regulated industry would be Planning and Budget. per response reporting estimate of 48 significantly less in that other [FR Doc. 2010–15302 Filed 6–23–10; 8:45 am] hours is based on information received manufacturers and suppliers would not BILLING CODE 4160–01–S from representatives of the food have to prepare, and FDA would not packaging and processing industries and have to review, similar submissions for agency records. identical components of food-contact DEPARTMENT OF HEALTH AND FDA estimates that approximately 7 articles used under identical conditions. HUMAN SERVICES requests per year will be submitted Manufacturers and other interested Food and Drug Administration under the threshold of regulation persons can easily access an up-to-date exemption process of § 170.39, for a list of exempted substances which is on [Docket No. FDA–2010–N–0273] total of 336 hours. The threshold of display at FDA’s Division of Dockets Agency Information Collection regulation process offers one advantage Management and on the Internet at Activities; Proposed Collection; over the premarket notification process http://www.cfsan.fda.gov. Having the for food-contact substances established Comment Request; Medical Devices: list of exempted substances publicly Current Good Manufacturing Practice by section 409(h) of the act (OMB available decreases the likelihood that a Quality System Regulations control number 0910–0495) in that the company would submit a food additive use of a substance exempted by the petition or a notification for the same AGENCY: Food and Drug Administration, agency is not limited to only the type of food-contact application of a HHS. manufacturer or supplier who submitted substance for which the agency has ACTION: Notice. the request for an exemption. Other previously granted an exemption from SUMMARY: manufacturers or suppliers may use the food additive listing regulation The Food and Drug exempted substances in food-contact Administration (FDA) is announcing an requirement. articles as long as the conditions of use opportunity for public comment on the (e.g., use levels, temperature, type of proposed collection of certain

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information by the agency. Under the the information will have practical and Servicing.’’ The CGMP/QS Paperwork Reduction Act of 1995 (the utility; (2) the accuracy of FDA’s information collections will assist FDA PRA), Federal agencies are required to estimate of the burden of the proposed inspections of manufacturers for publish notice in the Federal Register collection of information, including the compliance with QS requirements concerning each proposed collection of validity of the methodology and encompassing design, production, information, including each proposed assumptions used; (3) ways to enhance installation, and servicing processes. extension of an existing collection of the quality, utility, and clarity of the Section 820.20(a) through (e) requires information, and to allow 60 days for information to be collected; and (4) management with executive public comment in response to the ways to minimize the burden of the responsibility to establish, maintain, notice. This notice solicits comments on collection of information on and/or review the following topics: (1) recordkeeping requirements related to respondents, including through the use The quality policy, (2) the the medical devices current good of automated collection techniques, organizational structure, (3) the quality manufacturing practice (CGMP) quality when appropriate, and other forms of plan, and (4) the quality system system (QS) regulation (CGMP/QS information technology. procedures of the organization. regulation). Medical Devices: Current Good Section 820.22 requires the conduct DATES: Submit either electronic or Manufacturing Practice Quality System and documentation of QS audits and written comments on the collection of Regulations—21 CFR Part 820 (OMB reaudits. information by August 23, 2010. Control Number 0910–0073)—Extension Section 820.25(b) requires the establishment of procedures to identify ADDRESSES: Submit electronic Under section 520(f) of the Federal training needs and documentation of comments on the collection of Food, Drug, and Cosmetic Act (the act) such training. information to http:// (21 U.S.C. 360j(f)), the Secretary of the Section 820.30(a)(1) and (b) through www.regulations.gov. Submit written Department of Health and Human (j), requires in respective order, the comments on the collection of Services has the authority to prescribe establishment, maintenance, and/or information to the Division of Dockets regulations requiring that the methods documentation of the following topics: Management (HFA–305), Food and Drug used in, and the facilities and controls (1) Procedures to control design of class Administration, 5630 Fishers Lane, rm. used for, the manufacture, pre- III and class II devices and certain class 1061, Rockville, MD 20852. All production design validation (including I devices as listed therein; (2) plans for comments should be identified with the a process to assess the performance of design and development activities and docket number found in brackets in the a device but not including an evaluation updates; (3) procedures identifying, heading of this document. of the safety and effectiveness of a documenting, and approving design FOR FURTHER INFORMATION CONTACT: device), packing, storage, and installation of a device conform to input requirements; (4) procedures Daniel Gittleson, Office of Information defining design output, including Management, Food and Drug CGMP, as described in such regulations, to assure that the device will be safe and acceptance criteria, and documentation Administration, 1350 Piccard Dr., PI50– of approved records; (5) procedures for 400B, Rockville, MD 20857, 301–796– effective and otherwise in compliance with the act. formal review of design results and 5156 email: documentation of results in the design [email protected]. The CGMP/QS regulation implementing authority provided by history file (DHF); (6) procedures for SUPPLEMENTARY INFORMATION: Under the this statutory provision is found under verifying device design and PRA (44 U.S.C. 3501–3520), Federal part 820 (21 CFR part 820) and sets forth documentation of results and approvals agencies must obtain approval from the basic CGMP requirements governing the in the DHF; (7) procedures for validating Office of Management and Budget design, manufacture, packing, labeling, device design, including documentation (OMB) for each collection of storage, installation, and servicing of all of results in the DHF; (8) procedures for information they conduct or sponsor. finished medical devices intended for translating device design into ‘‘Collection of information’’ is defined in human use. The authority for this production specifications; (9) 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) regulation is covered under sections procedures for documenting, verifying, and includes agency requests or 501, 502, 510, 513, 514, 515, 518, 519, and validating approved design changes requirements that members of the public 520, 522, 701, 704, 801, and 803 of the before implementation of changes; and submit reports, keep records, or provide act (21 U.S.C. 351, 352, 360, 360c, 360d, (10) the records and references information to a third party. Section 360e, 360h, 360i, 360j, 360l, 371, 374, constituting the DHF for each type of 3506(c)(2)(A) of the PRA (44 U.S.C. 381, and 383). The CGMP/QS regulation device. 3506(c)(2)(A)) requires Federal agencies includes requirements for purchasing Section 820.40 requires manufacturers to provide a 60-day notice in the and service controls, clarifies to establish and maintain procedures Federal Register concerning each recordkeeping requirements for device controlling approval and distribution of proposed collection of information, failure and complaint investigations, required documents and document including each proposed extension of an clarifies requirements for verifying/ changes. existing collection of information before validating production processes and Section 820.40(a) and (b) requires the submitting the collection to OMB for process or product changes, and establishment and maintenance of approval. To comply with this clarifies requirements for product procedures for the review, approval, requirement, FDA is publishing notice acceptance activities quality data issuance, and documentation of of the proposed collection of evaluations and corrections of required records (documents) and information set forth in this document. nonconforming product/quality changes to those records. With respect to the following problems. Section 820.50(a)(1), (a)(2), (a)(3), and collection of information, FDA invites Requirements are compatible with (b) requires the establishment and comments on these topics: (1) Whether specifications in the international maintenance of procedures and the proposed collection of information standards ‘‘ISO 9001: Quality Systems requirements to ensure service and is necessary for the proper performance Model for Quality Assurance in Design/ product quality, records of acceptable of FDA’s functions, including whether Development, Production, Installation, suppliers, and purchasing data

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describing specified requirements for device master record (DMR) activities respectively, the maintenance of records products and services. are completed; (5) records in the device that are: (1) Retained at prescribed Sections 820.60 and 820.65 require, history record (DHR) showing site(s), made readily available and respectively, the establishment and acceptance dates, results, and accessible to FDA and retained for the maintenance of procedures for equipment used; and (6) the acceptance/ device’s life expectancy or for 2 years; identifying all products from receipt to rejection identification of products from (2) contained or referenced in a DMR distribution and for using control receipt to installation and servicing. consisting of device, process, quality numbers to track surgical implants and Sections 820.90(a), (b)(1), and (b)(2) assurance, packaging and labeling, and life-sustaining or supporting devices and 820.100 require, respectively, the installation, maintenance, and servicing and their components. establishment, maintenance and/or specifications and procedures; (3) Section 820.70(a)(1) through (a)(5), (b) documentation of the following topics: contained in a DHR and demonstrate the through (e), (g)(1) through (g)(3), (h), and (1) Procedures for identifying, manufacture of each unit, lot, or batch (i) requires the establishment, recording, evaluating, and disposing of of product in conformance with DMR maintenance, and/or documentation of nonconforming product; (2) procedures and regulatory requirements, include the following topics: (1) Process control for reviewing and recording concessions manufacturing and distribution dates, procedures; (2) procedures for verifying made for, and disposition of, quantities, acceptance documents, or validating changes to specification, nonconforming product; (3) procedures labels and labeling, control numbers; method, process, or procedure; (3) for reworking products, evaluating and (4) contained in a quality system procedures to control environmental possible adverse rework effect and record (QSR), consisting of references, conditions and inspection result recording results in the DHR; (4) documents, procedures, and activities records; (4) requirements for personnel procedures and requirements for not specific to particular devices. hygiene; (5) procedures for preventing corrective and preventive actions, Sections 820.198(a) through (c) and contamination of equipment and including analysis, investigation, 820.200(a) through (d), respectively, products; (6) equipment adjustment, identification and review of data, require the establishment, maintenance, cleaning, and maintenance schedules; records, causes, and results; and (5) and/or documentation of the following (7) equipment inspection records; (8) records for all corrective and preventive topics: (1) Complaint files and equipment tolerance postings, action activities. procedures for receiving, reviewing and procedures for utilizing manufacturing Section 820.100(a)(1) through (a)(7) evaluating complaints; (2) complaint materials expected to have an adverse states that procedures and requirements investigation records identifying the effect on product quality; and (9) shall be established and maintained for device, complainant, and relationship of validation protocols and validation corrective/preventive actions, including the device to the incident; (3) complaint records for computer software and the following: (1) Analysis of data from records that are reasonably accessible to software changes. process, work, quality, servicing the manufacturing site or at prescribed Sections 820.72(a), (b)(1), and (b)(2) records; investigation of sites; (4) procedures for performing and and 820.75(a) through (c) require, nonconformance causes; (2) verifying that device servicing respectively, the establishment, identification of corrections and their requirements are met and that service maintenance, and/or documentation of effectiveness; (3) recording of changes reports involving complaints are the following topics: (1) Equipment made; and (4) appropriate distribution processed as complaints; and (5) service calibration and inspection procedures; and managerial review of corrective and reports that record the device, service (2) national, international or in-house preventive action information. activity, and test and inspection data. calibration standards; (3) records that Section 820.120 states that Section 820.250 requires the identify calibrated equipment and next manufacturers shall establish/maintain establishment and maintenance of calibration dates; (4) validation procedures to control labeling storage/ procedures to identify valid statistical procedures and validation results for application; and examination/release for techniques necessary to verify process processes not verifiable by inspections storage and use, and document those and product acceptability; and sampling and tests; (5) procedures for keeping procedures. plans, when used, which are written validated processes within specified Sections 820.120(b) and (d), 820.130, and based on valid statistical rationale; limits; (6) records for monitoring and 820.140, 820.150(a) and (b), 820.160(a) and procedures for ensuring adequate controlling validated processes; and (7) and (b), and 820.170(a) and (b), sampling methods. The CGMP/QS records of the results of revalidation respectively, require the establishment, regulation amends and revises the where necessitated by process changes maintenance, and/or documentation of CGMP requirements for medical devices or deviations. following topics: (1) Procedures for set out under part 820. The regulation Sections 820.80(a) through (e) and controlling and recording the storage, adds design and purchasing controls; 820.86, respectively, require the examination, release, and use of modifies previous critical device establishment, maintenance, and/or labeling; (2) the filing of labels/labeling requirements; revises previous documentation of the following topics: used in the DHR; (3) procedures for validation and other requirements; and (1) Procedures for incoming acceptance controlling product storage areas and harmonizes device CGMP requirements by inspection, test, or other verification; receipt/dispatch authorizations; (4) with QS specifications in the (2) procedures for ensuring that in- procedures controlling the release of international standard ‘‘ISO 9001: process products meet specified products for distribution; (5) Quality Systems Model for Quality requirements and the control of product distribution records that identify Assurance in Design/Development, until inspection and tests are consignee, product, date, and control Production, Installation, and Servicing.’’ completed; (3) procedures for, and numbers; and (6) instructions, The rule does not apply to records that show, incoming acceptance inspection and test procedures that are manufacturers of components or parts of or rejection is conducted by inspections, made available, and the recording of finished devices, nor to manufacturers tests or other verifications; (4) results for devices requiring installation. of human blood and blood components procedures for, and records that show, Sections 820.180(b) and (c), subject to 21 CFR part 606. With respect finished devices meet acceptance 820.181(a) through (e), 820.184(a) to devices classified in class I, design criteria and are not distributed until through (f), and 820.186 require, control requirements apply only to class

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I devices listed in § 820.30(a)(2) of the servicing specifications and, thus are (CDRH), Office of Surveillance and regulation. The rule imposes burden safe, effective and suitable for their Biometrics. Respondents to this upon: (1) Finished device manufacturer intended purpose. In particular, collection have no reporting activities, firms, which are subject to all compliance with CGMP design control but must make required records recordkeeping requirements; (2) requirements should decrease the available for review or copying during finished device contract manufacturers, number of design-related device failures FDA inspection. The regulation contains specification developers; and (3) that have resulted in deaths and serious additional recordkeeping requirements repacker, relabelers, and contract injuries. in such areas as design control, sterilizer firms, which are subject only The CGMP/QS regulation applies to purchasing, installation, and to requirements applicable to their approximately 8,924 respondents. These information relating to the recordkeepers consist of 8,945 original activities. In addition, remanufacturers remanufacture of SUDs. The estimates respondents and an estimated 18 of hospital single-use devices (SUDs) for this burden are derived from those will now be considered to have the hospitals that remanufacture or reuse incremental tasks that were determined same requirements as manufacturers in SUDs. They include manufacturers, when the new CGMP/QS regulation regard to this regulation. The subject to all requirements and contract became final as well as those carryover establishment, maintenance and/or manufacturers, specification developers, documentation of procedures, records, repackers, relabelers, and contract requirements. The carryover and data required by this regulation will sterilizers, subject only to requirements requirements are based on decisions assist FDA in determining whether applicable to their activities. Hospital made by the agency on July 16, 1992, firms are in compliance with CGMP remanufacturers of SUDs are now under OMB Control Number 0910–0073, requirements, which are intended to defined to be manufacturers under which still provides valid base line data. ensure that devices meet their design, guidelines issued by FDA’s Center for FDA estimates the burden for this production, labeling, installation, and Devices and Radiological Health collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Total Operating No. of Record- Annual Frequency per Total Annual Hours Per and 21 CFR Section keepers Recordkeeping Records Record Maintenance Total Hours Costs

820.20(a) 8,924 1 8,924 7 62,468

820.20(b) 8,924 1 8,924 4 35,696

820.20(c) 8,924 1 8,924 6 53,544

820.20(d) 8,924 1 8,924 10 89,240

820.20(e) 8,924 1 8,924 10 89,240

820.22 8,924 1 8,924 33 294,492

820.25(b) 8,924 1 8,924 13 116,012

820.30(a)(1) 8,924 1 8,924 2 17,848

820.30(b) 8,924 1 8,924 6 53,544

820.30(c) 8,924 1 8,924 2 17,848

820.30(d) 8,924 1 8,924 2 17,848

820.30(e) 8,924 1 8,924 23 205,252

820.30(f) 8,924 1 8,924 37 330,188

820.30(g) 8,924 1 8,924 37 330,188

820.30(h) 8,924 1 8,924 3 26,772

820.30(i) 8,924 1 8,924 17 151,708

820.30(j) 8,924 1 8,924 3 26,772

820.40 8,924 1 8,924 9 80,316

820.40(a) and (b) 8,924 1 8,924 2 17,848

820.50(a)(1) through (a)(3) 8,924 1 8,924 22 1,300,805 196,328

820.50(b) 8,924 1 8,924 6 53,544

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TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

Total Operating No. of Record- Annual Frequency per Total Annual Hours Per and 21 CFR Section keepers Recordkeeping Records Record Maintenance Total Hours Costs

820.6 8,924 1 8,924 1 8,924

820.65 8,924 1 8,924 1 8,924

820.70(a)(1) through (a)(5) 8,924 1 8,924 2 17,848

820.70(b) and (c) 8,924 1 8,924 2 17,848

820.70(d) 8,924 1 8,924 3 26,772

820.70(e) 8,924 1 8,924 2 17,848

820.70(g)(1) through (g)(3) 8,924 1 8,924 1 8,924

820.70(h) 8,924 1 8,924 2 17,848

820.70(i) 8,924 1 8,924 8 71,392

820.72(a) 8,924 1 8,924 5 44,620

820.72(b)(1) and (b)(2) 8,924 1 8,924 1 8,924

820.75(a) 8,924 1 8,924 3 26,772

820.75(b) 8,924 1 8,924 1 8,924

820.75(c) 8,924 1 8,924 1 8,924

820.80(a) through (e) 8,924 1 8,924 5 44,620

820.86 8,924 1 8,924 1 8,924

820.90(a) 8,924 1 8,924 5 44,620

820.90(b)(1) and (b)(2) 8,924 1 8,924 5 44,620

820.100(a)(1) through (a)(7) 8,924 1 8,924 12 107,088

820.100(b) 8,924 1 8,924 1 8,924

820.120(b) 8,924 1 8,924 1 8,924

820.120(d) 8,924 1 8,924 1 8,924

820.130 8,924 1 8,924 1 8,924

820.140 8,924 1 8,924 6 53,544

820.150(a) and (b) 8,924 1 8,924 6 53,544

820.160(a) and (b) 8,924 1 8,924 1 8,924

820.170(a) and (b) 8,924 1 8,924 2 17,848

820.180(b) and (c) 8,924 1 8,924 2 17,848

820.181(a) through (e) 8,924 1 8,924 1 8,924

820.184(a) through (f) 8,924 1 8,924 1 8,924

820.186 8,924 1 8,924 1 8,924

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TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

Total Operating No. of Record- Annual Frequency per Total Annual Hours Per and 21 CFR Section keepers Recordkeeping Records Record Maintenance Total Hours Costs

820.198(a) through (c) 8,924 1 8,924 5 44,620

820.200(a) and (d) 8,924 1 8,924 3 26,772

820.25 8,924 1 8,924 1 8,924

Total 1,300,805 3,105,552 1 There are no capital costs associated with this collection of information.

Explanation of Recordkeeping Burden • Potentially affected establishments: DEPARTMENT OF HEALTH AND Estimate Except for manufacturers, not every type HUMAN SERVICES FDA estimates respondents will have of firm is subject to every CGMP/QS a total annual recordkeeping burden of requirement. For example, all are Food and Drug Administration approximately 3,105,552 hours. This subject to Quality Policy (§ 820.20(a)), figure also consists of approximately Document Control (§ 820.40), and other [Docket No. FDA–2010–N–0180] 143,052 hours spent on a startup basis requirements, whereas only Agency Information Collection by 734 new firms. manufacturers and specification Activities; Submission for Office of Burden (labor) hour and cost developers are subject to Subpart C, estimates were originally developed Management and Budget Review; Design Controls. The type of firm Comment Request; Adoption of the under FDA contract by Eastern Research subject to each requirement was Group, Inc. (ERG) in 1996 when the Food and Drug Administration Food identified by the ERG. Code by Local, State, and Tribal CGMP/QS regulation became final. • Additional factors considered in FDA estimated the burden hours Governments (and costs) for the previous CGMP deriving estimates included the AGENCY: regulation in 1992. That estimate was Food and Drug Administration, following: HHS. • Establishment type: Query has been submitted to OMB on May 4, 1992, ACTION: made of CDRH’s registration/listing data under OMB Paperwork Reduction Act Notice. bank and the current count was 7,748 Control Number 0910–0073. It was SUMMARY: The Food and Drug domestic firms subject to CGMPs. It was approved by OMB on July 16, 1992, and Administration (FDA) is announcing also calculated that each year, the expired on June 30, 1995. The that a proposed collection of number of new domestic firms subject methodology used is different than that information has been submitted to the to CGMPs is 734. The average amount used by ERG in estimating incremental Office of Management and Budget of firms therefore subject to CGMPs over tasks when the new CGMP/QS became (OMB) for review and clearance under the 3 years is therefore 8,924 and this final rule. Nevertheless, the agency the Paperwork Reduction Act of 1995. figure has been used to calculate the believes its 1992 estimate adequately total burden. Because the total number DATES: Fax written comments on the represents labor hours (and costs) collection of information by July 26, of registered firms is not static, the needed to comply with previous CGMP number of respondents will fluctuate 2010. requirements carried over into the new from year to year resulting in slight ADDRESSES: To ensure that comments on CGMP/QS regulation. The 1992 estimate changes to the overall burden. the information collection are received, used 9,289 respondents (rather than • During the last report it was OMB recommends that written 8,924 respondents), which compensates estimated that this number was 8,963. comments be faxed to the Office of When the last set of numbers was for differences in methodology. Information and Regulatory Affairs, calculated, FDA was still using a paper Dated: June 18, 2010. OMB, Attn: FDA Desk Officer, FAX: based system to register and list firms. Leslie Kux, 202–395–7285, or e-mailed to On October 1, 2007, FDA switched to an _ Acting Assistant Commissioner for Policy. oira [email protected]. All electronic system for registration and comments should be identified with the [FR Doc. 2010–15338 Filed 6–23–10; 8:45 am] listing. Also at that time the Food and OMB control number 0910–0448. Also Drug Administration Amendments Act BILLING CODE 4160–01–S include the FDA docket number found of 2007 instituted an establishment in brackets in the heading of this registration fee for some types of document. facilities. FDA believes that during the FY 2008 annual registration cycle, FOR FURTHER INFORMATION CONTACT: establishments that had previously Denver Presley Jr., Office of Information registered but were not required to do Management, Food and Drug so, removed themselves from inventory Administration, 1350 Piccard Dr., PI50– of active establishments. FDA believes 400B, Rockville, MD 20850, 301–796– that the current figures reported by the 3793. electronic system more accurately SUPPLEMENTARY INFORMATION: In reflect the inventory of registered compliance with 44 U.S.C. 3507, FDA establishments. has submitted the following proposed

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collection of information to OMB for toward the agency’s goal for consistent, process that can extend for several review and clearance. scientifically sound, and risk-based food years. For this reason, many agencies safety standards and practices. A have reported that they are still in the Adoption of the FDA Food Code by rulemaking process to adopt or update Local, State, and Tribal Governments— current, comprehensive, and accurate their food codes. Thus, FDA believes 42 U.S.C. 243(a) (OMB Control Number inventory of food code adoptions by 0910–0448)—Extension States and U.S. territories, local, and that extension of OMB approval of the tribal governments is necessary to survey is needed in order to keep the FDA has developed its model Food determine the status of up-to-date current database accurate and up-to- Code to assist and promote consistent protection of the U.S. population and to date. The contractor will collect the implementation of national food safety identify areas where assistance to these information electronically and/or regulatory policy among the local, State, governments may promote the adoption telephonically and will be able to and tribal governmental agencies that of regulations based on the FDA Food provide respondents with previous have primary responsibility for the Code. survey responses already in the regulation or oversight of retail level This collection effort, which began in database. Respondents to this food operations. The FDA Food Code information collection are States and 2001, has had remarkable success with provides a scientifically sound technical U.S. territories, local, and tribal 97 percent participation from State and and legal basis for regulating the retail governmental agencies. segment of the food industry. Authority territorial governmental agencies. FDA for providing such assistance is derived contracted with the Association of Food In the Federal Register of April 14, from section 311(a) of the Public Health and Drug Officials (AFDO) to conduct 2010 (71 FR 19405), FDA published a Service Act (42 U.S.C. 243(a)). Under 31 the initial survey using the OMB 60-day notice requesting public U.S.C. 1535, FDA provides assistance to approved survey form. The rulemaking comment on the proposed collection of other Federal agencies such as the process that local, State, territorial, and information. No comments were Indian Health Service (IHS). tribal governmental agencies must received. Nationwide adoption of the model follow to adopt the model FDA Food FDA estimates the burden of this FDA Food Code is an important step Code is often a long and complicated collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Annual Frequency per Total Annual Hours per Food Code Survey Respondents Response Responses Response Total Hours

Respondents 75 4 300 1 300 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

This estimate is based on FDA’s DEPARTMENT OF HEALTH AND Secretary, HHS, the Assistant Secretary experience and the number of updates HUMAN SERVICES for Health, and the Director, CDC received in the past 3 years. FDA regarding the formative research, estimates that 75 respondents will Centers for Disease Control and development, implementation and provide four quarterly updates each, Prevention evaluation of evidence-based activities resulting in an estimated 300 total designed to prevent breast cancer Notice of Establishment annual responses. The agency estimates (particularly among those at heightened that each quarterly update will take Pursuant to Section 10413, Part V of risk) and promote the early detection about 1 hour. Of the 75 respondents, the Patient Protection and Affordable and support of young women who those who amend their regulations with Care Act (which established Section develop the disease. The advice changes unrelated to the risk factors and 399NN of the Public Health Service Act, provided by the Committee will assist in interventions, and those who are not as amended); Public Law 111–48, the ensuring scientific quality, timeliness, adopting model FDA Food Code Director, Centers for Disease Control utility, and dissemination of credible provisions, but are incorporating certain and Prevention (CDC), announces the appropriate messages and resource Conference for Food Protection establishment of the Advisory materials. recommendations only, will likely need Committee on Breast Cancer in Young For more information, contact Ena only annual contact. Women. Wanliss, M.S., Lead Public Health This committee is established to assist Dated: June 18, 2010. Advisor, CDC, National Center for in creating a national evidence-based Chronic Disease Prevention and Health Leslie Kux, public education and media campaign Promotion, Division of Cancer to provide age-appropriate messages and Acting Assistant Commissioner for Policy. Prevention and Control, 4770 Buford materials to: (1) Increase awareness of [FR Doc. 2010–15337 Filed 6–23–10; 8:45 am] Highway, Mailstop K–57, Chamblee, good breast health habits; (2) identify BILLING CODE 4160–01–S Georgia 30316, Telephone: 770–488– risk factors based on familial, racial 4225. ethnic and cultural backgrounds; (3) encourage young women and healthcare The Director, Management Analysis professionals to increase early detection and Services Office, has been delegated of breast cancers; and (4) increase the the authority to sign Federal Register availability of health information and notices pertaining to announcements of other resources for young women meetings and other committee diagnosed with breast cancer. management activities for both CDC and The Advisory Committee on Breast the Agency for Toxic Substances and Cancer in Young Women will advise the Disease Registry.

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Dated: June 18, 2010. repaid in full, whichever occurs first. DEPARTMENT OF HEALTH AND Elaine L. Baker, (Section 5201(a)(1)(B) of the ACA). HUMAN SERVICES Director, Management Analysis and Services Office, Centers for Disease Control and Service Default Interest Rate Food and Drug Administration Prevention. In the past, PCL borrowers who did [Docket Nos. FDA–2009–M–0317, FDA– [FR Doc. 2010–15293 Filed 6–23–10; 8:45 am] not fulfill the service requirements and 2009–M–0369, FDA–2009–M–0370, FDA– BILLING CODE 4163–18–P began practicing in a discipline or 2009–M–0485, FDA–2009–M–0536, FDA– specialty other than primary health care 2009–M–0540] DEPARTMENT OF HEALTH AND were penalized by having their interest Medical Devices; Availability of Safety HUMAN SERVICES rate on the PCL recalculated at 18 and Effectiveness Summaries for percent. The ACA change requires that Premarket Approval Applications Health Resources and Services borrowers who receive a PCL on or after Administration March 23, 2010, and fail to comply with AGENCY: Food and Drug Administration, the service requirements of the program HHS. Legislative Changes to Primary Care will have their loans begin to accrue ACTION: Notice. Loan Program Authorized Under Title interest at an annual rate of 2 percent VII of the Public Health Service Act SUMMARY: The Food and Drug greater than the rate the student would Administration (FDA) is publishing a AGENCY: Health Resources and Services pay if compliant. (Section 5201(a)(3) of list of premarket approval applications Administration, HHS. the ACA.) (PMAs) that have been approved. This ACTION: Notice. Parental Financial Information list is intended to inform the public of SUMMARY: On March 23, 2010, President Requirement for Independent Students the availability of safety and Obama signed into law the Affordable effectiveness summaries of approved Care Act (ACA), Public Law 111–148. Prior to enactment of the new law, PMAs through the Internet and the Section 5201 of the ACA changes the independent students were required to agency’s Division of Dockets Primary Care Loan (PCL) program by: (1) provide parental financial information Management. Reducing the number of years for the to the school’s financial aid office so ADDRESSES: Submit written requests for primary health care service requirement; that the school could consider all copies of summaries of safety and (2) lowering the interest rate for service financial resources available to the effectiveness data to the Division of default; and (3) eliminating the HHS independent student for a PCL. The Dockets Management (HFA–305), Food requirement that parental financial ACA change eliminates the HHS and Drug Administration, 5630 Fishers information be submitted for requirement for independent students to Lane, rm. 1061, Rockville, MD 20852. independent students. provide parental financial information Please cite the appropriate docket SUPPLEMENTARY INFORMATION: The PCL to determine financial need. At its number as listed in table 1 of this program was created through the Health discretion, a school may still require document when submitting a written Professions Education Extension parental financial information for request. See the SUPPLEMENTARY Amendments of 1992 (Pub. L. 102–408), independent students seeking a PCL. INFORMATION section for electronic which established a new requirement (Section 5201(b) of the ACA.) For this access to the summaries of safety and for the use of the Health Professions program, an independent student is a effectiveness. Student Loan funds for allopathic and student who is at least 24 years of age FOR FURTHER INFORMATION CONTACT: osteopathic schools. The PCL program and has been independent for a Nicole Wolanski, Center for Devices and strives to increase the number of minimum of 3 years. Dependent primary care physicians by providing Radiological Health, Food and Drug students are still required to submit long-term, low interest rate loans to full- Administration, 10903 New Hampshire parental financial information. time students with financial need Ave., Bldg. 66, rm. 1650, Silver Spring, pursuing a degree in allopathic or The ACA changes to the PCL program MD 20993, 301–796–6570. osteopathic medicine. Below are details will require a participating school to SUPPLEMENTARY INFORMATION: on how the ACA changes Section 723 of revise its PCL master promissory note I. Background the Public Health Service Act (PHSA) for new loans made on or after March regarding administration of the PCL 23, 2010, to be consistent with the ACA. In the Federal Register of January 30, program. 1998 (63 FR 4571), FDA published a Dated: June 21, 2010. final rule that revised 21 CFR 814.44(d) Primary Health Care Service Mary K. Wakefield, and 814.45(d) to discontinue individual Requirement Administrator. publication of PMA approvals and Under the PCL program, students [FR Doc. 2010–15354 Filed 6–23–10; 8:45 am] denials in the Federal Register. Instead, were required to enter and complete a BILLING CODE 4165–15–P the agency now posts this information residency training program in primary on the Internet on FDA’s home page at health care and practice in primary http://www.fda.gov. FDA believes that health care until the PCL borrower’s this procedure expedites public loan was repaid in full. The ACA notification of these actions because change requires that for any new PCLs announcements can be placed on the made on or after March 23, 2010, the Internet more quickly than they can be PCL borrowers are to enter and published in the Federal Register, and complete residency training in primary FDA believes that the Internet is health care and practice in primary accessible to more people than the health care for either 10 years (including Federal Register. the years spent in residency training) or In accordance with section 515(d)(4) through the date on which the loan is and (e)(2) of the Federal Food, Drug, and

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Cosmetic Act (the act) (21 U.S.C. FDA may, for good cause, extend this following is a list of approved PMAs for 360e(d)(4) and (e)(2)), notification of an 30-day period. Reconsideration of a which summaries of safety and order approving, denying, or denial or withdrawal of approval of a effectiveness were placed on the withdrawing approval of a PMA will PMA may be sought only by the Internet from July 1, 2009, through continue to include a notice of applicant; in these cases, the 30-day September 30, 2009, and from October opportunity to request review of the period will begin when the applicant is 1, 2009, through December 31, 2009. order under section 515(g) of the act. notified by FDA in writing of its There were no denial actions during The 30-day period for requesting decision. either period. The list provides the reconsideration of an FDA action under The regulations provide that FDA manufacturer’s name, the product’s § 10.33(b) (21 CFR 10.33(b)) for notices publish a quarterly list of available generic name or the trade name, and the announcing approval of a PMA begins safety and effectiveness summaries of approval date. on the day the notice is placed on the PMA approvals and denials that were Internet. Section 10.33(b) provides that announced during that quarter. The

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2009, THROUGH DECEMBER 31, 2009.

PMA No. Docket No. Applicant Trade Name Approval Date

P070022 Hologic, Inc. ADIANA PERMANENT CONTRACEPTION SYS- July 6, 2009 FDA–2009–M–0317 TEM

P060008/S11 Boston Scientific Corp. TAXUS LIBERTE LONG PACLITAXEL ELUING July 13, 2009 FDA–2009–M–0369 STENT SYSTEM

P030050/S2 Sanofi Aventis, LLC SCULPTRA AESTHETIC July 28, 2009 FDA–2009–M–0370

P080013 Confluent Surgical, Inc. DURASEAL XACT SEALANT SYSTEM September 4, 2009 FDA–2009–M–0485

P080008 bioMerieux, Inc. VIDAS FREE PSA RT (fPSA) ASSAY October 8, 2009 FDA–2009–M–0536

P030042 Wright Medical Technology, CONSERVE PLUS TOTAL RESURFACING HIP November 3, 2009 FDA–2009–M–0540 Inc. SYSTEM

II. Electronic Access the discussions could disclose Dated: June 18, 2010. Persons with access to the Internet confidential trade secrets or commercial Anna P. Snouffer, may obtain the documents at http:// property such as patentable material, Deputy Director, Office of Federal Advisory www.fda.gov/cdrh/pmapage.html. and personal information concerning Committee Policy. individuals associated with the contract [FR Doc. 2010–15311 Filed 6–23–10; 8:45 am] Dated: June 17, 2010. proposals, the disclosure of which BILLING CODE 4140–01–P Nancy Stade, would constitute a clearly unwarranted Acting Associate Director for Regulations and invasion of personal privacy. Policy, Center for Devices and Radiological Name of Committee: National Institute of DEPARTMENT OF HEALTH AND Health. HUMAN SERVICES [FR Doc. 2010–15259 Filed 6–23–10; 8:45 am] Child Health and Human Development Special Emphasis Panel National Childrens BILLING CODE 4160–01–S National Institutes of Health Study. Date: July 12, 2010. Eunice Kennedy Shriver National DEPARTMENT OF HEALTH AND Time: 8 a.m. to 5 p.m. Institute of Child Health and Human HUMAN SERVICES Agenda: To review and evaluate contract Development; Notice of Closed proposals. Meeting National Institutes of Health Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Pursuant to section 10(d) of the Eunice Kennedy Shriver National Contact Person: Sathasiva B. Kandasamy, Federal Advisory Committee Act, as PhD, Scientific Review Administrator, Institute of Child Health & Human amended (5 U.S.C. App.), notice is Division of Scientific Review, National Development; Notice of Closed hereby given of the following meeting. Meeting Institute of Child Health and Human Development, 6100 Executive Boulevard, The meeting will be closed to the Pursuant to section 10(d) of the Room 5B01, Bethesda, MD 20892–9304, (301) public in accordance with the Federal Advisory Committee Act, as 435–6680, [email protected]. provisions set forth in sections amended (5 U.S.C. App.), notice is (Catalogue of Federal Domestic Assistance 552b(c)(4) and 552b(c)(6), title 5 U.S.C., hereby given of the following meeting. Program Nos. 93.864, Population Research; as amended. The grant applications and The meeting will be closed to the 93.865, Research for Mothers and Children; the discussions could disclose public in accordance with the 93.929, Center for Medical Rehabilitation confidential trade secrets or commercial provisions set forth in sections Research; 93.209, Contraception and property such as patentable material, 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Infertility Loan Repayment Program, National and personal information concerning as amended. The contract proposals and Institutes of Health, HHS) individuals associated with the grant

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applications, the disclosure of which Contact Person: Norman Chang, PhD, Place: National Institutes of Health, 6701 would constitute a clearly unwarranted Scientific Review Administrator, Division of Rockledge Drive, Bethesda, MD 20892, invasion of personal privacy. Scientific Review, National Institute of Child (Telephone Conference Call). Health and Human Development, NIH, 6100 Contact Person: Robert Garofalo, PhD, Name of Committee: National Institute of Executive Blvd., Room 5B01, Bethesda, MD Scientific Review Officer, Center for Child Health and Human Development 20892, (301) 496–1485, Scientifice Review, National Institute of Special Emphasis Panel; Geisha. [email protected]. Date: July 13, 2010. Health, 6701 Rockledge Drive, Room 6156, Time: 2 p.m. to 4 p.m. (Catalogue of Federal Domestic Assistance MSC 7892, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant Program Nos. 93.864, Population Research; 1043, [email protected]. 93.865, Research for Mothers and Children; applications. (Catalogue of Federal Domestic Assistance Place: National Institutes of Health, 6100 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Program Nos. 93.306, Comparative Medicine; Executive Boulevard, Rockville, MD 20852 93.333, Clinical Research, 93.306, 93.333, (Telephone Conference Call). Infertility Loan Repayment Program, National 93.337, 93.393–93.396, 93.837–93.844, Contact Person: Norman Chang, PhD, Institutes of Health, HHS) 93.846–93.878, 93.892, 93.893, National Scientific Review Administrator, Division of Dated: June 18, 2010. Institutes of Health, HHS) Scientific Review, National Institute of Child Anna P. Snouffer, Health and Human Development, NIH, 6100 Dated: June 18, 2010. Executive Blvd., Room 5B01, Bethesda, MD Deputy Director, Office of Federal Advisory Anna P. Snouffer, 20892, (301) 496–1485, Committee Policy. [email protected]. [FR Doc. 2010–15312 Filed 6–23–10; 8:45 am] Deputy Director, Office of Federal Advisory Committee Policy. (Catalogue of Federal Domestic Assistance BILLING CODE 4140–01–P Program Nos. 93.864, Population Research; [FR Doc. 2010–15314 Filed 6–23–10; 8:45 am] 93.865, Research for Mothers and Children; BILLING CODE 4140–01–P 93.929, Center for Medical Rehabilitation DEPARTMENT OF HEALTH AND Research; 93.209, Contraception and HUMAN SERVICES Infertility Loan Repayment Program, National DEPARTMENT OF HEALTH AND Institutes of Health, HHS). National Institutes of Health HUMAN SERVICES Dated: June 18, 2010. Anna P. Snouffer, Center for Scientific Review; Notice of Food and Drug Administration Deputy Director, Office of Federal Advisory Closed Meetings Committee Policy. Pursuant to section 10(d) of the [Docket No. FDA–2010–N–0001] [FR Doc. 2010–15309 Filed 6–23–10; 8:45 am] Federal Advisory Committee Act, as BILLING CODE 4140–01–P Dermatologic and Ophthalmic Drugs amended (5 U.S.C. App.), notice is Advisory Committee; Cancellation hereby given of the following meetings. DEPARTMENT OF HEALTH AND The meetings will be closed to the AGENCY: Food and Drug Administration, HUMAN SERVICES public in accordance with the HHS. provisions set forth in sections ACTION: National Institutes of Health 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Notice. as amended. The grant applications and Eunice Kennedy Shriver National the discussions could disclose SUMMARY: The meeting of the Institute of Child Health & Human confidential trade secrets or commercial Dermatologic and Ophthalmic Drugs Development; Notice of Closed property such as patentable material, Advisory Committee scheduled for June Meeting and personal information concerning 28, 2010, is cancelled. This meeting was Pursuant to section 10(d) of the individuals associated with the grant announced in the Federal Register of Federal Advisory Committee Act, as applications, the disclosure of which May 11, 2010 (75 FR 26264). The amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted meeting was to discuss new drug hereby given of the following meeting. invasion of personal privacy. application (NDA) 22–340, voclosporin The meeting will be closed to the 10-milligram capsules, by Lux Name of Committee: AIDS and Related Biosciences Inc. This meeting has been public in accordance with the Research Integrated Review Group; AIDS provisions set forth in sections Immunology and Pathogenesis Study cancelled to allow time for the 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Section. resolution of several outstanding issues. as amended. The grant applications and Date: July 16, 2010. The agency intends to continue the discussions could disclose Time: 8 a.m. to 6 p.m. evaluating NDA 22–340 and, as needed, confidential trade secrets or commercial Agenda: To review and evaluate grant may schedule an advisory committee property such as patentable material, applications. meeting in the future. Place: The Westin Seattle, 1900 5th and personal information concerning Avenue, Seattle, WA 98101. FOR FURTHER INFORMATION CONTACT: individuals associated with the grant Contact Person: Mary Clare Walker, PhD, Yvette Waples, Center for Drug applications, the disclosure of which Scientific Review Officer, Center for Evaluation and Research, Food and would constitute a clearly unwarranted Scientific Review, National Institutes of Drug Administration, 10903 New invasion of personal privacy. Health, 6701 Rockledge Drive, Room 5208, Hampshire Ave., Bldg. 31, rm. 2417, Name of Committee: National Institute of MSC 7852, Bethesda, MD 20892, (301) 435– Silver Spring, MD 20993–0002, 301– Child Health and Human Development 1165, [email protected]. 796–9001, FAX: 301–847–8533, e-mail: Special Emphasis Panel Slack and Slick Name of Committee: Center for Scientific [email protected], or FDA Channels. Review Special Emphasis Panel; PAR–08– Advisory Committee Information Line, 160: Metabolic Effects of Psychotropic Date: July 12, 2010. 1–800–741–8138 (301–443–0572 in the Time: 12:30 p.m. to 3:30 p.m. Medications. Agenda: To review and evaluate grant Date: July 20, 2010. Washington, DC area), code applications. Time: 1 p.m. to 5 p.m. 3014512534. Please call the Information Place: National Institutes of Health, 6100 Agenda: To review and evaluate grant Line for up-to-date information on this Executive Boulevard, Rockville, MD 20852. applications. meeting.

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Dated: June 18, 2010. intended to assist in the evaluation of Staff, at 301–796–5966, at least 7 days Thinh Nguyen, pigmented skin lesions, including in advance of the meeting. Acting Associate Commissioner for Special atypical moles, which have one or more FDA is committed to the orderly Medical Programs. clinical or historical characteristics of conduct of its advisory committee [FR Doc. 2010–15352 Filed 6–23–10; 8:45 am] melanoma, before a final decision to meetings. Please visit our Web site at BILLING CODE 4160–01–S biopsy has been rendered. MelaFind http://www.fda.gov/Advisory acquires and displays multi-spectral Committees/AboutAdvisoryCommittees/ (from blue to near infrared) digital ucm111462.htm for procedures on DEPARTMENT OF HEALTH AND images of pigmented skin lesions and public conduct during advisory HUMAN SERVICES uses automatic image analysis and committee meetings. statistical pattern recognition to help Notice of this meeting is given under Food and Drug Administration identify lesions to be considered for the Federal Advisory Committee Act (5 U.S.C. app. 2). [Docket No. FDA–2010–N–0001] biopsy to rule out melanoma. FDA intends to make background Dated: June 18, 2010. General and Plastic Surgery Devices material available to the public no later Thinh Nguyen, Panel of the Medical Devices Advisory than 2 business days before the meeting. Acting Associate Commissioner for Special Committee; Notice of Meeting If FDA is unable to post the background Medical Programs. material on its Web site prior to the [FR Doc. 2010–15351 Filed 6–23–10; 8:45 am] AGENCY: Food and Drug Administration, meeting, the background material will BILLING CODE 4160–01–S HHS. be made publicly available at the ACTION: Notice. location of the advisory committee This notice announces a forthcoming meeting, and the background material DEPARTMENT OF HEALTH AND meeting of a public advisory committee will be posted on FDA’s Web site after HUMAN SERVICES the meeting. Background material is of the Food and Drug Administration National Institutes of Health (FDA). The meeting will be open to the available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ public. Center for Scientific Review; Amended default.htm. Scroll down to the Name of Committee: General and Notice of Meeting Plastic Surgery Devices Panel of the appropriate advisory committee link. Medical Devices Advisory Committee. Procedure: Interested persons may Notice is hereby given of a change in General Function of the Committee: present data, information, or views, the meeting of the Center for Scientific To provide advice and orally or in writing, on issues pending Review Special Emphasis Panel, July 14, recommendations to the agency on before the committee. Written 2010, 8:30 a.m. to July 15, 2010, 5 p.m., FDA’s regulatory issues. submissions may be made to the contact State Plaza Hotel, 2117 E Street, NW., Date and Time: The meeting will be person on or before August 17, 2010. Washington, DC 20037 which was held on August 26, 2010, from 8 a.m. to Oral presentations from the public will published in the Federal Register on 6 p.m. be scheduled between approximately 1 June 14, 2010, 75 FR 33626–33627. Location: Holiday Inn College Park, p.m. and 2 p.m. Those desiring to make The meeting will be held July 13, Grand Ballroom, 1000 Baltimore Ave., formal oral presentations should notify 2010 to July 14, 2010. The meeting time College Park, MD. the contact person and submit a brief and location remain the same. The Contact Person: Margaret McCabe- statement of the general nature of the meeting is closed to the public. Janicki, Food and Drug Administration, evidence or arguments they wish to Dated: June 18, 2010. Center for Devices and Radiological present, the names and addresses of Anna P. Snouffer, Health, 10903 New Hampshire Ave., proposed participants, and an Deputy Director, Office of Federal Advisory Bldg. 66, rm. 1535, Silver Spring, MD indication of the approximate time Committee Policy. 20993–0002, 301–796–7029, or FDA requested to make their presentation on [FR Doc. 2010–15313 Filed 6–23–10; 8:45 am] or before August 5, 2010. Time allotted Advisory Committee Information Line, BILLING CODE 4140–01–P 1–800–741–8138 (301–443–0572 in the for each presentation may be limited. If Washington, DC area), code the number of registrants requesting to 3014512519. Please call the Information speak is greater than can be reasonably DEPARTMENT OF HEALTH AND Line for up-to-date information on this accommodated during the scheduled HUMAN SERVICES meeting. A notice in the Federal open public hearing session, FDA may Register about last minute modifications conduct a lottery to determine the Health Resources and Services that impact a previously announced speakers for the scheduled open public Administration advisory committee meeting cannot hearing session. The contact person will always be published quickly enough to notify interested persons regarding their Recruitment of Sites for Assignment of provide timely notice. Therefore, you request to speak by August 10, 2010. National Health Service Corps (NHSC) should always check the agency’s Web Persons attending FDA’s advisory Personnel Obligated Under the NHSC site and call the appropriate advisory committee meetings are advised that the Scholarship Program committee hot line/phone line to learn agency is not responsible for providing AGENCY: Health Resources and Services about possible modifications before access to electrical outlets. Administration, HHS. coming to the meeting. FDA welcomes the attendance of the ACTION: General notice. Agenda: On August 26, 2010, the public at its advisory committee committee will discuss, make meetings and will make every effort to SUMMARY: The Health Resources and recommendations, and vote on accommodate persons with physical Services Administration (HRSA) premarket approval application for disabilities or special needs. If you announces that the listing of entities, MelaFind, sponsored by MELA require special accommodations due to and their Health Professional Shortage Sciences, Inc. MelaFind is a non- a disability, please contact AnnMarie Area (HPSA) scores, that will receive invasive computer vision system Williams, Conference Management priority for the assignment of National

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Health Service Corps (NHSC) Entities that receive assignment of report. The UDS system allows the site scholarship recipients (NHSC NHSC personnel must assure that: (1) to assess the age, sex, race/ethnicity of, Personnel, NHSC members) during the the position will permit the full scope and provider encounter records for, its period July 1, 2010, through June 30, of practice and that the clinician meets user population. The UDS reports are 2011, is posted on the NHSC Web site the credentialing requirements of the site specific. Providers fulfilling NHSC at http://nhscjobs.hrsa.gov/. This list State and site; and (2) the NHSC commitments are assigned to a specific specifies which entities are eligible to member assigned to the entity is site or, in some cases, more than one receive assignment of NHSC members engaged in full-time clinical practice at site. The scope of activity to be reported who are participating in the NHSC the approved service location. For all in UDS includes all activity at the site(s) Scholarship Program. Please note that health professionals except those noted to which the NHSC member is assigned. not all vacancies associated with sites below, ‘‘full-time clinical practice’’ Evaluation and Selection Process on the list described below will be for means a minimum of 40 hours per week NHSC members, but could be for NHSC with at least 32 hours per week spent In order for a site to be eligible for Scholarship Program participants providing direct patient care in placement of NHSC personnel, it must serving their obligation through the outpatient ambulatory care setting(s) at be approved by the NHSC following the Private Practice Option. the approved practice site(s), during site’s submission of a Multi-Year Eligible HPSAs and Entities normally scheduled office hours. The Recruitment and Retention (R&R) remaining 8 hours of the minimum 40 Assistance Application. The R&R To be eligible to receive assignment of hours per week must be spent providing Application approval is good for a NHSC personnel, entities must: (1) Have clinical services for patients in the period of 3 years from the date of a current HPSA designation by the approval. Office of Shortage Designation, Bureau approved practice site(s), or providing In approving applications for the of Health Professions, HRSA; (2) not clinical services in alternative settings assignment of NHSC members, the deny requested health care services, or (e.g., hospitals, nursing homes, shelters) Secretary shall give priority to any such discriminate in the provision of services as directed by the approved practice application that is made regarding the to an individual because the individual site(s), or performing practice-related provision of primary health services to is unable to pay for the services or administrative duties not to exceed 8 a HPSA with the greatest shortage. For because payment for the services would hours per week. For obstetricians/ the program year July 1, 2010, through be made under Medicare, Medicaid, or gynecologists, certified nurse midwives the Children’s Health Insurance (CNMs), family practitioners who June 30, 2011, HPSAs of greatest Program (CHIP); (3) enter into an practice obstetrics on a regular basis, shortage for determination of priority for agreement with the State agency that psychiatrists, pediatric dentists, and assignment of NHSC scholarship- administers Medicaid and CHIP, accept providers of geriatric services, at least obligated NHSC personnel will be assignment under Medicare, see all 21 of the minimum 40 hours per week defined as follows: (1) Primary medical patients regardless of their ability to must be spent providing direct patient care HPSAs with scores of 17 and above pay, and use and post a discounted fee care (direct patient counseling for are authorized for the assignment of plan; and (4) be determined by the psychiatrists) in the outpatient NHSC scholarship recipients who are Secretary to have: (a) a need and ambulatory care setting(s) at the primary care physicians, family nurse demand for health manpower in the approved practice site(s), during practitioners (NPs), or CNMs; (2) mental area; (b) appropriately and efficiently normally scheduled office hours. The health HPSAs with scores of 17 and used NHSC members assigned to the remaining 19 hours of the minimum 40 above are authorized for the assignment entity in the past; (c) general community hours per week must be spent providing of NHSC scholarship recipients who are support for the assignment of NHSC clinical services for patients in the psychiatrists; (3) primary medical care members; (d) made unsuccessful efforts approved practice site(s), or providing HPSAs with scores of 15 and above are to recruit; (e) a reasonable prospect for clinical services in alternative settings authorized for the assignment of NHSC sound fiscal management by the entity (e.g., hospitals, nursing homes, shelters) scholarship recipients who are with respect to NHSC members assigned as directed by the approved practice physician assistants (PAs); (4) dental there; and (f) demonstrated a site(s), or performing practice-related HPSAs with scores of 17 and above are willingness to support and facilitate administrative activities (not to exceed authorized for the assignment of NHSC mentorship, professional development, 8 hours per week). For all NHSC scholarship recipients who are dentists. and training opportunities for NHSC Scholars, time spent on-call does not The NHSC has determined that a members. Priority in approving count toward the 40 hours per week. In minimum HPSA score of 15 for applications for assignment of NHSC addition, sites receiving assignment of Physician Assistants, and 17 for all members goes to sites that: (1) Provide NHSC personnel are expected to: (1) other eligible clinicians will enable it to primary medical care, mental health, Report to the NHSC all absences, meet its statutory obligation to identify and/or oral health services to a primary including those in excess of the a number of approved service sites at medical care, mental health, or dental authorized number of days (up to 35 least equal to, but not greater than, twice HPSA of greatest shortage, respectively; work days or 280 hours per service the number of NHSC scholars available (2) are part of a system of care that year); (2) report to the NHSC any change to serve in the 2010–2011 placement provides a continuum of services, in the status of an NHSC clinician at the cycle. including comprehensive primary site; (3) provide the time and leave The number of new NHSC placements health care and appropriate referrals or records, schedules, and any related through the Scholarship Program arrangements for secondary and tertiary personnel documents for NHSC allowed at any one site is limited to the care; (3) have a documented record of assignees (including documentation, if following: sound fiscal management; and (4) will applicable, of the reason(s) for the (1) Primary Medical Care experience a negative impact on its termination of an NHSC clinician’s capacity to provide primary health employment at the site prior to his or No more than 1 physician (MD or services if a NHSC member is not her obligated service end date); and (4) DO); and no more than 1 NP, PA, or assigned to the entity. submit a Uniform Data System (UDS) CNM.

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(2) Dental Dated: June 21, 2010. Office of Acquisitions Management and Mary K. Wakefield, Policy (RB3) No more than 1 dentist. Administrator. (1) Provides leadership in the (3) Mental Health [FR Doc. 2010–15356 Filed 6–23–10; 8:45 am] planning, development, and BILLING CODE 4165–15–P No more than 1 psychiatrist. implementation of policies and procedures for contracts; (2) exercises Application Requests, Dates and the sole responsibility within HRSA for DEPARTMENT OF HEALTH AND Address the award and management of contracts; HUMAN SERVICES The list of HPSAs and entities that are (3) provides advice and consultation of eligible to receive priority for the Health Resources and Services interpretation and application of the placement of NHSC personnel may be Administration Department of Health and Human updated periodically. Entities that no Services’ policies and procedures longer meet eligibility criteria, including Statement of Organization, Functions governing contracts management and those sites whose NHSC 3-year approval and Delegations of Authority inter/intra agency agreements; (4) develops operating procedures and has lapsed or whose HPSA designation This notice amends Part R of the has been proposed for withdrawal will policies for the Agency’s contracts Statement of Organization, Functions programs and inter/intra agency be removed from the priority listing. and Delegations of Authority of the New entities interested in being added agreements; (5) establishes standards, Department of Health and Human guides and evaluation procedures for to the high priority list must submit a Services (HHS), Health Resources and Multi-Year NHSC R&R Assistance contract operations throughout the Services Administration (HRSA) (60 FR Agency; (6) coordinates the Agency’s Application to: National Health Service 56605, as amended November 6, 1995; Corps, 5600 Fishers Lane, Room 8A–30, positions and actions with respect to the as last amended at 75 FR 12559 dated audit of contracts; (7) maintains liaison Rockville, MD 20857, fax 301–594– March 16, 2010). 9009. directly with or through Agency This notice reflects organizational Bureaus or Offices with contractors, Entities interested in receiving changes in the Health Resources and other organizations, and various application materials may do so by Services Administration. Specifically, components of the Department; (8) calling the HRSA call center at 1–800– this notice updates the functional provides leadership, guidance, and 221–9393. They may also get statement for the Office of Acquisitions advice on the promotion of the activities information and download application Management and Policy (RB3) within in HRSA relating to procurement and materials at: http://nhsc.hrsa.gov/ the Office of Operations (RB). material management governed by the communities/apply.htm. Chapter RB3, Office of Acquisitions Small Business Act of 1958, Executive A listing of HPSAs and their scores is Management and Policy Order 11625, other statutes and national posted at http://hpsafind.hrsa.gov/. policy directives for augmenting the role Section RB3–10, Organization Additional Information of private industry, small and minority Delete in its entirety and replace with businesses as sources of supply to the Entities wishing to provide additional the following: Government and Government data and information in support of their The Office of Acquisitions contractors; and (9) plans, directs, and inclusion on the proposed list of HPSAs Management and Policy (RB3) is headed coordinates the Agency’s sourcing and entities that would receive priority by the Director who reports directly to program. in assignment of scholarship-obligated the Chief Operating Officer, Health Division of Contract Services for NHSC members must do so in writing Resources and Services Administration. Primary Care, Health Systems and no later than July 26, 2010. This The Office of Acquisitions Management Clinician Recruitment and Retention information should be submitted to: and Policy (RB3) includes the following (RB35) Lori Roche, Acting Director, Division of components: Site and Clinician Recruitment, Bureau (1) Immediate Office of the Director (1) Responsible for providing of Clinician Recruitment and Service, (RB3); comprehensive acquisition services 5600 Fishers Lane, Room 8A–55, (2) Division of Contract Services for including planning, soliciting, Rockville, MD 20857 or faxed to: 301– Primary Care, Health Systems and negotiating, awarding, and 480–4577, attention: Lori Roche. This Clinician Recruitment and Retention administering simplified and negotiated information will be considered in (RB35); procurement actions tailored to the preparing the final list of HPSAs and following functions in HRSA: (3) Division of Contract Services for entities that are receiving priority for the Maternal and Child Health and a. Funding health centers in assignment of scholarship-obligated Administrative Support Offices communities, providing access to high NHSC personnel. (RB36); quality, family oriented, comprehensive Paperwork Reduction Act: The R&R (4) Division of Contact Services for primary and preventive health care for Assistance Application has been HIV/AIDS, Health Professions, Rural people who are low income, uninsured, approved by the Office of Management Health and Grants Management (RB37); or living where health care is scarce; and Budget under the Paperwork and b. Helping underserved communities Reduction Act. The OMB clearance (5) Division of Contracts and facilities experiencing critical number is 0915–0230 and expires Administration (RB38). shortages of health care providers, September 30, 2011. recruit and retain clinicians through The program is not subject to the Section RB3–20, Functions scholarship and educational loan provisions of Executive Order 12372, (1) Delete the functions for the Office repayment opportunities in exchange Intergovernmental Review of Federal of Acquisitions Management and Policy for service; and Programs (as implemented through 45 (RB3) in its entirety and replace with c. Protecting the public health and CFR part 100). the following: promoting practices that improve

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personal health, including organ, bone contracts reporting systems including inquiries and requests for acquisition marrow and cord blood donation. data input, data accuracy assessments, information from other Federal agencies (2) Ensures compliance with Federal review and correction of data reports; and non-Federal sources. laws and regulations, departmental and (4) provides professional, in-depth Agency guidelines, policies and advice and consultation, customized to Division of Contracts Administration procedures; (3) utilizes the automated the Bureaus/Offices named above, (RB38) contracts reporting systems including regarding the appropriate contract (1) Administers the training and data input, data accuracy assessments, vehicles and the various phases of the certification programs in collaboration review and correction of data reports; acquisition cycle; (5) conducts pre- (4) provides professional, in-depth award reviews of proposed contracts with HRSA’s programs and offices for advice and consultation, customized to that exceed the requirements called for HRSA’s Contracting Officers’ Technical the Bureaus/Offices named above, in the Federal and departmental Representatives (COTRS), FAC–C regarding the appropriate contract acquisition regulations in conjunction acquisition professionals, and P/PM vehicles and the various phases of the with the other Contract Services Program Managers; (2) administers and acquisition cycle; (5) conducts pre- Customer Divisions; (6) plans and oversees HRSA’s automated contracts award reviews of proposed contracts coordinates acquisition reviews of reporting systems; (3) manages the inter/ that exceed the requirements called for contracting activities within HRSA intra agency agreement process; (4) in the Federal and departmental headquarters and the field components; manages the close out process of acquisition regulations in conjunction and (7) responds to congressional negotiated and simplified acquisition with the other Contract Services inquiries and requests for acquisition actions and other related actions; (5) Customer Divisions; (6) plans and information from other Federal agencies conducts and monitors the performance coordinates acquisition reviews of and non-Federal sources. of the HRSA purchase card program for contracting activities within HRSA Division of Contract Services for HIV/ headquarters, satellite contracts office, headquarters and the field components; AIDS, Health Professions, Rural Health and regional field offices; (6) develops and (7) responds to congressional and Grants Managements (RB37) and implements policies, procedures, inquiries and requests for acquisition and other internal controls in (1) Responsible for providing information from other Federal agencies compliance with Federal, departmental, and non-Federal sources. comprehensive acquisition services including planning, soliciting, and Agency acquisition laws, Division of Contract Services for negotiating, awarding, and regulations, policies and procedures; (7) Maternal and Child Health and administering simplified and negotiated coordinates and responds to acquisition- Administrative Support Offices (RB36) procurement actions tailored to the related information requests including (1) Responsible for providing following functions in HRSA: congressional inquiries and requests for comprehensive acquisition services a. Increasing the access to health care information from other departments and including planning, soliciting, by developing, distributing and non-Federal sources; (8) conducts cost negotiating, awarding, and retaining a diverse, culturally competent analysis for HRSA’s acquisition actions administering simplified and negotiated health workforce; in coordination with the Contract procurement actions tailored to the b. Administering the Ryan White HIV/ Services Divisions of OAMP; and (9) following functions in HRSA: AIDS Program, the largest Federal conducts independent reviews and a. Improving the health of mothers, program focused exclusively on HIV/ analysis requested by external and children and their families as AIDS care; internal customers. authorized under Title V of the Social c. Providing grant funding Security Act; information and services; and Section RB3–30, Delegations of b. Information technology services d. Promoting better health care service Authority including translating HRSA business and seeking solutions to health care needs into effective technical solutions, problems in rural America. All delegations of authority and re- using proven methodologies to (2) Ensure compliance with Federal delegations of authority made to HRSA minimize costs, reduce risks, and laws and regulations, departmental and officials that were in effect immediately shorten application development times; Agency guidelines, policies and prior to this reorganization, and that are c. Financial and operational services procedures; (3) utilizes the automated consistent with this reorganization, including budget execution and contracts reporting systems including shall continue in effect pending further formulation, procurement, facilities, data input, data accuracy assessments, re-delegation. workforce management, issuance of review and correction of data reports; This reorganization is effective upon financial policies, managing HRSA’s (4) provides professional, in-depth signature. internal and external communications, advice and consultation, customized to coordinating HRSA’s actions on the Bureaus/Offices named above, Dated: June 17, 2010. legislation, special health affairs, equal regarding the appropriate contract Mary K. Wakefield, opportunity, civil rights and diversity vehicles and the various phases of the Administrator. management, planning analysis and acquisition cycle; (5) conducts pre- [FR Doc. 2010–15253 Filed 6–23–10; 8:45 am] award reviews of proposed contracts evaluation; and BILLING CODE 4165–15–P d. Partnering with key stakeholders in that exceed the requirements called for regions around the Nation to increase in the Federal and departmental access to quality health care, reduce acquisition regulations in conjunction disparities and improve various with the other Contract Services dimensions of public health. Customer Divisions; (6) plans and (2) Ensure compliance with Federal coordinates acquisition reviews of laws and regulations, departmental and contracting activities within HRSA Agency guidelines, policies and headquarters and the field components; procedures; (3) utilizes the automated and (7) responds to congressional

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DEPARTMENT OF HOMELAND for the proper performance of the Type of Review: Revision and SECURITY functions of the agency/component, extension of an existing information including whether the information will collection. U.S. Customs and Border Protection have practical utility; Affected Public: Businesses. (2) Evaluate the accuracy of the Estimated Number of Respondents: Agency Information Collection agencies/components estimate of the 2,000. Activities: Distribution of Continued burden of The proposed collection of Estimated Time per Respondent: 1 Dumping and Subsidy Offset to information, including the validity of hour. Affected Domestic Producers (CDSOA) the methodology and assumptions used; Estimated Total Annual Burden Hours: 2,000. AGENCY: U.S. Customs and Border (3) Enhance the quality, utility, and If additional information is required Protection, Department of Homeland clarity of the information to be contact: Tracey Denning, U.S. Customs Security collected; and and Border Protection, Office of ACTION: 30-Day notice and request for (4) Minimize the burden of the Regulations and Rulings, 799 9th Street, comments; Revision of an existing collections of information on those who NW., 7th floor, Washington, DC 20229– information collection: 1651–0086. are to respond, including the use of 1177, at 202–325–0265. appropriate automated, electronic, SUMMARY: U.S. Customs and Border mechanical, or other technological Dated: June 21, 2010. Protection (CBP) of the Department of techniques or other forms of Tracey Denning, Homeland Security will be submitted information. Agency Clearance Officer, the following information collection Title: Distribution of Continued U.S. Customs and Border Protection. request to the Office of Management and Dumping and Subsidy Offset to Affected [FR Doc. 2010–15303 Filed 6–23–10; 8:45 am] Budget (OMB) for review and approval Domestic Producers (CDSOA). BILLING CODE 9111–14–P in accordance with the Paperwork Reduction Act: Distribution of OMB Number: 1651–0086. Continued Dumping and Subsidy Offset Form Number: 7401. DEPARTMENT OF HOMELAND to Affected Domestic Procedures. This is Abstract: This collection of SECURITY a proposed extension of an information information is required to implement collection that was previously the Continued Dumping and Subsidy Coast Guard Offset Act of 2000 (CDSOA). This Act approved. CBP is proposing that this [Docket No. USCG–2010–0535] information collection be extended with prescribes the administrative a change to the burden hours. This procedures, including the time and Certificate of Alternative Compliance document is published to obtain manner, under which antidumping and for the Offshore Supply Vessel comments from the public and affected countervailing duties assessed on SOUTHERN CROSS agencies. This proposed information imported products are distributed to collection was previously published in affected domestic producers that AGENCY: Coast Guard, DHS. the Federal Register (75 FR 16493) on petitioned for or supported the issuance ACTION: Notice. April 1, 2010, allowing for a 60-day of the order under which the duties SUMMARY: comment period. One comment was were assessed. The amount of any The Coast Guard announces received. This notice allows for an distribution afforded to these domestic that a Certificate of Alternative additional 30 days for public comments. producers is based upon certain Compliance was issued for the offshore This process is conducted in accordance qualifying expenditures that they incur supply vessel SOUTHERN CROSS as with 5 CFR 1320.10. after the issuance of the order or required by 33 U.S.C. 1605(c) and 33 CFR 81.18. DATES: Written comments should be finding. This distribution is known as DATES: received on or before July 26, 2010. the continued dumping and subsidy The Certificate of Alternate Compliance was issued on June 7, 2010. ADDRESSES: Interested persons are offset. The claims process for the invited to submit written comments on CDSOA program is provided for in 19 ADDRESSES: The docket for this notice is this proposed information collection to CFR 159.61 and 159.63. available for inspection or copying at the Office of Information and Regulatory CBP Form 7401 captures the the Docket Management Facility (M–30), Affairs, Office of Management and information from claimants that CBP U.S. Department of Transportation, Budget. Comments should be addressed needs to determine how the West Building Ground Floor, Room to the OMB Desk Officer for Customs distributions are made. This form is W12–140, 1200 New Jersey Avenue, SE., and Border Protection, Department of published in the Federal Register each Washington, DC 20590, between 9 a.m. Homeland Security, and sent via year in order to inform claimants that and 5 p.m., Monday through Friday, electronic mail to they can make claims under the CDSOA except Federal holidays. You may also [email protected] or faxed program and also provide them with a find this docket on the Internet by going to (202) 395–5806. copy of the form. The form can also be to http://www.regulations.gov, inserting USCG–2010–0535 in the ‘‘Keyword’’ SUPPLEMENTARY INFORMATION: submitted electronically through http:// U.S. Customs and Border Protection www.pay.gov. box, pressing Enter, and then clicking ‘‘ ’’ (CBP) encourages the general public and In order to expedite the distribution Search. affected Federal agencies to submit process, CBP proposes to add two data FOR FURTHER INFORMATION CONTACT: If written comments and suggestions on elements to both the paper form and the you have questions on this notice, call proposed and/or continuing information electronic form, including: ‘‘Start Date of LTJG Christine Dimitroff, District Eight, collection requests pursuant to the Qualifying Expenditures’’ and ‘‘End Date Prevention Branch, U.S. Coast Guard, Paperwork Reduction Act (Pub. L. 104– of Qualifying Expenditures’’. telephone 504–671–2176. If you have 13). Your comments should address one Current Actions: This submission is questions on viewing or submitting of the following four points: being made to extend the expiration material to the docket, call Renee V. (1) Evaluate whether the proposed date with a revision to Form 7401 and Wright, Program Manager, Docket collection of information is necessary to the on-line application. Operations, telephone 202–366–9826.

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SUPPLEMENTARY INFORMATION: Dated: June 8, 2010. points, and 1 fragment of worked bone. RS Keister, The 32 lots of objects are 4 lots of Background and Purpose Commander, U.S. Coast Guard, Chief, animal remains, 5 lots of antler A Certificate of Alternative Inspections Section, By Direction of the fragments, 2 lots of antler wedge Compliance, as allowed for under Title Commander, Eighth Coast Guard District. fragments, 2 lots of antler wedges, 9 lots 33, Code of Federal Regulation, Parts 81 [FR Doc. 2010–15275 Filed 6–23–10; 8:45 am] of flakes, 2 lots of modified flakes, 1 lot of shell beads, 5 lots of shell remains, and 89, has been issued for the offshore BILLING CODE 9110–04–P 1 lot of straight pins, and 1 lot of wood supply vessel SOUTHERN CROSS, O.N. fragments. 1223869. Full compliance with 72 DEPARTMENT OF THE INTERIOR In 1975, cultural items were removed COLREGS and the Inland Rules Act from burials at 45CO1, Columbia would hinder the vessel’s ability to National Park Service County, WA. The burials were removed conduct loading and unloading during the Tucannon Burial Relocation operations, and would hinder the Notice of Intent to Repatriate Cultural Project conducted by the University of vessel’s ability to maneuver within close Items: U.S. Department of Defense, Idaho under contract with the Army proximity to offshore platforms. Placing Army Corps of Engineers, Walla Walla Corps of Engineers. Following removal, the aft masthead light at the horizontal District, Walla Walla, WA and Museum the cultural items and burials were distance from the forward masthead of Anthropology, Washington State delivered to the University of Idaho. light as required by Annex I, paragraph University, Pullman, WA The human remains were reburied in 3(a) of the 72 COLREGS, and Annex I, Idaho in 1977. In 2000, the remaining AGENCY: Section 84.05(a) of the Inland Rules Act, National Park Service, Interior. cultural items were transferred from the would result in an aft masthead light ACTION: Notice. University of Idaho to Washington State University, and are now unassociated location directly over the aft cargo deck Notice is here given in accordance funerary objects. The 653 unassociated where it would interfere with loading with the Native American Graves and unloading operations and would funerary objects are 95 counted items Protection and Repatriation Act and 558 lots of objects. The 95 counted make the mast highly susceptible to (NAGPRA), 25 U.S.C. 3005, of the intent damage during such operations. objects are 2 beaver incisors, 4 bifaces, to repatriate cultural items in the 1 worked bone fragment, 1 bottle Therefore, the horizontal distance control of the U.S. Department of between the forward and aft masthead fragment, 13 bullet cartridges, 3 copper Defense, Army Corps of Engineers, pendants, 6 cores, 1 digging stick lights may be 23′″–11⁄8″, placing the aft Walla Walla District, Walla Walla, WA, fragment, 8 elk tooth beads, 1 hafted masthead light over the pilot house. and in the possession of the Museum of drill, 2 incised bone fragments, 2 In addition, due to the design of the Anthropology, Washington State incised digging stick fragments, 1 vessel it would be difficult and University, Pullman, WA, that meet the marble, 1 net sinker, 8 stone pestles, 3 impractical to build a supporting definition of unassociated funerary pipes, 1 piece of polished stone, 15 structure that would put the side lights objects under 25 U.S.C. 3001. projectile points, 3 railroad spikes, 6 within 10% inboard from the greatest This notice is published as part of the scrapers, 4 shell pendants, 2 stone shaft breadth of the vessel, as required by National Park Service’s administrative abraders, and 7 pieces of worked bone. Annex I, paragraph 3(b) of the 72 responsibilities under NAGPRA, 25 The 558 lots of objects are 4 lots of COLREGS and Annex I, Section U.S.C. 3003(d)(3). The determinations in buttons or grommets, 1 lot of ceramic 84.05(b), of the Inland Rules Act. this notice are the sole responsibility of fragments, 3 lots of cigar box fragments, Compliance with the rule would cause the museum, institution, or Federal 4 lots of clothing and shoes, 3 lots of agency that has control of the cultural the side lights to be in a location which cordage fragments, 39 lots of flakes, 47 items. The National Park Service is not would be highly susceptible to damage lots of glass and metal beads, 19 lots of responsible for the determinations in from offshore platforms. glass fragments, 1 lot of matting this notice. fragments, 8 lots of metal can fragments, ′″ 5 ″ Locating the side lights 7 – 9 ⁄8 In 1972, cultural items were removed 30 lots of metal fragments, 1 lot of inboard from the greatest breadth of the from burials at 45AS2, Asotin County, mussel fragments, 5 lots of nails, 3 lots vessel on the pilot house will provide a WA. The cultural items and burials of paper fragments, 327 lots of shell sheltered location for the lights and were removed during the Nez Perce beads, 12 lots of shell fragments, 29 lots allow maneuvering within close Grave Removal Project by the University of shell remains, 15 lots of rolled metal proximity to offshore platforms. of Idaho under contract with the Army tinklers, 3 lots of utilized flakes, and 4 The Certificate of Alternative Corps of Engineers. Following removal, lots of worked bone. Compliance allows for the placement of the burials were delivered to the In 1958 and 1959, cultural items were the side lights to deviate from University of Idaho. The human remains removed from burials at Fishhook requirements set forth in Annex I, were returned to the Nez Perce Tribe Island, 45FR42, Franklin County, WA. and reburied in Spalding, ID, in 1973. paragraph 3(b) of 72 COLREGS, and In 1958, the Columbia Archaeological Between 1996 and 2000, the cultural Annex I, paragraph 84.05(b) of the Society excavated at Fishhook Island. In items were transferred from the Inland Rules Act. In addition, the 1959, the Washington State University University of Idaho to Washington State excavated at Fishhook Island while Certificate of Alternative Compliance University, and are now unassociated under contract with the National Park allows for the horizontal separation of funerary objects. The 66 unassociated Service. The 1958 and 1959 excavations the forward and aft masthead lights to funerary objects are 34 counted objects took place before the land was acquired deviate from the requirements of Annex and 32 lots of objects. The 34 counted by the Army Corps of Engineers. At an I, paragraph 3(a) of 72 COLREGS, and objects are 1 abrader, 1 adze, 1 awl, 3 unknown date, the human remains Annex I, Section 84.05(a) of the Inland bifaces, 6 cobble spalls, 5 cores, 2 excavated were delivered to the Rules Act. digging stick handles, 2 flake Washington State University and This notice is issued under authority perforators, 2 hafted drills, 1 piece of University of Idaho. In 2000, the of 33 U.S.C. 1605(c), and 33 CFR 81.18. incised bone, 7 pestles, 2 projectile University of Idaho transferred the

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45FR42 materials to Washington State funerary objects from other 45FR47 Grave Recovery Project. Following University. In 2006, the Army Corps of burials. The burials associated with the removal, the cultural items and burials Engineers physical anthropologists 45FR47 collection are Native American were delivered to the University of inventoried the human remains. Some as demonstrated by the presence of Idaho and Washington State University. of the human remains collected are not Native American Plateau objects, The human remains from both currently in the museum collection, and Plateau burial patterns, and eyewitness excavations were reburied at Spalding, are believed to have been reburied in accounts of Indian people living on ID, in 1978. In 2000, the cultural items 1991. Burials numbers 1 through 21 Ford Island in the 1900s. Dentalia shell from both excavations were transferred were consecutively assigned by the beads start to be common in the Plateau from the University of Idaho to Columbia Archaeological Society to archeological record about 3,000 years Washington State University, and are their excavations. Washington State ago. Glass beads became available to now unassociated funerary objects. The University assigned burial numbers 1 Indian groups from the 1780s through 149 unassociated funerary objects are 17 through 24 to their excavations. The the 1810s. Early and late ethnographic counted objects and 132 lots of objects. duplicate burial numbers and scant documentation indicates the island is The 17 counted objects are 2 bone records do not, in many instances, located within the overlapping 19th pendants, 1 digging stick handle, 2 permit clear association of funerary century territories of the Palus and hammerstones, 1 incised bone fragment, objects with the burials removed. The Walla Walla people. The 165 5 stone beads, 5 stone knives, and 1 45FR42 burials are estimated to range unassociated funerary objects are 17 tack. The 132 lots of objects are 6 lots from the proto-historic/historic time counted objects and 148 lots of objects. of animal remains, 2 lots of bone awl periods to the early 1920s. Native The 17 counted objects are 2 bells, 1 fragments, 23 lots of bone beads, 1 lot American objects found with the burials copper ring, 1 copper screw, 1 of buttons, 4 lots of elk tooth beads, 35 include olivella and dentalia shell beads hammerstone, 1 metal ring, 2 net lots of flakes, 44 lots of glass trade and glass beads. In the early 1900s, local sinkers, 1 ochre stained ground stone, 3 beads, 3 lots of leather fragments, 8 lots residents witnessed Native American shell ornaments, 1 spoon, 1 spoon of shell beads, 2 lots of ochre stained burial ceremonies held on Fishhook handle, 1 preform, 1 core, and 1 pipe. cobbles, 2 lots of red and yellow ochre, Island, and remember Cayuse, Walla The 148 lots of objects are 1 lot of and 2 lots of soil. Walla, Wallula, and Palus people in the animal remains, 1 lot of bag residue, 3 In 1967, cultural items were removed general area during the late 1880s and lots of buttons, 2 lots of charcoal, 21 lots from burials at the Ferguson Burial Site, early 1900s. Fishhook Island is located of fabric remains, 5 lots of flakes, 51 lots 45WT55, Whitman County, WA. The within the overlapping 19th century of glass and metal beads, 2 lots of glass Washington State University field territories of the Palus and the Walla beads, 2 lots of glass fragments, 7 lots school excavated Burials 1 through 7 Walla people. The 171 unassociated of leather fragments, 27 lots of metal prior to land acquisition by the Army funerary objects are 80 counted objects fragments, 1 lot of nails, 7 lots of organic Corps of Engineers. The burials were and 91 lots of objects. The 80 counted remains, l lot of soil, and 17 lots of delivered to Washington State objects are 27 cobble spalls, 1 core, 23 wood fragments. University following removal. At an elk tooth beads, 2 beaver incisors, 6 In 1963, cultural items were removed unknown time, the human remains were bone awls, 1 digging stick fragment, 1 from 45WT2, Whitman County, WA. transferred to the University of Idaho digging stick handle, 2 hafted drills, 1 The excavation took place under where a pre-NAGPRA program of contract with the National Park Service repatriation was ongoing. In 2000, the adze, 10 preforms, 4 projectile points, and before the land was acquired by the University of Idaho transferred the and 2 scrapers. The 91 lots of objects are Army Corps of Engineers. The cultural remaining 45WT55 collection back to 22 lots of flakes, 3 lots of red ochre, 24 items were with Burial 1 when Washington State University. Site lots of shell beads, 5 lots of shell excavated. At an unknown date, the 45WT55 is adjacent to judicially remains, 7 lots of animal remains, 6 lots materials associated with this established Nez Perce Indian land and of bag residue, 1 lot of charcoal, 2 lots excavation were delivered to within the overlapping 19th century of fire-cracked rock, 5 lots of glass and Washington State University and the territories of the Palus and Nez Perce metal beads, 3 lots of juniper seed University of Idaho. In 2000, one box of people. The unassociated funerary items beads, 4 lots of matting fragments, 1 lot materials was transferred from the are six lots of wood fragments. of metal fragments, 3 lots of plant University of Idaho to Washington State In 1971, cultural items were removed remains, 1 lot of shell pendant University. The Burial 1 remains are not from burials at 45WT101, Whitman fragments, and 4 lots of wood fragments. labeled and the funerary objects are County, WA. The University of Idaho In 1960, cultural items were removed therefore no longer associated. The three removed 33 burials while under from burials at Ford Island, 45FR47, unassociated funerary objects are one contract to the Army Corps of Engineers Franklin County, WA. Washington State counted object and two lots of objects, as part of the Nez Perce Grave Removal University excavated at Ford Island which are one pestle, one lot of red Project. The 45WT101 burials were under contract with the Army Corps of ochre, and one lot of wood fragments. reported as reburied at Spalding, ID, in Engineers. The burials were delivered to In 1977 and 1978, cultural items were 1978. In 1998 and 2000, the University the University of Idaho and Washington removed from burials at 45WT53, of Idaho transferred the collection to State University. The human remains Whitman County, WA. In 1977, Burials Washington State University. In 2001, are thought to have been reburied before 1 and 2 were removed by the University during a collections assessment 1985. In 1992, a Washington State of Idaho while under contract with the inventory, the Washington State University inventory recorded the Army Corps of Engineers. Following University encountered cultural items presence of Burial 6 materials in the removal, the cultural items and burials associated with many of the burials. The collection. Between 1996 and 2000, the were delivered to the University of cultural items are now unassociated University of Idaho transferred materials Idaho and Washington State University. funerary objects. The 88 unassociated to Washington State University. In 2003, In 1978, Burials 3 through 5 were funerary objects are 24 counted objects the transferred materials were removed by the University of Idaho and 64 lots of objects. The 24 counted inventoried, and the presence of Burial while under contract to the Army Corps objects are 2 abalone shell pendants, 1 9 materials was recorded along with of Engineers as part of the Nez Perce abrading stone, 1 biface, 4 bone gaming

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pieces, 1 incised stone, 1 nipple topped Army Corps of Engineers, Walla Walla to repatriate cultural items in the maul, 1 modified pebble, 6 preforms, 4 District, have determined that there is a possession of the California Department projectile points, 1 scraper, and 2 stone cultural relationship between the of Parks and Recreation, Sacramento, pipes. The 64 lots of objects are 1 lot of unassociated funerary objects and the CA, that meet the definition of abalone shell fragments, 3 lots of antler Wanapum Band, a non-federally unassociated funerary objects under 25 fragments, 21 lots of flakes, 2 lots of red recognized Indian group. U.S.C. 3001. ochre, 24 lots of shell beads, 2 lots of Representatives of any other Indian This notice is published as part of the shell remains, and 11 lots of modified tribe that believes itself to be culturally National Park Service’s administrative wood fragments. affiliated to the unassociated funerary responsibilities under NAGPRA, 25 Six lines of evidence - geographical, objects should contact LTC Michael U.S.C. 3003(d)(3). The determinations in archeological, anthropological, Farrell, U.S. Department of Defense, this notice are the sole responsibility of linguistic, oral tradition, and historical Army Corps of Engineers, Walla Walla the museum, institution, or Federal - support cultural affiliation of the District, 201 North Third Avenue, Walla agency that has control of the Native Confederated Tribes of the Colville Walla, WA 99362, telephone (509) 527– American cultural items. The National Reservation, Confederated Tribes of the 7700, before July 26, 2010. Repatriation Park Service is not responsible for the Umatilla Indian Reservation, of the unassociated funerary objects to determinations in this notice. Confederated Tribes of the Warm the Confederated Tribes of the Colville In 1962, the Bowles site, CA–BUT– Springs Indian Reservation of Oregon, Reservation, Washington; Confederated 452, in Butte County, CA, was recorded Confederated Tribes and Bands of the Tribes of the Umatilla Indian by Francis A. Riddell, possibly as part Yakama Nation, and the Nez Perce Tribe Reservation, Oregon; Confederated of the Oroville reservoir survey. with the unassociated funerary objects Tribes of the Warm Springs Indian Additional Native American human identified in the above-mentioned sites Reservation of Oregon; Confederated remains and associated funerary objects and collections. Additionally, a cultural Tribes and Bands of the Yakama Nation, from Butte County that are in the relationship is determined to exist Washington; and Nez Perce Tribe, possession of the California Department between the unassociated funerary Idaho, may proceed after that date if no of Parks and Recreation are described in objects and the Wanapum Band, a non- additional claimants come forward. a previously published Notice of federally recognized Indian group. Lastly, the U.S. Department of Defense, Inventory Completion (73 FR 20937– Other relevant information provided by Army Corps of Engineers, Walla Walla 20939, April 17, 2008). In the collection, the Indian tribes and the Wanapum District, acknowledges the participation there are 24 Olivella beads, of which 18 Band indicates they are direct of the Wanapum Band, a non-federally are complete, and all are unifacially descendant communities from the recognized Indian group, in the transfer drilled. Acquisition documents are Native people that jointly used this area, of the unassociated funerary objects to missing, although a tag indicates these are intermarried, have enrolled the Indian tribes. beads are from burial #2. However, there members with documented connections The U.S. Department of Defense, are no human remains from this site in to ancestors buried along the Snake Army Corps of Engineers, Walla Walla the institution’s collection. Therefore, River, and are all part of the more District, is responsible for notifying the the institution reasonably believes the broadly defined Plateau cultural Confederated Tribes of the Colville 24 beads are unassociated funerary community. Reservation, Washington; Confederated objects. Officials of the U.S. Department of Tribes of the Umatilla Indian The age of these funerary objects is Defense, Army Corps of Engineers, Reservation, Oregon; Confederated unknown. They are consistent with the Walla Walla District, have determined Tribes of the Warm Springs Indian occupation of the site by the historic Konkow (Northwestern Maidu). that, pursuant to 25 U.S.C. 3001(3)(B), Reservation of Oregon; Confederated Generally, archeologists believe that the the 1,301 objects, which are 268 Tribes and Bands of the Yakama Nation, Penutian-speaking Maidu are descended counted objects and 1,033 lots of Washington; Nez Perce Tribe, Idaho; from what have been identified as the objects, described above are reasonably and the Wanapum Band, a non-federally Windmiller people who occupied the believed to have been placed with or recognized Indian group, that this notice Central Valley of California from 3,000 near individual human remains at the has been published. time of death or later as part of the death to 4,000 years ago. Geographic rite or ceremony and are believed, by a Dated: June 18, 2010 affiliation is consistent with the preponderance of the evidence, to have David Tarler, historically documented Konkow been removed from a specific burial site Acting Manager, National NAGPRA Program. (Northwestern Maidu). Descendants of of Native American individuals. [FR Doc. 2010–15379 Filed 6–23–10; 8:45 am] the Konkow (Northwestern Maidu) are Officials of the U.S. Department of BILLING CODE 4312–50–S members of the Berry Creek Rancheria Defense, Army Corps of Engineers, of Maidu Indians of California; Walla Walla District, also have Enterprise Rancheria of Maidu Indians determined that, pursuant to 25 U.S.C. DEPARTMENT OF THE INTERIOR of California; Mechoopda Indian Tribe 3001(2), there is a relationship of shared of Chico Rancheria, California; group identity that can be reasonably National Park Service Mooretown Rancheria of Maidu Indians traced between the unassociated of California; and Round Valley Indian funerary objects and the Confederated Notice of Intent to Repatriate Cultural Tribes of the Round Valley Reservation, Tribes of the Colville Reservation, Items: California Department of Parks California. Washington; Confederated Tribes of the and Recreation, Sacramento, CA Officials of the California Department Umatilla Indian Reservation, Oregon; AGENCY: National Park Service, Interior. of Parks and Recreation have Confederated Tribes of the Warm ACTION: Notice. determined that, pursuant to 25 U.S.C. Springs Indian Reservation of Oregon; 3001(3)(B), the 24 cultural items Confederated Tribes and Bands of the Notice is here given in accordance described above are reasonably believed Yakama Nation, Washington; and the with the Native American Graves to have been placed with or near Nez Perce Tribe, Idaho. Lastly, officials Protection and Repatriation Act individual human remains at the time of of the U.S. Department of Defense, (NAGPRA), 25 U.S.C. 3005, of the intent death or later as part of the death rite

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or ceremony and are believed, by a ACTION: Notice. is identified as Tequesta territory. In preponderance of the evidence, to have 1513, Tequesta villages were described been removed from a specific burial site Notice is here given in accordance in the records of the Ponce de Leon of a Native American individual. with the Native American Graves expedition. The Tequesta suffered from Officials of the California Department of Protection and Repatriation Act diseases and other disrupting forces of Parks and Recreation also have (NAGPRA), 25 U.S.C. 3003, of the European contact, and, by 1743, a determined that, pursuant to 25 U.S.C. completion of an inventory of human distinct group that could be identified 3001(2), there is a relationship of shared remains in the possession and control of as Tequesta had disappeared. In 1763, group identity that can be reasonably the New York University College of the remnant communities of Native traced between the unassociated Dentistry, New York, NY. The human Floridians in south Florida were taken funerary objects and the Berry Creek remains were removed from Broward to Cuba when Florida was transferred and Levy Counties, FL, and an unknown Rancheria of Maidu Indians of from Spanish to British control. mound in East Florida. California; Enterprise Rancheria of At an unknown date, human remains This notice is published as part of the Maidu Indians of California; Mechoopda representing a minimum of one National Park Service’s administrative individual were removed from a mound Indian Tribe of Chico Rancheria, responsibilities under NAGPRA, 25 California; Mooretown Rancheria of at Hog Island, Levy County, FL. It is U.S.C. 3003(d)(3). The determinations in likely that the remains were collected by Maidu Indians of California; and Round this notice are the sole responsibility of Valley Indian Tribes of the Round William Bryant in 1918. The remains the museum, institution, or Federal from Hog Island were in the collection Valley Reservation, California. agency that has control of the Native Representatives of any other Indian of William L. Bryant when it was sold American human remains. The National to the Museum of the American Indian, tribe that believes itself to be culturally Park Service is not responsible for the affiliated with the unassociated funerary Heye Foundation in 1920. In 1956, the determinations in this notice. Museum of the American Indian objects should contact Rebecca A detailed assessment of the human transferred the remains to Dr. Theodore Carruthers, NAGPRA Coordinator, remains was made by the New York Kazamiroff, New York University California Department of Parks and University College of Dentistry College of Dentistry. No known Recreation, 1416 Ninth St., Room 902, professional staff in consultation with individual was identified. No associated Sacramento, CA 95814, telephone (916) representatives of the Alabama- funerary objects are present. 653–8893, before July 26, 2010. Quassarte Tribal Town, Oklahoma; Hog Island is located within the North Repatriation of the unassociated Choctaw Nation of Oklahoma; Jena Peninsular Coast region. Florida state funerary objects to the Berry Creek Band of Choctaw Indians, Louisiana; site files identify a Weeden Island Rancheria of Maidu Indians of Kialegee Tribal Town, Oklahoma; Period burial mound, 8Lv2, on Hog California; Enterprise Rancheria of Miccosukee Tribe of Indians of Florida; Island. Artifacts from the mound Maidu Indians of California; Mechoopda Mississippi Band of Choctaw Indians, indicate that it is associated with the Indian Tribe of Chico Rancheria, Mississippi; Muscogee (Creek) Nation, Weeden Island 2 phase of the Weeden California; Mooretown Rancheria of Oklahoma; Poarch Band of Creek Island I Period, circa A.D. 150-450. The Maidu Indians of California; and Round Indians of Alabama; Seminole Nation of morphology of the remains is consistent Valley Indian Tribes of the Round Oklahoma; Seminole Tribe of Florida with an individual of Native American Valley Reservation, California, may (Dania, Big Cypress, Brighton, ancestry. During the Weeden Island II proceed after that date if no additional Hollywood & Tampa Reservations); and Period (circa A.D. 600-1200), the North claimants come forward. Thlopthlocco Tribal Town, Oklahoma. Peninsular coastal region of Florida The California Department of Parks In 1937, human remains representing remained a distinct region. The cultural and Recreation is responsible for a minimum of one individual were sequence after A.D. 1200 is difficult to notifying the Berry Creek Rancheria of removed from a mound at Lettuce Lake, determine. The Safety Harbor culture to Maidu Indians of California; Enterprise (8Bd7), Broward County, FL. The the south, the Northwest Florida Rancheria of Maidu Indians of mound was excavated by Geoffrey cultures to the northwest, and Alachua California; Mechoopda Indian Tribe of Olson and William C. Orchard as part of culture to the east abut the region, but Chico Rancheria, California; Mooretown an expedition sponsored by the do not extend into the Northwest Rancheria of Maidu Indians of Museum of the American Indian, Heye Peninsular Coast area. The early California; and Round Valley Indian Foundation. The remains were Spanish explorations of Ponce de Leon, Tribes of the Round Valley Reservation, accessioned by the Museum of the Narvaez, and DeSoto did not enter the California, that this notice has been American Indian in 1937. In 1956, the coastal Northwest Florida Peninsular published. Museum of the American Indian areas. The Spanish did not establish any Dated: June 18, 2010 transferred the remains to Dr. Theodore missions in the region after claiming La Kazamiroff, New York University David Tarler, Florida. As a result, there is no College of Dentistry. No known information from early colonial Acting Manager, National NAGPRA Program. individual was identified. No associated documents regarding any people living [FR Doc. 2010–15287 Filed 6–23–10; 8:45 am] funerary objects are present. in this region. This stands in marked BILLING CODE 4312–50–S Artifacts recovered from the mound contrast to the records for the area from indicate that it dates to the Glades IIIa Tampa Bay to the south and for the Period, A.D. 1200-1400, and is a Glades northwest coast of Florida. There are DEPARTMENT OF THE INTERIOR culture site of the Glades Tradition. The also no records to identify people from National Park Service morphology of the remains is consistent the region in subsequent French or with an individual of Native American English documents. It is likely that Notice of Inventory Completion: New ancestry. There is evidence for cultural inhabitants of the Northwest Peninsular York University College of Dentistry, continuity between the Glades IIIa Coast quickly felt the effects of New York, NY Period and the post-contact people of European diseases that were introduced the Broward County area. In the Historic by the Spanish in the early 16th AGENCY: National Park Service, Interior. Period, the area around Broward County century. As in other portions of Florida,

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their communities probably shrank in the state to migration by the Lower Indians of Florida; Mississippi Band of size until only a small portion of the Creek. The first Creek settlements were Choctaw Indians, Mississippi; Muscogee original population was left. These located in northern Florida. Conflicts (Creek) Nation, Oklahoma; Poarch Band people may have sought refuge with the British, and then the American of Creek Indians of Alabama; Seminole elsewhere in Florida, but were never government, pushed the Creek into the Nation of Oklahoma; Seminole Tribe of identified. southern half of the state. These Creek Florida (Dania, Big Cypress, Brighton, In 1920, human remains representing communities grew independent of Creek Hollywood & Tampa Reservations); and a minimum of seven individuals were nations to the north and became known Thlopthlocco Tribal Town, Oklahoma, removed from an unidentified mound in as the Seminole and Miccosukee. that this notice has been published. East Florida by Charles Hallock. The Officials of the New York University Dated: June 18, 2010 remains and objects from the mound College of Dentistry have determined were loaned by the Long Island that, pursuant to 25 U.S.C. 3001(9), the David Tarler, Historical Society (now the Brooklyn human remains described above Acting Manager, National NAGPRA Program. Historical Society) to the Museum of the represent the physical remains of nine [FR Doc. 2010–15286 Filed 6–23–10; 8:45 am] American Indian, Heye Foundation in individuals of Native American BILLING CODE 4312–50–S 1920. According to archival records, the ancestry. Officials of the New York loan was made permanent in 1967. In University College of Dentistry also 1956, the Museum of the American have determined that, pursuant to 25 DEPARTMENT OF THE INTERIOR Indian transferred the remains to Dr. U.S.C. 3001(2), a relationship of shared National Park Service Theodore Kazamiroff, New York group identity cannot reasonably be University College of Dentistry. No traced between the Native American Notice of Inventory Completion: known individuals were identified. No human remains and any present-day Cranbrook Institute of Science, associated funerary objects are present. Indian tribe. Bloomfield Hills, MI The specific site and age for the The Native American Graves remains is not known, but the Protection and Repatriation Review AGENCY: National Park Service, Interior. morphology of the remains is consistent Committee (Review Committee) is ACTION: Notice. with individuals of Native American responsible for recommending specific ancestry. In prehistoric cultural actions for disposition of culturally Notice is here given in accordance sequences, the area of eastern Florida is unidentifiable human remains. In July with the Native American Graves identified with the St. Johns culture, 2009, the New York University College Protection and Repatriation Act whose territory lay in the portions of of Dentistry requested that the Review (NAGPRA), 25 U.S.C. 3003, of the eastern and central Florida where the St. Committee recommend disposition of completion of an inventory of human Johns River and its tributaries flow. The the culturally unidentifiable human remains and associated funerary objects St. Johns tradition first appeared around remains of nine individuals to the in the possession of the Cranbrook 500 B.C. and continued until European Miccosukee Tribe of Indians of Florida. Institute of Science, an institutional contact. It is divided into several The Review Committee considered the member of the Cranbrook Educational periods, all of which include burial proposal at its October 30-31, 2009, Community, Bloomfield Hills, MI. The mounds. In 16th century records, the meeting and recommended disposition human remains and associated funerary people living in the St. Johns River area of the human remains to the Miccosukee objects were removed from Macomb, are identified as the Timucua. Historic Tribe of Indians of Florida. Monroe, Oakland, and Wayne Counties, mission records suggest that diseases A March 4, 2010, letter from the MI. introduced between 1562 and 1595 had Designated Federal Official, writing on This notice is published as part of the decimated the population in the St. behalf of the Secretary of the Interior, National Park Service’s administrative Johns River area. Additional epidemics transmitted the authorization for the responsibilities under NAGPRA, 25 in the first half of the 17th century College to effect disposition of the U.S.C. 3003(d)(3). The determinations in resulted in massive population loss and human remains to the Miccosukee Tribe this notice are the sole responsibility of changes to the diet, health, economy, of Indians of Florida contingent on the the museum, institution, or Federal and religion of the Timucua. In 1684, publication of a Notice of Inventory agency that has control of the Native the British began to attack the Spanish Completion in the Federal Register. American human remains and missions where the Timucua were This notice fulfills that requirement. associated funerary objects. The living in order to gain control of Florida. Representatives of any other Indian National Park Service is not responsible At the same time, the missions were tribe that believes itself to be culturally for the determinations in this notice. also subject to slave raiding by tribes affiliated with the human remains A detailed assessment of the human from the north. By 1704, all missions should contact Dr. Louis Terracio, New remains was made by the Cranbrook but St. Augustine were destroyed and York University College of Dentistry, Institute of Science professional staff in the remaining Timucua took refuge at it. 345 East 24th St., New York, NY 10010, consultation with representatives of the In 1711, only 942 Timucua and telephone (212) 998–9917, before July Little Traverse Bay Bands of Odawa Apalachee were living around St. 26, 2010. Disposition of the human Indians, Michigan, on behalf of the Augustine. Slave raiding, disease, and remains to the Miccosukee Tribe of Michigan Anishnaabek Cultural English attacks further reduced the Indians of Florida may proceed after Preservation and Repatriation Alliance population; by 1759, only 59 Timucua that date if no additional claimants (MACPRA), a non-federally recognized and Apalachee remained at St. come forward. Indian group. Augustine. The Spanish withdrew from The New York University College of On an unknown date, human remains St. Augustine between 1763-1764, Dentistry is responsible for notifying the representing a minimum of one taking the 89 Indians from St. Augustine Alabama-Quassarte Tribal Town, individual were removed from with them to Cuba. Oklahoma; Choctaw Nation of Birmingham, Oakland County, MI. On In all three sites mentioned-above, the Oklahoma; Jena Band of Choctaw April 1937, the City Coroner of population vacuum created by the Indians, Louisiana; Kialegee Tribal Birmingham gave the human remains to absence of Florida tribal groups opened Town, Oklahoma; Miccosukee Tribe of the museum (CIS reference #116). No

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known individual was identified. No On an unknown date, human remains location in Oakland County, MI. In May associated funerary objects are present. representing a minimum one individual 1951, the human remains were given to Museum records indicate that the were removed from Mill Street, Auburn the museum by an unidentified source individual is a female and probably Heights, Oakland County, MI. On April (CIS reference #7523). No known Native American. There was no 29, 1951, the human remains were individual was identified. No associated stratigraphic report or supplemental received from Mr. and Mrs. Chester funerary objects are present. information available to help determine Wade and given to the museum (CIS Museum records indicate that, ‘‘from further cultural affiliation, and thus, the reference ι6873). No known individual context and bone condition – not human remains were classified as was identified. The eight associated morphology, these skeletal remains culturally unidentifiable. funerary objects are seven pieces of might possibly be American Indian but On an unknown date, human remains trade silver, including a brooch and with such little identification and no representing a minimum of one several wrist cuffs/bracelets, and a other information, no consultation individual were removed from the fragment of cloth (CIS reference #6874). could be conducted.’’ Therefore, the Gibraltar Site, Monroe County, MI. On According to museum records, the human remains were classified as February 18, 1938, Darrel J. Richards human remains are probably a female culturally unidentifiable. gave the human remains to the museum Native American. The file of record On an unknown date, human remains (CIS reference #280). No known indicates that, ‘‘even with the trade representing a minimum of one individual was identified. No associated silver items’’, ‘‘there was no actual individual were removed from a funerary objects are present. indication of stratigraphic or artifact location in Oakland County, MI. In May Originally museum records indicated association on which to begin dialogue.’’ 1951, the human remains were given to that, ‘‘With no artifacts or temporal Therefore ‘‘no consultation could be the museum by an unidentified source information to work with, no conducted.’’ These human remains were (CIS reference #7524). No known individual was identified. No associated consultation could be conducted.’’ thus classified as culturally funerary objects are present. Therefore, the human remains were unidentifiable. On an unknown date, human remains According to museum records, the classified as culturally unidentifiable. representing a minimum of two human remains are probably Native The individual described above has the individuals were removed from a American from the Prehistoric or Early same donor, date of donation, and site location in Oakland County, MI. In May Historic Period. Records also indicate name as the human remains and 1951, the human remains were given to that, ‘‘from context and bone condition associated funerary objects described in the museum by an unidentified source – not morphology, these skeletal the next paragraph, but were assigned (CIS reference #7520). No known remains might possibly be American different reference numbers. individuals were identified. No Indian but with such little identification On an unknown date, human remains associated funerary objects are present. and no other information, no representing a minimum of four The human remains are the co- consultation could be conducted.’’ individuals were removed from the mingled remains of at least two Therefore, the human remains were Gibraltar Site, Monroe County, MI. On individuals that are probably Native classified as culturally unidentifiable. February 18, 1938, Darrel J. Richards American based on context and bone On an unknown date, human remains gave the human remains to the museum condition. Museum records indicate, representing a minimum of eight (CIS reference #281). No known ‘‘from context and bone condition – not individuals were removed from Kennet individuals were identified. The 25 morphology, these skeletal remains Road, Pontiac, Oakland County, MI, by associated funerary objects are 24 might possibly be American Indian but the Pontiac Police Department (case pottery fragments and 1 container of with such little identification and no number 194312). On April 15, 1968, the unidentified material. other information, no consultation human remains were given to the The human remains are possibly could be conducted.’’ Therefore, the museum by Warren L. Wittry (CIS Native American. Museum records human remains were classified as reference #9734). No known individuals indicate that with ‘‘no additional culturally unidentifiable. were identified. No associated funerary information to work with, no additional On an unknown date, human remains objects are present. no dialog could be initiated.’’ Therefore, representing a minimum of four Museum records indicate that, ‘‘With the human remains were classified as individuals were removed from a no additional association to use as a culturally unidentifiable. location in Oakland County, MI. In May basis, no consultation could be On an unknown date, human remains 1951, the human remains were given to conducted.’’ Therefore, the human representing a minimum of three the museum by an unidentified source remains were classified as culturally individuals were removed from the New (CIS reference #7522). No known unidentifiable. Baltimore Site, Macomb County, MI. On individuals were identified. No On an unknown date, human remains June 13, 1940, the human remains were associated funerary objects are present. representing a minimum of one donated by Gwynn Cushman to the According to museum records the individual were removed from the museum (CIS reference #911). No human remains are possibly Native homestead of Henry Barnes, 822 Shady known individuals were identified. No American based on bone condition. The Hollow Circle, Bloomfield Hills, associated funerary objects are present. records also indicate that, ‘‘from context Oakland County, MI. In the 1960s, the According to museum records, the and bone condition – not morphology, human remains were given to the human remains are the co-mingled these skeletal remains might possibly be museum by Warren L. Wittry (CIS remains of at least three individuals that American Indian but with such little reference #9735). No known individual date from either the Prehistoric or early identification and no other information, was identified. No associated funerary Historic Period. Museum records no consultation could be conducted.’’ objects are present. indicate that ‘‘no linear descendants Therefore, the human remains were According to museum records, the could be substantiated; therefore no classified as culturally unidentifiable. human remains are probably a female consultation could be conducted.’’ Thus, On an unknown date, human remains Native American. Records also indicate the human remains were classified as representing a minimum of one that the ‘‘remains are too incomplete’’ culturally unidentifiable. individual were removed from a and ‘‘no beginning was found for the

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initiation of consultations.’’ Therefore, was identified. No associated funerary contains chert fragments, soil samples, the human remains were classified as objects are present. and pottery fragments. culturally unidentifiable. According to museum records, the According to museum records, the On an unknown date, human remains human remains are probably Native human remains are Native American. representing a minimum of one American based on femoral shaft According to Mr. Martinez, the Drake individual were removed from near morphology. Records also indicate that site falls into the early Younge Tradition Coolidge Road, Troy, Oakland County, geographical and collection data were or late Wayne ceramic tradition, which MI. On November 9, 1963, the human not available, and therefore, no dates to approximately A.D. 700–800. remains were given to the museum by consultation could be conducted. Thus, Records indicate that there was a lack of Detective Mortensen, Troy Police the human remains were classified as information pertaining to linear Department (CIS reference #9736). No culturally unidentifiable. descendants; therefore no consultation known individual was identified. No On an unknown date, human remains could be conducted by the museum. associated funerary objects are present. representing a minimum of one Thus, the human remains were According to museum records, the individual were removed from an classified as culturally unidentifiable. individual is a mature male, and unknown location, but probably in The above-described human remains probably Native American. Records Michigan. On an unknown date, the came to the museum through a variety indicate that no basis was found for the human remains were given to the of channels, but primarily as the result initiation of consultations. Therefore, museum by an unidentified source (CIS of construction work in southeastern the human remains were classified as reference #9817). No known individual Michigan over four decades prior to culturally unidentifiable. was identified. No associated funerary 1980. All have been identified as Native On an unknown date, human remains objects are present. American based on skeletal morphology According to museum records, the representing a minimum of one and/or archeological context. All have human remains are probably a female been determined to be culturally individual were removed from near Native American based on femoral shaft unidentifiable. Plymouth, Wayne County, MI. On an morphology. Records also indicate that Officials of the Cranbrook Institute of unknown date, the museum received geographical and collection data were Science have determined that, pursuant the human remains from an not available, and therefore, no to 25 U.S.C. 3001(9), the human remains unidentified source (CIS reference consultation could be conducted. Thus, described above represent the physical #9737). No known individual was the human remains were classified as remains of at least 39 individuals of identified. No associated funerary culturally unidentifiable. Native American ancestry. Officials of objects are present. On an unknown date, human remains the Cranbrook Institute of Science also According to museum records, the representing a minimum of two have determined that, pursuant to 25 human remains are probably a female individuals were removed from the U.S.C. 3001(3)(A), the 34 objects Native American. Records also indicate Norton Site, Romeo, in Macomb County, described above are reasonably believed that, ‘‘no further information was MI. On an unknown date, the human to have been placed with or near available, no consultation could be remains were given to the museum (CIS individual human remains at the time of conducted.’’ Therefore, the human reference #10123 and #10124). No death or later as part of the death rite remains were classified as culturally known individuals were identified. No or ceremony. Lastly, officials of the unidentifiable. associated funerary objects are present. Cranbrook Institute of Science have On an unknown date, human remains According to museum records, the determined that, pursuant to 25 U.S.C. representing a minimum of two human remains are probably Native 3001(2), a relationship of shared group individuals were removed from a site at American. An assessment dated October identity cannot be reasonably traced Hamlin and Rochester Roads, Rochester, 30, 1994, notes that, ‘‘one tooth which between the Native American human Oakland County, MI. On December 17, is not human, and a non-human long remains and associated funerary objects 1970, the human remains were given to bone midshaft fragment’’ was and any present-day Indian tribe. the museum by Dr. John Burton, intermingled with the human remains at The Native American Graves Oakland County Medical Examiner (CIS the time the osteology review was Protection and Repatriation Review reference #9738 and #9739). No known conducted. It is unknown what was Committee (Review Committee) is individuals were identified. No done with the non-human material. The responsible for recommending specific associated funerary objects are present. Norton site is identified as Late actions for disposition of culturally According to museum records, the Woodland Younge tradition based on unidentifiable human remains. In April human remains are possibly Native ‘‘animal bones’’ and ‘‘fragments of 2008, a request for the disposition of the American. One of the individuals pottery’’ as evidenced in ‘‘pits dug by the Native American human remains was exhibits a pattern of wear consistent occupants.’’ No other dating was officially submitted to the Cranbrook with that known for aboriginal performed at the Norton site; therefore Institute of Science by the Little populations. Records also indicate that, no consultation could be conducted. Traverse Bay Bands of the Odawa ‘‘necessary practical information was not Thus, the human remains were Indians on behalf of the Michigan available; therefore no consultation classified as culturally unidentifiable. Anishnaabek Cultural Preservation and could be conducted.’’ Therefore, the On an unknown date, human remains Repatriation Alliance (MACPRA), a non- human remains were classified as representing a minimum of four federally recognized Indian group, culturally unidentifiable. individuals were removed from the whose members are the following On an unknown date, human remains Drake Site, Farmington Hills, Oakland Federally-recognized Indian tribes: Bay representing a minimum of one County, MI. In August 1977, the human Mills Indian Community, Michigan; individual were removed from an remains were given to the museum by Grand Traverse Band of Ottawa and unknown location, but probably in Charles Martinez and Rick Zurel, local Chippewa Indians, Michigan; Michigan. On an unknown date, the archeologists, (CIS reference #10138). Keweenaw Bay Indian Community, human remains were given to the No known individuals were identified. Michigan; Lac Vieux Desert Band of museum by an unidentified source (CIS The associated funerary object is one Lake Superior Chippewa Indians, reference #9816). No known individual box of excavated material, which Michigan; Little River Band of Ottawa

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Indians, Michigan; Little Traverse Bay The Cranbrook Institute of Science is professional staff in consultation with Bands of Odawa Indians, Michigan; responsible for notifying the Bay Mills representatives of Confederated Tribes Nottawaseppi Huron Band of the Indian Community, Michigan; Grand of the Colville Reservation, Washington; Potawatomi, Michigan; Pokagon Band of Traverse Band of Ottawa and Chippewa Confederated Tribes of the Umatilla Potawatomi Indians, Michigan and Indians, Michigan; Keweenaw Bay Indian Reservation, Oregon; Indiana; Saginaw Chippewa Indian Indian Community, Michigan; Lac Confederated Tribes of the Warm Tribe of Michigan; and Sault Ste. Marie Vieux Desert Band of Lake Superior Springs Reservation of Oregon; Tribe of Chippewa Indians of Michigan. Chippewa Indians, Michigan; Little Confederated Tribes and Bands of the These Indian tribes are considered to be River Band of Ottawa Indians, Yakama Nation, Washington; Nez Perce the Anishnaabek People of the Great Michigan; Little Traverse Bay Bands of Tribe, Idaho; and the Wanapum Band, a Lakes region. Odawa Indians, Michigan; non-federally recognized Indian group. On July 30, 2008, the Cranbrook Nottawaseppi Huron Band of the In 1965, human remains representing Institute requested that the Review Potawatomi, Michigan; Pokagon Band of a minimum of one individual were Committee recommend disposition of Potawatomi Indians, Michigan and removed from the village portion of site 60 culturally unidentifiable human Indiana; Saginaw Chippewa Indian 45CO1 near the mouth of the Tucannon remains to the Indian tribes, as Tribe of Michigan; and Sault Ste. Marie River, Columbia County, WA. The aboriginal occupants of Michigan. The Tribe of Chippewa Indians of Michigan excavation was conducted on Army Review Committee considered the that this notice has been published. Corps of Engineers land under contract with the National Park Service. No proposal at its October 11–12, 2008, Dated: June 18, 2010 meeting and recommended disposition burials were reported during the David Tarler, excavations. In 1996, Washington State of the human remains to the Indian Acting Manager, National NAGPRA Program. tribes listed above, as they are University unexpectedly encountered [FR Doc. 2010–15335 Filed 6–23–10; 8:45 am] considered to be the Anishnaabek human remains in level bags containing People of the Great Lakes region, and BILLING CODE 4312–50–S unprovenienced materials collected the aboriginal occupants of the area from the surface of site 45CO1. No currently referenced as Michigan. known individual was identified. No DEPARTMENT OF THE INTERIOR associated funerary objects are present. An April 3, 2009, letter from the This individual was determined to be Designated Federal Officer, writing on National Park Service Native American based on significant behalf of the Secretary of the Interior, tooth wear and the types of artifacts Notice of Inventory Completion: U.S. transmitted the authorization for the removed during the excavation, Department of Defense, Army Corps of museum to effect disposition of the including projectile points, scrapers, Engineers, Walla Walla District, Walla physical remains of 39 of the 60 antler tine tools, utilized flakes, and Walla, WA and Museum of culturally unidentifiable individuals awls, which are tool types common in Anthropology, Washington State contingent on the publication of a the Plateau culture area. Site 45CO1 is University, Pullman, WA Notice of Inventory Completion in the adjacent to Cayuse, Nez Perce, and Federal Register. This notice fulfills AGENCY: National Park Service, Interior. Palus Indian lands judicially established that requirement. In the same letter, the ACTION: Notice. in 1978. Secretary recommended the transfer of In 1958 and 1959, human remains the associated funerary objects to the Notice is here given in accordance representing a minimum of 14 Indian tribes listed above to the extent with the Native American Graves individuals were removed from allowed by Federal, state, or local law. Protection and Repatriation Act Fishhook Island Site, 45FR42, Franklin Representatives of any other Indian (NAGPRA), 25 U.S.C. 3003, of the County, WA. In 1958, the Columbia tribe that believes itself to be culturally completion of an inventory of human Archaeological Society excavated at affiliated with the human remains and/ remains and associated funerary objects Fishhook Island. In 1959, the or associated funerary objects should in the control of the U.S. Department of Washington State University excavated contact Michael Stafford, PhD., Director, Defense, Army Corps of Engineers, at Fishhook Island while under contract Cranbrook Institute of Science, PO Box Walla Walla District, Walla Walla, WA, with the National Park Service. The 801, Bloomfield Hills, MI 48303, and in the physical custody of the 1958 and 1959 excavations took place telephone (248) 645–3204, before July Museum of Anthropology, Washington before the land was acquired by the 26, 2010. Disposition of the human State University, Pullman, WA. The Army Corps of Engineers. At an remains and associated funerary objects human remains and associated funerary unknown date, the human remains to the Bay Mills Indian Community, objects were removed from Columbia, excavated were delivered to Washington Michigan; Grand Traverse Band of Franklin, Garfield, and Whitman State University and University of Ottawa and Chippewa Indians, Counties, WA. Idaho. In 2000, the University of Idaho Michigan; Keweenaw Bay Indian This notice is published as part of the transferred the 45FR42 materials to Community, Michigan; Lac Vieux Desert National Park Service’s administrative Washington State University. In 2006, Band of Lake Superior Chippewa responsibilities under NAGPRA, 25 the Army Corps of Engineers’ physical Indians, Michigan; Little River Band of U.S.C. 3003(d)(3). The determinations in anthropologists inventoried the human Ottawa Indians, Michigan; Little this notice are the sole responsibility of remains. Some of the human remains Traverse Bay Bands of Odawa Indians, the museum, institution, or Federal collected are not currently in the Michigan; Nottawaseppi Huron Band of agency that has control of the Native museum collection, and may have been the Potawatomi, Michigan; Pokagon American human remains and reburied in 1991. Burials numbers 1 Band of Potawatomi Indians, Michigan associated funerary objects. The through 21 were consecutively assigned and Indiana; Saginaw Chippewa Indian National Park Service is not responsible by the Columbia Archaeological Society Tribe of Michigan; and Sault Ste. Marie for the determinations in this notice. to their burial excavations. Washington Tribe of Chippewa Indians of Michigan, A detailed assessment of the human State University assigned burial may proceed after that date if no remains was made by U.S. Department numbers 1 through 24 to their burial additional claimants come forward. of Defense, Army Corps of Engineers excavations. The duplicate burial

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numbers and scant records do not, in The human remains were associated collection. Between 1996 and 2000, the many instances, permit clear association with a prehistoric housepit village and University of Idaho transferred materials of funerary objects with the burials Native American artifacts dating to the to Washington State University. In 2003, removed. No known individuals were Harder Phase (2500 BP to 1000 BP). the transferred materials were identified. The 351 associated funerary Early and late ethnographic inventoried, and the presence of Burial objects are 102 counted objects and 249 documentation indicates the present- 9 materials was recorded along with lots of objects. The 102 counted objects day location of 45FR43 is within the funerary objects from other 45FR47 are 9 adzes, 5 bifaces, 9 bone awls, 2 overlapping 19th century territories of burials. No known individuals were bone tool fragments, 3 bone wedges, 2 the Cayuse, Palus, and Walla Walla identified. The 168 associated funerary combs, 1 composite harpoon, 2 copper people. objects are 6 counted objects and 162 pendants, 13 cores, 1 digging stick In 1959, 1960, or 1961, human lots of objects. The six counted objects handle, 5 drills, 1 grooved cobble, 1 remains representing a minimum of are one core, two unidentified ground hafted beaver tooth chisel, 1 three individuals were removed from stone items, one iron container, and two hammerstone, 1 jadite club, 1 metal the Windust Caves Site, 45FR46, shell ornaments. The 162 lots of objects bracelet, 1 pestle, 2 preforms, 32 Franklin County, WA. Washington State are 1 lot of animal remains, 10 lots of projectile points, 4 scrapers, 2 cobble University excavated in three of the bag residue, 1 lot of buttons, 17 lots of spalls, 2 stone abraders, 1 stone nine caves in this complex while under fabric remains, 1 lot of feathers, 6 lots pendant, and 1 thimble. The 249 lots of contract with the National Park Service. of flakes, 2 lots of leather fragments, 3 objects are 4 lots of animal hair, 17 lots A lined storage pit feature was lots of metal beads, 2 lots of organic of animal remains, 26 lots of bag encountered in Cave C, but no burials items, 1 lot of red ochre, 4 lots of shell residue, 18 lots of modified bone were reported during the excavations. beads, 98 lots of trade beads, 1 lot of fragments, 2 lots of charcoal, 1 lot of Unknown collectors dug in Cave C unidentified glass items, 13 lots of cordage, 7 lots of elk tooth beads, 2 lots between Washington State University’s unidentified metal items, and 2 lots of of fabric remains, 1 lot of fire cracked field seasons. In 1997, Washington State wood fragments. rock, 81 lots of flakes, 8 lots of glass and University unexpectedly found human The burials associated with the metal beads, 7 lots of juniper seed remains in an unsorted Cave C level bag 45FR47 collection are Native American beads, 2 lots of leather fragments, 4 lots containing material from a collector’s as demonstrated by the presence of of matting, 5 lots of metal fragments, 2 back dirt pile. No known individuals Native American Plateau objects, lots of nails, 6 lots of plant remains, 4 were identified. The 84 associated Plateau burial patterns, and eyewitness lots of red ochre, 35 lots of shell beads, funerary objects are 9 counted objects accounts of Native Americans living on 4 lots of shell pendant fragments, 4 lots and 75 lots of objects. The nine counted Ford Island in the 1900s. Dentalia shell of shell remains, and 9 lots of wood objects are three bifaces, four cores, and beads start to be common in the Plateau fragments. two projectile points. The 75 lots of archeological record about 3,000 years objects are 4 lots of animal remains, 9 ago. Glass beads became available to The 45FR42 burials are estimated to lots of bag residue, 2 lots of bird Indian groups from the 1780s through range from the proto-historic/historic remains, 1 lot of bullet cartridge the 1810s. Early and late ethnographic time periods to the early 1920s. In the fragments, 1 lot of can fragments, 4 lots documentation indicates the island is early 1900s, local residents witnessed of charcoal, 2 lots of cordage, 1 lot of located within the overlapping 19th Native American burial ceremonies held fabric remains, 24 lots of flakes, 2 lots century territories of the Palus and on Fishhook Island, and remember of glass fragments, 2 lots of metal Walla Walla people. Cayuse, Walla Walla, Wallula, and Palus fragments, 3 lots of modified wood, 1 lot In 1981, human remains representing people in the general area during the of nails, 5 lots of paper fragments, 6 lots a minimum of one individual were late 1880s and early 1900s. Fishhook of plant remains, 4 lots of shell remains, removed from the Lyon’s Fish Hatchery/ Island is located within the overlapping and 4 lots of wood fragments. Trestle City/Joso Site, 45FR51, Franklin 19th century territories of the Palus and Information is limited making it County, WA. The Lyons Ferry Fish Walla Walla people. impossible to determine the age of the Hatchery Project was proposed for In 1959, human remains representing remains. However, Native American construction in the area of 45FR51 a minimum of two individuals were materials and features associated with during the late 1970s. An archeological removed from the Klundt or Page Site, the late prehistoric period are present, survey and test excavations were 45FR43, Franklin County, WA. including preserved Native American conducted prior to project initiation. No Washington State University excavated cordage and wood artifacts. Early and burials were reported during the three housepits at 45FR43 on Army late ethnographic documentation archeological investigations; however, a Corps of Engineers project lands while indicates the present-day location of canoe burial was unexpectedly under contract with the National Park 45FR46 is within the overlapping 19th encountered during hatchery Service. The resultant collection was century territories of the Palus and construction. The burial was removed curated at Washington State University, Walla Walla people. and delivered to the University of Idaho but was not formally reported. In 1992, In 1960, human remains representing under contract with the Army Corps of Washington State University a minimum of two individuals were Engineers. In 2000, the University of unexpectedly encountered human removed from the Ford Island Site, Idaho transferred the materials to remains listed in collection records. In 45FR47, Franklin County, WA. Washington State University. No known 2006, Army Corps of Engineers physical Washington State University excavated individual was identified. The 15 lots of anthropologists inventoried the human at 45FR47 while under contract with the associated funerary objects are 3 lots of remains. No known individuals were Army Corps of Engineers. The remains animal remains, 1 lot of fabric remains, identified. The four associated funerary were delivered to the University of 6 lots of leather fragments, 1 lot of metal objects are one counted object and three Idaho and Washington State University fragments, 2 lots of plant remains, 1 lot lots of objects, which are one ceramic and are thought to have been reburied of sediment, and 1 lot of shell remains. bead, one lot of fire cracked rock, one before 1985. In 1992, a Washington The use of canoes in a burial setting lot of charcoal, and one lot of bag State University inventory recorded the is consistent with the Native American residue. presence of Burial 6 materials in the Plateau cultural area. The age of the

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burial is estimated to range from 1820 identified. The eight associated funerary University while under contract with to 1850. Site 45FR51 is within judicially objects are one counted object and seven the National Park Service and prior to established Palus Indian land, and north lots of objects, which are one piece of land acquisition by the Army Corps of of the judicially established Cayuse and modified bone, four lots of flakes, one Engineers. Following removal, the Nez Perce Indian lands. lot of red ochre, one lot of shell remains, remains were delivered to Washington In 1977, human remains representing and one lot of animal remains. State University. In 1992, Washington a minimum of two individuals were The burials, the housepit, and the State University identified one human removed from the Kelly Bar Site, presence of Native American tools and molar in the collection. No known 45GA37, Garfield County, WA. The materials are consistent with Plateau individual was identified. No associated remains were found within slumped culture area customs and characteristics. funerary objects are present. sediments and appeared to lie within a Early and late ethnographic The site is described as a prehistoric redeposited Mt. Mazama ash layer. The documentation indicates that the village that included no reports of human remains were removed by the present-day locations are within burials. This individual was determined University of Idaho under contract with overlapping 19th century territories of to be Native American based on the Army Corps of Engineers. Following the Palus and Nez Perce people. significant tooth wear and the types of removal, the remains were delivered to In 1981, 1982 or 1989, human remains artifacts present in the collection, which the University of Idaho. In 2000, the representing a minimum of one are common in the Plateau culture area. University of Idaho transferred the individual were removed from beach lag Early and late ethnographic remains to Washington State University. deposits at the Riparia Site, 45WT1, documentation indicates site 45WT35 is In 2003, Washington State University Whitman County, WA. The partial within the overlapping 19th century inventoried the human remains of an remains were removed by Washington territory of the Palus and Nez Perce adult and a child. There are no records State University while under contract people. regarding the collection of a second with the Army Corps of Engineers. In 1977 or 1978, human remains burial. These individuals were Following removal, the human remains representing a minimum of one determined to be Native American were delivered to Washington State individual were removed from the based on artifacts observed at site University. No known individual was Blyton Landing Burial Site, 45WT53, 45GA37 which are common in the identified. No associated funerary Whitman County, WA. The University Plateau culture area. No known objects are present. of Idaho removed burials from this individuals were identified. No The archeological assemblage location while under contract with the associated funerary objects are present. associated with the 45WT1 beach lag Army Corps of Engineers as part of the In 1966, human remains representing deposits is consistent with the Native Army Corps of Engineers’ Nez Perce a minimum of one individual were American Plateau culture area. The Grave Recovery Project. The human removed from site 45GA53, Garfield Riparia Site is located within the 19th remains were reburied at Spalding, ID, County, WA. The human remains are century Palus territory, north of the 19th in 1978. In 1987, Washington State unprovenienced and were collected century Walla Walla territory, and west University students observed a human from the surface of the site during the of the 19th century Nez Perce territory. bone fragment at Blyton Landing and Lower Granite/Little Goose Survey and In 1963, human remains representing delivered it to Washington State delivered to the University of Idaho a minimum of one individual were University. In 2000, the University of prior to land acquisition by the Army removed from 45WT2, Whitman Idaho transferred a portion of the Corps of Engineers. Between 1996 and County, WA. Washington State 45WT53 collection to Washington State 1998, the human remains were University excavated three disturbed University. In 2003, Washington State transferred to Washington State burials and Burial 1 while under University inventoried the transferred University. In 2006, Army Corps of contract with the National Park Service materials, and identified funerary Engineers physical anthropologists and prior to land acquisition by the objects associated with the reburied inventoried the remains. No known Army Corps of Engineers. Following Burials 1 through 5 and surface- individual was identified. No associated removal, the human remains and collected human remains from an funerary objects are present. funerary objects were delivered to unknown burial, and these unassociated The individual is determined to be Washington State University. No known funerary objects are in a companion Native American due to burial cairns individual was identified. The three Notice of Intent to Repatriate Cultural and artifacts at 45GA53, which are associated funerary objects are one Items. The only human remains consistent with the Plateau culture area. counted object and two lots of objects, remaining in the collection are from the Site 45GA53 is adjacent to judicially which are one hammerstone, one lot of removal in 1987. No known individual established Nez Perce lands and within shell beads, and one lot of stones. was identified. No associated funerary the overlapping 19th century territories The historic period burial pattern is objects are present. of the Nez Perce and Palus people. consistent with the cultural traditions of The human remains from Burials 1 In 1970, human remains representing the Palus Indians who occupied the through 5 and the unknown burial are a minimum of two individuals were Palouse River drainage during historic determined to be Native American, as removed during excavation of Housepit times. Site 45WT2 is located at the was previously determined during the 7, 45GA61, Garfield County, WA. The mouth of the Palouse River and is Nez Perce Grave Recovery Project. Site burials were removed from Army Corps within judicially established Palus 45WT53 is adjacent to judicially of Engineers land by Washington State Indian land, and north and northwest of established Nez Perce Indian lands and University while under contract with judicially established Cayuse and Nez east of judicially established Palus the National Park Service. Following Perce Indian lands. Indian lands. removal, the burials were delivered to In 1965, human remains representing In 1967, human remains representing the University of Idaho and Washington a minimum of one individual were a minimum of five individuals were State University. In 2000, the University removed from the Lower Granite Dam removed from the Ferguson Burial Site, of Idaho transferred human remains and Site, 45WT35, Whitman County, WA. 45WT55, Whitman County, WA. The funerary objects to Washington State The partial human remains were Washington State University field University. No known individuals were removed by Washington State school excavated Burials 1 through 7

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prior to land acquisition by the Army Washington State University Army Corps of Engineers, Walla Walla Corps of Engineers. The burials were encountered partial human remains District, have determined that there is a delivered to Washington State from Burial 7 during a collections cultural relationship between the Native University following removal. At an inventory. The individual was American human remains and unknown time, the human remains were previously determined to be Nez Perce associated funerary objects and the transferred to the University of Idaho during initiation and completion of the Wanapum Band, a non-federally where a pre-NAGPRA program of Nez Perce Grave Removal Project. No recognized Indian group. repatriation was ongoing. In 2000, the known individual was identified. No Representatives of any other Indian University of Idaho transferred the associated funerary objects are present. tribe that believes itself to be culturally collection to Washington State Evidence supports cultural affiliation affiliated with the human remains and University. In 2006, the human remains of the Confederated Tribes of the associated funerary objects should were inventoried and Burials 1, 3, 4, 5, Colville Reservation, Confederated contact LTC Michael Farrell, U.S. and 6 were found in the collection. No Tribes of the Umatilla Indian Department of Defense, Army Corps of known individuals were identified. The Reservation, Confederated Tribes of the Engineers, Walla Walla District, 201 seven associated funerary objects are Warm Springs Indian Reservation of North Third Ave., Walla Walla, WA one counted object and six lots of Oregon, Confederated Tribes and Bands 99362, telephone (509) 527–7700, before objects, which are one pestle, one lot of of the Yakama Nation, and the Nez July 26, 2010. Repatriation of the human animal remains, one lot of basketry Perce Tribe with the above-mentioned remains and associated funerary objects fragments, and four lots of wood sites and collections. Additionally, a to the Confederated Tribes of the fragments. cultural relationship is determined to Colville Reservation, Washington; The individuals are determined to be exist between the sites and collections Confederated Tribes of the Umatilla Native American based on dental and the Wanapum Band, a non-federally Indian Reservation, Oregon; characteristics, significant tooth wear, recognized Indian group. Other relevant Confederated Tribes of the Warm and archeological burial patterns which information provided by Indian tribes Springs Indian Reservation of Oregon; are age diagnostic attributes of the late and the Wanapum Band indicates they Confederated Tribes and Bands of the prehistoric period on the southern are direct descendant communities from Yakama Nation, Washington; and the Columbia Plateau. Site 45WT55 is the Native people that jointly used the Nez Perce Tribe, Idaho, may proceed adjacent to judicially established Nez areas, are intermarried, have enrolled after that date if no additional claimants Perce Indian land and within the members with documented connections come forward. The U.S. Department of overlapping 19th century territories of to ancestors buried along the Snake Defense, Army Corps of Engineers, the Palus and Nez Perce people. River, and are all part of the more Walla Walla District, acknowledges the In 1971, human remains representing broadly defined Plateau cultural participation of the Wanapum Band, a a minimum of one individual were community. removed from the Lawyer Burial Site, Officials of the U.S. Department of non-federally recognized Indian group, 45WT101, Whitman County, WA. This Defense, Army Corps of Engineers, in the transfer of the human remains individual is 1 of 33 burials removed by Walla Walla District, have determined and associated funerary objects to the the University of Idaho while under that, pursuant to 25 U.S.C. 3001(9), the Indian tribes. contract to the Army Corps of Engineers human remains described above The U.S. Department of Defense, as part of the Nez Perce Grave Removal represent the physical remains of 39 Army Corps of Engineers, Walla Walla Project. The 45WT101 burials were individuals of Native American District, is responsible for notifying the reported as reburied at Spalding, ID, in ancestry. Officials of the U.S. Confederated Tribes of the Colville 1978. In 1998 and 2000, the University Department of Defense, Army Corps of Reservation, Washington; Confederated of Idaho transferred the 45WT101 Engineers, Walla Walla District, also Tribes of the Umatilla Indian collection to Washington State have determined that, pursuant to 25 Reservation, Oregon; Confederated University. In 2001, Washington State U.S.C. 3001(3)(A), the 642 objects Tribes of the Warm Springs Indian University encountered human remains described above, which are 123 counted Reservation of Oregon; Confederated associated with Burial 21 during a objects and 519 lots of objects, are Tribes and Bands of the Yakama Nation, collections assessment inventory. The reasonably believed to have been placed Washington; Nez Perce Tribe, Idaho; individual was previously determined with or near individual human remains and the Wanapum Band, a non-federally to be Nez Perce as part of the Nez Perce at the time of death or later as part of recognized Indian group, that this notice Grave Removal Project. No known the death rite or ceremony. Further, has been published. individual was identified. The two officials of the U.S. Department of Dated: June 18, 2010 associated funerary objects are projectile Defense, Army Corps of Engineers, David Tarler, points. Walla Walla District, have determined Acting Manager, National NAGPRA Program. In 1973, human remains representing that, pursuant to 25 U.S.C. 3001(2), a minimum of one individual were there is a relationship of shared group [FR Doc. 2010–15325 Filed 6–23–10; 8:45 am] removed from the Wilma Bar Culvert identity that can be reasonably traced BILLING CODE 4312–50–S Burial Site, 45WT103, Whitman County, between the Native American human WA. This individual is one of nine remains and associated funerary objects DEPARTMENT OF THE INTERIOR burials removed by the University of and the Confederated Tribes of the Idaho while under contract to the Army Colville Reservation, Washington; Bureau of Indian Affairs Corps of Engineers as part of the Nez Confederated Tribes of the Umatilla Perce Grave Removal Project. Following Indian Reservation, Oregon; No Child Left Behind School Facilities removal, the burials were delivered to Confederated Tribes of the Warm and Construction Negotiated the University of Idaho. The 45WT103 Springs Indian Reservation of Oregon; Rulemaking Committee—Notice of burials were reported as reburied at Confederated Tribes and Bands of the Meeting Spalding, ID, in 1978. The collection Yakama Nation, Washington; and the was transferred to Washington State Nez Perce Tribe, Idaho. Lastly, officials AGENCY: Bureau of Indian Affairs, University at an unknown date. In 2003, of the U.S. Department of Defense, Interior.

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ACTION: Notice. • Bureau of Indian Education briefing DATES: Effective Date: June 24, 2010. on Native American Student FOR FURTHER INFORMATION CONTACT: SUMMARY: In accordance with the Information System; Duane Marti, Realty Specialist, at 916– Federal Advisory Committee Act, the • Small group and subcommittee 978–4675 or via e-mail at Bureau of Indian Affairs is announcing work: Dormitory Standards, Catalog/ [email protected]. that the No Child Left Behind School Inventory, Formula for Repair and SUPPLEMENTARY INFORMATION: The Facilities and Construction Negotiated Renovation, and Education; Bureau of Reclamation has determined Rulemaking Committee will hold its • Report back from subcommittee that the lands are no longer needed for third meeting in Rapid City, South work and discussion; Dakota. The purpose of the meeting is • School visit to Wounded Knee reclamation purposes as previously to continue working on reports and District School and Loneman Day withdrawn and has requested the partial revocation. These lands are included in recommendations to Congress and the School; Secretary as required under the No • Reflections on the school visit; an overlapping reservation on behalf of Child Left Behind Act of 2001. • Brief update on school facilities the Chemehuevi Indian Tribe, therefore the lands will remain withdrawn from DATES: The Committee’s third meeting FY11 budget; • all forms of settlement and entry. The will begin at 8:30 a.m. on July 12, 2010, Review any language drafted by Bureau of Indian Affairs has requested and end at 5 p.m. on July 15, 2010. Committee members concurrent with that the Bureau of Land Management ADDRESSES: The meeting will be held at school visit; • Review third meeting discussions; issue a trust patent for the Chemehuevi the Rushmore Plaza Holiday Inn, 505 and Indian Tribe’s reservation along the North Fifth Street, Rapid City, South • Public comments. Colorado River in San Bernardino Dakota 57709. Written comments may be sent to the County. The lands are being opened to FOR FURTHER INFORMATION CONTACT: The Designated Federal Official listed in the the Act of Congress dated January 12, Designated Federal Official, Michele F. FOR FURTHER INFORMATION CONTACT 1891 (26 Stat. 712), as amended by the Singer, Director, Office of Regulatory section above. All meetings are open to Act of Congress dated March 1, 1907 (34 Affairs and Collaborative Action, Office the public; however, transportation, Stat. 1015, 1022), to facilitate the of the Assistant Secretary—Indian lodging, and meals are the responsibility issuance of the trust patent. Affairs, 1001 Indian School Road, NW., of the participating public. Suite 312, Albuquerque, NM 87104; Order Dated: June 18, 2010. telephone (505) 563–3805; fax (505) By virtue of the authority vested in 563–3811. Donald Laverdure, the Secretary of the Interior by Section Deputy Assistant Secretary—Indian Affairs. SUPPLEMENTARY INFORMATION: The No 204 of the Federal Land Policy and Child Left Behind School Facilities and [FR Doc. 2010–15261 Filed 6–23–10; 8:45 am] Management Act of 1976, 43 U.S.C. Construction Negotiated Rulemaking BILLING CODE 4310–W7–P 1714, it is ordered as follows: Committee was established to prepare 1. The Secretarial Orders dated July 2, and submit to the Secretary a catalog of 1902 (as modified by the Secretarial the conditions at Bureau-funded DEPARTMENT OF THE INTERIOR Order dated August 26, 1902), April 14, 1903, September 8, 1903, June 4, 1930, schools, and to prepare reports covering: Bureau of Land Management The school replacement and new and October 16, 1931, respectively, construction needs at Bureau-funded [LLCA930000, L14300000.ER0000; CACA which withdrew public lands for school facilities; a formula for the 7059, CACA 7060, CACA 7101, CACA 7102, Colorado River Surveys and reclamation equitable distribution of funds to and CACA 7239] project purposes (including Colorado River Surveys and a ‘‘Colorado River address those needs; a list of major and Public Land Order No. 7743; Partial Project’’), are hereby revoked insofar as minor renovation needs at those Revocation of Five Secretarial Orders they affect the following described facilities; and a formula for equitable for Reclamation Project Purposes on lands: distribution of funds to address those the Colorado River, California. needs. The reports are to be submitted San Bernardino Meridian AGENCY: Bureau of Land Management, to the Secretary and to Congress. The T. 6 N., R. 24 E., Committee also expects to draft Interior. Sec. 35. proposed regulations covering ACTION: Public Land Order. T. 4 N., R. 25 E., construction standards for heating, Sec. 25, lots 1 and 2, W1⁄2 NE1⁄4, NW1⁄4, lighting, and cooling in home-living SUMMARY: This order partially revokes and S1⁄2. (dormitory) situations. five Secretarial Orders insofar as they T. 4 N., R. 26 E., The following items will be on the affect 2,865.86 acres of public lands Sec. 19, lots 1, 2, and 3; agenda: previously withdrawn for reclamation Sec. 29, lots 1 and 2; Sec. 30, lots 1 to 20, inclusive; • Review and approve April 2010 project purposes on the Colorado River. Sec. 31, lots 1 to 10, inclusive, S1⁄2 NE1⁄4, meeting summary; The lands are no longer needed for 1 • and SE ⁄4; Review of April 2010 action items; reclamation purposes and the Bureau of Sec. 32, lots 1 to 9, inclusive, SW1⁄4 NE1⁄4, • Discussion on report outline; Reclamation has relinquished the lands and S1⁄2; • Discussion of Committee caucusing accordingly. This order opens the lands Sec. 33, lots 1 to 8, inclusive, and SW1⁄4 and outreach procedures and to the Act of Congress dated January 12, SW1⁄4. identifying any upcoming outreach 1891, as amended by the Act of The areas described aggregate 2,865.86 opportunities; Congress dated March 1, 1907, to acres in San Bernardino County. • Updates from and discussion on: facilitate the issuance of a trust patent 2. At 10 a.m. on June 24, 2010, the The Dormitory Standards to the Chemehuevi Indian Tribe. The lands described in Paragraph 1 will be Subcommittee, Catalog/Inventory lands will remain withdrawn from all opened to the provisions of the Act of Subcommittee, Formula for Repair and forms of settlement and entry under the Congress dated January 12, 1891 (26 Renovation Subcommittee, and the terms of an Order of the Secretary of the Stat. 712), as amended by the Act of Education Subcommittee; Interior dated February 2, 1907. Congress dated March 1, 1907 (34 Stat.

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1015, 1022), generally, subject to valid SUPPLEMENTARY INFORMATION: The The authority for the Commission’s existing rights, the provisions of existing Commission instituted this investigation determination is contained in section withdrawals (including, but not limited on January 14, 2009, based on a 337 of the Tariff Act of 1930, as to, the withdrawal made by Secretarial complaint filed by O2 Micro amended (19 U.S.C. 1337), and in Order dated February 2, 1907), other International, Ltd. of the Cayman sections 210.42–50 of the Commission’s segregations of record, and the Islands and O2 Micro, Inc. of Santa Rules of Practice and Procedure (19 CFR requirements of applicable law. Clara, California. 74 FR 2099. The 210.42–50). Dated: June 16, 2010. complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. Issued: June 18, 2010. Wilma A. Lewis, 1337) in the importation into the United By order of the Commission. Assistant Secretary—Land and Minerals States, the sale for importation, and the Marilyn R. Abbott, Management. sale within the United States after [FR Doc. 2010–15382 Filed 6–22–10; 11:15 am] Secretary to the Commission. importation of certain cold cathode [FR Doc. 2010–15266 Filed 6–23–10; 8:45 am] BILLING CODE 4310–MN–P fluorescent lamp inverter circuits and products containing the same by reason BILLING CODE 7020–02–P of infringement of various U.S. patents. INTERNATIONAL TRADE The complaint names ten respondents, INTERNATIONAL TRADE COMMISSION including Monolithic Power Systems COMMISSION Inc. of San Jose, California (‘‘MPS’’); [Investigation No. 337–TA–666] Microsemi Corporation of Irvine, ‘‘ ’’ [USITC SE–10–022] In the Matter of Certain Cold Cathode California ( Microsemi ); ASUSTeK Computer Inc. of Taipei, Taiwan and Fluorescent Lamp (‘‘CCFL’’) Inverter Government in the Sunshine Act Circuits and Products Containing the ASUS Computer International America of Fremont, California (collectively, Meeting Notice Same; Notice of Commission Final ‘‘ASUS’’). Determination of No Violation of On April 19, 2010, the ALJ issued his AGENCY HOLDING THE MEETING: United Section 337; Termination of final ID finding no violation of section States International Trade Commission. Investigation 337 in the importation into the United TIME AND DATE: June 30, 2010 at 10 a.m. AGENCY: U.S. International Trade States, the sale for importation, and the Commission. sale within the United States after PLACE: Room 101, 500 E Street SW., importation of CCFL inverter circuits ACTION: Notice. Washington, DC 20436, Telephone: and products containing the same by (202) 205–2000. SUMMARY: Notice is hereby given that reason of infringement of U.S. Patent STATUS: the U.S. International Trade 7,417,382 (‘‘the ‘382 patent’’). The Open to the public. Commission has determined to review Commission investigative attorney MATTERS TO BE CONSIDERED (‘‘IA’’), complainant O2 Micro, portions of the final initial 1. Agenda for future meetings: none. determination (‘‘ID’’) issued by the respondents MPS and ASUS, and presiding administrative law judge respondent Microsemi each filed 2. Minutes. (‘‘ALJ’’) on April 19, 2010, and to affirm petitions for review of the ID on May 3, 3. Ratification list. 2010. The IA, O2 Micro, respondents the final ID’s finding of no violation of 4. Inv. Nos. 701–TA–473 and 731– section 337 on modified grounds. The MPS and ASUS, and respondent Microsemi each filed responses to the TA–1173 (Final) (Certain Potassium above-captioned investigation is Phosphate Salts from China)—briefing terminated. petitions for review on May 11, 2010. Having examined the record of this and vote. (The Commission is currently FOR FURTHER INFORMATION CONTACT: investigation, including the ALJ’s final scheduled to transmit its determinations Daniel E. Valencia, Office of the General ID, the petitions for review, and the and Commissioners’ opinions to the Counsel, U.S. International Trade responses thereto, the Commission has Secretary of Commerce on or before July Commission, 500 E Street, SW., determined to review the final ID in 13, 2010.) Washington, DC 20436, telephone part. In particular, the Commission has 5. Outstanding action jackets: None. (202) 205–1999. Copies of non- determined to review (1) the ID’s confidential documents filed in findings that the LX1691 and LX1693 In accordance with Commission connection with this investigation are or Microsemi products infringe the policy, subject matter listed above, not will be available for inspection during asserted claims of the ‘382 patent, and disposed of at the scheduled meeting, official business hours (8:45 a.m. to 5:15 (2) the ID’s finding that O2 Micro has may be carried over to the agenda of the p.m.) in the Office of the Secretary, U.S. not satisfied the domestic industry following meeting. International Trade Commission, 500 E requirement. Issued: June 22, 2010. Street, SW., Washington, DC 20436, Upon review, the Commission has telephone (202) 205–2000. General determined to (1) reverse the ALJ’s By order of the Commission: information concerning the Commission findings that the LX1691 and LX1693 William R. Bishop, may also be obtained by accessing its Microsemi products infringe the Hearings and Meetings Coordinator. Internet server at http://www.usitc.gov. asserted claims of the ‘382 patent, and [FR Doc. 2010–15521 Filed 6–22–10; 4:15 pm] The public record for this investigation (2) reverse the ALJ’s determination that BILLING CODE 7020–02–P may be viewed on the Commission’s O2 Micro has not satisfied the domestic electronic docket (EDIS) at http:// industry requirement. The Commission edis.usitc.gov. Hearing-impaired has determined that neither MPS, persons are advised that information on ASUS, nor Microsemi have violated this matter can be obtained by section 337, and has terminated the contacting the Commission’s TDD investigation. A Commission opinion terminal on (202) 205–1810. will issue shortly.

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DEPARTMENT OF LABOR I. Background recordkeeping provisions for 30 CFR Section 317(c) of the Federal Mine 75.1702 and 75.1702–1 Safety Standards Mine Safety and Health Administration Safety and Health Act of 1977 (Mine for Underground Coal Mines-Smoking, Prohibition and Smoking Programs. Proposed Information Collection Act), 30 U.S.C. 877(c), and 30 CFR 75.1702 prohibit persons from smoking While there is no specific requirement Request Submitted for Public that records be maintained for more Comment and Recommendations; or carrying smoking materials underground or in places where there is than three years, all underground coal Program To Prevent Smoking mines must have an approved program Underground and in Hazardous a fire or explosion hazard. Under the Mine Act and § 75.1702, coal mine for searching miners for smoking Surface Areas (Pertains to materials in effect during the entire time Underground Coal Mines) operators are required to develop programs to prevent persons from they are operating. MSHA requires this program as one of the preliminary plans ACTION: Notice. carrying smoking materials, matches, or lighters underground and to prevent which must be submitted for approval smoking in hazardous areas, such as in in accordance with 30 CFR SUMMARY: The Department of Labor, as 75.1721(b)(9) prior to commencing the part of its continuing effort to reduce or around oil houses, explosives magazines, etc. Section 75.1702–1 extraction of coal (30 CFR 75.1721— paperwork and respondent burden, Opening of new underground coal conducts a pre-clearance consultation requires that the mine operator submit the program for searching miners for mines, or reopening and reactivating of program to provide the general public abandoned or deactivated coal mines, and Federal agencies with an smoking materials to MSHA for approval. The purpose of the program is notification by the operator; opportunity to comment on proposed requirements). Once submitted and and/or continuing collections of to ensure that a fire or explosion hazard does not occur. Section 103(h) of the approved, revisions to the revised information in accordance with the approved plan is only required where Paperwork Reduction Act of 1995 Mine Act, 30 U.S.C. 813, authorizes MSHA to collect information necessary the mine ownership changes or the (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This smoker search plan proves to be program helps to ensure that requested to carry out its duty in protecting the safety and health of miners. inadequate to prevent the carrying of data can be provided in the desired smoking articles underground. This format, reporting burden (time and II. Desired Focus of Comments collection of information is otherwise financial resources) is minimized, consistent with the guidelines in 5 CFR collection instruments are clearly MSHA is particularly interested in comments that: 1320.5. MSHA does not intend to understood, and the impact of collection • publish the results of this information requirements on respondents can be Evaluate whether the proposed collection of information is necessary collection and there are no forms properly assessed. Currently, the Mine associated with this information Safety and Health Administration for the proper performance of the functions of the agency, including collection on which to display the OMB (MSHA) is soliciting comments number and expiration date. concerning the extension of the whether the information will have There are no certification exceptions information collection related to the 30 practical utility; • identified with this information CFR 75.1702 and 75.1702–1. Evaluate the accuracy of the agency’s estimate of the burden of the collection and the collection of this DATES: All comments must be received proposed collection of information, information does not employ statistical by midnight Eastern Daylight Savings including the validity of the methods. Time on August 23, 2010. methodology and assumptions used; Type of Review: Extension. ADDRESSES: Comments must clearly be • Enhance the quality, utility, and Agency: Mine Safety and Health identified with the rule title and may be clarity of the information to be Administration. submitted to MSHA by any of the collected; and OMB Number: 1219–0041. • following methods: Minimize the burden of the Frequency: On Occasion. collection of information on those who (1) Electronic mail: zzMSH- Affected Public: Business or other for- are to respond, including through the [email protected]. profit. use of appropriate automated, (2) Facsimile: (202) 693–9441. electronic, mechanical, or other Cost to Federal Government: (3) Regular Mail: MSHA, Office of technological collection techniques or $2,425.68. Standards, Regulations, and Variances, other forms of information technology, Total Burden Respondents: 144. 1100 Wilson Blvd., Room 2350, e.g., permitting electronic submissions Total Number of Responses: 144. Arlington, VA 22209–3939. of responses. Total Burden Hours: 72. (4) Hand Delivery or Courier: MSHA, A copy of the proposed information Total Hour Burden Cost (operating/ Office of Standards, Regulations, and collection request can be obtained by maintaining): $6,098.40 Variances, 1100 Wilson Blvd., Room contacting the employee listed in the Comments submitted in response to 2350, Arlington, VA 22209–3939. Sign FOR FURTHER INFORMATION CONTACT this notice will be summarized and/or in at the receptionist’s desk on the 21st section of this notice, or viewed on the included in the request for Office of floor. Internet by selecting ‘‘Rules & Reg’’, and Management and Budget approval of the FOR FURTHER INFORMATION CONTACT: then selecting ‘‘FedReg.Docs’’. On the information collection request; they will Mario Distasio, Chief of the Economic next screen, select ‘‘Paperwork also become a matter of public record. Analysis Division, Office of Standards, Reduction Act Supporting Statement’’ to view documents supporting the Federal Dated June 18, 2010. Regulations, and Variances, MSHA, at Patricia W. Silvey, [email protected] (e-mail), 202– Register Notice. Director, Office of Standards, and 693–9445 (voicemail), 202–693–9441 III. Current Actions Regulations, and Variances. (facsimile). This request for collection of [FR Doc. 2010–15269 Filed 6–23–10; 8:45 am] SUPPLEMENTARY INFORMATION: information contains notification and BILLING CODE 4510–43–P

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DEPARTMENT OF LABOR I. Background • 75.352(a) and 75.352(b) require the The Safety Standards for designated AMS operator or other Mine Safety and Health Administration Underground Coal Mine Ventilation appropriate personnel to take actions Belt Entry rule provides safety promptly when malfunction, alert, or Proposed Information Collection alarm signals are received. Request Submitted for Public requirements for the use of the conveyor Comment and Recommendations; belt entry as a ventilation intake to II. Desired Focus of Comments course fresh air to working sections and Safety Standards for Underground MSHA is particularly interested in areas where mechanized mining Coal Mine Ventilation—Belt Entry Used comments that: as an Intake Air Course To Ventilate equipment is being installed or removed • Evaluate whether the proposed Working Sections and Areas Where in mines with three or more entries. collection of information is necessary Mechanized Mining Equipment Is This rule establishes additional for the proper performance of the Being Installed or Removed protective provisions that mine functions of the agency, including operators must follow if they want to whether the information will have ACTION: Notice. use belt air to ventilate working practical utility; sections. • Evaluate the accuracy of the SUMMARY: The Department of Labor, as • 75.351(b)(3) requires posting at the agency’s estimate of the burden of the part of its continuing effort to reduce surface location of an up-to-date map or proposed collection of information, paperwork and respondent burden, schematic showing air flow directions including the validity of the conducts a pre-clearance consultation and the location and type of all methodology and assumptions used; program to provide the general public Atmospheric Monitoring System (AMS) • Enhance the quality, utility, and and Federal agencies with an sensors. clarity of the information to be • opportunity to comment on proposed 75.351(n)(1) requires that sensors collected; and and/or continuing collections of used to detect CO or smoke be visually • Minimize the burden of the information in accordance with the examined at least once each shift, when collection of information on those who Paperwork Reduction Act of 1995 belts are operated as part of a are to respond, including through the (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This production shift. If hazardous use of appropriate automated, program helps to ensure that requested conditions are found during the visual electronic, mechanical, or other data can be provided in the desired exam, then a log of such conditions technological collection techniques or format, reporting burden (time and must be filed under existing section other forms of information technology, financial resources) is minimized, 75.363(b)—Hazardous conditions; e.g., permitting electronic submissions collection instruments are clearly posting, correcting and recording (OMB of responses. understood, and the impact of collection approval 1219–0088). A copy of the proposed information • requirements on respondents can be 75.351(n)(2) and 75.351(n)(3) collection request can be obtained by properly assessed. Currently, the Mine require that alarms for AMS be tested contacting the employee listed in the Safety and Health Administration every seven days and that CO, smoke, or FOR FURTHER INFORMATION CONTACT (MSHA) is soliciting comments methane sensors be calibrated, every 31 section of this notice, or viewed on the concerning the extension of the days respectively. Internet by selecting ‘‘Rules & Reg’’, and • information collection related to the 30 75.351(o)(1)(i) requires that a record then selecting ‘‘FedReg.Docs’’. On the CFR 75.350, 75.351, 75.352, 75.371. be made if the AMS emits an alert or next screen, select ‘‘Paperwork DATES: All comments must be received alarm signal. Reduction Act Supporting Statement’’ to • by midnight Eastern Daylight Savings 75.351(o)(1)(ii) requires that, if a view documents supporting the Federal Time on August 23, 2010. malfunction in the system occurs, a Register Notice. ADDRESSES: record be made of the malfunction and Comments must clearly be III. Current Actions identified with the rule title and may be the corrective action to return the system to proper operating condition. This request for collection of submitted to MSHA by any of the • following methods: 75.351(o)(1)(iii) requires that the information contains recordkeeping (1) Electronic mail: zzMSHA- persons doing the weekly test of alert provisions for 30 CFR 75.350, 75.351, [email protected]. and alarm signals, the monthly 75.352, 75.371 Safety Standards for (2) Facsimile: (202) 693–9441. calibration, or maintenance of the Underground Coal Mine Ventilation— (3) Regular Mail: MSHA, Office of system make a record of these tests, Belt Entry Used as an Intake Air Course calibrations, or maintenance. To Ventilate Working Sections and Standards, Regulations, and Variances, • 1100 Wilson Blvd., Room 2350, 75.351(o)(3) requires that all records Areas Where Mechanized Mining Arlington, VA 22209–3939. concerning the AMS be kept in a book Equipment Is Being Installed or (4) Hand Delivery or Courier: MSHA, or electronically in a computer system Removed. MSHA does not intend to Office of Standards, Regulations, and that is secure and not susceptible to publish the results of this information alteration. collection and is not seeking approval to Variances, 1100 Wilson Blvd., Room • 2350, Arlington, VA 22209–3939. Sign 75.351(p) requires the mine not display the expiration date or OMB in at the receptionist’s desk on the 21st operator to keep these records for at approval number for this collection of floor. least one year at a surface location and information. to make them available for inspection by There are no certification exceptions FOR FURTHER INFORMATION CONTACT: authorized representatives of the identified with this information Mario Distasio, Chief of the Economic Secretary and representatives of miners. collection and the collection of this Analysis Division, Office of Standards, • 75.351(q) requires that a record of information does not employ statistical Regulations, and Variances, MSHA, at the annual AMS operator training be methods. [email protected] (e-mail), 202– kept. The record will include the Type of Review: Extension. 693–9445 (voicemail), 202–693–9441 content of training, the person Agency: Mine Safety and Health (facsimile). conducting the training, and the date Administration. SUPPLEMENTARY INFORMATION: the training is conducted. OMB Number: 1219–0138.

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Frequency: On Occasion. (2) Facsimile: (202) 693–9441. FOR FURTHER INFORMATION CONTACT Affected Public: Business or other for- (3) Regular Mail: MSHA, Office of section of this notice, or viewed on the profit. Standards, Regulations, and Variances, Internet by selecting ‘‘Rules & Reg’’, and Cost to Federal Government: No cost 1100 Wilson Blvd., Room 2350, then selecting ‘‘FedReg.Docs’’. On the to Federal Government. Arlington, VA 22209–3939. next screen, select ‘‘Paperwork Total Burden Respondents: 21. (4) Hand Delivery or Courier: MSHA, Reduction Act Supporting Statement’’ to Total Number of Responses: 251. Office of Standards, Regulations, and view documents supporting the Federal Total Burden Hours: 4,255. Variances, 1100 Wilson Blvd., Room Register Notice. Total Hour Burden Cost (operating/ 2350, Arlington, VA 22209–3939. Sign III. Current Actions maintaining): $303,512. in at the receptionist’s desk on the 21st Comments submitted in response to floor. This request for collection of this notice will be summarized and/or FOR FURTHER INFORMATION CONTACT: information contains notification and included in the request for Office of recordkeeping provisions for the Management and Budget approval of the Mario Distasio, Chief of the Economic Analysis Division, Office of Standards, Proposed Information Collection information collection request; they will Request Submitted for Public Comment also become a matter of public record. Regulations, and Variances, MSHA, at [email protected] (e-mail), 202– and Recommendations; Operations Dated: June 18, 2010. 693–9445 (voicemail), 202–693–9441 Under Water (pertains to underground Patricia W. Silvey, (facsimile). coal mines). MSHA does not intend to Director, Office of Standards, and publish the results of this information SUPPLEMENTARY INFORMATION: Regulations, and Variances. collection and is not seeking approval to [FR Doc. 2010–15270 Filed 6–23–10; 8:45 am] I. Background not display the expiration date or OMB BILLING CODE 4510–43–P approval number for this collection of Title 30 CFR 75.1716, 75.1716–1 and information. 75.1716–3 require operators of There are no certification exceptions underground coal mines to provide DEPARTMENT OF LABOR identified with this information MSHA notification before mining under collection and the collection of this Mine Safety and Health Administration bodies of water and to obtain a permit information does not employ statistical to mine under a body of water if, in the methods. Proposed Information Collection judgment of the Secretary, it is Type of Review: Extension. Request Submitted for Public sufficiently large to constitute a hazard Agency: Mine Safety and Health Comment and Recommendations; to miners. The regulation is necessary to Administration. Operations Under Water (Pertains to prevent the inundation of underground OMB Number: 1219–0020. Underground Coal Mines) coal mines with water which has the Frequency: On Occasion. potential of drowning miners. Section Affected Public: Business or other for- ACTION: Notice. 103(h) of the Mine Act, 30 U.S.C. 813, profit. authorizes MSHA to collect information Cost to Federal Government: $45,862. SUMMARY: The Department of Labor, as necessary to carryout its duty in Total Burden Respondents: 80. part of its continuing effort to reduce protecting the safety and health of Total Number of Responses: 80. paperwork and respondent burden, miners. Total Burden Hours: 400. conducts a pre-clearance consultation Total Hour Burden Cost (operating/ program to provide the general public II. Desired Focus of Comments maintaining): $33,880. and Federal agencies with an MSHA is particularly interested in Comments submitted in response to opportunity to comment on proposed comments that: this notice will be summarized and/or and/or continuing collections of • Evaluate whether the proposed included in the request for Office of information in accordance with the collection of information is necessary Management and Budget approval of the Paperwork Reduction Act of 1995 for the proper performance of the information collection request; they will (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This functions of the agency, including also become a matter of public record. program helps to ensure that requested whether the information will have Dated: June 18, 2010. data can be provided in the desired practical utility; Patricia W. Silvey, format, reporting burden (time and • Evaluate the accuracy of the financial resources) is minimized, agency’s estimate of the burden of the Director, Office of Standards, and Regulations, and Variances. collection instruments are clearly proposed collection of information, understood, and the impact of collection including the validity of the [FR Doc. 2010–15271 Filed 6–23–10; 8:45 am] requirements on respondents can be methodology and assumptions used; BILLING CODE 4510–43–P properly assessed. Currently, the Mine • Enhance the quality, utility, and Safety and Health Administration clarity of the information to be (MSHA) is soliciting comments collected; and NATIONAL ARCHIVES AND RECORDS concerning the extension of the • Minimize the burden of the ADMINISTRATION information collection related to the 30 collection of information on those who Agency Information Collection CFR 75.1716, 75.1716–1 and 75.1716–3. are to respond, including through the Activities: Proposed Collection; DATES: All comments must be received use of appropriate automated, Comment Request by midnight Eastern Daylight Savings electronic, mechanical, or other Time on August 23, 2010. technological collection techniques or AGENCY: National Archives and Records ADDRESSES: Comments must clearly be other forms of information technology, Administration (NARA). identified with the rule title and may be e.g., permitting electronic submissions ACTION: Notice. submitted to MSHA by any of the of responses. following methods: A copy of the proposed information SUMMARY: NARA is giving public notice (1) Electronic mail: zzMSHA- collection request can be obtained by that the agency proposes to request use [email protected]. contacting the employee listed in the of two forms to obtain authorization

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from customers of the Office of Not-for-profit institutions, and Federal agency’s estimate of burden including Government Information Services Government. the validity of the methodology and (OGIS) to make inquiries on their behalf Estimated number of respondents: assumptions used; (c) ways to enhance and to release information and records 600. the quality, utility and clarity of the related to their Freedom of Information Estimated time per response: 1 information to be collected; (d) ways to Act/Privacy Act requests/appeals. The minute. minimize the burden of the collection of public is invited to comment on the Frequency of response: On occasion. information on those who are to proposed information collection Estimated total annual burden hours: respond, including through the use of pursuant to the Paperwork Reduction 10 hours. appropriate automated, electronic, Act of 1995. Abstract: In order to fulfill its mechanical, or other technological DATES: Written comments must be government-wide statutory mission, collection techniques or other forms of received on or before August 23, 2010 OGIS provides varying types of information technology should be to be assured of consideration. assistance to its customers, which addressed to: Office of Information and requires communicating with Regulatory Affairs of OMB, Attention: ADDRESSES: Comments should be sent government departments and agencies Desk Officer for National Science to: Paperwork Reduction Act Comments regarding the customer’s FOIA/Privacy Foundation, 725—17th Street, NW., (NHP), Room 4400, National Archives Act request/appeal. Handling requests Room 10235, Washington, DC 20503, and Records Administration, 8601 for OGIS assistance must conform to the and to Suzanne H. Plimpton, Reports Adelphi Rd., College Park, MD 20740– legal requirements of the Freedom of Clearance Officer, National Science 6001; or faxed to 301–713–7409; or Information Act (FOIA) and the Privacy Foundation, 4201 Wilson Boulevard, electronically mailed to Act of 1974. Authority for the Suite 295, Arlington, Virginia 22230 or [email protected]. requirements set forth in these forms is send e-mail to [email protected]. FOR FURTHER INFORMATION CONTACT: also contained in 5 U.S.C. 552a(b). OGIS Comments regarding these information Requests for additional information or will use the information submitted in collections are best assured of having copies of the proposed information the proposed forms to provide the their full effect if received within 30 collection and supporting statement requested assistance. Without the days of this notification. Copies of the should be directed to Tamee Fechhelm information submitted in these forms, submission(s) may be obtained by at telephone number 301–837–1694, or OGIS would be unable to fulfill its calling 703–292–7556. fax number 301–713–7409. mission. NSF may not conduct or sponsor a SUPPLEMENTARY INFORMATION: Pursuant Dated: June 21, 2010. collection of information unless the to the Paperwork Reduction Act of 1995 Martha Morphy, collection of information displays a currently valid OMB control number (Pub. L. 104–13), NARA invites the Assistant Archivist for Information Services. general public and other Federal and the agency informs potential [FR Doc. 2010–15446 Filed 6–23–10; 8:45 am] agencies to comment on proposed persons who are to respond to the information collections. The comments BILLING CODE 7515–01–P collection of information that such and suggestions should address one or persons are not required to respond to more of the following points: (a) the collection of information unless it Whether the proposed information NATIONAL SCIENCE FOUNDATION displays a currently valid OMB control collection is necessary for the proper number. Under OMB regulations, NSF Agency Information Collection performance of the functions of NARA; may continue to conduct or sponsor the Activities: Comment Request (b) the accuracy of NARA’s estimate of collection of information while this the burden of the proposed information AGENCY: National Science Foundation. submission is pending at OMB. collection; (c) ways to enhance the ACTION: Submission for OMB review; SUPPLEMENTARY INFORMATION: quality, utility, and clarity of the comment request. Title: Antarctic Conservation Act information to be collected; and (d) Application and Permit Form. ways to minimize the burden of the SUMMARY: The National Science OMB Control Number: 3145–0034. collection of information on Foundation (NSF) has submitted the Proposed Project: The current respondents, including the use of following information collection Antarctic Conservation Act Application information technology; and (e) whether requirement to OMB for review and Permit Form (NSF 1078) has been in use small businesses are affected by this clearance under the Paperwork for several years. The form requests collection. The comments that are Reduction Act of 1995, Public Law 104– general information, such as name, submitted will be summarized and 13. This is the second notice for public affiliation, location, etc., and more included in the NARA request for Office comment; the first was published in the specific information as to the type of of Management and Budget (OMB) Federal Register at 75 FR 18240, and no object to be taken (plant, native approval. All comments will become a substantial comments were received. mammal, or native bird). matter of public record. In this notice, NSF is forwarding the proposed renewal Use of the Information: The purpose NARA is soliciting comments submission to the Office of Management of the regulations (45 CFR part 670) is concerning the following information and Budget (OMB) for clearance to conserve and protect the native collection: simultaneously with the publication of mammals, birds, plants, and Title: Freedom of Information Act this second notice. The full submission invertebrates of Antarctica and the (FOIA) Request for Assistance and may be found at: http:// ecosystem upon which they depend and Consent. www.reginfo.gov/public/do/PRAMain. to implement the Antarctic OMB number: 3095–00XX. Comments regarding (a) Whether the Conservation Act of 1978, Public Law Agency form number: NA Forms collection of information is necessary 95–541, as amended by the Antarctic 10003 and 10004. for the proper performance of the Science, Tourism, and Conservation Act Type of review: Regular. functions of the agency, including of 1996, Public Law 104–227. Affected public: Individuals or whether the information will have Burden on the Public: The Foundation households, Business or other for-profit, practical utility; (b) the accuracy of the estimates about 25 responses annually

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at 1⁄2 hour per response; this computes The NRC requests that any party a more objective, predictable, and to approximately 12.5 hours annually. soliciting or aggregating comments transparent process for licensees and Dated: June 21, 2010. received from other persons for members of the general public. To meet these objectives, the NRC staff is Suzanne H. Plimpton, submission to the NRC inform those persons that the NRC will not edit their undertaking a comprehensive effort to Reports Clearance Officer, National Science develop a Construction Reactor Foundation. comments to remove any identifying or contact information, and therefore, they Oversight Process using risk-informed [FR Doc. 2010–15347 Filed 6–23–10; 8:45 am] should not include any information in and performance based tools. The NRC BILLING CODE 7555–01–P their comments that they do not want staff’s efforts will be consistent with the publicly disclosed. recent Commission guidance in this Federal Rulemaking Web site: Go to area, notably the guidance provided in NUCLEAR REGULATORY http://www.regulations.gov and search the Staff Requirements Memoranda COMMISSION for documents filed under Docket ID (M081022) dated December 5, 2008 [NRC–2010–0230] NRC–2010–0230. Address questions (Agencywide Documents Access and about NRC dockets to Carol Gallagher Management System [ADAMS] Construction Reactor Oversight 301–492–3668; e-mail Accession No. ML083400193). Process Request for Public Comment [email protected]. In SECY–09–0113, ‘‘Update on the Mail comments to: Cindy Bladey, Development of Construction AGENCY: Nuclear Regulatory Chief, Rules, Announcements and Assessment Process Policy Options and Commission. Directives Branch (RADB), Division of the Construction Inspection Program ACTION: Notice of opportunity for public Administrative Services, Office of Information Management System,’’ comment. Administration, Mail Stop: TWB–05– dated August 14, 2009 (Agencywide B01M, U.S. Nuclear Regulatory Documents Access and Management SUMMARY: The U.S. Nuclear Regulatory Commission, Washington, DC 20555– System Accession No. ML091970152), Commission (NRC) staff is reconsidering 0001, or by fax to RADB at (301) 492– the NRC staff updated the Commission the Construction Reactor Oversight 3446. on the development of construction Process (cROP), including the You can access publicly available assessment process policy options. construction assessment process, as documents related to this notice using Following the issuance of SECY–09– presented in IMC 2505, ‘‘Periodic the following methods: 0113, the staff formed a cROP team in Assessment of Construction Inspection NRC’s Public Document Room (PDR): December 2009 with representatives Program Results,’’ in order to propose The public may examine and have from each regional office, the Office of policy options to the Commission to copied for a fee publicly available Nuclear Reactor Regulation, the Office revise the oversight process. The staff documents at the NRC’s PDR, Public of Nuclear Security and Incident proposal will include program oversight File Area O1 F21, One White Flint Response, and the Office of New currently included as part of the North, 11555 Rockville Pike, Rockville, Reactors. Team members offer a cross Inspections, Tests, Analyses, and Maryland. section of experience including Acceptance Criteria (ITAAC) monitoring NRC’s Agencywide Documents Access personnel with extensive experience in and closure processes, and evaluate the and Management System (ADAMS): developing and implementing the ROP. inclusion of objective performance Publicly available documents created or Through public workshops and monitoring elements such as received at the NRC are available stakeholder interactions, the cROP team construction program Performance electronically at the NRC’s Electronic is developing options for a cROP with Indicators (PIs) and a Significance Reading Room at http://www.nrc.gov/ elements similar to those used in the Determination Process (SDP) analogous reading-rm/adams.html. From this page, ROP. Specifically, the team is to those used in the Reactor Oversight the public can gain entry into ADAMS, identifying the objectives, attributes, Process (ROP) for the current operating which provides text and image files of and activities that a construction reactor fleet. NRC’s public documents. If you do not oversight process would need to DATES: The comment period expires have access to ADAMS or if there are adequately and objectively assess August 9, 2010. Comments received problems in accessing the documents licensee performance, as well as the after this date will be considered if it is located in ADAMS, contact the NRC’s sources of information necessary to practical to do so, but the Commission PDR reference staff at 1–800–397–4209, support the assessment. These attributes is able to ensure consideration only for 301–415–4737, or by e-mail to include the application of thresholds to comments received on or before this [email protected]. determine the significance of findings, a date. viable means to ensure appropriate NRC FOR FURTHER INFORMATION CONTACT: response to degrading licensee ADDRESSES: You may submit comments Kevin Mattern, Division of Construction performance, and the assessment of by any one of the following methods. Inspection and Operational Programs, licensee safety culture. Please include Docket ID NRC–2010– U.S. Nuclear Regulatory Commission, In SECY–10–0038, ‘‘Update Status on 0230 in the subject line of your Two White Flint North, 11545 Rockville the Development of Construction comments. Comments submitted in Pike, Rockville, MD 20852–2738. Reactor Oversight Process Options,’’ writing or in electronic form will be Telephone: (301) 415–6622 or (301) dated April 2, 2010 (Agencywide posted on the NRC Web site and on the 415–1395; Fax (301) 415–5400; E-mail: Documents Access and Management Federal rulemaking Web site [email protected]. System Accession No. ML100550490), Regulations.gov. Because your SUPPLEMENTARY INFORMATION: NRC staff the NRC staff provided the Commission comments will not be edited to remove are currently developing options and a with an additional update on staff’s any identifying or contact information, recommendation to the Commission for progress toward the development of the NRC cautions you against including a revised oversight process for new construction oversight process options any information in your submission that reactor construction with the objective for Commission consideration. you do not want to be publicly of developing a risk-informed and In order to ensure all stakeholder disclosed. performance based process, resulting in input is considered during development

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of options for revising the cROP, NRC End of Questions activities associated with the review of staff is seeking public comment and Documents may be examined, and/or amendment applications and review of feedback on the specific topics copied for a fee, at the NRC’s Public design certification and combined highlighted in the questions below. In Document Room at One White Flint license applications for the Office of providing comments, each commenter’s North, 11555 Rockville Pike (first floor), New Reactors. The NRC staff intends to response should reference the number Rockville, Maryland. Publicly available incorporate the final approved guidance of the applicable question. Comments records will be accessible electronically into the next revision of NUREG–0800, should be as specific as possible and from the ADAMS Public Electronic SRP Section 13.6.2, Revision 1 and should indicate why a commenter Reading Room on the Internet at the Regulatory Guide 1.206, ‘‘Combined supports or does not support an aspect NRC Web site, http://www.nrc.gov/NRC/ License Applications for Nuclear Power of this plan. The use of examples is ADAMS/index.html. If you do not have Plants (LWR Edition),’’ June 2007. encouraged. access to ADAMS or if you have DATES: Comments must be filed no later (1) The staff has developed a draft of problems accessing the documents in than 30 days from the date of a new cROP regulatory framework, ADAMS, contact the NRC Public publication of this notice in the Federal including cornerstone objectives, Document Room (PDR) reference staff at Register. Comments received after this attributes and areas to measure (ADAMS 1–800–397–4209 or 301–415–4737 or by date will be considered, if it is practical Accession Nos. ML101050249; e-mail to [email protected]. to do so, but the Commission is able to ML101050247). Are there important Dated at Rockville, Maryland this 16th day ensure consideration only for comments aspects of new reactor construction of June 2010. received on or before this date. licensee performance that are not For the Nuclear Regulatory Commission. ADDRESSES: You may submit comments captured by the draft cROP regulatory Mohammed Shuaibi, by any one of the following methods. framework? Acting Deputy Director, Division of Please include Docket ID NRC–2010– (2) Is there a role for construction Construction Inspection & Operational 0222 in the subject line of your performance indicators as an input into Programs, Office of New Reactors. comments. Comments submitted in the assessment of licensee construction [FR Doc. 2010–15321 Filed 6–23–10; 8:45 am] writing or in electronic form will be activities? If so, what aspects of licensee BILLING CODE 7590–01–P posted on the NRC website and on the activities during construction could be Federal rulemaking Web site at http:// objectively measured by a PI? What www.regulations.gov. Because your should be considered in determining NUCLEAR REGULATORY comments will not be edited to remove performance indicators and their COMMISSION any identifying or contact information, thresholds? the NRC cautions you against including [NRC–2010–0222] (3) In the ROP, inspection findings are any information in your submission that evaluated and given a color designation Office of New Reactors; Proposed you do not want to be publicly based on their safety significance using Revision to Standard Review Plan, disclosed. a risk-informed approach (the Section 13.6.2, Revision 1 on Physical The NRC requests that any party Significance Determination Process). Security—Design Certification soliciting or aggregating comments What processes could be used to received from other persons for AGENCY: Nuclear Regulatory effectively and efficiently evaluate the submission to the NRC inform those Commission (NRC). safety significance of construction persons that the NRC will not edit their inspection findings? ACTION: Solicitation of public comment. comments to remove any identifying or contact information, and therefore, they (4) For the cROP, the staff intends to SUMMARY: The NRC is soliciting public should not include any information in use a Construction Action Matrix comment on NUREG–0800, ‘‘Standard their comments that they do not want similar to the ROP to assess licensee Review Plan for the Review of Safety publicly disclosed. performance. Is there a more effective Analysis Reports for Nuclear Power and efficient alternative approach that Plants,’’ on a proposed Revision 1 to Federal Rulemaking Web site: Go to could be taken? If not, what inputs Standard Review Plan (SRP), Section http://www.regulations.gov and search should be considered in the 13.6.2 on ‘‘Physical Security—Design for documents filed under Docket ID Construction Action Matrix? Certification,’’ (Agencywide Documents NRC–2010–0222. Address questions Access and Management System about NRC dockets to Carol Gallagher (5) In the ROP, the NRC currently 301–492–3668; e-mail at assigns safety culture component (ADAMS) Accession No. ML100640121). The Office of Nuclear [email protected]. aspects to findings when appropriate. Mail comments to: Cindy Bladey, Substantive cross-cutting issues are Security and Incident Response is revising SRP Section 13.6.2, which Chief, Rulemaking, Announcements and identified when certain thresholds are Directives Branch (RADB), Division of crossed. Should the NRC treat findings updates the initial issuance of this section, dated March 2007, to reflect the Administrative Services, Office of in a similar manner in the construction Administration, Mail Stop: TWB–05– environment? changes of the recently issued Title 10 of the Code of Federal Regulations, part B01M, U.S. Nuclear Regulatory (6) When is the appropriate time to 73, Power Reactor Security Rule Commission, Washington, DC 20555– transition from the cROP to the ROP? (published in the Federal Register (FR) 0001, or by fax to RDB at 301–492–3446. What is the basis for this proposed on March 27, 2009 (74 FR 13926). The You can access publicly available transition point? previous version of this SRP section was documents related to this notice using (7) In addition to the previously published in March 2007 as initial the following methods: mentioned issues, commenters are issuance (ADAMS Accession No. NRC’s Public Document Room (PDR): invited to give any other views on the ML070720289). The public may examine and have NRC assessment process that could The NRC staff issues notices to copied for a fee publicly available assist the NRC in improving its facilitate timely implementation of the documents at the NRC’s PDR, Public effectiveness. current staff guidance and to facilitate File Area O1 F21, One White Flint

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North, 11555 Rockville Pike, Rockville, updates the initial issuance of this Administrative Services, Office of Maryland. section, dated March 2007, to reflect the Administration, Mail Stop: TWB–05– The NRC ADAMS provides text and changes of the recently issued Title 10 B01M, U.S. Nuclear Regulatory image files of NRC’s public documents. of the Code of Federal Regulations, part Commission, Washington, DC 20555– These documents may be accessed 73, Power Reactor Security Rule 0001, or by fax to RADB at 301–492– through the NRC’s Public Electronic (published in the Federal Register (FR) 3446. Reading Room on the Internet at on March 27, 2009 (74 FR 13926). The You can access publicly available http://www.nrc.gov/reading-rm/ previous version of this SRP section was documents related to this notice using adams.html. Persons who do not have published in March 2007 as initial the following methods: access to ADAMS, or who encounter issuance (ADAMS Accession No. NRC’s Public Document Room (PDR): problems in accessing the documents ML070720310). The public may examine and have located in ADAMS, should contact the The NRC staff issues notices to copied for a fee publicly available NRC Public Document Room reference facilitate timely implementation of the documents at the NRC’s PDR, Room O1 staff at 1–800–397–4209, 301–415–4737, current staff guidance and to facilitate F21, One White Flint North, 11555 or by e-mail at [email protected]. activities associated with the review of Rockville Pike, Rockville, Maryland. The NRC ADAMS provides text and FOR FURTHER INFORMATION CONTACT: Mr. amendment applications and review of image files of NRC’s public documents. William F. Burton, Chief, Rulemaking design certification and combined license applications for the Office of These documents may be accessed and Guidance Development Branch, through the NRC’s Public Electronic Division of New Reactor Licensing, New Reactors. The NRC staff intends to incorporate the final approved guidance Reading Room on the Internet at http:// Office of New Reactors, U.S. Nuclear www.nrc.gov/reading-rm/adams.html. Regulatory Commission, Washington, into the next revision of NUREG–0800, SRP Section 13.6.3, Revision 1 and Persons who do not have access to DC 20555–0001; telephone at 301–415– ADAMS, or who encounter problems in 6332 or e-mail at Regulatory Guide 1.206, ‘‘Combined License Applications for Nuclear Power accessing the documents located in [email protected]. ADAMS, should contact the NRC Public The NRC staff is issuing this notice to Plants (LWR Edition),’’ June 2007. Document Room reference staff at 1– solicit public comments on the DATES: Comments must be filed no later 800–397–4209, 301–415–4737, or by e- proposed SRP Section 13.6.2, Revision than 30 days from the date of mail at [email protected]. 1. After the NRC staff considers any publication of this notice in the Federal FOR FURTHER INFORMATION CONTACT: public comments, it will make a Register. Comments received after this Mr. determination regarding the proposed date will be considered, if it is practical William F. Burton, Chief, Rulemaking SRP Section 13.6.2, Revision 1. to do so, but the Commission is able to and Guidance Development Branch, Division of New Reactor Licensing, Dated at Rockville, Maryland, this 15th day ensure consideration only for comments received on or before this date. Office of New Reactors, U.S. Nuclear of June 2010. Regulatory Commission, Washington, ADDRESSES: For the Nuclear Regulatory Commission. You may submit comments DC 20555–0001; telephone at 301–415– William F. Burton, by any one of the following methods. 6332 or e-mail at Chief, Rulemaking and Guidance Please include Docket ID NRC–2010– [email protected]. Development Branch, Division of New Reactor 0223 in the subject line of your The NRC staff is issuing this notice to Licensing, Office of New Reactors. comments. Comments submitted in solicit public comments on the [FR Doc. 2010–15316 Filed 6–23–10; 8:45 am] writing or in electronic form will be proposed SRP Section 13.6.3, Revision BILLING CODE 7590–01–P posted on the NRC Web site and on the 1. After the NRC staff considers any Federal rulemaking Web site at http:// public comments, it will make a www.regulations.gov. Because your determination regarding the proposed NUCLEAR REGULATORY comments will not be edited to remove SRP Section 13.6.3, Revision 1. COMMISSION any identifying or contact information, the NRC cautions you against including Dated at Rockville, Maryland, this 15th day of June 2010. [NRC–2010–0223] any information in your submission that you do not want to be publicly For the Nuclear Regulatory Commission. Office of New Reactors; Proposed William F. Burton, Revision to Standard Review Plan disclosed. The NRC requests that any party Chief, Rulemaking and Guidance Section 13.6.3, Revision 1 on Physical Development Branch, Division of New Reactor Security—Early Site Permit soliciting or aggregating comments received from other persons for Licensing, Office of New Reactors. AGENCY: Nuclear Regulatory submission to the NRC inform those [FR Doc. 2010–15319 Filed 6–23–10; 8:45 am] Commission (NRC). persons that the NRC will not edit their BILLING CODE 7590–01–P ACTION: Solicitation of public comment. comments to remove any identifying or contact information, and therefore, they NUCLEAR REGULATORY SUMMARY: The NRC is soliciting public should not include any information in COMMISSION comment on NUREG–0800, ‘‘Standard their comments that they do not want Review Plan for the Review of Safety publicly disclosed. [NRC–2010–0228] Analysis Reports for Nuclear Power Federal Rulemaking Web site: Go to Plants,’’ on a proposed Revision 1 to http://www.regulations.gov and search Office of New Reactors; Proposed Standard Review Plan (SRP), Section for documents filed under Docket ID Revision to Standard Review Plan 13.6.3 on ‘‘Physical Security—Early Site NRC–2010–0223. Address questions Section 13.6.1, Revision 1 on Physical Permit,’’ (Agencywide Documents about NRC dockets to Carol Gallagher at Security—Combined License and Access and Management System 301–492–3668; e-mail at Operating Reactors (ADAMS) Accession No. [email protected]. AGENCY: Nuclear Regulatory ML100980132). The Office of Nuclear Mail comments to: Cindy Bladey, Commission (NRC). Security and Incident Response is Chief, Rulemaking, Announcements and ACTION: Solicitation of public comment. revising SRP Section 13.6.3, which Directives Branch (RADB), Division of

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SUMMARY: The NRC is soliciting public should not include any information in PENSION BENEFIT GUARANTY comment on NUREG–0800, ‘‘Standard their comments that they do not want CORPORATION Review Plan for the Review of Safety publicly disclosed. Analysis Reports for Nuclear Power Federal Rulemaking Web site: Go to Proposed Submission of Information Plants,’’ on a proposed Revision 1 to http://www.regulations.gov and search Collection for OMB Review; Comment Standard Review Plan (SRP), Section for documents filed under Docket ID Request; Annual Reporting and 13.6.1 on ‘‘Physical Security—Combined NRC–2010–0228. Address questions Disclosure License and Operating Reactors,’’ about NRC dockets to Carol Gallagher at AGENCY: Pension Benefit Guaranty (Agencywide Documents Access and 301–492–3668; e-mail at Corporation. Management System (ADAMS) [email protected]. ACTION: Notice of intention to request Accession No. ML100350158). The Mail comments to: Cindy Bladey, Office of Nuclear Security and Incident extension of OMB approval of revised Chief, Rulemaking, Announcements and collection of information. Response is revising SRP Section 13.6.1, Directives Branch (RADB), Division of which updates the initial issuance of Administrative Services, Office of SUMMARY: The Pension Benefit Guaranty this section, dated March 2007, to Administration, Mail Stop: TWB–05– Corporation (PBGC) intends to request reflect the changes of the recently issued B01M, U.S. Nuclear Regulatory that the Office of Management and Title 10 of the Code of Federal Commission, Washington, DC 20555– Budget (OMB) extend approval, under Regulations, part 73, Power Reactor 0001, or by fax to RADB at 301–492– the Paperwork Reduction Act, of its Security Rule (published in the Federal 3446. collection of information for annual Register (FR) on March 27, 2009 (74 FR You can access publicly available reporting and disclosure under 29 CFR 13926). The previous version of this Part 2520 (OMB control number 1212– SRP section was published in March documents related to this notice using the following methods: 0057, expires September 30, 2010), 2007 as initial issuance (ADAMS without change. This notice informs the NRC’s Public Document Room (PDR): Accession No. ML070720094). public of PBGC’s intent and solicits The public may examine and have The NRC staff issues notices to public comment on the collection of copied for a fee publicly available facilitate timely implementation of the information. current staff guidance and to facilitate documents at the NRC’s PDR, Room O1 activities associated with the review of F21, One White Flint North, 11555 DATES: Comments must be submitted by amendment applications and review of Rockville Pike, Rockville, Maryland. August 23, 2010. design certification and combined The NRC ADAMS provides text and ADDRESSES: Comments may be license applications for the Office of image files of NRC’s public documents. submitted by any of the following New Reactors. The NRC staff intends to These documents may be accessed methods: incorporate the final approved guidance through the NRC’s Public Electronic • Federal eRulemaking Portal: http:// into the next revision of NUREG–0800, Reading Room on the Internet at http:// www.regulations.gov. Follow the Web SRP Section 13.6.1, Revision 1 and www.nrc.gov/reading-rm/adams.html. site instructions for submitting Regulatory Guide 1.206, ‘‘Combined Persons who do not have access to comments. License Applications for Nuclear Power ADAMS, or who encounter problems in • E-mail: [email protected]. Plants (LWR Edition),’’ June 2007. accessing the documents located in • Fax: 202–326–4224. • DATES: Comments must be filed no later ADAMS, should contact the NRC Public Mail or Hand Delivery: Legislative than 30 days from the date of Document Room reference staff at 1– and Regulatory Department, Pension publication of this notice in the FR. 800–397–4209, 301–415–4737, or by e- Benefit Guaranty Corporation, 1200 K Comments received after this date will mail at [email protected]. Street, NW., Washington, DC 20005– 4026. be considered, if it is practical to do so, FOR FURTHER INFORMATION CONTACT: Mr. but the Commission is able to ensure Comments received, including William F. Burton, Chief, Rulemaking personal information provided, will be consideration only for comments and Guidance Development Branch, received on or before this date. posted to http://www.pbgc.gov. Division of New Reactor Licensing, Copies of the collection of ADDRESSES: You may submit comments Office of New Reactors, U.S. Nuclear information and comments may be by any one of the following methods. Regulatory Commission, Washington, Please include Docket ID NRC–2010– obtained without charge by writing to DC 20555–0001; telephone at 301–415– the Disclosure Division, Office of 0228 in the subject line of your 6332 or e-mail at comments. Comments submitted in General Counsel, at the above address or [email protected]. by visiting the Disclosure Division or writing or in electronic form will be The NRC staff is issuing this notice to posted on the NRC Web site and on the calling 202–326–4040 during normal solicit public comments on the business hours. (TTY/TDD users may Federal rulemaking Web site at http:// proposed SRP Section 13.6.1, Revision www.regulations.gov. Because your call the Federal relay service toll-free at 1. After the NRC staff considers any 1–800–877–8339 and ask to be comments will not be edited to remove public comments, it will make a any identifying or contact information, connected to 202–326–4040.) determination regarding the proposed FOR FURTHER INFORMATION CONTACT: the NRC cautions you against including SRP Section 13.6.1, Revision 1. any information in your submission that Grace Kraemer, Attorney, Legislative you do not want to be publicly Dated at Rockville, Maryland, this 15th day and Regulatory Department, Pension disclosed. of June 2010. Benefit Guaranty Corporation, 1200 K The NRC requests that any party For the Nuclear Regulatory Commission, Street, NW., Washington, DC 20005– soliciting or aggregating comments William F. Burton, 4026; 202–326–4024. (TTY/TDD users received from other persons for Chief, Rulemaking and Guidance may call the Federal relay service toll- submission to the NRC inform those Development Branch, Division of New Reactor free at 1–800–877–8339 and ask to be persons that the NRC will not edit their Licensing, Office of New Reactors. connected to 202–326–4024.) comments to remove any identifying or [FR Doc. 2010–15323 Filed 6–23–10; 8:45 am] SUPPLEMENTARY INFORMATION: The contact information, and therefore, they BILLING CODE 7590–01–P Employee Retirement Income Security

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Act of 1974 (ERISA) contains three for the proper performance of the SECURITIES AND EXCHANGE separate sets of provisions—in Title I functions of the agency, including COMMISSION (Labor provisions), Title II (Internal whether the information will have [Release No. 34–62314; File No. SR– Revenue Code provisions), and Title IV practical utility; NASDAQ–2010–072] (PBGC provisions)—requiring • Evaluate the accuracy of the administrators of employee benefit agency’s estimate of the burden of the Self-Regulatory Organizations; Notice pension and welfare plans (collectively proposed collection of information, of Filing and Immediate Effectiveness referred to as employee benefit plans) to including the validity of the of a Proposed Rule Change by The file returns or reports annually with the methodologies and assumptions used; NASDAQ Stock Market LLC To Clarify federal government. • the Applicable Time Period of Trading Since enactment of ERISA, PBGC, the Enhance the quality, utility, and clarity of the information to be Pauses on Trading Days With an Early Department of Labor (DOL), and the Scheduled Close Internal Revenue Service (IRS) collected; and (collectively, the Agencies), have • Minimize the burden of the June 17, 2010. worked together (under DOL’s collection of information on those who Pursuant to Section 19(b)(1) of the leadership) to produce the Form 5500 are to respond, including through the Securities Exchange Act of 1934 Annual Return/Report, through which use of appropriate automated, (‘‘Act’’),1 and Rule 19b–4 thereunder,2 the regulated public can satisfy the electronic, mechanical, or other notice is hereby given that on June 14, combined reporting/filing requirements technological collection techniques or 2010, The NASDAQ Stock Market LLC applicable to employee benefit plans. other forms of information technology. (‘‘Nasdaq’’ or ‘‘Exchange’’) filed with the The Form 5500 Series is the primary Issued in Washington, DC, this 21st day of Securities and Exchange Commission source of information concerning the June 2010. (‘‘Commission’’) the proposed rule operation, funding, assets and John H. Hanley, change as described in Items I and II investments of pension and other below, which Items have been prepared employee benefit plans. In addition to Director, Legislative and Regulatory Department, Pension Benefit Guaranty by the Exchange. The Exchange has being an important disclosure document Corporation. designated the proposed rule change as for plan participants and beneficiaries, [FR Doc. 2010–15339 Filed 6–23–10; 8:45 am] constituting a non-controversial rule the Form 5500 is a compliance and BILLING CODE 7709–01–P change under Rule 19b-4(f)(6) under the research tool for the Agencies, and a Act,3 which renders the proposal source of information for use by other effective upon filing with the federal agencies, Congress, and the Commission. The Commission is private sector in assessing employee SECURITIES AND EXCHANGE publishing this notice to solicit benefit, tax, and economic trends and COMMISSION comments on the proposed rule change policies. from interested persons. On November 16, 2007, the Agencies adopted revisions to the Form 5500 [File No. 500–1] I. Self-Regulatory Organization’s Annual Return/Report in order to Statement of the Terms of the Substance Green Energy Resources, Inc.; Order update and streamline the annual of the Proposed Rule Change of Suspension of Trading reporting process in conjunction with The Exchange is filing with the establishing a wholly electronic June 22, 2010. Commission a proposed rule change to processing system for the receipt of the It appears to the Securities and clarify the applicable time period of Form 5500 Annual Return/Reports and Exchange Commission that there is a trading pauses on trading days with an to conform the forms and instructions to lack of current and accurate information early scheduled close. the provisions of the Pension Protection concerning the securities of Green The text of the proposed rule change Act of 2006 (PPA). ‘‘ ’’ is below. Proposed new language is OMB has approved PBGC’s annual Energy Resources, Inc. ( Green Energy ) because of questions regarding the underlined and proposed deletions are reporting and disclosure collection of 4 accuracy of statements by Green Energy in brackets. information (2008–2010 Forms and * * * * * Instructions) under control number in press releases concerning, among 1212–0057 (expires September 30, other things, the company’s 4120. Trading Halts 2010). PBGC intends to request that involvement in the Gulf of Mexico oil spill cleanup effort. (a) Authority To Initiate Trading Halts OMB extend approval of this collection or Pauses of information for three years, without The Commission is of the opinion that change. An agency may not conduct or the public interest and the protection of In circumstances in which Nasdaq sponsor, and a person is not required to investors require a suspension of trading deems it necessary to protect investors respond to, a collection of information in the securities of Green Energy. and the public interest, Nasdaq, unless it displays a currently valid OMB Therefore, it is ordered, pursuant to pursuant to the procedures set forth in control number. Section 12(k) of the Securities Exchange paragraph (c): (1)–(10) No Change. PBGC estimates that it will receive Act of 1934, that trading in the (11) shall, between 9:45 a.m. and 3:35 30,300 Form 5500 and Form 5500–SF securities of the above-listed company is p.m., or in the case of an early filings per year under this collection of suspended for the period from 9:30 a.m. scheduled close, 25 minutes before the information. PBGC further estimates EDT June 22, 2010 through 11:59 p.m. close of trading, immediately pause that the total annual burden of this EDT, on July 6, 2010. collection of information is 1,200 hours By the Commission. 1 and $1,250,000. 15 U.S.C. 78s(b)(1). Elizabeth M. Murphy, 2 17 CFR 240.19b–4. PBGC is soliciting public comments 3 Secretary. 17 CFR 240.19b–4(f)(6). to— 4 • Changes are marked to the rule text that appears Evaluate whether the proposed [FR Doc. 2010–15425 Filed 6–22–10; 4:15 pm] in the electronic manual of NASDAQ found at collection of information is necessary BILLING CODE 8010–01–P http://nasdaqomx.cchwallstreet.com.

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trading for 5 minutes in any Nasdaq- the most significant aspects of such the protection of investors or the public listed security when the price of such statements. interest; (ii) impose any significant security moves 10 percent or more burden on competition; and (iii) become A. Self-Regulatory Organization’s within a 5-minute period. At the end of operative for 30 days from the date on Statement of the Purpose of, and the trading pause, Nasdaq will re-open Statutory Basis for, the Proposed Rule which it was filed, or such shorter time the security using the Halt Cross process Change as the Commission may designate, it has set forth in Nasdaq Rule 4753. In the become effective pursuant to Section event of a significant imbalance at the 1. Purpose 19(b)(3)(A) of the Act 7 and Rule 19b– end of a trading pause, Nasdaq may Nasdaq proposes to clarify the 4(f)(6) thereunder.8 The Exchange has delay the re-opening of a security. applicable time period of trading pauses asked the Commission to waive the 30- Nasdaq will issue a notification if it on trading days with an early scheduled day operative delay so that the proposal cannot resume trading for a reason other close. Under the proposal, trading may become operative upon filing. The than a significant imbalance. pauses on days with an early scheduled Commission notes that the proposed Price moves under this paragraph will close would be initiated no later than 25 rule change clarifies how the Exchange be calculated by changes in each minutes before that close. On trading handles Trading Pauses in the case of an consolidated last-sale price days with an early scheduled close, the early scheduled closing of the Exchange disseminated by a network processor proposal will ensure a minimum pause- which is the same way the other listing over a five minute rolling period free time period before the close exactly markets will handle Trading Pauses measured continuously. Only regular the same as that applicable on trading during an early scheduled closing, and way in-sequence transactions qualify for days with a regular 4 p.m. close. how indications will be published use in calculations of price moves. during all Trading Pauses. The proposed Nasdaq can exclude a transaction price 2. Statutory Basis rule change does not raise any new from use if it concludes that the NASDAQ believes that the proposed substantive issues. For these reasons, transaction price resulted from an rule change is consistent with the the Commission believes that the waiver erroneous trade. provisions of Section 6 of the Act,5 in of the 30-day operative delay is If a trading pause is triggered under general, and with Sections 6(b)(5) of the consistent with the protection of this paragraph, Nasdaq shall Act,6 in particular, in that the proposal investors and the public interest.9 immediately notify the single plan is designed to prevent fraudulent and At any time within 60 days of the processor responsible for consolidation manipulative acts and practices, to filing of the proposed rule change, the of information for the security pursuant promote just and equitable principles of Commission may summarily abrogate to Rule 603 of Regulation NMS under trade, to foster cooperation and such rule change if it appears to the the Securities Exchange Act of 1934. coordination with persons engaged in Commission that such action is If a primary listing market issues an regulating, clearing, settling, processing necessary or appropriate in the public individual stock trading pause, Nasdaq information with respect to, and interest, for the protection of investors, will pause trading in that security until facilitating transactions in securities, to or otherwise in furtherance of the trading has resumed on the primary remove impediments to and perfect the purposes of the Act. listing market or notice has been mechanism of a free and open market IV. Solicitation of Comments received from the primary listing market and a national market system, and, in that trading may resume. If the primary general, to protect investors and the Interested persons are invited to listing market does not reopen within 10 public interest. The Exchange believes submit written data, views, and minutes of notification of a trading that the proposed rule meets these arguments concerning the foregoing, pause, Nasdaq may resume trading the requirements in that it promotes including whether the proposed rule security. uniformity regarding pause periods on change is consistent with the Act. The provisions of this paragraph shall all trading days. Comments may be submitted by any of only apply to securities in the Standard B. Self-Regulatory Organization’s the following methods: & Poor’s 500 Index. Statement on Burden on Competition Electronic Comments The provisions of this paragraph shall be in effect during a pilot set to end on The Exchange does not believe that • Use the Commission’s Internet December 10, 2010. the proposed rule change will result in comment form (http://www.sec.gov/ (b)–(c) No Change. any burden on competition that is not rules/sro.shtml); or necessary or appropriate in furtherance * * * * * • Send an e-mail to rule- of the purposes of the Act. (b) Not applicable. [email protected]. Please include File (c) Not applicable. C. Self-Regulatory Organization’s Number SR–NASDAQ–2010–072 on the Statement on Comments on the subject line. II. Self-Regulatory Organization’s Proposed Rule Change Received From Paper Comments Statement of the Purpose of, and Members, Participants, or Others Statutory Basis for, the Proposed Rule • Send paper comments in triplicate Change Written comments on the proposed rule change were neither solicited nor to Elizabeth M. Murphy, Secretary, In its filing with the Commission, the received. Securities and Exchange Commission, Exchange included statements 100 F Street, NE., Washington, DC concerning the purpose of and basis for III. Date of Effectiveness of the 20549–1090. the proposed rule change and discussed Proposed Rule Change and Timing for any comments it received on the Commission Action 7 15 U.S.C. 78s(b)(3)(A). proposed rule change. The text of these Because the foregoing proposed rule 8 17 CFR 240.19b–4(f)(6). statements may be examined at the change does not: (i) Significantly affect 9 For purposes only of waiving the 30-day operative delay of this proposal, the Commission places specified in Item IV below. The has considered the proposed rule’s impact on Exchange has prepared summaries, set 5 15 U.S.C. 78f. efficiency, competition and capital formation. 15 forth in Sections A, B, and C below, of 6 15 U.S.C. 78f(b)(5). U.S.C. 78c(f).

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All submissions should refer to File ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 FLEX’’).4 Such FLEX Options could Number SR–NASDAQ–2010–072. This notice is hereby given that on June 2, have either an American Style exercise file number should be included on the 2010, NYSE Arca, Inc. (‘‘NYSE Arca’’ or or a European Style exercise. The same subject line if e-mail is used. To help the the ‘‘Exchange’’) filed with the Securities rule change also allowed for FLEX Index Commission process and review your and Exchange Commission (the Options to expire on or within two comments more efficiently, please use ‘‘Commission’’) the proposed rule business days of a third-Friday-of-the- only one method. change as described in Items I and II month expiration, provided they only The Commission will post all below, which Items have been prepared have an exercise settlement value on the comments on the Commission’s Internet by the self-regulatory organization. The expiration date determined by reference Web site (http://www.sec.gov/rules/ Commission is publishing this notice to to the reported level of the index as sro.shtml). Copies of the submission, all solicit comments on the proposed rule derived from the opening prices of the subsequent amendments, all written change from interested persons. component securities (‘‘a.m. settlement’’). statements with respect to the proposed I. Self-Regulatory Organization’s rule change that are filed with the The rule change provided that Statement of the Terms of the Substance expiration FLEX options will be Commission, and all written of the Proposed Rule Change communications relating to the permitted before (but not after) Non- proposed rule change between the The Exchange proposes to amend FLEX Options with identical terms are Commission and any person, other than Commentary .01 to Rule 5.32, Terms of listed. Once and if an option series is those that may be withheld from the FLEX Options, to permit certain FLEX listed for trading as a Non-FLEX Option public in accordance with the Options to trade under the FLEX series, (i) all existing open positions provisions of 5 U.S.C. 552, will be Trading Procedures for a limited time. established under the FLEX Trading available for Web site viewing and The text of the proposed rule change is procedures shall be fully fungible with printing in the Commission’s Public attached at Exhibit 5 to the 19b–4 form. transactions in the respective Non-FLEX Reference Room on official business A copy of this filing is available on the Options series, and (ii) any further days between the hours of 10 a.m. and Exchange’s Web site at http:// trading in the series would be as Non- 3 p.m. Copies of such filing also will be www.nyse.com, on the Commission’s FLEX Options subject to the Non-FLEX available for inspection and copying at Web site at http://www.sec.gov, at the trading procedures and rules. the principal office of NASDAQ. All Exchange’s principal office, and at the The Options Clearing Corporation comments received will be posted Commission’s Public Reference Room. (‘‘OCC’’) became concerned that, in without change; the Commission does certain circumstances, in the event a not edit personal identifying II. Self-Regulatory Organization’s Non-FLEX Option is listed with information from submissions. You Statement of the Purpose of, and identical terms to an existing FLEX should submit only information that Statutory Basis for, the Proposed Rule option, OCC could not net the positions you wish to make available publicly. Change in the contracts until the next business All submissions should refer to File In its filing with the Commission, the day. If the Non-FLEX Option were listed Number SR–NASDAQ–2010–072 and self-regulatory organization included intra-day, and the holder of a position should be submitted on or before July statements concerning the purpose of, in the FLEX option attempted to close 15, 2010. and basis for, the proposed rule change the position using the Non-FLEX and discussed any comments it received Option, the holder would be technically For the Commission, by the Division of long in one contract and short in the Trading & Markets, pursuant to delegated on the proposed rule change. The text authority.10 of those statements may be examined at other contract. This would expose the holder to assignment risk until the next Florence E. Harmon, the places specified in Item IV below. day despite having offsetting positions. Deputy Secretary. The Exchange has prepared summaries, set forth in sections A, B, and C below, The limited circumstances are: [FR Doc. 2010–15247 Filed 6–23–10; 8:45 am] • The Non-Flex Option is listed intra- of the most significant parts of such BILLING CODE 8010–01–P day. statements. • The FLEX contract is for American A. Self-Regulatory Organization’s style exercise. SECURITIES AND EXCHANGE Statement of the Purpose of, and • All other terms are identical and the COMMISSION Statutory Basis for, the Proposed Rule contracts are otherwise fungible. Change The risk does not occur in expiration [Release No. 34–62321; File No. SR– Friday FLEX option positions during the NYSEArca–2010–46] 1. Purpose five days prior to expiration, as no new The purpose of this filing is to allow Non-FLEX Option series may be listed Self-Regulatory Organizations; NYSE within five days of expiration. It also Arca, Inc.; Notice of Filing and certain FLEX options, which are identical in all terms to a Non-FLEX does not exist for FLEX option positions Immediate Effectiveness of Proposed that will be identical to Non-FLEX Rule Change Amending Commentary option, to trade using FLEX Trading Procedures for the balance of the trading series to be added after expiration, as .01 to Rule 5.32 To Permit Certain those new series are added ‘‘overnight’’ FLEX Options To Trade Under the day on which the Non-FLEX Option is added as an intra-day add. and OCC will convert the FLEX position FLEX Trading Procedures for a Limited to the Non-FLEX Options series at the The Exchange recently adopted rule Time on a Closing Only Basis time the Non-FLEX series is created. changes to allow FLEX options to expire Further, it does not exist for FLEX Index June 17, 2010. within two business days of a third- Options listed on NYSE Arca, as Non- 1 Friday-of-the-month expiration, Pursuant to Section 19(b)(1) of the FLEX Index options currently traded on Securities Exchange Act of 1934 (the including expiration Friday (‘‘expiration 4 See Exchange Act Release No. 60549, SR– 10 17 CFR 200.30–3(a)(12). 2 15 U.S.C. 78a. NYSE–Arca–2009–75 (August 20, 2009), 74 FR 1 15 U.S.C.78s(b)(1). 3 17 CFR 240.19b–4. 44415 (August 28, 2009).

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NYSE Arca are all European style and thus will not clear such American 2. Statutory Basis exercise, and thus the Non-FLEX Index style FLEX options. The Exchange believes the proposed Options cannot be exercised on the day NYSE Arca is proposing a limited rule change is consistent with Section the series is listed. exception to the requirement that the 6(b) 7 of the Securities Exchange Act of As an example, suppose underlying trading in such options be under the 1934 (the ‘‘Act’’), in general, and furthers issue XYZ, trading around $25 per Non-FLEX Trading Procedures. The the objectives of Section 6(b)(5) 8 in share, has options listed on the March Exchange proposes that, in the event a particular in that it is designed to cycle, and in February an investor Non-FLEX Option is listed intra-day, the promote just and equitable principles of wishes to buy just-out-of-the-money call holder of a FLEX Option with identical trade, to prevent fraudulent and options that will expire in May. Since terms could close the FLEX position manipulative acts, to remove the Non-FLEX May Options will not be under the FLEX Trading procedures, but impediments to and to perfect the listed until after the March expiration, only for the balance of the trading day mechanism for a free and open market the investor enters a FLEX Option order on which the series is added. Under the and a national market system and, in in February to buy 250 Call 30 options proposed rule change, both sides of the general, to protect investors and the expiring on the third Friday of May. If, FLEX transaction would have to be public interest, by giving OTP Holders, as expected, the Non-FLEX May 30 call closing only positions. OTP Firms, and investors with options are listed on the Monday after additional tools to trade customized March expiration, the investor’s open This change will allow the holder of a FLEX position to trade in such a options in an exchange environment FLEX position will be converted by OCC while allowing the holder of a FLEX over the weekend following March manner to mitigate the assignment risk. position to trade in such a manner as to expiration to the Non-FLEX series. 5 A FLEX Post Official has the mitigate inadvertent assignment risk. However, if XYZ stock should decline regulatory responsibility for reviewing between the time of the FLEX the conformity of FLEX trades to the B. Self-Regulatory Organization’s transaction and March expiration, the terms and specifications contained in Statement on Burden on Competition May 30 calls may not be added after Rule 5.32. In the event a Non-FLEX The Exchange does not believe that March expiration. If that were to occur, series, having the same terms as an the proposed rule change will impose the May 30 calls may be added existing expiration Friday FLEX option, any burden on competition that is not sometime later. Suppose the Exchange is listed intra-day, the FLEX Post necessary or appropriate in furtherance receives a request to add the May 30 Official will review any subsequent of the purposes of the Act. calls on the morning of the Wednesday FLEX transactions in that series and after expiration, and the Exchange lists verify that the order is being executed C. Self-Regulatory Organization’s them immediately. The investor with for the purpose of closing out an Statement on Comments on the the FLEX position may then decide it is existing FLEX position. The FLEX Post Proposed Rule Change Received From an opportune time to close his position. Official will not disseminate a FLEX Members, Participants, or Others Under current rules, the investor Request for Quote for any order No written comments were solicited would be required to close the position representing a FLEX series having the or received with respect to the proposed by entering a sell order in the new Non- same terms as a Non-FLEX series, unless rule change. FLEX Option series. However, when the such FLEX order is a closing order (and Non-FLEX transaction is reported to III. Date of Effectiveness of the it is the day the Non-FLEX series has OCC, the investor is considered short in Proposed Rule Change and Timing for been added). In addition, if the FLEX the Non-FLEX Option series, and is still Commission Action Post Official were to disseminate a long in the FLEX Option. OCC cannot FLEX Request for Quotes for a closing The Exchange has filed the proposed aggregate the FLEX positions into the order representing a FLEX series having rule change pursuant to Section Non-FLEX series until after exercise and 9 the same terms as a Non-FLEX series, 19(b)(3)(A)(iii) of the Act and Rule assignment processing. If a buyer in the 10 the FLEX Post Official would only 19b–4(f)(6) thereunder. Because the new Non-FLEX series were to exercise accept response quotes and orders from proposed rule change does not: the options, the original investor who Options Trading Permit (‘‘OTP’’) Holders (i) Significantly affect the protection of had attempted to close the FLEX that were closing out an existing FLEX investors or the public interest; position with an offsetting Non-FLEX position. (ii) impose any significant burden on trade would be at risk of being assigned competition; and (iii) become operative on the technically short Non-FLEX The NYSE Regulatory Department prior to 30 days from the date on which position. reviews FLEX trading activity, and, in it was filed, or such shorter time as the Because of this risk, OCC will not the event a non-FLEX series with the Commission may designate, if clear an American style expiration same terms as an expiration Friday consistent with the protection of Friday FLEX option. The Exchange has FLEX option is listed intra-day, will investors and the public interest, the spoken to OCC, and OCC has agreed that review any subsequent FLEX proposed rule change has become allowing the holder of an open position transactions in the series to verify that 6 effective pursuant to Section 19(b)(3)(A) in a FLEX contract to close the position they are closing a position. of the Act 11 and Rule 19b–4(f)(6)(iii) using a FLEX option in such thereunder.12 circumstances will mitigate the risk. 5 FLEX Post Officials are Exchange employees designated pursuant to Rule 5.38(a). The assignment risk does not exist if 7 15 U.S.C. 78f(b). 6 Through a Regulatory Services Agreement the Non-FLEX option is to be added the 8 15 U.S.C. 78f(b)(5). (‘‘RSA’’) between NYSE Regulation, Inc. (‘‘NYSE 9 next trading day. In situations where Regulation’’) and NYSE Arca, staff of NYSE 15 U.S.C. 78s(b)(3)(A)(iii). OCC is aware that a series will be added Regulation conducts, among other things, 10 17 CFR 240.19b–4(f)(6). overnight, they can convert the FLEX surveillances of the NYSE Arca options trading 11 15 U.S.C. 78s(b)(3)(A). Position to a Non-FLEX position before platform for purposes of monitoring compliance 12 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– with the relevant trading rules by NYSE Arca 4(f)(6)(iii) requires that a self-regulatory the next trading day. However, OCC participants. NYSE Arca represents that, through organization submit to the Commission written cannot guarantee that an identical Non- this RSA, there are appropriate surveillance in notice of its intent to file the proposed rule change, FLEX series will not be added intra-day, place to monitor transactions in FLEX options. Continued

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At any time within 60 days of the Exchange. All comments received will off-floor broker dealer may be entered filing of the proposed rule change, the be posted without change; the into the Exchange’s enhanced electronic Commission may summarily abrogate Commission does not edit personal trading platform for options, Phlx XL,5 such rule change if it appears to the identifying information from by an agent of the off-floor broker Commission that such action is submissions. You should submit only dealer. Third, the Exchange is adding necessary or appropriate in the public information that you wish to make opening-only-market orders and limit interest, for the protection of investors, available publicly. All submissions on opening orders to the list of eligible or otherwise in furtherance of the should refer to File No. SR–NYSEArca– orders in Rule 1080(b)(i), as order types purposes of the Act. 2010–46 and should be submitted on or eligible for entry into the trading system. The Exchange proposes to add IV. Solicitation of Comments before July 15, 2010. For the Commission, by the Division of a definition of limit on opening order to Interested persons are invited to Trading and Markets, pursuant to delegated Rule 1066. submit written data, views, and authority.13 The text of the proposed rule change arguments concerning the foregoing, Florence E. Harmon, is available on the Exchange’s Internet including whether the proposed rule Deputy Secretary. Web site at change is consistent with the Act. http://www.nasdaqtrader.com/ [FR Doc. 2010–15248 Filed 6–23–10; 8:45 am] Comments may be submitted by any of micro.aspx?id=PHLXRulefilings, on the the following methods: BILLING CODE 8010–01–P Commission’s Internet Web site at Electronic Comments http://www.sec.gov, at the principal office of the Exchange, and at the • SECURITIES AND EXCHANGE Use the Commission’s Internet Commission’s Public Reference Room. comment form (http://www.sec.gov/ COMMISSION rules/sro.shtml); or [Release No. 34–62320; File No. SR–Phlx– II. Self-Regulatory Organization’s • Send an e-mail to rule- 2010–83] Statement of the Purpose of, and [email protected]. Please include File Statutory Basis for, the Proposed Rule Number SR–NYSEArca–2010–46 on the Self-Regulatory Organizations; Change subject line. NASDAQ OMX PHLX, Inc.; Notice of In its filing with the Commission, the Filing and Immediate Effectiveness of self-regulatory organization included Paper Comments Proposed Rule Change To Modify Its • statements concerning the purpose of Send paper comments in triplicate Rules Relating to Directed Orders and and basis for the proposed rule change to Elizabeth M. Murphy, Secretary, Eligible Orders and discussed any comments it received Securities and Exchange Commission, on the proposed rule change. The text 100 F Street, NE., Washington DC June 17, 2010. Pursuant to Section 19(b)(1) of the of those statements may be examined at 20549–1090. the places specified in Item IV below. All submissions should refer to File Securities Exchange Act of 1934 (‘‘Act’’),1 and Rule 19b–4 thereunder,2 The Exchange has prepared summaries, Number SR–NYSEArca–2010–46. This set forth in sections A, B, and C below, file number should be included on the notice is hereby given that on June 14, 2010, NASDAQ OMX PHLX, Inc. of the most significant parts of such subject line if e-mail is used. To help the statements. Commission process and review your (‘‘Phlx’’ or ‘‘Exchange’’) filed with the comments more efficiently, please use Securities and Exchange Commission A. Self-Regulatory Organization’s only one method. The Commission will (‘‘Commission’’) the proposed rule Statement of the Purpose of, and post all comments on the Commission’s change as described in Items I and II Statutory Basis for, the Proposed Rule Internet Web site (http://www.sec.gov/ below, which Items have been prepared Change by the Exchange. The Exchange filed the rules/sro.shtml). Copies of the 1. Purpose submission, all subsequent proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 3 and In May 2005 the Exchange adopted amendments, all written statements 4 with respect to the proposed rule Rule 19b–4(f)(6) thereunder. The rules for Phlx XL that permit Exchange change that are filed with the Commission is publishing this notice to specialists, Streaming Quote Traders solicit comments on the proposed rule (‘‘SQTs’’),6 and Remote Streaming Quote Commission, and all written 7 communications relating to the change from interested persons. Traders (‘‘RSQTs’’) to receive Directed Orders, and to provide a participation proposed rule change between the I. Self-Regulatory Organization’s guarantee to specialists, SQTs and Commission and any person, other than Statement of the Terms of Substance of those that may be withheld from the the Proposed Rule Change 5 See Securities Exchange Act Release No. 59995 public in accordance with the The Exchange proposes to clarify the (May 28, 2009), 74 FR 26750 (June 3, 2009) (SR– provisions of 5 U.S.C. 552, will be definition of ‘‘Directed Order’’ in Rule Phlx–2009–32). available for Web site viewing and 1080(l)(i)(A) by removing the limiting 6 An SQT is an Exchange Registered Options Trader (‘‘ROT’’) who has received permission from printing in the Commission’s Public word ‘‘customer’’ before the word Reference Room, 100 F Street, NE., the Exchange to generate and submit option ‘‘order.’’ A conforming change to the quotations electronically through Phlx XL in Washington, DC 20549, on official definition of ‘‘Order Flow Provider’’ is eligible options to which such SQT is assigned. An business days between the hours of 10 proposed to be made in Rule SQT may only submit such quotations while such SQT is physically present on the floor of the a.m. and 3 p.m. Copies of such filing 1080(l)(i)(B). Second, amendments to also will be available for inspection and Exchange. See Phlx Rule 1014(b)(ii)(A). Rule 1080(b)(i)(C) are proposed which 7 An RSQT is an ROT that is a member or member copying at the principal office of the specify that orders for the account of an organization with no physical trading floor presence who has received permission from the along with a brief description and text of the Exchange to generate and submit option quotations 13 17 CFR 200.30–3(a)(12). proposed rule change, at least five business days electronically through Phlx XL in eligible options 1 prior to the filing of the proposed rule change, or 15 U.S.C. 78s(b)(1). to which such RSQT has been assigned. An RSQT such shorter time as designated by the Commission. 2 17 CFR 240.19b–4. may only submit such quotations electronically The Commission notes that the Exchange has 3 15 U.S.C. 78s(b)(3)(A)(iii). from off the floor of the Exchange. See Phlx Rule satisfied this requirement. 4 17 CFR 240.19b–4(f)(6). 1014(b)(ii)(B).

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RSQTs that receive Directed Orders.8 an agent, on behalf of the off-floor C. Self-Regulatory Organization’s The proposed amendment to Rule broker-dealer as well as by the off-floor Statement on Comments on the 1080(l)(i)(A) is intended to clarify that broker-dealer itself. This situation Proposed Rule Change Received From Rule 1080(1)(i)(A) does not limit occurs, for example, where the off-floor Members, Participants or Others Directed Orders to public customer broker-dealer is not itself a Phlx member No written comments were either orders. The Exchange notes that other and uses a Phlx member for execution solicited or received. exchanges’ Directed Orders rules do not of its proprietary orders on Phlx. limit Directed Orders to public customer III. Date of Effectiveness of the orders.9 Rule 1080(b)(i) lists the types of Proposed Rule Change and Timing for Currently, the term ‘‘Directed Order’’ orders that are eligible for entry into the Commission Action is defined in Rule 1080(l)(i)(A) as ‘‘any Phlx XL trading system by various categories of market participants. The Because the foregoing rule does not: customer order (other than a stop or (i) Significantly affect the protection of Exchange is proposing to add opening- stop-limit order as defined in Rule 1066) investors or the public interest; (ii) only-market orders to the list of agency to buy or sell which has been directed impose any significant burden on to a particular specialist, RSQT, or SQT orders eligible for entry into the system competition; and (iii) become operative by an Order Flow Provider * * *’’ The 10 in Rule 1080(b)(i)(A). It also proposes for 30 days from the date on which it Exchange proposes to remove the word to add limit-on-opening orders to each was filed, or such shorter time as the ‘‘customer’’ from this definition to avoid of the lists of eligible orders that market Commission may designate, the any suggestion that Directed Orders are participants are permitted to enter in proposed rule change has become limited to orders of ‘‘public’’ customers. Rules 1080(b)(i)(A), (B) and(C). ‘‘Limit- effective pursuant to Section 19(b)(3)(A) Directed Orders can be broker-dealer on-Opening Order’’ would be defined in of the Act 14 and Rule 19b–4(f)(6) orders as well as public customer new Section 9 of Rule 1066(c) as thereunder.15 orders. meaning a limit order which is to be Rule 1080(b)(i)(A) provides in At any time within 60 days of the executed in whole or in part during the relevant part that ‘‘[f]or purposes of filing of such proposed rule change, the Exchange options trading, an agency opening rotation of an options series or Commission may summarily abrogate order is any order entered on behalf of not at all. Phlx notes that at least one such rule change if it appears to the a public customer, and does not include other options exchange already accepts Commission that such action is any order entered for the account of a opening only limit and market orders.11 necessary or appropriate in the public interest, for the protection of investors, broker-dealer, or any account in which 2. Statutory Basis a broker-dealer or an associated person or otherwise in furtherance of the of a broker-dealer has any direct or The Exchange believes that its purposes of the Act. indirect interest.’’ In adopting the proposal is consistent with Section 6(b) IV. Solicitation of Comments Directed Order program, the Exchange 12 of the Act in general, and furthers the Interested persons are invited to did not limit Directed Orders to agency objectives of Section 6(b)(5) of the Act 13 orders as defined in Rule 1080(b)(i)(A). submit written data, views, and in particular, in that it is designed to arguments concerning the foregoing, The Exchange believes, however, that promote just and equitable principles of use of the word ‘‘customer’’ in the including whether the proposed rule trade, to remove impediments to and change is consistent with the Act. definition of Directed Order is perfect the mechanism of a free and potentially confusing and unnecessary Comments may be submitted by any of open market and a national market and is therefore deleting it. For the same the following methods: system, and, in general to protect reason, the modifier ‘‘customer’’ is Electronic Comments deleted before the word ‘‘order’’ in the investors and the public interest, by • Use the Commission’s Internet definition of Order Flow Provider in permitting the Exchange to modify its comment form (http://www.sec.gov/ Rule 1080(l)(i)(B). Accordingly, this rules relating to Directed Orders and rules/sro.shtml); or change clarifies that Directed Orders can eligible orders for the benefit of • Send an e-mail to be sent not only on behalf of public investors. [email protected]. Please include customers but also on behalf of broker B. Self-Regulatory Organization’s File Number SR–Phlx–2010–83 on the dealers. Directed Orders are limited to Statement on Burden on Competition subject line. orders sent on an agency basis by Order Flow Providers and not on behalf of the The Exchange does not believe that Paper Comments sender’s proprietary account. the proposed rule change will impose • Send paper comments in triplicate Currently, Rule 1080(b)(i)(C) provides any burden on competition not to Elizabeth M. Murphy, Secretary, that certain ‘‘off-floor broker-dealer’’ necessary or appropriate in furtherance Securities and Exchange Commission, limit orders may be entered into Phlx of the purposes of the Act. 100 F Street, NE., Washington, DC XL. The rule currently defines ‘‘off-floor 20549–1090. broker-dealer’’ as a broker-dealer that delivers orders from off the floor of the All submissions should refer to File Exchange for the proprietary account(s) 10 Rule 1066(c)(5) provides that ‘‘[a]n opening- Number SR–Phlx-2010–83. This file of such broker-dealer. Rule 1080(b)(i)(C) only-market order is a market order which is to be number should be included on the is being revised to specify that orders for executed in whole or in part during the opening an off-floor broker-dealer’s proprietary rotation of an options series or not at all.’’ 14 15 U.S.C. 78s(b)(3)(A). 15 account may be entered into Phlx XL by 11 See NYSE Arca Rule 6.62(r) which defines an 17 CFR 240.19b–4(f)(6). Rule 19b–4(f)(6)(iii) ‘‘Opening Only Order’’ as ‘‘a market order or limit requires a self-regulatory organization to give the order which is to be executed in whole or in part Commission written notice of its intent to file the 8 See Securities Exchange Act Release No. 51759 during the opening auction of an options series or proposed rule change, along with a brief description (May 27, 2005), 70 FR 32860 (June 6, 2005). See also and text of the proposed rule change, at least five not at all. Any portion not so executed is to be Phlx Rule 1014(g)(viii) (setting forth the automatic business days prior to the date of filing of the treated as cancelled.’’ trade allocation algorithm for Directed Orders). proposed rule change, or such shorter time as 9 See, e.g., NYSE Amex Rule 900.3NY(s), NYSE 12 15 U.S.C. 78f(b). designated by the Commission. The Exchange has Arca Rule 6.62(z) and ISE Rule 811(a)(1). 13 15 U.S.C. 78f(b)(5). satisfied this requirement.

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subject line if e-mail is used. To help the change as described in Items I, II, and (ii) Market Maker Plus; 4 (iii) Non-ISE Commission process and review your III below, which Items have been Market Maker; 5 (iv) Firm Proprietary; comments more efficiently, please use prepared by the Exchange. The (v) Customer (Professional); 6 (vi) only one method. The Commission will Commission is publishing this notice to Priority Customer,7 100 or more post all comments on the Commission’s solicit comments on the proposed rule contracts; and (vii) Priority Customer, Internet Web site (http://www.sec.gov/ change from interested persons. less than 100 contracts.8 rules/sro.shtml). Copies of the I. Self-Regulatory Organization’s Current Transaction Charges for Adding submission, all subsequent Statement of the Terms of Substance of and Removing Liquidity amendments, all written statements the Proposed Rule Change with respect to the proposed rule The Exchange currently assesses a per change that are filed with the The ISE is proposing to amend its contract transaction charge to market Commission, and all written Schedule of Fees in order to increase the participants that remove, or ‘‘take,’’ communications relating to the number of options classes to be liquidity from the Exchange in the proposed rule change between the included in the Exchange’s current following 20 options classes: Commission and any person, other than schedule of transaction fees and rebates PowerShares QQQ trust (‘‘QQQQ’’), those that may be withheld from the for adding and removing liquidity. The Bank of America Corporation (‘‘BAC’’), public in accordance with the text of the proposed rule change is Citigroup, Inc. (‘‘C’’), Standard and provisions of 5 U.S.C. 552, will be available on the Exchange’s Web site Poor’s Depositary Receipts/SPDRs available for Web site viewing and (http://www.ise.com), at the principal (‘‘SPY’’), iShares Russell 2000 (‘‘IWM’’), printing in the Commission’s Public office of the Exchange, at the Financial Select Sector SPDR (‘‘XLF’’), Reference Room, on official business Commission’s Public Reference Room, Apple, Inc. (‘‘AAPL’’), General Electric days between the hours of 10 a.m. and and on the Commission’s Web site at Company (‘‘GE’’), JPMorgan Chase & Co. 3 p.m. Copies of the filing also will be http://www.sec.gov. (‘‘JPM’’), Intel Corporation (‘‘INTC’’), available for inspection and copying at Goldman Sachs Group, Inc. (‘‘GS’’), the principal office of the Exchange. All II. Self-Regulatory Organization’s Research in Motion Limited (‘‘RIMM’’), comments received will be posted Statement of the Purpose of, and AT&T, Inc. (‘‘T’’), Verizon without change; the Commission does Statutory Basis for, the Proposed Rule not edit personal identifying Change 4 A Market Maker Plus is a market maker who is on the National Best Bid or National Best Offer 80% information from submissions. You In its filing with the Commission, the of the time in that symbol during the current should submit only information that self-regulatory organization included trading month for series trading between $0.03 and you wish to make available publicly. All statements concerning the purpose of, $5.00 in premium. The Exchange determines submissions should refer to File whether a market maker qualifies as a Market Maker and basis for, the proposed rule change Plus at the end of each month by looking back at Number SR–Phlx–2010–83 and should and discussed any comments it received each market maker’s quoting statistics during that be submitted on or before July 15, 2010. on the proposed rule change. The text month. If at the end of the month, a market maker For the Commission, by the Division of of these statements may be examined at meets the 80% criteria, the Exchange rebates $0.10 Trading and Markets, pursuant to delegated the places specified in Item IV below. per contract for transactions executed by that 16 market maker during that month. The Exchange authority. The self-regulatory organization has provides market makers a report on a daily basis Florence E. Harmon, prepared summaries, set forth in with quoting statistics so that market makers can Deputy Secretary. sections A, B and C below, of the most determine whether or not they are meeting the 80% criteria. On May 26, 2010, the Exchange submitted [FR Doc. 2010–15267 Filed 6–23–10; 8:45 am] significant aspects of such statements. a proposed rule change, SR–ISE–2010–54, to be BILLING CODE 8010–01–P A. Self-Regulatory Organization’s effective on June 1, 2010, to amend the qualification standards for market makers to receive the $0.10 per Statement of the Purpose of, and contract rebate. Pursuant to that proposed rule Statutory Basis for, the Proposed Rule change, a market maker must be on the National SECURITIES AND EXCHANGE Change Best Bid or National Best Offer 80% of the time for COMMISSION series trading between $0.03 and $5.00 in premium 1. Purpose in each of the front two expiration months and 80% [Release No. 34–62319; File No. SR–ISE– of the time for all series trading between $0.03 and 2010–57] The Exchange proposes to increase $5.00 in order to receive the rebate. liquidity and attract order flow by 5 A Non-ISE Market Maker, or Far Away Market Self-Regulatory Organizations; Maker (‘‘FARMM’’), is a market maker as defined in amending its transaction fees and Section 3(a)(38) of the Securities Exchange Act of International Securities Exchange, rebates for adding and removing LLC; Notice of Filing and Immediate 1934, as amended (‘‘Exchange Act’’), registered in liquidity (‘‘maker/taker fees’’).3 The the same options class on another options Effectiveness of a Proposed Rule Exchange’s maker/taker fees currently exchange. Change Relating to Fees and Rebates apply to the following categories of 6 A Customer (Professional) is a person who is not for Adding and Removing Liquidity a broker/dealer and is not a Priority Customer. market participants: (i) Market Maker; 7 A Priority Customer is defined in ISE Rule June 17, 2010. 100(a)(37A) as a person or entity that is not a 3 These fees are similar to the ‘‘maker/taker’’ fees broker/dealer in securities, and does not place more Pursuant to Section 19(b)(1) of the currently assessed by NASDAQ OMX PHLX than 390 orders in listed options per day on average Securities Exchange Act of 1934 (‘‘Act’’)1 (‘‘PHLX’’). PHLX currently charges a fee for during a calendar month for its own beneficial and Rule 19b–4 thereunder,2 notice is removing liquidity to the following class of market account(s). hereby given that on June 1, 2010, the participants: (i) Customer, (ii) Directed Participant, 8 The Chicago Board Options Exchange (‘‘CBOE’’) (iii) Specialist, ROT, SQT and RSQT, (iv) Firm, (v) currently makes a similar distinction between large International Securities Exchange, LLC Broker-Dealer, and (vi) Professional. PHLX also size customer orders that are fee liable and small (the ‘‘ISE’’ or ‘‘Exchange’’) filed with the provides a rebate for adding liquidity to the size customer orders whose fees are waived. CBOE Securities and Exchange Commission following class of market participants: (i) Customer, currently waives fees for customer orders of 99 (‘‘Commission’’) the proposed rule (ii) Directed Participant, (iii) Specialist, ROT, SQT contracts or less in options on exchange-traded and RSQT, and (iv) Professional. See Securities funds (‘‘ETFs’’) and Holding Company Depositary Exchange Act Release Nos. 61684 (March 10, 2010), Receipts (‘‘HOLDRs’’) and charges a transaction fee 16 17 CFR 200.30–3(a)(12). 75 FR 13189 (March 18, 2010); 61932 (April 16, for customer orders that exceed 99 contracts. See 1 15 U.S.C. 78s(b)(1). 2010), 75 FR 21375 (April 23, 2010); and 61961 Securities Exchange Act Release No. 59892 (May 8, 2 17 CFR 240.19b–4. (April 22, 2010), 75 FR 22881 (April 30, 2010). 2009), 74 FR 22790 (May 14, 2009).

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Communications, Inc. (‘‘VZ’’), United included in the Exchange’s maker/taker MSFT, MU, PALM, PBR, PG, POT, RIG, States Natural Gas Fund (‘‘UNG’’), fee schedule: Alcoa Inc. (‘‘AA’’), SDS, SLV, XLE, and XOM options.12 Freeport-McMoRan Copper & Gold, Inc. American International Group, Inc. • The Exchange has a $0.20 per (‘‘FCX’’), Cisco Systems, Inc. (‘‘CSCO’’), (‘‘AIG’’), American Express Company contract fee credit for members who, Diamonds Trust, Series 1 (‘‘DIA’’), (‘‘AXP’’), Best Buy Company (‘‘BBY’’), pursuant to Supplementary Material .02 Amazon.com, Inc. (‘‘AMZN’’) and Caterpillar, Inc. (‘‘CAT’’), Chesapeake to Rule 803, execute a transaction in the United States Steel Corporation (‘‘X’’). Energy Corporation (‘‘CHK’’), Dendreon Exchange’s flash auction as a response The per contract transaction charge Corporation (‘‘DNDN’’), iShares MSCI to orders from persons who are not depends on the category of market Emerging Markets Index Fund (‘‘EEM’’), broker/dealers and who are not Priority participant submitting an order or quote iShares MSCI EAFE Index Fund Customers.13 For QQQQ, BAC, C, SPY, to the Exchange that removes liquidity.9 (‘‘EFA’’), iShares MSCI Brazil Index IWM, XLF, AAPL, GE, JPM, INTC, GS, Priority Customer Complex orders, Fund (‘‘EWZ’’), Ford Motor Company RIMM, T, VZ, UNG, FCX, CSCO, DIA, regardless of size, are not assessed a fee (‘‘F’’), Direxion Shares Financial Bull AMZN, X, AA, AIG, AXP, BBY, CAT, for removing liquidity. (‘‘FAS’’), Direxion Shares Financial Bear CHK, DNDN, EEM, EFA, EWZ, F, FAS, The Exchange also currently assesses (‘‘FAZ’’), First Solar, Inc. (‘‘FSLR’’), FAZ, FSLR, GDX, GLD, IYR, MGM, MS, transaction charges for adding liquidity Market Vectors ETF Gold Miners MSFT, MU, PALM, PBR, PG, POT, RIG, in options on QQQQ, BAC, C, SPY, (‘‘GDX’’), SPDR Gold Trust (‘‘GLD’’), SDS, SLV, XLE, and XOM options, the IWM, XLF, AAPL, GE, JPM, INTC, GS, iShares DJ US Real Estate Index Fund Exchange proposes to lower the per RIMM, T, VZ, UNG, FCX, CSCO, DIA, (‘‘IYR’’), MGM Mirage (‘‘MGM’’), Morgan contract fee credit for members who AMZN and X. Priority Customer orders, Stanley (‘‘MS’’), Microsoft Corporation execute a transaction in the Exchange’s regardless of size, and Market Maker (‘‘MSFT’’), Micron Technology, Inc. flash auction as a response to orders Plus orders are not assessed a fee for (‘‘MU’’), Palm, Inc. (‘‘PALM’’), Petroleo from persons who are not broker/dealers adding liquidity. Brasileiro S.A. (‘‘PBR’’), The Procter & and who are not Priority Customers to ‘‘ ’’ Current Rebates Gamble Company ( PG ), Potash $0.10 per contract. Corporation of Saskatchewan (‘‘POT’’), • The Exchange has a $0.20 per In order to promote and encourage Transocean Ltd. (‘‘RIG’’), ProShares contract fee for market maker orders liquidity in options classes that are UltraShort S&P 500 (‘‘SDS’’), iShares sent to the Exchange by EAMs.14 Market subject to maker/taker fees, the Silver Trust (‘‘SLV’’), Energy Select maker orders sent to the Exchange by Exchange currently offers a $0.10 per Sector SPDR Fund (‘‘XLE’’), and Exxon EAMs will be assessed a fee of $0.25 per contract rebate for Market Maker Plus Mobil Corporation (‘‘XOM’’). 10 contract for removing liquidity in orders sent to the Exchange. Further, QQQQ, BAC, C, SPY, IWM, XLF, AAPL, in order to incentivize members to Other Fees • GE, JPM, INTC, GS, RIMM, T, VZ, UNG, direct retail orders to the Exchange, Fees for orders executed in the FCX, CSCO, DIA, AMZN, X, AA, AIG, Priority Customer Complex orders, Exchange’s Facilitation, Solicited Order, AXP, BBY, CAT, CHK, DNDN, EEM, regardless of size, currently receive a Price Improvement and Block Order EFA, EWZ, F, FAS, FAZ, FSLR, GDX, rebate of $0.15 per contract on all legs Mechanisms are for contracts that are GLD, IYR, MGM, MS, MSFT, MU, when these orders trade with non- part of the originating or contra order. PALM, PBR, PG, POT, RIG, SDS, SLV, customer orders in the Exchange’s • Complex orders executed in the XLE, and XOM options and $0.10 per Complex Orderbook. Additionally, the Facilitation and Solicited Order contract for adding liquidity in QQQQ, Exchange’s Facilitation Mechanism has Mechanisms are charged fees only for BAC, C, SPY, IWM, XLF, AAPL, GE, an auction which allows for the leg of the trade consisting of the JPM, INTC, GS, RIMM, T, VZ, UNG, participation in a trade by members most contracts. FCX, CSCO, DIA, AMZN, X, AA, AIG, other than the member who entered the • Payment for Order Flow fees will AXP, BBY, CAT, CHK, DNDN, EEM, trade. To incentivize members, the not be collected on transactions on EFA, EWZ, F, FAS, FAZ, FSLR, GDX, Exchange currently offers a rebate of QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GLD, IYR, MGM, MS, MSFT, MU, $0.15 per contract to contracts that do GE, JPM, INTC, GS, RIMM, T, VZ, UNG, PALM, PBR, PG, POT, RIG, SDS, SLV, not trade with the contra order in the FCX, CSCO, DIA, AMZN, X, AA, AIG, XLE, and XOM options. Facilitation Mechanism. AXP, BBY, CAT, CHK, DNDN, EEM, The Exchange has designated this EFA, EWZ, F, FAS, FAZ, FSLR, GDX, Fee Changes proposal to be operative on June 1, GLD, IYR, MGM, MS, MSFT, MU, 2010. The Exchange proposes to add the PALM, PBR, PG, POT, RIG, SDS, SLV, following 30 options classes to be XLE, and XOM options.11 2. Statutory Basis • The Cancellation Fee will continue The basis under the Exchange Act for 9 Although these options classes will no longer be to apply in QQQQ, BAC, C, SPY, IWM, subject to the tiered market maker transaction fees, this proposed rule change is the the volume from these options classes will continue XLF, AAPL, GE, JPM, INTC, GS, RIMM, requirement under Section 6(b)(4) that to be used in the calculation of the tiers so that this T, VZ, UNG, FCX, CSCO, DIA, AMZN, an exchange have an equitable new pricing does not affect a market maker’s fee in X, AA, AIG, AXP, BBY, CAT, CHK, all other names. DNDN, EEM, EFA, EWZ, F, FAS, FAZ, 12 10 The concept of incenting market makers with The Exchange assesses a Cancellation Fee of a rebate is not novel. In 2008, the CBOE established FSLR, GDX, GLD, IYR, MGM, MS, $2.00 to EAMs that cancel at least 500 orders in a a program for its Hybrid Agency Liaison whereby month, for each order cancellation in excess of the it provides a $0.20 per contact rebate to its market 11 ISE currently has a payment-for-order-flow total number of orders such member executed that makers provided that at least 80% of the market (‘‘PFOF’’) program that helps the Exchange’s market month. All orders from the same clearing EAM maker’s quotes in a class during a month are on one makers establish PFOF arrangements with an executed in the same underlying symbol at the side of the national best bid or offer. Market makers Electronic Access Member (‘‘EAM’’) in exchange for same price within a 300-second period are not meeting CBOE’s criteria are not eligible to that EAM preferencing some or all of its order flow aggregated and counted as one executed order for receive a rebate. See Securities Exchange Act to that market maker. This program is funded purposes of this fee. This fee is charged only to Release No. 57231 (January 30, 2008), 73 FR 6752 through a fee paid by Exchange market makers for customer orders. (February 5, 2008). The CBOE has since lowered the each customer contract they execute, and is 13 See Securities Exchange Act Release No. 61731 criteria from 80% to 60%. See Securities Exchange administered by both Primary Market Makers (March 18, 2010), 75 FR 14233 (March 24, 2010). Act Release No. 57470 (March 11, 2008), 73 FR (‘‘PMM’’) and Competitive Market Makers (‘‘CMM’’), 14 See Securities Exchange Act Release No. 60817 14514 (March 18, 2008). depending to whom the order is preferenced. (October 13, 2009), 74 FR 54111 (October 21, 2009).

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allocation of reasonable dues, fees and necessary or appropriate in the public For the Commission, by the Division of other charges among its members and interest, for the protection of investors, Trading and Markets, pursuant to delegated other persons using its facilities. The or otherwise in furtherance of the authority.17 impact of the proposal upon the net fees purposes of the Act. Florence E. Harmon, paid by a particular market participant Deputy Secretary. IV. Solicitation of Comments will depend on a number of variables, [FR Doc. 2010–15280 Filed 6–23–10; 8:45 am] the most important of which will be its Interested persons are invited to BILLING CODE 8010–01–P propensity to add or remove liquidity in submit written data, views, and QQQQ, BAC, C, SPY, IWM, XLF, AAPL, arguments concerning the foregoing, GE, JPM, INTC, GS, RIMM, T, VZ, UNG, including whether the proposed rule SECURITIES AND EXCHANGE FCX, CSCO, DIA, AMZN, X, AA, AIG, change is consistent with the Act. COMMISSION AXP, BBY, CAT, CHK, DNDN, EEM, Comments may be submitted by any of EFA, EWZ, F, FAS, FAZ, FSLR, GDX, the following methods: [Release No. 34–62304; File No. SR– GLD, IYR, MGM, MS, MSFT, MU, NYSEArca–2010–31] PALM, PBR, PG, POT, RIG, SDS, SLV, Electronic Comments XLE, and XOM options. The Exchange • Use the Commission’s Internet Self-Regulatory Organizations; NYSE operates in a highly competitive market comment form (http://www.sec.gov/ Arca, Inc.; Order Approving Proposed in which market participants can rules/sro.shtml); or Rule Change To Amend NYSE Arca readily direct order flow to another Rule 3.3(a) and Section 401(a) of the • Send an e-mail to rule- exchange if they deem fee levels at a Exchange’s Bylaws To Eliminate the [email protected]. Please include File particular exchange to be excessive. The Exchange’s Audit Committee, Number SR–ISE–2010–57 on the subject Exchange believes that the proposed Compensation Committee, and line. fees it charges for options overlying Regulatory Oversight Committee QQQQ, BAC, C, SPY, IWM, XLF, AAPL, Paper Comments June 16, 2010. GE, JPM, INTC, GS, RIMM, T, VZ, UNG, • FCX, CSCO, DIA, AMZN, X, AA, AIG, Send paper comments in triplicate On April 20, 2010, NYSE Arca, Inc. AXP, BBY, CAT, CHK, DNDN, EEM, to Secretary, Securities and Exchange (‘‘NYSE Arca’’ or ‘‘Exchange’’) filed with EFA, EWZ, F, FAS, FAZ, FSLR, GDX, Commission, Station Place, 100 F Street, the Securities and Exchange GLD, IYR, MGM, MS, MSFT, MU, NE., Washington, DC 20549–1090. Commission (‘‘Commission’’) pursuant PALM, PBR, PG, POT, RIG, SDS, SLV, All submissions should refer to File to Section 19(b)(1) of the Securities 1 XLE, and XOM remain competitive with Number SR–ISE–2010–57. This file Exchange Act of 1934 (‘‘Act’’), and Rule 2 fees charged by other exchanges and number should be included on the 19b–4 thereunder, a proposed rule therefore continue to be reasonable and subject line if e-mail is used. To help the change to amend NYSE Arca Rule 3.3(a) equitably allocated to those members Commission process and review your and Section 401(a) of the Exchange’s that opt to direct orders to the Exchange comments more efficiently, please use Bylaws to eliminate the Exchange’s rather than to a competing exchange. only one method. The Commission will Audit Committee, Compensation post all comments on the Commission’s Committee, and Regulatory Oversight B. Self-Regulatory Organization’s Committee. The proposed rule change Statement on Burden on Competition Internet Web site (http://www.sec.gov/ rules/sro.shtml). Copies of the was published for comment in the 3 The proposed rule change does not submission, all subsequent Federal Register on May 11, 2010. The impose any burden on competition that amendments, all written statements Commission received no comments is not necessary or appropriate in with respect to the proposed rule regarding the proposal. This order furtherance of the purposes of the Act. change that are filed with the approves the proposed rule change. C. Self-Regulatory Organization’s Commission, and all written I. Description of the Proposed Rule Statement on Comments on the communications relating to the Change Proposed Rule Change Received From proposed rule change between the Currently, the Board of Directors of Members, Participants or Others Commission and any person, other than those that may be withheld from the the Exchange and its ultimate parent The Exchange has not solicited, and public in accordance with the company, NYSE Euronext, each does not intend to solicit, comments on provisions of 5 U.S.C. 552, will be maintain its own Audit Committee and this proposed rule change. The available for Web site viewing and Compensation Committee. As more Exchange has not received any printing in the Commission’s Public fully discussed in the Notice, the unsolicited written comments from Reference Room, 100 F Street, NE., Exchange states that it has found that members or other interested parties. Washington, DC 20549, on official the work of these committees overlaps 4 III. Date of Effectiveness of the business days between the hours of 10 substantially. As a result, the Exchange Proposed Rule Change and Timing for a.m. and 3 p.m. Copies of such filing has proposed to revise its Bylaws to Commission Action also will be available for inspection and allow for the elimination of its Audit and Compensation Committees. In The foregoing rule change has become copying at the principal office of the Exchange. All comments received will addition, the Exchange has proposed to effective pursuant to Section 19(b)(3) of eliminate its Regulatory Oversight the Act 15 and Rule 19b–4(f)(2) 16 be posted without change; the Commission does not edit personal Committee (‘‘ROC’’), and in lieu thereof, thereunder. At any time within 60 days provide that the Board of NYSE of the filing of such proposed rule identifying information from change, the Commission may summarily submissions. You should submit only 17 17 CFR 200.30–3(a)(12). abrogate such rule change if it appears information that you wish to make publicly available. All submissions 1 15 U.S.C. 78s(b)(1). to the Commission that such action is 2 should refer to File Number SR–ISE– 17 CFR 240.19b–4. 3 See Securities Exchange Act Release No. 62032 15 15 U.S.C. 78s(b)(3)(A). 2010–57 and should be submitted on or (May 4, 2010), 75 FR 26304 (‘‘Notice’’). 16 17 CFR 240.19b–4(f)(2). before July 15, 2010. 4 See Notice, supra note 3.

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Regulation, Inc. (‘‘NYSER’’) 5 and the Board of NYSE Amex each exercise a self-regulatory organizations whose Board of the Exchange each will portion of the Regulatory Oversight ultimate parent is NYSE Euronext, exercise a portion of the current Committee responsibilities for NYSE through delegated authority and responsibilities of the ROC, with the Amex, with NYSE Amex retaining regulatory services agreements; (iv) it is Board of the Exchange retaining ultimate legal responsibility for the the practice of NYSE Euronext’s Global ultimate legal responsibility for the regulation of its permit holders and its Risk and Audit Services Department regulation of its permit holders 6 and its market.13 (‘‘RAS’’), which performs internal audit market.7 The NYSE Arca Audit Committee. functions, to report to the NYSER Board Under current Exchange Rule on all internal audit matters relating to II. Discussion and Commission 3.3(a)(3)(B), the primary functions of the the Exchange’s regulatory Findings NYSE Arca Audit Committee are (i) to responsibilities, and to ensure that After careful review, the Commission conduct an annual review with the NYSER has the appropriate authority to finds that the proposed rule change is independent auditors, to determine the oversee RAS’s activities with respect to consistent with the requirements of the scope of their examination and the cost the Exchange’s regulatory Act and the rules and regulations thereof; (ii) to periodically review with responsibilities pursuant to the thereunder applicable to a national the independent auditors and the provisions of the RSA between the securities exchange.8 In particular, the internal auditor the Exchange’s internal Exchange and NYSER; (v) RAS’s written Commission finds that the proposed controls and the adequacy of the procedures will be amended to stipulate rule change is consistent with Section internal audit program; (iii) to review that the NYSER Board of Directors may, 6(b)(1) of the Act,9 which requires a the annual reports submitted both at any time, request that RAS conduct national securities exchange to be so internally and externally, and take such an audit of a matter of concern to it and organized and have the capacity to carry action with respect thereto as it may report the results of the audit both to the out the purposes of the Act and to deem appropriate, and (iv) to NYSER Board of Directors and the comply, and to enforce compliance by recommend to the Board of NYSE Arca NYSE Euronext Audit Committee; (vi) its members and persons associated independent public accountants as the chief regulatory officer of the with its members, with the provisions of auditors of the Exchange and its Exchange would be in attendance at any the Act. The Commission also finds that subsidiaries. meeting of the NYSER Board of the proposed rule change is consistent The NYSE Euronext Audit Committee Directors at which the results of any with Section 6(b)(5) of the Act,10 in that is responsible under its charter for such audit would be reported by RAS; it is designed, among other things, to assessing the effectiveness of the and (vii) the Exchange retains the prevent fraudulent and manipulative internal audit function and reviewing authority to direct NYSER to request acts and practices, to promote just and with management and the independent that RAS conduct such an audit of a equitable principles of trade, to remove auditor any major issues as to the matter of concern to it. impediments to and perfect the adequacy of NYSE Euronext’s internal The Commission notes that the mechanism of a free and open market risk management and internal controls, proposed elimination of the NYSE Arca and a national market system, and, in as well as meeting to review and discuss Audit Committee is comparable to a general, to protect investors and the with management and the independent structure for NYSE and NYSE Amex public interest. The Commission has auditor NYSE Euronext’s annual that the Commission has previously previously approved a structure in audited financial statements, quarterly considered and approved.14 The which certain committees of the Board financial statements prior to the filing of Commission finds that the proposed of NYSE Euronext, including its Audit Form 10–Q, and significant financial elimination of the NYSE Arca Audit and and Compensation Committees, were reporting issues and judgments made in Compensation committees is consistent authorized to perform functions for connection with the preparation of the with the Act. subsidiaries of NYSE Euronext, financial statements. NYSE Arca Compensation Committee. including the New York Stock In connection with this proposal, the The Exchange also proposes to Exchange, LLC (‘‘NYSE’’),11 and NYSE Exchange represents that: (i) The eliminate its Compensation Committee, Amex, Inc. (‘‘NYSE Amex’’).12 The specific responsibilities of the NYSE and to prescribe that the functions of Commission has also previously Euronext Audit Committee, as well as that committee be performed by the approved a structure for NYSE Amex in numerous others in its charter relating NYSE Euronext Human Resources and which the Board of NYSER and the to oversight of both the independent Compensation Committee. Pursuant to and internal auditors, financial current Exchange Rule 3.3(a)(4)(B), the 5 NYSER is a not-for-profit indirect subsidiary of statement and disclosure matters, and NYSE Arca Compensation Committee is NYSE Euronext. corporate oversight, result in the required to (i) review and approve 6 Permit holders at the Exchange are ‘‘members’’ responsibilities of the NYSE Arca Audit corporate goals and objectives relevant of the Exchange as that term is defined in Section Committee being fully duplicated by the to the Exchange CEO’s compensation; 3 of the Act. responsibilities of the NYSE Euronext 7 These arrangements are set forth in various (ii) evaluate the CEO’s performance in regulatory services agreements. See infra note 16 Audit Committee; (ii) the NYSE light of those goals and objectives; (iii) and accompanying text. Euronext Audit Committee will set the CEO’s compensation level based 8 In approving this proposed rule change, the continue to be composed at all times of on this evaluation; and (iv) make Commission notes that it has considered the independent directors and will continue recommendations to the Exchange’s proposed rule’s impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f). to review the financial condition of the Board of Directors with respect to the 9 15 U.S.C. 78f(b)(1). Exchange as part of its oversight of the design of incentive compensation and 10 15 U.S.C. 78f(b)(5). financial processes of NYSE Euronext equity-based plans. As more fully set 11 See Securities Exchange Act Release No. 55293 and of each of its consolidated forth in the Notice, the Exchange (February 14, 2007), 72 FR 8033 (February 22, 2007) subsidiaries; (iii) NYSER has broad represents that the NYSE Arca (SR–NYSE–2006–120). authority to oversee the regulatory Compensation Committee’s assigned 12 See Securities Exchange Act Release No. 58673 (September 29, 2008), 73 FR 57707 (October 3, activities of the Exchange and the other responsibilities with respect to 2008) (SR–Amex–2008–62, SR–NYSE–2008–60) (‘‘NYSE Amex Approval Order’’). 13 See id. 14 See supra notes 11 and 12.

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compensation and personnel matters NYSE Regulation to conduct its (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 overlap with the broader mandate of the regulatory activities with respect to the notice is hereby given that, on June 9, NYSE Euronext Human Resources and Exchange; and (iii) notwithstanding its 2010, New York Stock Exchange LLC Compensation Committee. The regulatory agreements, the Exchange (‘‘NYSE’’ or ‘‘Exchange’’) filed with the Commission notes that the proposed retains ultimate legal responsibility for Securities and Exchange Commission elimination of the NYSE Arca the regulation of its permit holders and (‘‘Commission’’) the proposed rule Compensation Committee is comparable its market and has full authority to take change as described in Items I, II, and to a structure for NYSE and NYSE Amex action to assure that its regulatory III below, which Items have been that the Commission has previously responsibilities are met. Acknowledging prepared by the self-regulatory considered and approved.15 The that it retains ultimate legal organization. The Commission is Commission finds that the proposed responsibility, the Exchange has further publishing this notice to solicit elimination of the NYSE Arca stated that its Board of Directors will comments on the proposed rule change Compensation Committees is consistent directly assume the ROC’s current from interested persons. with the Act. formal responsibility to ensure that I. Self-Regulatory Organization’s Exchange management fully supports Elimination of NYSE Arca Regulatory Statement of the Terms of Substance of the execution of the regulatory process Oversight Committee the Proposed Rule Change and that it retains the authority to direct The Exchange also proposes to NYSER and FINRA to take any action The Exchange proposes to amend eliminate its ROC, and in lieu thereof, necessary to fulfill the Exchange’s proposes to amend [sic] NYSE Rule provide for the exercise of the current statutory and self-regulatory obligations. 123C (‘‘The Closing Procedures’’) to formal responsibilities of the ROC to be The Commission notes that the describe the manner in which Exchange divided between the NYSER Board and proposed elimination of the NYSE Arca systems provide order imbalance the Exchange’s Board. Currently, the ROC is comparable to the structure that information to Floor brokers. The text of ROC is responsible for ensuring (i) the the Commission approved in the NYSE the proposed rule change is available at independence of Exchange regulation; Amex Approval Order.18 The the Exchange, the Commission’s Public (ii) adequate resources for the Exchange Commission finds that the proposed Reference Room, and http:// to properly fulfill its self-regulatory elimination of the NYSE Arca ROC is www.nyse.com. obligations; and (iii) that Exchange consistent with the Act. management fully supports the II. Self-Regulatory Organization’s execution of the regulatory process. III. Conclusion Statement of the Purpose of, and In support of its proposal to eliminate Statutory Basis for, the Proposed Rule It is therefore ordered, pursuant to Change the ROC, the Exchange represents that it Section 19(b)(2) of the Act,19 that the has previously entered into an RSA with proposed rule change (SR–NYSEArca– In its filing with the Commission, the NYSER to perform all of the Exchange’s 2010–31) be, and it hereby is, approved. self-regulatory organization included regulatory functions on the Exchange’s statements concerning the purpose of, behalf; that the Financial Industry For the Commission, by the Division of Trading and Markets, pursuant to delegated and basis for, the proposed rule change Regulatory Authority (‘‘FINRA’’) authority.20 and discussed any comments it received performs some of the regulatory Florence E. Harmon, on the proposed rule change. The text functions contracted out to NYSER of those statements may be examined at Deputy Secretary. pursuant to a separate multi-party the places specified in Item IV below. regulatory services agreement with [FR Doc. 2010–15285 Filed 6–23–10; 8:45 am] The Exchange has prepared summaries, FINRA; 16 and that these regulatory BILLING CODE 8010–01–P set forth in sections A, B, and C below, contractual arrangements closely of the most significant parts of such parallel the regulatory arrangements for statements. SECURITIES AND EXCHANGE NYSE Amex that the Commission COMMISSION A. Self-Regulatory Organization’s reviewed and approved in the NYSE Statement of the Purpose of, and the Amex Approval Order.17 The Exchange [Release No. 34–62312; File No. SR–NYSE– Statutory Basis for, the Proposed Rule states that the proposed elimination of 2010–20] Change its ROC will result in regulatory arrangements similar to those approved Self-Regulatory Organizations; New 1. Purpose York Stock Exchange LLC; Notice of for NYSE Amex. In addition to the The New York Stock Exchange LLC Filing of Proposed Rule Change foregoing, the Exchange specifically (‘‘NYSE’’ or ‘‘Exchange’’) proposes to Amending NYSE Rule 123C To Allow represents that (i) NYSER will provide amend NYSE Rule 123C(6) to specify Exchange Systems To Provide Order a comparable level of independence as that, beginning at 2:00 p.m. on every Imbalance Information With Respect to that of a ROC; (ii) NYSE Euronext has trading day,3 Floor brokers will receive Market At-The-Close and Marketable agreed to provide adequate funding to an electronic communication from Limit At-the-Close Interest to Floor Exchange systems that provides the 15 See supra note 12. Brokers Beginning Two Hours and amount of, and any imbalance between, 16 The Commission notes that on June 14, 2010, Until Fifteen Minutes Prior to the Market ‘‘At-The-Close’’ (‘‘MOC’’) interest NYSE, NYSER, NYSE Amex, and NYSE Arca Scheduled Close of Trading on Every (‘‘NYSE Parties’’) entered into a new multi-party and marketable Limit ‘‘At-The-Close’’ Trading Day regulatory services agreement with FINRA, (‘‘LOC’’) interest to buy and MOC pursuant to which FINRA will perform additional interest and marketable LOC interest to regulatory functions on behalf of the NYSE Parties, June 17, 2010. including market surveillance and enforcement Pursuant to Section 19(b)(1) of the activities. See http://www.nyse.com/press/ Securities Exchange Act of 1934 1 15 U.S.C. 78s(b)(1). 1276509404802.html. See also June 16, 2010 e-mail 2 17 CFR 240.19b–4. correspondence from William Love, Chief Counsel, 3 On any day that the scheduled close of trading NYSE Euronext, to Heidi Pilpel, Special Counsel, 18 See supra note 12. on the Exchange is earlier than 4:00 p.m., the Commission. 19 15 U.S.C. 78s(b)(2). information will be disseminated beginning two 17 See supra note 12. 20 17 CFR 200.30–3(a)(12). hours prior to the scheduled close of trading.

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sell in certain securities.4 The MOC/ brokers may still orally request and Finally, the Exchange proposes to LOC interest is executable only on the receive responses to market probes correct erroneous rule text in Close and is subject to cancellation at directly from DMMs. 123C(6)(a)(v). The rule text incorrectly any time before 3:45 p.m.5 states that the dissemination of the Proposed Amendments to NYSE Rule Order Imbalance Datafeed commences 123C(6) Background 10 minutes prior to the scheduled close Pursuant to NYSE Rule 115 The Exchange proposes to amend of trading on any day that the scheduled (‘‘Disclosure of Orders by DMMs’’), NYSE Rule 123C(6) to state that, close of trading on the Exchange is DMMs may, while acting in a market between 2 p.m. and 3:45 p.m. on any earlier than 4 p.m. The 10 minute making capacity, provide information trading day (or two hours prior to the interval is a legacy time frame related to about buying or selling interest in the closing transaction until 15 minutes the Exchange’s prior publication of market, including (a) Aggregated buying prior to the closing transaction on any imbalance at 3:40 p.m. and 3:50 p.m. or selling interest contained in Floor day that the scheduled close of trading When the Exchange moved to a single broker agency interest files other than on the Exchange is earlier than 4 p.m.), imbalance publication at 3:45 p.m., the interest the broker has chosen to Exchange systems shall automatically rule text should have been modified to exclude from the aggregated buying and provide the MOC/LOC imbalance reflect that dissemination of the Order selling interest, (b) aggregated interest of information to Floor brokers, Imbalance Information on any day that Minimum Display Reserve Orders and approximately every 15 seconds, for any the scheduled close was prior to 4 p.m. (c) the interest included in DMM security in which the Floor broker is would commence approximately 15 interest files, excluding CCS interest as representing an order and in any minutes before the scheduled closing described in Rule 1000(c), in response security that the Floor broker time consistent with the single to an inquiry from a member conducting specifically requests. Specific requests imbalance publication. The Exchange a market probe in the normal course of for information by Floor brokers will not therefore seeks to amend NYSE Rule business. Market probes assist Floor carry over to the next trading day and 123C(6)(a)(v) accordingly. must be re-entered on each trade date brokers in representing customer orders 2. Statutory Basis efficiently and effectively. There is no Floor brokers want to receive the limitation in Rule 115 as to the number information. Beginning at 3:45 p.m., The basis under the Act for the of market probes permitted during the Floor brokers may receive the proposed rule change is the requirement trading day. Exchange’s proprietary Order under Section 6(b)(5),8 which requires Historically, Floor brokers could only Information Imbalance datafeed that an exchange have rules that are orally request a market probe from the pursuant to NYSE Rule 123C(6)(a)(iv). designed to foster cooperation and specialist.6 As the NYSE evolved to a The Exchange provides the Order coordination with persons engaged in more automated trading venue, the Information Imbalance datafeed to regulating, clearing, settling, processing Exchange and the Floor community subscribers for a fee. information with respect to, and The Exchange’s proposed endeavored to address an increase in the facilitating transactions in securities, to dissemination of this MOC/LOC volume of market probes by Floor remove impediments to and perfect the imbalance information is the electronic brokers to specialists in the afternoon mechanism of a free and open market evolution of the market probe response hours leading up to the closing and a national market system and, in that Floor brokers have always been transaction. In May 2008, Exchange general, to protect investors and the entitled to receive and may otherwise systems began electronically providing public interest. The proposed rule orally request directly from DMMs. change is consistent with these to Floor brokers, the amount of, and any While a vast majority of the transactions imbalance between MOC interest and objectives in that the dissemination of executed on the Exchange are MOC/LOC imbalance information marketable LOC interest to buy and automated, Floor brokers play an MOC interest and marketable LOC would provide Floor brokers with an important role for customers in those understanding of developing trends interest to sell in each security in which transactions that require the expertise of a Floor broker is representing an order early enough to get appropriate a professional trading floor agent. direction from their customers and to or in any security that the Floor broker Providing the MOC/LOC imbalance electronically requests such know where on the physical Trading information to Floor brokers is Floor it needs to deploy its brokers in information. In March 2010, as part of appropriate because a key component of changes to the Exchange’s closing preparation for the closing transaction. their role as agent for these Overall, the Exchange believes that process, Exchange systems began sophisticated customers is to provide decrementing the total imbalance dissemination of MOC/LOC imbalance market ‘‘color’’ to the extent permitted information to Floor brokers is between MOC interest and marketable under applicable rules. The Exchange’s LOC interest to buy and MOC interest consistent with the above objectives electronic dissemination of this because it removes impediments to and and marketable LOC interest to sell by information would be limited to the any Closing Offset Orders on the perfects the mechanism of a free and Floor broker hand-held devices, which open market through the efficient opposite side of the imbalance to are unable to automatically forward or calculate the imbalance (the ‘‘MOC/LOC operation of the Exchange. re-transmit the electronic datafeed to Dissemination of MOC/LOC imbalance information’’). The any other location, although Floor dissemination of the MOC/LOC imbalance information to Floor brokers brokers are permitted to provide their would serve as an efficiency tool to imbalance information to Floor brokers customers with specific data points between 2:00 and 3:45 p.m. was 7 from the feed. hand-held device as permitted by the NYSE’s deactivated on May 17, 2010. Floor ‘‘Wireless Data Communications Initiatives’’ (See 7 Current NYSE rules permit a Floor broker to Securities Exchange Act Release No. 59626 (March 4 The Exchange notes that parallel changes are communicate information obtained through a 25, 2009), 74 FR 14831 (April 1, 2009) (SR–NYSE– proposed to the rules of its affiliate, NYSE Amex market probe to a customer using a wired telephone 2009–33). The Exchange records all of the LLC. See SR–NYSEAmex–2010–25. line (NYSE Rule 36.20), an NYSE approved portable information sent to and transmitted from the hand- 5 See NYSE Rule 123C(3) and (9). phone (NYSE Rule 36.21), or through a written held devices. 6 The specialist is the predecessor to the DMM. electronic communication from the Floor brokers’ 8 15 U.S.C. 78f(b)(5).

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enhance the Floor brokers’ ability to C. Self-Regulatory Organization’s Commission and any person, other than meet their best execution obligations in Statement on Comments on the those that may be withheld from the the face of a dilemma that is unique to Proposed Rule Change Received From public in accordance with the a physical Trading Floor, i.e., how to Members, Participants, or Others provisions of 5 U.S.C. 552, will be position resources so that they are in the No written comments were solicited available for Web site viewing and correct place to execute orders on behalf or received with respect to the proposed printing in the Commission’s Public of sophisticated customers whose needs rule change. Reference Room, 100 F Street, NE., are not effectively met by strictly Washington, DC 20549, on official electronic trading. While the imbalance III. Date of Effectiveness of the business days between the hours of 10 information is important to Floor Proposed Rule Change and Timing for a.m. and 3 p.m. Copies of such filing brokers in carrying out their obligations Commission Action also will be available for inspection and to those customers, the Exchange Within 35 days of the date of copying at the principal office of the believes this information would not be publication of this notice in the Federal Exchange. All comments received will material to market participants Register or within such longer period (i) be posted without change; the executing automated orders. In this as the Commission may designate up to Commission does not edit personal regard, the Exchange believes it is 90 days of such date if it finds such identifying information from appropriate to provide Floor brokers longer period to be appropriate and submissions. You should submit only with specific types of information that publishes its reasons for so finding or information that you wish to make is directly related to the unique (ii) as to which the self-regulatory available publicly. All submissions functions they perform on the Trading organization consents, the Commission should refer to File Number SR–NYSE– Floor. will: 2010–20 and should be submitted on or before July 15, 2010. In this particular case, the Exchange (A) By order approve such proposed believes that the dissemination of MOC/ rule change, or For the Commission, by the Division of LOC information to Floor brokers would (B) Institute proceedings to determine Trading and Markets, pursuant to delegated 11 promote the efficient operation of the whether the proposed rule change authority. Exchange’s market by reducing the should be disapproved. Florence E. Harmon, Deputy Secretary. frequency of time-consuming Floor IV. Solicitation of Comments broker oral market probes leading up to [FR Doc. 2010–15246 Filed 6–23–10; 8:45 am] the closing transaction, thus affording Interested persons are invited to BILLING CODE 8010–01–P DMMs more time to monitor trading. As submit written data, views, and trading has become more electronic, arguments concerning the foregoing, staffing on the trading Floor has including whether the proposed rule SECURITIES AND EXCHANGE declined, so that there are now fewer change is consistent with the Act. COMMISSION Floor brokers even as the number of Comments may be submitted by any of listed securities has increased.9 the following methods: [Release No. 34–62311; File No. SR– Similarly, DMM units and individual Electronic Comments NYSEAmex–2010–25] DMMs on the Floor are managing • trading in greater numbers of stocks Use the Commission’s Internet Self-Regulatory Organizations; NYSE than ever before. The need for DMMs to comment form (http://www.sec.gov/ Amex LLC; Notice of Filing of rules/sro.shtml); or Proposed Rule Change Amending be focused on their assigned securities, • particularly on high volume trading Send an e-mail to rule- NYSE Amex Rule 123C To Allow days, such as an Expiration Friday or an [email protected]. Please include File Exchange Systems To Provide Order index rebalancing event, or trading days Number SR–NYSE–2010–20 on the Imbalance Information With Respect to with high levels of market volatility, is subject line. Market At-the-Close and Marketable critical to the maintenance of fair and Paper Comments Limit At-the-Close Interest to Floor 10 Brokers Beginning Two Hours and orderly markets. • Send paper comments in triplicate Until Fifteen Minutes Prior to the B. Self-Regulatory Organization’s to Elizabeth M. Murphy, Secretary, Scheduled Close of Trading on Every Statement on Burden on Competition Securities and Exchange Commission, Trading Day 100 F Street, NE., Washington, DC The Exchange does not believe that 20549–1090. June 17, 2010. the proposed rule change will impose All submissions should refer to File Pursuant to Section 19(b)(1) of the any burden on competition that is not Number SR–NYSE–2010–20. This file Securities Exchange Act of 1934 necessary or appropriate in furtherance number should be included on the (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 of the purposes of the Act. subject line if e-mail is used. To help the notice is hereby given that, on June 9, Commission process and review your 2010, NYSE Amex LLC (‘‘NYSE Amex’’ 9 The number of Floor brokers operating on the comments more efficiently, please use ‘‘ ’’ Exchange Floor has decreased since 2004 from or Exchange ) filed with the Securities approximately 800 Floor brokers to approximately only one method. The Commission will and Exchange Commission 325 Floor brokers operating on the Floor today. post all comments on the Commission’s (‘‘Commission’’) the proposed rule 10 It should be noted that NYSE rules and the Internet Web site (http://www.sec.gov/ change as described in Items I, II, and Federal securities laws provide safeguards that are rules/sro.shtml). Copies of the III below, which Items have been designed to deter the potential abuse of market probe information. For example, Floor broker submission, all subsequent prepared by the self-regulatory member organizations are not permitted to initiate amendments, all written statements organization. The Commission is proprietary orders on the Floor. In addition, Floor with respect to the proposed rule publishing this notice to solicit brokers representing a principal or proprietary change that are filed with the order that has been initiated in the off-Floor premises of the firm are subject to the requirements Commission, and all written 11 17 CFR 200.30–3(a)(12). of Section 11(a) of the Securities Exchange Act of communications relating to the 1 15 U.S.C. 78s(b)(1). 1934. proposed rule change between the 2 17 CFR 240.19b–4.

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comments on the proposed rule change DMMs may, while acting in a market day that the scheduled close of trading from interested persons. making capacity, provide information on the Exchange is earlier than 4 p.m.), about buying or selling interest in the Exchange systems shall automatically I. Self-Regulatory Organization’s market, including (a) Aggregated buying provide the MOC/LOC imbalance Statement of the Terms of Substance of or selling interest contained in Floor information to Floor brokers, the Proposed Rule Change broker agency interest files other than approximately every 15 seconds, for any The Exchange proposes to amend interest the broker has chosen to security in which the Floor broker is NYSE Amex Rule 123C (‘‘The Closing exclude from the aggregated buying and representing an order and in any Procedures’’) to describe the manner in selling interest, (b) aggregated interest of security that the Floor broker which Exchange systems provide order Minimum Display Reserve Orders and specifically requests. Specific requests imbalance information to Floor brokers. (c) the interest included in DMM for information by Floor brokers will not The text of the proposed rule change is interest files, excluding CCS interest as carry over to the next trading day and available at the Exchange, the described in Rule 1000(c), in response must be re-entered on each trade date Commission’s Public Reference Room, to an inquiry from a member conducting Floor brokers want to receive the and http://www.nyse.com. a market probe in the normal course of information. Beginning at 3:45 p.m., II. Self-Regulatory Organization’s business. Market probes assist Floor Floor brokers may receive the Statement of the Purpose of, and brokers in representing customer orders Exchange’s proprietary Order Statutory Basis for, the Proposed Rule efficiently and effectively. There is no Information Imbalance datafeed Change limitation in Rule 115 as to the number pursuant to NYSE Amex Rule of market probes permitted during the 123C(6)(a)(iv). The Exchange provides In its filing with the Commission, the trading day. the Order Information Imbalance self-regulatory organization included Historically, Floor brokers could only datafeed to subscribers for a fee. statements concerning the purpose of, orally request a market probe from the The Exchange’s proposed and basis for, the proposed rule change specialist.6 As the NYSE Amex evolved dissemination of this MOC/LOC and discussed any comments it received to a more automated trading venue, the imbalance information is the electronic on the proposed rule change. The text Exchange and the Floor community evolution of the market probe response of those statements may be examined at endeavored to address an increase in the that Floor brokers have always been the places specified in Item IV below. volume of market probes by Floor entitled to receive and may otherwise The Exchange has prepared summaries, brokers to specialists in the afternoon orally request directly from DMMs. set forth in sections A, B, and C below, hours leading up to the closing While a vast majority of the transactions of the most significant parts of such transaction. In May 2008, Exchange executed on the Exchange are statements. systems began electronically providing automated, Floor brokers play an A. Self-Regulatory Organization’s to Floor brokers, the amount of, and any important role for customers in those Statement of the Purpose of, and the imbalance between MOC interest and transactions that require the expertise of Statutory Basis for, the Proposed Rule marketable LOC interest to buy and a professional trading floor agent. Change MOC interest and marketable LOC Providing the MOC/LOC imbalance interest to sell in each security in which information to Floor brokers is 1. Purpose a Floor broker is representing an order appropriate because a key component of NYSE Amex LLC (‘‘NYSE Amex’’ or or in any security that the Floor broker their role as agent for these ‘‘Exchange’’) proposes to amend NYSE electronically requests such sophisticated customers is to provide Amex Rule 123C(6) to specify that, information. In March 2010, as part of market ‘‘color’’ to the extent permitted beginning at 2:00 p.m. on every trading changes to the Exchange’s closing under applicable rules. The Exchange’s day,3 Floor brokers will receive an process, Exchange systems began electronic dissemination of this electronic communication from decrementing the total imbalance information would be limited to the Exchange systems that provides the between MOC interest and marketable Floor broker hand-held devices, which amount of, and any imbalance between, LOC interest to buy and MOC interest are unable to automatically forward or Market ‘‘At-The-Close’’ (‘‘MOC’’) interest and marketable LOC interest to sell by re-transmit the electronic datafeed to and marketable Limit ‘‘At-The-Close’’ any Closing Offset Orders on the any other location, although Floor (‘‘LOC’’) interest to buy and MOC opposite side of the imbalance to brokers are permitted to provide their interest and marketable LOC interest to calculate the imbalance (the ‘‘MOC/LOC customers with specific data points sell in certain securities.4 The MOC/ imbalance information’’). The from the feed.7 LOC interest is executable only on the dissemination of the MOC/LOC Finally, the Exchange proposes to Close and is subject to cancellation at imbalance information to Floor brokers correct erroneous rule text in any time before 3:45 p.m.5 between 2 and 3:45 p.m. was 123C(6)(a)(v). The rule text incorrectly deactivated on May 17, 2010. Floor Background states that the dissemination of the brokers may still orally request and Order Imbalance Datafeed commences Pursuant to NYSE Amex Rule 115 receive responses to market probes 10 minutes prior to the scheduled close (‘‘Disclosure of Orders by DMMs’’), directly from DMMs. 7 Current NYSE Amex rules permit a Floor broker 3 Proposed Amendments to NYSE Amex See e-mail from Theodore R. Lazo, NYSE to communicate information obtained through a Euronext, to Steve Kuan, Securities and Exchange Rule 123C(6) market probe to a customer using a wired telephone Commission, on June 16, 2010 (‘‘June 16, 2010 The Exchange proposes to amend line (NYSE Amex Rule 36.20), an NYSE Amex e-mail’’). On any day that the scheduled close of approved portable phone (NYSE Amex Rule 36.21), trading on the Exchange is earlier than 4:00 p.m., NYSE Amex Rule 123C(6) to state that, or through a written electronic communication from the information will be disseminated beginning two between 2:00 p.m. and 3:45 p.m. on any the Floor brokers’ hand-held device as permitted by hours prior to the scheduled close of trading. trading day (or two hours prior to the the NYSE Amex’s ‘‘Wireless Data Communications 4 The Exchange notes that parallel changes are closing transaction until 15 minutes Initiatives’’ (See Securities Exchange Act Release proposed to the rules of its affiliate, the New York No. 59627 (March 25, 2009), 74 FR 14834 (April 1, Stock Exchange LLC. See SR–NYSE–2010–20 and prior to the closing transaction on any 2009) (SR–NYSEAmex–2009–02). See June 16, 2010 June 16, 2010 e-mail. e-mail. The Exchange records all of the information 5 See NYSE Rule 123C(3) and (9). 6 The specialist is the predecessor to the DMM. sent to and transmitted from the hand-held devices.

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of trading on any day that the scheduled believes this information would not be Register or within such longer period (i) close of trading on the Exchange is material to market participants as the Commission may designate up to earlier than 4 p.m. The 10 minute executing automated orders. In this 90 days of such date if it finds such interval is a legacy time frame related to regard, the Exchange believes it is longer period to be appropriate and the Exchange’s prior publication of appropriate to provide Floor brokers publishes its reasons for so finding or imbalance at 3:40 p.m. and 3:50 p.m. with specific types of information that (ii) as to which the self-regulatory When the Exchange moved to a single is directly related to the unique organization consents, the Commission imbalance publication at 3:45 p.m., the functions they perform on the Trading will: rule text should have been modified to Floor. (A) By order approve such proposed reflect that dissemination of the Order In this particular case, the Exchange rule change, or Imbalance Information on any day that believes that the dissemination of MOC/ (B) Institute proceedings to determine the scheduled close was prior to 4 p.m. LOC information to Floor brokers would whether the proposed rule change would commence approximately 15 promote the efficient operation of the should be disapproved. minutes before the scheduled closing Exchange’s market by reducing the IV. Solicitation of Comments time consistent with the single frequency of time-consuming Floor imbalance publication. The Exchange broker oral market probes leading up to Interested persons are invited to therefore seeks to amend NYSE Amex the closing transaction, thus affording submit written data, views, and Rule 123C(6)(a)(v) accordingly. DMMs more time to monitor trading. As arguments concerning the foregoing, trading has become more electronic, including whether the proposed rule 2. Statutory Basis staffing on the trading Floor has change is consistent with the Act. The basis under the Act for the declined, so that there are now fewer Comments may be submitted by any of proposed rule change is the requirement Floor brokers even as the number of the following methods: 8 9 under Section 6(b)(5), which requires listed securities has increased. Electronic Comments that an exchange have rules that are Similarly, DMM units and individual • designed to foster cooperation and DMMs on the Floor, are managing Use the Commission’s Internet coordination with persons engaged in trading in greater numbers of stocks comment form (http://www.sec.gov/ regulating, clearing, settling, processing rules/sro.shtml); or than ever before. The need for DMMs to • information with respect to, and be focused on their assigned securities, Send an e-mail to rule- facilitating transactions in securities, to particularly on high volume trading [email protected]. Please include File remove impediments to and perfect the days, such as an Expiration Friday or an Number SR–NYSEAmex–2010–25 on mechanism of a free and open market index rebalancing event, or trading days the subject line. and a national market system and, in with high levels of market volatility, is Paper Comments general, to protect investors and the critical to the maintenance of fair and • Send paper comments in triplicate public interest. The proposed rule orderly markets.10 change is consistent with these to Elizabeth M. Murphy, Secretary, objectives in that the dissemination of B. Self-Regulatory Organization’s Securities and Exchange Commission, MOC/LOC imbalance information Statement on Burden on Competition 100 F Street, NE., Washington, DC would provide Floor brokers with an The Exchange does not believe that 20549–1090. understanding of developing trends the proposed rule change will impose All submissions should refer to File early enough to get appropriate any burden on competition that is not Number SR–NYSEAmex–2010–25. This direction from their customers and to necessary or appropriate in furtherance file number should be included on the know where on the physical Trading of the purposes of the Act. subject line if e-mail is used. To help the Floor it needs to deploy its brokers in Commission process and review your C. Self-Regulatory Organization’s comments more efficiently, please use preparation for the closing transaction. Statement on Comments on the Overall, the Exchange believes that only one method. The Commission will Proposed Rule Change Received From post all comments on the Commission’s dissemination of MOC/LOC imbalance Members, Participants, or Others information to Floor brokers is Internet Web site (http://www.sec.gov/ consistent with the above objectives No written comments were solicited rules/sro.shtml). Copies of the because it removes impediments to and or received with respect to the proposed submission, all subsequent perfects the mechanism of a free and rule change. amendments, all written statements open market through the efficient III. Date of Effectiveness of the with respect to the proposed rule operation of the Exchange. Proposed Rule Change and Timing for change that are filed with the Dissemination of MOC/LOC Commission Action Commission, and all written imbalance information to Floor brokers communications relating to the would serve as an efficiency tool to Within 35 days of the date of proposed rule change between the enhance the Floor brokers’ ability to publication of this notice in the Federal Commission and any person, other than meet their best execution obligations in those that may be withheld from the the face of a dilemma that is unique to 9 The number of Floor brokers operating on the public in accordance with the Exchange Floor has decreased since 2004 from a physical Trading Floor, i.e., how to approximately 800 Floor brokers to approximately provisions of 5 U.S.C. 552, will be position resources so that they are in the 325 Floor brokers operating on the Floor today. available for Web site viewing and correct place to execute orders on behalf 10 It should be noted that NYSE rules and the printing in the Commission’s Public of sophisticated customers whose needs Federal securities laws provide safeguards that are Reference Room, 100 F Street, NE., designed to deter the potential abuse of market are not effectively met by strictly probe information. For example, Floor broker Washington, DC 20549, on official electronic trading. While the imbalance member organizations are not permitted to initiate business days between the hours of 10 information is important to Floor proprietary orders on the Floor. In addition, Floor a.m. and 3 p.m. Copies of such filing brokers in carrying out their obligations brokers representing a principal or proprietary also will be available for inspection and order that has been initiated in the off-Floor to those customers, the Exchange premises of the firm are subject to the requirements copying at the principal office of the of Section 11(a) of the Securities Exchange Act of Exchange. All comments received will 8 15 U.S.C. 78f(b)(5). 1934. be posted without change; the

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Commission does not edit personal order that cannot be executed upon remove impediments to and perfect the identifying information from entry, or placed on the Exchange’s limit mechanism for a free and open market submissions. You should submit only order book, will be automatically and a national market system, and in information that you wish to make cancelled. general, to protect investors and the available publicly. All submissions public interest. In particular, the Supplementary Material to Rule 715 should refer to File Number SR– proposal will give customers greater NYSEAmex–2010–25 and should be .01 no change. control over where their orders are submitted on or before July 15, 2010. *** executed if they so choose. For the Commission, by the Division of II. Self-Regulatory Organization’s B. Self-Regulatory Organization’s Trading and Markets, pursuant to delegated Statement of the Purpose of, and Statement on Burden on Competition authority.11 Statutory Basis for, the Proposed Rule The proposed rule change does not Florence E. Harmon, Change impose any burden on competition that Deputy Secretary. In its filing with the Commission, the is not necessary or appropriate in [FR Doc. 2010–15245 Filed 6–23–10; 8:45 am] self-regulatory organization included furtherance of the purposes of the BILLING CODE 8010–01–P statements concerning the purpose of, Exchange Act. and basis for, the proposed rule change and discussed any comments it received C. Self-Regulatory Organization’s SECURITIES AND EXCHANGE on the proposed rule change. The text Statement on Comments on the COMMISSION of these statements may be examined at Proposed Rule Change Received from Members, Participants or Others [Release No. 34–62301; File No. SR–ISE– the places specified in Item IV below. 2010–49] The self-regulatory organization has The Exchange has not solicited, and prepared summaries, set forth in does not intend to solicit, comments on Self-Regulatory Organizations; sections A, B and C below, of the most this proposed rule change. The International Securities Exchange, significant aspects of such statements. Exchange has not received any LLC; Notice of Filing and Immediate unsolicited written comments from Effectiveness of Proposed Rule A. Self-Regulatory Organization’s members or other interested parties. Change Related to Do-Not-Route Statement of the Purpose of, and Orders Statutory Basis for, the Proposed Rule III. Date of Effectiveness of the Change Proposed Rule Change and Timing for June 16, 2010. (1) Purpose—The Exchange’s rules Commission Action Pursuant to Section 19(b)(1) of the related to intermarket linkage provide, Because the foregoing proposed rule Securities Exchange Act of 1934 (the change does not: (i) Significantly affect 1 among other things, that transactions ‘‘Exchange Act’’), and Rule 19b–4 the protection of investors or the public 2 not be executed at prices that are thereunder, notice is hereby given that inferior to the national best bid or offer interest; (ii) impose any significant on June 14, 2010, the International (the ‘‘trade-through rule’’).3 Currently, burden on competition; and (iii) become Securities Exchange, LLC (the the Exchange cancels marketable non- operative for 30 days after the date of ‘‘ ’’ ‘‘ ’’ Exchange or the ISE ) filed with the customer orders that cannot be executed the filing, or such shorter time as the Securities and Exchange Commission because its prices are inferior to the Commission may designate, it has ‘‘ ’’ ‘‘ ’’ (the SEC or the Commission ) the national best bid or offer, while such become effective pursuant to Section proposed rule change as described in marketable customer orders are 19(b)(3)(A) of the Act 6 and Rule 19b– Items I, II, and III below, which items presented to the primary market maker 4(f)(6) thereunder.7 have been prepared by the self- for handling.4 The Exchange is At any time within 60 days of the regulatory organization. The proposing to adopt a do-not-route order filing of the proposed rule change, the Commission is publishing this notice to so that customers may indicate that they Commission may summarily abrogate solicit comments on the proposed rule want their orders canceled if they are such rule change if it appears to the change from interested persons. marketable, but not executable on the Commission that such action is I. Self-Regulatory Organization’s Exchange. If a customer order is not necessary or appropriate in the public Statement of the Terms of Substance of marked as a do-not-route order, it would interest, for the protection of investors, the Proposed Rule Change continue to be presented to the primary or otherwise in furtherance of the purposes of the Act. The Exchange proposes to adopt a do- market maker for handling if it is not-route order type. The text of the rule marketable but not executable on the IV. Solicitation of Comments Exchange. A do-not-route order is a amendment is as follows (additions are Interested persons are invited to in italics): market or limit order. This order type is commonly offered on other exchanges.5 submit written data, views, and Rule 715. Types of Orders (2) Basis—The basis under the arguments concerning the foregoing, Securities Exchange Act of 1934 including whether the proposed rule (a) through (l) no change. change is consistent with the Act. (m) Do-Not-Route Orders. A do-not- (‘‘Exchange Act’’) for this proposed rule Comments may be submitted by any of route order is a market or limit order change is the requirement under Section the following methods: that is to be executed in whole or in part 6(b)(5) that an exchange have rules that on the Exchange only. Due to prices are designed to promote just and equitable principles of trade, and to 6 15 U.S.C. 78s(b)(3)(A). available on another options exchange 7 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– (as provided in Chapter 19 (Order 4(f)(6)(iii) requires the self-regulatory organization Protection; Locked and Crossed 3 ISE Rule 1901 (Order Protection). to submit to the Commission written notice of its Markets)), any balance of a do-not-route 4 ISE Rule 714 (Automatic Execution of Orders). intent to file the proposed rule change, along with 5 E.g., NYSE Arca Rule 6.62(p) (PNP Orders are a brief description and text of the proposed rule not routable orders); NASDAQ OMX PHLX Rule change, at least five business days prior to the date 11 17 CFR 200.30–3(a)(12). 1066(c)(8) (Immediate or Cancel Orders are not of filing of the proposed rule change, or such 1 15 U.S.C. 78s(b)(1). routable orders); and CBOE Rule 6.53(s) (CBOE shorter time as designated by the Commission. The 2 17 CFR 240.19b–4. Only orders are not routable orders). Exchange has satisfied this requirement.

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Electronic Comments SECURITIES AND EXCHANGE to have the capacity to be able to carry out the purposes of the Act and to • COMMISSION Use the Commission’s Internet comply, and to enforce compliance by comment form (http://www.sec.gov/ [Release No. 34–62323; File No. SR–C2– 2010–002] its members and persons associated rules/sro.shtml); or with its members, with the provisions of • Send an e-mail to rule- Self-Regulatory Organizations; C2 the Act, the rules and regulations [email protected]. Please include File Options Exchange, Incorporated; thereunder, and the rules of C2. The Number SR–ISE–2010–49 on the subject Order Granting Approval of a Commission also finds that this filing line. Proposed Rule Change Relating to the furthers the objectives of Section 6(b)(5) Corporate Restructuring of C2 in of the Act insofar as it would result in Paper Comments Connection With the Demutualization an exchange governance structure of the Chicago Board Options • Send paper comments in triplicate designed to prevent fraudulent and Exchange, Incorporated to Elizabeth M. Murphy, Secretary, manipulative acts and practices, to Securities and Exchange Commission, June 17, 2010. promote just and equitable principles of 100 F Street, NE., Washington, DC trade, to remove impediments to, and I. Introduction 20549–1090. perfect the mechanism of a free and On May 14, 2010, pursuant to Section open market and, in general, to protect All submissions should refer to File 19(b)(1) of the Securities Exchange Act investors and the public interest.8 In Number SR–ISE–2010–49. This file of 1934 (‘‘Act’’),1 and Rule 19b–4 particular, the Commission believes that number should be included on the thereunder,2 C2 Options Exchange, the Certificate of Incorporation and subject line if e-mail is used. To help the Incorporated (‘‘C2’’) filed with the Bylaws of CBOE Holdings and C2 are Commission process and review your Securities and Exchange Commission designed to protect and maintain the comments more efficiently, please use (‘‘Commission’’) a proposed rule change integrity of the self-regulatory functions only one method. The Commission will relating to its corporate structure in of C2 and to allow it to carry out it post all comments on the Commission’s connection with the plan of its parent regulatory responsibilities under the Internet Web site (http://www.sec.gov/ company, the Chicago Board Options Act. Exchange, Incorporated (‘‘CBOE’’), to rules/sro.shtml). Copies of the C2 is currently a wholly-owned restructure from a Delaware non-stock submission, all subsequent subsidiary of CBOE.9 When the amendments, all written statements corporation to a Delaware stock corporation that would be a corporate restructuring in connection with respect to the proposed rule with the CBOE Demutualization is change that are filed with the wholly-owned subsidiary of CBOE Holdings, Inc. (‘‘CBOE Holdings’’), a complete, CBOE will become a wholly- Commission, and all written owned subsidiary of CBOE Holdings. At communications relating to the holding company organized as a ‘‘ the same time, C2 has proposed to proposed rule change between the Delaware stock corporation ( CBOE ’’ 3 become a wholly-owned subsidiary Commission and any person, other than Demutualization ). The proposed rule change was published for comment in CBOE Holdings by having CBOE those that may be withheld from the the Federal Register on May 25, 2010.4 dividend-up to CBOE Holdings all of the public in accordance with the 10 The Commission received no comments shares of C2. Consequently, after the provisions of 5 U.S.C. 552, will be on the proposal. corporate restructuring in connection available for Web site viewing and with the CBOE Demutualization is printing in the Commission’s Public II. Discussion and Commission completed, CBOE Holdings would hold Reference Room, on official business Findings all of the outstanding common stock of days between the hours of 10 a.m. and After careful review of the proposal, both C2 and CBOE, as well as certain 3 p.m. Copies of the filing also will be the Commission finds that the proposed other entities that are currently available for inspection and copying at rule change is consistent with the the principal office of the Exchange. All requirements of the Act and the rules 8 15 U.S.C. 78f(b)(5). comments received will be posted and regulations thereunder applicable to 9 See Securities Exchange Act Release No. 61152 without change; the Commission does a national securities exchange.5 In (December 10, 2009), 74 FR 66699 (December 16, particular, as discussed in more detail 2009) (File No. 10–191) (order approving the not edit personal identifying application of C2 for registration as a national information from submissions. You below, the Commission finds that the securities exchange). See also Securities Exchange should submit only information that proposed rule change is consistent with Act Release No. 61140 (December 10, 2009), 74 FR you wish to make available publicly. All Section 6(b) of the Act 6 in general, and 67294 (December 18, 2009) (SR–CBOE–2009–048) furthers the objectives of Section 6(b)(1) (order approving a proposed rule change regarding submissions should refer to File authority over C2 Options Exchange, Incorporated). 7 Number SR–ISE–2010–49 and should be of the Exchange Act, in particular, in 10 After the restructuring, the owners of submitted on or before July 15, 2010. that it enables C2 to be so organized as membership interests in CBOE will become stockholders of CBOE Holdings through the For the Commission, by the Division of 1 15 U.S.C. 78s(b)(1). conversion of their memberships into shares of Trading and Markets, pursuant to delegated 2 17 CFR 240.19b–4. common stock of CBOE Holdings. In addition, members of the settlement class in the lawsuit authority.8 3 See Securities Exchange Act Release No. 62158 brought by The Board of Trade of the City of (May 24, 2010), 75 FR 30082 (May 28, 2010) (SR– Florence E. Harmon, Chicago, Inc., its parent company, CME Group, Inc., CBOE–2008–88) (order approving the CBOE and a class of individuals (collectively, the ‘‘CBOT Deputy Secretary. Demutualization). Parties’’) against CBOE and CBOE’s board of 4 [FR Doc. 2010–15242 Filed 6–23–10; 8:45 am] See Securities Exchange Act Release No. 62118 directors will become stockholders of CBOE (May 18, 2010), 75 FR 29375. BILLING CODE 8011–01–P Holdings. CME Group Inc. et al. v. CBOE Inc. et al., 5 In approving the proposed rule change, the Civil Action No. 2369–VCN (Filed Aug. 23, 2006). Commission has considered its impact on CBOE entered into a Stipulation of Settlement efficiency, competition, and capital formation. See (‘‘Stipulation’’) on August 20, 2008 with the CBOT 15 U.S.C. 78c(f). Parties to resolve this lawsuit. The Stipulation and 6 15 U.S.C. 78f. amendments to it can be found at (http:// 8 17 CFR 200.30–3(a)(12). 7 15 U.S.C. 78f(b)(1). www.cboe.org/Legal/).

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subsidiaries of CBOE.11 C2 and CBOE, though a wholly-owned subsidiary of CBOE Holdings, and not be used for any however, would continue to be CBOE Holdings, is able to maintain the commercial purposes.18 CBOE Holdings separately registered national securities independence of its self-regulatory Certificate of Incorporation also exchanges under Section 6 of the Act 12 function and operate unencumbered in contains a provision requiring each and would continue to operate their a manner that complies with the federal director of the CBOE Holdings board to exchange businesses and facilities. securities laws, and, along with the take into consideration the effect that The Commission recently approved Commission, is able to fulfill its CBOE Holdings’ actions would have on C2’s registration as a national securities regulatory and oversight obligations CBOE’s ability to carry out its exchange and, in that context, approved under the Act. responsibilities under the Act.19 C2’s Certificate of Incorporation and Specifically, the Certificate of Pursuant to the CBOE Holdings Bylaws.13 In connection with its Incorporation of CBOE Holdings Certificate of Incorporation, for so long currently proposed corporate provides that CBOE Holdings, its as CBOE Holdings controls any restructuring, C2 does not propose any officers, directors, employees, and Regulated Securities Exchange significant changes to these governing agents must irrevocably submit to the Subsidiary, each officer, director and documents but does propose, as jurisdiction of the United States federal employee of CBOE Holdings must give discussed further below, to make certain courts, the Commission, and the due regard to the preservation of the changes to its Certificate of Regulated Securities Exchange independence of the self-regulatory Incorporation to effect the change of Subsidiaries 15 for the purposes of any function of the Regulated Securities ownership of C2 from CBOE to CBOE suit, action or proceeding pursuant to Exchange Subsidiaries and to their Holdings, to clarify certain aspects of the United States federal securities laws, obligations under the Exchange Act.20 C2’s Bylaws as a result of this transfer and the rules and regulations Finally, CBOE Holdings Certificate of of ownership, and to make certain thereunder, commenced or initiated by Incorporation provides that for so long ministerial changes to C2’s Certificate of the Commission arising out of, or as CBOE Holdings controls any Incorporation and Bylaws. relating to, the Regulated Securities Regulated Securities Exchange 16 CBOE Holdings Exchange Subsidiaries’ activities. Subsidiary, before any amendment, Further, so long as CBOE Holdings alteration or repeal of any provision of As mentioned above, C2 is now controls any Regulated Securities the Certificate of Incorporation and proposing a corporate restructuring that Exchange Subsidiaries, the books, Bylaws of CBOE Holdings becomes would transfer ownership of C2 from records, premises, officers, directors, effective, such amendment, alteration or CBOE to CBOE Holdings. C2 is not and employees of CBOE Holdings is repeal will be submitted to the board of proposing any changes to the governing deemed to be the books, records, directors of each Regulated Securities documents of CBOE Holdings, which premises, officers, directors, and Exchange Subsidiary, and if such already contemplate the ownership by employees of the Regulated Securities amendment, alteration or repeal must be CBOE Holdings of one or more self- Exchange Subsidiary for purposes of filed with or filed with and approved by ‘‘ ’’ regulatory organizations ( SRO ) (e.g., and subject to oversight pursuant to the the Commission, then such amendment, ‘‘ CBOE and C2) (the Regulated Securities Act to the extent that they relate to the alteration or repeal will not become ’’ 14 Exchange Subsidiaries ). business of such Regulated Securities effective until filed with or filed with Consequently, CBOE Holdings’ Exchange Subsidiary.17 In addition, all and approved by the Commission, as the Certificate of Incorporation and Bylaws confidential information pertaining to case may be.21 approved by the Commission in the self-regulatory function of Regulated In approving the CBOE connection with the CBOE Securities Exchange Subsidiaries Demutualization and permitting CBOE Demutualization will continue to govern contained in the books and records of an Holdings to wholly own CBOE, the the activities of CBOE Holdings. exchange that comes into the possession Commission noted that the governing Although CBOE Holdings is not itself of CBOE Holdings must not be made documents of CBOE Holdings are an SRO, its activities with respect to the available to any persons other than to designed to facilitate Regulated operation of any SRO subsidiary, those officers, directors, employees and Securities Exchange Subsidiaries’ ability including C2, must be consistent with, agents of CBOE Holdings that have a to fulfill their self-regulatory obligations and must not interfere with, the self- reasonable need to know the contents and are, therefore, consistent with the regulatory obligations of that SRO 22 thereof, be retained in confidence by Act. C2’s proposal to become a subsidiary. To this end, certain CBOE Holdings and the officers, wholly-owned subsidiary of CBOE provisions of CBOE Holdings’ directors, employees and agents of Holdings is identical to the SRO Certificate of Incorporation and the ownership structure the Commission Bylaws are designed to ensure that C2, 15 ‘‘Regulated Securities Exchange Subsidiary’’ approved in the CBOE Demutualization means any national securities exchange controlled, 11 These subsidiaries are: CBOE Futures directly or indirectly, by the Corporation, including, 18 Notwithstanding this restriction, nothing in the Exchange, LLC, which operates an electronic but not limited to CBOE. See Article Fifth(xi) of the CBOE Holdings Certificate of Incorporation is to be futures exchange; Chicago Options Exchange CBOE Holdings Certificate of Incorporation. Thus, interpreted so as to limit or impede the rights of the Building Corporation, which owns the building in C2 as a registered national securities exchange Commission or CBOE to access and examine such which CBOE operates; CBOE, LLC, which holds a would fit within the definition of a Regulated confidential information or to limit or impede the 24.01% interest in OneChicago, LLC, a security Securities Exchange Subsidiary. ability of any officers, directors, employees or futures exchange; CBOE II, LLC, which has no 16 See Article Fourteen of the CBOE Holdings agents of CBOE Holdings to disclose such assets or activities; DerivaTech Corporation, which Certificate of Incorporation. confidential information to the Commission or owns certain educational software; Market Data 17 The books and records of CBOE Holdings CBOE. See Article Fifteen of the CBOE Holdings Express, LLC, which distributes various types of relating to the business of a Regulated Securities Certificate of Incorporation. 19 market data; and The Options Exchange, Exchange Subsidiary is subject at all times to See Article Sixteen(d) of the CBOE Holdings Incorporated, which currently has no assets or inspection and copying by the Commission and the Certificate of Incorporation. activities. Regulated Securities Exchange Subsidiary. See 20 See Article Sixteen(c) of the CBOE Holdings 12 15 U.S.C. 78f. Article Fifteen of the CBOE Holdings Certificate of Certificate of Incorporation. 13 See Securities Exchange Act Release No. 61152, Incorporation. In addition, the CBOE Holdings 21 See Article Eleven of the CBOE Holdings supra note 9. Bylaws provide that the books of CBOE Holdings Certificate of Incorporation and Section 10.2 of the 14 See infra note 15 (discussing the term must be kept within the United States. See Section CBOE Holdings Bylaws. ‘‘Regulated Securities Exchange Subsidiary’’). 1.3 of the CBOE Holdings Bylaws. 22 See supra note 3.

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and does not raise any new regulatory C2’s Bylaws as a result of this transfer rules, and also incorporate by reference issues. Consistent with its approval of of ownership, and to make certain certain CBOE rules, C2 also proposes to the CBOE Demutualization, the ministerial changes to C2’s Certificate of make minor, non-substantive changes to Commission similarly believes that the Incorporation and Bylaws. Namely, C2 its rules to reflect the changes in governing documents of CBOE Holdings proposes to amend its Certificate of terminology and other technical changes are designed to protect the Incorporation in connection with the that CBOE plans to make to its rules in independence of the self-regulatory transfer of ownership of all of the connection with the CBOE function of a wholly-owned C2, enable common stock of C2 from CBOE to Demutualization.30 C2 to operate in a manner that complies CBOE Holdings and to require C2 currently has in place a voting with the Federal securities laws, and Commission approval if CBOE Holdings agreement with CBOE in which CBOE facilitate the ability of C2 and the sells, transfers, or assigns any shares of agrees to vote in favor of those Commission to fulfill their regulatory C2 common stock.25 In addition, C2 individuals nominated by C2’s and oversight obligations under the proposes a number of other changes to Nominating and Governance Committee Act.23 reflect and generally conform to the for election as C2 Representative most recent version of the C2 Directors. After the demutualization, corresponding governing documents of CBOE Holdings, and not CBOE, would Although CBOE Holdings would CBOE that were approved by the be the sole stockholder of C2. replace CBOE as the parent company Commission in connection with the Accordingly, C2 has proposed to enter and sole shareholder of C2, C2 would CBOE Demutualization. These changes into a new voting agreement with CBOE continue to be registered as a national include amending C2’s Bylaws to Holdings that similarly would require securities exchange under Section 6 of provide that all directors of the C2 board CBOE Holding to vote in favor of those the Exchange Act. In this respect, would serve one-year terms, rather than individuals nominated by C2’s certain provisions of C2’s Certificate of staggered two-year terms 26 and to Nominating and Governance Committee Incorporation and Bylaws are designed remove a reference to electing a class of for election as C2 Representative to enable C2 to carry out the purposes directors; 27 amending its Bylaws to Directors. In addition, C2 proposes to of the Act and to comply and enforce provide that Representative Directors (as add a provision in the voting agreement compliance by its members and persons opposed to any Director) may be to reflect the ‘‘for cause’’ removal associated with its members with all removed for cause by the holders of a standard for Representative Directors in 24 applicable rules and regulations. majority of the shares of stock then C2’s Bylaws, as discussed above. As noted above, C2 does not propose entitled to vote at an election of The Commission notes that changes any significant changes to its governing directors; 28 and amending its Bylaws to proposed by C2 in its governing documents but does propose to make provide that the C2 Regulatory documents and rules are mostly certain changes to its Certificate of Oversight Committee would consist of technical in nature. Further, the Incorporation to effect the change of at least three directors instead of at least Commission notes that C2’s proposed ownership of C2 from CBOE to CBOE four directors.29 Finally, because the amendment to require the removal of Holdings, to clarify certain aspects of rules of C2 use terms from the CBOE Representative Directors, rather than

23 any director, for cause by the holders of The Commission also notes that the Certificate 25 See Article Four of the C2 Certificate of a majority of the shares of stock is of Incorporation of CBOE Holdings places certain Incorporation. In addition, C2 proposes to delete ownership and voting limits on the holders of Article Twelve of the Certificate of Incorporation consistent with provisions approved by CBOE Holdings stock and their Related Persons. because it is no longer necessary. the Commission for other SROs’ These restrictions are intended to address the 26 See Section 3.1 of the C2 Bylaws. Further, C2 possibility that a person holding a controlling proposes to delete the second sentence of Section 30 interest in an SRO could use that interest to affect For example, CBOE is replacing the term 3.1, which provides that ‘‘[t]he Board shall initially the SRO’s regulatory responsibilities under the Act. ‘‘member’’ (or variations of it) with the term consist of 23 directors, including the Chief In particular, these restrictions provide that no ‘‘Trading Permit Holder’’ (or variations of it) Executive Officer, twelve Non-Industry Directors person, either alone or together with its Related throughout its rulebook in connection with its and ten Industry Directors,’’ because the initial Persons, may own directly or indirectly more than demutualization. Similarly, C2 proposes to replace board of directors of C2 has already been appointed. 10% of the CBOE Holdings or more than 20% in references in its rules to a CBOE ‘‘member’’ with the C2 also proposes to change the reference to the the event a public offering of the CBOE Holdings. term ‘‘CBOE Trading Permit Holder’’ (or ‘‘Trading ‘‘Board of the Corporation’’ in Section 3.1 to the Further, no person, either alone or together with its Permit Holder’’ in certain instances where there is ‘‘Board’’ and to delete a reference in the last Related Persons, will be entitled to vote more than a direct cross-reference to CBOE rules). Further, C2 sentence of the first paragraph regarding the initial 10% of the CBOE Holdings common interest or proposes to adopt in C2 Rule 1.1 the term ‘‘CBOE C2 Board, because that Board has already been more than 20% in the event a public offering of the Trading Permit,’’ which is defined as a ‘‘Trading appointed. CBOE Holdings. See Article Six(a) and (b) of the Permit’’ as such term is defined in CBOE’s Bylaws 27 CBOE Holdings Certificate of Incorporation. See Section 3.2 of the C2 Bylaws. C2 would no and rules, and the term ‘‘CBOE Trading Permit longer have different classes of directors. 24 For example, C2’s current board composition is Holder,’’ which is defined as a ‘‘Trading Permit 28 designed to be comparable to the board See Section 3.4(c) of the C2 Bylaws. C2 also Holder’’ as such term is defined in CBOE’s Bylaws compositions the Commission has approved for proposes to amend Section 3.4(c) to replace a and rules. C2 also proposes to replace the term other SROs. Namely, the number of Non-Industry reference to ‘‘SEC’’ with ‘‘Securities and Exchange CBOE ‘‘membership’’ with the term ‘‘CBOE Trading Directors on C2 board must equal or exceed the sum Commission (‘‘SEC’’).’’ In addition, C2 proposes to Permit’’ (or ‘‘Trading Permit’’ in certain instances of the number of Industry Directors and the number move a reference to ‘‘Representative Directors’’ where there is a direct cross-reference to CBOE of Industry Directors must equal or exceed 30% of (described below) in the first sentence of the rules) and a CBOE ‘‘Clearing Member’’ (or variations the board. Further, at least 20% of the directors on seventh paragraph of Section 3.1 of the C2 Bylaws of it) with the term ‘‘Clearing Trading Permit the board must be nominated (or otherwise selected to clarify the intent of that sentence. Holder.’’ In addition, C2 proposes to make a few by a petition of C2 members) by the Industry- 29 See Section 4.6 of the C2 Bylaws. C2 also minor, non-substantive fixes to its rules. For Director Subcommittee of the Nominating and proposes to amend Section 5.8 of the Bylaws to example, C2 proposes to replace references to a C2 Governance Committee (such directors, modify the responsibilities of the Treasurer of C2. ‘‘member’’ in its rules with the term ‘‘Permit Holder’’ ‘‘Representative Directors’’). See Section 3.1 of the Specifically, C2 is proposing to delete the second or ‘‘Participant’’ (which both have the same meaning C2 Bylaws. For definitions of ‘‘Non-Industry sentence in Section 5.8, which reads ‘‘[i]n addition, under C2 rules). C2 also proposes to delete a Directors’’ and ‘‘Industry Directors,’’ see Section 3.1 the Treasurer shall perform such duties and have reference in C2 Rule 3.3(b) regarding member of the C2 Bylaws. For the definition of ‘‘Industry- such powers that are incident to the office of organizations not registered as broker-dealers, Director Subcommittee of the Nominating and Treasurer, including without limitation the duty to because C2 does not have such organizations (i.e., Governance Committee,’’ see Section 3.2 of the C2 keep and be responsible for all funds of the all Permit Holders of C2 are required to be Bylaws. Further, C2 has a Regulatory Oversight Corporation,’’ to make this section consistent with registered as broker-dealers). In addition, C2 Committee (‘‘ROC’’) that monitors its regulatory the Treasurer provision in CBOE’s post- proposes to fix some of the cross-references in its operations. See Section 4.6 of C2 Bylaws. demutualization Bylaws. rules to CBOE rules.

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governing documents.31 Moreover, as For the Commission, by the Division of participation entitlement(s)’’); a market the ROC would continue to be Trading and Markets, pursuant to delegated turner priority for participants that are 35 composed solely of Non-Industry authority. the first to improve CBOE’s Directors, the Commission does not Florence E. Harmon, disseminated quote; and a modified believe C2’s proposal to decreased size Deputy Secretary. participation entitlement overlay 4 in of the committee compromises its [FR Doc. 2010–15281 Filed 6–23–10; 8:45 am] which the original participation ability to monitor the adequacy and BILLING CODE 8010–01–P entitlement would apply only if there effectiveness of C2’s regulatory program. are no public customer orders resting at Finally, the Commission believes that a the best price or a public customer was SECURITIES AND EXCHANGE the first to rest interest at the best price. new voting agreement, as proposed by COMMISSION In addition, a small order participation C2, is appropriate to ensure that C2 entitlement overlay for Designated meet its statutory obligation to provide [Release No. 34–62317; File No. SR–CBOE– 2010–038] Primary Market-Makers (‘‘DPMs’’) and for the fair representation of its Lead Market-Makers (‘‘LMMs’’) can be members in the administration of C2.32 Self-Regulatory Organizations; applied to each of the three allocation As the Commission has previously Chicago Board Options Exchange, algorithms (i.e., price-time, pro-rata or noted in the context of other exchange Incorporated; Order Approving UMA).5 These overlays are all optional. governance proposals, this requirement Proposed Rule Change, as Modified by The proposed rule change would helps to ensure that an exchange’s Amendment No. 1 Thereto, Related to amend the Exchange’s priority overlays. members have a voice in the governing the Hybrid Matching Algorithms CBOE proposes to make the market body of the exchange and the turner overlay available for classes corresponding exercise by the exchange June 17, 2010. utilizing any of the priority methods of its self-regulatory authority, and that On April 22, 2010, the Chicago Board offered by the Exchange. The Exchange the exchange is administered in a way Options Exchange, Incorporated also proposes to amend the application that is equitable to all who trade on its (‘‘CBOE’’ or ‘‘Exchange’’) filed with the of the modified participation market or through its facilities.33 Securities and Exchange Commission entitlement overlay. Under the proposal, (‘‘Commission’’), pursuant to Section a Market-Maker that is the subject of a III. Conclusion 19(b)(1) of the Securities Exchange Act participation entitlement would only of 1934 (‘‘Act’’) 1 and Rule 19b–4 receive an entitlement if the amount it For the foregoing reasons, the thereunder,2 a proposed rule change to is entitled to pursuant to the Commission believes that the proposed revise its market turner and modified participation entitlement is greater than rule changes in connection with the participation entitlement priority the amount the Market-Maker would transfer of ownership of C2 from CBOE overlays. On May 6, 2010, CBOE filed otherwise receive pursuant to the to CBOE Holdings is consistent with the Amendment No. 1 to the proposed rule algorithm. In all other cases, the Act and that C2 will be so organized and change. The proposed rule change was participation entitlement and public have the capacity to be able to carry out published for comment in the Federal customer priority would not be applied. the purposes of the Act. The provisions Register on May 18, 2010.3 The This allocation would be subject to the in the applicable governing documents, Commission received no comment following: • discussed above, should minimize the letters on the proposal. This order The Market-Maker’s entitlement potential that any person could interfere approves the proposed rule change, as share would be calculated based on any with or restrict the ability of C2 or the modified by Amendment No. 1. remaining balance after all public Commission to effectively carry out CBOE Rules 6.45A (Priority and customer orders at the best price are their respective regulatory oversight Allocation of Equity Option Trades on satisfied. For options classes using the responsibilities. Further, the the CBOE Hybrid System), and 6.45B pro-rata method, the Exchange may Commission notes that CBOE Holding (Priority and Allocation of Trades in determine on a class-by-class basis to has undertaken to ensure and maintain Index Options and Options on ETFs on calculate the Market-Maker’s the regulatory independence of C2 to the CBOE Hybrid System) set forth, entitlement share using the UMA methodology or the pro-rata enable C2 to operate in a manner that among other things, the manner in methodology. For options classes using complies with the federal securities which incoming electronic orders in options are allocated on the Hybrid the price-time method, the Market- laws, including the objectives of Maker’s entitlement share would be Sections 6(b) of the Act. System. Each rule currently provides allocation algorithms the Exchange can calculated using the price-time It is therefore ordered, pursuant to utilize when executing incoming methodology only.6 Section 19(b)(2) of the Act,34 that the electronic orders, including the proposed rule change (SR–C2–2010– Ultimate Matching Algorithm (‘‘UMA’’), 4 Securities Exchange Act Release No. 60665 002) be, and it hereby is, approved. (September 14, 2009), 74 FR 48114 (September 21, and price-time and pro-rata priority 2009) (SR–CBOE–2009–052). allocation algorithms. The price-time 5 If the small order priority overlay is in effect for 31 See, e.g., Section 7 of the Amended and and pro-rata priority overlays currently an option class, then orders for five (5) contracts or Restated By-Laws of BATS Exchange, Inc. and include: public customer priority for fewer will be executed first by the DPM or LMM, Section 7 of the Amended and Restated Bylaws of public customer orders resting on the as applicable, appointed to the option class. This EDGX Exchange, Inc. participation entitlement is subject to certain Hybrid System; participation 32 Section 6(b)(3) of the Act, 15 U.S.C. 78f(b)(3). conditions, including a condition that public customer priority must be in effect in priority 33 See, e.g., Securities Exchange Act Release Nos. entitlements for certain qualifying market-makers (the ‘‘original sequence ahead of the participation entitlement. 53128 (January 13, 2006), 71 FR 3550, 3553 (January See Rules 6.45A(a)(iii) and 6.45B(a)(iii). 23, 2006) (File No. 10–131); 53382 (February 27, 6 This modified participation entitlement overlay 35 2006), 71 FR 11251, 11259 (March 6, 2006) (File No. 17 CFR 200.30–3(a)(12). would only be applicable to automatic executions SR–NYSE–2005–77); and 58375 (August 18, 2008), 1 15 U.S.C. 78s(b)(1). and would not be applicable for executions of 73 FR 49498, 49501 (August 21, 2008) (File No. 10– 2 17 CFR 240.19b–4. incoming electronic orders initiated from PAR or 182). 3 See Securities Exchange Act Release No. 62083 from electronic auctions. Instead, the original 34 15 U.S.C. 78s(b)(2). (May 12, 2010), 75 FR 27850. Continued

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• When calculating the amount the found consistent with the Act.10 In relating to its public access facility and Market-Maker would otherwise receive addition, the Exchange’s overlay access to printed copies of certain pursuant to the operation of the determinations will be distributed via documents made available by the MSRB algorithm, the participation entitlement regulatory circular. For these reasons, to the public. and public customer priority overlays the Commission believes that the The text of the proposed rule change would not be considered. Instead the proposed rule change is consistent with is available on the MSRB’s Web site at calculation would be based on a price- the Act. http://www.msrb.org/msrb1/sec.asp, at time or pro-rata basis, as applicable, and It is therefore ordered, pursuant to the MSRB’s principal office, and at the subject to any other applicable priority Section 19(b)(2) of the Act,11 that the Commission’s Public Reference Room. proposed rule change (SR–CBOE–2010– overlays, such as market turner priority. II. Self-Regulatory Organization’s 038), as modified by Amendment No. 1, In addition, the Exchange proposes Statement of the Purpose of, and be, and hereby is, approved. that the modified participation Statutory Basis for, the Proposed Rule entitlement overlay would be available For the Commission, by the Division of Change to modify the application of the small Trading and Markets, pursuant to delegated order participation entitlement. authority.12 In its filing with the Commission, the The Commission has carefully Florence E. Harmon, MSRB included statements concerning reviewed the proposed rule change and Deputy Secretary. the purpose of and basis for the finds that it is consistent with the proposed rule change and discussed any [FR Doc. 2010–15279 Filed 6–23–10; 8:45 am] comments it received on the proposed requirements of the Act and the rules BILLING CODE 8010–01–P and regulations thereunder applicable to rule change. The text of these statements a national securities exchange.7 In may be examined at the places specified particular, the Commission finds that SECURITIES AND EXCHANGE in Item IV below. The MSRB has the proposed rule change is consistent COMMISSION prepared summaries, set forth in with Section 6(b)(5) of the Act,8 which Sections A, B, and C below, of the most [Release No. 34–62322; File No. SR–MSRB– significant aspects of such statements. requires, among other things, that the 2010–04] rules of an exchange be designed to A. Self-Regulatory Organization’s promote just and equitable principles of Self-Regulatory Organizations; Statement of the Purpose of, and trade, remove impediments to and Municipal Securities Rulemaking Statutory Basis for, the Proposed Rule perfect the mechanism of a free and Board; Notice of Filing and Immediate Change open market and a national market Effectiveness of Proposed Rule 1. Purpose system, and, in general, to protect Change Relating to the investors and the public interest; and Discontinuation of the MSRB Public The proposed rule change would are not designed to permit unfair Access Facility (a) terminate the public access facility discrimination between customers, created under the MSRB’s Municipal issuers, brokers, or dealers; as well as June 17, 2010. Securities Information Library (‘‘MSIL’’) Section 6(b)(8) of the Act, which Pursuant to Section 19(b)(1) of the system 5 and (b) revise a related Rule G– requires the rules of an exchange not to Securities Exchange Act of 1934 37 interpretive Question & Answer to 1 2 impose any burden on competition not (‘‘Act’’), and Rule 19b–4 thereunder, delete a reference to the public access necessary or in furtherance of the Act.9 notice is hereby given that on June 14, facility. The public access facility is The Commission believes that the 2010, the Municipal Securities physically located at the offices of the ‘‘ ’’ proposed rule change amending the Rulemaking Board ( MSRB ), filed with MSRB and makes official statements market turner and modified the Securities and Exchange and advance refunding documents ‘‘ ’’ participation entitlement overlays is Commission ( Commission ) the available to the public for viewing and consistent with the Act. All public proposed rule change as described in photocopying. Over the years, the MSRB customer orders at the best price will Items I, II and III below, which Items has undertaken to make other items have been prepared by the MSRB. The continue to be satisfied before a available through the public access MSRB has filed the proposal pursuant to participation entitlement will be facility including, but not limited to, Section 19(b)(3)(A)(iii) of the Act,3 and applied. If an entitlement is not applied, copies of Forms G–37, G–37x and G– Rule 19b–4(f)(3) thereunder,4 which then the incoming order will be 38t, certain transaction data and renders the proposal effective upon allocated among all market participants comment letters received in connection filing with the Commission. The using the underlying matching with requests for comment. All current Commission is publishing this notice to algorithm—price-time or pro-rata—both information that is accessible to the solicit comments on the proposed rule of which the Commission already has public through the public access facility change from interested persons. is now readily accessible through the participation entitlement parameters would be I. Self-Regulatory Organization’s MSRB Web site or the EMMA Web site. applied for PAR and electronic auctions. In pro-rata Statement of the Terms of Substance of Accordingly, the MSRB will discontinue classes where the UMA method is selected to the Proposed Rule Change the public access facility but will retain calculate the Market-Maker’s modified participation the ability to provide photocopies of the entitlement share, executions of incoming The MSRB has filed with the electronic orders initiated from PAR and electronic Commission a proposed rule change documents for members of the public auctions would be allocated using the UMA without Internet access, upon written method. Therefore, in such classes, the Market- 10 Maker’s original participation entitlement share of See Securities Exchange Act Release No. 51822 (June 10, 2005), 70 FR 35321 (June 17, 2005) 5 The MSIL system, originally established by the a PAR or electronic auction execution would be MSRB in 1990 to collect official statements and calculated using the UMA method. (Adopting CBOE Rule 6.45B). 11 15 U.S.C. 78s(b)(2). advance refunding documents, was discontinued 7 In approving this proposed rule change, the for purposes of accepting submissions of such 12 17 CFR 200.30–3(a)(12). Commission has considered the proposed Rule’s documents upon the establishment by the MSRB of 1 impact on efficiency, competition, and capital 15 U.S.C. 78s(b)(1). its Electronic Municipal Market Access (EMMA) formation. See 15 U.S.C. 78c(f). 2 17 CFR 240.19b–4. System’s Primary Market Disclosure Service. The 8 15 U.S.C. 78f(b)(5). 3 15 U.S.C. 78s(b)(3)(A)(iii). MSIL system continues to operate in a limited 9 15 U.S.C. 78f(b)(8). 4 17 CFR 240.19b–4(f)(3). capacity for internal MSRB purposes only.

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request, for a copying charge at a rate change if it appears to the Commission submissions should refer to File equal to the then-current Commission that such action is necessary or Number SR–MSRB–2010–04 and should copying charge under its schedule of appropriate in the public interest, for be submitted on or before July 15, 2010. fees for records services as published on the protection of investors, or otherwise For the Commission, by the Division of the Commission Web site. in furtherance of the purposes of the Trading and Markets, pursuant to delegated Act.9 10 2. Statutory Basis authority. Florence E. Harmon, The MSRB believes that the proposed IV. Solicitation of Comments Deputy Secretary. rule change is consistent with Section Interested persons are invited to 15B(b)(2)(C) of the Act,6 which provides submit written data, views, and [FR Doc. 2010–15268 Filed 6–23–10; 8:45 am] that the MSRB’s rules shall: arguments concerning the foregoing, BILLING CODE 8010–01–P be designed to prevent fraudulent and including whether the proposed rule manipulative acts and practices, to promote change is consistent with the Act. just and equitable principles of trade, to Comments may be submitted by any of DEPARTMENT OF TRANSPORTATION foster cooperation and coordination with the following methods: persons engaged in regulating, clearing, Surface Transportation Board Electronic Comments settling, processing information with respect [Docket No. AB 33 (Sub-No. 284X)] to, and facilitating transactions in municipal • Use the Commission’s Internet securities, to remove impediments to and comment form (http://www.sec.gov/ Union Pacific Railroad Company— perfect the mechanism of a free and open rules/sro.shtml); or Abandonment Exemption—in Kane market in municipal securities, and, in • general, to protect investors and the public Send an e-mail to rule- County, IL. interest. [email protected]. Please include File Number SR–MSRB–2010–04 on the On June 4, 2010, Union Pacific The MSRB believes that the proposed subject line. Railroad Company (UP) filed with the rule change is consistent with the Act Board a petition under 49 U.S.C. 10502 since broad public access to documents Paper Comments for exemption from the provisions of 49 otherwise available through the public • Send paper comments in triplicate U.S.C. 10903 to abandon a 3.17-mile access facility will continue to be to Elizabeth M. Murphy, Secretary, line of railroad known as the St. Charles available through the MSRB Web site, Securities and Exchange Commission, Industrial Lead, extending from the EMMA Web site, or upon written 100 F Street, NE., Washington, DC milepost 35.13 to the end of the line at request from the MSRB. 20549–1090. milepost 38.30, near St. Charles, in Kane B. Self-Regulatory Organization’s All submissions should refer to File County, Ill. The line traverses United Statement on Burden on Competition Number SR–MSRB–2010–04. This file States Postal Service Zip Code 60174, and includes no stations. The MSRB does not believe the number should be included on the subject line if e-mail is used. To help the The line does not contain Federally proposed rule change will impose any granted rights-of-way. Any burden on competition not necessary or Commission process and review your comments more efficiently, please use documentation in the possession of UP appropriate in furtherance of the will be made available promptly to purposes of the Act. The documents that only one method. The Commission will post all comments on the Commission’s those requesting it. are available through the public access The interest of railroad employees facility are readily available to the Internet Web site (http://www.sec.gov/ rules/sro.shtml). Copies of the will be protected by the conditions set public on an equal and forth in Oregon Short Line Railroad— nondiscriminatory manner on the MSRB submission, all subsequent amendments, all written statements Abandonment Portion Goshen Branch Web site, the EMMA Web site, or upon Between Firth & Ammon, In Bingham & written request from the MSRB. with respect to the proposed rule change that are filed with the Bonneville Counties, Idaho, 360 I.C.C. C. Self-Regulatory Organization’s Commission, and all written 91 (1979). Statement on Comments on the communications relating to the By issuance of this notice, the Board Proposed Rule Change Received From proposed rule change between the is instituting an exemption proceeding Members, Participants or Others Commission and any person, other than pursuant to 49 U.S.C. 10502(b). A final Written comments were neither those that may be withheld from the decision will be issued on or before solicited nor received on the proposed public in accordance with the September 22, 2010. rule change. provisions of 5 U.S.C. 552, will be Any offer of financial assistance available for Web site viewing and (OFA) under 49 CFR 1152.27(b)(2) will III. Date of Effectiveness of the printing in the Commission’s Public be due no later than 10 days after Proposed Rule Change and Timing for Reference Room, 100 F Street, NE., service of a decision granting the Commission Action Washington, DC 20549, on official petition for exemption. Each OFA must The proposed rule change has become business days between the hours of 10 be accompanied by a $1,500 filing fee. effective pursuant to Section a.m. and 3 p.m. Copies of such filing See 49 CFR 1002.2(f)(25). 19(b)(3)(A)(iii) of the Act 7 and Rule also will be available for inspection and All interested persons should be 19b–4(f)(3) thereunder 8 because it is copying at the principal office of the aware that, following abandonment of concerned solely with the operation and MSRB. All comments received will be rail service and salvage of the line, the administration of the MSRB. At any posted without change; the Commission line may be suitable for other public time within 60 days of the filing of the does not edit personal identifying use, including interim trail use. Any proposed rule change, the Commission information from submissions. You request for a public use condition under may summarily abrogate such rule should submit only information that 49 CFR 1152.28 or for trail use/rail you wish to make available publicly. All banking under 49 CFR 1152.29 will be 6 15 U.S.C. 78o–4(b)(2)(C). due no later than July 14, 2010. Each 7 15 U.S.C. 78s(b)(3)(A). 9 See Section 19(b)(3)(C) of the Act, 15 U.S.C. 8 17 CFR 240.19b–4(f)(3). 78s(b)(3)(C). 10 17 CFR 200.30–3(a)(12).

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trail request must be accompanied by a announces that the Information revised information no later than 30 $250 filing fee. See 49 CFR Collection Request (ICR) abstracted days after a change in the business that 1002.2(f)(27). below has been forwarded to the Office affects the validity of that information All filings in response to this notice of Management and Budget (OMB) for has occurred. must refer to Docket No. AB 33 (Sub-No. review and comment. The ICR describes Estimated Burden Hours: 33. 284X), and must be sent to: (1) Surface the nature of the information collection Number of Respondents: 200. Transportation Board, 395 E Street, SW., and its expected burden. The Federal ADDRESSES: Send comments, within 30 Washington, DC 20423–0001; and (2) Register Notice with a 60-day comment days, to the Office of Information and Mack H. Shumate, Jr., 101 North Wacker period was published on July 20, 2009 Regulatory Affairs, Office of Drive, Room 1920, Chicago, Ill. 60606. (74 FR 35227). Management and Budget, 725 17th Replies to the petition are due on or DATES: Comments must be submitted on Street, NW., Washington, DC 20503, before July 14, 2010. or before July 26, 2010. Attention NHTSA Desk Officer. Persons seeking further information Comments are invited on: Whether FOR FURTHER INFORMATION CONTACT: concerning abandonment procedures Coleman Sachs, National Highway the proposed collection of information may contact the Board’s Office of Public Traffic Safety Administration, Office of is necessary for the proper performance Assistance, Governmental Affairs and Vehicle Safety Compliance (NVS–223), of the functions of the Department, Compliance at (202) 245–0238 or refer 1200 New Jersey Avenue, SE., Room including whether the information will to the full abandonment or W43–481, Washington, DC 20590. have practical utility; the accuracy of discontinuance regulations at 49 CFR the Department’s estimate of the burden part 1152. Questions concerning SUPPLEMENTARY INFORMATION: of the proposed information collection; environmental issues may be directed to National Highway Traffic Safety ways to enhance the quality, utility and the Board’s Section of Environmental Administration clarity of the information to be Analysis (SEA) at (202) 245–0305. collected; and ways to minimize the Title: 49 CFR part 566, Manufacturers’ Assistance for the hearing impaired is burden of the collection of information Identification. available through Federal Information OMB Number: 2127–0043. on respondents, including the use of Relay Service (FIRS) at 1–800–877– Type of Request: Reinstatement of an automated collection techniques or 8339. information collection for which OMB other forms of information technology. An environmental assessment (EA) (or approval has expired. A Comment to OMB is most effective if environmental impact statement (EIS), if Affected Public: Business or other for- OMB receives it within 30 days of necessary) prepared by SEA will be profit organizations. publication. served upon all parties of record and Abstract: If a motor vehicle or item of Issued on: June 17, 2010. upon any agencies or other persons who replacement motor vehicle equipment Claude Harris, commented during its presentation. contains a defect related to motor Director, Office of Vehicle Safety Compliance. Other interested persons may contact vehicle safety or fails to comply with an SEA to obtain a copy of the EA (or EIS). [FR Doc. 2010–15292 Filed 6–23–10; 8:45 am] applicable Federal motor vehicle safety BILLING CODE 4910–59–P EAs in these abandonment proceedings standard, the manufacturer is required normally will be made available within under 49 U.S.C. 30118 to furnish 60 days of the filing of the petition. The notification of the defect or DEPARTMENT OF TRANSPORTATION deadline for submission of comments on noncompliance to the Secretary of the EA generally will be within 30 days Transportation, as well as to owners, Federal Highway Administration of its service. purchasers, and dealers of the motor Board decisions and notices are vehicle or replacement equipment, and Notice of Final Federal Agency Action available on our Web site at http:// to remedy the defect or noncompliance on Proposed Transportation Project in www.stb.dot.gov. without charge to the owner. To ensure Illinois Decided: June 18, 2010. that manufacturers are meeting these AGENCY: Federal Highway By the Board, Rachel D. Campbell, and other responsibilities under the Administration (FHWA), DOT. Director, Office of Proceedings. statutes and regulations administered by ACTION: Notice of limitation on claims Jeffrey Herzig, NHTSA, the agency issued 49 CFR part for judicial review of actions by FHWA Clearance Clerk. 566, Manufacturer Identification. The and other Federal agencies. [FR Doc. 2010–15290 Filed 6–23–10; 8:45 am] regulations in part 566 require BILLING CODE 4915–01–P manufacturers of motor vehicles or SUMMARY: This notice announces actions motor vehicle equipment, other than taken by the FHWA and other Federal tires, to which a Federal motor vehicle agencies that are final within the DEPARTMENT OF TRANSPORTATION safety standard (FMVSS) applies, to meaning of 23 U.S.C. 139(l)(1). The submit to NHTSA, on a one-time basis, actions relate to a proposed highway National Highway Traffic Safety identifying information on themselves and transit project within the Tier 1 Administration and on the products that they Elgin O’Hare—West Bypass study area, manufacture to those standards. The which is bounded roughly by I–90 on Reports, Forms and Record Keeping information must be submitted no later the north, I–294 on the east, I–290 on Requirements; Agency Information than 30 days after the manufacturer the south, and the Elgin O’Hare Collection Activity Under OMB Review begins to manufacture motor vehicles or Expressway on the west and located in AGENCY: National Highway Traffic motor vehicle equipment subject to the Cook and DuPage Counties in Illinois Safety Administration, DOT FMVSS. No specific form need be used just northwest of the City of Chicago. ACTION: Notice. for the submission of this information. The Federal actions, taken as a result of Manufacturers who have previously a tiered environmental review process SUMMARY: In compliance with the submitted identifying information must under the National Environmental Paperwork Reduction Act of 1995 (44 ensure that the information on file is Policy Act, 42 U.S.C. 4321–4351 U.S.C. 3501 et seq.), this notice accurate and complete by submitting (NEPA), and implementing regulations

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on tiering, 40 CFR 1502.20, 40 CFR Action Alternative, Alternative 402, and Issued on: June 17, 2010. 1508.28, and 23 CFR part 771, South Connection Option A. Norman R. Stoner, determined certain issues relating to the Interested parties may consult the Division Administrator, Springfield, Illinois. proposed project. Those Tier 1 decisions ROD and FEIS for further information [FR Doc. 2010–15358 Filed 6–23–10; 8:45 am] will be used by Federal agencies in on each of the decisions described BILLING CODE 4910–22–P subsequent proceedings, including above. decisions whether to grant licenses, The Tier 1 actions by the Federal permits, and approvals for the highway agencies, and the laws under which DEPARTMENT OF TRANSPORTATION and transit project. Tier 1 decisions also such actions were taken, are described may be relied upon by State and local in the FEIS for the project approved on Federal Highway Administration agencies in proceedings on the proposed April 30, 2010, the ROD approved June project. Notice of Final Federal Agency Actions 17, 2010, and in other documents in the on Proposed Highway in California; DATES: By this notice, the FHWA is FHWA administrative record. The scope Notice of Statute of Limitations on advising the public of final agency and purpose of the Tier 1 FEIS are Claims actions subject to 23 U.S.C. 139(l)(1). A described in Sections 1.1 and 1.2 of the claim seeking judicial review of the Tier FEIS. The FEIS, ROD and other AGENCY: Federal Highway 1 Federal agency actions of the documents in the FHWA administrative Administration (FHWA), DOT. proposed highway and transit project record are available by contacting ACTION: Notice of Limitation on Claims will be barred unless the claim is filed FHWA or the Illinois Department of for Judicial Review of Actions by the on or before December 21, 2010. If the Transportation at the addresses California Department of Transportation Federal law that authorizes judicial provided above. Project information can (Caltrans), pursuant to 23 USC 327, the review of a claim provides a time period be viewed and downloaded from the US Army Corps of Engineers (USACOE), of less than 180 days for filing such project Web site http://www.elginohare- and the U.S. Fish and Wildlife Service claim, then that shorter time period still westbypass.org. The FEIS can also be (USFWS). applies. downloaded from http://www.dot.il.gov/ desenv/env.html, or hard copies of the SUMMARY: The FHWA, on behalf of FOR FURTHER INFORMATION CONTACT: Mr. Caltrans, is issuing this notice to Norman R. Stoner, P.E., Division FEIS and the ROD are available upon request. announce actions taken by Caltrans, Administrator, Federal Highway USACOE, and USFWS, that are final This notice applies to all Federal Administration, 3250 Executive Park within the meaning of 23 U.S.C. agency Tier 1 decisions that are final Drive, Springfield, Illinois 62703, 139(l)(1). The actions relate to a within the meaning of 23 U.S.C. Phone: (217) 492–4600, E-mail address: proposed highway project, on Interstate 139(l)(1) as of the issuance date of this Norman.Stoner@ dot.gov. The FHWA 15 (I–15) between the existing notice and all laws under which such Illinois Division Office’s normal Winchester Road (State Route 79, SR– actions were taken, including, but not business hours are 7:30 a.m. to 4:15 p.m. 79)/I–15 Interchange and Murrieta Hot limited to: You may also contact Ms. Diane M. Springs Road in the vicinity of the I–15/ O’Keefe, P.E., Illinois Department of 1. General: National Environmental I–215 junction within the cities of Transportation, Deputy Director of Policy Act (NEPA) [42 U.S.C. 4321– Temecula and Murrieta in Riverside Highways, Region One Engineer, 201 4351] Federal-Aid Highway Act [23 County, State of California. Those West Center Court, Schaumburg, Illinois U.S.C. 109 and 23 U.S.C. 128]. actions grant licenses, permits, and 60196, Phone: (847) 705–4110. The 2. Air: Clean Air Act [42 U.S.C. 7401– approvals for the project. Illinois Department of Transportation 7671(q)]. DATES: By this notice, the FHWA, on Region One’s normal business hours are 3. Land: Section 4(f) of the behalf of Caltrans, is advising the public 8 a.m. to 4:30 p.m. Department of Transportation Act of of final agency actions subject to 23 SUPPLEMENTARY INFORMATION: Notice is 1966 [49 U.S.C. 303 and 23 U.S.C. 138]. U.S.C. 139(l)(1). A claim seeking hereby given that the FHWA has issued 4. Historic and Cultural Resources: judicial review of the Federal agency a Tier 1 Final Environmental Impact Section 106 of the National Historic actions on the highway project will be Statement (FEIS) and Record of Decision Preservation Act of 1966, as amended barred unless the claim is filed on or (ROD) in connection with proposed [16 U.S.C. 470(f) et seq]. before December 21, 2010. If the Federal highway and transit projects within the 5. Wetlands and Water Resources: law that authorizes judicial review of a Elgin O’Hare—West Bypass study area Safe Drinking Water Act [42 U.S.C. claim provides a time period of less in Cook and DuPage Counties in Illinois. 300(f)–300(j)(6)]; Wild and Scenic than 180 days for filing such claim, then Decisions in the Tier 1 ROD include, but Rivers Act [16 U.S.C. 1271–1287]. that shorter time period still applies. are not limited to, the following: 6. Executive Orders: E.O. 11990 FOR FURTHER INFORMATION CONTACT: For a. Purpose and need for the project, Protection of Wetlands; E.O. 11988 Caltrans: James Shankel, Senior including improving regional and local Floodplain Management; E.O. 12898 Environmental Planner, Environmental travel by reducing congestion, Federal Actions to Address Studies ‘‘C’’ Branch Chief, California improving travel efficiency, improving Environmental Justice in Minority Department of Transportation, District access to O’Hare Airport from the west, Populations and Low Income 8, Division of Environmental Planning, and improving modal opportunities and Populations. 464 West 4th Street, 6th Floor MS–827, connections. (Catalog of Federal Domestic Assistance San Bernardino, California 92401–1400, b. Alternative 203 with South Program Number 20.205, Highway Research, available 8 a.m.–5 p.m. Monday through Connection Option D will be carried Planning and Construction. The regulations Friday, phone number (909) 383–6379 forward for further evaluation in the implementing Executive Order 12372 or e-mail: james_shankel@dot. Tier 2 environmental review process. regarding intergovernmental consultation on ca.gov. For USACOE: Stephanie J. Hall, c. Alternatives have been eliminated Federal programs and activities apply to this Environmental Protection Specialist/ from further consideration and study, program). Senior Project Manager, Regulatory including but not limited to, the No- Authority: 23 U.S.C. 139(l)(1) Division, 915 Wilshire Blvd., Los

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Angeles, CA 90017–3401, phone 4. Historic and Cultural Resources: FOR FURTHER INFORMATION CONTACT: For number (213) 452–3410. For USFWS: Section 106 of the National Historic further information or to obtain a copy Sally Brown, 6010 Hidden Valley Road, Preservation Act of 1966, as amended of the submission to OMB, please Ste. 101, Carlsbad, CA 92011, phone [16 U.S.C. 470]; Antiquities Act of 1906 contact Ira L. Mills at, number (760) 431–9440. [16 U.S.C. 431–433]. [email protected] (202) 906–6531, SUPPLEMENTARY INFORMATION: Effective 5. Social and Economic: Civil Rights or facsimile number (202) 906–6518, July 1, 2007, the Federal Highway Act of 1964 [42 U.S.C. 2000(d)– Regulations and Legislation Division, Administration (FHWA) assigned, and 2000(d)(1)]; the Uniform Relocation Chief Counsel’s Office, Office of Thrift the California Department of Assistance and Real Property Supervision, 1700 G Street, NW., Transportation (Caltrans) assumed, Acquisition Policies Act of 1970, as Washington, DC 20552. environmental responsibilities for this amended [42 U.S.C. 61]. SUPPLEMENTARY INFORMATION: OTS may project pursuant to 23 U.S.C. 327. 6. Wetlands and Water Resources: not conduct or sponsor an information Notice is hereby given that Caltrans, Clean Water Act, [33 U.S.C. 1251–1377]. collection, and respondents are not USACOE, and USFWS have taken final 7. Hazardous Materials: required to respond to an information agency actions subject to 23 U.S.C. Comprehensive Environmental collection, unless the information 139(l)(1) by issuing licenses, permits, Response, Compensation, and Liability collection displays a currently valid and approvals for the following highway Act [42 U.S.C. 9601–9675]; Resource OMB control number. As part of the project in the State of California: Conservation and Recovery Act [42 approval process, we invite comments Construction of a new interchange, U.S.C. 6901–6992(j)]. on the following information collection. French Valley Parkway, along with 8. Executive Orders: E.O. 11990 Title of Proposal: Savings Association enhancements to facilitate improved Protection of Wetlands; E.O. 11988 Holding Company Report H–(b)11 operations on the existing mainline Floodplain Management; E.O. 12898 OMB Number: 1550–0060. facility. The purpose of the project is to Federal Actions to Address Form Number: OTS Form H–(b)11. improve traffic flow and enhance safety Environmental Justice in Minority Regulation requirement: 12 CFR by reducing congestion. The project Populations and Low Income 584.1. proposes a partial cloverleaf interchange Populations; and E.O. 13112 Invasive Description: Section 10(b) of the at French Valley Parkway with loop on- Species. Home Owners’ Loan Act and 12 CFR ramps in the northwestern and (Catalog of Federal Domestic Assistance 584.1(a)(2) provide that each savings southeastern quadrants and direct on- Program Number 20.205, Highway Planning and loan holding company is required ramps in the southwestern and and Construction. The regulations to file an annual report H–(b)11 within northeastern quadrants. French Valley implementing Executive Order 12372 90 days of the end of its fiscal year. Parkway will be constructed as a six- regarding intergovernmental consultation on Quarterly filings are also required lane arterial highway from Jefferson Federal programs and activities apply to this within 45 days of the end of the first Avenue to Ynez Road. Auxiliary lanes program.) three fiscal quarters, and should will be provided in both the northbound Authority: 23 U.S.C. 139(l)(1) describe any material changes from the and southbound directions. An up to Issued on: June 18, 2010. most recently filed H–(b)11. If material three-lane collector-distributor (C/D) changes have occurred during the fourth Karen A. Bobo, system will be constructed parallel to I– quarter, an H–(b)11 filing must be filed 15/I–215 confluence and Winchester Director, Local Programs, Federal Highway within 45 days of the end of the holding Administration, Sacramento, California. Road in both the northbound and company’s fiscal fourth quarter as well. southbound directions. The actions by [FR Doc. 2010–15291 Filed 6–23–10; 8:45 am] The information gathered is essential for the Federal agencies, and the laws BILLING CODE 4910–RY–P OTS to monitor whether savings and under which such actions were taken, loan holding companies are in are described in the Final compliance with applicable statutes, Environmental Assessment (FEA) for DEPARTMENT OF THE TREASURY regulations, and conditions of approval the project, approved via issuance of a to acquire an insured savings Office of Thrift Supervision Finding of No Significant Impact association. (FONSI) on January 29, 2010, and in Type of Review: Revision of a other documents in the FHWA project Savings Association Holding Company Report H–(b)11 currently approved collection. records. The FEA, FONSI, and other Affected Public: Business or other for- project records are available by AGENCY: Office of Thrift Supervision profit. contacting Caltrans at the addresses (OTS), Treasury. Estimated Number of Respondents: provided above. ACTION: Notice and request for comment. 951. This notice applies to all Federal Estimated Burden Hours per agency decisions as of the issuance date SUMMARY: The proposed information Response: 2 hours. of this notice and all laws under which collection request (ICR) described below Estimated Frequency of Response: On such actions were taken, including but has been submitted to the Office of occasion; quarterly; other. not limited to: Management and Budget (OMB) for Estimated Total Burden: 7,608 hours. 1. General: National Environmental review and approval, as required by the Clearance Officer: Ira L. Mills, (202) Policy Act (NEPA) [42 U.S.C. 4321– Paperwork Reduction Act of 1995. OTS 906–6531, Office of Thrift Supervision, 4351]; Federal Aid-Highway Act of 1970 is soliciting public comments on the 1700 G Street, NW., Washington, DC [23 U.S.C. 109]. proposal. 20552. 2. Air: Clean Air Act, as amended [42 U.S.C. 7401–7671(q)]. DATES: Submit written comments on or Dated: June 21, 2010. 3. Wildlife: Endangered Species Act before July 26, 2010. A copy of this ICR, Ira L. Mills, [16 U.S.C. 1531–1544], Fish and with applicable supporting Paperwork Clearance Officer, Office of Chief Wildlife Coordination Act [16 U.S.C. documentation, can be obtained from Counsel, Office of Thrift Supervision. 661–667 (d)], Migratory Bird Treaty Act RegInfo.gov at http://www.reginfo.gov/ [FR Doc. 2010–15343 Filed 6–23–10; 8:45 am] [16 U.S.C. 703–712]. public/do/PRAMain. BILLING CODE 6720–01–P

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DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY Questions concerning this Notice may be directed to the U.S. Department of Fiscal Service Fiscal Service the Treasury, Financial Management Service, Financial Accounting and Surety Companies Acceptable On Surety Companies Acceptable On Services Division, Surety Bond Branch, Federal Bonds—Change in Business Federal Bonds—Change In Business Address: American Economy 3700 East-West Highway, Room 6F01, Address and Redomestication: First Hyattsville, MD 20782. Liberty Insurance Corporation; Liberty Insurance Company; American Fire Insurance Corporation; LM Insurance and Casualty Company; American Dated: June 10, 2010. States Insurance Company; Employers Corporation William J. Erie, Insurance Company of Wausau; Acting Director, Financial Accounting and Liberty Mutual Fire Insurance AGENCY: Financial Management Service, Services Division. Company; Ohio Casualty Insurance Fiscal Service, Department of the [FR Doc. 2010–15065 Filed 6–23–10; 8:45 am] Company; Peerless Insurance Treasury. Company; West American Insurance BILLING CODE 4810–35–M ACTION: Notice. Company AGENCY: Financial Management Service, DEPARTMENT OF THE TREASURY SUMMARY: This is Supplement No. 13 to Fiscal Service, Department of the the Treasury Department Circular 570, Treasury. Fiscal Service 2009 Revision, published July 1, 2009, ACTION: Notice. at 74 FR 31536. Surety Companies Acceptable on SUMMARY: This is Supplement No. 15 to Federal Bonds—Terminations: Victore FOR FURTHER INFORMATION CONTACT: the Treasury Department Circular 570, Insurance Company Surety Bond Branch at (202) 874–6850. 2009 Revision, published July 1, 2009, SUPPLEMENTARY INFORMATION: Notice is at 74 FR 31536. AGENCY: Financial Management Service, hereby given by the Treasury that the FOR FURTHER INFORMATION CONTACT: Fiscal Service, Department of the above-named companies formally Surety Bond Branch at (202) 874–6850. Treasury. changed their ‘‘BUSINESS ADDRESS’’ to SUPPLEMENTARY INFORMATION: Notice is ACTION: Notice. ‘‘2815 Forbs Avenue, Suite 200, hereby given by the Treasury that the Hoffman Estates, IL 60192’’ effective above-named companies formally SUMMARY: This is Supplement No. 17 to immediately. In addition, The First changed their ‘‘BUSINESS ADDRESS’’ as the Treasury Department Circular 570, Liberty Insurance Corporation (NAIC# follows: 2009 Revision, published July 1, 2009, 33588) and LM Insurance Corporation American Economy Insurance at 74 FR 31536. (NAIC# 33600) have redomesticated Company (NAIC #19690). BUSINESS from the state of Iowa to the state of ADDRESS: 500 North Meridian Street, FOR FURTHER INFORMATION CONTACT: Illinois effective September 2, 2009. Indianapolis, IN 46204. Surety Bond Branch at (202) 874–6850. American Fire and Casualty Company Federal bond-approving officers should (NAIC #24066). BUSINESS ADDRESS: SUPPLEMENTARY INFORMATION: Notice is annotate their reference copies of the 9450 Seward Road, Fairfield, OH 45014. hereby given that the Certificate of ‘‘ ’’ Treasury Circular 570 ( Circular ), 2009 American States Insurance Company Authority issued by the Treasury to the Revision, to reflect these changes. (NAIC #19704). BUSINESS ADDRESS: above-named company under 31 U.S.C. The Circular may be viewed and 500 North Meridian Street, Indianapolis, 9305 to qualify as acceptable surety on downloaded through the Internet at IN 46204. Federal bonds is terminated effective http://www.fms.treas.gov/c570. Employers Insurance Company of today. Federal bond-approving officials Wausau (NAIC #21458) BUSINESS should annotate their reference copies Questions concerning this Notice may ADDRESS: 2000 Westwood Drive, be directed to the U.S. Department of of the Treasury Department Circular 570 Wausau, WI 54401. ‘‘ ’’ the Treasury, Financial Management Liberty Mutual Fire Insurance ( Circular ), 2009 Revision, to reflect Service, Financial Accounting and Company (NAIC #23035). BUSINESS this change. Services Division, Surety Bond Branch, ADDRESS: 2000 Westwood Drive, With respect to any bonds currently 3700 East-West Highway, Room 6F01, Wausau, WI 54401. in force with this company, bond- Hyattsville, MD 20782. Ohio Casualty Insurance Company approving officers may let such bonds Dated: June 10, 2010. (The) (NAIC #24074). BUSINESS run to expiration and need not secure ADDRESS: 9450 Seward Road, Fairfield, William J. Erie, new bonds. However, no new bonds OH 45014. should be accepted from this company, Acting Director, Financial Accounting and Peerless Insurance Company (NAIC Services Division. and bonds that are continuous in nature #24198). BUSINESS ADDRESS: 62 should not be renewed. [FR Doc. 2010–15064 Filed 6–23–10; 8:45 am] Maple Avenue, Keene, NH 03431. BILLING CODE 4810–35–M West American Insurance Company The Circular may be viewed and (NAIC #44393). BUSINESS ADDRESS: downloaded through the Internet at 7999 Knue Road, Suite 450, http://www.fms.treas.gov/c570. Indianapolis, IN 46250–1901. Questions concerning this notice may Federal bond-approving officers be directed to the U.S. Department of should annotate their reference copies the Treasury, Financial Management of the Treasury Circular 570 (‘‘Circular’’), Service, Financial Accounting and 2009 Revision, to reflect these changes. Services Division, Surety Bond Branch, The Circular may be viewed and 3700 East-West Highway, Room 6F01, downloaded through the Internet at http://www.fms.treas.gov/c570. Hyattsville, MD 20782.

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Dated: June 10, 2010. being made pursuant to Section information by the agency. Under the William J. Erie, 3506(c)(2)(A) of the PRA. Paperwork Reduction Act (PRA) of Acting Director, Financial Accounting and With respect to the following 1995, Federal agencies are required to Services Division. collection of information, VBA invites publish notice in the Federal Register [FR Doc. 2010–15066 Filed 6–23–10; 8:45 am] comments on: (1) Whether the proposed concerning each proposed collection of BILLING CODE 4810–35–M collection of information is necessary information, including each proposed for the proper performance of VBA’s extension of a currently approved functions, including whether the collection, and allow 60 days for public comment in response to the notice. This DEPARTMENT OF VETERANS information will have practical utility; notice solicits comments for information AFFAIRS (2) the accuracy of VBA’s estimate of the burden of the proposed collection of needed to determine a claimant’s [OMB Control No. 2900–0046] information; (3) ways to enhance the eligibility for disability insurance quality, utility, and clarity of the benefits. Proposed Information Collection information to be collected; and (4) DATES: Written comments and (Statement of Heirs for Payment of ways to minimize the burden of the recommendations on the proposed Credits Due Estate of Deceased collection of information on collection of information should be Veteran) Activity: Comment Request respondents, including through the use received on or before August 23, 2010. of automated collection techniques or AGENCY: Veterans Benefits ADDRESSES: Submit written comments the use of other forms of information Administration, Department of Veterans on the collection of information through technology. Affairs. Federal Docket Management System Title: Statement of Heirs for Payment ACTION: Notice. (FDMS) at http://www.Regulations.gov; of Credits Due Estate of Deceased or to Nancy J. Kessinger, Veterans Veteran, VA Form Letter 29–596. SUMMARY: The Veterans Benefits Benefits Administration (20M35), OMB Control Number: 2900–0046. Administration (VBA), Department of Department of Veterans Affairs, 810 Type of Review: Extension of a Veterans Affairs (VA), is announcing an Vermont Avenue, NW., Washington, DC currently approved collection. opportunity for public comment on the 20420 or e-mail Abstract: VA Form 29–596 is use by proposed collection of certain [email protected]. Please refer to administrator, executor, or next of kin to information by the agency. Under the ‘‘OMB Control No. 2900–0066’’ in any support a claim for money in the form Paperwork Reduction Act (PRA) of correspondence. During the comment of unearned or unapplied insurance 1995, Federal agencies are required to period, comments may be viewed online premiums due to a deceased veteran’s publish notice in the Federal Register through FDMS. estate. concerning each proposed collection of FOR FURTHER INFORMATION CONTACT: Affected Public: Individuals or information, including each proposed Nancy J. Kessinger at (202) 461–9769 or households. extension of a currently approved FAX (202) 275–5947. Estimated Annual Burden: 78 hours. collection, and allow 60 days for public Estimated Average Burden per SUPPLEMENTARY INFORMATION: Under the comment in response to the notice. This Respondent: 15 minutes. PRA of 1995 (Pub. L. 104–13; 44 U.S.C. notice solicits comments for information Frequency of Response: On occasion. 3501–3521), Federal agencies must needed to determine a claimant’s Estimated Number of Respondents: obtain approval from the Office of eligibility for refundable credit. 312. Management and Budget (OMB) for each DATES: Written comments and collection of information they conduct recommendations on the proposed Dated: June 18, 2010. or sponsor. This request for comment is collection of information should be By direction of the Secretary. being made pursuant to Section received on or before August 23, 2010. Denise McLamb, 3506(c)(2)(A) of the PRA. ADDRESSES: Submit written comments Program Analyst, Enterprise Records Service. With respect to the following on the collection of information through [FR Doc. 2010–15263 Filed 6–23–10; 8:45 am] collection of information, VBA invites Federal Docket Management System BILLING CODE 8320–01–P comments on: (1) Whether the proposed (FDMS) at http://www.Regulations.gov; collection of information is necessary or to Nancy J. Kessinger, Veterans for the proper performance of VBA’s Benefits Administration (20M35), DEPARTMENT OF VETERANS functions, including whether the Department of Veterans Affairs, 810 AFFAIRS information will have practical utility; Vermont Avenue, NW., Washington, DC [OMB Control No. 2900–0066] (2) the accuracy of VBA’s estimate of the 20420 or e-mail burden of the proposed collection of [email protected]. Please refer to Proposed Information Collection information; (3) ways to enhance the ‘‘OMB Control No. 2900–0046’’ in any (Request to Employer for Employment quality, utility, and clarity of the correspondence. During the comment Information in Connection With Claim information to be collected; and (4) period, comments may be viewed online for Disability Benefits) Activity: ways to minimize the burden of the through FDMS. Comment Request collection of information on respondents, including through the use FOR FURTHER INFORMATION CONTACT: AGENCY: Veterans Benefits of automated collection techniques or Nancy J. Kessinger at (202) 461–9769 or Administration, Department of Veterans the use of other forms of information FAX (202) 275–5947. Affairs. technology. SUPPLEMENTARY INFORMATION: Under the ACTION: Notice. Title: Request to Employer for PRA of 1995 (Pub. L. 104–13; 44 U.S.C. Employment Information in Connection 3501–3521), Federal agencies must SUMMARY: The Veterans Benefits With Claim for Disability Benefits, VA obtain approval from the Office of Administration (VBA), Department of Form Letter 29–459. Management and Budget (OMB) for each Veterans Affairs (VA), is announcing an OMB Control Number: 2900–0066. collection of information they conduct opportunity for public comment on the Type of Review: Extension of a or sponsor. This request for comment is proposed collection of certain currently approved collection.

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Abstract: VA Form Letter 29–459 is Affected Public: Individuals or Dated: June 18, 2010. used to request employment households. By direction of the Secretary. information from an employer in Estimated Annual Burden: 862 hours. Denise McLamb, connection with a claim for disability Estimated Average Burden per Respondent: 10 minutes. Program Analyst, Enterprise Records Service. benefits. VA uses the information to [FR Doc. 2010–15264 Filed 6–23–10; 8:45 am] establish the insured’s eligibility for Frequency of Response: On occasion. Estimated Number of Respondents: BILLING CODE 8320–01–P disability insurance benefits. 5,167.

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Part II

Department of Health and Human Services 45 CFR Part 170 Establishment of the Temporary Certification Program for Health Information Technology; Final Rule

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DEPARTMENT OF HEALTH AND EHR Electronic Health Record 2. Types of Testing and Certification HUMAN SERVICES FACA Federal Advisory Committee Act a. Complete EHRs and EHR Modules FFP Federal Financial Participation b. Complete EHRs for Ambulatory or 45 CFR Part 170 FFS Fee for Service (Medicare Program) Inpatient Settings HHS Department of Health and Human c. Integrated Testing and Certification of RIN 0991–AB59 Services EHR Modules HIPAA Health Insurance Portability and E. Application Process Establishment of the Temporary Accountability Act 1. Application Prerequisite Certification Program for Health HIT Health Information Technology 2. Application Information Technology HITECH Health Information Technology for a. Part 1 Economic and Clinical Health b. Part 2 AGENCY: Office of the National ISO International Organization for 3. Principles of Proper Conduct for ONC– Coordinator for Health Information Standardization ATCBs Technology, Department of Health and IT Information Technology a. Operation in Accordance With Guide 65 and ISO 17025 Including Developing a Human Services. MA Medicare Advantage NHIN Nationwide Health Information Quality Management System ACTION: Final rule. Network b. Use of NIST Test Tools and Test NIST National Institute of Standards and Procedures SUMMARY: This final rule establishes a Technology i. Establishment of Test Tools and Test temporary certification program for the OIG Office of Inspector General Procedures purposes of testing and certifying health OMB Office of Management and Budget ii. Public Feedback Process information technology. This final rule ONC Office of the National Coordinator for c. ONC Visits to ONC–ATCB Sites is established under the authority Health Information Technology d. Lists of Tested and Certified Complete granted to the National Coordinator for ONC–ACB ONC–Authorized Certification EHRs and EHR Modules Body i. ONC–ATCB Lists Health Information Technology (the ii. Certified HIT Products List National Coordinator) by section ONC–ATCB ONC–Authorized Testing and Certification Body e. Records Retention 3001(c)(5) of the Public Health Service OPM Office of Personnel Management f. Refunds Act (PHSA), as added by the Health PHSA Public Health Service Act g. Suggested New Principles of Proper Information Technology for Economic RFA Regulatory Flexibility Act Conduct and Clinical Health (HITECH) Act. The RIA Regulatory Impact Analysis 4. Application Submission National Coordinator will utilize the SDO Standards Development Organization 5. Overall Application Process SSA Social Security Act F. Application Review, Application temporary certification program to Reconsideration and ONC–ATCB Status authorize organizations to test and Table of Contents 1. Review of Application certify Complete Electronic Health 2. ONC–ATCB Application Records (EHRs) and/or EHR Modules, I. Background Reconsideration thereby making Certified EHR A. Previously Defined Terminology 3. ONC–ATCB Status B. Legislative and Regulatory History Technology available prior to the date G. Testing and Certification of Complete 1. Legislative History EHRs and EHR Modules on which health care providers seeking a. Standards, Implementation incentive payments available under the 1. Complete EHRs Specifications, and Certification Criteria 2. EHR Modules Medicare and Medicaid EHR Incentive b. Medicare and Medicaid EHR Incentive a. Applicable Certification Criteria or Programs may begin demonstrating Programs Criterion meaningful use of Certified EHR i. Medicare EHR Incentive Program b. Privacy and Security Testing and Technology. ii. Medicaid EHR Incentive Program Certification c. HIT Certification Programs c. Identification of Certified Status DATES: These regulations are effective 2. Regulatory History and Related H. The Testing and Certification of June 24, 2010. The incorporation by Guidance ‘‘Minimum Standards’’ reference of certain publications listed a. Initial Set of Standards, Implementation I. Authorized Testing and Certification in the rule is approved by the Director Specifications, and Certification Criteria Methods of the Federal Register as of June 24, Interim Final Rule J. Good Standing as an ONC–ATCB, 2010. b. Medicare and Medicaid EHR Incentive Revocation of ONC–ATCB Status and Programs Proposed Rule Effect of Revocation on Certifications FOR FURTHER INFORMATION CONTACT: c. HIT Certification Programs Proposed Issued by a Former ONC–ATCB Steven Posnack, Director, Federal Policy Rule and the Temporary Certification 1. Good Standing as an ONC–ATCB Division, Office of Policy and Planning, Program Final Rule 2. Revocation of ONC–ATCB Status Office of the National Coordinator for d. Recognized Certification Bodies as 3. Effect of Revocation on Certifications Health Information Technology, 202– Related to the Physician Self-Referral Issued by a Former ONC–ATCB 690–7151. Prohibition and Anti-Kickback EHR K. Sunset of the Temporary Certification Exception and Safe Harbor Final Rules Program SUPPLEMENTARY INFORMATION: II. Overview of the Temporary Certification L. Recognized Certification Bodies as Acronyms Program Related to the Physician Self-Referral III. Provisions of the Temporary Certification Prohibition and Anti-Kickback EHR APA Administrative Procedure Act Program; Analysis and Response to Exception and Safe Harbor Final Rules ARRA American Recovery and Public Comments on the Proposed Rule M. Grandfathering Reinvestment Act of 2009 A. Overview N. Concept of ‘‘Self-Developed’’ CAH Critical Access Hospital B. Scope and Applicability O. Validity of Complete EHR and EHR CCHIT Certification Commission for Health C. Definitions and Correspondence Module Certification and Expiration of Information Technology 1. Definitions Certified Status CGD Certification Guidance Document a. Days P. General Comments CHPL Certified Health Information b. Applicant Q. Comments Beyond the Scope of this Technology Products List c. ONC–ATCB Final Rule CMS Centers for Medicare & Medicaid 2. Correspondence IV. Provisions of the Final Regulation Services D. Testing and Certification V. Technical Correction to § 170.100 CORE Committee on Operating Rules for 1. Distinction Between Testing and VI. Waiver of 30-day Delay in the Effective Information Exchange® Certification Date

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VII. Collection of Information Requirements the National Coordinator for Health i. Medicare EHR Incentive Program A. Collection of Information: Application Information Technology (the National for ONC–ATCB Status Under the Coordinator) and the Secretary of Health Section 4101 of the HITECH Act Temporary Certification Program and Human Services (the Secretary) added new subsections to section 1848 B. Collection of Information: ONC–ATCB with new responsibilities and of the SSA to establish incentive Collection and Reporting of Information payments for the meaningful use of Related to Complete EHR and/or EHR authorities related to HIT. The HITECH Module Certifications Act also amended several sections of the Certified EHR Technology by eligible C. Collection of Information: ONC–ATCB Social Security Act (SSA) and in doing professionals participating in the Retention of Testing and Certification so established the availability of Medicare Fee-for-Service (FFS) program Records and the Submission of Copies of incentive payments to eligible beginning in calendar year (CY) 2011 Records to ONC professionals and eligible hospitals to and beginning in CY 2015, downward VIII. Regulatory Impact Analysis promote the adoption and meaningful payment adjustments for covered A. Introduction use of interoperable HIT. professional services provided by B. Why is this Rule needed? eligible professionals who are not C. Executive Order 12866—Regulatory a. Standards, Implementation Planning and Review Analysis Specifications, and Certification Criteria meaningful users of Certified EHR Technology. Section 4101(c) of the 1. Comment and Response With the passage of the HITECH Act, 2. Executive Order 12866 Final Analysis HITECH Act added a new subsection to a. Temporary Certification Program two new Federal advisory committees section 1853 of the SSA that provides Estimated Costs were established, the HIT Policy incentive payments to Medicare i. Application Process for ONC–ATCB Committee and the HIT Standards Advantage (MA) organizations for their Status Committee (sections 3002 and 3003 of affiliated eligible professionals who ii. Testing and Certification of Complete the PHSA, respectively). Each is meaningfully use Certified EHR EHRs and EHR Modules responsible for advising the National Technology beginning in CY 2011 and iii. Costs for Collecting, Storing, and Coordinator on different aspects of beginning in CY 2015, downward Reporting Certification Results standards, implementation iv. Costs for Retaining Records and specifications, and certification criteria. payment adjustments to MA Providing Copies to ONC The HIT Policy Committee is organizations to account for certain b. Temporary Certification Program affiliated eligible professionals who are Benefits responsible for, among other duties, recommending priorities for the not meaningful users of Certified EHR D. Regulatory Flexibility Act Technology. E. Executive Order 13132—Federalism development, harmonization, and F. Unfunded Mandates Reform Act of 1995 recognition of standards, Section 4102 of the HITECH Act implementation specifications, and added new subsections to section 1886 I. Background certification criteria, while the HIT of the SSA that establish incentive A. Previously Defined Terminology Standards Committee is responsible for payments for the meaningful use of recommending standards, In addition to new terms and Certified EHR Technology by subsection implementation specifications, and definitions created by this rule, the (d) hospitals (defined under section certification criteria for adoption by the following terms have the same meaning 1886(d)(1)(B) of the SSA) that Secretary under section 3004 of the as provided at 45 CFR 170.102. participate in the Medicare FFS program • PHSA consistent with the ONC- beginning in Federal fiscal year (FY) Certification criteria coordinated Federal Health IT Strategic • Certified EHR Technology 2011 and beginning in FY 2015, • Plan (the ‘‘strategic plan’’). downward payment adjustments to the Complete EHR Section 3004 of the PHSA defines • Disclosure market basket updates for inpatient • how the Secretary adopts standards, hospital services provided by such EHR Module implementation specifications, and • Implementation specification hospitals that are not meaningful users certification criteria. Section 3004(a) of • Qualified EHR of Certified EHR Technology. Section the PHSA defines a process whereby an • Standard 4102(b) of the HITECH Act amends obligation is imposed on the Secretary section 1814 of the SSA to provide an B. Legislative and Regulatory History to review standards, implementation incentive payment to critical access specifications, and certification criteria 1. Legislative History hospitals that meaningfully use and identifies the procedures for the Certified EHR Technology based on the The Health Information Technology Secretary to follow to determine for Economic and Clinical Health whether to adopt any group of hospitals’ reasonable costs beginning in (HITECH) Act, Title XIII of Division A standards, implementation FY 2011 and downward payment and Title IV of Division B of the specifications, or certification criteria adjustments for inpatient hospital American Recovery and Reinvestment included among National Coordinator- services provided by such hospitals that Act of 2009 (ARRA) (Pub. L. 111–5), was endorsed recommendations. are not meaningful users of Certified enacted on February 17, 2009. The EHR Technology for cost reporting HITECH Act amended the Public Health b. Medicare and Medicaid EHR periods beginning in FY 2015. Section Service Act (PHSA) and created ‘‘Title Incentive Programs 4102(c) of the HITECH Act adds a new XXX—Health Information Technology Title IV, Division B of the HITECH subsection to section 1853 of the SSA to and Quality’’ (Title XXX) to improve Act establishes incentive payments provide incentive payments to MA health care quality, safety, and under the Medicare and Medicaid organizations for certain affiliated efficiency through the promotion of programs for eligible professionals and eligible hospitals that meaningfully use health information technology (HIT) and eligible hospitals that meaningfully use Certified EHR Technology and electronic health information exchange. Certified Electronic Health Record beginning in FY 2015, downward Section 3001 of the PHSA establishes (EHR) Technology. The Centers for payment adjustments to MA the Office of the National Coordinator Medicare & Medicaid Services (CMS) is organizations for those affiliated for Health Information Technology charged with developing the Medicare hospitals that are not meaningful users (ONC). Title XXX of the PHSA provides and Medicaid EHR incentive programs. of Certified EHR Technology.

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ii. Medicaid EHR Incentive Program certification criteria. The standards, organizations to perform the Section 4201 of the HITECH Act implementation specifications, and certification of HIT. amends section 1903 of the SSA to certification criteria adopted by the We stated in the Proposed Rule that provide 100 percent Federal financial Secretary establish the capabilities that we expected to issue separate final rules participation (FFP) to States for Certified EHR Technology must include for each of the certification programs. incentive payments to eligible health in order to, at a minimum, support the This final rule establishes a temporary care providers participating in the achievement of what has been proposed certification program whereby the Medicaid program and 90 percent FFP for meaningful use Stage 1 by eligible National Coordinator will authorize organizations to test and certify for State administrative expenses related professionals and eligible hospitals Complete EHRs and/or EHR Modules, to the incentive program. under the Medicare and Medicaid EHR Incentive Programs proposed rule (see thereby assuring the availability of c. HIT Certification Programs 75 FR 1844 for more information about Certified EHR Technology prior to the Section 3001(c)(5) of the PHSA meaningful use and the proposed Stage date on which health care providers provides the National Coordinator with 1 requirements). seeking the incentive payments the authority to establish a certification available under the Medicare and b. Medicare and Medicaid EHR Medicaid EHR Incentive Programs may program or programs for the voluntary Incentive Programs Proposed Rule certification of HIT. Specifically, section begin demonstrating meaningful use of 3001(c)(5)(A) specifies that the On January 13, 2010, CMS published Certified EHR Technology. ‘‘National Coordinator, in consultation in the Federal Register (75 FR 1844) the d. Recognized Certification Bodies as with the Director of the National Medicare and Medicaid EHR Incentive Related to the Physician Self-Referral Institute of Standards and Technology, Programs proposed rule. The rule Prohibition and Anti-Kickback EHR shall keep or recognize a program or proposes a definition for meaningful use Exception and Safe Harbor Final Rules programs for the voluntary certification Stage 1 and regulations associated with In August 2006, HHS published two of health information technology as the incentive payments made available final rules in which CMS and the Office being in compliance with applicable under Division B, Title IV of the of Inspector General (OIG) promulgated certification criteria adopted under this HITECH Act. CMS has proposed that an exception to the physician self- subtitle’’ (i.e., certification criteria meaningful use Stage 1 would begin in referral prohibition and a safe harbor adopted by the Secretary under section 2011 and has proposed that Stage 1 under the anti-kickback statute, 3004 of the PHSA). The certification would focus on ‘‘electronically respectively, for certain arrangements program(s) must also ‘‘include, as capturing health information in a coded involving the donation of interoperable appropriate, testing of the technology in format; using that information to track EHR software to physicians and other accordance with section 13201(b) of the key clinical conditions and health care practitioners or entities (71 [HITECH] Act.’’ communicating that information for care FR 45140 and 71 FR 45110, Section 13201(b) of the HITECH Act coordination purposes (whether that respectively). The exception and safe requires that with respect to the information is structured or harbor provide that EHR software will development of standards and unstructured), but in structured format be ‘‘deemed to be interoperable if a implementation specifications, the whenever feasible; consistent with other certifying body recognized by the Director of the National Institute of provisions of Medicare and Medicaid Secretary has certified the software no Standards and Technology (NIST), in law, implementing clinical decision more than 12 months prior to the date coordination with the HIT Standards support tools to facilitate disease and it is provided to the [physician/ Committee, ‘‘shall support the medication management; and reporting recipient].’’ ONC published separately a establishment of a conformance testing clinical quality measures and public Certification Guidance Document (CGD) infrastructure, including the health information.’’ (71 FR 44296) to explain the factors development of technical test beds.’’ The c. HIT Certification Programs Proposed ONC would use to determine whether to United States Congress also indicated recommend to the Secretary a body for that ‘‘[t]he development of this Rule and the Temporary Certification Program Final Rule ‘‘recognized certification body’’ status. conformance testing infrastructure may The CGD serves as a guide for ONC to include a program to accredit Section 3001(c)(5) of the PHSA, evaluate applications for ‘‘recognized independent, non-Federal laboratories specifies that the National Coordinator certification body’’ status and provides to perform testing.’’ ‘‘shall keep or recognize a program or the information a body would need to 2. Regulatory History and Related programs for the voluntary certification apply for and obtain such status. To Guidance of health information technology as date, the Certification Commission for being in compliance with applicable Health Information Technology (CCHIT) a. Initial Set of Standards, certification criteria adopted [by the has been the only organization that has Implementation Specifications, and Secretary] under this subtitle.’’ Based on both applied for and been granted Certification Criteria Interim Final Rule this authority, we proposed both a ‘‘recognized certification body’’ status In accordance with section 3004(b)(1) temporary and permanent certification under the CGD. of the PHSA, the Secretary issued an program for HIT in a notice of proposed In section VI of the CGD, ONC interim final rule with request for rulemaking entitled ‘‘Proposed notified the public, including potential comments entitled ‘‘Health Information Establishment of Certification Programs applicants, that the recognition process Technology: Initial Set of Standards, for Health Information Technology’’ (75 explained in the CGD would be Implementation Specifications, and FR 11328, March 10, 2010) (RIN 0991– formalized through notice and comment Certification Criteria for Electronic AB59) (the ‘‘Proposed Rule’’). In the rulemaking and that when a final rule Health Record Technology’’ (HIT Proposed Rule, we proposed to use the has been promulgated to govern the Standards and Certification Criteria certification programs for the purposes process by which a ‘‘recognized interim final rule) (75 FR 2014), which of testing and certifying HIT. We also certification body’’ is determined, adopted an initial set of standards, specified the processes the National certification bodies recognized under implementation specifications, and Coordinator would follow to authorize the CGD would be required to complete

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new applications and successfully is determined to be appropriate by the EHRs and EHR Modules to be tested and demonstrate compliance with all National Coordinator. certified in advance of meaningful use requirements of the final rule. Stage 1. The commenters expressed an III. Provisions of the Temporary In the Proposed Rule, we began the understanding of the rationale we Certification Program; Analysis and formal notice and comment rulemaking provided for proposing a temporary described in the CGD. We stated that the Response to Public Comments on the certification program and the urgency processes we proposed for the Proposed Rule we associated with establishing the temporary certification program and A. Overview temporary certification program. permanent certification program, once Some commenters suggested that we This section discusses the 84 timely finalized, would supersede the CGD, use the terms ‘‘interim,’’ ‘‘transitional’’ or received comments on the Proposed and the authorization process would ‘‘provisional’’ to describe the temporary Rule’s proposed temporary certification constitute the new established method certification program. One commenter program and our responses. We have for ‘‘recognizing’’ certification bodies, as asserted that the term ‘‘interim’’ is referenced in the physician self-referral structured this section of the final rule particularly appropriate because it is prohibition and anti-kickback EHR based on the proposed regulatory used in Federal rulemaking to denote exception and safe harbor final rules. As sections of the temporary certification regulatory actions that are fully in effect a result of our proposal, certifications program and discuss each regulatory but will be replaced with more refined issued by a certification body section sequentially. For each versions in the future. Other ‘‘authorized’’ by the National discussion of the regulatory provision, commenters contended that using the Coordinator would constitute we first restate or paraphrase the term ‘‘temporary’’ to describe the short- certification by ‘‘a certifying body provision as proposed in the Proposed term program and its associated recognized by the Secretary’’ in the Rule as well as identify any correlated certifications may cause confusion in context of the physician self-referral issues for which we sought public the market and prolong, instead of EHR exception and anti-kickback EHR comment. Second, we summarize the reduce, uncertainty among eligible safe harbor. We requested public comments received. Lastly, we provide professionals and eligible hospitals. One comment on this proposal and have our response to the comments, commenter recommended that we responded to those comments in Section including stating whether we will establish a comprehensive educational III of this final rule. finalize the provision as proposed in the program about our proposed Proposed Rule or modify the proposed certification programs. II. Overview of the Temporary provision in response to public Some commenters stated that the Certification Program comment. Comments on the certification programs should not be The temporary certification program incorporation of the ‘‘recognized vague and expansive by encompassing provides a process by which an certification body’’ process, various, unidentified areas of HIT, but organization or organizations may ‘‘grandfathering’’ of certifications, the instead should be targeted to the become an ONC–Authorized Testing concept of ‘‘self-developed,’’ validity objectives of achieving meaningful use and Certification Body (ONC–ATCB) and expiration of certifications, general of Certified EHR Technology. One and be authorized by the National comments, and comments beyond the commenter also mentioned the need for Coordinator to perform the testing and scope of this final rule are discussed the certification programs to focus on certification of Complete EHRs and/or towards the end of the preamble. the implementation of the Nationwide EHR Modules. B. Scope and Applicability Health Information Network (NHIN). Under the temporary certification Response. We appreciate the program, the National Coordinator will In the Proposed Rule, we indicated in commenters’ expressions of support for accept applications for ONC–ATCB section 170.400 that the temporary the temporary certification program. We status at any time. In order to become certification program would serve to also appreciate the commenters’ an ONC–ATCB, an organization or implement section 3001(c)(5) of the suggestions and rationale for renaming organizations must submit an Public Health Service Act, and that the temporary certification program. We application to the National Coordinator subpart D would also set forth the rules believe, however, that we have to demonstrate its competency and and procedures related to the temporary described the temporary certification ability to test and certify Complete EHRs certification program for HIT program in the Proposed Rule and this and/or EHR Modules. An applicant will administered by the National final rule in a manner that clearly need to be able to both test and certify Coordinator. Under section 170.401, we conveys its purpose and scope such that Complete EHRs and/or EHR Modules. proposed that subpart D would establish renaming the program is not necessary. We anticipate that only a few the processes that applicants for ONC– Furthermore, as generally recommended organizations will qualify and become ATCB status must follow to be granted by a commenter, we will continue to ONC–ATCBs under the temporary ONC–ATCB status by the National communicate with and educate certification program. These Coordinator, the processes the National stakeholders about the temporary organizations will be required to remain Coordinator would follow when certification program and the eventual in good standing by adhering to the assessing applicants and granting ONC– transition to the proposed permanent Principles of Proper Conduct for ONC– ATCB status, and the requirements of certification program. ATCBs. ONC–ATCBs will also be ONC–ATCBs for testing and certifying We believe that we clearly indicated required to follow the conditions and Complete EHRs and/or EHR Modules in in the Proposed Rule’s preamble and the requirements applicable to the testing accordance with the applicable proposed temporary certification and certification of Complete EHRs and/ certification criteria adopted by the program’s scope and applicability or EHR Modules as specified in this Secretary in subpart C of this part. provisions that one of the goals of the final rule. The temporary certification Comments. We received many temporary certification program is to program will sunset on December 31, comments that expressed support for support the achievement of meaningful 2011, or if the permanent certification our proposal for a temporary use by testing and certifying Complete program is not fully constituted at that certification program that would EHRs and EHR Modules to the time, then upon a subsequent date that provide the opportunity for Complete certification criteria adopted by the

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Secretary in subpart C of part 170. such an approach. We noted in the National Coordinator and an applicant Therefore, we do not believe that the Proposed Rule that single organizations for ONC–ATCB status or an ONC–ATCB programs are overly vague or expansive. and consortia would be eligible to apply would be the day the e-mail was sent. We believe that the commenters who for ONC–ATCB status under the We further proposed that in expressed these concerns focused on temporary certification program. We circumstances where it was necessary our proposals to permit other types of also stated that we would expect a for an applicant for ONC–ATCB status HIT to be certified under the permanent consortium to be comprised of one or ONC–ATCB to correspond or certification program. We plan to organization that would serve as a communicate with the National address this issue in the final rule for testing laboratory and a separate Coordinator by regular or express mail, the permanent certification program, but organization that would serve as a the official date of receipt would be the in the interim, we remind these certification body. We further stated date of the delivery confirmation. We commenters of a fact we stated in the that, as long as such an applicant could did not receive any comments on these Proposed Rule. The Secretary would perform all of the required proposals. We are, however, revising first need to adopt certification criteria responsibilities of an ONC–ATCB, we this section to include ‘‘or ONC–ATCB’’ for other types of HIT before we would would fully support the approach. in paragraph (b) to clarify that either an consider authorizing, in this case, ONC– Accordingly, we are finalizing this applicant for ONC–ATCB status or an ACBs to certify those other types of HIT. provision without modification. ONC–ATCB may, when necessary, We are revising § 170.401 to clearly Although we are unclear as to what utilize the specified correspondence state that this subpart includes the commenter meant by a ‘‘third-party methods. This reference was requirements that ONC–ATCBs must organization,’’ we can state that a testing inadvertently left out of § 170.405(b) in follow to maintain good standing under laboratory could apply to become an the Proposed Rule. the temporary certification program. ONC–ATCB in a manner described This reference was inadvertently left out above (i.e., as a member or component D. Testing and Certification of § 170.401 in the Proposed Rule. of a consortium) or the laboratory could 1. Distinction Between Testing and apply independently to become an C. Definitions and Correspondence Certification ONC–ATCB, but it would need to meet We proposed in the Proposed Rule to all the application requirements, We stated in the Proposed Rule that define three terms related to the including the requisite certification there is a distinct difference between the temporary certification program and to body qualifications as specified in ISO/ ‘‘testing’’ and ‘‘certification’’ of a establish a process for applicants for IEC Guide 65:1996 (Guide 65). In the Complete EHR and/or EHR Module. We ONC–ATCB status and ONC–ATCBs to Proposed Rule, we proposed that a described ‘‘testing’’ as the process used correspond with the National testing laboratory would need to become to determine the degree to which a Coordinator. accredited by the testing laboratory Complete EHR or EHR Module can meet specific, predefined, measurable, and 1. Definitions accreditor under the permanent certification program. This process and quantitative requirements. We noted a. Days whether an organization that becomes that such results would be able to be We proposed in the Proposed Rule to an ONC–ACB under the permanent compared to and evaluated in add the definition of ‘‘day or days’’ to certification program can be affiliated accordance with predefined measures. section 170.102. We proposed to define with an accredited testing laboratory are In contrast, we described ‘‘certification’’ ‘‘day or days’’ to mean a calendar day or matters we requested the public to as the assessment (and subsequent calendar days. We did not receive any comment on in the Proposed Rule and assertion) made by an organization, comments on this provision. Therefore, will be more fully discussed when we once it has analyzed the quantitative we are finalizing this definition without finalize the permanent certification results rendered from testing along with modification. program. other qualitative factors, that a Complete EHR or EHR Module has met all of the b. Applicant c. ONC–ATCB applicable certification criteria adopted We proposed in section 170.402 to We proposed in section 170.402 to by the Secretary. We noted that define applicant to mean a single define an ONC–Authorized Testing and qualitative factors could include organization or a consortium of Certification Body (ONC–ATCB) to whether a Complete EHR or EHR organizations that seeks to become an mean an organization or a consortium of Module developer has a quality ONC–ATCB by requesting and organizations that has applied to and management system in place, or subsequently submitting an application been authorized by the National whether the Complete EHR or EHR for ONC–ATCB status to the National Coordinator pursuant to subpart D to Module developer has agreed to the Coordinator. perform the testing and certification of policies and conditions associated with Comments. One commenter Complete EHRs and/or EHR Modules being certified (e.g., proper logo usage). recommended that we encourage and under the temporary certification We further stated that the act of support the establishment of coalitions program. We did not receive any certification typically promotes or partnerships for testing and comments on this provision. Therefore, confidence in the quality of a product certification that leverage specialized we are finalizing this definition without (and the Complete EHR or EHR Module expertise. Another commenter asked modification. developer that produced it), offers whether third-party organizations will assurance that the product will perform be allowed to become testing 2. Correspondence as described, and helps consumers to laboratories for the temporary and We proposed in section 170.405 to differentiate which products have met permanent certification programs. require applicants for ONC–ATCB status specific criteria from others that have Response. We agree with the and ONC–ATCBs to correspond and not. commenter that coalitions or communicate with the National To further clarify, we stated that a partnerships for testing and certification Coordinator by e-mail, unless otherwise fundamental difference between testing are capable of leveraging specialized necessary. We proposed that the official and certification is that testing is expertise and we continue to support date of receipt of any e-mail between the intended to result in objective,

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unanalyzed data. In contrast, accordance with Guide 65. Guide 65 with a request made by a Complete EHR certification is expected to result in an specifies the requirements that an or EHR Module developer to have its overall assessment of the test results, organization must follow to operate a Complete EHR or EHR Module tested consideration of their significance, and certification program. Moreover, and certified solely to the certification consideration of other factors to because Guide 65 states in section 4.6.1 criteria adopted by the Secretary and determine whether the prerequisites for that a ‘‘certification body shall specify not to any other factors beyond those we certification have been achieved. To the conditions for granting, maintaining require ONC–ATCBs to follow when illustrate an important difference and extending certification,’’ we believe issuing a certification as discussed between testing and certification, we that it would be inappropriate to dictate above (i.e., responsibilities specified in provided the example that we recite every specific aspect related to an ONC– subpart D of part 170). However, this below. ATCB’s certification program does not preclude an ONC–ATCB from An e-prescribing EHR Module operations. We understand the concerns also offering testing and certification developer that seeks to have its EHR expressed by commenters over our options that include additional Module certified would first submit the example of a ‘‘quality management requirements beyond the certification EHR Module to be tested. To system’’ as another factor that ONC– criteria adopted by the Secretary. If an successfully pass the established testing ATCBs may choose to include, in ONC–ATCB chooses to offer testing and requirements, the e-prescribing EHR accordance with Guide 65, as part of certification options that specify Module would, among other functions, their certification requirements for additional requirements as a matter of need to transmit an electronic assessing Complete EHRs and/or EHR its own business practices, we expect prescription using mock patient data Modules and have considered how to that in accordance with Guide 65, according to the standards adopted by best address such concerns. section 6, the ONC–ATCB would ‘‘give the Secretary. Provided that the e- With respect to those commenters due notice of any changes it intends to prescribing EHR Module successfully who requested that we clarify the make in its requirements for passed this test it would next be purview of ONC–ATCBs related to certification’’ and ‘‘take account of views evaluated for certification. Certification certification and expressed concerns expressed by interested parties before could require that the EHR Module about the discretion afforded to ONC– deciding on the precise form and developer agree to a number of ATCBs, we agree that additional clarity effective date of the changes.’’ provisions, including, for example, is necessary regarding our intent and We note, however, that while we do displaying the EHR Module’s version expectations of ONC–ATCBs in our and revision number so potential discussion of the differences between not preclude an ONC–ATCB from purchasers could discern when the EHR testing and certification in the Proposed certifying HIT in accordance with its Module was last updated or certified. If Rule. We believe commenters were own requirements that may be unrelated the EHR Module developer agreed to all expressing a concern that certification to and potentially exceed the of the applicable certification could include other factors beyond the certification criteria adopted by the requirements and the EHR Module certification criteria adopted by the Secretary, such activities are not within achieved a passing test result, the e- Secretary in subpart C of part 170, the scope of an ONC–ATCB’s authority prescribing EHR Module would be which could prevent them from granted under the temporary certified. In these situations, both the receiving a certification in a timely certification program and are not EHR Module passing the technical manner if they were not aware of those endorsed or approved by the National requirements tests and the EHR Module factors. We agree with commenters that Coordinator or the Secretary. vendor meeting the other certification this is a legitimate concern and did not Accordingly, we have added as a requirements would be required for the intend to convey, through our examples, component of a new principle in the EHR Module to achieve certification. that we would adopt additional Principles of Proper Conduct for ONC– Comments. Multiple commenters requirements for certification in this ATCBs (discussed in more detail in asked for additional clarification for the final rule beyond the certification section O. Validity of Complete EHR distinction between testing and criteria adopted by the Secretary in and EHR Module Certification and certification. Commenters were subpart C of part 170 and the other Expiration of Certified Status) that any concerned that ONC–ATCBs would responsibilities specified in subpart D of certifications issued to HIT that would have too much discretion related to part 170 that we require an ONC–ATCB constitute a Complete EHR or EHR certification. The commenters asserted to fulfill in order to perform the testing Module and based on the applicable that ONC–ATCBs should only be and certification of Complete EHRs and/ certification criteria adopted by the empowered to assess whether adopted or EHR Modules. Secretary at subpart C must be separate certification criteria have been met or We seek to make clear that the and distinct from any other whether other applicable policies primary responsibility of ONC–ATCBs certification(s) that are based on other adopted by the National Coordinator under the temporary certification criteria or requirements. To further through regulation, such as ‘‘labeling’’ program is to test and certify Complete clarify, HIT which constitutes a policies, have been complied with. EHRs and/or EHR Modules in Complete EHR or EHR Module that is Commenters expressed specific concern accordance with the certification criteria tested and certified to the certification with one of our examples of potential adopted by the Secretary. In criteria adopted by the Secretary as well qualitative factors, which was the need consideration of the comments and the as an ONC–ATCB’s own certification to have ‘‘a quality management system preceding discussion, we have revised criteria would need to have its certified in place.’’ The commenters suggested § 170.445 and § 170.450 to make it status as a Complete EHR or EHR that a requirement to have a quality explicitly clear that an ONC–ATCB Module noted separately and distinctly management system in place is vague must offer the option of testing and from any other certification the ONC– and gave too much discretion to an certification of a Complete EHR or EHR ATCB may issue based on the successful ONC–ATCB. Module solely to the certification demonstration of compliance with its Response. We require as a Principle of criteria adopted by the Secretary and no own certification criteria. For example, Proper Conduct that ONC–ATCBs shall other certification criteria. In other an ONC–ATCB should indicate that the operate their certification programs in words, an ONC–ATCB must comply HIT has been certified as a ‘‘Complete

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EHR in accordance with the applicable permanent certification program or that inpatient settings, there would not be certification criteria adopted by the we ensure that there will be at least two enough ONC–ATCBs to test and certify Secretary of Health and Human ONC–ATCBs for both Complete EHR Complete EHRs for each setting. Services’’ and, if applicable, separately and EHR Module testing and Therefore, these commenters’ support indicate that the HIT meets ‘‘XYZ certification. As discussed in the for the option was conditioned on the certification criteria as developed and/ Proposed Rule, the temporary National Coordinator ensuring that there or required by [specify certification certification program’s processes and were an adequate number of ONC– body].’’ requirements are different than the ATCBs for each setting. One commenter permanent certification program only supported giving ONC–ATCBs an 2. Types of Testing and Certification because of the urgency with which the option to test and certify Complete We proposed in section 170.410 that temporary certification program must be EHRs for either ambulatory or inpatient applicants for ONC–ATCB status may established. We are also unable to settings if the option included testing seek authorization from the National ensure that there will be any specific and certification of EHR Module level Coordinator to perform Complete EHR number of ONC–ATCBs. We believe it is interactions necessary for the exchange testing and certification and/or EHR best to let the marketplace dictate the of data between ambulatory and Module testing and certification. amount of qualified applicants that will inpatient Complete EHRs. We received multiple comments on apply for ONC–ATCB status. We are, Some commenters stated that the the types of testing and certification that however, confident that there are option could lead to ‘‘almost complete’’ ONC–ATCBs can and should perform. sufficient incentives for applicants to EHRs, which could then lead to eligible Many of these comments were in apply and that the program is structured professionals and eligible hospitals response to our requests for public in a manner that will maximize the paying large sums for niche EHR comments on whether ONC–ATCBs number of qualified applicants. Modules based on complicated should test and certify the integration of certification criteria such as EHR Modules and on whether b. Complete EHRs for Ambulatory or biosurveillance or quality reporting. applicants should be permitted to apply Inpatient Settings One commenter asserted that under our to either test and certify only Complete We requested public comment in the current proposal an applicant for ONC– EHRs designed for an ambulatory setting Proposed Rule on whether the National ATCB status could seek authorization to or Complete EHRs designed for an Coordinator should permit applicants to test and certify EHR Modules that inpatient setting. seek authorization to test and certify together would essentially constitute a only Complete EHRs designed for an a. Complete EHRs and EHR Modules Complete EHR for an ambulatory setting ambulatory setting or, alternatively, (or an inpatient setting). Therefore, the We proposed that potential applicants Complete EHRs designed for an commenter contended that we should have the option of seeking authorization inpatient setting. Under our proposal, allow an applicant for ONC–ATCB from the National Coordinator to an applicant seeking authorization to status the option to seek authorization perform Complete EHR testing and perform Complete EHR testing and to test and certify Complete EHRs for certification and/or EHR Module testing certification would be required to test either ambulatory or inpatient settings and certification. and certify Complete EHRs designed for because an applicant for ONC–ATCB Comments. We received comments both ambulatory and inpatient settings. status could essentially choose that expressing support for our proposal Comments. We received comments option by seeking all the necessary EHR because of the flexibility it would ranging from support for providing the Module authorizations for either provide to applicants and the industry. option for applicants to test and certify ambulatory or inpatient settings. We also received a few comments Complete EHRs for either ambulatory or Response. We believe that based on expressing positions contrary to our inpatient settings to support for our the concerns expressed by the proposal. One commenter proposal to require an ONC–ATCB to commenters that it would be recommended that we add more perform testing and certification for inappropriate at this time to allow flexibility by allowing applicants, both settings. Some commenters thought applicants for ONC–ATCB status to seek similar to our proposals for the that our proposal could stifle authorization for the testing and proposed permanent certification competition and expressed concern that certification of Complete EHRs for either program, to either do only testing or there may not be enough entities ambulatory settings or inpatient certification. Conversely, a few capable of performing Complete EHR settings. We will, however, reconsider commenters recommended that we not testing and certification for both this option for the permanent give applicants the option to select, but settings. These commenters stated that certification program based on the instead require ONC–ATCBs to perform allowing for Complete EHR testing and comments received on the proposed testing and certification for both certification for either an ambulatory or permanent certification program. Complete EHRs and EHR Modules. One inpatient setting could add competition To address the commenters’ concerns commenter wanted us to ensure that and expedite certifications. Conversely, about ‘‘almost complete’’ EHRs, we want there were at least two ONC–ATCBs for a few commenters stated that providing to reiterate that for EHR technology to both Complete EHR and EHR Module the option would multiply the National be considered a Complete EHR it would testing and certification. Coordinator’s application workload and have to meet all applicable certification Response. We have attempted to slow the authorization of ONC–ATCBs. criteria adopted by the Secretary. For create a temporary certification program One commenter also thought that the example, a Complete EHR for an that allows for as many qualified option may lead to applicants for ONC– ambulatory setting would have to meet applicants to apply and become ATCB status competing for limited all certification criteria adopted at authorized as possible in the limited resources, such as specialized staff for § 170.302 and § 170.304. Therefore, if time allotted under the temporary conducting testing and certification. we had provided the option for ONC– certification program. We do not agree Some commenters expressed concern ATCBs to seek authorization to test and with the commenters that recommended that if the National Coordinator were to certify Complete EHRs for either that we pattern the applicant allow applicants to test and certify ambulatory or inpatient settings, the requirements after the proposed Complete EHRs for either ambulatory or Complete EHRs that ONC–ATCBs tested

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and certified would have had to meet all technically infeasible as well as both EHR Module integration may be the applicable certification criteria logistically (e.g., multiple testing and advantageous in certain instances, but adopted by the Secretary. certification sites and multiple EHR we do not believe, for the reasons We agree with the one commenter Module developers) and financially discussed above, that we could set all that an applicant for ONC–ATCB status impractical to attempt to test and certify the necessary parameters for testing could seek authorization to test and for integration given the huge and EHR Module-to-EHR Module integration certify EHR Modules that together shifting numbers of possible within the allotted timeframe of the would potentially cover all the combinations. Some commenters, temporary certification program. applicable certification criteria for an however, suggested that EHR Modules E. Application Process ambulatory setting. In fact, in relation to could be tested and certified as the privacy and security testing and integrated bundles. One commenter As outlined in greater detail below, certification of EHR Modules, we state recommended that if we were to pursue the proposed application process in this final rule that if EHR Modules any type of EHR Module-to-EHR consisted of an applicant abiding by are presented for testing and Module integration, it should be no certain prerequisites before receiving an certification as an integrated bundle that earlier than when we adopt the next set application, adhering to the application would otherwise constitute a Complete of standards, implementation requirements and submitting the EHR we would consider them a specifications, and certification criteria, application by one of the proposed Complete EHR for the purposes of being and then it should only be done methods. certified by an ONC–ATCB. The selectively based on meaningful use 1. Application Prerequisite important distinction between the requirements. Another commenter commenter’s suggested approach and We proposed in section 170.415 that suggested that ONC–ATCBs be given the applicants would be required to request, the option we proposed is that under option, but not be required, to the commenter’s approach the ONC– in writing, an application for ONC– determine if EHR Modules are ATCB status from the National ATCB would not be able to issue a compatible. ‘‘Complete EHR certification’’ for a Coordinator. We further proposed that Response. We believe that the testing combination of EHR Modules because applicants must indicate the type of and certification of EHR Modules for the the ONC–ATCB had not received authorization sought pursuant to purposes of integration is inappropriate authorization to test and certify § 170.410, and if seeking authorization for the temporary certification program Complete EHRs. Consequently, if a to perform EHR Module testing and Complete EHR developer wanted to due to various impracticalities. We certification, the specific type(s) of EHR obtain Complete EHR certification, they believe that EHR Module-to-EHR Module(s) they seek authorization to could not seek such certification from Module integration is inappropriate test and certify. Finally, we proposed an ONC–ATCB that did not have primarily because of the impracticalities that applicants would only be authorization to grant Complete EHR pointed out by commenters related to authorized to test and certify the types certifications. We would assume that a the numerous combinations of EHR of EHR Modules for which the potential applicant for ONC–ATCB Modules that will likely exist and the applicants sought and received status would consider this impact on its associated technical, logistical, and authorization. customer base when determining what financial costs of determining EHR Comments. A commenter expressed type of authorization to seek. Module-to-EHR Module integration. To agreement with our proposal to limit an the extent that an EHR Module applicant’s authorization to test and c. Integrated Testing and Certification of developer or developers present EHR certify EHR Modules to the EHR EHR Modules Modules together as an integrated Modules specified in the applicant’s In the Proposed Rule, we requested bundle for testing and certification, we application. The commenter requested, public comment on whether ONC– would allow the testing and certification however, that we establish a process for ATCBs should be required to test and of the bundle only if it was capable of allowing ONC–ATCBs to apply for certify that any EHR Module presented meeting all the applicable certification additional authorization to test and by one EHR Module developer for criteria and would otherwise constitute certify additional EHR Modules and to testing and certification would properly a Complete EHR. In all other allow for the expansion of authorization work (i.e., integrate or be compatible) circumstances, we would not require over time. Another commenter asked with other EHR Modules presented by testing and certification for EHR that we clarify that ONC–ATCBs that different EHR Module developers. Module-to-EHR Module integration as choose to only test and certify EHR Comments. Multiple commenters part of the temporary certification Modules be allowed to limit their stated that testing and certifying EHR program. Nothing in this final rule testing and certification to one health Modules to determine whether they can precludes an ONC–ATCB or other entity care setting, such as testing and integrate with one another is a from offering a service to test and certify certifying a ‘‘laboratory’’ EHR Module worthwhile endeavor. These EHR Module-to-EHR Module solely for an ambulatory setting. commenters stated that such testing and integration. However, to be clear, Response. The only process that we certification would make it easier for although we do not require or intend to use to authorize ONC–ATCBs eligible professionals and eligible specifically preclude an ONC–ATCB under the temporary certification hospitals to purchase certified EHR from testing and certifying EHR Module- program is the application process that Modules that are compatible and could to-EHR Module integration, any EHR we have proposed. Therefore, if an be used together to achieve meaningful Module-to-EHR Module testing and ONC–ATCB authorized to test and use and could increase or improve certification done by an ONC–ATCB or certify a certain type(s) of EHR interoperability among HIT in general. other entity will be done so without Module(s) wanted to seek additional Conversely, many other commenters specific authorization from the National authorization for the testing and strongly disagreed with requiring EHR Coordinator and will not be considered certification of other types of EHR Modules to be tested and certified for part of the temporary certification Modules, it would need to submit compatibility. Overall, these program. We understand that testing another application requesting that commenters asserted that it would be and certification for EHR Module-to- specific authorization. We would

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anticipate in that situation, however, received multiple comments requesting enable a new entrant to build and that the application process and review that we provide more explanation about demonstrate their capabilities would proceed fairly quickly. In Guide 65 and ISO 17025. The throughout the application process addition, we will consider whether an commenters requested information while still requiring full adherence to alternative method would be about how Guide 65 and ISO 17025 are the application requirements before an appropriate for such a situation under related to Complete EHRs and EHR applicant is granted ONC–ATCB status. the proposed permanent certification Modules, why we selected Guide 65 and Response. With respect to those program. Lastly, we note, in response to ISO 17025 as conformance requirements comments that requested further a commenter’s question about whether for the temporary certification program, explanation about Guide 65 and ISO an ONC–ATCB authorized to test and and how Guide 65 and ISO 17025 are 17025, we would note that the certify a certain type of EHR Module is related to one another, including International Organization for required to test and certify for both explaining why ISO 17025 is Standardization (ISO) developed both ambulatory and inpatient settings, that appropriate for the temporary standards. As explained in the the answer would depend on what type certification program but not for the Introduction of Guide 65, the of EHR Module authorization the permanent certification program. observance of the Guide’s specifies applicant for ONC–ATCB status sought. Commenters also recommended that we requirements is intended to ensure that As previously noted, it is possible to consult with NIST to develop an certification bodies operate third-party seek authorization to test and certify ‘‘information paper’’ or other certification systems in a consistent and EHR Modules that address only an supplemental guidance document to reliable manner, which will facilitate ambulatory or inpatient setting. assist the industry with understanding their acceptance on a national and Accordingly, we are finalizing this Guide 65 and ISO 17025 and how they international basis. ISO 17025 is also an provision without modification. will apply to the certification programs. international standard intended to serve One commenter stated that as a basis for accreditation, which 2. Application conformance to ISO 17025 was not a accreditation bodies use when assessing We proposed in section 170.420 that barrier to entry because there are at least the competence of testing and the application for ONC–ATCB status two commercial laboratories currently calibration laboratories. We note that would consist of two parts. We further accredited to ISO 17025 and performing both standards have been developed by proposed that applicants would be testing in a similar government program a voluntary consensus standards body, required to complete both parts of the (USGv6 Testing Program). Conversely, as required by the National Technology application and submit them to the other commenters expressed concern Transfer and Advancement Act of 1995 National Coordinator for the application that Guide 65 and ISO 17025 were and the Office of Management and to be considered complete. possible barriers to entry. Some Budget (OMB) Circular A–119, and we a. Part 1 commenters thought that the are aware of no alternative voluntary documentation requirements would be consensus standards that would serve In Part 1 of the application, we too high an administrative burden for the purpose for which these standards proposed that an applicant provide applicants, while others thought there are intended to serve. general identifying information was not enough time for applicants to Guide 65 will be utilized to determine including the applicant’s name, address, demonstrate compliance with Guide 65 if an applicant for ONC–ATCB status is city, state, zip code, and Web site. We and ISO 17025 in time to apply for, and capable of conducting an appropriate proposed that an applicant also receive authorization, under the certification program for certifying designate an authorized representative temporary certification program. Complete EHRs and/or EHR Modules. and provide the name, title, phone The commenters offered various ISO 17025 will be utilized to determine number, and e-mail address of the recommendations for addressing their if an applicant for ONC–ATCB status is person who would serve as the stated concerns. One commenter capable of conducting an appropriate applicant’s point of contact. We suggested that we delay compliance testing program for testing Complete proposed that an applicant complete with Guide 65 and ISO 17025 until the EHRs and/or EHR Modules. We believe and submit self audits to all sections of permanent certification program is that Guide 65 and ISO 17025 are clear Guide 65 and ISO/IEC 17025:2005 (ISO implemented. A second option in the requirements they impose on a 17025) as well as submit additional recommended by commenters was to testing and certification body, and documentation related to Guide 65 and not require strict compliance with therefore, we do not see the need for an ISO 17025. We also proposed that an Guide 65 and ISO 17025, but rather ‘‘information’’ paper or additional applicant had to agree to adhere to the allow for material compliance. In guidance at this time. We would, as Principles of Proper Conduct for ONC– support of this recommendation, one appropriate, consider issuing guidance ATCBs. commenter contended that certain to further clarify any requirements of Comments. We received several provisions of ISO 10725 (i.e., provisions this final rule. comments expressing agreement with on uncertainty of measurements, We agree with the commenters that the application requirements, including sampling, calibration methods, and stated that our application requirements the use of Guide 65 and ISO 17025. One environmental conditions that impact for the temporary certification program commenter specifically stated that results) do not appropriately address are appropriate and do not constitute a requiring applicants for ONC–ATCB HIT testing and therefore should not barrier to entry. As stated by status to demonstrate their conformance apply. A third option presented by commenters, requiring applicants for to both Guide 65 and ISO 17025 is an commenters was for us to embrace a ONC–ATCB status to demonstrate their appropriate and effective means to glide path that would allow qualified conformance to both Guide 65 and ISO demonstrate an applicant’s competency organizations to move towards 17025 is an appropriate and effective and ability to test and certify Complete compliance in a systematic way. A more method for determining an applicant’s EHRs and/or EHR Modules and, specific recommendation illustrating competency and ability to test and therefore, an appropriate means for this sentiment was to allow applicants certify Complete EHRs and/or EHR initiating our proposed testing and for ONC–ATCB status to meet certain Modules and, therefore, an appropriate certification program. However, we also requirements on a timeline that would method for initiating our proposed

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temporary certification program. By 3. Principles of Proper Conduct for divided the comments into two proposing these requirements, we have ONC–ATCBs categories, which are: Establishment of not only indicated that we believe them We received multiple comments on test tools and test procedures; and to be appropriate measures of the proposed Principles of Proper public feedback process. applicants’ competencies, but that they Conduct for ONC–ATCBs. We did not, i. Establishment of Test Tools and Test are also not overly burdensome and that however, receive any comments on the Procedures applicants will have sufficient time to Principles of Proper Conduct proposed meet the requirements in time to apply Comments. While some commenters in paragraphs (c), (d) and (f) of expressed agreement with the use of under the temporary certification § 170.423. Therefore, we are finalizing program. As we noted in the Proposed NIST test tools and test procedures, these Principles of Proper Conduct many commenters requested Rule, applicants under the permanent without modification. While we certification program may have to meet clarification on NIST’s role and scope of received comments on all the other authority. A commenter specifically potentially more comprehensive proposed Principles of Proper Conduct requirements in order to meet the asked whether NIST would be the for ONC–ATCBs and suggestions for author of both the test tools and test proposed accreditation requirement. In additional principles of proper conduct, procedures for each and every regard to the commenter’s question the majority of the comments were certification criterion. Other about the application of ISO 17025 to focused on compliance with Guide 65 commenters requested clarification of the proposed permanent certification and ISO 17025, the proposed use of the phrase ‘‘functionally equivalent program, we have proposed that a NIST test tools and test procedures, the testing tools and procedures published separate accreditation process for testing requirement that ONC–ATCBs provide by another entity’’ and specifically laboratories would exist through the ONC, no less frequently than weekly, a requested that we create a process for National Voluntary Laboratory current list of Complete EHRs and EHR the timely establishment of functionally Accreditation Program (NVLAP) and Modules that have been tested and equivalent test tools and test anticipate that process would include certified, the proposed records retention procedures, with one commenter compliance with ISO 17025. requirement, and our proposed recommending that ‘‘functionally By ensuring that an ONC–ATCB is requirement that ONC–ATCBs issue equivalent’’ be determined by ONC capable of performing its refunds for tests and certifications that during the application process. responsibilities related to testing and were not completed. Commenters noted that NIST has certification we believe industry and a. Operation in Accordance With Guide published draft versions of test consumer confidence will be 65 and ISO 17025 Including Developing procedures that will likely change once established in the temporary a Quality Management System the final rules for both the HIT certification program and in the Standards and Certification Criteria Complete EHRs and EHR Modules We proposed in section 170.423(a) interim final rule and the CMS Medicare tested and certified under the program. that an ONC–ATCB would be required and Medicaid EHR Incentive Programs Based on these reasons and our stated to operate its certification program in proposed rule are issued. One belief that there is sufficient time for an accordance with Guide 65 and its commenter concluded that ‘‘functionally applicant to apply for ONC–ATCB testing program in accordance with ISO equivalent’’ would not be able to be status, we do not believe that any type 17025. We also proposed in § 170.423(b) determined until the final NIST test of application or authorization process that an ONC–ATCB be required to procedures are issued. To address this that would provide for any less than full maintain an effective quality issue, the commenter recommended that achievement and compliance with the management system which addresses all we adopt CCHIT ‘‘IFR Stage 1 application requirements of the requirements of ISO 17025. Certification’’ procedures (with temporary certification program is The comments we received on Guide appropriate modifications once a final appropriate, including allowing for 65 and ISO 17025 were repetitive and rule is published) for testing at the start material compliance or a glide path to essentially indistinguishable from the of the temporary certification program full compliance. As to the one comments we received on Guide 65 and and that ONC–ATCBs use NIST test commenter’s contention that certain ISO 17025 in relation to our proposed procedures once they became available provisions of ISO 17025 do not apply to application process. Therefore, we do at which point the NIST test procedures the testing of HIT, it is incumbent upon not discuss them again in this section could serve as an option for the an applicant for ONC–ATCB status to and we are finalizing this Principle of temporary certification program, and demonstrate in its self audit to ISO Proper Conduct for ONC–ATCBs subsequently be deemed the only 17025 and/or Guide 65 why provisions without modification. acceptable set of test procedures for the proposed permanent certification or requirements do not apply to its b. Use of NIST Test Tools and Test program. Another commenter expressed request for authorization to test and Procedures certify Complete EHRs and/or EHR a lack of confidence in functionally Modules. We proposed in section 170.423(e), equivalent test tools and test procedures that an ONC–ATCB would be required and requested that we confirm that We are finalizing this provision to ‘‘[u]se testing tools and procedures Complete EHR and EHR Module without modification. published by NIST or functionally developers would have no liability b. Part 2 equivalent testing tools and procedures regarding the functional equivalence of published by another entity for the an ONC–ATCB’s test tools and test We proposed for Part 2 of the purposes of assessing Complete EHRs procedures. The commenter stated that application that an applicant must and/or EHR Modules compliance with if this assurance could not be provided submit a completed proficiency the certification criteria adopted by the then only NIST test tools and test examination. We did not receive any Secretary.’’ procedures should be utilized. comments on this provision. Therefore, We received a number of comments Commenters also asked for clarification we are finalizing this provision without on this proposed Principle of Proper on the extent to which ONC–ATCBs are modification. Conduct for ONC–ATCBs. We have permitted to modify test procedures/test

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scripts and how test procedures/test primary source for ONC–ATCBs to use National Coordinator has approved test scripts could be corrected, if necessary. as they develop their test scripts. We tools and/or test procedures, we will Some commenters expressed a understand that NIST may establish test publish a notice of availability in the preference for consistency of test data tools and test procedures based on Federal Register and identify the and test criteria across all testing multiple sources, such as NIST- approved test tools and test procedures organizations and were concerned about developed tools, industry-developed on the ONC Web site. allowing ONC–ATCBs to define their tools, or open source tools, as Once test tools and test procedures own test scripts or test procedures. The appropriate. NIST has been exploring have been approved by the National commenters reasoned that some ONC– and will likely utilize all three of these Coordinator, ONC–ATCBs will have the ATCBs may have ‘‘easier’’ tests than options. That being said, this revised responsibility and flexibility to others, and therefore, the credibility of Principle of Proper Conduct for ONC– configure their own test scripts (i.e., the process will be uneven and ATCBs will provide the National specific scenarios using the test tools questionable. Finally, a commenter also Coordinator with the ability to approve and test procedures), to create, for asked who would develop not only NIST test tools and test example, a testing sequence that an implementation guidance for standards procedures, but potentially other test ONC–ATCB believes is the most adopted in the HIT Standards and tools and test procedures that are efficient way for testing a certain suite Certification Criteria interim final rule identified or developed by other of capabilities. Given the level and type and how this guidance would be linked organizations. We understand that of adjustments that we expect ONC– to the test methods in a way that would commenters would prefer to have the ATCBs to make, we do not believe that accurately reflect a common National Coordinator serve as the locus it will be possible for ONC–ATCBs to interpretation of a standard. of control with respect to which test include significant variations in their Response. First and foremost, we tools and test procedures ONC–ATCBs test scripts such that a Complete EHR or reiterate that the National Coordinator is are permitted to use. We also inferred EHR Module will pass a test responsible for administering the from the comments that such an administered by one ONC–ATCB but temporary certification program. approach would provide greater fail a test administered by a different Consistent with the HITECH Act, we are certainty to Complete EHR and EHR ONC–ATCB. As to the commenter’s in consultation with NIST to learn from Module developers as to which test inquiry about how ‘‘implementation its resident experts and have requested tools and test procedures may be used guidance’’ will link to test tools and test NIST’s assistance in the development of by ONC–ATCBs, as well as greater procedures, we believe that, where test tools and test procedures that all consistency among ONC–ATCBs’ testing implementation specifications have ONC–ATCBs could use to properly and and certification processes. been adopted in the HIT Standards and consistently test and certify Complete Certification Criteria interim final rule, EHRs and EHR Modules in accordance A person or entity may submit a test they will be considered in the with the standards, implementation tool and/or test procedure to the development of test tools and test specifications, and certification criteria National Coordinator to be considered procedures. adopted by the Secretary. We expect for approval to be used by ONC–ATCBs. Comments. A commenter that NIST will develop a test tool and The submission should identify the recommended, based on the increased test procedure for each and every developer of the test tool and/or test focus on the safety of EHRs, that the certification criterion. procedure, specify the certification NIST testing framework be developed We have reviewed the commenters’ criterion or criteria that is/are addressed using auditable quality guidelines, concerns and requests for clarification. by the test tool and/or test procedure, including documentation on the After further consideration, we have and explain how the test tool and/or test purpose, installation, configuration, use decided to modify this Principle of procedure would evaluate a Complete and traceability of the NIST testing Proper Conduct for ONC–ATCBs to EHR’s or EHR Module’s compliance framework. Some commenters provided more thoroughly clarify our intent. We with the applicable certification recommendations on the processes for have revised the Principle of Proper criterion or criteria. The submission the development of test tools and test Conduct for ONC–ATCBs to remove the should also provide information procedures. A commenter suggested that concept of ‘‘functionally equivalent’’ and describing the process used to develop NIST look to adopt existing test tools to clearly state that the National the test tool and/or test procedure, and test procedures currently Coordinator would play the central role including any opportunity for the public operational and developed via industry in determining which test tools and test to comment on the test tool and/or test consensus, while other commenters procedures will be approved for ONC– procedure and the degree to which specifically recommended that we ATCBs to use. The revised Principle of public comments were considered. In utilize HL7 EHR–S FM and its profiles Proper Conduct requires ONC–ATCBs to determining whether to approve a test and the Committee on Operating Rules ‘‘[u]se test tools and test procedures tool and/or test procedure, the National for Information Exchange® (CORE) approved by the National Coordinator Coordinator will consider whether it is testing processes. Other commenters for the purposes of assessing Complete clearly traceable to a certification contended that the scope of the test EHRs’ and/or EHR Modules’ compliance criterion or criteria adopted by the procedures currently developed by with the certification criteria adopted by Secretary, whether it is sufficiently NIST is too narrow and does not take the Secretary.’’ comprehensive (assesses all required into account clinical realities when We believe that this revision provides capabilities) for ONC–ATCBs to use in systems are implemented in a clinical the National Coordinator with greater testing and certifying a Complete EHR’s setting. Another commenter flexibility and discretion to ensure that or EHR Module’s compliance with the recommended that the test tools and test Complete EHRs and EHR Modules are certification criterion or criteria adopted procedures support end-user needs. being tested and certified by ONC– by the Secretary, whether an Response. The NIST test tools and test ATCBs according to the best test tools appropriate public comment process procedures include components to help and test procedures available. In that was used during the development of the ensure traceability of a specific regard, we believe that NIST test tools test tool and/or test procedure, and any certification criterion. The test tools and and test procedures will likely be a other relevant factors. When the test procedures also have

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documentation for installation, tools and test procedures on its Web site some HIT vendors treat their software configuration and use. As noted above, and has been accepting and reviewing screens and other elements as trade the National Coordinator may approve public comments since releasing the secrets. Additionally, the commenter test tools and test procedures for the drafts. Specifically, NIST began stated that during site testing of temporary certification program based publishing test tools and test procedures hospital-developed EHRs, protected on multiple sources, as appropriate. We on its Web site on February 23, 2010. health information may inadvertently would further note that while we The test tools and test procedures have appear on screen in reports or audit recognize the utility of other sources, been published in four ‘‘waves’’ or trails. The commenter contended that if such as HL7 EHR–S FM or CORE testing groups of test tools and test procedures. ONC or its authorized agent(s) were processes, the temporary certification At the time this final rule was prepared, unable to execute such confidentiality program’s primary focus is to test and NIST had received over 100 public and/or business associate agreements, certify Complete EHRs and EHR comments on its drafts. In response, then ONC observation may have to be Modules to the certification criteria NIST has issued revised drafts of the limited to those elements of testing that adopted by the Secretary. The scope of test tools and test procedures and is do not risk revealing vendor trade the test tools and test procedures is developing ‘‘frequently asked questions secrets or protected health information; defined by the applicable certification and answers’’ that it plans to post on its or ONC might have observation of criterion or criteria. Therefore, the test Web site to address common comments testing limited to Complete EHR or EHR tools and test procedures are not on the draft test tools and test Module developers who waive their currently focused on addressing matters procedures. NIST intends to continue to confidentiality requirements for ONC outside the scope of adopted seek and consider public feedback until observers. certification criteria such as usability or the test tools and test procedures are Response. Our original proposal gave ‘‘end-user needs.’’ finalized, which will likely occur in us the option to either conduct conjunction with the publication of the ii. Public Feedback Process scheduled or unannounced visits. After final rules for both the HIT Standards considering the comments, we believe it Comments. Commenters expressed and Certification Criteria interim final is appropriate to maintain both options. concern that there was a lack of a rule and the Medicare and Medicaid If we determine that there is a specific specified process for stakeholders, EHR Incentive Programs proposed rule. testing and/or certification that would particularly Complete EHR and EHR It is not within the scope of this be appropriate for us or our authorized Module developers, to participate in the rulemaking to instruct NIST to consult agent(s) to observe, we may find it is development, review and validation of with other entities. However, we note more prudent to schedule a visit. test procedures. Multiple commenters that all stakeholders, including However, to monitor compliance with asked for a formal role for Complete Complete EHR and EHR Module the provisions of the temporary EHR and EHR Module developers as developers and SDO publishers, may certification program and to maintain well as eligible professionals and participate in the public comment the integrity of the program, we believe eligible hospitals to give feedback to process described above. Furthermore, that unannounced visits are appropriate. NIST. A commenter noted that the we believe that the feedback process In addition, we expect that any Proposed Rule stated that the test tools currently employed by NIST is an confidentiality agreement executed and test procedures would be published appropriate and acceptable method for between an ONC–ATCB and a customer, by NIST on its Web site or through a soliciting, accepting and meaningfully such as Complete EHR and EHR Module notice in the Federal Register, but that considering public comments on the test developers, for the purposes of testing the Proposed Rule did not clearly tools and test procedures. and certification under the temporary delineate the processes, how the certification program would include processes will be managed, and a c. ONC Visits to ONC–ATCB Sites ONC and its authorized representatives timeline. Another commenter stated that We proposed in section 170.423(g) to when ‘‘test scripts’’ involve or relate to require an ONC–ATCB to allow ONC, or as parties who may observe the testing the implementation of an adopted its authorized agent(s), to periodically and certification of the customer’s standard, NIST should be required to observe on site (unannounced or Complete EHR or EHR Module. We consult with the standards development scheduled), during normal business would also expect that the organization (SDO) publisher of the hours, any testing and/or certification confidentiality agreement would cover standard for review of proposed ‘‘test performed to demonstrate compliance any proprietary information, trade scripts,’’ and should be required to with the requirements of the temporary secrets, or protected health information. consider comments made by the SDO certification program. Therefore, we are finalizing this prior to publication of final ‘‘test Comments. A commenter stated that if Principle of Proper Conduct without scripts.’’ A final comment expressed visits are unannounced, then there can modification. concern that the test tools and test be no assurance that a test or d. Lists of Tested and Certified procedures being developed by NIST are certification will actually be underway Complete EHRs and EHR Modules not following the government protocol upon arrival of an ONC representative. for openness and transparency by Therefore, the commenter i. ONC–ATCB Lists allowing for an open, public comment recommended that we should revise the We proposed in section 170.423(h) to period on the test tools and test requirement to require that an ONC– require an ONC–ATCB to provide ONC, procedures before adoption. ATCB respond within 2 business days no less frequently than weekly, a Response. We noted in the Proposed to an ONC request to observe testing current list of Complete EHRs and/or Rule that the test tools and test and/or certification by providing the EHR Modules that have been tested and procedures would be published in some date, time, and location of the next certified which includes, at a minimum, manner and suggested, as examples, that scheduled test or certification. The the vendor name (if applicable), the date publication on NIST’s Web site or by commenter further stated that ONC certified, product version, the unique notice in the Federal Register would be observers for site visits would likely certification number or other specific acceptable methods. As noted above, need to execute confidentiality and/or product identification, and where NIST has published drafts of the test business associate agreements because applicable, the certification criterion or

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certification criteria to which each EHR and certification of Complete EHRs and with a certification criterion or criteria Module has been tested and certified. EHR Modules will likely vary based on adopted by the Secretary. We do not Comments. Many provider many factors and, in some cases, may intend or expect this requirement to be organizations expressed appreciation for not be completed due to various construed as a comprehensive the proposed requirement and the reasons. Therefore, we do not believe specifications list or similar type of proposed frequency for which the lists that the reporting of products in an inclusive list. Rather, our rationale for were to be updated. In relation to what ONC–ATCB’s queue should be a including this requirement is to ensure ONC–ATCBs report, a commenter requirement at this time. that eligible professionals and eligible specifically expressed support for We agree with the commenter who hospitals who adopt a certified making timely, complete, and useful indicated that useful information should Complete EHR or EHR Module information available to eligible be made available to eligible understand what is necessary for the professionals and eligible hospitals as professionals and eligible hospitals as Complete EHR or EHR Module to they work to purchase and implement they decide which Certified EHR operate in compliance with the Certified EHR Technology that will Technology to adopt. Moreover, we note certification criterion or criteria to enable them to demonstrate meaningful that much of the information reported which it was tested and certified. use. by ONC–ATCBs will be included in the For example, if a Complete EHR relied Some commenters requested Certified HIT Products List (CHPL) that upon an operating system’s automatic clarification and made will be available on ONC’s Web site. log-off functionality to demonstrate its recommendations for revisions to the After consideration of public comments compliance with this certification provision. One commenter suggested and our own programmatic objectives, criterion, we would expect the operating that the provision should be revised to we accordingly believe that two system relied upon to be reported. require an ONC–ATCB to notify ONC additional elements should be reported Conversely, if a Complete EHR included within a week of successful testing and by ONC–ATCBs in order to improve its own automatic log-off capability, certification of new Complete EHRs transparency and assist eligible even though the Complete EHR may and/or EHR Modules. Additionally, the professionals and eligible hospitals who have been tested and certified on a commenter contended that the proposed seek to adopt certified Complete EHRs particular operating system, we would provision was unclear as to whether an and EHR Modules. The two additional not require the operating system to be ONC–ATCB was required to send a elements we will require ONC–ATCBs reported because it was not relied upon complete, current list or only new to report are the clinical quality to demonstrate compliance with the additions and whether the list could be measures to which a Complete EHR or certification criterion. sent via e-mail. Another commenter EHR Module has been tested and Finally, we note that our required suggested revising the provision to certified and, where applicable, any reporting elements constitute a require an ONC–ATCB to also report a additional software a Complete EHR or minimum. We do not preclude ONC– current list of ‘‘applicants’’ and their EHR Module relied upon to demonstrate ATCBs from including in their weekly status in the testing or certification its compliance with a certification reports additional information that queue. criterion or criteria adopted by the prospective purchasers and users of Response. We will, as proposed, Secretary. As with the other information Complete EHRs and EHR Modules require that ONC–ATCBs provide the that ONC–ATCBs must report, these two would find useful, such as specifying National Coordinator with a current list additional elements, as suggested by the the Complete EHR or EHR Module’s of Complete EHRs and/or EHR Modules commenter, will enable eligible compatibility with other software or that have been tested and certified no professionals and eligible hospitals to compatibility with other EHR Modules. less frequently than weekly. We make informed purchasing decisions. If not reported to the National anticipate only requiring weekly The reporting of clinical quality Coordinator, we encourage ONC–ATCBs updates, but ONC–ATCBs are free to measures to which a Complete EHR or to consider making such information provide more frequent updates. We EHR Module has been tested and available on their own Web sites to believe that weekly updates are certified will enable an eligible better inform prospective purchasers sufficient for providing current professional or eligible hospital to and users of Complete EHRs and EHR information to the market on the status identify and adopt a Complete EHR or Modules. of Complete EHRs and EHR Modules EHR Module that includes the clinical We are revising § 170.423(h) without placing an administrative quality measures they seek to consistent with our discussion above. burden on ONC–ATCBs. In this regard, implement. Knowledge of the additional ii. Certified HIT Products List we have previously stated and continue software a Complete EHR or EHR to expect that the information would be Module has relied upon to demonstrate We stated in the Proposed Rule that provided electronically, such as through compliance with a certification criterion in an effort to make it easier for eligible e-mail. We also agree with the or criteria will be useful, and in some professionals and eligible hospitals to commenter that it would be unnecessary cases essential, for eligible professionals cross-validate that they have in fact for an ONC–ATCB to continue to report and eligible hospitals who are deciding adopted Certified EHR Technology, the on previously certified Complete EHRs which Complete EHR or EHR Module to National Coordinator intends to make a and/or EHR Modules and, therefore, adopt. With this information, eligible master CHPL of all Complete EHRs and only expect these weekly reports to professionals and eligible hospitals EHR Modules tested and certified by include new certifications issued would be able to assess whether a ONC–ATCBs available on the ONC Web between the last weekly report and the specific certified Complete EHR or EHR site. The CHPL would be a public newly submitted weekly report. Module may be incompatible with their service and would be a single, aggregate Additionally, we do not believe that any current information technology (IT) or source of all the certified product substantial benefit would come from would require them to install additional information ONC–ATCBs provide to the having an ONC–ATCB report on the IT. We stress that this reporting National Coordinator. The CHPL would status of Complete EHRs and/or EHR requirement only relates to software that also represent all of the Complete EHRs Modules currently being tested and is relied upon by a Complete EHR or and EHR Modules that could be used to certified. The time needed for testing EHR Module to demonstrate compliance meet the definition of Certified EHR

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Technology. We also noted that, over maintain on its own Web site a current Comments. A commenter asserted time, we anticipate adding features to list of the Complete EHRs and/or EHR that requesting ‘‘all’’ testing and the Web site, which could include Modules that it has certified, but instead certification records will lead to ONC interactive functions to enable eligible reference the CHPL on ONC’s Web site receiving a voluminous amount of professionals and eligible hospitals to for the complete list of certified records that we likely never intended to determine whether a combination of Complete EHRs and EHR Modules. receive. The commenter recommended certified EHR Modules could constitute Response. We appreciate the that we be more specific about the Certified EHR Technology. commenters’ support for the CHPL and records ONC–ATCBs will need to Comments. Many commenters their recommendations for its provide copies of to ONC. expressed support for our decision to enhancement. We intend for the CHPL Many commenters noted that CMS create a list of certified Complete EHRs to be a single, aggregate source of all has proposed in its Medicare and and EHR Modules and to post a link to certified Complete EHRs and EHR Medicaid EHR Incentive Programs that list on our Web site. Many Modules reported by ONC–ATCBs to proposed rule to require providers to commenters also provided the National Coordinator. The CHPL maintain records demonstrating recommendations for how to enhance will comprise all of the certified meaningful use, which includes the use the list. One commenter endorsed an Complete EHRs and EHR Modules that of Certified EHR Technology, for 10 online system whereby physicians could be used to meet the definition of years. The commenters noted that in the could type in or select information on Certified EHR Technology. It will also event of an audit, eligible professionals the Complete EHR or EHR Module they include the other pertinent information and eligible hospitals may need to go planned on using to determine whether we require ONC–ATCBs to report to the back to the certification body or ONC, their selected combination would National Coordinator, such as a certified in the case of the temporary certification enable them to meet the CMS Medicare Complete EHR’s version number. program, to verify that a particular and Medicaid EHR Incentive Programs Eligible professionals and eligible product was indeed certified at a requirements. The commenter reasoned hospitals that elect to use a combination particular point in time. Therefore, the that the steps were necessary because of certified EHR Modules may also use commenters recommended that our eligible professionals, especially in the CHPL Web page to validate whether proposed retention period for smaller practices, did not have the the EHR Modules they have selected certification bodies needs to be equal to technical expertise or support to satisfy all of the applicable certification the length of time that eligible ascertain whether or not a Complete criteria that are necessary to meet the professionals and eligible hospitals EHR, EHR upgrades, EHR Module(s), or definition of Certified EHR Technology. must maintain records under CMS’s a combination of EHR Modules would The CHPL Web page will include a proposal, plus two or more additional enable them to perform the meaningful unique identifier (such as a code or years to ensure that records are available use requirements. Another commenter number) for each certified Complete during an audit process. A commenter requested an explicit commitment from EHR and each combination of certified also requested that ONC specify how ONC that the use of certified Complete EHR Modules that satisfies all of the long it would retain copies of records EHRs and/or EHR Modules on the CHPL applicable certification criteria provided by ONC–ATCBs at the sunset will support their ability to report all necessary to meet the definition of of the temporary certification program. required meaningful use measures. Certified EHR Technology. The unique Response. To address the Some commenters expressed a code or number listed on the CHPL Web commenter’s concern about voluminous preference that the CHPL contain page could subsequently be used to records being provided to ONC and to information on the capabilities of submit to CMS for attestation purposes. provide clarity to ONC–ATCBs about certified Complete EHRs and EHR We believe that only ONC should their records retention responsibility, Modules associated with adopted maintain the CHPL to ensure that the we are clarifying the language of this certification criteria. Other commenters CHPL is accurate and comprehensive. Principle of Proper Conduct. For the requested that the CHPL contain However, we do not believe that it is duration of the temporary certification information on whether certified appropriate to preclude an ONC–ATCB program, an ONC–ATCB will be Complete EHRs or EHR Modules are from maintaining on its own Web site a required to retain all records related to compatible with other HIT. In list of Complete EHRs and/or EHR tests and certifications in accordance particular, commenters stated that it Modules that it tests and certifies. An with Guide 65 and ISO 17025. Upon the was important to eligible professionals ONC–ATCB’s own list could have conclusion of testing and certification and eligible hospitals for Complete EHR benefits for the market in identifying the activities under the temporary and EHR Module developers to fully specific ONC–ATCB that tested and certification program, ONC–ATCBs will disclose the functions for which their certified a Complete EHR or EHR be required to provide copies of the products are certified, which software Module. The ONC–ATCB may also final results of all completed tests and components are necessary to meet create a link on its Web site to the certifications to ONC (i.e., all passed certification criteria, and to also fully CHPL, which conceivably would be a and failed results). ONC will retain all disclose any compatibility issues. A few user-friendly feature. records received from ONC–ATCBs in commenters also suggested that the accordance with applicable federal law CHPL contain data on usability features e. Records Retention and may use the records for assessing of certified Complete EHRs and EHR We proposed in section 170.423(i) to compliance with temporary certification Modules. require an ONC–ATCB to retain all program requirements. Our records One commenter recommended that records related to the testing and retention requirement should be ONC and each ONC–ATCB maintain a certification of Complete EHRs and/or construed as an independent list of certified Complete EHRs and EHR EHR Modules for the duration of the requirement. Any other records Modules. Another commenter temporary certification program and to retention requirements or potential legal recommended that, in order to prevent provide copies of all testing and compliance requirements should be the conveyance of potentially inaccurate certification records to ONC at the complied with fully and not in information and confusion in the sunset of the temporary certification association or correlation with our market, an ONC–ATCB should not program. records retention requirements.

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We are revising § 170.423(i) consistent interest in more than one entity remain in good standing. As noted in with our discussion above. receiving ONC–ATCB status nor have the previous response, a Principle of any conflict of interest with EHR Proper Conduct for ONC–ATCBs f. Refunds product companies actively promoting requires ONC–ATCBs to adhere to the We proposed in section 170.423(j) to EHR products in the marketplace. provisions of Guide 65 and ISO 17025, require an ONC–ATCB to promptly Response. Applicants for ONC–ATCB which require an ONC–ATCB to have refund any and all fees received for tests status and ONC–ATCBs must adhere to policies and procedures to avoid and certifications that will not be the requirements of Guide 65 and ISO involvement in any activities that would completed. 17025. These requirements explicitly diminish confidence in its competence, Comments. While a vendor obligate testing and certification bodies impartiality, judgment or operational organization expressed agreement with to conduct business in an impartial integrity as well as have a documented our proposed refund requirement, manner. For instance, an applicant for structure that safeguards impartiality potential applicants for ONC–ATCB ONC–ATCB status and/or an ONC– including provisions that ensure the status requested that we clarify that ATCB must have policies and impartiality of its operations. The refunds would only be required where procedures to avoid involvement in any National Coordinator will review the an ONC–ATCB’s conduct caused the activities that would diminish policies, procedures, and documented testing and certification to be confidence in its competence, structure of applicants for ONC–ATCB incomplete as opposed to a Complete impartiality, judgment or operational status during the application process to EHR or EHR Module developer’s integrity and must ensure that activities ensure that a potential ONC–ATCB conduct or a Complete EHR’s or EHR of related bodies do not affect the meets the impartiality requirements. An Module’s failure to achieve a confidentiality, objectivity and ONC–ATCB would also have to certification. One commenter asked impartiality of its certifications. We maintain impartiality in its operations whether this clause was meant to apply believe these provisions as well as other to remain in good standing under the only when an ONC–ATCB had its status impartiality provisions contained in temporary certification program. revoked. Another commenter suggested Guide 65 and ISO 17025 adequately We believe that the requirements of that our proposed requirement for ONC– address any potential conflicts of Guide 65 and ISO 17025 clearly require ATCBs to return funds should also interest or other situations that might ONC–ATCBs to develop an impartial apply to situations where Complete EHR jeopardize the integrity of the temporary process for handling requests for the or EHR Module developers are required certification program. testing and certification of Complete to recertify their products because of Comments. We received a few EHRs and EHR Modules. Guide 65 misconduct by an ONC–ATCB. comments recommending that ONC– ‘‘ Response. We agree with the ATCBs’ business practices be specifically states that access shall not commenters that suggested our considered and evaluated. In particular, be conditional upon the size of the proposed refund requirement needs one commenter recommended that we [Complete EHR or EHR Module clarification. As advocated by the adopt a principle of proper conduct that developer] or membership [in] any commenters, it was our intention to requires an ONC–ATCB to establish, association or group, nor shall require ONC–ATCBs to issue refunds publish and adhere to a non- certification be conditional upon the ’’ only in situations where an ONC– discriminatory protocol to ensure that number of certificates already issued. ATCB’s conduct caused testing and requests for testing and certification are As for the one commenter’s certification to not be completed. We processed in a timely manner beginning recommendation that we require also agree with the one commenter that on the date the ONC–ATCB sets for requests for testing and certification to this would include situations where a accepting requests for testing and be completed within six months, we Complete EHR or EHR Module is certification. The commenter asserted will not adopt such a requirement. Due required to be recertified because of the that no one should be allowed to make to factors such as the uncertainty of how conduct of an ONC–ATCB. Similarly, if a request prior to the date set by the many ONC–ATCBs will exist and how an ONC–ATCB were to be suspended by ONC–ATCB and requests should be many requests for the testing and the National Coordinator under the processed in the order in which they are certification of Complete EHRs and EHR suspension provisions we have received without regard to whether they Modules will be received by each ONC– incorporated in this final rule, an ONC– are for Complete EHRs or EHR Modules. ATCB, we do not believe such a ATCB would be required to refund all The commenter further asserted that in requirement would be equitable or fees paid for testing and certification if the event of simultaneously submitted enforceable. a Complete EHR or EHR Module requests, the National Coordinator 4. Application Submission developer withdraws a request for should conduct a randomized, fair and testing and certification while the ONC– transparent method for selecting the We proposed in section 170.425 to ATCB is under suspension. order in which the requests will be allow an applicant for ONC–ATCB We are revising § 170.423(j) consistent reviewed. Conversely, another status to submit its application either with our discussion above. commenter suggested that requests for electronically via e-mail (or web testing and certification of Complete submission if available), or by regular or g. Suggested New Principles of Proper EHRs and/or EHR Modules that cover express mail at any time during the Conduct the largest market share should be existence of the temporary certification We received a few comments that processed first. One commenter program. We did not receive any suggested we adopt additional recommended that all requests for comments on this provision. Therefore, principles of proper conduct. These testing and certification be required to we are finalizing this provision without comments concerned the impartiality be processed within six months of modification. and business practices of ONC–ATCBs. receipt by an ONC–ATCB. 5. Overall Application Process Comments. A commenter Response. We have established the recommended that applicants for ONC– Principles of Proper Conduct for ONC– We received a few comments ATCB status should be required to not ATCBs. ONC–ATCBs must abide by regarding the overall application have an interest, stake and/or conflict of these Principles of Proper Conduct to process.

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Comment. One commenter suggested We proposed that if an application were itself as an ONC–ATCB and begin that applicants for ONC–ATCB status deemed satisfactory, we would make it testing and certifying Complete EHRs preferably be not-for-profit companies, publicly known that the applicant had and EHR Modules consistent with its while another commenter suggested that achieved ONC–ATCB status and the authorization. the number of applicants be limited to ONC–ATCB would be able to begin Comments. A commenter requested five. testing and certifying consistent with that the National Coordinator clarify Response. We believe it is appropriate the authorization granted by the that an application will be deemed to allow all qualified applicants to apply National Coordinator. In association satisfactory based on the submission of and obtain ONC–ATCB status. We with these proposals, we specifically an application that substantially or believe that the more applicants that can requested that the public comment on materially complied with the obtain ONC–ATCBs status the more the whether we should review an entire requirements set forth in regulation. market will benefit in terms of increased application at once or as proposed, in Another commenter recommended that competition and more options for the parts; and whether we should we develop an expeditious internal testing and certification of Complete reconsider a twice deficient application review and approval process for ONC– EHRs and EHR Modules. Restrictions on for any reason besides a clear factual ATCB applications. The commenter the number of applicants that can apply error. suggested that this process include a or requiring an applicant for ONC– fast-track reprocessing system, as ATCB status to be a not-for-profit entity 1. Review of Application necessary, to allow ONC–ATCB will only limit these potential benefits. We proposed in section 170.430 that applicants to swiftly correct initial Comment. A commenter we would review applications in the errors and deficiencies. recommended as part of the ONC–ATCB order in which we received them, that A commenter expressed agreement application process that an applicant the National Coordinator would review and support for the proposed process indicate the testing site methods it is Part 1 of the application and determine affording the National Coordinator capable of supporting. The commenter whether Part 1 of the application was discretion to request clarifications of reasoned that this would provide complete and satisfactory before statements or corrections of errors or another basis for vendors to select an proceeding to review Part 2 of the omissions, but the commenter did not ONC–ATCB. application, and that the National agree that such requests should be Response. An ONC–ATCB is required Coordinator would issue a decision limited to only inadvertent or minor to provide the types of testing and within 30 days of receipt of an errors. The commenter reasoned that certification methods that we have application submitted for the first time. given the time constraints and specified in § 170.457. We believe that We proposed that the National complexity of the application process, an applicant will make such methods Coordinator would be able to request the National Coordinator should be able and any additional methods it offers clarification of statements and the to consider requesting clarifications or known to the market as a means of correction of inadvertent errors or minor corrections in a collaborative process attracting customers. omissions. We proposed that the with applicants, as appropriate. The Comment. A commenter National Coordinator would identify commenter also expressed general recommended that the temporary any deficiencies in an application part agreement with our proposal that an certification program serve as a ‘‘test and provide an applicant with an applicant be provided up to fifteen (15) bed’’ for the accreditation process so that opportunity to both correct any days to respond to a formal deficiency the permanent certification program deficiencies and submit a revised notice. The commenter suggested, may limit the frequency with which application in response to a deficiency however, that considering the National applicants can reapply for ONC–ACB notice on each part of the application. Coordinator’s opinion that few status. We further proposed that if the National organizations will be able to meet the Response. As discussed in the Coordinator determined that a revised criteria in the temporary certification Proposed Rule, we are unable to application still contained deficiencies, program, the National Coordinator establish an accreditation process for the applicant would be issued a denial should have the discretion to grant an the temporary certification program due notice related to that part of the extension beyond the 15 days upon a to the need to establish a certification application. We proposed that the showing of good cause by the applicant. program as soon as possible. Although denial notice would indicate that the The commenter asserted that this we do not have sufficient time to applicant would no longer be proposal would provide flexibility and establish an accreditation program, we considered for authorization under the assist in ensuring that the process for believe that we have established temporary certification program, but approving ONC–ATCBs is successful. sufficiently stringent requirements for that the applicant could request We received two comments that ONC–ATCB applicants and ONC– reconsideration of the decision in expressed agreement with our proposal ATCBs that, if an ONC–ATCB chose to accordance with § 170.435. In to review ONC–ATCB applications in apply for accreditation under the association with these proposals, we parts and two comments recommending proposed permanent certification specifically requested that the public that we review the whole application program, it would be well situated to comment on whether it would be before issuing a deficiency notice. One successfully navigate the process. preferable for applicants to have their commenter recommended processing entire application reviewed all at once the application based on the request of F. Application Review, Application and then issued a formal deficiency the applicant or the needs of the Reconsideration and ONC–ATCB Status notice or whether we should, as reviewer. Both sides contended that We proposed in the Proposed Rule to proposed, review applications in parts. their recommended method was more review an application for ONC–ATCB We proposed that an application efficient and better for the applicant and status and, in most circumstances, issue would be deemed satisfactory if it met reviewer. A couple of commenters a decision within 30 days. We proposed all the application requirements. We requested that, if the review process that if an application was rejected and further proposed that once the applicant were to remain a two part process, we certain criteria were met, an applicant was notified of this determination, the make clear that each part of the could seek reconsideration of the denial. applicant would be able to represent application will be reviewed in its

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entirety before a deficiency notice application in response to a deficiency would have up to 15 days to consider would be issued. One of the notice. a timely reconsideration request. We commenters also requested that we We agree with the commenter’s further proposed that if, after reviewing make clear that each part receives two recommendation and are revising an applicant’s reconsideration request, review opportunities. § 170.430 to allow an applicant for the National Coordinator determined Response. We believe that applicants ONC–ATCB status to request an that the applicant did not identify any should be required to fully meet all the extension of the 15-day period to submit factual errors or that correction of those requirements of the application process a revised application in response to a factual errors would not remove all to ensure that they are properly deficiency notice and to provide the identified deficiencies in the qualified to be an ONC–ATCB. We National Coordinator with the option of application, the National Coordinator believe that our proposed process granting an applicant’s request for could reject the applicant’s provides for a thorough and expeditious additional time to respond to a reconsideration request and that this review of an application, which is in the deficiency notice upon a showing of decision would be final and not subject best interest of all parties. We also good cause by the applicant. In to further review. believe that reviewing applications in determining whether good cause exists, In association with these proposals, two parts is the most efficient method, the National Coordinator will consider we specifically requested that the public offers the most flexibility, and provides factors such as: change in ownership or comment on whether there are an applicant with the best opportunity control of the applicant organization; instances, besides an applicant to be successful. We do believe, the unexpected loss of a key member of demonstrating that a clear, factual error however, that making some the applicant’s personnel; damage to or was made in the review of its modifications to the application review loss of use of the applicant’s facilities, application and that the error’s process in response to comments will working environment or other correction could lead to the applicant benefit both the applicants and the resources; or other relevant factors that receiving ONC–ATCB status, in which National Coordinator. would prevent the applicant from the National Coordinator should submitting a timely response to a reconsider an application that has been We agree with the commenter that deficiency notice. deemed deficient multiple times. additional clarity can be provided by We believe it is unnecessary to Comments. A commenter expressed specifically stating that the National establish a predetermined length of time agreement with our proposed ONC– Coordinator will review each part of the for a good cause extension in the ATCB application reconsideration application in its entirety. Therefore, we regulation text. The length of time for an process. Another commenter stated, have modified § 170.430(a)(2) to extension will be based on an however, that the National Coordinator emphasize this point. We also can applicant’s particular circumstances should have discretion to reconsider an confirm that an applicant will have its that constitute good cause for an application that has been deemed initial Part 1 application reviewed and extension. For example, if an applicant deficient multiple times for reasons then have an opportunity to submit a lost a key member of its personnel, then besides a clear factual error that could revised application if necessary. Part 2 the timeframe extension would reflect a lead to the applicant receiving ONC– of an applicant’s application will be reasonable period of time in which the ATCB status. The commenter concluded given these same two opportunities for applicant could remedy that particular that the National Coordinator is in the review only if Part 1 of the application issue. unique position to determine on a case- is deemed satisfactory. We believe that another means of by-case basis whether multiple We agree with the commenter that the adding greater flexibility to the deficiencies should prevent process for the National Coordinator to application review process as sought by reconsideration of a particular seek corrections of errors and omissions the commenter is to provide the application. The commenter suggested should be revised. Therefore, as National Coordinator with the same that the National Coordinator should recommended by the commenter, we are ability to request clarification of consider several factors in determining removing the words ‘‘inadvertent’’ and statements and the correction of errors whether to reconsider an application ‘‘minor’’ from § 170.430(b)(1). Although or omissions in a revised application as that has been deemed deficient multiple we anticipate that the National the National Coordinator can do prior to times, including the severity and type of Coordinator would likely only seek issuing a deficiency notice. the deficiency, the implications of the correction of minor errors or omissions, Accordingly, we are revising § 170.430 deficiencies, the applicant’s level of these revisions provide the National to state that the National Coordinator responsiveness and cooperation, and the Coordinator with more flexibility to may request clarification of statements remedial efforts taken by the applicant. allow an error or omission to be and the correction of errors or omissions The commenter also requested that, due corrected instead of issuing a deficiency during the 15-day period provided for to the differences between the proposed notice. This flexibility will be beneficial review of a revised application. temporary and permanent certification for both applicants and the National programs and the timeframes associated Coordinator considering the limited 2. ONC–ATCB Application with each, we consider applications for opportunities and short timeframes for Reconsideration each program independently (i.e., a correcting applications. In an effort to We proposed in section 170.435 that reconsideration denial of an application further increase the flexibility of the an applicant may request that the under the temporary certification process, we are making additional National Coordinator reconsider a program would not impact an revisions to § 170.430 in response to a denial notice issued for each part of an applicant’s ability to apply to be an commenter’s recommendation. The application only if the applicant can ONC–ACB under the permanent commenter recommended that the demonstrate that a clear, factual error(s) certification program). National Coordinator should have the was made in the review of the Response. We appreciate the one discretion, upon a showing of good application part and that the error’s commenter’s expression of support for cause by the applicant, to grant an correction could lead to the applicant our proposals. We do not agree with the extension beyond 15 days for an obtaining ONC–ATCB status. We commenter that the National applicant to submit a revised proposed that the National Coordinator Coordinator should reconsider all twice-

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deficient applications for any reason. would not need to renew its status We do not accept the commenter’s Rather, we continue to believe that the during the temporary certification recommendation to associate National Coordinator should only program, but that an ONC–ATCB’s authorization and the expiration of reconsider an application if the status would expire upon the sunset of authorization to the stages of applicant for ONC–ATCB status can the temporary certification program in meaningful uses. As previously noted, demonstrate that there was a clear accordance with § 170.490. the temporary certification program will factual error in the review of its Comments. A commenter expressed sunset on December 31, 2011, or if the application that could lead to the support for our proposal that an ONC– permanent certification program is not applicant obtaining ONC–ATCB status. ATCB may only test and certify HIT that fully constituted at that time, then upon We believe that the application it is authorized to test and certify. a subsequent date that is determined to requirements and application review Another commenter expressed an be appropriate by the National processes that we have proposed ensure opinion that is important to the industry Coordinator. Therefore, the temporary that only qualified applicants are timely that the National Coordinator makes certification program must be capable of authorized to be ONC–ATCBs. The distinctions as to what a certifying body conducting testing and certification for application requirements proposed are is approved to certify. One commenter the applicable stage(s) of meaningful designed to ensure that applicants are recommended that our requirements use. qualified to both test and certify related to marketing and G. Testing and Certification of Complete Complete EHRs and/or EHR Modules. communications be limited to the ONC– EHRs and EHR Modules Our review process is designed to ATCB’s Web site and all marketing and establish the veracity of an application communications pertaining to its role in We proposed in the Proposed Rule the and to test and verify that an applicant the testing and certification of EHRs and scope of authority granted to ONC– ATCBs by ONC authorization. We also has the necessary capabilities to be HIT. As currently written, the specified which certification criteria or authorized to conduct the testing and commenter contended that the certification criterion ONC–ATCBs certification sought by the applicant. requirements apply to all marketing and would be required to use to test and Our review process is also designed to communications made by the entity certify Complete EHRs and EHR reach final decisions in a manner that even if unrelated to their ONC–ATCB Modules. will allow the temporary certification status. program to become operational in a A commenter recommended that the 1. Complete EHRs timely manner. We believe the authorization status of ONC–ATCBs We proposed in section 170.445 that application review process contains should be limited to Stage 1 sufficient opportunities for an applicant to be authorized to test and certify certification. Based on this Complete EHRs under the temporary to demonstrate that it is qualified to be recommendation, the commenter stated an ONC–ATCB, including opportunities certification program, an ONC–ATCB that the authorization should remain under both Parts 1 and 2 of an would need to be capable of testing and valid as long as Stage I incentives are application for the National Coordinator certifying Complete EHRs to all available (i.e., through 2014) and not to request clarifications and corrections applicable certification criteria adopted expire upon the proposed sunset of the to the application, opportunities for an by the Secretary at subpart C of part 170. temporary certification program. applicant to respond to a deficiency We further proposed that an ONC– notice, and opportunities to request Response. We appreciate the support ATCB that had been authorized to test reconsideration of a denial notice if for our proposals and reiterate that, as and certify Complete EHRs would also there is a clear, factual error that, if proposed, an ONC–ATCB will only be be authorized to test and certify all EHR corrected, could lead to the applicant able to test and certify Complete EHRs Modules under the temporary obtaining ONC–ATCB status. and/or EHR Modules consistent with certification program. Accordingly, we have finalized this the scope of authorization granted by Comments. Commenters expressed provision without modification. the National Coordinator. Additionally, agreement with our proposals that, in We do, however, want to assure the as proposed, the ONC–ATCB will have order to be authorized to test and certify commenter that a negative to prominently and unambiguously Complete EHRs under the temporary reconsideration decision regarding an display the scope of authorization certification program, an ONC–ATCB application under the temporary granted to it by the National must be capable of testing and certifying certification program will not impact an Coordinator. To address the Complete EHRs to all applicable applicant’s ability to apply to be an commenter’s concern about the certification criteria and that such an ONC–ACB under the permanent overreach of our proposed requirement ONC–ATCB would also be authorized to certification program. that an ONC–ATCB ‘‘identify on its Web test and certify all EHR Modules under site and in all marketing and the temporary certification program. 3. ONC–ATCB Status communications statements (written One commenter recommended that we We proposed in section 170.440 that and oral) the scope of its authorization’’ require ONC–ATCBs authorized to test the National Coordinator will we have clarified the language to clearly and certify Complete EHRs to also test acknowledge and make publicly state that the requirement only applies and certify EHR Modules. available the names of ONC–ATCBs, to activities conducted by the ONC– Response. We appreciate the including the date each was authorized ATCB under the temporary certification commenters’ support for our proposals, and the type(s) of testing and program. Specifically, we have revised but we do not adopt the one certification each has been authorized to the provision to state, in relevant part, commenter’s recommendation that we perform. We proposed that each ONC– ‘‘each ONC–ATCB must prominently require an ONC–ATCB that is ATCB would be required to prominently and unambiguously identify the scope authorized to test and certify Complete and unambiguously identify on its Web of its authorization on its Web site, and EHRs to also test and certify EHR site and in all marketing and in all marketing and communications Modules. We clearly acknowledged in communications statements (written statements (written and oral) pertaining the preamble of the Proposed Rule and and oral) the scope of its authorization. to its activities under the temporary in our proposed regulatory provision We also proposed that an ONC–ATCB certification program.’’ that an ONC–ATCB authorized to test

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and certify Complete EHRs would also be equivalent to one certification because, in most cases, this level of a have the capability and, more criterion. criterion most fully represents the importantly, the authorization from the Comments. We received two capabilities that are needed to perform National Coordinator to test and certify comments on our proposal. One the associated meaningful use EHR Modules. We do not, however, commenter expressed agreement with objectives. believe that we should regulate a private our proposal, including the We believe that the specific concerns entity’s business practices to require it appropriateness of requiring an EHR raised by the commenter related to the to test and certify EHR Modules. An Module to be capable of performing all ‘‘drug-drug, drug-allergy, drug-formulary ONC–ATCB, despite authorization to do the functions specified at the paragraph checks’’ criterion and the ‘‘incorporate so, might have multiple business level of a certification criterion. The clinical lab-test results into EHR as justifications for not testing and commenter reasoned that to allow structured data’’ criterion are more certifying EHR Modules, such as an testing and certification at a lower level appropriately suited for discussion and insufficient number of qualified (subparagraph) would result in a very resolution in the forthcoming final rule employees to conduct the testing and large number of modules that would to finalize the certification criteria certification of EHR Modules in overcomplicate the certification adopted in the HIT Standards and addition to conducting testing and program. The commenter stated that the Certification Criteria interim final rule. certification of Complete EHRs, or that only exception might be if there were a We are finalizing paragraph (a) of doing both would not be as profitable a very large number of subparagraphs § 170.450 without modification, but we business model. within a criterion or a very large number are modifying § 170.450 to remove of criterion within a single objective paragraph (b) because it is repetitive of Based on consideration of the (e.g., if the number of quality measures the requirements set forth in paragraph comments received and review of the remains very high). In that case, the (a). proposed provision, we are revising commenter asserted that the module § 170.445(a) to state that ‘‘An ONC– b. Privacy and Security Testing and might be divided into two or more Certification ATCB must test and certify Complete logically related groups. But in general, EHRs to all applicable certification the commenter stated that having a With respect to EHR Modules, we criteria adopted by the Secretary at range of 20–25 certification criteria, and discussed in the Proposed Rule when subpart C of this part.’’ This revision is therefore potential EHR Modules, was ONC–ATCBs would be required to test consistent with our description of an appropriate level of granularity. and certify EHR modules to the privacy testing and certification of Complete The other commenter stated that and security certification criteria EHRs in the Proposed Rule preamble. It requiring a module to perform all of the adopted by the Secretary. We proposed also makes explicit that ONC–ATCBs listed functions or capabilities that EHR Modules must be tested and must not only be capable, but as with associated with a specific certification certified to all privacy and security EHR Modules, are required to test and criterion would create a significant certification criteria adopted by the certify Complete EHRs to the applicable problem. In particular, the commenter Secretary unless the EHR Module(s) is/ certification criteria adopted by the stated that for the ‘‘drug-drug, drug- are presented for testing and Secretary under subpart C of Part 170. allergy, drug-formulary checks’’ certification in one of the following certification criterion, there did not manners: 2. EHR Modules appear to be a single EHR Module in the • The EHR Module(s) are presented a. Applicable Certification Criteria or current HIT marketplace that performs for testing and certification as a pre- Criterion all of the four listed capabilities under coordinated, integrated ‘‘bundle’’ of EHR the criterion. The commenter also Modules, which could otherwise We proposed in sections 170.450(a) surmised that the ‘‘incorporate clinical constitute a Complete EHR. In such and (b) that an ONC–ATCB must test lab-test results into EHR as structured instances, the EHR Module(s) shall be and certify EHR Modules in accordance data’’ certification criterion may cause tested and certified in the same manner with the applicable certification similar problems due to its multiple as a Complete EHR. Pre-coordinated criterion or criteria adopted by the capabilities. Based on these bundles of EHR Module(s) which Secretary at subpart C of part 170. In the considerations, the commenter include EHR Module(s) that would not preamble of the Proposed Rule, we recommended that we narrow the scope be part of a local system and under the clarified that a single certification of EHR Module testing and certification end user’s direct control are excluded criterion would encompass all of the to one of the capabilities or functions from this exception. The constituent specific capabilities referenced below (subparagraphs) of a criterion. The EHR Modules of such an integrated the first paragraph level. For example, commenter stated that this solution bundle must be separately tested and 45 CFR 170.302, paragraph ‘‘(e)’’ (the would necessitate that the ONC–ATCB certified to all privacy and security first paragraph level) identifies that this provide modules that only perform such certification criteria; certification criterion relates to discrete functions with a ‘‘conditional • An EHR Module is presented for recording and charting vital signs. It certification’’ that carries the caveat that testing and certification, and the includes three specific capabilities at the module must be used in conjunction presenter can demonstrate to the ONC– (e)(1), (2), and (3) (the second paragraph with other certified modules to offer full ATCB that it would be technically level): The ability to record, modify, and and complete functionality for the infeasible for the EHR Module to be retrieve patients’ vital signs; the ability applicable criterion. tested and certified in accordance with to calculate body mass index (BMI); and Response. We agree with the first some or all of the privacy and security the ability to plot and display growth commenter that, as proposed, EHR certification criteria; or charts. We stated that we viewed the Modules should be tested and certified • An EHR Module is presented for entire set of specific capabilities to the first paragraph level of a testing and certification, and the required by paragraph ‘‘(e)’’ (namely, certification criterion, as described in presenter can demonstrate to the ONC– (e)(1), (2), and (3)) as one certification the example above. We believe that this ATCB that the EHR Module is designed criterion. The specific capability to is the most appropriate level for testing to perform a specific privacy and calculate BMI, for example, would not and certification of EHR Modules security capability. In such instances,

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the EHR Module may only be tested and appropriate, the covered entity is having to include a particular privacy or certified in accordance with the required to: (1) document why it would security capability. applicable privacy and security not be reasonable and appropriate to We also agree with the commenter certification criterion/criteria. implement the addressable that stated that we should remove the Comments. A number of commenters implementation specification; and (2) third exception and simply require all supported our proposed approach and implement an equivalent alternative modules, if not included in a pre- agreed that EHR Modules should be measure if reasonable and appropriate. coordinated integrated bundle, to follow tested and certified to all adopted While this is a sensible approach for the same approach. As a result, only the privacy and security certification HIPAA covered entities, we do not first and second exception will be criteria unless there were justifiable believe that it translates well into the included in the final rule. We recognize reasons for which they should not. testing and certification of EHR that, with respect to an EHR Module Other commenters suggested changes to Modules. that is focused exclusively on providing one or more of the stated exceptions and All HIPAA covered entities are one or more privacy and security posed questions for our consideration. required to comply with the HIPAA capabilities, the remaining privacy and Some commenters recommended that Security Rule with respect to their security certification criteria may be we deem certification criteria electronic protected health information, inapplicable or compliance with them ‘‘addressable’’ similar to the Health regardless of their size and resources. may be technically infeasible. However, Insurance Portability and Accordingly, the HIPAA Security Rule we do not believe it is prudent to Accountability Act (HIPAA) Security provides for a flexible approach, presume that this will always be the Rule’s application of the word allowing a HIPAA covered entity to case. ‘‘addressable’’ to certain implementation implement safeguards that are Comments. Several commenters asked specifications (in the HIPAA context) reasonable and appropriate for its for clarification on the circumstances within a security standard (in the unique environment. We do not believe under which the first exception we HIPAA context). Other commenters that this approach is appropriate for proposed applied in relation to a pre- noted that with respect to the second testing and certifying EHR Modules coordinated, integrated ‘‘bundle’’ of EHR exception, involving the demonstration because one purpose of certification is Modules, the carve out to this exception that it would be technically infeasible to assure eligible professionals and related to EHR Modules that were ‘‘not for an EHR Module to be tested and eligible hospitals that an EHR Module be part of a local system,’’ and our use certified to some or all privacy and includes a specified capability or set of of the term ‘‘end user.’’ security certification criteria, that the capabilities. For these reasons, we Response. Overall, the premise term ‘‘inapplicable’’ should be added as believe that the proposed standard of behind the first exception is to release a condition in addition to ‘‘technically ‘‘technically infeasible’’ is more the general requirement that each infeasible.’’ Another commenter stated appropriate than the HIPAA Security individual EHR Module be tested and that we should remove the third Rule’s ‘‘addressable’’ concept for the certified to all adopted privacy and exception, involving the demonstration purposes of testing and certifying EHR security criteria. We believe that it that an EHR Module is designed to Modules. Thus, an EHR Module would be pragmatic to release this perform a specific privacy and security developer must satisfy each privacy and requirement in situations where several capability, because, depending on how security criterion where it is technically EHR Module developers (e.g., different the privacy and security EHR Module is feasible. vendors) or a single EHR Module developed, it may also need to include To complement our ‘‘technically developer presents a collection of EHR certain capabilities, such as an audit log. infeasible’’ standard, we agree with Modules as a pre-coordinated, Response. We appreciate commenters’ those commenters that recommended integrated bundle to an ONC–ATCB for support for our proposed approach and the addition of the word ‘‘inapplicable’’ testing and certification. In these the thoughtfulness of the responses. to the second proposed exception. We circumstances, the integrated bundle of While we understand and appreciate the believe that in some cases a privacy and EHR Modules would otherwise similarities some commenters saw with security certification criterion may be constitute a Complete EHR. Therefore, respect to the HIPAA Security Rule and inapplicable to an EHR Module while we clarify that in the circumstances leveraging the ‘‘addressable’’ concept, technically feasible to implement, and where an integrated bundle of EHR we do not believe that making each in other cases a privacy and security Modules is presented for testing and privacy and security certification certification criterion may be applicable certification and one or more of the criterion ‘‘addressable’’ in the way it is but technically infeasible to implement. constituent EHR Modules is/are implemented under the HIPAA Security For example, it may be technically demonstrably responsible for providing Rule is an appropriate approach for the feasible to implement an automatic log- all of the privacy and security purposes of testing and certifying EHR off or emergency access capability for capabilities for the entire bundle of EHR Modules. several types of EHR Modules, but such Modules, that those other EHR Modules In the context of the HIPAA Security capabilities may be inapplicable given would be exempt from being tested and Rule, HIPAA covered entities must the EHR Module’s anticipated function certified to adopted privacy and security assess whether each addressable and/or point of integration. certification criteria. To illustrate, four implementation specification (in the We require that an EHR Module EHR Module developers each develop HIPAA Security Rule) is a reasonable developer provide sufficient one EHR Module (EHR Modules A, B, C, and appropriate safeguard in its documentation to support a claim that and D) and form an affiliation. The EHR environment. If a HIPAA covered entity a particular privacy and security Module developers present their EHR determines that an addressable certification criterion is inapplicable or Modules for testing and certification as implementation specification is that satisfying the certification criterion an integrated bundle and identify that reasonable and appropriate, then the is technically infeasible. Based on this EHR Module ‘‘C’’ is responsible for covered entity is required to implement documentation, the ONC–ATCB should providing the privacy and security it. If a HIPAA covered entity determines independently assess and make a capabilities for the rest of the entire that an addressable implementation reasonable determination as to whether bundle (EHR Modules A, B, and D). In specification is not reasonable and the EHR Module should be exempt from this scenario, EHR Modules A, B, and D

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would be exempt from also being tested capabilities for the entire bundle of EHR c. Identification of Certified Status and certified to the adopted privacy and Module(s); or We proposed in section 170.450(d) to security certification criteria. (2) An EHR Module is presented for With respect to the proposed carve require ONC–ATCBs authorized to test testing and certification, and the and certify EHR Modules to clearly out to this exception related to EHR presenter can demonstrate to the ONC– ‘‘ indicate the certification criterion or Modules that were not be part of a local ATCB that a privacy and security ’’ criteria to which an EHR Module has system, we sought to limit those certification criterion is inapplicable or circumstances where a group of EHR been tested and certified in the EHR that it would be technically infeasible Module’s certification documentation. Module developers could claim that a for the EHR Module to be tested and collection of EHR Modules was an certified in accordance with such Comments. We received two ‘‘integrated bundle,’’ yet it would be certification criterion. comments requesting that we technically infeasible for one or all of standardize the certification the EHR Modules in the collection to be We would like to clarify two points documentation requirements or at least demonstrably responsible for providing related to integrated bundles of EHR provide clear guidelines for certificate all of the privacy and security Modules. First, an integrated bundle of design. The commenters were capabilities for the rest of the EHR EHR Modules will only qualify for this concerned that if left to the discretion of Modules. We believe this would occur special treatment if, and only if, the ONC–ATCBs, the resulting certification in situations where a presented integrated bundle would otherwise certificates could look quite different ‘‘integrated bundle’’ of EHR Modules constitute a Complete EHR. In other and result in marketplace confusion. includes one or more services offered by words, three EHR Modules that have One commenter recommended that the different EHR Module developers that been integrated and ‘‘bundled’’ but do certification certificate, which will have been implemented on different not meet the definition of Complete figure prominently in EHR software technical architectures or hosted over EHR, would not qualify for this specific vendor marketing, should be uniform in the Internet on one or multiple different certification. In those cases, we would appearance and depict HHS authority servers. In this situation we do not view such a bundle as an EHR Module and assurance. that provides multiple capabilities. believe that it would be possible for one Response. We agree with the Second, because an integrated bundle of or more of the EHR Modules to be commenters that certificate EHR Modules would otherwise demonstrably responsible for providing documentation should be designed in a constitute a Complete EHR, we would all of the privacy and security way that does not lead to market treat it as a Complete EHR and when capabilities for the rest of the EHR confusion. Therefore, we are listing it as part of our master certified Modules. For example, we do not establishing a new Principle of Proper believe that it is possible, at the present HIT products list, we would provide a Conduct for ONC–ATCBs regarding the time, for a web-based EHR Module to designation, noting that it was an proper identification of Complete EHRs offer authentication for another EHR integrated bundle of EHR Modules. and EHR Modules. We further discuss Module that may be installed on an Comments. A few commenters the basis for this new Principle of eligible professional’s laptop, nor do we requested that we clarify whether there Proper Conduct under the heading titled believe that one or more web-based could be specific privacy and security- ‘‘O. Validity of Complete EHR and EHR services could provide an audit log for focused EHR Modules. That is, in the Module Certification and Expiration of actions that took place outside of that context of the definition of EHR Certified Status’’ later in this section. service. Module, whether we intended to permit We believe that with this additional Consistent with this decision, we are EHR Modules to exist that only modifying proposed § 170.450 to clarity the explicit mention of the first addressed one or more adopted privacy exception’s carve out is no longer remove paragraph (d). This modification and security certification criteria. One necessary and have revised the first will eliminate any potential redundancy commenter asked for clarification as to exception accordingly to include the with the new Principle of Proper whether a specific privacy and security- clarifying concepts we discuss above. Conduct on the proper identification of focused EHR Module would meet a This revision has also resulted in the Complete EHRs and EHR Modules. certification criterion if its purpose was removal of the term ‘‘end user,’’ which to call or assign the actual capability H. The Testing and Certification of commenters requested we clarify. The required by a certification criterion to ‘‘Minimum Standards’’ entire provision, including the changes another function or service. from both our responses above, will In the Proposed Rule, we summarized read: Response. Yes, we believe that there the approach set forth in the HIT EHR Modules shall be tested and could be specific privacy and security- Standards and Certification Criteria certified to all privacy and security focused EHR Modules and do not interim final rule (75 FR 2014) to treat certification criteria adopted by the preclude such EHR Modules from being certain vocabulary code set standards as Secretary unless the EHR Module(s) is/ presented for certification. However, ‘‘minimum standards.’’ We noted that are presented for testing and with respect to the second comment and the establishment of ‘‘minimum certification in one of the following request for clarification, we believe that standards’’ for specific adopted code sets manners: an EHR Module, itself, must be capable would, in certain circumstances, allow (1) The EHR Module(s) is/are of performing a capability required by a Complete EHR and/or EHR Module to presented for testing and certification as an adopted privacy and security be tested and certified to a permitted a pre-coordinated, integrated bundle of certification criterion and that newer version of an adopted code set EHR Modules, which would otherwise delegating the responsibility to another without the need for additional meet the definition of and constitute a service or function would not be rulemaking. Additionally, we noted that Complete EHR (as defined in 45 CFR acceptable. In those cases there would this approach would enable Certified 170.102), and one or more of the be no proof that the EHR Module could EHR Technology to be upgraded to a constituent EHR Modules is/are actually perform the specific capability, permitted newer version of a code set demonstrably responsible for providing only that it could tell something else to without adversely affecting its certified all of the privacy and security do it. status.

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At the end of this summary, we These commenters also encouraged us code set to test and certify Complete reiterated a previously identified to pursue both of the proposed EHRs and/or EHR Modules if the limitation of the ‘‘minimum standards’’ approaches (notification of the National accepted newer version has been approach with respect to significant Coordinator by the general public and incorporated into a product by a revisions to adopted code sets. We proactive identification by the Complete EHR or EHR Module stated that a newer version of an Secretary). Some commenters developer. In these instances, we adopted ‘‘minimum standard’’ code set recommended that we establish open believe this approach benefits Complete would be permitted for use in testing lines of communication with the EHR or EHR Module developers because and certification unless it was a organizations responsible for they would be able to adopt a newer significant revision to a code set that maintaining identified ‘‘minimum version of a code set voluntarily and represented a ‘‘modification, rather than standard’’ code sets in order to facilitate have their Complete EHR or EHR maintenance or a minor update of the the process of identifying newer Module certified according to it, rather code set.’’ In those cases, we reiterated versions. than having to use an older version for that the Secretary would likely proceed Response. We appreciate the certification. The second prong would with notice and comment rulemaking to commenters’ support for our proposals. permit, but not require, eligible adopt a significantly revised code set Based on this feedback, we have professionals and eligible hospitals who standard. decided to adopt both of the approaches are already using Certified EHR We proposed two methods through we have proposed. In addition, we Technology to receive an upgrade from which the Secretary could identify new expect to work, as appropriate, with the their Complete EHR or EHR Module versions of adopted ‘‘minimum maintenance organizations for the developer or voluntarily upgrade standard’’ code sets. The first method ‘‘minimum standard’’ code sets, as well themselves to an accepted newer would allow any member of the general as the HIT Standards Committee, to version of a ‘‘minimum standard’’ code public to notify the National identify new versions when they set without adversely affecting the Coordinator about a new version. Under become available. certification status of their Certified the second method, the Secretary would Comments. A few commenters EHR Technology. Again, we believe this proactively identify newly published recommended that ONC–ATCBs not be is a benefit to eligible professionals and versions. After a new version has been required to use an accepted newer eligible hospitals and provides greater identified, a determination would be version of a ‘‘minimum standard’’ code flexibility. The third prong explicitly issued as to whether the new version set for certification. Along those lines, a states that an ONC–ATCB would not be constitutes maintenance efforts or minor few other commenters recommended required to use any other version of a updates of the adopted code set and that there be a delay period between the ‘‘minimum standard’’ code set beyond consequently would be permitted for Secretary’s acceptance of a new version the one adopted at 45 CFR part 170 use in testing and certification. We and when it would be required for subpart B until the Secretary further proposed that once the Secretary testing and certification. One incorporates by reference a newer has accepted a new version of an commenter noted that supporting version of that code set. adopted ‘‘minimum standard’’ code set multiple versions of standards should We recognize that a few different that: be avoided and that there would be versions of adopted ‘‘minimum (1) Any ONC–ATCB may test and differences in what was certified versus standards’’ could all be implemented at certify Complete EHRs and/or EHR what was implemented, while another the same time and before a subsequent Modules according to the new version; noted that even permitting the use of a rulemaking potentially changes what (2) Certified EHR Technology may be minor update could affect constitutes the ‘‘minimum.’’ We also upgraded to comply with the new interoperability. Some commenters understand the point raised by the version of an adopted minimum specifically requested clarification commenter who expressed concerns standard accepted by the Secretary regarding the timeline associated with about this approach because it could without adversely affecting the the Secretary’s acceptance of a newer potentially create a situation where certification status of the Certified EHR version and its publication and what there could be differences in what was Technology; and requirement there would be for its certified versus what was implemented. (3) ONC–ATCBs would not be inclusion in testing and certification. Along those lines, we also appreciate required to test and certify Complete Response. We believe that some the point made by the commenter that EHRs and/or EHR Modules according to commenters misunderstood the a minor update could affect the new version until we updated the implications of the Secretary’s interoperability. We acknowledge these incorporation by reference of the acceptance of a newer version of a concerns and considered them as part of adopted version to a newer version. ‘‘minimum standard’’ code set. We our analysis in determining whether to Finally, we stated that for either therefore clarify that if the Secretary adopt minimum standards and to permit method, we would regularly publish on accepts a newer version of a ‘‘minimum such standards to be exceeded when a quarterly basis, either by presenting to standard’’ code set, nothing is required newer versions had been made available the HIT Standards Committee or by of ONC–ATCBs, Complete EHR or EHR for use. However, we would like to posting a notification on our Web site, Module developers, or the eligible make clear that we provide this any Secretarial determinations that have professionals and eligible hospitals who flexibility on a voluntary basis and been made with respect to ‘‘minimum have implemented Certified EHR believe that the benefit of accepting standard’’ code sets. We requested Technology. In the Proposed Rule, we newer versions of a ‘‘minimum public comment on the frequency of used a three-pronged approach in order standard’’ (namely, enabling the HIT publication, any other approaches we to provide greater flexibility and industry to keep pace with new code should consider to identify newer accommodate industry practice with sets) outweighs any potential or versions of adopted code set standards, respect to code sets that must be temporary risk to interoperability. and whether both methods described maintained and frequently updated. The In light of the discussion above, we do above should be used. first prong would permit, but not not believe it is necessary to change any Comments. Many commenters require, ONC–ATCBs to use an accepted of our proposals, and we hope the supported our proposed approaches. newer version of a ‘‘minimum standard’’ additional clarification above addresses

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the concerns and questions raised by Commenters noted that to require ATCB offer such testing and commenters. eligible professionals or eligible certification. As indicated by Comments. Some commenters hospitals with self-developed Complete commenters and our own additional requested that we clarify the process the EHRs to physically move their Complete research, the market currently utilizes Secretary would follow before accepting EHRs to another location for testing and predominantly remote methods for the a newer version of an adopted certification would not only be testing and certification of HIT. On-site ‘‘minimum standard’’ code set. burdensome but in many cases testing and certification was cited as Response. We expect that after a new impossible. Instead, many commenters costly and inefficient. Therefore, we are version of an adopted ‘‘minimum recommended that we require ONC– not requiring ONC–ATCBs to offer such standard’’ code set has been identified ATCBs to have the capacity to certify testing and certification, but anticipate (either through the general public’s products through all of the secondary that some ONC–ATCBs will offer on-site notification of the National Coordinator methods we proposed. Some testing and certification if there is a or the Secretary proactively identifying commenters supported secondary market demand. In response to those its availability), the National methods without preference, while commenters who requested Coordinator would ask the HIT many commenters recommended that clarification, we also want to make clear Standards Committee to assess and we require ONC–ATCBs to offer remote that we do not believe that a Complete solicit public comment on the new testing as the primary method because EHR or EHR Module must be ‘‘live at a version. We expect that the HIT of its efficiency and low cost to customer’s site’’ in order to qualify for Standards Committee would Complete EHR and EHR Module testing and certification by an ONC– subsequently issue a recommendation to developers. Commenters also noted that ATCB. As stated above, a Complete EHR the National Coordinator which would ONC–ATCBs could offer other methods, or EHR Module could be tested and identify whether the Secretary’s including performing testing and certified at a Complete EHR and/or EHR acceptance of the newer version for certification at an ONC–ATCB’s facility. Module developer’s development site. voluntary implementation and testing One commenter recommended that, as Consistent with this discussion, we and certification would burden the HIT the primary method, ONC–ATCBs have revised § 170.457 to require an industry, negatively affect should be required to support testing ONC–ATCB to provide remote testing interoperability, or cause some other and certification at the Complete EHR or and certification for both development type of unintended consequence. After EHR Module developer’s site, which and deployment sites and have included considering the recommendation of the could include a development or the definitions of ‘‘development site,’’ HIT Standards Committee, the National deployment site. Another commenter ‘‘deployment site,’’ and ‘‘remote testing Coordinator would determine whether stated that each method should be and certification’’ in § 170.402. or not to seek the Secretary’s acceptance considered equal because different of the new version of the adopted J. Good Standing as an ONC–ATCB, methods may be appropriate for ‘‘minimum standard’’ code set. If the Revocation of ONC–ATCB Status, and different developers. Some commenters Secretary approves the National Effect of Revocation on Certifications recommended that we clarify whether Coordinator’s request, we would issue Issued by a Former ONC–ATCB we expected Complete EHRs and EHR guidance on an appropriate but timely We proposed in the Proposed Rule Modules to be ‘‘live’’ at customer sites basis indicating that the new version of requirements that ONC–ATCBs would before they can be tested and certified. the adopted ‘‘minimum standard’’ code need to meet in order to maintain good The commenters asserted that such a set has been accepted by the Secretary. standing under the temporary prerequisite will significantly delay the certification program, the processes for I. Authorized Testing and Certification roll out of customer upgrades. revoking an ONC–ATCB’s status for Methods Response. We appreciate the many failure to remain in good standing, the We proposed in section 170.457 that, options and preferences expressed by effects that revocation would have on a as a primary method, an ONC–ATCB the commenters. We believe that in former ONC–ATCB, and the potential would be required to be capable of order to adequately and appropriately effects that revocation could have on testing and certifying Complete EHRs address the commenters’ concerns, an certifications issued by the former and/or EHR Modules at its facility. We ONC–ATCB must have the capacity to ONC–ATCB. also proposed that an ONC–ATCB provide remote testing and certification would be required to have the capacity for both development and deployment 1. Good Standing as an ONC–ATCB to test and certify Complete EHRs and/ sites. A development site is the physical We proposed in section 170.460 that, or EHR Modules through one of the location where a Complete EHR or EHR in order to maintain good standing, an following secondary methods: at the site Module was developed. A deployment ONC–ATCB would be required to where the Complete EHR or EHR site is the physical location where a adhere to the Principles of Proper Module has been developed; or at the Complete EHR or EHR Module resides Conduct for ONC–ATCBs and refrain site where the Complete EHR or EHR or is being or has been implemented. As from engaging in other types of Module resides; or remotely (i.e., discussed in the Proposed Rule, remote inappropriate behavior, such as through other means, such as through testing and certification would include misrepresenting the scope of its secure electronic transmissions and the use of methods that do not require authorization or testing and certifying automated web-based tools, or at a the ONC–ATCB to be physically present Complete EHRs and/or EHR Modules for location other than the ONC–ATCB’s at the development or deployment site. which it was not given authorization. In facilities). This could include the use of web-based order to maintain good standing, we Comments. We received many tools or secured electronic also proposed that an ONC–ATCB comments on our proposal. We received transmissions. In addition to remote would be expected to follow all varying recommendations and testing and certification, an ONC–ATCB applicable Federal and state laws. proposals, but the majority of may also offer testing and certification Comments. Commenters expressed commenters did not agree with testing at its facility or at the physical location opinions that ONC–ATCBs should be and certification at an ONC–ATCB’s of a development or deployment site, expected to meet high standards for facility as the primary method. but we are not requiring that an ONC– ethics and compliance, and therefore

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were appreciative of our proposed would include without limitation, certification body had its ONC–ATCB standards of conduct for ONC–ATCBs. failure to adhere to the Principles of status revoked for a Type-1 violation, it One commenter encouraged us to Proper Conduct for ONC–ATCBs and would be prohibited from reapplying for evaluate ONC–ATCBs’ compliance with engaging in other inappropriate ONC–ATCB status under the temporary the Principles of Proper Conduct on an behavior. We proposed that if the certification program for one year. If the ongoing basis and at the time for re- National Coordinator were to obtain temporary certification program sunset authorization, particularly if either a reliable evidence that an ONC–ATCB during this time, the testing and Type-1 or Type-2 violation had may no longer be in compliance with certification body would be prohibited occurred. § 170.460, the National Coordinator from applying for ONC–ACB status Response. We believe that our would issue a noncompliance under the permanent certification proposed Principles of Proper Conduct notification. We proposed that an ONC– program for the remainder of the one for ONC–ATCBs are essential to ATCB would have an opportunity to year prohibition period. maintaining the integrity of the respond and demonstrate that no We proposed that failure to promptly temporary certification program, as well violation occurred or that the alleged refund any and all fees for uncompleted as ensuring public confidence in the violation had been corrected. We further tests and/or certifications of Complete program and the Complete EHRs and proposed that the National Coordinator EHRs and EHR Modules after the EHR Modules that are tested and would review the response and revocation of ONC–ATCB status would certified under the program. We intend determine whether a violation had be considered a violation of the to monitor compliance with the occurred and whether it had been Principles of Proper Conduct for ONC– Principles of Proper Conduct for ONC– adequately corrected. ATCBs. We proposed that the National ATCBs on an ongoing basis by, among We proposed that the National Coordinator would consider such other means, following up on concerns Coordinator could propose to revoke an violations in the event that a testing and expressed by Complete EHR and EHR ONC–ATCB’s status if the National certification body reapplied for ONC– Module developers and the general Coordinator has evidence that the ONC– ATCB status under the temporary public. It is also expected that ONC– ATCB committed a Type-1 violation. certification program or applied for ATCBs will maintain relevant We proposed that the National ONC–ACB status under the permanent documentation of their compliance with Coordinator could propose to revoke an certification program. the Principles of Proper Conduct for ONC–ATCB’s status if the ONC–ATCB In association with these proposals, ONC–ATCBs because such failed to rebut an alleged Type-2 we specifically requested that the public documentation would be necessary, for violation with sufficient evidence comment on two additional proposals. instance, to rebut a notice of showing that the violation did not occur First, we requested that the public noncompliance with the Principles of or that the violation had been corrected, comment on whether the National Proper Conduct issued by the National or if the ONC–ATCB did not submit a Coordinator should consider proposing Coordinator. We continue to believe that written response to a Type-2 the revocation of an ONC–ATCB’s status a violation of the Principles of Proper noncompliance notification within the for repeatedly committing Type-2 Conduct for ONC–ATCBs, a violation of specified timeframe. We proposed that violations even if the ONC–ATCB law, or other inappropriate behavior an ONC–ATCB would be able to adequately corrected the violations each must be promptly and appropriately continue its operations under the time. In conjunction with this request, addressed to maintain the program’s temporary certification program during we asked how many corrected Type-2 integrity and the public’s confidence in the time periods provided for the ONC– violations would be sufficient for the program and the products that are ATCB to respond to a proposed proposing revocation of an ONC–ATCB certified. If a violation or other revocation notice and the National and to what extent the frequency of inappropriate behavior were to occur, it Coordinator to review the response. these violations should be a would be addressed in accordance with We proposed that the National consideration. Second, we requested section 170.465. With consideration of Coordinator could revoke an ONC– that the public comment on whether the the public comments received, we are ATCB’s status if it is determined that National Coordinator should also finalizing section 170.460 without revocation is appropriate after include a process to suspend an ONC– modification. considering the ONC–ATCB’s response ATCB’s status. to the proposed revocation notice or if Comments. We received general 2. Revocation of ONC–ATCB Status the ONC–ATCB does not respond to a support for our proposed revocation We proposed in section 170.465 that proposed revocation notice within the process with commenters encouraging the National Coordinator could revoke specified timeframe. We further us to take a stringent position regarding an ONC–ATCB’s status if it committed proposed that a decision to revoke an Type-1 and Type-2 violations out of fear a Type-1 violation or if it failed to ONC–ATCB’s status would be final and that a lack of confidence in the timely or adequately correct a Type-2 not subject to further review unless the qualifications or integrity of an ONC– violation. We defined Type-1 violations National Coordinator chose to ATCB could seriously undermine the to include violations of law or reconsider the revocation. temporary certification program’s temporary certification program policies We proposed that a revocation would objectives. Commenters requested that that threaten or significantly undermine be effective as soon as the ONC–ATCB vendors, self-developers and providers the integrity of the temporary received the revocation notice. We be notified if an ONC–ATCB is certification program. These violations proposed that a testing and certification suspended, the National Coordinator include, but are not limited to: false, body that had its ONC–ATCB status proposes to revoke an ONC–ATCB’s fraudulent, or abusive activities that revoked would be prohibited from status, and/or an ONC–ATCB’s status is affect the temporary certification accepting new requests for testing and revoked. One commenter recommended program, a program administered by certification and would be required to that there not be a ‘‘broad’’ categorical HHS or any program administered by cease its current testing and certification Type-1 violation bar on reapplying for the Federal government. operations under the temporary ONC–ATCBs that had their status We defined Type-2 violations as certification program. We further revoked, while other commenters noncompliance with § 170.460, which proposed that if a testing and suggested that we extend the timeframe

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for barring ONC–ATCBs that have an acceptable proposition under certain would be appropriate for the permanent committed Type-1 violations from conditions. While we agree that certification program when we finalize reapplying to at least three years and to committing multiple Type-2 violations, the permanent certification program. require that a ‘‘re-authorized’’ former even if corrected, is cause for concern, We agree with the commenters that ONC–ATCB serve a probationary it would be difficult to establish a suspension could be an effective way to period. sufficiently objective and equitable protect purchasers of certified products We received a few comments on standard for initiating revocation and ensure patient health and safety. As whether we should revoke an ONC– proceedings on that basis against an a result, we agree with the commenter ATCB’s status under the temporary ONC–ATCB. As evidenced by the and believe that the National certification program for committing comments, it is difficult to determine Coordinator should have the ability to multiple Type-2 violations even if the the appropriate number of corrected suspend an ONC–ATCB’s operations violations were corrected. A couple of Type-2 violations that would lead to under the temporary certification commenters suggested that an ONC– revocation proceedings. An ONC–ATCB program when there is reliable evidence ATCB should have its status revoked for could commit and correct two Type-2 indicating that the ONC–ATCB committing multiple violations. One violations involving a missed training or committed a Type-1 or Type-2 violation commenter reasoned that if an ONC– a timely update to ONC on a key and that the continued testing and ATCB committed three or more personnel change. In such a situation, certification of Complete EHRs and/or violations in the short time of the we do not believe that automatically EHR Modules could have an adverse anticipated existence of the temporary initiating revocation proceedings would impact on patient health or safety. As certification program then it deserved to be warranted. We also do not believe it mentioned in the Proposed Rule, the have its status revoked. Another would be appropriate to adopt the one National Coordinator’s process for commenter recommended that the commenter’s recommendation to allow obtaining reliable evidence would National Coordinator retain the the National Coordinator to use involve one or more of the following discretion to review and judge each discretion to address such instances. methods: Fact-gathering; requesting situation as opposed to setting a certain This would not give an ONC–ATCB information from an ONC–ATCB; threshold for automatic revocation. sufficient notice of what Type-2 contacting an ONC–ATCB’s customers; We received multiple comments on violation, even if corrected, could lead witnessing an ONC–ATCB perform our proposed alternative of a suspension to revocation proceedings nor an testing or certification; and/or reviewing process with all of the commenters indication of the amount or frequency of substantiated complaints. suggesting that there could be value in the violations that could lead to Due to the disruption a suspension a suspension process. One commenter revocation proceedings. Therefore, we may cause for an ONC–ATCB, and more so for the market, we believe that stated that our goal should be first and believe that an ONC–ATCB should foremost to protect the needs of product suspension is appropriate in only the remain in good standing if it sufficiently purchasers and patients. Commenters limited circumstances described above corrects a Type-2 violation, no matter stated that suspension could be and have revised § 170.465 to provide how many times an ONC–ATCB warranted in lieu of proposing the National Coordinator with the commits a Type-2 violation. Such revocation and/or during the period discretion to suspend an ONC–ATCB’s violations will be a matter of public between a proposed revocation and a operations accordingly. An ONC–ATCB record that may influence Complete final decision on revocation. Some would first be issued a notice of EHR and EHR Module developers’ commenters recommended that an proposed suspension. Upon receipt of a decisions on which ONC–ATCB to ONC–ATCB be allowed to continue notice of proposed suspension, an select for the testing and certification of operations during a suspension or be ONC–ATCB will be permitted up to 3 provided ‘‘due process’’ rights before their Complete EHRs and/or EHR days to submit a written response to the being suspended, while others Modules. National Coordinator explaining why its suggested that allowing an ONC–ATCB We believe that Type-1 violations as operations should not be suspended. to continue during instances where an described are not too ‘‘broad’’ in that The National Coordinator will be investigation is ongoing and violations they must also ‘‘threaten or significantly permitted up to 5 days to review the are being resolved could jeopardize the undermine the integrity of the ONC–ATCB’s response and issue a industry’s confidence level in the temporary certification program.’’ In determination. In the determination, the certification process. One commenter such cases, we believe that barring a National Coordinator will either rescind suggested that an ONC–ATCB be former ONC–ATCB from reapplying for the proposed suspension, suspend the allowed to continue operations unless ONC–ATCB status for one year is an ONC–ATCB’s operations until it has the alleged violation would or could appropriate remedy under the adequately corrected a Type-2 violation, adversely impact patient safety and/or temporary certification program, which or propose revocation in accordance quality of care. we do not anticipate lasting beyond with § 170.465(c) and suspend the Response. We do not believe that it is December 31, 2011. As noted in the ONC–ATCB’s operations for the appropriate to initiate revocation Proposed Rule, a Type-1 violation could duration of the revocation process. The proceedings against an ONC–ATCB for significantly undermine the public’s National Coordinator may also make any amount of corrected Type-2 faith in our temporary certification any one of the above determinations if violations under the temporary program. Therefore, removing the ONC– an ONC–ATCB fails to submit a timely certification program. We did not ATCB from the program is an response to a notice of proposed originally propose to initiate revocation appropriate remedy. The 1-year bar on suspension. A suspension will become proceedings for multiple corrected reapplying will allow the former ONC– effective upon an ONC–ATCB’s receipt Type-2 violations, but requested public ATCB sufficient time to address the of a notice of suspension. We believe comment on the possibility. reasons for the Type-1 violation before that this process addresses the Commenters appeared to agree that reapplying. We will, however, commenters’ concerns regarding due initiating revocation proceedings against reconsider the appropriate length of a process and maintaining the industry’s an ONC–ATCB for committing multiple bar on reapplying for ONC–ACB status confidence in the temporary Type-2 violations, even if corrected, was and whether a probationary period certification program by not allowing an

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ONC–ATCB to continue operations however, that we should determine Complete EHR and EHR Module while an investigation is ongoing and/ whether an improperly certified product developers can have confidence in the or violations are being resolved related negatively and substantially affected the temporary certification program and, to the patient health or safety. performance of a Complete EHR or EHR more importantly, in the Complete As discussed in a previous section of Module in achieving a meaningful use EHRs and EHR Modules that are this preamble, we have revised objective before requiring certified under the program. As we § 170.423(j) to clarify that an ONC– recertification. Other commenters stated stated in the Proposed Rule, we believe ATCB would have to refund any fees that ‘‘good faith’’ eligible professionals it would be an extremely rare paid by a Complete EHR or EHR Module and eligible hospitals who can occurrence for an ONC–ATCB to have developer that seeks to withdraw a demonstrate meaningful use with a its status revoked and for the National request for testing and certification previously certified Complete EHR or Coordinator to determine that Complete while an ONC–ATCB is suspended. EHR Module should continue to qualify EHRs and/or EHR Modules were We intend to provide public for payments under the Medicare and improperly certified. If such events were notification via our Web site and list Medicaid EHR Incentive Programs. to occur, the regulatory provisions serve if an ONC–ATCB is suspended, Commenters further stated that enable the National Coordinator to focus issued a notice proposing its revocation, providers should be allowed to replace recertification on specific Complete and/or has its status revoked. We also the previously certified product when EHRs and/or EHR Modules that were note that we revised § 170.465(c)(1) to new certification criteria have been improperly certified in lieu of requiring state that ‘‘[t]he National Coordinator finalized for the affected meaningful use recertification of all Complete EHRs and may propose to revoke an ONC–ATCB’s criteria, or when their own strategic and EHR Modules tested and certified by the status if the National Coordinator has technical requirements necessitate an former ONC–ATCB. reliable evidence that the ONC–ATCB upgrade, whichever comes first. In this regard, the National committed a Type-1 violation.’’ The Commenters contended that the only Coordinator has a statutory term ‘‘reliable’’ was inadvertently left overriding factor that should require responsibility to ensure that Complete out of the Proposed Rule. recertification is if there is a EHRs and EHR Modules certified under 3. Effect of Revocation on Certifications demonstrable risk to patient safety from the temporary certification program are Issued by a Former ONC–ATCB the use of improperly certified Complete in compliance with the applicable EHRs and/or EHR Modules. certification criteria adopted by the We proposed in section 170.470 to A few commenters expressed Secretary. We do not believe that the allow the certified status of Complete concerns about the potential negative alternatives suggested by the EHRs and/or EHR Modules certified by financial impact recertification would commenters, such as whether a ‘‘good an ONC–ATCB that subsequently had have on Complete EHR and EHR faith’’ eligible professional or eligible its status revoked to remain intact Module developers, eligible hospital can demonstrate meaningful unless a Type-1 violation was professionals and eligible hospitals as use with a previously certified Complete committed that called into question the well as the potential for legal liability EHR or EHR Module, would enable the legitimacy of the certifications issued by related to eligible professionals and National Coordinator to fulfill this the former ONC–ATCB. In such eligible hospitals making attestations to statutory responsibility. Consequently, circumstances, we proposed that the federal and state agencies that they are if the National Coordinator determines National Coordinator would review the using Certified EHR Technology. that a Complete EHR or EHR Module facts surrounding the revocation of the Some commenters agreed with our was improperly certified, then retesting ONC–ATCB’s status and publish a 120-day proposal, while many and recertification by an ONC–ATCB notice on ONC’s Web site if the National commenters recommended 6, 9, 12, and are the only means by which to ensure Coordinator believed that Complete 18-month ‘‘grace periods’’ for improperly that the Complete EHR or EHR Module EHRs and/or EHR Modules were certified Complete EHRs and/or EHR satisfies the certification criteria. fraudulently certified by a former ONC– Modules. One commenter Moreover, an attestation by a Complete ATCB and the certification process itself recommended an extension of the 120- EHR or EHR Module developer and/or failed to comply with regulatory day grace period if there were less than user of a Complete EHR or EHR Module requirements. We further proposed that 3 ONC–ATCBs at the time of would not be an acceptable alternative if the National Coordinator determined decertification. One commenter noted to retesting and recertification because that Complete EHRs and/or EHR that the revocation process through the National Coordinator could not Modules were improperly certified, the potential decertification of Complete sufficiently confirm that all applicable ‘‘certified status’’ of affected Complete EHRs and/or EHR Modules could take certification criteria are met. EHRs and/or EHR Modules would longer than the life of the temporary We appreciate the concerns expressed remain intact for 120 days after the certification program and likely overlap by commenters related to the potential National Coordinator published the with the issuance of new standards and financial burden of recertification, the notice. We specifically requested that certification criteria, which itself will potential legal liability for providers the public comment on our proposed require ‘‘recertification’’ under the attesting to the use of Certified EHR approach and the timeframe for re- permanent certification program. Technology, and the perceived certification. Response. In instances where the insufficient amount of time to have a Comments. Multiple commenters National Coordinator determines that Complete EHR and/or EHR Modules expressed agreement and understanding Complete EHRs and/or EHR Modules recertified. We believe, however, that with the need to protect the integrity of were improperly certified, we believe some of these concerns may be the temporary certification program by that recertification is necessary to unfounded. Any decertification of a ensuring the legitimacy of certifications maintain the integrity of the temporary Complete EHR or EHR Module will be issued by a former ONC–ATCB and certification program and to ensure the made widely known to the public by requiring recertification of Complete efficacy and safety of certified Complete ONC through publication on our Web EHRs and/or EHR Modules where it is EHRs and EHR Modules. By requiring site and list serve, which we believe found that they were improperly recertification, eligible professionals will help eligible professionals or certified. Many commenters stated, and eligible hospitals as well as eligible hospitals identify whether the

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certified status of their Certified EHR Comments. Commenters meaningful use illustrates a Technology is still valid. We also recommended various methods and misunderstanding of the purpose of the believe that programmatic steps, such as means for ending the temporary certification programs. Consistent with identifying ONC–ATCB(s) that could be certification program. The predominant statutory instruction, the primary used for retesting and recertification, suggestion from commenters was to purpose of the certification programs is could be taken to assist Complete EHR devise a method for ending the to ensure that Complete EHRs, EHR and/or EHR Module developers with temporary certification program that Modules, and possibly other HIT, meet achieving timely and cost effective would limit the amount of uncertainty the standards, implementation recertifications. Most importantly, in the for vendors, self-developers, and specifications, and certification criteria rare circumstance that recertification is providers. In this regard, multiple adopted by the Secretary. We have required, we believe that the need to commenters recommended a date proposed a temporary certification protect the public from potentially certain with 12/31/2011 being the only program in order to ensure that Certified unsafe Complete EHRs and/or EHR date specified by commenters. EHR Technology will be available for Modules outweighs the concerns Commenters reasoned that a set date the start of the Medicare and Medicaid expressed by the commenters. would give the industry and market a EHR Incentive Programs and to allow Accordingly, we are finalizing this target for planning purposes. Many sufficient time for the development of a provision without modification. commenters, however, stated that a set more rigorous permanent certification date was only viable if there were at program. Linking the temporary K. Sunset of the Temporary Certification least one ONC–ACB. Some commenters certification program to a proposed Program recommended that there be two ONC– stage of meaningful use could cause the We proposed in section 170.490 that ACBs and some also requested that we program to last longer than is necessary, the temporary certification program ensure that there are one or two which would be inconsistent with the would sunset on the date when the accredited testing labs before we sunset purpose of the program. National Coordinator authorized at least the temporary certification program. We agree with the majority of one ONC–ACB under the permanent Commenters contended that having commenters that we should strive to certification program. We further more than one ONC–ACB would help achieve as much certainty as possible proposed that on the date the sunset prevent a backlog and potential for the market while also ensuring the occurred, ONC–ATCBs under the monopolies. existence of a sufficient supply of temporary certification program would Multiple commenters recommended authorized testing and/or certification be prohibited from accepting new that we tie the certification programs bodies so as to enable eligible hospitals requests to certify Complete EHRs or with the meaningful use stages (i.e., use and eligible providers to achieve EHR Modules. ONC–ATCBs would, the temporary certification program for meaningful use. Therefore, we have however, be able to complete the Stage 1 and the permanent certification modified our proposed timeframe such program for Stage 2 and beyond) and that the temporary certification program processing of Complete EHRs and EHR allow the temporary certification will sunset on December 31, 2011, or if Modules that were being tested and program to continue to certify for Stage the permanent certification program is certified at the time the sunset occurred. 1 until it was no longer needed. One not fully constituted at that time, then We clarified that ONC–ATCBs would be commenter recommended that the upon a subsequent date that is able to review any pending applications temporary certification program should determined to be appropriate by the that they had received prior to the be phased out only after it has been National Coordinator. On and after the termination date of the temporary determined that a significant percentage temporary certification program sunset certification program and complete the of the industry is ready to move to Stage date, ONC–ATCBs will be prohibited certification process for those Complete 2 of the Medicare and Medicaid EHR from accepting new requests to test and EHRs and EHR Modules. Incentive Programs. certify Complete EHRs or EHR Modules. We requested that the public One commenter proposed that there ONC–ATCBs will, however, be comment on whether we should be a period of overlap of up to a year permitted up to six months after the establish a set date for the temporary between the temporary certification sunset date to complete all testing and certification program to sunset, such as program and the permanent certification certification activities associated with 12/31/2011, instead of a date that program to enable ONC–ATCBs to requests for testing and certification of depends on a particular action—the complete the testing and certification of Complete EHRs and/or EHR Modules authorization of at least one ONC–ACB. products that were presented prior to received prior to the sunset date. We noted that a set date would provide the beginning of the permanent We believe that our proposal provides certainty and create a clear termination certification program. As part of the the appropriate balance between market point for the temporary certification proposal, the commenter stated that certainty and ensuring that there program by indicating to any ONC– products not completely tested and remains a body authorized to test and ATCBs and other certification bodies certified by an ONC–ATCB by the end certify Complete EHRs and EHR that in order to be authorized to certify date would need to be resubmitted Modules. We believe that many Complete EHRs and/or EHR Modules under the permanent certification applicants will seek to become ONC– after 12/31/2011, they would need to be program. ACBs and that there is sufficient accredited and reapply to become ONC– Another commenter recommended flexibility in the transition to the ACBs. We further noted that one that the rules for the transition period permanent certification program for potential downside to a set date would must be flexible enough to ONC–ATCBs either to apply to become be the possibility that it would accommodate an ONC–ATCB to apply ONC–ACBs or to become accredited temporarily prevent certifications from to become a testing lab and/or an ONC– testing labs. We further believe that being issued during the time period it ACB under the permanent certification applicants will be motivated by takes potential ONC–ACB applicants to program. business dynamics, such as capturing an get accredited and receive their Response. The commenters’ increased market share, to become authorizations from the National recommendation to link the certification authorized as soon as possible under the Coordinator. programs to the proposed stages of permanent certification program.

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Therefore, we believe that there will be appropriate period than ‘‘up to a year’’ disruption of pending and executed multiple ONC–ACBs by December 31, because, as previously stated, we contracts as well as ongoing EHR 2011. anticipate the next set of standards, installations. To address these concerns, In the event that the National implementation specifications, and some commenters recommended that Coordinator is unable to begin the certification criteria to be published in EHRs certified by a ‘‘recognized permanent certification program on late summer of 2012. Therefore, market certification body’’ continue to be January 1, 2012, we believe it is confusion can be avoided by ending all permitted for donation under the appropriate for the temporary vestiges of the temporary certification exception and safe harbor if they still certification program to remain program before the start of testing and satisfied the parameters set by the operational until the National certification to newly adopted physician self-referral prohibition Coordinator determines that the standards, implementation exception and anti-kickback statute safe permanent certification program is fully specifications, and certification criteria. harbor final rules. The commenters also constituted. As stated above, keeping If the testing and certification of a recommended that the subsequent the temporary certification program Complete EHR or EHR Module is not ‘‘rollout’’ of EHR installations to operational will help ensure that a body completed prior to the end of the 6- physician offices should be deemed to authorized to test and certify Complete month period, the Complete EHR or qualify for the exception and safe harbor EHRs and EHR Modules remains EHR Module would have to be based on certification status as of the available. This flexibility provided to resubmitted for testing and certification original purchase date, regardless of the the National Coordinator will help to under the permanent certification date of actual installation in physician alleviate the ‘‘consumer’’ concerns program. offices. expressed by commenters related to the Some commenters recommended that potential existence of backlogs or L. Recognized Certification Bodies as the term of recognition for certified EHR monopolies at the start of the permanent Related to the Physician Self-Referral technology under the exception and safe certification program. In determining Prohibition and Anti-Kickback EHR harbor should be equal to the whether the proposed permanent Exception and Safe Harbor Final Rules ‘‘certification time period of two (2) certification program is fully The physician self-referral prohibition years, and not 12 months as currently constituted, the National Coordinator exception and anti-kickback statute safe specified.’’ Another commenter will consider whether there are a harbor for donations of EHR software recommended that any EHR certified by sufficient number of ONC–ACBs and (42 CFR 411.357(w) and 42 CFR the Certification Commission for Health accredited testing laboratories to 1001.952(y), respectively) include Information Technology (CCHIT) should address the current market demand. For among their conditions a provision that continue to qualify for the exception example, if multiple ONC–ATCBs exist, donated software must be interoperable and safe harbor at least through the end but only one ONC–ACB has been and that, for purposes of the exception of Stage 1 of the Medicare and Medicaid authorized and no testing laboratories and safe harbor, software is deemed to EHR Incentive Programs. are accredited (or alternatively one or be interoperable ‘‘if a certifying body One commenter noted that the more testing laboratories exist, but no recognized by the Secretary has certified physician self-referral prohibition ONC–ACBs), and the Secretary will the software within no more than 12 exception and anti-kickback statute safe soon issue newly adopted standards, months prior to the date it is provided harbor final rules define implementation specifications and to the [recipient].’’ This final rule ‘‘interoperability’’ and that an EHR’s certification criteria, then it is unlikely addresses the process in which the ability to be interoperable is a factor in that the permanent certification program Secretary recognizes a certifying body. its ability to be donated under those would be considered fully constituted. As to the process, we requested rules. The commenter requested that the We believe this approach sufficiently comment in the Proposed Rule on National Coordinator clarify and addresses the concerns expressed by whether we should construe the provide guidance on the standards and various commenters and provides the proposed ‘‘authorization’’ process for interoperability requirements to which most assurance to the market, ONC–ATCBs and ONC–ACBs as the ONC–ATCBs and ONC–ACBs would particularly for Complete EHR and EHR Secretary’s method for ‘‘recognizing’’ test and certify EHRs for purposes of the Module developers that seek testing and certification bodies. exception and safe harbor. certification of Complete EHRs and/or Comments. The vast majority of A commenter recommended that we EHR Modules. commenters supported replacing the clarify that Complete EHRs and EHR Consistent with our original proposal, Secretary’s current method for Modules that are certified under the we are allowing ONC–ATCBs to ‘‘recognizing’’ certification bodies with temporary or permanent certification complete the processing of all requests the proposed ‘‘authorization’’ process for programs may be deemed interoperable for the testing and certification of ONC–ATCBs and ONC–ACBs. The and may qualify for the physician self- Complete EHRs and/or EHR Modules commenters reasoned that our proposal referral prohibition exception or the received prior to the sunset date. By offered consistency and efficiency for all anti-kickback statute safe harbor for completing the processing of a request, stakeholders involved. Only one EHR donations. The commenter also we expect that all testing and commenter recommended that the recommended that we state that certification activities would be current process for ‘‘recognizing’’ Complete EHRs and EHR Modules will completed including the issuance of a certification bodies not be superseded also be required to meet other regulatory certification, if appropriate. We are by the proposed ‘‘authorization’’ process, provisions outlined in 42 CFR 411.351 limiting the time to complete the but that commenter did so based on a et seq. or 1001.952 in order to qualify processing of requests to a period of six concern expressed by multiple for the exception or safe harbor (e.g., an months after the sunset date of the commenters. The concern was over EHR must be used for any patient temporary certification program. We whether the proposed ‘‘authorization’’ without regard to payer status). The agree with the commenter that a process would negatively affect commenter proposed that we include a limitation is necessary to bring finality donations of ‘‘certified EHRs’’ currently new requirement that a certifying body to the temporary certification program. in progress, including the invalidation cannot certify EHRs or EHR Modules if We believe that six months is a more of existing investments and the they unnecessarily limit or restrict their

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use or compatibility with other HIT by a ‘‘recognized certification body’’ petition process whereby an individual (e.g., if an entity binds physicians to a qualify for donation under the EHR eligible professional or eligible hospital particular entity to receive the EHR or exception and safe harbor, these EHRs could apply directly to ONC for a the EHR Module, or uses a combination will not meet the definition of Certified waiver to use a non-certified EHR to of certified EHR Modules that do not EHR Technology and therefore must be qualify for meaningful use. work together). recertified by an ONC–ATCB in order to Response. We believe that this final Response. We appreciate the be used by an eligible professional or rule is the most appropriate rulemaking commenters’ support for our proposal to eligible hospital to demonstrate to address comments on grandfathering. incorporate the current ‘‘recognition’’ of meaningful use. The definition of Certified EHR certification bodies into the ONC–ATCB All other issues raised by commenters Technology specified by Congress at and ONC–ACB ‘‘authorization’’ are outside the scope of this rulemaking section 3000 of the PHSA set forth clear processes. We agree with commenters and in many cases would require notice parameters that dictate when HIT will that folding the ‘‘recognition’’ process and comment rulemaking in order to be be considered Certified EHR into the ONC–ATCB and ONC–ACB appropriately addressed. Technology. To be Certified EHR ‘‘authorization’’ processes will lead to Technology, HIT must first meet the M. Grandfathering greater clarity and consistency for all definition of a Qualified EHR, which in stakeholders. Accordingly, the ONC– Grandfathering would essentially turn must be certified pursuant to the ATCB and ONC–ACB ‘‘authorization’’ involve a determination by the National certification program(s) established processes will constitute the Secretary’s Coordinator that existing EHR systems under section 3001(c)(5) by the National ‘‘recognition’’ of a certification body. developed by vendors and self- Coordinator as meeting standards This final rule only addresses the developers, as well as those systems adopted under section 3004 by the issue of how the Secretary recognizes a being used by providers in a possible Secretary. Certification is used to certifying body. It does not address modified state, are equivalent to the provide consumers with assurance and issues related to the application of the definition of Certified EHR Technology confidence that the product or service exception or safe harbor, as those issues and thus are capable of being used to they seek to purchase and use will work are beyond the scope of this final rule achieve meaningful use. Although we as expected and will include the and are better directed to CMS and OIG, did not propose or discuss the concept capabilities for which it was purchased. respectively. As noted in the Proposed of grandfathering in the Proposed Rule, While grandfathering may appear Rule, CCHIT is the only organization several commenters made convenient in that it would allow that has both applied for and been recommendations on the subject. eligible professionals and eligible granted ‘‘recognized certification body’’ Comments. On all three recent hospitals to use the HIT they already status under ONC’s Certification meaningful use related rulemakings (the have in place, we believe that in this Guidance Document (CGD). As implied HIT Standards and Certification Criteria context grandfathering is inappropriate in the Proposed Rule and the CGD, all interim final rule, the Medicare and and would be inconsistent with the ‘‘recognized certification bodies’’ will Medicaid EHR Incentive Programs statutory requirements for Certified EHR lose their status upon the effective date proposed rule, and the HIT Certification Technology specified in the PHSA. of this final rule. As a result, they will Programs proposed rule), HHS received Grandfathering provides neither need to reapply to become an ONC– comments related to the concept of assurance nor confidence for eligible ATCB (and in the future an ONC–ACB) ‘‘grandfathering’’ existing EHRs in some professionals and eligible hospitals that in order to be a ‘‘recognized certification form or another. Some comments their existing HIT will have the capacity body’’ after the effective date of this final requested that we deem all CCHIT- to support their attempts to meet rule. Loss of ‘‘recognized’’ status under certified EHRs from 2008 onward to be meaningful use Stage 1 objectives and the CGD upon the effective date of this Certified EHR Technology. Others measures. In this regard, we do not final rule does not impact the fact that requested that we deem all existing believe that the variations to certifications made by CCHIT while EHRs regardless of whether these EHRs ‘‘grandfathering’’ some commenters recognized under the CGD were made had been certified by CCHIT. In both suggested (that an EHR should be by a ‘‘recognized certification body.’’ cases, these commenters argued that this grandfathered if it could enable an With respect to the request for would enable eligible professionals and eligible professional or eligible hospital clarification regarding the standards and eligible hospitals who were early to meet some or all applicable interoperability requirements to which adopters to possess HIT that met the meaningful use objectives and ONC–ATCBs and ONC–ACBs would definition of Certified EHR Technology measures) are valid approaches. test and certify Complete EHRs and EHR right away. One commenter offered a Conversely, we believe those Modules, we clarify that we will not variant to this suggestion by adding a approaches are risky from a adopt different or additional qualification that we should only deem programmatic perspective with respect certification criteria to which Complete EHRs if the EHR currently in the to the potential for fraud, and from an EHRs or EHR Modules must be tested possession of an eligible professional or eligible professional or eligible and certified in order to meet the eligible hospital could enable them to hospital’s perspective in that they deeming provision, and we do not meet some (at least 5) number of would have no demonstrable proof that expect ONC–ATCBs and ONC–ACBs to meaningful use objectives. While other their EHR possessed the capabilities use different certification criteria to test commenters using this same line of necessary to meet the certification and certify Complete EHRs and EHR reasoning believed that an EHR should criteria adopted by the Secretary. More Modules. We believe that the qualify for grandfathering if it could importantly, if we were to permit certification criteria adopted by the enable an eligible professional or grandfathering according to the logic Secretary specify several important eligible hospital to meet all applicable expressed by these commenters, the interoperability requirements and build objectives and measures, but that such only way we, and the commenters, the foundation for more advanced certification would only be valid until would be able to tell if an EHR should interoperability in the future. It is also the temporary certification program was legitimately be deemed grandfathered important to note that regardless of operational. One commenter specifically would be if the eligible professional or whether EHRs certified in 2009 or 2010 recommended that ONC establish a eligible hospital had successfully

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achieved meaningful use. We question ‘‘self-developed’’ if the health care and most likely sold to many eligible whether commenters would be willing provider paid the total costs to have the professionals and eligible hospitals from to take the risk of attempting meaningful Complete EHR or EHR Module tested those that would be certified once and use without the certainty of knowing and certified. used primarily by the person or entity that their EHR provided the capabilities Comments. Multiple hospitals and who paid for the certification. We they would need to attempt to achieve hospital associations requested that we believe that many commenters were not it. clarify the definition of ‘‘self-developed’’ concerned about the fact that brand Furthermore, while a deeming of this to include an indication of the extent to new, built from scratch self-developed sort may address a very short term need which modifications can be made to Complete EHRs and EHR Modules of existing HIT users, we believe it previously certified Complete EHRs or would need to be tested and certified. would significantly undercut our long- EHR Modules without requiring a Rather, it appeared that commenters term policy goals and objectives, as well system to be certified as ‘‘self- were concerned about whether any as provide eligible professionals and developed.’’ The commenters noted that modification to an already certified eligible professionals with a false sense we have clearly stated that eligible Complete EHR or EHR Module, of security. Without the assurances professionals and eligible hospitals bear including those that would be provided by the testing and certification full responsibility for making certified enhancements or required to integrate process, grandfathering would require EHR Modules work together. Therefore, several EHR Modules, would invalidate HHS to permit eligible professionals and the commenters contended that a certification or certifications and eligible hospitals to use HIT that may be providers must have the ability to make consequently require the eligible incapable from the start of supporting needed modifications to certified EHR professional or eligible hospital to seek their achievement of meaningful use Modules to achieve that purpose. The a new certification because it would be Stage 1. Along those lines, we do not commenters stated that often there is a considered self-developed. We believe believe that the petition and waiver need for custom configurations or this concern stems from the following process a commenter suggested is a settings within the parameters of statement we made in the preamble of feasible option because HHS would certified EHRs, including modifications the Proposed Rule. incur the risk that eligible professionals that may be necessary to ensure that the Self-developed Complete EHRs and EHR and eligible hospitals would fail to EHR works properly when implemented Modules could include brand new Complete achieve meaningful use Stage 1 because within an organization’s entire HIT EHRs or EHR Modules developed by a health their existing HIT is incapable of environment. The commenters further care provider or their contractor. It could also meeting the applicable objectives and stated that such modifications may include a previously purchased Complete measures even though we had deemed affect, or even enhance, the capabilities EHR or EHR Module which is subsequently it ‘‘certified.’’ addressed by the certification criteria by modified by the health care provider or their providing additional and specific contractor and where such modifications are N. Concept of ‘‘Self-Developed’’ made to capabilities addressed by decision-support functions or allowing certification criteria adopted by the We stated in the Proposed Rule that for additional quality improvement Secretary. We limit the scope of we interpreted the HIT Policy activities. The commenters asserted that ‘‘modification’’ to only those capabilities for Committee’s use of the word ‘‘self- as long as the system can still perform which the Secretary has adopted certification developed’’ to mean a Complete EHR or the function for which it was originally criteria because other capabilities (e.g., a EHR Module that has been designed, certified, these modifications should not different graphical user interface (GUI)) modified, or created by, or under trigger the need for a self-developed would not affect the underlying capabilities contract for, a person or entity that will certification, even if the changes are a Complete EHR or EHR Module would need to include in order to be tested and certified. assume the total costs for its testing and made to the capabilities addressed by certification and will be a primary user the certification criteria. In response to these concerns, we of the Complete EHR or EHR Module. The commenters stated clarity was would like to further clarify the intent We noted that self-developed Complete needed due to the substantial resources of our statements, specifically the EHRs and EHR Modules could include that will be required for certification of statement that a self-developed brand new Complete EHRs or EHR self-developed systems. In addition, Complete EHR or EHR Module ‘‘could Modules developed by a health care commenters stated that, for legal also include a previously purchased provider or their contractor. We further compliance purposes, clarity will allow Complete EHR or EHR Module which is noted that it could also include a providers to confidently submit subsequently modified by the health previously purchased Complete EHR or attestations to federal and state agencies care provider or their contractor and EHR Module which is subsequently about the certification status of the where such modifications are made to modified by the health care provider or Certified EHR Technology they use. capabilities addressed by certification their contractor and where such Response. We understand the unique criteria adopted by the Secretary.’’ We modifications are made to capabilities needs and requirements eligible agree with commenters that not every addressed by certification criteria professionals and eligible hospitals have modification would or should constitute adopted by the Secretary. We with respect to successfully a modification such that a Complete specifically stated that we would limit implementing and integrating HIT into EHR or EHR Module’s certified status the scope of ‘‘modification’’ to only operational environments. We provided would become invalid. We provided an those capabilities for which the a description of the term ‘‘self- example in the proposed rule, quoted Secretary has adopted certification developed’’ in the Proposed Rule’s above, that spoke to modifications not criteria because other capabilities (e.g., preamble for two reasons. First, in order related to any of the capabilities a different graphical user interface to provide greater clarity for addressed by certification criteria (GUI)) would not affect the underlying stakeholders regarding who would be adopted by the Secretary. We did not, capabilities a Complete EHR or EHR responsible for the costs associated with however, provide any additional Module would need to include in order testing and certification and, second, to information regarding what we would to be tested and certified. Accordingly, clearly differentiate in our impact consider an appropriate or we stated that we would only refer to analysis those Complete EHRs and EHR inappropriate modification to an already the Complete EHR or EHR Module as Modules that would be certified once certified Complete EHR or EHR Module

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and now take the opportunity to provide O. Validity of Complete EHR and EHR Secretary at 45 CFR part 170 subpart C that clarification. Module Certification and Expiration of in order to meet the definition of We recognize that a certified Certified Status Certified EHR Technology. Finally, we Complete EHR or certified EHR Module In the Proposed Rule, we discussed asked for public comment on the best way to assist eligible professionals and may not automatically work ‘‘out of the the validity of ‘‘certified status’’ of eligible hospitals who begin meaningful box’’ once it is implemented in an Complete EHRs and EHR Modules, as use in 2013 or 2014 (at Stage 1) in operational environment. We also well as the expiration of that status as it related to the definition of Certified identifying Complete EHRs and/or EHR cautioned eligible professionals and Modules that have been certified to the eligible hospitals in the HIT Standards EHR Technology. We stated that certification represented ‘‘a snapshot, a most current set of adopted certification and Certification Criteria interim final criteria and therefore could be used to rule that, if they chose to use EHR fixed point in time, where it has been confirmed that a Complete EHR or EHR meet the definition of Certified EHR Modules to meet the definition of Technology. Module has met all applicable Certified EHR Technology, they alone Comments. Several commenters certification criteria adopted by the would be responsible for properly disagreed with our position. Other Secretary.’’ We went on to say that as the integrating multiple EHR Modules. commenters agreed and contended that Secretary adopts new or modified Given that many of the certification Certified EHR Technology should certification criteria, the previously always be as up-to-date and as current criteria adopted by the Secretary express adopted set of certification criteria minimum capabilities, which may be as possible. Of those commenters that would no longer constitute all of the disagreed, their concerns focused on added to or enhanced by eligible applicable certification criteria to which professionals and eligible hospitals to two areas: The validity/expiration of a Complete EHR or EHR Module would certified status and how eligible meet their health care delivery needs need to be tested and certified. Thus, we (e.g., more than five rules could be professionals and eligible hospitals who clarified that after the Secretary has adopt Certified EHR Technology in the added to the clinical decision support adopted new or modified certification year before we anticipate updating capability), we believe that it is criteria, a previously certified Complete adopted standards, implementation unrealistic to expect that the certified EHR or EHR Module’s certification specifications, and certification criteria capabilities of a Complete EHR or EHR would no longer be valid for purposes for a future stage of meaningful use Module will remain 100% unmodified of meeting the definition of Certified would be affected. in all cases. As a result, we believe it is EHR Technology. In other words, Commenters asserted that some possible for an eligible professional or because new or modified certification certification criteria were unlikely to eligible hospital to modify a Complete criteria had been adopted, previously change between meaningful use stages EHR or EHR Module’s certified issued certifications would no longer and that a Complete EHR or EHR capability provided that due diligence is indicate that a Complete EHR or EHR Module’s certification should remain taken to prevent such a modification Module possessed all of the capabilities valid and not expire until the Secretary from adversely affecting the certified necessary to support an eligible had adopted updated certification capability or precluding its proper professional’s or eligible hospital’s criteria. These commenters requested operation. While we cannot review achievement of meaningful use. that ONC only make changes to every eligible professional and eligible Accordingly, we noted that Complete certification criteria on a cyclical basis hospital’s use of Certified EHR EHRs and EHR Modules that had been and only when necessary for meaningful certified to the previous set of adopted Technology and every potential use or to advance interoperability. certification criteria would no longer modification that may be made to Finally, within the context of their constitute ‘‘Certified EHR Technology.’’ determine whether such modification responses, many of these commenters We also discussed that the planned signaled favorable support for our may have invalidated a Complete EHR two-year schedule for updates to proposal to include ‘‘differential or EHR Module’s certification, we meaningful use objectives and measures certification’’ in the permanent strongly urge eligible professionals and and correlated certification criteria certification program. In that regard, eligible hospitals to consider the created a natural expiration with respect some commenters noted that we should following. Certification is meant to to the validity of a previously certified not require Complete EHRs and EHR provide assurance that a Complete EHR Complete EHR’s or EHR Module’s Modules certified under the purview of or EHR Modules will perform according certified status and its continued ability the temporary certification program to to the certification criteria to which they to be used to meet the definition of be fully retested and recertified once the were tested and certified. Any Certified EHR Technology. We stated permanent certification program has modification to a Complete EHR or EHR that after the Secretary has adopted new been initiated. Module after it has been certified has or modified certification criteria, A number of commenters expressed the potential to jeopardize the proper previously certified Complete EHRs and concerns about our position and operation of the Complete EHR or EHR EHR Modules must be retested and contended that it required eligible Module and thus the eligible recertified in order to continue to professionals and eligible hospitals who professional or eligible hospital’s ability qualify as Certified EHR Technology. adopt Certified EHR Technology in 2012 to achieve meaningful use. If an eligible We offered further clarification by (to attempt meaningful use Stage 1) to professional or eligible hospital would stating that regardless of the year and upgrade their Certified EHR Technology like absolute assurance that any meaningful use stage at which an twice in two years (according to the modifications made did not impact the eligible professional or eligible hospital proposed meaningful use stage enters the Medicare or Medicaid EHR staggering) in order to continue to be proper operation of certified Incentive Program, the Certified EHR eligible for meaningful use incentives capabilities, they may find it prudent to Technology that would need to be used during 2013 when they would only still seek to have the Complete EHR or EHR would have to include the capabilities have to meet meaningful use Stage 1. Module(s) retested and recertified. necessary to meet the most current Some of these commenters viewed this certification criteria adopted by the as a penalty and disagreed with our

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position that eligible professionals and present, capabilities from Certified EHR Secretary adopts new standards, eligible hospitals should have to use Technology in order to meet meaningful implementation specifications, or Certified EHR Technology that had been use Stage 1 requirements in 2013. certification criteria, a Complete EHR or certified to the most recently adopted In this regard, and consistent with the EHR Module may no longer provide a certification criteria. Additionally, these caveat many commenters articulated, valid set of capabilities to satisfy the commenters conveyed their belief that it we identified that an eligible definition of Certified EHR Technology is not in the best interest of eligible professional or eligible hospital would or support an eligible professional’s or professionals and eligible hospitals to no longer be able to assert that a eligible hospital’s attempt to achieve a require that they use Certified EHR Complete EHR or EHR Module’s particular meaningful use stage. Technology that includes more certification was valid for purposes of Accordingly, and because the HITECH advanced capabilities than are necessary satisfying the definition of Certified Act requires eligible professionals and to qualify for the meaningful use stage EHR Technology in subsequent years for eligible hospitals to use Certified EHR that they are attempting to meet. at least two reasons: (1) The certification Technology in order to qualify for Finally, one commenter requested that criteria related to particular capabilities incentive payments, we reaffirm our we offer a graphical depiction to more had been modified; and/or (2) the previous position. Regardless of the year clearly convey our position. standard(s) and implementation and meaningful use stage at which an Response. We appreciate commenters’ specification(s) associated with a eligible professional or eligible hospital support for our proposal for differential certification criterion had been modified enters the Medicare or Medicaid EHR Incentive Program, the Certified EHR certification. Because this concept is (newly adopted or replaced). With solely relevant to the policies of the Technology that they would need to use respect to either of these two reasons, in permanent certification program, we do would have to include the capabilities order for a Complete EHR or EHR not address it in this final rule. necessary to meet the most current Module to continue to meet the As previously mentioned in both the certification criteria adopted by the definition of Certified EHR Technology, HIT Standards and Certification Criteria Secretary at 45 CFR 170 subpart C. We it would need to be retested and interim final rule and the Medicare and believe that this position takes into recertified to the new certification Medicaid EHR Incentive Programs account the best interests of eligible criteria or newly adopted standards proposed rule, ONC and CMS anticipate professionals and eligible hospitals. It and/or implementation specifications that the requirements for meaningful will also serve to assure eligible use will be adjusted every two years. We for the subsequent years for which they professionals and eligible hospitals who do not expect to adopt certification had been adopted. Only then would an implement HIT that meets the definition criteria more frequently than every two eligible professional or eligible hospital of Certified EHR Technology that they years. In its proposed rule (75 FR 1854), be able to assert that it continues to will have the requisite technical CMS also indicated that ‘‘[t]he stages of possess a Complete EHR or EHR Module capabilities to attempt to achieve criteria of meaningful use and how they with a valid certification that could be meaningful use. Just as important, this are demonstrated are described further used to meet the definition of Certified position ensures that all Certified EHR in this proposed rule and will be EHR Technology. For example, a Technology will have been tested and updated in subsequent proposed rules Complete EHR would need to be certified to the same standards and to reflect advances in HIT products and retested and recertified as being implementation specifications and infrastructure. This could include compliant with a newly adopted provide the same level of updates to the Stage 1 criteria in future standard for the 2013/2014 certification interoperability, which would not be the rulemaking.’’ (Emphasis added.) period in order for a Complete EHR case if we were to permit different We believe that commenters who developer, an eligible professional, or an variations of Certified EHR Technology expressed concerns and objected to our eligible hospital to validly assert that to exist. discussion of the expiration/validity of the certification issued for the Complete To further address concerns raised by a Complete EHR or EHR Module’s EHR enables it to meet the definition of the commenters, we clarify that if the certified status did not account for the Certified EHR Technology. As we stated temporary certification program sunsets real possibility that the requirements for in the Proposed Rule, if the previously on December 31, 2011 and the an eligible professional or eligible certified Complete EHR were not permanent certification program is fully hospital to meet meaningful use Stage 1 retested and recertified as being constituted at the start of 2012, in 2013 (or 2014) could be different and compliant with the newly adopted Complete EHRs and EHR Modules that possibly more demanding than they standard, it would not ‘‘lose its were previously certified by ONC– were for meaningful use Stage 1 in 2012. certification.’’ However, the previous ATCBs to the 2011/2012 certification Contrary to some commenters’ certification would no longer enable the criteria adopted by the Secretary will assumptions, it is possible that while Complete EHR to meet the definition of not need to be retested and recertified establishing the objectives and measures Certified EHR Technology. Many as having met the certification criteria for meaningful use Stage 2 (in a commenters recognized this fact by for those years. In other words, the fact subsequent rulemaking) that CMS could indicating that in situations where that the permanent certification program revise what it means to meet meaningful interoperability was a focus, retesting had replaced the temporary certification use Stage 1 in 2013. Consequently, such and recertification would be needed and program would not automatically revisions could include additional justified. With respect to the validity of invalidate certifications that were requirements, based on advances in a Complete EHR or EHR Module’s previously issued by ONC–ATCBs HIT, beyond the requirements that will certification, we ask commenters to pursuant to the 2011/2012 certification be established in the forthcoming final consider how they would expect to meet criteria. rule that specifies what meaningful use a subsequent stage of meaningful use However, we reiterate for commenters Stage 1 will require in 2011 and 2012. without the technical capabilities what we stated in the Proposed Rule (75 Therefore, the potential remains that an necessary to do so. A Complete EHR or FR 11351): ‘‘[S]ince a new certification eligible professional or eligible hospital EHR Module’s certification is only as program would exist, which would who becomes a meaningful user in 2012 good as the capabilities that can be include different processes, we would need additional, not currently associated with that certification. If the emphasize that Complete EHRs and

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EHR Modules tested and certified under approximately two years from now), all Modules to the 2013/2014 certification the temporary certification program by Complete EHRs and EHR Modules that criteria would need to begin by mid- an ONC–ATCB would need to be tested were previously certified under the 2012 in order for Complete EHRs and and certified according to the temporary certification program by EHR Modules to be retested and permanent certification program once ONC–ATCBs will need to be tested by recertified prior to the start of the next the Secretary adopts certification an accredited testing laboratory and meaningful use reporting period. criteria to replace, amend, or add to certified by an ONC–ACB. Pursuant to We provide the following illustration previously adopted certification our discussion regarding the sunset of overlaid on CMS’s proposed staggered criteria.’’ Thus, once the permanent the temporary certification program payment year/adoption year chart for certification program is fully constituted combined with the two year cycle on the Medicare program to more clearly and after the Secretary has adopted which we expect to adopt certification convey the discussion above. This additional or revised certification criteria, we anticipate the testing and illustration would also be applicable to criteria (which we expect will occur certification of Complete EHRs and EHR the Medicaid program.

Payment year First payment year 2011 2012 2013 2014

2011 ...... Stage 1 ...... Stage 1 ...... Stage 2 ...... Stage 2. 2012 ...... Stage 1 ...... Stage 1 ...... Stage 2. 2013 ...... Stage 1 ...... Stage 2. 2014 ...... Stage 1. Complete EHRs and EHR Modules certified by ONC– Complete EHRs and EHR Modules certified by ONC– ATCBs or ONC–ACBs 1 to certification criteria adopted ACBs to certification criteria adopted for 2013 & 2014 for 2011 & 2012 meet the definition of Certified EHR meet the definition of Certified EHR Technology. Technology.

Comments. In response to our integrated bundles of EHR Modules. certificates submitted by an applicant as question about how to best indicate to Another comment suggested ‘‘labeling’’ part of its application. eligible professionals and eligible constraints be assigned when a Accordingly, we also believe that this hospitals those Complete EHRs and/or Complete EHR or EHR Module had been new Principle of Proper Conduct for EHR Modules certified to the most tested at an eligible professional or ONC–ATCBs related to how a Complete current set of adopted certification eligible hospital’s site (e.g., at the EHR or EHR Module’s certification is criteria (which could be used to meet hospital where the Complete EHR is communicated is a logical extension of the definition of Certified EHR deployed). our proposals, is similar to the requirement we place on ONC–ATCBs Technology), several commenters Response. We agree with the offered suggestions regarding ‘‘labeling’’ with respect to how they represent commenters who requested more themselves, and provides more conventions for Complete EHRs and specific requirements surrounding how EHR Modules. Overall, commenters specificity and clarity around a Complete EHR or EHR Module’s requirements to which ONC–ATCBs indicated that specific ‘‘labeling’’ certified status should be represented parameters would help clarify the would already be subject. The new and communicated and believe that it Principle of Proper Conduct requires ‘‘currency’’ of a Complete EHR or EHR will provide the most benefit to eligible Module’s certification and whether the that: professionals and eligible hospitals who • All certifications must require that certification was valid. These are interested in easily identifying a Complete EHR or EHR Module commenters offered a variety of Complete EHRs and EHR Modules that developer conspicuously include the suggested techniques, including have been tested and certified by an following text on its Web site and in all identifying Complete EHRs and EHR ONC–ATCB. In fact, Guide 65, Section marketing materials, communications Modules according to: the applicable 14, requires evidence of policies and statements, and other assertions related meaningful use stage they could be used procedures for use and display of to the Complete EHR or EHR Module’s for; the month and year they had been certificates (e.g., logos). We proposed certification: tested and certified; and the year and, as discussed above, will require Æ ‘‘This [Complete EHR or EHR associated with the most current set of applicants for ONC–ATCB status to Module] is 201[X]/201[X] compliant and adopted standards, implementation provide the National Coordinator with a has been certified by an ONC–ATCB in specifications, and certification criteria. copy of their policies related to the use accordance with the applicable Additionally, in light of the EHR and display of certificates. We believe certification criteria adopted by the Module ‘‘bundle’’ concept we proposed that the most effective method to ensure Secretary of Health and Human with respect to when EHR Modules that the certified status of a Complete Services. This certification does not need to be tested and certified to EHR or EHR Module is appropriately represent an endorsement by the U.S. adopted privacy and security criteria, represented and communicated is Department of Health and Human one commenter recommended that we through the addition of a new principle Services or guarantee the receipt of assign specific ‘‘labeling’’ constraints to to the Principles of Proper Conduct for incentive payments.’’; and certifications issued to pre-coordinated, ONC–ATCBs. This new Principle of Æ The information an ONC–ATCB Proper Conduct will also provide is required to report to the National 1 If the permanent certification program is fully additional clarity for applicants in terms Coordinator for the specific Complete constituted and the temporary certification program of the information that the National EHR or EHR Module at issue. sunsets on 12/31/2011, all new requests made after • 12/31/2011 for certification of Complete EHRs or Coordinator expects to be contained in A certification issued to an EHR Modules to the 2011/2012 certification criteria the copy of the policies and procedures integrated bundle of EHR Modules shall will be processed by an ONC–ACB. associated with the use and display of be treated the same as a certification

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issued to a Complete EHR for the maintenance upgrades to customers on that an ONC–ATCB must accept purposes of the above requirement a regular basis and that those versions requests for an updated version of a except that it must also indicate each are normally denoted by a new ‘‘dot previously certified Complete EHR or EHR Module that comprises the bundle. release’’ (e.g., version 7.1.1 when 7.1 EHR Module to inherit the previously With respect to the requirement that received certification). certified Complete EHR or EHR includes ‘‘201[X]/20‘[X],’’ we expect Response. We understand that Module’s issued certification without ONC–ATCBs to put the years ‘‘2011/ Complete EHR and EHR Module being retested and recertified. However, 2012’’ where we have provided for developers will conduct routine the Complete EHR or EHR Module variability in the date range and have maintenance. We also recognize that at developer must submit an attestation as only provided this flexibility in the rare times Complete EHR and EHR Module described above in the form and format circumstance that the temporary developers will provide new or specified by the ONC–ATCB that the certification program does not sunset modified capabilities to either make the newer version does not adversely affect according to the schedule that we have Complete EHR or EHR Module perform the proper functionality of previously discussed. Given our clarifications more efficiently and/or to improve user certified capabilities. Upon receipt of about the validity of a Complete EHR or experiences related to certain the attestation, an ONC–ATCB would be EHR Module’s certification, we believe functionality (e.g., a new graphical user permitted to determine whether the that it would be inappropriate and interface (GUI)). Our main concern, as updates and/or modifications are such misleading to adopt an identification we stated in the preamble, is whether that the new version would adversely requirement solely associated with these changes adversely affect the affect previously certified capabilities meaningful use stages. We also believe capabilities to which a Complete EHR or and therefore need to be retested and that it would be inappropriate to EHR Module has already been tested recertified, or whether to grant certified constrain a particular certification based and certified and whether those changes status to the new version derived from on whether the certification could be are such that the Complete EHR or EHR the previously certified Complete EHR attributed to a particular entity at a Module would no longer support an or EHR Module. particular location. While unlikely, we eligible professional or eligible If the ONC–ATCB awards a do not want to presume that such a hospital’s achievement of meaningful certification to a newer version of a certified Complete EHR or EHR Module use. Accordingly, we clarify that a previously certified Complete EHR or would or could not be useful to another previously certified Complete EHR or EHR Module, we expect the ONC–ATCB eligible professional or eligible hospital. EHR Module may be updated for routine to include this issued certification in its We do, however, agree with the maintenance or to include new weekly report to the National commenter who suggested the specific capabilities that both affect capabilities Coordinator. We note that aside from constraint for a bundle of EHR Modules. related and unrelated to the certification specifying an ONC–ATCB must provide Such bundles, by their very nature, criteria adopted by the Secretary this mechanism and review the would otherwise constitute a Complete without its certification becoming submitted attestation, we do not specify EHR and therefore must be integrated in invalid.2 However, we do not believe the fees or any other processes an ONC– such a way in order to even be tested that it would be wise to simply permit ATCB may determine necessary before and certified as a bundle. In the case of a Complete EHR or EHR Module granting certified status to a newer a bundle of EHR Modules, the bundle is developer to claim without any version of a previously certified greater than the sum of each individual verification that the routine Complete EHR or EHR Module based on EHR Module, and for that reason, we maintenance or new/modified the submitted attestation. would like to clarify that EHR Modules, capabilities included in a new version once certified as part of a bundle, would P. General Comments did not adversely affect the proper not separately inherit a certification just We received comments that were not functioning of the previously certified because they were certified as part of a attributable to a specific provision or capabilities. We believe that an ONC– bundle. For example, if EHR Modules A, proposal in the Proposed Rule, but were ATCB should, at a minimum, review an B, C, and D, are certified as an still within the scope of the temporary attestation submitted by a Complete integrated bundle, EHR Module C certification program. These comments EHR or EHR Module developer would not on its own be certified, just were on such matters as the timing of indicating the changes that were made, by virtue of the fact that it was part of the temporary certification program, the the reasons for those changes, and other a certified bundle. If an EHR Module use of elements in the proposed developer wanted to make EHR Module such information and supporting permanent certification program for the C available for uses outside the bundle, documentation that would be necessary temporary certification program, the then they would have to seek to have to properly assess the potential effects potential for a backlog of requests for EHR Module C separately tested and the new version would have on testing and certification, the costs of certified. previously certified capabilities. testing and certification, the use and Comments. Several commenters As a result, we have added to both testing of open source Complete EHRs requested that we clarify whether every § 170.445 and § 170.450 a requirement or EHR Modules, and the safety of single updated version of a Complete Complete EHRs and EHR Modules. 2 We understand that Complete EHR and EHR EHR or EHR Module would need to be Module developers typically consider a ‘‘minor Comments. One commenter suggested retested and recertified in order to have version release’’ to be, for example, a version that we not implement the temporary a valid certification and whether there number change from 3.0 to 3.1 and consider a certification program. Rather, the would be a mechanism available to ‘‘major version release’’ to be, for example, a version commenter suggested that we proceed number change from 4.0 to 5.0. In providing for this accommodate routine changes and flexibility, we do not presume the version straight to implementing the permanent product maintenance without the need numbering schema that a Complete EHR or EHR certification program. Some other to fully retest and recertify each Module developer may choose to utilize. As a commenters suggested we were moving instantiation of a previously certified result, we do not preclude a Complete EHR or EHR too fast, while still other commenters Module developer from submitting an attestation to Complete EHR or EHR Module. Some of an ONC–ATCB for a Complete EHR or EHR Module suggested we were not moving fast these commenters stressed that they whose version number may represent a minor or enough in implementing the temporary provide bug-fixes and other major version change. certification program. Some commenters

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suggested utilizing elements that we Comments. One commenter requested IV. Provisions of the Final Regulation proposed for the permanent certification that we only allow the testing and For the most part, this final rule program, such as accreditation and post certification of open source Complete incorporates the provisions of the market surveillance in the temporary EHRs and EHR Modules under the Proposed Rule. Those provisions of this certification program. temporary certification program and final rule that differ from the Proposed Response. We discussed in detail the exclude proprietary Complete EHRs and Rule are as follows: urgency for establishing the temporary EHR Modules. Commenters also • In § 170.401, we added ‘‘the certification program, particularly the inquired as to how we would test open requirements that ONC–ATCBs must need for making Certified EHR source Complete EHRs and EHR follow to remain in good standing’’ to Technology available so that eligible Modules. properly identify that this subpart Response. We do not agree with the professionals and eligible hospitals contains requirements that ONC–ATCBs commenter that the temporary would have the ability to attempt to must follow to remain in good standing certification program should be limited achieve meaningful use Stage 1. In under the temporary certification to only open source Complete EHRs and discussing this urgency and the program. This reference was differences between the temporary EHR Modules. Proprietary Complete EHRs and EHR Modules will likely be inadvertently left out of the Proposed certification program and the permanent Rule. certification program, we explained how widely purchased and/or utilized by the • HIT market and we see no valid reason In § 170.402, we added the there was not sufficient time to ‘‘ ’’ to exclude them from the temporary definitions of development site, implement such elements as ‘‘ ’’ ‘‘ certification program. Open source deployment site, and remote testing accreditation and post market ’’ Complete EHRs and EHR Modules will and certification. surveillance. If we were to attempt to • ‘‘ be tested and certified in the same In § 170.405(b), we added or ONC– establish an accreditation process, ATCB’’ to clarify that either an applicant Certified EHR Technology would likely manner as proprietary Complete EHRs and EHR Modules under the temporary for ONC–ATCB status or an ONC–ATCB not be available in a timely manner. may, when necessary, utilize the Further, the limited time that we certification program. Comments. A few commenters specified correspondence methods. This anticipate the temporary certification expressed concern over the potential reference was inadvertently left out of program being in existence prevents us safety risks that could be associated the Proposed Rule. from establishing a post market • with poorly planned, implemented, and In § 170.423, in response to public surveillance program. By the time we used EHR technology and suggested that comments, we added a new Principle of would be able to establish and get patient safety should be considered in Proper Conduct designated as paragraph results from a post market surveillance the same context as the speed with (k). The new Principle of Proper program, the temporary certification which we develop and implement the Conduct will require ONC–ATCBs to program will likely have sunset. temporary certification program. ensure that all Complete EHRs and EHR Comments. Commenters requested Response. We understand and are Modules are properly identified and that we prevent testing and certification acutely aware of the concerns expressed marketed. monopolies and backlogs of requests for by the commenters regarding patient • In § 170.423(e), we modified the testing and certification. Commenters health and safety. We believe that the language to require that ONC–ATCBs also requested that we mandate pricing temporary certification program has ‘‘[u]se test tools and test procedures for testing and certification or at least been sufficiently constituted to ensure approved by the National Coordinator establish a reasonable fee requirement. that ONC–ATCBs will competently test for the purposes of assessing Complete Response. We believe that through the and certify Complete EHRs and EHR EHRs and/or EHR Modules compliance policies we have established in this Modules. Further, we have established a with the certification criteria adopted by final rule that the temporary process in the temporary certification the Secretary.’’ certification program is inclusive of as program that the National Coordinator • In § 170.423(h), we have specified many potential applicants for ONC– could use to immediately suspend an that an ONC–ATCB will be additionally ATCB status as possible and that we ONC–ATCB’s ability to perform testing required to report the clinical quality have created an environment that is and certification if there is reliable measures to which a Complete EHR or likely to result in multiple ONC–ATCBs. evidence indicating that allowing an EHR Module has been tested and Further, we believe that multiple ONC– ONC–ATCB to continue its testing and certified and, where applicable, any ATCBs and market dynamics, certification processes would pose an additional software a Complete EHR or particularly competition, will address adverse risk to patient health and safety. EHR Module relied upon to demonstrate the commenters’ concerns about its compliance with a certification potential monopolies, appropriate costs Q. Comments Beyond the Scope of This criterion or criteria adopted by the for testing and certification, and the Final Rule Secretary. timely and efficient processing of In response to the Proposed Rule, • In § 170.423(i), in response to requests for the testing and certification some commenters chose to raise issues comments, we made revisions to clarify of Complete EHRs and EHR Modules. that are beyond the scope of our that an ONC–ATCB must retain all Guide 65 also requires ONC–ATCBs to proposals. We do not summarize or records related to tests and certifications make their services accessible to all respond to those comments in this final according to ISO Guide 65 and ISO applicants whose activities fall within rule. However, we will review the 17025 for the duration of the temporary its declared field of operation (i.e., the comments and consider whether other certification program and provide temporary certification program), actions may be necessary, such as copies of the final results of all including not having any undue addressing the comments in the completed tests and certifications to financial or other conditions. As noted permanent certification program’s ONC at the conclusion of testing and throughout this rule, an ONC–ATCB rulemaking or clarifying program certification activities under the must be in compliance with Guide 65 to operating procedures, based on the temporary certification program. remain in good standing under the information or suggestions in the • In § 170.423(j), we made revisions temporary certification program. comments. to clarify that an ONC–ATCB will only

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be responsible for issuing refunds in certified solely to the applicable evidence indicating that the ONC–ATCB situations where the ONC–ATCB’s certification criteria adopted by the has committed a Type-1 or Type-2 conduct caused testing and certification Secretary at subpart C of this part. We violation and that the continued testing to be suspended and a request for also added another new provision, and certification of Complete EHRs and/ testing and certification is withdrawn, designated as paragraph (c), that or EHR Modules by the ONC–ATCB and in instances where the ONC– requires an ONC–ATCB to accept could have an adverse impact on patient ATCB’s conduct caused the testing and requests for an updated version of a health or safety. An ONC–ATCB will certification not to be completed or previously certified Complete EHR to have 3 days to respond to a notice of necessitated the recertification of inherit the previously certified proposed suspension by explaining in Complete EHRs or EHR Modules it had Complete EHR issued certification writing why its operations should not be previously certified. without being retested and recertified. suspended. The National Coordinator • In § 170.430(a)(2), to provide clarity • In § 170.450, we removed proposed will be permitted up to 5 days to review in response to public comments, we paragraphs (b) and (d) because they are the response and issue a determination have stated that the National redundant of other regulatory to the ONC–ATCB. The National Coordinator will review each part of the requirements within this subpart. We Coordinator will make a determination application ‘‘in its entirety.’’ then added a new provision, designated to either rescind the proposed • In § 170.430(b)(1), we have removed as paragraph (b), which states that an suspension, suspend the ONC–ATCB the terms ‘‘inadvertent’’ and ‘‘minor’’ in ONC–ATCB must provide the option for until it has adequately corrected a Type- response to public comment. an EHR Module or a bundle of EHR 2 violation, or propose revocation in • In § 170.430(c), to respond to public Modules to be tested and certified solely accordance with § 170.465(c) and comments, we have revised paragraph to the applicable certification criteria suspend the ONC–ATCB’s operations (c)(1) to allow an applicant for ONC– adopted by the Secretary at subpart C of for the duration of the revocation ATCB status to request an extension of this part. We also added another new process. The National Coordinator may the 15-day period provided to submit a provision, designated as paragraph (d), also make any one of the above revised application in response to a that requires an ONC–ATCB to accept determinations if an ONC–ATCB fails to deficiency notice. We have revised requests for an updated version of a submit a timely response to a notice of paragraph (c)(2) to state that the previously certified EHR Module or proposed suspension. A suspension will National Coordinator can grant an bundle of EHR Modules to inherit the become effective upon an ONC–ATCB’s applicant’s request for an extension of previously certified EHR Module or receipt of a notice of suspension. the 15-day period based on a finding of bundle of EHR Modules issued • In § 170.465(c)(1) we revised the good cause. We have also revised certification without being retested and provision to state that ‘‘[t]he National paragraph (c)(3) to permit the National recertified. Coordinator may propose to revoke an Coordinator to request clarification of • In § 170.450(c), we revised the ONC–ATCB’s status if the National statements and the correction of errors paragraph to state that EHR Modules Coordinator has reliable evidence that or omissions in a revised application shall be tested and certified to all the ONC–ATCB committed a Type-1 during the 15-day period that the privacy and security certification violation.’’ The term ‘‘reliable’’ was National Coordinator has to review a criteria adopted by the Secretary unless inadvertently left out of the Proposed revised application. the EHR Module(s) is/are presented for Rule. • In § 170.440(b), to respond to public testing and certification in one of the • In § 170.490, we revised the section comments, we have revised the following manners: (1) The EHR to state that the temporary certification paragraph to state, in relevant part, Module(s) is/are presented for testing program will sunset on December 31, ‘‘Each ONC–ATCB must prominently and certification as a pre-coordinated, 2011, or if the permanent certification and unambiguously identify the scope integrated bundle of EHR Modules, program is not fully constituted at that of its authorization on its Web site, and which would otherwise meet the time, then upon a subsequent date that in all marketing and communications definition of and constitute a Complete is determined to be appropriate by the statements (written and oral) pertaining EHR (as defined in 45 CFR 170.102), National Coordinator. We clarified that to its activities under the temporary and one or more of the constituent EHR ONC–ATCBs will be prohibited from certification program.’’ Modules is/are demonstrably accepting new requests to test and • In § 170.445(a), we revised the responsible for providing all of the certify Complete EHRs or EHR Modules paragraph to state that ‘‘An ONC–ATCB privacy and security capabilities for the ‘‘on and after the temporary certification must test and certify Complete EHRs to entire bundle of EHR Module(s); or (2) program sunset date.’’ We also revised all applicable certification criteria An EHR Module is presented for testing the section to state that ONC–ATCBs are adopted by the Secretary at subpart C of and certification, and the presenter can permitted up to six months after the this part.’’ This revision addresses demonstrate and provide sunset date to complete all testing and public comments and ensures consistent documentation to the ONC–ATCB that a certification activities associated with requirements for ONC–ATCBs with privacy and security certification requests for testing and certification of regard to testing and certification criterion is inapplicable or that it would Complete EHRs and/or EHR Modules requirements for Complete EHRs and be technically infeasible for the EHR received prior to the sunset date. EHR Modules. An ONC–ATCB must not Module to be tested and certified in • We added § 170.499 to incorporate just be capable of conducting the accordance with such certification by reference ISO/IEC Guide 65:1996 and applicable testing and certification, but criterion. ISO/IEC 17025:2005. they are required to perform the • In § 170.457, we revised the section appropriate testing and certification. to require that an ONC–ATCB provide V. Technical Correction to § 170.100 • In § 170.445, we re-designated remote testing and certification for both We are making a technical correction paragraph (b) as paragraph (d). We then development and deployment sites. to § 170.100. We inadvertently left out a added a new provision, designated as • In § 170.465, we revised the section citation to section 3001(c)(5) of the paragraph (b), which states that an to provide the National Coordinator PHSA, which provides the statutory ONC–ATCB must provide the option for with the discretion to suspend an ONC– basis for the National Coordinator to a Complete EHR to be tested and ATCB’s operations if there is reliable establish certification program(s) for

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HIT. We have revised § 170.100 to prior to the proposed beginning of A. Collection of Information: include reference to this statutory meaningful use Stage 1 in 2011. Application for ONC–ATCB Status authority. Several commenters voiced their Under the Temporary Certification Program VI. Waiver of the 30-Day Delay in the strong concern that the temporary Effective Date certification program needs to be Section 170.420 requires an applicant established immediately so as to enable for ONC–ATCB status to submit to the We ordinarily provide a 30-day delay organizations to apply and be National Coordinator a completed in the effective date of a final rule as authorized to serve as ONC–ATCBs, to application. The application consists of required by section 553(d) of the enable Complete EHR and EHR Module two parts. Part 1 requires an applicant Administrative Procedure Act (APA). 5 to submit general identifying U.S.C. § 553(d). However, we can waive developers to have their Complete EHRs information, complete self audits to the 30-day delay in the effective date if and/or EHR Modules certified, and to Guide 65 and ISO 17025, and agree to the Secretary finds, for good cause, that enable eligible professionals and eligible adhere to the Principles of Proper the delay is impracticable, unnecessary, hospitals to obtain and implement Conduct for ONC–ATCBs. Part 2 or contrary to the public interest, and Certified EHR Technology that will requires an applicant to complete a includes a statement of the finding and support their achievement of proficiency examination. The the reasons in the rule issued. The meaningful use. These commenters proficiency examination is not, Secretary finds that good cause exists to encouraged us to take immediate steps however, considered ‘‘information’’ for waive the 30-day delay in the effective to issue this final rule and to permit PRA collection purposes because it falls date of this final rule. A delayed organizations to apply for ONC–ATCB under the exception to the definition of effective date would be contrary to the status. These commenters explained information at 5 CFR 1320.3(h)(7). We public interest because it would restrict that it is necessary to have ONC–ATCBs estimated in the Proposed Rule that the ability of eligible professionals and in place as soon as possible in order for there would be no more than 3 eligible hospitals to adopt and them to be positioned and prepared to applicants for ONC–ATCB status. We implement Certified EHR Technology. test and certify Complete EHRs and EHR also assumed that these applicants Modules in a timely manner. As previously discussed, the HITECH would be familiar with the relevant Act provides incentive payments For the reasons stated above, we requirements found in Guide 65 and beginning in 2011 under the Medicare believe that a delayed effective date for ISO 17025 and would have a majority, and Medicaid programs for eligible this final rule would be contrary to the if not all, of the documentation professionals and eligible hospitals that public interest. Therefore, we find there requested in the application already demonstrate meaningful use of Certified is good cause to waive the 30-day delay developed and available before applying EHR Technology. The rules in the effective date of this final rule. for ONC–ATCB status. Therefore, with promulgated by ONC and CMS establish the exception of completing a VII. Collection of Information the regulatory framework through which proficiency examination, we concluded eligible professionals and eligible Requirements that an applicant would only spend hospitals may seek to qualify for those In accordance with section 3507(j) of time collecting and assembling already incentive payments. The Medicare and developed information to submit with Medicaid EHR Incentive Programs the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., the their application. Based on these proposed rule would establish assumptions, we estimated that it would meaningful use Stage 1 beginning in information collection included in this final rule has been submitted for take approximately: 2011. The HIT Standards and • Certification Criteria interim final rule emergency approval to OMB. 10 minutes for an applicant to provide the general identifying adopted certification criteria that The two information collections directly support the proposed information requested in the specified under sections A and B below application; meaningful use Stage 1 objectives. This were previously published in the • 2 hours to complete the Guide 65 final rule establishes a temporary Federal Register as part of the Proposed certification program that will allow self audit and assemble associated Rule and HHS invited interested documentation; Complete EHRs and EHR Modules to be persons to submit comments on any • 2 hours to complete the ISO 17025 tested and certified to the adopted aspect of each of the two information certification criteria. self audit and assemble associated collections, including the following: (1) documentation; and As a result, Certified EHR Technology Necessity and utility of the information • 20 minutes to review and agree to will not be available to eligible collection; (2) the accuracy of the the ‘‘Principles of Proper Conduct for professionals and eligible hospitals until estimate of the burden; (3) ways to ONC–ATCBs.’’ the temporary certification program enhance the quality, utility, and clarity begins. Eligible professionals and of the information to be collected; and Comments. One commenter expressed eligible hospitals will need time to a concern that we had underestimated (4) ways to minimize the burden of select, adopt, and implement Certified the potential burden hours associated collection without reducing the quality EHR Technology before they attempt to with applying for the temporary of the collected information. demonstrate meaningful use in 2011. In certification program. The commenter addition, before testing and certification The final rule contains one new cited that while they had significant can begin, ONC must review and deem information collection requirement familiarity with testing and certification, satisfactory applications that are pertaining to records retention and their organization was not totally submitted by organizations that seek disclosure to ONC that was conformant to both Guide 65 and ISO ONC–ATCB status. A delayed effective inadvertently left out of the Proposed 17025. The commenter stated that it had date for this final rule would delay the Rule, but included in the emergency taken 120 hours to perform a gap process for making Certified EHR request to OMB. Please refer to section analysis and that it would take Technology available to eligible C below for this new information approximately another several hundred professionals and eligible hospitals collection. more hours to properly conform to our

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proposed requirements in order to be status (‘‘partially conformant estimated that the remaining time it may ready to apply for ONC–ATCB status. applicants’’) may need to perform more take a potential applicant to become Response. We agree with this upfront work than other potential conformant with both Guide 65 and ISO commenter. As noted, we previously applicants. As a result, we have revised 17025 would be a maximum of 280 assumed and based on that assumption, our estimates below to account for the hours. Thus, in order to be ready to estimated that applicants for ONC– fact that, at most, two potential apply for ONC–ATCB status, we believe ATCB status would already be applicants may need to perform more that it will take approximately a conformant with Guide 65 and ISO upfront work to prepare to apply for maximum of 400 hours for a potential 17025 and would have ‘‘in hand’’ the ONC–ATCB status and to account for applicant to become conformant with documentation we requested copies of the fact that we now anticipate that Guide 65 and ISO 17025 and have as part of the ONC–ATCB application there may be up to five applicants for equally distributed the burden among (‘‘conformant applicants’’). Given this ONC–ATCB status. commenter’s analysis, we believe that it In consultation with NIST, we believe these two requirements. Our revised is reasonable to expect that one or two that the 120 hours to perform a gap analysis is expressed in the table below. potential applicants for ONC–ATCB analysis is reasonable and have

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Burden hours Type of respondent Form name Number responses per per Total burden of respondents respondent response hours

Conformant Applicant ...... ONC–ATCB Application ...... 3 1 4.5 13.5 Partially Conformant Applicant ...... ONC–ATCB Application ...... 2 1 400.5 801

Total ...... 814.5

B. Collection of Information: ONC– measures to which a Complete EHR or so, we have maintained our prior ATCB Collection and Reporting of EHR Module has been tested and assumptions. For the purposes of Information Related to Complete EHR certified and, where applicable, any estimating the potential burden, we and/or EHR Module Certifications additional software a Complete EHR or assume that all of the estimated EHR Module relied upon to demonstrate applicants will apply and become ONC– Section 170.423(h) requires an ONC– its compliance with a certification ATCB to provide ONC, no less ATCBs. We also assume that ONC– criterion or criteria adopted by the ATCBs will report weekly (i.e., frequently than weekly, a current list of Secretary). ONC–ATCBs will be Complete EHRs and/or EHR Modules respondents will respond 52 times per capturing these additional reporting year). Finally, we assume that the that have been tested and certified as elements in conjunction with the other information collections will be well as certain minimum information information we request that they report accomplished through electronic data about each certified Complete EHR and/ on a weekly basis. Consequently, we do or EHR Module. not believe that the reporting of these collection and storage, which will be We did not receive any comments on two additional elements will increase part of the normal course of business for this collection of information. We have, the reporting burden for ONC–ATCBs. ONC–ATCBs. Therefore, with respect to however, specified in this final rule two Based on our new estimate that there this proposed collection of information, additional reporting elements that must may be up to 5 applicants that apply for the estimated burden is limited to the be submitted by ONC–ATCBs on a ONC–ATCB status, we have revised our actual electronic reporting of the weekly basis (i.e., clinical quality overall annual burden estimate. In doing information to ONC.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Average Type of respondent Number of responses per burden hours Total burden respondents respondent per response hours

ONC–ATCB Testing and Certification Results ...... 5 52 1 260

C. Collection of Information: ONC– under the temporary certification final results of all completed tests and ATCB Retention of Testing and program. certifications. Certification Records and the We do not believe that there are any For the purposes of estimating the Submission of Copies of Records to ONC specific recordkeeping burdens potential burden, we assume that all of Section 170.423(i) requires ONC– associated with this requirement. Based the estimated number of applicants for ATCBs to retain all records related to on our consultations with NIST, we the temporary certification program (i.e., tests and certifications according to understand that it is standard industry five) will become ONC–ATCBs. For Guide 65 and ISO 17025 for the practice to retain records related to calculation purposes, we also assume duration of the temporary certification testing and certification. Therefore, we that each ONC–ATCB will incur the program and provide copies of the final believe that the only burden attributable same burden. We assume that on results of all completed tests and to our requirement is associated with average each ONC–ATCB will test and certifications to ONC at the conclusion the submission of copies to ONC of the certify an equal amount of ONC’s of testing and certification activities estimate of the maximum amount of

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Complete EHRs and EHR Modules that ONC–ATCBs to be approximately 205. effort in organizing, categorizing and will be tested and certified under the Finally, we assume that an ONC–ATCB submitting the requested information. temporary certification program as will submit copies of the final results of We estimate that this amount of time specified in the regulatory impact all completed tests and certifications to will be approximately 8 hours for each analysis of this final rule. We estimate ONC by either electronic transmission ONC–ATCB. Our estimates are the equal amount of Complete EHRs or paper submission. In either instance, expressed in the table below. and/or EHR Modules that will be tested we believe that an ONC–ATCB will and certified by each of the 5 estimated spend a similar amount of time and

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Average Type of respondent Number of responses per burden hours Total burden respondents respondent per response hours

ONC–ATCB Testing and Certification Records ...... 5 1 8 40

VIII. Regulatory Impact Analysis programs for the voluntary certification could base revisions. Conversely, we of HIT. This final rule is needed to believe that commenters who expressed A. Introduction outline the processes by which the concerns about the potential costs, We have examined the impacts of this National Coordinator would exercise largely did so from the perspective of final rule as required by Executive this authority to authorize certain stating a request that we ensure the Order 12866 on Regulatory Planning organizations to test and certify costs for testing and certification were and Review (September 30, 1993, as Complete EHRs and/or EHR Modules. not prohibitively high. further amended), the Regulatory Once certified, Complete EHRs and EHR While we understand these Flexibility Act (RFA) (5 U.S.C. 601 et Modules will be able to be used by commenters’ perspectives, we do not seq.), section 202 of the Unfunded eligible professionals and eligible believe that it is appropriate to dictate Mandates Reform Act of 1995 (2 U.S.C. hospitals as, or be combined to create, the minimum or maximum amount an 1532), Executive Order 13132 on Certified EHR Technology. Eligible ONC–ATCB should be able to charge for Federalism (August 4, 1999), and the professionals and eligible hospitals who testing and certifying a Complete EHR Congressional Review Act (5 U.S.C. seek to qualify for incentive payments or EHR Module. However, as evidenced 804(2)). under the Medicare and Medicaid EHR by the increase in our estimate of the Executive Order 12866 directs Incentive Programs are required by number of ONC–ATCB applicants under statute to use Certified EHR Technology. agencies to assess all costs and benefits the temporary certification program, it is of available regulatory alternatives and, C. Executive Order 12866—Regulatory our hope that multiple ONC–ATCBs if regulation is necessary, to select Planning and Review Analysis will be authorized and will compete for regulatory approaches that maximize market share. As a result of expected 1. Comment and Response net benefits (including potential increased competition among ONC– economic, environmental, public health Comments. A few commenters ATCBs, we believe there could also be and safety effects, distributive impacts, expressed concerns that the costs we increased downward pressure on the and equity). A regulatory impact attributed in the Proposed Rule related costs associated with testing and analysis (RIA) must be prepared for to the testing and certification of certification. If that cost pressure occurs, major rules with economically Complete EHRs and EHR Modules were we believe that the upper ranges of the significant effects ($100 million or more too high, unrealistic, and unreliable. cost estimates we provide in this final in any one year). Based on the analysis One commenter requested that we rule could be overestimates. of costs and benefits that follows, we remove our cost estimates because they have determined that this final rule believed they were based on a Comments. Some commenters covering the temporary certification monopolistic pricing structure. Other questioned our estimates related to the program is not an economically commenters indicated that we should number of EHR Modules we expected to significant rule because we estimate that regulate the pricing related to testing be tested and certified. One commenter the overall costs and benefits associated and certification in order to ensure that suggested that the number of self- with the temporary certification prices were not exorbitant and did not developed EHR Modules should be program, including the costs associated preclude smaller Complete EHR and much higher than we estimated. Other with the testing and certification of EHR Module developers from being able commenters expressed that this rule Complete EHRs and EHR Modules, to be to attain certification for their product. needed to account for other costs less than $100 million per year. Response. We understand the associated with testing and certification Nevertheless, because of the public commenters’ concerns; however, we (e.g., reprogramming a Complete EHR or interest in this final rule, we have have a responsibility to put forth a good EHR Module) and not just the costs prepared an RIA that to the best of our faith effort to estimate the potential associated with the application process ability presents the costs and benefits of costs associated with this final rule. Part and for Complete EHRs and EHR the final rule. of that effort includes using the best Modules to be tested and certified. available data to inform our Response. This final rule is one of B. Why is this rule needed? assumptions and estimates. While we three coordinated rulemakings. Each of As stated in earlier sections of this were open to revising our cost estimates these rulemakings accounts for its final rule, section 3001(c)(5) of the in response to public comment, in no specific effects. In the HIT Standards PHSA provides the National instance did a commenter provide and Certification Criteria interim final Coordinator with the authority to alternative estimates or reference rule (75 FR 2038), we summarized these establish a certification program or additional information from which we effects as follows:

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While there is no bright line that divides and safety, and other advantages; for ONC–ATCB status. Therefore, with the effects of this interim final rule and the distributive impacts; and equity). the exception of completing a other two noted above, we believe that each Executive Order 12866 classifies a proficiency examination, we believe analysis properly focuses on the direct effects regulation as significant if it meets any ‘‘conformant applicants’’ will only spend of the provisions it creates. This interim final one of a number of specified conditions, time collecting and assembling already rule estimates the costs commercial vendors, open source developers, and relevant Federal including having an annual effect on the developed information to submit with agencies will incur to prepare Complete economy of $100 million, or in a their application. Conversely, we EHRs and EHR Modules to be tested and material way adversely affecting the believe that there will be up to two certified to adopted standards, economy, a sector of the economy, ‘‘partially conformant applicants’’ and implementation specifications, and competition, or jobs. While this rule is that these applicants will spend certification criteria. The Medicare and therefore not ‘‘economically significant,’’ significantly more time establishing Medicaid EHR Incentive Programs proposed as defined by Executive Order 12866, their compliance with Guide 65 and ISO rule estimates the impacts related to the OMB has determined that this rule 17025. Based on our assumptions, actions taken by eligible professionals or constitutes a ‘‘significant regulatory review of comments, and consultations eligible hospitals to become meaningful action’’ as defined by Executive Order with NIST, we anticipate that it will users, including purchasing or self- developing Complete EHRs or EHR Modules. 12866 because it raises novel legal and take a ‘‘conformant applicant’’ The HIT Certification Programs proposed policy issues. approximately 28.5 hours and a ‘‘partially conformant applicant’’ rule estimates the testing and certification a. Temporary Certification Program approximately 424.5 hours to complete costs for Complete EHRs and EHR Modules. Estimated Costs the application and submit the As result, we estimate in this final i . Application Process for ONC–ATCB requested documentation. Our estimates rule, as we had before, the effects of the Status include the time discussed above in our application process for ONC–ATCB collection of information section and status and the costs for Complete EHRs Applicant Costs approximately up to 24 hours for all and EHR Modules to be tested and As discussed under the collection of applicants to complete the proficiency certified by ONC–ATCBs. With respect information section, we have increased examination—8 hours (1 full work day) to EHR Modules, especially self- our estimate of the number of applicants to complete section 1 (demonstration of developed EHR Modules, we agree with we expect will apply for ONC–ATCB technical expertise related to Complete those commenters regarding our status. In the Proposed Rule, we stated EHRs and/or EHR Modules); 6 hours to estimates and have provided revised that we anticipated that there would be complete section 2 (demonstration of estimates that factor in a potential larger no more than 3 applicants for ONC– test tool identification); and 10 hours to number of self-developed EHR Modules. ATCB status. Based on the comments complete section 3 (demonstration of While neither commenter who offered received, we now believe that there may proper use of test tools and this concern related to EHR Modules be up to 5 applicants for ONC–ATCB understanding of test results). Moreover, provided any data to substantiate their status. In addition, we believe that up to after consulting with NIST we assume claims, we determined that this revision 2 of these applicants will not have the that: was necessary because we had level of preparedness that we originally • An employee equivalent to the previously grouped self-developed estimated for all potential applicants for Federal Salary Classification of GS–9 Complete EHRs and EHR Modules ONC–ATCB status. Step 1 could provide the general together. Upon further review and other As part of the temporary certification information requested in the application comments addressed above regarding program, an applicant will be required and accomplish the paperwork duties EHR Modules, we believe that in order to submit an application and complete associated with the application; to provide a more accurate estimate, a proficiency exam. We do not believe • An employee equivalent to the self-developed Complete EHRs and EHR that there will be an appreciable Federal Salary Classification of GS–15 Modules should be separately difference in the time commitment an Step 1 would be responsible for accounted for. We believe our prior applicant for ONC–ATCB status will conducting the self audits and agreeing estimates related to self-developed have to make based on the type of to the ‘‘Principles of Proper Conduct for Complete EHRs and EHR Modules are authorization it seeks (i.e., we believe ONC–ATCBs’’; and more appropriately attributable to the the application process and time • An employee or employees number of self-developed Complete commitment will be the same for equivalent to the Federal Salary EHRs. Accordingly, we have developed applicants seeking authorization to Classification of GS–15 Step 1 would be new estimates (captured in the conduct the testing and certification of responsible for completing the discussion and tables below) for the either Complete EHRs or EHR Modules). proficiency examination. number of self-developed EHR Modules We do, however, believe that there will We have taken these employee that we believe will be presented for be a distinction between applicants assumptions and utilized the testing and certification. based on their level of preparedness. For corresponding employee hourly rates for the purposes of estimating applicant the locality pay area of Washington, 2. Executive Order 12866 Final Analysis costs, we have divided applicants into D.C. as published by the U.S. Office of As required by Executive Order two categories, ‘‘conformant applicants’’ Personnel Management (OPM), to 12866, we have examined the economic and ‘‘partially conformant applicants.’’ calculate our cost estimates. We have implications of this rule as it relates to We still believe, after reviewing also calculated the costs of an the temporary certification program. comments, that there will be three employee’s benefits while completing Executive Order 12866 directs agencies ‘‘conformant applicants’’ and that these the application. We have calculated to assess all costs and benefits of applicants will have reviewed the these costs by assuming that an available regulatory alternatives and, relevant requirements found in the ISO/ applicant expends thirty-six percent when regulation is necessary, to select IEC standards and will have a majority, (36%) of an employee’s hourly wage on regulatory approaches that maximize if not all, of the documentation benefits for the employee. We have net benefits (including potential requested in the application already concluded that a 36% expenditure on economic, environmental, public health developed and available before applying benefits is an appropriate estimate

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because it is the routine percentage used calculations are expressed in Tables 1 by HHS for contract cost estimates. Our and 2 below.

TABLE 1—TEMPORARY CERTIFICATION PROGRAM: COST TO APPLICANTS TO APPLY TO BECOME AN ONC–ATCB

Burden hours Cost per applicant Employee Cost of Application requirement Employee Partially hourly wage employee Partially equivalent Conformant conformant rate benefits Conformant conformant applicant applicant per hour applicant applicant

General Identifying In- GS–9 Step 1 .. 10/60 10/60 $22.39 $8.06 $5.07 $5.07 formation. Self Audits and Docu- GS–15 Step 1 4 400 59.30 21.35 322.60 32,260.00 mentation. Principles of Proper GS–15 Step 1 20/60 20/60 59.30 21.35 26.89 26.89 Conduct. Proficiency Examina- GS–15 Step 1 24 24 59.30 21.35 1,935.60 1,935.60 tion.

Total Cost Per Ap- ...... $2,290.16 $34,227.56 plication.

TABLE 2—TEMPORARY CERTIFICATION PROGRAM: TOTAL APPLICANT COST

Anticipated Cost of Type of applicant number of application per Total cost applicants applicant ($) estimate ($)

Conformant Applicant ...... 3 $2,290.16 $6,870.48 Partially Conformant Applicant ...... 2 34,227.56 68,455.12

Total Cost of Application Process ...... 75,325.60

We based our cost estimates on the We also anticipate that there will be As previously noted, we will also post amount of applicants that we believe costs associated with reviewing the names of applicants granted ONC– will apply over the life of the temporary applications under the temporary ATCB status on our Web site. We certification program. We assume that certification program. We expect that a believe that there will be minimal cost all applicants will apply during the first GS–15 Step 1 employee will review the associated with this action and have year of the program and thus all applications and the National calculated the potential cost to be application costs should be attributed to Coordinator (or designated approximately $260 on an annual basis the first year of the program. However, representative) will issue final decisions for posting and maintaining the based on our projection that the on all applications. We anticipate that it information on our Web site (a temporary certification program will last will take approximately 40 hours to maximum of 5 hours of work for a approximately two years and that one or review and reach a final decision on Federal Salary Classification GS–12 two applicants may choose to apply in each application. This estimate assumes Step 1 employee located in Washington, the second year, the annualized cost of a satisfactory application (i.e., no formal DC). the application process will be $37,663. deficiency notifications) and includes ii. Testing and Certification of Complete the time necessary to verify the Costs to the Federal Government EHRs and EHR Modules information in each application, assess We have estimated the cost to develop the results of the proficiency Section 3001(c)(5)(A) of the PHSA the ONC–ATCB application, including examination, and prepare a briefing for indicates that certification is a voluntary the development and administration of the National Coordinator. We estimate act; however, due to the fact that the the proficiency examination to be the cost for the application review Medicare and Medicaid EHR Incentive $34,618 based on the 495 hours we process, which we anticipate will Programs require eligible professionals believe it will take to develop the include the review of 5 applications, to and eligible hospitals to use Certified application, prepare standard operating be $16,900. EHR Technology in order to qualify for procedures as well as create the As a result, we estimate the Federal incentive payments, we anticipate that a requisite pools of questions for the government’s overall cost of significant portion of Complete EHR and proficiency examinations. More administering the entire application EHR Module developers will seek to specifically, we believe it will take 360 process, for the length of the temporary have their HIT tested and certified. hours of work of a Federal Salary certification program, at approximately In Tables 3 through 8 below, we Classification GS–14 Step 1 employee $51,518. Based on our projection that estimate the costs for Complete EHRs located in Washington, DC to develop the temporary certification program will and EHR Modules to be tested and the proficiency examination, 80 hours of last approximately two years and that certified under the temporary work by the same employee to develop one or two applicants may choose to certification program. As discussed in the standard operation procedures and apply in the second year, the annualized the HIT Standards and Certification the actual application, and 55 hours to cost to the Federal government for Criteria interim final rule, and to remain score all the exams and handle related administering the entire application consistent with our previous estimates administrative tasks. process will be $25,759. (75 FR 2039), we believe that

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approximately 93 commercial/open estimate by providing low and high or ‘‘level 2.’’ As a result, we estimate that source Complete EHRs and 50 EHR probability assumptions (10% and 70%, approximately 10% of these large Modules will be tested and certified respectively) to represent the likelihood eligible hospitals have a self-developed under our proposed temporary that any one of these large practices Complete EHR and would seek to have certification program. In addition to possess a self-developed EHR Module it tested and certified. We believe that these costs, we also take into account that they would seek to have tested and this estimate is generous and that a good what we believe will be the costs certified. Given that no commenter portion of the eligible professionals and incurred by a percentage of eligible provided data to further support this eligible hospitals who would likely seek professionals and eligible hospitals who estimate, we believe that our maximum to qualify for incentive payments with themselves will incur the costs number of self-developed EHR Modules self-developed Complete EHRs would associated with the testing and estimate is generous. While we do not only do so for meaningful use Stage 1. certification of their self-developed dispute that practice sizes smaller than After meaningful use Stage 1 we Complete EHR or EHR Module(s). 50 could also possess self-developed anticipate that the number of eligible With respect to the potential for EHR Modules, we believe those smaller professionals and eligible hospitals who eligible professionals to seek testing and practices will be the exception, not the would incur the costs of testing and certification for a self-developed rule, and that separately calculating a certification themselves will go down Complete EHR, DesRoches found that total for these smaller practices would because the effort involved to maintain only 5% of physicians are in large produce a negligible amount of EHR a Complete EHR may be time and cost practices of over 50 doctors.3 Of these Modules to add to our overall range. prohibitive as the Secretary continues to large practices, 17% use an ‘‘advanced With respect to eligible hospitals, adopt additional certification criteria to EHR system’’ that could potentially be similar to eligible professionals, we support future stages of meaningful use. tested and certified if it were self- believe that only large eligible hospitals With respect to self-developed EHR developed (we assume that smaller would have the IT staff and resources Modules, we believe the probability physician practices do not have the available to possess a self-developed varies across different types of eligible resources to self-develop a Complete Complete EHR that they would seek to hospitals (CAHs, Small/Medium, and EHR). We are unaware of any reliable have tested and certified. Again, we are Large) regarding their IT staff resources data on the number of large practices unaware of any reliable data on the and ability to self-develop EHR who may have a self-developed number of eligible hospitals who may Modules. For each hospital type Complete EHR for which they would have a self-developed Complete EHR for (identified in Table 38) we provide an seek to be tested and certified. As a which they would seek to be tested and estimate of the average number of self- result, we offer the following estimate certified. Further, we believe that with developed EHR Modules we believe based on currently available data. We respect to EHR Modules the probability each type of eligible hospital would believe that the total number of eligible varies across different types of eligible seek to have tested and certified. Again, professionals in large practices who hospitals regarding their IT staff we believe that our high average number both possess an IT staff with the resources and ability to self-develop an of self-developed EHR Modules is resources to develop and support a EHR Module and seek to have it tested generous. Complete EHR and would seek to have and certified. As a result, we offer the Due to the fact that an ONC–ATCB such a self-developed Complete EHR following estimates based on currently will be responsible for testing and tested and certified will be low—no available data. We have based our certifying Complete EHRs and/or EHR more than 10%. By taking CMS’s calculations on the Medicare eligible Modules, we have combined the costs estimate in its proposed rule of hospital table CMS provided in its for testing and certification because we approximately 450,000 eligible proposed rule (Table 38) (75 FR 1980) believe they would be difficult to professionals (75 FR 1960) we multiply which conveys hospital IT capabilities independently estimate. Our cost range through by the numbers above (450,000 according to three levels of adoption by for the testing and certification of × .05 × .17 × .10) and then divide by a hospital size according to the 2007 AHA Complete EHRs and EHR Modules practice size of at least 50 which yields annual survey. These three levels includes consideration of how the testing and certification will be approximately 8 self-developed included: (1) Hospitals which had conducted (i.e., by remote testing and Complete EHRs designed for an already implemented relatively certification, on-site testing and ambulatory setting that could be advanced systems that included CPOE certification, or at the ONC–ATCB and submitted for testing and certification. systems for medications; (2) hospitals for the complexity of an EHR Module). Additionally, we believe that a which had implemented more basic systems through which lab results could On July 14, 2009, CCHIT testified in reasonable estimate for the number of front of the HIT Policy Committee on large practices with the IT staff and be shared, but not CPOE for medications; and (3) hospitals starting the topic of EHR certification, including resources to self-develop an EHR from a base level either CPOE or lab the certification of EHR Modules. Module and that would seek to have reporting. CMS indicated that CPOE for CCHIT estimated that ‘‘EHR- such an EHR Module tested and medication standard was chosen comprehensive’’ according to CCHIT certified can also be derived from the because expert input indicated that the certification criteria would have testing calculation above but with a few CPOE standard in the proposed and certification costs that would range differences. We start with the total meaningful use definition will be the from approximately $30,000 to $50,000. number of large practices from the ∼ hardest one for hospitals to meet. CCHIT also estimated that the testing calculation above ( 77). We then As stated above, we believe that only and certification of EHR Modules would assume an average number (1.1) of self- large hospitals (defined in Table 38 as range from approximately $5,000 to developed EHR Modules for this group those with 400+ beds) would have the $35,000 depending on the scope of the of large practices and further refine this IT staff and resources to develop, testing and certification. We believe that support, and seek the testing and these estimates provide a reasonable 3 DesRoches, CM et al. Electronic Health Records in Ambulatory Care—A National Survey of certification of a self-developed foundation and have used them for our Physicians, New England Journal of Medicine July Complete EHR. CMS indicated that 331 cost estimates. However, we assume that 2008; 359:50–60. large hospitals had met either ‘‘level 1’’ competition in the testing and

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certification market will reduce the • Commercial/Open Source Complete • Number of Self-developed EHR costs of testing and certification as EHRs and EHR Modules—Table 3; Modules by type of eligible hospital— estimated by CCHIT but we are unable • Self-developed Complete EHRs— Table 6; and to provide a reliable estimate at this Table 4; • Total costs associated with self- time of what the potential reduction in • developed EHR Modules—Table 7. costs might be. The following tables Number of Self-developed EHR represent our cost estimates for the Modules by eligible professionals in preceding discussion and include: large practices—Table 5;

TABLE 3—TEMPORARY CERTIFICATION PROGRAM: ESTIMATED COSTS FOR TESTING & CERTIFICATION OF COMMERCIAL/ OPEN SOURCE COMPLETE EHRS AND EHR MODULES

Number Cost per complete EHR/EHR module Total cost for all complete EHRs/EHR Type tested and ($M) modules over 3-year period ($M) certified Low High Mid-point Low High Mid-point

Complete EHR ...... 93 $0.03 $0 .05 $0.04 $2.79 $4.65 $3.72 EHR Module ...... 50 0.005 0 .035 0.02 0.25 1.75 1 .0

Total ...... 143 ...... 3.04 6.4 4 .72

TABLE 4—TEMPORARY CERTIFICATION PROGRAM: ESTIMATED COSTS FOR TESTING & CERTIFICATION OF SELF- DEVELOPED COMPLETE EHRS

Number Cost per complete EHR Total cost for all complete EHRs over 3- Type tested and ($M) year period ($M) certified Low High Mid-point Low High Mid-point

Self Developed Complete EHRs Am- bulatory Setting ...... 8 $0.03 $0.05 $0.04 $0 .24 $0.4 $0 .32 Self-Developed Complete EHRs Inpa- tient Setting ...... 30 0.03 0.05 0.04 0.9 1.5 1.2

Total ...... 38 ...... 1.14 1.9 1.52

In Table 5 below, we provide our practices of eligible professionals could estimate for the number of potential seek to have tested and certified. self-developed EHR Modules large

TABLE 5—TEMPORARY CERTIFICATION PROGRAM: ESTIMATED NUMBER OF SELF-DEVELOPED EHR MODULES DESIGNED FOR AN AMBULATORY SETTING BY ELIGIBLE PROFESSIONALS IN LARGE PRACTICES

Average Number of % with EHR % with EHR number of Min number Max number Eligible professional practice type large module module EHR mod- of EHR EHR practices (low) (high) ules, if any modules modules

Large ...... 77 10 70 1.25 10 67

In Table 6 below, we provide our hospital type that eligible hospitals estimate for the number of potential could seek to have tested and certified. self-developed EHR Modules varied by

TABLE 6—TEMPORARY CERTIFICATION PROGRAM: ESTIMATED NUMBER OF SELF-DEVELOPED EHR MODULES DESIGNED FOR AN INPATIENT SETTING STRATIFIED BY TYPE OF ELIGIBLE HOSPITAL

Average Number of % with EHR % with EHR number of Min number Max number Type of eligible hospital EHs module module EHR mod- of EHR EHR (low) (high) ules, if any modules modules

CAH ...... 518 1 10 1.1 6 57 S/M ...... 1951 5 15 1.5 146 439 Large ...... 331 25 70 2.0 166 463

Total ...... 2800 ...... 318 959

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In Table 7 below, we provide our certification costs associated with the self-developed EHR Modules from Table estimate for the total testing and minimum and maximum number of 5 and Table 6.

TABLE 7—TEMPORARY CERTIFICATION PROGRAM: ESTIMATED COSTS FOR TESTING & CERTIFICATION OF ALL SELF- DEVELOPED EHR MODULES

Number Cost per EHR module ($M) Total cost for all EHR modules over 3- Self-developed EHR modules tested and year period ($M) certified Low High Mid-point Low High Mid-point

Min No. of EHR Modules ...... 328 $0.005 $0.035 $0.02 $1.64 $11.5 $6 .56 Max No. of EHR Modules ...... 1026 0.005 0.035 0.02 5.13 35.9 20 .52

Total ...... 6.77 47.4 27.1

Our estimates cover anticipated part of the temporary certification estimated (commercial, open source, testing and certification costs under the program. and self-developed), 45% will be tested temporary certification program from Consistent with our estimates in the and certified in 2010, 40% will be tested 2010 through some portion of 2012 as HIT Standards and Certification Criteria and certified in 2011, and 15% will be we expect the permanent certification interim final rule (75 FR 2041) about tested and certified in 2012. Table 8 program to be operational by 2012. when Complete EHRs and EHR Modules below represents this proportional However, because we cannot predict the will be prepared for testing and distribution of the estimated costs we exact date at which ONC–ATCBs will certification to the certification criteria calculated for the testing and finish any remaining tests and adopted by the Secretary for meaningful certification of Complete EHRs and EHR certifications in their queue, we believe use Stage 1, we anticipate that they will Modules to the certification criteria that it is reasonable to assume the be tested and certified in the same adopted to support meaningful use possibility that 2012 costs for testing proportions. Therefore, we believe that Stage 1 under the temporary of the total number of Complete EHRs certification program as expressed in and certification could be considered as and EHR Modules that we have Table 3 above.

TABLE 8—DISTRIBUTED TOTAL COSTS FOR THE TESTING AND CERTIFICATION OF COMPLETE EHRS AND EHR MODULES TO STAGE 1 MU BY YEAR (3-YEAR PERIOD)—TOTALS ROUNDED

Total low Total high Total aver- cost cost age cost Year Ratio estimate estimate estimate ($M) ($M) ($M)

2010 ...... 45% $4.93 $25.07 $15.00 2011 ...... 40% 4.38 22.28 13.34 2012 ...... 15% 1.64 8.36 5.00

3-Year Totals ...... 10.95 55.7 33.34

iii. Costs for Collecting, Storing, and section, we have specified in this final of GS–9 Step 1 could complete the Reporting Certification Results rule two additional reporting elements transmissions of the requested Costs to ONC–ATCBs that must be submitted by ONC–ATCBs information to ONC. We have utilized on a weekly basis (i.e., clinical quality the corresponding employee hourly rate Under the temporary certification measures to which a Complete EHR or for the locality pay area of Washington, program, ONC–ATCBs will be required EHR Module has been tested and D.C., as published by OPM, to calculate to provide ONC, no less frequently than certified and, where applicable, any our cost estimates. We have also weekly, an up-to-date list of Complete additional software a Complete EHR or calculated the costs of the employee’s EHRs and/or EHR Modules that have EHR Module relied upon to demonstrate benefits while completing the been tested and certified as well as its compliance with a certification transmissions of the requested certain minimum information about criterion or criteria adopted by the information. We have calculated these each certified Complete EHR and/or Secretary). ONC–ATCBs will be EHR Module. capturing these additional reporting costs by assuming that an ONC–ATCB As stated in the collection of elements in conjunction with the other or ONC–ACB expends thirty-six percent information section, we will require the information we request that they report (36%) of an employee’s hourly wage on reporting of this information on a on a weekly basis. Consequently, we do benefits for the employee. We have weekly basis and that it will take ONC– not believe that the reporting of these concluded that a 36% expenditure on ATCBs about an hour to prepare and two additional elements will increase benefits is an appropriate estimate electronically transmit the information the reporting burden or costs for ONC– because it is the routine percentage used to ONC each week (i.e., respondents ATCBs. by HHS for contract cost estimates. Our will respond 52 times per year). As also We believe that an employee cost estimates are expressed in Table 9 noted in the collection of information equivalent to the Federal Classification below.

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TABLE 9—ANNUAL COSTS FOR AN ONC–ATCB TO REPORT CERTIFICATIONS TO ONC

Annual burden Employee Employee Program requirement Employee equivalent hours per hourly wage benefits hourly Total cost per ONC–ATCB rate cost ONC–ATCB

ONC–ATCB Certification Results ...... GS–9 Step 1 ...... 52 $22.39 $8.06 $1,583.40

To estimate the highest possible cost, to retain all records related to tests and submitting the requested information. we assume that all of the estimated certifications according to Guide 65 and We estimate that this amount of time applicants (i.e., five) that we anticipate ISO 17025 for the duration of the will be approximately 8 hours for each will apply under the temporary temporary certification program and ONC–ATCB. certification program will become ONC– provide copies of the final results of all Based on our own assumptions and ATCBs. Therefore, we estimate the total completed tests and certifications to consultations with NIST, we believe annual reporting cost under the ONC at the conclusion of testing and temporary certification program to be certification activities under the that an employee equivalent to the $7,917. temporary certification program. Federal Classification of GS–9 Step 1 We believe that the requirement for We do not believe that there are any could organize, categorize, and submit ONC–ATCBs to retain certification specific recordkeeping or capital costs the final results of all completed tests records for the length of the temporary associated with this requirement. Based and certifications either by electronic certification program is in line with on our consultations with NIST, we transmission or through paper common industry practices and, understand that it is standard industry submission of photocopies to ONC. We consequently, does not represent practice to retain records related to have taken this employee assumption additional costs to ONC–ATCBs as a testing and certification. Therefore, we and utilized the corresponding result of this final rule. believe that the only costs attributable to employee hourly rate for the locality our requirement are those associated Costs to the Federal Government pay area of Washington, DC, as with the submission of copies to ONC published by the U.S. Office of As stated previously in this final rule, of the final results of all completed tests Personnel Management, to calculate the we will post a comprehensive list of all and certifications. cost estimates. We have also calculated certified Complete EHRs and EHR As stated in the collection of the costs of the employee’s benefits Modules on our Web site. We believe information section, we estimate that while organizing, categorizing, and that there will be minimal cost each ONC–ATCB will incur the same submitting the final results. We have associated with this action and have burden and, assuming that there are 5 calculated these costs by assuming that calculated the potential cost, including ONC–ATCBs, will test and certify, at weekly updates, to be $8,969 on an most, approximately 205 Complete an ONC–ATCB will expend thirty-six annualized basis. This amount is based EHRs and/or EHR Modules under the percent (36%) of an employee’s hourly on 173 hours of yearly work of a Federal temporary certification program. We wage on benefits for the employee. We Salary Classification GS–12 Step 1 also assume that an ONC–ATCB will have concluded that a 36% expenditure employee located in Washington, DC. submit copies of the final results of all on benefits is an appropriate estimate because it is the routine percentage used iv. Costs for Retaining Records and completed tests and certifications to by HHS for contract cost estimates. Our Providing Copies to ONC ONC by either electronic transmission or paper submission. In either instance, calculations are expressed in the table Costs to ONC–ATCBs we believe that an ONC–ATCB will below. Under the temporary certification spend a similar amount of time and program, ONC–ATCBs will be required effort in organizing, categorizing and

TABLE 10—COSTS FOR AN ONC–ATCB TO SUBMIT COPIES OF RECORDS TO ONC

Burden hours Employee Employee Program requirement Employee equivalent per ONC– hourly wage benefits hourly Total cost per ATCB rate cost ONC–ATCB

Submission of Testing and Certification Records GS–9 Step 1 ...... 8 $22.39 $8.06 $243.60

To estimate the highest possible cost, Costs to the Federal Government temporary certification program will we assume that all of the estimated allow for the rapid influx of Complete We anticipate that ONC will simply applicants (i.e., five) that we anticipate EHRs and EHR Modules to be tested and receive copies of the final results of all will apply under the temporary completed tests and certifications. certified at a sufficient pace for eligible certification program will become ONC– Therefore, we believe the Federal professionals and eligible hospitals to ATCBs. Therefore, we estimate the total government will only incur negligible adopt and implement Certified EHR cost for submitting the requested costs. Technology for meaningful use Stage 1 records at the conclusion of testing and and thus potentially qualify for certification activities under the b. Temporary Certification Program incentive payments under the CMS temporary certification program to be Benefits Medicare and Medicaid EHR Incentive $1,218.00. We believe that several benefits will Programs proposed rule. The time accrue from the establishment of the between the temporary certification temporary certification program. The program and the permanent certification

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program will permit the HIT industry the annual receipts of any one ONC– in any 1 year.’’ The current inflation- the time it needs for accredited testing ATCB could be in the low millions of adjusted statutory threshold is laboratories to come forward, for an dollars. Moreover, it is unclear, whether approximately $133 million. We did not ONC-authorized accreditor to be these entities may be involved in other receive any comments related to the approved and for additional applicants testing and certification programs which temporary certification program on our for ONC–ACB status to come forward. would increase their annual receipts analysis presented in the Proposed Rule. We further believe that the temporary and potentially place them outside the Therefore, we have determined that this certification program will meet our SBA’s size standards. final rule will not constitute a overall goals of accelerating health IT We believe that we have established significant rule under the Unfunded adoption and increasing levels of the minimum amount of requirements Mandates Reform Act, because it interoperability. At this time, we cannot necessary to accomplish our policy imposes no mandates. predict how fast all of these savings will goals and that no appropriate regulatory OMB reviewed this final rule. alternatives could be developed to occur or their precise magnitude as they List of Subjects in 45 CFR Part 170 are partly dependent on future final lessen the compliance burden for rules for meaningful use and the applicants for ONC–ATCB status as well Computer technology, Electronic subsequent standards and certification as ONC–ATCBs once they have been health record, Electronic information criteria adopted by the Secretary. granted such status by the National system, Electronic transactions, Health, Coordinator. Moreover, we believe that Health care, Health information D. Regulatory Flexibility Act this final rule will create direct positive technology, Health insurance, Health The RFA requires agencies to analyze effects for entities because their records, Hospitals, Incorporation by options for regulatory relief of small attainment of ONC–ATCB status will reference, Laboratories, Medicaid, businesses if a rule has a significant permit them to test and certify Complete Medicare, Privacy, Reporting and impact on a substantial number of small EHRs and/or EHR Modules. Thus, we recordkeeping requirements, Public entities. For more information on the expect that their annual receipts will health, Security. Small Business Administration’s increase as a result of becoming an ■ For the reasons set forth in the (SBA’s) size standards, see the SBA’s ONC–ATCB. preamble, 45 CFR subtitle A, subchapter Web site.4 For purposes of the RFA, We did not receive any comments D, part 170, is amended as follows: small entities include small businesses, related to our RFA analysis during the nonprofit organizations, and small comment period available for the PART 170—HEALTH INFORMATION governmental jurisdictions. When temporary certification program. As a TECHNOLOGY STANDARDS, conducting a RFA we are required to result, we examined the economic IMPLEMENTATION SPECIFICATIONS, assess the potential effects of our rule on implications of this final rule and have AND CERTIFICATION CRITERIA AND small entities and to make every effort concluded that it will not have a CERTIFICATION PROGRAMS FOR to minimize the regulatory burden that significant impact on a substantial HEALTH INFORMATION might be imposed on small entities. We number of small entities. The Secretary TECHNOLOGY certifies that this final rule will not have believe that the entities that are likely to ■ 1. The authority citation for part 170 a significant impact on a substantial be directly affected by this final rule are is revised to read as follows: applicants for ONC–ATCB status. number of small entities. Furthermore, we believe that these Authority: 42 U.S.C. 300jj–11; 42 U.S.C E. Executive Order 13132—Federalism 300jj–14; 5 U.S.C. 552. entities would either be classified under the North American Industry Executive Order 13132 establishes ■ 2. Revise § 170.100 to read as follows: Classification System (NAICS) codes certain requirements that an agency § 170.100 [Amended] 541380 (Testing Laboratories) or 541990 must meet when it promulgates a rule (Professional, Scientific and Technical that imposes substantial direct The provisions of this subchapter Services).5 We believe that there will be requirement costs on State and local implement sections 3001(c)(5) and 3004 up to 5 applicants for ONC–ATCB governments, preempts State law, or of the Public Health Service Act. status. According to the NAICS codes otherwise has federalism implications. ■ 3. In § 170.102, add in alphabetical Nothing in this final rule imposes identified above, this would mean SBA order the definition of ‘‘Day or Day(s)’’ substantial direct requirement costs on size standards of $12 million and $7 to read as follows: State and local governments, preempts million in annual receipts, State law or otherwise has federalism § 170.102 Definitions. respectively.6 Because this segment of implications. We are not aware of any the HIT industry is in a nascent stage * * * * * State laws or regulations that conflict Day or Days means a calendar day or and is comprised of very few entities, with or are impeded by our temporary calendar days. we have been unable to find reliable certification program, and we did not data from which to determine what * * * * * receive any comments to the contrary in realistic annual receipts would be. ■ 4. Add a new subpart D to part 170 response to the Proposed Rule. However, based on our total estimates to read as follows: for Complete EHRs and EHR Modules to F. Unfunded Mandates Reform Act of Subpart D—Temporary Certification be tested and certified, we assume that 1995 Program for HIT Title II of the Unfunded Mandates Sec. 4 http://sba.gov/idc/groups/public/documents/ _ _ _ Reform Act of 1995 (Pub. L. 104–4) 170.400 Basis and scope. sba homepage/serv sstd tablepdf.pdf. 170.401 Applicability. 5 requires cost-benefit and other analyses See 13 CFR 121.201 170.402 Definitions. 6 before any rulemaking if the rule The SBA references that annual receipts means 170.405 Correspondence. ‘‘total income’’ (or in the case of a sole includes a ‘‘Federal mandate that may 170.410 Types of testing and certification. proprietorship, ‘‘gross income’’) plus ‘‘cost of goods result in the expenditure by State, local, sold’’ as these terms are defined and reported on 170.415 Application prerequisite. Internal Revenue Service tax return forms. http:// and tribal governments, in the aggregate, 170.420 Application. www.sba.gov/idc/groups/public/documents/ or by the private sector, of $100,000,000 170.423 Principles of proper conduct for sba_homepage/guide_to_size_standards.pdf. or more (adjusted annually for inflation) ONC–ATCBs.

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170.425 Application submission. been authorized by the National (1) General identifying information 170.430 Review of application. Coordinator pursuant to this subpart to including: 170.435 ONC–ATCB application perform the testing and certification of (i) Name, address, city, state, zip code, reconsideration. Complete EHRs and/or EHR Modules and Web site of applicant; and 170.440 ONC–ATCB status. 170.445 Complete EHR testing and under the temporary certification (ii) Designation of an authorized certification. program. representative, including name, title, 170.450 EHR Module testing and Remote testing and certification phone number, and e-mail address of certification. means the use of methods, including the the person who will serve as the 170.455 Testing and certification to newer use of web-based tools or secured applicant’s point of contact. versions of certain standards. electronic transmissions, that do not (2) Documentation of the completion 170.457 Authorized testing and certification require an ONC–ATCB to be physically and results of a self-audit against all methods. present at the development or sections of ISO/IEC Guide 65:1996 170.460 Good standing as an ONC–ATCB. deployment site to conduct testing and (incorporated by reference in § 170.499), 170.465 Revocation of authorized testing and certification body status. certification. and the following: (i) A description of the applicant’s 170.470 Effect of revocation on the § 170.405 Correspondence. certifications issued to complete EHRs management structure according to and EHR Modules. (a) Correspondence and section 4.2 of ISO/IEC Guide 65:1996; 170.490 Sunset of the temporary communication with the National (ii) A copy of the applicant’s quality certification program. Coordinator shall be conducted by e- manual that has been developed 170.499 Incorporation by reference. mail, unless otherwise necessary. The according to section 4.5.3 of ISO/IEC official date of receipt of any e-mail Guide 65:1996; Subpart D—Temporary Certification between the National Coordinator and (iii) A copy of the applicant’s policies Program for HIT an applicant for ONC–ATCB status or an and approach to confidentiality § 170.400 Basis and scope. ONC–ATCB is the day the e-mail was according to section 4.10 of ISO/IEC sent. This subpart implements section Guide 65:1996; (b) In circumstances where it is 3001(c)(5) of the Public Health Service (iv) A copy of the qualifications of necessary for an applicant for ONC– Act, and sets forth the rules and each of the applicant’s personnel who ATCB status or an ONC–ATCB to procedures related to the temporary oversee or perform certification correspond or communicate with the certification program for health according to section 5.2 of ISO/IEC National Coordinator by regular or information technology administered by Guide 65:1996; express mail, the official date of receipt the National Coordinator for Health (v) A copy of the applicant’s will be the date of the delivery Information Technology. evaluation reporting procedures confirmation. according to section 11 of ISO/IEC § 170.401 Applicability. § 170.410 Types of testing and Guide 65:1996; and This subpart establishes the processes certification. (vi) A copy of the applicant’s policies that applicants for ONC–ATCB status Applicants may seek authorization for use and display of certificates must follow to be granted ONC–ATCB from the National Coordinator to according to section 14 of ISO/IEC status by the National Coordinator, the perform the following types of testing Guide 65:1996. (3) Documentation of the completion processes the National Coordinator will and certification: follow when assessing applicants and (a) Complete EHR testing and and results of a self-audit against all granting ONC–ATCB status, the certification; and/or sections of ISO/IEC 17025:2005 requirements that ONC–ATCBs must (b) EHR Module testing and (incorporated by reference in § 170.499), follow to remain in good standing, and certification. and the following: the requirements of ONC–ATCBs for (i) A copy of the applicant’s quality testing and certifying Complete EHRs § 170.415 Application prerequisite. system document according to section and/or EHR Modules in accordance Applicants must request in writing an 4.2.2 of ISO/IEC 17025:2005; with the applicable certification criteria application for ONC–ATCB status from (ii) A copy of the applicant’s policies adopted by the Secretary in subpart C of the National Coordinator. Applicants and procedures for handling testing this part. must indicate: nonconformities according to section (a) The type of authorization sought 4.9.1 of ISO/IEC 17025:2005; and § 170.402 Definitions. pursuant to § 170.410; and (iii) The qualifications of each of the For the purposes of this subpart: (b) If seeking authorization to perform applicant’s personnel who oversee or Applicant means a single organization EHR Module testing and certification, conduct testing according to section 5.2 or a consortium of organizations that the specific type(s) of EHR Module(s) of ISO/IEC 17025:2005. seeks to become an ONC–ATCB by they seek authorization to test and (4) An agreement, properly executed requesting and subsequently submitting certify. If qualified, applicants will only by the applicant’s authorized an application for ONC–ATCB status to be granted authorization to test and representative, that it will adhere to the the National Coordinator. certify the types of EHR Modules for Principles of Proper Conduct for ONC– Deployment site means the physical which they seek authorization. ATCBs. location where a Complete EHR or EHR (b) Part 2. An applicant must submit Module resides or is being or has been § 170.420 Application. a completed proficiency examination. implemented. The application for ONC–ATCB status Development site means the physical consists of two parts. Applicants must § 170.423 Principles of proper conduct for location where a Complete EHR or EHR complete both parts of the application ONC–ATCBs. Module was developed. in their entirety and submit them to the An ONC–ATCB shall: ONC–ATCB or ONC–Authorized National Coordinator for the application (a) Operate its certification program in Testing and Certification Body means an to be considered complete. accordance with ISO/IEC Guide 65:1996 organization or a consortium of (a) Part 1. An applicant must provide (incorporated by reference in § 170.499) organizations that has applied to and all of the following: and testing program in accordance with

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ISO/IEC 17025:2005 (incorporated by reference in § 170.499) and ISO/IEC electronically via e-mail (or web reference in § 170.499); 17025:2005 (incorporated by reference submission if available), or by regular or (b) Maintain an effective quality in § 170.499) for the duration of the express mail. management system which addresses all temporary certification program and (b) An application for ONC–ATCB requirements of ISO/IEC 17025:2005 provide copies of the final results of all status may be submitted to the National (incorporated by reference in § 170.499); completed tests and certifications to Coordinator at any time during the (c) Attend all mandatory ONC training ONC at the conclusion of testing and existence of the temporary certification and program update sessions; certification activities under the program. (d) Maintain a training program that temporary certification program; includes documented procedures and (j) Promptly refund any and all fees § 170.430 Review of application. training requirements to ensure its received for: (a) Method of review and review personnel are competent to test and (1) Requests for testing and timeframe. certify Complete EHRs and/or EHR certification that are withdrawn while (1) Applications will be reviewed in Modules; its operations are suspended by the the order they are received. (e) Use test tools and test procedures National Coordinator; (2) The National Coordinator will approved by the National Coordinator (2) Testing and certification that will review Part 1 of the application in its for the purposes of assessing Complete not be completed as a result of its entirety and determine whether Part 1 of EHRs and/or EHR Modules compliance conduct; and the application is complete and with the certification criteria adopted by (3) Previous testing and certification satisfactory before proceeding to review the Secretary; that it performed if its conduct Part 2 of the application in its entirety. (f) Report to ONC within 15 days any necessitates the recertification of (3) The National Coordinator is changes that materially affect its: Complete EHRs and/or EHR Modules; permitted up to 30 days to review an (1) Legal, commercial, organizational, (k) Ensure adherence to the following application (submitted for the first time) or ownership status; requirements when issuing a upon receipt. (2) Organization and management, certification to Complete EHRs and/or (b) Application deficiencies. including key testing and certification EHR Modules: (1) If the National Coordinator personnel; (1) All certifications must require that identifies an area in an application that (3) Policies or procedures; a Complete EHR or EHR Module requires the applicant to clarify a (4) Location; developer conspicuously include the statement or correct an error or (5) Facilities, working environment or following text on its Web site and in all omission, the National Coordinator may other resources; marketing materials, communications contact the applicant to make such (6) ONC authorized representative statements, and other assertions related clarification or correction without (point of contact); or to the Complete EHR or EHR Module’s (7) Other such matters that may issuing a deficiency notice. If the certification: National Coordinator has not received otherwise materially affect its ability to (i) ‘‘This [Complete EHR or EHR the requested information after five test and certify Complete EHRs and/or Module] is 201[X]/201[X] compliant and days, the applicant may be issued a EHR Modules; has been certified by an ONC–ATCB in deficiency notice specifying the error, (g) Allow ONC, or its authorized accordance with the applicable omission, or deficient statement. agents(s), to periodically observe on site certification criteria adopted by the (2) If the National Coordinator (unannounced or scheduled) during Secretary of Health and Human determines that deficiencies in either normal business hours, any testing and/ Services. This certification does not part of the application exist, the or certification performed to represent an endorsement by the U.S. National Coordinator will issue a demonstrate compliance with the Department of Health and Human deficiency notice to the applicant and requirements of the temporary Services or guarantee the receipt of return the application. The deficiency certification program; incentive payments.’’; and (h) Provide ONC, no less frequently (ii) The information an ONC–ATCB is notice will identify the areas of the than weekly, a current list of Complete required to report to the National application that require additional EHRs and/or EHR Modules that have Coordinator under paragraph (h) of this information or correction. been tested and certified which section for the specific Complete EHR or (c) Revised application. includes, at a minimum: EHR Module at issue; (1) An applicant is permitted to (1) The vendor name (if applicable); (2) A certification issued to an submit a revised application in response (2) The date certified; integrated bundle of EHR Modules shall to a deficiency notice. An applicant may (3) The product version; be treated the same as a certification request an extension for good cause (4) The unique certification number or issued to a Complete EHR for the from the National Coordinator of the 15- other specific product identification; purposes of paragraph (k)(1) of this day period provided in paragraph (c)(2) (5) The clinical quality measures to section except that it must also indicate of this section to submit a revised which a Complete EHR or EHR Module each EHR Module that comprises the application. has been tested and certified; bundle; and (2) In order to continue to be (6) Where applicable, any additional (3) A certification issued to a considered for ONC–ATCB status, an software a Complete EHR or EHR Complete EHR or EHR Module based on applicant’s revised application must Module relied upon to demonstrate its applicable certification criteria adopted address the specified deficiencies and compliance with a certification criterion by the Secretary at subpart C of this part be received by the National Coordinator or criteria adopted by the Secretary; and must be separate and distinct from any within 15 days of the applicant’s receipt (7) Where applicable, the certification other certification(s) based on other of the deficiency notice unless the criterion or criteria to which each EHR criteria or requirements. National Coordinator grants an Module has been tested and certified. applicant’s request for an extension of (i) Retain all records related to tests § 170.425 Application submission. the 15-day period based on a finding of and certifications according to ISO/IEC (a) An applicant for ONC–ATCB good cause. If a good cause extension is Guide 65:1996 (incorporated by status must submit its application either granted, then the revised application

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must be received by the end of the review the information submitted by the § 170.445 Complete EHR testing and extension period. applicant and issue a decision. certification. (3) The National Coordinator is (d) Decision. (a) An ONC–ATCB must test and certify Complete EHRs to all applicable permitted up to 15 days to review a (1) If the National Coordinator certification criteria adopted by the revised application once it has been determines that clear, factual errors Secretary at subpart C of this part. received and may request clarification were made during the review of the of statements and the correction of (b) An ONC–ATCB must provide the application and that correction of the option for a Complete EHR to be tested errors or omissions in a revised errors would remove all identified application during this time period. and certified solely to the applicable deficiencies, the applicant’s authorized certification criteria adopted by the (4) If the National Coordinator representative will be notified of the determines that a revised application Secretary at subpart C of this part. National Coordinator’s decision to (c) Inherited certified status. An still contains deficiencies, the applicant reverse the previous decision(s) not to will be issued a denial notice indicating ONC–ATCB must accept requests for a approve part of the applicant’s newer version of a previously certified that the applicant will no longer be application or the entire application. considered for authorization under the Complete EHR to inherit the previously temporary certification program. An (i) If the National Coordinator’s certified Complete EHR’s certified status applicant may request reconsideration decision to reverse the previous without requiring the newer version to of a denial in accordance with decision(s) affected part 1 of an be retested and recertified. § 170.435. application, the National Coordinator (1) Before granting certified status to will subsequently review part 2 of the (d) Satisfactory application. a newer version of a previously certified application. (1) An application will be deemed Complete EHR, an ONC–ATCB must satisfactory if it meets all application (ii) If the National Coordinator’s review an attestation submitted by the requirements, including a passing score decision to reverse the previous developer of the Complete EHR to on the proficiency examination. decision(s) affected part 2 of an determine whether the newer version has adversely affected any previously (2) The National Coordinator will application, the applicant’s authorized certified capabilities. notify the applicant’s authorized representative will be notified of the National Coordinator’s decision as well (2) An ONC–ATCB may grant certified representative of its satisfactory status to a newer version of a previously application and its successful as the applicant’s successful achievement of ONC–ATCB status. certified Complete EHR if it determines achievement of ONC–ATCB status. that previously certified capabilities (3) Once notified by the National (2) If, after reviewing an applicant’s reconsideration request, the National have not been adversely affected. Coordinator of its successful (d) An ONC–ATCB that has been Coordinator determines that the achievement of ONC–ATCB status, the authorized to test and certify Complete applicant did not identify any factual applicant may represent itself as an EHRs is also authorized to test and errors or that correction of those factual ONC–ATCB and begin testing and certify all EHR Modules under the errors would not remove all identified certifying Complete EHRs and/or EHR temporary certification program. Modules consistent with its deficiencies in the application, the authorization. National Coordinator may reject the § 170.450 EHR module testing and applicant’s reconsideration request. certification. § 170.435 ONC–ATCB application (a) When testing and certifying EHR reconsideration. (3) Final decision. A reconsideration decision issued by the National Modules, an ONC–ATCB must test and (a) An applicant may request that the Coordinator is final and not subject to certify in accordance with the National Coordinator reconsider a further review. applicable certification criterion or denial notice issued for each part of an certification criteria adopted by the application only if the applicant can § 170.440 ONC–ATCB status. Secretary at subpart C of this part. demonstrate that clear, factual errors (a) Acknowledgement and (b) An ONC–ATCB must provide the were made in the review of the publication. The National Coordinator option for an EHR Module or a bundle applicable part of the application and will acknowledge and make publicly of EHR Modules to be tested and that the errors’ correction could lead to available the names of ONC–ATCBs, certified solely to the applicable the applicant obtaining ONC–ATCB including the date each was authorized certification criteria adopted by the status. and the type(s) of testing and Secretary at subpart C of this part. (b) Submission requirement. An certification each has been authorized to (c) Privacy and security testing and applicant is required to submit, within perform. certification. EHR Modules shall be 15 days of receipt of a denial notice, a tested and certified to all privacy and (b) Representation. Each ONC–ATCB written statement to the National security certification criteria adopted by must prominently and unambiguously Coordinator contesting the decision to the Secretary unless the EHR Module(s) identify the scope of its authorization on deny its application and explaining is/are presented for testing and its Web site, and in all marketing and with sufficient documentation what certification in one of the following communications statements (written factual errors it believes can account for manners: and oral) pertaining to its activities the denial. If the National Coordinator (1) The EHR Module(s) is/are under the temporary certification does not receive the applicant’s presented for testing and certification as program. submission within the specified a pre-coordinated, integrated bundle of timeframe, its reconsideration request (c) Renewal. ONC–ATCB status does EHR Modules, which would otherwise may be rejected. not need to be renewed during the meet the definition of and constitute a (c) Reconsideration request review. If temporary certification program. Complete EHR (as defined in 45 CFR the National Coordinator receives a (d) Expiration. The status of all ONC– 170.102), and one or more of the timely reconsideration request, the ATCBs will expire upon the sunset of constituent EHR Modules is/are National Coordinator is permitted up to the temporary certification program in demonstrably responsible for providing 15 days from the date of receipt to accordance with § 170.490. all of the privacy and security

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capabilities for the entire bundle of EHR § 170.457 Authorized testing and National Coordinator may, if necessary, Module(s); or certification methods. request additional information from the (2) An EHR Module is presented for An ONC–ATCB must provide remote ONC–ATCB during this time period. testing and certification, and the testing and certification for both (ii) If the National Coordinator presenter can demonstrate and provide development and deployment sites. determines that no violation occurred or that the violation has been sufficiently documentation to the ONC–ATCB that a § 170.460 Good standing as an ONC– corrected, the National Coordinator will privacy and security certification ATCB. issue a memo to the ONC–ATCB criterion is inapplicable or that it would An ONC–ATCB must maintain good confirming this determination. be technically infeasible for the EHR standing by: (iii) If the National Coordinator Module to be tested and certified in (a) Adhering to the Principles of determines that the ONC–ATCB failed accordance with such certification Proper Conduct for ONC–ATCBs; to demonstrate that no violation criterion. (b) Refraining from engaging in other occurred or to correct the area(s) of non- (d) Inherited certified status. An types of inappropriate behavior, compliance identified under paragraph ONC–ATCB must accept requests for a including an ONC–ATCB (b)(1) of this section within 30 days of newer version of a previously certified misrepresenting the scope of its receipt of the noncompliance EHR Module or bundle of EHR Modules authorization as well as an ONC–ATCB notification, then the National to inherit the previously certified EHR testing and certifying Complete EHRs Coordinator may propose to revoke the Module’s or bundle of EHR Modules and/or EHR Modules for which it does ONC–ATCB’s status. certified status without requiring the not have authorization; and (c) Proposed revocation. newer version to be retested and (c) Following all other applicable (1) The National Coordinator may recertified. Federal and state laws. propose to revoke an ONC–ATCB’s status if the National Coordinator has (1) Before granting certified status to § 170.465 Revocation of authorized testing and certification body status. reliable evidence that the ONC–ATCB a newer version of a previously certified committed a Type-1 violation; or EHR Module or bundle of EHR Modules, (a) Type-1 violations. The National (2) The National Coordinator may an ONC–ATCB must review an Coordinator may revoke an ONC– propose to revoke an ONC–ATCB’s attestation submitted by the developer ATCB’s status for committing a Type-1 status if, after the ONC–ATCB has been of the EHR Module or presenter of the violation. Type-1 violations include notified of a Type-2 violation, the ONC– bundle of EHR Modules to determine violations of law or temporary ATCB fails to: whether the newer version has certification program policies that (i) To rebut the finding of a violation adversely affected any previously threaten or significantly undermine the with sufficient evidence showing that certified capabilities. integrity of the temporary certification the violation did not occur or that the program. These violations include, but (2) An ONC–ATCB may grant certified violation has been corrected; or are not limited to: False, fraudulent, or status to a newer version of a previously (ii) Submit to the National abusive activities that affect the Coordinator a written response to the certified EHR Module or bundle of EHR temporary certification program, a Modules if it determines that previously noncompliance notification within the program administered by HHS or any specified timeframe under paragraph certified capabilities have not been program administered by the Federal adversely affected. (b)(2). government. (d) Suspension of an ONC–ATCB’s § 170.455 Testing and certification to (b) Type-2 violations. The National operations. newer versions of certain standards. Coordinator may revoke an ONC– (1) The National Coordinator may ATCB’s status for failing to timely or suspend the operations of an ONC– (a) ONC–ATCBs may test and certify adequately correct a Type-2 violation. ATCB under the temporary certification Complete EHRs and EHR Module to a Type-2 violations constitute program based on reliable evidence newer version of certain identified noncompliance with § 170.460. indicating that: minimum standards specified at subpart (1) Noncompliance notification. If the (i) The ONC–ATCB committed a B of this part if the Secretary has National Coordinator obtains reliable Type-1 or Type-2 violation; and accepted a newer version of an adopted evidence that an ONC–ATCB may no (ii) The continued testing and minimum standard. longer be in compliance with § 170.460, certification of Complete EHRs and/or (b) Applicability of an accepted new the National Coordinator will issue a EHR Modules by the ONC–ATCB could version of an adopted minimum noncompliance notification with have an adverse impact on the health or standard. reasons for the notification to the ONC– safety of patients. ATCB requesting that the ONC–ATCB (2) If the National Coordinator (1) ONC–ATCBs are not required to respond to the alleged violation and determines that the conditions of test and certify Complete EHRs and/or correct the violation, if applicable. paragraph (d)(1) have been met, an EHR Modules according to newer (2) Opportunity to become compliant. ONC–ATCB will be issued a notice of versions of an adopted minimum After receipt of a noncompliance proposed suspension. standard accepted by the Secretary until notification, an ONC–ATCB is permitted (3) Upon receipt of a notice of the incorporation by reference provision up to 30 days to submit a written proposed suspension, an ONC–ATCB of the adopted version is updated in the response and accompanying will be permitted up to 3 days to submit Federal Register with a newer version. documentation that demonstrates that a written response to the National (2) Certified EHR Technology may be no violation occurred or that the alleged Coordinator explaining why its upgraded to comply with newer violation has been corrected. operations should not be suspended. versions of an adopted minimum (i) If the ONC–ATCB submits a (4) The National Coordinator is standard accepted by the Secretary response, the National Coordinator is permitted up to 5 days from receipt of without adversely affecting the permitted up to 30 days from the time an ONC–ATCB’s written response to a certification status of the Certified EHR the response is received to evaluate the notice of proposed suspension to review Technology. response and reach a decision. The the response and make a determination.

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(5) The National Coordinator may (2) A testing and certification body the notice. The certification status of the make one of the following that has had its ONC–ATCB status Complete EHR and/or EHR Module can determinations in response to the ONC– revoked is prohibited from accepting only be maintained thereafter by being ATCB’s written response or if the ONC– new requests for testing and re-certified by an ONC–ATCB in good ATCB fails to submit a written response certification and must cease its current standing. within the timeframe specified in testing and certification operations paragraph (d)(3): under the temporary certification § 170.490 Sunset of the temporary certification program. (i) Rescind the proposed suspension; program. or (3) A testing and certification body (a) The temporary certification (ii) Suspend the ONC–ATCB’s that has had its ONC–ATCB status program will sunset on December 31, operations until it has adequately revoked for a Type-1 violation is 2011, or if the permanent certification corrected a Type-2 violation; or prohibited from reapplying for ONC– program is not fully constituted at that (iii) Propose revocation in accordance ATCB status under the temporary time, then upon a subsequent date that with § 170.465(c) and suspend the certification program for one year. If the is determined to be appropriate by the ONC–ATCB’s operations for the temporary certification program sunsets National Coordinator. On and after the duration of the revocation process. during this time, the testing and temporary certification program sunset (6) A suspension will become certification body is prohibited from date, ONC–ATCBs will be prohibited effective upon an ONC–ATCB’s receipt applying for ONC–ACB status under the from accepting new requests to test and of a notice of suspension. permanent certification program for the certify Complete EHRs or EHR Modules. (e) Opportunity to respond to a time that remains within the one year (b) ONC–ATCBs are permitted up to proposed revocation notice. six months after the sunset date to (1) An ONC–ATCB may respond to a prohibition. (4) The failure of a testing and complete all testing and certification proposed revocation notice, but must do certification body that has had its ONC– activities associated with requests for so within 10 days of receiving the ATCB status revoked, to promptly testing and certification of Complete proposed revocation notice and include refund any and all fees for tests and/or EHRs and/or EHR Modules received appropriate documentation explaining prior to the sunset date. in writing why its status should not be certifications of Complete EHRs and revoked. EHR Modules not completed will be § 170.499 Incorporation by reference. considered a violation of the Principles (2) Upon receipt of an ONC–ATCB’s (a) Certain material is incorporated by of Proper Conduct for ONC–ATCBs and response to a proposed revocation reference into this subpart with the will be taken into account by the notice, the National Coordinator is approval of the Director of the Federal National Coordinator if the testing and permitted up to 30 days to review the Register under 5 U.S.C. 552(a) and 1 certification body reapplies for ONC– information submitted by the ONC– CFR part 51. To enforce any edition ATCB status under the temporary ATCB and reach a decision. other than that specified in this section, certification program or applies for (3) Unless suspended, an ONC–ATCB the Department of Health and Human ONC–ACB status under the permanent will be permitted to continue its Services must publish notice of change certification program. operations under the temporary in the Federal Register and the material certification program during the time § 170.470 Effect of revocation on the must be available to the public. All period provided for the ONC–ATCB to certifications issued to complete EHRs and approved material is available for respond to the proposed revocation EHR Modules. inspection at the National Archives and notice and the National Coordinator to (a) The certified status of Complete Records Administration (NARA). For review the response. EHRs and/or EHR Modules certified by information on the availability of this (f) Good standing determination. If an ONC–ATCB that had it status material at NARA, call 202–741–6030 or the National Coordinator determines revoked will remain intact unless a go to http://www.archives.gov/ that an ONC–ATCB’s status should not Type-1 violation was committed that federal_register/ be revoked, the National Coordinator calls into question the legitimacy of the code_of_federal_regulations/ will notify the ONC–ATCB’s authorized certifications issued by the former ibr_locations.html. Also, it is available representative in writing of this ONC–ATCB. for inspection at U.S. Department of determination. Health and Human Services, Office of (g) Revocation. (b) If the National Coordinator (1) The National Coordinator may determines that a Type-1 violation the National Coordinator for Health revoke an ONC–ATCB’s status if: occurred that called into question the Information Technology, Hubert H. (i) A determination is made that legitimacy of certifications conducted Humphrey Building, Suite 729D, 200 revocation is appropriate after by the former ONC–ATCB, then the Independence Ave, SW., Washington, considering the information provided by National Coordinator would: DC 20201, call ahead to arrange for the ONC–ATCB in response to the (1) Review the facts surrounding the inspection at 202–690–7151, and is proposed revocation notice; or revocation of the ONC–ATCB’s status; available from the source listed below. (ii) The ONC–ATCB does not respond and (b) International Organization for to a proposed revocation notice within (2) Publish a notice on ONC’s Web Standardization, Case postale 56, the specified timeframe in paragraph site if the National Coordinator believes CH·1211, Geneve 20, Switzerland, (d)(1) of this section. that Complete EHRs and/or EHR telephone +41–22–749–01–11, http:// (2) A decision to revoke an ONC– Modules were improperly certified by www.iso.org. ATCB’s status is final and not subject to the former ONC–ATCB. (1) ISO/IEC 17025 General further review unless the National (c) If the National Coordinator Requirements for the Competence of Coordinator chooses to reconsider the determines that Complete EHRs and/or Testing and Calibration Laboratories revocation. EHR Modules were improperly certified, (Second Edition), May 15, 2005, IBR (h) Extent and duration of revocation. the certification status of affected approved for § 170.420 and § 170.423. (1) The revocation of an ONC–ATCB Complete EHRs and/or EHR Modules (2) ISO/IEC GUIDE 65 General is effective as soon as the ONC–ATCB would only remain intact for 120 days Requirements for Bodies Operating receives the revocation notice. after the National Coordinator publishes Product Certification Systems (First

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Edition), 1996, IBR approved for Dated: June 8, 2010. § 170.420 and § 170.423. Kathleen Sebelius, (3) [Reserved] Secretary. [FR Doc. 2010–14999 Filed 6–18–10; 11:15 am] BILLING CODE 4150–45–P

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Part III

Nuclear Regulatory Commission 10 CFR Parts 30, 31, 32, et al. Requirements for Distribution of Byproduct Material; Proposed Rule

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NUCLEAR REGULATORY do not receive a reply e-mail confirming you do not want to be publicly COMMISSION that we have received your comments, disclosed. The NRC requests that any contact us directly at 301–415–1966. party soliciting or aggregating comments 10 CFR Parts 30, 31, 32, 40, and 70 Hand Deliver comments to: 11555 received from other persons for RIN 3150–AH91 Rockville Pike, Rockville, Maryland submission to the NRC inform those 20852 between 7:30 a.m. and 4:15 p.m. persons that the NRC will not edit their [NRC–2008–0338] during Federal workdays (Telephone comments to remove any identifying or 301–415–1966). contact information, and therefore, they Requirements for Distribution of Fax comments to: Secretary, U.S. should not include any information in Byproduct Material Nuclear Regulatory Commission at 301– their comments that they do not want AGENCY: Nuclear Regulatory 415–1101. publicly disclosed. Commission. You may submit comments on the You can access publicly available information collections by the methods ACTION: Proposed rule. documents related to this document indicated in the Paperwork Reduction using the following methods: SUMMARY: The Nuclear Regulatory Act Statement. NRC’s Public Document Room (PDR): Commission (NRC) is proposing to FOR FURTHER INFORMATION CONTACT: The public may examine and have amend its regulations to make Catherine R. Mattsen, Office of Federal copied for a fee, publicly available requirements for distributors of and State Materials and Environmental documents at the NRC’s PDR, Room byproduct material clearer, less Management Programs, U.S. Nuclear O–1F21, One White Flint North, 11555 prescriptive, and more risk-informed Regulatory Commission, Washington, Rockville Pike, Rockville, Maryland. and up to date. The Commission is also DC 20555–0001, telephone 301–415– NRC’s Agencywide Documents Access proposing to redefine categories of 6264, e-mail, and Management System (ADAMS): devices to be used under exemptions, [email protected]. Publicly available documents created or add explicit provisions regarding the received at the NRC are available SUPPLEMENTARY INFORMATION: sealed source and device registration electronically at the NRC’s Electronic process, and add flexibility to the I. Submitting Comments and Accessing Reading Room at http://www.nrc.gov/ licensing of users of sealed sources and Information reading-rm/adams.html. From this page, devices. This action is primarily II. Background the public can gain entry into ADAMS, A. Introduction which provides text and image files of intended to make licensing processes B. Regulatory Framework more efficient and effective. These III. Proposed Actions NRC’s public documents. If you do not changes would affect manufacturers and A. Actions Related to Sealed Source and have access to ADAMS or if there are distributors of sources and devices Device Registration problems in accessing the documents containing byproduct material and B. Establish a New Class Exemption for located in ADAMS, contact the NRC’s future users of some products currently Certain Industrial Products PDR reference staff at 1–800–397–4209, used under a general or specific license. C. Remove Unnecessary Limitations From or 301–415–4737, or by e-mail to the Class Exemption for Gas and Aerosol [email protected]. DATES: The comment period expires Detectors September 7, 2010. Submit comments Federal Rulemaking Web site: Public D. Update the Regulations on Certain Static comments and supporting materials specific to the information collections Eliminators and Ion Generating Tubes aspects of this rule by July 26, 2010. E. Remove Prescriptive Requirements for related to this proposed rule can be Comments received after these dates Distributors of Generally Licensed found at http://www.regulations.gov by will be considered if it is practical to do Devices and Exempt Products searching on Docket ID NRC–2008– so, but the NRC is able to assure F. Make the Requirements for Distributors 0338. of Exempt Products More Risk-Informed consideration only for comments II. Background received on or before these dates. G. Specific Questions for Comment H. Minor Clarifying or Administrative A. Introduction ADDRESSES: Please include Docket ID Revisions NRC–2008–0338 in the subject line of IV. Summary of Proposed Amendments by The Commission has authority to your comments. For instructions on Section issue both general and specific licenses submitting comments and accessing V. Criminal Penalties for the use of byproduct material and documents related to this action, see VI. Agreement State Compatibility also to exempt byproduct material from Section I, ‘‘Submitting Comments and VII. Plain Language regulatory control under section 81 of Accessing Information’’ in the VIII. Voluntary Consensus Standards the Atomic Energy Act of 1954, as IX. Finding of No Significant Environmental SUPPLEMENTARY INFORMATION section of amended (hereafter, ‘‘the Act’’ or the Impact: Availability AEA). A general license is provided by this document. You may submit X. Paperwork Reduction Act Statement comments by any one of the following XI. Regulatory Analysis regulation, grants authority to a person methods. XII. Regulatory Flexibility Certification for particular activities involving Federal Rulemaking Web Site: Go to XIII. Backfit Analysis byproduct material as described within http://www.regulations.gov and search the general license, and is effective for documents filed under Docket ID I. Submitting Comments and Accessing without the filing of an application with NRC–2008–0338 Address questions Information the Commission or the issuance of a about NRC dockets to Carol Gallagher, Comments submitted in writing or in licensing document to a particular telephone 301–492–3668; e-mail electronic form will be posted on the person. Requirements for general [email protected]. NRC Web site and on the Federal licensees appear in the regulations and Mail comments to: Secretary, U.S. rulemaking Web site http:// are designed to be commensurate with Nuclear Regulatory Commission, www.regulations.gov. Because your the specific circumstances covered by Washington, DC 20555–0001, ATTN: comments will not be edited to remove each general license. A specific license Rulemakings and Adjudications Staff. any identifying or contact information, is issued to a named person who has E-mail comments to: the NRC cautions you against including filed an application with the [email protected]. If you any information in your submission that Commission.

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In considering its exemptions from quantities are used in products than is (distribution) of items containing licensing, the Commission is directed by potentially allowed under the byproduct material to persons exempt the Act to make ‘‘a finding that the exemption. from licensing requirements and to exemption of such classes or quantities The NRC has reviewed the regulations persons using a general license. It also of such material or such kinds of uses governing the distribution of byproduct includes requirements applicable to or users will not constitute an material to persons for use under the certain manufacturers and distributors unreasonable risk to the common exemptions, as well as other regulations of products and materials to be used by defense and security and to the health governing distribution of products specific licensees. The requirements for and safety of the public.’’ As beneficial containing byproduct material. The distributors address such measures as uses of radioactive material were Commission decided to make these prototype testing, labeling, reporting developed and experience grew, new regulations more flexible, user-friendly, and recordkeeping, quality control, and, products intended for use by the general and performance-based, and to improve in some cases, specific sampling public were invented and the its ability to risk-inform its regulatory procedures. regulations were amended to program. These concepts have been accommodate the use of new products. considered in developing potential III. Proposed Actions Although presenting very low risks of revisions to the regulatory program in This proposed rule would make a significant individual doses to members the area of distribution of byproduct number of revisions to the regulations of the general public, exempt products material. governing the use of byproduct material are a source of routine exposure to the In a final rule published October 16, under exemptions from licensing and public. A substantial portion of the 2007 (72 FR 58473), some of these under general license, and to the population uses and enjoys benefits revisions were made, including the requirements for those who distribute from exempt products, such as smoke removal of obsolete exemptions. This products and materials. The changes are detectors, but also receives some action is a follow-on to that effort. To intended to improve the efficiency and radiation exposure from those products. make optimal use of rulemaking effectiveness of certain licensing In keeping with its consumer product resources, both for the NRC and the actions. policy, which calls for the Commission States who must develop conforming to evaluate the total effect of consumer regulations, several issues have been A. Actions Related to Sealed Source and products on the public, the Commission combined into this proposed rule. Device Registration conducted a systematic reevaluation of B. Regulatory Framework A.1 Updating Regulations To Add the exemptions from licensing. A major Registration Requirements part of the effort was an assessment of The Commission’s regulations in Part the potential and likely doses to workers 30 contain the basic requirements for Section 32.210 provides for the and the public under these exemptions. licensing of byproduct material. Part 30 registration of sealed sources and Dose assessments for most of these includes a number of provisions that devices containing sealed sources exemptions can be found in NUREG– exempt the end user from licensing intended for use under a specific 1717 1, ‘‘Systematic Radiological requirements, so-called ‘‘exemptions.’’ license. Manufacturers or distributors Assessment of Exemptions for Source Some exemptions are product-specific, may submit a request to NRC for an and Byproduct Materials,’’ June 2001. intended only for specific purposes evaluation of radiation safety Actual exposures of the public likely to which are narrowly defined by information for a product and for occur are in line with Commission regulation. More broadly defined are the registration of the product. After policy concerning acceptable doses from general materials exemptions, which satisfactory completion of the products and materials used under allow the use of many radionuclides in evaluation, the NRC issues a certificate exemptions. For some exemptions, there many chemical and physical forms of registration to the person making the was a significant difference between subject to limits on activity, and which request. Subsequently, under § 30.32(g), potential and likely doses because the are specified in §§ 30.14 and 30.18 for specific licensees or applicants for a use of the exemption is limited or exempt concentrations and exempt specific license who wish to use the nonexistent, or significantly lower quantities, respectively. The registered product need only identify Commission’s regulations also include the source or device by manufacturer 1 NUREG–1717 is a historical document two class exemptions—for self- and model number as registered with developed using the models and methodology luminous products and gas and aerosol the Commission under § 32.210 or with available in the 1990s. The NUREG provides the detectors, in §§ 30.19 and 30.20, an Agreement State in their estimate of the radiological impacts of the various exemptions from licensing based on what was respectively—which cover a broad class applications. Because the source or known about distribution of material under the of products not limited to certain device has already been evaluated and exemptions in the early 1990s. NUREG–1717 was quantities or radionuclides. Under the its safety information is a matter of used as the initial basis for evaluating the record, the users are not required to regulations for exemptions from licensing class exemptions, many products can be requirements and determining whether those approved for use through the licensing submit the detailed radiation safety regulations adequately ensured that the health and process if the applicant demonstrates information for the source or device in safety of the public were protected consistent with that the specific product is within the their license applications. This greatly NRC policies related to radiation protection. The simplifies the licensing process for the agency will not use the results presented in class and meets certain radiation dose NUREG–1717 as a sole basis for any regulatory criteria. users of specifically licensed sources decisions or future rulemaking without additional Part 31 provides general licenses for and devices. The registration system is analysis. Copies of NUREGs may be purchased from the use of certain items containing referred to as the Sealed Source and the Superintendent of Documents, U. S. Device (SS & D) Registry. Many Government Printing Office, P.O. Box 37082, byproduct material and the Washington, DC 20013–7082. Copies are also requirements associated with these Agreement States have similar available from the National Technical Information general licenses. The general licenses registration procedures. Registration Service, 5285 Port Royal Road, Springfield, VA are established in §§ 31.3, 31.5, 31.7, certificates for the sources and devices 22161. A copy is also available for inspection and/ or copying for a fee at the NRC Public Document 31.8, 31.10, 31.11, and 31.12. reviewed by the Agreement States are Room, One White Flint North, 11555 Rockville Part 32 sets out requirements for the also added to the national SS & D Pike, Public File Area O1–F21, Rockville, MD. manufacture or initial transfer Registry. However, some Agreement

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States do not include the evaluation and process are indicated in guidance, e.g., cases, by the various Agreement States registration of sealed sources and NUREG–1556, Vol. 3, Rev. 1, for distribution to all jurisdictions. For devices in their agreements; authority ‘‘Consolidated Guidance About those products that are registered by the for these reviews remains under NRC Materials Licenses: Applications for manufacturer or distributor, the regulatory jurisdiction. Sealed Source and Device Evaluation registration information is available to A definition of the registry is included and Registration’’; NUREG–1556, Vol. 8, NRC and all of the Agreement States in § 35.2 as follows: ‘‘Sealed Source and ‘‘Consolidated Guidance About through the SS & D Registry. In this Device Registry means the national Materials Licenses: Program-Specific way, the various jurisdictions can be registry that contains all the registration Guidance About Exempt Distribution assured of the radiation safety of the certificates, generated by both NRC and Licenses’’; and NUREG–1556, Vol. 16, products being used under their the Agreement States, that summarize ‘‘Consolidated Guidance About regulations that have been evaluated by the radiation safety information for the Materials Licenses: Program-Specific another jurisdiction. The registration of sealed sources and devices and describe Guidance About Licenses Authorizing products by model number also assists the licensing and use conditions Distribution to General Licenses.’’ For a in the tracking of generally licensed approved for the product.’’ This same number of categories of specifically devices by NRC and the Agreement definition would be added to 10 CFR licensed sources and devices, an States. In some cases, a secondary part 32 by this action, as the information explicit requirement for registration is distributor of a generally licensed requirements for the SS & D review and included in the regulations. Existing device may refer to the registration registration are in part 32. The SS & D specific requirements include §§ 35.400, certificate obtained by the manufacturer, Registry is maintained in a computer 35.500, 35.600, 36.21, and 39.41(f). or more frequently a source to be database, which is available to the These concern certain medical use installed in a generally licensed device Agreement States. While this process, in products, sealed sources installed in may be manufactured by a different which the manufacturer or initial irradiators after July 1, 1993, and energy entity who has registered the source distributor obtains a registration compensation sources (a specific type of separately. certificate for the source or device, is reference source used in well logging). For those products used under a generally used for most specifically The only products used under product-specific exemption, for which licensed sources and devices, in some exemption from licensing for which the registration certificates are not issued, cases of custom-made sources or NRC issues registration certificates are the safety of the product has been devices, the planned user will those distributed for use under a ‘‘class evaluated based primarily on the sometimes submit the detailed radiation exemption.’’ As noted earlier, a class constraints contained in the regulations, safety information. As a matter of exemption allows for the use under such as a quantity limit for a specific licensing practice, such a custom exemption of a category of products radionuclide, and what can be projected device, if containing more than certain with the safety decision for individual about the life cycle of the product and quantities of radioactive material, is also products made through the licensing how it is used. Some of these registered; however, it only allows for process. The safety review for these evaluations are documented in NUREG/ the use of the custom-made source or products includes evaluating the CR–1775, ‘‘Environmental Assessment device by the specified user. As product against specific safety criteria of Consumer Products Containing § 30.32(g) requires the radiation safety contained in the regulations in 10 CFR Radioactive Material,’’ October 1980 information to be submitted by part 32. The regulations currently (available at the NRC’s electronic applicants to use sealed sources and contain two class exemptions. These are Reading Room, ADAMS Accession No. devices if they are not registered, found in § 30.19, Self-luminous ML082910862), and NUREG–1717, manufacturers and distributors products containing tritium, krypton-85, ‘‘Systematic Radiological Assessment of generally register the sources and or promethium-147, and § 30.20, Gas Exemptions for Source and Byproduct devices that are to be used under a and aerosol detectors containing Materials,’’ June 2001. The applicable specific license. Sealed source or device byproduct material, and equivalent requirements in § 32.14(b) require review and registration are conducted Agreement State regulations. As information to be submitted to allow an for most sealed sources and devices to discussed later in this document, this evaluation of the potential radiation be used under a specific license. proposed rule would establish a third exposure and in accordance with This registration process has also been class exemption for certain industrial § 32.14(d), the NRC makes a extended to many generally licensed products. determination that the byproduct and some exempt products. The In the case of generally licensed material is ‘‘properly contained in the regulations in 10 CFR part 32 contain products, sealed source and device product under the most severe requirements for submittal of radiation registration certificates are issued for conditions that are likely to be safety information concerning these products distributed for use under encountered in normal use and products by the manufacturer or initial §§ 31.3, 31.5, 31.7, and 31.10, and handling.’’ But the information to distributor. Although registration of equivalent Agreement State regulations. support this evaluation of the particular these products by the manufacturer or (Note that this registration is distinct product is not considered necessary to initial distributor is not addressed by and different in scope and purpose from routinely provide to the Agreement the regulations, the NRC’s licensing the registration of devices by some States through the SS & D Registry. practice is to issue registration general licensees under § 31.5(c)(13).) No sealed source and device review is certificates for certain of these products Neither general licensees nor persons conducted for the products used under based on the radiation safety exempt from licensing requirements the general licenses in § 31.8 or § 31.11. information submitted. Also, fees are need to submit any safety information in The general license in § 31.8 is assessed based on whether or not a order to obtain a product. For these specifically for no more than 0.185 MBq ‘‘sealed source and/or device review’’ is products, however, the registration (5 μCi) of americium-241 or radium-226 required. process also serves the important in the form of calibration and reference The products in each of these purpose of providing information to the sources, and applies only to specific categories for which the registration regulators in all jurisdictions. Products licensees. The safety of these sources is process is used as part of the licensing are approved by NRC and, in some also well established, with the

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individual product being reviewed and greater, for beta and/or gamma emitters. the authority to revoke a registration approved in the licensing process. The The limits using current guidance for certificate, if for example, it determines general license in § 31.11 pertains to in- beta/gamma emitters range from 3.7 that the registration is inconsistent with vitro clinical or laboratory testing using MBq (100 μCi) to 370 MBq (10 mCi). current regulatory standards. However, prepackaged units containing certain Thus, for any particular radionuclide, the current regulations do not reference limited quantities of byproduct material, the proposed criterion is no more than this authority. Therefore, § 30.61 is e.g., iodine-125 in units not exceeding ten times higher to ten times lower than being revised to explicitly implement 10 μCi (0.37 MBq). These in vitro kits current practice. As certificates typically the Commission’s authority to modify or are not sealed sources or devices. They cover a large number of radionuclides revoke registration certificates. can be used only by physicians, clinical for this type of sealed source, this As a registration certificate, in laboratories, hospitals, and practitioners change from current practice is not conjunction with the license, authorizes of veterinary medicine who preregister expected to affect the overall number of distribution of a product, a certificate with the Commission and by part 35 registration certificates issued. may be reevaluated at the time of licensees. There is also no SS & D The proposed rule would explicitly license renewal. Generally, this has not registration for the recently added add registration requirements to the been the practice of NRC, but may be general license in § 31.12, which covers regulations for byproduct material in the case for some Agreement States. In only items produced prior to the NRC products used under general licenses the case of licenses authorizing gaining jurisdiction over radium-226. and under exemptions from licensing distribution to exempt persons, a Because there is no allowance for future requirements, as well as for additional limited review of the certificate(s), when production of items to be used under specifically licensed sources and applicable, has typically been this general license, there are no devices for which this is not currently conducted to ensure that the associated distributor requirements and addressed by the regulations. This will information is complete and accurate thus, no requirement for a product to be make it easier for potential applicants with respect to any changes that may registered in the SS & D Registry. These for a license to distribute these products have occurred since issuance of the products are mostly antiquities to determine the applicable certificate. For all types of certificates, it produced before States had regulations requirements and associated fees. These is important that there be consistency similar to NRC’s. proposed provisions are in large part between the license and the Registration certificates are issued for consistent with present licensing certificate(s). most specifically licensed sealed practice. They would appear in The Commission does not believe that sources and devices. The exceptions are §§ 32.22(a)(3)(ii), 32.26(c)(2), 32.30(c)(3), it is necessary to conduct a complete for small calibration and reference 32.51(a)(6), 32.53(f), 32.61(g), reevaluation of sealed sources and sources and for sources and devices to 32.74(a)(4), and 32.210. devices at the time that distribution be used by (1) Broad scope licensees licenses are renewed, usually every 10 A.2 Adding Provisions for under part 33 and equivalent Agreement years, since generally, there are fewer Amendment, Modification and State regulations, (2) research and safety significant aspects that are likely Revocation, Review, and Inactivation of development licensees, and (3) licensees to change reflected in the registration Registration Certificates for whom the source or device was built certificate than those addressed in the to their unique specifications and The Commission is adding a number license. The Commission does recognize contain no more than 740 GBq (20 Ci) of other explicit provisions to the a need to update registration certificates of tritium or 7.4 GBq (200 mCi) of any regulations concerning registration and currently relies, for the most part, other radionuclide. These three certificates. Many certificates are on certificate holders to request categories of licensees must be qualified revised and updated from time to time amendments of certificates, as by training and experience and have as a result of amendment requests made appropriate. One factor is that the NRC sufficient facilities and equipment to by manufacturers or distributors to is required to consider the application safely use and handle the requested accommodate desired changes in a of industry standards, for example, as quantity of radioactive material in any product or associated procedures or to reflected in § 32.210(d). These industry form as indicated in their license(s). add new products to a registration standards may be updated to provide Under these circumstances, licensing certificate covering a series of models. improved safety. Also, licensees are these three types of users does not rely Sections 30.38 and 30.39, which required by § 20.1101 to implement on the inherent safety features of the currently address only amendment of radiation protection programs and to source or device; users will be evaluated licenses, would be revised to also use, to the extent practical, procedures under the criteria in § 30.33(a)(2) and (3) address amendment of registration and engineering controls based upon and licensed to handle equivalent certificates. sound radiation protection principles to quantities of the materials in any form. Unlike specific licenses, registration achieve occupational doses and doses to If the source is registered but not the certificates are not issued with members of the public that are as low device, the users must be licensed to expiration dates. If a significant safety as is reasonably achievable (ALARA). handle equivalent quantities of the issue arises with a product, regulatory Thus, it is appropriate for licensees to materials in unshielded form. means are available to address it, such consider new developments in For specifically licensed calibration as an order issued to a distributor to technology and standards as they may and reference sources, the proposed cease distribution until the safety issue impact ALARA in the design of quantity cutoffs for small sources is resolved. The Commission has products. However, because § 32.210(f) excluded from the requirement for authority to request additional requires the certificate holder to registration are 0.37 MBq (10 μCi) for information or to modify requirements manufacture and distribute products in alpha emitters and 37 MBq (1 mCi) for under the general provisions in accordance with the provisions of the beta and/or gamma emitters. This is a §§ 2.204, 30.34(e), and 30.61. In registration certificate and any simplification from current licensing addition, since the Commission has statements made in the request for practice, which uses a limit of 3.7 MBq authority to revoke a license, and registration, and no reevaluation of a (100 μCi) or ten times the quantity registration is used as part of the source or device, once approved, is specified in § 30.71, whichever is licensing process, the Commission has normally required, the current

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regulatory structure may limit rather restrict further distribution of a State regulations, and thus, the quality than encourage industry improvement. previously approved product. However, of the information concerning current There may be reasons to reevaluate a in a separate action, the Commission distribution available to regulators. sealed source or device in some has proposed to revise § 31.5 to restrict A.3 Adding Flexibility for Licensing circumstances with regard to either the quantities of certain radionuclides that Users of Sealed Sources and Devices actual design of a source or device, or are authorized under the general license such other aspects as quality assurance (August 3, 2009; 74 FR 38372). That As noted, the safety information for or information provided to the user on action would impact the authority to every sealed source and device to be safe use. While the current regulations distribute certain devices. The used under a specific license is not provide adequate authority to do so, Commission therefore seeks comment included in the SS & D Registry. recalling a registration certificate for on how certificates for devices However, the wording of § 30.32(g) has review and reissuance in the absence of previously approved for use under the not allowed as much flexibility as was a significant safety problem with the general license in § 31.5 (and equivalent expected when this provision was product is an activity very rarely Agreement State provisions) should be added to the regulations. In some conducted by NRC in the past. This reevaluated and required to meet such circumstances, it has been impractical proposed rule also includes an explicit new limits. In addition, the Commission or impossible for users to provide all of provision to specifically address such a seeks comments on how the NRC might the information required by § 30.32(g). process in § 32.210(h). The Commission use the proposed provision for review in This has caused some applicants and would complete its evaluation in § 32.210(h) in relation to any changes in licensees renewing their licenses to seek accordance with the criteria specified in standards for products or applicable exemptions from § 30.32(g) for the use § 32.210. As noted under Section III. limits with respect to continued of products for which the manufacturer A.1, ‘‘Updating Regulations to Add distribution, such as under what or distributor has not obtained an SS & Registration Requirements,’’ of this circumstances distribution of a product D registration. document, this proposed rule would should be stopped by a certain date, or In addition to providing criteria in a add specific provisions delineating under what circumstances changes to proposed revision to § 32.210 for which sealed sources and devices must individual certificates might be situations where an SS & D registration be registered in the SS & D, broadening considered on a case-by-case basis. would not be required, revisions to the applicability of § 32.210 to some Currently, registrations in the SS & D § 30.32(g) are also being proposed which generally licensed and exempt products. Registry are kept active until a would accommodate exceptions made The Commission may use the proposed distributor who is no longer distributing in the SS & D registration process. In provision in § 32.210(h) to update the a particular source or device, requests to particular, a proposed § 30.32(g)(4) certificate with respect to applicable change the status. At this point, the would provide that limited information industry standards or current security registration is changed to inactive would be required for the smaller concerns or to ensure the quality of the status, meaning that the covered calibration and reference sources that summary of safety information and the products are no longer authorized to be are not registered. Also included is a information on conditions of use distributed. Annual fees are assessed by proposed provision to allow for licenses contained in the registration certificate NRC only for active registrations. The to be issued without the need for every that is available to the various SS & D registrations are kept individual sealed source or device to be jurisdictions. The Commission indefinitely in inactive status after used to be identified by the applicant. specifically seeks comment on the authorization to distribute has ceased, A proposed § 30.32(g)(5) would allow an circumstances under which such a so that the registration information is applicant to propose constraints on the reevaluation should be made and also available for sources and devices number and type of sealed sources and on how such a reevaluation may be previously distributed and possibly still devices to be used and the conditions conducted with minimum impact to in use. under which they will be used as an industry. Because some States do not have alternative to identifying each sealed The Commission requests comment annual fees for maintaining active source and device individually. on how it might best provide for the SS & D certificates, distributors do not This latter provision is not intended update of registration certificates so as consistently request inactivation of as a broadly applied change in the not to discourage improvement in the certificates, leaving active certificates in approach to licensing the use of sealed design of sources or devices, more the database that do not reflect any sources and devices. This change is readily allow for the application of continued distribution. This somewhat intended to accommodate certain updated industry standards, and ensure limits the information available to other expected situations in which having to that information in the certificates is jurisdictions as to what sources and identify each sealed source or device fully consistent with current practices. devices are authorized for continued presents an undue burden. For example, In addition to the proposed provision in distribution. This rule includes a military applicants are sometimes § 32.210(h), other options could include proposed provision for inactivation unable to identify exactly which reviewing certificates at the time of (§ 32.211), which would require product they may be procuring. This license renewal, in part or in whole; distributors to request inactivation of provision could also be used by the adding separate expiration dates to certificates within 2 years following the types of applicants/licensees identified certificates with typically longer terms last initial transfer of a source or device in proposed § 32.210(g)(2), namely those than licenses, e.g., 10 to 20 years; and covered by the certificate. Two years licensed for research and development explicitly allowing licensees to make was chosen to minimize any impact on (R & D), those licensed under part 33, changes without NRC approval, if these certificate holders. NRC certificate and certain custom users who have changes do not reduce safety margins. holders typically request inactivation of adequate training and experience and Generally, the Commission has not certificates within about a year. This facilities and equipment to handle previously made standards more provision is expected to improve the comparable quantities of material in restrictive with regard to products to be consistency of this approach across other forms. It may also be reasonable to used under a general license or under an jurisdictions through the addition of use such an approach to provide some exemption from licensing, such as to equivalent provisions to Agreement flexibility in the case of calibration and

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reference sources. It is anticipated that However, that amendment limited the considered an unnecessary regulatory except for the R & D licensees, part 33 provision to sealed sources and devices burden and an unnecessary expenditure licensees, and certain custom users, one containing naturally occurring and of user and NRC resources. However, it of the constraints would be that the accelerator-produced radioactive is not clear that each type of device sealed sources and devices are material (NARM), because the scope of would necessarily qualify for exemption registered, as it is generally not practical that rule was limited to such materials. for all of the radionuclides and for an applicant to supply adequate There are, however, a number of legacy quantities used. Therefore, the NRC is information to demonstrate that the sealed sources and devices containing proposing a new class exemption, rather radiation safety properties of pre-EPAct byproduct material, i.e., than attempting to create a number of unspecified sources or devices are byproduct material as defined in section additional product-specific exemptions inherently adequate to protect health 11e.(1) of the AEA, for which it may with appropriate limitations, such as and minimize danger to life and also be impossible to provide all of the radionuclide-specific quantity limits. property. information required under § 32.210(c). The new class exemption in proposed The use of the SS & D registration This rule proposes to extend that § 30.22, covering a broad range of process as a tool for licensing was provision to legacy sources and devices industrial devices, would maintain intended to provide a more efficient and containing any byproduct material, as protection of public health and safety effective licensing process than to have defined in Part 30. and, at the same time, relieve regulatory all users provide detailed information burden. Presently, most of these about the sources and devices to be B. Establish a New Class Exemption for products are licensed under the general used, and for license reviewers to Certain Industrial Products license in § 31.5 and equivalent evaluate the safety of the sources and As noted in the introduction on Agreement State regulations. In order devices in conjunction with the regulatory framework, class exemptions for a product to be distributed for use evaluation of the applicant’s training allow the Commission to exempt under the new class exemption, the and experience and facilities and categories of products or devices with manufacturer or importer would be equipment. The changes proposed to similar characteristics and purposes, required to demonstrate that a particular §§ 30.32(g) and 32.210(g) are intended to rather than requiring individual device meets certain safety criteria, with further improve the efficiency and exemptions for each product. For NRC review and approval. Such a class effectiveness of the licensing process by example, the existing class exemption in exemption would also allow for the eliminating the need for unnecessary § 30.20 for gas and aerosol detectors was development of new products within exemptions for recognized situations established in April 1969. Since that the class or category of industrial that are not unique to a particular time, new products possessing similar devices that could be approved for use applicant. attributes were allowed to be licensed under exemption without the need for for distribution under § 30.20 as they additional rulemaking to add product- A.4 Extending Requirements were developed. This regulatory specific exemptions. Concerning Legacy Sources and Devices structure allowed the new detectors to This approach allows for a broader to All Byproduct Material Covered by be used without product-specific number of devices to be exempted and Part 30 exemptions, which would have required for variations on a product or new In the final rule published October 1, additional rulemaking. The health and products in the class to be approved for 2007 (72 FR 55863), which amended the safety of the public is ensured by use under exemption from licensing Commission’s regulations to incorporate evaluating each specific product against without further need for rulemaking. the new categories of byproduct safety criteria contained in the The exemption may lead to more material added by the Energy Policy Act regulations that apply to all products in devices being developed with of 2005 (EPAct), a revision was made to a class. appropriately low risk that could meet § 30.32(g) to facilitate licensing the use There are a number of products used the criteria for the exemption. Thus, of legacy sealed sources and devices. under the general license in § 31.5 that additional benefit to society may accrue These are older sources and devices for could meet similar safety criteria but do if more people make use of the types of which the manufacturer is no longer in not come under either of the existing products in this class. existence and for which it may be classes, i.e., §§ 30.19 and 30.20. Certain Although some calibration and impossible to provide all of the industrial devices were identified by the reference sources are currently licensed categories of information identified in NRC staff for possible use under an under § 31.5, a clarification is included § 32.210(c), as required by § 30.32(g)(2). exemption from licensing requirements in the proposed exemption that such Generally, that amendment was because of their low risk; i.e., static sources are not covered, since it is more intended to cover sources and devices eliminators and ion generators difficult to assess likely scenarios of manufactured before the promulgation containing polonium-210, beta handling and use for sources not of § 32.210. This provision, in backscatter and transmission devices, incorporated into a specific device with § 30.32(g)(3), delineates additional electron capture detectors for gas a specific purpose; in particular, the information that is required to license chromatographs, x-ray fluorescence number of sources that might be used or the use of a sealed source or device for analyzers, and calibration and reference stored in close proximity is apt to be which all of the information previously sources. Dose assessments were greater and more uncertain. Also, required is not available. The conducted for these categories of calibration and reference sources are information must include a description products assuming use under an frequently used by persons using other of the source or device, a description of exemption from licensing and included radioactive materials under a license, radiation safety features, intended use in NUREG–1717. For each of the types minimizing the benefit of an exemption and associated operating experience, of licensed products suggested for in this case. Many of these are already and results of a recent leak test. The possible use under an exemption and used under the exemption in § 30.18. NRC licensing staff will review the included in the dose evaluations of Some containing americium-241 and submitted information to make a NUREG–1717, some of the products radium-226 are also covered by the licensing decision regarding possession clearly result in doses so low that general license in § 31.8. Therefore, it is and use of the source or device. requiring use under a license could be not believed that the type of exemption

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being proposed is an appropriate CFR part 20, as long as it did not result used in the home would tend to limit regulatory approach for calibration and in a significantly different level of the contribution by these products to reference sources. safety. disposal doses; e.g., the exposures of The proposed exemption would cover The NRC notes that the ICRP issued landfill workers. Nonetheless, the industrial devices with the same list of its latest recommendations in ICRP–103, proposal includes a separate criterion purposes as are covered by the general ‘‘The 2007 Recommendations of the for disposal, 10 μSv (1 mrem)/year. This license in § 31.5 with the exception of International Commission on criterion is lower than the proposed that of producing light. The existing Radiological Protection.’’ The specific criterion for routine use, because the class exemption for self-luminous dose conversion factors based on those same individuals are apt to be exposed products is considered adequate and recommendations have not yet been to all products disposed in any appropriate to provide for exempt use of calculated. However, as the safety particular landfill or municipal products of this type. criteria for the class exemption are incinerator. The proposed exemption of industrial design criteria, it is preferable to have Accident criteria would be similar to products would have a lower dose the flexibility to use the latest those for products to be used under criterion for routine use than that information on estimating risks. §§ 30.19 and 30.20. The higher of these associated with the general license and For the purposes of these provisions, limits, that for the lowest probability would include consideration of a definition of a generic term for accident, is also used in the safety potential doses from disposal. Devices internal dose, ‘‘committed dose,’’ would criteria for the general license in § 31.5, used under § 31.5 must be returned to be added to § 32.2 to encompass this under which many of the devices a specific licensee, such as a vendor or approach, which includes weighting of potentially covered by the proposed waste broker, and ultimately disposed of organ doses, but not strictly under one new class exemption are currently used as low-level radioactive waste. Under system. [§ 32.51(a)(2)(iii)]. However, the The proposed dose criterion for the proposed exemption from licensing proposed safety criteria for the new routine use of these devices is 200 μSv requirements, there would be no class exemption include additional (20 mrem)/year, which is significantly controls on disposal; the devices would criteria to ensure that the radionuclide be disposed without regard to their higher than that for gas and aerosol quantities allowed for use under the radioactivity. Thus, the potential detectors (5 mrem (50 μSv)/year). This exemption are limited, such that the impacts of uncontrolled disposal would exemption would cover industrial type maximum possible dose is controlled, need to be evaluated in the licensing devices, used almost exclusively on the even if the circumstances leading to process for each particular device. job, meaning that routine doses will The proposed safety criteria are normally be occupational, i.e., doses such a dose are extremely improbable. similar to the current criteria for received by individuals in the course of The accident criteria currently in licensing the manufacture or employment in which the individual’s § 32.23(d), § 32.24, Column IV, distribution of gas and aerosol detectors assigned duties involve exposure to § 32.27(c), § 32.28, Column III, and (contained in §§ 32.27 and 32.28). radiation or to radioactive material. In a § 32.51(a)(2)(iii) were expected to limit However, those criteria include more small proportion of cases, a user might the total amount of radioactive material organ-specific limits, because they were not be a worker, but a student, for likely to be approved for use under the based on the dose limitation example. However, these instances are relevant exemption or general license, methodology recommended by the likely to involve a limited amount of irrespective of the design to contain or International Commission on Radiation time for exposure over the year, shield the material. However, designs to Protection (ICRP) in 1959 in ICRP–2, reducing doses to these types of users. contain the material even under severe ‘‘Report of ICRP Committee II on Due to the industrial purpose of the conditions of use or accident have Permissible Dose for Internal Radiation,’’ devices, these products are not expected resulted in relatively large quantities of whereas more recently developed to be sold in the large quantities materials being approved in some cases. approaches to radiation protection rely possible for consumer products, such as Although the risk is well controlled by less on individual organ dose limits or smoke detectors. Therefore, these these designs, possible scenarios of constraints, particularly when doses are products would contribute to the doses misuse or malicious use are not required low, and include weighting organ dose of many fewer people. Doses to to be evaluated. contributions to overall dose. These members of the public would generally For this new exemption, a proposed newer approaches involve calculating be smaller, usually much less than that criterion would require that specific doses in total effective dose equivalent to the user. scenarios of misuse be analyzed and as in 10 CFR part 20, based on ICRP– In order to provide reasonable shown to meet certain dose limits. The 26, ‘‘Recommendations of the assurance that members of the public analysis required to meet this misuse International Commission on are not routinely exposed to more than criterion would be relatively simple. Radiological Protection,’’ or effective a few mrem/year (few 10’s of μSv/year), Evaluating actual risk from possible dose, based on the subsequent the proposal would also include a misuse or malicious use would be much recommendations of the ICRP. The criterion that the device is unlikely to be more difficult, but such risks would be proposed safety criteria for the new routinely used by members of the limited by this proposed criterion. The class exemption would not require that general public in a non-occupational proposed criterion is 100 mSv (10 rem), the exposures be estimated specifically environment. The Commission’s policy plus an additional skin dose criterion. in terms of total effective dose for consumer products is for the general This criterion is slightly lower than the equivalent (TEDE) or effective dose. public to receive no more than a small accident criterion of 15 rem (150 mSv) The intent is that generally the most fraction of the public dose limit from applicable to products covered by the up-to-date dose calculation exempt products, so that their exposures existing class exemptions and the methodology would be used, and that from all sources are not likely to general license in § 31.5. The proposed the approach would allow for future routinely exceed the public dose limit, criterion is considered to be a more updates. However, the staff would which is now 100 mrem (1 mSv)/year. appropriate value given the high level of normally accept the use of another The fact that industrial products are uncertainty in estimates of doses under method such as that now reflected in 10 not as widely used as items commonly accident conditions.

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Limiting the radionuclide quantities benefit. ‘‘Designed to protect life or actions. As a result of competing allowed for use under the exemption, property from fires and airborne priorities for staff effort at the time, that even if well contained, has the hazards’’ would be replaced with, rule was never finalized. additional benefits of: (1) Minimizing ‘‘designed to protect health, safety, or Although these products have a long risks associated with devices becoming property.’’ This would allow other history of use, there have been relatively subject to scrap metal recycling, such as potential applications under an existing few licensed distributors. Nonetheless, property damage due to contamination regulatory framework, which has safety this situation has caused some resulting from smelting; (2) further criteria designed to adequately protect confusion in the licensing process. The controlling overall impacts to waste public health and safety. Commission is proposing to change this disposal workers; (3) minimizing overall general license into an exemption from D. Update the Regulations on Certain impacts to the environment from licensing in § 30.15(a)(2). The current Static Eliminators and Ion Generating uncontrolled disposal of products used licensed distributor would not be Tubes under exemptions from licensing; and required to amend its license, but any (4) minimizing the potential problems of Section 31.3 provides a general future distributors would come under products exempted by NRC being license for certain static eliminators and the distributor provisions associated detected at and sometimes rejected for ion generating tubes. The static with § 30.15; i.e., §§ 32.14, 32.15, and disposal in landfills and municipal eliminators distributed for use under 32.16. This change is intended to have incinerators by State and local this provision include those intended no effect on any current distributor or restrictions. for use by the general public. There are user of these products, only to remove In addition, a fixed limit for no requirements associated with this an inconsistency in the regulations and radionuclides of concern for security, in general license; however, the provision to make any future licensing decisions terms of a small fraction of the Category does not explicitly contain an in this regard more efficient and 2 threshold as listed in Appendix E of exemption from parts 19, 20, and 21. effective. Part 20 (which is based on the Nonetheless, the Commission has With respect to the issue of International Atomic Energy Agency generally treated products covered by requirements for sealed source and (IAEA) Code of Conduct on the Safety this provision as if the users were device review, this change would and Security of Radioactive Sources), is exempt from licensing. Distribution remove the need for a registration also included (in proposed § 32.30(c)(4)) must be authorized only by NRC and certificate if these products are to further ensure that the quantities of not by the Agreement States. There are distributed under the authority of a these radionuclides in exempt products no distribution requirements specified license issued under § 32.14. The are not such that they would be a in part 32. Distributors are licensed licensing practice of using the sealed practical source of obtaining radioactive under Part 30, with particular license source and device review and materials in quantities sufficient to conditions related to distribution registration process for products to be cause significant harm. determined on a case-by-case basis. used under the general license in § 31.3 Reporting requirements in licenses have primarily resulted from the lack of C. Remove Unnecessary Limitations been similar to exempt distribution specific requirements for a distribution From the Class Exemption for Gas and reporting requirements. license in the regulations. Thus, Aerosol Detectors This inconsistency results from the § 32.210 provided the types of The class exemption in § 30.20 is for fact that the use of the static eliminators information to be provided concerning gas and aerosol detectors ‘‘designed to covered by this general license predated the product for NRC review. protect life or property from fires and the regulations in 10 CFR parts 19, 20, airborne hazards.’’ At the time that this 21, 30, and 32. The general license for E. Remove Prescriptive Requirements for exemption was added to the regulations, static eliminators was first issued in part Distributors of Generally Licensed the applications of these types of 30 in the 1950s shortly before the Devices and Exempt Products devices under consideration were formalization of radiation protection The Commission has determined that smoke detectors and devices to detect requirements was completed by the requirements for manufacturers or chemicals that would constitute an issuance of part 20. Therefore, the initial distributors of exempt and airborne hazard if inhaled. The words original general license did not include generally licensed products are in some ‘‘designed to protect life or property an exemption from part 20. Training cases overly prescriptive, particularly in from fires and airborne hazards’’ were requirements were separated from part the areas of prototype testing and included to ensure that the products 20 and issued in part 19 at a later date. acceptance sampling/quality control provided a clear societal benefit. The ion generating tubes covered by (QC) procedures. The current Products similar to those allowed, but paragraph (d) of § 31.3 were also prescriptive approach is easy to not quite fitting the ‘‘class,’’ cannot be covered by the general license in part 30 implement and regulate, but is relatively approved for use under this exemption. prior to the recodification of byproduct inflexible. When evaluating a new or For example, drug detectors were material regulations into 10 CFR parts redesigned product, the NRC requires rejected for distribution for use under 30, 31, 32, 33, 34, 35, and 36 in 1965. prototype testing to validate the design this exemption because they do not The general licenses for byproduct of products and their ability to contain specifically protect life or property from material were moved from part 30 to byproduct material. Acceptance fires or airborne hazards. The NRC part 31 at that time. sampling (a specific QC process) believes that there is a clear societal In 1971 (36 FR 6015; April 1, 1971), monitors the effectiveness of the benefit from this application and the Commission proposed to change this manufacturing process for safety- allowing its use under the exemption general license to an exemption, and significant parts to minimize the would be justified, as long as a also to expand it into a class exemption likelihood of failures and events caused particular device meets the applicable under which additional static by inadequate manufacturing quality. safety standards. A minor modification, elimination devices and ion generating This proposed rule is intended to therefore, is proposed to allow for a tubes with differing radionuclides and focus the regulations on performance, slightly broader class of product without quantities could be approved for use rather than procedures. The regulations eliminating the expectation of a societal under the exemption through licensing would retain general requirements and

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provide general standards by which choose to follow current prototype test ‘‘Ice detection devices containing performance may be judged, rather than procedures, as they would satisfy the strontium-90’’); and specifying detailed procedures that outcomes required by this proposed rule • Section 32.110, ‘‘Acceptance must be followed, except for products in every situation. The specific sampling procedures under certain for which oversight of these activities procedures would be removed from the specific licenses.’’ would no longer be required as regulations and included as example The prescriptive requirements for discussed under Section III.F., ‘‘Make acceptable procedures in guidance acceptance sampling/quality control the Requirements for Distributors of documents. procedures pertaining to manufacturers Exempt Products More Risk-Informed.’’ In the case of generally licensed of exempt products are paragraphs The NUREG–1556 series of documents products, regulations that contain (a)(2), (a)(3), and (c)(2) of § 32.15, ‘‘Same: provides guidance to licensees and prescriptive requirements for prototype Quality assurance, prohibition of applicants on acceptable approaches to testing are: transfer, and labeling.’’ (‘‘Same’’ refers to meeting these requirements. • Paragraph (d)(4) of § 32.53, ‘‘Certain items containing byproduct The procedures included in the ‘‘Luminous safety devices for use in material.’’) current regulatory requirements are aircraft: Requirements for license to These all include specified generally acceptable to meet the manufacture, assemble, repair or procedures; §§ 32.15(a) and (c), 32.55(b) proposed performance-based initially transfer,’’ standard to pass tests and (d), and 32.62(c) and (e) specifically requirements. Safety benefits of the described in § 32.101; refer to § 32.110. proposed changes in this area would • Paragraph (d)(2) of § 32.57, The NRC intends to allow acceptance primarily be gained indirectly by ‘‘Calibration or reference sources sampling to be performance-based, removing overly burdensome and containing americium-241 or radium- rather than specifying procedural possibly counterproductive 226: Requirements for license to details. Section 32.110 provides that a procedures—and more importantly, by manufacture or initially transfer,’’ random sample shall be taken from each accommodating the use of new standard to pass tests described in inspection lot of specified licensed technologies. The intent is for the § 32.102; devices for which testing is required in proposed regulatory requirements to be • Paragraph (e)(4) of § 32.61, ‘‘Ice accordance with the appropriate equivalent to the current practices detection devices containing strontium- sampling table in that section. If the (except as noted), so that existing 90; requirements for license to number of defectives in the sample does licensees would not have to change manufacture or initially transfer,’’ not exceed the acceptance number in their procedures as a result of this standard to pass tests described in the appropriate sampling table, the lot rulemaking. However, the provisions are § 32.103; shall be accepted, while if the number written so that applicants and licensees • Section 32.101, ‘‘Schedule B— of defectives exceeds the acceptance would have flexibility in the methods prototype tests for luminous safety number, the entire inspection lot shall that they use to determine the design devices for use in aircraft’’; be rejected. There is no longer a need for quality (prototype tests) and • Section 32.102, ‘‘Schedule C— NRC to maintain the acceptance manufacturing quality (acceptance prototype tests for calibration or sampling tables in § 32.110, which sampling/QC) of these products. In reference sources containing americium- provides the number of acceptable keeping with international best 241 or radium-226’’; and defective units in various lot sizes for a manufacturing standards, manufacturers • Section 32.103, ‘‘Schedule D— variety of Lot Tolerance Percent and the distributors that represent them prototype tests for ice detection devices Defective values. Note: Lot Tolerance are expected to maintain a quality containing strontium-90.’’ Percent Defective is defined in § 32.2 as management system that stresses No prescriptive prototype testing the poorest quality in an individual continual improvement. Examples of requirements pertaining to inspection lot that should be accepted. such system requirements can be found manufacturers of exempt products The table in § 32.110(b)(6) Lot Tolerance in ISO 9001:2000, ‘‘Quality Management remain in the regulations, as they have Percent Defective 5.0 percent correlates Systems—Requirements,’’ and, unique been previously removed. Most with the standard in the above cited to the nuclear safety field, IAEA Safety recently, §§ 32.14(d)(2) and 32.40 were regulations. However, the other seven Series No. 50–C/SG–Q, ‘‘Quality removed by a rule published October tables in § 32.110 apparently have been Assurance for Safety in Nuclear Power 16, 2007 (72 FR 58473). little used since their publication in Plants and Other Nuclear Installations, 1974, as there are no specific standards Code and Safety Guides Q1–Q14.’’ Acceptance Sampling and Quality in Part 32 requiring Lot Tolerance While the focus of ISO 9001:2000 is on Control Procedures Percent Defectives other than 5 percent. customer satisfaction, and the primary In the case of generally licensed Licensees can now easily use widely focus of the IAEA series is on nuclear products, regulations that contain available computer software to facility safety, these documents contain prescriptive requirements for determine their own acceptance some quality management concepts that acceptance sampling/quality control sampling procedures to best monitor are appropriate to the distribution of procedures are: their manufacturing processes. This rule generally licensed and exempt products • Paragraphs (a) though (d) of § 32.55, would remove § 32.110. Acceptance containing byproduct material. ‘‘Same: Quality assurance; prohibition of sampling criteria would continue to be transfer’’ (‘‘Same’’ refers to ‘‘Luminous specified in §§ 32.15, 32.55, and 32.62, Prototype Test Procedures safety devices for use in aircraft’’); specifying the values required for This rule proposes to simplify current • Section 32.59, ‘‘Same: Leak testing quality (Lot Tolerance Percent prescriptive regulations for prototype of each source’’ (‘‘Same’’ refers to Defective) and confidence. Section testing for new products proposed for ‘‘Calibration or reference sources 32.59 requires leak testing of each use under general license. The proposed containing americium-241 or radium- source for calibration or reference provisions include only those aspects 226’’); sources containing americium-241 or that are results-oriented, rather than • Paragraphs (a) through (e) of radium-226 generally licensed under specifying detailed procedures that § 32.62, ‘‘Same: Quality assurance; § 31.8, rather than sampling of lots. This must be followed. An applicant may prohibition of transfer’’ (‘‘Same’’ refers to rule does not propose to change that

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provision other than providing minor tested in such a way as to demonstrate • Leak testing all units to 185 Bq clarifications. compliance with the required measures (0.005 μCi). Presently, the NRC requires the of quality assurance, the entire lot • Testing all units for proper affected categories of licensees to should be rejected. The proposed rule operation of all safety features. perform acceptance sampling in would require that distribution of any • Verifying that, for all units, the accordance with § 32.110 or propose part, or sub-lot, of a rejected lot must be radiation levels do not exceed the alternative procedures (under § 32.15(b), in accordance with procedures spelled maximum values stated in the § 32.55(c), or § 32.62(d)) which provide out in the license, and that testing after application. a Lot Tolerance Percent Defective of 5.0 repairs must be performed by an The proper treatment and definition percent at a consumer’s risk of 0.10. independent reviewer. The provision for of lots is essential from a statistical This ‘‘consumer’s risk’’ criterion is an independent reviewer is a proposed perspective, and relevant to acceptance equivalent to 90 percent confidence that new requirement, but it is an IAEA sampling procedures. For the purposes the Lot Tolerance Percent Defective will recommendation, and may have been of acceptance sampling, a ‘‘lot’’ should not be exceeded. The applicant’s quality used voluntarily as an industry best consist of homogeneous products control procedures, including any practice. IAEA recommends that, based manufactured from the same or similar alternate procedures proposed, are on sound statistical theory, depending machines, interchangeable in terms of reviewed and approved by NRC. The on the safety significance of the their intended use or function. proposed rule would not change the 5 defective item or lot, the independent Similarly, from a statistical perspective, percent criterion for Lot Tolerance reviewer may be a different inspector a sampling plan must demonstrate Percent Defective (i.e., 95 percent from the one that performed the original certain characteristics to sufficiently acceptance). The current value of sampling, or an inspector from a third guarantee quality: Manufacturer consumer risk of 10 percent is more party. In the case of the products for compliance with predetermined lot relaxed than others used by NRC, such which these changes are being sizes, sample sizes, sampling as in inspections, which use standards proposed, the risk is low and it is methodology, and acceptance criteria; agreement with a one-time decision to of no more than 5 percent defective at sufficient for the independent inspector accept or reject a lot in its entirety; 5 percent risk. The proposed rule would to simply be another qualified separate, predetermined treatment of revise the acceptance sampling standard employee. Individual worker sub-lots; and the calculation and to no more than 5 percent risk, accountability plays an important role reporting of separate measures for expressed as ‘‘95 percent confidence,’’ in an effective quality assurance (QA) quality and for confidence. It should be for those categories of products for program, and an independent reviewer, emphasized, however, that the which the acceptance criteria are besides adding another layer of regulatory requirement for acceptance specified in the regulations. The term assurance that the sub-lot or part is sampling is not an attempt to control ‘‘confidence’’ is now more commonly acceptable, would add accountability to overall product quality, but to minimize used in this context. the program. Most of NRC’s statistical acceptance the possibility that a distributed product criteria today B such as in inspections The sampling plan will normally be has inadequate or malfunctioning safety B are, at least, 95 percent acceptance detailed in the license, which will features. with 95 percent confidence. Raising the ensure that the quality assurance In summary, this proposed rule would required confidence level from 90 program is systematic and planned revise the cited paragraphs concerning percent to 95 percent may be an where justified, such as for lot sizes, prototype testing and quality control, increase in burden, but is justified, sample sizes, criteria, and procedures. including specific sampling because the current standard is The primary source of current guidance requirements, to make these inconsistent with other agency on quality control and quality assurance requirements for distributors more practices, as well as industry standards. is NUREG–1556, Volume 3, Rev. 1, flexible and performance-based rather However, it is expected that because of ‘‘Consolidated Guidance About than prescriptive. Guidance on quality the nature of the products covered by Materials Licenses, Applications for assurance methods is included in these regulations, the lot sizes apt to be Sealed Source and Device Evaluation NUREG–1556, Volume 3, Revision 1, used, and other factors, the proposed and Registration.’’ This guidance including specifically Appendix G. revision is unlikely to change the indicates that NRC may accept a Less prescriptive, more flexible, approaches used by the limited number certificate of accreditation in lieu of a performance-based regulations would of current licensees under these full set of QA/QC plans or procedures. continue to specify performance provisions. The vendor providing certification requirements. Generally, the specific Another proposed change in NRC’s must, however, make the commitment procedures being removed from the acceptance sampling regulations is a that the generic QA/QC program regulations would continue to be clarification of the prohibition on the includes provisions which address the considered acceptable. The NRC transfer of any defective lot. The specific requirements in the regulations normally evaluates products using prohibition of transfer of rejected lots, for the fabrication of the sealed sources radiation safety criteria in accepted currently appearing in §§ 32.15(c)(2), or devices. Depending on the specific industry standards. If these standards 32.55(d)(2), and 32.62(e)(2), would be requirements of the fabrication process, and criteria do not readily apply to a revised. Currently, the prohibition of such provisions would include: particular case, NRC formulates transfer appears to apply only to • Verifying that the design conforms reasonable standards and criteria in individual items found to be defective, fully with the statements and consultation with the manufacturer or rather than addressing all items in a commitments submitted in support of distributor. References to appropriate sampled lot that do not meet the the application (including materials, industry and consensus standards are acceptance standard. As proposed, these dimensions within stated tolerances, included in NUREG–1556, Volume 3, revisions concerning rejected lots would manufacturing methods, assembly Rev. 1, Appendix F. Updated guidance appear in §§ 32.15(b)(2), 32.55(d)(2), and methods, labeling), using sampling would be provided when a new or 32.62(e)(2). From a statistical methods that meet applicable revised industry standard becomes standpoint, unless a lot is sampled and provisions, such as § 32.55. available that NRC considers more

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appropriate. The licensee would be free Although it may be possible to The NRC used NUREG–1717 as a to propose alternative methods to those develop an explicit approach to allow primary resource concerning estimates presented in industry standards and for removal of oversight of these types of doses that result from the guidance, provided that the methods of procedures for some of the products distribution, use, maintenance and provide sufficient evidence that all distributed under the class exemptions, repair, disposal, and accidents involving safety related components are capable of the burden of these requirements is not these products. The NRC considered the performing their intended functions. so great that the effort to develop a extent to which these doses might be Current licensees would need to make specific procedure for this did not seem affected if the lack of oversight over any necessary upgrade to their QC worthwhile. Applicants and licensees prototype testing resulted in a product programs when the rule becomes do nonetheless have the option to seek design that was less effective in effective. However, because license an individual specific exemption under containing or shielding the byproduct conditions are written broadly, it is not § 30.11 from any requirement applicable material. The NRC also considered the expected that any such changes in the to the use of byproduct material. extent that doses or probability of QC program would be inconsistent with The NRC evaluated the inherent accidents could be affected if the lack of an existing license (or registration potential for radiation exposures from oversight of quality control/quality certificate). Any changes needed in the products containing byproduct material assurance significantly reduced the license to better ensure consistency with used under product-specific exemptions effectiveness of licensees’ programs in the revised requirements would likely and the likelihood of increases in risks this area. This assessment was semi- be made at the time of the next license if oversight of the subject procedures qualitative as there is no data available renewal or related amendment of the were removed. The product-specific on products used without regulatory license. exemptions appear in § 30.15. There are control, which could support a F. Make the Requirements for currently four types of products listed in quantitative probabilistic risk Distributors of Exempt Products More that provision for which future assessment. This proposed rule would eliminate Risk-Informed distribution is allowed, specifically NRC oversight for these types of To a large extent, NRC applies similar timepieces, ionization chamber smoke detectors, electron tubes, and ionizing activities for a few of the exempt requirements throughout Part 32 on products as not justified, based on risk. manufacturers and distributors of all radiation measuring instruments. (Note that in the discussion under Section Requirements to submit information on categories of products, irrespective of prototype tests in § 32.14(b)(4) would be III.D., ‘‘Update the Regulations on the quantity of byproduct material eliminated for products exempt under Certain Static Eliminators and Ion within or the risk of a product. § 30.15(a)(7) and (8), ionization chamber Generating Tubes,’’ the Commission is However, given the low risk of some smoke detectors and electron tubes proposing to add another exemption to exempt products, some of the existing respectively. This requirement would § 30.15.) The requirements of this type requirements may be unnecessary, and also be eliminated for timepieces under for manufacturers and distributors of not commensurate with the associated § 30.15(a)(1) containing promethium- products used under § 30.15 are risk. This is particularly true in the 147 or tritium in the form of gaseous contained in: § 32.14(b)(4), on submittal areas of prototype testing and quality tritium light sources. Oversight of of information on prototype test control requirements for products to be quality control/quality assurance would used under exemptions from licensing. procedures used and the results; be eliminated for these same products as The NRC considered whether some of § 32.14(b)(5), on submittal of quality well as for products to be used under the products used under an exemption control procedures to be used; and the new exemption in § 30.15(a)(2), from licensing present such low levels §§ 32.15(a)(2) and (a)(3) and 32.110, on static eliminators and ion generating of radiation exposures, both routinely specific sampling procedures for quality tubes formerly covered by the general and in the event of accidents, that control. Paragraph 32.15(c) also contains license in § 31.3. This is in a proposed continued NRC oversight of the specific a prohibition on transferring any revised § 32.14(b)(5), which would prototype tests and/or the quality defective lot or item to exempt persons. require that quality control procedures control/quality assurance to be applied Even without NRC’s continuing be submitted for approval only for by the manufacturer or distributor oversight of these procedures, licensees ionizing radiation measuring would not be warranted. would be motivated to retain them as instruments and timepieces containing Although many products distributed good business practices. There are a tritium in the form of paint. Other under the class exemptions would likely number of factors that would likely requirements in the application for a meet such a low-risk standard, the cause manufacturers and distributors to license to distribute these products Commission does not believe it prudent continue to conduct prototype testing would remain, such as the submittal to eliminate any of these requirements and at least some form of quality (under § 32.14(b)) and evaluation for the class exemptions. The safety control/assurance. In some cases, (§ 32.14(d)) of basic design features criteria for each class exemption are functionality testing closely aligns with intended to contain the byproduct intended to ensure that the risks testing for containment of radioactive material. associated with any product approved material. The consideration of risk for Based on the assessment of the for use under the associated exemption these products, however, did not rely on inherent safety of these products, it is are quite low. Nonetheless, because of this expectation, beyond some estimated that even if a lack of the nature of a class exemption to allow reasonable bounding assumptions about appropriate prototype testing resulted in for new products to be approved, it is the likelihood and consequences of lower quality product designs in the not possible to conclude that distributing defective products. For future or poor quality control resulted in elimination of oversight of prototype example, failures that result in degradation of production quality, the testing or quality control procedures for functional failure may happen more potential increases in individual doses an entire class of products is prudent. frequently, but it is not reasonable to would be less than 10μSv (1 mrem)/year The evaluation of the safety of the assume that manufacturers would in any situation where significant individual product may depend on continue to distribute a large percentage numbers of products could be affected. knowledge of such procedures. of defective devices over long periods. Also, in the extreme case of a significant

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change in future distributor behavior, (a) Under what circumstances should the number of products likely to some individual doses could be proposed § 32.210(h) be used to require accumulate in one place in the dose increased by somewhat higher amounts a reevaluation? How should such a assessments for all scenarios? in non-routine situations. Overall, reevaluation be conducted with 3. Expanding the class exemption for considering both potential increases in minimum impact to industry? gas and aerosol detectors in § 30.20 by doses and the probability of (b) How might registration certificates revising the requirement of ‘‘designed to circumstances resulting in those best be updated so as not to discourage protect life or property from fires and increases, the potential incremental risk improvement in the design of sources or airborne hazards’’ to instead be is estimated to be insignificant. devices, more readily allow for the ‘‘designed to protect health, safety, or Unnecessary regulatory burden on application of updated industry property’’ (Discussed in Section III. C.): distributors of these products would be standards, and ensure that information (a) Are there additional products that reduced. Because, as noted above, in the certificates is fully consistent may be exempted under this expanded licensees are not likely to eliminate with current practices? (For example, in definition of the class not specifically such procedures as a result of addition to the proposed provision in considered by the NRC? discontinued NRC oversight, the § 32.210(h), other options could include (b) Are these words adequate to benefits assumed are only those reviewing certificates at the time of ensure that products present a clear associated with eliminating the license renewal, in part or in whole; societal benefit? (c) Are there any potential problems submittal of testing/sampling adding separate expiration dates to with approving additional products for procedures for review and approval, certificates with typically longer terms use under this exemption and later eliminating the submittal of prototype than licenses, e.g., 10 to 20 years; and reevaluating the safety criteria testing results, and allowing added explicitly allowing licensees to make changes without NRC approval, if these associated with this exemption for flexibility to change procedures in potential alignment with newer response to other factors, including changes do not reduce safety margins.) (c) How should certificates for recommendations of the ICRP? competitive demands for continuous 4. Changes to certain quality control quality improvement, without NRC previously approved devices be handled if the device does not meet current requirements in §§ 32.15, 32.55, and permission. standards, such as in the case of the 32.62 to (i) raise the statistical Current licensees authorized to separately proposed (August 3, 2009; 74 acceptance criteria; i.e., increasing the distribute products affected by this FR 38372) quantity limit in the general required confidence that the Lot change would need to amend their license in § 31.5 (and comparable Tolerance Percent Defective will not be license in order to not be held Agreement State provisions)? How exceeded from the current 90 percent accountable for continuing to follow the should registration certificates be (consumer risk of 0.10) to 95 percent; QC/QA program as delineated in their handled in this situation? (For example, and (ii) require that distribution of any license. This would be a simple in some cases, the distributor may be part, or sub-lot, of a rejected lot must be amendment as the regulations would be able to limit the quantity of affected in accordance with procedures spelled clear that this license condition is no radionuclides, rather than change its out in the license and that testing after longer required. certificate to one for specifically repairs must be performed by an The NRC does not currently believe licensed devices.) independent reviewer (Discussed in that any similar requirements for (d) In general, how might the NRC use Section III. E.). These proposed submitting information on such the proposed provision for review in revisions are in § 32.15(a) and (b) for procedures for generally licensed § 32.210(h) in relation to changes in certain exempt items, § 32.55(b) and (d) devices are candidates for revocation standards for products or limits in for luminous safety devices used in based on risk, as the safety of these addressing continued distribution and aircraft, and § 32.62(c) and (e) for ice devices generally relies on the design the timing for changes to the authority detection devices.: and manufacturing process quality to a to distribute tied to the registration (a) Would any actual changes in greater degree than for these exempt certificate? practice need to be made by affected products. This is less so in the case of 2. New class exemption for industrial licensees? The NRC would welcome calibration and reference sources used products in § 30.20 (Discussed in information that would aid in under § 31.8 and the risk directly Section III. B.): evaluating any impact. associated with these sources may be (a) Is the 20 mrem/year routine dose (b) Would there be any impact on sufficiently low to consider removing criterion appropriate, given that users manufacturers or distributors of oversight of prototype testing or quality are workers, but there is no control of products for which oversight of quality control, particularly given the general conditions of use once a product is control practices are proposed to be license’s applicability only to distributed for use under an exemption removed, if the new provisions were specifically licensed persons. However, from license? applied to these products instead, i.e., if problems with leakage or significant (b) Would it be appropriate to apply all of the exceptions in § 32.14(b)(5) variation of quantities would affect the certain aspects of the proposed were not made effective as proposed? use of these sources so as to indirectly standards for this class exemption to the (As discussed under Section III. F. affect health and safety of other safety criteria (§§ 32.23 and 32.27) for ‘‘Make the Requirements for Distributors activities. the existing class exemptions (§§ 30.19 of Exempt Products More Risk- and 30.20), namely, the use of more up- Informed,’’ products for which quality G. Specific Questions for Comment to-date methodology for dose control oversight may be removed are: The NRC invites comments on any assessment as reflected in the proposed Ionization chamber smoke detectors, aspect of this proposed rule, but has definition of the term ‘‘committed dose,’’ electron tubes, and timepieces these specific questions for the inclusion of a misuse scenario and/ containing promethium-147 or tritium consideration: or a specific quantity limit to control in the form of gaseous tritium light 1. Updating of registration certificates quantities that may meet the safety sources, covered by exemptions in in the SS & D Registry (Discussed in criteria when a source is well contained § 30.15, and for products to be used Section III. A.2): and shielded, and the consideration of under the proposed new exemption in

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§ 30.15(a)(2), static eliminators and ion 10 CFR 30.32(g)(3)—Would extend 10 CFR 32.22—Would add an explicit generating tubes formerly covered by the provision for providing alternative requirement for sealed source and the general license in § 31.3.) information on NARM legacy sealed device registration. 5. Proposal in § 30.32(g)(5) to allow sources and devices to all legacy sealed 10 CFR 32.26—Would revise the some licenses to specify only sources and devices. introductory text to expand the constraints on the number and type of 10 CFR 30.32(g)(4)—Would add a limitation of ‘‘from fires or airborne sealed sources and devices to be used provision for providing limited hazards,’’ for the purpose of the and the conditions under which they information for certain calibration and detectors, thus, expanding the class of are to be used (Discussed in Section III. reference sources. products covered; and would add an A.3): 10 CFR 30.32(g)(5)—Would add a explicit requirement for sealed source (a) In view of the expectation that this provision to allow for constraints on the and device registration. authorization would only be granted in number and type of sealed sources and 10 CFR 32.30—Would establish limited situations and due to special devices to be used and the conditions requirements for an application to circumstances, how can NRC make it under which they are to be used rather manufacture, process, produce, or clear that approval of this approach than requiring complete identification initially transfer for sale or distribution would be at the NRC’s discretion, rather of all sealed sources and devices to be exempt industrial devices. than this being an open-ended option licensed. 10 CFR 32.31—Would establish safety for anyone, or should the regulation 10 CFR 30.38—Would add an explicit criteria for approving industrial devices specify when this approach is provision for amendment of registration to be distributed for use under 10 CFR acceptable? certificates. 30.22 and equivalent Agreement State (b) Are there other situations besides 10 CFR 30.39—Would add regulations. 10 CFR 32.32—Would establish those discussed, when identifying all of registration certificates to clarify that the specific conditions of license for the sealed sources and devices to be same requirements are applicable to distribution of exempt industrial licensed is particularly impractical? amendment of a registration certificate as for issuance of a new certificate. devices, including quality control, H. Minor Clarifying or Administrative 10 CFR 30.61—Would add labeling, and reporting and Revisions registration certificates to provisions for recordkeeping requirements. 10 CFR 32.51(a)(6)—Would add an Other minor revisions are proposed to modification and revocation of licenses explicit requirement for sealed source better organize, clarify, or update the and update reference to Parts under and device registration for devices to be regulations in these parts, such as the which licenses are issued. 10 CFR 31.3—General license would transferred for use under 10 CFR 31.5 renaming of subparts C and D and the be removed, section reserved, and and equivalent Agreement State movement of §§ 32.72 and 32.74 from replaced by a new exemption in 10 CFR regulations. subpart B to subpart C. These two 30.15(a)(2). 10 CFR 32.53—Would remove the sections would be moved because they 10 CFR 31.23—Would remove reference to 10 CFR 32.101 and add do not cover generally licensed items. reference to 10 CFR 31.3 and make other requirements for prototype testing Minor conforming amendments are minor corrections. without details of procedures to be included in Parts 40 and 70 because the 10 CFR 32.1—Would expand the followed; would revise the requirement delineation of the delegation of description of the scope of 10 CFR Part for information to be submitted on licensing programs to the Regions is 32 to cover additional requirements and quality control/quality assurance to be written broadly in these parts. All such make clarifications. consistent with less prescriptive revisions are noted in the following 10 CFR 32.2—Would add definitions approach in 10 CFR 32.55; would add section. of ‘‘committed dose’’ and ‘‘sealed source an explicit requirement for sealed IV. Summary of Proposed Amendments and device registry.’’ source and device registration. by Section 10 CFR 32.8—Would add to the list of 10 CFR 32.55—Would revise the information collection requirements: 10 requirement to conduct quality 10 CFR 30.6(b)(1)(iv)—Would add a CFR 32.30 on application requirements assurance to be clearer and less reference to new 10 CFR 32.30 as a for distributors of exempt industrial prescriptive and revise the acceptance licensing category not delegated to the devices, 10 CFR 32.31 on safety criteria criterion. NRC Regions. to be addressed in the application for 10 CFR 32.56—Would add ATTN: 10 CFR 30.15(a)(2)—Would add an license under 10 CFR 32.30, 10 CFR GLTS to address for reporting, explicitly exemption for certain static eliminators 32.32 on reporting and recordkeeping require reports to Agreement States, and and ion generators in place of the requirements for distributors of exempt clarify the need for reporting even if no general license in 10 CFR 31.3. industrial devices, and 10 CFR 32.211 transfers were made during the 10 CFR 30.19(b)—Would clarify that on requesting inactivation of registration reporting period. applicants under 10 CFR 32.22 should certificates. 10 CFR 32.57(d)(2) and (e)—Would also apply for a registration certificate. 10 CFR 32.14(b)(4)—Would make remove reference to 10 CFR 32.102 and 10 CFR 30.20—Would slightly expand exceptions to prototype testing add less prescriptive requirement for the class of products covered under this requirements. prototype testing in paragraph (e). exemption from licensing; would clarify 10 CFR 32.14(b)(5)—Would make 10 CFR 32.59—Would make minor that applicants under 10 CFR 32.26 exceptions to quality control clarifying amendments to testing should also apply for a registration requirements. requirements for calibration and certificate; would update parts of the 10 CFR 32.15(a), (b), and (c)—Would reference sources to be used under 10 regulations from which persons are remove the specific procedural CFR 31.8 and equivalent Agreement exempt to include 10 CFR Part 19. requirements for quality assurance, State regulations. 10 CFR 30.22—Would establish a new revise the acceptance criterion, and 10 CFR 32.61(e)(4) and (f)—Would class exemption for industrial devices limit these requirements to products for revise the prototype test requirement by initially transferred from 10 CFR 32.30 which such procedures would be removing reference to 10 CFR 32.103 licensees. required under 10 CFR 32.14. and adding less prescriptive

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requirement for prototype testing in 10 CFR 32.210(h)—Would add an in the regulation of agreement material paragraph (f). explicit provision for additional review on a nationwide basis. Compatibility 10 CFR 32.61(g)—Would add an of registration certificates. Category B are those program elements explicit requirement for sealed source 10 CFR 32.211—Would add an that apply to activities that have direct and device registration. explicit provision for inactivation of and significant effects in multiple 10 CFR 32.62(c), (d), and (e)—Would sealed source and device registration jurisdictions. An Agreement State revise and clarify quality assurance certificates. should adopt Category B program requirements, acceptance criterion, and 10 CFR 32.303(b)—Would add elements in an essentially identical associated prohibition of transfer. reference to new requirements not manner. Compatibility Category C are Heading of Subpart C would be issued under section 223 of the AEA, as those program elements that do not changed to ‘‘Specifically Licensed well as correct previous omissions. Items.’’ 10 CFR 40.5(b)(1)(iv)—Would add meet the criteria of Category A or B, but 10 CFR 32.72 and 10 CFR 32.74 reference to new 10 CFR 32.30 as a the essential objectives of which an would be moved from Subpart B to licensing category not delegated to the Agreement State should adopt to avoid renamed Subpart C. NRC Regions. conflict, duplication, gaps, or other 10 CFR 32.74(a)(4)—Would add an 10 CFR 70.5(b)(1)(iv)—Would add conditions that would jeopardize an explicit requirement for sealed source reference to new 10 CFR 32.30 as a orderly pattern in the regulation of and device registration for sealed licensing category not delegated to the agreement material on a national basis. sources and devices for medical use. NRC Regions. An Agreement State should adopt the 10 CFR 32.101—Specific prototype essential objectives of the Category C V. Criminal Penalties test procedures for luminous safety program elements. Compatibility devices for use in aircraft would be For the purpose of Section 223 of the Category D are those program elements removed. Atomic Energy Act (AEA), the 10 CFR 32.102—Specific prototype that do not meet any of the criteria of Commission is proposing to amend 10 Category A, B, or C, above, and, thus, do test procedures for calibration and CFR parts 30 and 32 under one or more reference sources containing americium- not need to be adopted by Agreement of Sections 161b, 161i, or 161o of the States for purposes of compatibility. 241 or radium-226 would be removed. AEA. Willful violations of the rule 10 CFR 32.103—Specific prototype Compatibility Category NRC are those would be subject to criminal test procedures for ice detection devices program elements that address areas of enforcement. containing strontium-90 would be regulation that cannot be relinquished removed. VI. Agreement State Compatibility to the Agreement States under the 10 CFR 32.110—Specific acceptance Under the ‘‘Policy Statement on Atomic Energy Act of 1954, as amended, sampling procedures would be Adequacy and Compatibility of or provisions of Title 10 of the Code of removed. Agreement State Programs’’ approved by Federal Regulations (CFR). These Heading of Subpart D would be the Commission on June 30, 1997, and program elements should not be changed to ‘‘Sealed Source and Device adopted by the Agreement States. H&S ’’ published in the Federal Register on Registration. are program elements that are required 10 CFR 32.201—Would be moved September 3, 1997 (62 FR 46517), NRC from Subpart D to renamed Subpart C. program elements (including because of a particular health and safety 10 CFR 32.210(a) and (e)—Would regulations) are placed into role in the regulation of agreement remove restriction of applicability to compatibility categories A, B, C, D, NRC material within the State and should be specifically licensed items. or adequacy category Health and Safety adopted in a manner that embodies the 10 CFR 32.210(b)—Would add ATTN: (H&S). Compatibility Category A are essential objectives of the NRC program. SSDR to address for requests. those program elements that are basic The proposed rule would be a matter 10 CFR 32.210(d)—Would add radiation protection standards and of compatibility between the NRC and scientific terms and definitions that are reference to other criteria which apply the Agreement States, thereby providing necessary to understand radiation to various categories of sealed sources consistency among Agreement State and and devices. protection concepts. An Agreement NRC requirements. The proposed 10 CFR 32.210(g)—Would add criteria State should adopt Category A program for sources and devices not requiring elements in an essentially identical compatibility categories are designated SS & D registration. manner in order to provide uniformity in the following table:

COMPATIBILITY TABLE

Compatibility Section Change Subject Existing New

30.6(b)(1)(iv) ...... Amend ...... Communications ...... D ...... D 30.15(a)(2) ...... Add ...... Certain items containing byproduct material ...... B 30.19(b) ...... Amend ...... Self-luminous products containing tritium, krypton-85, or B ...... B promethium-147. 30.20 ...... Amend ...... Gas and aerosol detectors containing byproduct material .. B ...... B 30.22 ...... New ...... Certain industrial devices ...... B 30.32(g)(3) ...... Amend ...... Application for specific licenses ...... C ...... C 30.32(g)(4) ...... Add ...... Application for specific licenses ...... C 30.32(g)(5) ...... Add ...... Application for specific licenses ...... C 30.38 ...... Amend ...... Application for amendment of licenses and registration D ...... D certificates. 30.39 ...... Amend ...... Commission action on applications to renew or amend ..... D ...... D 30.61 ...... Amend ...... Modification and revocation of licenses and registration D ...... D certificates.

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COMPATIBILITY TABLE—Continued

Compatibility Section Change Subject Existing New

31.3 ...... Remove ...... [Existing title—Certain devices and equipment] ...... B ...... ★ 31.23(b) ...... Amend ...... Criminal penalties ...... D ...... D 32.1(a) ...... Amend ...... Purpose and scope ...... D ...... D 32.2 ...... Add ...... Definition: Committed dose ...... NRC 32.2 ...... Add ...... Definition: Sealed source and device registry ...... D 32.8(b) ...... Amend ...... Information collection requirements: OMB approval ...... D ...... D 32.14(b)(4) and (b)(5) ...... Amend ...... Certain items containing byproduct material; requirements NRC ..... NRC for license to apply or initially transfer. 32.15(a), (b), and (c) ...... Amend ...... Same: Quality assurance, prohibition of transfer, and la- NRC ..... NRC beling. 32.22(a)(3) ...... Add ...... Self-luminous products containing tritium, krypton-85 or NRC ..... NRC promethium-147: Requirements for license to manufac- ture, process, produce, or initially transfer. 32.26 ...... Amend ...... Gas and aerosol detectors containing byproduct material: NRC ..... NRC Requirements for license to manufacture, process, produce, or initially transfer. 32.30 ...... New ...... Certain industrial devices containing byproduct material: ...... NRC Requirements for license to manufacture, process, produce, or initially transfer. 32.31 ...... New ...... Certain industrial devices containing byproduct material: ...... NRC Safety criteria. 32.32 ...... New ...... Conditions of licenses issued under § 32.30: Quality con- ...... NRC trol, labeling, and reports of transfer. 32.51(a)(6) ...... Add ...... Byproduct material contained in devices for use under ...... B § 31.5; requirements for license to manufacture, or ini- tially transfer. 32.53(b)(5) and (d)(4) ...... Amend ...... Luminous safety devices for use in aircraft: Requirements B ...... B for license to manufacture, assemble, repair or initially transfer. 32.53(e) and (f) ...... Add ...... Luminous safety devices for use in aircraft: Requirements B ...... B for license to manufacture, assemble, repair or initially transfer. 32.55 ...... Amend ...... Same: Quality assurance, prohibition of transfer ...... B ...... B 32.56 ...... Amend ...... Same: Material transfer reports ...... B ...... B 32.57(d)(2) ...... Amend ...... Calibration or reference sources containing americium-241 B ...... B or radium-226: Requirements for license to manufacture or initially transfer. 32.57(e) ...... Add ...... Calibration or reference sources containing americium-241 B ...... B or radium-226: Requirements for license to manufacture or initially transfer. 32.59 ...... Amend ...... Same: Leak testing of each source ...... B ...... B 32.61(e)(4) ...... Amend ...... Ice detection devices containing strontium-90; require- B ...... B ments for license to manufacture or initially transfer. 32.61(f) and (g) ...... Add ...... Ice detection devices containing strontium-90; require- ...... B ments for license to manufacture or initially transfer. 32.62(c), (d), and (e) ...... Amend ...... Same: Quality assurance; prohibition of transfer ...... B ...... B 32.74(a)(4) ...... Add ...... Manufacture and distribution of sources or devices con- ...... B taining byproduct material for medical use. 32.101 ...... Remove ...... [Existing title—Schedule B—prototype tests for luminous B ...... ★ safety devices for use in aircraft]. 32.102 ...... Remove ...... [Existing title—Schedule C—prototype tests for calibration B ...... ★ or reference sources containing americium-241 or ra- dium-226]. 32.103 ...... Remove ...... [Existing title—Schedule D—prototype tests for ice detec- B ...... ★ tion devices containing strontium-90]. 32.110 ...... Remove ...... [Existing title—Acceptance sampling procedures under B ...... ★ certain specific licenses]. 32.210(a), (b), (d), and (e) .... Amend ...... Registration of product information ...... B ...... B ★★ ...... ★★ 32.210(g) and (h) ...... Add ...... Registration of product information ...... B ★★ 32.211 ...... New ...... Inactivation of certificates of registration of sealed sources ...... B and devices. ★★ 32.303(b) ...... Amend ...... Criminal penalties ...... D ...... D 40.5(b)(1)(iv) ...... Amend ...... Communications ...... D ...... D 70.5(b)(1)(iv) ...... Amend ...... Communications ...... D ...... D ★ Denotes regulations that are designated Compatibility Category B but which will be removed from the regulations as a result of these pro- posed amendments. Agreement States should remove these provisions from their regulations when the regulations become final. ★★ D—for States that do not perform SS & D evaluations.

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VII. Plain Language product-specific exemption, broaden an responses + 6 recordkeepers) + (NRC The Presidential Memorandum ‘‘Plain existing class exemption, add flexibility Form 313—15 responses)] The estimated number of annual Language in Government Writing’’ to the basis for licensing the use of respondents: 44 (25 NRC licensees + 19 published June 10, 1998 (63 FR 31883), sealed sources and devices, and remove some requirements for the distributors Agreement State licensees) directed that the Government’s An estimate of the total number of documents be in clear and accessible of low risk exempt products. The Commission has concluded that none of hours needed annually to complete the language. The NRC requests comments requirement or request: 951 hours [10 on this proposed rule specifically with these actions would have significant impacts to the environment or otherwise CFR Part 32—957 (351 reporting + 606 respect to the clarity and effectiveness recordkeeping) + (NRC Form 313— of the language used. Comments should include any condition requiring consultation under section 102(2)(C) of decrease of 6 hours reporting)] be sent to the address listed under the Abstract: The NRC is proposing to ADDRESSES heading. NEPA. The determination of this amend its regulations to make VIII. Voluntary Consensus Standards Environmental Assessment is that there requirements for distributors of byproduct material clearer, less The National Technology Transfer will be no significant impact to the prescriptive, and more risk-informed and Advancement Act of 1995 (Pub. L. public from this action. However, the and up to date. The Commission is also 104–113) requires that Federal agencies general public should note that the NRC proposing to redefine categories of use technical standards that are welcomes public participation. devices to be used under exemptions, developed or adopted by voluntary Comments on any aspect of the add explicit provisions regarding the consensus standards bodies unless the Environmental Assessment may be sealed source and device registration use of such a standard is inconsistent submitted to the NRC as indicated process, and add flexibility to the with applicable law or otherwise under the ADDRESSES heading. The NRC has sent a copy of the licensing of users of sealed sources and impractical. In this proposed rule, the Environmental Assessment and this devices. This action is primarily NRC would make the requirements for proposed rule to every State Liaison intended to make licensing processes distributors of byproduct material Officer and requested their comments more efficient and effective. These clearer, less prescriptive, and more risk- on the Environmental Assessment. The changes would affect manufacturers and informed and up to date. The Environmental Assessment may be distributors of sources and devices Commission is also proposing to examined on http:// containing byproduct material and redefine categories of devices to be used www.regulations.gov and at the NRC future users of some products currently under exemptions, add explicit Public Document Room, O–1F21, 11555 used under general or specific license. provisions regarding the sealed source Rockville Pike, Rockville, MD 20852. The NRC is seeking public comment and device registration process, and add Single copies of the Environmental on the potential impact of the flexibility to the licensing of users of Assessment may be obtained from information collections contained in sealed sources and devices. This action Catherine R. Mattsen, Office of Federal this proposed rule and on the following does not constitute the establishment of and State Materials and Environmental issues: a standard that establishes generally Management Programs, U.S. Nuclear 1. Is the proposed information applicable requirements. However, the Regulatory Commission, Washington, collection necessary for the NRC to regulations being amended concerning DC 20555–0001, telephone 301–415– properly perform its functions? Does the sealed source and device reviews, in 6264, e-mail, information have practical utility? particular § 32.210(d), would continue [email protected]. 2. Is the burden estimate accurate? to indicate that the NRC uses accepted 3. Is there a way to enhance the industry standards, if applicable, in its X. Paperwork Reduction Act Statement quality, utility, and clarity of the evaluations. This proposed rule would contain information to be collected? IX. Finding of No Significant new or amended information collection 4. How can the burden of the Environmental Impact: Availability requirements that are subject to the information collection be minimized, Paperwork Reduction Act of 1995 (44 including the use of automated The Commission has determined U.S.C. 3501, et seq.). This proposed rule collection techniques or other forms of under the National Environmental has been submitted to the Office of information technology? Policy Act of 1969, as amended (NEPA), Management and Budget for review and A copy of the OMB clearance package and the Commission’s regulations in approval of the information collection may be viewed free of charge at the NRC subpart A of 10 CFR Part 51, not to requirements. Public Document Room, One White prepare an environmental impact Type of submission, new or revision: Flint North, 11555 Rockville Pike, Room statement for this proposed rule because Revision. O–1F21, Rockville, MD 20852. The the Commission has concluded on the The title of the information collection: OMB clearance package and rule are basis of an environmental assessment 10 CFR Parts 30, 31, 32, 40, and 70, available at the NRC World Wide Web that this proposed rule, if adopted, Requirements for Distribution of site: http://www.nrc.gov/public-involve/ would not be a major Federal action Byproduct Material, Proposed Rule doc-comment/omb/index.html for 60 significantly affecting the quality of the The form number if applicable: NRC days after the signature date of this human environment. The following is a Form 313 notice. summary of the Environmental How often the collection is required: Send comments on any aspect of Assessment: Many of the individual One time; annual; and occasional. these proposed regulations related to actions being proposed are the type of Who will be required or asked to information collections, including actions described in the categorical report: Applicants and licensees who suggestions for reducing the burden and exclusions of §§ 51.22(c)(2) and manufacture or initially distribute on the above issues, by July 26, 2010, to 51.22(c)(3)(i) and (iii). In addition, the sealed sources and devices, and some Information Services Branch (T–5 F52), proposed rule would remove users of those sources and devices. U.S. Nuclear Regulatory Commission, prescriptive procedural provisions, add An estimate of the number of annual Washington, DC 20555–0001, or by a new class exemption and a new responses: 58 [(10 CFR part 32—37 Internet electronic mail to

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[email protected], and to 121. However, none of the proposed equipment, Security measures, Special Christine J. Kymn, Desk Officer, Office revisions to the regulatory program nuclear material. of Information and Regulatory Affairs, would result in a significant economic For the reasons set out in the NEOB–10202 (3150–0017, 3150–0001, impact on the affected entities. preamble and under the authority of the and 3150–0120), Office of Management XIII. Backfit Analysis Atomic Energy Act of 1954, as amended; and Budget, Washington, DC 20503. the Energy Reorganization Act of 1974, Comments on the proposed information The NRC’s backfit provisions are as amended; and 5 U.S.C. 553, the NRC collections may also be submitted via found in the regulations at §§ 50.109, is proposing to adopt the following the Federal eRulemaking Portal https:// 52.39, 52.63, 52.83, 52.98, 52.145, amendments to 10 CFR parts 30, 31, 32, www.regulations.gov, Docket No. NRC– 52.171, 70.76, 72.62, and 76.76. The 40, and 70. 2008–0338. Comments received after requirements contained in this proposed this date will be considered if it is rule do not involve any provisions that PART 30—RULES OF GENERAL practical to do so, but assurance of would impose backfits on nuclear APPLICABILITY TO DOMESTIC consideration cannot be given to power plant licensees as defined in 10 LICENSING OF BYPRODUCT comments received after this date. You CFR parts 50 or 52, or on licensees for MATERIAL may also e-mail comments to gaseous diffusion plants, independent [email protected] or spent fuel storage installations or 1. The authority citation for part 30 comment by telephone at (202) 395– special nuclear material as defined in 10 continues to read as follows: 4638. CFR parts 70, 72 and 76, respectively, Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, Public Protection Notification and as such a backfit analysis is not required. Therefore, a backfit analysis sec. 234, 83 Stat. 444, as amended (42 U.S.C. The NRC may not conduct or sponsor, need not be prepared for this proposed 2111, 2112, 2201, 2232, 2233, 2236, 2282); and a person is not required to respond secs. 201, as amended, 202, 206, 88 Stat. rule to address these classes of entities. 1242, as amended, 1244, 1246 (42 U.S.C. to, a request for information or an With respect to licenses issued under information collection requirement 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 parts 30, 31, and 32, the NRC has (44 U.S.C. 3504 note); sec. 651(e), Pub. L. unless the requesting document determined that there are no applicable 109–58, 119 Stat. 806–810 (42 U.S.C. 2014, displays a currently valid OMB control provisions for backfit. Therefore, a 2021, 2021b, 2111). number. backfit analysis need not be prepared for Section 30.7 also issued under Pub. L. 95– XI. Regulatory Analysis this proposed rule to address parts 30, 601, sec. 10, 92 Stat. 2951 as amended by 31, or 32 licensees. Pub. L. 102–486, sec. 2902, 106 Stat. 3123 (42 The Commission has prepared a draft U.S.C. 5851). Section 30.34(b) also issued regulatory analysis on this proposed List of Subjects under sec. 184, 68 Stat. 954, as amended (42 regulation. The analysis examines the U.S.C. 2234). Section 30.61 also issued under 10 CFR Part 30 costs and benefits of the alternatives sec. 187, 68 Stat. 955 (42 U.S.C. 2237). considered by the Commission. Byproduct material, Criminal 2. In § 30.6, paragraph (b)(1)(iv) is The Commission requests public penalties, Government contracts, revised to read as follows: comment on the draft regulatory Intergovernmental relations, Isotopes, analysis. Comments on the draft Nuclear materials, Radiation protection, § 30.6 Communications. analysis may be submitted to the NRC Reporting and recordkeeping * * * * * as indicated under the ADDRESSES requirements. (b) * * * heading. The analysis is available for (1) * * * 10 CFR Part 31 inspection on http:// (iv) Distribution of products www.regulations.gov and in the NRC Byproduct material, Criminal containing radioactive material to Public Document Room, 11555 penalties, Labeling, Nuclear materials, persons exempt under §§ 32.11 through Rockville Pike, Rockville, MD 20852. Packaging and containers, Radiation 32.30. Single copies of the Regulatory Analysis protection, Reporting and recordkeeping * * * * * may be obtained from Catherine R. requirements, Scientific equipment. 3. In § 30.15, paragraph (a)(2) is added Mattsen, Office of Federal and State 10 CFR Part 32 to read as follows: Materials and Environmental Management Programs, U.S. Nuclear Byproduct material, Criminal § 30.15 Certain items containing Regulatory Commission, Washington, penalties, Labeling, Nuclear materials, byproduct material. DC 20555–0001, telephone 301–415– Radiation protection, Reporting and (a) * * * 6264, e-mail, recordkeeping requirements. (2)(i) Static elimination devices which [email protected]. contain, as a sealed source or sources, 10 CFR Part 40 byproduct material consisting of a total XII. Regulatory Flexibility Certification Criminal penalties, Government of not more than 18.5 MBq (500 μCi) of In accordance with the Regulatory contracts, Hazardous materials polonium-210 per device. Flexibility Act of 1980 (5 U.S.C. 605(b)), transportation, Nuclear materials, (ii) Ion generating tubes designed for the Commission certifies that this rule Reporting and recordkeeping ionization of air that contain, as a sealed would not, if promulgated, have a requirements, Source material, source or sources, byproduct material significant economic impact on a Uranium. consisting of a total of not more than substantial number of small entities. A 18.5 MBq (500 μCi) of polonium-210 per 10 CFR Part 70 significant number of the licensees device or of a total of not more than 1.85 affected by this action would meet the Criminal penalties, Hazardous GBq (50 mCi) of hydrogen-3 (tritium) definition of ‘‘small entities’’ set forth in materials transportation, Material per device. the Regulatory Flexibility Act or the control and accounting, Nuclear (iii) Such devices authorized before Small Business Size Standards set out in materials, Packaging and containers, (insert effective date of this rule) for use regulations issued by the Small Radiation protection, Reporting and under the general license then provided Business Administration at 13 CFR Part recordkeeping requirements, Scientific in § 31.3 and equivalent regulations of

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Agreement States and manufactured, gauging or controlling thickness, registration of safety information in tested, and labeled by the manufacturer density, level, interface location, accordance with § 32.210(g)(1) of this in accordance with the specifications radiation, leakage, or qualitative or chapter, the applicant may supply only contained in a specific license issued by quantitative chemical composition, or the manufacturer, model number, and the Commission. for producing an ionized atmosphere, radionuclide and quantity; or * * * * * any person is exempt from the (5) Propose constraints on the number 4. In § 30.19, paragraph (b) is revised requirements for a license set forth in and type of sealed sources and devices to read as follows: section 81 of the Act and from the to be used and the conditions under regulations in parts 19, 20, 21, 30 which they will be used, as an § 30.19 Self-luminous products containing through 36, and 39 of this chapter to the alternative to identifying each sealed tritium, krypton-85, or promethium-147. extent that such person receives, source and device individually. * * * * * possesses, uses, transfers, owns, or * * * * * (b) Any person who desires to acquires byproduct material, in these 8. Section 30.38 is revised to read as manufacture, process, or produce, or certain detecting, measuring, gauging, or follows: initially transfer for sale or distribution controlling devices and certain devices self-luminous products containing for producing an ionized atmosphere, § 30.38 Application for amendment of tritium, krypton-85, or promethium-147 and manufactured, processed, licenses and registration certificates. for use under paragraph (a) of this produced, or initially transferred in Applications for amendment of a section, should apply for a license accordance with a specific license license shall be filed on Form NRC–313 under § 32.22 of this chapter and for a issued under § 32.30 of this chapter, in accordance with § 30.32 and shall certificate of registration in accordance which license authorizes the initial specify the respects in which the with § 32.210 of this chapter. transfer of the device for use under this licensee desires its license to be * * * * * section. This exemption does not cover amended and the grounds for the 5. Section 30.20 is revised to read as sources not incorporated into a device, amendment. Applications for follows: such as calibration and reference amendment of sealed source and device sources. registration certificates shall be filed in § 30.20 Gas and aerosol detectors (b) Any person who desires to accordance with § 32.210 of this chapter containing byproduct material. manufacture, process, produce, or and any other applicable provisions and (a) Except for persons who initially transfer for sale or distribution shall specify the respects in which the manufacture, process, produce, or industrial devices containing byproduct licensee desires its certificate to be initially transfer for sale or distribution material for use under paragraph (a) of amended and the grounds for the gas and aerosol detectors containing this section, should apply for a license amendment. byproduct material, any person is under § 32.30 of this chapter and for a 9. Section 30.39 is revised to read as exempt from the requirements for a certificate of registration in accordance follows: license set forth in section 81 of the Act with § 32.210 of this chapter. and from the regulations in parts 19, 20, 7. In § 30.32, paragraph (g)(3) is § 30.39 Commission action on applications to renew or amend. 21, and 30 through 36 and 39 of this revised and paragraphs (g)(4) and (g)(5) chapter to the extent that such person are added to read as follows: In considering an application to receives, possesses, uses, transfers, renew or amend a license or to amend owns, or acquires byproduct material in § 30.32 Application for specific licenses. a sealed source or device registration gas and aerosol detectors designed to * * * * * certificate, the Commission will apply protect health, safety, or property, and (g) * * * the applicable criteria set forth in manufactured, processed, produced, or (3) For sources or devices § 30.33 and parts 32 through 36 and 39 initially transferred in accordance with manufactured before (insert effective of this chapter. a specific license issued under § 32.26 date of this rule) that are not registered 10. Section 30.61 is revised to read as of this chapter, which license authorizes with the Commission under § 32.210 of follows: the initial transfer of the product for use this chapter or with an Agreement State, and for which the applicant is unable to § 30.61 Modification and revocation of under this section. licenses and registration certificates. (b) Any person who desires to provide all categories of information manufacture, process, or produce gas specified in § 32.210(c) of this chapter, (a) The terms and conditions of each and aerosol detectors containing the applicant must provide: license and registration certificate byproduct material, or to initially (i) All available information identified issued under the regulations in this part transfer such products for use under in § 32.210(c) of this chapter concerning and parts 31 through 36 and 39 of this paragraph (a) of this section, should the source, and, if applicable, the chapter shall be subject to amendment, apply for a license under § 32.26 of this device; and revision, or modification by reason of chapter and for a certificate of (ii) Sufficient additional information amendments to the Act, or by reason of registration in accordance with § 32.210 to demonstrate that there is reasonable rules, regulations, and orders issued in of this chapter. assurance that the radiation safety accordance with the terms of the Act. 6. Section 30.22 is added under the properties of the source or device are (b) Any license or registration undesignated heading Exemptions to adequate to protect health and minimize certificate may be revoked, suspended, read as follows: danger to life and property. Such or modified, in whole or in part, for any information must include a description material false statement in the § 30.22 Certain industrial devices. of the source or device, a description of application or any statement of fact (a) Except for persons who radiation safety features, the intended required under section 182 of the Act, manufacture, process, produce, or use and associated operating or because of conditions revealed by initially transfer for sale or distribution experience, and the results of a recent such application or statement of fact or industrial devices containing byproduct leak test; or any report, record, or inspection or material designed and manufactured for (4) For sealed sources and devices other means that would warrant the the purpose of detecting, measuring, allowed to be distributed without Commission to refuse to grant a license

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or registration certificate on an original byproduct material for sale or 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, application, or for violation of, or failure distribution to: 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, to observe any of the terms and (i) Persons exempted from the 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, provisions of the Act or of any rule, licensing requirements of part 30 of this 32.74, 32.201, 32.210, and 32.211. regulation, or order of the Commission. chapter, or equivalent regulations of an * * * * * (c) Except in cases of willfulness or Agreement State; or 18. In § 32.14, paragraphs (b)(4) and those in which the public health, (ii) Persons generally licensed under (b)(5) are revised to read as follows: interest, or safety requires otherwise, no part 31 of this chapter or equivalent license or registration certificate shall be regulations of an Agreement State; or § 32.14 Certain items containing modified, suspended, or revoked unless, (iii) Persons licensed under part 35 of byproduct material; requirements for before the institution of proceedings this chapter. license to apply or initially transfer. therefor, facts or conduct that may (2) This part prescribes requirements * * * * * warrant such action shall have been for the issuance of specific licenses to (b) * * * called to the attention of the licensee in persons who introduce byproduct (4) Except for electron tubes and writing and the licensee shall have been material into a product or material ionization chamber smoke detectors and given an opportunity to demonstrate or owned by or in the possession of a timepieces containing promethium-147 achieve compliance with all lawful licensee or another, and regulations or tritium in the form of gaseous tritium requirements. governing holders of such licenses. light sources, procedures for and results (3) This part prescribes certain of prototype testing to demonstrate that PART 31—GENERAL DOMESTIC requirements governing holders of the byproduct material will not become LICENSES FOR BYPRODUCT licenses to manufacture or distribute detached from the product and that the MATERIAL items containing byproduct material. byproduct material will not be released (4) This part describes procedures and to the environment under the most 11. The authority citation for Part 31 prescribes requirements for the issuance severe conditions likely to be continues to read as follows: of certificates of registration (covering encountered in normal use of the Authority: Secs. 81, 161, 183, 68 Stat. 935, radiation safety information about a product; 948, 954, as amended (42 U.S.C. 2111, 2201, product) to manufacturers or initial (5) In the case of ionizing radiation 2233); secs. 201, as amended, 202, 88 Stat. transferors of sealed sources or devices measuring instruments and timepieces 1242, as amended, 1244 (42 U.S.C. 5841, containing sealed sources. 5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. containing tritium in the form of paint, * * * * * quality control procedures to be 3504 note); sec. 651(e), Pub. L. 109–58, 119 16. In § 32.2, the definitions of Stat. 806–810 (42 U.S.C. 2014, 2021, 2021b, followed in the fabrication of 2111). Committed dose and Sealed Source and production lots of the product and the Device Registry are added in quality control standards the product § 31.3 [Removed and Reserved] alphabetical order to read as follows: will be required to meet; 12. Section 31.3 is removed and § 32.2 Definitions. * * * * * reserved. 19. In § 32.15, paragraph (c) is 13. In § 31.23, paragraph (b) is revised * * * * * Committed dose means the radiation removed and reserved and paragraphs to read as follows: dose that will accumulate over time as (a) and (b) are revised to read as follows: § 31.23 Criminal penalties. a result of retention in the body of § 32.15 Same: Quality assurance, * * * * * radioactive material. For the purposes of prohibition of transfer, and labeling. this part, committed dose is a generic (b) The regulations in part 31 that are (a) Each person licensed under § 32.14 term for internal dose and means not issued under sections 161b, 161i, or for products for which quality control committed effective dose equivalent, as 161o for the purposes of section 223 are procedures are required must: defined in part 20 of this chapter, or as follows: §§ 31.1, 31.2, 31.4, 31.9, (1) Maintain quality assurance 31.22, and 31.23. committed effective dose as defined by the International Commission on systems in the manufacture of the part or product, or the installation of the part PART 32—SPECIFIC DOMESTIC Radiation Protection. into the product, in a manner sufficient LICENSES TO MANUFACTURE OR * * * * * to provide reasonable assurance that the TRANSFER CERTAIN ITEMS Sealed Source and Device Registry safety-related components of the CONTAINING BYPRODUCT MATERIAL means the national registry that contains distributed products are capable of all the registration certificates, generated performing their intended functions; 14. The authority citation for Part 32 by both NRC and the Agreement States, (2) Subject inspection lots to continues to read as follows: that summarize the radiation safety acceptance sampling procedures, by Authority: Secs. 81, 161, 182, 183, 68 Stat. information for the sealed sources and procedures specified in the license 935, 948, 953, 954, as amended (42 U.S.C. devices and describe the licensing and issued under § 32.14, to provide at least 2111, 2201, 2232, 2233); sec. 201, 88 Stat. use conditions approved for the 95 percent confidence that the Lot 1242, as amended (42 U.S.C. 5841); sec. 1704, product. Tolerance Percent Defective of 5.0 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 17. In § 32.8, paragraph (b) is revised 651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 percent will not be exceeded; and to read as follows: U.S.C. 2014, 2021, 2021b, 2111). (3) Visually inspect each unit in 15. In § 32.1, paragraph (a) is revised § 32.8 Information collection inspection lots. Any unit which has an to read as follows: requirements: OMB approval. observable physical defect that could * * * * * adversely affect containment of the § 32.1 Purpose and scope. (b) The approved information byproduct material shall be considered (a)(1) This part prescribes collection requirements contained in a defective unit. requirements for the issuance of specific this part appear in §§ 32.11, 32.12, (b) No person licensed under § 32.14 licenses to persons who manufacture or 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, shall transfer to other persons for use initially transfer items containing 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, under § 30.15 of this chapter or

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equivalent regulations of an Agreement 22. Section 32.30 is added under (11) Procedures for prototype testing State: Subpart A to read as follows: of the device to demonstrate the (1) Any part or product tested and effectiveness of the containment, found defective under the criteria and § 32.30 Certain industrial devices shielding, and other safety features containing byproduct material: procedures specified in the license Requirements for license to manufacture, under both normal and severe issued under § 32.14, unless the process, produce, or initially transfer. conditions of handling, storage, use, and defective part or product has been disposal of the device; An application for a specific license repaired or reworked, retested, and (12) Results of the prototype testing of to manufacture, process, produce, or found by an independent inspector to the device, including any change in the initially transfer for sale or distribution meet the applicable acceptance criteria; form of the byproduct material devices containing byproduct material or contained in the device, the extent to for use under § 30.22 of this chapter or (2) Any part or product contained which the byproduct material may be equivalent regulations of an Agreement within any lot that has been sampled released to the environment, any State will be approved if: and rejected as a result of the increase in external radiation levels, and (a) The applicant satisfies the general procedures in paragraph (a)(2) of this any other changes in safety features; requirements of § 30.33 of this chapter: section, unless: (13) The estimated external radiation However, the requirements of (i) A procedure for defining sub-lot doses and committed doses resulting § 30.33(a)(2) and (a)(3) do not apply to size, independence, and additional from the intake of byproduct material in an application for a license to transfer testing procedures is contained in the any one year relevant to the safety byproduct material in such industrial license issued under § 32.14; and criteria in § 32.31 and the basis for these devices manufactured, processed, or (ii) Each individual sub-lot is estimates; sampled, tested, and accepted in produced under a license issued by an (14) A determination that the accordance with the procedures Agreement State; probabilities with respect to the doses (b) The applicant submits sufficient specified in paragraphs (a)(2) and referred to in § 32.31(a)(4) meet the information relating to the design, (b)(2)(i) of this section and any other criteria of that paragraph; manufacture, prototype testing, quality criteria that may be required as a (15) Quality control procedures to be control procedures, labeling or marking, condition of the license issued under followed in the fabrication of and conditions of handling, storage, use, § 32.14. production lots of the devices and the (c) [Reserved] and disposal of the industrial devices to quality control standards the devices demonstrate that the device will meet * * * * * will be required to meet; and the safety criteria set forth in § 32.31. (16) Any additional information, 20. In § 32.22, paragraph (a)(3) is The information should include: added to read as follows: including experimental studies and (1) A description of the device and its tests, required by the Commission. § 32.22 Self-luminous products containing intended use or uses; (c)(1) The Commission determines tritium, krypton-85 or promethium-147: (2) The type and quantity of that the device meets the safety criteria Requirements for license to manufacture, byproduct material in each unit; in § 32.31. process, produce, or initially transfer. (3) Chemical and physical form of the (2) The device is unlikely to be (a) * * * byproduct material in the device and routinely used by members of the (3)(i) The Commission determines changes in chemical and physical form general public in a non-occupational that the device meets the safety criteria that may occur during the useful life of environment. in § 32.23; and the device; (3) The device has been registered in (ii) The device has been evaluated by (4) Solubility in water and body fluids the Sealed Source and Device Registry. NRC and registered in the Sealed Source of the forms of the byproduct material (4) The quantity of byproduct material and Device Registry. identified in paragraphs (b)(3) and in the device does not exceed 10¥4 * * * * * (b)(12) of this section; times the value listed in Appendix E to 21. In § 32.26, the introductory text is (5) Details of construction and design part 20 of this chapter as a Category 2 revised and paragraph (c) is added to of the device as related to containment quantity. read as follows: and shielding of the byproduct material 23. Section 32.31 is added under and other safety features under normal Subpart A to read as follows: § 32.26 Gas and aerosol detectors and severe conditions of handling, containing byproduct material: storage, use, and disposal of the device; § 32.31 Certain industrial devices Requirements for license to manufacture, (6) Maximum external radiation levels containing byproduct material: Safety process, produce, or initially transfer. at 5 and 25 centimeters from any criteria. An application for a specific license external surface of the device, averaged (a) An applicant for a license under to manufacture, process, or produce gas over an area not to exceed 10 square § 32.30 shall demonstrate that the and aerosol detectors containing centimeters, and the method of device is designed and will be byproduct material and designed to measurement; manufactured so that: protect health, safety, or property, or to (7) Degree of access of human beings (1) In normal use, handling, and initially transfer such products for use to the device during normal handling storage of the quantities of exempt units under § 30.20 of this chapter or and use; likely to accumulate in one location, equivalent regulations of an Agreement (8) Total quantity of byproduct including during marketing, State, will be approved if: material expected to be distributed in distribution, installation, and servicing * * * * * the devices annually; of the device, it is unlikely that the (c)(1) The Commission determines (9) The expected useful life of the external radiation dose in any one year, that the device meets the safety criteria device; or the committed dose resulting from in § 32.27; and (10) The proposed methods of the intake of radioactive material in any (2) The device has been evaluated by labeling or marking the device and its one year, to a suitable sample of the NRC and registered in the Sealed Source point-of-sale package to satisfy the group of individuals expected to be and Device Registry. requirements of § 32.32(b); most highly exposed to radiation or

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radioactive material from the device § 32.32 Conditions of licenses issued (2) The report must indicate that the will exceed 200 μSv (20 mrem). under § 32.30: Quality control, labeling, and devices are transferred for use under (2) It is unlikely that the external reports of transfer. § 30.22 of this chapter or equivalent radiation dose in any one year, or the Each person licensed under § 32.30 regulations of an Agreement State. committed dose resulting from the shall: (3) The report must include the intake of radioactive material in any one (a) Carry out adequate control following information on devices year, to a suitable sample of the group procedures in the manufacture of the transferred to other persons for use of individuals expected to be most device to ensure that each production under § 30.22 or equivalent regulations highly exposed to radiation or lot meets the quality control standards of an Agreement State: radioactive material from disposal of the approved by the Commission; (i) A description or identification of quantities of units likely to accumulate (b) Label or mark each device and its the type of each device and the model in the same disposal site will exceed 10 point-of-sale package so that: number(s); μSv (1 mrem). (1) Each item has a durable, legible, (ii) For each radionuclide in each type (3) It is unlikely that there will be a readily visible label or marking on the of device and each model number, the significant reduction in the effectiveness external surface of the device total quantity of the radionuclide; and of the containment, shielding, or other containing: (iii) The number of units of each type safety features of the device from wear (i) The following statement: of device transferred during the and abuse likely to occur in normal ‘‘CONTAINS RADIOACTIVE reporting period by model number. handling and use of the device during MATERIAL’’; (4)(i) The licensee shall file the report, its useful life. (ii) The name of the radionuclide(s) covering the preceding calendar year, on (4) In use, handling, storage, and and quantity(ies) of activity; or before January 31 of each year. disposal of the quantities of exempt (iii) An identification of the person (ii) Licensees who permanently units likely to accumulate in one licensed under § 32.30 to transfer the discontinue activities authorized by the location, including during marketing, device for use under § 30.22 of this license issued under § 32.30 shall file a distribution, installation, and servicing chapter or equivalent regulations of an report for the current calendar year of the device, the probability is low that Agreement State; and within 30 days after ceasing the containment, shielding, or other (iv) Instructions and precautions distribution. safety features of the device would fail necessary to assure safe installation, (5) If no transfers of byproduct under such circumstances that a person operation, and servicing of the device material have been made under § 32.30 would receive an external radiation (documents such as operating and during the reporting period, the report dose or committed dose in excess of service manuals may be identified in the must so indicate. 5 mSv (500 mrem), and the probability label and used to provide this (6) The licensee shall maintain the is negligible that a person would receive information). record of a transfer for a period of one an external radiation dose or committed (2) The external surface of the point- year after the transfer is included in a dose of 100 mSv (10 rem) or greater.1 of-sale package has a legible, readily report to the Commission. (b) An applicant for a license under visible label or marking containing: 25. In § 32.51, paragraph(a)(6) is § 32.30 shall demonstrate that, even in (i) The name of the radionuclide and added to read as follows: unlikely scenarios of misuse, including quantity of activity; (ii) An identification of the person § 32.51 Byproduct material contained in those resulting in direct exposure to the devices for use under § 31.5; requirements unshielded source removed from the licensed under § 32.30 to transfer the for license to manufacture, or initially device for 1,000 hours at an average device for use under § 30.22 of this transfer. distance of 1 meter and those resulting chapter or equivalent regulations of an (a) * * * in dispersal and subsequent intake of Agreement State; and (6) The device has been registered in 10¥4 of the quantity of byproduct (iii) The following or a substantially the Sealed Source and Device Registry. material (or in the case of tritium, an similar statement: ‘‘THIS DEVICE CONTAINS RADIOACTIVE MATERIAL * * * * * intake of 10 percent), a person will not 26. In § 32.53, paragraphs (b)(5) and AND HAS BEEN MANUFACTURED IN receive an external radiation dose or (d)(4) are revised and paragraphs (e) and COMPLIANCE WITH U.S. NUCLEAR committed dose in excess of 100 mSv (f) are added to read as follows: (10 rem), and, if the unshielded source REGULATORY COMMISSION SAFETY is small enough to fit in a pocket, that CRITERIA IN 10 CFR 32.31. THE § 32.53 Luminous safety devices for use in the dose to localized areas of skin PURCHASER IS EXEMPT FROM ANY aircraft: Requirements for license to REGULATORY REQUIREMENTS.’’ manufacture, assemble, repair or initially averaged over areas no larger than 1 transfer. square centimeter from carrying the (3) Each device and point-of-sale unshielded source in a pocket for 80 package contains such other information * * * * * hours will not exceed 2 Sv (200 rem). as may be required by the Commission; (b) * * * 24. Section 32.32 is added under and (5) Quality assurance procedures to be Subpart A to read as follows: (c) Maintain records of all transfers followed that are sufficient to ensure and file a report with the Director of the compliance with § 32.55; 1 It is the intent of this paragraph that as the Office of Federal and State Materials * * * * * magnitude of the potential dose increases above and Environmental Management (d) * * * that permitted under normal conditions, the Programs by an appropriate method (4) Prototypes of the device have been probability that any individual will receive such a listed in § 30.6(a) of this chapter, subjected to and have satisfactorily dose must decrease. The probabilities have been expressed in general terms to emphasize the including in the address: ATTN: passed the tests required by paragraph approximate nature of the estimates which are to be Document Control Desk/Exempt (e) of this section. made. The following values may be used as guides Distribution. (e) The applicant must subject at least in estimating compliance with the criteria: Low— (1) The report must clearly identify five prototypes of the device to tests as not more than one such failure/incident per year for each 10,000 exempt units distributed. Negligible— the specific licensee submitting the follows: not more than one such failure/incident per year for report and include the license number (1) The devices are subjected to tests each one million exempt units distributed. of the specific licensee. that adequately take into account the

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individual, aggregate, and cumulative (2) Inspection for evidence of physical June 30 and must be filed within thirty effects of environmental conditions damage, containment failure, or for loss (30) days thereafter. If no transfers have expected in service that could adversely of tritium or promethium-147 after each been made to or from persons generally affect the effective containment of stage of testing, using methods of licensed under § 31.7 of this chapter tritium or promethium-147, such as inspection adequate for applying the during the reporting period, the report temperature, moisture, absolute following criteria for defective: must so indicate. pressure, water immersion, vibration, (i) A leak resulting in a loss of 0.1 (b) Each person licensed under shock, and weathering. percent or more of the original amount § 32.53 shall report annually all (2) The devices are inspected for of tritium or promethium-147 from the transfers of devices to persons for use evidence of physical damage and for device; under a general license in an Agreement loss of tritium or promethium-147, after (ii) Levels of radiation in excess of 5 State’s regulations that are equivalent to each stage of testing, using methods of microgray (0.5 millirad) per hour at 10 § 31.7 of this chapter to the responsible inspection adequate for determining centimeters from any surface when Agreement State agency. The report compliance with the criteria in measured through 50 milligrams per must state the total quantity of tritium paragraph (e)(3) of this section. square centimeter of absorber, if the or promethium-147 transferred, identify (3) Device designs are rejected for device contains promethium-147; and each general licensee by name, state the which the following has been detected (iii) Any other criteria specified in the kinds and numbers of luminous devices for any unit: license issued under § 32.53. transferred, and specify the quantity of (i) A leak resulting in a loss of 0.1 (d) No person licensed under § 32.53 tritium or promethium-147 in each kind percent or more of the original amount shall transfer to persons generally of device. If no transfers have been of tritium or promethium-147 from the licensed under § 31.7 of this chapter, or made to a particular Agreement State device; or under an equivalent general license of during the reporting period, this (ii) Surface contamination of tritium an Agreement State: information shall be reported to the or promethium-147 on the device of (1) Any luminous safety device tested responsible Agreement State agency more than 2,200 disintegrations per and found defective under any upon request of the agency. minute per 100 square centimeters of condition of a license issued under 29. In § 32.57, paragraph (d)(2) is surface area; or § 32.53, or paragraph (b) of this section, revised and paragraph (e) is added to (iii) Any other evidence of physical unless the defective luminous safety read as follows: damage. device has been repaired or reworked, (f) The device has been registered in retested, and determined by an § 32.57 Calibration or reference sources the Sealed Source and Device Registry. independent inspector to meet the containing americium-241 or radium-226: 27. Section 32.55 is revised to read as applicable acceptance criteria; or Requirements for license to manufacture or follows: (2) Any luminous safety device initially transfer. § 32.55 Same: Quality assurance, contained within any lot that has been * * * * * prohibition of transfer. sampled and rejected as a result of the (d) * * * (a) Each person licensed under § 32.53 procedures in paragraph (b)(2) of this (2) The source has been subjected to must visually inspect each device and section, unless: and has satisfactorily passed must reject any that has an observable (i) A procedure for defining sub-lot appropriate tests required by paragraph physical defect that could adversely size, independence, and additional (e) of this section. affect containment of the tritium or testing procedures is contained in the (e) The applicant must subject at least promethium-147. license issued under § 32.53; and five prototypes of each source that is (b) Each person licensed under (ii) Each individual sub-lot is designed to contain more than 0.185 § 32.53 must: sampled, tested, and accepted in kilobecquerel (0.005 microcurie) of (1) Maintain quality assurance accordance with paragraphs (b)(2) and americium-241 or radium-226 to tests as systems in the manufacture of the (d)(2)(i) of this section and any other follows: luminous safety device in a manner criteria that may be required as a (1) The initial quantity of radioactive sufficient to provide reasonable condition of the license issued under material deposited on each source is assurance that the safety-related § 32.53. measured by direct counting of the components of the distributed devices 28. Section 32.56 is revised to read as source. are capable of performing their intended follows: (2) The sources are subjected to tests functions; and that adequately take into account the (2) Subject inspection lots to § 32.56 Same: Material transfer reports. individual, aggregate, and cumulative acceptance sampling procedures, by (a) Each person licensed under § 32.53 effects of environmental conditions procedures specified in paragraph (c) of shall file an annual report with the expected in service that could adversely this section and in the license issued Director, Office of Federal and State affect the effective containment or under § 32.53, to provide at least 95 Materials and Environmental binding of americium-241 or radium- percent confidence that the Lot Management Programs, ATTN: 226, such as physical handling, Tolerance Percent Defective of 5.0 Document Control Desk/GLTS, by an moisture, and water immersion. percent will not be exceeded. appropriate method listed in § 30.6(a) of (3) The sources are inspected for (c) The licensee must subject each this chapter, which must state the total evidence of physical damage and for inspection lot to: quantity of tritium or promethium-147 loss of americium-241 or radium-226, (1) Tests that adequately take into transferred to persons generally licensed after each stage of testing, using account the individual, aggregate, and under § 31.7 of this chapter. The report methods of inspection adequate for cumulative effects of environmental must identify each general licensee by determining compliance with the conditions expected in service that name, state the kinds and numbers of criteria in paragraph (e)(4) of this could adversely affect the effective luminous devices transferred, and section. containment of tritium or promethium- specify the quantity of tritium or (4) Source designs are rejected for 147, such as absolute pressure and promethium-147 in each kind of device. which the following has been detected water immersion. Each report must cover the year ending for any unit: removal of more than 0.185

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kilobecquerel (0.005 microcurie) of (3) Device designs are rejected for detection device has been repaired or americium-241 or radium-226 from the which the following has been detected reworked, retested, and determined by source or any other evidence of physical for any unit: an independent inspector to meet the damage. (i) A leak resulting in a loss of 0.1 applicable acceptance criteria; or 30. Section 32.59 is revised to read as percent or more of the original amount (2) Any ice detection device follows: of strontium-90 from the device; or containing strontium-90 contained (ii) Surface contamination of within any lot that has been sampled § 32.59 Same: Leak testing of each source. strontium-90 on the device of more than and rejected as a result of the Each person licensed under § 32.57 2,200 disintegrations per minute per 100 procedures in paragraph (c)(2) of this must perform a dry wipe test upon each square centimeters of surface area; or section, unless: source containing more than 3.7 (iii) Any other evidence of physical (i) A procedure for defining sub-lot kilobecquerels (0.1 microcurie) of damage. size, independence, and additional americium-241 or radium-226 before (g) The device has been registered in testing procedures is contained in the transferring the source to a general the Sealed Source and Device Registry. license issued under § 32.61; and licensee under § 31.8 of this chapter or 32. In § 32.62, paragraphs (c), (d), and (ii) Each individual sub-lot is under equivalent regulations of an (e) are revised to read as follows: sampled, tested, and accepted in Agreement State. This test must be § 32.62 Same: Quality assurance; accordance with paragraphs (c)(2) and performed by wiping the entire prohibition of transfer. (e)(2)(i) of this section and any other radioactive surface of the source with a criteria as may be required as a * * * * * filter paper with the application of condition of the license issued under (c) Each person licensed under § 32.61 moderate finger pressure. The § 32.61. must: radioactivity on the filter paper must be (1) Maintain quality assurance measured using methods capable of Subpart C—Specifically Licensed systems in the manufacture of the ice detecting 0.185 kilobecquerel (0.005 Items detection device containing strontium- microcurie) of americium-241 or 90 in a manner sufficient to provide 33. The heading of Subpart C is radium-226. If a source has been shown reasonable assurance that the safety- revised to read as previously set out. to be leaking or losing more than 0.185 related components of the distributed 34. Sections 32.72 and 32.74 are kilobecquerel (0.005 microcurie) of devices are capable of performing their transferred from Subpart B to Subpart C; americium-241 or radium-226 by the intended functions; and § 32.74 is amended by adding paragraph methods described in this section, the (2) Subject inspection lots to (a)(4) to read as follows: source must be rejected and must not be acceptance sampling procedures, by transferred to a general licensee under procedures specified in paragraph (d) of § 32.74 Manufacture and distribution of § 31.8 of this chapter, or equivalent sources or devices containing byproduct this section and in the license issued material for medical use. regulations of an Agreement State. under § 32.61, to provide at least 95 31. In § 32.61, paragraph (e)(4) is percent confidence that the Lot (a) * * * revised and paragraphs (f) and (g) are Tolerance Percent Defective of 5.0 (4) The source or device has been added to read as follows: percent will not be exceeded. registered in the Sealed Source and Device Registry. § 32.61 Ice detection devices containing (d) Each person licensed under strontium-90; requirements for license to § 32.61 must subject each inspection lot * * * * * manufacture or initially transfer. to: § 32.101 [Removed] (1) Tests that adequately take into * * * * * 35. Section 32.101 is removed. (e) * * * account the individual, aggregate, and cumulative effects of environmental (4) Prototypes of the device have been § 32.102 [Removed] conditions expected in service that subjected to and have satisfactorily 36. Section 32.102 is removed. could possibly affect the effective passed the tests required by paragraph containment of strontium-90, such as § 32.103 [Removed] (f) of this section. absolute pressure and water immersion. 37. Section 32.103 is removed. * * * * * (2) Inspection for evidence of physical (f) The applicant must subject at least damage, containment failure, or for loss § 32.110 [Removed] five prototypes of the device to tests as of strontium-90 after each stage of 38. Section 32.110 is removed. follows: testing, using methods of inspection (1) The devices are subjected to tests adequate to determine compliance with Subpart D—Sealed Source and Device that adequately take into account the the following criteria for defective: a Registration individual, aggregate, and cumulative leak resulting in a loss of 0.1 percent or effects of environmental conditions 39. The heading of Subpart D is more of the original amount of revised to read as previously set out. expected in service that could adversely strontium-90 from the device and any affect the effective containment of other criteria specified in the license § 32.201 [Amended] strontium-90, such as temperature, issued under § 32.61. 40. Section 32.201 is transferred from moisture, absolute pressure, water (e) No person licensed under § 32.61 Subpart D to Subpart C. immersion, vibration, shock, and shall transfer to persons generally 41. In § 32.210, paragraphs (a), (b), (d), weathering. licensed under § 31.10 of this chapter, and (e) are revised, and paragraphs (g) (2) The devices are inspected for or under an equivalent general license and (h) are added to read as follows: evidence of physical damage and for of an Agreement State: loss of strontium-90 after each stage of (1) Any ice detection device § 32.210 Registration of product testing, using methods of inspection containing strontium-90 tested and information. adequate for determining compliance found defective under the criteria (a) Any manufacturer or initial with the criteria in paragraph (f)(3) of specified in a license issued under distributor of a sealed source or device this section. § 32.61, unless the defective ice containing a sealed source may submit

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a request to the NRC for evaluation of (i) The intended recipients are Authority: Secs. 62, 63, 64, 65, 81, 161, radiation safety information about its licensed under part 33 of this chapter or 182, 183, 186, 68 Stat. 932, 933, 935, 948, product and for its registration. comparable Agreement State provisions; 953, 954, 955, as amended, secs. 11e(2), 83, (b) The request for review must be 84, Pub. L. 95–604, 92 Stat. 3033, as or amended, 3039, sec. 234, 83 Stat. 444, as sent to the NRC’s Office of Federal and (ii) The recipients are authorized for amended (42 U.S.C. 2014(e)(2), 2092, 2093, State Materials and Environmental research and development; or 2094, 2095, 2111, 2113, 2114, 2201, 2232, Management Programs, ATTN: SSDR by (iii) The sources and devices are to be 2233, 2236, 2282); sec. 274, Pub. L. 86–373, an appropriate method listed in § 30.6(a) built to the unique specifications of the 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as of this chapter. particular recipient and contain no more amended, 202, 206, 88 Stat. 1242, as * * * * * than 740 GBq (20 Ci) of tritium or 7.4 amended, 1244, 1246 (42 U.S.C. 5841, 5842, (d) The NRC normally evaluates a GBq (200 mCi) of any other 5846); sec. 275, 92 Stat. 3021, as amended by sealed source or a device using radiation radionuclide. Pub. L. 97–415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as amended safety criteria in accepted industry (h) After the certificate is issued, the Commission may conduct an additional by Pub. L. 104–134, 110 Stat. 1321, 1321–349 standards. If these standards and criteria (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 do not readily apply to a particular case, review as it determines is necessary to U.S.C. 3504 note). Section 40.7 also issued the NRC formulates reasonable ensure compliance with current under Pub. L. 95–601, sec. 10, 92 Stat. 2951 standards and criteria with the help of regulatory standards. In conducting its (42 U.S.C. 5851). Section 40.31(g) also issued the manufacturer or distributor. The review, the Commission will complete under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). NRC shall use criteria and standards its evaluation in accordance with Section 40.46 also issued under sec. 184, 68 sufficient to ensure that the radiation criteria specified in this section. The Stat. 954, as amended (42 U.S.C. 2234). safety properties of the device or sealed Commission may request such Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237). source are adequate to protect health additional information as it considers and minimize danger to life and necessary to conduct its review. 45. In § 40.5, paragraph (b)(1)(iv) is property. Subpart A of this part includes 42. Section 32.211 is added under revised to read as follows: Subpart D to read as follows: specific criteria that apply to certain § 40.5 Communications. exempt products and Subpart B § 32.211 Inactivation of certificates of includes specific criteria applicable to * * * * * registration of sealed sources and devices. (b) * * * certain generally licensed devices. A specific licensee who no longer (1) * * * Subpart C includes specific provisions intends to manufacture or initially (iv) Distribution of products that apply to certain specifically transfer a sealed source or device containing radioactive material to licensed items. persons exempt under §§ 32.11 through (e) After completion of the evaluation, registered with the Commission shall 32.30 of this chapter. the Commission issues a certificate of request inactivation of the registration registration to the person making the certificate. Such a request shall be made * * * * * request. The certificate of registration no later than two years after the last PART 70—DOMESTIC LICENSING OF acknowledges the availability of the initial transfer of a source or device SPECIAL NUCLEAR MATERIAL submitted information for inclusion in covered by the certificate. If this an application for a specific license cessation of activity is associated with 46. The authority citation for part 70 proposing use of the product, or the termination of a specific license, the continues to read as follows: request for inactivation of registration concerning use under an exemption Authority: Secs. 51, 53, 161, 182, 183, 68 from licensing or general license as should state the intent to terminate a license giving the specific license Stat. 929, 930, 948, 953, 954, as amended, applicable for the category of certificate. sec. 234, 83 Stat. 444, as amended (42 U.S.C. number. A specific license to * * * * * 2071, 2073, 2201, 2232, 2233, 2282, 2297f); (g) Authority to manufacture or manufacture or initially transfer a secs. 201, as amended, 202, 204, 206, 88 Stat. initially distribute a sealed source or source or device covered only by an 1242, as amended, 1244, 1245, 1246 (42 device to specific licensees may be inactivated certificate no longer U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 provided in the license without the authorizes the licensee to transfer such Stat. 2835, as amended by Pub. L. 104–134, sources or devices for use. Servicing of 110 Stat. 1321, 1321–349 (42 U.S.C. 2243); issuance of a certificate of registration in sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 the following cases: devices must be in accordance with any conditions in the certificate, including note). (1) Calibration and reference sources Sections 70.1(c) and 70.20a(b) also issued containing no more than: in the case of an inactive certificate. under secs. 135, 141, Pub. L. 97–425, 96 Stat. (i) 37 MBq (1 mCi), for beta and/or 43. In § 32.303, paragraph (b) is 2232, 2241 (42 U.S.C. 10155, 10161). Section gamma emitting radionuclides; or revised to read as follows: 70.7 is also issued under Pub. L. 95–601, sec. μ 10, 92 Stat. 2951 as amended by Pub. L. 102– (ii) 0.37 MBq (10 Ci), for alpha § 32.303 Criminal penalties. emitting radionuclides; or 486, sec. 2902, 106 Stat. 3123 (42 U.S.C. (2) The intended recipients are * * * * * 5851). Section 70.21(g) also issued under sec. qualified by training and experience and (b) The regulations in part 32 that are 122, 68 Stat. 939 (42 U.S.C. 2152). Section have sufficient facilities and equipment not issued under subsections 161b, 161i, 70.31 also issued under sec. 57d, Pub. L. 93– 377, 88 Stat. 475 (42 U.S.C. 2077). Sections to safely use and handle the requested or 161o for the purposes of section 223 are as follows: §§ 32.1, 32.2, 32.8, 32.11, 70.36 and 70.44 also issued under sec. 184, quantity of radioactive material in any 68 Stat. 954, as amended (42 U.S.C. 2234). form in the case of unregistered sources 32.14, 32.18, 32.21, 32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, Section 70.81 also issued under secs. 186, or, for registered sealed sources 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). contained in unregistered devices, are 32.53, 32.57, 32.61, 32.71, 32.72, 32.74, Section 70.82 also issued under sec. 108, 68 qualified by training and experience and 32.301, and 32.303. Stat. 939, as amended (42 U.S.C. 2138). have sufficient facilities and equipment PART 40—DOMESTIC LICENSING OF 47. In § 70.5, paragraph (b)(1)(iv) is to safely use and handle the requested SOURCE MATERIAL revised to read as follows: quantity of radioactive material in unshielded form, as specified in their 44. The authority citation for part 40 § 70.5 Communications. licenses; and continues to read as follows: * * * * *

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(b) * * * persons exempt under §§ 32.11 through For the Nuclear Regulatory Commission. (1) * * * 32.30 of this chapter. Annette Vietti-Cook, * * * * * Secretary of the Commission. (iv) Distribution of products containing radioactive material to Dated at Rockville, Maryland, this 17th day [FR Doc. 2010–15202 Filed 6–23–10; 8:45 am] of June 2010. BILLING CODE 7590–01–P

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Part IV

Department of Education National Institute on Disability and Rehabilitation Research (NIDRR)— Disability and Rehabilitation Research Projects and Centers Program— Rehabilitation Research and Training Centers (RRTCs)—Improved Outcomes for Individuals With Serious Mental Illness and Co-Occurring Conditions; Office of Special Education and Rehabilitative Services; Notices

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DEPARTMENT OF EDUCATION rehabilitation outcomes for underserved • Serve as centers of national populations; (4) identify research gaps; excellence in rehabilitation research for National Institute on Disability and (5) identify mechanisms of integrating individuals with disabilities, their Rehabilitation Research (NIDRR)— research and practice; and (6) representatives, providers, and other Disability and Rehabilitation Research disseminate findings. interested parties. Projects and Centers Program— Purpose of Program: The purpose of Applicants for RRTC grants must also Rehabilitation Research and Training the Disability and Rehabilitation demonstrate in their applications how Centers (RRTCs)—Improved Outcomes Research Projects and Centers Program they will address, in whole or in part, for Individuals With Serious Mental is to plan and conduct research, the needs of individuals with Illness and Co-Occurring Conditions demonstration projects, training, and disabilities from minority backgrounds. related activities, including Program Authority: 29 U.S.C. 762(g) Catalog of Federal Domestic Assistance international activities, to develop and 764(b)(2). (CFDA) Number: 84.133B–5. methods, procedures, and rehabilitation Applicable Program Regulations: 34 AGENCY: Office of Special Education and technology, that maximize the full CFR part 350. Rehabilitative Services, Department of inclusion and integration into society, We published a notice of proposed Education. employment, independent living, family priority (NPP) for NIDRR’s Disability ACTION: Notice of final priority. support, and economic and social self- and Rehabilitation Research Projects sufficiency of individuals with and Centers Program in the Federal SUMMARY: The Assistant Secretary for disabilities, especially individuals with Register on April 23, 2010 (75 FR Special Education and Rehabilitative the most severe disabilities, and to 21282). The NPP included a background Services announces a priority for the improve the effectiveness of services statement that described our rationale Disability and Rehabilitation Research authorized under the Rehabilitation Act for the priority proposed in that notice. Projects and Centers Program of 1973, as amended. There are no differences between the administered by NIDRR. Specifically, proposed priority and this final priority. this notice announces a priority for an RRTC Program Public Comment: In response to our RRTC on Improved Outcomes for The purpose of the RRTC program is invitation in the NPP, we did not Individuals With Serious Mental Illness to improve the effectiveness of services receive any substantive comments on and Co-Occurring Conditions. The authorized under the Rehabilitation Act the proposed priority. Assistant Secretary may use this priority of 1973, as amended, through advanced Final Priority for competitions in fiscal year (FY) 2010 research, training, technical assistance, and later years. We take this action to and dissemination activities in general The Assistant Secretary for Special focus research attention on areas of problem areas, as specified by NIDRR. Education and Rehabilitative Services national need. We intend this priority to Such activities are designed to benefit announces a priority for a Rehabilitation improve rehabilitation services and rehabilitation service providers, Research and Training Center (RRTC) on outcomes for individuals with individuals with disabilities, and the Improved Outcomes for Individuals disabilities. family members or other authorized with Serious Mental Illness and Co- Occurring Conditions. The RRTC must DATES: representatives of individuals with Effective Date: This priority is conduct research to adapt, modify, and effective July 26, 2010. disabilities. In addition, NIDRR intends to require all RRTC applicants to meet enhance health and mental health FOR FURTHER INFORMATION CONTACT: models to improve health and Lynn Medley, U.S. Department of the requirements of the General Rehabilitation Research and Training employment outcomes for individuals Education, 400 Maryland Avenue, SW., with serious mental illness (SMI) and Room 5140, Potomac Center Plaza Centers (RRTC) Requirements priority that it published in a notice of final co-occurring conditions. The RRTC (PCP), Washington, DC 20202. must conduct research, knowledge Telephone: (202) 245–7338 or by e-mail: priorities in the Federal Register on February 1, 2008 (73 FR 6132). translation, training, dissemination, and [email protected]. technical assistance within a framework If you use a telecommunications Additional information on the RRTC program can be found at: http:// of self-management and consumer- device for the deaf (TDD), call the directed services. Under this priority, Federal Relay Service (FRS), toll free, at www.ed.gov/rschstat/research/pubs/res- program.html#RRTC. the RRTC must contribute to the 1–800–877–8339. following outcomes: SUPPLEMENTARY INFORMATION: This Statutory and Regulatory Requirements (a) Increased knowledge that can be notice of final priority is in concert with of RRTCs used to enhance the health and well- NIDRR’s Final Long-Range Plan for FY RRTCs must— being of individuals with SMI and co- 2005–2009 (Plan). The Plan, which was • Carry out coordinated advanced occurring conditions. The RRTC must published in the Federal Register on programs of rehabilitation research; contribute to this outcome by: February 15, 2006 (71 FR 8165), can be • Provide training, including (1) Conducting research to develop a accessed on the Internet at the following graduate, pre-service, and in-service better understanding of the health, and site: http://www.ed.gov/about/offices/ training, to help rehabilitation health care needs of individuals with list/osers/nidrr/policy.html. personnel more effectively provide SMI and co-occurring conditions. Through the implementation of the rehabilitation services to individuals (2) Conducting research to identify or Plan, NIDRR seeks to: (1) Improve the with disabilities; develop and then test interventions that quality and utility of disability and • Provide technical assistance to aim to improve health outcomes and rehabilitation research; (2) foster an individuals with disabilities, their promote recovery among individuals exchange of expertise, information, and representatives, providers, and other living with SMI and co-occurring training to facilitate the advancement of interested parties; conditions. These interventions must knowledge and understanding of the • Disseminate informational materials include individual-level health unique needs of traditionally to individuals with disabilities, their promotion strategies, such as peer underserved populations; (3) determine representatives, providers, and other supports and consumer control, as well best strategies and programs to improve interested parties; and as system-level strategies for the

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delivery of physical and mental health that does not meet the priority (34 CFR all other documents of this Department services. These interventions must be 75.105(c)(2)(ii)). published in the Federal Register, in based on the findings of research Invitational priority: Under an text or Adobe Portable Document conducted under paragraph (a)(1) of this invitational priority, we are particularly Format (PDF) on the Internet at the priority. In carrying out this activity, the interested in applications that meet the following site: http://www.ed.gov/news/ grantee must investigate the priority. However, we do not give an fedregister. To use PDF you must have applicability of strategies that have application that meets the priority a Adobe Acrobat Reader, which is proven successful with the general preference over other applications (34 available free at this site. population or other subpopulations to CFR 75.105(c)(1)). This notice does not preclude us from Note: The official version of this document determine if they are effective with is the document published in the Federal individuals with SMI and co-occurring proposing additional priorities, Register. Free Internet access to the official conditions. requirements, definitions, or selection edition of the Federal Register and the Code (b) Improved employment outcomes criteria, subject to meeting applicable of Federal Regulations is available on GPO among individuals with SMI and co- rulemaking requirements. Access at: http://www.gpoaccess.gov/nara/ index.html. occurring conditions. The RRTC must Note: This notice does not solicit contribute to this outcome by applications. In any year in which we choose Dated: June 21, 2010. conducting research that demonstrates to use this priority, we invite applications how improvements in health service through a notice in the Federal Register. Alexa Posny, delivery mechanisms, self-management, Assistant Secretary for Special Education and peer support, and consumer control Executive Order 12866: This notice Rehabilitative Services. affect employment outcomes in has been reviewed in accordance with [FR Doc. 2010–15344 Filed 6–23–10; 8:45 am] Executive Order 12866. Under the terms individuals with SMI and co-occurring BILLING CODE 4000–01–P conditions. In carrying out this activity of the order, we have assessed the the grantee must utilize one or more of potential costs and benefits of this final the interventions developed under regulatory action. DEPARTMENT OF EDUCATION The potential costs associated with paragraph (a)(2) of this priority. this final regulatory action are those Office of Special Education and (c) Increased incorporation of research resulting from statutory requirements Rehabilitative Services; Overview findings related to SMI, co-occurring and those we have determined as Information; National Institute on conditions, health management, and necessary for administering this Disability and Rehabilitation Research employment into practice or policy. The program effectively and efficiently. (NIDRR)—Disability and Rehabilitation RRTC must contribute to this outcome In assessing the potential costs and Research Projects and Centers by coordinating with appropriate benefits—both quantitative and Program—Rehabilitation Research and NIDRR-funded knowledge translation qualitative—of this final regulatory Training Centers (RRTCs)—Improved grantees to advance their work in the action, we have determined that the Outcomes for Individuals With Serious following areas: benefits of the final priority justify the Mental Illness and Co-Occurring (1) Developing, evaluating, or costs. Conditions; Notice Inviting implementing strategies to increase Applications for New Awards for Fiscal Discussion of Costs and Benefits utilization of research findings related Year (FY) 2010 to SMI, co-occurring conditions, health The benefits of the Disability and management, and employment. Rehabilitation Research Projects and Catalog of Federal Domestic (2) Conducting training, technical Centers Program have been well Assistance (CFDA) Number: 84.133B–5. assistance, and dissemination activities established over the years in that similar Dates: to increase utilization of research projects have been completed Applications Available: June 24, 2010. findings related to SMI, co-occurring successfully. This final priority will Date of Pre-Application Meeting: July conditions, health management, and generate new knowledge through 8, 2010. employment. research and development. Deadline for Transmittal of Applications: August 23, 2010. Types of Priorities Another benefit of this final priority is that the establishment of a new RRTC Full Text of Announcement When inviting applications for a will advance research to improve the competition using one or more lives of individuals with disabilities. I. Funding Opportunity Description priorities, we designate the type of each The new RRTC will disseminate and Purpose of Program: The purpose of priority as absolute, competitive promote the use of new information that the RRTC program is to improve the preference, or invitational through a will improve the options for individuals effectiveness of services authorized notice in the Federal Register. The with disabilities to obtain, retain, and under the Rehabilitation Act of 1973, as effect of each type of priority follows: advance in employment. amended, through advanced research, Absolute priority: Under an absolute Accessible Format: Individuals with training, technical assistance, and priority, we consider only applications disabilities can obtain this document in dissemination activities in general that meet the priority (34 CFR an accessible format (e.g., braille, large problem areas, as specified by NIDRR. 75.105(c)(3)). print, audiotape, or computer diskette) Such activities are designed to benefit Competitive preference priority: by contacting the Grants and Contracts rehabilitation service providers, Under a competitive preference priority, Services Team, U.S. Department of individuals with disabilities, and the we give competitive preference to an Education, 400 Maryland Avenue, SW., family members or other authorized application by (1) Awarding additional room 5075, PCP, Washington, DC representatives of individuals with points, depending on the extent to 20202–2550. Telephone: (202) 245– disabilities. which the application meets the priority 7363. If you use a TDD, call the FRS, toll Additional information on the RRTC (34 CFR 75.105(c)(2)(i)); or (2) selecting free, at 1–800–877–8339. program can be found at: http:// an application that meets the priority Electronic Access to This Document: www.ed.gov/rschstat/research/pubs/res- over an application of comparable merit You can view this document, as well as program.html#RRTC.

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Priorities: NIDRR has established two award as indirect cost charges (34 CFR • Use one of the following fonts: absolute priorities for this competition. 350.23). Times New Roman, Courier, Courier Absolute Priorities: The General Estimated Number of Awards: 1. New, or Arial. An application submitted Rehabilitation Research and Training Note: The Department is not bound by any in any other font (including Times Centers (RRTC) Requirements priority is estimates in this notice. Roman or Arial Narrow) will not be from the notice of final priorities for the accepted. Disability and Rehabilitation Research Project Period: Up to 60 months. The recommended page limit does not Projects and Centers program, published III. Eligibility Information apply to Part I, the cover sheet; Part II, the budget section, including the in the Federal Register on February 1, 1. Eligible Applicants: States; public narrative budget justification; Part IV, 2008 (73 FR 6132). The Improved or private agencies, including for-profit the assurances and certifications; or the Outcomes for Individuals with Serious agencies; public or private one-page abstract, the resumes, the Mental Illness and Co-Occurring organizations, including for-profit bibliography, or the letters of support. Conditions priority is from the notice of organizations; IHEs; and Indian Tribes However, the recommended page limit final priority for the Disability and and Tribal organizations. does apply to all of the application Rehabilitation Research Projects and 2. Cost Sharing or Matching: This narrative section (Part III). Centers Program, published elsewhere competition does not require cost The application package will provide in this issue of the Federal Register. sharing or matching. For FY 2010, these priorities are instructions for completing all absolute priorities. Under 34 CFR IV. Application and Submission components to be included in the 75.105(c)(3) we consider only Information application. Each application must applications that meet these priorities. 1. Address to Request Application include a cover sheet (Standard Form These priorities are: Package: ED Pubs, U.S. Department of 424); budget requirements (ED Form General Rehabilitation Research and Education, P.O. Box 22207, Alexandria, 524) and narrative justification; other Training Centers (RRTC) Requirements VA 22304. Telephone, toll free: 1–877– required forms; an abstract; Human and Improved Outcomes for Individuals 433–7827. FAX: (703) 605–6794. If you Subjects narrative; Part III narrative; with Serious Mental Illness and Co- use a telecommunications device for the resumes of staff; and other related Occurring Conditions. deaf (TDD), call, toll free: 1–877–576– materials, if applicable. 7734. 3. Submission Dates and Times: Note: The full text of each of these Applications Available: June 24, 2010. priorities is included in the applicable notice You can contact ED Pubs at its Web site, also: http://www.EDPubs.gov or at Date of Pre-Application Meeting: of final priorities published in the Federal Interested parties are invited to Register and in the applicable application its e-mail address: [email protected]. package. If you request an application package participate in a pre-application meeting from ED Pubs, be sure to identify this and to receive information and technical Program Authority: 29 U.S.C. 762(g) and program or competition as follows: assistance through individual 764(b)(2). CFDA number 84.133B–5. consultation with NIDRR staff. The pre- Applicable Regulations: (a) The Individuals with disabilities can application meeting will be held on July Education Department General obtain a copy of the application package 8, 2010. Interested parties may Administrative Regulations (EDGAR) in in an accessible format (e.g., braille, participate in this meeting by 34 CFR parts 74, 75, 77, 80, 81, 82, 84, large print, audiotape, or computer conference call with NIDRR staff from 85, 86, and 97. (b) The regulations for diskette) by contacting the person or the Office of Special Education and this program in 34 CFR part 350. (c) The team listed under Accessible Format in Rehabilitative Services between 1:00 notice of final priorities for the section VIII of this notice. p.m. and 3:00 p.m., Washington, DC Disability and Rehabilitation Research 2. Content and Form of Application time. NIDRR staff also will be available Projects and Centers program, published Submission: Requirements concerning from 3:30 p.m. to 4:30 p.m., in the Federal Register on February 1, the content of an application, together Washington, DC time, on the same day, 2008 (73 FR 6132). (d) The notice of with the forms you must submit, are in by telephone, to provide information final priority for the Disability and the application package for this and technical assistance through Rehabilitation Research Projects and competition. individual consultation. For further Centers program, published elsewhere Page Limit: The application narrative information or to make arrangements to in this issue of the Federal Register. (Part III of the application) is where you, participate in the meeting via the applicant, address the selection conference call or for an individual Note: The regulations in 34 CFR part 86 criteria that reviewers use to evaluate consultation, contact Lynn Medley, U.S. apply to institutions of higher education Department of Education, Potomac (IHEs) only. your application. We recommend that you limit Part III to the equivalent of no Center Plaza (PCP), room 5140, 550 12th II. Award Information more than 125 pages, using the Street, SW., Washington, DC 20202. following standards: Telephone: (202) 245–7338 or by e-mail: Type of Award: Discretionary grants. • A ‘‘page’’ is 8.5″ x 11″, on one side [email protected]. Estimated Available Funds: $950,000. only, with 1″ margins at the top, bottom, Deadline for Transmittal of Maximum Award: We will reject any and both sides. Applications: August 23, 2010. application that proposes a budget • Double space (no more than three Applications for grants under this exceeding $950,000 for a single budget lines per vertical inch) all text in the competition must be submitted period of 12 months. The Assistant application narrative. Single spacing electronically using the Electronic Grant Secretary for Special Education and may be used for titles, headings, Application System (e-Application) Rehabilitative Services may change the footnotes, quotations, references, and accessible through the Department’s e- maximum amount through a notice captions, as well as all text in charts, Grants site. For information (including published in the Federal Register. tables, figures, and graphs. dates and times) about how to submit • Note: The maximum amount includes Use a font that is either 12 point or your application electronically, or in direct and indirect costs. A grantee may not larger or no smaller than 10 pitch paper format by mail or hand delivery collect more than 15 percent of the total grant (characters per inch). if you qualify for an exception to the

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electronic submission requirement, accordance with the instructions in this elsewhere in this section, and submit please refer to section IV. 7. Other section. your application in paper format. Submission Requirements of this notice. • You must submit all documents a. Electronic Submission of We do not consider an application electronically, including all information Applications that does not comply with the deadline you typically provide on the following requirements. Applications for grants under the forms: the Application for Federal Individuals with disabilities who Rehabilitation Research and Training Assistance (SF 424), the Department of need an accommodation or auxiliary aid Centers (RRTCs)—Improved Outcomes Education Supplemental Information for in connection with the application for Individuals with Serious Mental SF 424, Budget Information—Non- process should contact the person listed Illness and Co-Occurring Conditions Construction Programs (ED 524), and all under For Further Information Contact competition—CFDA Number 84.133B–5 necessary assurances and certifications. in section VII of this notice. If the must be submitted electronically using You must attach any narrative sections Department provides an accommodation e-Application, accessible through the of your application as files in a .DOC or auxiliary aid to an individual with a Department’s e-Grants Web site at: (document), .RTF (rich text), or .PDF disability in connection with the http://e-grants.ed.gov. (Portable Document) format. If you application process, the individual’s We will reject your application if you upload a file type other than the three application remains subject to all other submit it in paper format unless, as file types specified in this paragraph or requirements and limitations in this described elsewhere in this section, you submit a password protected file, we notice. qualify for one of the exceptions to the will not review that material. 4. Intergovernmental Review: This electronic submission requirement and • Your electronic application must program is not subject to Executive submit, no later than two weeks before comply with any page limit Order 12372 and the regulations in 34 the application deadline date, a written requirements described in this notice. CFR part 79. statement to the Department that you • Prior to submitting your electronic 5. Funding Restrictions: We reference qualify for one of these exceptions. application, you may wish to print a regulations outlining funding Further information regarding copy of it for your records. restrictions in the Applicable calculation of the date that is two weeks • After you electronically submit Regulations section of this notice. before the application deadline date is 6. Data Universal Numbering System your application, you will receive an provided later in this section under Number, Taxpayer Identification automatic acknowledgment that will Exception to Electronic Submission Number, and Central Contractor include a PR/Award number (an Requirement. Registry: To do business with the identifying number unique to your While completing your electronic Department of Education, (1) you must application). application, you will be entering data • have a Data Universal Numbering Within three working days after online that will be saved into a System (DUNS) number and a Taxpayer submitting your electronic application, database. You may not e-mail an Identification Number (TIN); (2) you fax a signed copy of the SF 424 to the electronic copy of a grant application to must register both of those numbers Application Control Center after us. with the Central Contractor Registry following these steps: Please note the following: (1) Print SF 424 from e-Application. (CCR), the Government’s primary • registrant database; and (3) you must You must complete the electronic (2) The applicant’s Authorizing provide those same numbers on your submission of your grant application by Representative must sign this form. application. 4:30:00 p.m., Washington, DC time, on (3) Place the PR/Award number in the You can obtain a DUNS number from the application deadline date. upper right hand corner of the hard- Dun and Bradstreet. A DUNS number E-Application will not accept an copy signature page of the SF 424. can be created within one business day. application for this competition after (4) Fax the signed SF 424 to the If you are a corporate entity, agency, 4:30:00 p.m., Washington, DC time, on Application Control Center at (202) institution, or organization, you can the application deadline date. 245–6272. obtain a TIN from the Internal Revenue Therefore, we strongly recommend that • We may request that you provide us Service. If you are an individual, you you do not wait until the application original signatures on other forms at a can obtain a TIN from the Internal deadline date to begin the application later date. Revenue Service or the Social Security process. Application Deadline Date Extension Administration. If you need a new TIN, • The hours of operation of the in Case of e-Application Unavailability: please allow 2–5 weeks for your TIN to e-Grants Web site are 6:00 a.m. Monday If you are prevented from electronically become active. until 7:00 p.m. Wednesday; and 6:00 submitting your application on the The CCR registration process may take a.m. Thursday until 8:00 p.m. Sunday, application deadline date because e- five or more business days to complete. Washington, DC time. Please note that, Application is unavailable, we will If you are currently registered with the because of maintenance, the system is grant you an extension of one business CCR, you may not need to make any unavailable between 8:00 p.m. on day to enable you to transmit your changes. However, please make certain Sundays and 6:00 a.m. on Mondays, and application electronically, by mail, or by that the TIN associated with your DUNS between 7:00 p.m. on Wednesdays and hand delivery. We will grant this number is correct. Also note that you 6:00 a.m. on Thursdays, Washington, extension if— will need to update your CCR DC time. Any modifications to these (1) You are a registered user of e- registration on an annual basis. This hours are posted on the e-Grants Web Application and you have initiated an may take three or more business days to site. electronic application for this complete. • You will not receive additional competition; and 7. Other Submission Requirements: point value because you submit your (2)(a) E-Application is unavailable for Applications for grants under this application in electronic format, nor 60 minutes or more between the hours competition must be submitted will we penalize you if you qualify for of 8:30 a.m. and 3:30 p.m., Washington, electronically unless you qualify for an an exception to the electronic DC time, on the application deadline exception to this requirement in submission requirement, as described date; or

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(b) E-Application is unavailable for Service or a commercial carrier) your grant application. If you do not receive this any period of time between 3:30 p.m. application to the Department. You grant notification within 15 business days and 4:30:00 p.m., Washington, DC time, must mail the original and two copies from the application deadline date, you on the application deadline date. of your application, on or before the should call the U.S. Department of Education We must acknowledge and confirm application deadline date, to the Application Control Center at (202) 245– 6288. these periods of unavailability before Department at the following address: granting you an extension. To request U.S. Department of Education, V. Application Review Information this extension or to confirm our Application Control Center, Attention: acknowledgment of any system (CFDA Number 84.133B–5), LBJ Selection Criteria: The selection unavailability, you may contact either Basement Level 1, 400 Maryland criteria for this competition are from 34 (1) the person listed elsewhere in this Avenue, SW., Washington, DC 20202– CFR 350.54 and are listed in the notice under For Further Information 4260. application package. Contact (see VII. Agency Contact) or (2) You must show proof of mailing VI. Award Administration Information the e-Grants help desk at 1–888–336– consisting of one of the following: 8930. If e-Application is unavailable (1) A legibly dated U.S. Postal Service 1. Award Notices: If your application due to technical problems with the postmark. is successful, we notify your U.S. system and, therefore, the application (2) A legible mail receipt with the Representative and U.S. Senators and deadline is extended, an e-mail will be date of mailing stamped by the U.S. send you a Grant Award Notification sent to all registered users who have Postal Service. (GAN). We may notify you informally, initiated an e-Application. Extensions (3) A dated shipping label, invoice, or also. referred to in this section apply only to receipt from a commercial carrier. If your application is not evaluated or the unavailability of e-Application. (4) Any other proof of mailing not selected for funding, we notify you. Exception to Electronic Submission acceptable to the Secretary of the U.S. 2. Administrative and National Policy Requirement: You qualify for an Department of Education. Requirements: We identify If you mail your application through exception to the electronic submission administrative and national policy the U.S. Postal Service, we do not requirement, and may submit your requirements in the application package accept either of the following as proof application in paper format, if you are and reference these and other of mailing: unable to submit an application through requirements in the Applicable (1) A private metered postmark. Regulations section of this notice. e-Application because— (2) A mail receipt that is not dated by • We reference the regulations outlining You do not have access to the the U.S. Postal Service. Internet; or the terms and conditions of an award in • If your application is postmarked after You do not have the capacity to the application deadline date, we will the Applicable Regulations section of upload large documents to not consider your application. this notice and include these and other e-Application; and specific conditions in the GAN. The • No later than two weeks before the Note: The U.S. Postal Service does not GAN also incorporates your approved application deadline date (14 calendar uniformly provide a dated postmark. Before relying on this method, you should check application as part of your binding days or, if the fourteenth calendar day with your local post office. commitments under the grant. before the application deadline date 3. Reporting: At the end of your falls on a Federal holiday, the next c. Submission of Paper Applications by project period, you must submit a final business day following the Federal Hand Delivery performance report, including financial holiday), you mail or fax a written information, as directed by the If you qualify for an exception to the statement to the Department, explaining Secretary. If you receive a multi-year electronic submission requirement, you which of the two grounds for an award, you must submit an annual exception prevents you from using the (or a courier service) may deliver your paper application to the Department by performance report that provides the Internet to submit your application. If most current performance and financial you mail your written statement to the hand. You must deliver the original and two copies of your application, by hand, expenditure information as directed by Department, it must be postmarked no the Secretary under 34 CFR 75.118. The later than two weeks before the on or before the application deadline date, to the Department at the following Secretary may also require more application deadline date. If you fax frequent performance reports under 34 your written statement to the address: U.S. Department of Education, Application Control Center, Attention: CFR 75.720(c). For specific Department, we must receive the faxed requirements on reporting, please go to statement no later than two weeks (CFDA Number 84.133B–5), 550 12th Street, SW., Room 7041, Potomac Center http://www.ed.gov/fund/grant/apply/ before the application deadline date. appforms/appforms.html. Address and mail or fax your Plaza, Washington, DC 20202–4260. The Note: NIDRR will provide information by statement to: Lynn Medley, U.S. Application Control Center accepts hand deliveries daily between 8:00 a.m. letter to grantees on how and when to submit Department of Education, 400 Maryland the final performance report. Avenue, SW., Room 5140, PCP, and 4:30:00 p.m., Washington, DC time, Washington, DC 20202–2700. FAX: except Saturdays, Sundays, and Federal 4. Performance Measures: To evaluate (202) 245–7323. holidays. the overall success of its research Your paper application must be Note for Mail or Hand Delivery of Paper program, NIDRR assesses the quality of submitted in accordance with the mail Applications: If you mail or hand deliver its funded projects through a review of or hand delivery instructions described your application to the Department— grantee performance and products. Each in this notice. (1) You must indicate on the envelope year, NIDRR examines a portion of its and—if not provided by the Department—in grantees to determine: b. Submission of Paper Applications by Item 11 of the SF 424 the CFDA number, • The percentage of NIDRR-supported Mail including suffix letter, if any, of the competition under which you are submitting fellows, post-doctoral trainees, and If you qualify for an exception to the your application; and doctoral students who publish results of electronic submission requirement, you (2) The Application Control Center will NIDRR-sponsored research in refereed may mail (through the U.S. Postal mail to you a notification of receipt of your journals.

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• The number of accomplishments VII. Agency Contact Electronic Access to This Document: (e.g., new or improved tools, methods, For Further Information Contact: You can view this document, as well as discoveries, standards, interventions, Lynn Medley, U.S. Department of all other documents of this Department programs, or devices) developed or Education, 400 Maryland Avenue, SW., published in the Federal Register, in tested with NIDRR funding that have Room 5140, PCP, Washington, DC text or Adobe Portable Document been judged by expert panels to be of 20202–2700. Telephone: (202) 245–7338 Format (PDF) on the Internet at the high quality and to advance the field. or by e-mail: [email protected]. following site: http://www.ed.gov/news/ • If you use a TDD, call the Federal fedregister. To use PDF you must have The average number of publications Adobe Acrobat Reader, which is per award based on NIDRR-funded Relay Service (FRS), toll free, at 1–800– 877–8339. available free at this site. research and development activities in refereed journals. VIII. Other Information Note: The official version of this document is the document published in the Federal • The percentage of new NIDRR Accessible Format: Individuals with Register. Free Internet access to the official grants that assess the effectiveness of disabilities can obtain this document edition of the Federal Register and the Code interventions, programs, and devices and a copy of the application package in of Federal Regulations is available on GPO using rigorous methods. an accessible format (e.g., braille, large Access at: http://www.gpoaccess.gov/nara/ print, audiotape, or computer diskette) index.html. Each grantee must annually report on by contacting the Grants and Contracts its performance through NIDRR’s Services Team, U.S. Department of Dated: June 21, 2010. Annual Performance Report (APR) form. Education, 400 Maryland Avenue, SW., Alexa Posny, NIDRR uses APR information submitted Room 5075, PCP, Washington, DC Assistant Secretary for Special Education and by grantees to assess progress on these 20202–2550. Telephone: (202) 245– Rehabilitative Services. measures. 7363. If you use a TDD, call the FRS, toll [FR Doc. 2010–15345 Filed 6–23–10; 8:45 am] free, at 1–800–877–8339. BILLING CODE 4000–01–P

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Part V

Department of Health and Human Services Department of Transportation Notice of Funding Availability for the Department of Housing and Urban Development’s Community Challenge Planning Grants and the Department of Transportation’s TIGER II Planning Grants; Notice

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DEPARTMENT OF HOUSING AND Challenge Planning Grant Program also participation in the ‘‘Partnership for URBAN DEVELOPMENT supports the development of affordable Sustainable Communities’’ with the U.S. housing through the development and Environmental Protection Agency DEPARTMENT OF TRANSPORTATION adoption of inclusionary zoning (‘‘EPA’’) to help American families in all [Docket No. FR–5415–N–12] ordinances and other activities such as communities—rural, suburban and acquisition of land for affordable urban—gain better access to affordable Notice of Funding Availability for the housing projects. housing, more transportation options, Department of Housing and Urban The Community Challenge Planning lower transportation costs, and a cleaner Development’s Community Challenge Grant Program differs from HUD’s environment. HUD and DOT have Planning Grants and the Department of Sustainable Communities Regional considered the comments that were Transportation’s TIGER II Planning Planning Grant Program, a $100 million submitted in accordance with the Grants program also created in the FY2010 interim notice and decided to conduct Appropriations Act. While the latter a multi-agency evaluation and award AGENCY: Office of Sustainable Housing program is designed to support regional process. The details of this multi-agency and Communities, Office of the Deputy planning efforts, the Community planning grant program, including Secretary, HUD; and Office of the Challenge Planning Grant Program information about eligibility, selection Secretary, DOT. focuses on individual jurisdictions and criteria, and pre-application and ACTION: Notice of Funding Availability more localized planning. HUD will application requirements are included (NOFA). publish a separate NOFA for the in this joint notice. The final notice for Sustainable Communities Regional the TIGER II Discretionary Grant SUMMARY: This notice announces the Planning Grant Program. availability of funding and requests program (the ‘‘TIGER II Discretionary DOT is authorized to use up to $35 Grant NOFA’’) was published on June 1, proposals for the Department of Housing million of the funds available for TIGER and Urban Development’s (‘‘HUD’s’’) 2010 (75 FR 30460). Interested parties II Discretionary Grants for TIGER II are encouraged to review the TIGER II Community Challenge Planning Grants Planning Grants to fund the planning, (‘‘Community Challenge Planning Discretionary Grant NOFA for more preparation, or design of surface information about that program. Grants’’) in conjunction with a portion transportation projects that would be DATES: Pre-applications are due by July of the Department of Transportation’s eligible for funding under the TIGER II 26, 2010, at 5 p.m. EDT, and (‘‘DOT’s’’) National Infrastructure Discretionary Grant program. Investments Grants that can be used for DOT and HUD have decided to issue applications must be submitted by transportation planning grants. this NOFA jointly in order to better August 23, 2010, at 5 p.m. EDT. Only On December 16, 2009, the President align transportation, housing, economic pre-applications received and signed the Consolidated Appropriations development, and land use planning applications received through Act, 2010 (Pub. L. 111–117) that and to improve linkages between DOT Grants.gov will be deemed properly provided $40 million for HUD’s and HUD’s programs. HUD’s funding is filed. Instructions for submitting pre- Community Challenge Planning Grants designed to target housing, economic applications and applications are and up to $35 million for DOT’s development, and land use planning included in Section VI. transportation planning grants to be strategies that will increase the FOR FURTHER INFORMATION CONTACT: For awarded as part of the National efficiency and effectiveness of a related further information concerning this Infrastructure Investments program. The transportation project being planned. notice please contact the TIGER II National Infrastructure Investments Therefore, DOT and HUD believe this Discretionary Grant program manager program is similar, but not identical to, joint effort has the potential to via e-mail at [email protected], or the Transportation Investment encourage and reward more holistic call Robert Mariner at 202–366–8914 Generating Economic Recovery, or planning efforts that result in better (this is not a toll-free number). A TDD ‘‘TIGER Discretionary Grant Program.’’ projects being built with Federal dollars. is available for individuals who are deaf Because of the similarity in program The effort is also consistent with the or hearing-impaired, at 202–366–3993 structure, DOT is referring to the grants Obama Administration’s priority on (this is not a toll-free number). In for National Infrastructure Investments removing artificial barriers between addition, DOT will regularly post under the FY 2010 Appropriations Act Federal programs and barriers to State answers to questions and requests for as ‘‘TIGER II Discretionary Grants’’ and and local governmental level clarifications on DOT’s Web site at the transportation planning grants as innovation. http://www.dot.gov/recovery/ost/ ‘‘TIGER II Planning Grants.’’ On April 26, 2010 (75 FR 21695), DOT TIGERII. Questions regarding HUD’s HUD’s $40 million Community published an interim notice announcing Community Challenge Planning Grant Challenge Planning Grant Program will the availability of funding for TIGER II Program should be directed to foster reform and reduce barriers to Discretionary Grants. Because the [email protected] or achieving affordable, economically vital, TIGER II Discretionary Grant program is may be submitted through the http:// and sustainable communities. Such a new program, the interim notice www.hud.gov/sustainability Web site. efforts may include amending or requested comments on the proposed HUD’s contact person is Zuleika K. replacing local master plans, zoning selection criteria and guidance for Morales-Romero, Office of Sustainable codes, and building codes, either on a awarding TIGER II Discretionary Grants. Housing and Communities, 451 Seventh jurisdiction-wide basis or in a specific In the interim notice, DOT specifically Street, SW., Washington, DC 20410– neighborhood, district, corridor, or requested comments on its intention to 3000, telephone number 202–402–7683 sector to promote mixed-use conduct a multi-agency evaluation and (this is not a toll-free number) facsimile development, affordable housing, the award process with HUD for the 202–708–0465, or e-mail: reuse of older buildings and structures Community Challenge Planning Grants [email protected]. For the for new purposes, and similar activities and the TIGER II Planning Grants. DOT hearing- or speech-impaired, contact the with the goal of promoting indicated that this multi-agency above telephone number via TTY by sustainability at the local or approach for the planning grants would dialing the toll-free Federal Information neighborhood level. HUD’s Community be consistent with DOT and HUD’s Relay Service at 1–800–877–8339.

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SUPPLEMENTARY INFORMATION: Grants. DOT is referring to the grants for through a competition made available as National Infrastructure Investments as a NOFA under its Community Challenge Table of Contents TIGER II Discretionary Grants. The FY and TIGER II Planning Grants. Overview Information 2010 Appropriations Act permits DOT A. The Partnership for Sustainable Full Text Announcement to use up to $35 million of the funds Communities. This NOFA is being I. Funding Opportunity Description available for TIGER II Discretionary initiated in close coordination between II. Award Information Grants for TIGER II Planning Grants. DOT, HUD and the EPA, through the III. Eligibility Information The TIGER II Discretionary Grant NOFA Partnership for Sustainable IV. Threshold Requirements was published on June 1, 2010 (75 FR Communities (the Partnership). V. Application Review Information The Partnership was conceived to VI. Application and Submission Information 30460), and awards will be announced VII. Award Administration Information at the same time as awards made under coordinate Federal housing, VIII. Other Information this NOFA. transportation and environmental b. Community Challenge Planning investments, protect public health and Overview Information Grants. the environment, promote equitable A. Federal Agency Name: Office of The FY 2010 Appropriations Act also development, and help address the Sustainable Housing and Communities, appropriated $40 million to HUD to challenges of climate change. Office of the Deputy Secretary, HUD; establish a Community Challenge Recognizing the fundamental role that and Office of the Secretary, DOT. Planning Grant Program ‘‘to foster public investment plays in achieving B. Funding Opportunity Title: reform and reduce barriers to achieve these outcomes, the Administration Community Challenge and affordable, economically vital, and charged three agencies whose programs Transportation Planning Grants. sustainable communities.’’ The most directly impact the physical form C. Funding Opportunity Number: The Community Challenge Planning Grant of communities—HUD, DOT, and funding opportunity number is FR– Program differs from HUD’s Sustainable EPA—to lead the way in reshaping the 5415–N–12. Community Challenge and Communities Regional Planning Grant role of the Federal government in Transportation Planning Grant. The Program, a $100 million program also helping communities obtain the OMB Approval Number is 2501–0025. created in the FY 2010 Appropriations capacity to embrace a more sustainable D. Catalog of Federal Domestic Act. While the latter program is future. Assistance (CFDA) Number: The Catalog designed to support regional planning One of the first acts of the Partnership of Federal Domestic Assistance (CFDA) efforts, the Community Challenge was to agree to a set of six ‘‘Livability numbers for the HUD Community Planning Grant Program focuses on Principles’’ to govern the work of the Challenge and DOT TIGER II Planning individual jurisdictions and more Partnership and for each of the three Grant are 14.704 and 20.933, localized planning. HUD will publish a agencies to strive to incorporate into respectively. separate NOFA for the Sustainable their policies and funding programs to E. Additional Overview Information: Communities Regional Planning Grant the degree possible. In addition, each 1. Background. Program. agency has clear and defined roles: HUD a. TIGER II Planning Grants. 2. Available Funds. Up to $75 million, will take the lead in funding, evaluating, On February 17, 2009, the President including $40 million for Community and supporting integrated regional signed the American Recovery and Challenge Planning Grants and up to planning for sustainable development, Reinvestment Act of 2009 (Pub. L. 111– $35 million for TIGER II Planning and will invest in sustainable housing 05) (Recovery Act), which appropriated Grants. and community development efforts. $1.5 billion of discretionary grant funds 3. Funding Categories. Given the DOT will focus on building the capacity to be awarded by DOT for capital range of planning activities that of transportation agencies to integrate investments in surface transportation potential applicants are trying to their planning and investments into infrastructure. DOT refers to these accomplish, DOT and HUD will support broader plans and actions that promote grants as Grants for Transportation a variety of eligible activities spelled out sustainable development, and investing Investment Generating Economic in Section III.C.1.a–c. in transportation infrastructure that Recovery or ‘‘TIGER Discretionary 4. Authority. The program was directly supports sustainable Grants.’’ DOT solicited applications for authorized by the Consolidated development and livable communities. TIGER Discretionary Grants through a Appropriations Act, 2010 (Pub. L. 111– EPA will provide technical assistance to notice of funding availability published 117, approved December 16, 2009). communities and States to help them in the Federal Register on June 17, 2009 5. Application of HUD’s General implement sustainable community (74 FR 28775) (an interim notice was Section. All applicants accessing strategies, and develop environmental published on May 18, 2009 (74 FR resources available through HUD’s sustainability metrics and practices. The 23226)). Applications for TIGER Community Challenge Planning Grants three agencies have made a commitment Discretionary Grants were due on are subject to the requirements of the to coordinate activities, integrate September 15, 2009, and DOT received General Section to HUD’s FY 2010 funding requirements, and adopt a more than 1,400 applications with NOFAs for discretionary programs. common set of performance metrics for funding requests totaling almost $60 Applicants for such grants should use by grantees. billion. Funding for 51 projects was carefully review the requirements B. Program Goals. announced on February 17, 2010. described in this NOFA and HUD’s 1. To better align Federal programs to On December 16, 2009, the President General Section. HUD’s General Section support the building of projects that signed the Fiscal Year (FY) 2010 is not applicable to applicants accessing further the six Livability Principles Consolidated Appropriations Act, resources available through TIGER II (listed in rating factor 1 below). which appropriated $600 million to Planning Grants. 2. To remove artificial or bureaucratic DOT for National Infrastructure barriers among Federal programs and Investments using language that is Full Text Announcement create a more coordinated point of similar, but not identical to, the I. Funding Opportunity Description: contact for State and local governments language in the Recovery Act This notice announces DOT’s and building innovative projects that authorizing the TIGER Discretionary HUD’s intention to offer funding coordinate housing, economic

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development, transportation, and rural area if all or the majority of a supporting documentation, that environmental policies and goals. project is located in a rural area. Finally, application will be considered on awarding TIGER II Discretionary ineligible. II. Award Information Grants, including TIGER II Planning C. Other Requirements. A. Award Size. For both Community Grants, DOT must take measures to 1. Eligible Activities. In order to Challenge Planning Grants and TIGER II ensure an equitable geographic explain the variety of activities eligible Planning Grants, there is no minimum distribution of grant funds, an for funding under this joint notice, the grant size, but the maximum grant size appropriate balance in addressing the activities are described in three is $3 million. needs of urban and rural areas, and groupings: B. Type of Awards. All awards will be investment in a variety of transportation a. TIGER II Planning Grants: made in the form of Cooperative modes. Activities related to the planning, Agreements. HUD and DOT anticipate TIGER II Discretionary Grants, preparation, or design of surface having substantial involvement in the including TIGER II Planning Grants, transportation projects, including, but work being conducted under this award may be used for up to 80 percent of the not limited to: to ensure the purposes of the grant costs of a project; however, applications (1) Highway or bridge projects eligible program are being carried out and that will be more competitive to the extent under Title 23, United States Code; entities are following through on their they include significant non-Federal (2) Public transportation projects commitments. This includes making financial contributions. The minimum eligible under Chapter 53 of Title 49, progress in meeting established and maximum grant sizes established by United States Code; performance metrics, and ensuring the FY 2010 Appropriations Act for (3) Passenger and freight rail consistency in projects in participating TIGER II Discretionary Grants do not transportation projects; and jurisdictions that are funded through apply to TIGER II Planning Grants. (4) Port infrastructure investments. other HUD, DOT, and EPA programs so b. Community Challenge Planning that they are implemented in a manner III. Eligibility Information Grants: Activities related to the consistent with the Livability A. Eligible Applicants. State and local following: Principles. governments, including U.S. territories, C. Period of Performance. The period tribal governments, transit agencies, (1) Development of master plans or of performance shall not exceed 36 port authorities, metropolitan planning comprehensive plans that promote months from the date the funds are organizations (MPOs), other political affordable housing co-located and/or obligated. All funds awarded must be subdivisions of State or local well-connected with retail and business obligated by September 30, 2012. governments, and multi-State or development and discourage D. Statutory Distributional multijurisdictional groupings. development not aligned with Requirements Only Applicable to TIGER B. Cost Sharing or Leveraging sustainable transportation plans or II Funds. This joint notice was Resources. For those seeking TIGER II disaster mitigation analyses; developed and is being published in Planning Grants, a 20 percent match is (2) Development and implementation conjunction with the TIGER II required. DOT will consider any non- of local, corridor or district plans and Discretionary Grants NOFA. The Federal funds as a local match for strategies that promote livability and selection process for TIGER II Planning purposes of this program, whether such sustainability (see the Livability Grants will be conducted in parallel funds are contributed by the public Principles in Section V); with the selection process for TIGER II sector (State or local) or the private (3) Revisions to zoning codes, Discretionary Grants, and awards of sector. However, DOT will not consider ordinances, building standards, or other TIGER II Planning Grants are subject to funds already expended as a local laws to remove barriers and promote several distributional requirements match. The 20 percent matching sustainable and mixed-use development under the FY 2010 Appropriations Act. requirement does not apply to projects and to overcome the effects of These requirements do not apply to in rural areas. For those seeking HUD impediments to fair housing choice in HUD Community Challenge Planning Community Challenge Planning Grants, local zoning codes and other land use Grants. First, no more than 25 percent applicants must provide 20 percent of laws, including form-based codes and of the funds made available for TIGER the requested funding amount in inclusionary zoning ordinances to II Discretionary Grants (or $150 leveraged resources in the form of cash promote accessible, permanently million), including any funding used for and/or verified in-kind contributions or affordable housing that reduces racial TIGER II Planning Grants, may be a combination of these sources. In-kind and poverty housing concentration and awarded to projects in a single State. contributions may be in the form of staff expands fair housing choice for low- Additionally, not less than $140 million time, donated materials, or services. All income minorities; of the funds provided for TIGER II assistance provided to meet this (4) Revisions to building codes to Discretionary Grants, including TIGER II requirement must be identified by their promote the energy-efficient Planning Grants, is to be used for dollar equivalent based upon accepted rehabilitation of older structures in projects located in rural areas. For salary or regional dollar values. Cash order to create affordable and healthy purposes of this notice, DOT is contributions may come from any housing; generally defining ‘‘rural area’’ as any combination of local, state and/or (5) Strategies for creating or area not in an Urbanized Area, as such Federal funds, and/or private and preserving affordable housing for low-, term is defined by the Census Bureau1 philanthropic contributions dedicated very low-, and extremely low-income and will consider a project to be in a to the express purposes of this proposal. families or individuals in mixed- Applicants will receive credit for income, mixed-use neighborhoods along 1 For the 2000 Census, the Census Bureau defined leveraging or matching resources greater an existing or planned transit corridor; an Urbanized Area (UA) as an area that consists of than 20 percent of the requested amount (6) Strategies to bring additional densely settled territory that contains 50,000 or as described in Rating Factor 4. If an affordable housing to areas that have more people. Updated lists of UAs are available on the Census Bureau Web site. Urban Clusters (UCs) applicant does not include the few affordable housing opportunities will be considered rural areas for purposes of this minimum 20 percent leveraged or and are close to suburban job clusters; NOFA. matched resources with its appropriate and

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(7) Planning, establishing, and activities and would benefit from proscribing discrimination in housing maintaining acquisition funds and/or funding and associated activities in both based on sexual orientation or gender land banks for development, DOT and HUD’s programs, applicants identity; or redevelopment, and revitalization that should indicate that in their application 5. Have received a cause reserve property for the development of and the agencies may both award determination from a substantially affordable housing within the context of funding to the project, with DOT and equivalent state or local fair housing sustainable development HUD each awarding its funds for the agency concerning a systemic violation c. Combination of TIGER II Planning eligible activities under its own of a state or local law proscribing Grant and Community Challenge respective program. However, only one discrimination in housing based on Planning Grant activities. There are a application per project will be accepted lawful source of income; and variety of projects that may include (see Threshold Requirements, Section a. The charge, cause determination, eligible activities under both the TIGER IV.C.). lawsuit, or letter of findings referenced II Planning Grants and the Community in subparagraphs (1), (2), (3), (4), or (5) Challenge Planning Grants programs. IV. Threshold Requirements above has not been resolved to HUD’s Rather than have applicants proceed Evaluation teams from DOT and HUD satisfaction before the application through two separate grant application will review each pre-application that is deadline, then you, the applicant, are procedures, this joint NOFA is intended received on or prior to the Pre- ineligible for funding. HUD will to create one point of entry to Federal Application Deadline and will be determine if actions to resolve the resources to support related components responsible for analyzing whether the charge, cause determination, lawsuit, or of a single project. To illustrate the pre-application satisfies the following letter of findings taken before the possible combination of activities, key threshold requirements: application deadline are sufficient to please consider the following examples: A. The project and the applicant are resolve the matter. (1) Planning activities related to the eligible for funding under the TIGER II b. Examples of actions that would development of a particular Planning Grant or Community normally be considered sufficient to transportation corridor or regional Challenge Planning Grant program; and resolve the matter include, but are not transportation system, that promotes B. Local leveraging, or matching funds limited to: mixed-use, transit-oriented are committed to support 20 percent or c. Current compliance with a development with an affordable housing more of the costs of the transportation voluntary compliance agreement signed component. planning activities to be funded; this by all the parties; (2) Planning activities related to the requirement is not applicable to (1) Current compliance with a HUD- development of a freight corridor that transportation planning projects located approved conciliation agreement signed seeks to reduce conflicts with in rural areas. by all the parties; residential areas and with passenger and C. Only one application per project (2) Current compliance with a non-motorized traffic. In this type of will be accepted for review. An conciliation agreement signed by all the project, DOT might fund the applicant that submits more than one parties and approved by the State or transportation planning activities along application per project may have some local administrative agency with the corridor, and HUD may fund or all of the submissions deemed jurisdiction over the matter; changes in the zoning code to support ineligible. (3) Current compliance with a consent appropriate siting of freight facilities D. Resolution of Outstanding Civil order or consent decree; or and route the freight traffic around town Rights Matters for Applicants for HUD (4) Current compliance with a final centers, residential areas, and schools. Funding. If you, the applicant: judicial ruling or administrative ruling (3) Developing expanded public 1. Have received a charge from HUD or decision. transportation options, including concerning a systemic violation of the accessible public transportation and Fair Housing Act or a cause V. Application Review Information para-transit services for individuals determination from a substantially A. Criteria. with disabilities, to allow individuals to equivalent state or local fair housing 1. Rating Factor 1—Purpose and live in diverse, high opportunity agency concerning a systemic violation Outcomes (35 points): An applicant’s neighborhoods and communities and to of a substantially equivalent state or score on this rating factor will be based commute to areas with greater local fair housing law proscribing on a clear statement of the existing employment and educational discrimination based on race, color, condition that the proposed project is opportunities. religion, sex, national origin, disability intended to address and the proposed DOT and HUD are expecting to award or familial status; project’s alignment with the six the TIGER II Planning Grants and the 2. Are a defendant in a Fair Housing ‘‘Livability Principles.’’ Applicants that Community Challenge Planning Grants Act lawsuit filed by the Department of demonstrate that their project aligns for planning activities that ultimately Justice alleging a pattern or practice of well with the Livability Principles and lead to the development of projects that discrimination pursuant to 42 U.S.C. are consistent with any existing region integrate transportation, housing and 3614(a); wide plans that consider transportation, economic development components. 3. Have received a letter of findings economic development, housing, water, DOT and HUD plan to make joint identifying systemic noncompliance and other infrastructure needs and awards, where appropriate. However, under Title VI of the Civil Rights Act of investments will receive a higher score. we also expect DOT to make awards for 1964, Section 504 of the Rehabilitation The Livability Principles are as follows: TIGER II Planning Grant activities alone Act of 1973, or Section 109 of the a. Provide More Transportation and for HUD to make awards for Housing and Community Development Choices. Develop safe, reliable and Community Challenge Planning Grants Act of 1974; affordable transportation choices to alone. Applicants may apply for funding 4. Have received a cause decrease household transportation costs, from only TIGER II Planning Grants or determination from a substantially reduce energy consumption and from only Community Challenge equivalent state or local fair housing dependence on foreign oil, improve air Planning Grants. To the extent that an agency concerning a systemic violation quality, reduce greenhouse gas application has a project that has linked of provisions of a state or local law emissions, and promote public health.

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b. Promote equitable, affordable they articulate the elements of their plan the application addresses the quality housing. Expand location- and energy- that will help achieve those outcomes, and cost effectiveness of the proposed efficient housing choices for people of and the specificity of the benchmarks work plan. Applicants must develop a all ages, incomes, races, and ethnicities that they establish to measure progress work plan that includes specific to increase mobility and lower the toward a completed product that guides deliverables, and measurable, time- combined cost of housing and all of the necessary work. phased objectives for each major transportation. Applicants that receive awards will be activity. c. Enhance Economic expected to report on the progress of the This factor also addresses the Competitiveness. Improve economic project and outcomes realized at the performance metrics that will be used to competitiveness through reliable and mid-way point and at the end of the measure the success of the proposed timely access to employment centers, term of the grant. Where outcomes have activities. For a proposed project to educational opportunities, services and been realized, they should be detailed achieve results, expected outcomes and other basic needs by workers, as well as and backed with data. For projects that outputs must be clearly defined, and expanded business access to markets. must go to construction for many evaluation must take place to ensure d. Support Existing Communities. benefits to be realized, benchmarks will that those outcomes and outputs are Target Federal funding toward existing focus more on the progress of plan met. Outcomes are the ultimate communities—through strategies like development, any changes in the scope objectives of a project, and outputs are transit oriented, mixed-use of the work that occur during the the interim activities or products that development, and land recycling—to planning process, and how those lead to the achievement of those increase community revitalization and changes might impact the anticipated objectives. To track progress toward the the efficiency of public works outcomes. outputs and outcomes, a project must be investments and safeguard rural For projects that must go to evaluated based upon performance landscapes. construction for benefits to be realized, measures. Performance measures should e. Coordinate Policies and Leverage benchmarks will focus more on the be objectively quantifiable, and allow Investment. Align Federal policies and progress of plan development, any one to assess the degree of actual funding to remove barriers to changes in scope that occur, and how achievement against the expected collaboration, leverage funding, and those changes might impact the outputs and outcomes. Applications increase the accountability and anticipated outcomes. that demonstrate how outputs and effectiveness of all levels of government DOT and HUD recognize that each outcomes are fully defined and easily to plan for future growth, including project is unique. As such, the agencies measured will receive a higher score. making smart energy choices such as are allowing significant latitude to the The applicant’s budget proposal locally generated renewable energy. applicant to set the desired outcomes should thoroughly estimate all f. Value Communities and that will result from implementation of applicable costs (direct, indirect, and Neighborhoods. Enhance the unique the project. DOT and HUD have administrative), and be presented in a characteristics of all communities by identified six possible outcomes, listed clear and coherent format. The investing in healthy, safe, and walkable below, from which each applicant must applicant must thoroughly document neighborhoods—rural, urban, or select a minimum of two outcomes that and justify all budget categories, costs, suburban. it must pursue and report on during its and all major tasks, for the applicant, In order for points to be awarded, period of performance. sub-recipients, joint venture applicants shall also provide data to a. Travel changes, such as changes in participants, or other contributing support outcomes of the proposed mode share or vehicle miles traveled per resources to the project. project claimed in the application. capita. 3. Rating Factor 3—Leveraging and Based on the project being proposed, the b. Impact on affordability and Collaboration (15 points): An applicant shall identify the Livability accessibility, including the supply of applicant’s score on this rating factor Principle(s) that will be addressed and affordable housing units, household will be based on how well the detail how that success will be transportation costs, or proportion of application demonstrates the project’s documented. For example, if the low- and very-low income households ability to obtain other community, local, proposed program intends to expand the within a 30-minute transit commute of State, private, and Federal support, as presence of equitable, affordable major employment centers. applicable, and resources that can be housing, the applicant should provide c. Economic development, including combined with DOT and HUD program data to support this claim. infill development or recycled parcels of resources to achieve program objectives. As there is a wide range of projects land or private sector investment along Resources may include cash or in-kind that can be supported through this a project or corridor. contributions of services, equipment, or notice, not every project is expected to d. Improvement to the state of repair supplies allocated to the proposed address all six Livability Principles. of infrastructure. program. In evaluating this factor, HUD Points will be awarded based on the e. Environmental benefits, such as and DOT will consider the extent to extent to which the proposed project greenhouse gas or criteria pollutants which the applicant has established furthers the specifically identified emissions, oil consumption and working partnerships with other entities principles supported with data. recreational areas or open space to get additional resources or The applicant is required to clearly preserved. commitments to increase the identify the benefits or outcomes of its f. Increased participation and effectiveness of the proposed program proposed program. Because this decision-making in developing and activities. application seeks support to develop a implementing a plan, code, When evaluating this factor, HUD and plan for a specific project, all of the development strategy, or project by DOT will take into account two outcomes will not be realized during the populations traditionally marginalized considerations: the amount of resources duration of the grant period. Rather, in public planning processes. leveraged or matched that exceeds the applicants will be evaluated on their 2. Rating Factor 2—Work Plan (35 required 20 percent, and per capita ability to identify the outcomes they points): An applicant’s score on this income in the applicable jurisdiction seek to achieve, the clarity with which rating factor will be based on how well relative to the metropolitan average.

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Data must be provided for the indicator All applicants for HUD funding are describe the outreach methods that will when responding to this rating factor. subject to the requirements to be used to achieve this outcome. The 20 percent of leveraged or matched Affirmatively Further Fair Housing. Examples include establishing regular resources that are a threshold HUD will award additional points to partner dialogues, and structured peer requirement will not count as points applicants that prioritize additional exchange. According to the proposed toward this rating factor. To score points measures to advance civil rights, such as methods, the applicant should establish in this rating factor, resources may be Executive Order 12898, Federal Actions and specify the anticipated outputs (e.g., provided by governmental entities, to Address Environmental Justice in number of meetings, Web postings, public or private organizations, and Minority Populations and Low-Income number of participating partners, total other entities. Other resources from the Populations, and Executive Order staff exposed to new learning and private sector or other sources 13166, Improving Access to Services for promising practice, number of briefings, committed to the program that exceed Persons with Limited English issuance of monthly fact sheets, etc.) the required 20 percent leveraged or Proficiency. during the 3-year period of performance. matched resources will be given extra Applicants should indicate if, and HUD will work with grantees to support weight for this rating factor. The describe how, the following policy knowledge sharing and innovation by applicant should provide supporting priorities will be addressed: (1) Capacity disseminating best practices, documentation of all committed funds. Building and Knowledge Sharing and encouraging peer learning, publishing Please refer to Section VI., Application (2) Expand Cross-Cutting Policy data analysis and research, and helping and Submission, for more details. Knowledge. One point will be awarded to incubate and test new ideas. 4. Rating Factor 4—Capacity (15 for each policy priority. Identify specific b. Expand Cross-Cutting Policy points): An applicant’s score on this activities, outputs and outcomes that Knowledge. rating factor will be based on how well further these policy priorities over the Broadening the use of successful the application demonstrates the period of performance. models to other communities requires applicant’s capacity to successfully a. Capacity Building and Knowledge definitive evidence of which policies Sharing. implement the proposed activities in a work and how, and a plan for public HUD recognizes that successful timely manner. The applicant will dissemination of this information. program implementation can only occur To achieve full points, the applicant provide specific examples of previous in partnership with effectively prepared must indicate what data they and/or projects similar to the proposed effort grantees. It is therefore critical to partner organizations will collect on that demonstrate its capacity to strengthen the capacity of each outcomes for the defined target area implement the proposed work plan. consortium by developing partnerships (e.g., changes in commuting time, DOT and HUD will give priority to that will advance the objectives of improved health outcomes, VMT applications that demonstrate the prior proposed programs. HUD’s Strategic measures, etc.). The grantee must experience to bring this type of Plan emphasizes the importance of document a plan to engage credible project(s) that is the subject of the strengthening the capacity of state and policy researchers to assist in the planning activities to completion. local partners to implement HUD analysis of that data in order to measure Priority will also be given to programs, participate in decision- policy impact, and clarify the extent of applications that demonstrate strong making and planning processes, and data that will be made available to those collaboration among a broad range of coordinate on cross-programmatic, researchers through a data-sharing participants, including public, private place-based approaches through grant agreement. and nonprofit entities. making and technical assistance. To (1) For household-level data, this may The applicant shall designate the staff receive policy priority points, be an agreement with a university or that is anticipated to manage the applicants are expected to describe how other policy research group that proposed project, as well as other staff they will achieve the following regularly produces peer-reviewed anticipated to contribute to the project’s outcomes: research publications. completion. Ratings under this factor (1) Increase the skills and technical (2) For parcel-related data, this are based on the capacity of the expertise of partner organizations to agreement may be with a regional applicant’s organization, and its team, manage Federal awards, provide solid planning, non-profit, or government as applicable, and should include an financial management, and perform agency that provides consolidated local assessment of the capacity of sub- program performance assessment and data on a regular basis to the public for contractors, consultants, sub-recipients, evaluation. The applicant must describe free. community-based organizations, and the methods that will be used to achieve The applicant should specifically any other entities that are part of the this outcome. Examples include in- describe how they intend to disseminate project application, as applicable. service trainings, online information policy lessons learned during the Applicants should be prepared to provision (e.g., webinars, podcasts, etc.), planning process to a diverse range of initiate eligible activities within 120 and structured observation of best potential audiences, including days of the effective date of the grant practices. According to the proposed policymakers, other regional consortia, award. DOT and HUD reserve the right methods, the applicant should identify and interested community leadership. to terminate the grant if sufficient the anticipated outputs (e.g., number of The collection method and specific data personnel or qualified experts are not people trained, number of training elements will not be prescribed by HUD, retained within these 120 days. In rating events, volume of easily accessible but may be determined by the applicant. this factor, DOT and HUD will consider, training materials for targeted The applicant must establish and among other factors, the extent to which capacities, etc.) during the 3-year period provide the anticipated outputs within the application demonstrates that the of performance. the period of performance. Examples applicant has an adequate number of (2) Share knowledge among partners include the number of policy key staff or the ability to procure so that key personnel responsible for publications, number of research individuals with the knowledge and grant implementation coordinate cross- studies, anticipated distribution of recent experience in the proposed programmatic, placed-based findings, etc. activity. approaches. The applicant must B. Evaluation and Selection Process.

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1. Rating and Ranking. through Grants.gov by the Application d. State(s) where the project is Evaluation teams made up of a Deadline, which is August 23, 2010, at located; representative from DOT, HUD, and 5 p.m. EDT. The Grants.gov ‘‘Apply’’ e. County(s) where the project is EPA initially will evaluate each function will open on July 30, 2010, located; application as to how well it scores allowing applicants to submit f. City(s) where the project is located; against the ‘‘Rating Factors’’ identified applications. While applicants are g. Zip code(s) where the project is below, and will assign it a score on a encouraged to submit pre-applications located; scale of 1–100. The scoring system will in advance of the Pre-Application h. Project title (descriptive); not determine the specific projects that Deadline, pre-applications will not be i. Project type: specify eligible will be selected for funding; rather, the reviewed until after the Pre-Application activities proposed for funding, such as scoring system will be used to generate Deadline. Similarly, while applicants transportation planning activity, site a list of highly recommended projects. are encouraged to submit applications area plan, corridor plan, land assembly The highly recommended projects will in advance of the Application Deadline, or acquisition, etc.; then be forwarded to a senior-level applications will not be evaluated until j. Project description: describe the review team for review, and the senior- after the Application Deadline. Awards project in plain English terms that level review team will make funding will not be made until after September would be generally understood by the recommendations to the Secretaries of 15, 2010. public, using no more than 50 words; DOT and HUD, based on how the To apply for funding through this should be purely descriptive, not a project performed under the four rating Grants.gov, applicants must be properly discussion of the project’s benefits, factors, how each project addresses the registered. Complete instructions on background, or alignment with the Program Goals identified in Section I.B, how to register and submit applications selection criteria in this description; and statutory distributional can be found at www.grants.gov. Please k. Total cost of the project; considerations required in the National be aware that the registration process l. Total amount of TIGER II Planning Infrastructure Investments provision of usually takes 2–4 weeks and must be Grant and Community Challenge the FY 2010 Consolidated completed before an application can be Planning Grant funds requested; Appropriations Act for the DOT submitted. If interested parties m. Contact name, telephone number, Planning Grants. The review teams will experience difficulties at any point email address, and physical address of include senior-level representatives during the registration or application the applicant; from the three Partnership for process, please call the toll free n. Type of jurisdiction where the Sustainable Communities agencies: Grants.gov Customer Support Hotline at project is located (urban or rural); and DOT, HUD, and EPA. 1–800–518–4726, Monday to Friday o. An assurance that local matching from 7 a.m. to 9 p.m. EDT. funds are committed to support 20 VI. Application and Submission Applicants must submit a pre- percent or more of any transportation Information application as Stage 1, which qualifies planning activities to be funded. (This A. Address To Request Application applicants to submit an application in requirement does not apply to projects Package. Applications are available on Stage 2. An application submitted located in rural areas). the Federal Web site www.Grants.gov. during Stage 2 that does not correlate 3. Applications. An application for a To find this funding opportunity at with a properly completed Stage 1 pre- TIGER II Planning Grant or a Grants.gov, go to http://www.grants.gov/ application will not be considered. Community Challenge Planning Grant applicants/find_grant_opportunities.jsp 2. Contents of Pre-Applications. An should include all of the information at the www.Grants.gov Web site, where applicant for a TIGER II Planning Grant requested below. DOT and HUD reserve you can search by agency and/or or a Community Challenge Planning the right to ask any applicant to perform a Basic Search. Additional Grant should provide in its pre- supplement the data in its application, information on applying through application form, all of the information but expect applications to be complete Grants.gov is available at http:// requested below in its pre-application upon submission. www.grants.gov. form. DOT and HUD reserve the right to a. Standard Form SF–424, B. Content and Form of Application ask any applicant to supplement the Application for Federal Assistance. Submission. Applicants eligible to apply data in its pre-application but expect Please see www07.grants.gov/assets/ under this NOFA are to follow the pre-applications to be complete upon SF424Instructions.pdf for instructions submission requirements described submission. Applicants must complete on how to complete the SF–424, which below: the pre-application form and submit it is part of the standard Grants.gov 1. Pre-Application. Unless otherwise electronically on or prior to the Pre- submission. Additional clarifying indicated in this joint notice, applicants Application Deadline, in accordance guidance and Frequently Asked should submit pre-applications and with the instructions specified at Questions (FAQs) to assist applicants in applications in accordance with the http://www.dot.gov/recovery/ost/ completing the SF–424 will be available procedures specified in the TIGER II TIGERII. The pre-application form must at http://www.dot.gov/recovery/ost/ Discretionary Grant NOFA. To submit include the following information: TIGERII by July 30, 2010, when the an application, please access http:// a. Name of applicant (if the ‘‘Apply’’ function within Grants.gov www.dot.gov/recovery/ost/tigerii/ application is to be submitted by more opens to accept applications under this index.html or http://www.hud.gov/ than one entity, a lead applicant must notice. sustainability. Pre-applications must be be identified); b. In Responding to the First and submitted by the Pre-Application b. Applicant’s DUNS (Data Universal Second Rating Factor. (Attachment to Deadline, which is July 26, 2010, at 5 Numbering System) number; SF–424). A TIGER II Planning Grant and p.m. EDT. The pre-application system c. Type of applicant (State HUD Community Challenge Grant will be hosted by DOT, on behalf of government, local government, U.S. application must include information DOT and HUD, and will open no later territory, Tribal government, transit required for DOT and HUD to assess than June 23, 2010, to allow prospective agency, port authority, metropolitan each of the rating factors specified in applicants to submit pre-applications. planning organization, or other unit of Section III (Application Review and Final applications must be submitted government); Rating Factors). Applicants are

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encouraged to demonstrate the (3) Project Completion Schedule. experience of the applicant entity. The responsiveness of a project to any and Briefly describe the project completion application should also include a all of the rating factors with the most schedule, including milestones in each description of the applicant’s relevant information that applicants can month for the critical management experience in outreach efforts involving provide, regardless of whether such actions for you and any other entity low-income persons, particularly those information has been specifically whose cooperation or assistance is living in revitalization areas where requested, or identified, in this notice. necessary to achieve your desired result, funds are proposed to be used, residents In order to fulfill the requirements of including the end dates of each required of public housing, minorities, socially the first rating factor, an applicant must: action and your expected metrics and and economically disadvantaged (1) Submit a narrative describing how results. individuals, non-English speaking the applicant will use the funding (4) Performance Measures. List the persons, and persons with disabilities. sought to achieve its desired outcomes performance measures you will use to Applicants should demonstrate that and how the desired outcomes support evaluate the success of your project or they either have sufficient personnel or the six Livability Principles. The activity, as well as the benchmarks you the ability to procure qualified experts narrative should also state the problems expect to reach during the term of the or professionals, with the knowledge, grant and a timeline for reaching them. or barriers the project seeks to address, skills, and abilities with relevant c. In Responding to the Third Rating why they are an impediment to experience to carry out the proposed promoting a more sustainable future for Factor. Applicants will not receive full points if they do not submit evidence of activity. the applicant community, and the Contact information is requested as outcomes the project seeks to achieve. a firm commitment and the appropriate use of leveraged or matched resources part of the SF–424. This information (2) Submit data supporting any will be used in order to inform parties assertions made about the expected under the grant program. Such evidence must be provided in the form of letters of the selection of projects for funding, outcomes, as well as the nature and the of firm commitment, memoranda of as well as to contact parties in the event extent of the problems or barriers the understanding, or other signed additional information is needed. project seeks to remove. agreements to participate from those In responding to the second rating e. Page Limit. Applications should be entities identified as partners in the factor, applicants must provide a limited to a total of 15 pages. HUD and application. Each letter of commitment, narrative to discuss their project DOT will not refer to Web sites for memorandum of understanding, or outcomes, outputs, and performance information pertinent to the narrative agreement to participate should include response. All applications should measures. Applicants should also the organization’s name, the proposed identify important milestones (e.g., the include a detailed description of the level of commitment, and the proposed project and geospatial data for end of specific phases in a multiphase organization’s responsibilities as they project), which should also be clearly the project, including a map of the area relate to the proposed project. The to be planned and where other work indicated in the proposal timeline. commitment must be signed and dated Applicants should also identify will occur. by an official of the organization legally C. Submission Dates and Times. All potential obstacles in meeting outcomes able to make commitments on behalf of pre-applications must be submitted in and outputs and related performance the organization. Applicants should accordance with the instructions measures and discuss steps they would describe how they will ensure that specified at http://www.dot.gov/ take to respond to these obstacles. commitments to sub-grantees will be recovery/ost/TIGERII. The pre- Finally, applicants should describe how honored and executed, contingent upon application system will be hosted by project evaluation information will be an award from DOT or HUD. obtained, documented, and reported. (1) Applicants must support each DOT, on behalf of DOT and HUD. Final Applicants should submit a work plan source of contributions, cash or in-kind, applications must be submitted that includes the following: both for the required minimum and electronically through Grants.gov. Pre- (1) Proposed Activities. Briefly additional amounts, by a letter of applications are due by July 26, 2010, at describe the overall activity you propose commitment from the contributing 5 p.m. EDT, and applications must be to undertake, including any coordinated entity, whether a public or private submitted by August 23, 2010, at 5 p.m. components that will not be directly source. The letter must describe the EDT. funded under the TIGER II Planning contributed resources that you will use D. Funding Restrictions. Applicants Grant Program or the Community in the program and their designated should also be aware that DOT is Challenge Planning Grant Program. purpose. Staff in-kind contributions accepting applications for capital Describe the regional or local should be given a monetary value based expenditures associated with surface significance of the project and whether on the local market value of the staff transportation projects in the TIGER II it is a part of a comprehensive regional skills. If you do not provide letters from Discretionary Grant notice (Docket No. plan. Include public outreach and contributors specifying details and the DOT–OST–2010–0076). As part of that participation activities, including amount of the actual contributions, program, applicants may request minority and disadvantaged those contributions will not be counted. planning funds associated with their populations. d. In Responding to the Fourth Rating capital request. If DOT awards planning (2) Uses of Funds/Budget. Indicate Factor. DOT and HUD will consider funding to an applicant to the TIGER II how you will use the grant funds you how the applicant entity is organized Discretionary Grant program, the are seeking by providing a list or table and how it will function in funding available through this notice showing the amount of funds budgeted implementing the grant. The application will be lessened by that amount. for each activity you will undertake to should include a description of the Further, DOT has the option to use less achieve your desired result. Indicate the leadership responsibilities and than the $35 million permitted in the entity responsible for each use and procedures for allocating resources, statute and may do so based on activity, including any elected bodies or setting goals, and settling disputes. It distributional requirements or the need bodies appointed by elected officials. should also include an explanation of to fund highly recommended capital Specify administrative costs. the capacity and relevant, recent grant applications.

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VII. Award Administration Information a Grant Agreement. Selection for 3. Financial reporting requirements A. Award Notices. participation (preliminary approval) include, but are not limited to, the 1. Applicants Selected for Award. does not constitute approval of the submission of the financial status Projects selected for a TIGER II Planning proposed site(s). Each proposal will be report, SF–425, bi-annually. subject to a HUD environmental review, Grant will be administered by one of VIII. Other Information DOT’s modal administrations, pursuant in accordance with 24 CFR part 50, and to a grant agreement between the TIGER the proposal may be modified or the A. Compliance with Fair Housing and II Planning Grant recipient and the DOT proposed sites rejected as a result of that Civil Rights Laws and Affirmatively modal administration. review. Furthering Fair Housing for Community HUD awardees will be required to Submission of an application Challenge Planning Grant Applicants negotiate a final statement of work and involving a project requiring an Fair Housing and Civil Rights Laws: will enter into a Cooperative Agreement environmental review will constitute an 1. With the exception of Federally with HUD. The Cooperative Agreement assurance that the applicant shall assist recognized Indian tribes and their will also contain an agreed upon Logic HUD in complying with 24 CFR part 50 instrumentalities, applicants and their Model identifying specific activities and and shall: sub-recipients must comply with all performance criteria to be reported (1) Supply HUD with all available, applicable fair housing and civil rights against over a period of time. HUD relevant information necessary for HUD requirements in 24 CFR 5.105 (a), grantees must meet the requirements to perform for each property any including, but not limited to, the Fair contained in the General Section to environmental review required by 24 Housing Act, Title VI of the Civil Rights HUD’s FY 2010 Funding Notices. CFR part 50; Act of 1964, and the Rehabilitation Act 2. Adjustment of Funding. DOT and (2) Carry out mitigating measures of 1973. HUD reserve the right to fund less than required by HUD or select alternate 2. If you are a federally recognized the full amount requested in an eligible property; and Indian tribe, you must comply with the application based on the availability of (3) Not acquire, rehabilitate, nondiscrimination provisions funds, geographic diversity, and to demolish, convert, lease, repair, or enumerated at 24 CFR 1000.12, as ensure that the maximum number of construct property, nor commit or applicable. See the General Section for grants may be made. expend HUD or local funds for these further instructions on this requirement. 3. HUD grant recipients must comply program activities with respect to any 3. Affirmatively Furthering Fair with applicable Federal requirements, eligible property, until HUD approval of Housing: Section 808(e)(5) of the Fair including compliance with the Fair the property is received. Housing Act imposes a duty on HUD to Housing and Civil Rights Laws For assistance, contact the HUD affirmatively further the purposes of the applicable to all Federal awards. Environmental Review Officer in the Fair Housing Act in its housing and B. Administrative and National Policy HUD Field Office serving your area. urban development programs. This Requirements. Contact information is requested as obligation further applies generally to 1. Environmental Requirements. All part of the SF–424. DOT will use this recipients of HUD funds, including applicants that are proposing to use information to inform parties of DOT’s those awarded and announced under grant funds for land acquisition must decision regarding selection of projects, HUD’s FY 2010 funding notices. Your comply with HUD’s environmental as well as to contact parties in the event application must include a discussion procedures. In accordance with 24 CFR that DOT needs additional information on how your proposed plans 50.19(b)(1), (9), and (16), all other about an application. affirmatively further fair housing; eligible activities assisted by HUD funds 2. Administrative and Indirect Cost applications that include specific under this NOFA are categorically Requirements. For reference to the activities and outcomes that address this excluded from environmental review Administrative Cost requirements and requirement will be rated higher. under the National Environmental Indirect cost requirements, please see Applicants for Community Challenge Policy Act of 1969 and are not subject OMB Circulars A–21, A–87, and A–122, Planning Grants that are tribal to environmental review under the as applicable. governments are not subject to the related laws and authorities. For C. Reporting Requirements. HUD affirmatively furthering fair housing applicants requesting grant funds for Award Agreements will include the submission requirement in the General transportation planning, NEPA is not terms and conditions of the award Section. typically triggered (and even if including the reporting requirements. B. Additional Environmental triggered, categorical exclusions 1. Final Work Plan and Logic Model. Requirements. A Finding of No typically exist). However, if any projects Final work plan and completed Logic Significant Impact (FONSI) with respect planned with funding under this NOFA Model are due 60 days after the effective to the environment has been made for move to the construction phase and date of the grant agreement. See the this NOFA in accordance with HUD Federal funds are later sought for General Section for detailed information regulations at 24 CFR part 50, which construction, all appropriate NEPA on the use of the ‘‘Master’’ eLogic Model. implement section 102(2)(C) of the analyses will need to be completed prior 2. Successful applicants will be National Environmental Policy Act of to any Federal expenditures. required to submit bi-annual and final 1969 (42 U.S.C. 4332(2)(C)). The FONSI Under HUD’s environmental program reports according to the is available for public inspection procedures, for those applications requirements of the award agreement. between 8 a.m. and 5 p.m. weekdays in involving land acquisition activities Your bi-annual and final report must the Regulations Division, Office of requiring environmental review, the include a completed Logic Model, form General Counsel, Department of notification of award to a selected HUD–96010, approved and Housing and Urban Development, 451 applicant will constitute a preliminary incorporated into your award Seventh Street, SW., Room 10276, approval by HUD, subject to the agreement, showing specific outputs Washington, DC 20410–0500. Due to completion of an environmental review and outcome results against those security measures at the HUD of the proposed site(s), and the proposed and accepted as part of your Headquarters building, an advance execution by HUD and the recipient of approved grant agreement. appointment to review the FONSI must

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be scheduled by calling the Regulations Dated: June 18, 2010. Division at 202–708–3055 (this is not a Ray LaHood, toll-free number). Secretary, Department of Transportation. Shaun Donovan, Secretary, Department of Housing and Urban Development. [FR Doc. 2010–15353 Filed 6–21–10; 4:15 pm] BILLING CODE 4210–67–P

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Reader Aids Federal Register Vol. 75, No. 121 Thursday, June 24, 2010

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING JUNE

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 1 CFR 1604...... 34654, 36015 Executive orders and proclamations 741–6000 1651...... 34654, 36015 Proposed Rules: The United States Government Manual 741–6000 9...... 33734 7 CFR Other Services 11...... 33734 28...... 34319 Electronic and on-line services (voice) 741–6020 12...... 33734 271...... 33422 Privacy Act Compilation 741–6064 2 CFR 273...... 33422 Public Laws Update Service (numbers, dates, etc.) 741–6043 275...... 33422 TTY for the deaf-and-hard-of-hearing 741–6086 2339...... 31273 277...... 33422 3 CFR 301...... 34320, 34322 ELECTRONIC RESEARCH 305...... 34322 Proclamations: 755...... 34336 World Wide Web 8527...... 32075 916...... 31275 Full text of the daily Federal Register, CFR and other publications 8528...... 32077 917...... 31275 is located at: http://www.gpoaccess.gov/nara/index.html 8529...... 32079 923...... 31663 Federal Register information and research tools, including Public 8530...... 32081 925...... 34343 Inspection List, indexes, and links to GPO Access are located at: 8531...... 32083 930...... 33673 http://www.archives.gov/federallregister 8532...... 32085 944...... 34343 E-mail 8533...... 34305 956...... 34345 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 8534...... 34307 989...... 35959 an open e-mail service that provides subscribers with a digital 8535...... 34309 1218...... 31279 form of the Federal Register Table of Contents. The digital form 8536...... 34311 1470...... 31610, 34924 of the Federal Register Table of Contents includes HTML and 8537...... 35949 1774...... 35962 PDF links to the full text of each document. 8538...... 35951 3430...... 33497 To join or leave, go to http://listserv.access.gpo.gov and select Executive Orders: 4280...... 33501 Online mailing list archives, FEDREGTOC-L, Join or leave the list 13544...... 33983 Proposed Rules: (or change settings); then follow the instructions. Administrative Orders: 46...... 32306 PENS (Public Law Electronic Notification Service) is an e-mail Memorandums: 319...... 30303, 32310 service that notifies subscribers of recently enacted laws. Memorandum of May 930...... 31719, 33673 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 21, 2010 ...... 32087 984...... 34950 and select Join or leave the list (or change settings); then follow Memorandum of June 1000...... 33534, 36015 the instructions. 1, 2010 ...... 32245 1215...... 31730 FEDREGTOC-L and PENS are mailing lists only. We cannot Memorandum of June 1755...... 32313 respond to specific inquiries. 2, 2010 ...... 32247 Reference questions. Send questions and comments about the Memorandum of June 8 CFR Federal Register system to: [email protected] 10, 2010 ...... 33987 Proposed Rules: The Federal Register staff cannot interpret specific documents or Memorandum of June 103...... 33446 regulations. 18, 2010 ...... 35953 204...... 33446 Reminders. Effective January 1, 2009, the Reminders, including Memorandum of June 244...... 33446 Rules Going Into Effect and Comments Due Next Week, no longer 18, 2010 ...... 35955 274A ...... 33446 appear in the Reader Aids section of the Federal Register. This Notices: 9 CFR information can be found online at http://www.regulations.gov. Notice of June 8, CFR Checklist. Effective January 1, 2009, the CFR Checklist no 2010 ...... 32841 Proposed Rules: longer appears in the Federal Register. This information can be Notice of June 8, 201...... 35338 found online at http://bookstore.gpo.gov/. 2010 ...... 32843 Notice of June 14, 10 CFR FEDERAL REGISTER PAGES AND DATE, JUNE 2010 ...... 34317 72...... 33678 Notice of June 17, 170...... 34220 30267–30686...... 1 35289–35604...... 22 2010 ...... 34921 171...... 34220 30687–31272...... 2 35605–35956...... 23 Presidential 440...... 32089 31273–31662...... 3 35957–36256...... 24 Determinations: Proposed Rules: 31663–32074...... 4 No. 2010-09 of June 2, 30...... 33902, 36212 32075–32244...... 7 2010 ...... 33489 31...... 36212 32245–32648...... 8 No. 2010-10 of June 8, 32...... 33902, 36212 32649–32840...... 9 2010 ...... 34617 33...... 33902 32841–33158...... 10 34...... 33902 5 CFR 33159–33488...... 11 35...... 33902 33489–33672...... 14 Ch. LXXXII...... 35957 36...... 33902 33673–33982...... 15 531...... 34923 37...... 33902 33983–34318...... 16 630...... 33491 39...... 33902 34319–34616...... 17 875...... 30267 40...... 36212 34617–34922...... 18 Proposed Rules: 51...... 33902 34923–35288...... 21 1600...... 34388 70...... 36212

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71...... 33902 39 ...... 30740, 31324, 31327, 106...... 32658 32854, 33505 72...... 33736 31329, 31330, 31332, 31731, 107...... 32658 147...... 32273 73...... 33902 31734, 32315, 32863, 33738, 312...... 32658 165 ...... 30706, 30708, 32275, 430 ...... 31224, 31323, 34656 34062, 34390, 34657, 34661, 558...... 34361 32280, 32664, 32666, 32855, 433...... 34657 34663, 34953, 34956, 35354, 803...... 32658 33170, 33506, 33692, 33694, 435...... 34657 35356 872...... 33169 33696, 33698, 33701, 33995, 65...... 30742 33997, 33999, 34001, 34361, 12 CFR Proposed Rules: 71 ...... 30746, 32117, 32119, 1301...... 32140 34362, 34365, 34367, 34369, 205...... 31665, 33681 32120, 32317, 32865, 33556, 1309...... 32140 34372, 34374, 34376, 34379, 230...... 31673 33557, 33559, 33560, 33561, 34636, 34639, 34641, 34927, 561...... 33501 34391, 34393 24 CFR 34929, 34932, 34934, 34936, 604...... 35966 234...... 32318 Proposed Rules: 35294, 35296, 35299, 35648, 607...... 35966 244...... 32318 1000...... 36022 35649, 35651, 35652, 35968, 611...... 30687 250...... 32318 3280...... 34064 35970 612...... 35966 253...... 32318 3282...... 35902 334...... 34643 613...... 30687 259...... 32318 3285...... 35902 Proposed Rules: 614...... 35966 399...... 32318 3500...... 31334 100...... 32866 615...... 30687, 35966 117 ...... 30305, 30747, 30750, 15 CFR 618...... 35966 25 CFR 32349, 32351 619...... 30687 734...... 31678 900...... 31699 165...... 30753, 33741 620...... 30687 744...... 31678 1000...... 31699 627...... 35966 740...... 31678 34 CFR 701...... 34619 748...... 31678 26 CFR 5...... 33509 702...... 34619 750...... 31678 1 ...... 31736, 32659, 33990, 361...... 32857 704...... 34619 766...... 31678, 33682 35643 371...... 34296 708a...... 34619 774...... 31678, 33989 40...... 33683 691...... 32857 708b...... 34619 801...... 35289 49...... 33683 Proposed Rules: 709...... 34619 904...... 35631 54...... 34536 Ch. VI...... 31338 711...... 34619 Proposed Rules: 301...... 33992 600...... 34806 712...... 34619 700...... 32122 602 ...... 33683, 34536, 35643 602...... 34806 715...... 34619 902...... 32994 603...... 34806 716...... 34619 Proposed Rules: 668...... 34806 717...... 34619 16 CFR 1...... 35710 682...... 34806 721...... 34619 40...... 33740 320...... 31682 685...... 34806 722...... 34619 49...... 33740 1215 ...... 31688, 31691, 33683 686...... 34806 741...... 34619 54...... 34569 1216...... 35266, 35282 690...... 34806 742...... 34619 1500...... 35279 27 CFR 691...... 34806 745...... 34619 1512...... 34360 478...... 31285 747...... 34619 37 CFR 790...... 34619 17 CFR 28 CFR 2...... 35973 791...... 34619 30...... 35291 7...... 35973 792...... 34619 240...... 33100 542...... 34625 256...... 32857 793...... 34619 241...... 33100 Proposed Rules: 0...... 33205 795...... 34619 Proposed Rules: 38 CFR Proposed Rules: 36...... 33198 51...... 33205 17...... 32668, 32670 25...... 35686, 36016 37...... 33198 29 CFR 21...... 32293 228...... 35686, 36016 38...... 33198 36...... 33704 345...... 35686, 36016 230...... 35920 1202...... 32273 39...... 34004 563e...... 35686, 36016 242...... 32556 1206...... 32273 1282...... 32099 270...... 35920 1404...... 30704 Proposed Rules: 2530...... 32846 4...... 35711 14 CFR 18 CFR 2590...... 34536 17...... 30306, 33216 39 ...... 30268, 30270, 30272, 260...... 35632 2578...... 34626 39 CFR 30274, 30277, 30280, 30282, 375...... 32657 4022...... 33688 4044...... 33688 30284, 30287, 30290, 30292, Proposed Rules: 20...... 34017, 35302 30687, 31282, 32090, 32251, 40...... 35689 Proposed Rules: 111 ...... 30300, 31288, 31702 32253, 32255, 32260, 32262, 260...... 35700 1910...... 32142, 35360 Proposed Rules: 32263, 32266, 32649, 33159, 342...... 34959 111...... 32143 33162, 34347, 34349, 34354, 30 CFR 501...... 30309 34357, 34924, 35605, 35609, 19 CFR Proposed Rules: 3010...... 34074 35611, 35613, 35616, 35619, Proposed Rules: Ch. VII...... 34666 35622, 35624 351...... 32341, 34960 218...... 32343 40 CFR 65...... 31283 938...... 34960, 34962 7...... 31702 71 ...... 30295, 30689, 31677, 20 CFR 9...... 35977 31 CFR 32268, 32269, 32271, 32272, 404 ...... 30692, 32845, 33166, 50...... 35520 32651, 32652, 33164, 33165, 33167 560...... 34630 51...... 31514 33681, 34624 405...... 33167 Proposed Rules: 52 ...... 30710, 31288, 31290, 73...... 32093 408...... 33167 208...... 34394 31306, 31514, 31709, 31711, 91...... 30690 416...... 32845, 33167 32293, 32673, 32857, 32858, 97 ...... 32094, 32096, 32653, 418...... 33167 32 CFR 33172, 33174, 34644, 34939 32655, 35627, 35629 439...... 31273 320...... 34634 53...... 35520 234...... 34925 Proposed Rules: 58...... 35520 406...... 30690 1001...... 33203 33 CFR 63...... 31317, 34649 Proposed Rules: 100 ...... 30296, 32661, 32852, 70...... 31514 21...... 34953 21 CFR 33502, 33690, 34634 71...... 31514 23...... 33553 73...... 34360 117 ...... 30299, 30300, 32663, 81...... 35302

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82...... 34017 42 CFR 1...... 34260 3015...... 32723 141...... 32295 417...... 32858 3...... 34258 3016...... 32723 156...... 33705 422...... 32858 4...... 34260, 34271 3052...... 32723 174...... 34040 423...... 32858 5...... 34271, 34273 180 ...... 31713, 33190, 34045, 480...... 32858 6...... 34273 35653 8...... 34271 49 CFR Proposed Rules: 228...... 33708 10...... 34277 365...... 35318 260...... 31716 412 ...... 30756, 30918, 34612 12...... 34279 413 ...... 30756, 30918, 34612 387...... 35318 261...... 31716, 33712 13 ...... 34271, 34273, 34279 390...... 32860 262...... 31716 44 CFR 14...... 34279 395...... 32860 263...... 31716 15...... 34279 64...... 32302, 35666 541...... 34946 264...... 31716 16...... 34271 571...... 33515 265...... 31716 65 ...... 35670, 35672, 35674, 19...... 34260 830...... 35329 266...... 31716 35682 22...... 34282 268...... 31716 67...... 34381 24...... 34273 1002...... 30711 270...... 31716 Proposed Rules: 25...... 34282 1011...... 30711 271...... 35660 67 ...... 31361, 31368, 32684, 30...... 34283 1152...... 30711 300...... 33724 34415 31...... 34285, 34291 1180...... 30711 721...... 35977 44...... 34277 Proposed Rules: 1065...... 34653 45 CFR 49...... 34291 195...... 35366 Proposed Rules: 147...... 34536 52 ...... 34258, 34260, 34277, 535...... 33565 7...... 31738 170...... 36158 34279, 34282, 34283, 34286, 544...... 34966 52 ...... 30310, 31340, 32353, Proposed Rules: 34291 611...... 31321, 33757 33220, 33562, 34669, 34670, 301...... 32145 53...... 34260, 34286 34671, 34964, 36023 209...... 35684 302...... 32145 50 CFR 60 ...... 31938, 32613, 32682 303...... 32145 216...... 32641 63 ...... 31896, 32006, 32682, 307...... 32145 217 ...... 32638, 32639, 34942 17...... 35990 34673 225 ...... 32637, 32640, 34943 223...... 30714 72...... 33392 46 CFR 228...... 32642 600...... 30484 231...... 32642 75...... 33392 501...... 31320 622...... 35330, 35335 81...... 35362, 36023 234...... 32638 Proposed Rules: 635 ...... 30484, 30730, 30732, 86...... 33950 239...... 34946 97...... 34574, 34682 33531, 33731 87...... 36034 241...... 34942 148...... 34574, 34682 648 ...... 30739, 34049, 36012 98...... 33950 252 ...... 32642, 33195, 34943, 660...... 33196, 33733 122...... 35712 47 CFR 35684 679...... 31321, 31717 136...... 35712 505...... 32860 Proposed Rules: 156...... 33744 27...... 33729, 35989 3025...... 32676 17 ...... 30313, 30319, 30338, 228...... 33747 36...... 30301 3052...... 32676 30757, 30769, 31387, 32727, 241...... 31844, 32682 52...... 35305 Proposed Rules: 32728, 32869, 34077, 35375, 257...... 35128 73...... 34049 202...... 33752 35398, 35424, 35721, 35746, 261...... 35128 76...... 34941 203...... 33752 264...... 35128 90...... 35315 212...... 33752 35751, 36035 265...... 35128 Proposed Rules: 242...... 33237 20...... 32872 268...... 35128 2...... 33748 252...... 32636, 33752 80...... 32877 271 ...... 34674, 35128, 35720 15...... 33220 919...... 33752 223...... 30769 300...... 33747, 34405 54...... 32692, 32699 922...... 33752 224...... 30769 302...... 35128 73...... 30756, 33227 923...... 33752 600...... 33570 761...... 34076 90...... 35363 924...... 33752 635...... 35432 1039...... 32613 97...... 33748 925...... 33752 648...... 35435 1042...... 32613 926...... 33752 660...... 32994 1065...... 32613 48 CFR 952...... 33752 665...... 34088 1068...... 32613 Ch. I...... 34256, 34291 970...... 32719 697...... 34092

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Register but may be ordered advances from Oil Spill listserv.gsa.gov/archives/ in ‘‘slip law’’ (individual Liability Trust Fund for the publaws-l.html LIST OF PUBLIC LAWS pamphlet) form from the Deepwater Horizon oil spill. Superintendent of Documents, (June 15, 2010; 124 Stat. This is a continuing list of Note: This service is strictly U.S. Government Printing 1278) public bills from the current for E-mail notification of new Office, Washington, DC 20402 Last List June 14, 2010 session of Congress which laws. The text of laws is not have become Federal laws. It (phone, 202–512–1808). The text will also be made available through this service. may be used in conjunction PENS cannot respond to with ‘‘P L U S’’ (Public Laws available on the Internet from Public Laws Electronic specific inquiries sent to this Update Service) on 202–741– GPO Access at http:// Notification Service 6043. This list is also www.gpoaccess.gov/plaws/ (PENS) address. available online at http:// index.html. Some laws may www.archives.gov/federal- not yet be available. PENS is a free electronic mail register/laws.html. S. 3473/P.L. 111–191 notification service of newly The text of laws is not To amend the Oil Pollution enacted public laws. To published in the Federal Act of 1990 to authorize subscribe, go to http://

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