4–19–10 Monday Vol. 75 No. 74 Apr. 19, 2010
Pages 20237–20510
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Contents Federal Register Vol. 75, No. 74
Monday, April 19, 2010
Agriculture Department Assembly and Test Worldwide, Inc., Livonia, MI, Lake See Food and Nutrition Service Zurich, IL, and Shelton, CT, 20387 See National Institute of Food and Agriculture Auburn Hosiery Mills, Auburn, KY, 20386 See Rural Housing Service Autodie, LLC, Including On-site and Off-site Individual Contractors, Grand Rapids, MI, 20391 Centers for Medicare & Medicaid Services Chrysler Group LLC, Warren, MI, 20389 NOTICES Contech Castings, LLC, et al., Dowagiac, MI, 20387 Agency Information Collection Activities; Proposals, Crucible Materials Corp., Syracuse, NY et al., 20387– Submissions, and Approvals, 20365–20368 20388 Coast Guard Dell Products LP, 20385 Findlay Industries, Inc., Findlay Plant One, Findlay, OH, RULES Special Local Regulation for Marine Events: 20389–20390 Temporary Change of Dates for Recurring Marine Events International Business Machines Corp., Global in the Fifth Coast Guard District, 20294–20297 Technology Services Business Unit, et al., Armonk, NOTICES NY, 20388–20389 Certificate of Alternative Compliance for the Offshore LA-Z-BOY Casegoods, Inc., 20390 Supply Vessel LEBOUEF TIDE, 20371–20372 Resinoid Engineering Corp., Hebron and Heath, OH, Certificate of Alternative Compliance for the Offshore 20389 Supply Vessel RIG RUNNER, 20372 Robert Bosch LLC, Including On-Site Leased Workers of Meetings: Bosch Management Services North America, et al., Commercial Fishing Industry Vessel Safety Advisory 20390–20391 Committee, 20372–20373 Senco Brands, Inc., et al., Cincinnati, OH, 20390 The Boeing Co., et al., 20385–20386 Commerce Department Trane, et al., Pueblo, CO, 20386 See International Trade Administration Amended Notice of Revised Determination on See National Institute of Standards and Technology Reconsideration: See National Oceanic and Atmospheric Administration Agrium U.S., Inc., 20391–20392 NOTICES Investigations Regarding Certifications of Eligibility to Opportunity to Serve on the Board of Directors of the Apply for Worker Adjustment Assistance, 20392–20394 Corporation for Travel Promotion, 20325–20326 Negative Determination On Remand: American Racing Equipment, LLC; Denver, CO, 20394– Comptroller of the Currency 20396 NOTICES Negative Determination Regarding Application for Agency Information Collection Activities; Proposals, Reconsideration: Submissions, and Approvals, 20426 Terex USA, LLC; Cedar Rapids, IA, 20396–20397 Education Department Yale Industrial Trucks–PGH, Inc.; Monroeville, PA, 20396 NOTICES Agency Information Collection Activities; Proposals, Environmental Protection Agency Submissions, and Approvals, 20346 NOTICES Privacy Act; Systems of Records, 20346–20350 Board of Trustees for the National Environmental Education Foundation, 20350–20351 Employment and Training Administration Clean Water Act Section 303(d): NOTICES Availability of One Total Maximum Daily Load (TMDL) Affirmative Determination Regarding Application for in Arkansas, 20351–20352 Reconsideration: Innovoion Corp.; Gresham, OR, 20382 Meetings: Modine Manufacturing Company, Pemberville, OH, Climate Ready Water Utilities Working Group of the 20382 National Drinking Water Advisory Council, 20352 Amended Certification Regarding Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Executive Office of the President Adjustment Assistance: See Management and Budget Office ABB, Inc., Wichita Falls, TX, 20384 See Presidential Documents Chrysler LLC, 20384–20385 Chrysler LLC, St. Louis North Assembly Plant, Fenton, MO, 20382–20383 Federal Accounting Standards Advisory Board Delphi Thermal Systems, Lockport Operations, Lockport, NOTICES NY, 20383 Issuance of Statement of Federal Financial Accounting Hewlett Packard Co., et al., 20383–20384 Standard 38: Amended Certification Regarding Eligibility to Apply for Accounting for Federal Oil and Gas Resources, 20363– Worker Adjustment Assistance: 20364 Amtex, Inc., Manteca, CA, 20386–20387 Meetings, 20364
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Federal Aviation Administration Amended Authorizations of Emergency Use of Certain RULES Antiviral Drugs Zanamivir and Oseltamivir Phosphate; Airworthiness Directives: Availability, 20430–20437 Liberty Aerospace Inc. Model XL–2 Airplanes, 20265– Authorization of Emergency Use of Certain In Vitro 20268 Diagnostic Devices; Availability, 20441–20480 PROPOSED RULES Amendment of Class E Airspace; Smithfield, NC, 20320– Food and Nutrition Service 20321 PROPOSED RULES Proposed Amendment of Class E Airspace; Bozeman, MT, Geographic Preference Option for Procurement of 20321–20322 Unprocessed Agricultural Products in Child Nutrition Proposed Amendment of Class E Airspace; Kelso, WA, Programs, 20316–20320 20322–20323 Proposed Amendment to and Establishment of Restricted Foreign Assets Control Office Areas and Other Special Use Airspace: NOTICES Razorback Range Airspace Complex, AR, 20323–20324 Additional Designations, Foreign Narcotics Kingpin NOTICES Designation Act, 20425–20426 Meetings: RTCA Special Committee 214; Working Group 78: General Services Administration Standards for Air Traffic Data Communication NOTICES Services, 20423 Transfer of Property: Key Largo Beacon Annex Site; Key Largo, FL, 20364 Federal Communications Commission NOTICES Health and Human Services Department Agency Information Collection Activities; Proposals, See Centers for Medicare & Medicaid Services Submissions, and Approvals, 20352–20355 See Food and Drug Administration Meetings; Sunshine Act, 20355–20357 See Indian Health Service See National Institutes of Health Federal Deposit Insurance Corporation See Substance Abuse and Mental Health Services RULES Administration Amendment of Temporary Liquidity Guarantee Program: NOTICES Extend Transaction Account Guarantee Program with Statement of Organization, Functions, and Delegations of Opportunity to Opt-Out, 20257–20265 Authority, 20364–20365 NOTICES Agency Information Collection Activities; Proposals, Homeland Security Department Submissions, and Approvals: See Coast Guard National Survey of Unbanked and Underbanked See U.S. Customs and Border Protection Households, 20357–20358 NOTICES Intra-Agency Appeal Process: Meetings: Material Supervisory Determinations and Deposit Homeland Security Advisory Council, 20371 Insurance Assessment Determination, 20358–20363 Housing and Urban Development Department Updated Listing of Financial Institutions in Liquidation, RULES 20363 Regulatory Reporting Requirements: Indian Community Development Block Grant Program, Federal Reserve System 20269–20271 NOTICES Formations of, Acquisitions by, and Mergers of Bank Indian Health Service Holding Companies, 20364 NOTICES Agency Information Collection Activities; Proposals, Federal Transit Administration Submissions, and Approvals: NOTICES Application for Participation in IHS Scholarship Program, Environmental Impact Statements; Availability, etc.: 20369–20370 Expansion of Light Rail Transit Service from Glassboro, NJ to Camden, NJ, 20421–20423 Interior Department See Land Management Bureau Fiscal Service See Minerals Management Service PROPOSED RULES See National Park Service Garnishment of Accounts Containing Federal Benefit See Reclamation Bureau Payments, 20299–20314 International Trade Administration Food and Drug Administration NOTICES RULES Correction to Notice of Amended Final Determination Implantation or Injectable Dosage Form New Animal Drugs: Pursuant to Final Court Decision: Change of Sponsor; Propofol, 20268–20269 Circular Welded Carbon Quality Steel Line Pipe from the NOTICES People’s Republic of China, 20334–20335 Amended Authorization of Emergency Use of the Antiviral Final Determination of Sales at Less Than Fair Value, etc.: Product Peramivir Accompanied by Emergency Use Certain Oil Country Tubular Goods from the People’s Information; Availability, 20437–20441 Republic of China, 20335–20342
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Final Results of Antidumping Duty Administrative Review National Park Service and Rescission of Administrative Review in Part: NOTICES Certain Circular Welded Non-Alloy Steel Pipe from Agency Information Collection Activities; Proposals, Mexico, 20342–20344 Submissions, and Approvals, 20374–20376 Meetings: Labor Department Cape Cod National Seashore Advisory Commission, See Employment and Training Administration 20380–20381
Land Management Bureau Nuclear Regulatory Commission NOTICES RULES Environmental Impact Statements; Availability, etc.: Categorical Exclusions from Environmental Review, 20248– NextEra Energy Resources Genesis Solar Energy Project, 20257 etc., 20379–20380 NOTICES Possible Amendment to California Desert Conservation Meetings: Area Plan for Calico Solar Project, etc., 20376–20377 ACRS Subcommittee on Planning and Procedures, 20398 Proposed Hollister Underground Mine Project, Elko ACRS Subcommittee on Plant License Renewal, 20397– County, NV, 20379 20398 Proposed Sonoran Solar Energy Project, Maricopa ACRS Subcommittee on the AP1000, 20398–20399 County, AZ, 20377–20378 Regulatory Guides; Issuance, Availability, etc., 20399
Management and Budget Office Office of Management and Budget NOTICES See Management and Budget Office Work Reserved for Performance by Federal Government Employees; Correction, 20397 Personnel Management Office Minerals Management Service PROPOSED RULES RULES Federal Employees Health Benefits Program; Miscellaneous Oil and Gas and Sulphur Operations in the Outer Changes, 20314–20316 Continental Shelf: Garnishment of Accounts Containing Federal Benefit Oil and Gas Production Requirements, 20271–20294 Payments, 20299–20314 NOTICES Agency Information Collection Activities; Proposals, National Highway Traffic Safety Administration Submissions, and Approvals, 20399 NOTICES Agency Information Collection Activities; Proposals, Petition for Decision of Inconsequential Noncompliance: Submissions, and Approvals: Fuji Heavy Industries USA, Inc., 20423–20425 Federal Cyber Service; Scholarship for Service (SFS) Registration Website, 20400 National Institute of Food and Agriculture RULES Veterinary Medicine Loan Repayment Program (VMLRP), Presidential Documents 20239–20248 EXECUTIVE ORDERS Government agencies and employees: National Institute of Standards and Technology Interagency Group on Insular Areas; establishment (EO NOTICES 13537), 20237–20238 Availability of Funds; Meetings: Technology Innovation Program, 20326–20334 Public Debt Bureau See Fiscal Service National Institutes of Health NOTICES Railroad Retirement Board Meetings: PROPOSED RULES National Cancer Institute, 20370 Garnishment of Accounts Containing Federal Benefit National Institute of Environmental Health Sciences, Payments, 20299–20314 20371 National Institute of Neurological Disorders and Stroke, Reclamation Bureau 20370–20371 NOTICES Meetings: National Oceanic and Atmospheric Administration Glen Canyon Dam Adaptive Management Work Group NOTICES (AMWG), 20381–20382 Meetings: North Pacific Fishery Management Council, 20344 Takes of Marine Mammals Incidental to Specified Recovery Accountability and Transparency Board Activities: PROPOSED RULES Taking Marine Mammals Incidental to Exploration Privacy Act Regulations, 20298–20299 Drilling Program near Camden Bay, Beaufort Sea, AK, 20482–20509 Rural Housing Service Taking and Importing Marine Mammals: NOTICES Taking Marine Mammals Incidental to Rocket Launches Public Forums: from Kodiak, AK, 20344–20346 Section 523 Mutual Self-Help Housing Program, 20325
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Securities and Exchange Commission Veterans Affairs Department NOTICES PROPOSED RULES Self-Regulatory Organizations; Proposed Rule Changes: Garnishment of Accounts Containing Federal Benefit BATS Exchange, Inc., 20418–20420 Payments, 20299–20314 NASDAQ Stock Market LLC, 20415–20417 NOTICES NYSE Amex LLC, 20401–20413 Agency Information Collection Activities; Proposals, NYSE Arca, Inc., 20413–20415, 20417–20418 Submissions, and Approvals: Small Business Administration Insurance Surveys, 20427 NOTICES Reasonable Accommodation, 20427–20428 Disaster Declaration: Rehabilitation Needs Inventory, 20427 Maryland, 20400–20401 Meetings: West Virginia, 20400–20401 National Research Advisory Council, 20428 Social Security Administration PROPOSED RULES Garnishment of Accounts Containing Federal Benefit Separate Parts In This Issue Payments, 20299–20314
Substance Abuse and Mental Health Services Part II Administration Health and Human Services Department, Food and Drug Administration, 20430–20480 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20368–20369 Part III Commerce Department, National Oceanic and Atmospheric Transportation Department Administration, 20482–20509 See Federal Aviation Administration See Federal Transit Administration See National Highway Traffic Safety Administration NOTICES Reader Aids Privacy Act; Systems of Records, 20420–20421 Consult the Reader Aids section at the end of this page for Treasury Department phone numbers, online resources, finding aids, reminders, See Comptroller of the Currency and notice of recently enacted public laws. See Fiscal Service See Foreign Assets Control Office To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http:// U.S. Customs and Border Protection listserv.access.gpo.gov and select Online mailing list NOTICES archives, FEDREGTOC-L, Join or leave the list (or change Quarterly IRS Interest Rates Used in Calculating Interest on settings); then follow the instructions. Overdue Accounts and Refunds on Customs Duties, 20373–20374
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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.
3 CFR Executive Orders: 13537...... 20237 4 CFR Proposed Rules: 200...... 20298 5 CFR Proposed Rules: 831...... 20299 841...... 20299 890...... 20314 892...... 20314 7 CFR 3431...... 20239 Proposed Rules: 210...... 20316 215...... 20316 220...... 20316 225...... 20316 226...... 20316 10 CFR 51...... 20248 12 CFR 370...... 20257 14 CFR 39...... 20265 Proposed Rules: 71 (4 documents) ...... 20320, 20321, 20322, 20323 20 CFR Proposed Rules: 350...... 20299 404...... 20299 416...... 20299 21 CFR 522...... 20268 24 CFR 1003...... 20269 30 CFR 250...... 20271 31 CFR Proposed Rules: 212...... 20299 33 CFR 100...... 20294 38 CFR Proposed Rules: 1...... 20299
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Federal Register Presidential Documents Vol. 75, No. 74
Monday, April 19, 2010
Title 3— Executive Order 13537 of April 14, 2010
The President Interagency Group on Insular Areas
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Interagency Group on Insular Areas. (a) There is established, within the Department of the Interior for adminis- trative purposes, the Interagency Group on Insular Areas (IGIA) to address policies concerning Guam, American Samoa, the United States Virgin Islands, and the Commonwealth of the Northern Mariana Islands (Insular Areas). (b) The IGIA shall consist of: (i) the heads of the executive departments, as defined in 5 U.S.C. 101; (ii) the heads of such other executive agencies as the Co-Chairs of the IGIA may designate; and (iii) the Deputy Assistant to the President and Director of Intergovernmental Affairs. (c) The Secretary of the Interior and the Deputy Assistant to the President and Director of Intergovernmental Affairs shall serve as Co-Chairs of the IGIA, convene and preside at its meetings, direct its work, and establish such subgroups of the IGIA as they deem appropriate, consisting exclusively of members of the IGIA. (d) Members of the IGIA may designate a senior department or agency official who is a full-time officer or employee of the Federal Government to perform their IGIA functions. Sec. 2. Functions of the IGIA. The IGIA shall: (a) advise the President on establishment or implementation of policies concerning the Insular Areas; (b) solicit information and advice concerning the Insular Areas from the Governors of, and other elected officials in, the Insular Areas (including through at least one meeting each year with any Governors of the Insular Areas who may wish to attend) in a manner that seeks their individual advice and does not involve collective judgment, or consensus advice or deliberation; (c) solicit information and advice concerning the Insular Areas, as the IGIA determines appropriate, from representatives of entities or other individ- uals in a manner that seeks their individual advice and does not involve collective judgment, or consensus advice or deliberation; (d) solicit information from executive departments or agencies for purposes of carrying out its mission; and (e) at the request of the head of any executive department or agency who is a member of the IGIA, with the approval of the Co-Chairs, promptly review and provide advice on a policy or policy implementation action affecting the Insular Areas proposed by that department or agency. Sec. 3. Recommendations. The IGIA shall: (a) submit annually to the President a report containing recommendations regarding the establishment or implementation of policies concerning the Insular Areas; and (b) provide to the President, from time to time, as appropriate, rec- ommendations concerning proposed or existing Federal programs and poli- cies affecting the Insular Areas.
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Sec. 4. General Provisions. (a) The heads of executive departments and agencies shall assist and provide information to the IGIA, consistent with applicable law, as may be necessary to carry out the functions of the IGIA. Each executive department and agency shall bear its own expenses of participating in the IGIA. (b) Nothing in this order shall be construed to impair or otherwise affect: (i) authority granted by law to an executive department, agency, or the head thereof, or the status of that department or agency within the Federal Government; or (ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (c) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (d) This order shall supersede Executive Order 13299 of May 8, 2003. (e) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
THE WHITE HOUSE, April 14, 2010.
[FR Doc. 2010–9078 Filed 4–16–10; 8:45 am] Billing code 3195–W0–P
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Rules and Regulations Federal Register Vol. 75, No. 74
Monday, April 19, 2010
This section of the FEDERAL REGISTER Washington, DC 20250–2220; Voice: Administration, and Related Agencies contains regulatory documents having general 202–401–4952; Fax: 202–401–6156; Appropriations Act, 2006 (Pub. L. 109– applicability and legal effect, most of which E-mail: [email protected]. 97) appropriated $495,000 to implement are keyed to and codified in the Code of SUPPLEMENTARY INFORMATION: the Veterinary Medicine Loan Federal Regulations, which is published under Repayment Program (VMLRP) and 50 titles pursuant to 44 U.S.C. 1510. Establishment of National Institute of represented the first time funds had Food and Agriculture The Code of Federal Regulations is sold by been appropriated for this program. In the Superintendent of Documents. Prices of On October 1, 2009, the Secretary of February 2007, the Revised Continuing new books are listed in the first FEDERAL Agriculture (Secretary) established Appropriations Resolution, 2007 (Pub. REGISTER issue of each week. within USDA the National Institute of L. 110–5) appropriated an additional Food and Agriculture (NIFA), as $495,000 for support of the program, in mandated by section 251(f)(2) of the December 2007, the Consolidated DEPARTMENT OF AGRICULTURE Department of Agriculture Appropriations Act, 2008 appropriated an additional $868,875 for support of National Institute of Food and Reorganization Act of 1994 this program, and on March 11, 2009, Agriculture (Reorganization Act) (7 U.S.C. 6971(f)(2)). Section 251(f)(2) was added the Omnibus Appropriations Act, 2009 (Pub. L. 111–8) was enacted, providing 7 CFR Part 3431 by section 7511 of the Food, Conservation, and Energy Act of 2008 an additional $2,950,000, for the RIN 0524–AA43 (FCEA), Pub. L. 110–246. Pursuant to VMLRP. In October 2009, the President the FCEA, the Secretary transferred to signed into law, Public Law 111–80, Veterinary Medicine Loan Repayment NIFA, effective October 1, 2009, the Agriculture, Rural Development, Food Program (VMLRP) authorities (including all budget and Drug Administration, and Related AGENCY: National Institute of Food and authorities, available appropriations, Agencies Appropriations Act of 2010, Agriculture, USDA. and personnel), duties, obligations, and which appropriated $4,800,000 for the ACTION: Final rule. related legal and administrative VMLRP. functions prescribed by law or Consequently, there is a cumulative SUMMARY: This final rule establishes the otherwise granted to the Secretary, the total of approximately $9.6 million process and procedures for designating Department, or any other agency or available for NIFA to administer this veterinarian shortage situations, official of the Department under the program. Funding for future years will specifically for the Veterinary Medicine research, education, economic, be based on annual appropriations and Loan Repayment Program (VMLRP) cooperative State research programs, balances from prior years, and will authorized by the National Veterinary cooperative extension and education likely vary from year to year. Medical Service Act (NVMSA) and programs, international programs, and Section 7105 of the Food, administered by the National Institute of other functions and authorities Conservation, and Energy Act of 2008, Food and Agriculture (NIFA) of the U.S. delegated by the Under Secretary for Public Law 110–246, (FCEA) amended Department of Agriculture. NIFA will Research, Education, and Economics section 1415A to revise the designate geographic areas and other (‘‘REE’’) to the Administrator of the determination of veterinarian shortage practice situations that have a shortage Cooperative State Research, Education, situations to consider (1) geographical of food supply veterinarians in order to and Extension Service (CSREES) areas that the Secretary determines have carry out the VMLRP goals of pursuant to 7 CFR 2.66, and any and all a shortage of veterinarians; and (2) areas strengthening the nation’s animal health other authorities administered by the of veterinary practice that the Secretary infrastructure and supplementing the Administrator of CSREES. Accordingly, determines have a shortage of Federal response during animal health the agency known as CSREES was veterinarians, such as food animal emergencies. NIFA will carry out abolished upon establishment of NIFA. medicine, public health, epidemiology, NVMSA by entering into educational and food safety. This section also added loan repayment agreements with Background and Purpose that priority should be given to veterinarians who agree to provide In January 2003, the National agreements with veterinarians for the veterinary services in veterinarian Veterinary Medical Service Act practice of food animal medicine in shortage situations for a determined (NVMSA) was passed into law adding veterinarian shortage situations. period of time. NIFA is establishing section 1415A to the National NARETPA section 1415A requires the Subpart A for the designation of the Agricultural Research, Extension, and Secretary, when determining the veterinarian shortage situations and Teaching Policy Act of 1997 amount of repayment for a year of Subpart B for the administration of the (NARETPA). This law established a new service by a veterinarian to consider the VMLRP. Veterinary Medicine Loan Repayment ability of USDA to maximize the DATES: This final rule is effective April Program (7 U.S.C. 3151a) authorizing number of agreements from the amounts 19, 2010. the Secretary of Agriculture to carry out appropriated and to provide an FOR FURTHER INFORMATION CONTACT: Gary a program of entering into agreements incentive to serve in veterinary service Sherman; National Program Leader, with veterinarians under which they shortage areas with the greatest need. Veterinary Science; National Institute of agree to provide veterinary services in This section also provides that loan Food and Agriculture; U.S. Department veterinarian shortage situations. In repayments may consist of payments of of Agriculture; STOP 2220; 1400 November 2005, the Agriculture, Rural the principal and interest on Independence Avenue, SW.; Development, Food and Drug government and commercial loans
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received by the individual for the 32788–32798] with a 60-day comment Comment: Seven commentors attendance of the individual at an period. observed that disqualifying individuals accredited college of veterinary who consolidated their undergraduate Response to Comments on Interim Rule medicine resulting in a degree of Doctor student loans with veterinary school and Revisions Included in Final Rule of Veterinary Medicine or the loans would unfairly cause a large group equivalent. This program is not In the Interim Rule, CSREES of highly qualified veterinarians, many authorized to provide repayments for established rules and invited comments of whom have high levels of debt, any government or commercial loans on the process and procedures for (a) ineligible for the VMLRP. Additionally, incurred during the pursuit of another designating veterinarian shortage AAVMC reported that ‘‘the issue of degree, such as an associate or bachelor situations and (b) administration for the consolidated debt was the highest rated degree. Loans eligible for repayment VMLRP. CSREES received thirty-eight and most oft mentioned concern for include educational loans made for one sets of comments from individuals, AAVMC members.’’ or more of the following: Loans for including practicing veterinarians, NIFA Response: NIFA agrees. NIFA tuition expenses; other reasonable farmers, and students, and the following will allow individuals who consolidated educational expenses, including fees, veterinary professional associations and their veterinary school loans with other books, and laboratory expenses, organizations: American Veterinary educational loans (e.g. undergraduate) incurred by the individual; and Medical Association (AVMA), to apply for the VMLRP; however, only reasonable living expenses as Association of American Veterinary the eligible portion of the consolidation determined by the Secretary. In Medical Colleges (AAVMC), American will be repaid by the VMLRP, thus Parts addition, the Secretary is directed to Association of Veterinary Laboratory 3431.9(b)(3) and 3431.15(b)(4) have make such additional payments to Diagnosticians (AAVLD), National been removed from the final regulations. participants as the Secretary determines Association of Federal Veterinarians Furthermore, applicants with appropriate for the purpose of providing (NAFV), Humane Society Veterinary consolidated loans will be asked to reimbursements to participants for Medical Association (HSVMA), and provide a complete history of their individual tax liability resulting from North Dakota Stockmen’s Association student loans from the National Student participation in this program. Finally, (NDSA) as well as a joint statement from Loan Database System (NSLDS), a this section requires USDA to Washington Cattlemen’s Association central database for student aid operated promulgate regulations within 270 days (WCA) and Washington State Dairy by the U.S. Department of Education. of the enactment of FCEA (i.e., June 18, Federation (WSDF). NIFA considered all The NSLDS Web site can be found at 2008). The Secretary delegated the comments received in the development http://www.nslds.ed.gov. Individuals authority to carry out this program to of the final rule. who consolidated their DVM loans with NIFA. Non-Doctor of Veterinary Medicine non-educational loans or loans belonging to an individual other than Solicitation of Stakeholder Input and (D.V.M.) Loans the applicant, such as a spouse or child, Publication of the Interim Rule Comment: Three commentors will continue to be ineligible for the On August 29, 2008, CSREES expressed concern about the exclusion VMLRP. published a Federal Register notice [73 of education loans other than those FR 50928–50929] announcing a public obtained for the Doctorate of Veterinary Definitions meeting to be held on Monday, Medicine (or equivalent) from the Comment: Three commentors September 15, 2008, at the Waterfront VMLRP. AVMA, as one of the requested clarification on the definition Centre in Washington, DC, to solicit commentors, ‘‘contends that a veterinary for ‘‘accredited college of veterinary stakeholder input as well as the student’s undergraduate education is an medicine’’ as there are multiple instructions on how to submit written integral component of their academic accreditation bodies that could be comments by Tuesday, September 30, veterinary career. Veterinary students included in the definition. Two of the 2008, on the implementation of VMLRP. must take required prerequisites for the three commentors recommended that CSREES received oral and written doctoral program while enrolled in the definition be modified to specify comments from the following veterinary undergraduate studies. Without these accreditation by the AVMA Council on professional associations and required prerequisite courses a Education, a specialized accrediting organizations: American Veterinary prospective veterinary student would be agency recognized and authorized by Medical Association (AVMA), ineligible for admission to veterinary the U.S. Department of Education. Association of American Veterinary medical school.’’ NIFA Response: NIFA agrees. To Medical Colleges (AAVMC), American NIFA Response: The NVMSA eliminate any confusion, the definitions College of Veterinary Microbiologists legislation specifically states in Section have been modified in the definitions (ACVM), American Association of 1415A(c)(3) of NARETPA the following: (§ 3431.3) and eligibility (§ 3431.9) Veterinary Laboratory Diagnosticians Qualifying Educational Loans—Loan sections in the final regulations to (AAVLD), American College of repayments provided under this section specify that a veterinarian must have Veterinary Pathologists (ACVP), may consist of payments on behalf of attended a college of veterinary National Cattlemen’s Beef Association participating individuals of the medicine accredited by the AVMA (NCBA), Texas Cattle Feeders principal, interest, and related expenses Council on Education to be eligible to Association (TCFA), and Ohio’s on government and commercial loans apply to the VMLRP. Cattlemen Association (OCA) as well as received by the individual for Comment: One commentor asked a comprehensive joint statement from attendance of the individual at an NIFA to give serious consideration to AVMA and the AAVMC. In addition, accredited college of veterinary including U.S. citizens who are CSREES received 27 comments from medicine resulting in a degree of Doctor studying to become veterinarians in individuals, most of whom were of Veterinary Medicine or the equivalent veterinary schools in the Caribbean students at veterinary colleges. CSREES ***’’. Consequently, there is no basin. considered all comments received in the change to the regulations regarding NIFA Response: NIFA welcomes development of the interim rule which eligibility of non-DVM loans for the veterinarians that studied abroad to was published on July 9, 2009 [74 FR VMLRP. obtain their Doctorate in Veterinary
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Medicine degree (or equivalent) to apply panel will classify each shortage NIFA Response: NIFA recognizes that for the VMLRP as long as the situation as either ‘‘Recommended for NVMSA is intended to address a professional veterinary medicine degree designation’’ or ‘‘Not recommended for national problem. NIFA has also was obtained from a college of designation’’. acknowledged in the interim rule that veterinary medicine accredited by the Comment: One commentor suggested approximately 10 percent of the loan AVMA Council on Education, a list that that solicitation notices be published on repayment awards will be made includes fourteen schools outside the an annual basis instead of a biennial available to address public practice United States as of October 21, 2009. basis. Another commentor requested shortages and at least 90 percent of Comment: Two commentors, AVMA clarification on the frequency of the funds will be awarded to private and NAFV, recommended adding need to apply for the designation of practice food animal veterinarians to ‘‘animal health’’ to the definition of shortage areas and the need to reassess assure appropriate emphasis as ‘‘practice of food supply veterinary a designation once it is filled by a requested by the legislation set forth by medicine’’ and the areas that have food veterinarian enrolled in the VMLRP. Congress. Hence, some designated supply veterinarian shortages. NIFA Response: NIFA presumes that, veterinarian shortage situations may be NIFA Response: NIFA agrees. ‘‘Animal over time, the shortage situation Federal positions. However, these health’’ has been added to both priorities of a State will change due to positions must be nominated by the definitions in the definitions section veterinarians relocating to fill critical State Animal Health Official (SAHO), (§ 3431.3) in the final regulations. areas designated by the VMLRP. NIFA designated by the review panel as Comment: One commentor will also be mindful of spontaneous ‘‘recommended for designation,’’ and recommended that ‘‘caprine’’ be added shifts in perceived threats to animal approved by the Secretary for to the definition of ‘‘Food animal’’. health in time and space. To address designation. NIFA Response: ‘‘Caprine’’ has been changing conditions, NIFA program Retention added to the definition of ‘‘food animal’’ staff will assess the relative demand for in the definitions section (§ 3431.3). reprioritization of shortage situation Comment: Fourteen commentors stated the importance of making VMLRP State Animal Health Official distribution within the States on an annual basis. However, NIFA reserves awards to include veterinarians with Comment: Three commentors the right to conduct this solicitation on established practices in shortage areas suggested that the State Animal Health a biennial basis to save administrative as a form of retention in addition to the Official be required to consult with the costs and to adhere to the aggressive recruitment of veterinarians to shortage State Veterinary Association and other annual program schedule and/or to areas. interested parties within the State when NIFA Response: NIFA agrees. The respond to funding fluctuations. identifying underserved areas within a SAHO may identify and submit a State. Selection Process shortage situation based on the NIFA Response: We strongly assessment that there is a great risk of recommend that State Animal Health Comment: One commentor stated that the Interim Rule did not address how losing an established veterinarian in a Officials involve other leading animal given shortage situation and that the health experts in the nomination applicants would be chosen for specific shortage areas. need to retain a veterinarian in this area process as they identify underserved is of utmost importance. areas within their respective States. NIFA Response: NIFA will establish the evaluation criteria and process and Appropriation Shortage Nominations determine the makeup of the Comment: Three commentors Comment: One commentor expressed application review panel before the mentioned the importance of having concern that low density agricultural application period opens. Applicants adequate, stable, and reliable funding. areas will be regarded as less important will be ranked based on their AVMA and NAFV also stated that NIFA than areas of heavily concentrated qualifications relative to the attributes of should move towards optimal funding agriculture. the shortage situation applied for. of $6 million each year through fiscal Comment: One commentor Licensure year 2016. recommended that representatives of NIFA Response: NIFA and USDA both Federal agencies be included on an Comment: One commentor support the President’s proposed budget official review panel. recommended that licensure not be a each year. Congress is ultimately NIFA Response: NIFA will take these blanket requirement for eligibility to responsible for the development and comments into consideration as it apply for the VMLRP, but that passage of the annual Federal develops the solicitation for veterinarians should be in compliance appropriations bill. As NIFA is nominations for veterinarian shortage with State and local regulations, prohibited from lobbying Congress, the situations and implements the review including having the appropriate stability and magnitude of future panel. certifications and licenses, in the Federal funding for the VMLRP will Comment: One commentor urged jurisdiction of the shortage situation. depend on Congressional consideration USDA to examine the feasibility of NIFA Response: NIFA agrees and has of Presidential recommendations and establishing an indexing system updated Parts 3431.8 and 3431.10 of the public interests balanced against other whereby each shortage situation that is regulations to reflect that licensure is fiscal priorities. designated is awarded a weighted score required only if it is mandated by the for severity of shortage. State and local regulations in which the Allocation of Awards NIFA Response: As with other review shortage situation is sited. Comment: One commentor suggested processes conducted by NIFA, the that 90 percent of awards be devoted to Federal Veterinarians review panel will evaluate the veterinarians involved with food animal composite qualitative and quantitative Comment: Three commentors stated medicine and rural practice (mixed arguments presented in the submitted that it was not clear to what degree the large animal and small animal) who nomination packages against criteria VMLRP would apply to veterinarians have at least 30 percent or more described elsewhere in this notice. The working for the Federal government. involvement with food animal species.
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Another commentor recommended that individual’s debt level has no effect on recipient’s tax obligation be reviewed the 10 percent of the awards offered to the administrative cost to process an every three years to assure tax coverage mixed animal practitioners be devoted application and execute a service is adequate. to the food animal discipline for at least agreement. Establishing a debt threshold NIFA Response: NIFA will reassess half of their practice. eliminates the administrative burden of the tax percentage every three years to NIFA Response: NIFA agrees with the processing applications from those who ensure VMLRP participants are notion that there is practical value in will scarcely benefit from the VMLRP. provided proper tax coverage. Section identifying service commitment Diagnostic Lab 3431.13(e) has been broadened to allow requirements for practitioners of food that the amount provided for supply veterinary medicine of less than Comment: Two commentors reimbursement of tax liabilities will not 100 percent. Accordingly, all three requested NIFA to recognize the exceed ‘‘any other cap established by the shortage situation types identified in the shortage of veterinarians in AAVLD Secretary.’’ nomination form allow for different laboratories and to allow veterinarians percentages of full-time equivalent entering the diagnostic laboratory Increasing Educational Debt commitment, commensurate with a workforce to be considered under the Comment: Five commentors stated variety of different public and private category of ‘‘public practice’’. concerns about rising educational debt practice scenarios. NIFA Response: Veterinarians for aspiring veterinarians. One entering the diagnostic laboratory Scholarships commentor questioned whether the workforce will be eligible for the maximum annual loan repayment of Comment: One commentor VMLRP under the public practice $25,000 was sufficient. Another recommended that USDA allocate four nomination provisions and limitations. commentor stated that adjustments need scholarships to the Washington State The number of agreements available to to be included to allow for increases in University College of Veterinary this area depends on (a) the annual loan limits. Yet another Medicine to allow students to pay down nominations by the SAHOs, and (b) commentor stated that the $25,000 principal and interest on qualifying recommendations of designation by the repayment level is a meaningful amount loans accrued while a veterinary review panel. that will help address the educational student. debt load. NIFA Response: NIFA appreciates and Emergency Situations NIFA Response: After program accepts all comments. However, this Comment: Two commentors stated implementation, NIFA will continue to comment is beyond the scope of the their support for the concept of the monitor trends among participants, VMLRP as the VMLRP is a competitive proposed pilot program for VMLRP applicants, and graduating veterinarians program and its benefits apply to participants to be called away to work to ensure the VMLRP remains educational loans taken out by in emergency situations. However, both successful in providing a financial graduates of a school of veterinary commentors also shared concerns about incentive to fill shortage areas, while medicine. Furthermore, participants are the proper implementation of this maximizing the number of agreements required to hold a Doctor of Veterinary component of the program. at the same time. Medicine degree or the equivalent and NIFA Response: Due to limited serve in a shortage area immediately in funding and the intricacies involving Other Revisions to the Interim order to receive VMLRP benefits. the emergency component, this Regulation component will not be implemented Mentoring during the first year of the VMLRP. A correction was made to the Comment: Two commentors urged Withdrawal definition in § 3413.3 to Long-Term Program Impact NIFA to establish a mentoring program signify that a withdrawal occurs prior to for participants in the program. Comment: Two commentors the VMLRP making the first quarterly NIFA Response: NIFA agrees. NIFA expressed concern about the focus of the payment on behalf of the participant will investigate options for including a VMLRP. One commentor stated that ‘‘It rather than the first annual payment. mentoring component as part of the seems that many of these types of Timeline for Implementing the Program VMLRP. programs end up helping those who have a background and obvious desire NIFA published a solicitation for the Debt Threshold to already go into such a career.’’ The veterinarian shortage situations via a Comment: Two commentors other commentor cited a program where Federal Register notice on January 22, questioned the need to have a debt ‘‘most of the nurses, and other health 2010 [75 FR 3697–3704] with a threshold for individuals to be eligible care workers, only remain there as long solicitation period of 45 days. At the to apply to the VMLRP. as is necessary to receive the payback same time, NIFA will continue to work NIFA Response: NIFA disagrees. If and leave as quickly as possible with the NIH DLR on adapting the NIH there are veterinarians with minimal thereafter leaving the reservation’s DLR application forms for use by amounts of educational debt that are health care no better off than it was VMLRP as well as developing the other willing to commit for a number of years before.’’ associated business processes (e.g., of service to a shortage situation, they NIFA response: NIFA appreciates all reporting, payments). NIFA anticipates should be able to do so without the comments both positive and negative. soliciting for VMLRP participants in VMLRP benefit. The goal of the VMLRP NIFA plans to conduct an impact April 2010 (open for 60 days). is to fill shortage situations with evaluation on the VMLRP to assess In addition to this final regulation, veterinarians that would have otherwise whether the desired outcomes are which addresses most of the policies gone elsewhere. NIFA also aims to achieved. associated with this program, NIFA maximize the number of agreements, plans to create informational Web pages and entering agreements with those Program Benefits (providing detailed information and with negligible debt would create an Comment: One commentor procedures) for the program similar to additional administrative burden (both recommended that the amount of the pages created for the NIH DLR cost and personnel time) as an funding provided to cover a VMLRP programs.
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Please note that the solicitation for and the Unfunded Mandates Act of Subpart B—Administration of the Veterinary veterinary shortage situations and the 1995, 2 U.S.C. 1501 et seq., and has Medicine Loan Repayment Program VMLRP RFA will provide more specific found no potential or substantial direct 3431.8 Purpose and scope. details on the program. effects on the States, on the relationship 3431.9 Eligibility to apply. between the national government and 3431.10 Eligibility to participate. Administrative Requirements for the the States, or on the distribution of 3431.11 Application. Final Rulemaking power and responsibilities among the 3431.12 Selection of applicants. Executive Order 12866 various levels of government. As there 3431.13 Terms of loan repayment and length of service requirements. The Office of Management and Budget is no Federal mandate contained herein 3431.14 Priority. has reviewed this final rule because that could result in increased 3431.15 Qualifying loans. while it is not economically significant, expenditures by State, local Tribal 3431.16 Certifications and verifications. it implements the Veterinary Medicine governments or by the private sector, 3431.17 VMLRP service agreement offer. Loan Repayment Program (VMLRP). the Department has not prepared a 3431.18 Service agreement. This final rule will not materially alter budgetary impact statement. 3431.19 Payment and tax liability. 3431.20 Administration. the budgetary impact of entitlements, Executive Order 13175: Consultation 3431.21 Breach. grants, user fees, or loan programs; nor and Coordination With Indian Tribal 3431.22 Waiver. will it have an annual effect on the Governments 3431.23 Service to Federal government in economy of $100 million or more; nor The Department has reviewed this emergency situations. will it adversely affect the economy, a final rule in accordance with Executive 3431.24 Reporting requirements, sector of the economy, productivity, monitoring, and close-out. Order 13175, 65 FR 67249 (Nov. 9, competition, jobs, the environment, 2000), and has determined that it does Authority: 7 U.S.C. 3151a; Pub. L. 106–107 public health or safety, or State, local, not have ‘‘tribal implications.’’ The final (31 U.S.C. 6101 note). or Tribal governments or communities rule does not ‘‘have substantial direct in a material way. Furthermore, it does Subpart A—Designation of effects on one or more Indian tribes, on not raise a novel legal or policy issue Veterinarian Shortage Situations the relationship between the Federal arising out of legal mandates, the government and Indian Tribes, or on the President’s priorities or principles set § 3431.1 Applicability of regulations. distribution of power and forth in the Executive Order. This part establishes the process and responsibilities between the Federal procedures for designating veterinarian Regulatory Flexibility Act of 1980 government and Indian tribes.’’ shortage situations as well as the This final rule has been reviewed in Clarity of This Regulation administrative provisions for the accordance with the Regulatory Veterinary Medicine Loan Repayment Executive Order 12866 and the Flexibility Act of 1980, as amended by Program (VMLRP) authorized by the President’s memorandum of June 1, the Small Business Regulatory National Veterinary Medical Service Act 1998, require each agency to write all Enforcement Fairness Act of 1996, 5 (NVMSA), 7 U.S.C. 3151a. U.S.C. 601–612. The Department rules in plain language. The Department concluded that the rule does not involve invites comments on how to make this § 3431.2 Purpose. regulatory and informational final rule easier to understand. The Secretary will follow the requirements regarding businesses, List of Subjects in Part 3431 processes and procedures established in subpart A of this part to designate organizations, and governmental Administrative practice and jurisdictions subject to regulation. veterinarian shortage situations for the procedure, Agricultural research, VMLRP. Applications for the VMLRP Paperwork Reduction Act education, extension, Federal will be accepted from eligible The Department certifies that this assistance, Veterinarians. veterinarians who agree to serve in one final rule has been assessed in ■ For the reasons discussed in the of the designated shortage situations in accordance with the requirements of the preamble, NIFA amends Chapter XXXIV exchange for the repayment of an Paperwork Reduction Act, 44 U.S.C. of Title 7 of the Code of Federal amount of the principal and interest of 3501 et seq. (PRA). The VMLRP Regulations as follows: the veterinarian’s qualifying educational Veterinarian Shortage Situation Chapter XXXIV—National Institute of Food loans. The administrative provisions for Nomination form has been approved by and Agriculture the VMLRP, including the application OMB as No. 0524–0046. The VMLRP ■ 1. The heading of chapter XXXIV is process, are established in subpart B of Application Package and Reporting revised to read as set forth above. this part. Requirements have been approved by ■ 2. Part 3431 is revised to read as § 3431.3 Definitions and acronyms. OMB as No. 0524–0047. follows: (a) General definitions. As used in this Catalog of Federal Domestic Assistance PART 3431—VETERINARY MEDICINE part: This interim regulation applies to the LOAN REPAYMENT PROGRAM Act means the National Veterinary following Federal assistance program Medical Service Act, as amended. administered by NIFA, Catalog of Subpart A—Designation of Veterinarian Agency or NIFA means the National Federal Domestic Assistance (CFDA) Shortage Situations Institute of Food and Agriculture. No. 10.313, Veterinary Medicine Loan Sec. Department means the United States Repayment Program (VMLRP). 3431.1 Applicability of regulations. Department of Agriculture. 3431.2 Purpose. Food animal means the following Unfunded Mandates Reform Act of 1995 3431.3 Definitions and acronyms. species: Bovine, porcine, ovine/camelid, and Executive Order 13132 3431.4 Solicitation of stakeholder input. cervid, poultry, caprine, and any other 3431.5 Solicitation of veterinarian shortage The Department has reviewed this situations. species as determined by the Secretary. final rule in accordance with the 3431.6 Review of nominations. Food supply veterinary medicine requirements of Executive Order No. 3431.7 Notification and use of designated means all aspects of veterinary 13132, 64 FR 43225 (August 10, 1999) veterinarian shortage situations. medicine’s involvement in food supply
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systems, from traditional agricultural Veterinarian means a person who has materials, as required by an accredited production to consumption. received a professional veterinary college or school of veterinary medicine Insular area means the medicine degree from a college of as part of a Doctor of Veterinary Commonwealth of Puerto Rico, Guam, veterinary medicine accredited by the Medicine degree program, or the American Samoa, the Commonwealth of AVMA Council on Education. equivalent. The program participant the Northern Mariana Islands, the Veterinarian shortage situation means must submit sufficient documentation, Federated States of Micronesia, the any of the following situations in which as required by the Secretary, to Republic of the Marshall Islands, the the Secretary, in accordance with the substantiate the school requirement for Republic of Palau, and the Virgin process in subpart A of this part, the educational expenses incurred by Islands of the United States. determines has a shortage of the program participant. NVMSA means the National veterinarians: Qualifying educational loans means Veterinary Medicine Service Act. (1) Geographical areas that the loans that are issued by any Federal, Practice of food supply veterinary Secretary determines have a shortage of State, or local government entity, medicine includes corporate/private food supply veterinarians; and accredited academic institution(s), and/ practices devoted to food animal (2) Areas of veterinary practice that or commercial lender(s) that are subject medicine, mixed animal medicine the Secretary determines have a to examination and supervision in their located in a rural area (at least 30 shortage of food supply veterinarians, capacity as lending institutions by an percent of practice devoted to food such as food animal medicine, public agency of the United States or the State animal medicine), food safety, health, animal health, epidemiology, in which the lender has its principal epidemiology, public health, animal and food safety. place of business. Loans must have been health, and other public and private Veterinary medicine means all made for one or more of the following: practices that contribute to the branches and specialties included School tuition, other qualifying production of a safe and wholesome within the practice of veterinary educational expenses, or reasonable food supply. medicine. living expenses relating to the Practice of veterinary medicine means Veterinary Medicine Loan Repayment obtainment of a degree of Doctor of to diagnose, treat, correct, change, Program or VMLRP means the Veterinary Medicine from a college or alleviate, or prevent animal disease, Veterinary Medicine Loan Repayment school of veterinary medicine illness, pain, deformity, defect, injury, Program authorized by the National accredited by the AVMA Council on or other physical, dental, or mental Veterinary Medical Service Act. Education. Such loans must have conditions by any method or mode; (b) Definitions applicable to Subpart documentation which is including: B. contemporaneous with the training (1) The prescription, dispensing, Applicant means an individual who received in a college or school of administration, or application of any applies to and meets the eligibility veterinary medicine. If qualifying drug, medicine, biologic, apparatus, criteria for the VMLRP. educational loans are refinanced, the anesthetic, or other therapeutic or Breach of agreement results when a original documentation of the loan(s) diagnostic substance or medical or participant fails to complete the service will be required to be submitted to the surgical technique, or agreement obligation required under the Secretary to establish the (2) The use of complementary, terms and conditions of the agreement contemporaneous nature of such loans. alternative, and integrative therapies, or and will be subject to assessment of Reasonable living expenses means the (3) The use of any manual or monetary damages and penalties as ordinary living costs incurred by the mechanical procedure for reproductive determined in the service agreement, program participant while attending the management, or unless a waiver has been granted or an college of veterinary medicine, (4) The rendering of advice or exception applies. exclusive of tuition and educational recommendation by any means Current payment status means that a expenses. Reasonable living expenses including telephonic and other qualified educational loan is not past must be incurred during the period of electronic communications with regard due in its payment schedule as attendance and may include food and to any of paragraphs (1), (2), (3), or (4) determined by the lending institution. lodging expenses, insurance, of this definition. Debt threshold means the minimum commuting and transportation costs. Rural area means any area other than amount of qualified student debt an Reasonable living expenses must be a city or town that has a population of individual must have, on their program equal to or less than the sum of the 50,000 inhabitants and the urbanized eligibility date, in order to be eligible for school’s estimated standard student area contiguous and adjacent to such a program benefits, as determined by the budgets for living expenses for the city or town. Secretary. degree of veterinary medicine for the Secretary means the Secretary of Program eligibility date means the year(s) during which the program Agriculture and any other officer or date on which an individual’s VMLRP participant was enrolled in the school. employee of the Department to whom agreement is executed by the Secretary. However, if the school attended by the the authority involved has been Program participant means an program participant did not have a delegated. individual whose application to the standard student budget or if a program Service area means geographic area in VMLRP has been approved and whose participant requests repayment for which the veterinarian will be providing service agreement has been accepted living expenses which are in excess of veterinary medical services. and signed by the Secretary. the standard student budgets described State means any one of the fifty Qualifying educational expenses in the preceding sentence, the program States, the District of Columbia, and the means the costs of attendance of the participant must submit documentation, insular areas of the United States. applicant at a college of veterinary as required by the Secretary, to State animal health official or SAHO medicine accredited by the AVMA substantiate the reasonableness of living means the State veterinarian, or Council on Education, exclusive of the expenses incurred. To the extent that equivalent, who will be responsible for tuition and reasonable living expenses. the Secretary determines, upon review nominating and certifying veterinarian Educational expenses may include fees, of the program participant’s shortage situations within the State. books, laboratory expenses and documentation, that all or a portion of
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the living expenses are reasonable, these The solicitation may specify the veterinary shortage situations for a expenses will qualify for repayment. maximum number of nominations that prescribed period of time. In addition, Service agreement means the may be submitted by each State animal program participants may enter into an agreement, which is signed by an health official. agreement to provide services to the applicant and the Secretary for the (e) Nominations. Nominations shall Federal government in emergency VMLRP wherein the applicant agrees to identify the veterinarian shortage situations in exchange for salary, travel, accept repayment of qualifying situation and address the criteria in the per diem expenses, and additional educational loans and to serve in nomination form which may include the amounts of loan repayment assistance. accordance with the provisions of objectives of the position, the activities The purpose of the program is to assure NVMSA for a prescribed period of of the position, and the risk posed if the an adequate supply of trained food obligated service. position is not secured. animal veterinarians in shortage Termination means a waiver of the (f) Nominating Official. The State situations and provide USDA with a service obligation granted by the animal health official in each State is pool of veterinary specialists to assist in Secretary when compliance by the the person responsible for submitting the control and eradication of animal participant is impossible, would involve and certifying veterinarian shortage disease outbreaks. extreme hardship, or where enforcement situations within the State to NIFA with respect to the individual would be officials. It is strongly recommended § 3431.9 Eligibility to apply. unconscionable (see breach of that the State animal health official of (a) General. To be eligible to apply to agreement). each State involve the leading health the VMLRP an applicant must: Withdrawal means a request by a animal experts in the State in the (1) Have a degree of Doctor of participant for withdrawal from nomination process. Veterinary Medicine (DVM), or the equivalent, from a college of veterinary participation in the VMLRP after signing § 3431.6 Review of nominations. the service agreement, but prior to medicine accredited by the AVMA (a) Peer panel. State shortage VMLRP making the first quarterly Council on Education; situations nominations will be payment on behalf of the participant. A (2) Have qualifying educational loan evaluated by a peer panel of experts in withdrawal is without penalty to the debt as defined in § 3431.3; animal health convened by the (3) Secure an offer of employment or participant and without obligation to Secretary. The panel will evaluate the Program. establish and/or maintain a practice in nominations according to the criteria a veterinary shortage situation, as § 3431.4 Solicitation of stakeholder input. identified in the solicitation. The panel determined by the Secretary in The Secretary will solicit stakeholder will consider the objectives and accordance with the procedures in input on the process and procedures activities of the veterinarian position in subpart A of this part, within the time used to designate veterinarian shortage the veterinary service shortage situation period specified in the VMLRP service situations prior to the publication of the and the risks associated with not agreement offer; and solicitation for nomination of securing or retaining the position and (4) Provide certifications and veterinarian shortage situations. A make a recommendation regarding each verifications in accordance with notice may be published in the Federal nomination. § 3431.16. Register, on the Agency’s Web site, or (b) Agency review. The Secretary will (b) Non-eligibility. The following other appropriate format or forum. This evaluate the recommendations of the individuals are ineligible to apply to the request for stakeholder input may peer panel and designate shortage VMLRP: include the solicitation of input on the situations for the VMLRP. (1) An individual who owes an administration of VMLRP and its impact § 3431.7 Notification and use of obligation for veterinary service to the on meeting critical veterinarian shortage designated veterinarian shortage situations. Federal government, a State, or other situations. All comments will be made The Secretary will publish the entity under an agreement with such available and accessible to the public. designated veterinarian shortage Federal, State, or other entity are situations on the Agency’s Web site and ineligible for the VMLRP unless such § 3431.5 Solicitation of veterinarian obligation will be completely satisfied shortage situations. will use the designated veterinarian shortage situations to solicit VMLRP prior to the beginning of service under (a) General. The Secretary will follow loan repayment applications from the VMLRP; the procedures described in this part to individual veterinarians in accordance (2) An individual who has a Federal solicit veterinarian shortage situations with subpart B of this part. judgment lien against his/her property as the term is defined in § 3431.3. arising from Federal debt; and (b) Solicitation. The Secretary will Subpart B—Administration of the (3) An individual who has total publish a solicitation for nomination of Veterinary Medicine Loan Repayment qualified debt that does not meet the veterinarian shortage situations in the Program debt threshold. Federal Register, on the Agency’s Web site, or other appropriate format or § 3431.8 Purpose and scope. § 3431.10 Eligibility to participate. forum. (a) Purpose. The regulations of this To be eligible to participate in the (c) Frequency. Contingent on the subpart apply to the award of veterinary VMLRP, a participant must meet the availability of funds, the Secretary will medicine loan repayments under the following criteria: normally publish a solicitation on an Veterinary Medicine Loan Repayment (a) Meet the eligibility criteria of annual basis. However, the Secretary Program (VMLRP) authorized by the § 3431.9 for applying to the VMLRP; reserves the right to solicit veterinarian National Veterinary Medicine Service (b) Be selected for participation by the shortage situations every two or three Act, 7 U.S.C. 3151a. Secretary pursuant to § 3431.12. years, as appropriate. (b) Scope. Under the VMLRP, the (c) Comply with all State and local (d) Content. The solicitation will Secretary enters into service agreements regulations (including appropriate describe the nomination process, the with veterinarians to pay principal and licensure where required) in the review criteria and process, and include interest on education loans of jurisdiction in which he or she proposes the form used to submit a nomination. veterinarians who agree to work in to practice;
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(d) Be a citizen, national, or (1) An amount not exceeding $25,000 § 3431.14 Priority. permanent resident of the United States; per year of a program participant’s Pursuant to NVMSA, the Secretary (e) Sign a service agreement to qualifying loans; and will give priority to agreements with provide veterinary services in one of the (2) An additional amount not veterinarians for the practice of food veterinarian shortage situations; and exceeding $5,000 per year of a program animal medicine in veterinarian (f) Comply with the terms and participant’s qualifying loans, if the shortage situations, as determined by conditions of the Service Agreement. program participant has already been the Secretary. The Secretary may selected for participation in the VMLRP establish additional criteria in the RFA § 3431.11 Application. and agrees to enter into a one-year for assigning priority levels to Individuals who meet the eligibility agreement for each year of service to veterinarian shortage situations criteria of § 3431.9 may submit an provide up to 60 days of obligated nominated for award. online program application or any other service to the Federal government in application process provided by the animal health emergency situations, as § 3431.15 Qualifying loans. Secretary. determined by the Secretary, provided (a) General. Loan repayments the shortage situation in which the provided under the VMLRP may consist § 3431.12 Selection of applicants. participant has agreed to serve has been of payments on behalf of participating (a) Review of applications. Upon designated as suitable for the Federal individuals of the principal and interest receipt, applications for the VMLRP will obligated service. on qualifying educational loans received be reviewed for eligibility and (b) To maximize the number of by the individual for attendance of the completeness by the appropriate staff as agreements and to encourage qualified individual at an accredited college of determined by the Secretary. Incomplete veterinarians to participate in the veterinary medicine resulting in a or ineligible applications will not be VMLRP, the Secretary may establish a degree of Doctor of Veterinary Medicine, processed or reviewed. loan repayment cap that differs from the or the equivalent, which loans were (b) Peer review. (1) Applications for cap established under paragraph (a)(1) made for one or more of the following: the VMLRP that are deemed eligible and and (a)(2) of this section when it is in (1) Tuition expenses; complete will be referred to the VMLRP the best interest of VMLRP. This will be (2) All other reasonable educational peer panel for peer review. In evaluating identified in the RFA. expenses, as defined in this part and as (c) The Secretary will determine the the application, reviewers are directed determined by the Secretary; and to consider the following components, debt threshold in the RFA. (d) Loan repayments will be made (3) Reasonable living expenses, as as well as any other criteria identified directly to the loan provider on a defined in this part and as determined in the RFA, and how they relate to the quarterly basis, starting with the end of by the Secretary. likelihood that the applicant will meet the first quarter after the program (b) Non-eligible loans. The following the terms and conditions of the VMLRP eligibility date of the service agreement. loans are ineligible for repayment under agreement, continue to serve in a Tax payments equal to 39 percent of the the VMLRP: veterinary shortage situation, or pursue loan repayments will be credited (1) Loans not obtained from a bank, a career in food supply veterinary directly to the participant’s IRS (Federal credit union, savings and loan medicine: tax) account simultaneously with each association, not-for-profit organization, (i) Major or emphasis area(s) during loan repayment. insurance company, school, and other formal post-secondary training (e.g., (e) Once a service agreement has been financial or credit institution which is bachelors degree major, minor); signed by both parties, the Secretary subject to examination and supervision (ii) Major or emphasis area(s) during will obligate such funds as will be in its capacity as lending institution by formal training for DVM/VMD degree; necessary to ensure that sufficient funds an agency of the United States or of the (iii) Specialty training area/discipline will be available to make loan State in which the lender has its (e.g., board certification or graduate repayments and tax payments, as principal place of business; degree); specified in the service agreement, for (2) Loans for which supporting (iv) Non-degree/non-board the duration of the period of obligated documentation is not available; certification training or certifications service. Reimbursements for tax (3) Loans that have been consolidated (e.g., animal agrosecurity coursework liabilities in excess of the amount with loans of other individuals, such as and certifications); provided (not to exceed 39 percent of spouses or children; (v) Applicant’s personal statement; the amount of loan repayment or any (4) Loans or portions of loans (vi) Awards; other cap established by the Secretary) obtained for educational or living (vii) Letters or recommendation, if will be subject to the availability of expenses which exceed the standard of applicable; and funds. These additional tax payments, if reasonableness as determined by the (viii) Other documentation or criteria, available to the VMLRP participants, participant’s standard school budget for as specified in the RFA. will be identified in the RFA and in the the year in which the loan was made, (2) Applicants will then be ranked participant service agreement. and are not determined by the Secretary, based on their qualifications relative to (f) Participants are required to keep to be reasonable based on additional the attributes of the shortage situation payments current on all qualifying documentation provided by the applied for. VMLRP loans. individual; (g) Travel expenditures. The VMLRP (5) Loans, financial debts, or service § 3431.13 Terms of loan repayment and will not reimburse a program obligations incurred under another loan length of service requirements. participant for expenses associated with repayment or scholarship program, or (a) Loan repayment. For each year of traveling from the program participant’s similar programs, which provide loans, obligated service in a veterinary residence to the prospective practice scholarships, loan repayments, or other shortage situation, as determined by the site for the purpose of evaluating such awards in exchange for a future service Secretary, with a minimum of 3 years site or the expenses of relocating from obligation; (and maximum of 4 years) of obligated the program participant’s temporary or (6) Non-educational loans, including service, the Secretary may pay: permanent residence to a practice site. home equity loans; and
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(7) Any loan in default, delinquent, or the Secretary after acceptance of the and/or close-out) to allow for program not in a current payment status. terms and conditions of the loan monitoring and evaluation. repayment program by the program § 3431.16 Certifications and verifications. participant. § 3431.19 Payment and tax liability. (a) The application for the loan (b) The service agreement shall (a) Loan repayment. Loan repayments repayment program shall include a specify the period of obligated service. pursuant to a service agreement are personal statement describing how the (c) The service agreement shall made directly to a participant’s lender(s) applicant would meet the requirements specify the amount of loan repayment to by the Secretary or the VMLRP service of: be paid for each year of obligated provider. If there is more than one (1) The veterinary service shortage service. outstanding qualified educational loan, situations as defined in the RFA; (d) The service agreement shall the Secretary will repay the loans in the (2) The eligibility criteria for following order, unless the Secretary application of section § 3431.9 of this contain a provision defining when a breach of the agreement by the program determines significant savings to the part; and program would result from paying loans (3) The selection priority of § 3431.14 participant has occurred. (e) The service agreement shall in a different order of priority: of this part. (1) Loans guaranteed by the U.S. (b) The applicant shall provide provide remedies for the breach of a service agreement by a program Department of Education; sufficient documentation to establish (2) Loans made or guaranteed by a that the applicant has qualifying loans participant, including repayment or partial repayment of financial assistance State; as described in § 3431.15 of this part. (3) Loans made by a School; and received, with interest. (c) The applicant shall provide (4) Loans made by other entities, (f) The service agreement shall sufficient documentation to establish including commercial loans. that the applicant has the capacity to include provisions addressing the (b) Tax Liability Payments. Tax secure an offer of employment or granting of a waiver by the Secretary in payments equal to 39 percent of the establish and/or maintain a veterinary case of hardship. total loan repayment amount will be practice in a veterinary service shortage (g) Payments under the service credited directly to the participant’s IRS situation as defined in subpart A of this agreement do not exempt a program (Federal tax) account simultaneously part. participant from the responsibility and/ with each loan payment. The Secretary (d) The applicant shall provide, if or liability for any loan(s) for which he may make payments of an amount not applicable, sufficient documentation to or she is obligated, as the Secretary is to exceed 39 percent of the actual establish that the applicant is licensed not obligated to the lender/note holder annual loan repayments made in a to practice veterinary medicine in the for its commitment to the program calendar year for all or part of the jurisdiction in which the applicant has participant. increased Federal, State, and local tax an offer of employment. (h) During the term of the service liability resulting from loan repayments (e) The applicant shall provide, if agreement, the program participant shall received under the VMLRP. However, applicable, the required documentation agree that the Secretary or the the Secretary may increase the cap, if to establish whether the applicant designated VMLRP service provider is appropriate. Supplementary payments receives payments under any other authorized to verify the status of each for increased tax liability may be made Federal, State, institutional, or private loan for which the Secretary will be for the actual amount of tax liability loan repayment programs. reimbursing the participant. (f) The applicant shall provide the associated with the receipt of loan (i) The service agreement shall repayments under the VMLRP. required documentation to show that contain certifications, as determined by he/she has completed, or is in the Availability of these additional tax the Secretary. liability payments (i.e., in excess of 39 process of completing, the National (j) The service agreement shall Veterinary Accreditation Program percent or other approved cap) will be contain provisions addressing the identified in the RFA and in the (NVAP) if national accreditation is income tax liability of the program required for the veterinary shortage participant service agreement. Program participant and the availability of participants wishing to receive tax position for which the applicant has an reimbursement of taxes incurred as a offer of employment. liability payments will be required to result of an individual’s participation in submit their requests for such payments (g) The applicant shall provide the VMLRP. authorization to the appropriate staff as in a manner prescribed by the Secretary (k) Renewal. The service agreement and must provide the Secretary with designated by the Secretary to obtain a will indicate whether the existing copy of the participant’s credit report. any documentation the Secretary service agreement may be renewed. determines is necessary to establish a § 3431.17 VMLRP service agreement offer. However, renewal applications are program participant’s increased tax The Secretary will make an offer to subject to peer review and approval, liability. Tax liability payments in successful applicants to enter into an acceptance is not guaranteed, and the excess of 39 percent or other approved agreement with the Secretary to provide position must still be considered a cap will be made on a reimbursement veterinary services under the VMLRP. veterinarian shortage situation at the basis only. As part of the offer, successful VMLRP time of application for renewal. The (c) Under § 3431.19(a) and (b), the applicants will be provided a specific Secretary may request additional Secretary will make loan and tax period of time, as defined in the RFA, documentation in connection with the liability payments to the extent to secure an offer of employment or review and approval of a renewal appropriated funds are available for establish and/or maintain a veterinary application. The Secretary reserves the these purposes. practice in a veterinary shortage right not to offer renewals. Any requests § 3431.20 Administration. situation. for renewal applications will be solicited via the RFA. The VMLRP will be administered by § 3431.18 Service agreement. (l) The service agreement shall NIFA, Office of Extramural Programs (a) The service agreement shall be contain participant reporting (OEP). OEP may carry out this program signed by the program participant and requirements (e.g., quarterly, annual, directly or enter into agreements with
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another Federal agency or other service obligation would be against equity and receive a salary commensurate with the provider to assist in the administration good conscience. duties and shall be reimbursed for travel of the VMLRP. However, the (1) Compliance by a program and per diem expenses as appropriate determination of the veterinarian participant with a service or repayment for the duration of the service. shortage areas, peer review of individual obligation will be considered impossible VMLRP applications, and the overall if the Secretary determines, on the basis § 3431.24 Reporting requirements, monitoring, and close-out. VMLRP oversight and coordination will of information and documentation as reside with the Secretary. may be required: VMLRP participants will be required (i) That the program participant to submit periodic reports per the terms § 3431.21 Breach. suffers from a physical or mental and conditions of their service (a) General. If a program participant disability resulting in the permanent agreements. In addition, the Secretary is fails to complete the period of obligated inability of the program participant to responsible for ensuring that a VMLRP service incurred under the service perform the service or other activities participant is complying with the terms agreement, including failing to comply which would be necessary to comply and conditions of their service with the applicable terms and with the obligation; or agreement, including any additional conditions of a waiver granted by the (ii) That the employment of the reporting or close-out requirements. Secretary, the program participant must program participant has been Done in Washington, DC, this 9th day of pay to the United States an amount as terminated involuntarily for reasons April 2010. determined in the service agreement. unrelated to job performance. Dr. Meryl Broussard, Payment of this amount shall be made (2) In determining whether Interim Deputy Director, National Institute within 90 days of the date that the compliance by a program participant of Food and Agriculture. program participant failed to complete with the terms of a service or repayment [FR Doc. 2010–8628 Filed 4–16–10; 8:45 am] the period of obligated service, as obligation imposes an extreme hardship, BILLING CODE 3410–22–P determined by the Secretary. the Secretary may, on the basis of (b) Exceptions. information and documentation as may (1) A termination of service for be required, take into consideration the NUCLEAR REGULATORY reasons that are beyond the control of nature of the participant’s personal COMMISSION the program participant will not be problems and the extent to which these considered a breach. affect the participant’s ability to perform 10 CFR Part 51 (2) A transfer of service from one the obligation. shortage situation to another, if (c) All requests for waivers must be [NRC–2009–0269] approved by the Secretary, will not be submitted to the Secretary in writing. RIN 3150–AI27 considered a breach. (d) A program participant who is (3) A call or order to active duty will granted a waiver in accordance with this Categorical Exclusions From not be considered a breach. section will be notified by the Secretary Environmental Review (c) The Secretary may renegotiate the in writing. terms of a participant’s service (e) Any obligation of a program AGENCY: Nuclear Regulatory agreement in the event of a transfer, participant for service or payment will Commission. termination or call to active duty be canceled upon the death of the ACTION: Final rule. pursuant to paragraph (b) of this section. program participant. (d) Amount of repayment. The service SUMMARY: The U.S. Nuclear Regulatory agreement shall provide the method for § 3431.23 Service to Federal government Commission (NRC) is amending its the calculation of the amount owed by in emergency situations. regulations that describe the categories a program participant who has breached (a) The Secretary may enter into of actions which do not require an a service agreement. agreements of 1 year duration with environmental review under the (e) Debt Collection. Individuals in veterinarians who have service requirements of the National breach of a service agreement entered agreements for such veterinarians to Environmental Policy Act of 1969 into under this part are considered to provide services to the Federal (NEPA) as the NRC has determined that owe a debt to the United States for the Government in emergency situations, as such actions do not individually or amount of repayment. Any such debt determined by the Secretary, under cumulatively have a significant effect on will be collected pursuant to the terms and conditions specified in the the human environment. The amended Department’s Debt Management agreement. regulations eliminate the need for the regulations at 7 CFR part 3. (b) Pursuant to a service agreement preparation of environmental under this section, the Secretary shall assessments for NRC actions that are § 3431.22 Waiver. pay an amount, in addition to the minor, administrative, or procedural in (a) A program participant may seek a amount paid, as determined by the nature. The amendments do not change waiver or suspension of the service or Secretary and specified in the any requirements for licensees, but may payment obligations incurred under this agreement, of the principal and interest provide for more time for NRC action on part by written request to the Secretary of qualifying educational loans of the more substantial issues and/or speed up setting forth the bases, circumstances, veterinarians. This amount will be the process for review of the and causes which support the requested provided in the RFA. amendments. action. (c) Agreements entered into under (b) The Secretary may waive any this paragraph shall include the DATES: This final rule is effective on service or payment obligation incurred following: April 19, 2010. by a program participant whenever (1) A veterinarian shall not be ADDRESSES: You can access publicly compliance by the program participant required to serve more than 60 working available documents related to this is impossible or would involve extreme days per year of the agreement. document using the following methods: hardship to the program participant and (2) A veterinarian who provides • Federal e-Rulemaking Portal: Go to if enforcement of the service or payment service pursuant to the agreement shall http://www.regulations.gov and search
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for documents filed under Docket ID whether to approve or disapprove of the for and identification of licensing and NRC–2008–0269. Address questions proposed action. The NRC’s NEPA regulatory actions eligible for categorical about NRC dockets to Carol Gallagher at regulations are contained in 10 CFR Part exclusion.’’ 1 301–492–3668; e-mail 51, ‘‘Environmental Protection C. Amendments to NRC Categorical [email protected]. Regulations for Domestic Licensing and Exclusion Regulations • NRC’s Public Document Room Related Regulatory Functions.’’ (PDR): The public may examine and NRC has made 14 amendments to the A. General Overview of Categorical may have copied for a fee publicly categorical exclusions in § 51.22 since Exclusion available document at the NRC’s PDR, 1984. Ten of these amendments were Public File Area O1–F21, One White There are three types of NEPA minor, corrective, or conforming Flint North, 11555 Rockville Pike, analyses: An environmental impact changes, and four were more Rockville, Maryland. statement (EIS), an environmental substantive. All resulted from • NRC’s Agencywide Documents assessment (EA), and a categorical rulemaking efforts addressing other Access and Management System exclusion. An EIS documents an parts of NRC regulations. As a result of (ADAMS): Publicly available documents agency’s evaluation of the the 14 amendments, the list of created or received at the NRC are environmental impacts of a major categorical exclusions in § 51.22(c) available electronically at the NRC’s Federal action significantly affecting the increased from 18 to 23 categorical electronic Reading Room at http:// quality of the human environment. An exclusions. The NRC’s categorical www.nrc.gov/reading-rm/adams.html. EA is a concise, publicly available exclusions include administrative, From this page, the public can gain document that provides sufficient managerial, or organizational entry into ADAMS, which provides text evidence and analysis for determining amendments to certain types of NRC and image files of NRC’s public whether to prepare an EIS or make a regulations, licenses, and certificates; documents. If you do not have access to finding of no significant impact minor changes related to application ADAMS or if there are problems in (FONSI). If an EA supports a FONSI, the filing procedures; and certain personnel accessing the documents located in environmental review process is and procurement activities. complete. If the EA reveals that the ADAMS, contact the NRC’s PDR D. Basis for Amendment of Categorical proposed action may have a significant reference staff at 1–899–397–4209, Exclusion Regulation 301–415–4737, or by e-mail to effect on the human environment, the The NRC is amending the 10 CFR [email protected]. Federal agency then prepares an EIS. A categorical exclusion, in contrast, is a 51.22 categorical exclusions to reflect FOR FURTHER INFORMATION CONTACT: category of actions that the agency has regulatory experience gained since the Cardelia H. Maupin, Office of Federal determined not to have a significant development of this regulation in March and State Materials and Environmental effect, either individually or 1984. Prior to this amendment effort, Management Programs, U.S. Nuclear cumulatively, on the human there has been no comprehensive Regulatory Commission, Washington, environment. A categorical exclusion is review and update of § 51.22. The DC 20555–0001, telephone (301) 415– established by rulemaking. Once it has amendments being adopted in this final 2312, e-mail, [email protected]. established a categorical exclusion, the rule are based, in part, on the Council SUPPLEMENTARY INFORMATION: agency is not required to prepare an EA on Environmental Quality (CEQ) I. Background or EIS for any action that falls within September 2003 NEPA Task Force A. General Overview of Categorical the scope of the categorical exclusion, Report (Task Force Report) Exclusion unless the agency finds, for any ‘‘Modernizing NEPA Implementation,’’ B. NRC Categorical Exclusion Regulations particular action, that there are special http://www.nepa.gov/ntf/report/ C. Amendments to NRC Categorical (e.g., unique, unusual or controversial) pdftoc.html. The Task Force Report Exclusion Regulations circumstances that may have a notes that the development and D. Basis for Amendment of Categorical Exclusion Regulation significant effect on the human updating of categorical exclusions by II. Discussion environment. Categorical exclusions Federal agencies occurs infrequently A. What Is a Categorical Exclusion? streamline the NEPA process, saving and recommends that Federal agencies B. What Is NRC’s Definition of Categorical time, effort, and resources. examine their categorical exclusion Exclusion? regulations to identify potential C. How Should a Categorical Exclusion Be B. NRC Categorical Exclusion revisions that would eliminate Applied? Regulations unnecessary and costly EAs. It also D. What Action Is the NRC Taking? On July 18, 1974, the NRC published provides recommendations for E. Who Would This Action Affect? a final rule (39 FR 26279) that added 10 III. Discussion of Amendments by Section categorical exclusion development and IV. Agreement State Compatibility CFR Part 51, ‘‘Licensing and Regulatory revision. V. Plain Language Policy and Procedures for The Task Force Report notes that in VI. Voluntary Consensus Standards Environmental Protection,’’ to the NRC developing new or broadening existing VII. Environmental Assessment and Finding regulations. This rulemaking listed four categorical exclusions, a key issue is of No Significant Environmental Impact categorical exclusions. On March 12, how to evaluate whether a proposed VIII. Paperwork Reduction Act Statement 1984, the NRC published a final rule (49 categorical exclusion is appropriate and IX. Public Protection Notification FR 9352) revising and renaming 10 CFR how to support the determination that it X. Regulatory Analysis ‘‘ XI. Regulatory Flexibility Certification Part 51, Environmental Protection describes a category of actions that do XII. Backfit Analysis Regulations for Domestic Licensing and not individually or cumulatively have a XIII. Congressional Review Act Related Regulatory Functions and significant effect on the human Related Conforming Amendments.’’ This I. Background final rule expanded the number of 1 The section heading was revised to its current NEPA requires Federal agencies to categorical exclusions from four to heading, ‘‘Criterion for categorical exclusion; identification of licensing and regulatory actions undertake an assessment of the eighteen, and redesignated the section eligible for categorical exclusion or otherwise not environmental effects of their proposed listing the NRC’s approved categorical requiring environmental review,’’ by a final rule actions prior to making a decision on exclusions as 10 CFR 51.22, ‘‘Criterion published on July 3, 1989 (54 FR 27870).
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environment. The Task Force Report repeatedly document that fact. The Task number. In addition, these amendments recommends the use of information Force Report’s definition of a broaden the scope of the categorical from past actions to establish the basis ‘‘categorical exclusion’’ also provides for exclusion that addresses for the no significant effect ‘‘extraordinary circumstances’’ decommissioning activities and adds determination. It further advises Federal (essentially, the NRC equivalent of categorical exclusions that address the agencies to evaluate past actions that special circumstances) in which a awarding of education grants and the occurred during a particular period to normally excluded action may have a granting of exemptions from certain determine how often the NEPA analyses significant environmental effect, and regulatory requirements. resulted in FONSIs for the category of thus require preparation of an EA or an The amendments to the categorical actions being considered. The Task EIS. exclusion regulations will reduce Force Report indicates that an adequate inefficiencies and inconsistencies in the B. What Is NRC’s Definition of implementation of NRC’s regulatory basis for developing new or broadening Categorical Exclusion? existing categorical exclusions exists if program. The amendments will all the evaluated past actions resulted in A ‘‘categorical exclusion’’ is defined in eliminate the need to prepare FONSIs. It also provides that criteria for NRC’s regulations in 10 CFR 51.14 as a unnecessary EAs for NRC regulatory identifying new categorical exclusions ‘‘category of actions which do not actions that have no significant effect on should include: (1) Repetitive actions individually or cumulatively have a the human environment. The that do not individually or cumulatively significant effect on the human amendments will also support the have significant effects on the human environment and which the NRC’s organizational objectives of environment; (2) actions that generally Commission has found to have no such ensuring that its actions are effective, require limited environmental review; effect in accordance with procedures set efficient, realistic, and timely. out in § 51.22, and for which, therefore and (3) actions that are E. Who Would This Action Affect? noncontroversial. neither an environmental assessment The amendments being adopted in nor an environmental impact statement This amendment will not impose any this final rule are also based upon a is required.’’ The NRC has determined new requirements on NRC licensees. It review of NRC regulatory actions. As that the categorical exclusions listed in will ensure that review of licensees’ noted, the Task Force Report 10 CFR 51.22 do not have a significant amendment requests are completed by recommends that agencies evaluate past effect on the human environment. the NRC in a more efficient, effective, and timely manner, and will result in EA/FONSIs for particular categories of C. How Should a Categorical Exclusion cost savings to the NRC and licensees. actions to develop new or broaden Be Applied? The amendments eliminate the need for existing categorical exclusions. To Before applying a categorical comply with this recommendation, an the preparation of EA/FONSIs for exclusion to a proposed action, it actions that routinely have been shown NRC search of files for EA/FONSIs should be determined whether there are completed during the 20-year period to have no effect on the human any special circumstances that would environment, e.g., licensee requests from 1987 to 2007 was conducted. The potentially effect the human search revealed that more than 1,500 concerning administrative, managerial, environment. If such special or organizational matters. For example, actions resulted in EA/FONSIs. NRC circumstances are, or are likely to be conducted an in-depth review of the current ambiguities in the categorical present, the NRC would then prepare an exclusion regulations have created EA/FONSIs issued during the period EA and, if necessary, an EIS. If special 2003–2007. That review identified delays in licensee decisions when circumstances are not present, then the organizational name changes occur, several recurring categories of regulatory categorical exclusion may be applied actions that are not addressed in 10 CFR because these decisions must await the and the NRC will satisfy its NEPA completion of an EA/FONSI and 51.22, and have no significant effect on obligation for that proposed action. The the human environment, either publication in the Federal Register by determination of whether special the NRC. individually or cumulatively. These circumstances are present is a matter of categories of actions were considered in NRC discretion. The determination that III. Summary of Public Comments on the amendments being adopted in this special circumstances are not present the Proposed Rule final rule. will not require the preparation of any The proposed rule to amend the II. Discussion specific or additional documentation categorical exclusions in 10 CFR 51.22 beyond the documentation normally was published on October 9, 2008 (73 A. What Is a Categorical Exclusion? prepared, if any, indicating that the FR 59540), with a 75-day comment The CEQ Task Force report defines categorical exclusion is being invoked period, which ended on December 23, the term ‘‘categorical exclusion’’ as ‘‘a for the proposed action. 2009. The NRC received four comment category of actions that do not submissions on the proposed rule. The D. What Action Is the NRC Taking? individually or cumulatively have a commenters included a member of the significant effect on the human The NRC is amending its list of public, one industry organization, and environment and, therefore, preparing categorical exclusions to clarify the two State agencies. Copies of the public an EA or an EIS is not required unless scope of existing categories and to add comments are available for review in the extraordinary circumstances indicate new categories of actions that have been NRC Public Document Room, 11555 otherwise.’’ 2 If a certain type of shown to have no significant effect on Rockville Pike, Rockville, MD, or http:// regulatory action, such as the the human environment. For example, www.regulations.gov under Docket ID amendment of regulations, would not the provisions in § 51.22(c)(10) cover NRC–2008–0269. normally result in any significant effect administrative and procedural changes Analysis of Public Comments upon the human environment, then it is to a license or permit. However, because unnecessary to spend time and effort to of the ambiguity of the language in this 1. Comment. The commenter, a provision, the NRC has prepared member of the public, stated that there 2 CEQ regulations define the term ‘‘categorical numerous EA/FONSIs for changes to a should never be exemptions from any exclusion’’ at 40 CFR 1508.4. licensee’s name, address, or telephone environmental review. The comment
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submission also included other prepare either an EA or EIS for an action be deprived of an opportunity to comments that are beyond the scope of that is otherwise categorically excluded. comment on an exemption from one or this rulemaking. 2. Comment: The commenter, an more of the enumerated requirements Response: Excluding categories of industry organization, stated in its that potentially impacts public health, actions from environmental review, for comment submission that it had safety or welfare, and (2) important which the agency has demonstrated that reviewed the proposed revisions to 10 technical reviews will be foregone there will be no significant effect on the CFR Part 51 as described in the because a permit or license holder’s human environment, either individually proposed rule and agreed that the request for exemption is erroneously or cumulatively, is an established, categories of actions included therein considered insignificant. The authorized NEPA practice. CEQ have been shown to have no significant commenter concludes that the regulations expressly authorize and effect on the human environment, either amendment to 10 CFR 51.22(c)(9) is encourage the use of categorical individually or collectively, and should overly broad and warrants additional, exclusions by agencies to reduce be excluded in accordance with NEPA more refined conditioning language to ‘‘excessive paperwork.’’ 3 According to and as defined in NRC regulations. The ensure that the above two critical the CEQ Task Force Report, CEQ commenter supported issuance of a final defects are avoided. ‘‘strongly discourages procedures that rule to implement the proposed Response: The commenter asserts that require additional paperwork to revisions set forth in the proposed rule. the fact that an EA and FONSI have document that an activity has been Response: No response necessary. been issued in the past is not sufficient categorically excluded.’’ 4 The 3. Comment: The commenter, a State justification to preclude all future categorical exclusion process provides Department of Health, stated in its requests for an exemption from Part 50 that if a certain type of regulatory action comment submission that it had or 52 from a NEPA review under the would not normally result in any reviewed the proposed revisions to 10 amendment to 10 CFR 51.22(c)(9). As significant effect upon the human CFR Part 51 as described in the described in the CEQ Task Force Report, environment, then it is unnecessary to proposed rule and concurred with the a consistent record of EA and FONSIs spend time and effort to repeatedly recommendation that the NRC for a given category of actions is an document that fact. periodically examine its categorical acceptable basis to establish a Moreover, a categorical exclusion exclusion regulations to identify categorical exclusion. In this regard, the does not indicate the absence of an potential revisions that would eliminate NRC staff determined that during the 5- environmental review, but rather, that unnecessary and costly environmental year period 2003 through 2007, over 50 the agency has established a sufficient assessments. The commenter also EAs were prepared for licensee requests administrative record to show that the supported the concept that information for exemptions, all of which resulted in subject actions do not, either from past actions be used to identify a FONSI. individually or cumulatively, have a and modify or eliminate requirements Moreover, an environmental review is significant effect on the human that have no significant impact on not precluded by the establishment of environment. Agencies establish humans or the environment. The this categorical exclusion. Before the sufficient administrative records to commenter also agreed that the categorical exclusion is applied, the support categorical exclusions through proposed revisions of the categorical NRC staff must find that the exemption the use of professional staff opinions, exclusion regulations would minimize request involves no significant hazards past NEPA records which show that the inefficiencies and inconsistencies in the consideration, there is no significant agency made a FONSI each time it implementation of NRC’s regulatory change in the types or significant considered the action, and the program. increase in the amounts of any effluents establishment of similar categorical Response: No response necessary. that may be released offsite, and there exclusions by other agencies.5 4. Comment: The commenter, a State is no significant increase in individual With respect to those categorical Department of Environmental or cumulative occupational radiation exclusions established by this final rule, Conservation, raised concerns about the exposure.6 The above findings would be the NRC has established a sufficient broadening of existing categorical made as part of the NRC’s safety administrative record, consisting of exclusion 10 CFR 51.22(c)(9) to include analysis for any licensee exemption professional staff opinions and past power reactor licensee exemption request. If the NRC cannot make these NEPA records, which shows that these requests from requirements concerning findings, then the categorical exclusion actions, either individually or the installation or use of a facility will not apply and the NRC will prepare cumulatively, do not result in a component located within the restricted an EA, and if necessary, an EIS. significant effect on the human area of a Part 50 or 52 facility. The Furthermore, the NRC can, in the event environment. The statements of commenter stated that the fact that an of special circumstances, as provided in consideration for this final rule EA and FONSI have been issued in the 10 CFR 51.22(b), choose to prepare an summarize the NRC’s administrative past is not sufficient justification to EA or an EIS. Thus, the NRC concludes record for each categorical exclusion. preclude all future requests for an that the broadening of 10 CFR Also, under 10 CFR 51.22(b), in the exemption from Part 50 or 52 from a 51.22(c)(9) is appropriate. event that special circumstances are NEPA review. The commenter noted The commenter urges the NRC to take present, the NRC retains discretion to that Parts 50 and 52 regulate a broad a ‘‘hard look’’ at the breadth of activities range of activities at nuclear facilities to be covered under the amendment to 3 40 CFR 1500.4(p). See also 40 CFR 1501.4(a)(2) and urged the NRC to take a hard look 10 CFR 51.22(c)(9) in order to more (agency determines under its procedures whether at the breadth of activities to be covered carefully define the types of exemption action would be one that is normally subject to an EIS or is not subject to an EIS or EA and thus, a under the proposed revisions and to requests that ‘‘truly qualify’’ to be categorical exclusion); and 40 CFR 1508.4 (CEQ more carefully define the types of classified as categorical exclusions. The definition of categorical exclusion). exception requests that qualify to be amendment to this categorical 4 CEQ, ‘‘The NEPA Task Force Report to the classified as a ‘‘categorical exclusion.’’ exclusion, however, only covers Council on Environmental Quality: Modernizing NEPA Implementation’’ (Task Force Report) 57–58 The commenter stated that the proposed exemption requests from a specified (2003). revision to 10 CFR 51.22(c)(9) had two 5 Task Force Report at 59. critical defects: (1) That the public will 6 10 CFR 51.22(c)(9)(i)–(iii).
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subset of requirements under Part 50 or one of the new categorical exclusions, to make these findings as part of its 52, namely, those exemption requests 10 CFR 51.22(c)(25), which covers safety analysis provides adequate from Part 50 or 52 requirements related exemption requests from administrative, protection of public health and safety to the installation of or use of a facility managerial, or organizational and as such, the revised categorical component located within the restricted requirements. Specifically, the exclusion is appropriate. area, as defined by 10 CFR Part 20. The commenter stated that the activities land covered by the restricted area is addressed in subparagraphs (C), (D), and IV. Discussion of Amendments by typically improved or otherwise (F) of 10 CFR 51.22(c)(vi)(25) 7 appear to Section previously disturbed and restricted to be more safety-related than A. Why Revise the Description of plant personnel or other screened administrative, or that the requirements Categorical Exclusions in 10 CFR individuals. were more than administrative. 51.22(a)? Given the 10 CFR 51.22(c)(9)(i)–(iii) Subparagraph (C) covered exemption This rule amends § 51.22(a) to clarify criteria and the nature of the restricted requests from inspection or surveillance that the types of actions eligible for a area, it is extremely unlikely that requirements; subparagraph (D) covered categorical exclusion include granting any such exemption request exemption requests from equipment ‘‘administrative’’ actions in addition to would create any significant impact on servicing or maintenance requirements; ‘‘licensing’’ and ‘‘regulatory’’ actions. the aquatic or terrestrial habitat in the and subparagraph (F) covered vicinity of the plant, or to threatened, exemption requests from safeguards B. Why Revise the Categorical Exclusion endangered, or protected species under plans, including materials control, in 10 CFR 51.22(c)(1) Which Addresses the Endangered Species Act, or impacts accounting, or other inventory Amendments to 10 CFR Parts That to essential fish habitat covered by the requirements. The commenter urged the Pertain Solely to Organizational, Magnuson-Stevens Act. Similarly, it is NRC to remove these exemption Administrative or Procedural Matters? extremely unlikely that there will be requests from the list of activities This rule amends § 51.22(c)(1) to any impacts to socioeconomic, or eligible for listing as a categorical include references to 10 CFR Parts that historical and cultural resources. Thus, exclusion. the NRC concludes that the amendment Response: The NRC makes a were inadvertently omitted. The 10 CFR to 10 CFR 51.22(c)(9) is not overly distinction between conducting a safety Parts referenced in this section relate to broad, has sufficient protection, and is analysis and conducting an matters regarding Commission supported by an adequate environmental analysis. The NRC has organization, administration, or administrative record. determined that granting exemption procedure. They serve the dual purpose The commenter further asserts that requests from the types of requirements of making information readily available the public will be deprived of an described in subparagraphs (C), (D), and to the public and of establishing opportunity to comment on an (F) will not have a significant effect on administrative procedures for the exemption from one or more of the the human environment. The orderly conduct of Commission enumerated requirements that commenter asserts that these business. The NRC has established that potentially impact public health, safety, requirements are more safety-related these types of regulatory actions do not or welfare. In response, the NRC has than administrative. The NRC will individually or cumulatively have a concluded that broadening the conduct a safety review and must make significant effect on the human categorical exclusion to include findings similar to those required by 10 environment. exemption requests will not have a CFR 51.22(c)(9). The proposed rule This amendment updates 10 CFR significant effect on the human listed four findings, namely, that 51.22(c)(1) to include references to the environment and will reduce granting the exemption request would following Commission organizational, unnecessary agency work. The NRC has not result in a: (i) Significant change in administrative, or procedural further concluded that this amendment the types or significant increase in the requirements in the following 10 CFR will not adversely impact public health amounts of any effluents that may be Parts: and safety. This conclusion is based on released offsite; (ii) significant increase Part 5—Nondiscrimination on the the NRC’s administrative record and the in individual or cumulative public or Basis of Sex in Education Programs or findings that must be made before the occupational radiation exposure; (iii) Activities Receiving Federal Financial exemption can be approved, as required significant construction impact; or (iv) Assistance. This part is designed to by 10 CFR 51.22(c)(9)(i)–(iii). there is no significant increase the eliminate (with certain exceptions) sex The commenter also asserts that potential for or consequences from discrimination in any education important technical reviews will be radiological accidents. program or activity receiving Federal foregone because a permit or license In response to this comment, the final financial assistance. holder’s request for exemption is rule adds a fifth required finding that Part 12—Implementation of the Equal erroneously considered insignificant. there will be no significant hazards Access to Justice Act in Agency The application of the categorical consideration, set forth in this final rule Proceedings. This part establishes exclusion to any exemption request, as 10 CFR 51.22(c)(25)(i). In addition, regulatory requirements for awarding of however, is separate and distinct from the term ‘‘procedural’’ will be deleted attorney fees to eligible individuals and the safety analysis of the exemption from 10 CFR 51.22(c)(25)(vi)(I) (formerly entities in certain administrative request that will be conducted by the subparagraph (c)(25)(v)(J) in the proceedings before the Commission. NRC staff. Absent the EA, the staff will proposed rule) as the term ‘‘procedural’’ Part 13—Program Fraud Civil still review the plant’s procedures and could be misconstrued in this context to Remedies. This part establishes technical specifications as well as include the requirement for licensees to administrative procedures for imposing evaluate the exemption request against implement procedures for substantive civil penalties and assessments against the significance criteria in 10 CFR requirements. Thus, with these changes, persons who make, submit, or present, 51.22(c)(9)(i)–(iii). the NRC concludes that the requirement false, fictitious, or fraudulent claims. It 5. Comment: The commenter, a State also specifies the hearing and appeal Department of Environmental 7 The paragraph in question was designated as 10 rights of persons subject to allegations of Conservation, raised a concern about CFR 51.22(c)(25)(v) in the proposed rule. liability for such penalties.
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Part 15—Debt Collection Procedures. D. Why Revise the Categorical Exclusion F. Why Revise the Categorical Exclusion This part establishes administrative in 10 CFR 51.22(c)(3) Which Addresses in 10 CFR 51.22(c)(10) Which Addresses procedures for the Commission to Amendments to Administrative, Administrative, Procedural, collect the payment of debts owed to the Organizational or Procedural Organizational, or Editorial Changes to United States Government in the form of Requirements Within Other 10 CFR a Permit or License? money or property, unless a different Parts? The final rule amends 10 CFR procedure is specified in a statute, 51.22(c)(10) to delete the specific listing The final rule amends 10 CFR regulation, or contract. of 10 CFR Parts and to add a generic 51.22(c)(3) to delete the specific listing reference to cover any part of 10 CFR, Part 16—Salary Offset Procedures for of 10 CFR Parts and to add a generic Collecting Debts Owed by Federal Chapter 1. This revision eliminates the reference to reflect any part of CFR need for changes due to new parts being Employees to the Federal Government. Chapter 10. This revision eliminates the This part establishes procedures for the added or deleted. As a result, need for changes due to new parts being efficiencies are gained in the rulemaking collection by administrative offset of a added or deleted. As a result, Federal employee’s salary without his or process. efficiencies will be gained in the In addition, 10 CFR 51.22(c)(10) is her consent to satisfy certain debts owed rulemaking process. revised to add new subparagraphs (iii), to the Federal Government. This amendment redesignates the (iv), and (v) to clarify that changes to a Part 26—Fitness for Duty Programs. existing subparagraph (iv) as license or permit that are This part prescribes requirements and subparagraph (v) and adds a new administrative, organizational, or standards for the establishment and subparagraph (iv) to 10 CFR 51.22(c)(3) editorial in nature are not subject to maintenance of certain aspects of to expand the categorical exclusion to environmental review. The NRC has fitness-for-duty programs and include amendments concerning conducted several EAs, each resulting in procedures. education, training, experience, a FONSI, for minor administrative changes to licenses and permits because Part 160—Trespassing on Commission qualification, or other employment these actions were not specifically Property. This part provides for the suitability requirements established in identified in 10 CFR 51.22(c). These protection and security of NRC the regulations. types of amendments to a license or facilities, installations, and properties permit facilitate the orderly conduct of from unauthorized entry and from E. Why Revise Categorical Exclusion in the licensee’s business and ensure that unauthorized weapons or dangerous 10 CFR 51.22(c)(9) Which Addresses information needed by the Commission materials. Amendments to a Permit or License for a Reactor Under Parts 50 or 52? to perform its regulatory functions is C. Why the Commission Has Chosen Not readily available. These amendments To Revise the Categorical Exclusion in The final rule amends 10 CFR would also include the changing of 10 CFR 51.22(c)(2) 51.22(c)(9) to broaden the scope of the references on licenses and other categorical exclusion to include the licensee documents (e.g., licensee’s The proposed rule proposed granting of a power reactor licensee operational procedures) to reflect broadening the scope of 10 CFR exemption request from a requirement amendments to NRC regulations and 51.22(c)(2) to include regulatory pertaining to the installation or use of a updated NRC-approved guidance (e.g., amendments that updated references, facility component located within the NUREG documents). Under the previous and to make other modifications to the restricted area, as defined in 10 CFR provision, the NRC was required to language. Subsequent to the publication Part 20. Under the previous provision, prepare EA and FONSIs for the of the proposed rule, the NRC staff re- the granting of such an exemption following administrative actions: evaluated this proposed amendment request would not be covered by this (1) Amendments to reflect changes in and determined the proposed changes categorical exclusion and therefore, ownership; (2) Amendments to reflect were overly broad, particularly would have required the preparation of organization name changes; regarding those amendments to the NRC an EA. The Commission has now regulations that incorporated by (3) Amendments to reflect corporate determined that there is ample data in restructuring, including mergers; reference updates to American Society the form of EA and FONSIs to justify the (4) Amendments to licenses to reflect of Mechanical Engineers (ASME) or categorical exclusion of the granting of changes in references; and similar codes. For example, it was these exemptions, provided that for (5) Amendments correcting determined that certain code cases for each exemption request, the NRC first typographical and editorial errors on Section II of the ASME Boiler and finds that the safety criteria set forth in licenses, permits, and associated Pressure Vessel code, ‘‘Materials,’’ could 10 CFR 51.22(c)(9) are met (i.e., the technical specification documents. result in an alloy being altered to exemption involves no significant The Commission has consistently include a new material. Such new hazards consideration, there is no determined that these types of material, if in contact with the reactor significant change in the types of, or amendments have no significant effect coolant system, could become significant increase in the amounts of on the human environment. radioactively activated and could any effluents that may be released ultimately be released to the G. Why Revise the Categorical Exclusion offsite, and there is no significant in 10 CFR 51.22(c)(20) Which Addresses environment. Thus, the NRC staff increase in individual or cumulative Decommissioning of Sites? concluded that such reference updates occupational radiation exposure). should be subject to an environmental During the period 2003 through 2007, at The final rule adds a new review. The final rule will not amend 10 least 50 EA/FONSIs resulted from subparagraph (iii) to 10 CFR 51.22(c)(20) CFR 51.22(c)(2). licensee requests for such exemptions. to broaden the scope of the 10 CFR 51.22(c)(20) categorical exclusion to include Group 2 decommissioning activities. Decommissioning activities
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are described in NRC’s guidance, plan, but must demonstrate that their uses of unsealed radioactive materials at NUREG–1757, Vol. 1, Rev. 2, site meets the screening criteria of 10 each site prevented the environmental ‘‘Consolidated NMSS CFR 20.1402. impacts from being analyzed on a Decommissioning.’’ NUREG–1757 In many cases, the NRC conducts generic basis. Accordingly, the divides decommissioning activities into confirmatory surveys during the Commission relied on the GEIS to seven decommissioning groups, Groups licensee’s decommissioning activities to satisfy its obligations under NEPA 1–7. Prior to this amendment, the 10 verify the accuracy of the measuring regarding decommissioning decisions CFR 51.22(c)(20) categorical exclusion techniques used to satisfy the on sites that meet the 25 mrem/y (0.25 covered Group 1 decommissioning requirements of 10 CFR 20.1402. The mSv/yr) criterion for unrestricted use, activities only. Group 2 NRC uses a risk-informed process that but continued to require an EA for the decommissioning activities are those assigns higher priority for conducting decommissioning of any site on which activities that involve the confirmatory surveys at sites that may unsealed radioactive materials with decommissioning of sites where pose a greater threat to the public health half-lives of more than 120 days are licensed operations have been limited to and safety. The results of this survey are located. As such, based upon the 1997 the use of radioactive materials in such used by the NRC to support a decision Commission decision, EAs were a manner that a decommissioning plan on whether to approve a licensee’s performed for Group 2 is not required by 10 CFR 30.36(g)(1), request to terminate a license and decommissioning activities. 40.42(g)(1) or 70.38(g)(1), and the NRC release the site for unrestricted use. The Commission has now determined has determined that the facility meets Prior to this amendment, 10 CFR that there is ample data in the form of the radiological criteria for unrestricted 51.22(c)(20) categorically excluded from EA and FONSIs to justify the categorical use in 10 CFR 20.1402, without further further NRC environmental review those exclusion of Group 2 decommissioning remediation or analysis. activities which are defined in NUREG– activities. The data shows that, during Group 2 decommissioning activities 1757 as Group 1 decommissioning the period 2003 through 2007, each of cover: activities, namely, the decommissioning the 73 EAs performed for a Group 2 (1) Facilities where the licensee of sites where licensed operations had decommissioning action resulted in a possessed and used only sealed sources, been limited to the use of small FONSI. Thus, subparagraph (iii) is but the most recent leak tests indicate quantities of unsealed short-lived added to 10 CFR 51.22(c)(20) to that the sources leaked or leak tests are radioactive materials or radioactive categorically exclude from further not available; or materials in sealed sources, provided environmental review the (2) Facilities where the licensee used there is no evidence of leakage of decommissioning of sites where unsealed radioactive material and the radioactive material from these sealed radioactive material has been used in licensee’s survey demonstrated that sources. The 10 CFR 51.22(c)(20) such a manner that a decommissioning levels of radiological contamination on decommissioning categorical exclusion plan is not required based on 10 CFR building surfaces or surface soils meet was added with the promulgation of the 30.36(g)(1), 40.42(g)(1), or 70.38(g)(1) the provisions for unrestricted use in 10 license termination rule, ‘‘Radiological and the NRC has determined that the CFR 20.1402 by applying NRC-approved Criteria for License Termination’’ (July facility meets the radiological criteria decommissioning screening criteria, and 21, 1997; 62 FR 39058). The license for unrestricted use in 10 CFR 20.1402 the licensee is not required to submit a termination rule, codified at 10 CFR Part without further remediation or analysis. decommissioning plan. 20, Subpart E, established a dose-based If further remediation or analysis is Group 2 decommissioning requests radiological criterion of 25 mrem/yr in needed to meet 10 CFR 20.1402, the received by the NRC involve licensees 10 CFR 20.1402 for the release of a decommissioning activity would be who are authorized to possess and use decommissioned site for unrestricted considered a Group 3 or higher sealed and/or unsealed radioactive use. decommissioning activity in accordance materials with half-lives greater than In establishing the decommissioning with NUREG–1757, and would not be 120 days. For example, the most categorical exclusion, the Commission covered by this categorical exclusion. common unsealed radioactive materials relied on the ‘‘Generic Environmental used by Group 2 licensees are tritium Impact Statement in Support of H. Why Add a Categorical Exclusion in (H-3) and Carbon-14. Rulemaking on Radiological Criteria for 10 CFR 51.22(c)(24) Which Addresses Normally, Group 2 licensees in the License Termination on NRC-Licensed the Awarding of Education Grants? decommissioning process remediate Nuclear Facilities’’ (GEIS; NUREG–1496, The final rule adds a new categorical their sites, as necessary, using their Vol. 1). The GEIS concluded that with exclusion, 10 CFR 51.22(c)(24), which operating procedures. These licensees the use of ‘‘decay in storage’’ for the categorically excludes the issuance of are required to keep records of material short-lived nuclides (those with a half- grants, by the NRC, to institutions of receipt, use, and disposal, enabling life of less than or equal to 120 days) higher education in the United States, them to quantify past radiological and the time involved in submitting the for scholarships, fellowships, and material possession and use with a high information necessary to terminate a stipends in science, engineering, or degree of confidence. In order for the license, the activity of licensed material another field of study that the NRC decommissioning action to meet Group would reach sufficiently low levels such determines is in a critical skill area 2 criteria, the licensee must maintain that decontamination of the building or related to its regulatory mission. These radiological survey records that of soils would not be needed. grants may also support faculty or characterize the residual radiological However, the GEIS did not enable the curriculum development as well as contamination levels present within the Commission to determine that there other domestic educational, technical facilities and at their sites. In addition, would be no significant effect on the assistance, or training programs Group 2 licensees must be able to human environment from the use of (including those of trade schools) in demonstrate residual radiological unsealed radioactive materials with such fields. This categorical exclusion contamination levels without more half-lives of more than 120 days. covers those actions that are specifically sophisticated survey procedures or dose Specifically, the Commission geared toward the development of modeling. These licensees are not determined that the unique conditions teaching and educational programs in required to have a decommissioning of each licensee facility and the specific the nuclear field. The purpose of the
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grant program is to foster a work force be granted, the NRC must satisfy certain the safety findings described in 10 CFR capable of supporting the safe design, criteria, namely, it must make findings 51.22(c)(25)(i)–(v) and then determine construction, operation, and regulation that the exemption is ‘‘authorized by that the requirement is of a type listed of nuclear facilities, and the safe law,’’ ‘‘will not endanger life or property in 10 CFR 51.22(c)(25)(vi). handling of nuclear materials. or the common defense and security,’’ V. Agreement State Compatibility Sections 31.b.(2) and 243 of the and is ‘‘otherwise in the public interest.’’ Atomic Energy Act of 1954, as amended, In the case of Part 50 and 52 Under the ‘‘Policy Statement on constitute the statutory basis of this exemptions, the exemption request must Adequacy and Compatibility of grants program. Section 243 authorizes meet additional criteria.9 The NRC Agreement State Programs’’ approved by the creation of a scholarship and thoroughly evaluates each exemption the Commission on June 30, 1997, and fellowship program to fund request under these provisions, and published in the Federal Register on scholarships, fellowships, and stipends only those exemption requests that meet September 3, 1997 (62 FR 46517), this for the study of science, engineering, or these provisional criteria are granted. rule is classified as a Compatibility another field of study that the NRC Prior to this final rule, 10 CFR 51.22 Category ‘‘NRC.’’ The NRC program determines is a critical skill area related did not provide a categorical exclusion elements in this category are those that to its regulatory mission, to support for the granting of exemption requests relate directly to areas of regulation faculty and curricular development in from administrative, managerial, or reserved to the NRC by the Atomic such fields, and to support other organizational regulatory requirements Energy Act of 1954, as amended (AEA), domestic educational, technical that will not have a significant effect on or the provisions of Title 10 of the Code assistance, or training programs the human environment. The NRC has of Federal Regulations. Although an (including those of trade schools) in found that the majority of the Agreement State may not adopt program such fields. Section 31.b.(2) authorizes exemptions it grants are administrative elements reserved to NRC, it may wish the NRC to provide grants, loans, or otherwise minor in nature and do not to inform its licensees of certain cooperative agreements, contracts, and trigger any of the significance criteria requirements via a mechanism that is equipment to institutions of higher that are required findings under other consistent with the particular State’s education to support courses, studies, categorical exclusions, such as 10 CFR administrative procedure laws but does training, curricula, and disciplines 51.22(c)(9)(i)–(iii). The NRC has not confer regulatory authority on the pertaining to nuclear safety, security, or prepared numerous EAs, each resulting State. NEPA applies only to Federal environmental protection, or any other in a FONSI, to support the granting of agencies. This final rule will not have field that the NRC determines to be such exemption requests. any impact on Agreement States’ critical to its regulatory mission. This categorical exclusion contains regulations. Therefore, Agreement States This new categorical exclusion covers prescriptive criteria that limit its will not need to make conforming actions that the NRC has determined to application to only those exemptions changes to their regulations. be administrative in nature. The that will not have a significant effect on VI. Voluntary Consensus Standards categorical exclusion contains the human environment. The categorical prescriptive language (10 CFR exclusion only applies to those The National Technology Transfer 51.22(c)(24)(i)–(iv)) that limits its exemption requests that meet all of the and Advancement Act of 1995 (Pub. L. application to only those grants that will criteria enumerated in 10 CFR 104–113) requires that Federal agencies not have a significant effect on the 51.22(c)(25)(i)–(vi). Thus, the use technical standards that are human environment. In this regard, the requirements from which the exemption developed or adopted by voluntary categorical exclusion does not apply to is sought must be one of those listed in consensus standards bodies unless the those grants that may be used to directly 10 CFR 51.22(c)(25)(vi). In addition, the use of such a standard is inconsistent support the construction of facilities, granting of the exemption request with applicable law or otherwise field work (except field work which cannot result in any: impractical. The NRC is amending 10 only involves noninvasive or non- (1) Significant hazards consideration; CFR 51.22, the NRC’s list of categories harmful techniques), or the testing and (2) Significant change in the types or of actions that the NRC has determined release of radioactive material. significant increase in the amounts of to have no significant effect on the Furthermore, the categorical exclusion any effluents that may be released human environment. This action does would not apply to those grants that offsite; not constitute the establishment of a would directly support any action that (3) Significant increase in individual standard that establishes generally would lead to a major disturbance of the or cumulative public or occupational applicable requirements. environment brought about by blasting, radiation exposure; VII. Finding of No Significant (4) Significant construction impact; or drilling, excavating, or other means. Environmental Impact: Availability (5) Significant increase in the I. Why Add a Categorical Exclusion in potential for or consequences from Under NEPA and the NRC regulations 10 CFR 51.22(c)(25) Which Addresses radiological accidents. in Subpart A of 10 CFR Part 51, the NRC the Granting of Exemptions From The NRC has found that granting has determined that this rule would not Regulatory Requirements? exemptions for the types of be a major Federal action significantly The final rule adds a new categorical requirements listed in subparagraphs affecting the quality of the human exclusion, 10 CFR 51.22(c)(25), which 51.22(c)(25)(vi)(A)–(I) are categories of environment and, therefore, an EIS is addresses the granting of licensee actions that normally do not result in not required. The NRC prepared an EA exemption requests from certain any significant effect, either and, on the basis of this EA, has made regulatory requirements. Various NRC individually or cumulatively, on the a FONSI. These amendments are based regulations allow for the granting of human environment. Thus, in order for upon NRC review of environmental specific exemptions from NRC the categorical exclusion to be assessments conducted during the regulations.8 Before an exemption may applicable to a specific exemption period 2003–2007 that have consistently request, the NRC staff must first make resulted in FONSIs. The amendments to 8 E.g., 10 CFR 20.2301, 30.11, 40.14, 50.12, 52.7, the categorical exclusions are 70.17, 72.7, and 76.23. 9 10 CFR 50.12(a)(2); 10 CFR 52.7. administrative, procedural, or otherwise
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minor in nature (e.g., no significant determination with the Office of cumulatively have a significant effect on increases in the amounts of any Information and Regulatory Affairs of the human environment. effluents that may be released offsite). the Office of Management and Budget. * * * * * The NRC sent a copy of the EA and List of Subjects in Part 51 (c) * * * the proposed rule to every State Liaison (1) Amendments to Parts 1, 2, 4, 5, 7, Officer and requested their comments Administrative practice and 8, 9, 10, 11, 12, 13, 15, 16, 19, 21, 25, on the EA. Two State comment procedure, Environmental impact 26, 55, 75, 95, 110, 140, 150, 160, 170, submissions were received. The States’ statement, Hazardous waste, Nuclear or 171 of this chapter, and actions on comments and the NRC responses materials, Nuclear power plants and petitions for rulemaking relating to Parts thereto are described in the Analysis of reactors, Reporting and recordkeeping 1, 2, 4, 5, 7, 9, 10, 11, 12, 13, 14, 15, Public Comments section of this final requirements. 16, 19, 21, 25, 26, 55, 75, 95, 110, 140, rule. The EA may be examined at the ■ For the reasons set out in the 150, 160, 170, or 171 of this chapter. NRC Public Document Room, 11555 preamble and under the authority of the * * * * * Rockville Pike, Room O–1F23, Atomic Energy Act of 1954, as amended; (3) Amendments to any part in this Rockville, MD 20852. the Energy Reorganization Act of 1974, chapter which relate to— VIII. Paperwork Reduction Act as amended; and 5 U.S.C. 552 and 553; (i) Procedures for filing and reviewing Statement the NRC proposes to adopt the following applications for licenses or construction amendments to 10 CFR Part 51: permits or early site permits or other This rule does not contain forms of permission or for amendments information collection requirements PART 51—ENVIRONMENTAL to or renewals of licenses or and, therefore, is not subject to the PROTECTION REGULATIONS FOR construction permits or early site requirements of the Paperwork DOMESTIC LICENSING AND RELATED permits or other forms of permission; Reduction Act of 1995 (44 U.S.C. 3501 REGULATORY FUNCTIONS (ii) Recordkeeping requirements; et seq.). ■ 1. The authority citation for Part 51 (iii) Reporting requirements; IX. Public Protection Notification continues to read as follows: (iv) Education, training, experience, qualification or other employment The NRC may not conduct or sponsor, Authority: Sec. 161, 68 Stat. 948, as suitability requirements or and a person is not required to respond amended, sec. 1701, 106 Stat. 2951, 2952, (v) Actions on petitions for to, a request for information or an 2953, (42 U.S.C. 2201, 2297f); secs. 201, as rulemaking relating to these information collection requirement amended, 202, 88 Stat. 1242, as amended, amendments. unless the requesting document 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 displays a currently valid OMB control Stat. 2750 (44 U.S.C. 3504 note). Subpart A * * * * * also issued under National Environmental number. (9) Issuance of an amendment to a Policy Act of 1969, secs. 102, 104, 105, 83 permit or license for a reactor under part X. Regulatory Analysis Stat. 853–854, as amended (42 U.S.C. 4332, 50 or part 52 of this chapter, which 4334, 4335); and Pub. L. 95–604, Title II, 92 changes a requirement, or grants an This rule is anticipated to be cost- Stat. 3033–3041; and sec. 193, Pub. L. 101– effective. It would eliminate the need to 575, 104 Stat. 2835 (42 U.S.C. 2243). Sections exemption from any such requirement, prepare EAs for actions that have no 51.20, 51.30, 51.60, 51.80, and 51.97 also with respect to installation or use of a significant effect on the human issued under secs. 135, 141, Pub. L. 97–425, facility component located within the environment, and would eliminate the 96 Stat. 2232, 2241, and sec. 148, Pub. L. restricted area, as defined in part 20 of delays associated with the preparation 100–203, 101 Stat. 1330–223 (42 U.S.C. this chapter, or which changes an of these documents. A regulatory 10155, 10161, 10168). Section 51.22 also inspection or a surveillance issued under sec. 274, 73 Stat. 688, as requirement, provided that: analysis is not required because this amended by 92 Stat. 3036–3038 (42 U.S.C. rulemaking does not impose any new (i) The amendment or exemption 2021) and under Nuclear Waste Policy Act of involves no significant hazards requirements on NRC licensees. 1982, sec 121, 96 Stat. 2228 (42 U.S.C. consideration; XI. Regulatory Flexibility Certification 10141). Sections 51.43, 51.67, and 51.109 also under Nuclear Waste Policy Act of 1982, (ii) There is no significant change in Under the Regulatory Flexibility Act sec 114(f), 96 Stat. 2216, as amended (42 the types or significant increase in the of 1980 (5 U.S.C. 605(b)), the U.S.C. 10134(f)). amounts of any effluents that may be released offsite; and Commission certifies that this rule will ■ 2. Amend § 51.22 by revising (iii) There is no significant increase in not have a significant economic impact paragraphs (a), (c)(1), (c)(3), (c)(9), individual or cumulative occupational on a substantial number of small (c)(10), and (c)(20) and adding radiation exposure. entities. paragraphs (c)(24) and (c)(25) to read as (10) Issuance of an amendment to a follows: XII. Backfit Analysis permit or license issued under this The NRC has determined that the § 51.22 Criterion for categorical exclusion; chapter which— backfit rule (§§ 50.109, 70.76, 72.62, or identification of licensing and regulatory (i) Changes surety, insurance and/or 76.76) does not apply to this rule actions eligible for categorical exclusion or indemnity requirements; because this amendment would not otherwise not requiring environmental (ii) Changes recordkeeping, reporting, involve any provisions that would review. or administrative procedures or impose backfits as defined in 10 CFR (a) Licensing, regulatory, and requirements; Chapter I. Therefore, a backfit analysis administrative actions eligible for (iii) Changes the licensee’s or permit is not required. categorical exclusion shall meet the holder’s name, phone number, business following criterion: The action belongs or e-mail address; XIII. Congressional Review Act to a category of actions which the (iv) Changes the name, position, or In accordance with the Congressional Commission, by rule or regulation, has title of an officer of the licensee or Review Act of 1996, the NRC has declared to be a categorical exclusion, permit holder, including but not limited determined that this action is not a after first finding that the category of to, the radiation safety officer or quality major rule and has verified this actions does not individually or assurance manager; or
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(v) Changes the format of the license (vi) The requirements from which an the TAG, it modifies the assessment or permit or otherwise makes editorial, exemption is sought involve: basis for calculating the current risk- corrective or other minor revisions, (A) Recordkeeping requirements; based assessments to one based on including the updating of NRC (B) Reporting requirements; average daily balances in the TAG- approved references. (C) Inspection or surveillance related accounts. Further, the Interim * * * * * requirements; Rule requires IDIs participating in the (20) Decommissioning of sites where (D) Equipment servicing or TAG program that offer NOW accounts licensed operations have been limited to maintenance scheduling requirements; covered by the program to reduce the the use of— (E) Education, training, experience, interest rate on such accounts to a rate (i) Small quantities of short-lived qualification, requalification or other no higher than 0.25 percent and to radioactive materials; employment suitability requirements; commit to maintain that rate for the (ii) Radioactive materials in sealed (F) Safeguard plans, and materials duration of the TAG extension in order sources, provided there is no evidence control and accounting inventory for those NOW accounts to remain of leakage of radioactive material from scheduling requirements; eligible for the FDIC’s continued these sealed sources; or (G) Scheduling requirements; guarantee. (iii) Radioactive materials in such a (H) Surety, insurance or indemnity DATES: The Interim Rule becomes manner that a decommissioning plan is requirements; or effective on April 19, 2010. Comments not required by 10 CFR 30.36(g)(1), (I) Other requirements of an on the Interim Rule must be received by 40.42(g)(1), or 70.38(g)(1), and the NRC administrative, managerial, or the FDIC no later than May 19, 2010. organizational nature. has determined that the facility meets ADDRESSES: You may submit comments the radiological criteria for unrestricted Dated at Rockville, Maryland, this 13th day on the Interim Rule, by any of the use in 10 CFR 20.1402 without further of April 2010. following methods: remediation or analysis. For the Nuclear Regulatory Commission. • Agency Web Site: http:// * * * * * Annette Vietti-Cook, www.FDIC.gov/regulations/laws/ (24) Grants to institutions of higher Secretary of the Commission. federal/notices.html. Follow education in the United States, to fund [FR Doc. 2010–8921 Filed 4–16–10; 8:45 am] instructions for submitting comments scholarships, fellowships, and stipends BILLING CODE 7590–01–P on the Agency Web Site. for the study of science, engineering, or • E-mail: [email protected]. another field of study that the NRC Include RIN # 3064–AD37 on the determines is in a critical skill area FEDERAL DEPOSIT INSURANCE subject line of the message. • Mail: Robert E. Feldman, Executive related to its regulatory mission, to CORPORATION support faculty and curricular Secretary, Attention: Comments, Federal development in such fields, and to 12 CFR Part 370 Deposit Insurance Corporation, 550 17th support other domestic educational, Street, NW., Washington, DC 20429. • technical assistance, or training RIN 3064–AD37 Hand Delivery: Comments may be programs (including those of trade hand delivered to the guard station at Amendment of the Temporary Liquidity the rear of the 550 17th Street Building schools) in such fields, except to the Guarantee Program To Extend the extent that such grants or programs (located on F Street) on business days Transaction Account Guarantee between 7 a.m. and 5 p.m. include activities directly affecting the Program With Opportunity To Opt Out environment, such as: Instructions: All comments received (i) The construction of facilities; AGENCY: Federal Deposit Insurance will be posted generally without change (ii) A major disturbance brought about Corporation (FDIC). to http://www.fdic.gov/regulations/laws/ federal/final.html, including any by blasting, drilling, excavating or other ACTION: Interim Rule with request for personal information provided. means; comments. (iii) Field work, except that which FOR FURTHER INFORMATION CONTACT: A. only involves noninvasive or non- SUMMARY: The FDIC is issuing this Ann Johnson, Counsel, Legal Division, harmful techniques such as taking water Interim Rule to amend the Transaction (202) 898–3573 or [email protected]; or soil samples or collecting non- Account Guarantee (TAG) component of Robert C. Fick, Counsel, Legal Division, protected species of flora and fauna; or the Temporary Liquidity Guarantee (202) 898–8962 or [email protected]; Julia (iv) The release of radioactive Program (TLGP) by providing an 6- E. Paris, Senior Attorney, Legal material. month extension of the TAG program Division, (202) 898–3821 or (25) Granting of an exemption from for insured depository institutions (IDIs) [email protected]; Lisa D Arquette, the requirements of any regulation of currently participating in the TAG Associate Director, Division of this chapter, provided that— program, with the possibility of an Supervision and Consumer Protection, (i) There is no significant hazards additional 12-month extension of the (202) 898–8633 or [email protected]; consideration; program without further rulemaking, Donna Saulnier, Manager, Assessment (ii) There is no significant change in upon a determination by the FDIC’s Policy Section, Division of Finance, the types or significant increase in the Board of Directors (Board) that (703) 562–6167 or [email protected]; amounts of any effluents that may be continuing economic difficulties or Rose Kushmeider, Acting Chief, released offsite; warrant a continued extension. By Banking and Regulatory Policy Section, (iii) There is no significant increase in virtue of this Interim Rule, the TAG Division of Insurance and Research, individual or cumulative public or program will be extended through (202) 898–3861 or occupational radiation exposure; December 31, 2010, with the possibility [email protected]. (iv) There is no significant of an additional 12-month extension SUPPLEMENTARY INFORMATION: construction impact; through December 31, 2011. In addition, (v) There is no significant increase in while the Interim Rule presents no I. Background the potential for or consequences from changes in the amount of the assessment In October 2008, the FDIC adopted the radiological accidents; and for an IDI’s continued participation in TLGP following a determination of
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systemic risk by the Secretary of the The TAG component of the TLGP was changed to reflect an IDI’s risk profile, Treasury (after consultation with the developed, in part, to address concerns ranging from 15 basis points to up to 25 President) that was supported by that a large number of account holders basis points. The rule provided recommendations from the FDIC and might withdraw their uninsured participating IDIs with a second the Board of Governors of the Federal account balances from IDIs due to then- opportunity to opt out of the TAG Reserve System (Federal Reserve).1 The prevailing economic uncertainties. Such program.13 The initial TAG extension TLGP is part of an ongoing and withdrawals could have further also required participating IDIs to coordinated effort by the FDIC, the U.S. destabilized financial markets and extend their commitment to maintain Department of the Treasury, and the impaired the funding structure of interest rates on NOW account at no Federal Reserve to address smaller banks that rely on deposits as a higher than 0.50 percent during the unprecedented disruptions in the primary source of funding while also extended TAG program.14 financial markets and preserve negatively affecting other institutions In extending the TAG program confidence in the American economy. that had relationships with these through June 30, 2010, the FDIC 7 The FDIC’s October 2008 interim rule banks. In designing the TAG program, reiterated its belief that the country was 2 provided the blueprint for the TLGP. the FDIC sought to improve public experiencing overall improved The TLGP comprises two distinct confidence and to encourage depositors economic conditions and that it had components: The Debt Guarantee to maintain their transaction account made progress toward a stable, fully Program (DGP), pursuant to which the balances at IDIs participating in the functioning financial marketplace.15 Yet FDIC guarantees certain senior TAG program. the FDIC cautioned that this progress unsecured debt issued by entities In response to comments received by could be impeded or even undone by participating in the TLGP; and the TAG the FDIC following publication of the terminating the TAG program too program, pursuant to which the FDIC October 2008 interim rule, the FDIC quickly. As such, the FDIC deemed its guarantees all funds held at expanded the TAG program to cover, initial extension of the TAG an participating IDIs (beyond the standard among other accounts, ‘‘negotiable order appropriate step to a gradual phase out maximum deposit insurance limit) in of withdrawal,’’ or NOW accounts, with the program.16 qualifying noninterest-bearing interest rates no higher than 0.50 transaction accounts. percent if the IDI offering the account II. Rationale for Extending the TAG The DGP addressed the acute needs of committed to maintain that interest rate Program banks to obtain funding by permitting through December 31, 2009.8 If an IDI participating entities to issue FDIC- offering NOW accounts with an interest Since its inception, the TAG program guaranteed senior unsecured debt until rate in excess of 0.50 percent committed has been an important source of stability June 30, 2009, with the FDIC’s guarantee to reduce the rate to 0.50 percent or less for many banks with large transaction for such debt to expire on the earlier of by January 1, 2009, and to maintain that account balances. Currently, nearly the maturity or conversion of the debt rate for the duration of the program, its 6,400 insured depository institutions, (for mandatory convertible debt) or June NOW account would be considered representing approximately 80 percent 30, 2012.3 In order to reduce market eligible for the FDIC’s TAG guarantee.9 of all IDIs, continue to participate in the disruption at the conclusion of the DGP The TAG program was originally set TAG program and to benefit from the and to facilitate the orderly phase-out of to expire on December 31, 2009.10 The guarantee provided by the FDIC. These the program, the FDIC’s Board, in March FDIC recognized that the TAG program institutions held an estimated $340 2009, adopted another interim rule that, was contributing significantly to billion of deposits in accounts currently among other things, provided for a improvements in the financial sector, subject to the FDIC’s guarantee as of the limited four-month extension for the but also noted that many parts of the end of 2009. Of these, $266 billion issuance of senior unsecured debt under country were still suffering from the represented amounts above the insured the DGP.4 At the same time, the FDIC effects of economic turmoil. As a result, deposit limit and guaranteed by the extended the expiration of the guarantee on August 26, 2009, following a public FDIC through its TAG program. Among period from June 30, 2012, until notice and comment period,11 the FDIC the current participants in the program, December 31, 2012.5 The DGP issued a final rule that extended the the average TAG account size was about component of the TLGP has served a TAG program through June 30, 2010.12 $1.15 million. About 550 institutions vital role in helping to restore market- The initial TAG extension included relied on TAG accounts to fund 10 based liquidity and confidence in the an increased assessment rate designed percent or more of their assets. In this financial market.6 to offset the potential losses associated challenging banking environment, with the FDIC’s guarantee. Prior to the smaller IDIs have continued to find the 1 See Section 13(c)(4)(G) of the Federal Deposit extension, the fee for participating IDIs TAG program especially beneficial. Insurance Act (FDI Act), 12 U.S.C. 1823(c)(4)(G). was a flat rate of 0.10 percent annually While the immediate financial crisis The determination of systemic risk authorized the on all amounts in eligible TAG accounts that led to the creation of the TLGP in FDIC to take actions to avoid or mitigate serious adverse effects on economic conditions or financial not covered by regular deposit October 2008 has abated, it was stability, and the FDIC implemented the TLGP in insurance. Beginning on January 1, followed by an intensification of the response. 2010, the fee for continued participation recession that began in late 2007 and 2 73 FR 64179 (Oct. 29, 2008). This Interim Rule in the TAG was raised and the basis which continues to pressure local was followed by a Final Rule, published in the Federal Register on November 26, 2008. 73 FR communities across the country. At the 72244 (Nov. 26, 2008). FDIC issued a final rule terminating the DGP as of same time, the financial distress that 3 Id. at 64181–64182. October 31, 2009, and establishing a limited, six- emerged in 2008 has spread from large, month emergency guarantee facility. 74 FR 54743 4 74 FR 12078 (Mar. 23, 2009). This Interim Rule (Oct. 23, 2009). systemically important banks to banks was finalized and a Final Rule was published in the 7 of all sizes, particularly in regions Federal Register on June 3, 2009. 74 FR 26521 (June 73 FR 64182–64183. 3, 2009). 8 73 FR 72244, 72262 (Nov. 26, 2008). 5 74 FR 12078, 12080. 9 Id. 13 Id. 6 On September 16, 2009, the FDIC published for 10 73 FR 64179, 64182 (Oct. 29, 2008). 14 74 FR 45098. comment alternative proposals for winding down 11 74 FR 31217 (June 30, 2009). 15 74 FR 45095. the DGP component of the TLGP. Ultimately, the 12 74 FR 45093 (Sept. 1, 2009). 16 Id.
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suffering from ongoing economic acquirer in the event of a failure, thus and stability in the banking system. The turmoil. increasing the FDIC’s resolution costs. TAG program provides businesses and Since the establishment of the TLGP, By extending the TAG program other large depositors with complete there have been 187 bank and thrift beyond its current program termination assurance that qualifying noninterest- failures, and the number of ‘‘problem’’ date of June 30, 2010, the FDIC seeks to bearing transaction accounts are fully institutions has increased to 702, maintain stability for IDIs and to guaranteed in participating IDIs. This, in representing $403 billion in total assets, promote a continuing and sustainable turn, contributes to a more stable as of year-end 2009. Weaknesses facing economic recovery throughout the operating environment in which community banks have intensified as country. Specifically, the FDIC business activities may continue to the lingering consequences of the 2008 anticipates that its extended guarantee normalize. financial crisis and the recession place of noninterest-bearing transaction Moreover, the FDIC has received continued pressure on earnings and accounts may provide participating support from some industry participants asset quality. In 2009, community banks institutions with a continued stable for extending the program. These experienced an aggregate $104 million funding source. Moreover, recognizing stakeholders have commented that the loss, their first annual loss on record. the gap between funding costs of large TAG program has had a positive and Community banks increased their and small banks,17 the FDIC believes stabilizing effect on the banking provisions for loan and lease losses to that a continuation of its TAG program industry and public confidence; $5.1 billion during the fourth quarter of will help maintain community banks’ terminating the program on June 30, 2009, the highest level on record. The ability to compete for and secure low- 2010, would be premature given the effects of the financial crisis and cost large deposits, thereby preserving delicate state of the nation’s financial recession are expected to persist for deposit franchise value and supporting recovery. They further note that the some time, especially as the magnitude the rebuilding of earnings and capital. TAG program benefits small businesses of economic distress facing local In providing for a six-month by guaranteeing payroll accounts and markets places continued pressure on extension of the TAG program and for increasing the amount of funding asset quality and earnings, with the an additional 12-month extension available to make loans. Community without further rulemaking, if the Board potential for undermining the stability banks are key providers of credit to concludes that such extension is of the banking organizations that serve small businesses, which have warranted, the FDIC endeavors to avoid these markets. historically made significant liquidity failures that may be indirectly Although the condition of IDIs as a contributions to new job growth and the precipitated by deposit migrations overall strengthening of the economy. whole has deteriorated since the potentially caused by letting the TAG establishment of the TLGP, the TAG Thus, community bankers argue that program expire on June 30, 2010. In extending the TAG program would program has lessened some of their most cases, liquidity failures are more distress by enabling them to retain provide them with an important source costly for the FDIC to resolve as there is of liquidity necessary to continue longstanding customer transaction little time to market the institution. This relationships, such as payroll accounts providing credit to small businesses and leads to fewer and less informed bidders creditworthy borrowers. from municipalities and small who will reduce the value of their businesses. These deposits have proposals to compensate for the III. Authority To Extend TAG Program significantly improved the funding uncertainty in the transaction. Bidders The amendment to the TAG provided situation of IDIs and allowed them to are more reluctant to enter into continue making investments in the under the Interim Rule is based on the transactions that transfer high-risk authority for the establishment of the communities they serve. Over 70 assets without having the time to percent of industry assets were funded TLGP, including the determination of conduct due diligence; this will result systemic risk made in October 2008, by deposits as of fourth quarter 2009, up in more assets being retained by the from 65 percent a year ago. This pursuant to section 13(c)(4)(G) of the FDIC, as receiver for failed IDIs. In FDI Act.18 A systemic risk increased reliance on deposit funding addition, the loss of large balance highlights the importance of the TAG determination authorizes the FDIC to transaction accounts that may leave the not only take actions necessary at that program. IDIs in the absence of the TAG program Based on these economic factors, the time to avoid or mitigate serious adverse extension will reduce franchise values effects on economic conditions or FDIC has concluded that allowing the and make it more difficult for all- TAG to expire on June 30, 2010, could financial stability, but also to continue deposit resolution transactions to satisfy to take such action as necessary in the negatively affect the banking system at the least cost test. Finally, the a time when many IDIs continue to future where the economic conditions diminution of deposit franchises may and threats to financial stability that experience stressful economic and lead to more deposit payouts, which are financial conditions. The FDIC is first gave rise to the determination expensive and consume large amounts persist or have shifted to adversely concerned that allowing the TAG of FDIC resources. For these reasons, program to expire in the current affect other sections of the banking extending the TAG is mission-critical industry.19 The extension of the TAG environment could cause a number of for the FDIC, as steward of the DIF. community banks to experience deposit component of the TLGP provided for in As the effects of the financial crisis this Interim Rule represents a withdrawals from their large transaction and the recession continue to unfold, accounts and risk needless liquidity continuation of the previously the FDIC remains committed to its authorized action by the FDIC to failures. To the extent IDIs are able to primary goal of promoting confidence replace these deposits with brokered mitigate the continuing adverse effects, discussed in the preceding section, from deposits or secured borrowings, their 17 At year-end 2007, the average cost of interest- the financial crisis and the recession by overall liquidity risk profile would bearing domestic deposits at banks with over $100 increase going forward. However, the billion in total assets was 35 basis points lower than at banks with under $1 billion in total assts. At the 18 12 U.S.C. 1823(c)(4)(G). loss of longstanding large depositor end of the second quarter 2008, this difference 19 See id.; see also Senior Unsecured Creditors’ relationships would negatively affect increased to 64 basis points. By year-end 2009, the Comm. of First Republic Bank Corp. v. F.D.I.C., 749 IDIs’ deposit franchise values to an spread was 107 basis points. F. Supp. 758, 768 (N.D. Tex. 1990).
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providing additional stable funding for accounts that are subject to the FDIC’s made by typical business customers. IDIs. guarantee. Currently, the TAG total amounts and This Interim Rule provides that the accounts are reported on the IDI’s IV. The Interim Rule Board may determine that an additional Report of Condition or Thrift Report. A. Extension of the TAG Program for extension of the TAG through December In order to monitor and assess fees Participating IDIs 31, 2011, may be warranted without based upon the ongoing risk exposure of further rulemaking. FDIC estimates for the DIF, the Interim Rule provides that The TAG program currently expires this period assume some improvement IDIs that do not opt out of the TAG on June 30, 2010. This Interim Rule in the outlook for the banking industry program under the mechanism extends the termination of the TAG and consequently indicate that described in Paragraph E, below, will be program for six months, through projected revenues could cover, and required to report their TAG amounts as December 31, 2010, with the possibility possibly exceed, projected costs without average daily balance amounts. Under of an additional 12-month extension, a change in fee structure. As above, the Interim Rule, beginning with the through December 31, 2011, without FDIC estimates were made using September 30, 2010, report date for the further rulemaking, at the discretion of reasonable assumptions regarding Report of Condition or Thrift Financial the Board upon a finding of a continued participation in the program. Report, the total dollar amount of TAG- continuing need for the TAG program. However, projections beyond six qualifying accounts and the total If the Board determines that an months are always more problematic. number of accounts must be reported as additional 12-month extension of the While the FDIC made reasonable an average daily balance. This will TAG program is warranted, an assumptions regarding the costs that cover the period from July 1 through announcement to that effect will be could be incurred during the 6-month September 30, 2010. The amounts to be made by the FDIC no later than October extension and during a possible reported as daily averages are the total 29, 2010. The FDIC believes that additional 12-month extension, under dollar amount of the noninterest-bearing extending the TAG program will assist more severe, yet plausible, assumptions transactions accounts, as defined in 12 participating IDIs in successfully net losses under the TAG program could CFR 370.2(h), of more than $250,000 for weathering the nation’s continuing be greater. However, the FDIC does not each calendar day during the quarter financial distress and in ensuring a believe that the losses would be so divided by the number of calendar days more sustainable economic recovery. extreme under either extension as to in the quarter. For days that an office of cause the TLGP overall to experience a the reporting institution is closed (e.g., B. No Increased Fee for Continued net loss. In fact, the FDIC believes it is Saturdays, Sundays, or holidays), the Participation in the Extended TAG reasonable to expect that the 6-month amounts outstanding from the previous Program extension provided in this Interim Rule business day would be used. The total Under the current rule, the TAG will result in only a slight loss and that number of accounts to be reported program provides for a tiered-pricing if an additional 12-month extension is should be calculated on the same basis. assessment, ranging from 15 to 25 basis ultimately adopted, the TAG program Documentation supporting the amounts points based on an institution’s deposit for the two extension periods would be used in the calculation of the average insurance assessment risk category. The revenue neutral. Regardless of the daily balance amounts must be retained FDIC believes that maintaining the ultimate duration of the program and and be readily available upon request by current tiered pricing for the TAG even under the most severe loss the FDIC or the IDI’s primary Federal program will enable most participating estimates, the FDIC expects the TLGP regulator. In addition, all IDIs that do IDIs to remain in the program, thereby will remain a profitable program. not opt of the TAG program must providing a greater positive stimulus to Accordingly, the Interim Rule does not establish procedures to gather the the nation’s economic recovery. The increase the current tiered-assessment necessary daily data beginning July 1, FDIC believes that increasing the structure. 2010. To prevent unanticipated risks to the As indicated previously, the dollar assessment for participating IDIs at this DIF, the FDIC reminds participating IDIs amounts of TAG-related accounts are time would frustrate the overall goal of to exercise prudent marketing of TAG sizeable, and many institutions rely the extension of the TAG program and accounts that qualify for the FDIC’s significantly on these accounts as a could further pressure the liquidity guarantee and to continue to exercise funding source. However, the FDIC posture of participating IDIs. risk-management principles applicable notes that these balances are often held Although costs from the TAG program to an IDI’s existing business plan. in a relatively small number of will have exceeded revenues collected Because of the temporary nature of the individual accounts. The FDIC further under the program through June 30, TAG program, participating IDIs should notes that certain institutions with total 2010, no increase in fees is being not use the extension period to assets of more than $1 billion, all de proposed for the extension of the TAG aggressively market or grow their TAG- novo IDIs, and some other IDIs already program under this Interim Rule. The related accounts. report their regular deposit insurance FDIC estimates that projected revenues assessment balances based on an from assessments under a six-month C. Change in Basis for Reporting for average daily balance basis and extension in the TAG program could Assessment Purposes currently have in place the systems to cover projected costs for the duration of Participating IDIs currently report the report their TAG-qualifying account the extension, but will more likely show total dollar amount and the total balances on an average daily basis. All a small loss under reasonable number of TAG-qualifying noninterest- other institutions report their deposit assumptions regarding continued bearing transaction accounts as of the insurance assessment base on a quarter- participation in the program. In making end of the calendar quarter. By the very end basis. However, of those institutions our estimates, the FDIC expects that nature of these transaction accounts, the that use quarter-end reporting, fewer some IDIs will opt out of the TAG account balances are volatile, than 1,000 institutions report more than program and that participating IDIs will fluctuating greatly on any given day due 25 TAG-qualifying accounts. maintain, but not significantly increase, to the operational nature of the deposits, Given the limited number of these the amount of deposits in transaction such as for payrolls, and withdrawals accounts that would be included in an
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IDI’s average daily balance reporting applicable NOW accounts. Moreover, if whether the institution is participating base and the larger number of IDIs that an IDI offers both TAG-qualifying and in the TAG program.22 If an IDI is currently use average daily balances non-qualifying NOW accounts, participating in the TAG program, the reporting, the FDIC does not believe that appropriate disclosures should be notice must state that funds held in this change in assessment base would provided in order to avoid consumer noninterest-bearing transaction accounts create a significant administrative confusion. at the institution are guaranteed in full burden on IDIs that do not currently by the FDIC. Although existing employ average daily balance reporting. E. Opportunity To Opt Out of the regulations do not require specific Extended TAG Program language to appear in disclosures D. Treatment of NOW Accounts The Interim Rule imposes certain regarding the TAG program, the notices Currently, the TAG program provides regulatory modifications to the existing must be provided in simple, readily for an FDIC guarantee of NOW accounts TAG program. Some IDIs currently understandable text. with interest rates no higher than 0.50 participating in the TAG may feel that Disclosure Requirements for IDIs percent at participating IDIs that have their existing financial condition or Participating in the Extended TAG committed to maintain that rate for the future business plans would be best Program duration of the program. At the served by discontinuing their inception of the TAG program, 0.50 involvement in the TAG program. For Under the Interim Rule, participating percent was viewed as a low rate of these reasons, the Interim Rule provides IDIs that do not opt out of the extended interest and, as such, a NOW account IDIs currently participating in the TAG TAG program will be required to amend paying no more than this rate would be program with a one-time, irrevocable these disclosures on or before May 20, substantially similar to a noninterest opportunity to opt out of this TAG 2010. The Interim Rule requires IDIs bearing transaction account. Under the extension. A participating IDI’s decision that choose to remain in the TAG November 2008 Final Rule for the to remain in the extended TAG program program to update their disclosures to TLGP, these accounts were included in obligates it to remain in the program reference December 31, 2010, as the the TAG program to provide stability to through December 31, 2010, or for an termination date for this extension of payment processing accounts structured additional 12 months if the Board the TAG program. Further disclosures as NOW accounts, without creating the further extends the TAG program. An may be required if the Board determines risk of destabilizing money market IDI that wishes to opt out of the TAG that the TAG program should be mutual finds or allowing weaker extension must provide the FDIC with extended through December 31, 2011. institutions to attract deposits in these notice of its intent to opt out by April Disclosure Requirements for IDIs Opting ownership categories through offering 30, 2010 by submitting an e-mail with Out of the Extended TAG Program higher interest rates. the subject line ‘‘TLGP Election Form On or before May 20, 2010, However, the prevailing nationwide Opt Out Requested—Cert No. XXXXX’’ participating IDIs that opt out of the average rates for regular interest-bearing to [email protected]. The e-mail must extended TAG program will be required checking accounts now range from 0.12 include the following information: name to update their disclosures to inform percent to 0.16 percent for most of the IDI; FDIC certificate number; city, accounts, and from 0.26 percent to 0.29 customers and depositors that, state, and zip code for the IDI; contact beginning on July 1, 2010, they will no percent for premium interest bearing name and contact information accounts held by municipalities, school longer participate in the TAG program (telephone number and e-mail address); and the deposits in noninterest-bearing districts, and other typical large a concise statement that the IDI would transaction account holders.20 In order transaction accounts will no longer be like to opt out of the TAG program guaranteed in full by the FDIC. to align NOW accounts covered by the effective July 1, 2010; and confirmation TAG program with current market rates that, no later than May 20, 2010, the IDI V. Request for Comments and to ensure the program is not used will post a notice in the lobby of its inappropriately by institutions to attract The FDIC requests comments on all main office, each domestic branch, and aspects of the Interim Rule and solicits interest-rate-sensitive deposits to fund if it offers Internet deposit services, on risk activities, the Interim Rule reduces suggestions regarding its its website, clearly indicating that funds implementation, especially as to the the interest rate on NOW accounts held in noninterest-bearing transaction eligible for the FDIC’s guarantee from a change in reporting basis for assessment accounts that are in excess of the purposes. maximum of 0.50 percent to a maximum standard maximum deposit insurance of 0.25 percent. The Interim Rule also amount will not be guaranteed under VI. Regulatory Analysis and Procedure requires participating IDIs to commit to the TAG program after June 30, 2010. A. Regulatory Flexibility Act maintain the interest rate at or below Once this information has been The process of amending part 370 by 0.25 percent after June 30, 2010, and received and processed, FDIC staff will through December 31, 2010, or means of this Interim Rule is governed contact the IDI to confirm the IDI’s opt by the Administrative Procedure Act December 31, 2011, if the Board further out decision. extends the TAG program. (APA). Pursuant to section 553(b)(B) of The Interim Rule does not prescribe F. Disclosure Requirements the APA, general notice and opportunity specific disclosures related to NOW for public comment are not required Current Disclosure Requirements accounts. Participating IDIs are with respect to a rule making when an reminded, however, that contractual Regulations governing the existing agency for good cause finds that ‘‘notice terms governing individual deposit TAG program contain certain disclosure and public procedure thereon are accounts, as well as provisions of the requirements. Among other things, each impracticable, unnecessary, or contrary Truth in Savings Act,21 may require IDI that offers noninterest-bearing to the public interest.’’ Similarly, section disclosures to consumers regarding transaction accounts is required to post 553(d)(3) of the APA provides that the modifications of interest rates on a prominent notice in the lobby of its publication of a rule shall be made not main office, in each domestic branch less than 30 days before its effective 20 FDIC analysis of data provided by RateWatch. and, if it offers Internet deposit services, 21 12 U.S.C. 4301, et seq. on its Web site clearly indicating 22 12 CFR 370.5(h)(5).
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date, except ‘‘* * * (3) as otherwise immediate effective date for the Interim Pursuant to sections 370.5(c)(3) and provided by the agency for good cause Rule. (g)(3) of the Interim Rule, institutions found and published with the rule.’’ that do not wish to participate in the C. Small Business Regulatory Consistent with section 553(b)(B) of program extension must request Enforcement Fairness Act the APA, the FDIC finds that good cause authorization by April 30, 2010, to opt exists for a finding that general notice The Office of Management and Budget out of the TAG Program, effective July and opportunity for public comment are (OMB) has yet to issue its determination 1, 2010. The FDIC estimates that impracticable and contrary to the public as to whether the Interim Rule is a approximately one-third of current interest. The TLGP was announced by ‘‘major rule’’ within the meaning of the participants will elect to opt-out of the the FDIC on October 14, 2008, as an relevant sections of the Small Business extension. In addition, section initiative to counter the system-wide Regulatory Enforcement Act of 1996 370.5(h)(5) requires continuing program crisis in the nation’s financial sector, (SBREFA), 5 U.S.C. 801 et seq. However, participants to update notices posted in and involved a determination of a previous rule extending the TAG the lobby of their main offices and systemic risk by the Secretary of the Program was determined by OMB to be domestic branches and, if applicable, on Treasury after consultation with the ‘‘not major’’ and the FDIC believes that their Web sites, to reflect the new TAG President. The systemic risk this Interim Rule is also ‘‘not major.’’ As expiration date. The FDIC estimates that determination allowed the FDIC to take required by SBREFA, the FDIC will file approximately two-thirds of current certain actions to avoid or mitigate the appropriate reports with Congress participants will be required to update serious adverse effects on economic and the Government Accountability their disclosures to reflect a new conditions and financial stability. The Office as soon as it receives a termination date for the TAG program. purpose of the TLGP is to promote determination from OMB. Nevertheless, In the event the FDIC exercises the financial stability by preserving as discussed above, consistent with option to extend the program for an confidence in the banking system and section 553(b)(B) of the APA, the FDIC additional 12 months without further facilitating the flow of liquidity to has determined for good cause that rulemaking, it estimates that the same creditworthy businesses and consumers, general notice and opportunity for number of participants may need to favorably affecting both the availability public comment would be impracticable update their disclosures a second time. and cost of credit. Immediate issuance and contrary to the public interest. Any further adjustments to burden of this Interim Rule furthers the public Therefore, in accordance with 5 U.S.C. estimates required by a decision to interest by extending the time period of 808(2), this Interim Rule will take effect extend the program for an additional 12 the TAG program to promote continued upon publication in the Federal months will be submitted to OMB at the stability in the banking system through Register. time the extension is announced. guaranteeing large uninsured D. Regulatory Flexibility Act Although Section 370.7(c)(5) requires transaction account balances in order to that a new data element on average The Regulatory Flexibility Act provide participating IDIs with daily balances in noninterest-bearing (Pub. L. No. 96–354, Sept. 19, 1980) continued sources of funding to meet transaction accounts be incorporated (RFA) applies only to rules for which an their liquidity needs. For these same into the Consolidated Report of Income agency publishes a general notice of reasons, the FDIC finds good cause to and Condition (CALL Report) filed by proposed rule making pursuant to 5 publish this Interim Rule with an program extension participants, the 23 U.S.C. 553(b). As discussed above, immediate effective date. reporting requirement will not be consistent with section 553(b)(B) of the Although general notice and implemented until the quarterly report APA, the FDIC has determined for good opportunity for public comment are not filed for the period July 1, 2010, to cause that general notice and required prior to the effective date, the September 30, 2010. This change to the opportunity for public comment would FDIC invites comments on all aspects of CALL Report will be the subject of a be impracticable and contrary to the the Interim Rule, which the FDIC may separate notice under the Paperwork public interest. Therefore, the RFA, revise if necessary or appropriate in Reduction Act. light of the comments received. pursuant to 5 U.S.C. 601(2), does not Therefore, the new estimated burden apply. B. Riegle Community Development and for the Transaction Account Guarantee Regulatory Improvement Act E. Paperwork Reduction Act Program Extension information collection is as follows: The Riegle Community Development In accordance with the Paperwork Title: Temporary Transaction Account and Regulatory Improvement Act Reduction Act of 1995 (44 U.S.C. 3501 Guarantee Program Extension. et seq.), an agency may not conduct or provides that any new regulations or OMB Number: 3064–0166. amendments to regulations prescribed sponsor, and a person is not required to Affected Public: Insured depository by a Federal banking agency that impose respond to, a collection of information institutions. additional reporting, disclosures, or unless it displays a currently valid OMB Estimated Number of Respondents: other new requirements on insured control number. This Interim Rule, by Opt out of TAG program extension/ depository institutions shall take effect extending the termination date for the disclosure—2,113. on the first day of a calendar quarter TAG Program, will change the estimated Updated Disclosures by Participants which begins on or after the date on number of respondents for the reporting to Amend Termination Date—4,227. which the regulations are published in and recordkeeping requirements in an Frequency of Response: final form, unless the agency existing OMB-approved information Opt out of TAG program extension/ determines, for good cause published collection, entitled the ‘‘Transaction disclosure—once. with the rule, that the rule should Account Guarantee Program Extension,’’ Updated Disclosures by Participants become effective before such time.24 For (OMB No. 3064–0170). These burden to Amend Termination Date—once. the same reasons discussed above, the adjustments are being submitted to Average Time per Response: FDIC finds that good cause exists for an OMB as a request for a nonmaterial/ Opt out of TAG program extension/ nonsubstantive change. disclosure—1 hour. 23 5 U.S.C. 553(d)(3). Currently, there are 6,340 institutions Updated Disclosures by Participants 24 12 U.S.C. 4802. participating in the TAG program. to Amend Termination Date—1 hour.
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Estimated New Annual Burden: on how to make this regulation easier to debt guarantee program and the Opt out of TAG program extension/ understand. For example: transaction account guarantee program, disclosure—2,113 hours. • Has the FDIC organized the material (i) An eligible entity that became an Updated Disclosures by Participants to suit your needs? If not, how could eligible entity on or before December 5, to Amend Termination Date—4227 this material be better organized? 2008 and that has not opted out, or hours. • Are the requirements in the (ii) An entity that becomes an eligible Current Annual Burden—7,109 hours. regulation clearly stated? If not, how entity after December 5, 2008, and that Total New Burden—6,340 hours. could the regulation be more clearly the FDIC has allowed to participate in Total Adjusted Annual Burden— stated? the program, except. 13,449 hours. • Does the regulation contain (2) A participating entity that opted The FDIC has a continuing interest in language or jargon that is not clear? If out of the transaction account guarantee public feedback on its information so, which language requires program in accordance with collections and paperwork burden clarification? § 370.5(c)(2) ceased to be a participating estimates. Accordingly, public comment • Would a different format (grouping entity in the transaction account is invited on: (1) Whether this collection and order of sections, use of headings, guarantee program effective on January of information is necessary for the paragraphing) make the regulation 1, 2010. proper performance of the FDIC’s easier to understand? If so, what (3) A participating entity that opts out functions, including whether the changes to the format would make the of the transaction account guarantee information has practical utility; (2) the regulation easier to understand? program in accordance with • accuracy of the estimates of the burden What else could the FDIC do to § 370.5(c)(23) ceases to be a of the information collection, including make the regulation easier to participating entity in the transaction the validity of the methodologies and understand? account guarantee program effective on assumptions used; (3) ways to enhance July 1, 2010. the quality, utility, and clarity of the G. The Treasury and General information to be collected; and (4) Government Appropriations Act, 1999— * * * * * ways to minimize the burden of the Assessment of Federal Regulations and (h) *** information collection on respondents, Policies on Families (3) Notwithstanding paragraphs (h)(1) including through the use of automated The FDIC has determined that the and (h)(2) of this section, for purposes collection techniques or other forms of interim rule will not affect family well- of the transaction account guarantee information technology. Interested being within the measure of section 654 program, a noninterest-bearing parties are invited to submit written of the Treasury and General transaction account includes: comments on the estimated burden for Government Appropriations Act, (i) Accounts commonly known as information collections associated with enacted as part of the Omnibus Interest on Lawyers Trust Accounts the TAG program extension by any of Consolidated and Emergency (IOLTAs) (or functionally equivalent the following methods: Supplemental Appropriations Act of accounts); and • http://www.FDIC.gov/regulations/ 1999 (Pub. L. 105–277, 112 Stat. 2681). (ii) Negotiable order of withdrawal laws/federalpropose.html. accounts (NOW accounts) with interest • E-mail: [email protected]. List of Subjects in 12 CFR Part 370 rates: Include the name and number of the Banks, Banking, Bank deposit (A) No higher than 0.50 percent collection in the subject line of the insurance, Holding companies, National through June 30, 2010, if the insured message. banks, Reporting and recordkeeping depository institution at which the • Mail: Leneta Gregorie (202–898– requirements, Savings associations. account is held has committed to 3719), Counsel, Federal Deposit ■ For the reasons discussed in the maintain the interest rate at or below Insurance Corporation, 550 17th Street, preamble, the Federal Deposit Insurance 0.50 percent. through June 30, 2010; and NW., Washington, DC 20429. Corporation amends part 370 of chapter (B) No higher than 0.25 percent after • Hand Delivery: Comments may be III of Title 12 of the Code of Federal June 30, 2010, if the insured depository hand-delivered to the guard station at Regulations as follows: institution at which the account is held the rear of the 550 17th Street Building has committed to maintain the interest (located on F Street), on business days PART 370—TEMPORARY LIQUIDITY rate at or below 0.25 percent after June between 7 a.m. and 5 p.m. GUARANTEE PROGRAM 30, 2010 through the TAG expiration A copy of the comment may also be date. ■ submitted to the OMB Desk Officer for 1. The authority citation for part 370 (4) Notwithstanding paragraph (h)(3) the FDIC, Office of Information and continues to read as follows: of this section, a NOW account with an Regulatory Affairs, Office of Authority: 12 U.S.C. 1813(l), 1813(m), interest rate above 0.50 percent as of Management and Budget, New 1817(i), 1818, 1819(a)(Tenth), 1820(f), November 21, 2008, may be treated as Executive Office Building, Room 3208, 1821(a), 1821(c), 1821(d), 1823(c)(4). a noninterest-bearing transaction Washington, DC 20503. All comments ■ 2. Amend § 370.2 as follows: account for purposes of this part: should refer to the name and number of ■ a. Revise paragraph (g), (i) Through June 30, 2010, if the the collection. ■ b. Revise paragraphs (h)(3) and (h)(4), insured depository institution at which the account is held reduced the interest F. Solicitation of Comments on Use of and ■ rate on that account to 0.50 percent or Plain Language c. Add paragraph (o), to read as follows: lower before January 1, 2009, and Section 722 of the Gramm-Leach- committed to maintain that interest rate Bliley Act, Public Law 106–102, 113 § 370.2 Definitions. at no more than 0.50 percent through Stat. 1338, 1471 (Nov. 12, 1999), * * * * * June 30, 2010; and requires the federal banking agencies to (g) Participating entity. (1) Except as (ii) After June 30, 2010 through the use plain language in all proposed and provided in paragraphs (g)(2) and (g)(3) TAG expiration date, if the insured final rules published after January 1, of this section, the term ‘‘participating depository institution at which the 2000. The FDIC invites your comments entity’’ means with respect to each of the account is held reduces the interest rate
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on that account to 0.25 percent or lower (3) Any insured depository institution its Web site clearly indicating whether before July 1, 2010, and commits to that is participating in the transaction the institution is participating in the maintain that interest rate at no more account guarantee program may request transaction account guarantee program. than 0.25 percent through the TAG authorization to opt out of such program If the institution is participating in the expiration date. effective on July 1, 2010. Any such transaction account guarantee program, * * * * * election to opt-out must be made in the notice must state that funds held in (o) TAG expiration date. The term accordance with the procedures set noninterest-bearing transactions ‘‘TAG expiration date’’ means December forth in paragraph (g)(3) of this section. accounts at the entity are guaranteed in 31, 2010 unless the Board of Directors If the FDIC grants the request, the opt full by the FDIC. Participating entities of the FDIC (the ‘‘Board’’), for good out is irrevocable. must update their disclosures to reflect cause, extends the transaction account * * * * * the current TAG expiration date, guarantee program for an additional (g) * * * including any extension pursuant to year in which case the term ‘‘TAG (1) Except as provided in paragraphs § 370.2(o) or, if applicable, any decision expiration date’’ means December 31, (g)(2) and (g)(3) of this section, the FDIC to opt-out. 2011. Good cause exists if the Board will provide procedures for opting out (i) These disclosures must be finds that the economic conditions and and for making an affirmative decision provided in simple, readily circumstances that led to the to opt in using FDIC’s secure e-business understandable text. Sample disclosures establishment of the transaction account Web site, FDICconnect. Entities that are are as follows: guarantee program are likely to continue not insured depository institutions will For Participating Institutions beyond December 31, 2010 and that select and solely use an affiliated [Institution Name] is participating in extending the transaction account insured depository institution to submit the FDIC’s Transaction Account guarantee program for an additional their opt-out election or their affirmative Guarantee Program. Under that year will help mitigate or resolve those decision to opt in. program, through [June 30, 2010, conditions and circumstances. If the * * * * * December 31, 2010, or December 31, Board decides to extend the transaction (3) Pursuant to paragraph (c)(3) of this 2011, whichever is applicable], all account guarantee program to December section a participating entity may noninterest-bearing transaction 31, 2011, it will do so without further request authorization to opt out of the accounts are fully guaranteed by the rulemaking; however, the FDIC will transaction account guarantee program FDIC for the entire amount in the publish notice of any extension no later effective on July 1, 2010 by submitting account. than October 29, 2010. to the FDIC on or before 11:59 p.m., Coverage under the Transaction ■ 3. Amend § 370.4 by revising Eastern Daylight Saving Time, on April Account Guarantee Program is in paragraph (a) to read as follows: 30, 2010 an e-mail conveying the addition to and separate from the entity’s request to opt out. The subject § 370.4 Transaction Account Guarantee coverage available under the FDIC’s line of the e-mail must include: ‘‘TLGP general deposit insurance rules. Program. Request to Opt Out—Cert. No. (a) In addition to the coverage lllll.’’ The e-mail must be For Participating Institutions That Elect afforded to depositors under 12 CFR addressed to [email protected] and must to Opt-out of the Extended Transaction Part 330, a depositor’s funds in a include the following: Account Guaranty Program Effective on noninterest-bearing transaction account (i) Institution Name; July 1, 2010 maintained at a participating entity that (ii) FDIC Certificate number; Beginning July 1, 2010 [Institution is an insured depository institution are (iii) City, State, ZIP; Name] will no longer participate in the guaranteed in full (irrespective of the (iv) Name, Telephone Number and FDIC’s Transaction Account Guarantee standard maximum deposit insurance Email Address of a Contact Person; Program. Thus, after June 30, 2010, amount defined in 12 CFR 330.1(n)) (v) A statement that the institution is funds held in noninterest-bearing from October 14, 2008 through: requesting authorization to opt out of transaction accounts will no longer be (1) The date of opt-out, in the case of the transaction account guarantee guaranteed in full under the an entity that opted out prior to program effective July 1, 2010; and Transaction Account Guarantee December 5, 2008; (vi) Confirmation that no later than Program, but will be insured up to (2) December 31, 2009, in the case of May 20, 2010 the institution will post a $250,000 under the FDIC’s general an entity that opted out effective on prominent notice in the lobby of its deposit insurance rules. January 1, 2010; or main office and each domestic branch (3) June 30, 2010, in the case of an and, if it offers Internet deposit services, For Non-Participating Institutions entity that opts out of the transaction on its Web site clearly indicating that [Institution Name] has chosen not to account guarantee program effective on after June 30, 2010, funds held in participate in the FDIC’s Transaction July 1, 2010; or noninterest-bearing transaction accounts Account Guarantee Program. Customers (4) The TAG expiration date, in the will no longer be guaranteed in full of [Institution Name] with noninterest- case of an entity that does not opt out. under the Transaction Account bearing transaction accounts will * * * * * Guarantee Program, but will be insured continue to be insured for up to ■ 4. Amend § 370.5 as follows: up to $250,000 under the FDIC’s general $250,000 under the FDIC’s general ■ a. Add paragraph (c)(3), deposit insurance rules. deposit insurance rules. ■ b. Revise paragraph (g)(1), * * * * * (ii) If the institution uses sweep ■ c. Add paragraph (g)(3), and (h) * * * arrangements or takes other actions that ■ d. Revise paragraph (h)(5), to read as (5) Each insured depository result in funds being transferred or follows: institution that offers noninterest- reclassified to an account that is not bearing transaction accounts must post guaranteed under the transaction § 370.5 Participation. a prominent notice in the lobby of its account guarantee program, for * * * * * main office, each domestic branch and, example, an interest-bearing account, (c) * * * if it offers Internet deposit services, on the institution must disclose those
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actions to the affected customers and amount of the fee for each such entity Federal Deposit Insurance Corporation. clearly advise them, in writing, that is equal to the annualized, TAG Robert E. Feldman, such actions will void the FDIC’s assessment rate for the entity multiplied Executive Secretary. guarantee with respect to the swept, by the aggregate amount of the deposits [FR Doc. 2010–8911 Filed 4–16–10; 8:45 am] transferred, or reclassified funds. held in noninterest-bearing transaction BILLING CODE 6714–01–P * * * * * accounts (as defined in § 370.2(h) and ■ 5. Amend § 370.7 by revising including any amounts swept from a paragraphs (b) and (c) to read as follows: noninterest-bearing transaction account DEPARTMENT OF TRANSPORTATION into an noninterest-bearing savings § 370.7 Assessment for the Transaction deposit account as provided in Federal Aviation Administration Account Guarantee program. § 370.4(c)) that exceed the existing * * * * * deposit insurance limit of $250,000, 14 CFR Part 39 (b) Initiation of assessments. calculated based upon the average daily [Docket No. FAA–2009–0329; Directorate Beginning on November 13, 2008 each balances in such accounts as reported eligible entity that does not opt out of Identifier 2009–CE–020–AD; Amendment on the entity’s most recent quarterly the transaction account guarantee 39–16264; AD 2009–08–05 R1] Call Report. program on or before December 5, 2008 RIN 2120–AA64 will be required to pay the FDIC (4) The annualized TAG assessment assessments on all deposit amounts in rates are as follows: Airworthiness Directives; Liberty noninterest-bearing transaction accounts (i) 15 basis points, for the portion of Aerospace Incorporated Model XL–2 calculated in accordance with paragraph each quarter in which the entity is Airplanes (c) of this section. assigned to Risk Category I; AGENCY: Federal Aviation (c) Amount of assessment. (1) Except as provided in paragraphs (ii) 20 basis points, for the portion of Administration (FAA), Department of (c)(2) and (c)(3) of this section any each quarter in which the entity is Transportation (DOT). eligible entity that does not opt out of assigned to Risk Category II; and ACTION: Final rule. the transaction account guarantee (iii) 25 basis points, for the portion of SUMMARY: We are correcting the address, program shall pay quarterly an each quarter in which the entity is telephone, and fax information for the annualized 10 basis point assessment on assigned to either Risk Category III or reporting requirement in Airworthiness any deposit amounts exceeding the Risk Category IV. Directive (AD) 2009–08–05, which existing deposit insurance limit of (5) The amount to be reported for each applies to certain Liberty Aerospace $250,000, as reported on its quarterly noninterest-bearing transaction account Incorporated Model XL–2 airplanes. AD Consolidated Reports of Condition and as the average daily balance is the total 2009–08–05 currently requires Income, Thrift Financial Report, or dollar amount held in such account that repetitively inspecting the exhaust Report of Assets and Liabilities of U.S. exceeds $250,000 for each calendar day muffler for cracks, replacing the exhaust Branches and Agencies of Foreign Banks muffler when cracks are found, and (each, a ‘‘Call Report’’) in any during the quarter divided by the reporting the results of the inspections noninterest-bearing transaction accounts number of calendar days in the quarter. to the FAA. Since AD 2009–08–05 (as defined in § 370.2(h)), including any For those days that an office of the became effective, the FAA’s Atlanta such amounts swept from a noninterest- reporting institution is closed (e.g., Aircraft Certification Office (ACO) bearing transaction account into an Saturdays, Sundays, or holidays), the moved, which has caused the office noninterest-bearing savings deposit amounts outstanding from the previous personnel problems in receiving fax and account as provided in § 370.4(c). business day should be used. The total (2) For the period after December 31, number of accounts to be reported mailed copies of the inspection result 2009 through and including June 30, should be calculated on the same basis. reports. This document corrects the 2010, each participating entity that does Documentation supporting the amounts mailing address, telephone number, and not opt out of the transaction account used in the calculation of the average fax information of the Atlanta ACO. guarantee program in accordance with daily balance amounts must be retained DATES: This final rule is effective April § 370.5(c)(2) shall pay quarterly a fee and be readily available upon request by 19, 2010. The compliance date of this based upon its Risk Category rating. The the FDIC or the institution’s primary AD is April 20, 2009, which is the same amount of the fee for each such entity Federal regulator. In addition, all as the effective date of AD 2009–08–05. is equal to the annualized, TAG institutions that do not opt of the As of April 20, 2009 (74 FR 16117, assessment rate for the entity multiplied transaction account guarantee program April 9, 2009), the Director of the by the amount of the deposits held in must establish procedures to gather the Federal Register approved the noninterest-bearing transaction accounts necessary daily data beginning July 1, incorporation by reference of Liberty (as defined in § 370.2(h) and including 2010. Aerospace, Inc. Service Document Critical Service Bulletin (CSB) CSB–09– any amounts swept from a noninterest- (6) An entity’s Risk Category is bearing transaction account into an 001, Revision Level B, Revised on determined in accordance with the March 18, 2009. noninterest-bearing savings deposit FDIC’s risk-based premium system ADDRESSES: You may examine the AD account as provided in § 370.4(c)) that described in 12 CFR part 327. The docket on the Internet at http:// exceed the existing deposit insurance assessments provided in this paragraph www.regulations.gov or in person at limit of $250,000, as reported on the (c) shall be in addition to an Document Management Facility, U.S. entity’s most recent quarterly Call institution’s risk-based assessment Department of Transportation, Docket Report. imposed under Part 327. (3) Beginning on July 1, 2010, each Operations, M–30, West Building participating entity that does not opt out * * * * * Ground Floor, Room W12–140, 1200 of the transaction account guarantee By order of the Board of Directors. New Jersey Avenue, SE., Washington, program shall pay quarterly a fee based Dated at Washington, DC, this 13th day of DC 20590. upon its Risk Category rating. The April, 2010. FOR FURTHER INFORMATION CONTACT:
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—Corey Spiegel, Aerospace Engineer, revising the AD to incorporate the § 39.13 [Amended] Atlanta Aircraft Certification Office, language discussed above and to add the ■ 2. The FAA amends § 39.13 by 1701 Columbia Avenue, College Park, amendment to section 39.13 of the removing Airworthiness Directive (AD) Georgia 30337; telephone: (404) 474– Federal Aviation Regulations (14 CFR 2009–08–05, Amendment 39–15878 (74 5574; facsimile: (404) 474–5606; 39.13). FR 16117, April 9, 2009), and adding e-mail: [email protected]; or Since this action only corrects the the following new AD: —Cindy Lorenzen, Aerospace Engineer, address, telephone number, and fax Atlanta Aircraft Certification Office, 2009–08–05 R1 Liberty Aerospace 1701 Columbia Avenue, College Park, information for the reporting Incorporated: Amendment 39–16264; requirement and does not require any Docket No. FAA–2009–0329; Directorate Georgia 30337; telephone: (404) 474– Identifier 2009–CE–020–AD. 5524; facsimile: (404) 474–5606; additional actions over that originally e-mail: [email protected]. required by AD 2009–08–05, it has no Effective Date adverse economic impact and imposes SUPPLEMENTARY INFORMATION: (a) This final rule is effective April 19, no additional burden on any person 2010. The compliance date of this AD is Discussion than was already required. Therefore, April 20, 2009, which is the same as the On April 3, 2009, we issued AD 2009– the FAA has determined that prior effective date of AD 2009–08–05. 08–05, Amendment 39–15878 (74 FR notice and opportunity for public Affected ADs comment are unnecessary. 16117, April 9, 2009), to require (b) This AD revises AD 2009–08–05. repetitively inspecting the exhaust List of Subjects in 14 CFR Part 39 muffler for cracks, replacing the exhaust Applicability muffler when cracks are found, and Air transportation, Aircraft, Aviation (c) This AD applies to Model XL–2 reporting the results of the inspections safety, Incorporation by reference, airplanes, serial numbers 0007, 0009, and to the FAA. Safety. subsequent, that are certificated in any Since AD 2009–08–05 became category. effective, the FAA’s Atlanta Aircraft Adoption of the Amendment Unsafe Condition Certification Office (ACO) moved, ■ Accordingly, under the authority (d) This AD is the result of reports that which has caused the office personnel eight cracks have been found in the exhaust problems in receiving fax and mailed delegated to me by the Administrator, muffler during maintenance and service copies of the inspection result reports. the FAA amends 14 CFR part 39 as inspections. We are issuing this AD to detect Consequently, the FAA sees a need to follows: and correct cracks in the exhaust muffler, correct the mailing address, telephone which could result in carbon monoxide number, and fax information of the PART 39—AIRWORTHINESS entering the cabin heating system. This Atlanta ACO in AD 2009–08–05 to DIRECTIVES condition could lead to incapacitation of the pilot. assure that the inspection results are ■ received and reviewed to help assure 1. The authority citation for part 39 Compliance continues to read as follows: the continued operational safety of the (e) To address this problem, you must do affected airplanes. Thus, the FAA is Authority: 49 U.S.C. 106(g), 40113, 44701. the following, unless already done:
Actions Compliance Procedures
(1) Inspect the following: Initially inspect within the next 10 hours time- Follow Liberty Aerospace, Inc. Service Docu- (i) The exhaust muffler for cracks. There in-service (TIS) after April 20, 2009 (the ef- ment Critical Service Bulletin (CSB) CSB– are two different exhaust systems avail- fective date of AD 2009–08–05) or at the 09–001, Revision Level B, Revised on able for the affected airplanes. They are: next annual inspection, whichever occurs March 18, 2009. (A) Standard exhaust system, part first. Repetitively inspect the exhaust muf- number (P/N) DEL200201–002 that fler thereafter as specified in paragraph incorporates muffler P/N (e)(5) of this AD. DEL200201–101; and (B) Reduced sound exhaust system, P/N DEL200201–003 that incor- porates muffler P/N 200201–104. (ii) The tail pipe and the tail pipe opening in the lower cowl for a 0.5-inch minimum clearance. (iii) Inspect the propeller for proper pro- peller clocking position. (2) As a result of the inspections required in Before further flight after the inspection re- As specified in Liberty Aerospace, Inc. Serv- paragraphs (e)(1)(ii) and (e)(1)(iii) of this AD: quired in paragraph (e)(1) of this AD. ice Document Critical Service Bulletin (i) If the clearance between the tail pipe (CSB) CSB–09–001, Revision Level B, Re- and the tail pipe opening is less than the vised on March 18, 2009. required 0.5-inch minimum, trim the lower cowl as needed to achieve the minimum clearance. (ii) If there is a discrepancy in the propeller clocking position, remove and reinstall the propeller at the correct position.
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Actions Compliance Procedures
(3) As a result of the initial inspection required Before further flight after the initial inspection Follow Liberty Aerospace, Inc. Service Docu- in paragraph (e)(1)(i) of this AD or any repet- required in paragraph (e)(1) of this AD and ment Critical Service Bulletin (CSB) CSB– itive inspection required in paragraph (e)(5) before further flight after any repetitive in- 09–001, Revision Level B, Revised on of this AD, if a crack is found, replace the ex- spection required in paragraph (e)(5) of this March 18, 2009. haust muffler. AD. (i) The manufacturer will provide the re- placement exhaust system. (ii) A reduced sound exhaust system may be replaced with a standard exhaust sys- tem. (iii) Installing a reduced sound exhaust sys- tem as a replacement part also requires installing a bypass SCAT tube and a ‘‘Do Not Use’’ placard on or near the heater knob. (4) If the airplane is equipped with a reduced Within the next 10 hours TIS after April 20, Follow Liberty Aerospace, Inc. Service Docu- sound exhaust system and no cracks are 2009 (the effective date of AD 2009–08– ment Critical Service Bulletin (CSB) CSB– found during the initial inspection required in 05). 09–001, Revision Level B, Revised on paragraph (e)(1) of this AD, install a bypass March 18, 2009. SCAT tube and a ‘‘Do Not Use’’ placard on or near the heater knob. (5) If no cracks are found in the exhaust muffler (i) For airplanes equipped with a standard ex- Follow Liberty Aerospace, Inc. Service Docu- during the initial inspection required in para- haust system and the optional bypass ment Critical Service Bulletin (CSB) CSB– graph (e)(1) of this AD or if the exhaust muf- SCAT tube has not been installed, repet- 09–001, Revision Level B, Revised on fler was replaced as required in paragraph itively inspect thereafter every 25 hours TIS March 18, 2009. (e)(3) of this AD, repetitively inspect there- or every 12 months, whichever occurs first. after at the intervals specified in paragraphs (ii) For airplanes equipped with a standard ex- (e)(5)(i), (e)(5)(ii), and (e)(5)(iii) of this AD. haust system and the optional bypass SCAT tube has been installed, repetitively inspect thereafter every 50 hours TIS or every 12 months, whichever occurs first. (iii) For airplanes equipped with a reduced sound exhaust system and the required by- pass SCAT tube has been installed, repet- itively inspect thereafter every 50 hours TIS or every 12 months, whichever occurs first. (6) Report the results of the following inspec- Within 10 days after each inspection required Use the form (Figure 1 of this AD) and submit tions required in this AD to the FAA. by this AD. it to FAA, Atlanta Aircraft Certification Of- (i) Initial inspection required in paragraph fice, 1701 Columbia Avenue, College Park, (e)(1) of this AD. Georgia 30337; fax: (404) 474–5606; e-mail (ii) Repetitive inspections required in para- [email protected]. graph (e)(5) of this AD only if cracks are found. (iii) The Office of Management and Budget (OMB) approved the information collec- tion requirements contained in this regu- lation under the provisions of the Paper- work Reduction Act of 1980 (44 U.S.C. 3501 et seq.) and assigned OMB Control Number 2120–0056.
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AD 2009–08–05 R1 Inspection Report
Airplane Serial Number
Airplane Tach Hours at time of inspection
Propeller type (circle one) MT Sensenich
Propeller Tach Hours at time of inspection
Exhaust Type (circle one) Standard Reduced Sound
Is Exhaust Cracked? (circle one) YES NO
Did lower cowl require trimming at the tail pipe opening? (circle one) YES NO Not applicable after initial inspection
Did the propeller clocking position need to be corrected? (circle one) YES NO Not applicable after initial inspection.
Were any other discrepancies noticed during the inspection?
Name:
Telephone and/or e-mail address:
Date:
Send report to: Corey Spiegel, Aerospace Engineer, Atlanta ACO, 1701 Columbia Avenue, College Park, Georgia 30337; facsimile: (404) 474–5606; e-mail: [email protected].
Figure 1
Special Flight Permit (3) You may review copies of the service DEPARTMENT OF HEALTH AND (f) Under 14 CFR part 39.23, we are information incorporated by reference for HUMAN SERVICES limiting the special flight permits for this AD this AD at the FAA, Central Region, Office of by the following conditions: the Regional Counsel, 901 Locust, Kansas Food and Drug Administration (1) The cabin heat turned off; and City, Missouri 64106. For information on the (2) The fresh air vents are open. availability of this material at the Central 21 CFR Part 522 Alternative Methods of Compliance Region, call (816) 329–3768. [Docket No. FDA–2010–N–0002] (AMOCs) (4) You may also review copies of the service information incorporated by reference (g) The Manager, Atlanta Aircraft Implantation or Injectable Dosage Certification Office (ACO), FAA, has the for this AD at the National Archives and Records Administration (NARA). For Form New Animal Drugs; Change of authority to approve AMOCs for this AD, if Sponsor; Propofol requested using the procedures found in 14 information on the availability of this CFR 39.19. Send information to Attn: Corey material at NARA, call (202) 741–6030, or go AGENCY: Food and Drug Administration, _ Spiegel, Aerospace Engineer, Atlanta ACO, to: http://www.archives.gov/federal register/ HHS. 1701 Columbia Avenue, College Park, code_of_federal_regulations/ ACTION: Final rule. Georgia 30337. Before using any approved ibr_locations.html. AMOC on any airplane to which the AMOC applies, notify your appropriate principal Issued in Kansas City, Missouri, on April SUMMARY: The Food and Drug inspector (PI) in the FAA Flight Standards 7, 2010. Administration (FDA) is amending the District Office (FSDO), or lacking a PI, your Kim Smith, animal drug regulations to reflect a local FSDO. change of sponsor for a new animal drug Manager, Small Airplane Directorate, Aircraft Material Incorporated by Reference Certification Service. application (NADA) from Intervet, Inc., to Teva Animal Health, Inc. (h) You must use Liberty Aerospace, Inc. [FR Doc. 2010–8596 Filed 4–16–10; 8:45 am] DATES: This rule is effective April 19, Service Document Critical Service Bulletin BILLING CODE 4910–13–P (CSB) CSB–09–001, Revision Level B, 2010. Revised on March 18, 2009, to do the actions FOR FURTHER INFORMATION CONTACT: required by this AD, unless the AD specifies otherwise. David R. Newkirk, Center for Veterinary (1) On April 20, 2009 (74 FR 16117, April Medicine (HFV–100), Food and Drug 9, 2009), the Director of the Federal Register Administration, 7500 Standish Pl., previously approved the incorporation by Rockville, MD 20855, 240–276–8307, e- reference of this service information under 5 mail: [email protected]. U.S.C. 552(a) and 1 CFR part 51. SUPPLEMENTARY INFORMATION: Intervet, (2) For service information identified in this AD, contact Liberty Aerospace, 100 Inc., 56 Livingston Ave., Roseland, NJ Aerospace Drive, Melbourne, Florida 32901; 07068, has informed FDA that it has telephone: (321) 752–0332 or (800) 759–5953; transferred ownership of, and all rights fax: (321) 752–0377; Internet: http:// and interest in, approved NADA 141– www.libertyaircraft.com. 070 for RAPINOVET (propofol), an
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injectable anesthetic, to Teva Animal for short procedures; for induction and Broadway, 23rd Floor, Denver, CO Health, Inc., 3915 South 48th Street maintenance of general anesthesia using 80202, telephone number 301–675–1600 Ter., St. Joseph, MO 64503. incremental doses to effect; for (this is not a toll-free number). Hearing- Accordingly, the agency is amending induction of general anesthesia where or speech-impaired individuals may the regulations in 21 CFR 522.2005 to maintenance is provided by inhalant access this number through TTY by reflect the transfer of ownership and a anesthetics. calling the Federal Information Relay current format. (3) Limitations. Federal law restricts Service at 800–877–8339 (this is a toll- This rule does not meet the definition this drug to use by or on the order of free number). of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because a licensed veterinarian. SUPPLEMENTARY INFORMATION: it is a rule of ‘‘particular applicability.’’ Dated: April 13, 2010. Therefore, it is not subject to the I. Background Elizabeth Rettie, congressional review requirements in 5 On October 23, 2009 (74 FR 54886), U.S.C. 801–808. Deputy Director, Office of New Animal Drug HUD published for public comment a Evaluation, Center for Veterinary Medicine. proposed rule to revise the reporting List of Subjects in 21 CFR Part 522 [FR Doc. 2010–8945 Filed 4–16–10; 8:45 am] requirements for the Indian Community Animal drugs. BILLING CODE 4160–01–S Development Block Grant (ICDBG) Therefore, under the Federal Food, program. The purpose of the ICDBG Drug, and Cosmetic Act and under program is the development of viable authority delegated to the Commissioner DEPARTMENT OF HOUSING AND Indian and Alaska Native communities, of Food and Drugs and redelegated to URBAN DEVELOPMENT including the creation of decent the Center for Veterinary Medicine, 21 housing, suitable living environments, CFR part 522 is amended as follows: 24 CFR Part 1003 and economic opportunities primarily [Docket No. FR–5232–F–02] for persons with low and moderate PART 522—IMPLANTATION OR incomes. INJECTABLE DOSAGE FORM NEW RIN 2577–AC79 HUD’s regulations implementing the ANIMAL DRUGS ICDBG program are located at 24 CFR Regulatory Reporting Requirements part 1003 (entitled ‘‘Community ■ 1. The authority citation for 21 CFR for the Indian Community Development Development Block Grants for Indian part 522 continues to read as follows: Block Grant Program Tribes and Alaska Native Villages’’). Authority: 21 U.S.C. 360b. AGENCY: Office of the Assistant Section 1003.506 of the ICDBG program ■ 2. Revise § 522.2005 to read as Secretary for Public and Indian regulations establishes several reporting follows: Housing, HUD. requirements for ICDBG grantees. Specifically, grantees are required to ACTION: Final rule. § 522.2005 Propofol. submit an annual status and evaluation (a) Specifications. Each milliliter of SUMMARY: This final rule revises the report (ASER) on previously funded emulsion contains 10 milligrams (mg) reporting requirements for the Indian open grants 45 days after the end of the propofol. Community Development Block Grants fiscal year (FY) and upon grant closeout (b) Sponsors. See sponsor numbers in (ICDBG) program. First, the rule (§ 1003.506(a)). ICDBG grantees are also § 510.600(c) of this chapter. provides for submission of a single required to report on minority-owned (1) No. 059130 for use as in paragraph annual report on the hiring of minority business enterprises on a semiannual (c) of this section. business enterprises, due each October. basis, with reports being due to HUD on (2) No. 000074 for use as in Currently, ICDBG grantees are required April 10 and October 10 of each year paragraphs (c)(1)(i), (c)(2), and (c)(3) of to report on these activities on a (§ 1003.506(b)). HUD requires this section. semiannual basis, with reports being submission of these semiannual reports (c) Conditions of use in dogs and due to HUD on April 10 and October 10 to evaluate ICDBG grantee compliance cats—(1) Amount. The drug is of each year. Second, this rule requires with the government-wide grant administered by intravenous injection ICDBG grantees to use the Logic Model requirements regarding contracting with as follows: form developed as part of HUD’s Notice minority-owned business enterprises (i) Dogs. For induction of general of Funding Availability (NOFA) process. codified at 24 CFR 85.36(e). HUD anesthesia without the use of The required use of the Logic Model believes that a single report would be preanesthetics the dosage is 5.5 to 7.0 will conform the ICDBG reporting less burdensome for grantees to prepare mg per kilogram (mg/kg) (2.5 to 3.2 mg/ requirements to those of other HUD and would be enough for HUD to pound (lb)); for the maintenance of competitive funding programs, and monitor compliance with the part 85 general anesthesia without the use of enhance the evaluation of grantee minority business enterprise preanesthetics the dosage is 1.1 to 3.3 performance by ensuring uniformity in requirements. Therefore, this final rule, mg/kg (0.5 to 1.5 mg/lb). The use of consistent with the October 23, 2009, the information provided by ICDBG preanesthetic medication reduces proposed rule, revises § 1003.506(b) to grantees on performance goals. This propofol dose requirements. provide for a single annual report to be final rule follows publication of an (ii) Cats. For induction of general due each October 10. anesthesia without the use of October 23, 2009, proposed rule on Each year, HUD publishes NOFAs preanesthetics the dosage is 8.0 to 13.2 which HUD received two public that announce funding availability for mg/kg (3.6 to 6.0 mg/lb). For the comments, both of which were the majority of HUD’s competitive grant maintenance of general anesthesia supportive of the rule. programs, including the ICDBG without the use of preanesthetics the DATES: Effective Date: May 19, 2010. program. The FY 2004 NOFA process dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/ FOR FURTHER INFORMATION CONTACT: introduced a planning form known as lb). The use of preanesthetic medication Deborah Lalancette, Director, Office of the Logic Model (form HUD–96010). reduces propofol dose requirements. Grants Management, Office of Native Most grantees are required to submit a (2) Indications for use. As a single American Programs, Department of Logic Model form that identifies the injection to provide general anesthesia Housing and Urban Development, 1670 problem or need the grant will address,
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the services or activities to be provided uniformity of information provided by Environmental Impact with grant funding, and the reporting grantees on performance goals. tools that will be used to measure This final rule does not direct, III. Findings and Certifications results achieved. Indian tribes have not provide for assistance or loan and been required to use the Logic Model Paperwork Reduction Act mortgage insurance for, or otherwise form. Nevertheless, several ICDBG govern or regulate real property grantees have chosen to use the Logic The information collection acquisition, disposition, leasing, Model. requirements contained in this final rule rehabilitation, alteration, demolition, or This exemption for Indian tribes was have been submitted to the Office of new construction; or establish, revise, or based on HUD’s desire to consult with Management and Budget (OMB) under provide for standards for construction or Indian tribes before making the form the Paperwork Reduction Act of 1995 construction materials, manufactured HUD–96010 a mandatory reporting (44 U.S.C. 3501–3520) and assigned housing, or occupancy. Accordingly, OMB Control Number 2535–0114. In requirement for ICDBG grant funding. under 24 CFR 50.19(c)(1), this rule is accordance with the Paperwork As more fully described in section III of categorically excluded from Reduction Act, an agency may not the preamble to the October 23, 2009, environmental review under the proposed rule, HUD consulted with conduct or sponsor, and a person is not National Environmental Policy Act of Indian tribes on the Logic Model form. required to respond to, a collection of 1969 (42 U.S.C. 4321). After considering the views and information, unless the collection opinions expressed during the displays a currently valid OMB control Executive Order 13132, Federalism consultation process, HUD announced number. Executive Order 13132 (entitled its intent, through publication of the Regulatory Flexibility Act October 23, 2009, proposed rule, to ‘‘Federalism’’) prohibits an agency from require use of the Logic Model as an The Regulatory Flexibility Act (5 publishing any rule that has federalism ICDBG program requirement. U.S.C. 601 et seq.) generally requires an implications if the rule either imposes The proposed rule continued HUD’s agency to conduct a regulatory substantial direct compliance costs on process of developing the regulatory flexibility analysis of any rule subject to state and local governments and is not changes with active tribal participation, notice and comment rulemaking required by statute, or the rule preempts by soliciting comments from the public requirements, unless the agency certifies state law, unless the agency meets the on the mandatory use of the Logic that the rule will not have a significant consultation and funding requirements Model in the ICDBG program. As noted, economic impact on a substantial of section 6 of the Executive Order. This several Indian tribes already use form number of small entities. final rule does not have federalism HUD–96010. The use of the Logic Model This final rule would not impose any implications and does not impose form, as required by this final rule, will economic burdens on small entities. substantial direct compliance costs on help ensure uniformity in the Rather, the regulatory amendments will information provided by ICDBG state and local governments nor simplify and reduce the reporting grantees on performance goals, and preempt state law within the meaning of requirements for ICDBG program thereby facilitate the evaluation of the Executive Order. grantees. As discussed above in this grantee performance. The Logic Model preamble, the final rule will reduce the Unfunded Mandates Reform Act will be included as part of the ASER number of required small business requirement, which is codified at Title II of the Unfunded Mandates enterprise reports from two to a single § 1003.506(a). Reform Act of 1995 (2 U.S.C. 1531– report to be submitted each October. II. This Final Rule; Discussion of Public The final rule will also require the use 1538) (UMRA) establishes requirements Comments Received on the October 23, of the Logic Model form in the for federal agencies to assess the effects 2009, Proposed Rule preparation of the ASER, which ICDBG of their regulatory actions on state, grantees are already required by local, and tribal governments, and on This final rule follows publication of the private sector. This final rule does the October 23, 2009, proposed rule and regulation to submit to HUD. As noted, not impose any federal mandates on any takes into consideration the public several grantees are already using the state, local, or tribal governments, or on comments received on the proposed Logic Model, which has been a familiar rule. After considering the comments, part of the NOFA process since FY the private sector, within the meaning of HUD has decided to adopt the October 2004. While the format of the Logic UMRA. Model is relatively new, the data 23, 2009, proposed rule without change. Catalog of Federal Domestic Assistance The public comment period on the collection responsibility is not. The data proposed rule closed on December 22, required is already recorded by the The Catalog of Federal Domestic 2009, and HUD received two comments tribes; it will merely be presented in a Assistance number for the ICDBG from an Indian tribal community new format. The required use of the program is 14.862. development agency and an individual Logic Model will conform the ICDBG citizen. Both commenters expressed reporting requirements to those of other List of Subjects in 24 CFR Part 1003 HUD competitive funding programs. support for the proposed rule. One Alaska, Community development commenter stated that the new The change will also help ensure uniformity in the information provided block grants, Grant programs-housing requirement to provide HUD a single and community development, Grant annual report on the hiring of minority by ICDBG grantees on performance programs-Indians, Indians, Reporting business enterprises will reduce goals, and thereby facilitate the and recordkeeping requirements. redundant paperwork and eliminate evaluation of grantee performance. duplicative reporting. The second For the above reasons, the ■ For the reasons stated in the preamble, commenter stated support for HUD’s undersigned has determined that the HUD amends 24 CFR part 1003 as effort to conform the ICDBG reporting final rule will not have a significant follows: requirements with those of other HUD economic impact on a substantial funding programs in order to ensure the number of small entities.
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PART 1003—COMMUNITY FOR FURTHER INFORMATION CONTACT: requirements are located at 30 CFR DEVELOPMENT BLOCK GRANTS FOR Amy C. White, Regulations and subpart C—Pollution Prevention and INDIAN TRIBES AND ALASKA NATIVE Standards Branch, 703–787–1665. Control. In addition to the Subpart C VILLAGES SUPPLEMENTARY INFORMATION: regulations, oil and gas operators must submit projected air emissions for their ■ 1. The authority citation for part 1003 Background entire project as part of their continues to read as follows: Notice of Proposed Rulemaking Development and Production Plan Authority: 42 U.S.C. 3535(d) and 5301 et (DPP) or their Development Operations On March 6, 2007, the MMS seq. Coordination Document (DOCD) at 30 published a Notice of Proposed CFR 250.249. Requests to flare or vent ■ 2. In § 1003.506, redesignate Rulemaking (NPR) in the Federal natural gas must not exceed the volume paragraph (a)(3) as paragraph (a)(4), add Register (72 FR 9884). This NPR approved by MMS in the DPP or DOCD. a new paragraph (a)(3) and revise requested comments on proposed paragraph (b) to read as follows: The MMS also reviews the flaring and revisions to 30 CFR part 250, subpart K, venting requests to determine if they § 1003.506 Reports. Oil and Gas Production Rates. The MMS trigger an air quality review under 30 accepted comments on the NPR until CFR subpart C. However, the flaring and (a) * * * June 4, 2007 (90 days). We received (3) Program performance. Data on venting limits set in these final eight comments on the NPR. These program outputs and outcomes, in a regulations are low enough that comments came from producers of oil form prescribed by HUD. additional air quality review is seldom and natural gas in the Outer Continental required. * * * * * Shelf (OCS) and from the State of (b) Minority business enterprise With regards to greenhouse gas Alaska. The MMS made revisions to the emissions, MMS recognizes that this is reports. Grantees shall submit to HUD, proposed rule based on these comments. by October 10, a report on contract and an important issue. The CAA requires subcontract activity during the fiscal Mandate of the Outer Continental Shelf MMS to coordinate our air quality year. Lands Act regulations with EPA. If EPA establishes a NAAQS for greenhouse gas emissions, * * * * * Under the OCS Lands Act (OCSLA), MMS would be responsible for MMS has the responsibility to issue Dated: April 6, 2010. enforcing those standards in the western regulations governing oil and natural Sandra Henriquez, Gulf of Mexico and we would develop gas production operations on the OCS. Assistant Secretary for Public and Indian regulations to implement that authority Our regulations related to oil and Housing. under the regulations at 30 CFR subpart natural gas operations are primarily [FR Doc. 2010–8924 Filed 4–16–10; 8:45 am] C, as appropriate. based on three responsibilities given to BILLING CODE 4210–67–P the MMS by the OCSLA, these include: Purpose of These Revisions 1. Safety; The MMS is revising subpart K to: 2. Protection of the environment; and DEPARTMENT OF THE INTERIOR (1) Update the structure and 3. Conservation of resources. readability of the rule, bringing it into The primary purpose of the final rule Minerals Management Service compliance with the Department of the is to establish criteria for oil and natural Interior (DOI) plain language guidance; gas production to ensure conservation of 30 CFR Part 250 (2) Eliminate unnecessary resources. These regulations help ensure requirements; [MMS–2008–OMM–0034] that the American people received the (3) Clarify limits on the amount of maximum benefit from oil and natural RIN 1010–AD12 natural gas that may be flared or vented gas production by maximizing the during certain situations; Oil and Gas and Sulphur Operations in amount of oil and natural gas that is (4) Improve collection of data on the Outer Continental Shelf—Oil and produced and marketed. For example, flaring and venting; and Gas Production Requirements these regulations establish the criteria (5) Incorporate several existing for natural gas flaring and venting and Notices to Lessees (NTLs). AGENCY: Minerals Management Service set limits on the time that natural gas The DOI requires agencies to write (MMS), Interior. may be flared or vented. These regulations in plain language, that is in ACTION: Final rule. regulations are designed to work with a style that will ensure the regulations other MMS regulations related to safety are easy to read and clear. The MMS SUMMARY: The MMS is amending the and protection of the environment and follows DOI’s plain language guidelines regulations regarding oil and natural gas our other responsibilities under other when creating new regulations or production requirements. This is a Federal laws. updating existing regulations. These complete rewrite of these regulations, The MMS regulates air quality under regulations were originally written addressing issues such as production the authority of the Clear Air Act (CAA), before plain language standards were rates, burning oil, and venting and for areas in the Gulf of Mexico located required; we are updating the entire flaring natural gas, to ensure appropriate west of 87.5° longitude (western Gulf of subpart to comply with those standards. development of these natural resources. Mexico) and the Environmental Some requirements from the current The final rule eliminates most Protection Agency (EPA) has authority subpart K regulations are eliminated by restrictions on production rates and for air quality elsewhere on the OCS. the final rule because they are clarifies limits on the amount of natural The MMS must coordinate with EPA to unnecessary in today’s petroleum gas that can be flared or vented. The implement the CAA requirements. The industry. For example, MMS required final rule is written using plain EPA is responsible for setting National operators to establish maximum language, so it is easier to read and Ambient Air Quality Standards production rates (MPRs) for producing understand. (NAAQS); MMS enforces those well completions, and maximum DATES: Effective Date: This rule is standards for oil and natural gas efficient rates (MERs) for producing effective on May 19, 2010. operations on the OCS. Our air quality reservoirs, in OCS Order No. 11 in 1974,
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during a period of oil shortages and flaring or venting natural gas, the lessee flaring and venting, their contributions energy crises. In 1988, MMS reduced or operator must report the amounts to to greenhouse gas emissions, and the MER requirement. Currently, MERs MMS. The final rule requires separate opportunities for the Federal are required only on sensitive reservoirs reporting of the amount of natural gas Government to reduce flaring and (primarily oil reservoirs with associated flared and the amount of natural gas venting. gas caps). Determining and maintaining vented. This separate reporting The report concluded that more production rates imposes a significant requirement is in response the GAO accurate records are needed on flaring burden on operators. Based on the past report recommending that MMS collect and venting to determine the amount of 30 years of experience, MMS concluded these numbers separately. The MMS the resource that is lost and the volume that maximum rate requirements and will publish the raw data on our Web of greenhouse gas emissions these production balancing requirements can site, along with other oil and natural gas practices contribute to the atmosphere be largely eliminated without detriment production data. The Department of each year. The report also stated that the to efforts for conservation and Energy’s Energy Information impact of methane (a naturally maximization of ultimate recovery. Administration uses this production occurring gas released during venting) However, the final rule will allow the data for their statistics and analysis. on the earth’s atmosphere is about 23 Regional Supervisor to set production This requirement will improve the times greater than that of carbon dioxide rates in cases where excessive quality of the data that is available on (a byproduct of flaring). The GAO made production rates could harm ultimate natural gas emissions. two recommendations to the Secretary recovery from the reservoir. The final rule clarifies required of the Interior: (1) Consider the cost and The final rule clarifies limits on the information submittals to MMS, benefit of requiring that companies flare length of time of natural gas that may be including requirements relating to the the natural gas, whenever possible, flared or vented in certain situations. documents submitted to MMS and the when flaring or venting is necessary; The final rule requires approval from timing of those submissions. For and (2) consider the cost and benefit of the Regional Supervisor to flare or vent example, there are additional requiring that companies use flaring and natural gas except for situations that are requirements on notifying adjoining venting meters to improve oversight. In described in the rule. The situations that operators regarding production within addition, there was a recommendation don’t require Regional Supervisor 500 feet of a common lease or unit line. to the Secretary of Energy to consider approval (provided the activities are The final rule provides more detail as to consulting with EPA (Environmental completed within a specific time frame when the notification must occur, what Protection Agency), MMS, and BLM in most cases) include: the notice must include, and how to (Bureau of Land Management), on how (1) When the gas is lease use gas verify the notification with MMS. to best collect separate statistics on (produced natural gas which is used on There are several Notices to Lessees flaring and venting. or for the benefit of lease operations (NTLs) that will be rescinded when the The MMS conducted analyses to such as gas used to operate production final rule becomes effective. However, if assess the costs and benefits of requiring facilities) or is used as an additive necessary, MMS will issue additional flare/vent meters and of requiring necessary to burn waste products, such NTLs to provide guidance. We will flaring instead of venting. The first as H2S. rescind the following NTLs: analysis supported the recommendation (2) During the restart of a facility that • NTL No. 97–16, Production Within to require meters, provided that the was shut in because of weather 500 Feet of a Unit or Lease Line, facilities process more than 2,000 conditions, such as a hurricane. effective August 1, 1997. barrels of oil per day (bopd). This (3) During the blow down of • NTL No. 98–23, Interim Reporting requirement is included in the final transportation pipelines downstream of Requirements for 30 CFR part 250, rule. the royalty meter. subpart K, Oil and Gas Production The second analysis indicated that a (4) During the unloading or cleaning Rates, effective October 15, 1998. regulatory change to require flaring of a well, drill-stem testing, production • NTL No. 99–G20, Downhole instead of venting may be appropriate. testing, other well-evaluation testing, or Commingling Applications, effective However, the cost of implementing this the necessary blow down to perform September 7, 1999. requirement could be significant, and • these procedures. NTL No. 2006–N06, Flaring and input from potentially affected parties is (5) When properly working Venting Approvals, effective December necessary. We requested comments on equipment yields flash gas (natural gas 19, 2006. this issue in the proposed rule. released from liquid hydrocarbons as a This NTL also provides contact Commenters pointed out that converting result of a decrease in pressure, an information for each Region and existing facilities that are equipped to increase in temperature, or both) from provides sample field records. These vent natural gas to be able to flare storage vessels or other low-pressure two items are not addressed in the final natural gas may require significant production vessels, and you cannot rule. The MMS will issue a new NTL to redesign for safety. They also pointed economically recover this flash gas. include only this information, after the out that there are many factors in (6) When the equipment works effective date of this final rule. determining whether to flare natural gas properly but there is a temporary upset or vent natural when designing a GAO Report condition, such as a hydrate or paraffin facility. These factors include the plug. In July 2004, the GAO issued a report operating philosophy, nature and type (7) When equipment fails to work on world-wide emissions from vented of reservoir, facility design limitations properly, including equipment and flared natural gas titled, Natural or capabilities, operating practices, maintenance and repair, or when you Gas Flaring and Venting—Opportunities safety, and economics. Industry must relieve system pressures. to Improve Data and Reduce Emissions comments were consistent in We explain the length of time that gas (GAO–04–809). This report is available recommending that in addition to the may be flared or vented for each on the GAO Web site at: http:// considering requiring flaring instead of situation and clarify when approval www.gao.gov/new.items/d04809.pdf. venting, that MMS work with them to from the Regional Supervisor is This report reviewed the flaring and find ways to reduce overall natural gas required. Regardless of the reason for venting data available, the extent of emissions. They also stated that a
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requirement for flaring instead of emergency and shutdown situations. It have on GHG emissions until we begin venting should be only for new is virtually impossible to produce oil to gather more accurate data from the facilities. They requested that MMS and natural gas without any flaring or requirement to install flare/vent meters hold a workshop to discuss the issue. venting and it would be impractical to and to report flare volumes separately The MMS plans to work directly with shut in production every time an upset from vent volumes. Furthermore, it is interested parties to study the costs and occurs. It is estimated that operators in impractical, if not impossible, to benefits of requiring that companies the Gulf of Mexico Outer Continental eliminate all venting. Even if 100% of flare the natural gas, whenever possible, Shelf (OCS) flare and vent less than 0.5 the released OCS gas could be flared when flaring or venting is necessary, as percent of the gas produced, making this instead of vented, the impact on total recommended in the GAO report. We area a world leader in the conservation U.S. GHG emissions would be very will hold a workshop to discuss the of natural gas resources. small. issue of flaring instead of venting, Both flaring and venting on the OCS In 2005, U.S. greenhouse gas (GHG) shortly after this final rule is published. are highly regulated by the Minerals emissions totaled 7.986 × 10 9 tons of This workshop and additional cost- Management Service (MMS). Federal carbon dioxide equivalent (CO2e). Of benefit analysis will consider regulations (30 CFR 250, Subpart K) 6 that total, only 24.7 × 10 tons of CO2e, greenhouse gas issues associated with specify the limited circumstances under or 0.31 percent, were related to OCS oil flaring and venting. The workshop will which offshore oil and gas operators and gas production (including platform be the first step in considering how to may flare or vent natural gas. These and non-platform sources), flaring and best implement this recommendation. final regulations strictly limit the venting activities represent only a The MMS will decide how to move amount of time operators may flare or fraction of that amount. Under MMS forward with the rulemaking on flaring vent. In some cases, operators request oversight, OCS oil and gas operators are natural gas after we hold the workshop. additional time in order to complete already ahead of the curve in terms of Our next step would likely be an equipment repairs. We evaluate each of limiting GHG emissions. advance notice of proposed rulemaking these requests on a case-by-case basis, to further vet our approach with with conservation as a primary focus. Based on several assumptions, industry and other stakeholders. Even though they are already a world estimates, and existing analyses, MMS To improve data collection, as the leader, MMS continuously strives to roughly approximated the impact that GAO report suggested, MMS will improve our oversight of OCS flaring might occur if it were to mandate flaring require operators to report flaring and and venting. In most places around the over venting. These estimates indicate venting volumes to MMS separately. world, for example, there is minimal that such a requirement would reduce Previously, MMS only collected reporting or tracking of flare and/or vent total US GHG emissions by less than information on the total natural gas volumes. In the Federal OCS, MMS 0.05%. However, the accuracy of these flared and vented. Operators did not requires operators to continuously estimates will improve after the need to differentiate between the two record these volumes and report them regulatory change becomes final. categories. each month. These final regulations will Reported OCS flare and vent volumes require operators to install flare/vent could increase or decrease based solely Oil and Gas Industry Contributions to meters on large platforms and also to on improved reporting accuracy. In any Greenhouse Gases in the Federal OCS report gas flared separately from gas event, further analysis may shed light Most natural gas production involves vented. These regulatory changes would on whether flaring rather than venting extracting natural gas from wells drilled provide more accurate measurements of natural gas is cost effective from a into underground gas reservoirs; GHG emissions. greenhouse gas perspective, even if the however, some natural gas is generated Given the existing restrictions on OCS total amount of greenhouse gases is as a by-product of oil production. flaring and venting, there is minimal small. During oil and natural gas production it opportunity to further reduce the overall Public Comments on the Proposed Rule may become necessary to burn or volume of gas flared and vented. release natural gas for a number of However, the global warming potential The MMS received eight sets of operational reasons, including safety. (GWP) of GHG emissions could be comments on the NPR from industry These operations may be associated reduced if MMS were to require trade groups and representatives and with unloading or cleaning of a well, operators to flare instead of vent (when one comment from the State of Alaska. production testing, or relieving system the release of natural gas is necessary). The MMS reviewed and responded to pressure during equipment failure. The Such a requirement would reduce the these comments as appropriate. To help controlled burning of natural gas is GWP of GHG emissions by converting convey the comments, we summarized called flaring, while the controlled most methane to carbon dioxide as it is and combined similar comments. The release of unburned gases directly into released. As previously stated, MMS is results are explained in the following the atmosphere is called venting. Most planning a workshop to address this two tables. Table 1 contains our flaring and venting occurs at the end of topic. responses to general comments and a flare stack or boom which ensures that It is difficult to estimate the impact Table 2 addresses comments on specific natural gas can be safely disposed of in that flaring instead of venting would sections.
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TABLE 1—MMS RESPONSE TO GENERAL COMMENTS
Comment MMS response
Measurement
(1) Measurement accuracy for flared or vented gas envisioned by rule The MMS agrees. We will revise the accuracy requirement from 2 per- is not achievable given the wide range of conditions to which the cent to 5 percent. This is established technology in the North Sea meter would be exposed. and Canada, and a 5 percent accuracy requirement has been adopt- ed by regulatory bodies in those regions. Also, flare/vent meters with this accuracy are already used on some Gulf of Mexico (GOM) facili- ties. (2) Retrofitting may be a problem due to space limitations and safety Installation of meters is necessary to improve oversight of MMS’s flare/ concerns. vent program. A cost-benefit analysis conducted by MMS supports GAO’s recommendation to install meters on all facilities that process more than 2,000 bopd. The Regional Supervisor will work with oper- ators on a case-by-case basis if a safety or space issue is dem- onstrated, as a departure under § 250.142. (3) If deferment of this part of the rule is not acceptable, it is rec- Installation of meters is necessary to improve oversight of MMS’s flare/ ommended that meters be limited to new facilities under construction vent program. The cost-benefit analysis concluded that meters on all 6 months after date that final rule is published. facilities processing over 2,000 bopd is appropriate, not just new fa- cilities. Also, metering flare/vent volumes on all (existing and future) facilities processing over 2,000 bopd better implements the GAO rec- ommendations. (4) Defer requirement to install meters on all offshore complexes proc- The MMS has sufficient information to finalize the rule. Additional input essing 2,000 bopd to develop a best practice with industry that would from industry groups is not necessary and would delay implementa- have broad applicability to all facilities on the OCS, not just those tion of GAO recommendations. We agree that there should be a best processing 2,000 bopd. practice established for estimating volumes of gas flared or vented from facilities processing less than 2,000 bopd. However, metering is more accurate, and requiring meters on those facilities that process more than 2,000 bopd is consistent with the GAO recommendations. (5) The number of facilities impacted by the rule has been underesti- The commenter did not provide an alternate, documented number; mated since multiple facilities may be involved in processing/handling therefore, MMS must use our best analysis. production streams. (6) Cost impact of the rule has been underestimated. A higher cost estimate was provided by the commenter. We used the cost model that was submitted by the commenter in our cost-benefit analysis and determined that the difference is negligible and that a 2,000 bopd threshold for metering is still appropriate. (7) Set a thousand cubic feet (MCF) volume per day vented, calculated Volume estimates calculated from a test are far less accurate than me- by test, rather than having a mandatory metering system. tered volumes and would not achieve the improvements rec- ommended by GAO. (8) These meters should not be subject to the requirements of Subpart Flare/vent meters are subject to the requirements of Subpart K. L. (9) Cost is a huge burden to smaller facilities; increase meter require- See responses (2) and (6). Also see discussion concerning the Regu- ment to facilities with average throughput of 10,000 bopd or more. latory Flexibility Act. (10) Revise time to install meters from 120 days to 180 days to accom- The MMS agrees. We will revise the time allowed to install meters from modate design, shipping, and labor. 120 to 180 days for facilities processing more than 2,000 bopd when this final rule becomes effective. The time allowed to install meters on facilities that begin producing above 2,000 bopd, after this final rule is published, will also be revised from 90 to 120 days. (11) Revise accuracy to 15 percent. The MMS disagrees. See response (1). (12) Meter high flow events, calculate others. The MMS disagrees. See response (2). (13) What if we don’t have a flow when we schedule a calibration? At a minimum, calibration/verification of secondary devices associated Most of our flaring/venting is done during upset or emergency situa- with flare/vent meters can be performed in a no-flow situation in ac- tions. Flare pilot must be kept on at all times, hence, inert gas such cordance with American Petroleum Institute’s (API) Manual of Petro- as nitrogen cannot be used as it will pose a safety issue by extin- leum Measurement Standards (MPMS) Chapter 14 Section 10. Also, guishing the pilot flame. contingent upon the meter type, verification may include the perform- ance of manufacturer recommended inspections and diagnostics. However, after further review, we determined that calibrating meters once a year is adequate. (14) The time required to bring an existing facility into compliance The MMS agrees. See response (10). would far exceed 120 days. (15) Establish best practices for existing facilities to reduce overall lev- The limits on flaring and venting set by these regulations are minimal, els of gas vented/flared. additional reductions in the levels of natural gas flared or vented would not reduce the need for meters. However, MMS does agree that industry should establish best practices for reducing the amount of natural gas flared or vented and we will include this topic as part of the flaring and venting workshop we are planning. (16) Multiple meters would be required on most facilities. The MMS anticipates 2 or 3 meters on most facilities where meters are required. That is, one for each pressure system (High Pressure (HP), Intermediate Pressure (IP), and Low Pressure (LP)) that exists on the facility. The meters would likely be located near the base of the flare boom just before the piping for that pressure system exits the facility.
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TABLE 1—MMS RESPONSE TO GENERAL COMMENTS—Continued
Comment MMS response
(17) Wait for completion of API RP on measurement and allocation. The MMS has sufficient information to finalize the rule. As API Rec- ommended Practices (RP) are published, MMS will consider incor- porating these into our regulations. (18) Future workshop should be planned to discuss solutions and best The MMS will hold a workshop after this final rule is issued. This will practices. be included as a topic as part of our workshop on flaring and vent- ing. (19) Where did 2,000 bopd come from? The MMS conducted a cost-benefit analysis looking at equipment costs, gas prices, and platform life to determine a minimum produc- tion rate that could support the installation of flare/vent meters. Also see Regulatory Flexibility Act discussion.
Flaring/Venting
(20) Converting to flare on existing facilities may require redesign for The MMS is still evaluating the flare versus vent issue and will hold an safety. industry workshop to collect additional information. (21) Limiting the flaring or venting of gas-well gas to 2 hours and allow- We have always distinguished between gas-well gas and oil-well gas. ing 48 continuous hours for oil-well gas when a hydrate plug forms is The prior regulation stated that ‘‘lessees must not flare or vent gas- not consistent with prior guidance and actions. Previous MMS guid- well gas beyond the time required to eliminate an emergency unless ance made no distinction between gas-well gas and oil-well gas if the Regional Supervisor approves.’’ MMS policy has consistently the plug (hydrate) formed naturally. been to allow 2 hours to eliminate the flare or vent under this rule. We added an exception for hydrate plugs under § 250.1160(a)(6). (22) Short comment period for response did not allow industry to de- The MMS included information in the preamble on the flaring versus velop detailed comments on flaring versus venting. venting issue because it was addressed in the GAO report, and we wanted operators to be aware that MMS is considering possible changes to the regulations to address this issue in the future. The MMS is still evaluating this issue and we may hold a workshop to collect additional information, before proposing new regulations on this issue. (23) Retain records for 2 years instead of 6 years. There was no change proposed here; this is merely a clarification that existing law (30 U.S.C. 1713, implemented at 30 CFR part 212) ap- plies to flare/vent records. Those records must be maintained for 6 years (in accordance with 30 U.S.C. 1713 and 30 CFR part 212), in addition to being maintained on the facility for 2 years and available for inspection by MMS personnel.
Miscellaneous
(24) How much of the MMS budget is being supported by the cost re- The total discretionary budget for MMS in Fiscal Year 2007 was $288.2 covery program at this time; is an evaluation of the fee structure million. Total revenue generated by cost recovery fees that year to- being carried out to adjust for actual agency needs? taled $11.9 million or 4.1 percent of the total MMS discretionary budget. The MMS recently adjusted these fees by the Implicit Price Deflator for the Gross Domestic Product, as provided by regulation. The MMS plans to review cost recovery fees in the coming year. Should this review result in a need to change the fees significantly, rulemaking will be required and a proposed rule will be published in the Federal Register for public review and comment. Fees are established in accordance with the Independent Offices Ap- propriation Act of 1952, 31 U.S.C. 9701. It should be noted that MMS does not determine or adjust cost recovery fees to meet a pre- determined funding target, but rather to reflect the cost of actual services provided. (25) The OOC, in conjunction with API, will commit to the development The MMS has sufficient information to finalize this final rule. As API of a technical document or RP that would address quantification, in- RPs are published, MMS will consider incorporating these into our cluding volume, mass, and composition of flare and vent quantities regulations. within the oil and gas production process. The OOC proposes to start working on this document now, concurrent with the subpart K final rulemaking; document and workshops to industry could occur within 18 months. (26) For the protection of the State of Alaska’s correlative rights, re- The MMS does not agree that this final rule violates State correlative quire approval for operators to produce within 500 ft of a lease or rights. The MMS understands the State of Alaska’s interest in pro- unit line even if adjacent acreage is unleased, allow State to com- tecting its correlative rights in the event of development and produc- ment. tion from an OCS lease adjacent to State unleased lands. Under the MMS regulatory process, the State of Alaska will receive and will have the opportunity to comment on each OCS Development and Production Plan (DPP) (30 CFR part 250 subpart B). A DPP will in- clude information on surface and bottom hole locations to enable the State of Alaska to determine if its correlative rights are at risk. The State of Alaska is entitled to copies of the Application(s) for Permit to Drill (APD) to monitor and assure that activities are conducted in ac- cordance with an approved DPP.
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TABLE 2—MMS RESPONSE TO COMMENTS ON SPECIFIC REQUIREMENTS
Citation/comment MMS response
§ 250.1153(b)(2)—Consider completions with downhole The MMS is not implementing this suggestion in the final rule. This configuration re- gauges instead of requiring bottomhole pressure sur- sults in a single pressure measurement, which is not a survey. A survey is re- veys. quired in order to establish a pressure gradient, which is used to correct reservoir pressures to a common datum. As stated in § 250.1153(d), industry may continue to request departures from this requirement, if necessary. § 250.1160(a)—Add gas-well flash gas ...... Wording in the final rule will change from oil-well gas or gas-well gas to natural gas. This wording covers the venting or flaring of all natural gas regardless of the well type. § 250.1160(a)(3)(i)—Neither lease nor pipeline operator The commenter is correct, approval under this subpart will not be required for this needs MMS approval to blowdown pipelines down- situation since the activity is downstream of the royalty meter; however, flaring or stream of royalty meters. venting must be reported after the fact in accordance with this final rule. Approvals may be required under subparts H and J of this part. § 250.1160(a)(4)—Include unloading or cleaning of a well The MMS agrees. The wording was modified to be consistent with the Condition col- in addition to testing under the Additional requirements umn. column. § 250.1160(a)(5)—Define the amount of routine flaring or Since economic conditions vary with time, MMS cannot specify a fixed volume higher venting that is considered uneconomic. than 50 MCF per day. The Additional requirements column clearly indicates that a monthly average volume equal to 50 MCF per day or less is assumed by MMS to be uneconomic. If your facility averages more than 50 MCF per day, you will be expected to capture the gas or demonstrate that the volume is uneconomic and continue to monitor the economic viability as costs and prices change. § 250.1160(a)(6)—The time necessary to unload a well The initial cause of the problem will determine where the incident falls (either after an upset is remedied should be granted under § 250.1160(a)(2), (a)(4), (a)(6), or (a)(7)). For example, an operator may flare oil- § 250.1160(a)(4) and should not be included in the 48 well gas without prior approval for 48 continuous hours in order to remediate a hy- continuous hours or 144 cumulative hours allowed drate plug. However, that operator may not continue to flare without approval for under § 260.1160(a)(6) (upset due to hydrate plugs, an additional 48 hours in order to unload the well after the hydrate plug is remedi- etc.). ated. In this example, the initial cause of the problem was a hydrate plug; there- fore, the operator will only be authorized to flare oil-well gas for up to 48 contin- uous hours without approval (under § 250.1160(a)(6)). § 250.1160(a)(7)—The cumulative time allowed in para- The initial cause of the problem will determine where the incident falls (either graph (a)(4) should also be included in (a)(7)(iv). The § 250.1160(a)(2), (a)(4), (a)(6), or (a)(7)) and therefore the time allotted to perform hours accumulated to restore/optimize production the work related to the incident. If an equipment failure results in a need to flare or should not impact the hours accrued due to equipment vent under § 250.1160(a)(7), any additional procedures needed to restore produc- failures. tion (e.g., well blow down), must be performed within the time allotted under § 250.1160(a)(7). The operator would need to request approval from the Regional Supervisor if additional time is needed. § 250.1160(b)—Subpart C is sufficient to regulate pollu- The MMS agrees that it is not necessary to mention subpart C in subpart K. The tion issues, mentioning Subpart C in Subpart K is re- MMS also agrees that production upsets may not lend themselves to prior ap- dundant and confusing. Production upsets are not an- proval. Paragraph (a) details the periods allowable during production upsets before ticipated and therefore would not lend themselves to MMS approval is required. Regardless of whether or not operators need and re- prior approval. ceive prior approval under (a), however, they are still obligated to follow their ap- proved Development Operations Coordination Document (DOCD) or DPP under subpart B. We reworded § 250.1160(b) to clarify that MMS flare or vent approvals granted under subpart K do not exempt operators from the requirement to follow their DOCD or DPP. Before flaring and/or venting an amount that exceeds the lim- its specified in their DOCD or DPP, operators must submit and receive approval of a revised DOCD or DPP. § 250.1160(e)—If MMS approves flaring or venting, the The subject paragraph was eliminated since negligence related to flaring and venting volume should not be considered avoidably lost unless is adequately covered in the subsequent paragraph. information provided was incorrect. Revise wording to state RS will evaluate flaring and venting requests to determine if situation exceeds those in § 250.1160(a). § 250.1160(f)—If MMS approves flaring or venting, the Additional wording referencing § 250.1160(a) is not necessary. Although MMS does volume should not be considered avoidably lost unless not intend to commonly determine gas to be avoidably lost after we have approved information provided was incorrect. Revise wording to the flaring or venting, the Regional Supervisor must retain full authority to make state flaring or venting in excess of situations in that determination. § 250.1160(a) without approval, or if approval was ob- tained with misleading information, will be considered avoidably lost. § 250.1161(c)—Industry supports addressing small leaks The MMS agrees. Small leaks from valves, fittings, flanges, pressure relief valves or from valves, etc., if all safety concerns are addressed. similar components are considered fugitive emissions and are more appropriately addressed under 30 CFR 250.107 (‘‘What must I do to protect health, safety, prop- erty, and the environment?’’). Note that this paragraph was reworded and renum- bered as 30 CFR 250.1160(f). § 250.1162(a)—Include all liquid hydrocarbons, not just The MMS agrees. The word condensate will be replaced with liquid hydrocarbons. condensate.
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TABLE 2—MMS RESPONSE TO COMMENTS ON SPECIFIC REQUIREMENTS—Continued
Citation/comment MMS response
§ 250.1163(a)—Metering—defer this part until a work- The MMS has sufficient information to finalize this rule. Additional input from industry shop can be held with industry; work in conjunction groups is not necessary and would delay implementation of GAO recommenda- with API to develop a Technical Bulletin; not enough tions. The meter accuracy requirement has been changed from 2 percent to 5 per- time to retrofit existing facilities; high degree of meas- cent. We changed the time to install the meters on existing facilities from 120 days urement accuracy is unrealistic; if not deferred, limit to to 180 days based on an industry comment. Thus rulemaking is consistent with the new facilities; and pulling a portion of the metering re- Administrative Procedure Act (5 U.S.C. § 553, Rulemaking). quirement may conflict with the Administration and Pro- cedures Act. § 250.1163(a)(3)—OGOR–B submitted to MRM will not Note—The proposed rule did not have a § 250.1163(a)(3), this comment presumably accommodate multiple facility submissions. Flared or refers to § 250.1163(b)(3). The MMS agrees that modified reporting on Form vented gas at a host facility would have to be allocated MMS–4054 Part B (OGOR–B) is required in order to implement this GAO rec- back to the lease. ommendation. In order to implement this, § 250.1163(a)(1) of the final rule will re- quire operators to notify MMS of all facilities that process more than 2,000 bopd and therefore require meters. The Regional Supervisor will then establish Facility Measurement Point (FMP) numbers for those metering locations. These FMP num- bers will be used on the OGOR–B forms to identify the facilities where flaring and venting occurs. Further, in order to ease the reporting burden, the language will be modified from that in the proposed rule. Instead of requiring operators to associate all flared and vented volumes with the facilities where the flaring and venting oc- curred, such reporting (on OGOR–B forms) is only required for those facilities which are required to install flare/vent meters (§ 250.1160(b)(3)). For other facili- ties, operators must continue to report flared and vented volumes by lease or unit (§ 250.1163(b)(4)) (note that flared and vented volumes must be separated regard- less of whether reporting is by facility, lease, or unit). Additionally, MRM will send guidance to operators on all other reporting requirements necessitated by this reg- ulatory change. § 250.1163(b)(1)—Reporting separate flaring or venting See response § 250.1163(a)(3). on OGOR B will require modification to current report- ing requirements. § 250.1163(b)(2)—Lease use already reported on OGOR The MMS agrees. Section 250.1163(b)(2) requires reporting lease use gas on Form B. MMS–4054, which is the OGOR. This rule does not impose additional lease use reporting requirements. The wording was modified slightly to clarify this issue. § 250.1163(b)(3)—Reporting flaring or venting from mul- See response § 250.1163(a)(3). tiple facilities separately on a single lease is redundant and requires changes from industry and MRM. These records are kept at each facility and could be re- quested from the operator as needed to eliminate this burdensome requirement. § 250.1163(c)—Industry sends a letter summarizing perti- The MMS disagrees. Summary information submitted in a letter following an oral ap- nent flaring or venting information after receiving oral proval is only a portion of the required records to be saved on location. A complete approval to flare or vent; requiring actual flaring or record must be maintained on each facility for routine inspections by MMS per- venting records be kept on location is redundant. sonnel. § 250.1164(b)(1)—Subpart C is sufficient to regulate pol- The MMS agrees. This paragraph was deleted. lution issues. § 250.1167–General—Requiring the following additional Data submitted for an early application would often be obsolete interpretations and information is burdensome and redundant to data pre- result in inaccurate conclusions. Furthermore, receiving the data in separate sub- viously submitted in other documents (e.g. CIDs). mittals will expedite MMS review of industry applications. § 250.1167(a)(3)—net sand isopach. § 250.1167(a)(4)—net hydrocarbon isopach. § 250.1167(b)(2)—amplitude maps. § 250.1167(d)(1)—estimated recoverable reserves for each completion in a reservoir. § 250.1167(e)(2)—reservoir name and whether it is com- petitive.
After reviewing and responding to the appropriate rule language as specified in compares the changes from the NPR to comments, MMS changed the the MMS comment response. Table 3 this final rule.
TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.105—Removed the phrase ‘‘in the field’’ Flaring means the burning of gas in the field Flaring means the burning of natural gas as it from the definition of Flaring. This phrase is as it is released into the atmosphere. is released into the atmosphere. not necessary, since all activities under this regulation take place in the field. Also, changed ‘‘gas’’ to ‘‘natural gas’’ for clarity.
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.105—Revised the definition of Sensitive Sensitive reservoir means a reservoir in which Sensitive reservoir means a reservoir in which reservoir to state that it is a reservoir in high reservoir production rates will de- the production rate will affect ultimate re- which the production rate will affect ultimate crease ultimate recovery. covery. recovery. This is a more accurate and inclu- sive definition. § 250.1150—Revised wording back to the text You must produce wells and reservoirs at You must produce wells and reservoirs at in the existing rule, changed ‘‘without harm- rates that provide for economic develop- rates that provide for economic develop- ing ultimate recovery’’ to ‘‘while maximizing ment without harming ultimate recovery and ment while maximizing ultimate recovery ultimate recovery’’. This wording is more con- without adversely affecting correlative rights. and without adversely affecting correlative sistent with our mission and with the require- rights. ments of the final rule. § 250.1151(c)—Revised language to clarify sub- You must submit an original and one copy of You must submit to the Regional Supervisor mittal requirement for the required form (ei- the form required by paragraph (a) of this an original and two copies of the appro- ther form MMS–126 or MMS–128). Three section, as listed in the table in § 250.1167. priate form required by paragraph (a) of this copies of the form must be submitted, one of You must include one public information section; one of the copies of the form must those copies is a public information copy. A copy with each submittal in accordance with be a public information copy in accordance public information copy of the supporting doc- §§ 250.190 and 250.196, and mark that with §§ 250.186 and 250.197, and marked uments is not required, therefore only two copy ‘‘Public Information’’. ‘‘Public Information.’’ You must submit two copies of the supporting information must be copies of the supporting information as list- submitted. ed in the table in § 250.1167 with form MMS–126. § 250.1153(d)—Clarified language on request- The Regional Supervisor may grant a depar- The Regional Supervisor may grant a depar- ing a departure from conducting a static ture from the requirement to run a static ture from the requirement to run a static bottomhole pressure survey to specify what bottomhole pressure survey. You must re- bottomhole pressure survey. To request a information must be included with the request. quest a departure by letter, along with Form departure, you must submit a justification, MMS–140, Bottomhole Pressure Survey along with Form MMS–140, Bottomhole Report. You must include sufficient justifica- Pressure Survey Report, showing a cal- tion to support the departure request. culated bottomhole pressure or any meas- ured data. § 250.1154(a)(3)—Simplified wording—changed The reservoir is undergoing secondary or ter- The reservoir is undergoing enhanced recov- ‘‘secondary or tertiary’’ to ‘‘enhanced’’. The tiary recovery. ery. term enhanced includes secondary and ter- tiary recovery techniques. § 250.1154(b)—Restructured the paragraph, For the purposes of this subpart, near-critical For the purposes of this subpart, near-critical adding two subparagraphs. fluids are those fluids that occur in high fluids are: (1) Those fluids that occur in temperature, high-pressure reservoirs high temperature, high-pressure reservoirs where it is not possible to define the liquid- where it is not possible to define the liquid- gas contact or fluids in reservoirs that are gas contact; or near bubble point or dew point conditions. (2) Fluids in reservoirs that are near bubble point or dew point conditions. § 250.1155—Revised language to clarify sub- You must submit an original and three copies You must submit to the Regional Supervisor mittal requirements for form MMS–127. Three of Form MMS–127 and supporting informa- an original and two copies of Form MMS– copies of form MMS–127 must be submitted, tion, as listed in the table in § 250.1167 to 127; one of the copies must be a public in- one is a public information copy. A public in- the Regional Supervisor. You must include formation copy in accordance with formation copy of the supporting documents one public information copy with each sub- §§ 250.186 and 250.197, and marked is not required, therefore only two copies of mittal in accordance with §§ 250.190 and ‘‘Public Information.’’ You must also submit the supporting information must be submitted. 250.196, and mark that copy ‘‘Public Infor- two copies of the supporting information, as mation.’’ listed in the table in § 250.1167.* * * § 250.1155(b)—Added language to clarify that At least once during the calendar year ...... At least once during the calendar year, but the structure maps and well logs, required as you do not need to resubmit unrevised supporting information for form MMS–127, structure maps (§ 250.1167(a)(2)) or pre- are not required as part of the annual sub- viously submitted well logs mittal. (§ 250.1167(c)(1)).
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.1156(a)—Clarified that approval is need- You must obtain approval from the Regional You must obtain approval from the Regional ed before producing from a reservoir within in Supervisor before you start producing from Supervisor before you start producing from a well that is less than 500 ft. from a lease a well that has any portion of the completed a reservoir within a well that has any por- line. Reworded the section to clarify instruc- interval less than 500 feet from a unit or tion of the completed interval less than 500 tions on submitting the service fee and sup- lease line. Submit to MMS the service fee feet from a unit or lease line. Submit to porting information. Removed the phrase, listed in § 250.125 and the Regional Super- MMS the service fee listed in § 250.125, ac- ‘‘whether it is necessary to,’’ from the sen- visor will determine whether approval of cording to the instructions in § 250.126, and tence on how the Regional Supervisor will your request will maximize ultimate recov- the supporting information, as listed in the determine whether to approve the request. ery, avoids the waste of natural resources table in § 250.1167, with your request. The Added the parenthetical phrase record title or whether it is necessary to protect correl- Regional Supervisor will determine whether and operating rights to clarify the meaning of ative rights. You do not need to obtain ap- approval of your request will maximize ulti- lease interest and to be consistent with the proval if the adjacent leases or units have mate recovery, avoid the waste of natural definition of lessee in 30 CFR part 250 sub- the same unit, lease, and royalty interests resources, or protect correlative rights. You part A. as the lease or unit you plan to produce. do not need to obtain approval if the adja- You do not need to obtain approval if the cent leases or units have the same unit, adjacent block is unleased. lease (record title and operating rights), and royalty interests as the lease or unit you plan to produce. You do not need to obtain approval if the adjacent block is unleased. § 250.1157—Added wording to state that the You must request and receive written ap- (a) You must request and receive approval Regional Supervisor will determine whether proval from the Regional Supervisor before from the Regional Supervisor: the request to produce gas-cap-gas from an producing gas from each completion in an (1) Before producing gas-cap gas from each oil reservoir maximizes ultimate recovery. oil reservoir that is known to have an asso- completion in an oil reservoir that is known This informs the applicant of the basis for the ciated gas cap. If the oil reservoir is not ini- to have an associated gas cap. decision to approve or disapprove the re- tially known to have an associated gas cap, (2) To continue production from a well if the quest. We also restructured the section to im- but your oil well begins to show characteris- oil reservoir is not initially known to have an prove readability. tics of a gas well, you must request and re- associated gas cap, but the oil well begins ceive written approval from the Regional to show characteristics of a gas well. Supervisor to continue producing the well. (b) For either request, you must submit the You must include the service fee listed in service fee listed in § 250.125, according to § 250.125 and the supporting information, the instructions in § 250.126, and the sup- as listed in the table in § 250.1167, with porting information, as listed in the table in your request. § 250.1167, with your request. (c) The Regional Supervisor will determine whether your request maximizes ultimate recovery. § 250.1158(b)—Changed ‘‘commingled’’ to If one or more of the commingled reservoirs is If one or more of the reservoirs proposed for ‘‘proposed for commingling,’’ since the res- a competitive reservoir, you must notify the commingling is a competitive reservoir, you ervoirs are only proposed for commingling at operators of all leases that contain the res- must notify the operators of all leases that this stage of the process. ervoir that you intend to downhole com- contain the reservoir that you intend to mingle the reservoirs. downhole commingle the reservoirs. § 250.1159(b)—Changed ‘‘or’’ to ‘‘and/or.’’ ...... If the Regional Supervisor sets an MPR for a If the Regional Supervisor sets an MPR for a producing well completion, or an MER for a producing well completion and/or an MER reservoir, you may not exceed those rates for a reservoir, you may not exceed those except due to normal variations and fluctua- rates except due to normal variations and tions in production rates, as set by the Re- fluctuations in production rates as set by gional Supervisor. the Regional Supervisor. § 250.1160(a)—Per industry comment, we You must receive approval from the Regional You must request and receive approval from changed oil-well gas or gas-well gas to nat- Supervisor to flare or vent oil-well gas or the Regional Supervisor to flare or vent nat- ural gas. This wording covers the venting or gas-well gas at your facility, * * * ural gas at your facility, flaring of all natural gas regardless of the well type. § 250.1160(a)(4), Additional requirements col- You may not exceed 48 cumulative hours of You may not exceed 48 cumulative hours of umn—Per industry comment, we added dur- flaring or venting per testing operation on a flaring or venting per unloading or cleaning ing unloading or cleaning of a well to make single completion without Regional Super- or testing operation on a single completion wording consistent with wording under the visor approval. without Regional Supervisor approval. Condition column. § 250.1160(b)—Per industry comment, we sim- You must inform the Regional Supervisor and Regardless of the requirements in paragraph plified the wording and clarified that the oper- receive approval to flare or vent gas before (a) of this section, you must not flare or ators are accountable for estimated max- you exceed the volume specified in your vent gas over the volume approved in your imum flare/vent volumes provided to MMS in DPP submitted under subpart B of this part, Development Operations Coordination Doc- DPPs and DOCDs and removed reference to even if the flaring or venting does not re- ument (DOCD) or your Development and 30 CFR part 250 subpart C. quire approval under paragraph (a) of this Production Plan (DPP). section. The Regional Supervisor will deter- mine whether your proposed flaring or vent- ing complies with air emission thresholds under subpart C of this part. § 250.1160(e)—Per industry comment, we de- The Regional Supervisor will evaluate your re- Deleted entire paragraph. leted this paragraph and renumbered the quest for gas flaring or venting and deter- section, since negligence in flaring or venting mine if the loss of hydrocarbons is due to of gas is covered in § 250.1160(f). negligence, or could be avoided.
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.1161—Revised introductory paragraph to You may flare or vent oil-well gas and gas- You must request and receive approval from improve clarity. well flash gas for a period that the Regional the Regional Supervisor to flare or vent gas Supervisor will specify, and which will not for an extended period of time. The Re- exceed 1 year, if the Regional Supervisor gional Supervisor will specify the approved approves your request for one of the fol- period of time, which will not exceed 1 year. lowing reasons: The Regional Supervisor may deny your re- quest if it does not ensure the conservation of natural resources or is not consistent with national interests relating to develop- ment and production of minerals of the OCS. The Regional Supervisor may ap- prove your request for one of the following reasons: § 250.1161(c)—Moved to § 250.1160(f). Clari- § 250.1161(c) The Regional Supervisor deter- § 250.1160(f) Fugitive emissions from valves, fied how MMS will handle small emissions mines that an improperly working valve, fittings, flanges, pressure relief valves or that are not caught by a capture system. pipe fitting, or similar component results in similar components do not require approval Emissions that occur from leaking valves, fit- flaring or venting of less than 10 MCF per under this subpart unless specifically re- tings, flanges, pressure relief valves and day, and that it is prudent to repair the leak quired by the Regional Supervisor. similar components, are considered fugitive at a later date. The Regional Supervisor emissions. These emissions are more appro- may exempt this flaring or venting from the priately addressed under safety regulations time limits set in § 250.1160. than conservation regulations. Section 250.1161(c) was renumbered to § 250.1160(f) because this paragraph provides general guidance to operators and is therefore more appropriately listed under § 250.1160. § 250.1162(a)—Per industry comments, we re- You must request and receive approval from You must request and receive approval from placed the term condensate with liquid hydro- the Regional Supervisor to burn any pro- the Regional Supervisor to burn any pro- carbons to allow burning of oil in limited duced liquid hydrocarbons. The Regional duced liquid hydrocarbons. The Regional cases. In addition, we deleted the statement Supervisor may allow you to burn conden- Supervisor may allow you to burn liquid hy- ‘‘In most cases, the Regional Supervisor will sate if you demonstrate that transporting it drocarbons if you demonstrate that trans- not allow you to burn more than 300 barrels to market or re-injecting it is not feasible or porting them to market or re-injecting them of condensate in total during unloading or poses a significant risk of harm to offshore is not technically feasible or poses a signifi- cleaning of a well, drill-stem testing, produc- personnel or the environment. In most cant risk of harm to offshore personnel or tion testing, or other well-evaluation testing.’’ cases, the Regional Supervisor will not the environment. We decided it is better to make this decision allow you to burn more than 300 barrels of on a case-by-case basis. Also changed ‘‘fea- condensate in total during unloading or sible’’ to ‘‘technically feasible.’’ cleaning of a well, drill-stem testing, produc- tion testing, or other well-evaluation testing. § 250.1162(b)—We eliminated this paragraph The Regional Supervisor will evaluate your re- Paragraph deleted and subsequent paragraph and renumbered the subsequent paragraph quest for liquid hydrocarbon burning, and renumbered. because this is covered in § 250.1162(c). determine if the loss of hydrocarbons is due to negligence or could be avoided. § 250.1163(a)—Per industry comments, we If your facility processes more than an aver- If your facility processes more than an aver- changed the requirement to install meters on age of 2,000 bopd during May 2010, you age of 2,000 bopd during May 2010, you facilities that already process more than must install flare/vent meters within 120 must install flare/vent meters within 180 2,000 bopd from 120 days after the rule is days after May 2010. If your facility proc- days after May 2010. If your facility proc- published to 180 days after the rule is effec- esses more than an average of 2,000 bopd esses more than an average of 2,000 bopd tive. Per industry comments, we changed the during a calendar month after May 2010, during a calendar month after May 2010, requirement to install meters on facilities that you must install flare/vent meters within 90 you must install flare/vent meters within 120 begin to process more than 2,000 bopd, after days after the end of the month in which days after the end of the month in which the rule is effective, from 90 days to 120 the average amount of oil processed ex- the average amount of oil processed ex- days after the facility begins to process more ceeds 2,000 bopd. ceeds 2,000 bopd. than the 2,000 bopd. § 250.1163(a)(1)—Per industry comment, we No language proposed...... You must notify the Regional Supervisor added a new paragraph to require a one-time when your facility begins to process more notification to the Regional Supervisor if a fa- than an average of 2,000 bopd in a cal- cility processes more than 2,000 bopd. This endar month. will trigger FMP assignments to simplify re- porting. We renumbered the subsequent paragraphs. § 250.1163(a)(2)—Per industry comment, we The flare/vent meters must measure all flared The flare/vent meters must measure all flared revised the accuracy requirement from 2 per- and vented gas within 2 percent accuracy. and vented gas within 5 percent accuracy. cent to 5 percent. This is established tech- nology in the North Sea and Canada, and a 5 percent accuracy requirement has been adopted by regulatory bodies in those re- gions. Also, flare/vent meters with this accu- racy are already used on some Gulf of Mex- ico facilities.
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.1163(a)(3)—Per industry comment, we You must calibrate the meters regularly, in ac- You must calibrate the meters regularly, in ac- changed the calibration requirement from at cordance with the manufacturer’s rec- cordance with the manufacturer’s rec- least once every 6 months to at least once ommendation, or at least once every 6 ommendation, or at least once every year, every year. months, whichever is shorter. whichever is shorter. § 250.1163(a)(4)—Added a new paragraph to No language proposed ...... You must use and maintain the flare/vent me- clarify that meters should not be removed if ters for the life of the facility. the amount of oil the facility processes later drops below 2,000 bopd. § 250.1163(b)(2)—Simplified wording from, ‘‘gas You may classify and report gas used to op- You may classify and report gas used to op- used as pilot lights, instrument gas, purge erate equipment on the facility (such as gas erate equipment on the lease, such as gas gas used to prevent oxygen from entering the used to power engines, gas used as pilot used to power engines, instrument gas, and flare or vent stack, sparge gas used to re- lights, instrument gas, purge gas used to gas used to maintain pilot lights, as lease generate glycol, and blanket gas used to prevent oxygen from entering the flare or use gas. maintain pressure in low pressure vessels)’’ vent stack, sparge gas used to regenerate to ‘‘instrument gas, and gas used to maintain glycol, and blanket gas used to maintain pilot lights ’’ Per industry comment, we pressure in low pressure vessels) as lease changed ‘‘on the facility’’ to ‘‘on the lease.’’ use gas. § 250.1163(b)(3)—Per industry comment, we You must report the amount of gas flared and If flare/vent meters are required at one or added language to clarify that this only ap- vented at each facility on a lease or unit more of your facilities, you must report the plies to facilities that are required to have basis. Gas flared and vented from multiple amount of gas flared and vented at each of meters. facilities on a single lease or unit must be those facilities separately from those facili- reported separately. ties that do not require meters and sepa- rately from other facilities with meters. § 250.1163(b)(4)—Per industry comment, No language proposed ...... Added new paragraph: added a new paragraph to clarify that if a fa- (4) If flare/vent meters are not required at cility is not required to have meters, the oper- your facility: ator may report the amounts of gas flared or (i) You may report the gas flared and vented vented on a lease or unit basis. This reduces on a lease or unit basis. Gas flared and the reporting burden on industry. vented from multiple facilities on a single lease or unit may be reported together. (ii) If you choose to install meters, you may report the gas volume flared and vented ac- cording to the method specified in para- graph (b)(3) of this section. § 250.1163(c)—Restructured section. Split the You must prepare and maintain records de- You must prepare and maintain records de- introductory paragraph into subparagraphs tailing gas flaring, gas venting, and liquid tailing gas flaring, gas venting, and liquid and renumbered the section to conform. Re- hydrocarbon burning for each facility. You hydrocarbon burning for each facility for 6 moved reference to part 212, clarifying that must maintain these records for the period years. the retention period for these records is 6 specified in part 212 of this title. You must (1) You must maintain these records on the years, as specified in 30 U.S.C. 1713. The keep these records on the facility for 2 facility for at least the first 2 years and have MMS promulgated regulations under this law years and have them available for inspec- them available for inspection by MMS rep- at 30 CFR part 212, but specific reference to tion by MMS representatives. After 2 years, resentatives. part 212 is not necessary here. Revised you must maintain the records, allow MMS (2) After 2 years, you must maintain the paragraph (2) to make consistent with lan- representatives to inspect the records upon records, allow MMS representatives to in- guage in § 250.1163(d)(1)(ii). request, and provide copies to the Regional spect the records upon request and provide Supervisor upon request, but you are not copies to the Regional Supervisor upon re- required to keep them on the facility. The quest, but are not required to keep them on records must include, at a minimum: the facility. (3) The records must include, at a minimum: (1 O=’xl’) Daily volumes of gas flared, gas (i) Daily volumes of gas flared, gas vented, vented, and liquid hydrocarbons burned;. and liquid hydrocarbons burned; (2) Number of hours of gas flaring, gas vent- (ii) Number of hours of gas flaring, gas vent- ing, and liquid hydrocarbon burning, on a ing, and liquid hydrocarbon burning, on a daily basis; daily and monthly cumulative basis; (3) A list of the wells contributing to gas flar- (iii) A list of the wells contributing to gas flar- ing, gas venting, and liquid hydrocarbon ing, gas venting, and liquid hydrocarbon burning, along with gas-oil ratio data; burning, along with gas-oil ratio data; (4) Reasons for gas flaring, gas venting, and (iv) Reasons for gas flaring, gas venting, and liquid hydrocarbon burning; and liquid hydrocarbon burning; and (5) Documentation of all required approvals. (v) Documentation of all required approvals. § 250.1163(c)(3)(ii)—Renumbered from Number of hours of gas flaring, gas venting, Number of hours of gas flaring, gas venting, § 250.1163(c)(2). Added that the records and liquid hydrocarbon burning, on a daily and liquid hydrocarbon burning, on a daily must include the number of hours of gas flar- basis; and monthly cumulative basis; ing, gas venting, and liquid hydrocarbon burning on a monthly cumulative basis. This number is normally recorded by operators. This specifies that operators are required to add up the monthly cumulative on the field records because inspectors need this to verify that the operators are in compliance with §§ 250.1160(a)(6)(iii) and (a)(7)(iii).
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.1163(d)—Removed citations §§ 212.50 If your facility is required to have flare/vent If your facility is required to have flare/vent and 212.51. Restructured the section, to im- meters, you must maintain the meter re- meters: prove clarity. Retained the requirement to cordings for the period specified in (1) You must maintain the meter recordings keep meter recordings for 6 years. Also §§ 212.50 and 212.51 of this title. You must for 6 years. added requirement for maintaining calibration keep these recordings on the facility for 2 (i) You must keep these recordings on the fa- and maintenance records. years and have them available for inspec- cility for 2 years and have them available tion by MMS representatives. After 2 years, for inspection by MMS representatives. you must maintain the recordings, allow (ii) After 2 years, you must maintain the re- MMS representatives to inspect the record- cordings, allow MMS representatives to in- ings upon request, and provide copies to spect the recordings upon request and pro- the Regional Supervisor upon request, but vide copies to the Regional Supervisor are not required to keep them on the facil- upon request, but are not required to keep ity. These recordings must include the them on the facility. begin times, end times, and volumes for all (iii) These recordings must include the begin flaring and venting incidents. times, end times, and volumes for all flaring and venting incidents. (2) You must maintain flare/vent meter cali- bration and maintenance records on the fa- cility for 2 years. § 250.1163(e)—Deleted reference to § 250.140, If your flaring or venting of gas, or burning of If your flaring or venting of gas, or burning of because that section only applies to oral ap- liquid hydrocarbons, required written or oral liquid hydrocarbons, required written or oral provals. approval, you must submit documentation approval, you must submit documentation to the Regional Supervisor summarizing the to the Regional Supervisor summarizing the location, dates, number of hours, and vol- location, dates, number of hours, and vol- umes of gas flared, gas vented, and liquid umes of gas flared, gas vented, and liquid hydrocarbons burned under the approval, hydrocarbons burned under the approval. as required under § 250.140. § 250.1164(b)(1)—Per industry comment, we You may not emit more than 15 lbs of SO2 Deleted paragraph and renumbered subse- deleted this paragraph since air quality guide- per hour per mile from shore, without ap- quent paragraphs. lines are governed by Subpart C (Pollution proval from the Regional Supervisor. Prevention and Control). § 250.1164(b)(2)—Added a reference to If the Regional Supervisor determines that If the Regional Supervisor determines that § 250.303 to clarify the authority for request- flaring at a facility or group of facilities may flaring at a facility or group of facilities may ing additional air quality modeling analysis significantly affect the air quality of an on- significantly affect the air quality of an on- and the requirements for the analysis. shore area, the Regional Supervisor may shore area, the Regional Supervisor may require you to conduct an air quality mod- require you to conduct an air quality mod- eling analysis to determine the potential ef- eling analysis, under § 250.303, to deter- fect of facility emissions. The Regional Su- mine the potential effect of facility emis- pervisor may require monitoring and report- sions. The Regional Supervisor may require ing, or may restrict or prohibit flaring, under monitoring and reporting, or may restrict or §§ 250.303 and 250.304. prohibit flaring, under §§ 250.303 and 250.304. § 250.1164(c)—Deleted first sentence in intro- You must report flared and vented gas con- The Regional Supervisor may require you to ductory paragraph regarding reporting flared taining H2S as required under § 250.1163. submit monthly reports of flared and vented and vented gas containing H2S, because the In addition, the Regional Supervisor may gas containing H2S. reporting requirement is covered in para- require you to submit monthly reports of graph (b) of this section. flared and vented gas containing H2S. § 250.1165(b)—Removed the reference to sup- Before initiating enhanced recovery oper- Before initiating enhanced recovery oper- porting data (structure map and well log sec- ations, you must submit a proposed plan to ations, you must submit a proposed plan to tion) and cited § 250.1167 for the required the Regional Supervisor and receive ap- the Regional Supervisor and receive ap- supporting information for Form MMS–127. proval for pressure maintenance, secondary proval for pressure maintenance, secondary or tertiary recovery, cycling, and similar re- or tertiary recovery, cycling, and similar re- covery operations intended to increase the covery operations intended to increase the ultimate recovery of oil and gas from a res- ultimate recovery of oil and gas from a res- ervoir. The proposed plan must include, for ervoir. The proposed plan must include, for each project reservoir, a brief geologic and each project reservoir, a geologic and engi- engineering overview, structure map, well neering overview, Form MMS–127 and sup- log section, Form MMS–127, and any addi- porting data as required in § 250.1167, and tional information required by the Regional any additional information required by the Supervisor. Regional Supervisor. § 250.1165(c)—Changed citation from § 216.53 You must report to Minerals Revenue Man- You must report to Minerals Revenue Man- to § 210.102 to conform with changes made agement the volumes of oil, gas, or other agement the volumes of oil, gas, or other in the Minerals Revenue Management regu- substances injected, produced, or produced substances injected, produced, or produced lations. for a second time under § 216.53 of this title. for a second time under § 210.102 of this title.
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TABLE 3—CHANGES FROM THE PROPOSED RULE TO THIS FINAL RULE—Continued
Citation—description, or reason for the change Proposed rule language Final rule language
§ 250.1166(a)—Revised wording from ‘‘a great- For any development in the Alaska OCS Re- For any development in the Alaska OCS Re- er ultimate recovery of oil and gas’’ to ‘‘maxi- gion, you must submit an annual reservoir gion, you must submit an annual reservoir mize ultimate recovery of oil and gas.’’ The management report to the Regional Super- management report to the Regional Super- new wording is consistent with terminology visor. The report must contain information visor. The report must contain information used in the rest of the rule. detailing the activities performed during the detailing the activities performed during the previous year and planned for the upcom- previous year and planned for the upcom- ing year that will provide for: ing year that will: (1) the prevention of waste; ...... (1) provide for the prevention of waste; (2) the protection of correlative rights; and ..... (2) provide for the protection of correlative rights; and (3) a greater ultimate recovery of oil and gas. (3) maximize ultimate recovery of oil and gas. § 250.1167—Revised introductory paragraph to You must submit the supporting information You must submit the supporting information clarify that columns 1 and 2 are for forms listed in the following table with the forms listed in the following table with the forms and columns 3 through 6 are for approvals. and for the approvals required under this identified in columns 1 and 2 and for the subpart:. approvals required under this subpart iden- tified in columns 3 through 6: § 250.1167(a)(3) and(4) (table)—Changed the Required ...... Additional items the Regional Supervisor may submittal requirement for net sand isopach request. with total net sand penetrated for each well, identified at the penetration point, and net hy- drocarbon isopach with net feet of pay for each well, identified at the penetration point, for Form SRI MMS–127 from Required to Ad- ditional items the Regional Supervisor may request. § 250.1167(c)(2) (table)—Added that the Re- Not required ...... Additional items the Regional Supervisor may gional Supervisor may request the structural request. cross-sections for production within 500-ft of a lease or unit line. § 250.1167(e)(5) (table)—Revised wording, Explanation of why the proposed completion Explanation of why the proposed completion from ‘‘will not harm ultimate recovery’’ to ‘‘will scenario will not harm ultimate recovery. scenario will maximize ultimate recovery. maximize ultimate recovery.’’ This change is consistent with terminology used throughout the rest of the rule.
Final Rule Organization requirements regarding burning liquid applies to a particular situation. The hydrocarbons, as well as those numbering for subpart K starts at The final rule completely restructures governing flaring or venting natural gas, § 250.1150 instead of § 250.1100 to subpart K. The final rule is divided into were all together in one section. In the accommodate other planned shorter, easier-to-read sections, that final rule, these same requirements are rulemaking. The final rule structure is focus on only one topic. For example, in in five sections, making it easier for an shown in the following table: the current subpart K regulation, the operator to find the information that
Current regulations Final rule
§ 250.1100 Definitions for production rates ...... § 250.105 Definitions. § 250.105 Definitions § 250.1101 General requirements and classification of reservoirs ...... § 250.1150 What are the general reservoir production requirements? § 250.1154 How do I determine if my reservoir is sensitive? § 250.1155 What information must I submit for sensitive reservoirs? § 250.1156 What steps must I take to receive approval to produce within 500 feet of a unit or lease line? § 250.1157 How do I receive approval to produce gas-cap gas from an oil reservoir with an associated gas cap? § 250.1102 Oil and gas production rates ...... Requirements for production rates are largely eliminated. Portions re- tained were combined with new information. § 250.1159 May the Regional Supervisor limit my well or reservoir production rates? § 250.1103 Well production testing ...... § 250.1151 How often must I conduct well production tests? § 250.1152 How do I conduct well tests? § 250.1104 Bottomhole pressure survey ...... § 250.1153 When must I conduct a static bottomhole pressure sur- vey? § 250.1105 Flaring or venting of gas and burning liquid hydrocarbons § 250.1160 When may I flare or vent gas? § 250.1161 When may I flare or vent gas for extended periods of time? § 250.1162 When may I burn produced liquid hydrocarbons? § 250.1163 How must I measure gas flaring or venting volumes and liquid hydrocarbon burning volumes and what records must I main- tain?
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Current regulations Final rule
§ 250.1164 What are the requirements for flaring or venting gas con- taining H2S? § 250.1106 Downhole commingling ...... § 250.1158 How do I receive approval to downhole commingle hydro- carbons? § 250.1107 Enhanced oil and gas recovery operations ...... § 250.1165 What must I do for enhanced recovery operations? New ...... § 250.1159 May the Regional Supervisor limit my well or reservoir production rates? § 250.1166 What additional reporting is required for developments in the Alaska OCS Region? § 250.1167 What information must I submit with forms and for approv- als?
Procedural Matters OCS. This includes about 130 active meters on 112 facilities at an average Federal oil and gas lessees. Small cost of $77,000 per facility, with a total Regulatory Planning and Review lessees that operate under this rule fall cost to industry of $8,624,000 (112 × (Executive Order (E.O.) 12866) under the Small Business $77,000 = $8,624,000). Of those 34 The Office of Management and Budget Administration’s (SBA) North American companies, nine companies are (OMB) has designated this rule Industry Classification System (NAICS) considered small entities, based on the significant for OMB review under codes 211111, Crude Petroleum and NAICS. These nine companies represent Executive Order 12866. Natural Gas Extraction, and 213111, only 7 percent of the 130 operators in (1) The final rule will not have an Drilling Oil and Gas Wells. For these the OCS. We estimate that seven of annual effect of $100 million or more on NAICS code classifications, a small these nine companies will need to the economy. It will not adversely affect company is one with fewer than 500 install meters on one facility each; one in a material way the economy, employees. Based on these criteria, an company will need to install meters on productivity, competition, jobs, the estimated 70 percent of these companies two facilities; and one company will environment, public health or safety, or are considered small. This final rule, need to install meters on three facilities. State, local, or tribal governments or therefore, will affect a substantial This represents an average cost of communities. A cost-benefit and number of small entities, but the $102,667 for each of the small economic analysis is not required. changes in the rule will not have a companies (12 facilities × $77,000/9 This final rule revises the significant economic effect on a these companies). For the remaining requirements for oil and gas production. entities. companies, the average cost to install The changes in the rule are not The only new requirement that will meters will be $308,000 per company significant enough to have an impact on impose a cost to operators is a (100 facilities × $77,000/25 companies). the economy or an economic sector, requirement to install flaring/venting This does not represent an unfair productivity, jobs, the environment, or meters on all facilities that process more burden to small companies because the other units of government. Some of the than 2,000 bopd. The GAO report on cost of these meters is small in previous requirements will be relaxed. flaring and venting natural gas, released comparison to the revenues generated For example, limits on production rates in July 2004, recommended that MMS by the amount of oil processed by those were eliminated in most cases. This will require these meters to improve facilities. allow the operators to produce the oil oversight. The MMS agrees with this Your comments are important. The and gas at the rates that they determine recommendation. The MMS regulations Small Business and Agriculture are best, and will not have a significant allow flaring and venting in very limited Regulatory Enforcement Ombudsman effect on any sector of the economy. (2) The final rule will not create a circumstances. These meters will help and 10 Regional Fairness Boards were MMS: established to receive comments from serious inconsistency or otherwise • interfere with an action taken or Verify the amounts of natural gas small businesses about Federal agency planned by another agency because that operators flare or vent into the enforcement actions. The Ombudsman MMS is the only Federal agency directly environment; will annually evaluate the enforcement • Prevent waste of resources; activities and rate each agency’s involved in setting production • requirements for the offshore oil and Collect the proper royalties on responsiveness to small business. If you avoidably flared or vented gas; wish to comment on the actions of natural gas industry. • (3) This final rule will not alter the Determine if an operator is violating MMS, call 1–888–734–3247. You may MMS regulations; and comment to the Small Business budgetary effects of entitlements, grants, • user fees or loan programs or the rights Assess the impacts on the Administration without fear of or obligations of their recipients. environment. retaliation. Allegations of (4) This final rule will raise novel In determining the criteria for which discrimination/retaliation filed with the legal or policy issues. facilities must install the meters, MMS SBA will be investigated for appropriate considered the cost of the meters and action. Regulatory Flexibility Act the amount of production needed to Small Business Regulatory Enforcement The Department of the Interior justify the cost. To ensure that the Fairness Act certifies that this final rule will not have requirement to install flare/vent meters a significant economic effect on a will not produce an undue burden on The final rule is not a major rule substantial number of small entities small companies, it is limited to those under 5 U.S.C. 804(2) of the Small under the Regulatory Flexibility Act (5 facilities that process more than an Business Regulatory Enforcement U.S.C. 601 et seq.). average of 2,000 bopd. Fairness Act. This final rule: The changes in this rule will affect In the proposed rule, MMS estimated a. Will not have an annual effect on lessees and operators of leases in the that 34 companies will have to install the economy of $100 million or more.
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This final rule revises the requirements Federalism (E.O. 13132) information to be made available to the for oil and gas production. Most of the Under the criteria in E.O. 13132, this public or for limited inspection, and 30 new requirements are paperwork final rule does not have federalism CFR part 252, OCS Oil and Gas requirements, and will not add implications. This final rule will not Information Program. Proprietary significant time to development and substantially and directly affect the information concerning geological and production processes. One new relationship between the Federal and geophysical data will be protected requirement will add new costs for State governments. To the extent that according to 43 U.S.C. 1352. some operators. Operators will be State and local governments have a role The information collected under required to install flare/vent meters on in OCS activities, this final rule will not subpart K is used in our efforts to any facility that processes more than an affect that role. A Federalism conserve natural resources, prevent average of 2,000 bopd. The MMS Assessment is not required. waste, and protect correlative rights, estimates that 34 companies will have to including the Government’s royalty install meters on 112 facilities at an Civil Justice Reform (E.O. 12988) interest. Specifically, MMS uses the average cost of $77,000 per facility, with This rule complies with the information to: a total cost to industry of $8,624,000 requirements of E.O. 12988. • Evaluate requests to burn liquid (112 × $77,000 = $8,624,000). Specifically, this rule: hydrocarbons and vent and flare gas to b. Will not cause a major increase in (a) Meets the criteria of section 3(a) ensure that these requests are costs or prices for consumers, requiring that all regulations be appropriate; individual industries, Federal, State, or reviewed to eliminate errors and • Determine if a maximum local government agencies, or ambiguity and be written to minimize production or efficient rate is required; geographic regions. litigation; and and, The only change to this rule that has (b) Meets the criteria of section 3(b)(2) • Review applications for downhole a cost associated with it is a new requiring that all regulations be written commingling to ensure that action requirement to install meters on in clear language and contain clear legal maximizes ultimate recovery. facilities that process more than an standards. The IC burdens for these regulations average of 2,000 bopd. As discussed include several changes from the previously, this requirement will not Consultation With Indian Tribes (E.O. burdens published in the preamble to significantly increase the cost of doing 13175) the proposed rule. The changes and business offshore and will not cause an Under the criteria in E.O. 13175, we reasons for making them are: increase in costs or prices for have evaluated this final rule and (1) On August 25, 2008 (73 FR 49943) consumers, individual industries, determined that it has no potential a final rulemaking was published that Federal, State, or local government effects on federally recognized Indian increased the cost recovery fees required agencies, or geographic regions. tribes. There are no Indian or tribal under § 250.125. These fees became c. Will not have significant adverse lands in the OCS. effective on September 24, 2008, and the final rule includes these fees that affect effects on competition, employment, Paperwork Reduction Act (PRA) investment, productivity, innovation, or subpart K. the ability of U.S.-based enterprises to This rulemaking is a total rewrite of (2) The OMB approval of the compete with foreign-based enterprises. regulations under 30 CFR Part 250, information collection burden (1010– This final rule will eliminate the Subpart K, Oil and Gas Production 0041) for the current subpart K requirement for operators to set limits Rates. The rule changes the information regulations was due to expire before on production rates, allowing the collection (IC) burden already approved these final regulations became effective. operators to determine the best rate to for current subpart K regulations; As required by the Paperwork produce their reservoirs. There are therefore, a submission was made to Reduction Act, to renew the OMB clearer limits on burning, flaring, and OMB under 44 U.S.C. 3501 et seq. The approval of 1010–0041, we consulted venting, which will encourage OMB approved the collection of with several respondents and adjusted conservation of our natural resources. information under OMB Control the burden estimates and number of Number 1010–0041, expiration date responses accordingly. The burden Unfunded Mandates Reform Act 3/31/2013, for a total of 43,396 burden estimates for the final rule reflect these This final rule will not impose an hours and $9,234,392 non-hour cost updates. unfunded mandate on State, local, or burdens. (3) Based on a public comment, we tribal governments or the private sector The title of the collection of removed the requirements published in of more than $100 million per year. The information for the rule is 30 CFR Part proposed § 250.1164(b)(1) to request final rule will not have a significant or 250, Subpart K, Oil and Gas Production Regional Supervisor approval for unique effect on State, local, or tribal Requirements. Potential respondents emitting more than 15 pounds of SO2, governments or the private sector. A comprise Federal oil and gas and and § 250.1164(b)(2), submit to the statement containing the information sulphur lessees. Responses to this Regional Supervisor air quality required by the Unfunded Mandates collection are mandatory or are required modeling analysis. The commenter Reform Act (2 U.S.C. 1531 et seq.) is not to obtain or retain a benefit. The stated that 30 CFR 250, subpart C, was required. frequency of response is on occasion, sufficient to regulate pollution issues monthly, semi-annually, annually, and and MMS agreed. Takings Implication Assessment (E.O. as a result of situations encountered (4) We also added two IC 12630) depending upon the requirement. The requirements and burdens to the Under the criteria in E.O. 12630, this information collection does not include following IC burden table for the final final rule does not have significant questions of a sensitive nature. The regulations. takings implications. The final rule is MMS will protect proprietary (a) First, operators/lessees must not a governmental action capable of information according to the Freedom of provide notice to operator(s) of adjacent interference with constitutionally Information Act (5 U.S.C. 552) and its property(ies) of their request for MMS protected property rights. A Takings implementing regulations (43 CFR part approval to produce within 500 feet of Implication Assessment is not required. 2), and 30 CFR 250.197, Data and a unit or lease line or to commingle
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hydrocarbons. Sections 250.1156(b) and inadvertently omitted from the IC table BOPD per month. This change was 250.1158(b) allow the notified party(ies) in the proposed rule. made in response to a commenter’s to submit letters of acceptance or (b) Second, is a new paragraph (1) concern that the current Oil and Gas objection to MMS. This provision was under § 250.1163(a) that requires a Operations Report (OGOR)–B form does in the proposed rule, but was notice to MMS when a facility begins to not allow for multiple facility process more than an average of 2,000 submissions.
Non-hour cost burdens 30 CFR part 250 Reporting & recordkeeping subpart K requirement Average number of Hour burden annual responses Annual burden hours
WELL TESTS/SURVEYS and CLASSIFYING RESERVOIRS
1151(a)(1), (c); 1167.. Conduct well production test; submit 3 ...... 1,325 forms ...... 3,975 Form MMS–126 (Well Potential Test Report) and supporting information (within 15 days after end of test period). 1151(a)(2), (c); 1167.. Conduct well production test; submit 0.1 to 3 * ...... 13,000 GOM forms 3,100 Form MMS–128 (Semiannual Well Test 600 POCS forms. Report) and supporting information (within 45 days after end of calendar half-year). 1151(b) ...... Request extension of time to submit re- 0.5 ...... 37 requests ...... 19 sults of semi-annual well test. 1152(b), (c) ...... Request approval to conduct well testing 0.5 ...... 37 requests ...... 19 using alternative procedures. 1152(d) ...... Provide advance notice of time and date 0.5 ...... 10 notices ...... 5 of well tests. 1153 ...... Conduct static bottomhole pressure sur- 14 ...... 1,270 surveys ...... 17,780 vey; submit Form MMS–140 (Bottomhole Pressure Survey Report) (within 60 days after survey). 1153(d) ...... Submit a letter, along with Form MMS– 1 ...... 120 survey depar- 120 140, to request a departure from re- tures. quirement to run a static bottomhole survey. 1154; 1167 ...... Request approval, along with supporting 6 ...... 20 requests ...... 120 information, to reclassify reservoir. 1155; 1165(b); Submit Form MMS–127 (Sensitive Res- 2.2 ...... 2,189 forms ...... 4,816 1166(c); 1167. ervoir Information Report) and sup- porting information (within 45 days after certain events or at least annually).
Subtotal 18,608 responses 29,954 hours
APPROVALS PRIOR TO PRODUCTION
1156; 1167 ...... Request approval to produce within 500 5 ...... 33 requests ...... 165 feet of a unit or lease line; submit sup- porting information; pay service fee and include pay.gov payment confirmation with request; notify adjacent operators and provide MMS proof of notice date.
$3,608 × 33 requests = $119,064
1156(b); 1158(b) ...... Notify adjacent operators submit letters of .5 ...... 33 letters ...... 17 (rounded) acceptance or objection to MMS within 30 days after notice. 1157; 1167...... Request approval to produce gas-cap 12 ...... 51 requests ...... 612 gas in an oil reservoir with an associ- ated gas cap, or to continue producing an oil well showing characteristics of a gas well with an associated gas cap; submit supporting information; pay service fee and include pay.gov pay- ment confirmation with request.
$4,592 × 51 requests = $234,192
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Non-hour cost burdens 30 CFR part 250 Reporting & recordkeeping subpart K requirement Average number of Hour burden annual responses Annual burden hours
1158; 1167...... Request approval to downhole com- 6 ...... 48 applications ...... 288 mingle hydrocarbons; submit sup- porting information; pay service fee and include pay.gov payment confirmation with request; notify operators and pro- vide proof of notice date.
$5,357 × 48 applications = $257,136
165 responses 1,082 hours
Subtotal $610,392 non-hour costs
FLARING, VENTING, and BURNING HYDROCARBONS
1160; 1161; 1163(e) .. Request approval to flare or vent natural 0.5 ...... 1,007 requests/ 504 gas or exceed specified volumes; sub- reports. mit documentation; report flare/vent in- formation due to blow down of trans- portation pipelines within 72 hours after incident. 1162; 1163(e) ...... Request approval to burn produced liquid 0.5 ...... 60 requests/ 30 hydrocarbons; submit documentation reports.
1163(a) ...... One-time initial purchase and installation 112 meters × $77,000 ea = $8,624,000 of gas meters to measure and record the amount of gas flared or vented. This is a non-hour cost burden required to comply with revised regulations with relatively small or no burden in subse- quent years.
1163(a)(1) ...... Notify MMS when facility begins to proc- 0.833 ...... 112 notices ...... 93 (rounded) ess more than an average of 2,000 bopd per month.
1163(b); 1164(c) ...... Report to MRM hydrocarbons produced, including measured gas flared/vented and liq- 0 uid hydrocarbon burned—burden covered under 1010–0139.
1163(c), (d) ...... Maintain records for 6 years detailing gas 13 ...... 869 flare/vent 11,297 flaring/venting, liquid hydrocarbon burn- platforms. ing; and flare/vent meter recordings; make available for inspection or pro- vide copies upon request. 0.5 ...... 60 liquid hydro- 30 carbons. 1164(c) ...... Submit monthly reports of flared or vent- 2 ...... 3 operators × 12 72 ed gas containing H2S. mos. = 36.
1160(b); 1164(b)(1), H2S Contingency, Exploration, or Development and Production Plans and, Development 0 (2). Operations Coordination Documents—burdens covered under 1010–0141 and 1010– 0151. Monitor air quality and report—burdens covered under 1010–0057.
2,084 responses 12,026 hours
Subtotal $8,624,000 non-hour costs
OTHER REQUIREMENTS
1165 ...... Submit proposed plan and supporting in- 12 ...... 14 plans ...... 168 formation for enhanced recovery oper- ations; including Form MMS–127.
1165(c) ...... Submit periodic reports of volumes of oil, gas, or other substances injected, produced, 0 or produced for a second time—burden covered under OMB approval 1010–0139.
1166 ...... Alaska Region only: submit annual res- 1 ...... 1 (req’d by State, 1 ervoir management report and sup- MMS gets copy). porting information, including Form MMS–127. 100 ...... 1 new development 100 not State lands.
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Non-hour cost burdens 30 CFR part 250 Reporting & recordkeeping subpart K requirement Average number of Hour burden annual responses Annual burden hours
20 ...... 3 annual revisions ... 60 1150–1167 ...... General departure or alternative compli- 1 ...... 5 submissions ...... 5 ance requests not specifically covered elsewhere in subpart K.
Subtotal 24 responses 334 hours
20,881 responses 43,396 hours
TOTAL BURDEN $9,234,392 non-hour cost burdens * Reporting burden for this form is estimated to average 0.1 to 3 hours per form depending on the number of well tests reported, including the time for reviewing instructions, gathering and maintaining data, and completing and reviewing the form.
An agency may not conduct or Manual 15.4(C)(1). We have also PART 250—OIL AND GAS AND sponsor, and you are not required to determined that the rule does not SULPHUR OPERATIONS IN THE respond to, a collection of information involve any of the extraordinary OUTER CONTINENTAL SHELF unless it displays a currently valid OMB circumstances listed in 43 CFR 46.215 control number. The public may that would require further analysis ■ 1. The authority citation for part 250 comment, at any time, on the accuracy under the National Environmental continues to read as follows: of the IC burden in this rule and may Policy Act. Authority: 31 U.S.C. 9701, 43 U.S.C. 1334. submit any comments to the Department Data Quality Act of the Interior; Minerals Management ■ 2. Amend § 250.105 by revising the Service; Attention: Regulations and In developing this rule, we did not definition of Sensitive reservoir and Standards Branch; Mail Stop 5438; 381 conduct or use a study, experiment, or adding in alphabetical order definitions Elden Street; Herndon, Virginia 20170– survey requiring peer review under the for Flaring and Venting to read as 4817. Data Quality Act (Pub. L. 106–554, app. follows: C § 515, 114 Stat. 2763, 2763A–153– National Environmental Policy Act of 154). § 250.105 Definitions. 1969 Effects on the Energy Supply (E.O. * * * * * This rule does not constitute a major 13211) Federal action significantly affecting the Flaring means the burning of natural quality of the human environment. A This rule is not a significant energy gas as it is released into the atmosphere. detailed statement under the National action under the definition in E.O. * * * * * Environmental Policy Act of 1969 is not 13211. A Statement of Energy Effects is not required. Sensitive reservoir means a reservoir required because the rule is covered by in which the production rate will affect a categorical exclusion. This rule is List of Subjects in 30 CFR Part 250 ultimate recovery. excluded from the requirement to Continental shelf, Environmental * * * * * prepare a detailed statement because it protection, Oil and gas exploration, Venting means the release of gas into falls within the MMS categorical Public lands—mineral resources, ‘‘ the atmosphere without igniting it. This exclusion covering the [i]ssuance and reporting and recordkeeping includes gas that is released underwater modification of regulations, Orders, requirements. Standards, Notices to Lessees and and bubbles to the atmosphere. Dated: December 23, 2009. Operators. Guidelines and field rules for * * * * * which the impacts are limited to Ned Farquhar, administrative, economic, or Acting Assistant Secretary—Land and ■ 3. In § 250.125, revise paragraphs technological effects and the Minerals Management. (a)(27) through (29) to read as follows: environmental impacts are minimal.’’ ■ For the reasons stated in the preamble, § 250.125 Service fees. This categorical exclusion is Minerals Management Service (MMS) documented in 516 Departmental amends 30 CFR part 250 as follows: (a) * * *
SERVICE FEE TABLE
Service—processing of the following: Fee amount 30 CFR citation
.
******* (27) 500 Feet From Lease/Unit Line Production Request ...... 3,608 § 250.1156(a). (28) Gas Cap Production Request ...... 4,592 § 250.1157. (29) Downhole Commingling Request ...... 5,357 § 250.1158(a).
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■ 4. In § 250.199, paragraph (e)(10) is § 250.199 Paperwork Reduction Act (e) * * * revised to read as follows: statements—information collection. * * * * *
30 CFR subpart, title and/or MMS Form (OMB Control No.) Reasons for collecting information and how used
******* (10) Subpart K, Oil and Gas Production Rates (1010–0041), including To inform MMS of production rates for hydrocarbons produced on the Forms MMS–126, Well Potential Test Report; MMS–127, Sensitive OCS. To ensure economic maximization of ultimate hydrocarbon re- Reservoir Information Report; MMS–128, Semiannual Well Test Re- covery. port; MMS–140 Bottomhole Pressure Survey Report.
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§ 250.490 [Amended] Approvals Prior To Production Other Requirements ■ 5. In § 250.490, paragraph (o)(3), the 250.1156 What steps must I take to receive 250.1165 What must I do for enhanced citation ‘‘§ 250.1105’’ is revised to read approval to produce within 500 feet of a recovery operations? ‘‘§ 250.1164’’. unit or lease line? 250.1166 What additional reporting is 250.1157 How do I receive approval to required for developments in the Alaska ■ 6. Revise subpart K to read as follows: produce gas-cap gas from an oil reservoir OCS Region? with an associated gas cap? 250.1167 What information must I submit Subpart K—Oil and Gas Production 250.1158 How do I receive approval to with forms and for approvals? Requirements downhole commingle hydrocarbons? General General Production Rates § 250.1150 What are the general reservoir 250.1159 May the Regional Supervisor limit Sec. production requirements? 250.1150 What are the general reservoir my well or reservoir production rates? production requirements? Flaring, Venting, And Burning You must produce wells and Well Tests and Surveys Hydrocarbons reservoirs at rates that provide for economic development while 250.1160 When may I flare or vent gas? 250.1151 How often must I conduct well maximizing ultimate recovery and production tests? 250.1161 When may I flare or vent gas for 250.1152 How do I conduct well tests? extended periods of time? without adversely affecting correlative 250.1153 When must I conduct a static 250.1162 When may I burn produced liquid rights. bottomhole pressure survey? hydrocarbons? Well Tests and Surveys 250.1163 How must I measure gas flaring or Classifying Reservoirs venting volumes and liquid hydrocarbon § 250.1151 How often must I conduct well 250.1154 How do I determine if my burning volumes, and what records must production tests? reservoir is sensitive? I maintain? 250.1155 What information must I submit 250.1164 What are the requirements for (a) You must conduct well production for sensitive reservoirs? flaring or venting gas containing H2S? tests as shown in the following table:
You must conduct: And you must submit to the Regional Supervisor:
(1) A well-flow potential test on all new, recompleted, or reworked well Form MMS–126, Well Potential Test Report, along with the supporting completions within 30 days of the date of first continuous production. data as listed in the table in § 250.1167, within 15 days after the end of the test period. (2) At least one well test during a calendar half-year for each producing Results on Form MMS–128, Semiannual Well Test Report, of the most completion. recent well test obtained. This must be submitted within 45 days after the end of the calendar half-year.
(b) You may request an extension § 250.1152 How do I conduct well tests? per square inch absolute (psia) and 60° from the Regional Supervisor if you (a) When you conduct well tests you F for all tests; and cannot submit the results of a must: (5) Use measured specific gravity values to calculate gas volumes. semiannual well test within the (1) Recover fluid from the well (b) You may request approval from specified time. completion equivalent to the amount of the Regional Supervisor to conduct a (c) You must submit to the Regional fluid introduced into the formation well test using alternative procedures if Supervisor an original and two copies of during completion, recompletion, you can demonstrate test reliability reworking, or treatment operations the appropriate form required by under those procedures. before you start a well test; paragraph (a) of this section; one of the (c) The Regional Supervisor may also copies of the form must be a public (2) Produce the well completion require you to conduct the following information copy in accordance with under stabilized rate conditions for at tests and complete them within a §§ 250.186 and 250.197, and marked least 6 consecutive hours before specified time period: ‘‘Public Information.’’ You must submit beginning the test period; (1) A retest or a prolonged test of a two copies of the supporting (3) Conduct the test for at least 4 well completion if it is determined to be information as listed in the table in consecutive hours; necessary for the proper establishment § 250.1167 with form MMS–126. (4) Adjust measured gas volumes to of a Maximum Production Rate (MPR) the standard conditions of 14.73 pounds or a Maximum Efficient Rate (MER); and
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(2) A multipoint back-pressure test to must provide advance notice to the § 250.1153 When must I conduct a static determine the theoretical open-flow Regional Supervisor of the times and bottomhole pressure survey? potential of a gas well. dates of well tests. (a) You must conduct a static (d) An MMS representative may bottomhole pressure survey under the witness any well test. Upon request, you following conditions:
If you have . . . Then you must conduct . . .
(1) A new producing reservoir ...... A static bottomhole pressure survey within 90 days after the date of first continuous production. (2) A reservoir with three or more producing completions ...... Annual static bottomhole pressure surveys in a sufficient number of key wells to establish an average reservoir pressure. The Regional Supervisor may require that bottomhole pressure surveys be per- formed on specific wells.
(b) Your bottomhole pressure survey submit a request to the Regional table in § 250.1167, with your request. must meet the following requirements: Supervisor to reclassify the reservoir. The Regional Supervisor will determine (1) You must shut-in the well for a You must include supporting whether approval of your request will minimum period of 4 hours to ensure information, as listed in the table in maximize ultimate recovery, avoid the stabilized conditions; and § 250.1167, with your request. waste of natural resources, or protect (2) The bottomhole pressure survey (e) If information indicates that a correlative rights. You do not need to must consist of a pressure measurement reservoir previously classified as obtain approval if the adjacent leases or at mid-perforation, and pressure sensitive is now non-sensitive, you may units have the same unit, lease (record measurements and gradient information submit a request to the Regional title and operating rights), and royalty for at least four gradient stops coming Supervisor to reclassify the reservoir. interests as the lease or unit you plan to out of the hole. You must include supporting produce. You do not need to obtain (c) You must submit to the Regional information, as listed in the table in approval if the adjacent block is Supervisor the results of all static § 250.1167, with your request. unleased. bottomhole pressure surveys on Form (b) You must notify the operator(s) of MMS–140, Bottomhole Pressure Survey § 250.1155 What information must I submit adjacent property(ies) that are within Report, within 60 days after the date of for sensitive reservoirs? 500 feet of the completion, if the the survey. You must submit to the Regional adjacent acreage is a leased block in the (d) The Regional Supervisor may Supervisor an original and two copies of Federal OCS. You must provide the grant a departure from the requirement Form MMS–127; one of the copies must Regional Supervisor proof of the date of to run a static bottomhole pressure be a public information copy in the notification. The operators of the survey. To request a departure, you accordance with §§ 250.186 and adjacent properties have 30 days after must submit a justification, along with 250.197, and marked ‘‘Public receiving the notification to provide the Form MMS–140, Bottomhole Pressure Information.’’ You must also submit two Regional Supervisor letters of Survey Report, showing a calculated copies of the supporting information, as acceptance or objection. If an adjacent bottomhole pressure or any measured listed in the table in § 250.1167. You operator does not respond within 30 data. must submit this information: days, the Regional Supervisor will (a) Within 45 days after beginning presume there are no objections and Classifying Reservoirs production from the reservoir or proceed with a decision. The § 250.1154 How do I determine if my discovering that it is sensitive; notification must include: reservoir is sensitive? (b) At least once during the calendar (1) The well name; (2) The rectangular coordinates (x, y) (a) You must determine whether each year, but you do not need to resubmit of the location of the top and bottom of reservoir is sensitive. You must classify unrevised structure maps the completion or target completion the reservoir as sensitive if: (§ 250.1167(a)(2)) or previously referenced to the North American (1) Under initial conditions it is an oil submitted well logs (§ 250.1167(c)(1)); Datum 1983, and the subsea depths of reservoir with an associated gas cap; (c) Within 45 days after you revise (2) At any time there are near-critical reservoir parameters; and the top and bottom of the completion or fluids; or (d) Within 45 days after the Regional target completion; (3) The distance from the completion (3) The reservoir is undergoing Supervisor classifies the reservoir as or target completion to the unit or lease enhanced recovery. sensitive under § 250.1154(c). line at its nearest point; and (b) For the purposes of this subpart, Approvals Prior to Production (4) A statement indicating whether or near-critical fluids are: not it will be a high-capacity completion (1) Those fluids that occur in high § 250.1156 What steps must I take to having a perforated or open hole temperature, high-pressure reservoirs receive approval to produce within 500 feet interval greater than 150 feet measured where it is not possible to define the of a unit or lease line? depth. liquid-gas contact; or (a) You must obtain approval from the (2) Fluids in reservoirs that are near Regional Supervisor before you start § 250.1157 How do I receive approval to bubble point or dew point conditions. producing from a reservoir within a well produce gas-cap gas from an oil reservoir (c) The Regional Supervisor may that has any portion of the completed with an associated gas cap? reclassify a reservoir when available interval less than 500 feet from a unit or (a) You must request and receive information warrants reclassification. lease line. Submit to MMS the service approval from the Regional Supervisor: (d) If available information indicates fee listed in § 250.125, according to the (1) Before producing gas-cap gas from that a reservoir previously classified as instructions in § 250.126, and the each completion in an oil reservoir that non-sensitive is now sensitive, you must supporting information, as listed in the is known to have an associated gas cap.
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(2) To continue production from a supporting information, as listed in the reservoir, or both, if the Regional well if the oil reservoir is not initially table in § 250.1167, with your request. Supervisor determines that an excessive known to have an associated gas cap, (b) If one or more of the reservoirs production rate could harm ultimate but the oil well begins to show proposed for commingling is a recovery. An MPR or MER will be based characteristics of a gas well. competitive reservoir, you must notify on well tests and any limitations (b) For either request, you must the operators of all leases that contain imposed by well and surface equipment, submit the service fee listed in the reservoir that you intend to sand production, reservoir sensitivity, § 250.125, according to the instructions downhole commingle the reservoirs. gas-oil and water-oil ratios, location of in § 250.126, and the supporting Your request for approval of downhole perforated intervals, and prudent information, as listed in the table in commingling must include proof of the operating practices. § 250.1167, with your request. date of this notification. The notified (b) If the Regional Supervisor sets an operators have 30 days after notification (c) The Regional Supervisor will MPR for a producing well completion to provide the Regional Supervisor with determine whether your request and/or an MER for a reservoir, you may letters of acceptance or objection. If the maximizes ultimate recovery. not exceed those rates except due to notified operators do not respond normal variations and fluctuations in § 250.1158 How do I receive approval to within the specified period, the production rates as set by the Regional downhole commingle hydrocarbons? Regional Supervisor will assume the Supervisor. (a) Before you perforate a well, you operators do not object and proceed must request and receive approval from with a decision. Flaring, Venting, and Burning Hydrocarbons the Regional Supervisor to commingle Production Rates hydrocarbons produced from multiple § 250.1160 When may I flare or vent gas? reservoirs within a common wellbore. § 250.1159 May the Regional Supervisor The Regional Supervisor will determine limit my well or reservoir production rates? (a) You must request and receive whether your request maximizes (a) The Regional Supervisor may set a approval from the Regional Supervisor ultimate recovery. You must include the Maximum Production Rate (MPR) for a to flare or vent natural gas at your service fee listed in § 250.125, according producing well completion, or set a facility, except in the following to the instructions in § 250.126, and the Maximum Efficient Rate (MER) for a situations:
Condition Additional requirements
(1) When the gas is lease use gas (produced natural gas which is used The volume of gas flared or vented may not exceed the amount nec- on or for the benefit of lease operations such as gas used to operate essary for its intended purpose. Burning waste products may require production facilities) or is used as an additive necessary to burn approval under other regulations. waste products, such as H2S. (2) During the restart of a facility that was shut in because of weather Flaring or venting may not exceed 48 cumulative hours without Re- conditions, such as a hurricane. gional Supervisor approval. (3) During the blow down of transportation pipelines downstream of the (i) You must report the location, time, flare/vent volume, and reason for royalty meter. flaring/venting to the Regional Supervisor in writing within 72 hours after the incident is over. (ii) Additional approval may be required under subparts H and J of this part. (4) During the unloading or cleaning of a well, drill-stem testing, pro- You may not exceed 48 cumulative hours of flaring or venting per un- duction testing, other well-evaluation testing, or the necessary blow loading or cleaning or testing operation on a single completion with- down to perform these procedures. out Regional Supervisor approval. (5) When properly working equipment yields flash gas (natural gas re- You may not flare or vent more than an average of 50 MCF per day leased from liquid hydrocarbons as a result of a decrease in pres- during any calendar month without Regional Supervisor approval. sure, an increase in temperature, or both) from storage vessels or other low-pressure production vessels, and you cannot economically recover this flash gas. (6) When the equipment works properly but there is a temporary upset (i) For oil-well gas and gas-well flash gas (natural gas released from condition, such as a hydrate or paraffin plug. condensate as a result of a decrease in pressure, an increase in temperature, or both), you may not exceed 48 continuous hours of flaring or venting without Regional Supervisor approval. (ii) For primary gas-well gas (natural gas from a gas well completion that is at or near its wellhead pressure; this does not include flash gas), you may not exceed 2 continuous hours of flaring or venting without Regional Supervisor approval. (iii) You may not exceed 144 cumulative hours of flaring or venting dur- ing a calendar month without Regional Supervisor approval. (7) When equipment fails to work properly, during equipment mainte- (i) For oil-well gas and gas-well flash gas, you may not exceed 48 con- nance and repair, or when you must relieve system pressures. tinuous hours of flaring or venting without Regional Supervisor ap- proval. (ii) For primary gas-well gas, you may not exceed 2 continuous hours of flaring or venting without Regional Supervisor approval. (iii) You may not exceed 144 cumulative hours of flaring or venting dur- ing a calendar month without Regional Supervisor approval. (iv) The continuous and cumulative hours allowed under this paragraph may be counted separately from the hours under paragraph (a)(6) of this section.
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(b) Regardless of the requirements in hydrocarbons. The Regional Supervisor vented at each of those facilities paragraph (a) of this section, you must may allow you to burn liquid separately from those facilities that do not flare or vent gas over the volume hydrocarbons if you demonstrate that not require meters and separately from approved in your Development transporting them to market or re- other facilities with meters. Operations Coordination Document injecting them is not technically feasible (4) If flare/vent meters are not (DOCD) or your Development and or poses a significant risk of harm to required at your facility: Production Plan (DPP). offshore personnel or the environment. (i) You may report the gas flared and (c) The Regional Supervisor may (b) If you burn liquid hydrocarbons vented on a lease or unit basis. Gas establish alternative approval without the required approval, or if the flared and vented from multiple procedures to cover situations when you Regional Supervisor determines that facilities on a single lease or unit may cannot contact the MMS office, such as you were negligent or could have be reported together. during non-office hours. avoided burning liquid hydrocarbons, (ii) If you choose to install meters, you (d) The Regional Supervisor may the hydrocarbons will be considered may report the gas volume flared and specify a volume limit, or a shorter time avoidably lost or wasted. You must pay vented according to the method limit than specified elsewhere in this royalties on the loss or waste, according specified in paragraph (b)(3) of this part, in order to prevent air quality to part 202 of this title. You must value section. degradation or loss of reserves. any liquid hydrocarbons avoidably lost (c) You must prepare and maintain (e) If you flare or vent gas without the or wasted under the provisions of part records detailing gas flaring, gas required approval, or if the Regional 206 of this title. venting, and liquid hydrocarbon Supervisor determines that you were burning for each facility for 6 years. negligent or could have avoided flaring § 250.1163 How must I measure gas flaring (1) You must maintain these records or venting volumes and liquid hydrocarbon or venting the gas, the hydrocarbons on the facility for at least the first 2 burning volumes, and what records must I years and have them available for will be considered avoidably lost or maintain? wasted. You must pay royalties on the inspection by MMS representatives. (a) If your facility processes more than loss or waste, according to part 202 of (2) After 2 years, you must maintain an average of 2,000 bopd during May this title. You must value any gas or the records, allow MMS representatives 2010, you must install flare/vent meters liquid hydrocarbons avoidably lost or to inspect the records upon request and within 180 days after May 2010. If your wasted under the provisions of part 206 provide copies to the Regional facility processes more than an average of this title. Supervisor upon request, but are not (f) Fugitive emissions from valves, of 2,000 bopd during a calendar month required to keep them on the facility. fittings, flanges, pressure relief valves or after May 2010, you must install flare/ (3) The records must include, at a similar components do not require vent meters within 120 days after the minimum: approval under this subpart unless end of the month in which the average (i) Daily volumes of gas flared, gas specifically required by the Regional amount of oil processed exceeds 2,000 vented, and liquid hydrocarbons Supervisor. bopd. burned; (1) You must notify the Regional (ii) Number of hours of gas flaring, gas § 250.1161 When may I flare or vent gas Supervisor when your facility begins to venting, and liquid hydrocarbon for extended periods of time? process more than an average of 2,000 burning, on a daily and monthly You must request and receive bopd in a calendar month; cumulative basis; approval from the Regional Supervisor (2) The flare/vent meters must (iii) A list of the wells contributing to to flare or vent gas for an extended measure all flared and vented gas within gas flaring, gas venting, and liquid period of time. The Regional Supervisor 5 percent accuracy; hydrocarbon burning, along with gas-oil will specify the approved period of (3) You must calibrate the meters ratio data; time, which will not exceed 1 year. The regularly, in accordance with the (iv) Reasons for gas flaring, gas Regional Supervisor may deny your manufacturer’s recommendation, or at venting, and liquid hydrocarbon request if it does not ensure the least once every year, whichever is burning; and conservation of natural resources or is shorter; and (v) Documentation of all required not consistent with national interests (4) You must use and maintain the approvals. relating to development and production flare/vent meters for the life of the (d) If your facility is required to have of minerals of the OCS. The Regional facility. flare/vent meters: Supervisor may approve your request (b) You must report all hydrocarbons (1) You must maintain the meter for one of the following reasons: produced from a well completion, recordings for 6 years. (a) You initiated an action which, including all gas flared, gas vented, and (i) You must keep these recordings on when completed, will eliminate flaring liquid hydrocarbons burned, to Minerals the facility for 2 years and have them and venting; or Revenue Management on Form MMS– available for inspection by MMS (b) You submit to the Regional 4054 (Oil and Gas Operations Report), representatives. Supervisor an evaluation supported by in accordance with § 210.102 of this (ii) After 2 years, you must maintain engineering, geologic, and economic title. the recordings, allow MMS data indicating that the oil and gas (1) You must report the amount of gas representatives to inspect the recordings produced from the well(s) will not flared and the amount of gas vented upon request and provide copies to the economically support the facilities separately. Regional Supervisor upon request, but necessary to sell the gas or to use the gas (2) You may classify and report gas are not required to keep them on the on or for the benefit of the lease. used to operate equipment on the lease, facility. such as gas used to power engines, (iii) These recordings must include § 250.1162 When may I burn produced instrument gas, and gas used to the begin times, end times, and volumes liquid hydrocarbons? maintain pilot lights, as lease use gas. for all flaring and venting incidents. (a) You must request and receive (3) If flare/vent meters are required at (2) You must maintain flare/vent approval from the Regional Supervisor one or more of your facilities, you must meter calibration and maintenance to burn any produced liquid report the amount of gas flared and records on the facility for 2 years.
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(e) If your flaring or venting of gas, or restrict or prohibit flaring, under produced, or produced for a second burning of liquid hydrocarbons, §§ 250.303 and 250.304. time under § 210.102 of this title. required written or oral approval, you (c) The Regional Supervisor may must submit documentation to the § 250.1166 What additional reporting is require you to submit monthly reports required for developments in the Alaska Regional Supervisor summarizing the of flared and vented gas containing H2S. OCS Region? location, dates, number of hours, and Each report must contain, on a daily volumes of gas flared, gas vented, and basis: (a) For any development in the Alaska OCS Region, you must submit an annual liquid hydrocarbons burned under the (1) The volume and duration of each reservoir management report to the approval. flaring and venting occurrence; Regional Supervisor. The report must (2) H S concentration in the flared or § 250.1164 What are the requirements for 2 contain information detailing the vented gas; and flaring or venting gas containing H2S? activities performed during the previous (3) The calculated amount of SO (a) You may not vent gas containing 2 year and planned for the upcoming year emitted. H2S, except for minor releases during that will: maintenance and repair activities that Other Requirements (1) Provide for the prevention of do not result in a 15-minute time- waste; weighted average atmosphere § 250.1165 What must I do for enhanced (2) Provide for the protection of recovery operations? concentration of H2S of 20 ppm or correlative rights; and higher anywhere on the platform. (a) You must promptly initiate (3) Maximize ultimate recovery of oil (b) You may flare gas containing H2S enhanced oil and gas recovery and gas. only if you meet the requirements of operations for all reservoirs where these (b) If your development is jointly §§ 250.1160, 250.1161, 250.1163, and operations would result in an increase regulated by MMS and the State of the following additional requirements: in ultimate recovery of oil or gas under Alaska, MMS and the Alaska Oil and (1) For safety or air pollution sound engineering and economic Gas Conservation Commission will prevention purposes, the Regional principles. jointly determine appropriate reporting Supervisor may further restrict the (b) Before initiating enhanced requirements to minimize or eliminate flaring of gas containing H2S. The recovery operations, you must submit a duplicate reporting requirements. Regional Supervisor will use proposed plan to the Regional (c) Every time you are required to information provided in the lessee’s H2S Supervisor and receive approval for submit Form MMS–127 under Contingency Plan (§ 250.490(f)), pressure maintenance, secondary or § 250.1155, you must request an MER Exploration Plan, DPP, DOCD, and tertiary recovery, cycling, and similar for each producing sensitive reservoir in associated documents to determine the recovery operations intended to increase the Alaska OCS Region, unless need for restrictions; and the ultimate recovery of oil and gas from otherwise instructed by the Regional (2) If the Regional Supervisor a reservoir. The proposed plan must Supervisor. determines that flaring at a facility or include, for each project reservoir, a group of facilities may significantly geologic and engineering overview, § 250.1167 What information must I submit affect the air quality of an onshore area, Form MMS–127 and supporting data as with forms and for approvals? the Regional Supervisor may require required in § 250.1167, and any You must submit the supporting you to conduct an air quality modeling additional information required by the information listed in the following table analysis, under § 250.303, to determine Regional Supervisor. with the forms identified in columns 1 the potential effect of facility emissions. (c) You must report to Minerals and 2 and for the approvals required The Regional Supervisor may require Revenue Management the volumes of under this subpart identified in columns monitoring and reporting, or may oil, gas, or other substances injected, 3 through 6:
Produc- WPT SRI Gas cap Downhole Reservoir tion within MMS– MMS– produc- commin- reclassi- 500-ft of 126 (2 127 (2 tion gling fication a unit or copies) copies) lease line
(a) Maps: (1) Base map with surface, bottomhole, and completion locations with respect to the unit or lease line and the orientation of rep- resentative seismic lines or cross-sections ...... √ √ ...... √ (2) Structure maps with penetration point and subsea depth for each well penetrating the reservoirs, highlighting subject wells; reservoir boundaries; and original and current fluid levels ...... √ √ √ √ √ √ (3) Net sand isopach with total net sand penetrated for each well, identified at the penetration point ...... * √ √ (4) Net hydrocarbon isopach with net feet of pay for each well, identified at the penetration point ...... * √ √ (b) Seismic data: (1) Representative seismic lines, including strike and dip lines that confirm the structure; indicate polarity ...... √ √ ...... √ (2) Amplitude extraction of seismic horizon, if applicable ...... √ √ √ √ (c) Logs: (1) Well log sections with tops and bottoms of the reservoir(s) and proposed or existing perforations ...... √ √ √ √ √ √ (2) Structural cross-sections showing the subject well and nearby wells ...... √ √ √ * (d) Engineering data:
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Produc- WPT SRI Gas cap Downhole Reservoir tion within MMS– MMS– produc- commin- reclassi- 500-ft of 126 (2 127 (2 tion gling fication a unit or copies) copies) lease line
(1) Estimated recoverable reserves for each well completion in the reservoir; total recoverable reserves for each reservoir; method of calculation; reservoir parameters used in volumetric and de- cline curve analysis ...... √ † † ...... √ (2) Well schematics showing current and proposed conditions ...... √ √ ...... √ (3) The drive mechanism of each reservoir ...... √ √ √ √ √ (4) Pressure data, by date, and whether they are estimated or measured ...... √ √ √ (5) Production data and decline curve analysis indicative of the reservoir performance ...... √ √ √ (6) Reservoir simulation with the reservoir parameters used, his- tory matches, and prediction runs (include proposed develop- ment scenario) ...... * * * * (e) General information: (1) Detailed economic analysis ...... * * (2) Reservoir name and whether or not it is competitive as defined under § 250.105 ...... √ √ √ √ √ (3) Operator name, lessee name(s), block, lease number, royalty rate, and unit number (if applicable) of all relevant leases ...... √ √ ...... √ (4) Geologic overview of project ...... √ √ √ √ (5) Explanation of why the proposed completion scenario will maximize ultimate recovery ...... √ √ ...... √ (6) List of all wells in subject reservoirs that have ever produced or been used for injection ...... √ √ √ √ √ Required. † Each Gas Cap Production request and Downhole Commingling request must include the estimated recoverable reserves for (1) the case where your proposed production scenario is approved, and (2) the case where your proposed production scenario is denied. * Additional items the Regional Supervisor may request. Note: All maps must be at a standard scale and show lease and unit lines. The Regional Supervisor may waive submittal of some of the re- quired data on a case-by-case basis.
(f) Depending on the type of approval to provide for the safety of life on [email protected]. If you have requested, you must submit the navigable waters during the event. This questions on viewing or submitting appropriate payment of the service action is intended to restrict vessel material to the docket, call Renee V. fee(s) listed in § 250.125, according to traffic in portions of the Western Wright, Program Manager, Docket the instructions in § 250.126. Branch, Elizabeth River, VA, and North Operations, telephone 202–366–9826. [FR Doc. 2010–8798 Filed 4–16–10; 8:45 am] Atlantic Ocean, Ocean City, MD during SUPPLEMENTARY INFORMATION: BILLING CODE 4310–MR–P each event. DATES: Effective Date: This rule is Regulatory Information effective in the CFR on April 19, 2010. The Coast Guard is issuing this DEPARTMENT OF HOMELAND This rule is effective with actual notice temporary final rule without prior SECURITY for purposes of enforcement from April notice and opportunity to comment 17, 2010 through May 31, 2010. pursuant to authority under section 4(a) Coast Guard ADDRESSES: Documents indicated in this of the Administrative Procedure Act preamble as being available in the (APA) (5 U.S.C. 553(b)). This provision 33 CFR Part 100 docket are part of docket USCG–2010– authorizes an agency to issue a rule 0102 and are available online by going without prior notice and opportunity to [Docket No. USCG–2010–0102] to http://www.regulations.gov, inserting comment when the agency for good RIN 1625–AA08 USCG–2010–0102 in the ‘‘Keyword’’ cause finds that those procedures are box, and then clicking ‘‘Search.’’ They ‘‘impracticable, unnecessary, or contrary Special Local Regulation for Marine are also available for inspection or to the public interest.’’ Under 5 U.S.C. Events; Temporary Change of Dates copying at the Docket Management 553(b)(B), the Coast Guard finds that for Recurring Marine Events in the Facility (M–30), U.S. Department of good cause exists for not publishing a Fifth Coast Guard District Transportation, West Building Ground notice of proposed rulemaking (NPRM) AGENCY: Coast Guard, DHS. Floor, Room W12–140, 1200 New Jersey with respect to this rule because Avenue SE., Washington, DC 20590, ACTION: Temporary final rule. delaying the effective date would be between 9 a.m. and 5 p.m., Monday contrary to the public interest since SUMMARY: The Coast Guard proposes to through Friday, except Federal holidays. immediate action is needed to ensure temporarily change the enforcement FOR FURTHER INFORMATION CONTACT: If the public’s safety during the Virginia period of special local regulations for you have questions on this temporary State Hydroplane Championships and recurring marine events in the Fifth rule, call LT Tiffany Duffy, Project the Geico Offshore Grand Prix. Coast Guard District. These regulations Manager, Sector Hampton Roads, Under 5 U.S.C. 553(d)(3), the Coast apply to only two recurring marine Waterways Management Division, Guard finds that good cause exists for events that conduct power boat races. United States Coast Guard; telephone making this rule effective less than 30 Special local regulations are necessary 757–668–5580, e-mail days after publication in the Federal
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Register. Delaying the effective date inboard hydroplanes racing in heats that will be made to the maritime would be contrary to the public interest counter-clockwise around an oval race community via marine information since immediate action is needed to course. A fleet of spectator vessels is broadcasts, local radio stations and area ensure the public’s safety during the anticipated to gather nearby to view the newspapers so mariners can adjust their Virginia State Hydroplane competition. Therefore, to ensure the plans accordingly. Additionally, this Championships and the Geico Offshore safety of participants, spectators and rulemaking does not change the Grand Prix. transiting vessels, 33 CFR 100.501 permanent regulated areas that have would be enforced for the duration of been published in 33 CFR 100.501, Basis and Purpose the event. Under provisions of 33 CFR Table to § 100.501. In some cases vessel Marine events are frequently held on 100.501, from 9:30 a.m. to 5 p.m. on traffic may be able to transit the the navigable waters within the May 30 and 31, 2010, vessels may not regulated area when the Coast Guard boundary of the Fifth Coast Guard enter the regulated area unless they Patrol Commander deems it is safe to do District. The on water activities that receive permission from the Coast so. typically comprise marine events Guard Patrol Commander. Due to the Small Entities include sailing regattas, power boat need for vessel control during the event, races, swim races and holiday boat vessel traffic will be temporarily Under the Regulatory Flexibility Act parades. For a description of the restricted to provide for the safety of (5 U.S.C. 601–612), we have considered geographical area of each Coast Guard participants, spectators and transiting whether this rule would have a Sector—Captain of the Port Zone, please vessels. significant economic impact on a see 33 CFR 3.25. substantial number of small entities. This regulation temporarily changes Discussion of Rule The term ‘‘small entities’’ comprises the enforcement period of special local The Coast Guard is establishing small businesses, not-for-profit regulations for recurring marine events temporary special local regulations on organizations that are independently within the Fifth Coast Guard District. specified waters of the Western Branch, owned and operated and are not This regulation applies to two marine Elizabeth River, near Portsmouth, dominant in their fields, and events in 33 CFR 100.501, Table to Virginia; and North Atlantic Ocean near governmental jurisdictions with § 100.501. Ocean City, MD. The regulated areas populations of less than 50,000. On April 17 and 18, 2010, the Virginia will be established in the interest of The Coast Guard certifies under 5 Boat Racing Association will sponsor public safety during the Virginia State U.S.C. 605(b) that this rule will not have the ‘‘Virginia State Hydroplane Hydroplane Championships and the a significant economic impact on a Championship’’ hydroplane races on the Geico Offshore Grand Prix, and will be substantial number of small entities. waters of the Western Branch of the enforced on April 17 until April 18, This rule would affect the following Elizabeth River near Portsmouth, 2010, from 9 a.m. to 5:30 p.m. and on entities, some of which might be small Virginia. The regulation at 33 CFR May 30 until May 31, 2010, from 9:30 entities: the owners or operators of 100.501 is effective annually for this a.m. to 5 p.m. Access to the safety zone vessels intending to transit or anchor in river boat race marine event. The event will be restricted during the specified the areas where marine events are being will consist of approximately 60 date and times or until the powerboat held. This regulation will not have a hydroplane powerboats conducting races are complete, whichever is sooner. significant impact on a substantial high-speed competitive races on the Except for participants and vessels number of small entities because it will Western Branch of the Elizabeth River authorized by the Captain of the Port or be enforced only during marine events in the vicinity of Portsmouth City Park, his Representative, no person or vessel that have been permitted by the Coast Portsmouth, Virginia. A fleet of may enter or remain in the regulated Guard Captain of the Port. The Captain spectator vessels is expected to gather area. of the Port will ensure that small near the event site to view the entities are able to operate in the areas competition. To provide for the safety of Regulatory Analyses where events are occurring when it is participants, spectators, support and We developed this rule after safe to do so. This safety zone will not transiting vessels, the Coast Guard will considering numerous statutes and have a significant economic impact on temporarily restrict vessel traffic in the executive orders related to rulemaking. a substantial number of small entities event area during the hydroplane races. Below we summarize our analyses for the following reasons: (i) In some The regulation at 33 CFR 100.501 would based on 13 of these statutes or cases, vessels will be able to safely be enforced for the duration of the executive orders. transit around the regulated area at event. Under provisions of 33 CFR various times; (ii) with the permission Regulatory Planning and Review 100.501, from 9 a.m. to 5:30 p.m. on of the Patrol Commander, vessels may April 17 and 18, 2010, vessels may not This rule is not a significant transit through the regulated area; and enter the regulated area unless they regulatory action under section 3(f) of (iii) before the enforcement period, the receive permission from the Coast Executive Order 12866, Regulatory Coast Guard will issue maritime Guard Patrol Commander. Planning and Review, and does not advisories so mariners can adjust their The Offshore Performance require an assessment of potential costs plans accordingly. Association (OPA) Racing LLC annually and benefits under section 6(a)(3) of that sponsors the ‘‘Offshore Grand Prix’’, on Order. The Office of Management and Assistance for Small Entities the waters of the North Atlantic Ocean Budget has not reviewed it under that Under section 213(a) of the Small near Ocean City, MD. The regulation at Order. Business Regulatory Enforcement 33 CFR 100.501 is effective annually for Although this rule prevents traffic Fairness Act of 1996 (Pub. L. 104–121), the Ocean City Offshore race marine from transiting a portion of certain we offer to assist small entities in event. The event is conducted on the waterways during specified events, the understanding the rule so that they can waters of the North Atlantic Ocean effect of this regulation will not be better evaluate its effects on them and along the shoreline near Ocean City, significant due to the limited duration participate in the rulemaking process. MD. The event consists of that the regulated area will be in effect Small businesses may send comments approximately 50 V-hull and twin-hull and the extensive advance notifications on the actions of Federal employees
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who enforce, or otherwise determine Protection of Children Environment compliance with, Federal regulations to We have analyzed this rule under We have analyzed this rule under the Small Business and Agriculture Executive Order 13045, Protection of Department of Homeland Security Regulatory Enforcement Ombudsman Children from Environmental Health Management Directive 023–01 and and the Regional Small Business Risks and Safety Risks. This rule is not Commandant Instruction M16475.lD, Regulatory Fairness Boards. The an economically significant rule and which guide the Coast Guard in Ombudsman evaluates these actions does not create an environmental risk to complying with the National annually and rates each agency’s health or risk to safety that may Environmental Policy Act of 1969 responsiveness to small business. If you disproportionately affect children. (NEPA)(42 U.S.C. 4321–4370f), and wish to comment on actions by have concluded this action is one of a employees of the Coast Guard, call 1– Indian Tribal Governments category of actions that do not 888–REG–FAIR (1–888–734–3247). The This rule does not have tribal individually or cumulatively have a Coast Guard will not retaliate against implications under Executive Order significant effect on the human small entities that question or complain 13175, Consultation and Coordination environment. This rule is categorically about this rule or any policy or action with Indian Tribal Governments, excluded, under figure 2–1, paragraph of the Coast Guard. because it does not have a substantial (34)(h), of the Instruction. This rule direct effect on one or more Indian Collection of Information involves implementation of regulations tribes, on the relationship between the within 33 CFR part 100 that apply to Federal Government and Indian tribes, This rule calls for no new collection organized marine events on the or on the distribution of power and of information under the Paperwork navigable waters of the United States responsibilities between the Federal Reduction Act of 1995 (44 U.S.C. 3501– that may have potential for negative Government and Indian tribes. 3520). impact on the safety or other interest of Federalism Energy Effects waterway users and shore side activities in the event area. The category of water A rule has implications for federalism We have analyzed this rule under Executive Order 13211, Actions activities includes but is not limited to under Executive Order 13132, Concerning Regulations That sail boat regattas, boat parades, power Federalism, if it has a substantial direct Significantly Affect Energy Supply, boat racing, swimming events, crew effect on State or local governments and Distribution, or Use. We have racing, and sail board racing. would either preempt State law or determined that it is not a ‘‘significant Under figure 2–1, paragraph (34)(h), impose a substantial direct cost of energy action’’ under that order because of the Instruction, an environmental compliance on them. We have analyzed it is not a ‘‘significant regulatory action’’ analysis checklist and a categorical this rule under that Order and have under Executive Order 12866 and is not exclusion determination are not determined that it does not have likely to have a significant adverse effect required for this rule. implications for federalism. on the supply, distribution, or use of List of Subjects in 33 CFR Part 100 Unfunded Mandates Reform Act energy. The Administrator of the Office of Information and Regulatory Affairs Marine safety, Navigation (water), The Unfunded Mandates Reform Act has not designated it as a significant Reporting and recordkeeping of 1995 (2 U.S.C. 1531–1538) requires energy action. Therefore, it does not requirements, Waterways. Federal agencies to assess the effects of require a Statement of Energy Effects their discretionary regulatory actions. In ■ For the reasons discussed in the under Executive Order 13211. particular, the Act addresses actions preamble, the Coast Guard amends 33 that may result in the expenditure by a Technical Standards CFR part 100 as follows: State, local, or tribal government, in the The National Technology Transfer PART 100—SAFETY OF LIFE ON aggregate, or by the private sector of and Advancement Act (NTTAA) (15 NAVIGABLE WATERS $100,000,000 (adjusted for inflation) or U.S.C. 272 note) directs agencies to use more in any one year. Though this rule voluntary consensus standards in their ■ 1. The authority citation for part 100 will not result in such an expenditure, regulatory activities unless the agency continues to read as follows: we do discuss the effects of this rule provides Congress, through the Office of Authority: 33 U.S.C. 1233. elsewhere in this preamble. Management and Budget, with an Taking of Private Property explanation of why using these ■ 2. In § 100.501, suspend line No. 31 standards would be inconsistent with and 38 in the Table to § 100.501. This rule will not cause a taking of applicable law or otherwise impractical. ■ 3. In § 100.501 on April 17 and 18, private property or otherwise have Voluntary consensus standards are 2010, add line No. 58 in Table to taking implications under Executive technical standards (e.g., specifications § 100.501; on May 30 and 31, 2010, add Order 12630, Governmental Actions and of materials, performance, design, or line No. 59 in Table to § 100.501; to read Interference with Constitutionally operation; test methods; sampling as follows: Protected Property Rights. procedures; and related management § 100.501–T05–0102 Special Local Civil Justice Reform systems practices) that are developed or adopted by voluntary consensus Regulations; Marine Events in the Fifth This rule meets applicable standards standards bodies. Coast Guard District. in sections 3(a) and 3(b)(2) of Executive This rule does not use technical * * * * * Order 12988, Civil Justice Reform, to standards. Therefore, we did not Table To § 100.501.—All coordinates minimize litigation, eliminate consider the use of voluntary consensus listed in the Table to § 100.501 reference ambiguity, and reduce burden. standards. Datum NAD 1983.
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COAST GUARD SECTOR HAMPTON ROADS—COTP ZONE
No. Date Event Sponsor Location
******* 58 ...... April 17–April 18, Virginia state hy- Virginia Boat Rac- The waters of the Western Branch, Elizabeth River bounded by a line 2010. droplane cham- ing Association. connecting the following points: latitude 36°50′06″ N, longitude pionships. 076°22′27″ W, thence to latitude 36°50′06″ N, longitude 076°21′57″ W, thence to latitude 36°50′15″ N, longitude 076°21′55.8″ W, thence to latitude 36°50′15″ N, longitude 076°22′27″ W, thence to point of origin. 59 ...... May 30–May 31, Ocean City Mary- Offshore Perform- The waters of the Atlantic Ocean commencing at a point on the shoreline 2010. land Offshore ance Associa- at latitude 38°25′42″ N, longitude 075°03′06″ W; thence east southeast Grand Prix. tion, OPA Rac- to latitude 38°25′30″ N, longitude 075°02′12″ W, thence south south- ing, LLC. west parallel to the Ocean City shoreline to latitude 38°19′12″ N, lon- gitude 075°03′48″ W; thence west northwest to the shoreline at latitude 38°19′30″ N, longitude 075°05′00″ W. The waters of the Atlantic Ocean bounded by a line drawn from a position along the shoreline near Ocean City, MD at latitude 38°22′25.2″ N, longitude 075°03′49.4″ W, thence easterly to latitude 38°22′00.4″ N, longitude 075°02′34.8″ W, thence southwesterly to latitude 38°19′35.9″ N, longitude 075°03′35.4″ W, thence westerly to a position near the shoreline at latitude 38°20′05″ N, longitude 075°04′48.4″ W, thence northerly along the shoreline to the point of origin.
* * * * * Dated: April 7, 2010. M.S. Ogle, Captain, U.S. Coast Guard, Captain of the Port, Hampton Roads. [FR Doc. 2010–8861 Filed 4–16–10; 8:45 am] BILLING CODE 9110–04–P
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Proposed Rules Federal Register Vol. 75, No. 74
Monday, April 19, 2010
This section of the FEDERAL REGISTER RATB Investigative Files’’ and ‘‘RATB— to the subject in providing him or her contains notices to the public of the proposed 12—RATB Fraud Hotline Program with knowledge concerning the nature issuance of rules and regulations. The Files,’’ pursuant to the Privacy Act, as of the investigation and the coordinated purpose of these notices is to give interested amended (74 FR 60302, Nov. 20, 2009). investigative efforts and techniques persons an opportunity to participate in the The Board received no comments on employed by the cooperating agencies. rule making prior to the adoption of the final rules. these proposed systems of records. The This would greatly impede the Board’s following proposed amendments of the criminal law enforcement duties. Board’s Privacy Act regulations, 4 CFR (2) From subsection (c)(4) and (d) RECOVERY ACCOUNTABILITY AND part 200, exempt these systems of because notification would alert a TRANSPARENCY BOARD records from certain provisions of the subject to the fact that an open Privacy Act which require, among other investigation on that individual is 4 CFR Part 200 things, that the Board provide notice taking place, and might weaken the RIN 0430–AA03 when collecting information, account ongoing investigation, reveal for certain disclosures, permit investigatory techniques, and place Privacy Act Regulations individuals access to their records, and confidential informants in jeopardy. allow them to request that the records (3) From subsection (e)(1) because the AGENCY: Recovery Accountability and be amended. These provisions would nature of the criminal and/or civil Transparency Board. interfere with the Board’s oversight investigative function creates unique ACTION: Proposed rule. functions if applied to the Board’s problems in prescribing a specific maintenance of these systems of parameter in a particular case with SUMMARY: The Recovery Accountability records. respect to what information is relevant and Transparency Board (Board) Accordingly, it is proposed to exempt or necessary. Also, due to the Board’s proposes to amend the Board’s these systems of records from specified close working relationship with other regulations implementing the Privacy provisions of the Privacy Act, pursuant Federal, State and local law Act of 1974 (Privacy Act), as amended. to sections 552a(j)(2), (k)(2) and (k)(5). enforcement agencies, information may This proposed rule would exempt be received which may relate to a case List of Subjects in 4 CFR Part 200 certain systems of records from certain under the investigative jurisdiction of sections of the Privacy Act. These Privacy Act of 1974. another agency. The maintenance of this exemptions will help ensure that the For the reasons set forth in the information may be necessary to Board may efficiently and effectively preamble, the Board proposes to amend provide leads for appropriate law compile investigatory material to Chapter II of Title 4, Code of Federal enforcement purposes and to establish prevent and detect fraud, waste, and Regulations, as follows: patterns of activity which may relate to abuse and perform its other authorized CHAPTER II—RECOVERY the jurisdiction of other cooperating duties and activities relating to agencies. oversight of funds awarded pursuant to ACCOUNTABILITY AND TRANSPARENCY BOARD (4) From subsection (e)(2) because the American Recovery and collecting information to the fullest Reinvestment Act of 2009 (Recovery PART 200—PRIVACY ACT OF 1974 extent possible directly from the subject Act). individual may or may not be practical DATES: Comments on the proposed rule 1. The authority for Part 200 in a criminal and/or civil investigation. should be submitted no later than June continues to read as follows: (5) From subsection (e)(3) because 18, 2010. Authority: 5 U.S.C. 552a(f). supplying an individual with a form ADDRESSES: Comments on this proposed 2. Add § 200.17 to read as follows: containing a Privacy Act Statement rule may be submitted: would tend to inhibit cooperation by • By Mail or Hand Delivery: Office of § 200.17 Exemptions. many individuals involved in a criminal General Counsel, Recovery (a) General policy. The Privacy Act and/or civil investigation. The effect Accountability and Transparency Board, permits an agency to exempt certain would be somewhat adverse to 1717 Pennsylvania Avenue, NW., Suite types of systems of records from some established investigative methods and 700, Washington, DC, 20006; of the Privacy Act’s requirements. It is techniques. • By Fax: (202) 254–7970; or the policy of the Board to exercise (6) From subsection (e)(4)(G)–(I) • By E-mail to the Board: authority to exempt systems of records because this system of records is exempt [email protected]. only in compelling cases. from the access provisions of subsection All comments on this proposed (b) Specific systems of records (d). Privacy Act rule should be clearly exempted under (j)(2) and (k)(2). The (7) From subsection (e)(5) because the identified as such. Board exempts the RATB Investigative requirement that records be maintained FOR FURTHER INFORMATION CONTACT: Files (RATB—11) system of records with attention to accuracy, relevance, Jennifer Dure, General Counsel, (703) from the following provisions of 5 timeliness, and completeness would 487–5439. U.S.C. 552a: unfairly hamper the investigative SUPPLEMENTARY INFORMATION: On (1) From subsection (c)(3) because the process. It is the nature of law November 20, 2009, the Board release of accounting of disclosure enforcement for investigations to published in the Federal Register would inform a subject that he or she is uncover the commission of illegal acts proposed system notices to establish under investigation. This information at diverse stages. It is frequently new systems of records, ‘‘RATB—11— would provide considerable advantage impossible to determine initially what
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information is accurate, relevant, timely, could also subject sources and witnesses OFFICE OF PERSONNEL and least of all complete. With the to harassment or intimidation which MANAGEMENT passage of time, seemingly irrelevant or jeopardize the safety and well-being of untimely information may acquire new themselves and their families. 5 CFR Parts 831, 841 significance as further investigation (3) From subsection (e)(1) because the RIN 3206–AM17 brings new details to light. nature of the investigatory function (8) From subsection (e)(8) because the RAILROAD RETIREMENT BOARD notice requirements of this provision creates unique problems in prescribing specific parameters in a particular case could present a serious impediment to 20 CFR Part 350 law enforcement by revealing as to what information is relevant or investigative techniques, procedures, necessary. Due to close working RIN 3220–AB63 and existence of confidential relationships with other Federal, state investigations. and local law enforcement agencies, SOCIAL SECURITY ADMINISTRATION (9) From subsection (f) because the information may be received which may agency’s rules are inapplicable to those relate to a case under the investigative 20 CFR Parts 404, 416 portions of the system that are exempt jurisdiction of another government RIN 0960–AH18 and would place the burden on the agency. It is necessary to maintain this agency of either confirming or denying information in order to provide leads for DEPARTMENT OF THE TREASURY the existence of a record pertaining to a appropriate law enforcement purposes requesting individual, which might in and to establish patterns of activity Fiscal Service itself provide an answer to that which may relate to the jurisdiction of individual relating to an ongoing other cooperating agencies. 31 CFR Part 212 investigation. The conduct of a successful investigation leading to the (4) From subsection (e)(4)(G)–(H) RIN 1505–AC20 indictment of a criminal offender because this system of records is exempt precludes the applicability of from the access provisions of subsection DEPARTMENT OF VETERANS established agency rules relating to (d). AFFAIRS verification of record, disclosure of the (5) From subsection (f) because the 38 CFR Part 1 record to that individual, and record agency’s rules are inapplicable to those amendment procedures for this record portions of the system that are exempt RIN 2900–AN67 system. and would place the burden on the (10) For comparability with the agency of either confirming or denying Garnishment of Accounts Containing exemption claimed from subsection (f), Federal Benefit Payments the civil remedies provisions of the existence of a record pertaining to a subsection (g) must be suspended for requesting individual might in itself AGENCY: Department of the Treasury, this record system. Because of the provide an answer to that individual Fiscal Service (Treasury); Social nature of criminal investigations, relating to an on-going investigation. Security Administration (SSA); standards of accuracy, relevance, The conduct of a successful Department of Veterans Affairs (VA); timeliness, and completeness cannot investigation leading to the indictment Railroad Retirement Board (RRB); Office apply to this record system. Information of a criminal offender precludes the of Personnel Management (OPM). gathered in an investigation is often applicability of established agency rules ACTION: Joint notice of proposed fragmentary, and leads relating to an relating to verification of record, rulemaking. individual in the context of one disclosure of the record to that investigation may instead pertain to a individual, and record amendment SUMMARY: Treasury, SSA, VA, RRB and second investigation. procedures for this record system. OPM (Agencies) are publishing for (c) Specific systems of records comment a proposed rule to implement exempted under (k)(2) and (k)(5). The Ivan J. Flores, statutory restrictions on the garnishment Board exempts the RATB Fraud Hotline Paralegal Specialist, Recovery Accountability of Federal benefit payments. The Program Files (RATB—12) system of and Transparency Board. Agencies are taking this action in records from the following provisions of [FR Doc. 2010–8912 Filed 4–16–10; 8:45 am] response to recent developments in 5 U.S.C. 552a: BILLING CODE 6820–GA–P technology and debt collection practices (1) From subsection (c)(3) because that have led to an increase in the disclosures from this system could freezing of accounts containing Federal interfere with the just, thorough and benefit payments. The proposed rule timely resolution of the complaint or would establish procedures that inquiry, and possibly enable individuals financial institutions must follow when to conceal their wrongdoing or mislead a garnishment order is received for an the course of the investigation by account into which Federal benefit concealing, destroying or fabricating payments have been directly deposited. evidence or documents. The proposed rule would require (2) From subsection (d) because financial institutions that receive a disclosures from this system could garnishment order for an account to interfere with the just, thorough and determine whether any Federal benefit timely resolution of the complaint or payments were deposited to the account inquiry, and possibly enable individuals within 60 calendar days prior to receipt to conceal their wrongdoing or mislead of the order and, if so, would require the the course of the investigation by financial institution to ensure that the concealing, destroying or fabricating account holder has access to an amount evidence or documents. Disclosures equal to the sum of such payments in
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the account or to the current balance of (SSI) benefits, VA benefits, Federal Creditors and debt collectors are often the account, whichever is lower. Railroad retirement benefits, Federal able to obtain court orders garnishing DATES: Comments must be received on Railroad unemployment and sickness funds in an individual’s account at a or before June 18, 2010. benefits, Civil Service Retirement financial institution. Neither the ADDRESSES: The Agencies invite System benefits and Federal Employees creditor nor the court issuing the order comments on all aspects of this Retirement System benefits. These may know whether an account contains proposed rule. In accordance with the benefits, which are generally exempt Federal benefit payments. To comply U.S. government’s eRulemaking under Federal law from garnishment with court garnishment orders and Initiative, the Agencies publish orders and the claims of judgment preserve funds subject to the orders, rulemaking information on http:// creditors, often constitute a major financial institutions often place a www.regulations.gov. Regulations.gov portion, and sometimes all, of an temporary freeze on an account upon offers the public the ability to comment individual’s income. As a result, when receipt of a garnishment order. on, search, and view publicly available financial institutions receive Although state laws provide account rulemaking materials, including garnishment orders and place freezes on owners with an opportunity to assert comments received on rules. accounts containing exempt Federal any rights, exemptions, and challenges The Agencies will jointly review all of benefit payments, the recipients of these to the garnishment order, including the the comments submitted. Comments on funds can face significant hardship. At exemptions under applicable Federal this rule must only be submitted using the same time, financial institutions are benefits laws, the freezing of funds the following methods: required by law to comply with during the time it takes to file and • Federal eRulemaking Portal: http:// garnishment orders, which may adjudicate such a claim can cause www.regulations.gov. Follow the necessitate placing a freeze on an significant hardship for account owners. instructions on the Web site for account that contains Federal benefit This is especially true when, as is often submitting comments. payments. The Agencies are proposing • the case, the recipient of Federal Mail: Gary Grippo, Deputy to adopt a rule that would set forth benefits depends on these funds as his Assistant Secretary, Fiscal Operations straightforward, uniform procedures for or her primary or sole source of income. and Policy, U.S. Department of the financial institutions to follow in order Recent statistics show that 32 percent of Treasury, 1500 Pennsylvania Avenue, to minimize the hardships encountered Social Security beneficiary married NW., Room 2112, Washington, DC by Federal benefit payment recipients couples or nonmarried persons age 65 or 20220. whose accounts are frozen pursuant to older reported receiving 90 percent or Instructions: All submissions received a garnishment order. more of their income from Social must include the Agencies’ names and Security. In addition, Social Security RIN numbers 3206–AM17, 3220–AB63, I. Background benefits are the primary source of 0960–AH18, 1505–AC20, and 2900– Social Security benefits, SSI benefits, income (representing 50 percent or more AN67 for this rulemaking. In general, VA benefits, Federal Railroad comments received will be published on of total income) for 64 percent of Retirement benefits, Federal Railroad beneficiary married couples or Regulations.gov without change, unemployment and sickness benefits, 5 including any business or personal nonmarried persons age 65 or older. If Civil Service Retirement System their accounts are frozen, these information provided. Treasury will benefits and Federal Employees also make such comments available for individuals may find themselves Retirement System benefits are without access to the funds in their public inspection and copying in protected under Federal law from Treasury’s Library, Room 1428, account unless and until they contest garnishment and the claims of judgment the garnishment order in court, a Department of the Treasury, 1500 creditors.1 For example, Section 207 of Pennsylvania Avenue, NW., process that can be confusing, the Social Security Act provides that protracted and expensive. Washington, DC 20220, on official moneys paid or payable as Old-Age, business days between the hours of 10 Survivors, and Disability Insurance At the same time, financial a.m. and 5 p.m. Eastern Time. You can (OASDI) benefits are not ‘‘subject to institutions are required by law to make an appointment to inspect execution, levy, attachment, comply with garnishment orders. A comments by telephoning (202) 622– garnishment, or other legal process.’’ 2 financial institution that fails to 0990. Comments received, including Similarly, VA benefits are exempt, in preserve and remit funds may be at risk attachments and other supporting most cases, from ‘‘attachment, levy, or of being held in contempt of court. In materials, are part of the public record seizure by or under any legal or many cases, a financial institution and subject to public disclosure. Do not equitable process whatever, either would be liable for any funds that are include any information in your before or after receipt by the withdrawn by an account holder after comment or supporting materials that beneficiary’’ under a separate section of the financial institution has received a you consider confidential or the United States Code.3 Federal garnishment order for the account. inappropriate for public disclosure. Railroad Retirement benefits, Federal It can be difficult for a financial FOR FURTHER INFORMATION CONTACT: Gary Railroad unemployment and sickness institution to determine whether an Grippo, Deputy Assistant Secretary, benefits, Civil Service Retirement account contains Federal benefit Fiscal Operations and Policy, U.S. System benefits and Federal Employees payments that are exempt from Department of the Treasury, at (202) Retirement System benefits are similarly garnishment (‘‘exempt funds’’ or 622–6222, or e-mail questions to protected under Federal law.4 ‘‘exempt payments’’). A financial [email protected]. institution may not understand the SUPPLEMENTARY INFORMATION: The 1 See 42 U.S.C. 407(a); 42 U.S.C. 1383(d)(1); 38 Agencies are proposing to adopt a rule U.S.C. 5301(a); 45 U.S.C. 231m(a); 45 U.S.C. 352(e); 5 Annual Statistical Supplement to the Social 5 U.S.C. 8346(a) and 5 U.S.C. 8470. to address concerns associated with the Security Bulletin, 2008 Social Security 2 42 U.S.C. 407. Administration Office of Retirement and Disability garnishment of exempt Federal benefit 3 38 U.S.C. 5301(a)(1). Policy Office of Research, Evaluation, and Statistics payments, including Social Security 4 45 U.S.C. 231m(a); 45 U.S.C. 352(e); 5 U.S.C. SSA Publication No. 13–11700. Released: March benefits, Supplemental Security Income 8346; 5 U.S.C. 8470. 2009.
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Automated Clearing House 6 (ACH) In addition, garnishment orders may proposed rule has an exclusion for those batch header fields that accompany not provide sufficient information to cases where a Federal entity is the direct deposit payments and identify allow financial institutions to know if creditor. different Federal benefit programs, and an order is subject to one of the Account Review and Lookback Period thus the institution will not necessarily exceptions allowing garnishment of conclude from the information available Federal benefit payments. The second step for a financial to it that a direct deposit payment is an As a result of these complexities, institution that receives a garnishment exempt payment. Identifying exempt many financial institutions have order for an account would be to review payments can be even more challenging concluded that they are not in a position the account history during the 60-day when an account holder deposits checks to evaluate the extent to which funds in period that precedes the receipt of the representing benefit payments to an an account are protected from garnishment order. If, during this account. To determine whether a check garnishment, and that attempting to do ‘‘lookback period,’’ one or more exempt representing exempt funds was so may expose them to liability. The payments were directly deposited to the deposited to an account, a financial account holder is thus left to assert in account, the financial institution must institution would have to review images court any Federal law protections that allow the account holder to have access of the deposit tickets and the checks may be available to exempt funds in an to an amount equal to the lesser of the deposited to the account—a manual, account, resulting in the hardships sum of such exempt payments or the time-consuming, and costly process. discussed above. balance of the account on the date of the One of the biggest obstacles to account review (the ‘‘protected determining whether an account II. Overview of Proposed Rule amount’’). The financial institution must contains exempt funds arises when both To address the foregoing problems, notify the account holder of the exempt funds and non-exempt funds the Agencies are proposing to adopt a protections from garnishment that apply have been deposited to an account. In new rule. The primary goals of the to exempt funds. The Agencies are such cases, there is no single, proposed rule are (1) to ensure that proposing that the lookback period be consistently applied accounting benefit recipients have access to exempt 60 calendar days to provide financial standard to determine the proportion of funds while garnishment orders are institutions with a reasonable and easily the commingled funds that should be complied with, adjudicated, or applied boundary for the account protected from garnishment. For otherwise resolved; (2) to protect review, and so that the last two cycles example, if a $1000 exempt payment is financial institutions from liability of benefit payments under any of the deposited to John Doe’s account on May when, having received a garnishment Agencies’ programs are generally 1, followed by a $300 withdrawal on order for an account receiving Federal covered. The Agencies welcome May 2, a $200 deposit of non-exempt benefit payments, they allow the comment on the definition and effects of funds on May 3, and a $400 withdrawal account holder access to exempt funds the proposed lookback period. on May 4, it is not clear what amount in the account; and (3) to establish The Agencies considered using a of money is exempt from a garnishment straightforward, uniform, cost effective uniform, flat amount in the definition of order received on May 5. If a first-in, procedures addressing the extent to the protected amount that would apply first-out method of identifying funds is which financial institutions may, in all cases where a benefit payment used, $300 would be exempt.7 An pursuant to garnishment orders, freeze was deposited to an account during the alternative approach would result in the or seize funds in accounts that contain lookback period. For example, the determination that $500 would be Federal benefits. The rule would protect Agencies considered a policy that the exempt.8 Yet a third approach would financial institutions that follow protected amount would mean the lesser of (i) $2,200 or (ii) the balance in result in a determination that $389 specified procedures from the risk of the account on the date of account would be exempt.9 liability, contempt of court, or civil review. This approach of establishing a penalties when they permit account standard protected amount of $2,200 6 The Automated Clearing House is the holders to access funds in the account would provide certainty, clarity, and nationwide electronic fund transfer system that in accordance with the requisite provides for the inter-bank clearing of direct deposit administrative simplicity for all parties. procedures. The rule would not limit an transactions and for the exchange of payment- However, the Agencies are concerned account holder’s right to assert any related information among participating financial that such a definition may go beyond institutions. additional protections against the underlying statutory authorities to 7 There are $1000 in exempt funds at end of May garnishment that might be available protect ‘‘moneys paid’’ and would result 1; $700 in exempt funds at end of May 2; and $700 under Federal or state law. The in exempt funds and $200 in non-exempt funds at in the unauthorized over-protection of Agencies seek comment on all aspects of end of May 3. On May 4, the $400 withdrawal is funds when benefit payments were less applied against the first funds that were deposited the proposed rule. to the account, i.e., the remaining $700 exempt than the flat amount, or when the funds amount. Under this approach, there would be an Procedural Instructions for Financial in the account could not be reasonably exempt amount of $300 on May 5. Institutions traced back to earlier benefit payments. 8 There are $1000 in exempt funds at end of May The proposed rule is largely The Agencies welcome comment on the 1; $700 in exempt funds at end of May 2; and $700 underlying statutory authority and the in exempt funds and $200 in non-exempt funds at structured as a series of straightforward end of May 3. The May 4 $400 withdrawal is actions that a financial institution must definition of the protected amount. If an individual has multiple accounts allocated equally to the exempt and non-exempt carry out upon receipt of a garnishment funds, i.e., $200 is treated as being withdrawn from at a financial institution, the proposed order. The first step in the sequence is the exempt funds and $200 is treated as being rule would require a separate account withdrawn from the non-exempt funds, for an to determine if the United States is the review, and the establishment of a exempt amount of $500 on May 5. plaintiff that obtained the order against 9 separate protected amount, for each There are $1000 in exempt funds at end of May an account holder. For the reasons 1; $700 in exempt funds at end of May 2; $700 in account. Further, in some cases an discussed in more detail below, the exempt funds and $200 in non-exempt funds at end individual with multiple accounts may of May 3. On May 4, the $400 withdrawal is treated make one-time or recurring transfers as occurring in proportion to the nature of the funds 2⁄9 of the withdrawal, or $89, is treated as in the account, i.e., 7⁄9 of the withdrawal, or $311, withdrawn from the non-exempt funds. Under this between accounts. If an exempt is treated as withdrawn from the exempt funds and approach, $389 would be exempt on May 5. payment is directly deposited into one
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account and funds from that account are account. The Agencies are not as a protective measure to limit the subsequently transferred to a second proposing to address checks within the financial institution’s liability for account, the financial institution would rule for two reasons. First, checks do not releasing other funds to the account have no requirement to trace funds into appear to raise the same concerns raised holder, or because the financial the second account or to establish a by the direct deposit of exempt funds. institution is unaware of which funds in protected amount in the second account A benefit recipient who receives a the account are exempt from as a result of the transfer. The account Treasury check representing exempt garnishment. review on the second account would be funds can choose to cash the check As already discussed, Federal law performed independent of the first rather than to deposit the check and protects Federal benefits payments from account based on an examination for take on the risk that the funds will be garnishment, seizure, or other legal directly deposited Federal benefit garnished. In contrast, direct deposit by process.10 Some federal and state courts payments, not account transfers. The its very definition involves the have found that in certain Agencies request comment on this depositing of the payment to an account aspect of the proposed rule. without the intermediate step in which circumstances a temporary freeze on an the payment beneficiary receives the account containing exempt funds may Process for Identifying Exempt Funds payment instrument and has physical violate Federal anti-garnishment The Agencies will do two things to control of its disposition through statutes. See, e.g., Finberg v. Sullivan, assist financial institutions to determine endorsement and negotiation. Second, 634 F.2d 50 (3d Cir. 1980); Mayers v. whether exempt funds were directly there is no way currently for financial N.Y. Cmty. Bancorp, Inc., No. CV–03– deposited during the lookback period. institutions to readily identify whether 5837, 2005 U.S. Dist. LEXIS 20279 First, Treasury will encode an ‘‘X’’ in a Treasury check that was deposited to (E.D.N.Y. Aug. 13, 2005); Brosamer v. position 20 of the ‘‘Company Name’’ an account represents exempt funds. Mark, 540 N.E.2d 652 (Ind. Ct. App. Field of the Batch Header Record for Whereas the Agencies are proposing the 1989). Although the Agencies each Agency exempt benefit Automated inclusion of identifiers for directly considered limiting the rule to only Clearing House (ACH) payment. For deposited payments, there is no those freezes mandated by court order example, a typical Social Security equivalent approach that would make it or state statute or regulation, there is benefit payment would have a company possible for financial institutions to concern that in light of the legal name of ‘‘US TREASURY 303X.’’ This determine whether a Treasury check uncertainty such a limited rule could encoding, along with the current represents an exempt payment. Even if not be fashioned in a manner that would practice of encoding a ‘‘2’’ in the the Agencies could develop a way for an protect exempt funds from being frozen. ‘‘Originator Status Code’’ Field in the identifier to be included on a Treasury The Agencies have therefore determined Batch Header Record to designate check, a financial institution would that the only way to protect exempt payments originated from the Federal need to manually pull up images or funds from being subjected to government, will allow financial copies of recent items to find Treasury garnishment, seizure, or other legal institutions to identify Federal exempt checks and visually inspect them. process is to preclude financial payments through either manual or The fact that the rule would not institutions from placing freezes on systems inspection. address Treasury checks in no way protected funds in all circumstances. Second, the Agencies will publish a affects an individual’s right to assert or list of the unique ‘‘Entry Detail receive an exemption from garnishment Direct Service on Agencies for Alimony Description’’ Fields in the Batch Header by following the procedures specified and Child Support Obligations Record for all of their exempt benefit under the applicable law. Indeed, Under the proposed rule, financial payments. For example, the ‘‘SUPP SEC’’ nothing in the proposed rule in any way institutions would not be responsible entry denotes an exempt Supplemental limits or restricts an account holder’s for determining the purpose of a Security Income benefit payment, and right to assert a claim that any or all garnishment order, including whether ‘‘VA CH31’’ denotes an exempt VA funds in an account are protected from the order seeks to collect child support Vocational Rehabilitation & Education garnishment under Federal or state law, or alimony obligations. Financial benefit payment. including funds deposited by check or Because information in the ‘‘Company a balance in the account in excess of the institutions would calculate the Name’’ and the ‘‘Entry Detail protected amount. protected amount and ensure that the Description’’ Fields is typically included protected amount is not frozen, and on the account holder’s bank statement, Discretionary Account Freezes would be protected from any liability financial institutions should also be able The Agencies are aware that a for taking this action. to visually identify an exempt payment minority of jurisdictions may permit, Parties seeking to garnish Federal using a standard customer service or but not require, financial institutions to benefit payments for alimony or child account maintenance screen. respond to a garnishment order by support obligations would not be Treasury will update the Green Book, placing a freeze on the judgment foreclosed from recovering these A Guide to Federal Government ACH debtor’s entire account or on an amount amounts, however, as they can pursue Payments and Collections, to reflect of account funds greater than that which these benefits directly by garnishing these mechanisms for identifying the financial institution is directed to benefit payments before they are made exempt Federal payments, and financial sequester by court order. The proposed by the Agency issuing the payment. See institutions will be able to rely on this rule would preclude financial 42 U.S.C. 659. SSA, VA, RRB and OPM combination of identifiers to determine institutions from placing freezes on each accept service of process of whether exempt payments were protected funds in all circumstances, garnishment orders for child support deposited to an account during the even when the freeze is discretionary in and alimony, and will give effect to lookback period. the sense of not being compelled by such orders if the payments that are the Financial institutions would not be court order or state statute or regulation. required to research checks to determine Financial institutions may undertake 10 See 42 U.S.C. 407(a); 42 U.S.C. 1383(d)(1); 38 whether a Treasury check representing such ‘‘discretionary’’ freezes covering U.S.C. 5301(a); 45 U.S.C. 231m(a); 45 U.S.C. 352(e); an exempt payment was deposited to an amounts in excess of the judgment debt 5 U.S.C. 8346(a) and 5 U.S.C. 8470.
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subject of the order can legally be financial institution from complying that are specific to accounts to which garnished for these purposes.11 with the order’s ongoing requirements. exempt payments are deposited. In This partial preemption is necessary addition, for accounts containing a Protected Amount to give effect to the protections in the protected amount, a financial institution The Agencies are proposing that the anti-garnishment statutes, since it is not would not be permitted to charge or protected amount be the lesser of (1) the feasible to implement both a protected collect a garnishment fee after the date sum of all benefit payments directly amount and to permit continuing of account review. Thus, a financial deposited to the account during the garnishment. Unlike one-time institution could not defer a lookback period, or (2) the balance in garnishment orders, with respect to garnishment fee until future deposits are the account on the day when the which a financial institution may received in the account. comply by reviewing prior deposits in financial institution reviews the account Notice to Account Owner history.12 As described above, the intent an accounting system during a defined To ensure that recipients are aware of of the 60-day lookback period is to lookback period, continuing their rights to challenge a garnishment ensure that two benefit payment cycles garnishment orders would require order, financial institutions would be are generally captured and thus produce financial institutions to take action on required to deliver a notice explaining in most cases a protected amount equal each future deposit. That is, a benefit these rights to the owner of any account to twice the monthly benefit amounts. payment could be protected only if for which the financial institution The Agencies welcome comment on this financial institutions monitored new deposits in real time, or at least daily, conducted an account review and to definition of the protected amount. to assess which are exempt and which which an exempt payment was directly It is important to note that the are not exempt from garnishment, to be deposited during the lookback period. protected amount is not the same as the sure that exempt funds are never frozen. The notice, which would have to amount of funds that may ultimately be The Agencies believe that a policy of include certain information set forth in exempt from garnishment. The requiring financial institutions to the proposed rule, would be required to proposed rule would not prevent or monitor deposits daily would be neither be sent within two business days of the limit a benefit recipient from operationally nor economically feasible, completion of the account review. The challenging a garnishment order; it and would put financial institutions in proposed rule contains a model notice. would simply prevent the freezing of a the untenable position of having to Financial institutions would not be lifeline amount of exempt funds. Thus, choose between noncompliance with required to use the model notice, but if a benefit recipient believed that an the rule, by freezing accounts, or those that choose to do so would be account contained exempt funds in noncompliance with the continuing deemed to be in compliance with the excess of the protected amount, the garnishment order, by allowing the notice content requirements set forth in recipient could follow the procedures account holder access to all funds. Even the rule. established under the applicable law to if it were possible to implement such a Safe Harbor for Financial Institutions contest the garnishment. policy in a manner consistent with the The proposed rule would provide a Continuing Garnishments anti-garnishment statutes, its costs and burdens could result in benefit safe harbor for financial institutions that A small number of states authorize recipients finding it difficult to obtain comply with the required procedures. A the issuance of a ‘‘continuing’’ banking services. Accordingly, the financial institution that makes garnishment order, i.e., an order proposed rule necessarily preempts the available the protected amount to an requiring the garnishee to monitor, requirements of continuing garnishment account holder in accordance with the preserve and remit funds coming into in cases where a benefit payment was rule’s requirements would not be at risk the garnishee’s custody on an ongoing deposited into an account during the of contempt of court or liability to a basis.13 Under the proposed rule, a lookback period. The Agencies note, judgment creditor. The proposed rule financial institution that receives a however, that while the proposed rule would preempt any state or local garnishment order for an account preempts the continuing garnishment of government law or regulation that is containing a protected amount would an account pursuant to one court order, inconsistent with the proposed rule, but have no continuing obligation to garnish creditors are not restricted from only to the extent that an inconsistency amounts deposited or credited to the obtaining, and courts are not prohibited would prevent a financial institution account following the date of account from issuing, discrete new garnishment from complying with the requirements review, and would not be permitted to orders against the same account over of the proposed rule. Some state laws, take any action to freeze any amounts time. for example, may protect from garnishment funds in a bank account in subsequently deposited or credited Garnishment Fees unless served a new or different an amount that exceeds the protected The proposed rule would prohibit garnishment order. In effect, the amount. The proposed rule does not financial institutions from charging proposed rule would partially preempt displace or supersede such a state law garnishment fees against protected state law by converting an ongoing requirement. amounts. For an account that contains a garnishment order into a one-time protected amount, the financial Treatment of Garnishment Orders garnishment order and prohibiting the institution would be permitted to collect Obtained by the United States a garnishment fee only against funds in As described above, in cases where 11 See 5 CFR part 581; see also, 20 CFR 404.1820; SSA Program Operations Manual System GN the account in excess of the protected the United States is the plaintiff that has 02410.200–.210; 20 CFR part 350; and VA Veterans amount on the date of the account obtained a garnishment order against an Benefits Administration Manual Rewrite M21–1MR, review, and only if the financial account holder, the proposed rule part III, subpart v, chapter 3, section C.13. institution customarily charges its other would not require the financial 12 If the balance in the account is zero or if the account holders a garnishment fee of the institution to perform an account review account balance is negative, there would be no protected amount. same nature and in the same amount. or establish a protected amount. The 13 See, e.g., NY Civil Prac L & R 5222(b); Pa. R. Financial institutions would not be Agencies are adopting this categorical Civil P. 3111(c). permitted to charge garnishment fees exclusion of garnishment orders
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obtained by the United States for two to be continuing. See 28 U.S.C. 3104(a), Reserve Board, and Office of Thrift reasons. 3205(a). If both the FDCPA and the Supervision) and the National Credit First, while the statutes that prohibit proposed rule applied to the same Union Administration have authority the garnishment of Federal benefit garnishment orders, confusion would under the Federal Deposit Insurance Act payments apply in some instances when likely arise from the overlapping and (12 U.S.C. 1818) and the Federal Credit the United States is a creditor, there are conflicting provisions. Additional Union Act (12 U.S.C. 1786), several Federal statutes that expressly procedural steps are needed to respectively, to pursue enforcement permit the United States to garnish such harmonize the two authorities. actions against insured depository payments in other instances. These Therefore, in light of the express institutions and insured credit unions statutes permitting the United States to authority of the United States to garnish for violations of law, rule or regulation. garnish Federal benefits payments Federal benefit payments in certain The provisions of the rule that would be include 18 U.S.C. 3613(a), 26 U.S.C. instances, the protections already applicable to insured depository 6334(c), 31 U.S.C. 3716(c)(3)(A)(i), and guaranteed debtors under the FDCPA in institutions and insured credit unions 42 U.S.C. 1320a–8(e)(1)(C). Absent a all instances, and the confusion that would be subject to such enforcement carve-out for all garnishment orders would arise from having a rule with authority. obtained by the United States, financial exceptions to comply with conflicting institutions would face uncertainty and Federal statutes, the Agencies have III. Section-by-Section Analysis for 31 the burden of determining which chosen to establish a bright-line, CFR Part 212 authority applied in a given instance. procedural exclusion for garnishment The provisions of the proposed rule Second, garnishments obtained by the orders obtained by the United States. would be set forth in a new part 212 to United States are already governed by a With such orders, financial 31 CFR. SSA, VA, RRB and OPM are comprehensive Federal statute that institutions would not be required to each proposing to amend their existing would overlap with certain provisions perform an account review or take regulations to include a cross-reference in the proposed rule and conflict with actions otherwise required by the to 31 CFR Part 212. others. The Federal Debt Collection proposed rule. Rather, the proposed rule Procedures Act (FDCPA), 28 U.S.C. 3001 would direct financial institutions to Section 212.1 et seq., establishes a uniform framework follow their customary procedures for Section 212.1 sets forth the purposes with exclusive civil procedures for the garnishment orders and treat the of the proposed rule. collection of all judgments due the relevant account(s) as if no Federal United States, including cases where the benefit payment were present. Financial Section 212.2 United States is prohibited from institutions could rely on the naming of The proposed rule would apply to garnishing Federal benefit payments as the ‘‘United States of America,’’ ‘‘United every entity defined as a financial well as cases where it is expressly States,’’ or ‘‘U.S.’’ as the plaintiff in the institution, if the financial institution allowed to garnish such payments. See caption of the order, or on a standard holds accounts to which benefit H.R. Rep. No. 101–736, at 32 (1990) certification that a Federal entity payments are directly deposited by one (‘‘the purpose of [the FDCPA] is to create attaches to the order, to easily determine or more of the Agencies. a comprehensive statutory framework if the garnishment order was obtained Section 212.3 for the collection of debts owed to the by the United States. The proposed rule United States government. Creation of a would provide a safe harbor for Various terms used in the proposed uniform Federal framework for the financial institutions that comply with regulation are defined in section 212.3. collection of Federal debts in the the procedures required by the proposed ‘‘Account’’ is defined to mean any Federal Courts will improve the rule. account held by a financial institution efficiency and speed in collection of Finally, the Agencies note that the to which benefit payments can be those debts* * *’’). United States obtains all garnishment delivered by direct deposit. If a financial While the proposed rule is needed to orders in Federal court. Thus, although institution holds an account that does address the problems of garnishing the proposed rule establishes an not have the capability to receive direct exempt funds, it would both overlap exclusion for garnishment orders deposit payments, then that account and conflict with the framework of the obtained by the United States, it still would not fall within the definition, and FDCPA unless garnishment orders fulfills the goal of providing financial the proposed rule would not apply to obtained by the United States are institutions with a uniform national the financial institution’s handling of excluded. For example, the FDCPA policy for handling garnishment orders the order. includes numerous procedural issued by all state courts. The Agencies For the reasons discussed above, protections for debtors who owe money invite comments on all aspects of this ‘‘benefit payment’’ is defined as a direct to the United States that are intended to policy on garnishment orders obtained deposit payment, and not a check achieve similar goals as the proposed by the United States. payment. Accordingly, financial rule. It allows a debtor to exempt certain Notwithstanding the need for this institutions would not need to identify property from a money judgment based exclusion, to the extent that a Federal benefit checks deposited to an account, on either bankruptcy law or other non- benefit payment is exempt from a and any such deposits would not be bankruptcy Federal, State and local law, garnishment order obtained by the considered in determining whether including the debtor’s right to receive United States, this exclusion does not there is a protected amount. various benefits, maintenance alter such exempt status, or an ‘‘Financial institution’’ is defined as a payments, and pensions and annuities. individual’s right to assert an bank, savings association, credit union See 28 U.S.C. 3014 and 11 U.S.C. exemption, that may exist under Federal or other entity chartered under Federal 552(d). In addition, section 212.6(f) of law. or state law to engage in the business of the proposed rule would conflict with banking. The definition is intended to the FDCPA by providing that financial Enforcement be very broad, in order to capture any institutions shall have no continuing or The Federal banking agencies (the financial institution that might hold an periodic garnishment responsibilities. Comptroller of the Currency, Federal account to which Federal benefits may The FDCPA requires garnishment orders Deposit Insurance Corporation, Federal be directly deposited. The Agencies
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request comment on whether the required to follow the procedures in such a case, the financial institution proposed definition is appropriate. sections 212.5 and 212.6. must calculate the protected amount, as The definition of ‘‘garnish’’ and defined in proposed section 212.3. A Section 212.5 ‘‘garnishment’’ are based on the wording financial institution may not freeze, or of Agency statutes establishing the Proposed section 212.5 outlines the otherwise restrict the account holder’s exemption of certain Federal benefit account review a financial institution access to, the protected amount. The payments from garnishment. must conduct if it has determined, protection against freezing triggered by ‘‘Garnishment fee’’ is broadly defined to pursuant to section 212.4, that a the depositing of exempt funds during mean any kind of a fee that a financial garnishment order was not obtained by the lookback period is automatic. A institution charges to an account holder the United States. In such cases, a financial institution may not require an related to the receipt or processing of a financial institution must review the account holder to assert any right to a garnishment order. ‘‘Garnishment order’’ history of the account being garnished garnishment exemption or take any and ‘‘order’’ are defined to mean a writ, to determine if a benefit payment was other action prior to accessing the order notice, summons, or similar deposited into the account during the protected amount. written instruction issued by a court to lookback period. If no benefit payments Section 212.6(c) requires the financial effect a garnishment. were deposited to the account during institution to send a notice to the ‘‘Lookback period’’ is defined to mean the lookback period, then the financial account holder. The content and timing the 60 calendar-day period preceding institution would follow its otherwise required for the notice are set forth in the date on which a financial institution customary procedures for handling the section 212.7. is served a garnishment order. The order. If a benefit payment was Section 212.6(d) addresses the Agencies are proposing that the deposited into the account during the situation in which a financial institution lookback period be 60 calendar days lookback period, then the financial receives service of the same long in order to generally cover the last institution must follow the procedures garnishment order more than once. The two cycles of benefits paid under any of set forth in section 212.6. financial institution must execute the the Agencies’ programs. Proposed section 212.5(d) lists factors account review one time upon the first ‘‘Protected amount’’ is defined as the that are not relevant to a financial service of a given garnishment order. If lesser of (i) the sum of all benefit institution’s account review. The the same garnishment order is payments deposited to the account commingling of exempt and nonexempt subsequently served again upon the during the lookback period or (ii) the funds in the account is not relevant to financial institution, the financial balance in an account on the date of the account review, and neither is the institution is not required to perform account review. Under this definition, existence of a co-owner on the account. another account review and is restricted there would not be a protected amount Similarly, the fact that benefit payments from taking any action on the account. if the account balance is zero or the to multiple beneficiaries may have been If the financial institution is account is overdrawn. deposited to an account during the subsequently served a new or different ‘‘State’’ is defined to mean a state of lookback period is not relevant, as could garnishment order against the same the United States, the District of occur if an individual receives account, the financial institution must Columbia, the Commonwealth of Puerto payments on behalf of several execute a new account review. Rico, the Commonwealth of the beneficiaries. Finally, any instructions Section 212.6(e) provides that a Northern Mariana Islands, American or information in a garnishment order financial institution has no continuing Samoa, Guam, or the United States are not relevant, including information obligation to garnish amounts deposited Virgin Islands. about the nature of the debt or or credited to the account following the date of account review, and may not Section 212.4 obligation underlying the order, such as alimony or child support obligations. take any action to freeze any amounts Section 212.4 of the proposed rule Section 212.5(e) makes it clear that subsequently deposited or credited sets forth the first action that a financial financial institutions must perform the unless served a new or different institution must take when it receives a account review before taking any action garnishment order. A small number of garnishment order, which is to related to the garnishment order that states authorize the issuance of a determine whether the order was may affect funds in an account. Section ‘‘continuing’’ garnishment order, i.e., an obtained by the United States. In most 212.5(f) requires a separate account order requiring the garnishee to cases, garnishment orders obtained by review for each account against which monitor, preserve and remit funds the United States will be readily a garnishment order has been issued, coming into the garnishee’s custody on identifiable by the caption on the first even if an individual holds more than an ongoing basis. The proposed rule page of the order, which will read one account at a financial institution. would operate to prohibit a financial ‘‘United States of America,’’ or ‘‘United For example, if an individual maintains institution that is served with a States,’’ or ‘‘U.S.’’ In some cases, two accounts at the same financial continuing garnishment from complying however, this will not be the case. institution, and payments issued under with the order’s ongoing requirements. Accordingly, financial institutions must two different benefit programs are Section 212.6(f) provides that a also check to see whether the order is directly deposited to each account, both financial institution may collect a accompanied by a Notice of accounts must be separately reviewed garnishment fee only against funds in Garnishment by the United States, as set and a separate protected amount must the account in excess of the protected forth in Appendix B. Financial be calculated and applied for each amount on the date of account review. institutions may rely on this two-step account. Such a fee may be charged only if the test to determine if an order was financial institution generally imposes a obtained by the United States. For Section 212.6 fee of this nature and amount for its orders obtained by the United States, Proposed section 212.6 contains the accounts. The fee may not be imposed the financial institution would follow provisions that apply if a financial only on accounts to which benefit its otherwise customary procedures for institution determines that one or more payments are deposited. handling the order. For all other orders, benefit payments were deposited to an Section 212.6(g) prohibits a financial the financial institutions would be account during the lookback period. In institution from charging a garnishment
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fee against a protected amount, and Proposed section 212.8 provides that institution would not be liable even if further prohibits a financial institution the rule is not to be construed to a judgment creditor were able to from charging or collecting such a fee invalidate any term or condition of an establish in court that funds in the after the date of account review, i.e., account agreement between a financial account at the time the garnishment retroactively. institution and an account holder, as order was served were attributable to long as the term or condition is not Section 212.7 nonexempt deposits. In addition, if a inconsistent with the proposed rule. financial institution performed an Proposed section 212.7(a) sets forth The requirements of the proposed rule account review within the one business the content of the notice that financial may not be changed by agreement, day deadline, and funds were institutions are required to send to except in the narrow circumstance withdrawn from the account during this account holders. The financial permitted under proposed section time, the financial institution would not institution must notify the account 212.10(c), i.e., where an account holder be liable to a creditor or court for failure holder that the financial institution has expressly instructs a financial to preserve the funds in the account, received a garnishment order and must institution to use exempt funds to even if there was no protected amount briefly explain what a garnishment is. satisfy a garnishment order after being for the account. Under proposed section The notice must also include other notified of the order and the account 212.10(c), this protection exists for a information regarding the account holder’s rights. Thus, a financial financial institution despite the holder’s rights. Financial institutions institution may not require an account occurrence of a bona fide error or a may choose to use the model notice in holder to waive any protection available settlement adjustment. Appendix A to the proposed rule, in under the rule, nor may it include in an which case they will be deemed to be account agreement terms inconsistent Proposed section 212.10(c) allows a in compliance with the requirements of with the requirements of the proposed financial institution to follow an section 212.7(a). However, use of the rule. However, the section 212.6(b) account holder’s express instruction to model notice is optional. requirement that a financial institution use an otherwise protected amount to satisfy the garnishment order. The The financial institution must deliver ensure that the account holder has instruction must be in writing and must the notice separately from the account access to the protected amount would be delivered after the date on which the holder’s periodic account statement. be subject to any limitation on funds This is to ensure that the account holder availability to which the account is financial institution received the does not inadvertently disregard the subject. For example, if funds on garnishment order. This provision notice. However, the financial deposit are subject to a hold consistent would not permit an account holder to institution may deliver the notice with Regulation CC,14 or a limitation on instruct a financial institution, in concurrently with other garnishment withdrawal applicable to a time deposit, advance or in a standing agreement, to notices or forms required under state or the proposed rule would not override or use exempt funds to satisfy a local law. The notice must be sent affect those limitations. garnishment order. within two business days from the date Section 212.9 Section 212.11 of account review. The notice must be sent in any case where a benefit Proposed section 212.9 preempts any Under proposed section 212.11, payment was deposited into the account State or local government law or compliance with the rule will be during the lookback period, even if the regulation that is inconsistent with any enforced by the Federal banking financial institution does not freeze any provision of the proposed rule. Section agencies. Financial institutions must funds in the account. This could be the 212.9(b) makes it clear that such a maintain records of account activity and case where the account balance is zero. preemption occurs only to the extent actions taken in handling garnishment that an inconsistency between the orders sufficient to demonstrate Section 212.8 proposed rule and state law would compliance with the rule. Proposed section 212.8 makes it clear prevent a financial institution from Section 212.12 that the rule is not to be interpreted as complying with the requirements of the limiting any rights an individual may proposed rule. Some state laws, for example, may protect from garnishment Proposed section 212.12 provides that have under Federal law to assert an the proposed rule may be amended only exemption from garnishment, or as funds in a bank account in an amount that exceeds the protected amount. The by a joint rulemaking issued by altering the exempt status of funds in Treasury, SSA, VA, RRB and OPM. the account. For example, although the proposed rule does not displace or proposed rule does not require a supersede such a state law requirement. Appendix A to Part 212 financial institution to review and Section 212.9(c) allows a state to protect identify Federal benefits deposited by funds in an account from freezing or Appendix A sets forth proposed check to an account, those funds are garnishment to a greater extent than is model language that would satisfy the protected under Federal law and the required under the proposed rule. notice requirements of section 212.7(a). Financial institutions are not required to account holder may assert a claim for Section 212.10 that protection in accordance with the use this model language. However, Proposed section 212.10 provides a procedures specified under the financial institutions that use the model safe harbor for financial institutions that applicable law. In addition, it is notice would be deemed to be in comply in good faith with the rule. possible that an account holder could compliance with the requirements of Thus, for example, if a financial have exempt funds on deposit in excess section 212.7(a). institution made available the protected of the protected amount. In that case, amount to an account holder in Appendix B to Part 212 the account holder could assert the accordance with the rule, the financial protection available under Federal law Appendix B contains the form of Notice of Garnishment by the United for those funds. The proposed rule does 14 Regulation CC, 12 CFR part 229, is the Federal not limit or change the protected status Reserve’s regulation establishing rules covering the States which is referred to in section of those funds. collection and return of checks by banks. 212.4(a)(2).
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IV. Regulatory Analysis institution has received a garnishment million.15 In addition, the Agencies order for the account. estimate that there are 7,689 National A. Executive Order 12866 Furthermore, it can be difficult for a and State credit unions of which 88% It has been determined that this rule financial institution to determine have assets equal or less than $175 is a significant regulatory action as whether or the extent to which an million. The proposed rule would apply defined in E.O. 12866. The Office of account contains Federal benefit to all of these institutions. Management and Budget has reviewed payments that are exempt for this regulation. garnishment. If, for instance, an account 4. Projected Recordkeeping, Reporting, and Other Compliance Requirements B. Joint Regulatory Flexibility Act contains deposits of both exempt and Financial institutions currently Analysis non-exempt funds, there may be no established accounting rules to administer and respond to garnishment The Regulatory Flexibility Act (5 determine the proportion of the orders, and already maintain records U.S.C. 601–612) (RFA) requires agencies comingled funds that should be related to the actions they take in either to provide an Initial Regulatory protected from garnishment. response to garnishment orders, and so Flexibility Analysis with a proposed the basic requirements embodied in the rule or to certify that the proposed rule 2. Statement of Objectives and Legal proposed rule do not represent new will not have a significant economic Basis activities. Furthermore, the proposed impact on a substantial number of small The Agencies are proposing this new rule would not require investments in entities. In accordance with section 3(a) rule to give force and effect to the new equipment or modification to of the RFA, the Agencies have reviewed Federal anti-garnishment statutes and to systems. Financial institutions would, the proposed regulation, which affects provide financial institutions with however, have new requirements under all financial institutions, regardless of straightforward rules on the handling of the rule. They will need to modify their size. While the Agencies believe that the garnishment orders. The rule is garnishment operating procedures to proposed rule likely would not have a designed to address the hardships that determine whether orders are obtained significant economic impact on recipients of Federal benefit payments by the United States and ascertain financial institutions (5 U.S.C. 605(b)), are encountering when a financial whether benefit payments were the Agencies do not have complete data institution places a freeze on an account deposited to an account within 60 at this time to make this determination. and the difficulties that financial calendar days of receiving a Therefore, a joint Initial Regulatory institutions have in determining garnishment order. If so, they would be Flexibility Analysis has been prepared whether funds deposited into an required to establish a protected amount in accordance with 5 U.S.C. 603. The account are exempt from garnishment. which cannot be frozen and to issue a Agencies request comment on the rule’s As discussed above, the primary goals of notice to the account holder disclosing impact on small entities. The Agencies the proposed rule are (1) to ensure that facts and information about the will, if necessary, conduct a final benefit recipients have access to exempt garnishment order. regulatory flexibility analysis after funds while garnishment orders are Financial institutions would be able consideration of comments received complied with, adjudicated, or to utilize existing systems to comply during the public comment period. otherwise resolved; (2) to protect with the rule. As discussed above in the financial institutions from liability Overview of this proposed rule, 1. Reasons for Proposed Rule when, having received a garnishment Treasury will encode an ‘‘X’’ in position As discussed above, the Agencies are order for an account receiving Federal 20 of the ‘‘Company Name’’ Field of the publishing the proposed rule to benefit payments, they allow the Batch Header Record for each Agency implement statutory restrictions on the account holder access to exempt funds exempt benefit Automated Clearing garnishment of exempt Federal benefit in the account; and (3) to establish House (ACH) payment. This encoding, payments. Social Security benefits, straightforward, uniform, cost effective along with the current practice of Supplemental Security Income benefits, procedures addressing the extent to encoding a ‘‘2’’ in the ‘‘Originator Status VA benefits, Federal Railroad retirement which financial institutions may, Code’’ Field in the Batch Header Record benefits, Federal railroad pursuant to garnishment orders, freeze to designate payments originated from unemployment and sickness benefits, or seize funds in accounts that contain the Federal government, will allow and Civil Service Retirement System Federal benefits. financial institutions to readily identify benefits and Federal Employees Federal exempt payments through either 3. Description and Estimate of Small Retirement System benefits are manual or systems inspection without Entities Affected by the Proposed Rule generally exempt under Federal law additional resources or equipment. In from garnishment orders. These benefits The proposed rule would apply to addition, the Agencies will publish a often constitute a major portion and financial institutions, including national list of the unique ‘‘Entry Detail sometimes all of an individual’s income. banks, savings associations, state Description’’ Fields in the Batch Header As a result, when financial institutions member banks, and Federal and state Record that can be used to identify receive garnishment orders and place credit unions. The proposed rule would exempt benefit payments. freezes on accounts containing exempt affect all financial institutions, Given the existing burden under law Federal benefit payments, the recipients regardless of size, that might hold an to handle garnishment orders, coupled of these funds can face significant account to which Federal benefits may with the simplicity, uniformity, and hardship. At the same time, financial be directly deposited. For purposes of certainty of the requirement to establish institutions are required by law to the RFA, a ‘‘small entity’’ is a national a protected amount under the proposed comply with garnishment orders and bank, savings association, State member rule, the Agencies conclude that may be at risk of being held in contempt bank, or State or Federal credit union of court if they fail to preserve and remit with assets of $175 million or less. The 15 See FDIC Bank Find (Number of Small Banks), funds according to the order. In many Agencies estimate that there are 8,082 http://www2.fdic.gov/idasp/main_bankfind.asp (last visited Nov. 19, 2009); see also NCUA, Credit cases a financial institution would be national banks, savings associations, Union Data (Number of Small Credit Unions), liable for any funds that are withdrawn and state member banks, of which 56% http://webapps.ncua.gov/customquery/ (last visited by an account holder after the financial have assets equal or less than $175 Nov. 19, 2009).
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modifications to financial institution 5. Identification of Duplicative, ‘‘substantial direct effects’’ on the states, operating procedures represent a one- Overlapping, or Conflicting Federal the relationship between the national time administrative change that would Rules government and states, or on the require new internal documentation and The Agencies reviewed current law distribution of power and employee training but would not result and have constructed the proposed rule responsibilities among the various in substantive additional on-going so that no Federal statutes or rules levels of government. Federal agencies activities. The requirement to issue a would overlap or conflict with the promulgating regulations that have notice entails mailing a one-page proposed rule. The Agencies seek these Federalism implications must standard document and the Agencies comment and information about any consult with state and local officials, conclude that this requirement entails such statutes or rules, as well as any and describe the extent of their minimal resources. other State, local, or industry rules or consultation and the nature of the concerns of state and local officials in Therefore, the Agencies believe that policies that require a financial institution to implement business the preamble to the regulation. any costs incurred as a result of the In the Agencies’ view, the proposed proposed rule will be minimal. practices that would conflict with the requirements of the proposed rule. rule may have Federalism implications, Furthermore, the Agencies believe that because it has direct, although not financial institutions will benefit from 6. Discussion of Significant Alternatives substantial, effects on the States, the the clarity and uniformity the proposed The proposed rule would apply to all relationship between the national rule will bring to the handling of financial institutions that maintain government and states, or on the garnishment orders, and from the safe accounts to which Federal benefit distribution of power and harbor protections against liability. In payments may be deposited. One responsibilities among various levels of addition, the rule should result in fewer approach to minimizing the burden on government. The provision in the rule customer service issues arising from small entities would be to provide a (§ 212.4) where the Agencies establish a account freezes and garnishment orders specific exemption for small process for financial institutions’ generally. Finally, the Agencies are institutions. The Agencies propose that treatment of accounts upon the receipt aware that, for a variety of reasons, some the requirements in this rule be of a garnishment order could potentially financial institutions already attempt to applicable to all entities regardless of conflict with State garnishment laws review account histories and issue size, because an exemption for small prescribing a formula for financial notices to account holders upon receipt entities would diminish the usefulness institutions to pay such claims. of a garnishment order. To the extent of the policies and procedures laid out The proposed rule’s central provision that these activities already occur, the to ensure that all benefit recipients requiring a financial institution to proposed rule should have little or no nationwide have access to a certain establish a protected amount will affect impact. amount of lifeline funds. An exemption only a very small percentage of all might result in the continuation of the garnishment orders issued by State The Agencies seek information and current practice of account freezes for courts, since in the vast majority of comment on any costs, compliance some recipients. cases an account will not contain an requirements, or changes in operating On behalf of the Agencies, Treasury exempt Federal benefit payment. procedures arising from the application has worked over the past two years with Moreover, states may choose to provide of the proposed rule and the extent to major trade associations and various stronger protections against which those costs, requirements, or Federal regulators to devise a balanced, garnishment, and the proposed changes are in addition to or different uniform rule that will resolve the regulation will only override state law from those arising from current problems surrounding garnishment and to the minimum extent necessary to processes in effect when a court ordered Federal benefits. In consultation with protect Federal benefits payments from garnishment is served. The Agencies these organizations, the Agencies have garnishment. invite comment and data on the size of attempted to minimize burden by Under 42 U.S.C. 407(a) and 42 U.S.C. the incremental burden on small proposing a single rule that would apply 1383(d)(1), Federal Old-Age, Survivors, financial institutions in instituting to all types of exempt Federal benefit and Disability Insurance benefits and procedures not currently part of the payments and establish a consistent set Supplemental Security Income institution’s practices. In addition, the of practices for all financial institutions payments are generally exempt from Agencies are interested in knowing to follow. In addition, the Agencies have garnishment. 42 U.S.C. 405(a) provides whether particular aspects of the attempted to ensure that financial the Commissioner of Social Security proposed rule would be especially institutions will not incur legal liability with the authority to make rules and costly or burdensome. We also invite including in the proposed rule a safe regulations concerning Federal Old-Age, comment on Treasury’s plans to encode harbor provision and an express Survivors, and Disability Insurance its ACH entries with a garnishment preemption of inconsistent state law. benefits. The Social Security Act does identifier in the ‘‘Company Name’’ Field The result should be a straightforward not require State law to apply in the event of conflict between State and and to publish a list of unique ‘‘Entry rule that can be implemented in a cost- Federal law. Detail Description’’ Fields to facilitate effective manner. The Agencies Under 38 U.S.C. 5301(a), benefits the identification of exempt Federal welcome comments on any significant administered by VA are generally benefit payments. alternatives to the proposed rule. exempt from garnishment. 38 U.S.C. The Agencies anticipate contacting C. Executive Order 13132 Determination 501(a) provides the Secretary of trade groups representing participants Executive Order 13132 outlines Veterans Affairs with the authority to that qualify as small entities and fundamental principles of Federalism, make rules and regulations concerning encouraging them to provide comments and requires the adherence to specific VA benefits. The statutes governing VA during the comment period to ascertain, criteria by Federal agencies in the benefits do not require State law to among other things the costs imposed process of their formulation and apply in the event of conflict between on the regulated small entities. implementation of policies that have State and Federal law.
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Under 45 U.S.C. 231m(a), Federal an agency to identify and consider a The accuracy of the estimated burden railroad retirement benefits are reasonable number of regulatory associated with the proposed collection generally exempt from garnishment. 45 alternatives before promulgating a rule. of information; U.S.C. 231f(b)(5) provides the RRB with The Agencies have determined that this How the quality, utility, and clarity of rulemaking authority over issues rising proposed rule will not result in the information to be collected may be from the administration of Federal expenditures by state, local, and tribal enhanced; Railroad retirement benefits. The governments, or by the private sector, of How the burden of complying with Railroad Retirement Act of 1974 does $100 million or more. Accordingly, the the proposed collection of information not require State law to apply in the Agencies have not prepared a budgetary may be minimized, including through event of conflict between State and impact statement or specifically the application of automated collection Federal law. addressed the regulatory alternatives techniques or other forms of information Under 45 U.S.C. 352(e), Federal considered. technology; and railroad unemployment and sickness Estimates of capital or start-up costs benefits are generally exempt from E. Plain Language and costs of operation, maintenance, garnishment. 45 U.S.C. 362(1) provides In 1998, the President issued a and purchase of services to provide the RRB with rulemaking authority over memorandum directing each agency in information. issues rising from the administration of the Executive branch to use plain The collection of information in these Federal railroad unemployment and language for all new proposed and final proposed regulations are found in sickness benefits. The Railroad rulemaking documents issued on or §§ 212.5 and 212.9. Unemployment Insurance Act does not after January 1, 1999. The Agencies Estimated total annual reporting require State law to apply in the event specifically invite your comments on burden: 125,000 hours. of a conflict between State and Federal how to make this proposal easier to Estimated average annual burden per law. understand. For example: respondent: 8 hours. Under 5 U.S.C. 8346, for the Civil • Have we organized the material to Estimated number of respondents: Service Retirement System (CSRS) and suit your needs? If not, how could this 15,771. under 5 U.S.C. 8470, for the Federal material be better organized? Estimated frequency of responses: As Employees Retirement Systems (FERS), • Are the requirements in the needed. Federal retirement benefits are generally proposed rule clearly stated? If not, how An agency may not conduct or exempt from garnishment. 5 U.S.C. 8347 could the rule be more clearly stated? sponsor, and a person is not required to and 5 U.S.C. 8461, respectively, provide • Does the proposed rule contain respond to, a collection of information the Director of OPM with the authority language or jargon that is not clear? If unless it displays a valid control to make rules and regulations so, which language requires number assigned by the Office of concerning CSRS and FERS benefits. clarification? Management and Budget. • OPM benefits statutes do not require Would a different format (grouping List of Subjects State law to apply in the event of and order of sections, use of headings, conflict between State and Federal law. paragraphing) make the rule easier to 5 CFR Part 831 In accordance with the principles of understand? If so, what changes to the Administrative practice and Federalism outlined in Executive Order format would make them easier to procedure, alimony, benefit payments, 13132, the Agencies consulted with understand? claims, disability benefits, exempt • State officials on issues addressed in What else could we do to make the payments, financial institutions, this rulemaking. Specifically, the rule easier to understand? firefighters, garnishment, government Agencies sought perspective on those F. Paperwork Reduction Act employees, income taxes, matters where Federalism implications intergovernmental relations, law could potentially conflict with State The collection of information enforcement officers, pensions, garnishment laws. The proposed rule contained in this notice of proposed preemption, reporting and establishes certain processes that rulemaking has been submitted to the recordkeeping requirements, retirement. provide a financial institution Office of Management and Budget in protection from liability when a Federal accordance with the Paperwork 5 CFR Part 841 benefit payment exempt from Reduction Act of 1995 (44 U.S.C. Administrative practice and garnishment is directly deposited into 3507(d)). Comments on the collection of procedure, air traffic controllers, benefit an account and the financial institution information should be sent to the Office payments, claims, disability benefits, provides a certain amount of lifeline of Management and Budget, Attn: Desk exempt payments, financial institutions, funds to the benefit recipient. Officer for the Department of the firefighters, garnishment, government Treasury, Office of Information and employees, income taxes, D. Unfunded Mandates Reform Act of Regulatory Affairs, Washington, DC 1995 Determinations intergovernmental relations, law 20503, with copies to the Office of the enforcement officers, pensions, Section 202 of the Unfunded Deputy Assistant Secretary, Fiscal preemption, retirement. Mandates Reform Act of 1995, Public Operations and Policy, Department of Law 104–4 (Unfunded Mandates Act) the Treasury, 1500 Pennsylvania 20 CFR Part 350 requires that an agency prepare a Avenue, NW., Room 2112, Washington, Alimony, benefit payments, child budgetary impact statement before DC 20220. Comments on the collection support, exempt payments, financial promulgating a rule that includes a of information must be received by June institutions, garnishment, preemption, Federal mandate that may result in 18, 2010. Comments are specifically railroad retirement, railroad expenditure by state, local, and tribal requested concerning: unemployment insurance, governments, in the aggregate, or by the Whether the proposed collection of recordkeeping. private sector, of $100 million or more information is necessary for the proper in any one year. If a budgetary impact performance of the functions of the 20 CFR Part 404 statement is required, section 205 of the Agencies, including whether the Administrative practice and Unfunded Mandates Act also requires information will have practical utility; procedure, aged, alimony, benefit
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payments, blind, disability benefits, Appendix A to Part 212—Model Notice to Financial institution means a bank, exempt payments, financial institutions, Account Holder. savings association, credit union, or garnishment, government employees, Appendix B to Part 212—Form of Notice of other entity chartered under Federal or income taxes, insurance, investigations, Garnishment by the United States. State law to engage in the business of old-age, preemption, Survivors and Authority: 5 U.S.C. 8346; 5 U.S.C. 8470; banking. Disability Insurance, penalties, railroad 5 U.S.C. 1103; 31 U.S.C. 321; 31 U.S.C. 3321; Freeze or account freeze means an retirement, reporting and recordkeeping 31 U.S.C. 3332; 38 U.S.C. 5301(a); 38 U.S.C. action by a financial institution to seize, requirements, Social Security, travel 501(a); 42 U.S.C. 405(a); 42 U.S.C. 407; 42 withhold, or preserve funds, or to U.S.C. 659; 42 U.S.C. 1383(d)(1); 45 U.S.C. otherwise prevent an account holder and transportation expenses, treaties, 231f(b); 45 U.S.C. 231m; 45 U.S.C. 352(e); 45 veterans, vocational rehabilitation. U.S.C. 362(1). from drawing on or transacting against funds in an account, in response to a 20 CFR Part 416 § 212.1 Purpose. garnishment order. Administrative practice and The purpose of this part is to Garnish or garnishment means procedure, alcoholism, benefit implement statutory provisions that execution, levy, attachment, or other payments, drug abuse, exempt protect Federal benefits from legal process to enforce a money payments, financial institutions, garnishment by establishing procedures judgment. garnishment, investigations, Medicaid, that financial institutions must follow Garnishment fee means any service or penalties, preemption, reporting and when a garnishment order is received legal processing fee, charged by a recordkeeping requirements, for an account into which Federal financial institution to an account Supplemental Security Income (SSI), benefit payments have been directly holder, for processing a garnishment travel and transportation expenses, deposited. order or any associated withholding or vocational rehabilitation. release of funds. § 212.2 Scope. Garnishment order or order means a 31 CFR Part 212 This part applies to: writ, order, notice, summons, or similar Benefit payments, exempt payments, (a) Entities. All financial institutions, written instruction issued by a court to financial institutions, garnishment, as defined in § 212.3. effect a garnishment. preemption, recordkeeping. (b) Funds. Benefit payments issued Lookback period means the 60- under the following Federal programs: calendar-day period preceding the date 38 CFR Part 1 (1) SSA benefit payments protected on which a financial institution is Administrative practice and under 42 U.S.C. 407 and 42 U.S.C. served a garnishment order. procedure, archives and records, benefit 1383(d)(1); Protected amount means the lesser of payments, cemeteries, claims, courts, (2) VA benefit payments protected the sum of all benefit payments crime, flags, exempt payments, financial under 38 U.S.C. 5301(a); deposited to an account during the institutions, freedom of information, (3) RRB benefit payments protected lookback period or the balance in an garnishment, government contracts, under 45 U.S.C. 231m(a) and 45 U.S.C. account on the date of account review. government employees, government 352(e); and State means a state of the United property, infants and children, (4) OPM benefit payments protected States, the District of Columbia, the inventions and patents, parking, under 5 U.S.C. 8346 and 5 U.S.C. 8470. Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana penalties, preemption, privacy, § 212.3 Definitions. reporting and recordkeeping Islands, American Samoa, Guam, or the requirements, seals and insignia, For the purposes of this part, the United States Virgin Islands. security measures, wages. following definitions apply. Account means an account at a § 212.4 Initial action upon receipt of a Department of the Treasury, Fiscal financial institution to which benefit garnishment order. Service (Treasury) payments can be delivered by direct (a) Examination for orders obtained deposit. by the United States. Prior to taking any Authority and Issuance Account review means the process of other action related to a garnishment For the reasons set forth in the examining deposits in an account to order issued against an account, and no preamble, Treasury proposes to add a determine if a benefit agency has later than one business day following new part 212 to Title 31 of the Code of deposited a benefit payment into the receipt of the order, a financial Federal Regulations, to read as follows: account during the lookback period. institution shall examine the order to Benefit agency means the Social determine if it was obtained by the PART 212—GARNISHMENT OF Security Administration (SSA), the United States. A garnishment order ACCOUNTS CONTAINING FEDERAL Department of Veterans Affairs (VA), the shall conclusively be considered to have BENEFIT PAYMENTS Office of Personnel Management (OPM), been obtained by the United States if: Sec. or the Railroad Retirement Board (RRB). (1) The plaintiff named in the caption 212.1 Purpose. Benefit payment means a direct on the front page of the order is ‘‘United 212.2 Scope. deposit payment made by a benefit States of America,’’ or ‘‘United States,’’ 212.3 Definitions. agency to a natural person or to a or ‘‘U.S.’’; or 212.4 Initial action upon receipt of a representative payee receiving payments (2) The order is served on the garnishment order. on behalf of a natural person under a financial institution accompanied by a 212.5 Account review. Federal program listed in § 212.2(b). Notice of Garnishment by the United 212.6 Rules and procedures to protect Federal banking agency means the States, as set forth in Appendix B. benefits. Federal Deposit Insurance Corporation, (b) United States obtained the order. 212.7 Notice to the account holder. 212.8 Other rights and authorities. the Board of Governors of the Federal If an order meets either of the criteria set 212.9 Preemption of state law. Reserve System, the Office of the forth in § 212.4(a)(1) or (2), then the 212.10 Safe harbor. Comptroller of the Currency, the Office financial institution shall follow its 212.11 Compliance and record retention. of Thrift Supervision, or the National otherwise customary procedures for 212.12 Amendment of this part. Credit Union Administration. handling the garnishment order and
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shall not follow the procedures in § 212.6 Rules and procedures to protect or collect a garnishment fee against a § 212.5 and § 212.6. benefits. protected amount, and may not charge (c) United States did not obtain the The following provisions apply if an or collect a garnishment fee after the order. If an order does not meet either account review shows that a benefit date of account review. of the criteria set forth in § 212.4(a)(1) or agency deposited a benefit payment into (2), then the financial institution shall an account during the lookback period. § 212.7 Notice to the account holder. follow the procedures in § 212.5 and (a) Protected amount. The financial A financial institution shall issue the § 212.6. institution shall immediately calculate notice required by § 212.6(c) in and establish the protected amount for accordance with the following § 212.5 Account review. an account. The financial institution provisions. (a) Review for benefit payment. No shall ensure that the account holder has (a) Notice content. The financial later than one business day following access to the protected amount, which institution shall notify the account receipt of a garnishment order issued the financial institution shall not freeze holder of the following facts and events against an account, a financial in response to the garnishment order. in readily understandable language. institution shall perform an account An account holder shall have no (1) The financial institution’s receipt review. requirement to assert any right of of a garnishment order against the (b) No benefit payment deposited garnishment exemption prior to account holder. during lookback period. If the account accessing the protected amount. (2) The date on which the review shows that a benefit agency did (b) Funds in excess of the protected garnishment order was served. not deposit a benefit payment into the amount. For any funds in an account in (3) A succinct explanation of account during the lookback period, excess of the protected amount, the garnishment orders. then the financial institution shall financial institution shall follow its (4) The financial institution’s follow its otherwise customary otherwise customary procedures for requirement under Federal regulation to procedures for handling the handling garnishment orders, including ensure that account balances up to the garnishment order and shall not follow the freezing of funds, but consistent protected amount specified in § 212.3 the procedures in § 212.6. with paragraphs (e) and (f) of this are protected and made available to the (c) Benefit payment deposited during section. account holder if a benefit agency lookback period. If the account review (c) Notice. The financial institution deposited a benefit payment into the shows that a benefit agency deposited a shall issue a notice to the account account in the last 60 calendar days. benefit payment into the account during holder, in accordance with § 212.7. (5) The protected amount, if any, the lookback period, then the financial (d) One-time account review process. established by the financial institution. institution shall follow the procedures The financial institution shall perform (6) The financial institution’s in § 212.6. the account review only one time upon potential requirement pursuant to other (d) Uniform application of account the first service of a given garnishment law to freeze other amounts in the review. The financial institution shall order. The financial institution shall not account to satisfy the garnishment perform an account review without repeat the account review or take any order. consideration for any other attributes of other action related to the garnishment (7) An exemplary list of Federal, the account or the garnishment order, order if the same garnishment order is State, and other benefits generally including but not limited to: subsequently served again upon the exempt from garnishment. (1) The presence of other funds, from financial institution. If the financial (8) The account holder’s right to assert whatever source, that may be institution is subsequently served a new a further garnishment exemption for commingled in the account with funds or different garnishment order against amounts above the protected amount, by from a benefit payment; completing exemption claim forms, (2) The existence of a co-owner on the the same account holder, the financial contacting the court of jurisdiction, or account; institution shall perform a separate and (3) The existence of benefit payments new account review. contacting the judgment creditor, as to multiple beneficiaries, and/or under (e) No continuing or periodic customarily applicable for a given multiple programs, deposited in the garnishment responsibilities. The jurisdiction. account; financial institution shall have no (9) Means of contacting the judgment (4) The balance in the account, continuing obligation to garnish creditor. provided the balance is above zero amounts deposited or credited to the (10) Means of contacting the court of dollars on the date of account review; account following the date of account jurisdiction. (5) Instructions to the contrary in the review, and shall take no action to (11) Means of contacting the financial garnishment order; or freeze any funds subsequently deposited institution. (6) The nature of the debt or or credited unless the institution is (b) Notice delivery. The financial obligation underlying the garnishment served with a new or different institution shall not include the notice order, including whether the order seeks garnishment order, consistent with the with the delivery of a periodic account to collect alimony or child support requirements of this part. statement, but must deliver it under obligations. (f) Permissible garnishment fee. The separate cover. The financial institution (e) Priority of Account Review. The financial institution may collect a may deliver the notice concurrently financial institution shall perform the garnishment fee only against funds in with other garnishment notices or forms account review prior to taking any other the account in excess of the protected pursuant to State or local government actions related to the garnishment order amount on the date of account review, law. that may affect funds in the account. provided that the nature and amount of (c) Notice timing. The financial (f) Separate account reviews. The the fee is customary for the financial institution shall send the notice to the financial institution shall perform the institution’s accounts generally and is account holder within 2 business days account review separately for each not specific to accounts with benefit from the date of account review. account in the name of an account payments. (d) Notice requirement. The financial holder against whom a garnishment (g) Impermissible garnishment fee. institution shall send the notice in all order has been issued. The financial institution may not charge cases where a benefit agency deposited
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a benefit payment into the account other law for failing to honor a such as Social Security benefits, during the lookback period, including garnishment order in cases where Supplemental Security Income benefits, cases where the financial institution (1) A benefit agency has deposited a benefits administered by the Department of does not freeze any funds in the benefit payment into an account during Veterans Affairs, Railroad retirement benefits, Railroad Unemployment Insurance account. the lookback period or benefits, Civil Service Retirement System (2) The financial institution has § 212.8 Other rights and authorities. benefits or Federal Employees Retirement determined that an order was obtained System benefits. We are required by Federal (a) Exempt status. Nothing in this part by the United States by following the regulation to review your account and shall be construed to limit an procedures in § 212.4(a)(1) and (2). determine whether any such benefits were individual’s right under Federal law to (c) Protection for financial institution directly deposited to your account within 60 assert an exemption from garnishment from other potential liabilities. A calendar days preceding our receipt of the for funds in excess of the protected financial institution that complies in garnishment order. If so, the sum of all such amount, or to alter the exempt status of good faith with this part shall not liable benefits (or your full account balance, if it is funds that may be protected from less than that amount) cannot be turned over for: to your creditor or frozen, and you may garnishment under Federal law. (1) Bona fide errors that occur despite withdraw or use these funds as you normally (b) Account agreements. Nothing in reasonable procedures maintained by would. this part shall be construed to invalidate the financial institution to prevent such If your account contains funds in excess of any term or condition of an account errors in complying with the provisions the sum of the benefits directly deposited agreement between a financial of this part; during the 60-day period, those funds are institution and an account holder that is (2) Customary clearing and settlement subject to the garnishment order and may be not inconsistent with this part. adjustments that affect the balance in an frozen or turned over to your creditors. Protected Funds in Your Account § 212.9 Preemption of state law. account, including a protected amount, such as deposit reversals caused by the (a) Inconsistent law preempted. To the We have determined that one or more return of unpaid items; or Federal benefit payments were deposited to extent that any state or local government (3) Honoring an account holder’s your account within 60 calendar days law or regulation is inconsistent with a express written instructions, received by preceding our receipt of the garnishment provision of this part, it is hereby the financial institution following the order. The balance in your account when we preempted. date on which it has been served a conducted our review was $ll. Of this (b) Consistent law not preempted. particular garnishment order, to use an amount, [insert protected amount] is Nothing in this part shall be construed otherwise protected amount to satisfy protected under Federal law from garnishment or freezing. You may continue to preempt any state or local the garnishment order. government law or regulation in the to access these funds as usual. field of garnishment that is not § 212.11 Compliance and record retention. [Additional Funds in Your Account Your account also contains additional inconsistent with this part, including (a) Enforcement. Federal banking funds. We have placed a hold on these funds but not limited to procedures to agencies will enforce compliance with and may turn them over to your creditor as determine the disposition of funds in this part. directed by the garnishment order. If you excess of a protected amount. (b) Record retention. A financial believe that some or all of these additional (c) Higher protected amount. institution shall maintain records of funds are also Federal benefit payments, you Notwithstanding any provision of this account activity and actions taken in may have additional rights to protect these part, a state may by law or regulation response to garnishment orders funds. In addition, you may have rights to protect funds in an account from sufficient to demonstrate compliance protect other funds in your account from garnishment, such as public assistance freezing or garnishment at a higher with this part. protected amount than is required under (welfare), disability benefits, workers’ § 212.12 Amendment of this part. compensation benefits, and pension benefits. this part, provided that such law or You can make a claim for these rights by regulation is not inconsistent with any This part may be amended only by a (insert, as applicable and required for the other provision of this part. rulemaking issued jointly by Treasury jurisdiction, a standard instruction or a and all of the benefit agencies. reference to the jurisdiction’s notice for § 212.10 Safe harbor. completing an exemption claim form, process (a) Protection during examination and Appendix A to Part 212—Model Notice for contacting the court, or process for review. A financial institution that to Account Holder contacting the judgment creditor).] complies in good faith with this part A financial institution may use the Contact Information shall not be liable to a judgment creditor following model notice to meet the for any protected amounts, to an requirements of § 212.7(a). Although use of The creditor that obtained the garnishment this model is not required, a financial order against your account is [insert name] account holder for any frozen amounts, and may be contracted at [insert phone or for any penalties under state law, institution using it properly is deemed to be in compliance with § 212.7(a). number]. contempt of court, civil procedure, or The court that issued the garnishment other law for failing to honor a Notice of Garnishment order is [insert name] and their general garnishment order for account activity On [insert date of garnishment order information line is [insert phone number]. during the one business day following receipt], [insert financial institution name] You may call us at [insert phone number]. the financial institution’s receipt of a received an order of garnishment to freeze or garnishment order. remove funds from your account. Appendix B to Part 212—Form of (b) General protection for financial If you owe money to a creditor, Notice of Garnishment by the United institutions. A financial institution that garnishment is the legal process that allows States complies in good faith with this part your creditor to obtain a court order directing your financial institution to freeze or turn Notice of Garnishment by the United States shall not be liable to a judgment creditor over funds in your account to pay the debt The attached garnishment order was for any protected amounts, to an you owe the creditor. obtained by the United States. account holder for any frozen amounts, However, you have certain protections Accordingly, the garnishee is hereby or for any penalties under state law, from garnishment if the funds in your notified that the procedures established contempt of court, civil procedure, or account include Federal benefit payments under 31 CFR Part 212 for identifying and
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protecting Federal benefits deposited to 4. Add § 416.534 to read as follows: PART 350—GARNISHMENT OF accounts at financial institutions do not BENEFITS PAID UNDER THE apply to this garnishment order. § 416.534 Garnishment of Payments After RAILROAD RETIREMENT ACT, THE Disbursement. The garnishee should comply with the RAILROAD UNEMPLOYMENT terms of this order, including instructions for withholding and retaining any funds (a) Payments that are covered by INSURANCE ACT, AND UNDER ANY deposited to any account(s) covered by this section 1631(d)(1) of the Social Security OTHER ACT ADMINISTERED BY THE order, pending further order of the court. Act and made by direct deposit are BOARD I, the undersigned, certify that my subject to 31 CFR Part 212, Garnishment organization is part of the United States, as 1. Revise the authority citation to read of Accounts Containing Federal Benefit as follows: defined in 28 U.S.C. 3002(15), and has Payments. authority to conduct litigation for the Authority: 15 U.S.C. 1673(b)(2); 42 U.S.C. collection of debts on behalf of the United (b) This section may be amended only 659; and 45 U.S.C. 231f(b)(5), 231m, 352(e), States. by a rulemaking issued jointly by the and 362(l). Signature: llllllllllllllll Department of Treasury, the Social 2. Add a new § 350.6 to read as Title: llllllllllllllllll Security Administration, the follows: llllllllllllll Organization: Department of Veterans Affairs, the Date: llllllllllllllllll Railroad Retirement Board, and the § 350.6. Garnishment of payments after disbursement. Social Security Administration Office of Personnel Management. Payments that are covered by 45 20 CFR Parts 404 and 416 Department of Veterans Affairs U.S.C. 231m or 45 U.S.C. 352(e) and that Authority and Issuance Authority and Issuance are made by direct deposit are subject to For the reasons set forth in the preamble, 31 CFR part 212, Garnishment of the Social Security Administration proposes For the reasons set forth in the Accounts Containing Federal Benefit to amend Parts 404 and 416 of Title 20 of the preamble, the Department of Veterans Payments. This section may be amended Code of Federal Regulations as follows: Affairs proposes to amend Part 1 of Title only by a rulemaking issued jointly by the Department of the Treasury, the PART 404—FEDERAL OLD–AGE, 38 of the Code of Federal Regulations as follows: Social Security Administration, the SURVIVORS AND DISABILITY Department of Veterans Affairs, the INSURANCE (1950– ) PART 1—GENERAL PROVISIONS Railroad Retirement Board and the Subpart S—Payment Procedures Office of Personnel Management. 1. The authority citation for part 1 Office of Personnel Management 1. The authority citation for subpart S continues to read as follows: of Part 404 continues to read as follows: Authority and Issuance Authority: 38 U.S.C. 501(a), and as noted Authority: Secs. 205(a) and (n), 207, in specific sections. For the reasons set forth in the 702(a)(5) and 708(a) of the Social Security preamble, the Office of Personnel Act (42 U.S.C. 405(a) and (n), 407, 902(a)(5) 2. Add § 1.1000 and a new Management proposes to amend parts and 909(a)). undesignated center heading preceding 831 and 841 of Title 5 of the Code of 2. Add § 404.1821 to read as follows: the section to read as follows: Federal Regulations as follows: § 404.1821 Garnishment of Payments After Procedures for Financial Institutions PART 831—RETIREMENT Disbursement. Regarding Garnishment of Benefit (a) Payments that are covered by Payments After Disbursement 1. The authority citation for part 831 section 207 of the Social Security Act is revised to read as follows: and made by direct deposit are subject § 1.1000 Garnishment of payments after disbursement. Authority: Sec. 831.2203 also issued under to 31 CFR Part 212, Garnishment of section 7001(a)(4) of Pub. L. 101–508, 104 Accounts Containing Federal Benefit (a) Payments of benefits due under Stat. 1388–328; Secs. 831.115 and 831.116 Payments. any law administered by the Secretary also issued under 5 U.S.C. 8346(a). (b) This section may be amended only that are protected by 38 U.S.C. 5301(a) 2. Add a new § 831.115 to Subpart A by a rulemaking issued jointly by the and made by direct deposit to a to read as follows: Department of Treasury, the Social financial institution are subject to 31 Security Administration, the CFR part 212, Garnishment of Accounts § 831.115 Garnishment of CSRS payments. Department of Veterans Affairs, the Containing Federal Benefit Payments. CSRS payments are not subject to Railroad Retirement Board, and the execution, levy, attachment, (b) This section may be amended only Office of Personnel Management. garnishment or other legal process by a rulemaking issued jointly by the except as expressly provided by Federal PART 416—SUPPLEMENTAL Department of the Treasury, the Social law. SECURITY INCOME FOR THE AGED, Security Administration, the 3. Add a new section 831.116 to read BLIND, AND DISABLED Department of Veterans Affairs, the as follows: Railroad Retirement Board and the Subpart E—Payment of Benefits, Office of Personnel Management. § 831.116 Garnishment of payments after Overpayments, and Underpayments disbursement. Railroad Retirement Board 3. The authority citation for subpart E (a) Payments that are covered by 5 of Part 416 continues to read as follows: Authority and Issuance U.S.C. 8346(a) and made by direct deposit are subject to 31 CFR part 212, Authority: Secs. 702(a)(5), 1147, 1601, For the reasons set forth in the 1602, 1611(c) and (e), and 1631(a)–(d) and (g) Garnishment of Accounts Containing of the Social Security Act (42 U.S.C. preamble, the Railroad Retirement Federal Benefit Payments. 902(a)(5), 1320b–17, 1381, 1381a, 1382(c) Board proposes to amend Part 350 of (b) This section may be amended only and (e), and 1383(a)–(d) and (g)); 31 U.S.C. Title 20 of the Code of Federal by a rulemaking issued jointly by the 3720A. Regulations as follows: Department of the Treasury, the Social
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Security Administration, the OFFICE OF PERSONNEL Senate Restaurants are contracted to be Department of Veterans Affairs, the MANAGEMENT performed by a private business Railroad Retirement Board and the concern. The law provides that a Senate Office of Personnel Management. 5 CFR Parts 890 and 892 Restaurants employee who was an RIN 3206–AL95 employee of the Architect of the Capitol PART 841—FEDERAL EMPLOYEES on the date of enactment and who RETIREMENT SYSTEM—GENERAL Federal Employees Health Benefits accepted employment by the private ADMINISTRATION Program; Miscellaneous Changes business concern as part of the transition, may elect to continue Federal 1. The authority citation for part 841 AGENCY: U.S. Office of Personnel is revised to read as follows: benefits during continuous employment Management. with the business concern. We are Authority: 5 U.S.C. 8461; Sec. 841.108 also ACTION: Proposed rule. proposing to conform the regulations to issued under 5 U.S.C. 552a; subpart D also these provisions of Public Law 110–279. issued under 5 U.S.C. 8423; Sec. 841.504 also SUMMARY: The U.S. Office of Personnel issued under 5 U.S.C. 8422; Sec. 841.507 also Management is proposing to amend its Change in Dates of Open Season issued under section 505 of Pub. L. 99–335; regulations to provide for continuation The current regulations provide for subpart J also issued under 5 U.S.C. 8469; Sec. 841.506 also issued under 5 U.S.C. of Federal Employees Health Benefits the FEHB Program Open Season to be 7701(b)(2); Sec. 841.508 also issued under (FEHB) coverage for certain former held from the Monday of the second full section 505 of Pub. L. 99–335; Sec. 841.604 Senate Restaurant employees who workweek in November through the also issued under Title II, Pub. L. 106–265, transferred to employment with a Monday of the second full workweek in 114 Stat. 780; Secs. 841.110 and 841.111 also private contractor. We are also December of each year. We are revising issued under 5 U.S.C. 8470(a). proposing to change the annual FEHB the regulations to change these dates to 2. Add new § 841.110 to read as Program Open Season from the Monday the month of November. Therefore, follows: of the second full workweek in beginning in 2010, the Open Season November through the Monday of the dates will be November 1st through § 841.110 Garnishment of FERS payments. second full workweek in December, to November 30th of each year. This will FERS payments are not subject to November 1st through November 30th simplify the annual announcement of execution, levy, attachment, of each year. We are also adding a new the time period for Open Season and garnishment or other legal process opportunity for eligible employees to allow agencies and employees to better except as expressly provided by Federal enroll in the FEHB Program or to change plan for the enrollment opportunity law. enrollment from self only to self and since they will know well in advance 3. Add a new § 841.111 to read as family under the Children’s Health when it will occur each year. follows: Insurance Program Reauthorization Act New Enrollment Opportunities of 2009. Finally, we are proposing to § 841.111 Garnishment of payments after Public Law 111–3, the Children’s disbursement. allow FEHB plans to offer three options, without the requirement that one of the Health Insurance Program (CHIP) (a) Payments that are covered by 5 options be a high deductible health Reauthorization Act of 2009 (the Act), U.S.C. 8470(a) and made by direct plan. enacted on February 4, 2009, allows deposit are subject to 31 CFR part 212, States to subsidize health insurance Garnishment of Accounts Containing DATES: OPM must receive comments on premium payments for certain low- Federal Benefit Payments. or before June 18, 2010. income children who have access to (b) This section may be amended only ADDRESSES: Send written comments to qualified employer-sponsored health by a rulemaking issued jointly by the Ronald L. Brown, Healthy Policy, insurance coverage. FEHB-eligible Department of the Treasury, the Social Planning & Policy Analysis, Office of enrollees who meet the criteria for child Security Administration, the Personnel Management, 1900 E Street health assistance are eligible to receive Department of Veterans Affairs, the NW., Washington, DC 20415–3666; or State premium subsidy assistance Railroad Retirement Board and the deliver to OPM, Room 3425, 1900 E payments to help them pay for their Office of Personnel Management. Street NW., Washington, DC or FAX to FEHB plan premiums. Current FEHB By the Department of the Treasury. (202) 606–0633. Program regulations already allow an Richard L. Gregg, Comments may also be sent through eligible enrollee who loses coverage Acting Fiscal Assistant Secretary. the Federal eRulemaking Portal at: under the FEHB Program or another http://www.regulations.gov. All group health plan, including loss of By the Social Security Administration. submissions received through the Portal eligibility or assistance under Medicaid Michael J. Astrue, must include the agency name and or CHIP, to enroll or change enrollment Commissioner of Social Security. docket number or Regulation Identifier from self only to self and family within Dated: April 9, 2010. Number (RIN) for this rulemaking. the period beginning 31 days before and By the Department of Veterans Affairs. FOR FURTHER INFORMATION CONTACT: Ron ending 60 days after the date of loss of John R. Gingrich, Brown, (202) 606–0004, or e-mail at coverage. The Act provides new Chief of Staff. [email protected]. opportunities for eligible employees to enroll in the FEHB Program or to change Dated: April 6, 2010. SUPPLEMENTARY INFORMATION: By the Railroad Retirement Board. enrollment from self only to self and Beatrice Ezerski, Background family when the employee or an eligible family member becomes eligible for Secretary to the Board. Senate Restaurants Employees premium assistance under CHIP. By the Office of Personnel Management. Public Law 110–279, enacted July 17, Employees must request the change in John Berry, 2008, provides for certain Federal enrollment within 60 days after the date Director. employee benefits to be continued for the employee or eligible family member [FR Doc. 2010–8899 Filed 4–14–10; 4:15 pm] certain employees of the Senate is determined to be eligible for BILLING CODE 4810–25–P Restaurants after the operations of the assistance. Employees may make these
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enrollment changes regardless of § 890.803 also issued under 50 U.S.C. 403p, (b) * * * whether they are covered under 22 U.S.C. 4069c and 4069c–1; subpart L also (3)(i) Have more than two options and premium conversion (pay premiums issued under sec. 599C of Pub. L. 101–513, a high deductible health plan (26 U.S.C. with pre-tax dollars). 104 Stat. 2064, as amended; § 890.102 also 223(c)(2)(A)) if the plan is described issued under sections 11202(f), 11232(e), under 5 U.S.C. 8903(1) or (2); or Change in Options Offered 11246 (b) and (c) of Pub. L. 105–33, 111 Stat. (ii) Have either more than three 251; and section 721 of Pub. L. 105–261, 112 The current regulations state that an Stat. 2061. options, or more than two options and FEHB plan shall not have more than two a high deductible health plan (26 U.S.C. options and a high deductible health Subpart A—Administration and 223(c)(2)(A)) if the plan is described plan. We are proposing to revise the General Provisions under 5 U.S.C. 8903(3) or (4). regulations to allow employee * * * * * organization plans and health 2. Add § 890.112 to subpart A to read maintenance organizations to both offer as follows: Subpart C—Enrollment two options and a high deductible § 890.112 Continuation of coverage for 4. Amend § 890.301 as follows: health plan or to offer three options, certain Senate Restaurants employees. a. Revise paragraph (f)(1) to read as set without the requirement that one of the (a) A Senate Restaurants employee forth below. options be a high deductible health who was an employee of the Architect b. Add a new paragraph (m) to read plan. This will provide for more of the Capitol on July 17, 2008, who as set forth below. flexibility in contracting with health accepted employment with the private plans for modern types of benefits. business concern to which the Senate § 890.301 Opportunities for employees who are not participants in premium Regulatory Flexibility Act Restaurants’ food service operations conversion to enroll or change enrollment; were transferred as described in section I certify that this regulation will not effective dates. 1 of Public Law 110–279, and who have a significant economic impact on * * * * * elected to continue his or her Federal a substantial number of small entities (f) * * * (1) An open season will be employee retirement benefits is deemed because the regulation only affects held each year from November 1st to be an employee for purposes of this health insurance benefits of Federal through November 30th. part during continuous employment employees and annuitants. with the private business concern or its * * * * * Executive Order 12866, Regulatory successor. The individual shall be (m) An employee or eligible family Review entitled to the benefits of, and be subject member becomes eligible for premium assistance under Medicaid or a State This rule has been reviewed by the to all conditions under, the FEHB Program on the same basis as if the Children’s Health Insurance Program Office of Management and Budget in (CHIP). An eligible employee may enroll accordance with Executive Order 12866. individual were an employee of the Federal Government. and an enrolled employee may change Federalism (b) Cessation of employment with the his or her enrollment from self only to self and family, from one plan or option We have examined this rule in private business concern or its successor for any period terminates eligibility for to another, or make any combination of accordance with Executive Order 13132, these changes when the employee or an Federalism, and have determined that coverage under the FEHB Program as an employee during any subsequent eligible family member of the employee this rule will not have any negative becomes eligible for premium assistance impact on the rights, roles, and employment by the private business concern. under a Medicaid plan or CHIP. An responsibilities of State, local, or Tribal employee must enroll or change his or governments. (c) The private business concern or its successor must make arrangements for her enrollment within 60 days after the List of Subjects in 5 CFR Parts 890 and the withholding from pay of an date the employee or family member is 892 individual described by paragraph (a) of determined to be eligible for assistance. Administrative practice and this section of an amount equal to the PART 892—FEDERAL FLEXIBLE procedure, Employee benefit plans, premiums withheld from Federal BENEFITS PLAN: PRE–TAX PAYMENT Government employees, Reporting and employees’ pay for FEHB coverage and, OF HEALTH BENEFITS PREMIUMS recordkeeping requirements, in accordance with procedures Retirement. established by OPM, pay into the 5. The authority citation for part 892 Employees Health Benefits Fund the is revised to read as follows: John Berry, amounts deducted from the individual’s Authority: 5 U.S.C 8913; 5 U.S.C. Director, U.S. Office of Personnel pay. 1103(a)(7); 26 U.S.C. 125; § 892.101 also Management. (d) The private business concern or its issued under sec. 311 of Pub. L. 111–3, 123 Accordingly, OPM is proposing to successor shall, in accordance with Stat. 64. amend 5 CFR parts 890 and 892 as procedures established by OPM, pay 6. In § 892.101, amend the definition follows: into the Employees Health Benefits of qualifying life event by adding a new Fund amounts equal to any agency paragraph (13) to read as follows: PART 890—FEDERAL EMPLOYEES contributions required under the FEHB HEALTH BENEFITS PROGRAM Program. § 892.101 Definitions. 1. The authority citation for part 890 * * * * * Subpart B—Health Benefits Plans is revised to read as follows: Qualifying life event *** (13) An employee or eligible family Authority: 5 U.S.C. 8913; § 890.301 also 3. Revise § 890.201(b)(3) to read as issued under sec. 311 of Pub. L. 111–03, 123 follows: member becomes eligible for premium Stat. 64; § 890.111 also issued under section assistance. An eligible employee may 1622(b) of Pub. L. 104–106, 110 Stat. 521; § 890.201 Minimum standards for health enroll and an enrolled employee may § 890.112 also issued under section 1 of Pub. benefits plans. change his or her enrollment from self L. 110–279, 122 Stat. 2604; 5 U.S.C. 8913; * * * * * only to self and family, from one plan
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or option to another, or make any participating in the Child Nutrition optional geographic preference in the combination of these changes when the Programs. The proposed rule is procurement of unprocessed locally employee or an eligible family member intended to be implemented by grown or locally raised agricultural of the employee becomes eligible for institutions choosing to apply the products. This provision applies to premium assistance under a Medicaid geographic preference option for the institutions operating all of the Child plan or a State Children’s Health procurement of locally grown and Nutrition Programs, including the Insurance Program. An employee must locally raised agricultural products. National School Lunch Program, School enroll or change his or her enrollment DATES: Comments must be received on Breakfast Program, Fresh Fruit and within 60 days after the date the or before June 18, 2010 to be assured of Vegetable Program, Special Milk employee or family member is consideration. Program, Child and Adult Care Food determined to be eligible for assistance. ADDRESSES: The Food and Nutrition Program and Summer Food Service [FR Doc. 2010–8957 Filed 4–16–10; 8:45 am] Service, USDA, invites interested Program, as well as to purchases made for these programs by the Department of BILLING CODE 6325–39–P persons to submit comments on this proposed rule. Comments may be Defense Fresh Program. The provision submitted by one of the following does not apply to purchases made by the Department. However, the provision DEPARTMENT OF AGRICULTURE methods: • Federal e-Rulemaking Portal: Go to does also apply to State agencies making Food and Nutrition Service http://www.regulations.gov. Preferred purchases on behalf of any of the method; follow the online instructions aforementioned Child Nutrition Programs. We initially implemented the 7 CFR Parts 210, 215, 220, 225, and 226 for submitting comments. • Fax: Submit comments by facsimile provisions through policy memoranda RIN 0584–AE03 transmission to: (703) 305–2879, and explanatory question and answer communications dated January 9, 2009, Geographic Preference Option for the Attention: Melissa Rothstein. • Mail: Comments should be July 22, 2009 and October 9, 2009. Procurement of Unprocessed Traditionally, a geographic preference addressed to Melissa Rothstein, Chief, Agricultural Products in Child Nutrition established for a procurement provides Policy and Program Development Programs bidders located in a specified Branch, Child Nutrition Division, Food geographic area additional points or and Nutrition Service, U.S. Department AGENCY: Food and Nutrition Service, credit calculated during the evaluation of Agriculture, 3101 Park Center Drive, USDA. of the proposals or bids received in Room 634, Alexandria, Virginia 22302. ACTION: Proposed rule. response to a solicitation. A geographic • Hand Delivery or Courier: Deliver preference is not a procurement set- SUMMARY: comments to 3101 Park Center Drive, The 2008 Farm Bill amended aside for bidders located in the specified Room 634, Alexandria, Virginia 22302– the Richard B. Russell National School geographic area, guaranteeing them a 1594, during normal business hours of Lunch Act to direct that the Secretary of certain level or percentage of business. 8:30 a.m.–5 p.m. Agriculture encourage institutions In addition, including a geographic • All comments submitted in operating Child Nutrition Programs to preference in a procurement does not response to this proposed rule will be purchase unprocessed locally grown preclude a bidder from outside the included in the record and will be made and locally raised agricultural products. specified geographic area from available to the public. Please be Effective October 1, 2008, institutions competing for, and possibly being advised that the substance of the receiving funds through the Child awarded, the contract subject to the comments and the identity of the Nutrition Programs may apply an geographic preference. Rather, a individuals or entities submitting the optional geographic preference in the geographic preference is a tool that gives comments will be subject to public procurement of unprocessed locally bidders in a specified geographic area a grown or locally raised agricultural disclosure. FNS will make the specific, defined advantage in the products. This provision applies to comments publicly available on the procurement process. institutions in all of the Child Nutrition Internet via http://www.regulations.gov. By utilizing the statutorily established Programs, including the National School FOR FURTHER INFORMATION CONTACT: geographic preference option in Child Lunch Program, School Breakfast Melissa Rothstein, Chief, Policy and Nutrition Programs, purchasing Program, Fresh Fruit and Vegetable Program Development Branch at the institutions, such as States, school food Program, Special Milk Program for above address or by telephone at (703) authorities, child care institutions and Children, Child and Adult Care Food 305–2590. SFSP sponsors, may specifically Program and Summer Food Service SUPPLEMENTARY INFORMATION: identify the geographic area within Program, as well as to purchases made which unprocessed locally raised and Background for these programs by the Department of locally grown agricultural products will Defense Fresh Program. The provision Section 4302 of Public Law 110–246, originate. As proposed in this rule, a also applies to State Agencies making the Food, Conservation, and Energy Act responsive bidder would offer to purchases on behalf of any of the of 2008, amended section 9(j) of the provide unprocessed locally raised and aforementioned Child Nutrition Richard B. Russell National School locally grown agricultural products from Programs. The purpose of this proposed Lunch Act (42 U.S.C. 1758(j)) to require the specifically identified geographic rule is to incorporate this procurement the Secretary of Agriculture to area. In most cases, we would expect option in the Programs’ regulations and encourage institutions operating Child that a bidder would be located in the to define the term ‘‘unprocessed locally Nutrition Programs to purchase identified geographic area, though it is grown or locally raised agricultural unprocessed locally grown and locally possible for a responsive bidder to be products’’ to ensure that both the intent raised agricultural products. Pursuant to located outside of that area. These of Congress in providing for such a section 4407 of Public Law 110–246, procurements may be accomplished procurement option is met and that any beginning October 1, 2008, institutions through informal or formal procurement such definition will facilitate ease of receiving funds as participants in the procedures, as required by respective implementation for institutions Child Nutrition Programs may apply an Child Nutrition Program regulations.
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Local purchasing power not only We also researched the types of changed, forming such a ground frozen supports increasing economic handling and processing techniques that product into a ready-to-prepare meat opportunities for local farmers but also are available to bring agricultural patty would be considered as changing helps schools and other institutions products to the marketplace. There are the inherent character of the product include wholesome food choices which a variety of methods that may be used while adding significant value to that will encourage children to make healthy to process agricultural products for product. Under the proposed definition, food choices. Allowing a geographic consumption. In addition, we would the geographic preference procurement procurement preference option serves to note that at least one method— option would not apply to the reinforce the fundamental and critical pasteurization—is already a regulatory procurement of such products. reconnection between producers and requirement for all milk served in Child This proposed rule would prohibit the consumers. The effort builds on the Nutrition Programs. While the application of the geographic preference 2008 Farm Bill, which provides for Conference Report discusses de procurement option for products increases and flexibility for USDA minimus processing of such products, subjected to processing methods not programs in an effort to promote local the geographic preference option included in the definition of foods. allowed by statute prohibits the use of ‘‘unprocessed agricultural products.’’ The geographic preference option processing methods that add significant The geographic preference basically allows institutions operating value to the products. This is procurement option could only be used Child Nutrition Programs to specifically particularly important since the when purchasing locally grown and define geographic areas from which they geographic preference provision is a locally raised agricultural products as will seek to procure unprocessed local noteworthy exception to the standard defined in this rule. However, once such agricultural products. It is up to each procurement provisions of Child a purchase is made, the institution institution, whether it be a school food Nutrition Programs and other programs would be free to have the agricultural authority, a child care institution or a government-wide. product further processed under a Summer Food Service Program sponsor, Based upon our research, as well as separate processing contract. An to determine how to define the keeping in mind the intent of Congress institution would use regular geographic area. as expressed in the Conference Report, procurement procedures in acquiring processing services to have such As provided in the Joint Explanatory we are proposing that the definition of ‘‘ ’’ products processed in any way that they Statement of the Committee of unprocessed food specify a prohibition against any processing would like. In addition, it is important Conference in House Report 110–627, method that alters the inherent to note that, due to the geographic the term ‘‘unprocessed’’ precludes the character of the agricultural product. To diversity in each state, the institution use of geographic preference in that end, we have included in the responsible for the procurement of the procuring agricultural products that proposed definition a list of acceptable locally grown and locally raised product have significant value added food handling and preservation has the discretion to define the local components. The Conference report also techniques for purposes of applying the area for which any geographic noted the acceptability of de minimus geographic preference procurement preference (e.g., State, county, region, handling and preparation ‘‘such as may option. Such techniques would include: etc.) will be applied. However, be necessary to present an agricultural General heat transfer methods such as institutions should keep in mind that product to a school food authority in a cooling, refrigerating and freezing; size local preference should not be defined useable form, such as washing adjustment through size reduction in a way that excludes bidders from vegetables, bagging greens, butchering (peeling, slicing, dicing, cutting and outside the designated geographic area livestock and poultry, pasteurizing milk, grinding); drying/dehydration; vacuum or otherwise unnecessarily restricts ’’ and putting eggs in a carton. packing and bagging; pasteurization for competition. Proposed Action milk; cold storage; the application of Accordingly, this rule proposes to add high water pressure (‘‘cold new paragraphs to sections 210.21, We have determined that it is pasteurization’’); butchering of livestock 215.14a, 220.16, 225.17 and 226.22 of necessary to propose a rulemaking to and poultry and the cleaning of fish. We Title 7, CFR, to include the geographic define what would constitute believe that these handling and preference procurement option and ‘‘ ’’ unprocessed agricultural products for preservation techniques comply with define the term ‘‘unprocessed locally the purposes of implementing the the intent of the statute and do not alter grown or locally raised agricultural geographic preference procurement the inherent character of agricultural products’’. option in the Child Nutrition Programs. products subjected to them. Applicability to the Fresh Fruit and In developing such a rule, we are The reduction of the size of larger Vegetable Program proposing that the definition should: products would not be considered as (1) Comply with the language and altering the inherent character of the The geographic preference reflect the intent of the statute; agricultural product, nor would such procurement option is applicable to (2) Ensure that any processing of size reduction add significant value to purchases made in the Fresh Fruit and agricultural products results in only the product. For example, cutting full Vegetable Program, 42 U.S.C. 1769a minimal value added to such products; size carrots into smaller, student- (FFVP). However, this provision shall and friendly carrot sticks would not alter the only be applied within the context of (3) Facilitate ease of use of such inherent character of the agricultural the FFVP’s requirement that produce products for institutions. product but would enhance its usable utilized in the program be fresh. The In preparation for the development of form. However, combining or forming definition of ‘‘unprocessed locally this proposed rule, we researched a any agricultural product would not meet grown or locally raised agricultural variety of definitions of ‘‘unprocessed the definition of unprocessed products’’ does not change the basic food’’ used by a number of Federal agricultural products as proposed. For statutory requirement that only fresh agencies. Upon review, however, those example, while ground and frozen meat produce may be purchased using funds definitions do not meet the needs of the or poultry would not be considered as for the Fresh Fruit and Vegetable Child Nutrition Programs. having had its inherent character Program. Development of regulations
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pertaining to the requirements for the FR 29115, June 24, 1983), these a geographic preference should such Fresh Fruit and Vegetable Program are programs are included in the scope of institutions wish to procure currently in process and the provisions Executive Order 12372, which requires unprocessed locally grown or locally relating to the geographic preference intergovernmental consultation with raised agricultural products. procurement option will be included in State and local officials. Paperwork Reduction Act that proposed rule, as appropriate. Executive Order 13132 The Paperwork Reduction Act of 1995 Executive Order 12866 Executive Order 13132 requires (44 U.S.C. Chap. 35; see 5 CFR 1320) This rule has been determined to be Federal agencies to consider the impact requires that the Office of Management not significant and was not reviewed by of their regulatory actions on State and and Budget (OMB) approve all the Office Management and Budget in local governments. Where such actions collections of information by a Federal conformance with Executive Order have federalism implications, agencies agency before they can be implemented. 12866. are directed to provide a statement for Respondents are not required to respond inclusion in the preamble to the Regulatory Flexibility Act to any collection of information unless regulations describing the agency’s it displays a current valid OMB control This rule has been reviewed with considerations in terms of the three number. This rule does not contain regard to the requirements of the categories called for under section information collection requirements Regulatory Flexibility Act of 1980 (6)(b)(2)(B) of Executive Order 13132. subject to approval by OMB under the (5 U.S.C. 601–612). It has been certified The Food and Nutrition Service (FNS) Paperwork Reduction Act of 1995. that this rule will not have a significant has considered the impact of this rule economic impact on a substantial on State and local governments and has E-Government Act Compliance number of small entities. determined that this rule does not have The Food and Nutrition Service is federalism implications. This rule does Unfunded Mandates Reform Act committed to complying with the E- not impose substantial or direct Government Act, to promote the use of Title II of the Unfunded Mandates compliance costs on State and local the Internet and other information Reform Act of 1995 (UMRA), Public governments. Therefore, under Section technologies to provide increased Law 104–4, establishes requirements for 6(b) of the Executive Order, a federalism opportunities for citizen access to Federal agencies to assess the effects of summary impact statement is not Government information and services, their regulatory actions on State, local, required. and for other purposes. and tribal governments and the private sector. Under Section 202 of the UMRA, Executive Order 12988 List of Subjects the Department generally must prepare This rule has been reviewed under 7 CFR Part 210 a written statement, including a cost/ Executive Order 12988, Civil Justice benefit analysis, for proposed and final Reform. This rule is intended to have Grant programs–education; Grant rules with Federal mandates that may preemptive effect with respect to any programs–health; Infants and children; result in expenditures to State, local, or State or local laws, regulations or Nutrition; Penalties; Reporting and tribal governments, in the aggregate, or policies which conflict with its recordkeeping requirements; School to the private sector, of $100 million or provisions or which would otherwise breakfast and lunch programs; Surplus more in any one year. When such a impede its full implementation. This agricultural commodities. statement is needed for a rule, section rule is not intended to have retroactive 7 CFR Part 215 205 of the UMRA generally requires the effect unless specified in the DATES Department to identify and consider a section of the final rule. Prior to any Food assistance programs; Grant reasonable number of regulatory judicial challenge to the provisions of programs–education; Grant programs– alternatives and adopt the least costly, this rule or the application of its health; Infants and children; Milk; more cost-effective or least burdensome provisions, all applicable administrative Reporting and recordkeeping alternative that achieves the objectives procedures must be exhausted. requirements. of the rule. This rule does not contain Civil Rights Impact Analysis 7 CFR Part 220 Federal mandates (under the regulatory provisions of Title II of the UMRA) that FNS has reviewed this rule in Grant programs–education; Grant impose costs on State, local, or tribal accordance with Departmental programs–health; Infants and children; governments or to the private sector of Regulations 4300–4, ‘‘Civil Rights Nutrition; Reporting and recordkeeping $100 million or more in any one year. Impact Analysis’’, and 1512–1, requirements; School breakfast and This rule is, therefore, not subject to the ‘‘Regulatory Decision Making lunch programs. Requirements.’’ After a careful review of requirements of sections 202 and 205 of 7 CFR Part 225 the UMRA. the rule’s intent and provisions, FNS has determined that this rule is not Food assistance programs; Grant Executive Order 12372 intended to limit or reduce in any way programs–health; Infants and children; The National School Lunch Program the ability of protected classes of Labeling; Reporting and recordkeeping and the School Breakfast Program are individuals to receive benefits on the requirements. listed in the Catalog of Federal Domestic basis of their race, color, national origin, 7 CFR Part 226 Assistance under No. 10.555 and sex, age or disability nor is it intended 10.553, respectively. The Special Milk to have a differential impact on minority Accounting; Aged; Day care; Food Program is listed under No. 10.556. The owned or operated business assistance programs; Grant programs; Child and Adult Care Food Program is establishments, and woman-owned or Grant programs–health; Indians; listed under No. 10.558 and the Summer operated business establishments that Individuals with disabilities; Infants Food Service Program for Children is participate in the Child Nutrition and children; Intergovernmental listed under No. 10.559. For the reasons Programs. This rule simply allows relations; Loan programs; Reporting and set forth in the final rule in 7 CFR Part institutions that participate in the Child recordkeeping requirements; Surplus 3015, Subpart V and related Notice (48 Nutrition Programs the option to apply agricultural commodities.
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Accordingly, 7 CFR Parts 210, 215, (e) Geographic preference. A school PART 225—SUMMER FOOD SERVICE 220, 225, and 226 are proposed to be food authority participating in the PROGRAM amended as follows: Program may apply a geographic 7. The authority citation for 7 CFR preference when procuring milk. When Part 225 continues to read as follows: PART 210—NATIONAL SCHOOL utilizing the geographic preference to LUNCH PROGRAM procure milk, the school food authority Authority: Secs. 9, 13 and 14, Richard B. making the purchase has the discretion Russell National School Lunch Act, as 1. The authority citation for 7 CFR amended, (42 U.S.C. 1758, 1761 and 1762a). Part 210 continues to read as follows: to determine the local area to which the 8. In § 225.17, paragraph (e) is added Authority: 42 U.S.C. 1751–1760, 1779. geographic preference option will be applied. to read as follows: 2. In § 210.21, paragraph (g) is added to read as follows: * * * * * § 225.17 Procurement standards. * * * * * Subpart E—State Agency and School PART 220—SCHOOL BREAKFAST (e) Geographic preference. (1) Food Authority Responsibilities PROGRAM Sponsors participating in the Program may apply a geographic preference § 210.21 Procurement. 5. The authority citation for 7 CFR when procuring unprocessed locally * * * * * Part 220 continues to read as follows: grown or locally raised agricultural (g) Geographic preference. (1) A Authority: 42 U.S.C. 1773, 1779, unless products. When utilizing the geographic school food authority participating in otherwise noted. preference to procure such products, the the Program, as well as State agencies sponsor making the purchase has the making purchases on behalf of such 6. In § 220.16, paragraph (f) is added discretion to determine the local area to school food authorities, may apply a to read as follows: which the geographic preference option geographic preference when procuring will be applied; § 220.16 Procurement. unprocessed locally grown or locally (2) For the purpose of applying the raised agricultural products. When * * * * * optional geographic preference in utilizing the geographic preference to (f) Geographic preference. (1) School paragraph (e)(1) of this section, procure such products, the school food food authorities participating in the ‘‘unprocessed locally grown or locally authority making the purchase or the Program, as well as State agencies raised agricultural products’’ means only State agency making purchases on making purchases on behalf of such those agricultural products that retain behalf of such school food authorities their inherent character. The effects of have the discretion to determine the school food authorities, may apply a geographic preference when procuring the following food handling and local area to which the geographic preservation techniques shall not be preference option will be applied; unprocessed locally grown or locally raised agricultural products. When considered as changing an agricultural (2) For the purpose of applying the product into a product of a different utilizing the geographic preference to optional geographic procurement kind or character: Cooling; refrigerating; procure such products, the school food preference in paragraph (g)(1) of this freezing; size adjustment made by section, ‘‘unprocessed locally grown or authority making the purchase or the peeling, slicing, dicing, cutting, locally raised agricultural products’’ State agency making purchases on chopping, shucking, and grinding; means only those agricultural products behalf of such school food authorities drying/dehydration; washing; applying that retain their inherent character. The have the discretion to determine the high water pressure or ‘‘cold effects of the following food handling local area to which the geographic pasteurization’’; packaging (such as and preservation techniques shall not be preference option will be applied; placing eggs in cartons), vacuum considered as changing an agricultural (2) For the purpose of applying the packing and bagging (such as placing product into a product of a different optional geographic preference in vegetables in bags); butchering livestock kind or character: cooling; refrigerating; paragraph (f)(1) of this section, and poultry; cleaning fish; and the freezing; size adjustment made by ‘‘unprocessed locally grown or locally pasteurization of milk. peeling, slicing, dicing, cutting, raised agricultural products’’ means only chopping, shucking, and grinding; PART 226—CHILD AND ADULT CARE those agricultural products that retain drying/dehydration; washing; applying FOOD PROGRAM high water pressure or ‘‘cold their inherent character. The effects of pasteurization’’; packaging (such as the following food handling and 9. The authority citation for 7 CFR placing eggs in cartons), vacuum preservation techniques shall not be Part 226 continues to read as follows: packing and bagging (such as placing considered as changing an agricultural Authority: Secs. 9, 11, 14, 16, 17, Richard vegetables in bags); butchering livestock product into a product of a different B. Russell National School Lunch Act, as and poultry; cleaning fish; and the kind or character: Cooling; refrigerating; amended (42 U.S.C. 1758, 1759a, 1762a, 1765 pasteurization of milk. freezing; size adjustment made by and 1766). peeling, slicing, dicing, cutting, 10. In § 226.22, paragraph (n) is added PART 215—SPECIAL MILK PROGRAM chopping, shucking, and grinding; to read as follows: FOR CHILDREN drying/dehydration; washing; applying § 226.22 Procurement standards. 3. The authority citation for 7 CFR high water pressure or ‘‘cold * * * * * Part 215 continues to read as follows: pasteurization’’; packaging (such as placing eggs in cartons), vacuum (n) Geographic preference. (1) Authority: 42 U.S.C. 1772 and 1779. packing and bagging (such as placing Institutions participating in the Program 4. In § 215.14a, paragraph (e) is added vegetables in bags); butchering livestock may apply a geographic preference when procuring unprocessed locally to read as follows: and poultry; cleaning fish; and the grown or locally raised agricultural pasteurization of milk. § 215.14a Procurement standards. products. When utilizing the geographic * * * * * * * * * * preference to procure such products, the
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institution making the purchase has the 647–5527; Fax: 202–493–2251. You airports_airtraffic/air_traffic/ discretion to determine the local area to must identify the Docket Number FAA– publications/airspace_amendments/. which the geographic preference option 2010–0285; Airspace Docket No. 10– You may review the public docket will be applied; ASO–23, at the beginning of your containing the proposal, any comments (2) For the purpose of applying the comments. You may also submit and received, and any final disposition in optional geographic preference in review received comments through the person in the Dockets Office (see the paragraph (n)(1) of this section, Internet at ADDRESSES section for address and ‘‘unprocessed locally grown or locally http://www.regulations.gov. phone number) between 9 a.m. and raised agricultural products’’ means only FOR FURTHER INFORMATION CONTACT: 5 p.m., Monday through Friday, except those agricultural products that retain Melinda Giddens, Operations Support Federal holidays. An informal docket their inherent character. The effects of Group, Eastern Service Center, Federal may also be examined during normal the following food handling and Aviation Administration, P.O. Box business hours at the office of the preservation techniques shall not be 20636, Atlanta, Georgia 30320; Eastern Service Center, Federal Aviation considered as changing an agricultural telephone (404) 305–5610. Administration, room 210, 1701 product into a product of a different Columbia Avenue, College Park, Georgia SUPPLEMENTARY INFORMATION: kind or character: Cooling; refrigerating; 30337. freezing; size adjustment made by Comments Invited Persons interested in being placed on a mailing list for future NPRMs should peeling, slicing, dicing, cutting, Interested persons are invited to chopping, shucking, and grinding; contact the FAA’s Office of Rulemaking, comment on this rule by submitting (202) 267–9677, to request a copy of drying/dehydration; washing; applying such written data, views, or arguments, high water pressure or ‘‘cold Advisory circular No. 11–2A, Notice of as they may desire. Comments that Proposed Rulemaking distribution pasteurization’’; packaging (such as provide the factual basis supporting the placing eggs in cartons), vacuum System, which describes the application views and suggestions presented are procedure. packing and bagging (such as placing particularly helpful in developing vegetables in bags); butchering livestock reasoned regulatory decisions on the The Proposal and poultry; cleaning fish; and the proposal. Comments are specifically The FAA is considering an pasteurization of milk. invited on the overall regulatory, amendment to Title 14, Code of Federal Dated: April 8, 2010. aeronautical, economic, environmental, Regulations (14 CFR) part 71 to establish Julia M. Paradis, and energy-related aspects of the Class E airspace at Smithfield, NC to Administrator, Food and Nutrition Service. proposal. provide controlled airspace required to [FR Doc. 2010–8850 Filed 4–16–10; 8:45 am] Communications should identify both support the SIAPs for Johnston County BILLING CODE 3410–30–P docket numbers (FAA Docket No. FAA– Airport. The existing Class E airspace 2010–0285; Airspace Docket No. 10– extending upward from 700 feet above ASO–23) and be submitted in triplicate the surface would be modified for the DEPARTMENT OF TRANSPORTATION to the Docket Management System (see safety and management of IFR ADDRESSES section for address and operations. Federal Aviation Administration phone number). You may also submit Class E airspace designations are comments through the Internet at published in Paragraph 6005 of FAA 14 CFR Part 71 http://www.regulations.gov. order 7400.9T, signed August 27, 2009, Commenters wishing the FAA to [Docket No. FAA–2010–0285; Airspace and effective September 15, 2009, which Docket No. 10–ASO–23] acknowledge receipt of their comments is incorporated by reference in 14 CFR on this action must submit with those 71.1. The Class E airspace designation Amendment of Class E Airspace; comments a self-addressed, stamped listed in this document will be Smithfield, NC postcard on which the following published subsequently in the Order. statement is made: ‘‘Comments to The FAA has determined that this AGENCY: Federal Aviation Docket No. FAA–2010–0285; Airspace proposed regulation only involves an Administration (FAA), DOT. Docket No. 10–ASO–23.’’ The postcard established body of technical ACTION: Notice of proposed rulemaking will be date/time stamped and returned regulations for which frequent and (NPRM). to the commenter. routine amendments are necessary to All communications received before keep them operationally current. It, SUMMARY: This action proposes to the specified closing date for comments therefore, (1) is not a ‘‘significant amend Class E Airspace at Smithfield, will be considered before taking action regulatory action’’ under Executive NC, to accommodate the additional on the proposed rule. The proposal Order 12866; (2) is not a ‘‘significant airspace needed for the Standard contained in this notice may be changed rule’’ under DOT Regulatory Policies Instrument Approach Procedures in light of the comments received. A and Procedures (44 FR 11034; February (SIAPs) developed for Johnston County report summarizing each substantive 26, 1979); and (3) does not warrant Airport. This action enhances the safety public contact with FAA personnel preparation of a Regulatory Evaluation and airspace management of Instrument concerned with this rulemaking will be as the anticipated impact is so minimal. Flight Rules (IFR) operations at the filed in the docket. Since this is a routine matter that will airport. only affect air traffic procedures and air Availability of NPRMs DATES: 0901 UTC. Comments must be navigation, it is certified that this received on or before June 3, 2010. An electronic copy of this document proposed rule, when promulgated, ADDRESSES: Send comments on this rule may be downloaded from and would not have a significant economic to: U. S. Department of Transportation, comments submitted through http:// impact on a substantial number of small Docket Operations, West Building www.regulations.gov. Recently entities under the criteria of the Ground Floor, Room W12–140, 1200 published rulemaking documents can Regulatory Flexibility Act. New Jersey Avenue, SE., Washington, also be accessed through the FAA’s Web The FAA’s authority to issue rules DC 20590–0001; Telephone: 1–800– page at http://www.faa.gov/ regarding aviation safety is found in
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Title 49 of the United States Code. Signed By: regulatory, aeronautical, economic, Subtitle I, Section 106 describes the Myron A. Jenkins, environmental, and energy-related authority of the FAA Administrator. Acting Manager, Operations Support Group, aspects of the proposal. Subtitle VII, Aviation Programs, Eastern Service Center, Air Traffic Communications should identify both describes in more detail the scope of the Organization. docket numbers (FAA Docket No. FAA agency’s authority. This proposed [FR Doc. 2010–8855 Filed 4–16–10; 8:45 am] 2009–1220 and Airspace Docket No. 09– rulemaking is promulgated under the BILLING CODE 4910–13–P ANM–30) and be submitted in triplicate authority described in Subtitle VII, Part, to the Docket Management System (see A, Subpart I, Section 40103. Under that ADDRESSES section for address and section, the FAA is charged with DEPARTMENT OF TRANSPORTATION phone number). You may also submit prescribing regulations to assign the use comments through the Internet at Federal Aviation Administration http://www.regulations.gov. of airspace necessary to ensure the Commenters wishing the FAA to safety of aircraft and the efficient use of 14 CFR Part 71 acknowledge receipt of their comments airspace. This proposed regulation is on this action must submit with those within the scope of that authority as it [Docket No. FAA–2009–1220; Airspace Docket No. 09–ANM–30] comments a self-addressed stamped would amend Class E airspace at postcard on which the following Johnston County Airport, Smithfield, Proposed Amendment of Class E statement is made: ‘‘Comments to FAA NC. Airspace; Bozeman, MT Docket No. FAA–2009–1220 and Lists of Subjects in 14 CFR Part 71 Airspace Docket No. 09–ANM–30.’’ The AGENCY: Federal Aviation postcard will be date/time stamped and Airspace, Incorporation by reference, Administration (FAA), DOT. returned to the commenter. Navigation (Air). ACTION: Notice of proposed rulemaking All communications received on or (NPRM). before the specified closing date for The Proposed Amendment comments will be considered before SUMMARY: This action proposes to taking action on the proposed rule. The In consideration of the foregoing, the modify Class E airspace at Gallatin Field proposal contained in this action may Federal Aviation Administration Airport, Bozeman, MT, to accommodate be changed in light of comments proposes to amend 14 CFR Part 71 as aircraft using a new VHF Omni- received. All comments submitted will follows: Directional Radio Range (VOR) Standard be available for examination in the PART 71—DESIGNATION OF CLASS A, Instrument Approach Procedure (SIAP) public docket both before and after the at Gallatin Field Airport. This action B, C, D, AND CLASS E AIRSPACE closing date for comments. A report would enhance the safety and AREAS; AIR TRAFFIC SERVICE summarizing each substantive public management of aircraft operations at the ROUTES; AND REPORTING POINTS contact with FAA personnel concerned airport. with this rulemaking will be filed in the 1. The authority citation for Part 71 DATES: Comments must be received on docket. continues to read as follows: or before June 3, 2010. Availability of NPRMs ADDRESSES: Send comments on this Authority: 49 U.S.C. 106(g); 40103, 40113, An electronic copy of this document proposal to the U.S. Department of 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– may be downloaded through the Transportation, Docket Operations, M– 1963 Comp., p. 389. Internet at http://www.regulations.gov. 30, West Building Ground Floor, Room Recently published rulemaking W12–140, 1200 New Jersey Avenue, SE., § 71.1 [Amended] documents can also be accessed through Washington, DC 20590; telephone (202) the FAA’s web page at http:// 2. The incorporation by reference in 366–9826. You must identify FAA www.faa.gov/airports_airtraffic/ 14 CFR 71.1 of Federal Aviation Docket No. FAA–2009–1220; Airspace air_traffic/publications/ Administration Order 7400.9T, Airspace Docket No. 09–ANM–30, at the airspace_amendments/. Designations and Reporting Points, beginning of your comments. You may signed August 27, 2009, effective You may review the public docket also submit comments through the containing the proposal, any comments September 15, 2009, is amended as Internet at http://www.regulations.gov. follows: received, and any final disposition in FOR FURTHER INFORMATION CONTACT: person in the Dockets Office (see the Paragraph 6005 Class E Airspace Areas Eldon Taylor, Federal Aviation ADDRESSES section for the address and Extending Upward From 700 Feet or More Administration, Operations Support phone number) between 9 a.m. and 5 Above the Surface of the Earth. Group, Western Service Center, 1601 p.m., Monday through Friday, except Lind Avenue, SW., Renton, WA 98057; * * * * * Federal holidays. An informal docket telephone (425) 203–4537. may also be examined during normal ASO NC E5 Smithfield, NC [Amended] SUPPLEMENTARY INFORMATION: business hours at the Northwest Mountain Regional Office of the Federal Johnston County Airport, NC Comments Invited (Lat. 35°32′27″ N., long. 78°23′25″ W.) Aviation Administration, Air Traffic That airspace extending upward from 700 Interested parties are invited to Organization, Western Service Center, feet above the surface within a 6.5-mile participate in this proposed rulemaking Operations Support Group, 1601 Lind radius of the Johnston County Airport and by submitting such written data, views, Avenue, SW., Renton, WA 98057. within 2 miles each side of the 023° bearing or arguments, as they may desire. Persons interested in being placed on from the airport extending from the 6.5-mile Comments that provide the factual basis a mailing list for future NPRM’s should radius to 10.2 miles northeast of the Johnston supporting the views and suggestions contact the FAA’s Office of Rulemaking, County Airport. presented are particularly helpful in (202) 267–9677, for a copy of Advisory developing reasoned regulatory Circular No. 11–2A, Notice of Proposed Issued in College Park, Georgia, on April 9, decisions on the proposal. Comments Rulemaking Distribution System, which 2010. are specifically invited on the overall describes the application procedure.
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The Proposal List of Subjects in 14 CFR Part 71 DEPARTMENT OF TRANSPORTATION The FAA is proposing an amendment Airspace, incorporation by reference, Federal Aviation Administration to Title 14 Code of Federal Regulations Navigation (air). (14 CFR) part 71 by modifying Class E 14 CFR Part 71 airspace at Gallatin Field Airport, The Proposed Amendment Bozeman, MT. Additional controlled [Docket No. FAA–2009–1135; Airspace Accordingly, pursuant to the Docket No. 09–ANM–20] airspace designated as an extension to a authority delegated to me, the Federal Class D surface area, and airspace Aviation Administration proposes to Proposed Amendment of Class E extending upward from 700 feet above amend 14 CFR part 71 as follows: Airspace; Kelso, WA the surface, is necessary to accommodate aircraft using the new PART 71—DESIGNATION OF CLASS A, AGENCY: Federal Aviation VOR SIAP’s at Gallatin Field Airport, B, C, D AND E AIRSPACE AREAS; AIR Administration (FAA), DOT. Bozeman, MT. This action would TRAFFIC SERVICE ROUTES; AND ACTION: Notice of proposed rulemaking enhance the safety and management of REPORTING POINTS (NPRM). instrument flight rules operations at the airport. 1. The authority citation for 14 CFR SUMMARY: This action proposes to Class E airspace designations are part 71 continues to read as follows: amend Class E airspace at Southwest Washington Regional Airport, Kelso, published in paragraph 6004 and 6005, Authority: 49 U.S.C. 106(g), 40103, 40113, respectively, of FAA Order 7400.9T, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– WA, to accommodate aircraft using the signed August 27, 2009, and effective 1963 Comp., p. 389. new Area Navigation (RNAV) Global September 15, 2009, which is Positioning System (GPS) Standard incorporated by reference in 14 CFR § 71.1 [Amended] Instrument Approach Procedures (SIAP’s) at Southwest Washington 71.1. The Class E airspace designation 2. The incorporation by reference in Regional Airport. The FAA is proposing listed in this document will be 14 CFR 71.1 of the FAA Order 7400.9T, this action to enhance the safety and published subsequently in this Order. Airspace Designations and Reporting management of aircraft operations at the The FAA has determined this Points, signed August 27, 2009, and airport. This action will also change the proposed regulation only involves an effective September 15, 2009 is airport name from Kelso-Longview established body of technical amended as follows: Airport. regulations for which frequent and Paragraph 6004—Class E airspace are as DATES: routine amendments are necessary to designated as an Extension to a Class D Comments must be received on keep them operationally current. surface area. or before June 3, 2010. Therefore, this proposed regulation: * * * * * ADDRESSES: Send comments on this (1) Is not a ‘‘significant regulatory proposal to the U.S. Department of action’’ under Executive Order 12866; ANM MT E4 Bozeman, MT [Modified] Transportation, Docket Operations, M– (2) is not a ‘‘significant rule’’ under DOT Bozeman, Gallatin Field Airport, MT 30, West Building Ground Floor, Room Regulatory Policies and Procedures (44 (Lat. 45°46′37″ N., long. 111°09′07″ W.) W12–140, 1200 New Jersey Avenue, SE., FR 11034; February 26, 1979); and (3) That airspace extending upward from the Washington, DC 20590; Telephone (202) does not warrant preparation of a surface within 3 miles each side of the 316° 366–9826. You must identify FAA regulatory evaluation as the anticipated bearing of Gallatin Field Airport, extending Docket No. FAA–2009–1135; Airspace impact is so minimal. Since this is a from the 4.4-mile radius of the airport to 14 Docket No. 09–ANM–20, at the routine matter that will only affect air miles northwest of Gallatin Field Airport; beginning of your comments. You may traffic procedures and air navigation, it and that airspace 2.4 miles each side of the also submit comments through the 212° bearing of the Gallatin Field Airport, is certified this proposed rule, when extending from the 4.4-mile radius of the Internet at http://www.regulations.gov. promulgated, would not have a airport to 7 miles northwest of Gallatin Field FOR FURTHER INFORMATION CONTACT: significant economic impact on a Airport. Eldon Taylor, Federal Aviation substantial number of small entities Administration, Operations Support under the criteria of the Regulatory Paragraph 6005 Class E airspace areas extending upward from 700 feet or more Group, Western Service Center, 1601 Flexibility Act. above the surface of the earth. Lind Avenue, SW., Renton, WA 98057; The FAA’s authority to issue rules * * * * * Telephone (425) 203–4537. regarding aviation safety is found in SUPPLEMENTARY INFORMATION: Title 49 of the U.S. Code. Subtitle 1, ANM MT E5 Bozeman, MT [Modified] section 106, describes the authority for Bozeman, Gallatin Field Airport, MT Comments Invited the FAA Administrator. Subtitle VII, (Lat. 45°46′37″ N., long. 111°09′07″ W.) Interested parties are invited to Aviation Programs, describes in more That airspace extending upward from 700 participate in this proposed rulemaking detail the scope of the agency’s feet above the surface within a 13.5-mile by submitting such written data, views, authority. This rulemaking is radius of Gallatin Field Airport, and within or arguments, as they may desire. promulgated under the authority 4.8 miles northeast and 13 miles southwest Comments that provide the factual basis ° described in subtitle VII, part A, subpart of the 316 bearing of the airport extending supporting the views and suggestions I, section 40103. Under that section, the from the 13.5-mile radius to 24.4 miles presented are particularly helpful in northwest of Gallatin Field Airport. FAA is charged with prescribing developing reasoned regulatory regulations to assign the use of the Issued in Seattle, Washington, on April 7, decisions on the proposal. Comments airspace necessary to ensure the safety 2010. are specifically invited on the overall of aircraft and the efficient use of Robert E. Henry, regulatory, aeronautical, economic, airspace. This regulation is within the Acting Manager, Operations Support Group, environmental, and energy-related scope of that authority as it would Western Service Center. aspects of the proposal. modify controlled airspace at Gallatin [FR Doc. 2010–8854 Filed 4–16–10; 8:45 am] Communications should identify both Field Airport, Bozeman, MT. BILLING CODE 4910–13–P docket numbers (FAA Docket No. FAA
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2009–1135 and Airspace Docket No. 09– airspace extending upward from 700’ The Proposed Amendment ANM–20) and be submitted in triplicate above the surface at Southwest Accordingly, pursuant to the to the Docket Management System (see Washington Regional Airport, Kelso, authority delegated to me, the Federal ADDRESSES section for address and WA. Additional controlled airspace is Aviation Administration proposes to phone number). You may also submit necessary to accommodate aircraft using amend 14 CFR part 71 as follows: comments through the Internet at the new RNAV (GPS) SIAP’s at http://www.regulations.gov. Southwest Washington Regional PART 71—DESIGNATION OF CLASS A, Commenters wishing the FAA to Airport. This action would enhance the B, C, D AND E AIRSPACE AREAS; AIR acknowledge receipt of their comments safety and management of aircraft TRAFFIC SERVICE ROUTES; AND on this action must submit with those operations at the airport. This action REPORTING POINTS comments a self-addressed, stamped also would change the airport name postcard on which the following from Kelso-Longview Airport, to 1. The authority citation for 14 CFR statement is made: ‘‘Comments to FAA Southwest Washington Regional part 71 continues to read as follows: Docket No. FAA–2009–1135 and Airport. Authority: 49 U.S.C. 106(g), 40103, 40113, Airspace Docket No. 09–ANM–20.’’ The Class E airspace designations are 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– postcard will be date/time stamped and published in paragraph 6005, of FAA 1963 Comp., p. 389. returned to the commenter. Order 7400.9T, signed August 27, 2009, All communications received on or and effective September 15, 2009, which § 71.1 [Amended] before the specified closing date for is incorporated by reference in 14 CFR 2. The incorporation by reference in comments will be considered before 71.1. The Class E airspace designation 14 CFR 71.1 of the FAA Order 7400.9T, taking action on the proposed rule. The listed in this document will be Airspace Designations and Reporting proposal contained in this action may published subsequently in this Order. Points, signed August 27, 2009, and be changed in light of comments The FAA has determined that this effective September 15, 2009 is received. All comments submitted will proposed regulation only involves an amended as follows: be available for examination in the established body of technical public docket both before and after the regulations for which frequent and Paragraph 6005 Class E airspace areas closing date for comments. A report routine amendments are necessary to extending upward from 700 feet or more summarizing each substantive public keep them operationally current. above the surface of the earth. contact with FAA personnel concerned Therefore, this proposed regulation; (1) * * * * * with this rulemaking will be filed in the Is not a ‘‘significant regulatory action’’ ANM WA, E5 Kelso, WA [Modified] docket. under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Southwest Washington Regional Airport, WA (Lat. 46°07′05″ N., long. 122°53′54″ W.) Availability of NPRMs Regulatory Policies and Procedures (44 An electronic copy of this document FR 11034; February 26, 1979); and (3) That airspace extending upward from 700 feet above the surface within a 6.4-mile may be downloaded through the does not warrant preparation of a radius of the Southwest Washington Regional Internet at http://www.regulations.gov. regulatory evaluation as the anticipated Airport, and 2.4 miles each side of the 290° Recently published rulemaking impact is so minimal. Since this is a bearing of the airport extending 9.1 miles documents can also be accessed through routine matter that will only affect air west, and 4.3 miles each side of the 337° the FAA’s Web page at http:// traffic procedures and air navigation, it bearing of the airport extending 22.2 miles www.faa.gov/airports_airtraffic/ is certified that this proposed rule, northwest, and 5.8 miles west and 3 miles air_traffic/publications/ when promulgated, would not have a east of the 012° bearing of the airport airspace_amendments/. significant economic impact on a extending 18.2 miles north of the airport. You may review the public docket substantial number of small entities Issued in Seattle, Washington, on April 7, containing the proposal, any comments under the criteria of the Regulatory 2010. received, and any final disposition in Flexibility Act. Robert E. Henry, person in the Dockets Office (see the The FAA’s authority to issue rules Acting Manager, Operations Support Group, ADDRESSES regarding aviation safety is found in section for the address and Western Service Center. phone number) between 9 a.m. and Title 49 of the U.S. Code. Subtitle 1, 5 p.m., Monday through Friday, except Section 106, describes the authority for [FR Doc. 2010–8853 Filed 4–16–10; 8:45 am] Federal holidays. An informal docket the FAA Administrator. Subtitle VII, BILLING CODE 4910–13–P may also be examined during normal Aviation Programs, describes in more detail the scope of the agency’s business hours at the Northwest DEPARTMENT OF TRANSPORTATION Mountain Regional Office of the Federal authority. This rulemaking is Aviation Administration, Air Traffic promulgated under the authority Federal Aviation Administration Organization, Western Service Center, described in Subtitle VII, Part A, Operations Support Group, 1601 Lind Subpart I, Section 40103. Under that 14 CFR Part 71 Avenue, SW., Renton, WA 98057. section, the FAA is charged with Persons interested in being placed on prescribing regulations to assign use of [Docket No. FAA–2009–1050; Airspace a mailing list for future NPRM’s should the airspace necessary to ensure the Docket No. 09–ASW–40] contact the FAA’s Office of Rulemaking, safety of aircraft and the efficient use of RIN 2120–AA66 (202) 267–9677, for a copy of Advisory airspace. This regulation is within the Circular No. 11–2A, Notice of Proposed scope of that authority as it would add Proposed Amendment to and Rulemaking Distribution System, which additional controlled airspace at Establishment of Restricted Areas and describes the application procedure. Southwest Washington Regional Other Special Use Airspace; Airport, Kelso, WA. The Proposal Razorback Range Airspace Complex, AR The FAA is proposing an amendment List of Subjects in 14 CFR Part 71 to Title 14 Code of Federal Regulations Airspace, Incorporation by reference, AGENCY: Federal Aviation (14 CFR) part 71 by modifying Class E Navigation (air). Administration (FAA), DOT.
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ACTION: Notice of proposed rulemaking Airspace and AIM, Federal Aviation Correction to Proposed Rule (NPRM); correction. Administration, 800 Independence Accordingly, pursuant to the Avenue, SW., Washington, DC 20591; authority delegated to me, in proposed SUMMARY: This action corrects a NPRM telephone: (202) 267–8783. published in the Federal Register March rule FAA Docket No. FAA–2009–1050, 30, 2010. In that NPRM, the airspace SUPPLEMENTARY INFORMATION: on March 30, 2010 (75 FR 15632), make docket number was incorrectly the following correction: History published as ‘‘09–ASW–3’’ instead of § 71.1 [Amended] ‘‘09–ASW–40.’’ This action corrects that On March 30, 2010, a NPRM for On page 15632, columns 2, and 3, and error. Airspace Docket No. 09–ASW–3, FAA on page 15633, column 1, correct the DATES: Effective date 0901 UTC, April Docket No. FAA–2009–1050, was airspace docket number to read as 19, 2010. The Director of the Federal published in the Federal Register (75 follows: Airspace Docket No. 09–ASW– Register approves this incorporation by FR 15632) to amend and establish 40. reference action under 1 CFR part 51, restricted areas and other special use subject to the annual revision of FAA airspace in the Razorback Range Issued in Washington, DC, on April 8, Order 7400.9 and publication of Airspace Complex, AR. The airspace 2010. conforming amendments. docket number in that NPRM was Edith V. Parish, FOR FURTHER INFORMATION CONTACT: incorrect and should have read ‘‘09– Manager, Airspace and Rules Group. Colby Abbott, Airspace and Rules ASW–40’’ instead of ‘‘09–ASW–3.’’ This [FR Doc. 2010–8829 Filed 4–16–10; 8:45 am] Group, Office of System Operations action corrects that error. BILLING CODE 4910–13–P
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Notices Federal Register Vol. 75, No. 74
Monday, April 19, 2010
This section of the FEDERAL REGISTER DEPARTMENT OF COMMERCE equally, including areas not contains documents other than rules or traditionally visited by international proposed rules that are applicable to the Office of the Secretary travelers. public. Notices of hearings and investigations, The Corporation will be governed by committee meetings, agency decisions and Notice of an Opportunity To Serve on a board of directors of eleven members rulings, delegations of authority, filing of the Board of Directors of the with knowledge of international travel petitions and applications and agency Corporation for Travel Promotion statements of organization and functions are promotion and marketing and with examples of documents appearing in this AGENCY: Office of the Secretary, U.S. appropriate expertise and experience in section. Department of Commerce. specific sectors of the travel and tourism ACTION: Notice. industry. These members will broadly represent various regions of the United DEPARTMENT OF AGRICULTURE SUMMARY: The Department of Commerce States. is inviting expressions of interest to Selection Criteria Rural Housing Service serve on the initial Board of Directors of the Corporation for Travel Promotion The TPA directs the Secretary of Notice of Intent To Hold Public Forums (Board) from leaders with knowledge of Commerce (after consultation with the To Solicit Feedback From the Public international travel promotion and Secretary of Homeland Security and the Regarding the Section 523 Mutual Self- marketing and who have expertise and Secretary of State) to appoint the board Help Housing Program experience in specific sectors of the of directors for the Corporation for travel and tourism industry. The Travel Promotion. Thus, in accordance AGENCY: Rural Housing Service, USDA. purpose of the initial Board is to, among with the TPA, the Department of other things, serve as incorporators and Commerce will be selecting individuals ACTION: Notice. establish the Corporation for Travel with the appropriate expertise and Promotion. experience from specific sectors of the SUMMARY: The Rural Housing Service, DATES: All information must be received travel and tourism industry to serve on USDA published a document in the the Board as follows: Federal Register of February 2, 2010, by the Office of the Secretary at the email or postal address below by close (A) 1 shall have appropriate expertise concerning upcoming public forums of business (EDT) on May 10, 2010. and experience in the hotel and request for comments regarding the accommodations sector; ADDRESSES: Please submit relevant Section 523 Mutual Self-Help Housing (B) 1 shall have appropriate expertise information via e-mail to Program. There has been a change in the and experience in the restaurant sector; [email protected] or by mail to John date to receive written comments, a (C) 1 shall have appropriate expertise Connor, Office of the Secretary, U.S. and experience in the small business or change in one of the forum dates and a Department of Commerce, Room 5835, change in contact information. retail sector or in associations 1401 Constitution Avenue, NW., representing that sector; FOR FURTHER INFORMATION CONTACT: Washington, DC 20230. (D) 1 shall have appropriate expertise Carolyn L. Bell, Chief, Special Program SUPPLEMENTARY INFORMATION: and experience in the travel distribution and New Initiatives Branch, Single Background services sector; Family Housing Direct Loan Division, (E) 1 shall have appropriate expertise Rural Housing Service, USDA at 1400 The Travel Promotion Act of 2009 and experience in the attractions or (TPA) was passed on February 25, 2010 Independence Avenue, SW., Stop 0783, recreations sector; and signed into law on March 4, 2010. Washington, DC 20250–0783, telephone (F) 1 shall have appropriate expertise The TPA establishes the Corporation for (202) 720–1532, fax: (202) 720–2232, e- and experience as officials of a city Travel Promotion (Corporation), a non- mail [email protected]. convention and visitors’ bureau; profit corporation that will (G) 2 shall have appropriate expertise SUPPLEMENTARY INFORMATION: The date communicate United States entry and experience as officials of a State for all written questions and comments policies and otherwise promote leisure, tourism office; to be received has been changed to July business, and scholarly travel to the (H) 1 shall have appropriate expertise 15, 2010, and the date for Washington, United States. and experience in the passenger air DC has been changed to June 30, 2010. The TPA states that the Corporation sector; shall develop and execute a plan to (A) (I) 1 shall have appropriate expertise Dated: April 9, 2010. provide useful information to those and experience in immigration law and Kathy Mcentee, interested in traveling to the United policy, including visa requirements and Acting Administrator, Rural Housing Service. States; (B) identify and address United States entry procedures; and [FR Doc. 2010–8907 Filed 4–16–10; 8:45 am] perceptions regarding U.S. entry (J) 1 shall have appropriate expertise BILLING CODE 3410–XV–P policies; (C) maximize economic and in the intercity passenger railroad diplomatic benefits of travel to the business. United States through the use of various To be eligible for Board membership, promotional tools; and (D) ensure that one must have international travel and international travel benefits all States tourism marketing experience and must and the District of Columbia, and also be a U.S. citizen. In addition, identify opportunities to promote individuals cannot be federally tourism to rural and urban areas registered lobbyists or registered as a
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foreign agent under the Foreign Agents DEPARTMENT OF COMMERCE commercial carrier that routinely Registration Act of 1938, as amended. delivers mail to NIST. National Institute of Standards and Those selected for the initial Board Electronic submission: http:// Technology www.grants.gov. must be able to meet the time and effort commitments of the Board to establish [Docket No. 100407180–0181–01] FOR FURTHER INFORMATION CONTACT: the new Corporation. Thomas Wiggins at 301–975–5416 or by Technology Innovation Program (TIP) e-mail at [email protected]. Priority may be given to individuals Notice of Availability of Funds and SUPPLEMENTARY INFORMATION: with experience as a Chief Executive Announcement of Public Meetings Additional Information: The full Officer or President (or comparable level (Proposers’ Conferences) Federal Funding Opportunity (FFO) of responsibility) of an organization or AGENCY: National Institute of Standards announcement for this request for entity in the travel and tourism sector in proposals contains detailed information the United States. and Technology (NIST), Department of Commerce. and requirements for the program. Board members will serve at the Proposers are strongly encouraged to ACTION: Notice. discretion of the Secretary of Commerce read the FFO in developing proposals. (who may remove any member of the SUMMARY: The National Institute of The full FFO announcement text is Board for good cause). Standards and Technology’s (NIST) available at http://www.grants.gov and The term of office of each member of Technology Innovation Program (TIP) on the TIP Web site at http:// the Board will be 3 years, except that, announces that it will hold a single www.nist.gov/tip/helpful-resources.cfm. In addition, proposers are directed to of the members first appointed: (A) 3 fiscal year 2010 competition and is review the April 2010 Technology shall be appointed for terms of 1 year; soliciting high-risk, high-reward research and development (R&D) Innovation Program Proposal (B) 4 shall be appointed for terms of 2 Preparation Kit available at http:// years; and (C) 4 shall be appointed for proposals for financial assistance. TIP also announces that it will hold three www.nist.gov/tip/helpful-resources.cfm. terms of 3 years. Board members can The TIP Proposal Preparation Kit must serve a maximum of two consecutive public meetings (Proposers’ Conferences) for all interested parties. be used to prepare a TIP proposal. The full three-year terms. TIP is soliciting proposals under this TIP implementing regulations are Board members are not considered fiscal year 2010 competition in the area published at 15 CFR Part 296, and Federal government employees by of critical national need entitled included in the TIP Proposal virtue of their service as a member of ‘‘Manufacturing’’ as described in the Preparation Kit as Appendix B. the Board and will receive no Program Description section below. Public Meetings (Proposers’ Conferences): TIP will hold three public compensation from the Federal DATES: The due date for submission of meetings (Proposers’ Conferences) to government for their participation in proposals is 11:59 p.m. Eastern Time, provide general information regarding Board activities. Members participating Thursday, July 15, 2010. This deadline TIP, to offer guidance on preparing in Board meetings and events will be applies to any mode of proposal proposals, and to answer questions. paid actual travel expenses and per submission, including paper and Proprietary technical discussions about diem when away from their usual places electronic. Do not wait until the last specific project ideas with NIST staff are of residence. minute to submit a proposal. TIP will not permitted at these conferences or at not make any allowances for late To be considered for membership, any time before submitting the proposal submissions, including incomplete please provide the following: to TIP. Therefore, proposers should not Grants.gov registration or delays by expect to have proprietary issues 1. Name, title, and personal resume of guaranteed overnight couriers. To avoid addressed at the Proposers’ Conferences. the individual requesting consideration; any potential processing backlogs due to Also, NIST/TIP staff will not critique or and last minute registrations, proposers are provide feedback on project ideas while strongly encouraged to start their 2. A brief statement of why the person they are being developed by a proposer. Grants.gov registration process at least should be considered for membership However, NIST/TIP staff will answer four weeks prior to the proposal on the Board. This statement should questions about the TIP eligibility and submission due date. Review, selection, also address the individual’s relevant cost-sharing requirements, evaluation and award processing is expected to be international travel and tourism and award criteria, selection process, completed by the end of November marketing experience and indicate and the general characteristics of a 2010. clearly the sector or sectors enumerated competitive TIP proposal at the above in which the individual has the ADDRESSES: Proposals must be Proposers’ Conferences and by phone requisite expertise and experience. submitted to TIP as follows: and e-mail. Attendance at the TIP Individuals who have the requisite Paper submission: Send to National Proposers’ Conferences is not required. expertise and experience in more than Institute of Standards and Technology, The TIP Proposers’ Conferences will one sector can be appointed from only Technology Innovation Program, 100 be held on the following dates, times, one of those sectors. Bureau Drive, Stop 4750, Gaithersburg, and at the following locations: MD 20899–4750. Please note that the (1) April 28, 2010, 9 a.m.–2 p.m. Appointments of members to the NIST site is closed to the general public, Eastern Time: NIST Red Auditorium, Board will be made by the Secretary of and applicant personnel and couriers 100 Bureau Drive, Gaithersburg, MD. Commerce. will not be permitted onto the NIST site Pre-registration is required by 5 p.m. Dated: April 13, 2010. in order to deliver proposals. Also note Eastern Time on April 23, 2010, for the John Connor, that the NIST Visitors Center is not Proposers’ Conference being held at Director, Office of the Secretary. permitted to accept proposals on behalf NIST Gaithersburg, MD. Due to increased security at NIST, NO on-site [FR Doc. 2010–8856 Filed 4–16–10; 8:45 am] of the Technology Innovation Program. Paper submissions will be accepted registrations will be accepted and all BILLING CODE 3510–DR–P from the U.S. Mail or similar attendees MUST be pre-registered.
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Photo identification must be presented outlined in the white paper ‘‘Materials advances’’ are defined for at the NIST main gate to be admitted to Manufacturing and Biomanufacturing: purposes of this funding opportunity as: the April 28, 2010 conference. Materials Advances and Critical Materials that have been developed to the Attendees must wear their conference Processes (http://www.nist.gov/tip/ _ point that unique functionalities have been badge at all times while on the NIST cur comp/index.cfm). identified and these materials now need to be campus. Electronic Registration at: Materials performance is often a made available in quantities large enough for http://www.nist.gov/public_affairs/ critical consideration and controlling innovators and manufacturers to test and confpage/100428.htm. validate in order to develop new products. No registration fee will be charged for factor in the innovation process. High strength alloys are used to build attending the Proposers’ Conferences. The unique functionality that these Presentation materials from the stronger, lighter and safer vehicles; superalloys are used to make higher materials represent will require new Gaithersburg, MD Proposers’ Conference levels of understanding in the sciences will be made available on the TIP Web efficiency gas turbines; composites make larger, more efficient wind turbine of materials processing and process site. control. Nanomaterials, for example, The Gaithersburg, MD Proposers’ blades and provide improved will require manipulation and Conference will webcast details at the performance in aerospace applications; TIP Web site: http://www.nist.gov/tip. and nanomaterials are finding their way measurement at the atomic level. In (2) May 4, 2010, 1 p.m.–5 p.m. Pacific into better performing batteries, energy alloys, the measurements and control Time, Embassy Suites Hotel Los Angeles storage devices, electronic inks, high would be at the microscale (and International Airport—South, 1440 voltage transmission lines, and health eventually at the nanoscale) with an Imperial Avenue, El Segundo, CA care related applications (e.g., imaging emphasis on anisotropic features of the 90245. and therapeutics). Ceramics have new micro (nano) structure. With (3) May 6, 2010, 9:00 a.m.–1 p.m. uses in improving electronic and composites, ceramics, and glasses, Eastern Time, Detroit Marriott photonic devices, and glasses have measurements and control would be at Renaissance Center, Renaissance Drive many next-generation applications such the mesoscale and would take advantage N, Detroit, MI 48243. as wireless communication, displays, of the anisotropic layering of the No Pre-registration is required for the optical telecommunication, integrated process. Control of one material or Proposers’ Conferences in Los Angeles, circuits, and ion exchange membranes phase within another will also be an CA or Detroit, MI. for fuel cells. Overcoming scale-up important consideration. issues of moving novel materials Statutory Authority: Section 3012 of the A ‘‘critical process’’ is defined for America Creating Opportunities to advances from the laboratory into purposes of this funding opportunity as: Meaningfully Promote Excellence in manufacturing through ‘‘faster, better, Technology, Education, and Science cheaper’’ methods is just one way to A process that has a significant impact on (COMPETES) Act, Pub. L. 110–69 (August 9, help manufacturers be more successful capacity, output, quality, variability, 2007), codified at 15 U.S.C. 278n. and competitive. Critical processes are efficiencies, performance, flexibility, etc., as CFDA: 11.616, Technology Innovation generally manufacturing processes that well as a manufacturer’s competitiveness and Program. have the greatest impact on one or more success. Program Description: TIP is soliciting of the following characteristics: product Process improvements made through proposals under this fiscal year 2010 quality, product yields from raw high-risk, high-reward research and competition in the area of critical materials, scrap rates, efficiency of raw development, rather than simple national need entitled ‘‘Manufacturing’’ material consumption, and/or other engineering improvements or redesign, as described below. measures of efficiency. Many critical could lead to significant and Area of Critical National Need: manufacturing processes are not flexible quantifiable improvements in process Manufacturing enough to easily incorporate novel output measures. As an example from The goal of the research outcome/ materials advances into new products and many critical processes limit the last year’s news headlines, consider the impacts from this competition is to vaccine production response to the provide manufacturers and end users nation’s capacity to supply existing strategically important products. H1N1 flu outbreak. Experts were able to improved access to adequate quantities decode the virus to prepare a vaccine in of materials based on new advances at Finding technical solutions to these challenges in manufacturing can give record time, but encountered problems competitive costs that allow evaluation supplying the large volumes of vaccine and utilization of these materials in the comparative advantages necessary needed in a timely fashion. Vaccines are innovative ways, and new for retaining manufacturing in the grown in chicken eggs in a process that manufacturing processes that can United States. Outlined in this dates back to World War II. Each egg is transform the way products are made. announcement are three key areas TIP’s funding strategy for this related to the manufacturability of in effect its own factory with product competition will emphasize three materials advances and enhanced variability and purity issues. important elements: (1) Process scale- processing capabilities and descriptions Development of new processes for up, integration and design for materials of the supporting technical challenges production of recombinant vaccines as advances; (2) Predictive modeling for that need to be addressed. If successful, well as processes for real time materials advances and materials the manufacturing solutions envisioned monitoring and analysis could address processing; and (3) Critical process will have the potential to: these problems and would help to not advances related to the Create significant improvements in new only respond rapidly to new virus manufacturability of materials and and existing products and in their outbreaks, but could also reduce the manufacturing of both new and existing manufacture by accelerating the utilization of cost of clinical trials through better products. These three elements of the materials advances and overcoming critical scale-up methodologies. Addressing societal challenge of accelerating the use manufacturing process bottlenecks to these challenges and needs could also of materials advances and advances in improve the competitiveness of U.S. impact other industries such as critical processes will be addressed as manufacturers in the global marketplace. chemicals, biofuels, etc.
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Element 1—Process Scale-Up, new products can be made while manufacturing cost. For example, Integration, and Design for Materials maintaining the unique functionality of current sensing technologies typically Advances the materials as predicted. require manual sampling, are not rapid or robust to cleaning agents or New materials typically are developed Element 3—Critical Process Advances in a laboratory setting, and then samples processes, and are not sufficiently are given to end-users for alpha and beta As the availability of new materials reliable for imbedding in the testing. During this testing phase, it can increases and the modeling of their manufacturing environment as take considerable time and behavior becomes more refined, there is automated technology. Critical process experimentation to understand how the a complementary need to improve advances are needed, enabling rapid on- materials can be incorporated into a processing or manufacturing methods. line sensing and analytical capabilities. new product in a way that maintains High-risk, high-reward approaches are New tools are needed for bioprocess and utilizes their unique functionality. needed to exploit the properties of the optimization, control and improvement Scaling-up from laboratory quantities to materials advances into new and more to enable a cost-effective batch or larger volumes, validating properties, advanced products as well as support continuous manufacturing process. and then incorporating the materials the processing of existing materials in Processes that involve integrated into product manufacturing lines is new and different ways, resolving key sensing and detection capabilities for often non-linear and does not follow bottlenecks or critical problems such as measuring multiple parameters will be straightforward scaling laws, due to the energy consumption, processing time, useful. Moreover, purification and unique functionality that has been scrap rates, quality, and throughput. separation process advances involving obtained from the materials advances. Current methods of manufacturing often novel membranes and affinity reagents are not rapidly adaptable to making new are needed for cost-effective Element 2—Predictive Modeling Tools or different products, and are often not downstream processing in for Materials Advances and Materials optimized towards making existing biopharmaceutical manufacturing Processing products faster, more cheaply, and more processes. Predictive modeling capabilities are sustainably. Improving processes used The first two proposed elements for key to developing new processes, in the manufacture of new and existing Manufacturing and Biomanufacturing: scaling-up these processes, and products is an imperative for the Materials Advances and Critical understanding how to utilize the unique continued global competitiveness of Processes require research in new functionality of materials advances. U.S. manufacturers. Agile, flexible, and technologies. The table below can be Modeling capabilities are needed increasingly interoperable systems are used to illustrate possible relationships principally to: necessary enhancements to base between key challenges. TIP would a. Analyze and understand why manufacturing technologies in order to expect solutions to the first two newly discovered materials do what meet new productivity challenges. elements to map into one or more cells they do and then extrapolate their Significant biomanufacturing process in Table 1 below. It is possible that the behavior to new uses; and improvements are needed to enhance areas below could also impact or b. Incorporate this knowledge more safety, quality, and consistency of involve health care applications and/or efficiently into process design tools so biopharmaceuticals while reducing the biomanufacturing approaches.
TABLE 1
Superalloys, alloys Technological needs Nanomaterials & smart materials Composites Ceramics Glasses
Processing of Materials: Scale-up from Laboratory Quan- tities/Controls. Incorporate into New Uses/Main- tain Functionality. Predictive Modeling: Rules/Understand Why It Does What It Does. Process Modeling/Design Tools.
For the first element, process scale- instead by developing new techniques revolutionary functions of these new up, integration, and design for materials such as partial forging. materials. advances, new processes will need to be New instrumentation and Proposals addressing process scale- developed. These processes will measurement capabilities also will be up, integration, and design for materials increase to commercial scale the needed to support these new processes. advances will be considered responsive quantity and quality of available These instruments will need to measure if they include scale-up of materials in advanced materials; or help incorporate real-time process parameters such as the one of the specified five materials these materials into new, revolutionary properties that provide the unique classes (listed in Table 1) that are products based on a new material’s capabilities of the advanced materials derived from biological or other sources properties. These scaled-up processes (e.g., composition). In addition, and consist of one or more of the following: may be a next generation or an entirely instruments for real-time inspection are • new process. For example, forging ever- needed to ensure and/or verify materials A single process to achieve the larger parts cannot be solved by are being correctly incorporated into goals of the scale-up, or multiple building ever-larger forges (which manufactured products that require the processes integrated together into a becomes prohibitively expensive), but coherent solution (i.e., diverse processes
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or multiples of a single process for • Have the primary focus of the results, as well as for developing a ‘‘intensification’’); proposal on materials that are not greater understanding of the materials • Scale-up of materials processes to included within Table 1 (i.e. pure for end users and/or manufacture and apply coatings that are polymers). • Develop or use the constitutive within the scope requirements for the • Focus primarily on the application relationships and rules to develop material types (nanomaterials; of material coatings using a material not process design tools for the superalloys, alloys and smart materials; included in Table 1. manufacturing processes for these composites; ceramics; and glasses, • Do not provide a quantitative materials advances. including bulk metallic glasses); or technical discussion of baseline Proposals addressing predictive • Scale-up of materials processes for capabilities (state-of-the-practice or modeling for materials advances and healthcare applications (e.g., imaging, state-of-the-art). materials processing will be considered therapeutics, etc.). For the second element, predictive more competitive if they address: Some examples of responsive modeling for materials advances and • Collaboration by or with those who proposals (not all-inclusive) include: materials processing, new tools are manufacture the materials, in order to • Nano structured silica from rice needed to enable researchers to use validate the models and/or plant or algae. constitutive relations and rules (with • How users will specifically benefit • Oxide nanoparticles produced by validation) concerning the underlying from the acceleration and microorganisms. implementation of the proposed models • behavior of materials (understanding Quantum dot-based structure vs. function) and the changes in support of materials reliability (i.e. nanocomposites produced by to behavior due to manufacturing final properties or mechanical genetically engineered viruses (e.g. M13 processes. For example, new tools will performance) and materials behavior bacteriophage). • need to account for the scale-dependent before and after processing. Cellulose/polyethylene oxide behavior of materials advances. This Proposals addressing predictive nanocomposites produced by capability will enable a better and modeling for materials advances and genetically engineered bacteria quicker understanding of why materials materials processing that do not include (Acetobacter Xylium). do what they do. These efforts will also validation of models will be considered • Biologically produced silver carbon enable extrapolation of that knowledge less competitive. composites for optically functional thin beyond the laboratory conditions for Proposals addressing predictive film. • which they were developed, and will modeling for materials advances and Biologically produced natural fiber materials processing will be considered reinforced aerogel composites. therefore need new validation and • verification capabilities. nonresponsive if they: Composites made with chitosan • Have the primary focus of the derived from crustacean shells. In addition, critical knowledge is needed about why certain decisions or proposal on materials that are not Proposals addressing process scale- included within Table 1 (i.e., pure up, integration and design for materials assumptions were made, in order to incorporate new modeling capabilities polymers). advances must address all of the • Focus primarily on the application following issues: for laboratory results into process design • and modeling. Again, new validation of material coatings using a material not Address one or more of the included under Table 1. materials areas specified in this and verification methodologies will be • essential. Do not provide a quantitative announcement. technical discussion of baseline • Quantify the baseline processing With successful development of these tools, processes, and technologies, the capabilities (state-of-the-practice or capabilities. state-of-the-art). • Describe how the results of the manufacturing communities will have significantly improved capabilities to The third element, critical process process scale-up could lead to new advances, requires modifications in products and manufacturing process quickly incorporate advanced materials breakthroughs into revolutionary manufacturing processes that augment capabilities. and expand current limited capabilities. • Provide quantification and products based on new materials Applications could include those qualification of the estimated output of functionality, and thus establish new oriented towards the creation of novel the final project results. competitive advantages in a global • Scale-up of the quantities produced economy. methods to fabricate unique during the project must be targeted to Proposals addressing predictive components from complex, difficult-to- increase by a factor of 1,000 fold or modeling for materials advances and machine materials (advanced more (unit quantity per unit time) as materials processing must address all of engineering materials or smart compared to the baseline. the following issues: materials), or the design and • A detailed scientific rationale and • Address one or more of the implementation of real-time, sensor- description of the challenges to materials areas given in Table 1. based, feedback-optimized systems for accomplish scale-up of the process(es) • Quantify the baseline modeling discrete, continuous or batch must be included. capability. manufacturing processes. A discrete Proposals addressing process scale- • Describe how the results of the manufacturing example could be a up, integration, and design of materials proposed modeling capabilities could process for making customized parts advances will be considered more lead to new products and manufacturing such as medical implants, using competitive if they: process capabilities. techniques such as additive • Include validation methodologies Proposals for predictive modeling for manufacturing, near net-shape by or with processors or end users and/ materials advances and materials fabrication, or partial forging. Processes or processing must also address one or are needed for the manufacture of parts • Address sustainability issues. both of the following: possessing complex geometries from Proposals addressing process scale- • Develop constitutive relationships existing and novel materials while up, integration, and design for materials and rules that describe the behavior and preserving the properties of the advances will be considered the process of the materials at a level material. A batch process example nonresponsive if they: that is useful for describing laboratory would be improved process monitoring
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and in situ analytical tools, enabling a products produced in a more reliable critical process advances is given below. reduction in batch-to-batch variability and cost-effective manner. TIP would expect solutions to the third and an improvement in quality, and A table for guidance on categorizing societal challenge to map into one or quantity of biopharmaceuticals or other applicable processes and pathways to more of the cells in Table 2 below.
TABLE 2
Process State-of-the-art approaches to critical manufacturing process advances for: Batch Discrete Continuous
Improving quality ...... Increasing throughput ...... Reducing costs ...... Enhancing sustainability ...... Enabling new capabilities ...... Improving agility ...... Other improvements ......
Proposals addressing critical process parameters that are not discussed. For of engineered cells or tissues when advances will be considered responsive example, if a proposal claims lower cost developed as therapeutics. if they address improvements in quality, but does not mention quality, reviewers • Advanced bioprocesses for rapid throughput, costs, sustainability, new will have to consider the possibility that on-line analysis of biopharmaceuticals capabilities, and agility, relative to the quality is being sacrificed to save on (e.g. protein glycoforms, three- state-of-the-art for the process being cost, and such a proposal will be less dimensional structure, aggregates, proposed. competitive than one that offers immunogenicity and contaminating In drafting a proposal addressing comparable cost saving together with a bacteria, viruses, mycoplasma, critical process advances applicants claim for quality equal to or better than production cell proteins and nucleic should address topics in their area of current products. acids). interest such as: The term ‘‘biomanufacturing’’ as used • Advanced active control feedback • If a proposal offers improvements in throughout this notice and in the FFO systems for monitoring and controlling several of these categories, the multiple announcement refers to manufacturing complex bioprocesses and high improvements could be combined. For of biopharmaceuticals. throughput microreactor/bioreactor example, a proposed new process might Biopharmaceuticals are complex array systems for optimizing production offer half the setup time and triple the pharmaceutical products manufactured cell systems (e.g. engineered Chinese rate of production compared to existing by biotechnology. Two types of Hamster Ovary or CHO cells, insect processes. biomanufacturing are considered: cells, microorganisms, or algae). • • Benefits are not necessarily ‘‘linear’’; bioprocessing for production of Advances in critical processes in for example, a component of a machine biopharmaceuticals such as cost effective scale up of engineered might benefit from increased strength or recombinant proteins as vaccines, cells or engineered tissues. • durability up to a point, beyond which therapeutics, or as molecular probes for New, automated processes for there is little incremental benefit. diagnostics, and advanced producing parts using composite • Because manufacturing processes biofabrication and processing for materials. generally involve tradeoffs, a proposed • production of cell or tissue-based Affordable fabrication methods for new process may involve improvements biopharmaceuticals such as engineered lightweight components manufactured in some areas and tradeoffs in other cells and engineered tissues as from low cost titanium powders. areas. For example, a proposed process • therapies. Engineered tissues are Reduction of energy intensity and might offer a factor of six cost reduction complex structures involving cells, demand, carbon dioxide and greenhouse but a production rate decrease of a scaffolds and signaling molecules. gas emissions in glassmaking or other factor of two, and the net benefit of the Manufacturing of either type of high energy consuming sectors. tradeoff will be evaluated. • Precision additive manufacturing of biopharmaceuticals is within the scope • Proposals should quantify to the medical devices. of the competition. extent possible every aspect of the • Low cost technologies for advance in state of the art (as shown by Proposals addressing critical process advancing the uses of nanomaterials in the rows in the Table 2 above), advances will be considered responsive a variety of end products. including any that may offer decreased if they provide improvements in one or Responsive proposals addressing benefit as a tradeoff to further increase more critical processes integrated critical process advances must address the advance in another area. Claimed together into a coherent solution to all of the following issues: benefits must be quantified for significantly enhance process • Address how the improved particular target application(s). efficiencies and reduce process manufacturing processes are (Example: ‘‘a new forging and heat variability. transformational compared to the state- treatment process for automobile axles Some examples of responsive of-the-art; will allow 50% lighter parts to be used proposals (not all-inclusive) include: • Describe how the results of the and cut manufacturing cost by x%, • New biomanufacturing process research will lead to new and improved improving fuel economy by y%, and capabilities enabling rapid on-line manufacturing processes enabling safe, ultimately reducing greenhouse gas monitoring of production cell health cost effective and reliable production emissions by z million tons per year.’’) and function (e.g. cell viability, and new and improved products such as • The evaluation process should not metabolism, contaminants) and on line customized medical implants, large make assumptions about performance monitoring of the structure and function bearings, etc.;
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• Describe why the technological when the proposed research plan • Straightforward improvements of solutions are high-risk and high-reward includes validation by others of the existing products or product in nature; and research goals. When preparing a development. • Provide quantification and proposal, it is necessary to quantify and • Projects that are Phase II, III, or IV qualification of the estimated output of qualify the ability of the research results clinical trials. TIP will rarely fund Phase the final project results. to ‘‘Transform the Nation’s Capacity to I clinical trials and reserves the right not Proposals addressing critical process Deal with Major Societal Challenges’’. to fund a Phase I clinical trial. The advances will be considered more The claims that any proposal makes portion of a Phase I trial that may be competitive if they: relative to this key criterion are • funded must be critical to meeting Include multiple improvement strengthened by validation of the evaluation criterion (a)(1) addressing the areas from the table above; • research results with one or more end scientific and technical merit of the Include validation methodologies user(s) of the technology. The proposal proposal. The trial results must be by or with processors or end users; and/ may make assertions by narrative and essential for completion of a critical or • referenced third-party documentation. R&D task of the project. The definitions Address sustainability issues. ‘‘ ’’ Examples of proposals addressing The addition of letters of interest in of all phases of clinical trials are critical process advances that will be the research results by potential end provided in the TIP Guidelines and considered nonresponsive are: users adds strength to a proposal. Documentation Requirements for • Any manufacturing process that Ultimately, the addition of one or more Research Involving Human & Animal offers only incremental improvement end users in a validation task Subjects located at http://www.nist.gov/ over existing processes; implementing the research results tip/helpful-resources.cfm. • Processes that are intended would present the strongest case for • Pre-commercial-scale primarily for military/weaponry commitment to the planned research demonstration projects where the applications (e.g. warhead manufacture, goals. emphasis is on demonstrating that some chemical/biological warfare materials Examples of validation tasks within technology works on a large scale or is production); each of the three elements might economically sound rather than on R&D • Manufacturing processes that include: that advances the state of the art and is cannot be performed in the U.S. due to • Process scale-up, integration, and high-risk, high-reward. existing laws or regulations; design for advanced materials: Create a • Projects that TIP determines would • Projects primarily focused on prototype using the advanced material likely be completed without TIP funds production of non engineered cells or produced from the research. in the same time frame or nearly the tissues as therapeutics; • same time frame, or with the same scale • Predictive modeling for advanced Projects involving straightforward materials and materials processing: or scope. scale-up of biopharmaceuticals with Apply modeling capability by • Predominantly straightforward, incremental improvements in the implementing the new model routine data gathering (e.g., creation of manufacturing processes; voluntary consensus standards, data • information as a key knowledge Projects that involve incremental component into a process or product. gathering/handbook/specification sheet improvements in traditional processes • Critical process advances: Integrate preparation, testing of materials, or for biomolecule production (e.g. vaccine the research results into processes for unbounded research aimed at basic production in chicken eggs, hormones optimization, control and improvements discovery science) or application of such as insulin extracted from pig in manufacturing and product analysis standard engineering practices. tissue); • Projects in which the predominant • Biomanufacturing projects that (e.g. composites, metals, chemicals, biopharmaceuticals). risk is market oriented—that is, the risk primarily focus on processes for that the end product may not be production of non-biopharmaceutical Nonresponsive projects under this area of critical national need include: embraced by the marketplace. products (e.g. production of biofuels or • • Projects whose principal focus is on Projects with software work, that small molecule drugs); are predominantly about final product • Projects that primarily focus on discovery of new materials; details and product development, and drug discovery or design of new • Efforts related to the physical that have significant testing involving biomaterials; extraction of raw materials; users outside the research team to • Projects that primarily focus on • Straightforward improvements to discovery of new production cell determine if the software meets the existing processes or materials without original research objectives, are likely to systems; the potential for a transformational • be either uncompetitive or possibly Projects that use living genetically increase in performance to the technical modified vertebrate animals, ineligible for funding. However, R&D requirements; projects with limited software testing, invertebrate animals, or plants as • Integration projects using only bioreactors for biopharmaceutical involving users outside of the research existing state-of-the-art processes, team, or vertebrate animals, may be production; models or materials; • Production or scale up of scaffolds eligible for funding and contain eligible • Software development that is or biomaterials used in scaffold design costs within a TIP award when the predominantly straightforward, routine that are not a part of the manufacturing testing is critical to meeting evaluation data gathering using applications of of engineered tissues; and criteria and/or award criteria and the • Projects with a primary focus standard software development testing results are essential for (people, equipment, time, and/or funds) practices; and completion of a critical task in the • on device development. Projects that do not include a proposed research. This type of testing quantitative baseline and quantitative in projects may also be considered to Additional Requirements for All metrics for tracking research. involve human subjects or vertebrate Manufacturing Proposals In addition to the competition- animals in research and require TIP proposals are strengthened and specific nonresponsive projects, the compliance with applicable Federal generally considered most competitive following are nonresponsive projects: regulations and NIST policies for the
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protection of human subjects or live j. Patent costs and legal fees, unless provided in 15 CFR §§ 296.2, 296.4, and vertebrate animals. they are included in a Federally 296.5. Nonprofit organizations must Unallowable/Ineligible Costs: The approved indirect cost rate. meet the eligibility criteria set forth in following items, regardless of whether k. Preaward costs: i.e., any costs 15 CFR 296.5(a)(2), which explains the they are allowable under the Federal incurred prior to the award start date. eligibility criteria for companies. cost principles, are ineligible/ l. Profit, management fees, interest on Large-sized Company Participation: A unallowable under TIP: borrowed funds, or facilities capital cost large-sized company is not eligible to a. Bid and proposal costs unless they of money. However, profit is allowable apply for TIP funding. A large-sized are incorporated into a Federally- for contractors under a single company company is defined as any business, approved indirect cost rate (e.g., or joint venture. including any parent company plus payments to any organization or person m. Project development planning (e.g. related subsidiaries, having annual retained to help prepare a proposal). patent and literature searches) and revenues in excess of $1.7208 billion. b. Construction costs for new creation of milestones. For example, This number is based on the May 2009 buildings or extensive renovations of proposals that plan on developing issue of Fortune magazine’s Fortune existing buildings. However, costs for milestones only if an award is received 1000 list. (Note that the revenue amount the construction of experimental and after literature searches are will be updated annually and will be research and development facilities to performed under the award are noted in future annual announcements be located within a new or existing generally not competitive. Costs for of availability of funds.) literature searches in general are building are allowable provided the Cost-Sharing Requirements: Proposers ineligible. equipment or facilities are essential for must provide a cost share of at least 50 n. Relocation costs, unless they are carrying out the proposed project and percent of the yearly total project costs included in a Federally approved are approved in advanced by the NIST (direct plus all of the indirect costs). indirect cost rate. Grants Officer. These types of facility o. Salaries: NIST limits the salaries of Evaluation and Award Criteria: costs may need to be prorated if they project personnel to not exceed Level I Proposals are selected for funding based will not be used exclusively for the of the Executive Schedule ($199,700 as on the evaluation criteria listed in 15 research activities proposed. of January 2010 http://www.opm.gov/ CFR 296.21 and the award criteria listed c. Contractor office supplies and oca/10tables/html/ex.asp). in 15 CFR 296.22 as identified below. contractor expenses for conferences/ p. Tuition costs are generally not Additionally, pursuant to 15 U.S.C. workshops. allowed as direct costs on projects. An 278n(c), no proposal will be funded d. Contracts to another part of the institution of higher education unless TIP determines that it meets all same company or to another company participating in a TIP project as a of the award criteria listed in 15 CFR with identical or nearly identical contractor or as a joint venture member 296.22. Detailed guidance on how to ownership. Work proposed by another or lead may charge TIP for tuition address the evaluation and award part of the same company or by another remission or other forms of criteria is provided in Chapter 2 of the company with identical or nearly compensation paid as, or in lieu of, TIP Proposal Preparation Kit, which is identical ownership should be shown as wages to students performing necessary available at http://www.nist.gov/tip/ funded through inter-organizational work. These are allowable, provided the helpful-resources.cfm. transfers that do not contain profit. requirements are met under 2 CFR Evaluation Criteria: The two Inter-organizational transfers should be Subtitle A, Chapter 2, Part 220, components of the evaluation criteria broken down in the appropriate budget Appendix A. 45 (formerly OMB Circular and respective weights as listed in 15 categories. A–21, Section J. 41). In such cases, CFR 296.21 are as follows: e. For research involving human and/ tuition remission and other forms of (a)(1) The proposer(s) adequately or animal subjects, any costs used to compensation paid to students shall be addresses the scientific and technical secure Institutional Review Board or treated as direct costs in accordance merit and how the research may result Institutional Animal Care and Use with the actual work being performed, in intellectual property vesting in a Committee approvals before or during and listed in the budget under ‘‘Other.’’ United States entity including evidence the award. Tuition remission may be charged on an that: f. General purpose office equipment average rate basis. (i) The proposed research is novel; and supplies that are not used Funding Availability: Fiscal year 2010 (ii) The proposed research is high- exclusively for the research: e.g., office appropriations include funds in the risk, high-reward; computers, printers, copiers, paper, amount of approximately $25 million (iii) The proposer(s) demonstrates a pens, and toner cartridges. for new TIP awards. The anticipated high level of relevant scientific/ g. Indirect costs, which must be start date is January 1, 2010. The period technical expertise for key personnel, absorbed by the recipient. However, of performance depends on the R&D including contractors and/or informal indirect costs are allowable for activity proposed. A single company collaborators, and has access to the contractors under a single company or can receive up to a total of $3 million necessary resources, for example joint venture. (Note that indirect costs with a project period of performance of research facilities, equipment, materials, absorbed by the recipient may be used up to 3 years. A joint venture can and data, to conduct the research as to meet the cost-sharing requirement.) receive up to total of $9 million with a proposed; h. Marketing, sales, or project period of performance of up to (iv) The research result(s) has the commercialization costs, including 5 years. Continuation funding after the potential to address the technical needs marketing surveys, commercialization initial award is based on satisfactory associated with a major societal studies, and general business planning, performance, availability of funds, challenge not currently being addressed; unless they are included in a Federally continued relevance to program and approved indirect cost rate. objectives, and is at the sole discretion (v) The proposed research plan is i. Office furniture costs, unless they of NIST. scientifically sound with tasks, are included in a Federally approved Eligibility: Single companies and joint milestones, timeline, decision points indirect cost rate. ventures may apply for TIP funding as and alternate strategies.
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(2) Total weight of (a)(1)(i) through (v) addressed, and generate substantial raises a reasonable doubt as to the is 50%. benefits to the Nation that extend responsibility of the proposer. (b)(1) The proposer(s) adequately significantly beyond the direct return to Intellectual Property Requirements: establishes that the proposed research the proposer. For single company award recipients, has strong potential for advancing the NIST must determine that a proposal pursuant to the Bayh-Dole Act (35 state-of-the-art and contributing successfully meets all six award criteria U.S.C. 202(a) and (b)) and significantly to the United States for the proposal to receive funding ‘‘Memorandum to the Heads of science and technology knowledge base under the Program. Executive Departments and Agencies: and to address areas of critical national Selection Factors: In making final Government Patent Policy’’ (February need through transforming the Nation’s selections, the Selecting Official will 18, 1983), the entity that invents owns capacity to deal with a major societal select funding recipients based upon the the invention. However, pursuant to 35 challenge(s) that is not currently being Evaluation Panel’s rank order of the U.S.C. 202(a)(i), when a single company addressed, and generate substantial proposals and the following selection or its contractor under a TIP award is benefits to the Nation that extend factors: not located in the United States or does significantly beyond the direct return to a. Appropriate distribution of funds not have a place of business located in the proposer including an explanation among technologies and their the United States or is subject to the in the proposal: applications, control of a foreign government, NIST (i) Of the potential magnitude of b. Availability of funds, and/or will require that title to inventions made transformational results upon the c. Program priorities. by such parties be transferred to a Program Priorities: TIP is soliciting Nation’s capabilities in an area; United States entity that will ensure the (ii) Of how and when the ensuing proposals under this fiscal year 2010 commercialization of the technology in transformational results will be useful to competition in the area of critical a timely fashion. ‘‘ ’’ the Nation; and national need entitled Manufacturing For joint ventures, ownership of (iii) Of the capacity and commitment as described in the Program Description inventions arising from a TIP-funded of each award participant to enable or section above. project may vest in any participant in a advance the transformation to the Selection Procedures: Proposals are joint venture, as agreed by the members proposed research results (technology). selected based on a multi-disciplinary of the joint venture (notwithstanding 35 (2) Total weight of (b)(1)(i) through peer-review process, as described in 15 U.S.C. 202(a) and (b)). (Participant (iii) is 50%. CFR 296.20. A preliminary review is includes any entity that is identified as Award Criteria: The six components conducted to determine if the proposal a recipient, subrecipient, or contractor of the award criteria as listed in 15 CFR is in accordance with 15 CFR 296.3; on an award to a joint venture.) 296.22 are as follows: complies with the eligibility Title to any such invention shall not (a) The proposal explains why TIP requirements described in 15 CFR 296.5; be transferred or passed, except to a support is necessary, including addresses award criteria (a) through (c) participant in the joint venture, until the evidence that the research will not be of 15 CFR 296.22; was submitted to a expiration of the first patent obtained in conducted within a reasonable time previous TIP competition, and if so, has connection with such invention. period in the absence of financial been substantially revised; and is Should the last existing participant in assistance from TIP; complete. Proposals that are incomplete a joint venture cease to exist prior to the (b) The proposal demonstrates that or do not meet any one of the expiration of the first patent obtained in reasonable and thorough efforts have preliminary review requirements will connection with any invention been made to secure funding from normally be eliminated. All remaining developed from assistance provided alternative funding sources and no other proposals are then carefully reviewed by under TIP, title to such patent must be alternative funding sources are an Evaluation Panel consisting of transferred or passed to a U.S. entity reasonably available to support the Federal employees using the TIP that can commercialize the technology proposal; evaluation criteria listed in 15 CFR in a timely fashion. (c) The proposal explains the novelty 296.21 and award criteria listed in 15 The United States reserves a of the research (technology) and CFR 296.22. The Evaluation Panel will nonexclusive, nontransferable, demonstrates that other entities have present funding recommendations to the irrevocable paid-up license, to practice not already developed, commercialized, Selecting Official in rank order for or have practiced for or on behalf of the marketed, distributed, or sold similar further consideration. The Selecting United States any intellectual property research results (technologies); Official makes the final selections for developed from a TIP award. The (d) The proposal has scientific and funding. The selection of proposals by Federal government shall not in the technical merit and may result in the Selecting Official is final and cannot exercise of such license publicly intellectual property vesting in a United be appealed. The final approval of disclose proprietary information related States entity that can commercialize the selected proposals and award of to the license. This does not prohibit the technology in a timely manner; assistance will be made by the NIST licensing to any company of intellectual (e) The proposal establishes that the Grants Officer. The award decision of property rights arising from a TIP- research has strong potential for the NIST Grants Officer is final and funded project. (15 CFR 296.11(b)(3)). advancing the state-of-the-art and cannot be appealed. The Federal government also has march- contributing significantly to the United NIST reserves the right to negotiate in rights in accordance with 37 CFR States science and technology the cost and scope of the proposed work 401.6. Intellectual property means an knowledge base; and with the proposers that have been invention patentable under title 35, (f) The proposal establishes that the selected to receive awards. This may United States Code, or any patent on proposed transformational research include requesting that the proposer such an invention, or any work for (technology) has strong potential to delete from the scope of work a which copyright protection is available address areas of critical national need particular task that is deemed by NIST under title 17, United States Code. (15 through transforming the Nation’s to be inappropriate for support. NIST CFR 296.2.) capacity to deal with major societal also reserves the right to reject a Projects Involving Human Subjects. challenges that are not currently being proposal where information exists that Research involving human subjects
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must be in compliance with applicable funding. NIST will follow any of information, subject to the Federal regulations and NIST policies additional polices or guidance issued by requirements of the Paperwork for the protection of human subjects. the current Administration on this Reduction Act (PRA), unless that Human subjects research activities topic. collection of information displays a involve interactions with live human Projects Involving Live Vertebrate currently valid Office of Management subjects or the use of data, images, Animals. Research involving live and Budget (OMB) Control Number. tissue, and/or cells/cell lines (including vertebrate animals must be in This notice contains collection-of- those used for control purposes) from compliance with applicable Federal information requirements subject to the human subjects. Research involving regulations and NIST policies for the PRA. The use of Form NIST–1022, human subjects may include activities protection of live vertebrate animals. Standard Form-424 (R&R), SF–424B, such as the use of image and/or audio Vertebrate animal research involves live SF–LLL, Research and Related Other recording of people, taking surveys or animals that are being cared for, Project Information Form, and CD–346 using survey data, using databases euthanized, or used by the project has been approved by OMB under the containing personal information, testing participants to accomplish research respective control numbers 0693–0050, software with volunteers, and many goals or for teaching or testing. The 4040–0001, 4040–0007, 0348–0046, tasks beyond those within traditional regulations do not apply to animal 4040–0001, and 0605–0001. biomedical research. A Human Subjects tissues purchased from commercial Administrative and National Policy Determination Checklist is included in processors or tissue banks or to uses of Requirements. DoC Pre-Award the April 2010 TIP Proposal Preparation preexisting images of animals (e.g., a Notification Requirements. The wildlife documentary or pictures of Kit in Chapter 6 (http://www.nist.gov/ Department of Commerce Pre-Award animals in newscasts). The regulations tip/helpful-resources.cfm) to assist you Notification Requirements for Grants do apply to any animals that are in determining whether your proposed and Cooperative Agreements are transported, cared for, euthanized or research plan has human subjects contained in, 73 FR 7696 (February 11, used by a project participant for testing, involvement, which would require 2008), apply to this notice. On the form research, or training such as testing of additional information in your proposal SF–424 R&R items 5. and 6., the new procedures or projects, collection submission, and possibly more applicant’s 9-digit Employer/Taxpayer of biological samples or observation documentation during the Evaluation Identification Number (EIN/TIN) and 9- data on health and behavior. Detailed digit Dun and Bradstreet Data Universal Panel’s consideration of your proposal. information regarding the use of live See the TIP Guidelines and Numbering System (DUNS) number vertebrate animals in research plans and must be consistent with the information Documentation Requirements for required documentation is available in Research Involving Human & Animal on the Central Contractor Registration the TIP Guidelines and Documentation (CCR) (http://www.ccr.gov) and Subjects for more specific information Requirements for Research Involving on documentation requirements and Automated Standard Application for Human & Animal Subjects located at Payment System (ASAP). For complex due dates for documentation located at http://www.nist.gov/tip/helpful- http://www.nist.gov/tip/helpful- organizations with multiple EIN/TIN resources.cfm or by calling 1–888–847– and DUNS numbers, the EIN/TIN and resources.cfm or by calling 1–888–847– 6478. 6478. President Obama has issued Exec. DUNS number MUST be the numbers Executive Order 12372 for the applying organization. Order No. 13,505, 74 FR 10667 (March (Intergovernmental Review of Federal 9, 2009), revoking previous executive Organizations that provide incorrect/ Programs): Proposals under this inconsistent EIN/TIN and DUNS orders and Presidential statements program are not subject to Executive regarding the use of human embryonic numbers may experience significant Order 12372. delays in submitting their proposals stem cells in research. On July 30, 2009, Administrative Procedure Act and through grants.gov and receiving funds President Obama issued a memorandum Regulatory Flexibility Act: Prior notice if their proposal is selected for funding. directing that agencies that support and and comment are not required under 5 conduct stem cell research adopt the U.S.C. 553, or any other law, for rules Dated: April 13, 2010. ‘‘National Institutes of Health Guidelines relating to public property, loans, Marc G. Stanley, for Human Stem Cell Research’’ (NIH grants, benefits or contracts (5 U.S.C. Acting Deputy Director. Guidelines), which became effective on 553(a)). Because prior notice and an [FR Doc. 2010–8954 Filed 4–16–10; 8:45 am] ‘‘ July 7, 2009, to the fullest extent opportunity for public comment are not BILLING CODE 3510–13–P practicable in light of legal authorities required pursuant to 5 U.S.C. 553 or any and obligations.’’ On September 21, other law, the analytical requirements of 2009, the Department of Commerce the Regulatory Flexibility Act (5 U.S.C. DEPARTMENT OF COMMERCE submitted to the Office of Management 601 et seq.) are inapplicable. Therefore, and Budget a statement of compliance a regulatory flexibility analysis is not International Trade Administration with the NIH Guidelines. In accordance required and has not been prepared. [C–570–936] with the President’s memorandum, the E.O. 13132 (Federalism): This notice NIH Guidelines, and the Department of does not contain policies with Circular Welded Carbon Quality Steel Commerce statement of compliance, Federalism implications as defined in Line Pipe from the People’s Republic NIST will support and conduct research Executive Order 13132. of China: Correction to Notice of using only human embryonic stem cell E.O. 12866 (Regulatory Planning and Amended Final Determination lines that have been approved by NIH in Review): This notice is determined to be Pursuant to Final Court Decision accordance with the NIH Guidelines not significant under Executive Order and will review such research in 12866. AGENCY: Import Administration, accordance with the Common Rule and Paperwork Reduction Act: International Trade Administration, NIST implementing procedures, as Notwithstanding any other provision of Department of Commerce. appropriate. NIST will not support or the law, no person is required to, nor DATES: Effective Date: April 19, 2010. conduct any type of research that the shall any person be subject to penalty FOR FURTHER INFORMATION CONTACT: John NIH Guidelines prohibit NIH from for failure to, comply with a collection Conniff, AD/CVD Operations, Office 3,
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Import Administration, International ‘‘Department’’) published its notice of Tianjin Pipe (Group) Corp. and Tianjin Trade Administration, U.S. Department preliminary determination of sales at International Economic and Trading of Commerce, 14th Street and less than fair value (‘‘LTFV’’) and Corp. (collectively ‘‘TPCO’’). See the Constitution Avenue NW, Room 4014, affirmative preliminary determination of ‘‘Verification’’ section below for Washington, DC 20230; telephone: (202) critical circumstances in the additional information. 482–1009. antidumping investigation of certain oil On February 22, 2010, TMK IPSCO, SUPPLEMENTARY INFORMATION: country tubular goods (‘‘OCTG’’) from V&M Star L.P., V&M TCA, Wheatland the People’s Republic of China (‘‘PRC’’).1 Tube Corp., Evraz Rocky Mountain Correction The period of investigation (‘‘POI’’) is Steel, and the United States Steel On March 31, 2010, the Department of October 1, 2008, through March 31, Workers (collectively, ‘‘Petitioners’’) Commerce (‘‘the Department’’) published 2009. We invited interested parties to filed a submission with the Department a notice of amended final determination comment on our preliminary including an affidavit by a V&M Star pursuant to final court decision for determination of sales LTFV and the L.P. official attesting that V&M Star L.P. circular welded carbon quality steel line post–preliminary memoranda. Based on obtained and tested certain OCTG pipe from the People’s Republic of our analysis of the comments received, produced and exported by Changbao China. See Circular Welded Carbon we have made changes to our with the corresponding mill test Quality Steel Line Pipe from the calculations for the mandatory certificate allegedly issued by Changbao. People’s Republic of China: Notice of respondents. We determine that OCTG On March 4, 2010, Changbao filed a Amended Final Determination Pursuant from the PRC are being, or are likely to submission which it asserted included to Final Court Decision, 75 FR 16071 be, sold in the United States at LTFV as all laboratory test reports for all of the (March 31, 2010) (‘‘Court Amended provided in section 735 of the Tariff Act relevant OCTG addressed in Petitioners’ Final Determination’’). Subsequent to of 1930, as amended (‘‘the Act’’). The February 22, 2010 submission, to all the publication of the notice in the estimated margins of sales at LTFV are customers, in all markets for the period Federal Register, we identified an shown in the ‘‘Final Determination of July 2008, through April 2009. The inadvertent error. Margins’’ section of this notice. Department determined to accept both of these submissions.4 The Court Amended Final FOR FURTHER INFORMATION CONTACT: Paul Determination states that the rate for the On March 2, 2010, the Department Stolz or Eugene Degnan, AD/CVD issued a memorandum regarding the Huludao Companies (Huludao Seven Operations, Office 8, Import Star Group, Huludao Steel Pipe affiliations of TPCO in this Administration, International Trade investigation.5 On March 2, 2010, the Industrial Co. Ltd., and Huludao Bohai Administration, U.S. Department of Oil Pipe Industrial Co. Ltd.), the Department issued a memorandum Commerce, 14th Street and Constitution addressing the targeted dumping respondent, is 33.00 percent when it Avenue, NW, Washington, DC 20230; allegation made by Petitioners in this should be 33.43 percent. Additionally it telephone: (202) 482–4474 or (202) 482– investigation.6 Additionally, on March states that the All Others Rate is 36.53 0414, respectively. 9, 2010, we released certain U.S. percent when it should be 36.74 SUPPLEMENTARY INFORMATION: Customs and Border Protection (‘‘CBP’’) percent. These were both typographical information regarding entry errors. Case History documentation for sales of OCTG made This notice is published in The Department published its by Changbao.7 On March 23, 2010, the accordance with sections 777(i) and Preliminary Determination on Department released a Dunn & 705(d) of the Tariff Act of 1930, as November 17, 2009. The Department Bradstreet report related to the amended. subsequently issued a ministerial error ownership of a TPCO affiliate and, on Dated: April 13, 2010. allegation memorandum, in which it March 24, 2010, Petitioners also placed Ronald K. Lorentzen, agreed to correct several ministerial on the record a Dunn & Bradstreet report Deputy Assistant Secretary for Import errors.2 On December 30, 2009, relating to the ownership of a TPCO Administration. pursuant to the correction of ministerial affiliate. Also on March 25, 2010, [FR Doc. 2010–8992 Filed 4–16–10; 8:45 am] errors, the Department published an Changbao submitted a document 3 BILLING CODE 3510–DS–S amended preliminary determination. containing lab tests of its OCTG. We Between December 7, 2009, and retained all of this information on the December 18, 2009, the Department record. DEPARTMENT OF COMMERCE conducted verifications of Jiangsu We invited interested parties to Changbao Steel Tube Co., Ltd. and comment on the Preliminary International Trade Administration Jiangsu Changbao Precision Tube Co., Determination, and the post– [A–570–943] Ltd. (collectively ‘‘Changbao’’), and preliminary affiliation and Targeted
Certain Oil Country Tubular Goods 1 See Certain Oil Country Tubular Goods From 4 See Memorandum regarding Resubmission of the People’s Republic of China: Notice of Comments on Surrogate Values by Jiangsu from the People’s Republic of China: Preliminary Determination of Sales at Less Than Changbao Steel Tube Co., Ltd. to the Department of Final Determination of Sales at Less Fair Value, Affirmative Preliminary Determination Commerce, dated March 3, 2010. Than Fair Value, Affirmative Final of Critical Circumstances and Postponement of 5 See Memorandum regarding OCTG from the Determination of Critical Final Determination, 74 FR 59117 (November 17, PRC: Tianjin Pipe (Group) Co. Affiliations, dated Circumstances and Final 2009) (‘‘Preliminary Determination’’). March 2, 2010 (‘‘TPCO Affiliation Memo’’). 2 See Memorandum entitled ‘‘Ministerial Error 6 See Memorandum regarding Certain Oil Country Determination of Targeted Dumping Memorandum, Certain Oil Country Tubular Goods Tubular Goods from the People’s Republic of China: from the People’s Republic of China, Preliminary Targeted Dumping – Jiangsu Changbao Steel Tube AGENCY: Import Administration, Determination of Sales at Less Than Fair Value,’’ Co., Ltd. and Jiangsu Changbao Precision Steel Tube International Trade Administration, dated December 3, 2009. Co., Ltd. and Tianjin Pipe (Group) Co., dated March Department of Commerce. 3 See Certain Oil Country Tubular Goods From 2, 2010 (‘‘Targeted Dumping Memo’’). the People’s Republic of China: Notice of Amended 7 See Memorandum regarding Certain Oil Country DATES: Effective Date: April 19, 2010. Preliminary Determination of Sales at Less Than Tubular Goods from the People’s Republic of China: SUMMARY: On November 17, 2009, the Fair Value, 74 FR 69065 (December 30, 2009) Release of Customs and Border Patrol Data, dated Department of Commerce (the (‘‘Amended Preliminary Determination’’). March 9, 2010 (‘‘Changbao CBP information’’).
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Dumping Memo. Additionally, we as Appendix I. The Issues and Decision valued microchromium and invited interested parties to comment Memorandum is a public document and ferrochromium using Indian HTS on, and submit new factual rebuttal is on file in the CRU, and is accessible subheadings 7202.4900 and information regarding, the Changbao on the Web at ia.ita.doc.gov/frn. The 7202.4100, respectively. See Issues CBP information. On March 9, 2010, paper copy and electronic version of the and Decision Memorandum at multiple interested parties filed case memorandum are identical in content. Comment 26. briefs with respect to the Preliminary • For the final determination, we have Changes Since the Preliminary Determination, the TPCO Affiliation recalculated the surrogate value for Determination Memo and the Targeted Dumping iron ore powder by taking a simple Memo. On March 11, 2010, many of Based on our analysis of information average of two sets of financial these same parties filed case briefs and on the record of this investigation, we statements from Indian pig iron new factual rebuttal information have made the following changes: producers, Kirloskar Ferrous regarding the Changbao CBP Surrogate Financial Ratios Industries Limited and KIOCL information. These same parties filed Limited. See Issues and Decision • rebuttal briefs on March 15, 2010. The For the final determination we have Memorandum at Comment 27. Department held a public hearing on calculated surrogate financial ratios • For the final determination, we have March 26, 2010. using the fiscal year 2008–2009 valued oxygen and nitrogen based financial statements of three Indian on surrogate values derived from Tolling of Administrative Deadlines pipe producers: Indian Seamless the financial statements of Bhoruka As explained in the memorandum Metal Tubes Limited; Oil Country Gas, Ltd. See Issues and Decision from the Deputy Assistant Secretary for Tubular Ltd.; and Tata Steel Memorandum at Comment 28. Import Administration, the Department Limited. See Issues and Decision • For the final determination, the has exercised its discretion to toll Memorandum at Comment 13. Department separately valued deadlines for the duration of the closure • We have made several corrections to domestic inland insurance for of the Federal Government from the calculation of the surrogate TPCO’s U.S. sales. See Issues and February 5, through February 12, 2010. financial ratios. See Final SV Decision Memorandum at Comment Thus, all deadlines in this segment of Memo.8 3. • For the final determination, as the proceeding have been extended by Company–Specific Changes Since the partial AFA, we have valued seven days. The revised deadline for Preliminary Determination this final determination is now April 8, TPCO’s self–produced, as well as its 2010. See Memorandum to the Record TPCO purchased, compressed air. Because from Ronald Lorentzen, DAS for Import • For the final determination, we have TPCO removed the consumption Administration, regarding ‘‘Tolling of calculated TPCO’s inputs of iron figures for the purchased Administrative Deadlines As a Result of ore pellets using its market compressed air from its factors of the Government Closure During the economy purchase price for this production (‘‘FOP’’) database, we Recent Snowstorm,’’ dated February 12, factor. See Issues and Decision applied as the consumption rate the 2010. Memorandum at Comment 24. highest (originally) reported • For the final determination, we have consumption rate for any product, Verification determined to value TPCO’s billets and calculated cost based on the As provided in section 782(i) of the with data from Indonesia HTS electricity consumption required to Act, we conducted verification of the category 7207.20.100. See Issues produce that highest consumption information submitted by TPCO and and Decision Memorandum at rate of compressed air. See Issues Changbao for use in our final Comment 20. and Decision Memorandum at determination. See the Department’s • For the final determination, we have Comment 22. verification reports on the record of this applied partial adverse facts • In the Preliminary Determination we investigation in the Central Records available (‘‘AFA’’) for merchandise valued truck freight for water in the Unit (‘‘CRU’’), Room 1117 of the main TPCO shipped to Company B, calculation of normal value because Department building, with respect to which the Department finds is an TPCO reported truck freight for these entities. We used standard affiliate of TPCO. See Issues and water in its FOP database. For the verification procedures, including Decision Memorandum at Comment final determination, we have examination of relevant accounting and 31. determined that TPCO did not incur production records, as well as original • For the final determination, we have truck freight for water and have not source documents provided by determined to omit transportation included a value for truck freight respondents. costs for TPCO’s inputs of water. for water in the normal value See Issues and Decision calculation. See Issues and Decision Analysis of Comments Received Memorandum at Comment 14. Memorandum at Comment 14. All issues raised in the case and • For the final determination, we have • For the final determination we have rebuttal briefs by parties to this valued TPCO’s inputs of natural gas adjusted TPCO’s reported U.S. gross investigation are addressed in the using Gas Authority of India, Ltd. price for sales tax incurred in the ‘‘Investigation of Certain Oil Country prices inflated to the POI. See United States to ensure that the Tubular Goods from the People’s Issues and Decision Memorandum gross price value would reflect the Republic of China: Issues and Decision at Comment 25. actual invoice price because TPCO Memorandum,’’ dated concurrently with • For the final determination, we have reported a value for gross price that this notice and which is hereby adopted reflected the invoice price plus U.S. by this notice (‘‘Issues and Decision 8 Memorandum from Sergio Balbontin, through sales tax. See Issues and Decision Memorandum’’). A list of the issues Eugene Degnan regarding: Investigation of Certain Memorandum at Comment 12. Oil Country Tubular Goods from the People’s • which parties raised and to which we Republic of China: Surrogate Values Memorandum Based on verification findings, for respond in the Issues and Decision for the Final Results, dated April 8, 2010 (‘‘Final SV the final determination we are Memorandum is attached to this notice Memo’’) valuing lump ore using a surrogate
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value. Lump ore was valued at the (including green tubes and limited Initiation Notice.9 We received no Preliminary Determination using service OCTG products), whether or not comments from interested parties on market economy purchase prices. thread protectors are attached. The issues related to the scope. • Based on verification findings, for scope of the investigation also covers Targeted Dumping the final determination, we are OCTG coupling stock. Excluded from valuing pellets using market the scope of the investigation are casing We have analyzed the case and economy purchase prices. Pellets or tubing containing 10.5 percent or rebuttal briefs with respect to targeted were valued at the Preliminary more by weight of chromium; drill pipe; dumping issues submitted for the record Determination using a surrogate unattached couplings; and unattached in this investigation. As a result of our value. thread protectors. analysis, the Department finds that TPCO engaged in targeted dumping. We The merchandise covered by the • For the Preliminary Determination, determine that the standard average–to- investigation is currently classified in World Trade Atlas (‘‘WTA’’) data average comparison methodology does the Harmonized Tariff Schedule of the was available for only the first five not account for the identified pattern of ‘‘ ’’ months of the POI, October 2008 United States ( HTSUS ) under item price differences. Accordingly, we have through February 2009. Therefore, numbers: 7304.29.10.10, 7304.29.10.20, applied the alternative average–to- for surrogate values calculated for 7304.29.10.30, 7304.29.10.40, transaction to all sales to calculate the the Preliminary Determination 7304.29.10.50, 7304.29.10.60, dumping margin for TPCO. For further using WTA data, we relied on data 7304.29.10.80, 7304.29.20.10, discussion, see Issues and Decision from only five months of the POI. 7304.29.20.20, 7304.29.20.30, Memorandum at Comment 2. 7304.29.20.40, 7304.29.20.50, For the final determination, WTA Shorter Cost–Averaging Periods data covering the full POI is 7304.29.20.60, 7304.29.20.80, available. Therefore, for surrogate 7304.29.31.10, 7304.29.31.20, On May 22, 2009, Petitioners alleged values calculated for the final 7304.29.31.30, 7304.29.31.40, that OCTG prices, and the cost of raw determination derived from WTA 7304.29.31.50, 7304.29.31.60, material inputs used to produce subject data, we have relied on WTA data 7304.29.31.80, 7304.29.41.10, merchandise, decreased dramatically covering the full POI. 7304.29.41.20, 7304.29.41.30, during the POI.10 Petitioners claimed 7304.29.41.40, 7304.29.41.50, that in similar instances in other Changbao 7304.29.41.60, 7304.29.41.80, proceedings, the Department has used • For the final determination, we are 7304.29.50.15, 7304.29.50.30, shorter cost–averaging periods when denying Changbao a separate rate 7304.29.50.45, 7304.29.50.60, calculating normal value (i.e., the and, accordingly, have assigned 7304.29.50.75, 7304.29.61.15, Department calculated cost of Changbao the PRC–wide entity rate 7304.29.61.30, 7304.29.61.45, production or constructed values on a of 99.14 percent. See Issues and 7304.29.61.60, 7304.29.61.75, quarterly basis for comparison to sales Decision Memorandum at Comment 7305.20.20.00, 7305.20.40.00, prices, rather than using a POI or period 30, see also Memorandum from 7305.20.60.00, 7305.20.80.00, of review (‘‘POR’’) average).11 Eugene Degnan, through Wendy 7306.29.10.30, 7306.29.10.90, Accordingly, Petitioners requested that Frankel regarding: Application of 7306.29.20.00, 7306.29.31.00, the Department require respondents to Total Adverse Facts Available for 7306.29.41.00, 7306.29.60.10, report their material input usage rates Changbao Steel Tube Co. and 7306.29.60.50, 7306.29.81.10, and on a monthly basis for both the POI and Jiangsu Changbao Precision Steel 7306.29.81.50. the six months preceding the POI, and Tube Co., Ltd. in the Antidumping The OCTG coupling stock covered by that the Department calculate normal Duty Investigation of Oil Country the investigation may also enter under value using monthly consumption Tubular Goods from the People’s the following HTSUS item numbers: periods and monthly surrogate values Republic of China, dated April 8, 7304.39.00.24, 7304.39.00.28, rather than a POI–average of inputs and 2010 (‘‘Changbao AFA Memo’’). 7304.39.00.32, 7304.39.00.36, surrogate values. • For the final determination, because 7304.39.00.40, 7304.39.00.44, The Department stated in the Changbao is part of the PRC–wide 7304.39.00.48, 7304.39.00.52, Preliminary Determination that the entity, we have suspended 7304.39.00.56, 7304.39.00.62, Department has not considered using liquidation of entries exported by 7304.39.00.68, 7304.39.00.72, shorter cost–averaging periods in non Changbao, and determined that 7304.39.00.76, 7304.39.00.80, critical circumstances apply to 7304.59.60.00, , 7304.59.80.15, 9 See Antidumping Duties; Countervailing Duties; Final Rule, 62 FR 27296 27323 (May 19, 1997); see Changbao’s U.S. sales. 7304.59.80.20, 7304.59.80.25, also Oil Country Tubular Goods From the People’s Scope of Investigation 7304.59.80.30, 7304.59.80.35, Republic of China: Initiation of Antidumping Duty 7304.59.80.40, 7304.59.80.45, Investigations, 72 FR 20671, 20672 (May 5, 2009) The merchandise covered by the 7304.59.80.50, 7304.59.80.55, (‘‘Initiation Notice’’). 10 investigation consists of certain OCTG, 7304.59.80.60, 7304.59.80.65, See Petitioners’ Letter to the Department: which are hollow steel products of Certain Oil Country Tubular Goods from the 7304.59.80.70, and 7304.59.80.80. People’s Republic of China: Request that the circular cross–section, including oil The HTSUS subheadings are provided Department Collect Additional Data from the well casing and tubing, of iron (other for convenience and customs purposes Respondents (May 22, 2009) than cast iron) or steel (both carbon and 11 See 19 CFR 351.414(d)(3): Time period over only, the written description of the alloy), whether seamless or welded, which weighted average is calculated. When scope of the investigation is dispositive. applying the average-to-average method, the regardless of end finish (e.g., whether or Secretary normally will calculate weighted averages not plain end, threaded, or threaded and In accordance with the preamble to for the entire period of investigation or review, as coupled) whether or not conforming to our regulations, we set aside a period of the case may be. However, when normal values, American Petroleum Institute (‘‘API’’) or time for parties to raise issues regarding export prices, or constructed export prices differ product coverage and encouraged all significantly over the course of the period of non–API specifications, whether investigation or review, the Secretary may calculate finished (including limited service parties to submit comments within 20 weighted averages for such shorter period as the OCTG products) or unfinished calendar days of publication of the Secretary deems appropriate.
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market–economy (‘‘NME’’) cases, but Surrogate Country cannot be verified, the Department only in market–economy (‘‘ME’’) cases In the Preliminary Determination, we shall, subject to subsection 782(d) of the where we determine that actual stated that we had selected India as the Act, use facts otherwise available in production costs changed significantly appropriate surrogate country to use in reaching the applicable determination. Section 782(c)(1) of the Act provides during the POI/POR, and where there this investigation for the following that if an interested party ‘‘promptly was evidence of a linkage between the reasons: (1) it is a significant producer after receiving a request from {the actual cost changes and the sales prices of comparable merchandise; (2) it is at in a given POI/POR.12 We further stated Department} for information, notifies a similar level of economic development {the Department} that such party is that in an NME context, except in comparable to that of the PRC; and (3) limited circumstances when inputs are unable to submit the information we have reliable data from India that we requested in the requested form and purchased from ME suppliers, the can use to value the factors of Department calculates normal value manner, together with a full explanation production. See Preliminary and suggested alternative forms in using surrogate values in lieu of actual Determination. For the final input costs and, thus, because the use of which such party is able to submit the determination, we received no information,’’ the Department may the shorter cost–averaging periods comments and made no changes to our would not more accurately reflect modify the requirements to avoid findings with respect to the selection of imposing an unreasonable burden on experience of the respondent operating a surrogate country. in the NME during the period under that party. Section 782(d) of the Act provides examination, we would continue to base Separate Rates that, if the Department determines that costs on POI–average surrogate values In proceedings involving NME a response to a request for information rather than the shorter cost–averaging countries, the Department begins with a does not comply with the request, the periods for the Preliminary rebuttable presumption that all Department will inform the person Determination. companies within the country are submitting the response of the nature of We further stated that it is not clear subject to government control and, thus, the deficiency and shall, to the extent how the shorter cost–averaging period should be assigned a single practicable, provide that person the methodology employed in ME cases can antidumping duty deposit rate. It is the opportunity to remedy or explain the fit methodologically or analytically in Department’s policy to assign all deficiency. If that person submits an NME context, and we invited parties exporters of merchandise subject to an further information that continues to be to comment on these issues and on what investigation in an NME country this unsatisfactory, or this information is not facts would warrant the use of shorter single rate unless an exporter can submitted within the applicable time cost–averaging periods in this case for demonstrate that it is sufficiently limits, the Department may, subject to the final determination. independent so as to be entitled to a section 782(e), disregard all or part of separate rate. See Final Determination of the original and subsequent responses, Both in a January 22, 2010, Sales at Less Than Fair Value: Sparklers submission, and in their case briefs, as appropriate. from the People’s Republic of China, 56 Section 782(e) of the Act states that Petitioners argue that the Department FR 20588 (May 6, 1991), as amplified by the Department shall not decline to should use shorter cost–averaging Notice of Final Determination of Sales consider information deemed periods to calculate the margin for at Less Than Fair Value: Silicon Carbide ‘‘deficient’’ under section 782(d) if: (1) Changbao. Petitioners argue that both from the People’s Republic of China, 59 the information is submitted by the the significance aspect and the linkage FR 22585 (May 2, 1994), and 19 CFR established deadline; (2) the information aspect of the Department’s analysis 351.107(d). In the Preliminary can be verified; (3) the information is regarding the use of shorter cost– Determination, we found that Changbao, not so incomplete that it cannot serve as averaging periods are met in regards to TPCO and 37 separate rate–applicants a reliable basis for reaching the Changbao. Petitioners did not, however, demonstrated their eligibility for applicable determination; (4) the address the Department’s concerns, separate–rate status (collectively, interested party has demonstrated that it expressed in the Preliminary ‘‘Separate–Rate Recipients’’). For the acted to the best of its ability; and (5) Determination, regarding how the final determination, we continue to find the information can be used without shorter cost–averaging period that the evidence placed on the record undue difficulties. methodology can appropriately be of this investigation by TPCO and the Furthermore, section 776(b) of the Act applied in the context of an NME case. remaining Separate Rate Recipients states that if the Department ‘‘finds that Neither the January 22, 2010 submission demonstrate both a de jure and de facto an interested party has failed to nor the case briefs argued for the use of absence of government control, with cooperate by not acting to the best of its shorter cost–averaging periods to respect to their respective exports of the ability to comply with a request for calculate the margin for TPCO. merchandise under investigation and, information from the administering Accordingly, because the Petitioners’ thus, are eligible for separate rate status. authority or the Commission, the only argue that the Department should administering authority or the apply the shorter cost–averaging Use of Facts Available Commission ..., in reaching the methodology to Changbao, and we have Section 776(a)(2) of the Act, provides applicable determination under this determined that Changbao is not that, if an interested party: (A) title, may use an inference that is entitled to a separate rate in the withholds information that has been adverse to the interests of that party in investigation, we do not address the requested by the Department; (B) fails to selecting from among the facts issue of the use of shorter cost– provide such information in a timely otherwise available.’’13 averaging periods in this investigation. manner or in the form or manner For this final determination, in requested subject to sections 782(c)(1) accordance with sections 773(c)(3)(A) 12 See, e.g., Stainless Steel Plate in Coils From and (e) of the Act; (C) significantly Belgium: Final Results of Antidumping Duty impedes a proceeding under the 13 See also Statement of Administrative Action Administrative Review, 73 FR 75398 (December 11, (‘‘SAA’’) accompanying the Uruguay Round 2008) and accompanying Issues and Decision antidumping statute; or (D) provides Agreements Act (URAA), H.R. Rep. No. 103-316, Memorandum at Comment 4. such information but the information Vol. 1 at 870 (1994).
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and (B) of the Act and sections Value questionnaire or the full to the unreported sales the rate alleged 776(a)(2)(A), (B) and (D) and 776(b) of antidumping questionnaire. Therefore, in the Petition as adjusted by the the Act, we have determined that the in the Preliminary Determination we Department for the initiation.19 use of AFA is warranted for Changbao treated these PRC producers/exporters Corroboration and the PRC wide entity as discussed as part of the PRC–wide entity because below. they did not demonstrate that they Section 776(c) of the Act provides operate free of government control over that, when the Department relies on Changbao their export activities. No additional secondary information rather than on The Department has determined that information was placed on the record information obtained in the course of an the information to construct an accurate with respect to these entities after the investigation as facts available, it must, and otherwise reliable margin is not Preliminary Determination. In addition, to the extent practicable, corroborate available on the record with respect to because the PRC–wide entity has not that information from independent Changbao because Changbao withheld provided the Department with the sources reasonably at its disposal. information that had been requested, requested information; pursuant to Secondary information is described in significantly impeded this proceeding, section 776(a)(2)(A) and (C) of the Act, the SAA as ‘‘information derived from and provided information that could not the Department continues to find that the petition that gave rise to the be verified, pursuant to sections the use of facts available is appropriate investigation or review, the final 776(a)(1) and (2)(A), (C) and (D) of the to determine the PRC–wide rate. Section determination concerning subject of Act.14 As a result, the Department has 776(b) of the Act provides that, in merchandise, or any previous review determined to apply the facts otherwise selecting from among the facts under section 751 concerning the available. Further, because the otherwise available, the Department subject merchandise.’’20 The SAA Department finds that Changbao failed may employ an adverse inference if an provides that to ‘‘corroborate’’ means to cooperate to the best of its ability, interested party fails to cooperate by not simply that the Department will satisfy pursuant to section 776(b) of the Act, acting to the best of its ability to comply itself that the secondary information to the Department has determined to use with requests for information. See be used has probative value.21 The SAA an adverse inference when applying Notice of Final Determination of Sales also states that independent sources facts available in this review. In at Less Than Fair Value: Certain Cold– used to corroborate may include, for addition, we have concluded that the Rolled Flat–Rolled Carbon–Quality Steel example, published price lists, official nature of Changbao’s unreliable Products From the Russian Federation, import statistics and customs data, and submissions calls into question the 65 FR 5510, 5518 (February 4, 2000). information obtained from interested reliability of the questionnaire See also, SAA at 870. We have parties during the particular responses in their entirety as submitted determined that, because the PRC–wide investigation.22 To corroborate by Changbao in this investigation, entity did not respond to our request for secondary information, the Department including Changbao’s claim of eligibility information, it has failed to cooperate to will, to the extent practicable, examine for separate rate status. Thus, we find the best of its ability. Therefore, the the reliability and relevance of the that Changbao is part of the PRC–wide Department finds that, in selecting from information used.23 entity for purposes of this among the facts otherwise available, an As total AFA the Department investigation.15 adverse inference is warranted. As AFA, preliminarily selected the rate of 99.14 The PRC Entity (including Changbao) the Department is applying the rate from the Petition.24 Petitioners’ alleged in the Petition as adjusted by the methodology for calculating the export Because we begin with the Department for the initiation. price and normal value (‘‘NV’’) in the presumption that all companies within Petition is discussed in the Initiation an NME country are subject to Partial AFA to TPCO Notice.25 At the Preliminary government control and because only The Department has also determined Determination, in accordance with ‘‘ the companies listed under the Final that necessary information regarding the section 776(c) of the Act, we ’’ Determination Margins section below downstream sales of TPCO’s affiliate, corroborated our AFA margin by have overcome that presumption, we are Company B, is not on the record. comparing it to the margins we found applying a single antidumping rate - the Further, TPCO failed to report for the respondents. We found that the PRC–wide rate - to all other exporters of information that had been requested and margin of 99.14 percent had probative subject merchandise from the PRC, significantly impeded this proceeding, 16 value because it is in the range of including Changbao. The PRC–wide pursuant to sections 776(a)(1) and rate applies to all entries of subject (2)(A), and (C) of the of Act, by not 19 See TPCO Final Analysis Memo. merchandise except for entries from the reporting certain downstream sales of its 20 See SAA at 870. respondents identified as receiving a affiliate, as requested by the 21 See id. ‘‘ 22 separate rate in the Final Determination Department.17 As a result, the See id. ’’ 23 Margins section below. Department has determined to apply the See Tapered Roller Bearings and Parts Thereof, In the Preliminary Determination, the Finished and Unfinished, From Japan, and Tapered facts otherwise available for the Department found that the PRC–wide Roller Bearings, Four Inches or Less in Outside unreported downstream sales. Further, Diameter, and Components Thereof, From Japan; entity did not respond to our requests because the Department finds that TPCO Preliminary Results of Antidumping Duty for information because record evidence failed to cooperate to the best of its Administrative Reviews and Partial Termination of indicates there were more exporters of Administrative Reviews, 61 FR 57391, 57392 ability, pursuant to section 776(b) of the OCTG from the PRC during the POI than (November 6, 1996), unchanged in Tapered Roller Act, the Department has determined to Bearings and Parts Thereof, Finished and those that responded to the Quantity & use an adverse inference when applying Unfinished, From Japan, and Tapered Roller facts available in this review.18 As Bearings, Four Inches or Less in Outside Diameter, 14 See Changbao AFA Memo. and Components Thereof, From Japan; Final 15 See Changbao AFA Memo. partial AFA, the Department is applying Results of Antidumping Duty Administrative 16 See, e.g., Synthetic Indigo From the People’s Reviews and Termination in Part, 62 FR 11825 Republic of China; Notice of Final Determination of 17 See Issues and Decision Memorandum at (March 13, 1997). Sales at Less Than Fair Value, 65 FR 25706 (May Comment 9. 24 See Initiation Notice, 74 FR at 20676. 3, 2000). 18 Id. at 13-14. 25 See Initiation Notice, 74 FR at 20674.
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margins we found for the mandatory probative value. Accordingly, we find Determination, the Department respondents. Accordingly, we found that the rate of 99.14 percent is continues to find that critical that the rate of 99.14 percent was corroborated within the meaning of circumstances do not exist for TPCO or corroborated within the meaning of section 776(c) of the Act. the Separate Rate Recipients.26 We also section 776(c) of the Act. continue to find that critical Critical Circumstances Similarly, for the final determination, circumstances exist for the PRC entity, we have also corroborated our AFA In the Preliminary Determination, we and because Changbao is now part of margin by comparing it to the margins found that critical circumstances exist the PRC–wide entity, we also find that we found for the respondents. We find for the PRC–wide entity, however, we critical circumstances exist for that the margin of 99.14 percent has did not find that critical circumstances Changbao. probative value because it is in the exist with respect to the mandatory Final Determination Margins range of margins we found for one of the respondents or the Separate Rate mandatory respondents. Because no Recipients. No comments were received We determine that the following parties commented on the selection of regarding the Department’s preliminary percentage weighted–average margins the PRC–wide rate, we continue to find critical circumstances determination. exist for the following entities for the that the margin of 99.14 percent has For the reasons stated in the Preliminary POI:
Weighted–Average Exporter Producer Margin Percent
Tianjin Pipe International Economic and Trading Corporation ... Tianjin Pipe (Group) Corporation 29.94 Angang Group Hong Kong Co., Ltd...... Angang Steel Co. Ltd. 29.94 Angang Steel Co., Ltd., and Angang Group International Trade Corporation ...... Angang Steel Co. Ltd. 29.94 Anhui Tianda Oil Pipe Co., Ltd...... Anhui Tianda Oil Pipe Co., Ltd. 29.94 Anshan Zhongyou Tipo Pipe & Tubing Co., Ltd...... Anshan Zhongyou Tipo Pipe & Tubing Co., Ltd. 29.94 Baotou Steel International Economic and Trading Co., Ltd...... Seamless Tube Mill of Inner Mongolia Baotou Steel 29.94 Union Co., Ltd.27 Benxi Northern Steel Pipes Co., Ltd...... Benxi Northern Steel Pipes Co., Ltd. 29.94 Chengdu Wanghui Petroleum Pipe Co. Ltd...... Chengdu Wanghui Petroleum Pipe Co. Ltd. 29.94 Dalipal Pipe Company ...... Dalipal Pipe Company 29.94 Faray Petroleum Steel Pipe Co. Ltd...... Faray Petroleum Steel Pipe Co. Ltd. 29.94 Freet Petroleum Equipment Co., Ltd. of Shengli Oil Field, The Thermal Recovery Equipment, Zibo Branch ...... Freet Petroleum Equipment Co., Ltd. of Shengli Oil 29.94 Field, The Thermal Recovery Equipment, Zibo Branch Hengyang Steel Tube Group International Trading, Inc...... Hengyang Valin MPM Tube Co., Ltd.; Hengyang Valin 29.94 Steel Tube Co., Ltd. Huludao Steel Pipe Industrial Co., Ltd./Huludao City Steel Pipe Industrial Co., Ltd...... Huludao Steel Pipe Industrial Co., Ltd./Huludao City 29.94 Steel Pipe Industrial Co., Ltd. Jiangsu Chengde Steel Tube Share Co., Ltd...... Jiangsu Chengde Steel Tube Share Co., Ltd. 29.94 Jiangyin City Changjiang Steel Pipe Co., Ltd...... Jiangyin City Changjiang Steel Pipe Co., Ltd. 29.94 Pangang Group Beihai Steel Pipe Corporation ...... Pangang Group Beihai Steel Pipe Corporation 29.94 Pangang Group Chengdu Iron & Steel ...... Pangang Group Chengdu Iron & Steel 29.94 Qingdao Bonded Logistics Park Products International Trading Co., Ltd...... Shengli Oilfield Highland Petroleum Equipment Co., Ltd.; 29.94 Shandong Continental Petroleum Equipment Co., Ltd.; Aofei Tele Dongying Import & Export Co., Ltd.; Highgrade Tubular Manufacturing (Tianjin) Co., Ltd.; Cangzhou City Baohai Petroleum Material Co., Ltd. Qiqihaer Haoying Iron and Steel Co., Ltd. of Northeast Special Steel Group...... Qiqihaer Haoying Iron and Steel Co., Ltd. of Northeast 29.94 Special Steel Group Shandong Dongbao Steel Pipe Co., Ltd...... Shandong Dongbao Steel Pipe Co., Ltd. 29.94 ShanDong HuaBao Steel Pipe Co., Ltd...... ShanDong HuaBao Steel Pipe Co., Ltd. 29.94 Shandong Molong Petroleum Machinery Co., Ltd...... Shandong Molong Petroleum Machinery Co., Ltd. 29.94 Shanghai Metals & Minerals Import & Export Corp./ Shanghai Minmetals Materials & Products Corp...... Jiangsu Changbao Steel Pipe Co., Ltd.; Huludao Steel 29.94 Pipe Industrial Co., Ltd.; Northeast Special Steel Group Qiqihaer Haoying Steel and Iron Co., Ltd.; Beijing Youlu Co., Ltd. Shanghai Zhongyou Tipo Steel Pipe Co., Ltd...... Shanghai Zhongyou Tipo Steel Pipe Co., Ltd. 29.94 Shengli Oil Field Freet Petroleum Equipment Co., Ltd...... Freet Petroleum Equipment Co., Ltd. of Shengli Oil 29.94 Field, The Thermal Recovery Equipment, Zibo Branch; Faray Petroleum Steel Pipe Co., Ltd.; Shengli Oil Field Freet Petroleum Steel Pipe Co., Ltd. Shengli Oil Field Freet Petroleum Steel Pipe Co., Ltd...... Freet Petroleum Equipment Co., Ltd. of Shengli Oil 29.94 Field, The Thermal Recovery Equipment, Zibo Branch; Anhui Tianda Oil Pipe Co., Ltd; Wuxi Fastube Dingyuan Precision Steel Pipe Co., Ltd.
26 See Preliminary Determination.
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Weighted–Average Exporter Producer Margin Percent
Shengli Oilfield Highland Petroleum Equipment Co., Ltd...... Tianjin Pipe Group Corp.; Goods & Materials Supply 29.94 Dept. of Shengli Oilfield SinoPEC; Dagang Oilfield Group New Century Machinery Co. Ltd.;Tianjin Seamless Steel Pipe Plant; Baoshan Iron & Steel Co. Ltd Shengli Oilfield Shengji Petroleum Equipment Co., Ltd...... Shengli Oilfield Shengji Petroleum Equipment Co., Ltd. 29.94 Tianjin Xingyuda Import and Export Co., Ltd. & Hong Kong Gallant Group Limited ...... Tianjin Lifengyuanda Steel Group Co., Ltd. 29.94 Tianjin Seamless Steel Pipe Plant ...... Tianjin Seamless Steel Pipe Plant 29.94 Tianjin Tiangang Special Petroleum Pipe Manufacturer Co., Ltd...... Tianjin Tiangang Special Petroleum Pipe Manufacturer 29.94 Co., Ltd. Wuxi Baoda Petroleum Special Pipe Manufacturing Co., Ltd. ... Wuxi Baoda Petroleum Special Pipe Manufacturing Co., 29.94 Ltd. Wuxi Seamless Oil Pipe Co., Ltd...... Wuxi Seamless Oil Pipe Co., Ltd. 29.94 Wuxi Sp. Steel Tube Manufacturing Co., Ltd...... Wuxi Precese Special Steel Co., Ltd. 29.94 Wuxi Zhenda Special Steel Tube Manufacturing Co., Ltd...... Huai’an Zhenda Steel Tube Manufacturing Co., Ltd. 29.94 Xigang Seamless Steel Tube Co., Ltd...... Xigang Seamless Steel Tube Co., Ltd.; Wuxi Seamless 29.94 Special Pipe Co., Ltd. Yangzhou Lontrin Steel Tube Co., Ltd...... Yangzhou Lontrin Steel Tube Co., Ltd. 29.94 Zhejiang Jianli Co., Ltd. & Zhejiang Jianli Steel Tube Co., Ltd. Zhejiang Jianli Co., Ltd.; Zhejiang Jianli Steel Tube Co., 29.94 Ltd. PRC–wide Entity* ...... 99.14 27 In the Preliminary Determination and the Amended Preliminary Determination, we inadvertently identified the producer as Baotou Steel Inter- national Economic and Trading Co., Ltd. *Includes: Jiangsu Changbao Steel Tube Co., Ltd. and Jiangsu Changbao Precision Tube Co., Ltd. and Shengli Oil Field Freet Import & Ex- port Trade Co., Ltd.
Disclosure instructions for Changbao with this final these companies did not benefit from We will disclose the calculations affirmative determination of sales at less any export subsidy, we will not make an performed within five days of the date than fair value and affirmative finding adjustment to the antidumping duty rate of publication of this notice to parties in of critical circumstances. We will of these companies for purposes of cash this proceeding in accordance with 19 instruct CBP to continue to require a deposits. CFR 351.224(b). cash deposit or the posting of a bond for For the remaining separate–rate all companies based on the estimated companies, we will instruct CBP to Continuation of Suspension of weighted–average dumping margins adjust the dumping margin by the Liquidation shown above. amount of export subsidies included in In accordance with section Additionally, as the Department has the All Other rate from the CVD Final. 735(c)(1)(B) of the Act, we are directing determined in its Certain Oil Country These suspension of liquidation CBP to continue to suspend liquidation Tubular Goods From the People’s instructions will remain in effect until of all imports of subject merchandise Republic of China: Amended Final further notice. entered or withdrawn from warehouse, Affirmative Countervailing Duty ITC Notification for consumption on or after the Determination and Countervailing Duty following dates: (1) for TPCO and the Order, 75 FR 3203 (January 20, 2010) In accordance with section 735(d) of separate rate companies, on or after (‘‘CVD Final’’) that the merchandise the Act, we have notified the November 17, 2010, the date of under investigation, exported by TPCO, International Trade Commission (‘‘ITC’’) publication of the Preliminary benefitted from an export subsidy, we of our final determination of sales at Determination in the Federal Register, will instruct CBP to require an LTFV. As our final determination is (2) for the PRC–wide entity (except for antidumping cash deposit or posting of affirmative, in accordance with section Changbao), on or after April 19, 2009, a bond equal to the weighted–average 735(b)(2) of the Act, within 45 days the which is 90 days prior to the amount by which the NV exceeds the ITC will determine whether the publication of the Preliminary U.S. price for TPCO, as indicated above, domestic industry in the United States Determination (consistent with our minus the amount determined to is materially injured, or threatened with finding that critical circumstances exist constitute an export subsidy.28 material injury, by reason of imports or for the PRC–wide entity), and (3) for For the two separate–rate companies sales (or the likelihood of sales) for Changbao, which is now part of the in this investigation that also importation of the subject merchandise. PRC–wide entity, 90 days prior to the participated as mandatory respondents If the ITC determines that material date of publication of this final in the CVD investigation (i.e., Wuxi injury or threat of material injury does determination. Because Changbao had a Seamless Oil Pipe Co., Ltd., and not exist, the proceeding will be zero margin at the Preliminary Zhejiang Jianli Co., Ltd. & Zhejiang terminated and all securities posted will Determination, we instructed CBP to not Jianli Steel Tube Co., Ltd.), because it be refunded or canceled. If the ITC suspend liquidation of entries of was determined in the CVD Final that determines that such injury does exist, merchandise exported by Changbao. the Department will issue an 28 See, e.g., Notice of Final Determination of Sales Accordingly, pursuant to 19 CFR at Less Than Fair Value: Carbazole Violet Pigment antidumping duty order directing CBP 351.206(a), the Department will first 23 From India, 69 FR 67306, 67307 (November 17, to assess antidumping duties on all issue suspension of liquidation 2004). imports of the subject merchandise
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entered, or withdrawn from warehouse, VIII. By–Product Offsets (Ternium) 1 and Mueller Comercial de for consumption on or after the effective Comment 17: By–product Offset for Mexico, S. de R.L. (Mueller) as date of the suspension of liquidation. Steel Scrap mandatory respondents for the period November 1, 2007, to October 31, 2008. Notification Regarding APO IX. General Surrogate Value Issues Based on our analysis of the comments This notice also serves as a reminder Comment 18: Value of Ancillary received, we have made no changes to the parties subject to administrative Materials from the Preliminary Results. We have protective order (‘‘APO’’) of their Comment 19: Value of FOPs Purchased listed the final dumping margin below responsibility concerning the through Distributor in the section entitled ‘‘Final Results of disposition of proprietary information Comment 20: Value for Billet Review.’’ disclosed under APO in accordance Comment 21: Value for Coal DATES: Effective Date: April 19, 2010. with 19 CFR 351.305. Timely Comment 22: Value for Compressed Air FOR FURTHER INFORMATION CONTACT: notification of return or destruction of Comment 23: Value for Scrap Input Maryanne Burke or Robert James, AD/ APO materials or conversion to judicial Comment 24: Value for Iron Ore Pellets CVD Operations, Office 7, Import protective order is hereby requested. Comment 25: Value of Natural Gas Administration, International Trade Failure to comply with the regulations Comment 26: Value of Micro and Mid– Administration, U.S. Department of and the terms of an APO is a Chromium Commerce, 14th Street and Constitution sanctionable violation. Comment 27: Value of Iron Ore and Iron Avenue, NW., Washington, DC 20230; This determination and notice are Powder telephone: (202) 482–5604 and (202) issued and published in accordance Comment 28: Values of Oxygen and 482–0649, respectively. with sections 735(d) and 777(i)(1) of the Nitrogen SUPPLEMENTARY INFORMATION: Act. Comment 29: Value of Pig Iron Dated: April 8, 2010. Background Ronald K. Lorentzen, X. Changbao Related Issues On December 7, 2009, the Department Deputy Assistant Secretary for Import Comment 30: Total AFA to Changbao published in the Federal Register the Administration. Comment 31: Changbao’s Sales to preliminary results of the administrative Appendix I Unaffiliated PRC Trading Companies review of the antidumping duty order [FR Doc. 2010–8994 Filed 4–16–10; 8:45 am] on certain circular welded non-alloy I. General Issues BILLING CODE 3510–DS–S steel pipe from Mexico for the period Comment 1: Labor Wage Rate November 1, 2007, to October 31, 2008. See Preliminary Results. In response to Comment 2: Application of Targeted DEPARTMENT OF COMMERCE Dumping the Department’s invitation to comment on the preliminary results of this Comment 3: Deduction of Domestic International Trade Administration review, petitioner United States Steel Inland Insurance from U.S. Price Corporation (U.S. Steel), and Comment 4: Exchange Rate Rupees to [A–201–805] respondents Mueller and Ternium filed U.S. Dollars their case briefs on January 6, 2010. U.S. Comment 5: Deduction of Chinese VAT Certain Circular Welded Non-Alloy Steel and respondent TUNA submitted from U.S. Price Steel Pipe From Mexico: Final Results rebuttal briefs on January 14, 2010.2 Comment 6: Zeroing of Antidumping Duty Administrative As explained in the memorandum Comment 7: Double Counting Review and Rescission of from the Deputy Assistant Secretary for Administrative Review in Part II. TPCO Specific Issues Import Administration, the Department AGENCY: has exercised its discretion to toll Comment 8: Total AFA to TPCO Import Administration, International Trade Administration, deadlines for the duration of the closure Comment 9: Partial AFA for certain Department of Commerce. of the Federal Government from TPCO Transactions February 5, through February 12, 2010. SUMMARY: On December 7, 2009, the Comment 10: TPCO Affiliations Thus, all deadlines in this segment of Department of Commerce (the the proceeding have been extended by III. Credit Expense Department) published the preliminary seven days. The revised deadline for the results of the administrative review of Comment 11: Credit Expense final results of this administrative the antidumping duty order on certain review is now April 13, 2010. See IV. U.S. Price Deductions circular welded non-alloy steel pipe Memorandum to the Record from from Mexico. See Certain Circular Comment 12: Certain Deduction from Ronald Lorentzen, DAS for Import Welded Non-Alloy Steel Pipe From U.S. Price Administration, regarding ‘‘Tolling of Mexico; Preliminary Results of Administrative Deadlines As a Result of V. Surrogate Financial Statements Antidumping Duty Administrative the Government Closure During the Comment 13: Financial Statements for Review, 74 FR 64049 (December 7, 2009) (Preliminary Results). While the review Surrogate Ratios 1 Consistent with the Preliminary Results, and the originally covered eight companies, we Department’s changed circumstances review of this VI. Transportation Costs rescinded the review with respect to all order which found Ternium the successor-in- Comment 14: Water Transportation but the remaining three respondents. interest to Hylsa, we continue to consider Ternium See Certain Circular Welded Non-Alloy and Hylsa as a single entity. See Preliminary Costs Results; see also Final Results of Antidumping Duty Comment 15: Addition of Freight Costs Steel Pipe from Mexico: Notice of Partial Changed Circumstances Review: Certain Circular to ME Purchases Rescission of Antidumping Duty Welded Non-Alloy Steel Pipe and Tube from Administrative Review, 74 FR 20919 Mexico, 74 FR 41681 (August 18, 2009). VII. Certain Conversion Factor Issues (May 6, 2009). We therefore treated 2 On January 7, 2010, U.S. Steel requested an extension of its rebuttal brief which was granted by Comment 16: Conversion Factors for Tuberia Nacional, S.A. de C.V. (TUNA), the Department. The new deadline for all parties’ Argon, Nitrogen and Oxygen Ternium Mexico, S.A. de C.V. rebuttal briefs was set for January 14, 2010.
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Recent Snowstorm,’’ dated February 12, A list of the issues which parties have Final Results of Review 2010. raised and to which we have responded, We determine the following Scope of the Order all of which are in the Decision Memorandum, is attached to this notice percentage margin exists for the period The products covered by this order as an appendix. Parties can find a November 1, 2007 to October 31, 2008: are circular welded non-alloy steel complete discussion of all issues raised Weighted- pipes and tubes, of circular cross- in this review and the corresponding section, not more than 406.4 millimeters Average recommendations in this public Manufacturer/ margin (16 inches) in outside diameter, Exporter memorandum, which is on file in the (percent- regardless of wall thickness, surface Central Records Unit in room 1117 of age) finish (black, galvanized, or painted), or end finish (plain end, beveled end, the main Department building. In Ternium ...... 48.33 threaded, or threaded and coupled). addition, a complete version of the Mueller ...... 48.33 These pipes and tubes are generally Decision Memorandum can be accessed directly via the Internet at http:// known as standard pipes and tubes and Assessment are intended for the low pressure ia.ita.doc.gov/frn/index.html. The paper conveyance of water, steam, natural gas, copy and electronic version of the The Department will determine, and and other liquids and gases in plumbing Decision Memorandum are identical in CBP shall assess, antidumping duties on and heating systems, air conditioning content. all appropriate entries, pursuant to section 751(a)(1) of the Tariff Act of units, automatic sprinkler systems, and Rescission of Review in Part other related uses, and generally meet 1930, as amended (the Act) and 19 CFR ASTM A–53 specifications. Standard In the Preliminary Results, we 351.212(b). We will issue appraisement pipe may also be used for light load- preliminarily found TUNA’s claim that instructions directly to CBP to assess bearing applications, such as for fence it made no shipments of subject antidumping duties on appropriate tubing, and as structural pipe tubing merchandise during the period of entries by applying the assessment rate used for framing and support members review was consistent with import data to the entered value of the merchandise. for reconstruction or load-bearing provided by U.S. Customs and Border Pursuant to 19 CFR 356.8(a), the purposes in the construction, Protection (CBP) as well as additional Department intends to issue assessment shipbuilding, trucking, farm equipment, information developed on the record of instructions to CBP 41 days after the and related industries. Unfinished this review. Accordingly, we stated our date of publication of these final results conduit pipe is also included in these of review. orders. All carbon steel pipes and tubes intent to rescind the administrative within the physical description outlined review with respect to this company. Cash Deposit Requirements above are included within the scope of See Preliminary Results. We received The following cash deposit this order, except line pipe, oil country comments about this issue from TUNA requirements will be effective upon tubular goods, boiler tubing, mechanical and U.S. Steel, and continue to find that publication of these final results for all tubing, pipe and tube hollows for TUNA did not make entries, exports, or shipments of the subject merchandise redraws, finished scaffolding, and sales of subject merchandise during the finished conduit. Standard pipe that is POR. For the final results of this review, entered, or withdrawn from warehouse, dual or triple certified/stenciled that we are, therefore, rescinding the review for consumption on or after the enters the U.S. as line pipe of a kind with respect to TUNA. publication date of these final results of administrative review, consistent with used for oil or gas pipelines is also not Use of Total Adverse Facts Available included in this order. section 751(a)(1) of the Act: (1) The cash deposit rate for the reviewed companies The merchandise covered by the order The Department found in the and subject to this review are currently will be the rate listed above; (2) if the Preliminary Results that Ternium and exporter is not a firm covered in this classified in the Harmonized Tariff Mueller failed to cooperate to the best Schedule of the United States (HTSUS) review, but was covered in a previous of their ability by withholding review or the original less-than-fair- at subheadings: 7306.30.10.00, information requested by the 7306.30.50.25, 7306.30.50.32, value (LTFV) investigation, the cash Department’s questionnaire, and thereby deposit rate will continue to be the 7306.30.50.40, 7306.30.50.55, impeded the Department’s proceeding. 7306.30.50.85, and 7306.30.50.90. company-specific rate published for the See Preliminary Results. Therefore, in Although the HTSUS subheadings are most recent period; (3) if the exporter is accordance with section 776(b) of the provided for convenience and customs not a firm covered in this review, a prior Tariff Act of 1930, as amended (the Act), purposes, our written description of the review, or the original LTFV and 19 CFR 351.308(c), the Department scope of these proceedings is investigation, but the manufacturer is, preliminarily selected 48.33 percent as dispositive. the cash deposit rate will be the rate the adverse facts available dumping established for the most recent period Analysis of Comments Received margin. The Department received for the manufacturer of the All issues raised in the case and comments regarding its preliminary merchandise; and (4) the cash deposit rebuttal briefs by interested parties in application of the adverse facts available rate for all other manufacturers or this administrative review are addressed dumping margin to Ternium and exporters will continue to be 32.62 in the Issues and Decision Mueller. For these final results, the percent, the all-others rate established Memorandum (Decision Memorandum) Department has not altered its analysis in the LTFV investigation. See Final from John M. Andersen, Acting Deputy or decision to apply the adverse facts Determination of Sales at Less Than Assistant Secretary for Import available dumping margin to Ternium Fair Value: Circular Welded Non-Alloy Administration, to Ronald K. Lorentzen, and Mueller. See accompanying Steel Pipe From Mexico, 57 FR 42953 Deputy Assistant Secretary for Import Decision Memorandum for the issues (September 17, 1992). These deposit Administration, dated April 13, 2010, raised by the parties and addressed by requirements, when imposed, shall which is hereby adopted by this notice. the Department. remain in effect until further notice.
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Notification to Interested Parties (BSAI) groundfish plan teams will meet (AAC, formerly known as the Alaska This notice also serves as a final via teleconference May 6, 2010, 12:30 Aerospace Development Corporation), reminder to importers of their p.m. Alaska Standard Time (AST) to to take Steller sea lions (Eumetopias responsibility under 19 CFR review proposals for models to be jubatus) and Pacific harbor seals (Phoca 351.402(f)(2) to file a certificate considered for inclusion in the GOA vitulina richardsi) incidental to rocket regarding the reimbursement of and BSAI Pacific cod assessments. launches from the Kodiak Launch antidumping duties prior to liquidation DATES: The teleconference will be held Complex (KLC). of the relevant entries during this on May 6, 2010; telephone: (907) 271– DATES: Effective April 15, 2010, through review period. Failure to comply with 2896. February 28, 2011. this requirement could result in the ADDRESSES: Listening sites - North ADDRESSES: The LOA and supporting Department’s presumption that Pacific Fishery Management Council, documentation are available by writing reimbursement of the antidumping 605 W 4th Avenue, Anchorage, AK; and to Michael Payne, Chief, Permits, duties occurred and the subsequent Alaska Fisheries Science Center, 7600 Conservation, and Education Division, assessment of doubled antidumping Sand Point Way N.E., Building 4, Office of Protected Resources, National duties. Seattle, WA. Marine Fisheries Service, 1315 East- This notice also serves as a reminder Council address: North Pacific West Highway, Silver Spring, MD to parties subject to administrative Fishery Management Council, 605 W. 20910–3225, by telephoning one of the protective orders (APOs) of their 4th Ave., Suite 306, Anchorage, AK contacts listed here (see FOR FURTHER responsibility concerning the 99501–2252. INFORMATION CONTACT), or online at: disposition of proprietary information FOR FURTHER INFORMATION CONTACT: Jane http://www.nmfs.noaa.gov/pr/permits/ disclosed under APO in accordance DiCosimo; North Pacific Fishery incidental.htm. Documents cited in this with 19 CFR 351.305, which continues Management Council; telephone: (907) notice may be viewed, by appointment, to govern business proprietary 271–2809. during regular business hours, at the information in this segment of the SUPPLEMENTARY INFORMATION: Agenda: aforementioned address. proceeding. Timely written notification Review proposals for models Pacific cod FOR FURTHER INFORMATION CONTACT: of the return or destruction of APO stock assessments. The agenda is posted materials or conversion to judicial Howard Goldstein or Jaclyn Daly, Office on the Council website at: http:// of Protected Resources, NMFS, (301) protective order is hereby requested. www.alaskafisheries.noaa.gov/npfmc/ Failure to comply with the regulations 713–2289, or Brad Smith, Alaska and the terms of an APO is a Special Accommodations Regional Office, NMFS, (907) 271–3023. sanctionable violation. This meeting is physically accessible SUPPLEMENTARY INFORMATION: This notice is issued and published in to people with disabilities. Requests for Background accordance with sections 751(a)(1) and sign language interpretation or other 777(i)(1) of the Act. auxiliary aids should be directed to Gail Section 101(a)(5)(A) of the MMPA (16 Dated: April 13, 2010. Bendixen, (907) 271–2809, at least 5 U.S.C. 1361 et seq.) directs the National Ronald K. Lorentzen, working days prior to the meeting date. Marine Fisheries Service (NMFS) to allow, on request, the incidental, but not Deputy Assistant Secretary for Import Dated: April 14, 2010. Administration. intentional, taking of small numbers of Tracey L. Thompson, marine mammals by U.S. citizens who Appendix—List of Issues in Decision Acting Director, Office of Sustainable engage in a specified activity (other than Memorandum Fisheries, National Marine Fisheries Service. commercial fishing) within a specified [FR Doc. 2010–8898 Filed 4–16–10; 8:45 am] Comment 1: Application of Total AFA to geographical region if certain findings Ternium BILLING CODE 3510–22–S are made and regulations are issued. Comment 2: Application of Total AFA to Under the MMPA, the term ‘‘taking’’ Mueller means to harass, hunt, capture, or kill or Comment 3: Rescission of Administrative DEPARTMENT OF COMMERCE to attempt to harass, hunt, capture or Review for TUNA National Oceanic and Atmospheric kill marine mammals. [FR Doc. 2010–8991 Filed 4–16–10; 8:45 am] Administration Authorization may be granted for BILLING CODE 3510–DS–P periods up to five years if NMFS finds, RIN 0648–XV64 after notification and opportunity for public comment, that the taking will DEPARTMENT OF COMMERCE Taking and Importing Marine have a negligible impact on the species Mammals; Taking Marine Mammals or stock(s) of marine mammals and will National Oceanic and Atmospheric Incidental to Rocket Launches from Administration not have an unmitigable adverse impact Kodiak, AK on the availability of the species or RIN 0648–XV88 AGENCY: National Marine Fisheries stock(s) for subsistence uses. In Service, National Oceanic and addition, NMFS must prescribe North Pacific Fishery Management Atmospheric Administration, regulations that include permissible Council; Public Meeting Commerce. methods of taking and other means AGENCY: National Marine Fisheries ACTION: Notice; Issuance of a Letter of effecting the least practicable adverse Service (NMFS), National Oceanic and Authorization. impact on the species and its habitat Atmospheric Administration (NOAA), and on the availability of the species for Commerce. SUMMARY: In accordance with the subsistence uses, paying particular ACTION: Notice of a public meeting. Marine Mammal Protection Act attention to rookeries, mating grounds, (MMPA) and implementing regulations, and areas of similar significance. The SUMMARY: The North Pacific Fishery notification is hereby given that a Letter regulations must include requirements Management Council’s Gulf of Alaska of Authorization (LOA) has been issued for monitoring and reporting of such (GOA) and Bering Sea/Aleutian Islands to the Alaska Aerospace Corporation taking.
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Regulations governing the taking of 63 and 400 Hz with a maximum noise survey; however, this has been the trend Steller sea lions and harbor seals, by level at 105.8 dB at 315 Hz. during the past few years. One sea lion harassment, incidental to rocket Video equipment was focused on the was sighted during that day on the launches at KLC, became effective on Steller sea lion haulout on the east side suprtidal rock on the eastern side of February 27, 2006 (71 FR 4297), and of Ugak Island because no seal lions Ugak, the same location where they remain in effect until February 28, 2011. were present at the traditional haulout were sighted during the FTX–03 launch, For detailed information on this action, on the gravel spit at Ugak. This haulout as described above. please refer to that document. These was occupied by 1–5 seal lions during During the December 7 survey, 971 regulations include mitigation, the aerial surveys, and 0–3 sea lions harbor seals were sighted in the primary monitoring, and reporting requirements during video monitoring. However, the study area. All were sighted on Ugak for the incidental taking of marine camera battery was depleted about two Island with the largest single haulout mammals during rocket launches at hours before the launch so the located on the northeast side of the KLC. immediate effects of the launch on island with 444 seals. Because only one Steller sea lions could not be survey was completed and no video Summary of Request determined. However, three sea lions monitoring system was set up during NMFS received a request for an LOA were seen at the haulout during the the FTG–05 launch, the actual impacts pursuant to the aforementioned aerial survey conducted within two to Steller sea lions and harbor seals can regulations that would authorize, for a hours after the launch, the same number not be determined. However, AAC did period not to exceed 1 year, take of recorded when the camera battery died; collect video monitoring data of Steller marine mammals incidental to rocket therefore, if any behavioral impacts did sea lions during a FTG–02 launch in launches at KLC. occur, they were short lived. 2006. During that launch, two sea lions Summary of Activity and Monitoring Harbor seals were the most abundant were present on Ugak Rock. The Under the Current LOA marine mammal counted. Daily totals animals raised their heads in response No launch operations were conducted ranged from 610 seals on July 20, 2008 to launch noise, which peaked at 105.6 at KLC in 2009, and none were to 1,534 seals on July 21, 2008. The dBC and had an SEL of 90.1dBA over predicted or scheduled prior to count of harbor seals before the launch one minute and eight seconds; however, expiration of the current LOA. As such, (853 seals) was similar immediately post they did not flush into the water. For the most recent reports concerning launch (840 seals). For the three days comparative purposes, the Narrow Cape activity and monitoring at KLC were after launch, 744, 610, and 1,534 harbor the peak noise level during this launch submitted in compliance with the 2008 seals, respectively, were sighted in the was 128 dBC with a SEL of 112.5dBA LOA. A summary of those reports (R&M primary study area. Therefore, NMFS over one minute 23–seconds which is Consultants, 2008) follows. does not expect that the launch had a comparable to the December FTG–05 FTX–03 Mission long term impact on harbor seals in the launch, as described above. Therefore, action area. NMFS anticipates that reactions of Two launches were conducted at KLC FTG–05 Mission Steller sea lions, if present, were likely between March 12, 2008, and March 11, similar to those recorded previously. 2009. The first was a monitored launch The second monitored launch of an In summary, NMFS concludes the of a Flight Test Experimental–03 (FTX– Flight Test Ground-based Interceptor–05 impacts from the FTX–03 and FTG–05 03) long range ballistic missile on July (FTG–05) ballistic missile was flight were similar based on similar 18, 2008 at 1:47:00 a.m. ADT. Aerial conducted at KLC on December 5, 2008 acoustic monitoring measurements from surveys to document marine mammals at 11:04 a.m. ADT. Five monitoring both launches. No mortality or injury in the primary survey area (6–mile surveys were scheduled between was observed during the FTX–03 launch radius of the KLC launch pads) were December 4–8, 2008; however, foul and likely did not occur during the flown using single-engine fixed-wing weather precluded flying from all but FTG–05 launch. As described in aircraft 1 day prior to (July 17), the day one day. No monitoring survey was reporting from the 2008 LOA, the of (July 18), and 3 days (July 19–21) post completed pre-launch and only one applicant conducted activities as launch. On July 17, 2008, video survey was completed post-launch; described in the rule, implemented equipment and a noise monitor were however, one aerial survey was flown mitigation measures as stipulated in the deployed on the northeast side of Ugak over part of the primary study area three LOA, and conducted monitoring Island, 4.2 miles (6.8 km) from the days before the launch (December 2) required under the LOA. Monitoring launch site, and another noise monitor prior to the designated monitoring reports indicated that take of marine was deployed on Narrow Cape , 0.9 surveys. Foul weather precluded mammals did not exceed numbers or miles (1.4 km) from the launch site. helicopter access to Ugak Island, level authorized by the LOA and Sound level monitoring equipment at therefore no video equipment or sound analyzed in the associated rule. During Ugak Island registered noise above monitoring device was deployed at this the period of the current LOA, the general ambient levels for one minute location. However, a sound level applicant has not conducted any launch thirty three seconds with an SEL of 89.6 monitor was deployed on Narrow Cape. activities, and none are scheduled prior dBA. The one-second broadband peak This noise monitoring device registered to expiration of the current LOA. As noise level was 108.3 dBC. The 1/3 noise above general ambient levels for such, the applicant has conformed to octave broadband noise level peaked one minute forty one seconds with an the stipulations of the LOA. Based on between 63 and 250 Hz with a SEL of 112.4 dBA. The one-second these actions, the findings of negligible maximum noise level of 90.7 dB at 100 broadband peak noise level was 126.1 impact, no unmitigable adverse impact, Hz. Sound level monitoring equipment dBC. The 1/3 octave broadband noise and take of only small numbers are still at Narrow Cape registered noise above level peaked between 63 and 400 Hz applicable. general ambient levels for one minute with a maximum noise level at 106.6 dB fifty seconds with an SEL of 112.6 dBA. at 200 Hz. Authorization The one-second broadband peak noise Steller sea lions did not use the spit Accordingly, NMFS has issued an level was 145.6 dBC. The 1/3 octave on northern Ugak Island (the traditional LOA to AAC authorizing takes of marine broadband noise level peaked between haulout site) during the December 7 mammals incidental to rocket launches
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at the KLC. Issuance of this LOA is the collection; (4) Description of the be addressed to U.S. Department of based on findings, described in the need for, and proposed use of, the Education, 400 Maryland Avenue, SW., preamble to the final rule (71 FR 4297, information; (5) Respondents and LBJ, Washington, DC 20202–4537. January 26, 2006) and supported by frequency of collection; and (6) Requests may also be electronically information contained in AAC’s Reporting and/or Recordkeeping mailed to [email protected] or faxed required 2008 annual report (no launch burden. OMB invites public comment. to 202–401–0920. Please specify the activities took place in 2009), that the The Department of Education is complete title of the information activities described under this LOA will especially interested in public comment collection when making your request. result in the take of small numbers of addressing the following issues: (1) Is Comments regarding burden and/or marine mammals, have a negligible this collection necessary to the proper the collection activity requirements impact on marine mammal stocks, and functions of the Department; (2) will should be electronically mailed to will not have an unmitigable adverse this information be processed and used [email protected]. Individuals who impact on the availability of the affected in a timely manner; (3) is the estimate use a telecommunications device for the marine mammal stocks for subsistence of burden accurate; (4) how might the deaf (TDD) may call the Federal uses. Department enhance the quality, utility, Information Relay Service (FIRS) at Dated: April 12, 2010. and clarity of the information to be 1–800–877–8339. James H. Lecky, collected; and (5) how might the [FR Doc. 2010–8809 Filed 4–16–10; 8:45 am] Department minimize the burden of this Director, Office of Protected Resources, BILLING CODE 4000–01–P National Marine Fisheries Service. collection on the respondents, including through the use of information [FR Doc. 2010–8974 Filed 4–19–10; 8:45 am] technology. DEPARTMENT OF EDUCATION BILLING CODE 3510–22–S Dated: April 13, 2010. Privacy Act of 1974; System of Stephanie Valentine, Records DEPARTMENT OF EDUCATION Acting Director, Information Collection Clearance Division, Regulatory Information AGENCY: Federal Student Aid, Notice of Proposed Information Management Services, Office of Management. Department of Education. Collection Requests Office of Planning, Evaluation and ACTION: Notice of an altered system of AGENCY: Department of Education. Policy Development records. SUMMARY: The Acting Director, Type of Review: New. SUMMARY: In accordance with the Information Collection Clearance Title: Study of School Turnaround Privacy Act of 1974, as amended Division, Regulatory Information (Case Studies of Schools Receiving (Privacy Act), 5 United States Code Management Services, Office of School Improvement Grant Funds). (U.S.C.) 552a, the Chief Operating Management, invites comments on the Frequency: Annually. Officer for Federal Student Aid (FSA) of proposed information collection Affected Public: State, Local, or Tribal the U.S. Department of Education (the requests as required by the Paperwork Gov’t, SEAs or LEAs. Department) publishes this notice Reduction Act of 1995. Reporting and Recordkeeping Hour proposing to revise the system of DATES: Interested persons are invited to Burden: records entitled ‘‘Student Aid Internet submit comments on or before June 18, Responses: 1,267. Gateway (SAIG), Participation 2010. Burden Hours: 4,206. Management System’’ (18–11–10). SUPPLEMENTARY INFORMATION: Section Abstract: The study is designed to The SAIG, Participation Management 3506 of the Paperwork Reduction Act of document over time the intervention System is a system of records containing 1995 (44 U.S.C. Chapter 35) requires models, approaches, and strategies contact information that individuals that the Office of Management and adopted and implemented by a subset of affiliated with an authorized entity Budget (OMB) provide interested schools receiving federal School provide to request electronic access to Federal agencies and the public an early Improvement Grant funds. Data the Department’s Title IV Federal opportunity to comment on information collection includes interviews with Student Aid Systems. This notice collection requests. OMB may amend or state, local district and school officials, updates the categories of individuals waive the requirement for public parents and students, collection of covered by this system to include consultation to the extent that public school-level fiscal data, and individuals affiliated with secondary participation in the approval process observations in 50 school sites receiving schools, local educational agencies would defeat the purpose of the School Improvement Grants (SIGs) (LEAs) and States who are authorized by information collection, violate State or authorized under Title I, Section the Department and their respective Federal law, or substantially interfere 1003(G). The data collected through the secondary school, LEA or State to access with any agency’s ability to perform its survey will inform the documentation, the Department’s Title IV Federal statutory obligations. The Acting over time, of the intervention models, Student Aid Systems. Director, Information Collection approaches and strategies adopted and This change to the SAIG, Participation Clearance Division, Regulatory implemented by a subset of schools Management System is needed to enable Information Management Services, receiving SIG funds. the Department to implement a program Office of Management, publishes that Requests for copies of the proposed designed to improve access and promote notice containing proposed information information collection request may be enrollment in postsecondary education collection requests prior to submission accessed from http://edicsweb.ed.gov, by facilitating students’ completion of of these requests to OMB. Each by selecting the ‘‘Browse Pending the Free Application for Federal Student proposed information collection, Collections’’ link and by clicking on link Aid (FAFSA). As part of this program grouped by office, contains the number 4276. When you access the (the FAFSA Completion program), the following: (1) Type of review requested, information collection, click on Department will authorize a small e.g. new, revision, extension, existing or ‘‘Download Attachments’’ to view. number of secondary schools and LEAs reinstatement; (2) Title; (3) Summary of Written requests for information should to enroll through the SAIG,
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Participation Management System to Management System’’ in the subject line significant change to an established enable these entities to use the of your electronic message. system of records, reports to the Chair Department’s Title IV Federal Student During and after the comment period, of House Committee on Oversight and Aid Systems to obtain information about you may inspect all public comments Government Reform of the House of their students’ completion of the about this notice in room 44D2, UCP, Representatives, and the Chair of the FAFSA. In future years, the Department 4th Floor, 830 First Street, NE., Committee on Homeland Security and may seek to expand the FAFSA Washington, DC, between the hours of Governmental Affairs of the Senate, and Completion program to other secondary 8 a.m. and 4:30 p.m., local time, the Administrator of the Office of schools, LEAs, and States across the Monday through Friday of each week Information and Regulatory Affairs, Nation, which would substantially except Federal holidays. OMB. expand the number of secondary A system of records is considered Assistance to Individuals With schools, LEAs and States approved by ‘‘altered’’ whenever an agency expands Disabilities in Reviewing the the Department to access the the types or categories of information Rulemaking Record Department’s Title IV Federal Student maintained, significantly expands the Aid Systems to determine whether their On request, we will supply an types or categories of individuals about students have completed the FAFSA. appropriate aid, such as a reader or whom records are maintained, changes While the FAFSA Completion print magnifier, to an individual with a the purpose for which the information program provided the initial impetus for disability who needs assistance to is used, changes the equipment the Department to update the SAIG, review the comments or other configuration in a way that creates Participation Management System, the documents in the public rulemaking substantially greater access to the Department has also determined that record for this notice. If you want to records, or adds a routine use disclosure other changes are appropriate. schedule an appointment for this type of to the system. Since the last correction Specifically, through this notice, the aid, please contact the person listed to this system of records, which was Department proposes to update the under FOR FURTHER INFORMATION published in the Federal Register on system locations, the categories of CONTACT. January 28, 2005 (70 FR 4112–4115), a records maintained in this system, the FOR FURTHER INFORMATION CONTACT: number of changes are needed to update system’s purposes, and the system’s Director, Application Processing the current system of records. Most routine uses (by, for example, adding an Division, Program Management significantly, this notice updates the additional routine use, as required by Systems, 830 First Street, NE., room categories of individuals covered by this the Office of Management and Budget 63C4, UCP, Washington, DC 20202– system to include individuals affiliated (OMB)). 5454. Telephone number: (202) 377– with secondary schools, LEAs and 3205. If you use a telecommunications States who are authorized by the DATES: We must receive your comments device for the deaf (TDD), call the Department and their respective about this proposed system of records secondary school, LEA or State to access on or before May 19, 2010. Federal Relay Service (FRS), toll free, at 1–800–877–8339. the Department’s Title IV Federal The Department filed a report Individuals with disabilities can Student Aid Systems. This notice also describing the altered system of records obtain this document in an accessible updates the system locations, the covered by this notice with the Chair of format (e.g., braille, large print, categories of records maintained in the the Senate Committee on Homeland audiotape, or computer diskette) on system, the system’s purposes, adds an Security and Governmental Affairs, the request to the contact person listed in additional routine use disclosure that is Chair of the House Committee on the preceding paragraph. required by OMB, and makes other Oversight and Government Reform, and minor updates to the system. the Administrator of the Office of SUPPLEMENTARY INFORMATION: Information and Regulatory Affairs, Preamble Electronic Access to This Document Office of Management and Budget You may view this document, as well The Privacy Act (5 U.S.C. 552a(e)(4)) (OMB) on April 14, 2010. This altered as all other documents of this requires the Department to publish in system of records will become effective Department published in the Federal the Federal Register this notice of an at the later date of: (1) The expiration of Register, in text or Adobe Portable altered system of records maintained by the 40-day period for OMB review on Document Format (PDF) on the Internet the Department. The Department’s May 24, 2010; or (2) the expiration of a at the following site: http://www.ed.gov/ regulations implementing the Privacy 30-day OMB Review period on May 19, news/fedregister/index.html. Act are contained in the Code of Federal 2010, if OMB grants the Department’s To use PDF you must have the Adobe Regulations (CFR) in 34 CFR part 5b. request for a 10-day waiver of the Acrobat Reader, which is available free The Privacy Act applies to a record review period, unless the system of at this site. about an individual that is maintained records needs to be changed as a result in a system of records from which Note: The official version of this document of public comment or OMB review. information is retrieved by a unique is the document published in the Federal ADDRESSES: Address all comments about identifier associated with each Register. Free Internet access to the official the proposed altered system of records edition of the Federal Register and the Code individual, such as a name or Social of Federal Regulations is available on GPO to Director, Application Processing Security number. The information about Access at: http://www.gpoaccess.gov/nara/ Division, Program Management each individual is called a ‘‘record,’’ and index.html. Systems, 830 First Street, NE., room the system, whether manual or 63C4, Union Center Plaza (UCP), computer-based, is called a ‘‘system of Dated: April 14, 2010. Washington, DC 20202–5454. If you records.’’ William J. Taggart, prefer to send your comments through The Privacy Act requires each agency Chief Operating Officer, Federal Student Aid the Internet, use the following address: to publish notices of altered systems of U.S. Department of Education. [email protected]. records in the Federal Register and to For the reasons discussed in the You must include the term ‘‘Student prepare, whenever the agency publishes preamble, the Chief Operating Officer, Aid Internet Gateway, Participation a new system of records or makes a Federal Student Aid of the U.S.
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Department of Education (Department) of States, authorized employees or Management System for the purpose of publishes a notice of an altered system representatives of LEAs, and authorized allowing authorized users who are of records to read as follows: employees or representatives of eligible to participate in the electronic secondary schools. exchange of data with the Department to System Number: transmit files to and from the following CATEGORIES OF RECORDS IN THE SYSTEM: 18–11–10. Department databases and access the This system consists of contact Department’s Web sites online, based on SYSTEM NAME: information that individuals affiliated the approved program functions of each Student Aid Internet Gateway (SAIG), with an authorized entity (i.e., of the Department’s systems that Participation Management System. postsecondary institutions, third party include, but are not limited to the servicers, lenders, guaranty agencies, SECURITY CLASSIFICATION: following: State scholarship programs, States, None. (a) COD System; LEAs and secondary schools that the (b) CPS, under the Federal Student SYSTEM LOCATION: Department authorizes to access the Aid Application File; Pearson, PLC, 2510 N. Dodge, Iowa Department’s Title IV Federal Student (c) eCB System; City IA 52245–0030. (This facility hosts Aid Systems) provide to request (d) NSLDS; the database for the Participation electronic access to the Department’s (e) FMS; Management System.) Title IV Federal Student Aid Systems. (f) DMCS, under Common Services for Vangent, Inc., 2450 Oakdale This contact information includes the Borrowers (CSB); (g) TIVAS; and Boulevard, Coralville IA 52241–9728. individual’s name, address, and other (h) AIMS. (This facility stores paper documents authentication information (mother’s maiden name, user’s Social Security (2) Freedom of Information Act that are held for less than 12 months.) (FOIA) or Privacy Act Advice number, and the user’s date of birth). Iron Mountain, 4437 121st Street, Disclosure. The Department may Urbandale, IA 50323–2313. (This AUTHORITY FOR MAINTENANCE OF THE SYSTEM: disclose records to the Department of facility stores paper documents for Title IV of the Higher Education Act Justice (DOJ) or the Office of documents that are held for more than of 1965, as amended (HEA); 20 U.S.C. Management and Budget (OMB) if the 12 months.) Department seeks advice regarding Virtual Data Center (VDC), Dell Perot 1070 et seq. The collection of Social Security numbers of users of this system whether records maintained in this System, 2300 West Plano Parkway, system of records are required to be Plano, TX 75075–8427. (This facility is authorized by 31 U.S.C. 7701 and Executive Order 9397, as amended by disclosed under the FOIA or the Privacy hosts the SAIG Enrollment Web site Act. (titled FSAWebEnrollment.ed.gov) Executive Order 13478 (November 18, 2008). (3) Disclosure to the DOJ. The through which users enroll for Department may disclose records to the electronic access to the Department’s PURPOSE(S): DOJ to the extent necessary for Title IV Federal Student Aid Systems.) The information in this system is obtaining DOJ advice on any matter CATEGORIES OF INDIVIDUALS COVERED BY THE maintained for the purposes of: (1) relevant to an audit, inspection, or other SYSTEM: Processing stored data from the SAIG inquiry related to the programs covered This system contains records on those Enrollment Forms (Web and paper by this system. individuals who are eligible to versions); (2) maintaining the SAIG (4) Contract Disclosure. If the participate in the Department’s Title IV Enrollment Web site (titled Department contracts with an entity to Federal Student Aid Systems—to FSAWebEnrollment.ed.gov); (3) perform any function that requires participate in the electronic exchange of managing the assignment of individual disclosing records to the contractor’s data with the Department of Education electronic SAIG mailbox numbers, employees, the Department may via the SAIG, or enroll in the known as ‘‘TG numbers’’; and (4) disclose the records to those employees. Participation Management System for authenticating users of the CPS Online, Before entering into such a contract, the access to the Department’s Central eCB System, NSLDS Online, COD Department shall require the contractor Processing System (CPS) Online, System, FMS, DMCS, TIVAS, and to establish and maintain the safeguards required under the Privacy Act (5 U.S.C. eCampus-Based (eCB) System, National AIMS. 552a(m)) with respect to the records in Student Loan Data System (NSLDS) ROUTINE USES OF RECORDS MAINTAINED IN THE the system. Online, Common Origination and SYSTEM, INCLUDING CATEGORIES OF USERS AND (5) Litigation and Alternative Dispute THE PURPOSES OF SUCH USES: Disbursement (COD) System, Financial Resolution (ADR) Disclosures. Management System (FMS), Debt The Department may disclose (a) Introduction. In the event that one Management and Collections System information contained in a record in of the following parties is involved in (DMCS), Title IV Additional Servicers this system of records under the routine litigation or ADR, or has an interest in (TIVAS), and Access Information uses listed in this system of records litigation or ADR, the Department may Management System (AIMS). Those without the consent of the individual if disclose certain records to the parties individuals eligible to participate the disclosure is compatible with the described in paragraphs (b), (c), and (d) include: student financial aid purposes for which the record was of this routine use under the conditions administrators, authorized employees or collected. These disclosures may be specified in those paragraphs: representatives of postsecondary made on a case-by-case basis or, if the (i) The Department, or any of its institutions, authorized employees or Department has complied with the components; representatives of third-party servicers, computer matching requirements of the (ii) Any Department employee in his authorized employees or representatives Privacy Act of 1974, as amended or her official capacity; of lenders, authorized employees or (Privacy Act), under a computer (iii) Any Department employee in his representatives of guaranty agencies, matching agreement. or her individual capacity where the authorized employees or representatives (1) Program Disclosures. The DOJ agrees to or has been requested to of State scholarship programs, Department may disclose records provide or arrange for representation of authorized employees or representatives maintained in the SAIG, Participation the employee;
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(iv) Any Department employee in his administrative, civil, or criminal law or (12) Labor Organization Disclosure. or her individual capacity where the regulation if that information is relevant The Department may disclose records Department has agreed to represent the to any enforcement, regulatory, from this system of records to an employee; investigative, or prosecutorial arbitrator to resolve disputes under a (v) The United States where the responsibility within the receiving negotiated grievance process or to Department determines that the entity’s jurisdiction. officials of a labor organization litigation is likely to affect the (9) Enforcement Disclosure. In the recognized under 5 U.S.C. chapter 71 Department or any of its components. event that information in this system of when relevant and necessary to their (b) Disclosure to DOJ. If the records indicates, either on its face or in duties of exclusive representation. Department determines that disclosure connection with other information, a (13) Disclosure in the Course of of certain records to the DOJ is relevant violation or potential violation of any Responding to a Breach of Data. The and necessary to litigation or ADR, and applicable statute, regulation, or order Department may disclose records from is compatible with the purpose for of a competent authority, the this system to appropriate agencies, which the records were collected, the Department may disclose the relevant entities, and persons when (a) the Department may disclose those records records to the appropriate agency, Department suspects or has confirmed as a routine use to the DOJ. whether foreign, Federal, State, tribal or that the security or confidentiality of (c) Adjudicative Disclosures. If the local, charged with the responsibility of information in the system of records has Department determines that disclosure investigating or prosecuting that been compromised; (b) the Department of certain records to an adjudicative violation or charged with enforcing or has determined that as a result for the body before which the Department is implementing the statute, Executive suspected or confirmed compromise authorized to appear or to an individual Order, rule, regulation, or order issued there is a risk of harm to economic or or entity designated by the Department pursuant thereto. property interests, identity theft or or otherwise empowered to resolve or (10) Employment, Benefit, and fraud, or harm to the security or mediate disputes, is relevant and Contracting Disclosure. integrity of this system or other systems necessary to the litigation or ADR, the (a) For Decisions by the Department. or programs (whether maintained by the Department may disclose those records The Department may disclose a record Department or another agency or entity) as a routine use to the adjudicative to a Federal, State, or local agency that rely upon the compromised body, individual, or entity. maintaining civil, criminal, or other information; and (c) the disclosure made (d) Parties, Counsel, Representatives relevant enforcement or other pertinent to such agencies, entities, and persons is and Witnesses. If the Department records, or to another public authority reasonably necessary to assist in determines that disclosure of certain or professional organization, if connection with the Department’s records to a party, counsel, necessary to obtain information relevant efforts to respond to the suspected or representative or witness is relevant and to a Department decision concerning the confirmed compromise and prevent, necessary to the litigation or ADR, the hiring or retention of an employee or minimize, or remedy such harm. Department may disclose those records other personnel action, the issuance of as a routine use to the party, counsel, a security clearance, the letting of a DISCLOSURE TO CONSUMER REPORTING representative or witness. contract, or the issuance of a license, AGENCIES: (6) Research Disclosure. The grant, or other benefit. Disclosure pursuant to 5 U.S.C. Department may disclose records to a (b) For Decisions by Other Public 552a(b)(12): The Department may researcher if an appropriate official of Agencies and Professional disclose the following information to a the Department determines that the Organizations. The Department may consumer-reporting agency regarding a individual or organization to which the disclose a record to a Federal, State, valid overdue claim of the Department: disclosure would be made is qualified to local, or foreign agency or other public (1) The name, address, taxpayer carry out specific research related to authority or professional organization, identification number and other functions or purposes of this system of in connection with the hiring or information necessary to establish the records. The official may disclose retention of an employee or other identity of the individual responsible records from this system of records to personnel action, the issuance of a for the claim; (2) the amount, status, and that researcher solely for the purpose of security clearance, the reporting of an history of the claim; and (3) the program carrying out that research related to the investigation of an employee, the letting under which the claim arose. The functions or purposes of this system of of a contract, or the issuance of a Department may disclose the records. The researcher shall be license, grant, or other benefit, to the information specified in this paragraph required to maintain Privacy Act extent that the record is relevant and under 5 U.S.C. 552a(b)(12) and the safeguards with respect to the disclosed necessary to the receiving entity’s procedures contained in 31 U.S.C. records. decision on the matter. 3711(f). A consumer reporting agency to (7) Congressional Member Disclosure. (11) Employee Grievance, Complaint which these disclosures may be made is The Department may disclose records to or Conduct Disclosure. If a record is defined at 15 U.S.C. 1681a(f) and 31 a Member of Congress in response to an relevant and necessary to an employee U.S.C. 3701(a)(3). inquiry from the Member made at the grievance, complaint, or disciplinary written request of the individual whose action, the Department may disclose a POLICIES AND PRACTICES FOR STORING, records are being disclosed. The record in this system of records to RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: Member’s right to the information is no another agency of the Federal greater than the right of the individual Government if the record is relevant to STORAGE: who requested it. one of the following proceedings Records are maintained in a computer (8) Disclosure for Use by Other Law regarding a present or former employee database as well as in hard copy. All Enforcement Agencies. The Department of the Department: Complaint, hard copy forms are loaded into an may disclose information to any grievance, discipline or competence imaging system accessible through Federal, State, or local authority determination proceedings. The internal systems only. Paper documents responsible for enforcing, investigating, disclosure may only be made during the less than 12-months old are stored in or prosecuting violations of course of the proceeding. locked file cabinets at the Vangent, Inc.
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facility in Coralville, Iowa. Paper NOTIFICATION PROCEDURE: sustainable, environmentally sound documents older than 12 months are If you wish to determine whether a development. It provides the common stored at Iron Mountain secure storage record exists regarding you in this ground upon which leaders from facility. Documents are stored for three system of records, you must provide the business and industry, all levels of years after final contract payment. After system manager your name, date of government, public interest groups, and the three-year period, documents are birth, and Social Security number. others can work cooperatively to expand subsequently sent to the Federal Requests for notification about whether the reach of environmental education Records Center for storage. the system of records contains and training programs beyond the traditional classroom. The Foundation RETRIEVABILITY: information about an individual must meet the requirements of the supports a grant program that promotes All individuals affiliated with Department’s Privacy Act regulations at innovative environmental education authorized entities that have been and training programs; it also develops ‘‘ 34 CFR 5b.5, including proof of identity. granted access ( users of the SAIG, partnerships with government and other Participant Management System’’) to the RECORD ACCESS PROCEDURES: organizations to administer projects that Department’s Title IV Federal Student If you wish to gain access to a record promote the development of an Aid Systems whose information is in this system, you must contact the environmentally literate public. The included in this system of records have system manager and provide Administrator of the U.S. a unique user identification (ID) with a information as described in the Environmental Protection Agency, as password. Records are retrieved by the Notification Procedures. Such requests required, by the terms of the Act, names of the individual user and/or must meet the requirements of the announces the following appointment to their unique system User ID. Department’s Privacy Act regulations at the National Environmental Education SAFEGUARDS: 34 CFR 5b.5, including proof of identity. Foundation Board of Trustees. The All users of the SAIG, Participation CONTESTING RECORD PROCEDURES: appointee is Manuel Alberto Dim, a Management System will have a unique partner in the law firm Lydecker Dim, If you wish to contest or change the LLP. user ID with a password. content of a record about you in the All physical access to the data housed FOR FURTHER INFORMATION CONTACT: system of records, you must contact the For at the Pearson location and within the system manager with the information information regarding this Notice of VDC, and the locations of Department described in the notification procedures. Appointment, please contact Mr. contractors where this system of records Requests to amend a record must meet Andrew Burnett, Director, is maintained, is controlled and the requirements of the Department’s Environmental Education Division, monitored by security personnel who Privacy Act regulations at 34 CFR 5b.7. Office of Children’s Health Protection check each individual entering the and Environmental Education (1704A) building for his or her employee or RECORD SOURCE CATEGORIES: U.S. EPA, 1200 Pennsylvania Avenue, visitor badge. Information in this system is obtained NW., Washington, DC 20460. General The computer system employed by from the following entities: student information concerning NEEF can be the Department offers a high degree of financial aid administrators, found on their Web site at: http:// resistance to tampering and postsecondary institutions, third-party www.neefusa.org. circumvention. This security system servicers, lenders, guaranty agencies, SUPPLEMENTARY INFORMATION: limits data access to Department and State scholarship programs, States, Additional Considerations: Great care contract staff on a ‘‘need-to-know’’ basis, LEAs, and secondary schools. has been taken to ensure that this new and controls individual users’ ability to appointee not only has the highest access and alter records within the EXEMPTIONS CLAIMED FOR THE SYSTEM: degree of expertise and commitment, system. None. but also brings to the Board diverse All interactions by users of the SAIG, [FR Doc. 2010–8959 Filed 4–16–10; 8:45 am] Participation Management System are points of view relating to environmental BILLING CODE 4000–01–P recorded. education. This appointment is a four- year term, which may be renewed for an RETENTION AND DISPOSAL: additional four years pending successful Documents are stored for 3 years after ENVIRONMENTAL PROTECTION re-election by the NEEF nominating a user of the SAIG, Participation AGENCY committee. This appointee will join the current Management System’s individual [FRL–9139–2] enrollment account is terminated or Board members, which include: • closed. Thereafter, documents are sent Announcement of the Board of JL Armstrong (NEEF Vice Chair), to the Federal Records Center for Trustees for the National National Manger, Toyota Motor Sales, storage. These records are covered by Environmental Education Foundation USA, Inc. the General Records Schedule (GRS) 24, • Raymond Ban, Executive Vice Item 6(a). The retention requirement is AGENCY: Environmental Protection President, The Weather Channel. to destroy/delete the record 6 years after Agency (EPA). • Holly Cannon, Principal, Beveridge the user account is terminated or ACTION: Notice. and Diamond, P.C. • password is altered, or when no longer Phillipe Cousteau, Co-Founder and needed for investigative or security SUMMARY: The National Environmental CEO, EarthEcho International. • purposes, whichever is later. Education Foundation was created by Arthur Gibson (NEEF Chair), Vice Section 10 of Public Law 101–619, the President, Environment, Health and SYSTEM MANAGER(S) AND ADDRESS: National Environmental Education Act Safety, Baxter. Director, Application Processing of 1990. It is a private 501(c)(3) non- • Healthcare Corporation. Division, Program Management profit organization established to • Kenneth Olden, Chairman, Avon Systems, 830 First Street, NE., room promote and support education and Foundation Scientific Advisory Board. 63C4, Union Center Plaza (UCP), training as necessary tools to further • Trish Silber, President, Aliniad Washington, DC 20202–5454. environmental protection and Consulting Partners, Inc.
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• Bradley Smith, Dean, Huxley environmental professionals, and to of the Clean Water Act (CWA). This College of the Environment, Western assist them in the development and TMDL was completed in response to the Washington University. delivery of environmental education lawsuit styled Sierra Club, et al. v. EPA, • Kenneth Strassner (NEEF and training programs and studies. et al., No. LR–C–99–114. Treasurer), Vice President, Global The Foundation has a governing DATES: Comments must be submitted in Environment, Safety. Board of Directors (hereafter referred to • writing to EPA on or before May 19, Regulatory and Scientific Affairs, in this section as ‘the Board’), which 2010. Kimberly-Clark Corporation. consists of 13 directors, each of whom • Diane Wood (NEEF Secretary), shall be knowledgeable or experienced ADDRESSES: Comments on the TMDL President, National Environmental in the environment, education and/or should be sent to Ms. Diane Smith, Education Foundation. training. The Board oversees the Environmental Protection Specialist, Background: Section 10(a) of the activities of the Foundation and ensures Water Quality Protection Division, U.S. National Environmental Education Act that the activities of the Foundation are Environmental Protection Agency of 1990 mandates a National consistent with the environmental and Region 6, 1445 Ross Ave., Dallas, TX Environmental Education Foundation. education goals and policies of the 75202–2733, facsimile (214) 665–7373, The Foundation is established in order Environmental Protection Agency and or e-mail: [email protected]. For to extend the contribution of with the intents and purposes of the further information, contact Diane environmental education and training to Act. The membership of the Board, to Smith at (214) 665–2145. Documents meeting critical environmental the extent practicable, represents from the administrative record file for protection needs, both in this country diverse points of view relating to this TMDL are available for public and internationally; to facilitate the environmental education and training. inspection at this address as well. cooperation, coordination, and Members of the Board are appointed by Documents from the administrative contribution of public and private the Administrator of the Environmental record file may be viewed at http:// resources to create an environmentally Protection Agency. www.epa.gov/region6/water/npdes/ advanced educational system; and to Within 90 days of the date of the tmdl/index.htm, or obtained by calling foster an open and effective partnership enactment of the National (214) 665–2145 or writing Ms. Smith at among Federal, State and local Environmental Education Act, and as the above address. Please contact Ms. government, business, industry, appropriate thereafter, the Smith to schedule an inspection. academic institutions, community-based Administrator will publish in the FOR FURTHER INFORMATION CONTACT: environmental groups and international Federal Register an announcement of Diane Smith at (214) 665–2145. organizations. appointments of Directors of the Board. SUPPLEMENTARY INFORMATION: In 2000, The Foundation is a charitable and Such appointments become final and five Arkansas environmental groups, the nonprofit corporation whose income is effective 90 days after publication in the Sierra Club, Federation of Fly Fishers, exempt from tax and donations to which Federal Register. The directors are Crooked Creek Coalition, Arkansas Fly are tax deductible to the same extent as appointed for terms of 4 years. The Fishers, and Save our Streams those organizations listed pursuant to Administrator shall appoint an (plaintiffs), filed a lawsuit in Federal section 501(c) of the Internal Revenue individual to serve as a director in the Court against the EPA, styled Sierra Code of 1986. The Foundation is not an event of a vacancy on the Board within Club, et al. v. EPA, et al., No. LR–C–99– agency or establishment of the United 60 days of said vacancy in the manner 114. Among other claims, plaintiffs States. The purposes of the Foundation in which the original appointment was alleged that EPA failed to establish are— made. No individual may serve more Arkansas TMDLs in a timely manner. (A) Subject to the limitation contained than two consecutive terms as a EPA proposes this TMDL pursuant to a in the final sentence of subsection (d) director. consent decree entered in this lawsuit. herein, to encourage, accept, leverage, and administer private gifts for the Dated: March 11, 2010. EPA Seeks Comments on One TMDL Lisa P. Jackson, benefit of, or in connection with, the By this notice EPA is seeking environmental education and training Administrator. comment on the following TMDL for activities and services of the United [FR Doc. 2010–8927 Filed 4–16–10; 8:45 am] waters located within the State of States Environmental Protection BILLING CODE 6560–50–P Arkansas: Agency; (B) To conduct such other Waterbody environmental education activities as ENVIRONMENTAL PROTECTION Segment-reach name Pollutant will further the development of an AGENCY environmentally conscious and 11070208–901 Town Branch Total Phos- responsible public, a well-trained and [FRL–9139–5] phorus environmentally literate workforce, and Clean Water Act Section 303(d): EPA requests that the public provide an environmentally advanced Availability of One Total Maximum EPA with any significant water quality educational system; Daily Load (TMDL) in Arkansas (C) To participate with foreign entities related data or information that may be and individuals in the conduct and AGENCY: Environmental Protection relevant to the calculations for this coordination of activities that will Agency (EPA). TMDL. EPA will review all data and further opportunities for environmental ACTION: Notice of availability. information submitted during the public education and training to address comment period and revise the TMDL environmental issues and problems SUMMARY: This notice announces the where appropriate. EPA will then involving the United States and Canada availability of the administrative record forward the TMDL to the Arkansas or Mexico. file for comment on one TMDL and the Department of Environmental Quality The Foundation develops, supports, calculations for this TMDL prepared by (ADEQ). The ADEQ will incorporate the and/or operates programs and projects EPA Region 6 for waters listed in the TMDL into its current water quality to educate and train educational and State of Arkansas under Section 303(d) management plan.
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Dated: April 8, 2010. environment in which a utility can take Working Group Charge: The charge Miguel I. Flores, steps to be climate ready. The Working for the CRWU Working Group is to Director, Water Quality Protection Division, Group will discuss revisions and evaluate the concept of ‘‘Climate Ready EPA Region 6. refinements to these draft report Water Utilities’’ and provide [FR Doc. 2010–8925 Filed 4–16–10; 8:45 am] sections. Additionally, the working recommendations to the full NDWAC on BILLING CODE 6560–50–P group will discuss tools, training, and the development of an effective program resources needed to support water for drinking water and wastewater utilities and ways to integrate CRWU utilities, including recommendations to: ENVIRONMENTAL PROTECTION efforts with existing programs. (1) Define and develop a baseline AGENCY Public Participation: There will be an understanding of how to use available information to develop climate change [FRL–9139–3] opportunity for public comment during the CRWU Working Group meeting. adaptation and mitigation strategies, National Drinking Water Advisory Oral statements will be limited to five including ways to integrate this Council’s Climate Ready Water Utilities minutes, and it is preferred that only information into existing Working Group Meeting one person present the statement on complementary programs such as the Announcement behalf of a group or organization. Any Effective Utility Management and person who wishes to file a written Climate Ready Estuaries Program; (2) AGENCY: Environmental Protection statement can do so before or after the Identify climate change-related tools, Agency. CRWU Working Group meeting. Written training, and products that address ACTION: Notice. statements received prior to the meeting short-term and long-term needs of water will be distributed to all members of the and wastewater utility managers, SUMMARY: The U.S. Environmental Working Group before any final decision makers, and engineers, Protection Agency (EPA or Agency) is discussion or vote is completed. Any including ways to integrate these tools announcing the third in-person meeting statements received after the meeting and training into existing programs; and of the Climate Ready Water Utilities will become part of the permanent (3) Incorporate mechanisms to provide (CRWU) Working Group of the National meeting file and will be forwarded to recognition or incentives that facilitate Drinking Water Advisory Council the CRWU Working Group members for broad adoption of climate change (NDWAC). The purpose of this meeting their information. For information on adaptation and mitigation strategies by is for the Working Group to discuss key access or services for individuals with the water sector into existing EPA Office findings, the adaptive response disabilities, please contact Lauren of Water recognition and awards framework on what it means to be Wisniewski at 202–564–2918 or by programs or new recognition programs. climate ready, enabling environment e-mail at [email protected]. To Dated: April 13, 2010. recommendations, and climate-related request accommodation of a disability, tools to support utilities. Cynthia C. Dougherty, please contact Lauren Wisniewski, Director, Office of Ground Water and Drinking DATES: The third in-person CRWU preferably, at least 10 days prior to the Working Group meeting will take place Water. meeting to give EPA as much time as [FR Doc. 2010–8929 Filed 4–16–10; 8:45 am] on May 5, 2010, from 8:30 a.m. to 5:30 possible to process your request. BILLING CODE 6560–50–P p.m., Central Daylight Time (CDT) and Background: The Agency’s National on May 6, 2010, from 8:30 a.m. to 3 Water Program Strategy: Response to p.m., CDT. Climate Change (2008) identified the FEDERAL COMMUNICATIONS ADDRESSES: The meeting will take place need to provide drinking water and COMMISSION at the Omni Hotel Chicago, which is wastewater utilities with easy-to-use located at 676 North Michigan Avenue, resources to assess the risk associated Notice of Public Information Collection Chicago, Illinois 60611. with climate change and to identify Being Reviewed by the Federal FOR FURTHER INFORMATION CONTACT: potential adaptation strategies. The Communications Commission, Interested participants from the public NDWAC, established under the Safe Comments Requested should contact Lauren Wisniewski, Drinking Water Act, as amended (42 Designated Federal Officer, U.S. U.S.C. 300f et seq.), provides practical April 9, 2010. Environmental Protection Agency, and independent advice, consultation SUMMARY: The Federal Communications Office of Ground Water and Drinking and recommendations to the Agency on Commission, as part of its continuing Water, Water Security Division (Mail the activities, functions and policies effort to reduce paperwork burden Code 4608T), 1200 Pennsylvania related to the implementation of the invites the general public and other Avenue, NW., Washington, DC 20460. Safe Drinking Water Act. On May 28, Federal agencies to take this Please contact Lauren Wisniewski at 2009, the NDWAC voted on and opportunity to comment on the [email protected] or call 202– approved the formation of the CRWU following information collection, as 564–2918. CRWU Working Group Working Group. EPA anticipates that required by the Paperwork Reduction meeting agendas and summaries will be the Working Group will have five face- Act (PRA) of 1995, 44 U.S.C. 3501 – posted at: http://www.epa.gov/ to-face meetings between December 3520. Comments are requested safewater/ndwac/#current. 2009 and September 2010 in addition to concerning: (a) whether the proposed SUPPLEMENTARY INFORMATION: conference calls and/or video collection of information is necessary Agenda: The CRWU Working Group conferencing on an as needed basis. To for the proper performance of the has developed draft key findings on the date, there have been two face-to face functions of the Commission, including water sector and climate change, a draft meetings. After the Working Group whether the information shall have adaptive response framework that completes its charge, it will make practical utility; (b) the accuracy of the describes actions that a CRWU would recommendations to the full NDWAC. Commission’s burden estimate; (c) ways undertake, and draft enabling The NDWAC will consider these to enhance the quality, utility, and environment recommendations for recommendations and make its own clarity of the information collected; (d) activities needed to create a supportive recommendations to the EPA. ways to minimize the burden of the
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collection of information on the for specific entry options for telephone on all local communities identified and respondents, including the use of companies wishing to enter the video must include a statement informing the automated collection techniques or programming marketplace, one option local communities of the Commission’s other forms of information technology, being to provide cable service over an requirements for filing oppositions and and (e) ways to further reduce the ‘‘open video system’’ (‘‘OVS’’). The comments. Service by mail is complete information collection burden on small following information collection upon mailing, but if mailed, the served business concerns with fewer than 25 requirements listed below are covered documents must be postmarked at least employees. under information collection 3060– 3 days prior to the filing of the FCC The FCC may not conduct or sponsor 0700. Form 1275 with the Commission. a collection of information unless it 47 CFR 76.1502(a) states an operator 47 CFR 76.1502(d)(2) states that displays a currently valid control of an open video system must certify to parties are required to attach a cover number. No person shall be subject to the Commission that it will comply with sheet to the filing indicating that the any penalty for failing to comply with the Commission’s regulations in 47 CFR submission is an open video system a collection of information subject to the 76.1503, 76.1504, 76.1506, 76.1508, certification application. The only Paperwork Reduction Act (PRA) that 76.1509, and 76.1513. The Commission wording on this cover sheet shall be does not display a currently valid OMB must approve such certification prior to ‘‘Open Video System Certification control number. the commencement of service at such a Application’’ and ‘‘Attention: Media DATES: Written Paperwork Reduction point in time that would allow the Bureau.’’ This wording shall be located Act (PRA) comments should be applicant sufficient time to comply with in the center of the page and should be submitted on or before June 18, 2010. If the Commission’s notification in letters at least 1/2 inch in size. Parties you anticipate that you will be requirements. shall also include the words ‘‘open submitting PRA comments, but find it 47 CFR 76.1502(b) states that video systems’’ on their mailing difficult to do so within the period of certifications must be verified by an envelope. time allowed by this notice, you should officer or director of the applicant, 47 CFR 76.1502(e)(1) requires that advise the FCC contact listed below as stating that, to the best of his or her comments or oppositions to a soon as possible. information and belief, the certification must be filed within five calendar days of the Commission’s ADDRESSES: Direct all PRA comments to representations made therein are receipt of the certification and must be Nicholas A. Fraser, Office of accurate. served on the party that filed the Management and Budget, via fax at 202– 47 CFR 75.1502(c) require that certification. If, after making the 395–5167 or via email to certifications must be filed on FCC Form necessary calculations, the due date for [email protected] and 1275 and must include: filing comments falls on a holiday, to the Federal Communications (1) The applicant’s name, address and telephone number; comments shall be filed on the next Commission via email to [email protected] business day before noon, unless the and [email protected]. (2) A statement of ownership, including all affiliated entities; nearest business day precedes the fifth FOR FURTHER INFORMATION CONTACT: For (3) If the applicant is a cable operator calendar day following a filing, in additional information, contact Cathy applying for certification in its cable which case the comments will be due Williams on (202) 418–2918. franchise area, a statement that the on the preceding business day. SUPPLEMENTARY INFORMATION: applicant is qualified to operate an open 47 CFR 76.1502(e)(2) requires parties OMB Control Number: 3060–0700. video system under Section 76.1501. wishing to respond to a FCC Form 1275 Title: Open Video Systems Provisions, (4) A statement that the applicant filing must submit comments or FCC Form 1275. agrees to comply and to remain in oppositions with the Office of the Form Number: FCC Form 1275. compliance with each of the Secretary and the Bureau Chief, Media Type of Review: Extension of a Commission’s regulations in §§76.1503, Bureau. Comments will not be currently approved collection. 76.1504, 76.1506, 76.1508, 76.1509, and considered properly filed unless filed Respondents: Business or other for– with both of these Offices. Parties are profit entities; State, Local or Tribal 76.1513; (5) If the applicant is required under required to attach a cover sheet to the Government. filing indicating that the submission is Number of Respondents and 47 CFR 64.903(a) to file a cost allocation a pleading related to an open video Responses: 280 respondents and 4,672 manual, a statement that the applicant will file changes to its manual at least system application, the only wording on responses. this cover sheet shall be ‘‘Open Video Frequency of Response: On occasion 60 days before the commencement of System Certification Application reporting requirement; Recordkeeping service; Comments.’’ This wording shall be and third party disclosure requirements. (6) A list of the names of the Estimated Time per Response: 0.25 to anticipated local communities to be located in the center of the page and 20 hours. served upon completion of the system; should be in letters at least 1/2 inch in Total Annual Burden: 9,855 hours. (7) The anticipated amount and type size. Parties shall also include the words Total Annual Costs: None. (i.e., analog or digital) of capacity (for ‘‘open video systems’’ on their mailing Privacy Impact Assessment: No switched digital systems, the envelopes. impact(s). anticipated number of available channel 47 CFR 76.1502(f) states if the Obligation to Respond: Required to input ports); and Commission does not disapprove the obtain or retain benefits. The statutory (8) A statement that the applicant will certification application within ten days authority for this collection is contained comply with the Commission’s notice after receipt of an applicant’s request, in Section 302 of the Communications and enrollment requirements for the certification application will be Act of 1934, as amended. unaffiliated video programming deemed approved. If disapproved, the Confidentiality: No need for providers. applicant may file a revised certification confidentiality required with this 47 CFR 76.1502(d)(1) requires that on or refile its original submission with a collection of information. or before the date an FCC Form 1275 is statement addressing the issues in Needs and Uses: Section 302 of the filed with the Commission, the dispute. Such refilings must be served 1996 Telecommunications Act provides applicant must serve a copy of its filing on any objecting party or parties and on
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all local communities in which the processing and subsequent transmission operator. The open video system applicant intends to operate. The through the system. operator shall make all notifications Commission will consider any revised 47 CFR 76.1504(d) states complaints immediately available to the appropriate or refiled FCC Form 1275 to be a new regarding rates shall be limited to video video programming providers on its proceeding and any party who filed programming providers that have sought open video system. Operators may effect comments regarding the original FCC carriage on the open video system. If a the deletion of signals for which they Form 1275 will have to refile their video programming provider files a have received deletion notices unless original comments if they think such complaint against an open video system they receive notice within a reasonable comments should be considered in the operator meeting the above just and time from the appropriate programming subsequent proceeding. reasonable rate presumption, the burden provider that the rights claimed are 47 CFR 76.1503(b)(1) states an open of proof will rest with the complainant. invalid. The open video system operator video system operator shall file with the If a complaint is filed against an open shall not delete signals for which it has Secretary of the Federal video system operator that does not received notice from the programming Communications Commission a ‘‘Notice meet the just and reasonable rate provider that the rights claimed are of Intent’’ to establish an open video presumption, the open video system invalid. An open video system operator system, which the Commission will operator will bear the burden of proof to shall be subject to sanctions for any release in a Public Notice. Parties are demonstrate, using the principles set violation of this subpart. An open video required to attach a cover sheet to the forth below, that the carriage rates system operator may require filing indicating that the submission is subject to the complaint are just and indemnification as a condition of an Open Video System Notice of Intent. reasonable. carriage for any sanctions it may incur The only wording on this cover sheet 47 CFR 76.1504(e) states how in reliance on a programmer’s claim that shall be ‘‘Open Video System Notice of reasonable rates subject to complaints certain exclusive or non–duplication Intent’’ and ‘‘Attention: Media Bureau.’’ are determined and what tests must be rights are invalid. This wording shall be located in the met for such determinations. 47 CFR 76.1508(c) states any center of the page and should be in 47 CFR 76.1505(d)(8) states the open provision of § 76.94 that refers to a letters at least 1/2 inch in size. Parties video system operator and/or the local ‘‘cable system operator’’ or ‘‘cable shall also include the words ‘‘open franchising authority may file a television system operator’’ shall apply video systems’’ on their mailing complaint with the Commission, to an open video system operator. Any envelopes. Parties must submit copies of pursuant to our dispute resolution provision of § 76.94 that refers to a the Notice of Intent with the Office of procedures set forth in § 76.1514, if the ‘‘cable system’’ or ‘‘cable television the Secretary and the Bureau Chief, open video system operator and the system’’ shall apply to an open video Media Bureau. local franchising authority cannot agree system except § 76.94 (e) and (f) which 47 CFR 76.1503(b)(2) states that an as to the application of the shall apply to an open video system open video system operator shall Commission’s rules regarding the open operator. Open video system operators provide the following information to a video system operator’s public, shall make all notifications and video programming provider within five educational and governmental access information regarding the exercise of business days of receiving a written obligations under paragraph (d) of this network non–duplication rights request from the provider, unless section. immediately available to all appropriate otherwise included in the Notice of 47 CFR 76.1506(l)(2) states must– video programming provider on the Intent: carry/retransmission consent election system. An open video system operator (i) The projected activation date of the notifications shall be sent to the open shall not be subject to sanctions for any open video system. If a system is to be video system operator. An open video violation of these rules by an activated in stages, the operator should system operator shall make all must– unaffiliated program supplier if the describe the respective stages and the carry/retransmission consent election operator provided proper notices to the projected dates on which each stage will notifications received available to the program supplier and subsequently took be activated; appropriate programming providers on prompt steps to stop the distribution of (ii) A preliminary carriage rate its system. the infringing program once it was estimate; (3) Television broadcast stations are notified of a violation. (iii) The information a video required to make the same election for 47 CFR 76.1509(c) states any programming provider will be required open video systems and cable systems provision of § 76.155 that refers to a to provide to qualify as a video serving the same geographic area, unless ‘‘cable system operator’’ or ‘‘cable programming provider, e.g., the overlapping open video system is television system operator’’ shall apply creditworthiness; unable to deliver appropriate signals in to an open video system operator. Any (iv) Technical information that is conformance with the broadcast provision of § 76.155 that refers to a reasonably necessary for potential video station’s elections for all cable systems ‘‘cable system’’ or ‘‘cable television programming providers to assess serving the same geographic area. system’’ shall apply to an open video whether to seek capacity on the open (4) An open video system system except § 76.155(c) which shall video system, including what type of commencing new operations shall apply to an open video system operator. customer premises equipment notify all local commercial and Open video system operators shall make subscribers will need to receive service; noncommercial broadcast stations as all notifications and information (v) Any transmission or reception required under paragraph (l) of this regarding exercise of syndicated equipment needed by a video section on or before the date on which program exclusivity rights immediately programming provider to interface it files with the Commission its Notice available to all appropriate video successfully with the open video of Intent to establish an open video programming provider on the system. system; and system. An open video system operator shall not (vi) The equipment available to 47 CFR 76.1506(m)(2) states that be subject to sanctions for any violation facilitate the carriage of unaffiliated notification of programming to be of these rules by an unaffiliated program video programming and the electronic deleted pursuant to this section shall be supplier if the operator provided proper form(s) that will be accepted for served on the open video system notices to the program supplier and
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subsequently took prompt steps to stop rate estimate or a programming contract to matters contained in the answer and the distribution of the infringing that demonstrates a differential in price, shall not contain new matters. program once it was notified of a terms or conditions between 47 CFR 76.1513(g) requires that any violation. complainant and a competing video complaint filed pursuant to this 47 CFR 76.1513(a) states any party programming provider or, if no subsection must be filed within one year aggrieved by conduct that it believes programming contract or preliminary of the date on which one of the constitute a violation of the regulations carriage rate estimate is submitted with following events occurs: set forth in this part or in section 653 the complaint, an affidavit signed by an (1) The open video system operator of the Communications Act (47 U.S.C. officer of complainant alleging that a enters into a contract with the 573) may commence an adjudicatory differential in price, terms or conditions complainant that the complainant proceeding at the Commission to obtain exists, a description of the nature and alleges to violate one or more of the enforcement of the rules through the extent (if known or reasonably rules contained in this part; or filing of a complaint. The Commission estimated by the complainant) of the (2) The open video system operator shall resolve any such dispute within differential, together with a statement offers to carry programming for the 180 days after the filing of a complaint. that defendant refused to provide any complainant pursuant to terms that the The complaint shall be filed and further specific comparative complainant alleges to violate one or responded to in accordance with the information; more of the rules contained in this part, procedures specified in § 76.7 of this Note to paragraph (d)(2): Upon and such offer to carry programming is part with the following additions or request by a complainant, the unrelated to any existing contract changes. preliminary carriage rate estimate shall between the complainant and the open 47 CFR 76.1513(b) requires that an include a calculation of the average of video system operator; or open video system operator may not the carriage rates paid by the (3) The complainant has notified an provide in its carriage contracts with unaffiliated video programming open video system operator that it programming providers that any dispute providers receiving carriage from the intends to file a complaint with the must be submitted to arbitration, open video system operator, including Commission based on a request for such mediation, or any other alternative the information needed for any operator to carry the complainant’s method for dispute resolution prior to weighting of the individual carriage programming on its open video system submission of a complaint to the rates that the operator has included in that has been denied or Commission. the average rate. unacknowledged, allegedly in violation 47 CFR 76.1513(c) states that any (3) If a programming contract or a of one or more of the rules contained in aggrieved party intending to file a preliminary carriage rate estimate is this part. complaint under this section must first submitted with the complaint in notify the potential defendant open support of the alleged violation, specific Federal Communications Commission. video system operator that it intends to references to the relevant provisions Marlene H. Dortch, file a complaint with the Commission therein. Secretary, Office of the Secretary, based on actions alleged to violate one (4) The complaint must be Office of Managing Director. or more of the provisions contained in accompanied by appropriate evidence [FR Doc. 2010–8818 Filed 4–16–10; 8:45 am] this part or in Section 653 of the demonstrating that the required BILLING CODE: 6712–01–S Communications Act. The notice must notification pursuant to paragraph (c) of be in writing and must be sufficiently this section has been made. detailed so that its recipient(s) can 47 CFR 76.1513(e)(1) requires that any determine the specific nature of the open video system operator upon which FEDERAL COMMUNICATIONS potential complaint. The potential a complaint is served under this section COMMISSION complainant must allow a minimum of shall answer within thirty (30) days of ten (10) days for the potential service of the complaint, unless Sunshine Act Meeting; Open defendant(s) to respond before filing a otherwise directed by the Commission. Commission Meeting; April 21, 2010 complaint with the Commission. 47 CFR 76.1513(e)(2) states that an 47 CFR 76.1513(d) states that in answer to a discrimination complaint Date: April 14, 2010. addition to the requirements of § 76.7 of shall state the reasons for any The Federal Communications this part, an open video system differential in prices, terms or Commission will hold an Open Meeting complaint shall contain: conditions between the complainant on the subjects listed below on (1) The type of entity that describes and its competitor, and shall specify the Wednesday, April 21, 2010, which is complainant (e.g., individual, private particular justification relied upon in scheduled to commence at 10:30 a.m. in association, partnership, or support of the differential. Any Room TW–C305, at 445 12th Street, corporation), the address and telephone documents or contracts submitted S.W., Washington, D.C. number of the complainant, and the pursuant to this paragraph may be In accordance with the purpose of the address and telephone number of each protected as proprietary pursuant to § Sunshine period, comments submitted defendant; 76.9 of this part. on blog pages in broadband.gov during (2) If discrimination in rates, terms, 47 CFR 76.1513(f) states that within the Sunshine period will not be and conditions of carriage is alleged, twenty (20) days after service of an considered by the Commission in documentary evidence shall be answer, the complainant may file and finalizing the items under consideration submitted such as a preliminary carriage serve a reply which shall be responsive at the open meeting on April 21.
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ITEM NO. BUREAU SUBJECT
1 WIRELINE COMPETITION ...... TITLE: Connect America Fund; A National Broadband Plan for Our Future (GN Docket No 09–51); and High–Cost Universal Serv- ice Support (WC Docket No. 05–337) SUM- MARY: The Commission will consider a No- tice of Inquiry and Notice of Proposed Rule- making initiating universal service reforms as outlined in the National Broadband Plan and Joint Statement on Broadband. 2 WIRELESS TELE–COMMUNICATIONS ...... TITLE: Reexamination of Roaming Obligations of Commercial Mobile Radio Service Pro- viders and Other Providers of Mobile Data Services (WT Docket No. 05–265) SUM- MARY: The Commission will consider an Order on Reconsideration regarding auto- matic voice roaming requirements and a Second Further Notice of Proposed Rule- making regarding automatic roaming for mobile data services. 3 MEDIA ...... TITLE: Video Device Competition; Implemen- tation of Section 304 of the Telecommuni- cations Act of 1996: Commercial Availability of Navigation Devices (CS Docket No. 97– 80); and Compatibility Between Cable Sys- tems and Consumer Electronics Equipment (PP Docket No. 00–67) SUMMARY: The Commission will consider a Notice of Inquiry seeking comment on best approaches to assure the commercial availability of smart video devices and other equipment used to access the services of multichannel video programming distributors. 4 MEDIA ...... TITLE: Implementation of Section 304 of the Telecommunications Act of 1996: Commer- cial Availability of Navigation Devices(CS Docket No. 97–80); and Compatibility Be- tween Cable Systems and Consumer Elec- tronics Equipment (PP Docket No. 00–67) SUMMARY: The Commission will consider a Fourth Further Notice of Proposed Rule- making that proposes changes to the CableCARD rules for set–top boxes used with cable services, to improve the oper- ation of that framework pending the devel- opment of a successor framework. 5 PUBLIC SAFETY & HOMELAND SECURITY TITLE: Effects on Broadband Communications Networks Of Damage to or Failure of Net- work Equipment Or Severe Overload SUM- MARY: The Commission will consider a No- tice of Inquiry that examines the survivability of broadband infrastructure and seeks com- ment on the ability of existing broadband networks to withstand significant damage or severe overloads as result of natural disas- ters, terrorist attacks, pandemics or other major public emergencies. 6 PUBLIC SAFETY & HOMELAND SECURITY TITLE: Cyber Security Certification Program SUMMARY: The Commission will consider a Notice of Inquiry on whether to establish a voluntary cyber security certification pro- gram.
The meeting site is fully accessible to disabilities are available upon request. [email protected] or call the Consumer & people using wheelchairs or other In your request, include a description of Governmental Affairs Bureau at 202– mobility aids. Sign language the accommodation you will need and 418–0530 (voice), 202–418–0432 (tty). interpreters, open captioning, and a way we can contact you if we need Additional information concerning assistive listening devices will be more information. Last minute requests this meeting may be obtained from provided on site. Other reasonable will be accepted, but may be impossible Audrey Spivack or David Fiske, Office accommodations for people with to fill. Send an e–mail to: of Media Relations, (202) 418–0500;
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TTY 1–888–835–5322. Audio/Video institutions to bring those individuals Survey of Unbanked and Underbanked coverage of the meeting will be and families who have rarely, if ever, Households’’: broadcast live with open captioning held a checking account, a savings • http://www.FDIC.gov/regulations/ over the Internet from the FCC Live web account or other type of transaction or laws/federal/. page at www.fcc.gov/live. check cashing account at an insured • E-mail: [email protected]. For a fee this meeting can be viewed depository institution (hereafter in this Include the name and number of the live over George Mason University’s section referred to as the ‘unbanked’) collection in the subject line of the Capitol Connection. The Capitol into the conventional finance system.’’ message. Connection also will carry the meeting Section 7 further instructs the FDIC to • Mail: Leneta Gregorie (202–898– live via the Internet. To purchase these consider several factors in its conduct of 3719), Counsel, Legal Division, Federal services call (703) 993–3100 or go to the surveys, including: (1) ‘‘What Deposit Insurance Corporation, 550 17th www.capitolconnection.gmu.edu. cultural, language and identification Street, NW., Washington, DC 20429. Copies of materials adopted at this issues as well as transaction costs • Hand Delivery: Comments may be meeting can be purchased from the appear to most prevent ‘unbanked’ hand-delivered to the guard station at FCC’s duplicating contractor, Best Copy individuals from establishing the rear of the 550 17th Street Building and Printing, Inc. (202) 488–5300; Fax conventional accounts’’; and (2) ‘‘what is (located on F Street), on business days (202) 488–5563; TTY (202) 488–5562. a fair estimate of the size and worth of between 7 a.m. and 5 p.m. These copies are available in paper the ‘unbanked’ market in the United FOR FURTHER INFORMATION CONTACT: format and alternative media, including States.’’ The household survey is Interested members of the public may large print/type; digital disk; and audio designed to address these factors and obtain a copy of the survey and related and video tape. Best Copy and Printing, provide a factual basis on the instructions by clicking on the link for Inc. may be reached by e–mail at proportions of unbanked households. the National Unbanked and [email protected]. Such a factual basis is necessary to Underbanked Household Survey on the Federal Communications Commission. adequately assess banks’ efforts to serve following Web page: http:// these households as required by the Marlene H. Dortch, www.fdic.gov/regulations/laws/federal/ statutory mandate. Secretary, Office of the Secretary, Office of notices.html. Interested members of the Managing Director. To satisfy the Congressional mandate, public may also obtain additional the FDIC designed two complementary information about the collection, [FR Doc. 2010–9097 Filed 4–15–10; 8:45 am] surveys: a survey of FDIC-insured including a paper copy of the proposed BILLING CODE 6712–01–S depository institutions and a survey of collection and related instructions, households. The first survey of FDIC- without charge, by contacting Leneta insured depository institutions, aimed Gregorie at the address identified above, FEDERAL DEPOSIT INSURANCE at collecting data on their efforts to or by calling (202) 898–3719. CORPORATION serve underbanked, as well as SUPPLEMENTARY INFORMATION: The FDIC unbanked, populations (underbanked is considering possible revisions to the Agency Information Collection populations include individuals who following collection of information: Activities: Proposed Revision of have an account with an insured Title: National Unbanked and Information Collection; National depository but also rely on non-bank Underbanked Household Survey. Survey of Unbanked and Underbanked alternative financial service providers OMB Number: 3064–0167. Households; Comment Request for transaction services or high cost Frequency of Response: Once. AGENCY: Federal Deposit Insurance credit products), was conducted in mid- Affected Public: U.S. Households. Corporation (FDIC). 2007, with the results released in Estimated Number of Respondents: ACTION: Notice and request for comment. February 2008. The first survey of 50,000. unbanked and underbanked households Average time per response: 10 SUMMARY: The FDIC, as part of its was conducted in January 2009 as a CPS minutes (0.166 hours) per respondent. continuing effort to reduce paperwork supplement and the results were Estimated Total Annual Burden: and respondent burden and as required released to the public in December 0.166 hours × 50,000 respondents = by the Paperwork Reduction Act of 1995 2009. The household survey sought to 8,334 hours. (44 U.S.C. chapter 35), invites the estimate the proportions of unbanked general public and other Federal and underbanked households in the General Description of Collection agencies to comment on the survey U.S. and to identify the factors that A mandate in section 7 of the Reform collection instrument for its second inhibit the participation of these Act requires the FDIC to conduct National Survey of Unbanked and households in the mainstream banking ongoing surveys on efforts by banks to Underbanked Households (‘‘Household system. The results of these ongoing bring unbanked individuals and Survey’’), currently approved under surveys will help policymakers and families into the conventional finance OMB Control No. 3064–0167, scheduled bankers understand the issues and system. Section 7 further instructs the to be conducted in partnership with the challenges underserved households FDIC to consider several factors in its U.S. Census Bureau as a supplement to perceive when deciding how and where conduct of the surveys, including the its June 2011 Current Population Survey to conduct financial transactions. This size of the unbanked market in the (‘‘CPS’’). The collection is a key notice addresses the next Household United States and the cultural, language component of the FDIC’s efforts to Survey. and identification issues as well as comply with a Congressional mandate transaction costs that appear to most contained in section 7 of the Federal DATES: Comments must be submitted on prevent unbanked individuals from Deposit Insurance Reform Conforming or before June 18, 2010. establishing conventional accounts. To Amendments Act of 2005 (‘‘Reform ADDRESSES: Interested parties are obtain this information, the FDIC Act’’) (Pub. L. 109–173), which calls for invited to submit written comments by partnered with the U.S. Census Bureau, the FDIC to conduct ongoing surveys any of the following methods. All which administered the Household ‘‘on efforts by insured depository comments should refer to ‘‘National Survey supplement (‘‘FDIC
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Supplement’’) to households that Federal Deposit Insurance Corporation. Deposit Insurance Corporation, 550 17th participated in the January 2009 CPS. Robert F. Feldman, Street, NW., Washington, DC 20429. The FDIC supplement has yielded Executive Secretary. SUPPLEMENTARY INFORMATION: significant data on the extent and [FR Doc. 2010–8913 Filed 4–16–10; 8:45 am] Background demographic characteristics of the BILLING CODE 6714–01–P population that is unbanked or 1. Guidelines for Appeals of Material underbanked, the use by this population Supervisory Determinations of alternative financial services, and the FEDERAL DEPOSIT INSURANCE Section 309(a) of the Riegle reasons why some households do not CORPORATION make greater use of traditional banking Community Development and services. The Household Survey was the Intra-Agency Appeal Process: Regulatory Improvement Act of 1994 first survey of its kind to be conducted Guidelines for Appeals of Material (Pub. L. 103–325, 108 Stat. 2160) ‘‘ ’’ at the national level. An executive Supervisory Determinations and ( Riegle Act ) required the FDIC (as well summary of the results of the Household Guidelines for Appeals of Deposit as the other Federal banking agencies Survey, the full report, and the survey Insurance Assessment Determinations and the National Credit Union instrument can be accessed through the Administration Board) to establish an following link: http:// AGENCY: Federal Deposit Insurance independent intra-agency appellate www.economicinclusion.gov/ Corporation. process to review material supervisory determinations. about_survey.html. ACTION: Notice of guidelines. Consistent with the statutory mandate The Riegle Act defines the term to conduct the surveys on an ongoing SUMMARY: On April 13, 2010, the ‘‘independent appellate process’’ to basis, the FDIC already has in place Federal Deposit Insurance Corporation mean a review by an agency official who arrangements for conduct of its second (‘‘FDIC’’) Board of Directors (‘‘Board’’) does not directly or indirectly report to Household Survey as a supplement to adopted revised Guidelines for Appeals the agency official who made the the June 2011 CPS. However, prior to of Material Supervisory Determinations material supervisory determination finalizing the next survey instrument, (‘‘SARC Guidelines’’). The SARC under review. In the appeals process, the FDIC seeks to solicit public Guidelines govern the Supervision the FDIC is required to ensure that (1) comment on whether changes to the Appeals Review Committee (‘‘SARC’’) an appeal of a material supervisory existing instrument are desirable and, if process and supersede the FDIC’s prior determination by an insured depository so, to what extent. It should be noted SARC Guidelines, which were adopted institution is heard and decided that, as a supplement of the CPS survey, by the FDIC’s Board of Directors on expeditiously; and (2) appropriate the Household Survey needs to adhere September 16, 2008. In addition, on safeguards exist for protecting to specific parameters that include April 13, 2010, the Board also adopted appellants from retaliation by agency limits in the length and sensitivity of revised Guidelines for Appeals of examiners. the questions that can be asked of CPS Deposit Insurance Assessment On March 21, 1995, the FDIC’s Board respondents. Specifically, there is a Determinations (‘‘AAC Guidelines’’), of Directors adopted the original strict limitation on the number of which govern the Assessment Appeals Guidelines for Appeals of Material questions permitted (no more than 32) Committee (‘‘AAC’’) process and Supervisory Determinations, which and the average time required to supersede the FDIC’s prior AAC established and set forth procedures complete the survey (10 minutes on Guidelines, which were adopted on governing the SARC, whose purpose average). June 28, 2004. The SARC Guidelines was to consider and decide appeals of material supervisory determinations as Request for Comment have been amended to extend the decision deadline for requests for required by the Riegle Act. The SARC Comments are invited on: (a) Whether review and to clarify the decisional Guidelines were amended, after notice the collection of information is deadline for written decisions by the and comment, on July 9, 2004, adopting necessary for the proper performance of SARC. Also, both the SARC Guidelines revised Guidelines and changing the the FDIC’s functions, including whether and the AAC Guidelines have been composition and procedures of the the information has practical utility; (b) amended to make additional, limited SARC. (69 FR 41479 (July 9, 2004)). The SARC Guidelines were amended the accuracy of the estimates of the technical clarifying and conforming burden of the information collection; (c) again in 2008, after notice and amendments. Both sets of revised ways to enhance the quality, utility, and comment, to modify the supervisory guidelines are effective upon adoption. clarity of the information to be determinations eligible for appeal to collected; and (d) ways to minimize the DATES: The revised SARC Guidelines eliminate the ability of an FDIC- burden of the information collection on and the revised AAC Guidelines became supervised institution to file an appeal respondents, including through the use effective on April 13, 2010. with the SARC with respect to of automated collection techniques or For Further Information Concerning determinations or the facts and other forms of information technology. the SARC Guidelines Contact: Patricia circumstances underlying a The FDIC will consider all comments Colohan, Acting Associate Director, recommended or pending formal to determine the extent to which the Division of Supervision and Consumer enforcement-related action or decision, information collection should be Protection, (202) 898–7283; Richard and to make limited technical modified prior to submission to OMB Bogue, Counsel, Legal Division, (202) amendments. (73 FR 54822 (Sept. 23, for review and approval. After the 898–3726; Jeannette E. Roach, Counsel, 2008)). comment period closes, comments will Legal Division, (202) 898–3785, Federal Although the FDIC considered it be summarized and/or included in the Deposit Insurance Corporation, 550 17th desirable in those instances to garner FDIC’s request to OMB for approval of Street, NW., Washington, DC 20429. comments regarding the Guidelines, the collection. All comments will For Further Information Concerning notice and comment rulemaking was become a matter of public record. the AAC Guidelines Contact: not required, and the FDIC pointed out Dated at Washington, DC, this 13th day of Christopher Bellotto, Counsel, (202) that notice and comment rulemaking April 2010. 898–3801, Legal Division, Federal need not be employed in making future
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amendments. Notice and comment request for review of a material Paragraph E of the AAC Guidelines and rulemaking was not employed in supervisory determination with the Paragraph G of the SARC Guidelines making the present amendments. Director of DSC, the Director ‘‘will issue have been amended to provide that a a written determination of the request division director’s request to transfer a 2. Guidelines for Appeals of Deposit for review, setting forth the grounds for matter directly to the SARC or AAC will Insurance Assessment Determinations that determination, within 30 days of be done on the director’s The FDIC Board of Directors created receipt of the request.’’ Paragraph F(b). recommendation, rather than the the AAC in 1999 to provide a high-level This deadline has proven to provide director’s determination, since no process for considering all deposit insufficient time for the issuance of a determination will have been made. insurance assessment appeals brought determination following the necessary Paragraph L of the AAC Guidelines from determinations made by the analysis of the request and coordination (Publication of Decisions) provides that appropriate FDIC Divisions. between FDIC divisions and offices published AAC decisions will be Responsibility for deposit insurance charged with carrying out the appeals redacted to avoid the disclosure of assessments is shared by the Division of process. To provide the necessary time, exempt information. Because there may Finance (‘‘DOF’’), the Division of this language has been amended to be circumstances where no amount of Insurance and Research (‘‘DIR’’) and, in provide that the Director will issue the redaction of the full-text AAC decision some respects, the Division of written determination ‘‘within 45 days would be sufficient to prevent improper Supervision and Consumer Protection of receipt of the request.’’ disclosure while at the same time (‘‘DSC’’). DOF is responsible for The SARC Guidelines provided that providing a meaningful statement of calculating the assessments owed by written decisions of the SARC were to what the AAC has decided, Paragraph L individual insured institutions based on be issued ‘‘within 60 days from the date has been revised to provide for assessment risk rates assigned by DIR, the appeal is filed, or within 60 days summary form publication where which in turn uses supervisory from oral presentation, if held.’’ It was redaction is deemed to be insufficient to information provided by DSC. contemplated that oral presentations prevent improper disclosure. This Institutions that dispute the would be made at SARC meetings to aid amendment mirrors a change made to computation of their quarterly the Committee in issuing written the corresponding Paragraph N of the assessment payments may request decisions within 60 days thereafter. The SARC Guidelines in 2008. revision of their assessment payments prior language of the SARC Guidelines For the reasons stated in the by following the procedures set forth at (paragraph M), however, contemplated a Preamble, the Board has adopted the 12 CFR 327.3(f). Institutions that period of less than 60 days after the Guidelines for Appeals of Material dispute their risk assignment—or SARC met in which the Committee was Supervisory Determinations and the dispute any determination for which to issue a decision in cases where no Guidelines for Appeals of Deposit review may be requested as provided in oral presentation was held. To clarify Insurance Assessment Determinations Part 327—may request review by the decisional deadline for the as set forth below. following the procedures set forth at 12 Committee, the prior language has been CFR 327.4(c). amended to provide that, whether or not Guidelines for Appeals of Material The AAC provides a process for oral presentation has been held, the Supervisory Determinations considering all deposit insurance SARC will issue a decision ‘‘within 45 A. Introduction assessment appeals brought from days from the date the SARC meets to determinations made by the appropriate consider the appeal, which meeting will Section 309(a) of the Riegle FDIC divisions pursuant to 12 CFR be held within 90 days from the date of Community Development and 327.3(f) and 327.4(c). Having complied the filing of the appeal.’’ Regulatory Improvement Act of 1994 with those procedures and received a At various places throughout both the (Pub. L. 103–325, 108 Stat. 2160) determination from the appropriate SARC Guidelines and AAC Guidelines, (‘‘Riegle Act’’) required the Federal division, an institution dissatisfied with minor modifications of language are Deposit Insurance Corporation (‘‘FDIC’’) that division’s determination may file made to standardize references to FDIC to establish an independent intra-agency an appeal with the AAC. After divisions and FDIC officials who are appellate process to review material reviewing the determination made at the charged with carrying out the appeals supervisory determinations made at division level, the AAC will issue a final processes. In addition, where the FDIC’s insured depository institutions that it decision. regulations have been amended since supervises. The Guidelines for Appeals The AAC Guidelines were the AAC Guidelines were promulgated, of Material Supervisory Determinations promulgated by the FDIC on July 2, the current regulatory citations have (‘‘guidelines’’) describe the types of 2004, following notice and comment been provided. determinations that are eligible for rulemaking. (69 FR 41479 (July 9, Paragraph E of the AAC Guidelines review and the process by which 2004)). Although the FDIC considered it (Appeal to the AAC) provides that a appeals will be considered and decided. desirable in that instance to garner division director may, with the approval The procedures set forth in these comments regarding the AAC of the Chairperson of the AAC, transfer guidelines establish an appeals process Guidelines, notice and comment a request for review or request for for the review of material supervisory rulemaking was not required, and the revision directly to the AAC if the determinations by the Supervision FDIC pointed out that notice and director lacks delegated authority to Appeals Review Committee (‘‘SARC’’). grant relief. In order to further facilitate comment rulemaking need not be B. SARC Membership employed in making future the prompt resolution of such requests amendments. Notice and comment for review or requests for revision, a The following individuals comprise rulemaking was not employed in mechanism through which a division the three (3) voting members of the making the present amendments. director may seek guidance from the SARC: (1) One inside FDIC Board AAC Chairperson has been added to member, either the Chairperson, the Amendments to the Guidelines Paragraph E, which conforms to similar, Vice Chairperson, or the FDIC Director The SARC Guidelines provide that current language at Paragraph G of the (Appointive), as designated by the FDIC following an institution’s filing of a SARC Guidelines. In addition, both Chairperson (this person would serve as
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the Chairperson of the SARC); and (2) (l) Truth in Lending (Regulation Z) notice of intent to pursue formal one deputy or special assistant to each restitution; enforcement remedies. of the inside FDIC Board members who (m) Filings made pursuant to 12 CFR E. Good-Faith Resolution are not designated as the SARC 303.11(f), for which a Request for Chairperson. The General Counsel is a Reconsideration has been granted, other An institution should make a good- non-voting member of the SARC. The than denials of a change in bank control, faith effort to resolve any dispute FDIC Chairperson may designate change in senior executive officer or concerning a material supervisory alternate member(s) to the SARC if there board of directors, or denial of an determination with the on-site examiner are vacancies so long as the alternate application pursuant to section 19 of the and/or the appropriate Regional Office. member was not involved in making or FDI Act (which are contained in 12 CFR The on-site examiner and the Regional affirming the material supervisory 308, subparts D, L, and M, respectively), Office will promptly respond to any determination under review. A member if the filing was originally denied by the concerns raised by an institution of the SARC may designate and Director, Deputy Director, or Associate regarding a material supervisory authorize the most senior member of his Director of the Division of Supervision determination. Informal resolution of or her staff within the substantive area and Consumer Protection; and disputes with the on-site examiner and/ of responsibility related to cases before (n) Any other supervisory or the appropriate Regional Office is the SARC to act on his or her behalf. determination (unless otherwise not encouraged, but seeking such a C. Institutions Eligible To Appeal eligible for appeal) that may impact the resolution is not a condition to filing a capital, earnings, operating flexibility, request for review with the Division of The guidelines apply to the insured or capital category for prompt corrective Supervision and Consumer Protection depository institutions that the FDIC action purposes of an institution, or supervises (i.e., insured State or an appeal to the SARC under these otherwise affect the nature and level of guidelines. nonmember banks and insured branches supervisory oversight accorded an of foreign banks) and also to other institution. F. Filing a Request for Review With the insured depository institutions with Material supervisory determinations FDIC Division of Supervision and respect to which the FDIC makes do not include: Consumer Protection material supervisory determinations. (a) Decisions to appoint a conservator An institution may file a request for D. Determinations Subject To Appeal or receiver for an insured depository review of a material supervisory An institution may appeal any institution; determination with the Director, material supervisory determination (b) Decisions to take prompt Division of Supervision and Consumer pursuant to the procedures set forth in corrective action pursuant to section 38 Protection (‘‘Director’’ or ‘‘Division these guidelines. Material supervisory of the Federal Deposit Insurance Act, 12 Director’’), 550 17th Street, NW., Room determinations include: U.S.C. 1831o; F–4076, Washington, DC 20429, within (a) CAMELS ratings under the (c) Determinations for which other 60 calendar days following the Uniform Financial Institutions Rating appeals procedures exist (such as institution’s receipt of a report of System; determinations of deposit insurance examination containing a material (b) IT ratings under the Uniform assessment risk classifications and supervisory determination or other Interagency Rating System for Data payment calculations); written communication of a material Processing Operations; (d) Decisions to initiate informal supervisory determination. A request for (c) Trust ratings under the Uniform enforcement actions (such as review must be in writing and must Interagency Trust Rating System; memoranda of understanding); and include: (d) CRA ratings under the Revised (e) Formal enforcement-related (a) A detailed description of the issues Uniform Interagency Community actions and decisions, including in dispute, the surrounding Reinvestment Act Assessment Rating determinations and the underlying facts circumstances, the institution’s position System; and circumstances that form the basis of regarding the dispute and any (e) Consumer compliance ratings a recommended or pending formal arguments to support that position under the Uniform Interagency enforcement action, and FDIC (including citation of any relevant Consumer Compliance Rating System; determinations regarding compliance statute, regulation, policy statement, or (f) Registered transfer agent with an existing formal enforcement other authority), how resolution of the examination ratings; action. (g) Government securities dealer dispute would materially affect the A formal enforcement-related action examination ratings; institution, and whether a good-faith (h) Municipal securities dealer or decision commences, and therefore effort was made to resolve the dispute examination ratings; becomes unappealable, when the FDIC with the on-site examiner and the (i) Determinations relating to the initiates a formal investigation under 12 Regional Office; and U.S.C. 1820(c) or provides written adequacy of loan loss reserve (b) A statement that the institution’s provisions; notice to the bank indicating its board of directors has considered the (j) Classifications of loans and other intention to pursue available formal merits of the request and authorized that assets in dispute the amount of which, enforcement remedies under applicable individually or in the aggregate, exceeds statutes or published enforcement- it be filed. 10 percent of an institution’s total related policies of the FDIC, including The Division Director will issue a capital; written notice of a referral to the written determination of the request for (k) Determinations relating to Attorney General or a notice to the review, setting forth the grounds for that violations of a statute or regulation that Secretary of Housing and Urban determination, within 45 days of receipt may impact the capital, earnings, or Development for violations of the Equal of the request. No appeal to the SARC operating flexibility of an institution, or Credit Opportunity Act or the Fair will be allowed unless an institution has otherwise affect the nature and level of Housing Act. For the purposes of these first filed a timely request for review supervisory oversight accorded an guidelines, remarks in a Report of with the Division of Supervision and institution; Examination do not constitute written Consumer Protection.
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G. Appeal to the SARC process shall create any discovery or be redacted to avoid disclosure of other such rights. exempt information. In cases where An institution that does not agree redaction is deemed to be insufficient to J. Burden of Proof with the written determination rendered prevent improper disclosure, published by the Division Director must appeal The burden of proof as to all matters decisions may be presented in summary that determination to the SARC within at issue in the appeal, including form. Published SARC decisions may be 30 calendar days from the date of that timeliness of the appeal if timeliness is cited as precedent in appeals to the determination. The Director’s at issue, rests with the institution. SARC. determination will inform the institution of the 30-day time period for K. Oral Presentation O. SARC Guidelines Generally filing with the SARC and will provide The SARC may, in its discretion, Appeals to the SARC will be governed the mailing address for any appeal the whether or not a request is made, by these guidelines. The SARC will institution may wish to file. Failure to determine to allow an oral presentation. retain the discretion to waive any file within the 30-day time limit may The SARC generally grants a request for provision of the guidelines for good result in denial of the appeal by the oral presentation if it determines that cause; the SARC may adopt SARC. If the Division Director oral presentation is likely to be helpful supplemental rules governing SARC recommends that an institution receive or would otherwise be in the public operations; the SARC may order that relief that the Director lacks delegated interest. Notice of the SARC’s material be kept confidential; and the authority to grant, the Director may, determination to grant or deny a request SARC may consolidate similar appeals. with the approval of the Chairperson of for oral presentation will be provided to the SARC, transfer the matter directly to the institution. If oral presentation is P. Limitation on Agency Ombudsman the SARC without issuing a held, the institution will be allowed to The subject matter of a material determination. Notice of such a transfer present its positions on the issues raised supervisory determination for which will be provided to the institution. The in the appeal and to respond to any either an appeal to the SARC has been Division Director may also request questions from the SARC. The SARC filed or a final SARC decision issued is guidance from the SARC Chairperson as may also require that FDIC staff not eligible for consideration by the to procedural or other questions relating participate as the SARC deems Ombudsman. to any request for review. appropriate. Q. Coordination With State Regulatory H. Filing With the SARC L. Dismissal, Withdrawal and Rejection Authorities An appeal to the SARC will be An appeal may be dismissed by the In the event that a material considered filed if the written appeal is SARC if it is not timely filed, if the basis supervisory determination subject to a received by the FDIC within 30 calendar for the appeal is not discernable from request for review is the joint product of days from the date of the Division the appeal, or if the institution moves to the FDIC and a State regulatory Director’s written determination or if withdraw the appeal. An appeal may be authority, the Director, Division of the written appeal is placed in the U.S. rejected if the right to appeal has been Supervision and Consumer Protection, mail within that 30-day period. If the cut off under Section D, above. will promptly notify the appropriate State regulatory authority of the request, 30th day after the date of the Division M. Scope of Review and Decision Director’s written determination is a provide the regulatory authority with a The SARC will review the appeal for copy of the institution’s request for Saturday, Sunday, or Federal holiday, consistency with the policies, practices filing may be made on the next business review and any other related materials, and mission of the FDIC and the overall and solicit the regulatory authority’s day. The appeal should be sent to the reasonableness of and the support address indicated on the Division views regarding the merits of the request offered for the positions advanced, and before making a determination. In the Director’s determination being notify the institution, in writing, of its appealed. event that an appeal is subsequently decision concerning the disputed filed with the SARC, the SARC will I. Contents of Appeal material supervisory determination(s) notify the institution and the State within 45 days from the date the SARC regulatory authority of its decision. The appeal should be labeled to meets to consider the appeal, which Once the SARC has issued its indicate that it is an appeal to the SARC meeting will be held within 90 days determination, any other issues that and should contain the name, address, from the date of the filing of the appeal. may remain between the institution and and telephone number of the institution SARC review will be limited to the facts the State authority will be left to those and any representative, as well as a and circumstances as they existed prior parties to resolve. copy of the Division Director’s to or at the time the material determination being appealed. If oral supervisory determination was made, R. Effect on Supervisory or Enforcement presentation is sought, that request even if later discovered, and no Actions should be included in the appeal. Only consideration will be given to any facts The use of the procedures set forth in matters previously reviewed at the or circumstances that occur or these guidelines by any institution will division level, resulting in a written corrective action taken after the not affect, delay, or impede any formal determination or direct referral to the determination was made. The SARC or informal supervisory or enforcement SARC, may be appealed to the SARC. may reconsider its decision only on a action in progress or affect the FDIC’s Evidence not presented for review to the showing of an intervening change in the authority to take any supervisory or Division Director may be submitted to controlling law or the availability of enforcement action against that the SARC only if authorized by the material evidence not reasonably institution. SARC Chairperson. The institution available when the decision was issued. should set forth all of the reasons, legal S. Effect on Applications or Requests for and factual, why it disagrees with the N. Publication of Decisions Approval Division Director’s determination. SARC decisions will be published, Any application or request for Nothing in the SARC administrative and the published SARC decisions will approval made to the FDIC by an
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institution that has appealed a material part 327—must comply with the time determinations made pursuant to 12 supervisory determination that relates to limits and other filing requirements set CFR 327.3(f) by the Director of the or could affect the approval of the forth at 12 CFR 327.4(c). Generally, an Division of Finance regarding the application or request will not be institution may request review within computation of the institution’s considered until a final decision 90 days from the date it receives notice assessment payment and renders a final concerning the appeal is made unless of its risk assignment or other disputed determination. determination from the FDIC. The AAC otherwise requested by the institution. E. Appeal to the AAC provides a process for considering all T. Prohibition on Examiner Retaliation deposit insurance assessment appeals An institution that does not agree The FDIC has an experienced brought from determinations made by with the written determination rendered examination workforce and is proud of the appropriate FDIC divisions pursuant by the appropriate Division Director its professionalism and dedication. to 12 CFR 327.3(f) and 327.4(c). The pursuant to 12 CFR 327.4(c) and 327.3(f) FDIC policy prohibits any retaliation, procedures set forth in these guidelines must appeal that determination to the abuse, or retribution by an agency apply to all appeals to the AAC. AAC within 30 calendar days from the examiner or any FDIC personnel against date of the determination. The division B. AAC Membership an institution. Such behavior against an director’s determination will inform the institution that appeals a material The following individuals comprise institution of the 30-day time limit for supervisory determination constitutes the five (5) voting members of the AAC, filing with the AAC and will provide unprofessional conduct and will subject representing each member of the FDIC the mailing address for any appeal the the examiner or other personnel to Board of Directors: (1) One inside FDIC institution may wish to file. Failure to appropriate disciplinary or remedial Board member, either the Vice file within the 30-day time period may action. Institutions that believe they Chairperson or the Director result in denial of the appeal by the have been retaliated against are (Appointive), as designated by the FDIC AAC. encouraged to contact the Regional Chairperson (this person would serve as If a Division Director recommends Director for the appropriate FDIC region. Chairperson of the AAC); (2) one of the that an institution receive relief that the Any institution that believes or has any deputies or special assistants to the Director lacks delegated authority to evidence that it has been subject to FDIC Chairperson, to be designated by grant, the Director may, with the retaliation may file a complaint with the the FDIC Chairperson; (3) a deputy or approval of the Chairperson of the AAC, Director, Office of the Ombudsman, special assistant to the Office of the transfer the matter directly to the AAC Federal Deposit Insurance Corporation, Comptroller of the Currency’s member without issuing a determination. Notice 550 17th Street, Washington, DC 20429, on the FDIC’s Board of Directors; (4) a of such a transfer will be provided to the explaining the circumstances and the deputy or special assistant to the Office institution. A Division Director may also basis for such belief or evidence and of Thrift Supervision’s member on the request guidance from the AAC requesting that the complaint be FDIC’s Board of Directors; and (5) a Chairperson as to procedural or other investigated and appropriate deputy or special assistant to either the questions relating to any request for disciplinary or remedial action taken. Vice Chairperson or the inside Director revision or request for review. (Appointive), whoever is not the AAC The Office of the Ombudsman will work F. Filing With the AAC with the Division of Supervision and Chairperson. The General Counsel is a An appeal to the AAC will be Consumer Protection to resolve the non-voting member of the AAC. The considered filed if the written appeal is allegation of retaliation. FDIC Chairperson may designate alternative member(s) for the AAC if received by the FDIC within 30 calendar Guidelines for Appeals of Deposit vacancies occur. A member of the AAC days from the date of the Division Insurance Assessment Determinations may designate and authorize the most Director’s written determination or if the written appeal is placed in the U.S. A. Introduction senior member of his or her staff within the substantive area of responsibility mail within that 30-day period. If the The Assessment Appeals Committee related to cases before the AAC to act on 30th day after the date of the Division (‘‘AAC’’) was formed in 1999 and, his or her behalf. Director’s written determination is a pursuant to the direction of the FDIC Saturday, Sunday or Federal holiday, Board of Directors, has been functioning C. Institutions Eligible to Appeal filing may be made on the next business as the appellate entity responsible for These guidelines apply to all day. The appeal should be sent to the making final determinations pursuant to depository institutions insured by the address indicated on the determination Part 327 of the FDIC’s regulations FDIC. being appealed. regarding the assessment risk assignment, the assessment payment D. Determinations Subject to Appeal G. Contents of Appeal computation, and other related The AAC, upon appeal by an insured The appeal should be labeled to assessment determinations affecting depository institution, reviews indicate that it is an appeal to the AAC insured depository institutions. determinations of the Director of the and should contain the name, address, Institutions that dispute the Division of Insurance and Research or and telephone number of the institution computation of their quarterly the Director of the Division of and any representative, as well as a assessment payments must comply with Supervision and Consumer Protection copy of the determination being the time limits and other filing made pursuant to the procedures set appealed. If oral presentation is sought, requirements set forth at 12 CFR forth at 12 CFR 327.4(c) regarding the that request should be included in the 327.3(f). Generally, any such request assessment risk assignment provided by appeal. Only matters previously may be made within 90 days of the the FDIC to the institution—or any reviewed at the division level, resulting quarterly assessment invoice for which determination for which review may be in either a written determination or a a revision is requested. Institutions that requested as provided in Part 327—and direct referral to the AAC, may be dispute their risk assignment—or renders a final determination. The AAC appealed to the AAC. Evidence not dispute any determination for which also, upon appeal by an insured presented for review at the division review may be requested as provided in depository institution, reviews level may be submitted to the AAC only
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if authorized by the AAC Chairperson. the date the appeal is filed, or within 60 FEDERAL DEPOSIT INSURANCE The institution should set forth all of days from oral presentation, if held. The CORPORATION the reasons, legal and factual, why it AAC may reconsider its decision only disagrees with the determination. on a showing of an intervening change Update to Notice of Financial Nothing in the AAC administrative in the controlling law or the availability Institutions for Which the Federal process shall create any discovery or of material evidence not reasonably Deposit Insurance Corporation Has other such rights. available when the decision was issued. Been Appointed Either Receiver, H. Burden of Proof L. Publication of Decisions Liquidator, or Manager The burden of proof as to all matters AAC decisions will be published and AGENCY: Federal Deposit Insurance at issue in the appeal, including the published AAC decisions will be Corporation. timeliness of the appeal if timeliness is redacted to avoid disclosure of exempt at issue, rests with the institution. information. In cases where redaction is ACTION: Update Listing of financial institutions in liquidation. I. Oral Presentation deemed to be insufficient to prevent improper disclosure, published The AAC may, in its discretion, decisions may be presented in summary SUMMARY: Notice is hereby given that whether or not a request is made, form. Published decisions of the AAC the Federal Deposit Insurance determine to allow an oral presentation. may be cited as precedent in appeals to Corporation (Corporation) has been The AAC generally grants a request for the AAC. appointed the sole receiver for the oral presentation if it determines that following financial institutions effective oral presentation is likely to be helpful M. AAC Guidelines Generally as of the Date Closed as indicated in the or would otherwise be in the public Appeals to the AAC will be governed listing. This list (as updated from time interest. Notice of the AAC’s by these guidelines. The AAC will to time in the Federal Register) may be determination to grant or deny a request retain the discretion to waive any ‘‘ ’’ for oral presentation will be provided to provision of the guidelines for good relied upon as of record notice that the the institution. If oral presentation is cause; the AAC may adopt Corporation has been appointed receiver held, the institution will be allowed to supplemental rules governing AAC for purposes of the statement of policy present its position on the issues raised operations; the AAC may order that published in the July 2, 1992 issue of in the appeal and to respond to any material be kept confidential; and the the Federal Register (57 FR 29491). For questions from the AAC. The AAC may AAC may consolidate similar appeals. further information concerning the also require that FDIC staff participate identification of any institutions which as the AAC deems appropriate. N. Effect on Deposit Insurance have been placed in liquidation, please Assessment Payments J. Dismissal and Withdrawal visit the Corporation Web site at http:// The use of the procedures set forth in www.fdic.gov/bank/individual/failed/ An appeal may be dismissed by the these guidelines by an insured banklist.html or contact the Manager of AAC if it is not timely filed, if the legal institution will not affect, delay, or Receivership Oversight in the or factual basis for the appeal is not impede the obligation of that institution appropriate service center. discernable from the appeal, or if the to make timely payment of any deposit institution moves to withdraw the insurance assessment. Dated: April 13, 2010. Federal Deposit appeal. Insurance Corporation. By order of the Board of Directors. Robert Feldman, K. Scope of Review and Decision Dated at Washington, DC, this 13th day of Executive Secretary. The AAC will review all submissions April 2010. concerning an appeal, review the final Federal Deposit Insurance Corporation. Institutions in Liquidation (In determination being appealed, consider Robert E. Feldman, alphabetical order) any other matters it deems in its Executive Secretary. discretion to be appropriate, and issue [FR Doc. 2010–8923 Filed 4–16–10; 8:45 am] a written decision within 60 days from BILLING CODE 6714–01–P
FDIC ref. no. Bank Name City State Date closed
10209 ...... Beach First National Bank ...... Myrtle Beach ...... SC ...... 4/09/2010
[FR Doc. 2010–8918 Filed 4–16–10; 8:45 am] ACTION: Notice. The standard is available on the BILLING CODE 6714–01–P FASAB home page http:// Board Action: Pursuant to 31 U.S.C. www.fasab.gov/standards.html. Copies 3511(d), the Federal Advisory can be obtained by contacting FASAB at FEDERAL ACCOUNTING STANDARDS Committee Act (Pub. L. 92–463), as (202) 512–7350. ADVISORY BOARD amended, and the FASAB Rules of FOR FURTHER INFORMATION CONTACT: Procedure, as amended in April, 2004, Notice of Issuance of Statement of Wendy Payne, Executive Director, at notice is hereby given that the Federal (202) 512–7350. Federal Financial Accounting Standard Accounting Standards Advisory Board 38, Accounting for Federal Oil and Gas (FASAB) has issued Statement of Authority: Federal Advisory Committee Resources Federal Financial Accounting Standard Act, Pub. L. 92–463. AGENCY: Federal Accounting Standards 38, Accounting for Federal Oil and Gas Advisory Board Resources.
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Dated: April 14, 2010. Dated: April 13, 2010. Board of Governors of the Federal Reserve Charles Jackson, Charles Jackson, System, April 14, 2010. Federal Register Liaison Officer. Federal Register Liaison Officer. Robert deV. Frierson, [FR Doc. 2010–8966 Filed 4–16–10; 8:45 am] [FR Doc. 2010–8832 Filed 4–16–10; 8:45 am] Deputy Secretary of the Board. [FR Doc. 2010–8950 Filed 4–16–10; 8:45 am] BILLING CODE 1610–02–P BILLING CODE 1610–02–P BILLING CODE 6210–01–S
FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD FEDERAL RESERVE SYSTEM GENERAL SERVICES ADMINISTRATION Notice of Meeting Schedule for 2011 Formations of, Acquisitions by, and [Wildlife Order 187; 4–D–FL–1218] AGENCY: Federal Accounting Standards Mergers of Bank Holding Companies Advisory Board. Public Buildings Service; Key Largo The companies listed in this notice Beacon Annex Site; Key Largo, FL; ACTION: Notice. have applied to the Board for approval, Transfer of Property pursuant to the Bank Holding Company Board Action: Pursuant to 31 U.S.C. Act of 1956 (12 U.S.C. 1841 et seq.) Pursuant to section 2 of Public Law 3511(d), the Federal Advisory (BHC Act), Regulation Y (12 CFR Part 537, 80th Congress, approved May 19, Committee Act (Pub. L. 92–463), as 225), and all other applicable statutes 1948 (16 U.S.C. 667c), notice is hereby amended, and the FASAB Rules of given that: and regulations to become a bank Procedure, as amended in April, 2004, 1. The General Services holding company and/or to acquire the notice is hereby given that the Federal Administration transferred 4.2 acres of Accounting Standards Advisory Board assets or the ownership of, control of, or land and improvements, identified as (FASAB) will meet on the following the power to vote shares of a bank or Key Largo Beacon Annex Site, Key dates in room 7C13 of the US bank holding company and all of the Largo, FL to the U.S. Fish and Wildlife Government Accountability Office banks and nonbanking companies Service, Department of the Interior by (GAO) Building (441 G St., NW.) unless owned by the bank holding company, transfer letter dated August 17, 2004. otherwise noted: including the companies listed below. 2. The above property was conveyed —Wednesday and Thursday, February The applications listed below, as well for wildlife conservation in accordance 23 and 24, 2011 as other related filings required by the with the provisions of section 1 of —Wednesday and Thursday, April 27 Board, are available for immediate Public Law 80–537 (16 U.S.C. 667b), as and 28, 2011 inspection at the Federal Reserve Bank amended by Public Law 92–432. FOR FURTHER INFORMATION CONTACT: —Wednesday and Thursday, June 22 indicated. The applications also will be Mr. and 23, 2011 available for inspection at the offices of Rob Miller, Director of the Real Property the Board of Governors. Interested Disposal Division (4PZ), by phone on —Wednesday and Thursday, August 24 persons may express their views in (404) 331–5133. and 25, 2011 writing on the standards enumerated in Dated: April 6, 2010. —Wednesday and Thursday, October 26 the BHC Act (12 U.S.C. 1842(c)). If the Gordon S. Creed, and 27, 2011 proposal also involves the acquisition of —Monday and Tuesday, December 19 Acting Deputy Assistant Commissioner, a nonbanking company, the review also Office of Real Property Utilization & Disposal. and 20, 2011 includes whether the acquisition of the [FR Doc. 2010–8986 Filed 4–16–10; 8:45 am] The purpose of the meetings are to nonbanking company complies with the BILLING CODE 6820–96–P discuss issues related to: standards in section 4 of the BHC Act —FASAB’s conceptual framework (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be —Earmarked Funds DEPARTMENT OF HEALTH AND conducted throughout the United States. HUMAN SERVICES —Property, Plant and Equipment Additional information on all bank —Natural Resources holding companies may be obtained Office of the Secretary —Deferred Maintenance/Asset from the National Information Center Impairment website at www.ffiec.gov/nic/. Statement of Organization, Functions, and Delegations of Authority —Technical Agenda, and Unless otherwise noted, comments —Any other topics as needed. regarding each of these applications Part A, Office of the Secretary, Any interested person may attend the must be received at the Reserve Bank Statement of Organization, Functions, meetings as an observer. Board indicated or the offices of the Board of and Delegations of Authority for the discussion and reviews are open to the Governors not later than May 14, 2010. Department of Health and Human public. GAO Building security requires A. Federal Reserve Bank of Dallas (E. Services (HHS), as last amended at 70 advance notice of your attendance. Ann Worthy, Vice President) 2200 FR 48718, dated August 19, 2005, and Chapter AA, Immediate Office of the Please notify FASAB of your planned North Pearl Street, Dallas, Texas 75201– Secretary, as last amended at 70 FR attendance by calling 202–512–7350 at 2272: least one day prior to the respective 48718, dated August 19, 2005, are being meeting. 1. Hometown Community Bancorp, amended to establish a new chapter, Inc. Employee Stock Ownership Plan & Chapter AU, ‘‘Office of Consumer FOR FURTHER INFORMATION CONTACT: Trust, and Hometown Community Information and Insurance Oversight,’’ Wendy Payne, Executive Director, at Bancorp, Inc., both in Morton, Illinois; in the Office of the Secretary. The (202) 512–7350. to merge with TSB Financial, Inc., and changes are as follows: Authority: Federal Advisory Committee thereby indirectly acquire Tremont I. Under Part A, Chapter AA, Section Act, Pub. L. 92–463. Savings Bank, both in Tremont, Illinois. AA.10 Organization, insert the
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following: ‘‘Office of Consumer temporary high-risk pool programs and be collected; and (4) the use of Information and Insurance Oversight associated funding to states and the automated collection techniques or (AU).’’ early retiree reinsurance program. other forms of information technology to II. Under Part A, establish a new D. Office of Consumer Support (AUD). minimize the information collection Chapter AU, ‘‘Office of Consumer The Office of Consumer Support is burden. Information and Insurance Oversight’’ to headed by a Deputy Director, who 1. Type of Information Collection read as follows: reports to the Director of the Office of Request: Revision of a currently Consumer Information and Insurance approved collection; Title of Chapter AU, Office of Consumer Oversight. The Office’s responsibilities Information Collection: Medicare Information and Insurance Oversight include: (1) Collecting, compiling and Prescription Drug Benefit Plan; Use: Section AU.00 Mission maintaining comparative pricing data Section 101 of Title I of the Medicare Prescription Drug, Improvement, and Section AU.10 Organization for the Department’s Web site; (2) providing assistance to enable Modernization Act of 2003 added Section AU.20 Functions consumers to obtain maximum benefit sections 1860D–1 through D–42 to Section AU.00 Mission. The Office from the new health insurance system; establish this new program. Part D plans of Consumer Information and Insurance and (3) establishing and issuing use the information discussed to comply Oversight provides leadership for consumer assistance grants to states. with the eligibility and associated Part implementing the provisions of the E. Office of Health Insurance D participating requirements. CMS will use this information to approve contract health reform bill that address private Exchanges (AUE). The Office of Health applications, monitor compliance with health insurance. Insurance Exchanges is headed by a contract requirements, make proper Section AU.10 Organization. The Deputy Director, who reports to the payment to plans, and to ensure that Office of Consumer Information and Director of the Office of Consumer correct information is disclosed to Insurance Oversight is under the Information and Insurance Oversight. enrollees, both potential enrollees and direction of a Director, who reports to The Office’s responsibilities include: (1) enrollees. Form Number: CMS–10141 the Secretary, and consists of the Developing and implementing policies (OMB#: 0938–0964); Frequency: Yearly; following components: and rules governing state-based Affected Public: Individuals and • Office of the Director (AUA) exchanges; (2) establishing and issuing households, and Business or other for- • Office of Oversight (AUB) planning grants to states; and (3) • overseeing the operations of exchanges. profit and Not-for-profit institutions; Office of Insurance Programs (AUC) Number of Respondents: 19,937,660; • Office of Consumer Support (AUD) Dated: April 14, 2010. • Total Annual Responses: 43,153,271; Office of Health Insurance Kathleen Sebelius, Total Annual Hours: 36,520,101. (For Exchanges (AUE) Secretary. policy questions regarding this Section AU.20 Functions. [FR Doc. 2010–8949 Filed 4–16–10; 8:45 am] collection contact Christine Hinds at A. Office of the Director (AUA). The BILLING CODE 4150–03–P 410–786–4578. For all other issues call Office of the Director is headed by the 410–786–1326.) Director of the Office of Consumer 2. Type of Information Collection Information and Insurance Oversight, DEPARTMENT OF HEALTH AND Request: Revision of a currently who provides executive direction, HUMAN SERVICES approved collection; Title of leadership, and support to the entire Information Collection: Consumer Office. The Director is responsible for Centers for Medicare & Medicaid Assessment of Health Care Providers carrying out the Office’s mission and Services and Systems (CAHPS); Use: CMS is implementing the functions of the required to collect and report Office of Consumer Information and [Document Identifier: CMS–10141, CMS–R– 246, CMS–10305 and CMS–10313] information on the quality of health care Insurance Oversight. The Office is services and prescription drug coverage comprised of organizational Agency Information Collection available to persons enrolled in a components with responsibilities that Activities: Proposed Collection; Medicare health or prescription drug include planning, evaluation, regulatory Comment Request plan under provisions in the Medicare affairs, external relations, and Prescription Drug, Improvement, and administrative management. AGENCY: Centers for Medicare & Modernization Act of 2003 (MMA). B. Office of Oversight (AUB). The Medicaid Services, HHS. Specifically, the MMA under Sec. Office of Oversight is headed by a In compliance with the requirement 1860D–4 (Information to Facilitate Deputy Director, who reports to the of section 3506(c)(2)(A) of the Enrollment) requires CMS to conduct Director of the Office of Consumer Paperwork Reduction Act of 1995, the consumer satisfaction surveys regarding Information and Insurance Oversight. Centers for Medicare & Medicaid Medicare prescription drug plans and The Office’s responsibilities include: (1) Services (CMS) is publishing the Medicare Advantage plans and report Implementing, monitoring compliance following summary of proposed this information to Medicare with, and enforcing both the new rules collections for public comment. beneficiaries prior to the Medicare governing the insurance market and the Interested persons are invited to send annual enrollment period. The Medicare new rules regarding medical loss ratios; comments regarding this burden CAHPS survey meets the requirement of (2) performing rate reviews; and (3) estimate or any other aspect of this collecting and publicly reporting issuing rate review grants to states. collection of information, including any consumer satisfaction information. C. Office of Insurance Programs of the following subjects: (1) The Form Number: CMS–R–246 (OMB#: (AUC). The Office of Insurance necessity and utility of the proposed 0938–0732); Frequency: Yearly; Affected Programs is headed by a Deputy information collection for the proper Public: Individuals and households, and Director, who reports to the Director of performance of the agency’s functions; Business or other for-profit and Not-for- the Office of Consumer Information and (2) the accuracy of the estimated profit institutions; Number of Insurance Oversight. The Office is burden; (3) ways to enhance the quality, Respondents: 567,324; Total Annual responsible for administering both the utility, and clarity of the information to Responses: 567,324; Total Annual
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Hours: 242,376. (For policy questions at http://www.cms.hhs.gov/ performance of the agency’s functions; regarding this collection contact PaperworkReductionActof1995, or (2) the accuracy of the estimated Elizabeth Goldstein at 410–786–6665. E-mail your request, including your burden; (3) ways to enhance the quality, For all other issues call 410–786–1326.) address, phone number, OMB number, utility, and clarity of the information to 3. Type of Information Collection and CMS document identifier, to be collected; and (4) the use of Request: New collection; Title of [email protected], or call the automated collection techniques or Information Collection: Medicare Part C Reports Clearance Office on (410) 786– other forms of information technology to and Part D Data Validation (42 CFR 1326. minimize the information collection 422.516g and 423.514g); Use: In commenting on the proposed burden. Organizations contracted to offer information collections please reference 1. Type of Information Collection Medicare Part C and Part D benefits are the document identifier or OMB control Request: Revision of a currently required to report data to the Centers for number. To be assured consideration, approved collection; Title of Medicare & Medicaid Services on a comments and recommendations must Information Collection: Annual Early variety of measures. In order for the data be submitted in one of the following and Periodic Screening, Diagnostic and to be useful for monitoring and ways by June 18, 2010: Treatment (EPSDT) Services performance measurement, the data 1. Electronically. You may submit Participation Report; Form Number: must be reliable, valid, complete, and your comments electronically to http:// CMS–416 (OMB#: 0938–0354); Use: comparable among sponsoring www.regulations.gov. Follow the States are required to submit an annual organizations. To meet this goal, CMS is instructions for ‘‘Comment or report on the provision of EPSDT developing reporting standards and data Submission’’ or ‘‘More Search Options’’ services pursuant to section validation specifications with respect to to find the information collection 1902(a)(43)(D) of the Social Security the Part C and Part D reporting document(s) accepting comments. Act. These reports provide CMS with requirements. These standards will 2. By regular mail. You may mail data necessary to assess the provide a review process for Medicare written comments to the following effectiveness of State EPSDT programs, Advantage Organizations (MAOs), Cost address: CMS, Office of Strategic to determine a State’s results in Plans, and Part D sponsors to use to Operations and Regulatory Affairs, achieving its participation goal and to conduct data validation checks on their Division of Regulations Development, respond to inquiries. Respondents are reported Part C and Part D data. Form Attention: Document Identifier/OMB State Medicaid Agencies. The data is Number: CMS–10305 (OMB#: 0938– Control Number, Room C4–26–05, 7500 due April 1 of every year so States need NEW); Frequency: Yearly; Affected Security Boulevard, Baltimore, to have the form and instructions as Public: Business or other for-profit; Maryland 21244–1850. soon as possible in order to report Number of Respondents: 710; Total timely. Frequency: Yearly; Affected Annual Responses: 710; Total Annual Dated: April 13, 2010. Public: State, Tribal and Local Hours: 231,410. (For policy questions Michelle Shortt, governments; Number of Respondents: regarding this collection contact Terry Director, Regulations Development Group, 56; Total Annual Responses: 112; Total Lied at 410–786–8973. For all other Office of Strategic Operations and Regulatory Annual Hours: 1,568. (For policy issues call 410–786–1326.) Affairs. questions regarding this collection 4. Type of Information Collection [FR Doc. 2010–8958 Filed 4–16–10; 8:45 am] contact Cindy Ruff at 410–786–5916. Request: New collection; Title of BILLING CODE 4120–01–P For all other issues call 410–786–1326.) Information Collection: New Quality 2. 1. Type of Information Collection Measures for Medicare Advantage Request: Extension of a currently Organizations; Use: For CMS to DEPARTMENT OF HEALTH AND approved collection; Title of strengthen the oversight of quality HUMAN SERVICES Information Collection: Request for improvement programs implemented by Employment Information; Use: Section Medicare Advantage organizations, Centers for Medicare & Medicaid 1837(i) of the Social Security Act there is a need to collect additional data Services provides for a special enrollment period on quality and outcomes measures in [Document Identifier: CMS–416 and CMS– for individuals who delay enrolling in order to better track plan performance. R–297] Medicare Part B because they are Examples of additional areas on which covered by a group health plan based on CMS plans to collect data are post- Agency Information Collection their own or a spouse’s current surgical infections or patient falls. Activities: Proposed Collection; employment status. When these Collection will begin during contract Comment Request individuals apply for Medicare Part B, year 2012. The specific data elements they must provide proof that the group that will be collected are currently AGENCY: Centers for Medicare & health plan coverage is (or was) based under development. Form Number: Medicaid Services. on current employment status. This CMS–10313 (OMB#: 0938–NEW); In compliance with the requirement form is used by the Social Security Frequency: Yearly; Affected Public: of section 3506(c)(2)(A) of the Administration to obtain information Business or other for-profit and Not–for- Paperwork Reduction Act of 1995, the from employers regarding whether a profit institutions; Number of Centers for Medicare & Medicaid Medicare beneficiary’s coverage under a Respondents: 624; Total Annual Services (CMS) is publishing the group health plan is based on current Responses: 624; Total Annual Hours: following summary of proposed employment status. Form Number: 624,000. (For policy questions regarding collections for public comment. CMS–R–297 (OMB#: 0938–0787); this collection contact Sabrina Ahmed Interested persons are invited to send Frequency: Once; Affected Public: at 410–786–7499. For all other issues comments regarding this burden Private Sector: Business or other for- call 410–786–1326.) estimate or any other aspect of this profits and Not-for-profit institutions; To obtain copies of the supporting collection of information, including any Number of Respondents: 5,000; Total statement and any related forms for the of the following subjects: (1) The Annual Responses: 5,000; Total Annual proposed paperwork collections necessity and utility of the proposed Hours: 1,250. (For policy questions referenced above, access CMS’ Web site information collection for the proper regarding this collection contact Kevin
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Simpson at 410–786–0017. For all other Interested persons are invited to send Reduction Act (DRA). State Medicaid issues call 410–786–1326.) comments regarding this burden Agencies will complete the SPA pre- To obtain copies of the supporting estimate or any other aspect of this print, and submit it to CMS for a statement and any related forms for the collection of information, including any comprehensive analysis. The pre-print proposed paperwork collections of the following subjects: (1) The contains assurances, check-off items, referenced above, access CMS’ Web Site necessity and utility of the proposed and areas for States to describe policies at http://www.cms.hhs.gov/ information collection for the proper and procedures for subjects such as PaperworkReductionActof1995, or E- performance of the Agency’s function; quality assurance, risk management, and mail your request, including your (2) the accuracy of the estimated voluntary and involuntary address, phone number, OMB number, burden; (3) ways to enhance the quality, disenrollment; Frequency: Reporting— and CMS document identifier, to utility, and clarity of the information to Once; Affected Public: State, Local, or [email protected], or call the be collected; and (4) the use of Tribal Government; Number of Reports Clearance Office on (410) 786– automated collection techniques or Respondents: 56; Total Annual 1326. other forms of information technology to Responses: 20; Total Annual Hours: In commenting on the proposed minimize the information collection 400. (For policy questions regarding this information collections please reference burden. collection contact Carrie Smith at 410– the document identifier or OMB control 1. Type of Information Collection 786–4485. For all other issues call 410– number. To be assured consideration, Request: Extension of a currently 786–1326.) comments and recommendations must approved collection; Title of 3. Type of Information Collection be submitted in one of the following Information Collection: Recovery Act— Request: New collection; Title of ways by June 18, 2010: Reporting Requirements for States Information Collection: Medicare 1. Electronically. You may submit Under FMAP Increase and TMA Gainsharing Demonstration Evaluation: your comments electronically to http:// Provisions; Use: The American Physician Focus Groups; Use: The www.regulations.gov. Follow the Recovery and Reinvestment Act of 2009 proposed physician focus groups are instructions for ‘‘Comment or (Recovery Act), Public Law 111–5, part of an overall evaluation of the Submission’’ or ‘‘More Search Options’’ requires that States submit quarterly Centers for Medicare & Medicaid to find the information collection reports to the Secretary of Health and Services CMS’ congressionally document(s) accepting comments. Human Services in accordance with mandated Medicare Gainsharing 2. By regular mail. You may mail section 5001 Temporary Increase of Demonstration Evaluation. The written comments to the following Medicaid Federal Medical Assistance Congress, under Section 5007 of the address: CMS, Office of Strategic Percentage (FMAP) and section 5004(d) Deficit Reduction Act (DRA) of 2005, Operations and Regulatory Affairs, Extension of Transitional Medical requires CMS to conduct a qualified Division of Regulations Development, Assistance (TMA). The reports under gainsharing program to test alternative Attention: Document Identifier/OMB section 5001 are required for the period ways that hospitals and physicians can Control Number, Room C4–26–05, 7500 of October 1, 2008–September 30, 2011. share in efficiency gains. The primary Security Boulevard, Baltimore, The reports under section 5004 are goal of the demonstration is to evaluate Maryland 21244–1850. required beginning on July 1, 2009 until gainsharing as a means to align Dated: April 9, 2010. the Federal authority for TMA coverage physician and hospital incentives to Michelle Shortt, sunsets (now scheduled to sunset on improve quality and efficiency. The December 31, 2010). Each State demonstration has two mandated Director, Regulations Development Group, Office of Strategic Operations and Regulatory Medicaid agency will submit its Reports to Congress. Results from Affairs. quarterly reports to the appropriate physician focus groups will be included [FR Doc. 2010–8901 Filed 4–16–10; 8:45 am] Regional Office of CMS. The reports will in both Reports to Congress. Form be compiled and summarized for annual Number: CMS–10303 (OMB#: 0938– BILLING CODE 4120–01–P reports to Congress. Form Number: New); Frequency: Once; Affected Public: CMS–10295 (OMB#: 0938–1073); Private Sector, Business or other for DEPARTMENT OF HEALTH AND Frequency: Reporting—Quarterly; profits; Number of Respondents: 192; HUMAN SERVICES Affected Public: State, Local, or Tribal Total Annual Responses: 96; Total Governments; Number of Respondents: Annual Hours: 96. (For policy questions [Document Identifier: CMS–10295, CMS– 50; Total Annual Responses: 200; Total regarding this collection contact 10234, CMS–10303, CMS–10066 and CMS– Annual Hours: 600. (For policy William Buczko at 410–786–6593. For R–193] questions regarding this collection all other issues call 410–786–1326.) Centers for Medicare & Medicaid contact Richard Strauss at 410–786– 4. Type of Information Collection Services 2019. For all other issues call 410–786– Request: Extension of a currently 1326.) approved collection; Title of Agency Information Collection 2. Type of Information Collection Information Collection: Detailed Notice Activities: Submission for OMB Request: Extension of a currently of Discharge (DND); Use: A beneficiary/ Review; Comment Request approved collection; Title of enrollee who wishes to appeal a Information Collection: State Plan Pre- determination by a Medicare health AGENCY: Centers for Medicare & print implementing Section 6087 of the plan or hospital that inpatient care is no Medicaid Services. Deficit Reduction Act: Optional Self- longer necessary, may request Quality In compliance with the requirement Direction Personal Assistance Services Improvement Organization (QIO) review of section 3506(c)(2)(A) of the (PAS) Program (Cash and Counseling); of the determination. On the date the Paperwork Reduction Act of 1995, the Form Number: CMS–10234 (OMB#: QIO receives the beneficiary’s/enrollee’s Centers for Medicare & Medicaid 0938–1024); Use: Information submitted request, it must notify the plan and Services (CMS), Department of Health via the State Plan Amendment (SPA) hospital that the beneficiary/enrollee and Human Services, is publishing the pre-print is used by CMS and Regional has filed a request for an expedited following summary of proposed Offices to analyze a State’s proposal to determination. The plan (for a managed collections for public comment. implement Section 6087 of the Deficit care enrollee) or hospital (for an original
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Medicare beneficiary), in turn, must Responses: 13,218; Total Annual Hours: opportunity for public comment on deliver a detailed notice to the enrollee/ 19,680,000. (For policy questions proposed collections of information, the beneficiary. Form Number: CMS–10066 regarding this collection contact Evelyn Substance Abuse and Mental Health (OMB#: 0938–1019); Frequency: Blaemire at 410–786–1803. For all other Services Administration (SAMHSA) Reporting—Yearly; Affected Public: issues call 410–786–1326.) will publish periodic summaries of Business or other for-profits and Not- To obtain copies of the supporting proposed projects. To request more for-profit institutions; Number of statement and any related forms for the information on the proposed projects or Respondents: 6,163; Total Annual proposed paperwork collections to obtain a copy of the information Responses: 13,218; Total Annual Hours: referenced above, access CMS Web site collection plans, call the SAMHSA 13,218. (For policy questions regarding address at http://www.cms.hhs.gov/ Reports Clearance Officer on (240) 276– this collection contact Evelyn Blaemire PaperworkReductionActof1995, or E- 1243. at 410–786–1803. For all other issues mail your request, including your Comments are invited on: (a) Whether call 410–786–1326.) address, phone number, OMB number, the proposed collections of information 5. Type of Information Collection and CMS document identifier, to are necessary for the proper Request: Revision of a currently [email protected], or call the performance of the functions of the approved collection; Title of Reports Clearance Office on (410) 786– agency, including whether the Information Collection: Important 1326. information shall have practical utility; Message from Medicare (IM); Use: To be assured consideration, (b) the accuracy of the agency’s estimate Requirements that hospitals notify comments and recommendations for the of the burden of the proposed collection beneficiaries in inpatient hospital proposed information collections must of information; (c) ways to enhance the settings of their rights as a hospital be received by the OMB desk officer at quality, utility, and clarity of the patient including their discharge appeal the address below, no later than 5 p.m. information to be collected; and (d) rights are referenced in Section 1866 of on May 19, 2010: OMB, Office of ways to minimize the burden of the the Social Security Act (the Act). The Information and Regulatory Affairs, collection of information on authority for the right to an expedited Attention: CMS Desk Officer, Fax respondents, including through the use determination is set forth at Sections Number: (202) 395–6974, E-mail: of automated collection techniques or _ 1869 and 1154 of the Act. OIRA [email protected]. other forms of information technology. The hospital must deliver valid, Dated: April 9, 2010. Proposed Project: Confidentiality of written notice (the IM) of a patient’s Michelle Shortt, Alcohol and Drug Abuse Patient rights as a hospital patient including the Director, Regulations Development Group, Records—(OMB No. 0930–0092)— discharge appeal rights, within 2 Office of Strategic Operations and Regulatory Revision calendar days of admission. A follow-up Affairs. copy of the signed IM is given again as [FR Doc. 2010–8900 Filed 4–16–10; 8:45 am] Statute (42 U.S.C. 290dd–2) and far as possible in advance of discharge, BILLING CODE 4120–01–P regulations (42 CFR part 2) require but no more than 2 calendar days federally conducted, regulated, or before. Follow-up notice is not required directly or indirectly assisted alcohol if provision of the admission IM falls DEPARTMENT OF HEALTH AND and drug abuse programs to keep within 2 calendar days of discharge. The HUMAN SERVICES alcohol and drug abuse patient records collection has been revised to include confidential. Information requirements documentation of the time when the Substance Abuse and Mental Health are (1) written disclosure to patients beneficiary signs the document when it Services Administration about Federal laws and regulations that is delivered initially and as a follow-up Agency Information Collection protect the confidentiality of each ‘‘ copy. Form Number: CMS–R–193 Activities: Proposed Collection; patient, and (2) documenting medical ’’ (OMB#: 0938–1019); Frequency: Comment Request personnel status of recipients of a Reporting—Yearly; Affected Public: disclosure to meet a medical emergency. Business or other for-profits and Not- In compliance with section Annual burden estimates for these for-profit institutions; Number of 3506(c)(2)(A) of the Paperwork requirements are summarized in the Respondents: 3,193; Total Annual Reduction Act of 1995 concerning table below:
ANNUALIZED BURDEN ESTIMATES
Annual number Responses per Total responses Hours per Total hour of respondents 1 respondent response burden
Disclosure
42 CFR 2.22 ...... 10,064 185 1,865,503 2 .20 373,101
Recordkeeping
42 CFR 2.51 ...... 10,064 2 20,128 .167 3,361
Total ...... 10,064 ...... 1,885,631 ...... 376,462 1 The number of publicly funded alcohol and drug facilities from SAMHSA’s 2007 National Survey of Substance Abuse Treatment Services (N– SSATS). 2 The average number of annual treatment admissions from SAMHSA’s 2005–2007 Treatment Episode Data Set (TEDS).
Send comments to Summer King, Room 7–1044, One Choke Cherry Road, should be received within 60 days of SAMHSA Reports Clearance Officer, Rockville, MD 20857. Written comments this notice.
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Dated: April 12, 2010. 30-day advance opportunity for public Scholarship Branch needs this Elaine Parry, comment on the proposed information information for program administration Director, Office of Program Services. collection project, the Indian Health and uses the information to solicit, [FR Doc. 2010–8895 Filed 4–16–10; 8:45 am] Service (IHS) has submitted to the process, and award IHS Pre-graduate, BILLING CODE 4162–20–P Office of Management and Budget Preparatory, and/or Health Professions (OMB) a request to review and approve Scholarship grants and monitor the the information collection listed below. academic performance of awardees, to DEPARTMENT OF HEALTH AND This proposed information collection place awardees at payback sites, and for HUMAN SERVICES project was previously published in the awardees to request additional program Federal Register (74 FR 36714) on July information. The IHS Scholarship Indian Health Service 24, 2009 and allowed 60 days for public Program is streamlining the application comment. No public comment was to reduce the time needed by applicants Request for Public Comment: 30-Day received in response to the notice. The to complete and provide the information Proposed Information Collection: purpose of this notice is to allow 30 and plans on using information Application for Participation in the IHS days for public comment to be technology to make the application Scholarship Program submitted directly to OMB. electronically available on the Internet. AGENCY: Indian Health Service, HHS. Proposed Collection: Title: 0917– Affected Public: Individuals, not-for- ACTION: Notice. 0006, ‘‘Application for Participation in profit institutions and State, local or the IHS Scholarship Program.’’ Type of Tribal Government. Type of Note: The purpose of this second Information Collection Request: Respondents: Students pursuing health announcement is to provide another Previously Approved Collection (Form care professions. opportunity for public comment. The changes and additions). Form The table below provides: Types of previous Federal Register notice was Number(s): IHS–856, 856–2 through data collection instruments, Estimated published on December 31, 2009, FR Doc. 856–24, IHS–815, IHS–816, IHS–817, number of respondents, Number of E9–30947. and IHS–818. Reporting formats are responses per respondent, Annual SUMMARY: In compliance with Section contained in an IHS Scholarship number of responses, Average burden 3506(c)(2)(A) of the Paperwork Program application booklet. Need and hour per response, and Total annual Reduction Act of 1995 which requires a Use of Information Collection: The IHS burden hour(s).
Responses Annual Data collection instrument(s) Number of per Total annual Burden hour per burden respondents respondent response response* hours
Scholarship Application (IHS–856) ...... 1,500 1 1,500 1.00 (60 min) ...... 1,500 Application Checklist (IHS–856–2) ...... 1,500 1 1500 0.13 (8 min) ...... 200 Faculty/Employer Evaluation (IHS–856–3) ...... 1,500 2 3,000 0.83 (50 min) ...... 2,500 Narrative Statements (IHS–856–4) ...... 1,500 1 1,500 0.75 (45 min) ...... 1,125 Delinquent Federal Debt (IHS–856–5) ...... 1,500 1 1,500 0.13 (8 min) ...... 200 Course Curriculum Verification (IHS–856–6) ...... 1,500 1 1,500 0.70 (42 min) ...... 1,050 Verification of Acceptance (IHS–856–7) ...... 400 1 400 0.13 (8 min) ...... 53 Recipient’s Initial Program Progress Report 400 1 400 0.13 (8 min) ...... 53 (IHS–856–8). Notification of Academic Problem (IHS–856–9) ... 50 1 50 0.13 (8 min) ...... 7 Change of Status (IHS–856–10) ...... 50 1 50 0.45 (25 min) ...... 21 Request for Approval of Deferment (IHS–856– 50 1 50 0.13 (8 min) ...... 7 11). Preferred Placement (IHS–856–12) ...... 200 1 200 0.75 (45 min) ...... 150 Notice of Impending Graduation (IHS–856–13) ... 200 1 200 0.17 (10 min) ...... 33 Notification of Deferment Program (IHS–856–14) 50 1 50 0.13 (8 min) ...... 7 Placement Update (IHS–856–15) ...... 200 1 200 0.18 (11 min) ...... 37 Annual Status Report (IHS–856–16) ...... 200 1 200 0.25 (15 min) ...... 50 Extern Site Preference Request (IHS–856–17) ... 125 1 125 0.13 (8 min) ...... 17 Request for Extern Travel Reimbursement (IHS– 125 1 125 0.10 (6 min) ...... 13 856–18). Lost Stipend Checks (IHS–856–19) ...... 50 1 50 0.13 (8 min) ...... 7 Request for Tutorial Assistance (IHS–856–20) .... 150 1 150 0.13 (8 min) ...... 20 Summer School Request (IHS–856–21) ...... 75 1 75 0.10 (6 min) ...... 8 Change of Name or Address (IHS–856–22) ...... 50 1 50 0.13 (8 min) ...... 7 Request for Credit Validation (IHS–856–23) ...... 30 1 30 0.10 (6 min) ...... 3 Faculty/Advisor Evaluation (IHS–856–24) ...... 1,500 2 3,000 0.83 (50 min) ...... 2,500 Acknowledgment Card (IHS–815) ...... 1,500 1 1,500 0.03 (2 min) ...... 50 Address Change Notice (IHS–816) ...... 50 1 50 0.02 (1 min) ...... 1 Scholarship Program Agreement (IHS–817) ...... 175 1 175 0.05 (3 min) ...... 9 Health Professions Contract (IHS–818) ...... 225 1 225 0.05 (3 min) ...... 11 Total ...... 17,855 ...... 9,639 * For ease of understanding, burden hours are also provided in actual minutes.
There is no direct cost to respondents consideration. The estimated cost in GS–3 base pay rate = $10.31 per burden other than their time to voluntarily time to respondents, as a group, is hour). This total dollar amount is based complete the forms and submit them for $99,355.00 (9639 burden hours × 2009 upon the number of burden hours per
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data collection instrument, rounded to DEPARTMENT OF HEALTH AND MD 20892–8328, 301–451–4757, the nearest dollar. HUMAN SERVICES [email protected]. Request for Comments: Your written (Catalogue of Federal Domestic Assistance National Institutes of Health Program Nos. 93.392, Cancer Construction; comments and/or suggestions are 93.393, Cancer Cause and Prevention invited on one or more of the following National Cancer Institute; Notice of Research; 93.394, Cancer Detection and points: (a) Whether the information Closed Meetings Diagnosis Research; 93.395, Cancer collection activity is necessary to carry Treatment Research; 93.396, Cancer Biology out an agency function; (b) whether the Pursuant to section 10(d) of the Research; 93.397, Cancer Centers Support; agency processes the information Federal Advisory Committee Act, as 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, collected in a useful and timely fashion; amended (5 U.S.C. App.), notice is hereby given of the following meetings. HHS) (c) the accuracy of public burden The meetings will be closed to the Dated: April 10, 2010. estimate (the estimated amount of time public in accordance with the needed for individual respondents to Jennifer Spaeth, provisions set forth in sections Director, Office of Federal Advisory provide the requested information); (d) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., whether the methodology and Committee Policy. as amended. The grant applications [FR Doc. 2010–8984 Filed 4–16–10; 8:45 am] assumptions used to determine the and/or contract proposals and the BILLING CODE 4140–01–P estimates are logical; (e) ways to discussions could disclose confidential enhance the quality, utility, and clarity trade secrets or commercial property of the information being collected; and such as patentable material, and DEPARTMENT OF HEALTH AND (f) ways to minimize the public burden personal information concerning HUMAN SERVICES through the use of automated, individuals associated with the grant electronic, mechanical, or other applications and/or contract proposals, National Institutes of Health technological collection techniques or the disclosure of which would other forms of information technology. constitute a clearly unwarranted National Institute of Neurological Disorders and Stroke; Notice of Closed Direct Comments to OMB: Send your invasion of personal privacy. Meeting written comments and suggestions Name of Committee: National Cancer Institute Special Emphasis Panel, Assay regarding the proposed information Pursuant to section 10(d) of the collection contained in this notice, Systems for Drug Efficacy in Cancer Stem Cells. Federal Advisory Committee Act, as especially regarding the estimated Date: April 28, 2010. amended (5 U.S.C. App.), notice is public burden and associated response Time: 1 p.m. to 5 p.m. hereby given of the following meeting. time to: Office of Management and Agenda: To review and evaluate contract The meeting will be closed to the Budget, Office of Regulatory Affairs, proposals. public in accordance with the Place: National Institutes of Health, 6116 Attention: Desk Officer for IHS, New provisions set forth in sections Executive Office Building, Room 10235, Executive Boulevard, Room 6006, Rockville, MD 20852. (Telephone Conference Call) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Washington, DC 20503. Contact Person: Kirt Vener, PhD, Branch as amended. The grant applications and Send Comments and Requests for Chief, Special Review and Logistics Branch, the discussions could disclose Further Information: To request more Division of Extramural Activities, National confidential trade secrets or commercial information on the proposed collection Cancer Institute, NIH, 6116 Executive Blvd., property such as patentable materials, Room 8061, Bethesda, MD 20892–8329, 301– or to obtain a copy of the data collection and personal information concerning 496–7174, [email protected]. individuals associated with the grant instrument(s) and/or instruction(s) Name of Committee: National Cancer contact: Mr. Hershel Gorham, IHS applications, the disclosure of which Institute Special Emphasis Panel, Breast would constitute a clearly unwarranted Reports Clearance Officer, 801 Cancer Biology. Thompson Avenue, TMP, Suite 450, Date: May 20, 2010. invasion of personal privacy. Rockville, MD 20852, call non-toll free Time: 8 a.m. to 5 p.m. Name of Committee: National Institute of (301) 443–5932; send via facsimile to Agenda: To review and evaluate grant Neurological Disorders and Stroke Special (301) 443–9879; or send your e-mail applications. Emphasis Panel; NINDS Conference Grant Place: Hilton Washington/Rockville, 1750 Review Panel. requests, comments, and return address Rockville Pike, Rockville, MD 20852. Date: April 19, 2010. to: [email protected]. Contact Person: Zhiqiang Zou, MD, PhD, Time: 3 p.m. to 5 p.m. Comment Due Date: Comments Scientific Review Officer, National Cancer Agenda: To review and evaluate grant regarding this information collection are Institute, National Institutes of Health, 6116 applications. Executive Blvd., Room 8050A, MSC 8329, Place: National Institutes of Health, best assured of having full effect if Bethesda, MD 20852, [email protected]. Neuroscience Center, 6001 Executive received within 30 days of the date of Name of Committee: National Cancer Boulevard, Rockville, MD 20852, (Virtual this publication. Institute Special Emphasis Panel, Molecular Meeting). Dated: April 8, 2010. Oncology—Basic, Translational and Clinical Contact Person: Alan L. Willard, PhD, Studies. Chief, Scientific Review Branch, NINDS/ Yvette Roubideaux, Date: May 25–26, 2010 NIH/DHHS, 6001 Executive Blvd., Suite Deputy Director, Indian Health Service. Time: 7:30 a.m. to 4 p.m. 3208, MSC 9529, Bethesda, MD 20892–9529, [FR Doc. 2010–8842 Filed 4–16–10; 8:45 am] Agenda: To review and evaluate grant 301–496–5390, [email protected]. This notice is being published less than 15 BILLING CODE P applications. Place: Hilton Washington/Rockville, 1750 days prior to the meeting due to timing Rockville Pike, Rockville, MD 20852. limitations imposed by the review funding Contact Person: David G. Ransom, PhD, cycle. Scientific Review Officer, Research Programs (Catalogue of Federal Domestic Assistance Review Branch, Division of Extramural Program Nos. 93.853, Clinical Research Activities, National Cancer Institute, NIH, Related to Neurological Disorders; 93.854, 6116 Executive Blvd., Rm. 8133, Bethesda, Biological Basis Research in the
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Neurosciences, National Institutes of Health, Dated: April 9, 2010. FOR FURTHER INFORMATION CONTACT: HHS) Jennifer Spaeth, HSAC Staff at [email protected] or 202– Dated: April 7, 2010. Director, Office of Federal Advisory 447–3135. Committee Policy. Jennifer Spaeth, SUPPLEMENTARY INFORMATION: Notice of [FR Doc. 2010–8969 Filed 4–16–10; 8:45 am] Director, Office of Federal Advisory this meeting is given under the Federal Committee Policy. BILLING CODE 4140–01–P Advisory Committee Act, 5 U.S.C. App. [FR Doc. 2010–8973 Filed 4–16–10; 8:45 am] 2. The HSAC provides independent advice to the Secretary of the BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND Department of Homeland Security to aid SECURITY in the creation and implementation of critical and actionable policies and DEPARTMENT OF HEALTH AND [Docket No. DHS–2010–0030] HUMAN SERVICES capabilities across the spectrum of Homeland Security Advisory Council homeland security operations. The National Institutes of Health HSAC periodically reports, as requested, AGENCY: The Office of Policy, DHS. to the Secretary, on such matters. The National Institute of Environmental ACTION: Notice of Open Teleconference Federal Advisory Committee Act Health Sciences; Notice of Closed Federal Advisory Committee Meeting. requires Federal Register publication 15 Meeting days prior to a meeting. The HSAC will SUMMARY: The Homeland Security meet to review the Countering Violent Pursuant to section 10(d) of the Advisory Council (HSAC) will meet via Extremism Working Group findings and Federal Advisory Committee Act, as teleconference for the purpose of recommendations. amended (5 U.S.C. App.), notice is reviewing the findings and Public Participation: Members of the hereby given of the following recommendations of the HSAC’s public may register to participate in this meeting.The meeting will be closed to Countering Violent Extremism Working HSAC teleconference via afore the public in accordance with the Group. mentioned procedures. Each individual provisions set forth in sections DATES: The HSAC conference call will must provide his or her full legal name, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., take place from 4 p.m. to 5 p.m. EST on e-mail address and phone number no as amended. The grant applications and Thursday, May 13, 2010. Please be later than 5 p.m. EST on May 11, 2010, the discussions could disclose advised that the meeting is scheduled to a staff member of the HSAC via confidential trade secrets or commercial for one hour and all participating e-mail at [email protected] or via phone at property such as patentable material, members of the public should promptly (202) 447–3135. HSAC conference call and personal information concerning call-in at the beginning of the details will be provided to interested individualsassociated with the grant teleconference. members of the public at this time. applications, the disclosure of which ADDRESSES: The HSAC meeting will be Information on Services for would constitute a clearly unwarranted held via teleconference. Members of the Individuals with Disabilities: For invasion of personal privacy. public interested in participating in this information on facilities or services for Name of Committee: National Institute of teleconference meeting may do so by individuals with disabilities, or to Environmental Health Sciences Special following the process outlined below request special assistance at the Emphasis Panel; R21 Exploratory Research (see ‘‘Public Attendance’’). meeting, contact the HSAC as soon as Grant Award. Written comments must be submitted possible. Date: May 5, 2010. and received by May 7, 2010. Comments Dated: April 13th, 2010. Time: 2 p.m. to 4 p.m. must be identified by Docket No. DHS– Mike Miron, Agenda: To review and evaluate grant 2010–0030 and may be submitted by Director, Homeland Security Advisory applications. one of the following methods: Council, DHS. • Federal eRulemaking Portal: http:// Place: NIEHS, Keystone Building, 530 [FR Doc. 2010–8953 Filed 4–16–10; 8:45 am] Davis Drive, 2128, Research Triangle, NC www.regulations.gov. Follow the BILLING CODE 9110–9M–P 27709, (Telephone Conference Call) instructions for submitting comments. Contact Person: Leroy Worth, PhD, • E-mail: [email protected]. Include Scientific Review Administrator, Scientific docket number in the subject line of the DEPARTMENT OF HOMELAND Review Branch, Division of Extramural message. SECURITY Research and Training, Nat. Institute of • Fax: (202) 282–9207 • Environmental Health Sciences, P.O. Box Mail: Homeland Security Advisory Coast Guard 12233, MD EC–30/Room 3171, Research Council, Department of Homeland Triangle Park, NC 27709, (919) 541–0670, Security, Mailstop 0850, 245 Murray [Docket No. USCG–2010–0187] [email protected]. Lane, SW., Washington, DC 20528. (Catalogue of Federal Domestic Assistance Instructions: All submissions received Certificate of Alternative Compliance Program Nos. 93.115, Biometry and Risk must include the words ‘‘Department of for the Offshore Supply Vessel Estimation—Health Risks from Homeland Security’’ and DHS–2010– LEBOUEF TIDE Environmental Exposures; 93.142, NIEHS 0030, the docket number for this action. Hazardous Waste Worker Health and Safety Comments received will be posted AGENCY: Coast Guard, DHS. Training; 93.143, NIEHS Superfund without alteration at http:// ACTION: Notice. Hazardous Substances—Basic Research and www.regulations.gov, including any Education; 93.894, Resources and Manpower personal information provided. SUMMARY: The Coast Guard announces Development in the Environmental Health Docket: For access to the docket to that a Certificate of Alternative Sciences; 93.113, Biological Response to read background documents or Compliance was issued for the offshore Environmental Health Hazards; 93.114, comments received by the DHS supply vessel LEBOUEF TIDE as Applied Toxicological Research and Testing, Homeland Security Advisory Council, required by 33 U.S.C. 1605(c) and 33 National Institutes of Health, HHS) go to http://www.regulations.gov. CFR 81.18.
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DATES: The Certificate of Alternate DEPARTMENT OF HOMELAND and aft masthead lights may be 14.1′. Compliance was issued on March 4, SECURITY Placing the aft masthead light at the 2010. horizontal distance from the forward Coast Guard masthead light as required by Annex I, ADDRESSES: The docket for this notice is [Docket No. USCG–2010–0186] paragraph 3(a) of the 72 COLREGS and available for inspection or copying at Annex I, Section 84.05(a) of the Inland the Docket Management Facility (M–30), Certificate of Alternative Compliance Rules Act would result in an aft U.S. Department of Transportation, for the Offshore Supply Vessel RIG masthead light location directly over the West Building Ground Floor, Room RUNNER aft cargo deck where it would interfere W12–140, 1200 New Jersey Avenue, SE., with loading and unloading operations. Washington, DC 20590, between 9 a.m. AGENCY: Coast Guard, DHS. A Certificate of Alternative and 5 p.m., Monday through Friday, ACTION: Notice. Compliance, as allowed under title 33, except Federal holidays. You may also Code of Federal Regulations, parts 81 SUMMARY: The Coast Guard announces and 89, has been issued for the offshore find this docket on the Internet by going that a Certificate of Alternative to http://www.regulations.gov, inserting supply vessel RIG RUNNER, O.N. Compliance was issued for the offshore 1222591. The Certificate of Alternative USCG–2010–0187 in the ‘‘Keyword’’ supply vessel RIG RUNNER as required box, and then clicking ‘‘Search.’’ Compliance allows for the vertical by 33 U.S.C. 1605(c) and 33 CFR 81.18. placement of the forward masthead light FOR FURTHER INFORMATION CONTACT: If DATES: The Certificate of Alternative to deviate from requirements set forth in you have questions on this notice, call Compliance was issued on March 8, Annex I, paragraph 2(a) of 72 COLREGS. LTJG Christine Dimitroff, District Eight, 2010. In addition the Certificate of Alternative Prevention Branch, U.S. Coast Guard, ADDRESSES: The docket for this notice is Compliance allows for the horizontal telephone 504–671–2176. If you have available for inspection or copying at separation of the forward and aft questions on viewing or submitting the Docket Management Facility (M–30), masthead lights to deviate from the material to the docket, call Renee V. U.S. Department of Transportation, requirements of Annex I, paragraph 3(a) Wright, Program Manager, Docket West Building Ground Floor, Room of 72 COLREGS and Annex I, Section Operations, telephone 202–366–9826. W12–140, 1200 New Jersey Avenue SE., 84.05(a) of the Inland Rules Act. Washington, DC 20590, between 9 a.m. This notice is issued under authority SUPPLEMENTARY INFORMATION: and 5 p.m., Monday through Friday, of 33 U.S.C. 1605(c), and 33 CFR 81.18. Background and Purpose except Federal holidays. You may also Dated: March 26, 2010. find this docket on the Internet by going J.W. Johnson, A Certificate of Alternative to http://www.regulations.gov, selecting Commander, U.S. Coast Guard, Chief, Compliance, as allowed under title 33, the Advanced Docket Search option on Inspections and Investigations Branch, By Code of Federal Regulation, parts 81 and the right side of the screen, inserting Direction of the Commander, Eighth Coast 89, has been issued for the offshore USCG–2010–0186 in the ‘‘Keyword’’ Guard District. supply vessel LEBOUEF TIDE. The box, and then clicking ‘‘Search.’’ [FR Doc. 2010–8858 Filed 4–16–10; 8:45 am] horizontal distance between the forward FOR FURTHER INFORMATION CONTACT: If BILLING CODE 9110–04–P and aft masthead lights may be 25′–9″. you have questions on this notice, call Placing the aft masthead light at the CWO2 David Mauldin, District Eight, horizontal distance from the forward Prevention Branch, U.S. Coast Guard, DEPARTMENT OF HOMELAND SECURITY masthead light as required by Annex I, telephone 504–671–2153. If you have paragraph 3(a) of the 72 COLREGS, and questions on viewing or submitting Coast Guard Annex I, Section 84.05(a) of the Inland material to the docket, call Renee V. Rules Act, would result in an aft Wright, Program Manager, Docket [USCG–2010–0276] Operations, telephone 202–366–9826. masthead light location directly over the Commercial Fishing Industry Vessel SUPPLEMENTARY INFORMATION: cargo deck where it would interfere Safety Advisory Committee; Meeting with loading and unloading operations. Background and Purpose AGENCY: Coast Guard, DHS. The Certificate of Alternative A Certificate of Alternative ACTION: Notice of meeting. Compliance allows for the horizontal Compliance, as allowed under title 33, separation of the forward and aft Code of Federal Regulations, parts 81 SUMMARY: The Commercial Fishing masthead lights to deviate from the and 89, has been issued for the offshore Industry Vessel Safety Advisory requirements of Annex I, paragraph 3(a) supply vessel RIG RUNNER, O.N. Committee (CFIVSAC) will meet in of 72 COLREGS, and Annex I, Section 1222591. Full compliance with 72 Oakland, CA, to discuss various issues 84.05(a) of the Inland Rules Act. COLREGS and Inland Rules Act would relating to commercial vessel safety in This notice is issued under authority hinder the vessel’s ability to maneuver the fishing industry. This meeting will of 33 U.S.C. 1605(c), and 33 CFR 81.18. within close proximity of offshore be open to the public. platforms. The forward masthead light DATES: The Committee will meet on Dated: March 26, 2010. may be located on the top forward May 11–13, 2010, from 8 a.m. to 5 p.m. J.W. Johnson, portion of the pilothouse 17′ above the each day. This meeting may close early Commander, U.S. Coast Guard, Chief, hull. Placing the forward masthead light if all business is finished. Inspections and Investigations Branch, By at the height as required by Annex I, Written material and requests to make Direction of the Commander, Eighth Coast paragraph 2(a) of the 72 COLREGS oral presentations should reach the Guard District. would result in a masthead light Coast Guard on or before April 23, 2010. [FR Doc. 2010–8862 Filed 4–16–10; 8:45 am] location highly susceptible to damage Requests to have a copy of your material BILLING CODE 9110–04–P when working in close proximity to distributed to each member of the offshore platforms. Furthermore the committee should also reach the Coast horizontal distance between the forward Guard on or before April 23, 2010.
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ADDRESSES: The Committee will meet at CFIVSAC meeting will commence at 9 and Customs and Border Protection the Waterfront Hotel, 10 Washington a.m. on May 11, 2010. Please note, also, personnel. Street, Oakland, CA 94607. (510–836– the meeting may close early if all DATES: Effective Date: April 1, 2010. 3800, http:// business is finished. FOR FURTHER INFORMATION CONTACT: www.waterfronthoteloakland.com.) At the Chair’s discretion, members of Ron Send written material and requests to the public may make presentations Wyman, Revenue Division, Collection make oral presentations via mail to during the meeting. If you would like to and Refunds Branch, 6650 Telecom Captain Eric P. Christensen, Designated make an oral presentation at the Drive, Suite #100, Indianapolis, Indiana Federal Officer (DFO) of CFIVSAC, meeting, please send a request to the 46278; telephone (317) 614–4516. United States Coast Guard, Office of DFO no later than April 23, 2010. SUPPLEMENTARY INFORMATION: Vessel Activities (CG–543), 2100 2nd Written material for distribution at the Background Street, SW., Washington, DC 20593– meeting should reach the DFO no later 7581. This notice and documents than April 23, 2010. If you would like Pursuant to 19 U.S.C. 1505 and identified in the Supplementary a copy of your material distributed to Treasury Decision 85–93, published in Information section as being available in each member of the committee in the Federal Register on May 29, 1985 the docket may be viewed in our online advance of the meeting, please submit (50 FR 21832), the interest rate paid on docket, USCG–2010–0276, at http:// 20 copies to the DFO no later than April applicable overpayments or www.regulations.gov. 23, 2010. All requests and materials underpayments of customs duties must be in accordance with the Internal FOR FURTHER INFORMATION CONTACT: Mr. must be sent via mail as described in Revenue Code rate established under 26 Jack Kemerer, Assistant to the DFO of ADDRESSES. U.S.C. 6621 and 6622. Section 6621 was CFIVSAC, by telephone at 202–372– Information on Services for Individuals amended (at paragraph (a)(1)(B) by the 1249, fax 202–372–1917, e-mail: With Disabilities Internal Revenue Service Restructuring [email protected]. For information on facilities or and Reform Act of 1998, Public Law SUPPLEMENTARY INFORMATION: Notice of services for individuals with 105–206, 112 Stat. 685) to provide this meeting is given under the Federal disabilities, or to request special different interest rates applicable to Advisory Committee Act, 5 U.S.C. App. assistance at the meeting, contact the overpayments: one for corporations and (Pub. L. 92–463). DFO as soon as possible, but no later one for non-corporations. Agenda of Meeting than April 30, 2010. The interest rates are based on the Federal short-term rate and determined The agenda for the CFIVSAC meeting Dated: April 12, 2010. by the Internal Revenue Service (IRS) on is as follows: J.G. Lantz, behalf of the Secretary of the Treasury (1) Introductions and comments. Director of Commercial Regulations and on a quarterly basis. The rates effective (2) Updates on Coast Guard Standards. for a quarter are determined during the Commercial Fishing Vessel Safety [FR Doc. 2010–8857 Filed 4–16–10; 8:45 am] first-month period of the previous activities, pending legislation affecting BILLING CODE 9110–04–P quarter. commercial fishing vessels, and status In Revenue Ruling 2010–9, the IRS report on the Commercial Fishing determined the rates of interest for the Vessel Safety Rulemaking. DEPARTMENT OF HOMELAND calendar quarter beginning April 1, (3) Commercial Fishing Vessel Safety SECURITY 2010, and ending on June 30, 2010. The District Coordinator reports. interest rate paid to the Treasury for (4) Industry updates. Customs and Border Protection (5) Report of ongoing research work underpayments will be the Federal and safety related projects by the Quarterly IRS Interest Rates Used in short-term rate (1%) plus three National Institute for Occupational Calculating Interest on Overdue percentage points (3) for a total of four Safety and Health (NIOSH). Accounts and Refunds on Customs percent (4). For corporate overpayments, (6) Comments from the public. Duties the rate is the Federal short-term rate (7) Discussions and working group (1%) plus two percentage points (2) for sessions by the Communications and AGENCY: Customs and Border Protection, a total of three percent (3). For Risk Management Subcommittees, and Department of Homeland Security. overpayments made by non- others that may be established, on ACTION: General notice. corporations, the rate is the Federal current program strategies, future plans, short-term rate (1%) plus three recommendations to the Coast Guard, SUMMARY: This notice advises the public percentage points (3) for a total of four and goals for CFIVSAC. of the quarterly Internal Revenue percent (4). These interest rates are Service interest rates used to calculate subject to change for the calendar Procedural interest on overdue accounts quarter beginning July 1, 2010, and The CFIVSAC meeting is open to the (underpayments) and refunds ending September 30, 2010. public. Please note that from 8–9 a.m. (overpayments) of customs duties. For For the convenience of the importing on the first day of the meeting, May 11, the calendar quarter beginning April 1, public and Customs and Border 2010, the committee members will meet 2010, the interest rates for overpayments Protection personnel the following list to discuss administrative matters, will be 3 percent for corporations and 4 of IRS interest rates used, covering the including member training. This one- percent for non-corporations, and the period from before July of 1974 to date, hour meeting on administrative matters interest rate for underpayments will be to calculate interest on overdue is for committee members only in 4 percent. This notice is published for accounts and refunds of customs duties, accordance with 41 CFR 102.3–160; the the convenience of the importing public is published in summary format.
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Corporate Under- Over- over- Beginning date Ending date payments payments payments (percent) (percent) (Eff. 1–1–99) (percent)
070174 ...... 063075 6 6 ...... 070175 ...... 013176 9 9 ...... 020176 ...... 013178 7 7 ...... 020178 ...... 013180 6 6 ...... 020180 ...... 013182 12 12 ...... 020182 ...... 123182 20 20 ...... 010183 ...... 063083 16 16 ...... 070183 ...... 123184 11 11 ...... 010185 ...... 063085 13 13 ...... 070185 ...... 123185 11 11 ...... 010186 ...... 063086 10 10 ...... 070186 ...... 123186 9 9 ...... 010187 ...... 093087 9 8 ...... 100187 ...... 123187 10 9 ...... 010188 ...... 033188 11 10 ...... 040188 ...... 093088 10 9 ...... 100188 ...... 033189 11 10 ...... 040189 ...... 093089 12 11 ...... 100189 ...... 033191 11 10 ...... 040191 ...... 123191 10 9 ...... 010192 ...... 033192 9 8 ...... 040192 ...... 093092 8 7 ...... 100192 ...... 063094 7 6 ...... 070194 ...... 093094 8 7 ...... 100194 ...... 033195 9 8 ...... 040195 ...... 063095 10 9 ...... 070195 ...... 033196 9 8 ...... 040196 ...... 063096 8 7 ...... 070196 ...... 033198 9 8 ...... 040198 ...... 123198 8 7 ...... 010199 ...... 033199 7 7 6 040199 ...... 033100 8 8 7 040100 ...... 033101 9 9 8 040101 ...... 063001 8 8 7 070101 ...... 123101 7 7 6 010102 ...... 123102 6 6 5 010103 ...... 093003 5 5 4 100103 ...... 033104 4 4 3 040104 ...... 063004 5 5 4 070104 ...... 093004 4 4 3 100104 ...... 033105 5 5 4 040105 ...... 093005 6 6 5 100105 ...... 063006 7 7 6 070106 ...... 123107 8 8 7 010108 ...... 033108 7 7 6 040108 ...... 063008 6 6 5 070108 ...... 093008 5 5 4 100108 ...... 123108 6 6 5 010109 ...... 033109 5 5 4 040109 ...... 063010 4 4 3
Dated: April 13, 2010. DEPARTMENT OF THE INTERIOR 1320, Reporting and Recordkeeping Alan Bersin, Requirements, the National Park Service Commissioner, U.S. Customs and Border National Park Service invites public comments on an extension of a currently approved Protection. 60-Day Notice of Intention To Request [FR Doc. 2010–8961 Filed 4–16–10; 8:45 am] collection of information Office of Clearance of Collection of Management and Budget (OMB) #1024– BILLING CODE 9111–14–P Information—Opportunity for Public 0047. An agency may not conduct or Comment sponsor, and a person is not required to respond to, a collection of information AGENCY: National Park Service, Interior. unless it displays a currently valid OMB ACTION: Notice and request for control number. comments. DATES: Public comments will be SUMMARY: Under the provisions of the accepted on or before June 18, 2010. Paperwork Reduction Act of 1995 (Pub. ADDRESSES: Send comments to Michael L. 104–13, 44 U.S.C. 3507) and 5 CFR D. Wilson, Chief or Laurie Heupel,
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Outdoor Recreation Planner, State and information in your comment, you [email protected]. You are entitled Local Assistance Programs Division, should be aware that your entire to a copy of the entire ICR package free National Park Service (2225), 1849 C comment—including your personal of charge once the package is submitted Street, NW., Washington, DC 20240– identifying information—may be made to OMB for review. You can access this 0001 or via e-mail at publicly available at any time. While ICR at http://www.reginfo.gov/public/. [email protected] or you can ask us in your comment to SUPPLEMENTARY INFORMATION: [email protected]. All responses to withhold your personal identifying OMB Control Number: 1024–0021. this notice will be summarized and information we cannot guarantee that Title: National Park Service, National included in the request. we will be able to do so. Capital Region Application for a Permit To Request a Draft of Proposed Dated: April 14, 2010. to Conduct a Demonstration or Special Collection of Information Contact: Cartina Miller, Event in Park Areas and a Waiver of Michael D. Wilson, Chief or Laurie Information Collection Clearance Officer, Numerical Limitations on Heupel, Outdoor Recreation Planner, National Park Service. Demonstrations for White House State and Local Assistance Programs [FR Doc. 2010–8978 Filed 4–16–10; 8:45 am] Sidewalk and/or Lafayette Park. Division, National Park Service (2225), BILLING CODE 4312–52–P Form(s): None. 1849 C Street, NW., Washington, DC Expiration Date: 11/30/2010. 20240–0001 or via e-mail at Type of Request: Extension of a [email protected] or DEPARTMENT OF INTERIOR currently approved collection of [email protected]. You are information. entitled to a copy of the entire ICR National Park Service Abstract: The NPS requests comments package free-of-charge. on an application form that allows the 60-Day Notice of Intention to Request SUPPLEMENTARY INFORMATION: Park Programs Division of National Mall Clearance of Collection of Information; OMB Control Number: 1024–0047. and Memorial Parks to process requests Opportunity for Public Comment Title: Land and Water Conservation from individual and organizations to Fund (LWCF) Conversions of Use AGENCY: National Park Service, Interior. hold public gatherings on NPS property. Provisions. ACTION: Notice and request for These public gatherings consist of Form: None. comments. special events and demonstrations that Type of Request: Extension of the NPS is charged with regulating to currently approved information SUMMARY: Under the provisions of the insure protection of cultural and natural collection. Paperwork Reduction Act of 1995 and 5 resources within NPS property. The Expiration Date: August 31, 2010. CFR part 1320, Reporting and Record NPS will use the information you Abstract: In order to convert sites and Keeping Requirements, the National submit to determine whether or not to facilities assisted under the LWCF to Park Service (NPS) invites public make modifications to the application other than public outdoor recreation comments on an extension of a form. Once the NPS makes any uses, the grant recipient must submit currently approved collection of modifications that it may decide to documentation for NPS consideration. information Office of Management and adopt, the NPS plans to submit a Documentation includes appraisal Budget (OMB) #1024–0021. An agency proposed collection of information reports, statements regarding need for may not conduct or sponsor, and a package to OMB with a request that the conversion, and such additional person is not required to respond to, a OMB approve the package and reinstate information as may be necessary given collection of information unless it the OMB clearance number. The the peculiar nature of the specific displays a currently valid OMB control information collection responds to the request. number. statutory requirements that the NPS Affected Public: State Governments, DATES: Public comments on this preserve park resources and regulate the DC and Territories. Information Collection Request (ICR) use of units of the National Park System. Obligation to Respond: Required to will be accepted on or before June 18, The information to be collected Obtain a Benefit. 2010. identifies: (1) Those individuals and/or Frequency of Response: On occasion. ADDRESSES: Send comments directly to: organizations that wish to conduct a Estimated total annual responses: Ms. Robbin Owen, Chief, National Park public gathering on NPS property in the 450. Service, National Capital Region, National Capital Region, (2) the logistics Estimated average completion time National Mall and Memorial Parks, of a proposed demonstration or special per response: 1 hour. Division of Park Programs, 1100 Ohio event that aid the NPS in regulation Estimated annual reporting burden: Drive, SW., Room 128, Washington, DC activities to insure that they are 450 hours. 20242; or via fax at 202–401–2430; or consistent with the NPS mission, (3) Estimated annual non hour cost via e-mail at [email protected]. All potential civil disobedience and traffic burden: $9,560. responses to the notice will be control issues for the assignment of The NPS also is asking for comments summarized and included in the request United States Park Police personnel, (4) on (1) the practical utility of the for the OMB approval. All comments circumstances which may warrant to be information being gathered; (2) the will become a matter of public record. assigned to the event for the purpose of accuracy of the burden hour estimate; FOR FURTHER INFORMATION CONTACT: To covering potential cost to repair damage (3) ways to enhance the quality, utility, Request a Draft of Proposed Collection caused by the event. You may obtain and clarity of the information to be of Information Contact: Ms. Robbin copies of the application from the collected; and (4) ways to minimize the Owen, Chief, NPS, National Capital source listed below (see the ‘‘send burden to respondents, including use of Region, National Mall and Memorial comments to’’ section) http:// automated information collection Parks, Division of Park Programs, 1100 www.nps.gov/nama/planyourvisit/ techniques or other forms of information Ohio Drive, SW., Room 128, permits.htm. technology. Before including your Washington, DC 20242; or via phone at Description of respondents: address, phone number, e-mail address, 202- 619–7225; or via fax at 202–401– Respondents are those individuals or or other personal identifying 2430; or via e-mail at organizations that wish to conduct a
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special event or demonstration on NPS Statement (EIS)/Staff Assessment (SA), AFC to the CEC to construct and operate properties with the National Capital including a possible Draft Amendment the SES Solar One Project. In January Region that lie within the geographical to the California Desert Conservation 2010, the project name was formally limits set forth in 36 CFR 7.96(a). Area (CDCA) Plan (1980, as amended), changed to Calico Solar as a result of Obligation to Respond: Required to for the Calico Solar (formerly Stirling SES Solar Three, LLC merging with SES Obtain a Benefit. Energy Systems Solar One) Project, San Solar Six, LLC to create Calico Solar, Frequency of Response: On occasion. Bernardino County, California. The LLC. Estimated average number of Draft EIS/SA, prepared in compliance The proposed action is to construct an responses: 2,051 per year. with the National Environmental Policy 850-MW, 8,230-acre (13 square mile) Estimated average time burden per Act of 1969, as amended (NEPA), the solar energy facility on BLM- respondent: .5 hours. Federal Land Policy and Management administered land. Approximately 1,718 Estimated total annual reporting Act of 1976, as amended (FLPMA), and acres of public land within the proposed burden: 1,026 hours. the California Environmental Quality project area were either donated to the Estimated annual non hour cost Act (CEQA), evaluates the BLM or acquired by the BLM with Land burden: $102,550. environmental impacts of constructing and Water Conservation Funds (LWCF). Comments are invited on: (1) The and operating an 850 megawatt (MW) The project proposal includes building practical utility of the information being solar power facility on 8,230 acres of about 34,000, 25-kilowatt Stirling solar gathered; (2) the accuracy of the burden BLM-administered land. The Draft EIS/ dish systems. Each solar dish system hour estimate; (3) ways to enhance the SA is jointly prepared by the BLM and consists of an approximately 38-foot quality, utility, and clarity of the the CEC in response to Calico Solar, high by 40-foot wide solar concentrator information being collected; and (4) LLC’s right-of-way (ROW) application to dish that supports an array of curved ways to minimize the burden to the BLM and its Application for glass mirrors. These mirrors would respondents, including use of Certification (AFC) to the CEC. automatically track the sun and focus automated information collection DATES: The publication of the EPA’s solar energy onto a power conversion techniques or other forms of information Notice of Availability of this Draft EIS unit that generates electricity. technology. Before including your in the Federal Register initiates a 90- The Calico Solar Project would also address, phone number, e-mail address, day public comment period. To ensure include a number of related facilities or other personal identifying that comments will be considered, the and infrastructure, including: information in your comment, you BLM must receive written comments on • A new 230-kilovolt (kV) Calico should be aware that your entire the Draft EIS/SA and plan amendment Substation; approximately 2 miles of comment—including your personal within 90 days following the date the single-circuit 230-kV transmission line identifying information—may be made EPA publishes its Notice of Availability to connect the new Calico Substation to publicly available at any time. While in the Federal Register. The BLM will the existing Southern California Edison you can ask us in your comment to announce future meetings or hearings (SCE) Pisgah Substation; • withhold your personal identifying and any other public involvement Project roads and fencing; information from public review, we • An administration building; and activities at least 15 days in advance • cannot guarantee that we will be able to through public notices, media releases, A 45,000 square foot main services do so. and/or mailings. complex. Approximately 739 feet of the new Dated: April 12, 2010. ADDRESSES: Copies of the Calico Solar 230-kV transmission line would be Cartina A. Miller, Project Draft EIS/SA are available from outside of the project area. The solar Information Collection Clearance Officer, the BLM Barstow Field Office, 2601 facility would operate for about 20 years National Park Service. Barstow Road, Barstow, California based on the Purchase Power Agreement [FR Doc. 2010–8983 Filed 4–16–10; 8:45 am] 92311. The document may also be signed with SCE on August 9, 2005. BILLING CODE 4312–52–P viewed at public libraries in San Upgrades to the SCE transmission Bernardino County, Sacramento, Fresno, system are needed to transmit the San Francisco, Los Angeles, Eureka, and electricity generated from the Calico DEPARTMENT OF THE INTERIOR San Diego, California. Solar Project. These upgrades would FOR FURTHER INFORMATION CONTACT: Jim Bureau of Land Management take place outside the Calico Solar Stobaugh, BLM Project Manager, by project area. [CACA 49537, LLCAD08000, mail: P.O. Box 12000, Reno, Nevada The BLM is considering amending the L51030000.ER0000, LVRAB109AA02] 89520; phone: (775) 861–6478; or CDCA Plan as part of the proposed e-mail: [email protected]. action. The CDCA Plan requires that all Notice of Availability of the Draft SUPPLEMENTARY INFORMATION: On March sites associated with power generation Environmental Impact Statement/Staff 14, 2007, SES Solar Six, LLC and SES or transmission not identified in the Assessment and Possible Amendment Solar Three, LLC submitted applications CDCA Plan be considered through the to the California Desert Conservation for ROW grants to the BLM to construct BLM land use planning amendment Area Plan for the Calico Solar and operate a concentrated solar dish process. If the BLM decides to approve (Formerly SES Solar One) Project, San power plant facility on Federal public the ROW grant, the BLM would also Bernardino County, CA lands in San Bernardino County, amend the CDCA Plan, as required. The AGENCY: Bureau of Land Management, California. The two ROW application BLM’s proposed action in the Draft EIS/ Interior. areas were subsequently combined into SA is to authorize the 850-MW Calico ACTION: Notice of availability. one project (SES Solar One) proposed Solar Project and approve the CDCA for an 8,230-acre site located Plan amendment in response to the SUMMARY: The Department of the immediately north of Interstate 40, application received from Calico Solar, Interior (DOI), Bureau of Land approximately 37 miles east of Barstow, LLC. Management (BLM) and the California California. On December 2, 2008, SES The action alternatives include: (1) Energy Commission (CEC) have jointly Solar One, LLC (SES Solar Three, LLC The proposed action (as described released a Draft Environmental Impact and SES Solar Six, LLC) submitted an above); (2) a 720-MW, 6,512-acre (10.2
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square mile) alternative which avoids agency for preparing the environmental DEPARTMENT OF THE INTERIOR the 1,718 acres of donated and LWCF- documents. The joint environmental acquired lands; and (3) a reduced review is being conducted in a single Bureau of Land Management acreage alternative (2,320 acres (3.6 combined NEPA/CEQA analysis process [LLAZP02000–10– square mile)) which would connect a and document. The Draft EIS/SA L51010000.FX0000.LVRWA09A2400; AZA proposed 275-MW transmission upgrade analyzes site-specific impacts of the 034187] to the SCE grid capacity. As required proposed project on air quality; under CEQA and NEPA, the EIS is also biological, cultural, water, soil, visual, Notice of Availability of the Draft analyzing the following three ‘‘no paleontological, and geologic resources; Environmental Impact Statement for action’’ alternatives: (1) Deny the Calico the Proposed Sonoran Solar Energy recreation; land use; noise; public Solar Project applications and not Project, Maricopa County, AZ health; socioeconomics; and traffic and amend the CDCA Plan; (2) deny the AGENCY: Calico Solar Project but amend the transportation. The Draft EIS/SA also Bureau of Land Management, CDCA Plan to allow other solar energy addresses hazardous materials handling, Interior. projects on the proposed project site; waste management, worker safety, fire ACTION: Notice of availability. protection, facility design engineering, and (3) deny the Project and amend the SUMMARY: In accordance with the CDCA Plan to prohibit solar energy transmission system engineering, transmission line safety, and nuisance. National Environmental Policy Act of projects on the proposed project site. As 1969, as amended (NEPA), the Bureau of part of its review of the Calico Solar, Additionally, the applicant has Land Management (BLM) has prepared LLC applications, the BLM will consider applied to the Department of Energy a Draft Environmental Impact Statement the Energy Policy Act of 2005, (DOE) for a loan guarantee under Title (EIS) for the proposed Sonoran Solar Secretarial Order 3283 Enhancing XVII of the Energy Policy Act of 2005, Energy Project (SSEP) and by this notice Renewable Energy Development on the as amended by Section 406 of the is announcing the opening of the Public Lands, and Secretarial Order American Recovery and Reinvestment comment period. 3285 Renewable Energy Development by Act of 2009, Public Law 111–5. Should the Department of the Interior. DATES: To ensure comments will be If the Calico Solar Project is approved the DOE decide to enter into negotiation considered, the BLM must receive and constructed, a number of related of a possible loan guarantee with the written comments on the SSEP Draft EIS future actions are also anticipated. The Applicant, the DOE would become a within 45 days following the date the NEPA and CEQA require examination of cooperating agency in developing the Environmental Protection Agency reasonably foreseeable actions resulting Final EIS. The purpose and need for publishes its Notice of Availability in from a project under consideration. action by the DOE would be to comply the Federal Register. The BLM will Accordingly, the Draft EIS/SA examines with its mandate under the Energy announce future meetings or hearings the construction and operational Policy Act of 2005 to select eligible and any other public involvement impacts of future SCE transmission projects that meet the goals of the Act. activities at least 15 days in advance through public notices, media releases, substation/transmission line upgrade A Notice of Intent to Prepare an EIS/ and/or mailings. options and the nature and scope of the SA and Land Use Plan Amendment for ADDRESSES: You may submit comments probable impacts of each scenario, the SES Solar One Project (now called should they occur as a result of the related to the Proposed Sonoran Solar Calico Solar), San Bernardino County, approval of the Calico Solar Project. Energy Project by any of the following California was published in the Federal These future scenarios would require methods: additional utility and ROW applications Register on June 8, 2009 (73 FR 27176). • E-mail: [email protected]; or from SCE and additional environmental The BLM held a public scoping meeting • Mail: BLM Phoenix District Office, review under CEQA and NEPA. in Barstow, California, on June 22, 2009. Lower Sonoran Field Office, Sonoran The BLM’s purpose and need for the The formal 30-day public scoping Solar Energy Project, Attention: Joe Calico Solar project is to respond to the period ended July 7, 2009. Incardine, National Project Manager, Calico Solar, LLC’s application for a Before including your address, phone 21605 North 7th Avenue, Phoenix, ROW grant to construct, operate, and number, e-mail address, or other Arizona 85027. decommission a solar thermal facility personal identifying information in your Copies of the Proposed Sonoran Solar Energy Project Draft EIS are available in on public lands in compliance with comment, you should be aware that the Lower Sonoran Field Office at the Title V of FLPMA (43 U.S.C. 1761), the your entire comment—including your above address. BLM’s ROW regulations, and other personal identifying information—may applicable Federal laws. Upon The document may also be viewed at be made publicly available at any time. completion and consideration of the public libraries in Maricopa County, While you can ask us in your comment Final EIS/SA, the BLM will decide Arizona: • whether to approve, approve with to withhold your personal identifying Buckeye Public Library, 310 N. 6th modification, or deny issuance of a information from public review, we Street, Buckeye, Arizona 85236. • ROW grant to Calico Solar, LLC for the cannot guarantee that we will be able to Gila Bend Public Library, 202 N. proposed Calico Solar Project. do so. Euclid Avenue, Gila Bend, Arizona A joint Federal-State environmental 85337. Authority: 40 CFR 1506.6, 1506.10 and 43 • review of the Calico Solar Project is CFR 1610.2. Goodyear Public Library, 250 N. being prepared as a result of a 2007 Litchfield Road, Goodyear, Arizona Memorandum of Understanding (MOU) Tom Pogacnik, 85338. between the California Desert District of Deputy State Director. You may also access the document on the BLM and the CEC to conduct joint [FR Doc. 2010–8910 Filed 4–16–10; 8:45 am] the Internet at: http://www.blm.gov/az/ st/en/prog/energy/solar/ environmental review of solar thermal BILLING CODE 4310–40–P _ projects that are proposed on Federal sonoran solar.html. land managed by the BLM in California. FOR FURTHER INFORMATION CONTACT: Joe The MOU assigns the CEC as the lead Incardine, BLM National Project
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Manager, telephone: 801–524–3833; boilers would be constructed to resources, paleontology (fossils), land address: BLM Phoenix District Office, augment solar heating when less than use and access, livestock grazing, Lower Sonoran Field Office, 21605 optimal solar conditions existed (night recreation, wilderness characteristics, North 7th Avenue, Phoenix, Arizona time, cloud cover, etc.), and would visual resources, social and economic 85027; e-mail: [email protected]. provide up to 25 percent of annual total conditions, special designation areas, SUPPLEMENTARY INFORMATION: The Draft electric production. The boilers would transportation and traffic, hazardous EIS was prepared by the BLM in be supplied with natural gas via a new materials and hazardous and solid response to Boulevard Associates, LLC’s 5-mile, 8-inch pipeline. A thermal waste. The Draft EIS also includes a (Boulevard) right-of-way (ROW) energy storage (TES) system may also be discussion of the issue of climate installed to supplement electrical application to the BLM. Boulevard is change as it relates to the proposed output during reduced solar activity or proposing to construct up to a 375 action. megawatt (MW) concentrated solar to extend electrical output into the Three agencies are serving as thermal (CST) power plant and ancillary evening hours. The TES would use facilities on approximately 3,688 acres molten salt as its energy storage cooperating agencies in the preparation (5.76 square miles) on BLM- medium. of the Draft EIS because of their administered land. The proposed The proposed SSEP would include a jurisdictional responsibilities and/or project area totals approximately 3,702 number of related facilities and special expertise: the Arizona Game and acres and also includes land owned by infrastructure, including power blocks Fish Department, the City of Goodyear, and solar trough arrays (2,300 acres), the Arizona State Land Department and the Town of Buckeye. evaporation ponds, access roads, (approximately 5.3 acres) and private A Notice of Intent to Prepare an EIS administration buildings and other land owners (approximately 9.4 acres). support facilities, a land treatment unit, for the Proposed Sonoran Solar Energy The proposed CST project would be drainage collection and discharge Project, Maricopa County, Arizona, was sited in the Little Rainbow Valley, east facilities, and open areas totaling 1,400 published in the Federal Register on of State Route 85 and south of the acres for a total footprint of about 3,700 July 8, 2009 (74 FR 32641). The BLM Buckeye Hills in Maricopa County, acres. held three public scoping meetings in Arizona. The CST project is in the As required under NEPA, the EIS also Phoenix, Buckeye, and Gila Bend, BLM’s Lower Gila South Planning Area analyzes a no action alternative which Arizona, on August 4, 5, and 6, 2009, and would be managed in accordance would preclude development of the respectively. The formal 30-day public with the Lower Gila South Resource SSEP in any configuration and maintain scoping period ended September 8, Management Plan (1988) (RMP), as existing land uses in the project area. 2009. amended (2005). Related facilities The three action alternatives include: (1) All timely comments on the Draft EIS include road construction and The proposed action (as described will be considered in the preparation of improvements, a gas pipeline, electric above); (2) Alternative A: Reduced lines, and a water well field and Water Use (using a dry-cooling the Final EIS, currently scheduled for pipeline. Boulevard’s ROW application technology); and (3) Alternative B: release in the fall of 2010. Please only applies to BLM-administered land. Reduced Footprint (a 250 MW wet- include the commenter’s name and The BLM completed a land use plan cooled facility occupying 2,320 acres). street address. All substantive conformance analysis of the SSEP and Alternatives A and B were developed in comments and information submitted determined that the proposed land use response to issues raised during the will be summarized and addressed in is in conformance with the Lower Gila scoping process. A Brine Concentrator the Final EIS. South RMP, as amended. As part of its Option is also analyzed as a component Before including your address, phone review of the Boulevard’s ROW of the proposed action and Alternative number, e-mail address, or other application, the BLM will consider the B. personal identifying information in your Energy Policy Act of 2005, and The BLM’s purpose and need for the comment, you should be aware that Secretarial Orders 3283 Enhancing Sonoran Solar Energy Project is to your entire comment—including your Renewable Energy Development on the respond to Boulevard’s application for a personal identifying information—may Public Lands and 3285 Renewable ROW grant to construct, operate, and Energy Development by the Department decommission a solar thermal facility be made publicly available at any time. of the Interior. on public lands in compliance with While you can ask us in your comment The proposed SSEP would consist of Title V of the Federal Land Policy to withhold your personal identifying two independent, concentrated solar Management Act (43 U.S.C. 1761), the information from public review, we electric generating facilities with BLM’s ROW regulations, and other cannot guarantee that we will be able to expected outputs of 125 MW and 250 applicable Federal laws. Upon do so. MW. Both facilities would use parabolic completion and consideration of the Authority: 40 CFR 1506.6, 40 CFR trough solar thermal technology to Final EIS, the BLM will decide whether 1506.10. produce electrical power using steam to approve, approve with modification, turbine generators fed from solar steam or deny issuance of a ROW grant to James G. Kenna, generators. The generators would Boulevard for the proposed Sonoran State Director. connect to a new SSEP 500-kilovolt Solar Energy Project. If approved, the [FR Doc. 2010–8909 Filed 4–16–10; 8:45 am] onsite switchyard. Electricity from the solar facility would be authorized by the BILLING CODE 4310–32–P new switchyard would be transmitted BLM for a period of 30 years. through a generation tie-line to connect The Draft EIS analyzes the anticipated to the existing Jojoba Substation. The effects of the proposed SSEP and proposed SSEP would use a wet-cooling alternatives on air quality, noise, tower for power plant cooling with up geology and minerals, soils, surface and to 3,003 acre-feet per year of water being ground water resources, vegetation and supplied from an onsite groundwater special-status species, wildlife and well field. Three natural gas co-firing special-status species, cultural
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DEPARTMENT OF THE INTERIOR amendment to their plan of operations will be conducted and Tribal concerns for the Hollister Underground Mine will be given due consideration, Bureau of Land Management Project. The proposed amendment including impacts on Indian trust assets, [LLNVE02000 L51100000.GN0000 would expand Rodeo Creek Gold Inc.’s if any. Federal, State, and local agencies, LVEMF1000570 241A; MO:4500011675; 10– existing underground exploration along with other stakeholders that may 08807; TAS: 14X5017] activities into a full-scale underground be interested or affected by the BLM’s mining operation. Most of the necessary decision on this project are invited to Notice of Intent To Prepare an infrastructure to support full-scale participate in the scoping process and, Environmental Impact Statement for mining was authorized and built in if eligible, may request or be requested the Proposed Hollister Underground conjunction with the underground by the BLM to participate as a Mine Project, Elko County, NV exploration activities. Currently, the cooperating agency. project has created 66 acres of approved Before including your address, phone AGENCY: Bureau of Land Management, surface disturbance on public lands, of number, e-mail address, or other Interior. which approximately 75 percent of the personal identifying information in your ACTION: Notice of Intent. existing facilities are located on comment, you should be aware that previously disturbed ground within an your entire comment—including your SUMMARY: In compliance with the existing open pit mine. The proposed National Environmental Policy Act of personal identifying information—may expansion to full-scale mining would 1969, as amended, (NEPA) and the be made publicly available at any time. disturb an additional 58 acres of public Federal Land Policy and Management While you can ask us in your comment land for a total of 124 acres of surface Act of 1976, as amended, the Bureau of to withhold your personal identifying disturbance. The proposed action information from public review, we Land Management (BLM) Tuscarora consists of constructing a new Field Office, Elko, Nevada, intends to cannot guarantee that we will be able to production shaft; improving existing do so. prepare an Environmental Impact roads; building a power transmission Authority: 40 CFR 1501.7. Statement (EIS) and by this notice is line to the mine site; upgrading announcing the beginning of the ancillary facilities including storage Kenneth E. Miller, scoping process to solicit public areas, office, shop, and warehouse Manager, Elko District Office. comments and to identify issues. buildings; and continuing both surface [FR Doc. 2010–8906 Filed 4–16–10; 8:45 am] DATES: This notice initiates the public and underground exploration. The full- BILLING CODE 4310–HC–P scoping process for the EIS. Comments scale project would augment the on issues may be submitted in writing existing mine water management until May 19, 2010. The date(s) and facilities that currently include a DEPARTMENT OF THE INTERIOR location(s) of any scoping meetings will reverse-osmosis and desilting water be announced at least 15 days in treatment plant and rapid infiltration Bureau of Land Management advance through local media, basins by adding underground newspapers and the BLM Web site at: [CACA 048880, LLCAD06000, dewatering wells and obtaining a L51010000.FX0000, LVRWB09B2520] http://www.blm.gov/nv/st/en/fo/ National Pollutant Discharge _ _ elko field office.html. In order to be Elimination System permit to authorize Notice of Availability of the Draft included in the Draft EIS, all comments discharge of groundwater to Little Environmental Impact Statement/Staff must be received prior to the close of Antelope Creek. The Hollister Project Assessment for the NextEra Energy the scoping period or 15 days after the would haul the mined ore using Resources Genesis Solar Energy last public meeting, whichever is later. highway-legal trucks to existing off-site Project and Possible California Desert The BLM will provide additional milling facilities via existing roads that Conservation Area Plan Amendment opportunities for public participation would be improved as needed; no on- upon publication of the Draft EIS. site processing facilities are proposed. AGENCY: Bureau of Land Management, ADDRESSES: You may submit comments The project is expected to operate for 20 Interior. related to the Hollister Underground years. The proposed project is located in ACTION: Notice of Availability. and adjacent to the Tosawihi Quarries Mine Project by any of the following SUMMARY: Archaeological District and near the In accordance with the methods: National Environmental Policy Act of • Web site: http://www.blm.gov/nv/st/ Tosawihi Quarries Traditional Cultural _ _ Properties (TCP), 47 miles northwest of 1969, as amended (NEPA), and the en/fo/elko field office.html. Federal Land Policy and Management • E-mail: [email protected]. Elko, Nevada, in Elko County. Act of 1976, as amended (FLPMA), the • Fax: (775) 753–0255. The purpose of the public scoping • Mail: BLM Tuscarora Field Office, process is to determine relevant issues Bureau of Land Management (BLM) and Attn. Janice Stadelman, 3900 Idaho that will influence the scope of the the California Energy Commission (CEC) Street, Elko, Nevada 89801. environmental analysis, including have prepared a Draft Environmental Impact Statement (EIS), Draft California Documents pertinent to this proposal alternatives, and guide the process for developing the EIS. At present, the BLM Desert Conservation Area (CDCA) Plan may be examined at the Tuscarora Field Amendment, and Staff Assessment (SA) Office. has identified the following preliminary issues: cultural resources, Native as a joint environmental analysis FOR FURTHER INFORMATION CONTACT: For American religious concerns, hydrology, document for the Genesis Solar Energy further information and/or to have your and noise. Project (GSEP), Riverside County, name added to the mailing list, contact The BLM will use and coordinate the California, and by this notice are Janice Stadelman, Project Lead, NEPA commenting process to satisfy the announcing the opening of the comment telephone (775) 753–0346; address 3900 public involvement process for Section period. Idaho St., Elko, Nevada 89801; e-mail _ 106 of the National Historic DATES: To ensure that comments will be janice [email protected]. Preservation Act, 16 U.S.C. 470f, as considered, the BLM must receive SUPPLEMENTARY INFORMATION: Rodeo provided for in 36 CFR 800.2(d)(3). written comments on the Draft EIS/SA Creek Gold Inc. has proposed an Native American tribal consultations and plan amendment within 90 days
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following the date the Environmental CDCA Plan, while recognizing the transmission system engineering, Protection Agency publishes its Notice potential compatibility of solar transmission line safety, and nuisance. of Availability in the Federal Register. generation facilities on public lands, A Notice of Intent to Prepare an EIS/ The BLM will announce future meetings requires that all sites proposed for SA and Proposed Land Use Plan or hearings and any other public power generation or transmission not Amendment for the NextEra Genesis involvement activities at least 15 days identified in the Plan be considered Solar Energy Project in Riverside in advance through public notices, through the BLM land use plan County was published in the Federal media releases, and/or mailings. amendment process. If the BLM decides Register on November 23, 2009 (74 FR ADDRESSES: You may submit comments to grant a ROW for this project, the 61167). The BLM held two public related to the GSEP by any of the CDCA Plan would be amended as scoping meetings in Blythe, California, following methods: required. and Palm Desert, California, on • E-mail: The proposed action is to authorize December 10th and11th, 2009. The [email protected]. the GSEP and amend the CDCA Plan to formal scoping period ended December • Mail or other delivery service: designate the project area as available 23, 2009. Allison Shaffer, Project Manager, Palm for solar energy projects. In addition to Before including your address, phone Springs South Coast Field Office, the proposed action, the BLM is number, e-mail address, or other Bureau of Land Management, 1201 Bird analyzing an alternative that would personal identifying information in your Center Drive, Palm Springs, California reduce the project footprint by half, to comment, you should be aware that 92262. approximately 900 acres of disturbance, your entire comment—including your Copies of the GSEP Draft EIS/SA are by constructing only one power plant personal identifying information—may available from the BLM at the above for a total output of 125 MW. The BLM be made publicly available at any time. addresses. is also analyzing a dry-cooling While you can ask us in your comment FOR FURTHER INFORMATION CONTACT: alternative. All three action alternatives to withhold your personal identifying Allison Shaffer, BLM project manager, would amend the CDCA Plan to information from public review, we at (760) 833–7100. See also ADDRESSES designate the area as available for cannot guarantee that we will be able to above. commercial solar energy development. do so. SUPPLEMENTARY INFORMATION: NextEra As required under NEPA, the Draft EIS Authority: 40 CFR 1506.6, 1506.10, and 43 Energy Resources has submitted a right- analyzes a No Action alternative that CFR 1610.2 would not require a CDCA Plan of-way (ROW) application to the BLM Karla D. Norris, for development of the proposed GSEP amendment. The Draft EIS also analyzes Associate Deputy State Director. on public lands, consisting of two alternatives that reject the project, but concentrating solar electric generating amend the CDCA Plan to either: (1) [FR Doc. 2010–8905 Filed 4–16–10; 8:45 am] power plants each producing 125 Designate the project area as available BILLING CODE 4310–40–P megawatts (MW) for a total output of for future solar energy power generation approximately 250 MW of electricity at projects; or (2) designate the project area DEPARTMENT OF THE INTERIOR full development. The project would as unavailable for future solar energy use a wet-cooling tower for power plant power generation projects. The BLM National Park Service cooling. Water for the project will take into consideration the (approximately 1,644 acre-feet per year) provisions of the Energy Policy Act of Cape Cod National Seashore; South would be obtained from on-site wells. 2005 and Secretarial Order 3283 Wellfleet, Massachusetts; Cape Cod The project would include a 15-mile Enhancing Renewable Energy National Seashore Advisory transmission line to the Colorado River Development on the Public Lands and Commission Substation; 5.6 miles of this line would Secretarial Order 3285 Renewable use the existing 230-kilovolt Blythe Energy Development by the Department AGENCY: National Park Service, Interior. Energy Transmission Line. The total of the Interior in responding to the ACTION: Two hundredth seventy-third expected project footprint is about 1,800 NextEra application. notice of meeting. acres of BLM-managed lands for the two The BLM has entered into a SUMMARY: Notice is hereby given in power plants, and approximately 80 to Memorandum of Understanding with accordance with the Federal Advisory 90 acres in support of ancillary the CEC to conduct a joint Committee Act (Pub. L. 92–463, 86 Stat. facilities. The project is sited in an environmental review of solar thermal 770, 5 U.S.C. App 1, Section 10) of a undeveloped area of the Sonoran Desert, projects that are proposed on Federal meeting of the Cape Cod National near Ford Dry Lake, north of Interstate land managed by the BLM. The BLM Seashore Advisory Commission. 10 in Riverside County, approximately and CEC have agreed to conduct joint 25 miles west of Blythe, California, on environmental review of the project in DATES: The meeting of the Cape Cod lands managed by the BLM. The BLM’s a single combined NEPA/California National Seashore Advisory purpose and need for the GSEP is to Environmental Quality Act process and Commission will be held on May 24, respond to NextEra’s application for a document. The Draft EIS/SA analyzes 2010 at 1 p.m. ROW grant to construct, operate, and site-specific impacts of the proposed ADDRESSES: The Commission members decommission a solar power facility on project on air quality; biological, will meet in the meeting room at public lands in compliance with Title V cultural, water, soil, visual, Headquarters, 99 Marconi Station, of FLPMA (43 U.S.C. 1761), BLM ROW paleontological, and geological Wellfleet, Massachusetts. regulations, and other applicable resources; recreation; land use; noise; SUPPLEMENTARY INFORMATION: The Federal laws. The BLM will decide public health; socioeconomics; and Commission was reestablished pursuant whether to grant, grant with traffic and transportation. The Draft EIS/ to Public Law 87–126 as amended by modification, or deny a ROW to NextEra SA also addresses hazardous materials Public Law 105–280. The purpose of the for the proposed GSEP. The BLM will handling, waste management, worker Commission is to consult with the also consider amending the CDCA Plan safety, fire protection, facility design Secretary of the Interior, or his designee, (1980, as amended) in this analysis. The engineering, efficiency, reliability, with respect to matters relating to the
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development of Cape Cod National DEPARTMENT OF THE INTERIOR 2010, at 2 p.m. (EDT), 12 p.m. (MDT), Seashore, and with respect to carrying and 11 a.m. (PDT) to ensure that the out the provisions of sections 4 and 5 Bureau of Reclamation connections work properly. The one of the Act establishing the Seashore. hour test Web site is: https:// Glen Canyon Dam Adaptive The regular business meeting is being usgs.webex.com/usgs/ Management Work Group (AMWG) held to discuss the following: j.php?ED=135461697& 1. Adoption of Agenda. AGENCY: Bureau of Reclamation, UID=1123935637. 2. Approval of Minutes of Previous Interior. Note: If you have difficulties accessing the Meeting, (March 22, 2010). ACTION: Notice of public meeting test or AMWG meeting using the Web sites 3. Reports of Officers. (webinar conference call). above, attendees can browse for the WebEx meeting from the main USGS WebEx page: 4. Reports of Subcommittees. SUMMARY: The Glen Canyon Dam http://usgs.webex.com. Enter ‘‘Glen Canyon 5. Superintendent’s Report. Adaptive Management Program (AMP) Dam’’ in the search box at the top of the page, was implemented as a result of the • Update on Dune Shacks and then click on the meeting in which you • Record of Decision on the Operation of would like to participate. Recognizing some Improved Properties/Town Bylaws Glen Canyon Dam Final Environmental • computers may have difficulty accessing the Herring River Wetland Restoration Impact Statement to comply with platform, you are encouraged to call the • Wind Turbines/Cell Towers consultation requirements of the Grand WebEx number for technical assistance: 866– • Shorebird Management Canyon Protection Act (Pub. L. 102– 229–3239. If you cannot do the test run, 575) of 1992. The AMP includes a • Highlands Center Update contact Mary Daugherty (928–556–7217) at Federal advisory committee (AMWG), a the Grand Canyon Monitoring and Research • Alternate Transportation funding technical work group (TWG), a Center and arrange another time. • Other construction projects monitoring and research center, and • Land Protection independent review panels. The AMWG To view a copy of the agenda and • Salt Pond Visitor Center exhibit makes recommendations to the documents related to the above meeting, update Secretary of the Interior concerning please visit Reclamation’s Web site at: http://www.usbr.gov/uc/rm/amp/amwg/ • Storm Damage Glen Canyon Dam operations and other management actions to protect resources mtgs/10may06CC/index.html. 6. Old Business. downstream of Glen Canyon Dam ADDRESSES: Time will be allowed for 7. New Business. consistent with the Grand Canyon any individual or organization wishing Protection Act. The TWG is a 8. Date and agenda for next meeting. to make formal oral comments on the 9. Public comment. subcommittee of the AMWG and provides technical advice and call. To allow for full consideration of 10. Adjournment. recommendations to the AMWG. information by the AMWG members, written notice must be provided to The meeting is open to the public. It DATE AND TIME: The May 6, 2010, AMWG Dennis Kubly, Bureau of Reclamation, is expected that 15 persons will be able meeting will begin at 2 p.m. (EDT), 12 Upper Colorado Regional Office, 125 to attend the meeting in addition to p.m. (MDT), and 11 a.m. (PDT) and Commission members. conclude three (3) hours later in the South State Street, Room 6107, Salt Interested persons may make oral/ respective time zones. Lake City, Utah, 84138; telephone 801– written presentations to the Commission Conference Call Phone Number: The 524–3715; facsimile 801–524–3858; e- during the business meeting or file dial in number for the conference call is mail at [email protected] at least five (5) written statements. Such requests 203–320–3258; the pass code is: days prior to the call. Any written should be made to the park 1421568. The toll free number is: 888– comments received will be provided to superintendent prior to the meeting. 790–7012; the pass code is: 1421568. the AMWG members. Before including your address, phone There will be limited ports available, so FOR FURTHER INFORMATION CONTACT: number, e-mail address, or other if you wish to participate, please contact Dennis Kubly, Bureau of Reclamation, personal identifying information in your Linda Whetton at 801–524–3880 by telephone 801–524–3715; facsimile comment, you should be aware that April 30, 2010, to register. 801–524–3858; e-mail at your entire comment—including your Webex Webinar Information: In [email protected]. personal identifying information—may addition to the conference call line, a be made publicly available at any time. WebEx webinar has been set up for this SUPPLEMENTARY INFORMATION: The While you can ask us in your comment meeting. The WebEx webinar Web site purpose of the conference call will be to withhold your personal identifying for the May 6, 2010 AMWG meeting is: for the AMWG to review the AMP information from public review, we https://usgs.webex.com/usgs/ Proposed New Budget Process and Draft cannot guarantee that we will be able to j.php?ED=135461657& Budget for Fiscal Years 2011–12. do so. UID=1123935522. The WebEx webinar Before including your name, address, FOR FURTHER INFORMATION CONTACT: does not have audio functionality so if you plan to participate in the webinar, phone number, e-mail address, or other Further information concerning the personal identifying information in your meeting may be obtained from the you must dial into the telephone comment, you should be aware that Superintendent, Cape Cod National number listed above. your entire comment—including your Seashore, 99 Marconi Site Road, If you plan to participate in the personal identifying information—may Wellfleet, MA 02667. meeting via WebEx, please ensure your system is able to connect by going to be made publicly available at any time. April 6, 2010. http://www.webex.com/lp/jointest/. You While you can ask us in your comment George E. Price, Jr. can also ‘‘take a tour’’ at http:// to withhold your personal identifying Superintendent. www.webex.com/go/quick_tour. information from public review, we [FR Doc. 2010–8972 Filed 4–16–10; 8:45 am] A one hour ‘‘test run’’ will be cannot guarantee that we will be able to BILLING CODE P conducted on Wednesday, April 21, do so.
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Dated: April 13, 2010. DEPARTMENT OF LABOR DEPARTMENT OF LABOR Dennis Kubly, Chief, Adaptive Management Group, Employment and Training Employment and Training Environmental Resources Division, Upper Administration Administration Colorado Regional Office, Salt Lake City, [TA–W–63,052] Utah. [TA–W–70,599] [FR Doc. 2010–8896 Filed 4–16–10; 8:45 am] Chrysler LLC, St. Louis North BILLING CODE 4310–MN–P Innovion Corporation, Gresham, Assembly Plant, Including On-Site Oregon; Notice of Affirmative Leased Workers From HAAS TCM, Inc., Determination Regarding Application Logistics Services, Inc., Diversified DEPARTMENT OF LABOR for Reconsideration Contract Service, Inc. #639, and Logistics Management Services, Inc., Employment and Training On March 16, 2010, the Department Fenton, MO; Amended Certification Administration received the petitioner’s application Regarding Eligibility To Apply for [TA–W–71,291] (dated March 2, 2010) requesting Worker Adjustment Assistance and administrative reconsideration of the Alternative Trade Adjustment Modine Manufacturing Company, negative determination regarding Assistance Pemberville, OH; Notice of Affirmative workers’ eligibility to apply for Trade In accordance with section 223 of the Determination Regarding Application Adjustment Assistance (TAA) Trade Act of 1974 (19 U.S.C. 2273), and for Reconsideration applicable to workers and former section 246 of the Trade Act of 1974 (26 By application dated March 10, 2010, workers of the subject firm. The U.S.C. 2813), as amended, the a petitioner requested administrative determination was issued on December Department of Labor issued a reconsideration of the negative 15, 2009, and the Notice of Certification of Eligibility to Apply for determination regarding workers’ Determination was published in the Worker Adjustment Assistance and eligibility to apply for Trade Adjustment Federal Register on February 16, 2010 Alternative Trade Adjustment Assistance (TAA) applicable to workers (75 FR 7034). Assistance on April 14, 2008, applicable to workers of Chrysler LLC, St. Louis and former workers of the subject firm. The initial investigation resulted in a North Assembly Plant, Fenton, The determination was issued on negative determination based on the February 12, 2010. The Notice of Missouri. The notice was published in findings that there was no increase in the Federal Register on May 2, 2008 (73 Determination was published in the imports or shift/acquisition of ion Federal Register on March 12, 2010 (75 FR 24317). implantation services by the workers’ The certification was subsequently FR 11925). firm or customers. The workers’ The initial investigation resulted in a amended on November 18, 2008 to separations were held to be attributable negative determination based on the include on-site leased workers from to a major customer cancelling a finding that imports of Class 8 heavy HAAS TCM, amended on December 9, contract with the workers’ firm in order duty trucks did not contribute 2008 to include on-site leased workers importantly to worker separations at the to perform ion implantation services in- from Logistics Services, Inc., and subject firm and no shift of production house. amended on October 30, 2009 to include to a foreign source occurred. In the request for reconsideration, the on-site leased workers from Diversified In the request for reconsideration, the petitioner provided additional Contract Service, Inc., #639. Based on information provided by a petitioner provided additional information regarding customers of the representative of the State of Missouri information pertaining to the articles subject firm. manufactured at the subject firm and to Department of Economic Development, The Department has carefully Division of Workforce Development, in customers of the subject firm. reviewed the request for reconsideration The Department has carefully a Trade Adjustment Assistance petition and the existing record, and has reviewed the request for reconsideration (TA–W–72,679) that workers of determined that the Department will and the existing record and has Logistics Management Services, Inc. conduct further investigation to determined that the Department will worked on-site at the Chrysler LLC, conduct further investigation to determine if the workers meet the Fenton, Missouri plant (Logistics determine if the workers meet the eligibility requirements of the Trade Act Management Services, Inc. workers ‘‘ eligibility requirements of the Trade Act of 1974. sequenced the Dodge Ram pickup truck of 1974. frames to be the first item loaded onto Conclusion the assembly line’’) and that the Conclusion After careful review of the workers’ schedules were ‘‘under the After careful review of the application, I conclude that the claim is direct control of the production scheduling department’’ at the North application, I conclude that the claim is of sufficient weight to justify Assembly Plant, the Department of sufficient weight to justify reconsideration of the U.S. Department reconsideration of the U.S. Department reviewed the certification for workers of of Labor’s prior decision. The the subject firm. of Labor’s prior decision. The application is, therefore, granted. application is, therefore, granted. Based on the new information Signed at Washington, DC, this 31st day of provided by the State of Missouri, the Signed at Washington, DC, this 1st day of March, 2010. Department is amending this April, 2010. Del Min Amy Chen, certification to include workers leased Del Min Amy Chen, Certifying Officer, Division of Trade from Logistics Management Services, Certifying Officer, Division of Trade Adjustment Assistance. Inc. working on-site at the Fenton, Adjustment Assistance. Missouri location of Chrysler LLC. [FR Doc. 2010–8872 Filed 4–16–10; 8:45 am] [FR Doc. 2010–8873 Filed 4–16–10; 8:45 am] The intent of the Department’s BILLING CODE 4510–FN–P BILLING CODE 4510–FN–P certification is to include all workers
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employed at Chrysler LLC, St. Louis by General Motors and is currently Manpower, Inc., Netsource, Inc., Quality North Assembly Plant, Fenton, Missouri known as General Motors Components Logic, Inc., Spherion Corporation, who were adversely affected by Holdings LLC. Workers separated from Stilwell Baker, Stratus Global Partners, increased imports of Dodge Ram full- employment at the subject firm had Syncro Design, LLC, Techlink Systems, sized pickup trucks. their wages reported under two separate Technical Aid Corp., D.B.A. TAC The amended notice applicable to unemployment insurance (UI) tax Worldwide Company, Trinite, Inc., Volt TA–W–63,052 is hereby issued as accounts under the names of General Information Sciences, Inc., K Force, SHI, follows: Motors Components Holdings LLC and and Supply Source, Vancouver, All workers of Chrysler LLC, St. Louis Delphi Thermal Systems. Washington. North Assembly Plant, including on-site Accordingly, the Department is In accordance with Section 223 of the leased workers from HAAS TCM, Inc., amending this certification to properly Trade Act of 1974 (19 U.S.C. 2273), and Logistics Services, Inc., Diversified Contract reflect this matter. Section 246 of the Trade Act of 1974 (26 Service, Inc., #639, and Logistics The intent of the Department’s U.S.C. 2813), as amended, the Management Services, Inc., Fenton, Missouri, certification is to include all workers of Department of Labor issued a who became totally or partially separated Delphi Thermal Systems, currently Certification of Eligibility to Apply for from employment on or after March 18, 2007, Worker Adjustment Assistance and through April 14, 2010, are eligible to apply known as General Motors Components for adjustment assistance under Section 223 Holdings LLC, Lockport, New York, Alternative Trade Adjustment of the Trade Act of 1974, and are also eligible who were adversely affected by imports Assistance on December 19, 2008 to apply for alternative trade adjustment of articles like or directly competitive applicable to workers of Hewlett assistance under Section 246 of the Trade Act with automotive heat exchanger Packard Company, Imaging and Printing of 1974. products and HVAC modules. Group, Edgeline Development & Light Signed at Washington, DC this 31st day of The amended notice applicable to Production Systems (LPS) Operations March, 2010. TA–W–63,818 is hereby issued as Division, Edgeline Development and Del Min Amy Chen, follows: Operations, including on-site leased Certifying Officer, Division of Trade All workers of Delphi Thermal Systems, workers from Adea Solutions Company, Adjustment Assistance. currently known as General Motors Artech Information Systems, ATP [FR Doc. 2010–8880 Filed 4–16–10; 8:45 am] Components Holdings LLC, Lockport Personnel Services Corporation, CDI BILLING CODE 4510–FN–P Operations, Lockport, New York, who Corporation, Finesse Personnel became totally or partially separated from Associates (W.C. Barlow & Associates), employment on or after August 4, 2007 Hightower Technology Capital, Inc., DEPARTMENT OF LABOR through September 25, 2010 are eligible to Kelly Services, Inc., Lionbridge apply for adjustment assistance under Technologies, Inc., (AKA Veritest), Employment and Training Section 223 of the Trade Act of 1974, and are Northwest Software, Inc., PDG (Product Administration also eligible to apply for alternative trade adjustment assistance under Section 246 of Design Group), Radiant Systems, Inc., Siemens, Inc., Synova, Inc., Technical [TA–W–63,818] the Trade Act of 1974. Aid Corporation, d/b/a TAC Worldwide Delphi Thermal Systems Currently Signed in Washington, DC, this 6th day of Company, and Volt Information Known as General Motors April 2010. Sciences, Inc. The notice was published Components Holdings LLC, Lockport Elliott S. Kushner, in the Federal Register on January 14, Operations, Lockport, NY; Amended Certifying Officer, Division of Trade 2009 (74 FR 2136). Certification Regarding Eligibility To Adjustment Assistance. At the request of a petitioner, the Apply for Worker Adjustment [FR Doc. 2010–8881 Filed 4–16–10; 8:45 am] Department reviewed the certification for workers of the subject firm. The Assistance and Alternative Trade BILLING CODE 4510–FN–P Adjustment Assistance workers produce engineering specifications, software, and firmware In accordance with Section 223 of the DEPARTMENT OF LABOR used in the manufacture of HP Edgeline Trade Act of 1974 (19 U.S.C. 2273), and printers. An important part of this work Section 246 of the Trade Act of 1974 (26 Employment and Training involved the production and testing of U.S.C. 2813), as amended, the Administration printer prototypes. Department of Labor issued a New information shows that workers [TA–W–64,633] Certification of Eligibility to Apply for leased from the above mentioned firms Worker Adjustment Assistance and Amended Certification Regarding were employed on-site at the Alternative Trade Adjustment Eligibility To Apply for Worker Vancouver, Washington location of Assistance on September 25, 2008, Adjustment Assistance and Alternative Hewlett Packard Company, Imaging and applicable to workers of Delphi Thermal Trade Adjustment Assistance Printing Group, Edgeline Development Systems, Lockport Operations, & Light Production Systems (LPS) Lockport, New York. The notice was Hewlett Packard Company, Imaging Operations Division, Edgeline published in the Federal Register on and Printing Group, Edgeline Development and Operations. The October 8, 2008 (73 FR 58981). Development & Light Production Department has determined that these At the request of the State Agency, the Systems (LPS), Operations Division, workers were sufficiently under the Department reviewed the certification Edgeline Development and Operations, control of the subject firm to be for workers of the subject firm. The Including On-Site Leased Workers from considered leased workers. workers are engaged in activities related Adecco, ATA Engineering, Inc., CCSI, Based on these findings, the to the production of automotive heat Inc., Collabers (Formerly Global Department is amending this exchanger products and HVAC Consultants, Inc.), COMSYS Information certification to include workers leased modules. Technology Services, Inc., Conficio, from the above mentioned firms New information shows that LLC, DB Professionals, Inc., Everest working on-site at the Vancouver, following a bankruptcy agreement, Consultants, Inc., Global Consultants, Washington location of Hewlett Packard Delphi Thermal Systems was taken over Inc., H.L. Yoh Company LLC, Company, Imaging and Printing Group,
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Edgeline Development & Light Trade Act of 1974 (26 U.S.C. 2813), as DEPARTMENT OF LABOR Production Systems (LPS) Operations amended, the Department of Labor Division, Edgeline Development and issued a Certification of Eligibility to Employment and Training Operations. apply for Worker Adjustment Assistance Administration The amended notice applicable to and Alternative Trade Adjustment [TA–W–63,052] TA–W–64,633 is hereby issued as Assistance on June 17, 2009, applicable follows: to workers of ABB Inc., Wichita Falls, Chrysler LLC, St. Louis North All workers of Hewlett Packard Company, Texas. The notice was published in the Assembly Plant, Including On-Site Imaging and Printing Group, Edgeline Federal Register July 14, 2009 (74 FR Leased Workers From Haas TCM, Inc., Development and Light Production Systems 34038). Logistics Services, Inc. Diversified (LPS) Operations, Edgeline Development Contract Service, Inc. #639, and Operations, Vancouver, Washington, At the request of the State Agency, the Logistics Management Services, Inc. including on-site leased workers from Adea Department reviewed the certification Fenton, MO; Amended Certification Solutions Company, Artech Information for workers of the subject firm. The Regarding Eligibility To Apply for Systems, ATP Personnel Services workers are engaged in the production Corporation, CDI Corporation, Finesse Worker Adjustment Assistance and Personnel Associates (W.C. Barlow & of electrical components. Alternative Trade Adjustment Associates), Hightower Technology Capital, New information shows that workers Assistance Inc., Kelly Services, Inc., Lionbridge leased from Spherion Staffing, Dividend In accordance with Section 223 of the Technologies, Inc. (aka VeriTest), Northwest Staffing, MyStaff, and Zero Chaos were Software, Inc., PDG (Product Design Group), Trade Act of 1974 (19 U.S.C. 2273), and Radiant Systems, Inc., Siemens, Inc., Synova, employed on-site by the Wichita Falls, Section 246 of the Trade Act of 1974 (26 Inc., Technical Aid Corporation d/b/a TAC Texas location of ABB, Inc. The U.S.C. 2813), as amended, the Worldwide Company, Volt Information Department has determined that these Department of Labor issued a Sciences, Inc., Adecco, ATA Engineering, workers were sufficiently under the Certification of Eligibility to Apply for Inc., CCSI, Inc., Collabera, (formerly known control and in support of the subject Worker Adjustment Assistance and as Global Consultants, Inc.), COMSYS firm to be considered leased workers. Alternative Trade Adjustment Information Technology Services, Inc., Conficio, LLC, DB Professionals, Inc., Everest Based on these findings, the Assistance on April 14, 2008, applicable Consultants, Inc., Global Consultants, Inc., Department is amending this to workers of Chrysler LLC, St. Louis H.L. Yoh Company, LLC. Manpower, Inc., certification to include workers leased North Assembly Plant, Fenton, NetSource, Inc., Quality Logic, Inc., Spherion from Spherion Staffing, Dividend Missouri. The notice was published in Corporation, Stilwell Baker, Stratus Global Staffing, MyStaff, and Zero Chaos the Federal Register on May 2, 2008 (73 Partners, Syncro Design, LLC, TechLink FR 24317). Systems, Technical Aid Corp., d/b/a TAC working on-site at the Wichita Falls, The certification was subsequently Worldwide Company, Trinite, Inc., K Force, Texas location of ABB, Inc. amended on November 18, 2008 to SHI and Supply Source, who became totally The amended notice applicable to include on-site leased workers from or partially separated from employment on or TA–W–65,797 is hereby issued as HAAS TCM, amended on December 9, after December 3, 2007 through December 19, 2010, through April 27, 2011, are eligible to follows: 2008 to include on-site leased workers apply for adjustment assistance under All workers of ABB, Inc., include on-site from Logistics Services, Inc., and Section 223 of the Trade Act of 1974, and are leased workers from Spherion Staffing, amended on October 30, 2009 to include also eligible to apply for alternative trade Dividend Staffing, MyStaff, and Zero Chaos on-site leased workers from Diversified adjustment assistance under Section 246 of Wichita Falls, Texas, who became totally or Contract Service, Inc., #639. the Trade Act of 1974. partially separated from employment on or Based on information provided by a Signed at Washington, DC this 12th day of after April 13, 2008 through June 17, 2011 are representative of the State of Missouri April 2009. eligible to apply for adjustment assistance Department of Economic Development, Elliott S. Kushner, under Section 223 of the Trade Act of 1974, Division of Workforce Development, in Certifying Officer, Division of Trade and are also eligible to apply for alternative a Trade Adjustment Assistance petition Adjustment Assistance. trade adjustment assistance under Section (TA–W–72,679) that workers of [FR Doc. 2010–8882 Filed 4–16–10; 8:45 am] 246 of the Trade Act of 1974. Logistics Management Services, Inc. worked on-site at the Chrysler LLC, BILLING CODE 4510–FN–P Signed in Washington, DC this 7th day of Fenton, Missouri plant (Logistics April 2010. Management Services, Inc. workers DEPARTMENT OF LABOR Elliott S. Kushner, ‘‘sequenced the Dodge Ram pickup truck Certifying Officer, Division of Trade frames to be the first item loaded onto Employment and Training Adjustment Assistance. the assembly line’’) and that the Administration [FR Doc. 2010–8883 Filed 4–16–10; 8:45 am] workers’ schedules were ‘‘under the direct control of the production [TA–W–65,797] BILLING CODE 4510–FN–P scheduling department’’ at the North ABB, Inc., Including On-Site Leased Assembly Plant, the Department Workers From Spherion Staffing, reviewed the certification for workers of Dividend Staffing, Mystaff, and Zero the subject firm. Chaos, Wichita Falls, TX; Amended Based on the new information Certification Regarding Eligibility To provided by the State of Missouri, the Apply for Worker Adjustment Department is amending this Assistance and Alternative Trade certification to include workers leased Adjustment Assistance from Logistics Management Services, Inc. working on-site at the Fenton, In accordance with section 223 of the Missouri location of Chrysler LLC. Trade Act of 1974, as amended (19 The intent of the Department’s U.S.C. 2273), and section 246 of the certification is to include all workers
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employed at Chrysler LLC, St. Louis East were employed on-site at the Martin, Can-Tech, IT Services, IDEX North Assembly Plant, Fenton, Missouri Winston-Salem, North Carolina location Solutions (NWCAD), Media Logic, HL YOH, who were adversely affected by of Dell Products LP, Winston-Salem Volt, PDS, CDI Corp, Teksystems, Innovative increased imports of Dodge Ram full- (WS–1) Division. The Department has Systems, Inc., Murphy & Associates, Dell, Pfi Tech, and RMS Portland, Oregon. sized pickup trucks. determined that these workers were The amended notice applicable to sufficiently under the control of the In accordance with Section 223 of the TA–W–63,052 is hereby issued as subject firm to be considered leased Trade Act of 1974, as amended (‘‘Act’’), follows: workers. 19 U.S.C. 2273, the Department of Labor All workers of Chrysler LLC, St. Louis Based on these findings, the issued a Certification of Eligibility to North Assembly Plant, including on-site Department is amending this apply for Worker Adjustment Assistance leased workers from HAAS TCM, Inc., certification to include workers leased on October 19, 2009, applicable to Logistics Services, Inc., Diversified Contract from Staffing Solutions, South East workers of The Boeing Company, Service, Inc., #639, and Logistics working on-site at the Winston-Salem, Commercial Aircraft Group, Puget Management Services, Inc., Fenton, Missouri, North Carolina location of Dell Products Sound, Washington, (TA–W–70,520), who became totally or partially separated LP, Winston-Salem (WS–1) Division. and The Boeing Company, Commercial from employment on or after March 18, 2007, The amended notice applicable to Aircraft Group, Portland, Oregon (TA– through April 14, 2010, are eligible to apply for adjustment assistance under Section 223 TA–W–72,575 is hereby issued as W–70,520A). The notice was published of the Trade Act of 1974, and are also eligible follows: in the Federal Register on December 11, to apply for alternative trade adjustment All workers of Dell Products LP, Winston- 2009 (74 FR 65794–65795). The notice assistance under Section 246 of the Trade Act Salem (WS–1) Division, including on-site was amended on January 8, 2010 to of 1974. leased workers from Adecco, Spherion, include on-site leased workers. The Signed at Washington, DC, this 31st day of Patriot Staffing, Manpower, TEKsystems, notice was published in the Federal March, 2010. APN, ICONMA and Staffing Solutions, South Register on January 20, 2010 (75 FR East, Winston-Salem, North Carolina, who Del Min Amy Chen, 3250–3251). The workers are engaged in became totally or partially separated from Certifying Officer, Division of Trade activities related to the production of employment on or after October 13, 2008, large commercial aircraft. Adjustment Assistance. through March 1, 2012, and all workers in [FR Doc. 2010–8869 Filed 4–16–10; 8:45 am] the group threatened with total or partial The company reports that on-site leased workers from Dell, PFI Tech, and BILLING CODE 4510–FN–P separation from employment on the date of certification through two years from the date RMS were also employed on-site at both of certification, are eligible to apply for the Puget Sound, Washington and DEPARTMENT OF LABOR adjustment assistance under Chapter 2 of Portland, Oregon locations of The Title II of the Trade Act of 1974, as amended. Boeing Company, Commercial Aircraft Employment and Training Signed at Washington, DC, this 30th day of Group. The Department has determined Administration March 2010. that these workers were sufficiently under the control of the subject firm to [TA–W–72,575] Elliott S. Kushner, Certifying Officer, Division of Trade be considered leased workers. Amended Certification Regarding Adjustment Assistance. Based on these findings, the Eligibility To Apply for Worker [FR Doc. 2010–8865 Filed 4–16–10; 8:45 am] Department is amending the Adjustment Assistance BILLING CODE 4510–FN–P certification to include leased workers from Dell, PFI Tech, and RMS working Dell Products LP, Winston-Salem (WS– on-site at the Puget Sound, Washington 1) Division, Including On-Site Leased DEPARTMENT OF LABOR and Portland, Oregon locations of The Workers From Adecco, Spherion, Boeing Company, Commercial Aircraft Patriot Staffing, Manpower, Employment and Training Group. Teksystems, APN, ICONMA and Administration The amended notice applicable to the Staffing Solutions, South East Winston- TA–W–70,520 and TA–W 70,520A is [TA–W–70,520; TA–W–70,520A] Salem, North Carolina hereby issued as follows: In accordance with Section 223 of the Amended Certification Regarding ‘‘All workers of The Boeing Company, Trade Act of 1974, as amended (‘‘Act’’), Eligibility To Apply for Worker Commercial Aircraft Group, including on-site 19 U.S.C. 2273, the Department of Labor Adjustment Assistance leased workers from Comforce Corporation, issued a Certification of Eligibility to Adecco, Multax, Inconen, CTS, Hi-Tec, Apply for Worker Adjustment TA–W–70,520, The Boeing Company, Woods, Ciber, Kelly Services, Analysts Assistance on March 1, 2010, applicable Commercial Aircraft Group, Including On- International Corp, Comsys, Filter LLC, Site Leased Workers from Comforce Excell, Entegee, Chipton-Ross, Ian Martin, to workers of Dell Products LP, Corporation, Adecco, Multax, Inconen, CTS, Can-Tech, IT Services, IDEX Solutions Winston-Salem (WS–1) Division, Hi-Tec, Woods, Ciber, Kelly Services, (NWCAD), Media Logic, HL YOH, Volt, PDS, including on-site leased workers of Analysts International Corp, Comsys, Filter CDI Corp, Teksystems, Innovative Systems, Adecco, Spherion, Patriot Staffing, LLC, Excell, Entegee, Chipton-Ross, Ian Inc., Murphy & Associates, Dell, PFI Tech, Manpower, TEKsystems, APN, and Martin, Can-Tech, IT Services, IDEX and RMS, Puget Sound, Washington (TA–W– ICONMA, Winston-Salem, North Solutions (NWCAD), Media Logic, HL YOH, 70,520), and Portland, Oregon (TA–W– Carolina. The notice will be published Volt, PDS, CDI Corp, Teksystems, Innovative 70,520A), who became totally or partially soon in the Federal Register. Systems, Inc., Murphy & Associates, Dell, PFI separated from employment on or after May At the request of the State Agency, the Tech, and RMS Puget Sound, Washington. 22, 2008, through October 19, 2011, and all Department reviewed the certification TA–W–70,520A, The Boeing Company, workers in the group threatened with total or Commercial Aircraft Group, Including On- partial separation from employment on the for workers of the subject firm. The Site Leased Workers from Comforce date of certification through two years from workers are engaged in production of Corporation, Adecco, Multax, Inconen, CTS, the date of certification, are eligible to apply desktop computers. Hi-Tec, Woods, Ciber, Kelly Services, for adjustment assistance under Chapter 2 of The company reports that workers Analysts International Corp, Comsys, Filter Title II of the Trade Act of 1974, as leased from Staffing Solutions, South LLC, Excell, Entegee, Chipton-Ross, Ian amended.’’
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Signed in Washington, DC, this 26th day of through January 22, 2012, and all workers in All workers of Auburn Hosiery Mills, Inc., March 2010. the group threatened with total or partial Delta Galil, including on-site leased workers Michael W. Jaffe, separation from employment on date of from Quality Personnel, Auburn, Kentucky, certification through two years from the date Certifying Officer, Division of Trade who became totally or partially separated of certification, are eligible to apply for Adjustment Assistance. from employment on or after June 18, 2008, adjustment assistance under Chapter 2 of through July 8, 2011, and all workers in the [FR Doc. 2010–8871 Filed 4–16–10; 8:45 am] Title II of the Trade Act of 1974, as amended. group threatened with total or partial BILLING CODE 4510–FN–P Signed in Washington, DC, this 6th day of separation from employment on the date of April, 2010. certification through two years from the date of certification, are eligible to apply for Michael W. Jaffe, DEPARTMENT OF LABOR adjustment assistance under Chapter 2 of Certifying Officer, Division of Trade Title II of the Trade Act of 1974, as amended. Adjustment Assistance. Employment and Training Signed in Washington, DC, this 5th day of [FR Doc. 2010–8891 Filed 4–16–10; 8:45 am] Administration April, 2010. BILLING CODE 4510–FN–P [TA–W–71,482] Elliott S. Kushner, Certifying Officer, Division of Trade Trane a Subsidiary of Ingersoll Rand DEPARTMENT OF LABOR Adjustment Assistance. Including On-Site Leased Workers [FR Doc. 2010–8890 Filed 4–16–10; 8:45 am] From Aerotek, Express Personnel Employment and Training BILLING CODE 4510–FN–P Services, Select Staffing, and Administration Industrial Mechanical Contractors, Inc. [TA–W–71,321] Pueblo, CO; Amended Certification DEPARTMENT OF LABOR Regarding Eligibility To Apply for Auburn Hosiery Mills, Inc., Currently Worker Adjustment Assistance Known as Delta Galil, Including On- Employment and Training Administration In accordance with Section 223 of the Site Leased Workers From Quality Personnel, Auburn, KY; Amended Trade Act of 1974, as amended (‘‘Act’’), [TA–W–73,251] 19 U.S.C. 2273, the Department of Labor Certification Regarding Eligibility To issued a Certification of Eligibility to Apply for Worker Adjustment AMTEX Incorporated, a Subsidiary of Apply for Worker Adjustment Assistance Hayashi Telepu Company, Including Assistance on January 22, 2010, In accordance with section 223 of the On-Site Leased Workers of Availability applicable to workers of Trane, a Trade Act of 1974, as amended (‘‘Act’’), Personnel Services, Conerstone subsidiary of Ingersoll Rand, including 19 U.S.C. 2273, the Department of Labor Staffing Solutions, Priority Business on-site leased workers from Aerotek, issued a Certification of Eligibility to Services and Volt, Inc. Manteca, CA; Express Personnel Staffing, and Select Apply for Worker Adjustment Amended Certification Regarding Staffing, Pueblo, Colorado. The notice Assistance on July 8, 2009, applicable to Eligibility To Apply for Worker was published in the Federal Register workers of Auburn Hosiery Mills, Inc., Adjustment Assistance on March 5, 2010 (75 FR 10320). including on-site leased workers from At the request of the State Agency, the In accordance with Section 223 of the Quality Personnel, Auburn, Kentucky. Trade Act of 1974, as amended (‘‘Act’’), Department reviewed the certification The notice was published in the Federal 19 U.S.C. 2273, the Department of Labor for workers of the subject firm. The Register on August 19, 2009 (74 FR issued a Certification of Eligibility to workers are engaged in activities related 41933). to the production of air conditioning At the request of the state agency, the apply for Worker Adjustment Assistance equipment. Department reviewed the certification on March 16, 2010. The notice will be The company reports that workers for workers of the subject firm. The published in the Federal Register soon. leased from Industrial Mechanical workers are engaged in activities related At the request of the State Agency, the Contractors, Inc. were employed on-site to distribution, administration and Department reviewed the certification at the Pueblo, Colorado location of quality control services related to for workers of the subject firm. The Trane, a subsidiary of Ingersoll Rand. apparel. workers are engaged in activities related The Department has determined that Information shows that Auburn to the production of interior automotive these workers were sufficiently under Hosiery Mills was merged into its parent carpet. the control of the subject firm to be company, Delta Galil on January 1, 2010 The company reports that workers considered leased workers. and is now known as Delta Galil. Some leased from Volt, Inc. were employed Based on these findings, the of the workers separated from on-site at the Manteca, California Department is amending this employment at the subject firm had location of Amtex, Inc., a subsidiary of certification to include workers leased their wages reported under a separate Hayashi Telepu Company. The from Industrial Mechanical Contractors, unemployment insurance (UI) tax Department has determined that these Inc. working on-site at the Pueblo, account under the name of Delta Galil. workers were sufficiently under the Colorado location of Trane, a subsidiary Accordingly, the Department is control of the subject firm to be of Ingersoll Rand. amending this certification to properly considered leased workers. The amended notice applicable to reflect this matter. Based on these findings, the TA–W–71,482 is hereby issued as The intent of the Department’s Department is amending this follows: certification is to include all workers of certification to include workers leased the subject firm who were adversely from Volt, Inc. working on-site at the All workers of Trane, a subsidiary of Manteca, California location of Amtex, Ingersoll Rand, including on-site leased affected by the shift in distribution, workers from Aerotek, Express Personnel administration and quality control Inc., a subsidiary of Hayashi Telepu Staffing, Select Staffing, and Mechanical services to Bangladesh and China. Company. Contractors, Inc., Pueblo, Colorado, who The amended notice applicable to The amended notice applicable to became totally or partially separated from TA–W–71,321 is hereby issued as TA–W–73,251 is hereby issued as employment on or after June 22, 2008, follows: follows:
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All workers of Amtex, Inc., a subsidiary of Accordingly, the Department is custom component assembly and test Hayashi Telepu Company, including on-site amending this certification to properly systems. leased workers of Availability Personnel reflect this matter. The company reports that the worker Services, Cornerstone Staffing Solutions, The intent of the Department’s Priority Business Services and Volt, Inc, group also includes workers at the Lake Manteca, California, who became totally or certification is to include all workers of Zurich, Illinois and Shelton, partially separated from employment on or the subject firm who were adversely Connecticut locations of the subject firm after January 12, 2009 through March 16, affected by increased imports of that were inadvertently omitted from 2012, and all workers in the group threatened aluminum and magnesium die casted the Department’s decision. with total or partial separation from component parts for automobiles. Accordingly, the Department is employment on the date of certification The amended notice applicable to amending this certification to include through two years from the date of TA–W–72,649 is hereby issued as workers of the Lake Zurich, Illinois and certification, are eligible to apply for follows: adjustment assistance under Chapter 2 of Shelton, Connecticut locations of the Title II of the Trade Act of 1974, as amended. All workers of Contech Castings, LLC, subject firm. including workers whose UI wages are The intent of the Department’s Signed in Washington, DC, this 8th day of reported through Contech US LLC, including April 2010. certification is to include all workers of on-site leased workers from On Staff USA, the subject firm who were adversely Elliott S. Kushner, Dowagiac, Michigan, who became totally or affected by the shift in production of Certifying Officer, Division of Trade partially separated from employment on or Adjustment Assistance. after October 19, 2008, through February 23, custom component assembly and test systems to Brazil, China and Germany. [FR Doc. 2010–8894 Filed 4–16–10; 8:45 am] 2012, and all workers in the group threatened with total or partial separation from The amended notice applicable to BILLING CODE 4510–FN–P employment on date of certification through TA–W–72,075 is hereby issued as two years from the date of certification, are follows: eligible to apply for adjustment assistance DEPARTMENT OF LABOR under Chapter 2 of Title II of the Trade Act All workers of Assembly & Test of 1974, as amended. Worldwide, Inc., Livonia, Michigan (TA–W– Employment and Training 72,075); Assembly & Test Worldwide, Inc., Administration Signed in Washington, DC, this 6th day of Saginaw, Michigan (TA–W–72,075A); April 2010. Assembly & Test Worldwide, Inc., Lebanon, Elliott S. Kushner Missouri (TA–W–72,075B); Assembly & Test [TA–W–72,649] Certifying Officer, Division of Trade Worldwide, Inc., Dayton, Ohio (TA–W– Adjustment Assistance. 72,075C); Assembly & Test Worldwide, Lake Contech Castings, LLC, Including Zurich, Illinois (TA–W–72,075D); and [FR Doc. 2010–8893 Filed 4–16–10; 8:45 am] Workers Whose Unemployment Assembly & Test Worldwide, Shelton, Insurance (UI) Wages Are Reported BILLING CODE 4510–FN–P Connecticut (TA–W–72,075E), who became Through Contech Us LLC, Including totally or partially separated from On-Site Leased Workers From On Staff employment on or after August 10, 2008, USA, Dowagiac, MI; Amended DEPARTMENT OF LABOR through January 27, 2012, and all workers in Certification Regarding Eligibility To the group threatened with total or partial Employment and Training Apply for Worker Adjustment separation from employment on the date of Administration Assistance certification through two years from the date of certification, are eligible to apply for [TA–W–72,075; TA–W–72,075D; TA–W– adjustment assistance under Chapter 2 of In accordance with Section 223 of the 72,075E] Title II of the Trade Act of 1974, as amended. Trade Act of 1974, as amended (‘‘Act’’), 19 U.S.C. 2273, the Department of Labor Amended Certification Regarding Signed at Washington, DC this 6th day of issued a Certification of Eligibility to Eligibility To Apply for Worker April 2010. Apply for Worker Adjustment Adjustment Assistance Michael W. Jaffe, Certifying Officer, Division of Trade Assistance on February 23, 2010, TA–W–72,075, Assembly & Test applicable to workers of Contech Adjustment Assistance. Worldwide, Inc., Livonia, Michigan. [FR Doc. 2010–8892 Filed 4–16–10; 8:45 am] Castings, LLC, including on-site leased TA–W–72,075D, Assembly & Test BILLING CODE 4510–FN–P workers from On Staff USA, Dowagiac, Worldwide, Inc., Lake Zurich, Michigan. The notice will soon be Illinois. published in the Federal Register. TA–W–72,075E, Assembly & Test DEPARTMENT OF LABOR At the request of the State Agency, the Worldwide, Inc., Shelton, Department reviewed the certification Connecticut. Employment and Training for workers of the subject firm. The In accordance with Section 223 of the Administration workers are engaged in activities related Trade Act of 1974, as amended (‘‘Act’’), to the production of aluminum and 19 U.S.C. 2273, the Department of Labor [TA–W–71,272; TA–W–71,272A; TA–W– magnesium die casted component parts issued a Certification of Eligibility to 71,272B; TA–W–71,272C; TA–W–71,272D; for automobiles. Apply for Worker Adjustment TA–W–71,272E; TA–W–71,272F; TA–W– New information shows that the Assistance on January 27, 2010, 71,272G; TA–W–71,272H; TA–W–71,272I; assets of Contech US LLC were applicable to workers of Assembly & TA–W–71,272J; TA–W–71,272K; TA–W– purchased in June 2009 and a new Test Worldwide, Inc., Livonia, 71,272L; TA–W–71,272M; TA–W–71,272N; TA–W–71,272O] company, Contech Casting LLC was Michigan. The notice was published in formed. Some workers separated from the Federal Register on March 5, 2010 Amended Certification Regarding employment at the subject firm had (75 FR 10321). At the request of a Eligibility To Apply for Worker their wages reported under a separate company official, the Department Adjustment Assistance unemployment insurance (UI) tax reviewed the certification for workers of account under the name of Contech US the subject firm. The workers design, TA–W–71,272, Crucible Materials LLC. engineer, manufacture and integrate Corporation, Syracuse, New York.
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TA–W–71,272A, Crucible Materials workers of the Crucible Materials DEPARTMENT OF LABOR Corporation, Crucible Service Corporation, Crucible Service Centers Center, Auburn, Massachusetts. located in Auburn, Massachusetts; Employment and Training TA–W–71,272B, Crucible Materials Meadville, Pennsylvania; Troy, Administration Corporation, Crucible Service Michigan; Butler, Wisconsin; [TA–W–71,248] Center, Meadville, Pennsylvania. Miamisburg, Ohio; Chicago, Illinois; TA–W–71,272C, Crucible Materials Minneapolis, Minnesota; Charlotte, International Business Machines Corporation, Crucible Service North Carolina; Huntsville, Alabama; Corporation, Global Technology Center, Troy, Michigan. Arlington, Texas; Grand Rapids, Services Business Unit, Integrated TA–W–71,272D, Crucible Materials Michigan; St. Louis, Missouri; Technology Services, Cost and Corporation, Crucible Service Expense Team, Working From Various Center, Butler, Wisconsin. Cleveland, Ohio; Valley View, Ohio; and Romeoville, Illinois. States in the United States, Including TA–W–71,272E, Crucible Materials On-Site Leased Workers From Datrose, Corporation, Crucible Service The intent of the Department’s Inc., Reporting to Armonk, NY; Center, Miamisburg, Ohio. certification is to include all workers of Amended Certification Regarding TA–W–71,272F, Crucible Materials the subject firm who were adversely Eligibility To Apply for Worker Corporation, Crucible Service affected by the increased imports of Adjustment Assistance Center, Chicago, Illinois. steel components. TA–W–71,272G, Crucible Materials In accordance with section 223 of the Corporation, Crucible Service The amended notice applicable to Trade Act of 1974, as amended (‘‘Act’’), Center, Minneapolis, Minnesota. TA–W–71,272 is hereby issued as 19 U.S.C. 2273, the Department of Labor TA–W–71,272H, Crucible Materials follows: issued a Certification of Eligibility to Corporation, Crucible Service ‘‘All workers of Crucible Materials apply for Worker Adjustment Assistance Center, Charlotte, North Carolina. Corporation, Syracuse, New York (TA–W– on July 31, 2009, applicable to workers TA–W–71,272I, Crucible Materials 71,272), including the Crucible Service of International Business Machines Corporation, Crucible Service Centers located in Auburn, Massachusetts Corporation, Global Technology Center, Huntsville, Alabama. (TA–W–71,272A); Meadville, Pennsylvania Services Business Unit, Integrated TA–W–71,272J, Crucible Materials (TA–W–71,272B); Troy, Michigan (TA–W– Technology Services, Cost and Expense Corporation, Crucible Service 71,272C); Butler, Wisconsin (TA–W– Team working from various states in the Center, Arlington, Texas. 71,272D); Miamisburg, Ohio (TA–W– United States, reporting to Armonk, TA–W–71,272K, Crucible Materials 71,272E); Chicago, Illinois (TA–W–71,272F); New York. The notice will be published Corporation, Crucible Service Minneapolis, Minnesota (TA–W–71,272G); soon in the Federal Register. Center, Grand Rapids, Michigan. Charlotte, North Carolina (TA–W–71,272H); At the request of the State Agency, the TA–W–71,272L, Crucible Materials Huntsville, Alabama (TA–W–71,272I); Department reviewed the certification Corporation, Crucible Service Arlington, Texas (TA–W–71,272J); Grand for workers of the subject firm. The Center, St. Louis, Missouri. Rapids, Michigan (TA–W–71,272K); St. workers are engaged in activities related TA–W–71,272M, Crucible Materials Louis, Missouri (TA–W–71,272L); Cleveland, to support for the Global Technology Corporation, Crucible Service Ohio (TA–W–71,272M), Valley View, Ohio Services Business Unit. Center, Cleveland, Ohio. (TA–W–71,272N); and Romeoville, Illinois The company reports that workers TA–W–71,272N, Crucible Materials (TA–W–71,272O) who became totally or leased from Datrose, Inc., were Corporation, Crucible Service partially separated from employment on or employed on-site at the Armonk, New Center, Valley View, Ohio. after June 16, 2008, through December 14, York, location of International Business TA–W–71,272O, Crucible Materials 2011, and all workers in the group threatened Machines Corporation, Global Corporation, Crucible Service with total or partial separation from Technology Services Business Unit, Center, Romeoville, Illinois. employment on the date of certification Integrated Technology Services, Cost In accordance with Section 223 of the through two years from the date of and Expense Team. The Department has Trade Act of 1974, as amended (‘‘Act’’), certification, are eligible to apply for determined that these workers were 19 U.S.C. 2273, the Department of Labor adjustment assistance under Chapter 2 of sufficiently under the control of the issued a Certification of Eligibility to Title II of the Trade Act of 1974, as subject firm to be considered leased Apply for Worker Adjustment amended.’’ workers. Assistance on December 14, 2009, Signed in Washington, DC this 12th day of Based on these findings, the applicable to the workers of Crucible March, 2010. Department is amending this Materials Corporation, Syracuse, New Del Min Amy Chen, certification to include workers leased York. The Department’s Notice was from Datrose, Inc., working on-site at published in the Federal Register on Certifying Officer, Division of Trade Adjustment Assistance. the Armonk, New York location of February 16, 2010 (75 FR 7032). International Business Machines [FR Doc. 2010–8889 Filed 4–16–10; 8:45 am] At the request of a company official, Corporation, Global Technology the Department reviewed the BILLING CODE 4510–FN–P Services Business Unit, Integrated certification for workers of the subject Technology Services, Cost and Expense firm. The workers are engaged in Team. activities related to the production of The amended notice applicable to steel components. TA–W–71,248 is hereby issued as New findings show that a significant follows: proportion or number of workers are All workers of International Business separated at each of the above-listed Machines Corporation, Global Technology locations of the subject firm during the Services Business Unit, Integrated relevant time period. Technology Services, Cost and Expense Accordingly, the Department is Team, including on-site leased workers from amending this certification to include Datrose, Inc., working in various states but
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reporting to Armonk, New York, who became All workers of Resinoid Engineering The amended notice applicable to totally or partially separated from Corporation, Hebron, Ohio (TA–W–71,175) TA–W–71,049 is hereby issued as employment on or after June 1, 2008, through and Heath, Ohio (TA–W–71,175A) who follows: July 31, 2011, and all workers in the group became totally or partially separated from threatened with total or partial separation employment on or after June 4, 2008 through All workers of Chrysler Group LLC, from employment on date of certification January 25, 2012, and all workers in the formerly known as Chrysler LLC, Warren through two years from the date of group threatened with total or partial Office Building, including on-site leased certification, are eligible to apply for separation from employment on the date of workers from Product Action International, adjustment assistance under Chapter 2 of certification through two years from the date LLC, Warren, Michigan, who became totally Title II of the Trade Act of 1974, as amended. of certification, are eligible to apply for or partially separated from employment on or after May 27, 2008, through March 19, 2012, Signed in Washington, DC, this 8th day of adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended. and all workers in the group threatened with April, 2010. total or partial separation from employment Elliott S. Kushner, Signed in Washington, DC, this day of on the date of certification through two years Certifying Officer, Division of Trade April 2010. from the date of certification, are eligible to Adjustment Assistance. Elliott S. Kushner, apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, [FR Doc. 2010–8888 Filed 4–16–10; 8:45 am] Certifying Officer, Division of Trade as amended. BILLING CODE 4510–FN–P Adjustment Assistance. [FR Doc. 2010–8887 Filed 4–16–10; 8:45 am] Signed in Washington, DC, this 6th day of April, 2010. BILLING CODE 4510–FN–P DEPARTMENT OF LABOR Michael W. Jaffe, Certifying Officer, Division of Trade Employment and Training DEPARTMENT OF LABOR Adjustment Assistance. Administration [FR Doc. 2010–8886 Filed 4–16–10; 8:45 am] [TA–W–71,175; TA–W–71,175A] Employment and Training BILLING CODE 4510–FN–P Administration Resinoid Engineering Corporation [TA–W–71,049] Hebron, OH; Resinoid Engineering DEPARTMENT OF LABOR Corporation Heath, OH; Amended Chrysler Group LLC, Formerly Known Employment and Training Certification Regarding Eligibility To as Chrysler LLC, Warren Office Administration Apply for Worker Adjustment Building, Including On-Site Leased Assistance Workers from Product Action [TA–W–70,242] International, LLC, Warren, Michigan; In accordance with Section 223 of the Amended Certification Regarding Findlay Industries, Inc., Findlay Ohio Trade Act of 1974, as amended (‘‘Act’’), Eligibility To Apply for Worker Plant One; Including On-Site Leased 19 U.S.C. 2273, the Department of Labor Adjustment Assistance Workers From Alternative Management issued a Certification of Eligibility to Resource, Inc. (AMRI of Findlay) Also apply for Worker Adjustment Assistance In accordance with section 223 of the Known as Alternative Management on January 25, 2010, applicable to Trade Act of 1974, as amended (‘‘Act’’), Temporary Services Findlay, OH; workers of Resinoid Engineering 19 U.S.C. 2273, the Department of Labor Amended Certification Regarding Corporation, Hebron, Ohio. The notice issued a Certification of Eligibility to Eligibility To Apply for Worker was published in the Federal Register apply for Worker Adjustment Assistance Adjustment Assistance March 5, 2010 (75 FR 10323). on March 19, 2010 applicable to At the request of the State Agency, the workers of Chrysler Group LLC, In accordance with Section 223 of the Department reviewed the certification formerly known as Chrysler LLC, Trade Act of 1974, as amended (‘‘Act’’), for workers of the subject firm. The Warren Office Building, Warren, 19 U.S.C. 2273, the Department of Labor workers are engaged in activities related Michigan. The notice will be published issued a Certification of Eligibility to to the production of custom molded in the Federal Register soon. apply for Worker Adjustment Assistance plastic components. At the request of the State Agency, the on October 13, 2009, applicable to New findings show that the Heath, Department reviewed the certification workers of Findlay Industries, Inc., Ohio location of Resinoid also for workers of the subject firm. The Findlay Plant One, Findlay, Ohio. The experienced an employment decline workers are engaged in activities related notice was published in the Federal during the relevant period. Workers at to production of automobiles. Register December 11, 2009 (74 FR the Heath, Ohio facility produce The company reports that workers 65798). commutators and are not separately leased from Product Action At the request of the State Agency, the identifiable from the workers at the International, LLC were employed on- Department reviewed the certification Hebron facility. These workers directly site at the Warren, Michigan location of for workers of the subject firm. The support the Hebron, Ohio facility of the Chrysler Group LLC, formerly known as workers are engaged in activities related subject firm. Chrysler LLC, Warren Truck Assembly to the production of automotive and Accordingly, the Department is Plant. The Department has determined heavy truck interiors. amending the certification to cover that these workers were sufficiently The company reports that workers workers at the Heath, Ohio location of under the control of the subject firm to leased from Alternative Management Resinoid. be considered leased workers. Resource, Inc., (AMRI of Findlay), also The intent of the Department’s Based on these findings, the known as Alternative Management certification is to include all workers of Department is amending this Temporary Services were employed on- Resinoid who were adversely affected certification to include workers leased site at the Findlay, Ohio location of by the loss in sales to a TAA certified from Product Action International, LLC Findlay Industries, Inc., Findlay Plant firm. working on-site at the Warren, Michigan One. The Department has determined The amended notice applicable to location of Chrysler Group LLC, that these workers were sufficiently AT–W–71,175 is hereby issued as formerly known as Chrysler LLC, under the control of the subject firm to follows: Warren Office Building. be considered leased workers.
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Based on these findings, the for workers of the subject firm. The will be published in the Federal Department is amending this workers are engaged in activities related Register soon. certification to include workers leased to the production of automatic nail At the request of the State Agency, the from Alternative Management Resource, guns, nails, and staples. Department reviewed the certification Inc., (AMRI of Findlay), also known as The company reports that workers for workers of the subject firm. The Alternative Management Temporary leased from Commercial Construction workers are engaged in activities related Services working on-site at the Findlay, Management and Resources (CCMR) to the production of home furniture. Ohio location of Findlay Industries, were employed on-site at the Cincinnati, The review shows that on February Inc., Findlay Plant One. Ohio location of Senco Brands, Inc., fka 25, 2008, a certification of eligibility to The amended notice applicable to the Senco Products, Inc. The Department apply for adjustment assistance was TA–W–70,242 is hereby issued as has determined that these workers were issued for all workers of La-Z-Boy follows: sufficiently under the control of the Greensboro, Inc., North Wilkesboro, All workers of Findlay Industries, Inc., subject firm to be considered leased North Carolina, separated from Findlay Plant One, including on-site leased workers. employment on or after October 29, workers from Alternative Management Based on these findings, the 2007 through February 25, 2010. The Resource, Inc., (AMRI of Findlay), also Department is amending this notice was published in the Federal known as Alternative Management certification to include workers leased Register on March 11, 2008 (73 FR Temporary Services, Findlay, Ohio (TA–W– from Commercial Construction 13017). 70,242) and Findlay Industries, Inc., Management and Resource (CCMR) In order to avoid an overlap in worker Springfield Division, Springfield, Ohio (TA– working on-site at the Cincinnati, Ohio group coverage, the Department is W–70,242A), who became totally or partially location of Senco Brands, Inc., fka separated from employment on or after May amending the January 8, 2009 impact Senco Products, Inc. date established for TA–W–73,319, to 19, 2008, through October 13, 2011, and all The amended notice applicable to workers in the group threatened with total or read February 26, 2010. The amended partial separation from employment on date TA–W–70,115 is hereby issued as notice applicable to TA–W–73,319 is of certification through two years from the follows: hereby issued as follows: date of certification, are eligible to apply for All workers of Senco Brands, Inc., fka All workers of La-Z-Boy Casegoods, Inc.- adjustment assistance under Chapter 2 of Senco Products, Inc., including the on-site LEA, also known as American Drew, Title II of the Trade Act of 1974, as amended. leased workers of Manpower, Inc., Express Wilkesboro, North Carolina, who became Personnel Services, and Commercial totally or partially separated from Signed in Washington, DC, this 8th day of Construction Management and Resources employment on or after February 26, 2010, April, 2010. (CCMR), Cincinnati, Ohio, who became through March 19, 2012, and all workers in Elliott S. Kushner, totally or partially separated from the group threatened with total or partial Certifying Officer, Division of Trade employment on or after May 18, 2008, separation from employment on date of through December 10, 2011, and all workers Adjustment Assistance. certification through two years from the date in the group threatened with total or partial of certification, are eligible to apply for [FR Doc. 2010–8885 Filed 4–16–10; 8:45 am] separation from employment on date of adjustment assistance under Chapter 2 of BILLING CODE 4510–FN–P certification through two years from the date Title II of the Trade Act of 1974, as amended. of certification, are eligible to apply for adjustment assistance under Chapter 2 of Signed in Washington, DC, this 8th day of DEPARTMENT OF LABOR Title II of the Trade Act of 1974, as amended. April 2010. Signed in Washington, DC, this 8th day of Elliott S. Kushner, Employment and Training April, 2010. Certifying Officer, Division of Trade Administration Elliott S. Kushner, Adjustment Assistance. [TA–W–70,115] Certifying Officer, Division of Trade [FR Doc. 2010–8879 Filed 4–16–10; 8:45 am] Adjustment Assistance. BILLING CODE 4510–FN–P Senco Brands, Inc., fka Senco [FR Doc. 2010–8884 Filed 4–16–10; 8:45 am] Products, Inc., Including the On-Site BILLING CODE 4510–FN–P Leased Workers of Manpower, Inc., DEPARTMENT OF LABOR Express Personnel Services and, Commercial Construction Management DEPARTMENT OF LABOR Employment and Training and Resources (CCMR), Cincinnati, Administration OH; Amended Certification Regarding Employment and Training [TA–W–72,565] Eligibility To Apply for Worker Administration Adjustment Assistance [TA–W–73,319] Robert Bosch LLC, Including On-Site Leased Workers From Bosch In accordance with section 223 of the La-Z-Boy Casegoods, Inc.—LEA Also Management Services North America, ‘‘ ’’ Trade Act of 1974, as amended ( Act ), Known as American Drew Wilkesboro, South Haven Community Hospital, 19 U.S.C. 2273, the Department of Labor NC; Amended Certification Regarding Huffmaster Inc., and Williamson issued a Certification of Eligibility to Eligibility To Apply for Worker Employment Services St. Joseph, MI; apply for Worker Adjustment Assistance Adjustment Assistance Amended Certification Regarding on December 10, 2009, applicable to Eligibility To Apply for Worker workers of Senco Brands, Inc., fka Senco In accordance with Section 223 of the Adjustment Assistance Products, Inc., including the on-site Trade Act of 1974, as amended (‘‘Act’’), leased workers of Manpower, Inc., and 19 U.S.C. 2273, the Department of Labor In accordance with Section 223 of the Express Personnel Services, Cincinnati, issued a Certification of Eligibility to Trade Act of 1974, as amended (‘‘Act’’), Ohio. The notice was published in the apply for Worker Adjustment Assistance 19 U.S.C. 2273, the Department of Labor Federal Register on January 25, 2010 on March 19th, 2010 applicable to issued a Certification of Eligibility to (75 FR 3930). workers of La-Z-Boy Casegoods, Inc.- Apply for Worker Adjustment At the request of the State Agency, the LEA, also known as American Drew, Assistance on February 24, 2010, Department reviewed the certification Wilkesboro, North Carolina. The notice applicable to workers of Robert Bosch
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LLC, including on-site leased workers of DEPARTMENT OF LABOR DEPARTMENT OF LABOR Bosch Management Services North America, South Haven Community Employment and Training Employment and Training Hospital, Huffmaster Inc., and Administration Administration Williamson Employment Services, St. [TA–W–62,220] Joseph, Michigan. The notice will be [TA–W–72,241] published soon in the Federal Register. Agrium U.S., Inc., Kenai Nitrogen Autodie, LLC Including On-Site and Operation, Including On-Site Leased At the request of the State Agency, the Off-Site Individual Contractors Grand Workers From NMS (Nana Department reviewed the certification Rapids, MI; Amended Certification Management Systems) and Heat & for workers of the subject firm. The Regarding Eligibility To Apply for Frost Insulation, Inc., Kenai, AK; workers are engaged in the production Worker Adjustment Assistance Amended Notice of Revised of automotive brakes. Determination on Reconsideration The review shows that on September In accordance with Section 223 of the 24, 2007, a certification of eligibility to Trade Act of 1974, as amended (‘‘Act’’), In accordance with Section 223 of the apply for adjustment assistance was 19 U.S.C. 2273, the Department of Labor Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 issued for all workers of Robert Bosch issued a Certification of Eligibility to U.S.C. 2813), as amended, the LLC, including on-site leased workers of Apply for Worker Adjustment Department of Labor issued a Notice of Bosch Management Services North Assistance on March 3, 2010, applicable to workers of Autodie, LLC, including Revised Determination on America, South Haven Community Reconsideration on January 8, 2008. The Hospital, Huffmaster Inc., and on-site and off-site individual contractors, Grand Rapids, Michigan. notice was published in the Federal Williamson Employment Services, Register on January 16, 2008 (73 FR separated from employment on or after The notice will be published soon in the Federal Register. 2946). The Revised Determination was June 9, 2007 through November 28, amended on October 22, 2008 to include 2009. The notice was published in the At the request of the State Agency, the on-site leased workers from NMS (Nana Federal Register on December 11, 2007 Department reviewed the certification Management Systems). The notice was (72 FR 70345). for workers of the subject firm. The published in the Federal Register on workers are engaged in the production In order to avoid an overlap in worker November 3, 2008 (73 FR 65410–65411) of metal forming dies for automobiles At the request of the petitioner, the group coverage, the Department is and automobile components. amending the September 16, 2008 Department reviewed the Notice of impact date established for TA–W– The review shows that on September Revised Determination on 72,565, to read November 29, 2009. 24, 2007, a certification of eligibility to Reconsideration for workers of the apply for adjustment assistance was subject firm. The workers are engaged in The amended notice applicable to issued for all workers of Autodie, LLC, the production of anhydrous ammonia TA–W–62,337 is hereby issued as Grand Rapids, Michigan, separated from and urea. follows: employment on or after July 30, 2007 New information shows that workers All workers of Robert Bosch LLC, through September 24, 2009. The notice leased workers from Heat & Frost including on-site leased workers of Bosch was published in the Federal Register Insulation, Inc. were employed on-site Management Services North America, South on October 12, 2007 (72 FR 58131). at the Kenai, Alaska location of Agrium Haven Community Hospital, Huffmaster Inc., In order to avoid an overlap in worker U.S., Inc., Kenai Nitrogen Operation. and Williamson Employment Services, who group coverage, the Department is The Department has determined that became totally or partially separated from amending the August 31, 2008 impact these workers were sufficiently under employment on or after November 29, 2009, date established for TA–W–72,241, to the control of Agrium U.S., Inc., Kenai through February 24, 2012, and all workers read September 25, 2009. Nitrogen Operation to be considered in the group threatened with total or partial leased workers. separation from employment on the date of The amended notice applicable to Based on these findings, the certification through two years from the date TA–W–72,241 is hereby issued as Department is amending this revised of certification, are eligible to apply for follows: determination to include workers leased adjustment assistance under Chapter 2 of All workers of Autodie, LLC, including on- from Heat & Frost Insulation, Inc. Title II of the Trade Act of 1974, as amended. site and off-site individual contractors, Grand working on-site at the Kenai, Alaska Signed in Washington, DC, this 31st day of Rapids, Michigan, who became totally or location of the subject firm. March 2010. partially separated from employment on or The intent of the Department’s after September 25, 2009, through March 3, certification is to include all workers Michael W. Jaffe 2012, and all workers in the group threatened employed at Agrium U.S., Inc., Kenai Certifying Officer, Division of Trade with total or partial separation from Nitrogen Operation, Kenai, Alaska who Adjustment Assistance. employment on date of certification through were adversely affected by a shift in [FR Doc. 2010–8877 Filed 4–16–10; 8:45 am] two years from the date of certification, are production of anhydrous ammonia and BILLING CODE 4510–FN–P eligible to apply for adjustment assistance urea to Damietta, Egypt. under Chapter 2 of Title II of the Trade Act The amended notice applicable to of 1974, as amended. TA–W–62,220 is hereby issued as Signed in Washington, DC, this 30th day of follows: March, 2010. All workers of Agrium U.S., Inc., Kenai Elliott S. Kushner, Nitrogen Operation, including on-site leased workers from NMS (Nana Management Certifying Officer, Division of Trade Systems) and Heat & Frost Insulation, Inc., Adjustment Assistance. Kenai, Alaska, who became totally or [FR Doc. 2010–8876 Filed 4–16–10; 8:45 am] partially separated from employment on or BILLING CODE 4510–FN–P after April 13, 2007, through January 8, 2010,
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are eligible to apply for adjustment assistance of the Trade Act of 1974 (‘‘the Act’’) and Assistance, at the address shown below, under Section 223 of the Trade Act of 1974, are identified in the Appendix to this not later than April 29, 2010. and are also eligible to apply for alternative notice. Upon receipt of these petitions, Interested persons are invited to trade adjustment assistance under Section the Director of the Division of Trade 246 of the Trade Act of 1974. submit written comments regarding the Adjustment Assistance, Employment subject matter of the investigations to Signed at Washington, DC, this 22nd day and Training Administration, has the Director, Division of Trade of January 2010. instituted investigations pursuant to Elliott S. Kushner, Section 221 (a) of the Act. Adjustment Assistance, at the address Certifying Officer, Division of Trade The purpose of each of the shown below, not later than April 29, Adjustment Assistance. investigations is to determine whether 2010. [FR Doc. 2010–8868 Filed 4–16–10; 8:45 am] the workers are eligible to apply for The petitions filed in this case are BILLING CODE 4510–FN–P adjustment assistance under Title II, available for inspection at the Division Chapter 2, of the Act. The investigations of Trade Adjustment Assistance, will further relate, as appropriate, to the Employment and Training DEPARTMENT OF LABOR determination of the date on which total Administration, U.S. Department of or partial separations began or Employment and Training Labor, Room N–5428, 200 Constitution threatened to begin and the subdivision Avenue, NW., Washington, DC 20210. Administration of the firm involved. The petitioners or any other persons Signed at Washington, DC this 7th day of Investigations Regarding Certifications April 2010. of Eligibility To Apply for Worker showing a substantial interest in the Adjustment Assistance subject matter of the investigations may Elliott Kushner, request a public hearing, provided such Certifying Officer, Division of Trade Petitions have been filed with the request is filed in writing with the Adjustment Assistance. Secretary of Labor under Section 221 (a) Director, Division of Trade Adjustment
APPENDIX [TAA Petitions Instituted between 3/8/10 and 3/12/10]
Subject firm Date of Date of TA–W (petitioners) Location institution petition
73651 ...... File-EZ Folder, Inc. (Comp) ...... Spokane, WA ...... 03/08/10 03/05/10 73652 ...... Robert Bosch, LLC (State) ...... Plymouth, MI ...... 03/08/10 02/10/10 73653 ...... Heartland Companies, Ltd. (Wkrs) ...... San Francisco, CA ...... 03/08/10 02/10/10 73654 ...... Bose Corporation (State) ...... Framingham, MA ...... 03/08/10 03/01/10 73655 ...... Camson Pipe Company (Wkrs) ...... Erie, PA ...... 03/08/10 03/05/10 73656 ...... JK Products and Services, Inc. (Wkrs) ...... Jonesboro, AR ...... 03/08/10 03/05/10 73657 ...... SunGard Public Sector (Comp) ...... Lake Mary, FL ...... 03/08/10 03/05/10 73658 ...... Arrow Truck Sales (State) ...... Montebello, CA ...... 03/08/10 02/16/10 73659 ...... Meridian Enterprises Corporation (Wkrs) ...... Hazelwood, MO ...... 03/08/10 03/01/10 73660 ...... iLevel by Weyerhaeuser (Comp) ...... Boise, ID ...... 03/09/10 03/08/10 73661 ...... Maersk Agency USA, Inc. (Wkrs) ...... Charlotte, NC ...... 03/09/10 03/01/10 73662 ...... Saxon (State) ...... Elk River, MN ...... 03/09/10 01/06/10 73663 ...... Appleton Papers, Inc. (Comp) ...... Appleton, WI ...... 03/09/10 03/08/10 73664 ...... Coloplast US Headquarters (State) ...... Vadwais Heights, MN ...... 03/09/10 03/08/10 73665 ...... Peek Traffic Corporation (Wkrs) ...... Bedford, PA ...... 03/09/10 03/08/10 73666 ...... Badger Meter, Inc. (Comp) ...... Milwaukee, WI ...... 03/09/10 02/22/10 73667 ...... Saint-Gobain Performance Plastics (Comp) ...... Bristol, RI ...... 03/09/10 03/08/10 73668 ...... Swets (State) ...... Runnemede, NJ ...... 03/10/10 03/09/10 73669 ...... Lazar Industries, LLC (Comp) ...... Siler City, NC ...... 03/10/10 03/08/10 73670 ...... Bimbo Bakeries USA (Comp) ...... Houston, TX ...... 03/10/10 01/28/10 73671 ...... Vygon US, LLC (Comp) ...... Valley Forge, PA ...... 03/10/10 02/26/10 73672 ...... Continental Automotive Systems, Inc. (Comp) ...... Elma, NY ...... 03/10/10 03/09/10 73673 ...... General Motors Corporation (Comp) ...... Detroit, MI ...... 03/10/10 03/08/10 73674 ...... E. W. Daniel Company (USW) ...... Cleveland, OH ...... 03/10/10 02/11/10 73675 ...... Franklin Templeton Investments Company, LLC (Wkrs) ..... San Mateo, CA ...... 03/10/10 02/24/10 73676 ...... Adria Healthcare (Wkrs) ...... Irving, TX ...... 03/10/10 03/08/10 73677 ...... Robert Busch, LLC (State) ...... Plymouth, MI ...... 03/10/10 02/10/10 73678 ...... New United Motor Manufacturing, Inc. (Comp) ...... Fremont, CA ...... 03/10/10 02/22/10 73679 ...... Liz Claiborne, Inc. (Wkrs) ...... North Bergen, NJ ...... 03/10/10 02/18/10 73680 ...... Bleden (Hirschmann Automation and Controls) (Wkrs) ...... Chambersburg, PA ...... 03/10/10 03/01/10 73681 ...... Grant Products International (Wkrs) ...... Brownsville, TX ...... 03/11/10 03/10/10 73682 ...... Hartford Financial Services Group, Inc. (State) ...... Aurora, IL ...... 03/11/10 03/10/10 73683 ...... Contour Aerospace—A Vought Company (Comp) ...... Everett, WA ...... 03/11/10 03/10/10 73684 ...... Graphic Packaging (Wkrs) ...... Lawrenceburg, TN ...... 03/11/10 02/17/10 73685 ...... Northwestern Precision Manufacturing (Wkrs) ...... Vernon Hills, IL ...... 03/11/10 03/10/10 73686 ...... MWH Americas (Human Resources (Wkrs) ...... Broomfield, CO ...... 03/11/10 03/03/10 73687 ...... Somerset Plastics, Inc. (Comp) ...... Somerset, PA ...... 03/11/10 03/05/10 73688 ...... Double AA Parking and Trucking, Inc. (Wkrs) ...... Calexico, CA ...... 03/11/10 03/05/10 73689 ...... General Motors Component Holdings, LLC (Comp) ...... Kokomo, IN ...... 03/11/10 03/08/10 73690 ...... LSI Industries, Inc. (Comp) ...... Cincinnati, OH ...... 03/11/10 03/05/10 73691 ...... R. E. Phelon Company, Inc. (Rep) ...... Aiken, SC ...... 03/11/10 03/10/10 73692 ...... Perot Systems (Dell) (Wkrs) ...... Plano, TX ...... 03/11/10 02/27/10 73693 ...... Sony Ericsson, USA (Wkrs) ...... RTP, NC ...... 03/11/10 02/15/10
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APPENDIX—Continued [TAA Petitions Instituted between 3/8/10 and 3/12/10]
Subject firm Date of Date of TA–W (petitioners) Location institution petition
73694 ...... Travelers Indemnity Company (Wkrs) ...... Hartford, CT ...... 03/11/10 03/08/10 73695 ...... Woodland Mills (Wkrs) ...... Mill Spring, NC ...... 03/11/10 03/10/10 73696 ...... Deloitte FAS LLP (State) ...... Houston, TX ...... 03/11/10 05/27/09 73697 ...... Federal Coach (Wkrs) ...... Fort Smith, AR ...... 03/12/10 03/12/10 73698 ...... Holloway Sportswear Inc. (Wkrs) ...... Jackson Center, OH ...... 03/12/10 03/01/10 73699 ...... ABM Janitorial (Wkrs) ...... Fremont, CA ...... 03/12/10 03/11/10 73700 ...... Roche Diagnostics Operations, Centralized Diagnostics Indianapolis, IN ...... 03/12/10 03/11/10 (Wkrs). 73701 ...... Acuity Brands Lighting (Comp) ...... Cochran, GA ...... 03/12/10 03/11/10 73702 ...... Komatsu Latin America (Wkrs) ...... Miami, FL ...... 03/12/10 03/11/10
[FR Doc. 2010–8866 Filed 4–16–10; 8:45 am] instituted investigations pursuant to subject matter of the investigations to BILLING CODE 4510–FN–P Section 221 (a) of the Act. the Director, Division of Trade The purpose of each of the Adjustment Assistance, at the address investigations is to determine whether shown below, not later than April 29, DEPARTMENT OF LABOR the workers are eligible to apply for 2010. adjustment assistance under Title II, The petitions filed in this case are Employment and Training Chapter 2, of the Act. The investigations available for inspection at the Division will further relate, as appropriate, to the Administration of Trade Adjustment Assistance, determination of the date on which total Employment and Training Investigations Regarding Certifications or partial separations began or Administration, U.S. Department of threatened to begin and the subdivision of Eligibility to Apply for Worker Labor, Room N–5428, 200 Constitution Adjustment Assistance of the firm involved. The petitioners or any other persons Avenue, NW., Washington, DC 20210. Petitions have been filed with the showing a substantial interest in the Signed at Washington, DC, this 7th day of Secretary of Labor under Section 221 (a) subject matter of the investigations may April 2010. of the Trade Act of 1974 (‘‘the Act’’) and request a public hearing, provided such Elliott Kushner, are identified in the Appendix to this request is filed in writing with the Certifying Officer, Division of Trade notice. Upon receipt of these petitions, Director, Division of Trade Adjustment Adjustment Assistance. Assistance, at the address shown below, the Director of the Division of Trade Appendix Adjustment Assistance, Employment not later than April 29, 2010. Interested persons are invited to and Training Administration, has TAA petitions instituted between 3/15/10 submit written comments regarding the and 3/19/10
Date of institu- Date of peti- TA–W Subject firm (petitioners) Location tion tion
73703 ...... Betts, USA (Wkrs) ...... Florence, KY ...... 03/15/10 01/19/10 73704 ...... Qantas Airways Ltd (Wkrs) ...... Los Angeles, CA ...... 03/15/10 03/12/10 73705 ...... Lap Tech Industries (Wkrs) ...... Dayton, OH ...... 03/15/10 03/12/10 73706 ...... Blumental Printworks (Wkrs) ...... New Orleans, LA ...... 03/15/10 03/11/10 73707 ...... JD Norman Industries, Inc. (Comp) ...... Brooklyn, OH ...... 03/15/10 03/12/10 73708 ...... Hayden Twist Drill (Wkrs) ...... Warren, MI ...... 03/15/10 03/05/10 73709 ...... Kurrmi, Inc. (Wkrs) ...... New York, NY ...... 03/15/10 03/01/10 73710 ...... Sam Malone Enterprises, Inc. (Wkrs) ...... City of Industry, CA ...... 03/15/10 03/11/10 73711 ...... Air Products and Chemicals, Inc. (Wkrs) ...... Allentown, PA ...... 03/16/10 03/05/10 73712 ...... Fiserv Fulfillment Services, Inc. (Rep) ...... St. Louis Park, MN ...... 03/16/10 03/10/10 73713 ...... General Electric (Comp) ...... Euclid, OH ...... 03/16/10 03/03/10 73714 ...... Interscope Manufacturing, Inc. (Wkrs) ...... Middletown, OH ...... 03/16/10 03/09/10 73715 ...... Axiant, LLC (Wkrs) ...... Huntersville, NC ...... 03/16/10 02/16/10 73716 ...... Kmart (Sears holding Corp) (Comp) ...... Huber Heights, OH ...... 03/17/10 03/10/10 73717 ...... Aperto Networks Inc. (Wkrs) ...... Milpitas, CA ...... 03/17/10 03/15/10 73718 ...... Medica (STATE) ...... Minnesota, MN ...... 03/17/10 03/16/10 73719 ...... Franklin Disposables LP (Wkrs) ...... Columbus, OH ...... 03/17/10 03/16/10 73720 ...... Apria Health Care (Wkrs) ...... Irving, TX ...... 03/17/10 03/15/10 73721 ...... RCL Burco, Inc. (COMP) ...... Culloden, WV ...... 03/17/10 03/16/10 73722 ...... Sojitz Corporation of America (ONE–ST) ...... Seattle, WA ...... 03/17/10 03/15/10 73723 ...... First Solutions (STATE) ...... Duluth, MN ...... 03/17/10 03/16/10 73724 ...... Rhinestahl Corporation (STATE) ...... Cincinnati, OH ...... 03/17/10 03/15/10 73725 ...... Michaels (Wkrs) ...... Irving, TX ...... 03/17/10 03/10/10 73726 ...... Pentair Water (COMP) ...... Ashland, OH ...... 03/17/10 03/04/10 73727 ...... The Berry Company (COMP) ...... Honolulu, HI 968813, HI ...... 03/17/10 03/10/10 73728 ...... The Berry Company (COMP) ...... St. Peters, MO ...... 03/17/10 03/10/10 73729 ...... The Berry Company, LLC (LIYP) (COMP) ...... La Crosse, WI ...... 03/17/10 03/10/10
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Date of institu- Date of peti- TA–W Subject firm (petitioners) Location tion tion
73730 ...... The Berry Company, LLC (LIYP) (COMP) ...... Federal Way, WA ...... 03/17/10 03/10/10 73731 ...... The Berry Company, LLC (LIYP) (Comp) ...... Erie, PA ...... 03/17/10 03/10/10 73732 ...... The Berry Company, LLC (LIYP) (COMP) ...... Rochester, NY ...... 03/17/10 03/10/10 73733 ...... The Berry Company, LLC (LIYP) (COMP) ...... Matthews, NC ...... 03/17/10 03/10/10 73734 ...... Purchasingnet, Inc. (Wkrs) ...... Austin, TX ...... 03/17/10 03/16/10 73735 ...... Product Action (ONE–ST) ...... Dayton, OH ...... 03/17/10 03/05/10 73736 ...... Toyota engineering and Manufacturing North America Fremont, CA ...... 03/18/10 03/17/10 Team (TEMA) (State). 73737 ...... Cullman Casting Corporation (State) ...... Cullman, AL ...... 03/18/10 03/17/10 73738 ...... Allied Systems, Ltd. (Comp) ...... Atlanta, GA ...... 03/18/10 03/17/10 73739 ...... World Wide Technology (Wkrs) ...... St. Louis, MO ...... 03/18/10 03/17/10 73740 ...... Allstate Insurance Company (State) ...... Northbrook, IL ...... 03/18/10 03/12/10 73741 ...... Kenco/Komptsu America (State) ...... Lexington, KY ...... 03/18/10 03/16/10 73742 ...... Covidien (Comp) ...... Oriskany Falls, NY ...... 03/18/10 03/17/10 73743 ...... American Fiber and Finishing, Inc. (Comp) ...... Allemarte, NC ...... 03/18/10 03/17/10 73744 ...... Sony Ericsson, USA (Wkrs) ...... Research Triangle Park, NC 03/18/10 02/15/10 73745 ...... Zumtobel Lighting Inc. (UAW) ...... Garfield, NJ ...... 03/19/10 03/17/10 73746 ...... Price Water House Coopers LLP (Wkrs) ...... New York, NY ...... 03/19/10 03/17/10 73747 ...... Payroll Solutions/Synergy (Wkrs) ...... North Las Vegas, NV ...... 03/19/10 03/17/10 73748 ...... Commercial Construction Management and Resource Milford, OH ...... 03/19/10 03/09/10 (STATE). 73749 ...... Assembly and Test Worldwide, Inc. (STATE) ...... Shelton, CT ...... 03/19/10 03/17/10 73750 ...... General Motors Corporation (Wkrs) ...... Detroit, MI ...... 03/19/10 03/08/10 73751 ...... RHealth, LLC (STATE) ...... Memphis, TN ...... 03/19/10 03/17/10 73752 ...... Industrial Metal Products Corp. (STATE) ...... Lansing, MI ...... 03/19/10 03/17/10
[FR Doc. 2010–8867 Filed 4–16–10; 8:45 am] competitive with those warehoused and petitioners’ claims. The additional BILLING CODE 4510–FN–P wholesaled by the subject worker group. material, however, did not contain Additionally, the customers of the information sufficient to reverse the affiliate did not make import purchases initial negative determination. DEPARTMENT OF LABOR of these articles in the period under As a result of the reconsideration investigation. (AR 50.) investigation, the Department issued a Employment and Training By application dated April 25, 2009, Notice of Negative Determination Administration the petitioner requested administrative Regarding Application for [TA–W–65,433] reconsideration on the Department’s Reconsideration on June 26, 2009. (AR negative determination. In the request 83–85) The determination stated that American Racing Equipment, LLC, for reconsideration, the petitioner the Department did not find additional Denver, CO; Notice of Negative alleged that the workers of the subject information pertaining to a shift in Determination on Remand firm supported production of cast, one production or increased imports that piece wheels and that the subject firm contributed to the petitioners’ On January 8, 2010, the United States shifted production of these articles separations. (AR 84, 85) On July 14, Court of International Trade (USCIT) abroad and increased imports of these 2009, the Notice was published in the granted the Department of Labor’s products. (AR 61–73.) Federal Register (74 FR 34044). (AR 87, request for voluntary remand to conduct Because new information was 88.) further investigation in Former provided by the petitioners that had not In a letter to the Colorado Department Employees of American Racing been previously considered, the of Labor, dated July 23, 2009, the Equipment, LLC v. United States Department issued a Notice of Plaintiff appealed to the USCIT for Secretary of Labor (Court No. 09– Affirmative Determination Regarding judicial review. The Plaintiff stated that 00288). Application for Reconsideration for ‘‘the relevant period’’ for the On April 6, 2009, the Department of workers at the subject firm on May 11, investigation should have been identical Labor (Department) issued a Negative 2009. (AR 76.) The Notice was to the relevant time period covered in Determination regarding eligibility to published in the Federal Register on TAA certifications TA–W–58,665 and apply for Trade Adjustment Assistance June 16, 2009 (74 FR 28552). (AR 79.) TA–W–63,760 and based the appeal on (TAA) and Alternative Trade In the request for reconsideration, the ‘‘facts not considered’’ and Adjustment Assistance (ATAA) petitioner alleged that the workers of the misinterpretation of the facts. applicable to workers and former subject firm supported production of On December 14, 2009, the workers of American Racing Equipment, cast, one piece wheels, that the subject Department requested the USCIT to LLC, Denver, Colorado (the subject firm shifted production of the cast, one grant its request for remand to firm). (AR 49) The Department’s Notice piece wheels abroad, and that there was investigate further the Plaintiffs’ of negative determination was an increase in imports of these articles. allegations. On January 8, 2010, the published in the Federal Register on (AR 62–64, 68–70.) USCIT granted the Department’s Motion June 25, 2009 (74 FR 3033). (AR 59.) During the reconsideration for voluntary remand. The determination stated that the investigation, the Department obtained On May 18, 2009, the Department subject firm’s affiliate did not import additional information from the implemented the Trade and two piece wheels like or directly company official regarding the Globalization Adjustment Assistance
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Act of 2009 (TGAAA). Under Section eligibility requirements, the Department abroad from the subject firm’s 1891(a) of the TGAAA, only worker must first determine whether or not an production facility located in Rancho groups covered by petitions filed on or article was produced at the subject firm, Dominquez, California. The remand after May 18, 2009 are eligible to apply then determine whether the workers are investigation revealed that the worker for TAA under provisions set forth in adversely impacted by increased group at the Denver, Colorado facility the TGAAA. Worker groups covered by imports of articles like or directly did not support the production at the petitions filed before May 18, 2009 must competitive with those produced by the Rancho Dominguez, California location. meet the eligibility criteria that existed subject firm or by a shift in production Rather, the majority of the product at the time the petition was filed. abroad of articles like or directly warehoused and wholesaled by the Because the petition for TA–W–65,433 competitive with those which are Denver, Colorado worker group was was filed on February 26, 2009, in order produced by the subject firm. imported from China and a small for the subject worker group to be It is the Department’s policy that in portion entered the Denver, Colorado eligible to apply for TAA as primary order for petitioners to qualify for TAA facility as a finished article from the workers (workers of a firm that produces as primary workers, they must be (1) subject firm facility in Kansas City, an article), the workers must meet the engaged in domestic production; or (2) Missouri. The remand investigation also group eligibility requirements under be in support of an affiliated domestic revealed that the worker group at the Section 222(a) of the Trade Act of 1974, production facility; or (3) under the Denver, Colorado location was not as amended, which existed on February control of an unaffiliated company that engaged in the assembly or finishing of 26, 2009. produces the article that the subject the articles warehoused and wholesaled The group eligibility requirements workers support. Where the workers out of that location. Furthermore, when under Section 222(a) of the Trade Act support production, the facility that the Denver, Colorado facility ceased to which existed on February 26, 2009 can they support must be import-impacted operate in May 2008, the work was be satisfied in one of two ways: or have shifted to a country identified consolidated domestically. SAR 99–100, under Section 113 of the Trade 107–110, 111–113. I. Section (a)(2)(A)— Adjustment Assistance Reform Act of The Plaintiffs also allege that they A. A significant number or proportion of 2002 (Pub. L. 107–210). were impacted by the shift in the workers in such workers’ firm, or an In conducting the remand production abroad and subsequent appropriate subdivision of the firm, have investigation, the Department obtained imports. The worker group at the become totally or partially separated, or are additional information from the subject Denver, Colorado facility did not threatened to become totally or partially firm, SAR 89–90, 99–100, 111–113, and support the production at the Rancho separated; and solicited input from the Plaintiff. SAR Dominguez, California facility nor did B. The sales or production, or both, of such 91. Based on the information collected, they support production at any other firm or subdivision have decreased SAR 99–100, 107–110, 111–113, the absolutely; and domestic or affiliated facility of the C. Increased imports of articles like or Department determined that the worker subject firm. SAR 99–100, 107–110, directly competitive with articles produced group at the subject firm providing 111–113. by such firm or subdivision have contributed services such as warehousing and Additionally, the Plaintiffs allege that importantly to such workers’ separation or wholesaling of wheels was not in direct the period under investigation should threat of separation and to the decline in support of the production of these be the same as the period used for the sales or production of such firm or articles and, therefore, does not meet the TAA certifications of petitions TA–W– subdivision; test of being engaged in the production 58,665 and TA–W–63,760. The period or of an article for the purposes of the of the investigation is determined by the II. Section (a)(2)(B)— Trade Act. date of filing of the petition. See, e.g., A. A significant number or proportion of The Department’s policy is to provide 29 CFR 90.2 ‘‘increased imports’’ the workers in such workers’ firm, or an TAA benefits to workers covered by a definition identifying the representative appropriate subdivision of the firm, have petition filed before May 18, 2009, who base period. During the relevant period become totally or partially separated, or are work in a facility of the workers’ firm of investigation for the subject petition, threatened to become totally or partially (the ‘‘appropriate subdivision’’ identified however, the Denver, Colorado facility separated; and in the petition) that supports an import- did not support production at the B. There has been a shift in production by impacted domestic production facility Rancho Dominguez, California facility, such workers’ firm or subdivision to a foreign of the workers’ firm. 29 CFR Section nor was the product manufactured at country of articles like or directly 90.11(c)(7) requires that the petition competitive with articles which are produced the Rancho Dominguez, California by such firm or subdivision; and includes a ‘‘description of the articles facility sold out of the Denver, Colorado C. One of the Following Must be Satisfied: produced by the workers’ firm or location. SAR 99–100, 107–110, 111– 1. The country to which the workers’ firm appropriate subdivision, the production 113. has shifted production of the articles is a or sales of which are adversely affected The Department determined that the party to a free trade agreement with the by increased imports, and a description subject workers are not engaged in the United States; or of the imported articles concerned.’’ production of an article or in support of 2. The country to which the workers’ firm Further, 29 CFR Section 90.2 describes an affiliated, domestic production has shifted production of the articles is a an appropriate subdivision as ‘‘an facility. As such, the Department beneficiary country under the Andean Trade determines that there was no ‘‘shift in Preference Act, African Growth and establishment in a multi-establishment Opportunity Act, or the Caribbean Basin firm which produces the domestic production by such workers’ firm or Economic Recovery Act; or article in question’’ and includes subdivision to a foreign country’’ as 3. There has been or is likely to be an ‘‘auxiliary facilities operated in required by the Trade Act. Because the increase in imports of articles that are like or conjunction with (whether or not workers did not produce an article, and directly competitive with articles which are physically separate from) production did not support a firm or appropriate or were produced by such firm or facilities.’’ subdivision that produced an article subdivision. The Plaintiffs allege that they were domestically, the workers cannot be In order to determine whether the impacted by increased imports of considered import impacted or affected subject workers meet the TAA group wheels following a shift in production by a shift of production abroad.
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In order for the Department to issue sales and maintenance services or Signed in Washington, DC, this 1st day of a certification of eligibility to apply for imported forklift truck sales and April, 2010. ATAA, the subject worker group must maintenance services during the Del Min Amy Chen, be certified eligible to apply for TAA. relevant period; the declining customers Certifying Officer, Division of Trade Since the subject workers are denied of the subject firm had not obtained Adjustment Assistance. eligibility to apply for TAA, the workers truck sales and maintenance services [FR Doc. 2010–8874 Filed 4–16–10; 8:45 am] cannot be certified eligible for ATAA. from foreign firms during the relevant BILLING CODE 4510–FN–P Conclusion period; and the workers did not produce an article or supply a service that was After careful reconsideration, I affirm used by a firm with TAA-certified DEPARTMENT OF LABOR the original notice of negative workers in the production of an article determination of eligibility to apply for Employment and Training or supply of a service that was the basis worker adjustment assistance for Administration workers and former workers of for TAA-certification. American Racing Equipment, LLC, The petitioner stated that the workers [TA–W–72,103] Denver, Colorado. of the subject firm should be eligible for Terex USA, LLC, Cedar Rapids, IA; Signed at Washington, DC, this 8th day of TAA because some of that firm’s largest April, 2010. customers, who are TAA-certified, have Notice of Negative Determination Regarding Application for Del Min Amy Chen cut back production in some plants and Reconsideration Certifying Officer, Division of Trade shut down production at other plants Adjustment Assistance. because of foreign steel imports and By application dated March 8, 2010, [FR Doc. 2010–8870 Filed 4–16–10; 8:45 am] have consequently sent back a large the State of Iowa Trade Adjustment BILLING CODE 4510–FN–P number of the fork lift trucks leased and Assistance (TAA) Coordinator requested serviced by the subject firm. Moreover, administrative reconsideration of the the petitioner alleged that there were Department’s negative determination DEPARTMENT OF LABOR many fork lift truck companies selling regarding eligibility to apply for TAA foreign-made fork lift trucks. applicable to workers and former Employment and Training The initial investigation revealed that workers of the subject firm. The Notice Administration the secondary certification that the of negative determination was signed on [TA–W–71,634] petitioner is seeking is not possible February 3, 2010. The Department’s because the subject firm provided tools Notice was published in the Federal Yale Industrial Trucks-PGH, Inc. and related services used in production Register on March 12, 2010 (74 FR Monroeville, PA; Notice of Negative but not component parts, as required by 11925). Determination Regarding Application Section 222(d) of the Act, 19 U.S.C. The petitioner states in the request for for Reconsideration 2272(d). reconsideration that the initial customer By application received March 16, survey was limited to only the largest Furthermore, during the initial customer of the subject firm and that 2010, a petitioner requested investigation the Department surveyed administrative reconsideration of the perhaps many of the subject firm’s the subject firm’s major declining customers are purchasing imports of Department’s negative determination customers regarding their purchases of regarding eligibility to apply for Trade products like those produced by the forklift trucks and maintenance services subject firm, and that such purchasing Adjustment Assistance (TAA), during the relevant period. The survey applicable to workers and former of imports by many small customers revealed no imports of forklift trucks or could have brought about the worker workers of the subject firm. The related maintenance services. Department’s Notice of determination separations at the subject firm. was issued on March 3, 2010 and will The petitioner did not supply facts Pursuant to 29 CFR 90.18(c) soon be published in the Federal not previously considered; nor provide reconsideration may be granted under Register. additional documentation indicating the following circumstances: Pursuant to 29 CFR 90.18(c) that there was either (1) a mistake in the (1) If it appears on the basis of facts reconsideration may be granted under determination of facts not previously not previously considered that the the following circumstances: considered or (2) a misinterpretation of determination complained of was (1) If it appears on the basis of facts facts or of the law justifying erroneous; not previously considered that the reconsideration of the initial (2) If it appears that the determination determination complained of was determination. complained of was based on a mistake in the determination of facts not erroneous; After careful review of the request for previously considered; or (2) If it appears that the determination reconsideration, the Department (3) If in the opinion of the Certifying complained of was based on a mistake determines that 29 CFR 90.18(c) has not Officer, a misinterpretation of facts or of in the determination of facts not been met. previously considered; or the law justified reconsideration of the (3) If in the opinion of the Certifying Conclusion decision. Officer, a misinterpretation of facts or of The initial investigation resulted in a the law justified reconsideration of the After review of the application and negative determination, which was decision. investigative findings, I conclude that based on the finding that shifts of The negative determination of the there has been no error or production of crushing, screening, and TAA petition filed on behalf of workers misinterpretation of the law or of the paving equipment (types of construction at Yale Industrial Trucks-PGH, Inc., facts which would justify equipment) did not contribute Monroeville, Pennsylvania, was based reconsideration of the Department of importantly to worker separations at the on the findings that: The subject firm Labor’s prior decision. Accordingly, the subject firm and that a major portion of had not shifted abroad forklift truck application is denied. the sales decline of the subject firm can
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be attributed to a loss of exports and OFFICE OF MANAGEMENT AND procurement_gov_contracting/ thus is not affected by imports. BUDGET public_comments.pdf. During the initial investigation, the Daniel I. Gordon, subject firm provided sales and contact Work Reserved for Performance by Federal Government Employees; Administrator, Office of Federal Procurement information for its major declining Policy. customers: one domestic customer and Correction [FR Doc. 2010–8824 Filed 4–16–10; 8:45 am] three foreign customers. The sole AGENCY: Office of Federal Procurement BILLING CODE P domestic customer constituted 16 Policy, Office of Management and percent of the sales decline experienced Budget. by the subject firm and the three foreign customers constituted 72 percent of the ACTION: Notice; Correction. NUCLEAR REGULATORY subject firm’s sales decline. COMMISSION SUMMARY: The Office of Federal The Department confirmed during the Procurement Policy (OFPP) in the Office Advisory Committee On Reactor initial investigation that the three of Management and Budget (OMB) is Safeguards (ACRS); Meeting of the foreign customers were purchasing making corrections to the addresses and ACRS Subcommittee On Plant License finished articles and not component instructions for submitting and viewing Renewal parts of construction equipment from public comments on the Proposed the subject firm, and determined that The ACRS Subcommittee on Plant Policy Letter ‘‘Work Reserved for the subject firm’s declining sales with License Renewal will hold a meeting on Performance by Federal Government the three foreign customers was loss of May 5, 2010, Room T–2B1, 11545 Employees’’ (75 FR 16188–16197, March export business by the subject firm. Rockville Pike, Rockville, Maryland. 31, 2010). The ADDRESSES section and Further, during the initial investigation, The entire meeting will be open to updated Web site below should be used the Department had collected aggregate public attendance. in place of those previously published data that shows that imports into the The agenda for the subject meeting in the March 31, 2010 notice. All other United States of agricultural and shall be as follows: information from the March 31st notice, construction machinery decreased by including the June 1, 2010, deadline for Wednesday, May 5, 2010—8:30 a.m. almost 40 percent during the relevant submission of comments, remains until 12 p.m. period. unchanged. The full text of the original The Subcommittee will discuss the Because the export losses and the notice is available at http:// losses to the sole domestic customer Cooper Nuclear Station License edocket.access.gpo.gov/2010/2010– Renewal Application and the associated account for 88 percent of the decline in 7329.htm. sales for the subject firm and there were Safety Evaluation Report (SER) with decreasing aggregate imports of FOR FURTHER INFORMATION CONTACT: Open Items prepared by the staff. The construction equipment, the Department Mathew Blum, OFPP, (202) 395–4953 or Subcommittee will hear presentations determined that the customer survey [email protected]. by and hold discussions with representatives of the NRC staff, conducted during the initial Corrections investigation was appropriate. Nebraska Public Power District, and The petitioner did not supply facts In the Federal Register on March 31, other interested persons regarding this not previously considered; nor provide 2010, beginning at the top of page matter. The Subcommittee will gather additional documentation indicating 16189, correct the ADDRESSES to read: information, analyze relevant issues and that there was either (1) a mistake in the ADDRESSES: All comments should be facts, and formulate proposed positions determination of facts not previously submitted via one of the following and actions, as appropriate, for considered or (2) a misinterpretation of methods: deliberation by the Full Committee. Members of the public desiring to facts or of the law justifying • Online: http://www.regulations.gov. reconsideration of the initial • provide oral statements and/or written Fax: 202–395–5105. comments should notify the Designated determination. • Mail: Office of Federal Procurement Federal Official (DFO), Mrs. Kathy After careful review of the request for Policy, Attn: Mathew Blum, New Weaver (Telephone 301–415–6236 or E- reconsideration, the Department Executive Office Building, Room 9013, mail [email protected]) five days determines that 29 CFR 90.18(c) has not 725 17th Street, NW., Washington, DC prior to the meeting, if possible, so that been met. 20503. appropriate arrangements can be made. Conclusion • Instructions: Please submit Thirty-five hard copies of each comments only and include your name, presentation or handout should be After review of the application and company name (if any), and cite provided to the DFO thirty minutes investigative findings, I conclude that ‘‘Proposed OFPP Policy Letter’’ in all before the meeting. In addition, one there has been no error or correspondence. All comments received electronic copy of each presentation misinterpretation of the law or of the will be posted, without change, to should be emailed to the DFO one day facts which would justify http://www.regulations.gov, without before the meeting. If an electronic copy reconsideration of the Department of redaction, so commenters should not cannot be provided within this Labor’s prior decision. Accordingly, the include information that they do not timeframe, presenters should provide application is denied. wish to be posted (for example because the DFO with a CD containing each Signed in Washington, DC this 1st day of they consider it personal or business presentation at least 30 minutes before April 2010. confidential). the meeting. Electronic recordings will Del Min Amy Chen, In the Federal Register on March 31, be permitted only during those portions Certifying Officer, Division of Trade 2010, correct the hyperlink in the last of the meeting that are open to the Adjustment Assistance. sentence on page 16189 to read: public. Detailed procedures for the [FR Doc. 2010–8875 Filed 4–16–10; 8:45 am] For a copy of public comments, go to conduct of and participation in ACRS BILLING CODE 4510–FN–P http://www.whitehouse.gov/omb/assets/ meetings were published in the Federal
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Register on October 14, 2009, (74 FR (Telephone 301–415–2832 or E-mail: The proposed agenda for the subject 52829). [email protected]) five days prior to meeting is as follows: Detailed meeting agendas and meeting the meeting, if possible, so that Thursday, April 22, 2010—8:30 a.m.– transcripts are available on the NRC appropriate arrangements can be made. 5 p.m. Web site at http://www.nrc.gov/reading- Thirty-five hard copies of each rm/doc-collections/acrs. Information presentation or handout should be The Subcommittee will be briefed by regarding topics to be discussed, provided to the DFO thirty minutes NuStart and the NRC staff on the subject changes to the agenda, whether the before the meeting. In addition, one of Loss of Large Areas due to Fire/ meeting has been canceled or electronic copy of each presentation Explosions, and by Westinghouse on the rescheduled, and the time allotted to should be emailed to the DFO one day subject of Shield Building Design. present oral statements can be obtained before the meeting. If an electronic copy Westinghouse will also address issues from the website cited above or by cannot be provided within this associated with previous AP1000 contacting the identified DFO. timeframe, presenters should provide Subcommittee meetings. The Moreover, in view of the possibility that the DFO with a CD containing each Subcommittee will gather information, the schedule for ACRS meetings may be presentation at least 30 minutes before analyze relevant issues and facts, and adjusted by the Chairman as necessary the meeting. Electronic recordings will formulate proposed positions and to facilitate the conduct of the meeting, be permitted only during those portions actions, as appropriate, for deliberation persons planning to attend should check of the meeting that are open to the by the Full Committee. with these references if such public. Detailed procedures for the rescheduling would result in a major conduct of and participation in ACRS Members of the public desiring to inconvenience. meetings were published in the Federal provide oral statements and/or written Register on October 14, 2010, (74 FR comments should notify the Designated Dated: April 8, 2010. 58268–58269). Federal Official (DFO), Mr. Weidong Antonio Dias, Detailed meeting agendas and meeting Wang, (Telephone 301–415–6279, E- Chief, Reactor Safety Branch A, Advisory transcripts are available on the NRC mail: [email protected]) five days Committee on Reactor Safeguards. Web site at http://www.nrc.gov/reading- prior to the meeting, if possible, so that [FR Doc. 2010–8914 Filed 4–16–10; 8:45 am] rm/doc-collections/acrs. Information appropriate arrangements can be made. BILLING CODE 7590–01–P regarding topics to be discussed, Thirty-five hard copies of each changes to the agenda, whether the presentation or handout should be meeting has been canceled or provided to the DFO thirty minutes NUCLEAR REGULATORY rescheduled, and the time allotted to COMMISSION before the meeting. In addition, one present oral statements can be obtained electronic copy of each presentation from the website cited above or by Advisory Committee on Reactor should be e-mailed to the DFO one day contacting the identified DFO. Safeguards (ACRS); Meeting of the before the meeting. If an electronic copy Moreover, in view of the possibility that ACRS Subcommittee on Planning and cannot be provided within this the schedule for ACRS meetings may be Procedures timeframe, presenters should provide adjusted by the Chairman as necessary to facilitate the conduct of the meeting, the DFO with a CD containing each The ACRS Subcommittee on Planning presentation at least 30 minutes before and Procedures will hold a meeting on persons planning to attend should check with these references if such the meeting. Electronic recordings will May 5, 2010, in Room T–2B1, at 11545 be permitted only during those portions Rockville Pike, Rockville, MD. rescheduling would result in a major inconvenience. of the meeting that are open to the The entire meeting will be open to public. Detailed procedures for the Date: April 8, 2010. public attendance, with the exception of conduct of and participation in ACRS Antonio Dias, a portion that may be closed pursuant meetings were published in the Federal to 5 U.S.C. 552b(c)(2) and (6) to discuss Chief, Reactor Safety Branch A, Advisory Register on October 14, 2009 (74 FR Committee on Reactor Safeguards. organizational and personnel matters 58268–58269). that relate solely to the internal [FR Doc. 2010–8920 Filed 4–16–10; 8:45 am] BILLING CODE 7590–01–P Detailed ACRS meeting agendas and personnel rules and practices of the meeting transcripts are available on the ACRS, and information the release of NRC Web site at http://www.nrc.gov/ which would constitute a clearly NUCLEAR REGULATORY reading-rm/doc-collections/acrs/. unwarranted invasion of personal COMMISSION privacy. Information regarding topics to be discussed, changes to the agenda, The agenda for the subject meeting Advisory Committee on Reactor shall be as follows: whether the meeting has been canceled Safeguards (ACRS); Meeting of the or rescheduled, and the time allotted to ACRS Subcommittee on AP1000; Wednesday, May 5, 2010, 12:00 p.m.–1 present oral statements can be obtained Notice of Meeting p.m. from the Web site cited above or by The Subcommittee will discuss The ACRS Subcommittee on the contacting the identified DFO. proposed ACRS activities and related AP1000 will hold a meeting on April 22, Moreover, in view of the possibility that matters. The Subcommittee will gather 2010, at 11545 Rockville Pike, Room the schedule for ACRS meetings may be information, analyze relevant issues and T2–B1, Rockville, Maryland. adjusted by the Chairman as necessary facts, and formulate proposed positions Part of the meeting will be open to to facilitate the conduct of the meeting, and actions, as appropriate, for public attendance and the other part persons planning to attend should check deliberation by the Full Committee. will be closed to protect unclassified with these references if such Members of the public desiring to safeguards information or information rescheduling would result in major provide oral statements and/or written that is proprietary to Westinghouse inconvenience. comments should notify the Designated Electric Company and its contractors, Federal Official (DFO), Mr. Peter Wen pursuant to 5 U.S.C. 552b(c)(3) and (4).
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Dated: April 8, 2010. II. Further Information for the proper performance of the Antonio F. Dias, In September 2009, DG–6007 was functions of the agency, including Chief, Reactor Safety Branch B, Advisory published with a public comment whether the information will have Committee on Reactor Safeguards. period of 60 days from the issuance of practical utility; [FR Doc. 2010–8916 Filed 4–16–10; 8:45 am] the guide. No comments were received 2. Evaluate the accuracy of the BILLING CODE 7590–01–P and the public comment period closed agency’s estimate of the burden of the on November 21, 2009. Electronic proposed collection of information, copies of Regulatory Guide 6.9, Revision including the validity of the NUCLEAR REGULATORY 1 are available through the NRC’s public methodology and assumptions used; COMMISSION Web site under ‘‘Regulatory Guides’’ at 3. Enhance the quality, utility, and http://www.nrc.gov/reading-rm/doc- clarity of the information to be [NRC–2009–0418] collections/. collected; and In addition, regulatory guides are 4. Minimize the burden of the Notice of Issuance of Regulatory Guide available for inspection at the NRC’s collection of information on those who Public Document Room (PDR) located at AGENCY: Nuclear Regulatory are to respond, including through the 11555 Rockville Pike, Rockville, Commission. use of appropriate automated, Maryland. The PDR’s mailing address is electronic, mechanical, or other ACTION: Notice of Issuance and USNRC PDR, Washington, DC 20555– technological collection techniques or Availability of Regulatory Guide 6.9, 0001. The PDR can also be reached by other forms of information technology, Revision 1, ‘‘Establishing Quality telephone at (301) 415–4737 or (800) e.g., permitting electronic submissions Assurance Programs for the 397–4205, by fax at (301) 415–3548, and of responses. Manufacture and Distribution of Sealed by e-mail to [email protected]. Sources and Devices Containing Regulatory guides are not DATES: Comments are encouraged and Byproduct Material.’’ copyrighted, and NRC approval is not will be accepted until June 18, 2010. required to reproduce them. This process is conducted in accordance with 5 CFR 1320.1. FOR FURTHER INFORMATION CONTACT: Jack Dated at Rockville, Maryland, this 12th day W. Foster, Licensing Branch, Licensing of April 2010. ADDRESSES: Interested persons are and Inspection Support Directorate, For the Nuclear Regulatory Commission. invited to submit written comments on Division of Materials Safety and State Andrea D. Valentin, the proposed information collection to FIS, OPM, 1900 E Street, NW., Agreement, Office of Federal and State Chief, Regulatory Guide Development Branch, Materials and Environmental Division of Engineering, Office of Nuclear Washington, DC 20415, Attention: Lisa Management Programs, U.S. Nuclear Regulatory Research. Loss or sent via electronic mail to Regulatory Commission, Washington, [FR Doc. 2010–8922 Filed 4–16–10; 8:45 am] [email protected]. DC 20555–0001, telephone (301) 415– BILLING CODE 7590–01–P FOR FURTHER INFORMATION CONTACT: A 6250 or e-mail [email protected]. copy of this ICR, with applicable SUPPLEMENTARY INFORMATION: supporting documentation, may be OFFICE OF PERSONNEL obtained by contacting FIS, OPM, 1900 I. Introduction MANAGEMENT E Street, NW., Washington, DC 20503, The U.S. Nuclear Regulatory Attention: Lisa Loss or sent via Commission (NRC) is issuing a revision Submission for Review: Declaration for electronic mail to to an existing guide in the agency’s Federal Employment, OF 306, 3206– [email protected]. ‘‘Regulatory Guide’’ series. This series 0182 SUPPLEMENTARY INFORMATION: The was developed to describe and make AGENCY: U.S. Office of Personnel Declaration for Federal Employment available to the public information such Management. Optional Form (OF) 306, is completed as methods that are acceptable to the ACTION: 60-Day Notice and request for by applicants who are under NRC staff for implementing specific comments. consideration for Federal or Federal parts of the agency’s regulations, contract employment. The OF 306 techniques that the staff uses in SUMMARY: Federal Investigative Services requests that the applicant provide evaluating specific problems or (FIS), U.S. Office of Personnel personal identifying data, including postulated accidents, and data that the Management (OPM) offers the general convictions, imprisonments, probations, staff needs in its review of applications public and other Federal agencies the paroles or military court martial in the for permits and licenses. opportunity to comment on an expiring past 10 years, delinquency on a Federal Revision 1 of Regulatory Guide 6.9, information collection request (ICR), debt, Selective Service Registration, ‘‘Establishing Quality Assurance Office of Management and Budget United States military service and Programs for the Manufacture and (OMB) Control No. 3206–0182, for the Federal civilian or military retirement Distribution of Sealed Sources and Declaration for Federal Employment, pay or pension received or applied for. Devices Containing Byproduct Optional Form (OF) 306. As required by It is estimated that 178,114 individuals Material,’’ was issued with a temporary the Paperwork Reduction Act of 1995, will respond annually. Each form takes identification as Draft Regulatory Guide, (Pub. L. 104–13, 44 U.S.C. chapter 35) approximately 15 minutes to complete. DG–6007. This regulatory guide directs as amended by the Clinger-Cohen Act The annual estimated burden is 44,529 the reader to the type of quality (Pub. L. 104–106), OPM is soliciting hours. assurance (QA) and quality control (QC) comments for this collection. The Office program acceptable to the staff of the of Management and Budget (OMB) is U.S. Office of Personnel Management. NRC during the review of an application particularly interested in comments John Berry, to manufacture or distribute sealed that: Director. sources and devices containing 1. Evaluate whether the proposed [FR Doc. 2010–8955 Filed 4–16–10; 8:45 am] byproduct materials. collection of information is necessary BILLING CODE 6325–53–P
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OFFICE OF PERSONNEL Kathryn Roberson or sent via electronic Incident Period: 03/12/2010 and MANAGEMENT mail to: [email protected]. continuing through 04/09/2010. SUPPLEMENTARY INFORMATION: The SFS Effective Date: 04/09/2010. Submission for Review: Federal Cyber Program was established by the National Physical Loan Application Deadline Service: Scholarship for Service (SFS) Science Foundation in accordance with Date: 05/28/2010. Registration Web Site the Federal Cyber Service Training and EIDL Loan Application Deadline Date: 12/29/2010. AGENCY: U.S. Office of Personnel Education Initiative as described in the Management. President’s National Plan for ADDRESSES: Submit completed loan applications to: U.S. Small Business ACTION: 60-Day Notice and request for Information Systems Protection. This comments. program seeks to increase the number of Administration, Processing and qualified students entering the fields of Disbursement Center, 14925 Kingsport SUMMARY: The Human Resources information assurance and computer Road, Fort Worth, TX 76155. Solutions, Office of Personnel security in an effort to respond to the FOR FURTHER INFORMATION CONTACT: A. Management (OPM) offers the general threat to the Federal Government’s Escobar, Office of Disaster Assistance, public and other federal agencies the information technology infrastructure. U.S. Small Business Administration, opportunity to comment on an existing The program provides selected 4-year 409 3rd Street, SW., Suite 6050, information collection request (ICR) colleges and universities scholarship Washington, DC 20416. 3206–0246, SFS Registration. As grants to attract students to the SUPPLEMENTARY INFORMATION: The notice required by the Paperwork Reduction information assurance field. of the President’s major disaster Act of 1995, (Pub. L. 104–13, 44 U.S.C. Participating students who receive declaration for the State of West chapter 35) as amended by the Clinger- scholarships from this program are Virginia, dated 03/29/2010 is hereby Cohen Act (Pub. L. 104–106), OPM is required to serve a 10-week internship amended to establish the incident soliciting comments for this collection. during their studies and complete a period for this disaster as beginning 03/ The Office of Management and Budget post-graduation employment 12/2010 and continuing through 04/09/ is particularly interested in comments commitment equivalent to the length of 2010. that: the scholarship or one year, whichever All other information in the original 1. Evaluate whether the proposed is longer. Approval of the webpage is declaration remains unchanged. collection of information is necessary necessary to facilitate the timely for the proper performance of the registration, selection and placement of (Catalog of Federal Domestic Assistance Numbers 59002 and 59008) functions of the agency, including program-enrolled students in Federal whether the information will have agencies. James E. Rivera, practical utility; Analysis Associate Administrator for Disaster 2. Evaluate the accuracy of the Assistance. agency’s estimate of the burden of the Agency: Federal Cyber Service: [FR Doc. 2010–8844 Filed 4–16–10; 8:45 am] proposed collection of information, Scholarship For Service Program, Office BILLING CODE 8025–01–P including the validity of the of Personnel Management. methodology and assumptions used; Title: Scholarship For Service (SFS) 3. Enhance the quality, utility, and Program Internet Site. SMALL BUSINESS ADMINISTRATION clarity of the information to be OMB Number: 3260–0246. collected; and Frequency: Annually. [Disaster Declaration #12049 and #12050] 4. Minimize the burden of the Affected Public: Individuals or Maryland Disaster Number MD–00011 collection of information on those who Households. are to respond, including through the Number of Respondents: 630. AGENCY: U.S. Small Business use of appropriate automated, Estimated Time per Respondent: 1 Administration. electronic, mechanical, or other hour. ACTION: Amendment 1. technological collection techniques or Total Burden Hours: 630 hours. SUMMARY: other forms of information technology, John Berry, This is an amendment of the e.g., permitting electronic submissions Presidential declaration of a major Director, Office of Personnel Management. of responses. disaster for Public Assistance Only for [FR Doc. 2010–8942 Filed 4–16–10; 8:45 am] DATES: Comments are encouraged and the State of MARYLAND (FEMA–1875– will be accepted until June 18, 2010. BILLING CODE 6325–38–P DR), dated 02/19/2010. This process is conducted in accordance Incident: Severe Winter Storm and with 5 CFR 1320.1. Snowstorm SMALL BUSINESS ADMINISTRATION ADDRESSES: Interested persons are Incident Period: 12/18/2009 through invited to submit written comments on [Disaster Declaration #12096 and #12097] 12/20/2009 the proposed information collection to DATES: Effective Date: 04/09/2010. U.S. Office of Personnel Management, West Virginia Disaster Number WV– Physical Loan Application Deadline San Antonio Office, 8610 Broadway, 00016 Date: 04/20/2010. Economic Injury (EIDL) Loan Rm. 305, San Antonio, TX 78217, AGENCY: U.S. Small Business Application Deadline Date: 11/19/2010. Attention: Kathryn Roberson or sent via Administration. electronic mail to: [email protected]. ADDRESSES: Submit completed loan ACTION: Amendment 1. FOR FURTHER INFORMATION CONTACT: A applications to: U.S. Small Business copy of this ICR, with applicable SUMMARY: This is an amendment of the Administration, Processing and supporting documentation, may be Presidential declaration of a major Disbursement Center, 14925 Kingsport obtained by contacting the San Antonio disaster for the State of West Virginia Road, Fort Worth, TX 76155. Services Branch, Office of Personnel (FEMA–1893–DR), dated 03/29/2010. FOR FURTHER INFORMATION CONTACT: A. Management, 8610 Broadway, Rm. 305, Incident: Severe Storms, Flooding, Escobar, Office of Disaster Assistance, San Antonio, TX 78217, Attention: Mudslides, and Landslides. U.S. Small Business Administration,
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409 3rd Street, SW., Suite 6050, (Catalog of Federal Domestic Assistance II. Self-Regulatory Organization’s Washington, DC 20416. Numbers 59002 and 59008) Statement of the Purpose of, and SUPPLEMENTARY INFORMATION: The notice James E. Rivera, Statutory Basis for, the Proposed Rule of the President’s major disaster Associate Administrator for Disaster Change declaration for Private Non-Profit Assistance. In its filing with the Commission, the organizations in the State of Maryland, [FR Doc. 2010–8845 Filed 4–16–10; 8:45 am] self-regulatory organization included dated 02/19/2010, is hereby amended to BILLING CODE 8025–01–P statements concerning the purpose of, include the following areas as adversely and basis for, the proposed rule change affected by the disaster. and discussed any comments it received Primary Counties: Anne Arundel, on the proposed rule change. The text Charles, Talbot, and the SECURITIES AND EXCHANGE of those statements may be examined at Independent City of Baltimore. COMMISSION the places specified in Item IV below. All other information in the original The Exchange has prepared summaries, declaration remains unchanged. [Release No. 34–61890; File No. SR– set forth in sections A, B, and C below, NYSEAmex–2010–31] (Catalog of Federal Domestic Assistance of the most significant parts of such Numbers 59002 and 59008) Self-Regulatory Organizations; NYSE statements. James E. Rivera, Amex LLC; Notice of Filing of A. Self-Regulatory Organization’s Associate Administrator for Disaster Proposed Rule Change, and Statement of the Purpose of, and Assistance. Amendment No. 1 Thereto, To Adopt, Statutory Basis for, the Proposed Rule [FR Doc. 2010–8848 Filed 4–16–10; 8:45 am] as a Pilot Program, a New NYSE Amex Change Equities Rule Series for the Trading of BILLING CODE 8025–01–P Securities Listed on the Nasdaq Stock 1. Purpose Market Pursuant to a Grant of Unlisted The Exchange proposes to (i) adopt, as SMALL BUSINESS ADMINISTRATION Trading Privileges, and Amending a pilot program, a new NYSE Amex Existing NYSE Amex Equities Rules as Equities Rule Series (Rules 500–525) for [Disaster Declaration #12102 and #12103] Needed To Accommodate the Trading the trading of Nasdaq-listed securities West Virginia Disaster Number WV– of Nasdaq-Listed Securities on the pursuant to a grant of unlisted trading 00017 Exchange privileges and (ii) amend existing NYSE Amex Equities Rules as needed to AGENCY: U.S. Small Business April 12, 2010. accommodate the trading of Nasdaq- Administration. Pursuant to Section 19(b)(1) of the listed securities on the Exchange. ACTION: Amendment 1. Securities Exchange Act of 1934 (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 Overview SUMMARY: This is an amendment of the notice is hereby given that on March 26, As described in greater detail below, Presidential declaration of a major 2010, NYSE Amex LLC (‘‘Exchange’’ or the Exchange proposes to adopt, as a disaster for Public Assistance Only for ‘‘NYSE Amex’’) filed with the Securities pilot program, a new NYSE Amex the State of West Virginia (FEMA–1893– and Exchange Commission Equities Rule Series to specifically DR), dated 03/29/2010. (‘‘Commission’’) the proposed rule govern the trading of any security listed Incident: Severe Storms, Flooding, change as described in Items I, II, and on the Nasdaq that (i) is designated as Mudslides and Landslides. III below, which Items have been an ‘‘eligible security’’ under the Joint Incident Period: 03/12/2010 through prepared by Exchange. Subsequently, on Self-Regulatory Organization Plan 04/09/2010. April 6, 2010, NYSE Amex filed Governing the Collection, Consolidation Effective Date: 04/09/2010. Amendment No. 1 to the proposed rule and Dissemination of Quotation and Physical Loan Application Deadline change. The Commission is publishing Transaction Information for Nasdaq- Date: 05/28/2010. this notice to solicit comments on the Listed Securities Traded on Exchanges Economic Injury (EIDL) Loan proposed rule change, as amended, from Application Deadline Date: 12/29/2010. on an Unlisted Trading Privilege Basis, interested persons. as amended (‘‘UTP Plan’’),3 and (ii) has ADDRESSES: Submit completed loan been admitted to dealings on the applications to: U.S. Small Business I. Self-Regulatory Organization’s Exchange pursuant to a grant of unlisted Administration, Processing and Statement of the Terms of Substance of trading privileges in accordance with Disbursement Center, 14925 Kingsport the Proposed Rule Change Section 12(f) of the Act,4 (collectively, Road, Fort Worth, TX 76155. The Exchange proposes to (i) adopt, as ‘‘Nasdaq Securities’’).5 The Exchange FOR FURTHER INFORMATION CONTACT: A. a pilot program, a new NYSE Amex Escobar, Office of Disaster Assistance, Equities Rule Series (Rules 500–525) for 3 See Securities Exchange Act Release No. 58863 U.S. Small Business Administration, the trading of securities listed on the (October 27, 2008), 73 FR 65417 (November 3, 2008) 409 3rd Street, SW., Suite 6050, Nasdaq Stock Market (‘‘Nasdaq’’) (notice of filing and immediate effectiveness of Washington, DC 20416. Amendment No. 20 to the UTP Plan). The pursuant to a grant of unlisted trading Exchange’s predecessor, the American Stock SUPPLEMENTARY INFORMATION: The notice privileges and (ii) amend existing NYSE Exchange LLC, joined the UTP Plan in 2001. See of the President’s major disaster Amex Equities Rules as needed to Securities Exchange Act Release No. 55647 (April declaration for Private Non-Profit accommodate the trading of Nasdaq- 19, 2007), 72 FR 2091 (April 27, 2007) (S7–24–89). In March 2009, the Exchange changed its name to organizations in the State of West listed securities on the Exchange. The NYSE Amex LLC. See Securities Exchange Act Virginia, dated 03/29/2010, is hereby text of the proposed rule change is Release No. 59575 (March 13, 2009), 74 FR 11803 amended to establish the incident available at the Exchange, the (March 19, 2009) (SR–NYSEALTR–2009–24). See period for this disaster as beginning 03/ Commission’s Public Reference Room, also proposed Rule 501—NYSE Amex Equities. 4 12/2010 and continuing through 04/09/ and http://www.nyse.com. 15 U.S.C. 78l. 5 As proposed, Nasdaq Securities shall be 2010. included within the definition of ‘‘security’’ as that All other information in the original 1 15 U.S.C. 78s(b)(1). term is defined in Rule 3—NYSE Amex Equities declaration remains unchanged. 2 17 CFR 240.19b–4. Continued
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also proposes to amend existing NYSE • For those Nasdaq Securities in securities, subject to some distinctions. Amex Equities Rules as needed to which they are registered, DMM Units Thus, the Exchange proposes to adopt accommodate the trading of Nasdaq will be responsible for the affirmative Rule 500—NYSE Amex Equities to Securities on the Exchange. The obligation of maintaining a fair and provide that the trading of Nasdaq Exchange proposes that this pilot orderly market in accordance with Securities on the Exchange shall be program commence on the date the Exchange rules, subject to an enhanced governed by the Rule 500 Series and all proposed Rules are approved by the quoting requirement and a phased-in other NYSE Amex Equities Rules, Commission 6 and that it continue until implementation of Depth Guidelines to except to the extent they conflict with the earlier of the Commission’s approval enable the Exchange to collect trading the Rule 500 Series, in which case the to make such pilot program permanent data adequate to calculate such Rule 500 series will control. In addition, or September 30, 2010.7 guidelines. proposed Rule 500 provides that the In summary, the Exchange proposes • Nasdaq Securities will trade using Exchange’s Disciplinary Rules 475, 476, to trade Nasdaq Securities on the same different Liquidity Replenishment Point 476A and 477 will also apply to the systems and facilities it uses to trade its (‘‘LRP’’) parameters. trading of Nasdaq Securities on the • listed securities in accordance with the Trading in Nasdaq Securities will Exchange. same trading rules, subject to several be subject to rules that are substantially similar to FINRA’s ‘‘Manning Rule’’, 2. Proposed Rule 501—NYSE Amex key differences: Equities (Definitions) • There will not be an opening or rather than Rule 92—NYSE Amex closing auction for Nasdaq Securities Equities. Although Nasdaq Securities will trade • traded on the Exchange. Trading in The Exchange’s audit trail rules, primarily in accord with existing NYSE Nasdaq Securities will open on a quote including Rules 123— and 132B—NYSE Amex Equities Rules, the Exchange at 9:30 a.m. and will close at 4 p.m., or Amex Equities, will apply to the trading proposes to adopt Rule 501—NYSE immediately thereafter under certain of Nasdaq Securities on the Exchange, Amex Equities to define key terms for circumstances, using the last sale on the except that, those members and member the trading of Nasdaq Securities on the Exchange as the Closing Price (defined organizations that are also FINRA Exchange. All other terms will have the below). members and subject to FINRA’s Rule meanings assigned to them in other • ‘‘Good ‘til Canceled’’ (‘‘GTC’’) Orders 7400 Series (‘‘Order Audit Trail System’’ NYSE Amex Equities Rules. The and ‘‘Stop’’ Orders for Nasdaq Securities or ‘‘OATS’’) will be exempt from Rules definitions are discussed in greater will be modified to provide that any 123— and 132B—NYSE Amex Equities. detail in this filing where relevant. GTC or Stop Orders that are unexecuted NYSE Amex will trade Nasdaq-listed equities and any other Nasdaq-listed 3. Proposed Rule 502—NYSE Amex at the close of trading will be treated as Equities (Hours of Business) Day Orders and canceled. In addition, security that trades like an equity Pursuant to proposed Rule 502— the Exchange will not accept limit or security (e.g., rights, warrants), and will also trade the Invesco PowerShares NYSE Amex Equities, the Exchange market ‘‘At the Close’’ (‘‘MOC/LOC’’), ‘‘At QQQTM Exchange Traded Fund.9 proposes to trade Nasdaq Securities the Opening’’ (‘‘OPG’’), ‘‘Closing Offset’’ The Exchange intends to commence during regular trading hours in (‘‘CO’’) or ‘‘Good ‘til Cross’’ (‘‘GTX’’) implementation of the trading of Nasdaq accordance with Rule 51—NYSE Amex Orders for the trading of Nasdaq Securities using a phased-in approach Equities. Regular trading hours are Securities. All other order types will be and to expand the program to eventually usually from 9:30 a.m. to 4 p.m., or accepted. include all Nasdaq Securities. during such other hours as may be • Each Nasdaq Security will be specified by Exchange rules or as assigned one Designated Market Maker Proposed NYSE Amex Equities Rule 500 otherwise determined by the Board of ‘‘ ’’ Series 10 ( DMM ) Unit, though the allocation Directors of the Exchange. The process will be streamlined to follow The Exchange proposes to adopt a Exchange also proposes to permit the approach used by the Exchange for new series of NYSE Amex Equities Nasdaq Securities to trade in the Supplemental Liquidity Providers Rules (Rules 500 to 525) to specifically Exchange’s ‘‘Off-Hours Trading Facility’’ (‘‘SLPs’’) (see Rule 107B—NYSE Amex govern the trading of Nasdaq Securities 8 under Rules 900—907—NYSE Amex Equities). on the Exchange. Equities.11 As described more fully below, however, due to modifications to and as used in the NYSE Amex Equities Rules. In 1. Proposed Rule 500—NYSE Amex accordance with this definition, Nasdaq Securities Equities (Applicability) the opening and closing for Nasdaq shall be admitted to dealings on the Exchange on Securities, members and member an ‘‘issued’’, ‘‘when issued’’, or ‘‘when distributed’’ The Exchange will trade Nasdaq organizations will not be permitted to basis. See proposed Rule 501—NYSE Amex Securities as it currently trades its listed make any bid, offer or transaction for Equities. Nasdaq Securities on Exchange systems, 6 This sentence was revised per the e-mail from Exchange Act Release No. 61308 (January 7, 2010), Jason Harmon, Consultant, NYSE Regulation, Inc., 75 FR 2573 (January 15, 2010) (SR–NYSEAmex– or route an order for a Nasdaq Security to Christopher Chow, Special Counsel, Commission 2009–98). to another market center from Exchange (‘‘April 9 e-mail’’), dated April 9, 2010. 9 Although the Exchange may in the future seek systems, before 9:30 a.m. or after the 7 See proposed Rule 500—NYSE Amex Equities. to trade other Nasdaq Securities that are exchange This is the same date that New York Stock traded funds or similar products as part of its pilot 11 Currently, in accordance with NYSE Rule 1500, ‘‘ ’’ Exchange LLC’s ( NYSE ) New Market Model pilot program, the Exchange’s initial proposal is to limit members and member organizations of NYSE program expires. Because several elements of the the term ‘‘Exchange Traded Fund’’ to mean only the (which includes substantially all NYSE Amex TM Exchange’s proposal to trade Nasdaq Securities rely Invesco PowerShares QQQ . See proposed Rule Equities members and member organizations) are on the NYSE’s New Market Model (‘‘NMM’’), the 501—NYSE Amex Equities. For the purposes of also permitted to enter orders for Nasdaq-listed Exchange proposes to extend the duration of this trading Nasdaq Securities all references to an securities on a UTP basis into the NYSE MatchPoint pilot program as needed to track the NYSE’s NMM ‘‘Exchange Traded Fund’’ or ‘‘ETF’’ in the NYSE facility (‘‘NYSE MatchPoint’’), which has an After- pilot program and would file for permanent Amex Equities Rules shall refer to the definition Hours matching session at 4:45 p.m. However, approval at the same time or after the NYSE files contained in proposed Rule 501—NYSE Amex NYSE MatchPoint is not a system or facility of the for permanent approval of the NMM. Equities. Exchange, and thus the proposed NYSE Amex 8 The Exchange recently adopted Rule 107B— 10 As proposed, the NYSE Amex Equities Rule Equities Rule 500 Series, and Rule 502—NYSE NYSE Amex Equities (Supplemental Liquidity 500 Series is consecutively numbered from 500 to Amex Equities in particular, would not apply to Provider) to establish a new class of NYSE Amex 525. However, some rules are expressly reserved trading of Nasdaq-listed securities conducted on Equities market participants. See Securities and are not referenced in the filing herein. NYSE MatchPoint.
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close of the Off-Hours Trading session will not be permitted to be registered as Exchange believes, however, that the (e.g. Crossing Session II). both the DMM Unit and an SLP for the structures proposed for assigning and same Nasdaq Security. trading the QQQs and a subset of its 4. Proposed Rule 504—NYSE Amex component securities within a single Equities (Nasdaq Security Assignment) b. Assignment of the Invesco DMM Unit will reduce or substantially TM As described in this filing, the PowerShares QQQ eliminate those concerns, and are Exchange proposes to trade Nasdaq The Exchange intends to trade the therefore consistent with the Securities within the existing DMM and Invesco PowerShares QQQTM Exchange requirements of the Act and SLP framework used to trade its listed Traded Fund (the ‘‘QQQs’’) and has Commission policy. securities. The Exchange will create a proposed a set of special requirements The Commission has extensively ‘‘Nasdaq Securities Liaison Committee’’, governing the assignment of the QQQs addressed the issue of integrated market consisting of NYSE Euronext employees and its component securities.13 making and side-by-side trading in the of the Operations and U.S. Markets Under proposed Rule 504—NYSE context of trading index ETFs and Divisions (a representative of NYSE Amex Equities, a DMM Unit may be related options. In that guidance, the Regulation Inc. (‘‘NYSER’’) would act as registered in both the QQQs as well as Commission has repeatedly stated that an ad hoc member of the Committee as a component security or securities of the one of the touchstones is whether an needed), that will be responsible for QQQs provided that, at the time of ETF is ‘‘broad-based’’ and therefore reviewing and admitting Nasdaq assignment, (i) no single component in poses a low risk of being susceptible to Securities for trading on the Exchange. which the DMM Unit is registered manipulation.14 In making this At the time Nasdaq Securities are exceeds 10% of the index or portfolio assessment, the Commission has admitted to dealings on the Exchange, underlying the QQQs, and (ii) all weighed whether the underlying the Nasdaq Securities Liaison components in which the DMM Unit is component securities are sufficiently Committee will assign each such registered do not in the aggregate exceed liquid and well-capitalized such that security to a registered and qualified 20% of the index or portfolio they are not individually susceptible to DMM Unit and registered and qualified underlying the QQQs. Subsequently, if manipulation, together with whether the SLPs in accordance with procedures during any given month a single composition of the ETF as a whole is substantially similar to the Exchange’s component security or group of such that it is not unduly concentrated current SLP procedures in Rule 107B— securities in which the DMM Unit is in a single security or a small number NYSE Amex Equities. See proposed registered exceeds these concentration of securities. When an ETF meets both Rule 501—NYSE Amex Equities. The measures on an average basis, the criteria, and therefore can be considered Nasdaq Securities Liaison Committee Nasdaq Liaison Committee will reassign ‘‘broad-based’’, the Commission has may also, in its discretion, reassign one either the QQQs or the component explicitly permitted integrated market or more Nasdaq Securities to a different security or securities to another DMM making and side-by-side trading in both DMM Unit or to a different SLP or SLPs. Unit as needed to achieve compliance the ETF and related options, with no a. Assignment to DMM Units with the concentration measures. requirement for information barriers or The Exchange will calculate and physical or organizational separation. Existing NYSE Amex Equities DMM monitor the components and percentage See, e.g., CBOE Rule 54.7(d). Units will be automatically eligible for of the QQQs on a monthly basis in The Exchange believes that the logic the assignment of Nasdaq Securities, so accordance with the proposed inherent in permitting integrated market long as they qualify in accordance with concentration measures and report these making in broad-based ETFs and related Rules 98— and 103B(II)—NYSE Amex calculations to the Nasdaq Liaison options should also apply to permit Equities, and proposed Rule 504(b)— Committee. In addition, under proposed integrated market making in a broad- NYSE Amex Equities.12 For the Rule 504—NYSE Amex Equities the based ETF such as the QQQs and a purposes of trading Nasdaq Securities, DMM Unit registered in the QQQs will limited number of its component the Exchange proposes to amend the have an independent obligation to securities. The Exchange notes at the quoting requirements under Rule calculate, monitor and report to the outset that there do not appear to be 103B(II)—NYSE Amex Equities such Exchange on a monthly basis the rules on other exchanges expressly that a DMM Unit shall be required to component security or securities in maintain a quote at the National Best 14 which it is registered, the average See Securities Exchange Act Release No. 46213 Bid or Offer in each assigned Nasdaq (July 16, 2002), 67 FR 48232 (July 23, 2002) (SR– percentage of the underlying index or Security an average of at least 10% of Amex–2002–21) (order approving integrated market portfolio of each individual component making of broad index-based ETFs and related the time, or more, during the regular options). See also Securities Exchange Act Release business hours of the Exchange for each during the month, and the total average aggregate percentage of the underlying Nos. 56633 (October 9, 2007), 72 FR 58696 (October calendar month. This quoting 16, 2007) (SR–ISE–2007–60) (order approving requirement is also part of a DMM index or portfolio of all components generic listing standards for ETFs based on both Unit’s affirmative obligations under during the month. If these levels are U.S. and international indices, noting they are exceeded the DMM Unit will be ‘‘sufficiently broad-based in scope to minimize proposed Rule 509—NYSE Amex potential manipulation.’’); 55621 (April 12, 2007), Equities. required to report this to the Exchange 72 FR 19571 (April 18, 2007) (SR–NYSEArca–2006– The Exchange’s Nasdaq Securities as soon as possible. 86) (same); 54739 (November 9, 2006), 71 FR 66993 Liaison Committee will assign Nasdaq The Exchange recognizes that (November 17, 2006) (SR–Amex–2006–78) (same); integrated market-making and side-by- 57365 (February 21, 2008), 73 FR 10839 (February Securities to DMM Units for trading on 28, 2008) (SR–CBOE–2007–109) (order approving the Exchange. No more than one DMM side trading in related securities have generic listing standards for ETFs based on Unit will be assigned to any Nasdaq sometimes raised concerns about international indices, noting they are ‘‘sufficiently Security and a member organization manipulation or improper coordination broad-based in scope to minimize potential of trading between the related securities. manipulation.’’); 56049 (July 11, 2007), 72 FR 39121 (July 17, 2007) (SR–Phlx–2007–20) (same); 55113 12 The Exchange proposes to amend Rule 98(b)(2) As explained more fully below, the (January 17, 2007), 72 FR 3179 (January 24, 2007) (definition of ‘‘DMM unit’’) and (b)(15) (definition of (SR–NYSE–2006–101) (same); and 55269 (February ‘‘Related products’’)—NYSE Amex Equities to 13 See proposed Rule 501(b)—NYSE Amex 9, 2007), 72 FR 7490 (February 15, 2007) (SR– accommodate the trading of Nasdaq Securities on Equities, which defines ‘‘Exchange Traded Fund’’ as Nasdaq–2006–50) (same). The QQQs meet these the Exchange. ‘‘the Invesco PowerShares QQQTM.’’ criteria.
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addressing the latter type of integrated the theoretical possibility of successful traded, and the average daily trade market making, nor has the Exchange manipulation or front-running, the volume, the Exchange believes it to be identified guidance from the Exchange would only permit the QQQs highly unlikely that an individual Commission specifically addressing the DMM to also be the DMM in a limited standing on the Trading Floor could subject. Nevertheless, the Exchange number of component stocks. See enter a timely trade in response to believes that the extant Commission proposed Rule 504—NYSE Amex knowledge of a pending block trade in guidance on integrated market-making Equities. one of the component securities. For the and side-by-side trading in broad-based The existence of a manual market on same reasons, it would also be the Trading Floor does not materially ETFs and related options is highly inherently unprofitable for a DMM to relevant and informative to the current alter this fundamental risk calculus. attempt to manipulate a component in proposal, and is consistent with the First, there will be few, if any, order to effect an advantageous trade in Exchange’s proposal. circumstances in which a DMM in a Among other things, the Exchange’s Nasdaq Security will be in possession of the QQQs. current proposal is limited to a single material nonpublic order information In view of these concerns, however, broad-based ETF, the QQQs, which (i.e., a pending block transaction) that even if unlikely, as described above the meets the composition and could be used improperly. These Exchange proposes to adopt concentration measures previously situations are typically limited to concentration requirements for trading approved by the Commission (see circumstances when the market is slow the QQQs to limit the level of nonpublic footnote 14 herein) to be classified as a because of a pending manual trade and/ information regarding the component broad-based ETF, with minimal, if any, or when a Floor broker communicates securities available to the assigned potential to be manipulated. that he or she is seeking to execute a QQQs DMM Unit. Together with the Because the potential for block sized order. In listed securities market structure considerations manipulation of the QQQs is so today, a substantial percentage of outlined above which mitigate against minimal, the risk presented by limited manual trades occur in connection with possible manipulation and front- integrated market making is also the opening and closing auction or running, the Exchange believes that this extremely low. In this regard, the when a liquidity replenishment point Exchange notes that the QQQs is one of (‘‘LRP’’) has been reached. However, additional restriction will provide a the most actively traded securities in the there will not be an opening or closing ‘‘belt-and-suspenders’’ level of world. It is based on a group of highly auction in Nasdaq Securities and the protection. liquid securities (the top 100 Nasdaq- LRPs will be substantially widened. The Exchange also believes that any listed securities, ex-financial stocks); Thus the number of manual trades is potential concerns over ‘‘wash sales’’ or with the exception of Apple, no anticipated to be negligible. And, even inadvertent internal proprietary crosses component represents more than 10% of when a manual transaction in a by the DMM Unit are sufficiently the index; the ETF is itself very liquid component security does occur intraday addressed. First, Exchange DMM (with 3-month average volume in excess (e.g., in response to an LRP or algorithmic trading systems (commonly of 90 million shares per day); and it is publication of a gap quote), it is highly known as the ‘‘SAPI’’) prevent DMM actively traded in multiple markets unlikely that a DMM Unit could Unit trading interest from executing around the world. profitably use this information to effect against its own quotes or other trading Given all of this, the Exchange an advantageous trade in the QQQs for interest on the Exchange (i.e. an believes that it would be inherently the reasons described above. ‘‘ ’’ ineffective to attempt to either Second, the Exchange will not be the internal cross ) and virtually all DMM manipulate the price of a component or listing market in Nasdaq Securities and Unit trading interest is entered via the front-run pending nonpublic trading is expected to have limited market share SAPI. While a DMM Unit could, activity in a component in order to given the fragmentation of trading in theoretically, enter a proprietary order effect an advantageous trade in the Nasdaq-listed securities in the U.S. in one of its assigned securities other QQQs. First, because of the inherent equities markets. Thus any trading that than through the SAPI, which would leverage of the QQQs compared to its occurs on the Exchange will generally not be subject to the systemic internal components, such a manipulation of a equalize to trading on other markets, cross block, that possibility is remote component would require a with limited, if any, ability for the DMM since the DMM Unit would incur higher disproportionately large amount of to materially impact the price of a fees for such an order and less capital in order to be able to both impact component. In view of the depth and advantageous parity treatment in the price of the QQQs and liquidity of the Nasdaq-100 component connection with any execution of such simultaneously override potential securities, the Exchange does not order. Even so, DMM Units are required concurrent and counter-cyclical price believe that a block transaction in a to have policies and procedures in place movements in the other 99 components. component security of the QQQs would reasonably designed to prevent The amount of capital required to necessarily impact the price of the violations of Exchange rules and the successfully accomplish such a component security on a consolidated federal securities laws, including NYSE manipulation would seemingly be larger basis for a meaningful period of time. Amex Disciplinary Rule 476(a)(8), than the potential profit potential. More importantly, the Exchange does which prohibits ‘‘giving an order for the Similarly, the potential for successful not believe that a block transaction on purchase or sale of securities the front-running would require that the the Exchange in a component security execution of which would involve no impact of the pending component would predictably impact the price of trading activity not be neutralized by the QQQs for enough time, if at all, to change of beneficial ownership or price changes in the other components. alter the risk-reward calculus and executing such an order with knowledge For the same reasons, it would be incentivize front-running the of its character’’, as well as violations of difficult to effectively front-run component block transaction by trading the ‘‘wash sale’’ prohibition of Section 9 information about a component security in the QQQs. Given the high-speed pace of the Act. These policies and by trading in the QQQs. However, as of electronic trading generally, the procedures, including those governing a noted above, in order to mitigate against breadth of markets where the QQQs is firm’s risk management trading policies
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and systems, are subject to review and members and member organizations of Amex Equities. NYSE registered SLPs approval by the Exchange.15 the Exchange and DMM Units are that wish to trade Nasdaq Securities as In addition, because any firm assigned automatically granted an NYSE Amex SLPs will need to register with and be as the DMM Unit for the QQQs will Equities trading license. See Rules approved by the Exchange as SLPs in have, as part of its broader risk 2.10— and 2.20—NYSE Amex Equities. accordance with all applicable NYSE management capability, a unique ability Those NYSE DMM Units that wish to Amex Equities Rules. to view and assess its trading activity trade Nasdaq Securities and that are not The Nasdaq Securities Liaison across any and all markets in which it already registered as DMM Units on the Committee will assign one or more SLPs trades the QQQs and any components in Exchange will need to register as such to Nasdaq Securities for trading on the which it is registered on the Exchange,16 with the Exchange to ensure proper Exchange. A member organization in accordance with Rule 342—NYSE tracking and systems configuration. cannot be both the DMM Unit and an Amex Equities the Exchange will Similarly, individual DMMs will need SLP for the same Nasdaq Security. require the QQQs DMM to implement to register with the Exchange to confirm Because SLPs do not have a presence on adequate policies and procedures to that they meet all applicable registration the Trading Floor and do not have detect and deter the inappropriate requirements and to ensure proper access to the information there, access to information about pending tracking and systems set-up, including however, the Exchange does not block trades in a component security, ID Track requirements. In addition, propose the same limitations on the potential front-running and/or NYSE DMM Units seeking to register as assignment of ETFs and component manipulation based on such a DMM Unit on the Exchange will also securities to SLPs as it does for DMM information, intentional wash sales, or need to advise FINRA in order to enable Units. any other violations of Section 9 of the FINRA to assess whether such Finally, in the event an SLP Act. The DMM’s policies and registration triggers different and/or withdraws from its status as an SLP, procedures would also be required to additional financial and operational Nasdaq Securities will be reassigned to provide that the DMM firm will conduct requirements, including but not limited a different SLP(s) in accordance with surveillance to identify patterns of to those pertaining to net capital. Rule 107B—NYSE Amex Equities. trading that are indicative of possible As described more fully in the section front-running of block trades, proposing to amend Rule 103B—NYSE 5. Proposed Rule 506—NYSE Amex manipulation and/or intentional wash Amex Equities, infra, a DMM Unit that Equities (Units of Trading; Bids and sales, and to take appropriate steps to is registered to trade both NYSE and Offers; Dissemination of Quotations; investigate and report such trading to Exchange-listed securities, as well as Priority) the Exchange. As with all DMM Units, Nasdaq Securities, could trade all these Nasdaq Securities will be traded securities at the same post. However, the firm will be subject to periodic and, almost exactly as the Exchange’s listed such member organizations will be if warranted, special examinations by securities. Proposed Rule 506—NYSE required to commit sufficient staff for FINRA. Amex Equities prescribes the basic unit the trading of NYSE-listed securities As a result, the Exchange believes that of trading for Nasdaq Securities, and separate from that for the trading of the requirements governing the addresses some requirements for bids Exchange-listed securities and/or assignment of Nasdaq Securities in and offers, the dissemination of Nasdaq Securities at the same post on proposed Rule 504—NYSE Amex quotations, and priority and parity of the Trading Floor: individual DMMs Equities are sufficient to address any executions of Nasdaq Securities. and support staff will not be permitted market concerns. The Exchange also The Exchange will accept and process agrees to review proposed Rule 504— to trade both NYSE-listed and NYSE Amex-listed securities and/or Nasdaq bids and offers in Nasdaq Securities NYSE Amex Equities and the provisions according to the same rules for its listed governing the allocation of the QQQs Securities at the same time. Intraday moves of individual DMMs and support securities. In accordance with Rules and its component securities in the 55— and 56—NYSE Amex Equities, the event that the Exchange’s share of the staff between panels will be permitted, although DMMs and staffers will not be unit of trading in Nasdaq Securities is market for the Nasdaq Securities it 100 shares, rights or warrants, or such trades exceeds 10% of the consolidated permitted to be simultaneously logged- into both an NYSE panel and an lesser number as may be determined by Tape C aggregate average daily trading the UTP Listing Market or the Exchange. volume for these securities. Exchange panel. Finally, in conjunction with Rule Odd-lot bids or offers will be processed c. Integration of NYSE Amex Listed 103B(IX), proposed Rule 504(d)—NYSE and executed by means of the Securities and Nasdaq Securities at Amex Equities will require that Nasdaq Exchange’s odd-lot order system Posts on the Trading Floor Securities be allocated for trading only pursuant to Rule 124—NYSE Amex at panels exclusively designated for Equities. The round-lot and odd-lot The Exchange anticipates that some portions of partial round-lot orders will DMM Units currently registered on the trading listed and/or Nasdaq Securities on the Exchange (see infra). be processed and executed in NYSE will seek to register as DMM accordance with Rule 124—NYSE Amex Units on the Exchange in order to trade d. Assignment to SLPs Equities. Nasdaq Securities. Under Exchange NYSE Amex Equities members and Bids and offers in Nasdaq Securities Rules, all current NYSE members and member organizations may apply to be admitted to dealings on the Exchange on member organizations are deemed SLPs in Nasdaq Securities and will be an ‘‘issued’’ basis shall be made ‘‘regular eligible for the assignment of Nasdaq way’’ in accordance with Rules 64—, 15 The member firm currently anticipated to be assigned as the DMM Unit in the QQQs has Securities once they register and qualify 65— and 66—NYSE Amex Equities and, represented to the Exchange that the firm’s risk as SLPs in accordance with Rule 107B— for Nasdaq Securities admitted on a management system will reasonably prevent the NYSE Amex Equities. As with NYSE ‘‘when-issued’’ or ‘‘when-distributed’’ firm from effecting any internal proprietary crosses registered DMMs and DMM Units, basis, bids and offers shall only be made in its assigned securities. ‘‘ ’’ ‘‘ ’’ 16 Such firm’s risk management policies and NYSE registered SLPs are automatically when-issued or when-distributed in procedures will have to meet the requirements of deemed member organizations of NYSE accordance with Rule 63—NYSE Amex Rule 98—NYSE Amex Equities. Amex Equities under Rule 2.10—NYSE Equities.
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As enforced by Exchange systems, NYSE Amex Equities. In addition, Exchange and the closing price on the bids and offers in Nasdaq Securities because the Exchange will not conduct UTP Listing Market. To ensure this, shall comply with Rule 19—NYSE an opening auction for Nasdaq Floor Governor approval is required to Amex Equities concerning locking or Securities, DMM Units will not be close a Nasdaq Security that is ‘‘slow.’’ crossing protected quotations in permitted or required to hold or In the event of an extreme order Regulation NMS stocks and the represent orders for Nasdaq Securities imbalance at or near the close of the Exchange shall disseminate quotes in pursuant to Rule 115A.20—NYSE Amex regular trading session that could result accordance with Rule 60—NYSE Amex Equities. in Closing Price dislocation, the Equities. Also, the minimum price procedures of Rule 123C(9)—NYSE b. Closings variations prescribed in Rule 62—NYSE Amex Equities, which permit the Amex Equities shall apply to all bids Under Rule 508(b), trading in Nasdaq Exchange to temporarily suspend the and offers in Nasdaq Securities. Securities will not close based on a hours of operation for the solicitation Orders for Nasdaq Securities shall be closing auction but will instead close at and entry of orders into Exchange executed in price and time priority and the end of the regular trading session at systems, shall apply. However, because parity in accordance with all applicable 4 p.m., or at such other time as may be the Exchange will not conduct a closing NYSE Amex Equities Rules, including specified by the Exchange. Except for auction in Nasdaq Securities, no other Rule 72—NYSE Amex Equities. ‘‘aggregate-price orders’’,17 or ‘‘closing- procedures of Rule 123C—NYSE Amex The Exchange will display on the price orders’’ entered to offset an error, Equities shall apply to trading in Trading Floor quotes and executions for entered in the ‘‘Off-Hours Trading Nasdaq Securities. Nasdaq Securities on both the Exchange Facility’’ in accordance with proposed The proposed modifications to the as well as from other market centers in Rule 511—NYSE Amex Equities, orders opening and closing of the trading of accordance with the UTP Plan (‘‘Tape for Nasdaq Securities will not be Nasdaq Securities require corresponding C’’). Such display will include the accepted by the Exchange after the modifications to the ‘‘GTC’’ and ‘‘Stop’’ appropriate identifier indicating the regular trading session on any business order types. Specifically, GTC Orders SRO or exchange reporting the day.18 and unelected Stop Orders for Nasdaq execution to the Tape. Corporate action The ‘‘Closing Price’’ will be set at the Securities that are not fully executed at data for Nasdaq Securities will be price of the last sale in a Nasdaq the close of the regular trading session incorporated by the Exchange on a daily Security on the Exchange at or prior to shall be treated as Day Orders and shall basis after the close of regular trading the close of regular trading at 4 p.m. (see be cancelled; they will not remain on and any adjustments to share price will Rules 502— and 508—NYSE Amex the Exchange’s systems overnight. In be made at that time. Equities).19 Orders for Nasdaq Securities addition, because the Exchange will not 6. Proposed Rule 508—NYSE Amex that are unexecuted at the close of conduct either an opening or closing Equities (Openings and Closings) trading at 4 p.m. shall be cancelled. auction in Nasdaq Securities, the If, at or just prior to the close of Exchange will not accept MOC/LOC, Pursuant to proposed Rule 508— trading at 4 p.m., the market for a OPG, CO or GTX Orders for Nasdaq NYSE Amex Equities, the Exchange particular Nasdaq Security is manual or Securities. All other order types noted proposes to conduct openings and ‘‘slow’’ (for example, because a gap in Rule 13—NYSE Amex Equities will closings for Nasdaq Securities quote has been published or a Liquidity be permitted for the trading of Nasdaq differently than for listed securities. As Replenishment Point has been reached), Securities.20 described more fully below, the there will be a single trade at or Exchange will not conduct an opening immediately after the close that will set 7. Proposed NYSE Amex Equities Rule or closing auction in Nasdaq Securities the Closing Price. In such 509 (Dealings of DMM Units and SLPs) and will instead open trading on a quote circumstances, the DMM will pair off As noted above, the Exchange at 9:30 a.m. and close on the last sale liquidity to the extent available and proposes to trade Nasdaq Securities price on the Exchange at 4 p.m. then execute the final trade. All residual using the same DMM/SLP framework as a. Openings marketable interest for that security currently used for its listed securities. received prior to the close of trading a. DMM Units Under proposed Rule 508(a), trading shall first be executed at the Closing in Nasdaq Securities will not open Price and then all unexecuted interest DMM Units registered to trade Nasdaq based on an opening auction but will for the security shall be cancelled. Securities on the Exchange will be instead open at 9:30 a.m. or as soon When the market for a Nasdaq required to fulfill their responsibilities thereafter as possible, or at such other Security is slow at the close of trading, and duties for those securities in time as may be specified by the the DMM Unit must execute the final accordance with all applicable NYSE Exchange, based on a quote published trade in the security in a manner Amex Equities Rules and requirements by the DMM Unit assigned to each consistent with a fair and orderly (‘‘DMM rules’’),21 subject to two particular security. Orders for Nasdaq market, with reference to the trading modifications. Securities shall not be accepted by the characteristics of the stock at issue, Under Rule 104—NYSE Amex Exchange and will be systemically including its price, average daily trading Equities, for those Exchange-listed blocked before trading opens on any volume (‘‘ADTV’’), average volatility, the securities in which they are registered, business day. prior sale of the security on the DMM Units are required to use their The DMM Unit will be responsible for capital to meet the obligation of opening trading in its assigned Nasdaq 17 The Exchange is proposing to amend the maintaining a fair and orderly market to Securities by publishing an opening definition of ‘‘aggregate-price order’’ under Rule the extent reasonably practicable. This quote at 9:30 a.m. or as soon thereafter 900—NYSE Amex Equities in order to requirement, in turn, may be broken accommodate trading Nasdaq Securities in the Off- as possible. Because Nasdaq Securities down into certain components, which will open on a quote, DMM Units will Hours Trading Facility. 18 These terms are defined under Rule 900— not be permitted or required to provide NYSE Amex Equities. 20 See proposed Rule 501—NYSE Amex Equities. pre-opening or opening indications as 19 See also proposed Rule 501—NYSE Amex 21 The term ‘‘DMM rules’’ is defined under Rule prescribed by Rules 15— and 123D— Equities. 98—NYSE Amex Equities.
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include quoting at the National Best Bid DMM Unit will not be included in the Securities.26 In addition, DMMs would or National Best Offer for a certain inside quote calculations. Because this continue to be the sole market maker on percentage of time, supplying liquidity quoting requirement will be applied on the Exchange in their registered Nasdaq as needed, managing and/or facilitating a stock-by-stock basis, rather than Securities. manual or other transactions at aggregated across all securities that the The Exchange believes the enhanced specified times, minimizing and DMM Unit trades, the Exchange believes quoting requirement and phased-in stabilizing disparity in supply and it is a more stringent standard than is Depth Guidelines are appropriate in demand as needed, and maintaining currently in place for listed securities. connection with trading Nasdaq price continuity and depth within Second, pursuant to Rules 104(f)(ii)— Securities on the Exchange, particularly specified guidelines. None of these and (iii)—NYSE Amex Equities, DMM because the market dynamics for trading individual requirements is dispositive Units will continue to be responsible for Nasdaq Securities will be different from and they must all be viewed together maintaining price continuity with those for the Exchange’s listed when evaluating the broader obligation reasonable depth for their registered securities. Although the Exchange will to maintain a fair and orderly market.22 Nasdaq Securities in accordance with not be the primary market for Nasdaq In return for those obligations and Depth Guidelines published by the Securities and its market share is restrictions, DMM Units are entitled to Exchange. However, in order to give the expected to be small, at least initially, trade on parity with Floor brokers and Exchange time to phase-in appropriate the Exchange believes that its DMM/SLP off-Floor orders in their registered Depth Guidelines, these provisions will market model will, for some market securities, are the sole market maker on not be operative until 18 weeks after the participants, provide an attractive and the Exchange in those securities, and approval of the proposed rule changes competitive alternative for the trading of receive financial incentives for by the Commission.24 Nasdaq Securities that does not providing liquidity and executing odd- As is the case with listed securities, currently exist. lot orders. DMM Units also have the DMM Units will also be responsible for In addition, other provisions of the ability to set a Capital Commitment facilitating openings, reopenings and NYSE Amex Equities Rules related to Schedule (‘‘CCS’’), which allows them to closings for each of the Nasdaq DMM responsibilities and obligations indicate to Exchange systems where Securities in which they are registered would be modified, including the they are willing to add additional in accordance with applicable NYSE following: • DMMs will not be required to liquidity to the market; if these pre- Amex Equities Rules, including the obtain Floor Official approval prior to determined parameters are met, the procedures of proposed Rules 508– and engaging as a dealer in transactions for system automatically includes the 515—NYSE Amex Equities. DMM Units 23 Nasdaq Securities that fall under Rule additional CCS interest. will also be responsible for facilitating 79A.20—NYSE Amex Equities. For Nasdaq Securities, DMM Units trading when the market is ‘‘slow’’ (such • Notwithstanding the prescriptions will, insofar as reasonably practicable, as during a gap quote or an LRP) 25 and of Rule 36.30—NYSE Amex Equities continue to be responsible for engaging helping to close Nasdaq Securities that governing communications to and from in a course of dealings for their own are subject to an imbalance. Other the DMM Unit post on the Trading account and assisting in the obligations would continue to apply, Floor, an individual DMM registered in maintenance of a fair and orderly including providing contra side an ETF may use a telephone connection market for those securities in which liquidity as needed for the execution of or order entry terminal at the DMM they are registered in accordance with odd-lot orders for Nasdaq Securities Unit’s post to enter a proprietary order Rule 104—NYSE Amex Equities. There received on the Exchange, meeting in the ETF in another market center, in are two modifications, however. stabilization and re-entry requirements, a component security of such ETF, or in First, in lieu of the tiered quoting and complying with the net capital an options or futures contract related to requirement (5% and 10%) currently in requirements under Rules 103.20—, such ETF, and may use the post place for listed securities under Rule 4110— and 4120—NYSE Amex telephone to obtain public market 104(a)(1)(A)—NYSE Amex Equities, Equities, as well as the Act. information with respect to such ETF, proposed Rule 509(a)(1) requires a DMM Because DMMs would retain Unit to maintain a quote at the National options, futures, or component obligations that other market securities. If the order in the component Best Bid or Offer (‘‘inside’’) in each participants, both on the Exchange and assigned Nasdaq Security an average of security of the ETF is to be executed on in other markets, do not have, DMM the Exchange, the order must be entered at least 10% of the time, or more, during Units would retain the benefits of parity the regular business hours of the and executed in compliance with Rule and liquidity incentives, as well as the 112—NYSE Amex Equities and SEA Exchange for each calendar month. As ability to use CCS, when trading Nasdaq for listed securities, time at the inside Rule 11a2–2(T), and must be entered will be calculated as the average of the only for the purpose of creating a bona 24 A phased-in approach is necessary so that fide hedge for a position in the ETF. The percentage of time the DMM Unit has a appropriate Depth Guidelines may be calculated bid or offer at the inside, and credit will based on actual trading data of Nasdaq Securities Exchange is proposing to add this be given for executions for the liquidity on the Exchange. Accordingly, following provision in order to permit DMM Units provided by the DMM Unit. Reserve or implementation and roll-out of the pilot program, registered in an ETF to execute more the Exchange proposes to collect 60 trading days of other hidden orders entered by the efficiently hedging transactions for the trade data and would then implement Depth 27 Guidelines for trading Nasdaq Securities on NYSE security. 22 See Rules 72– and 104—NYSE Amex Equities. Amex within 30 calendar days of the collection of For a more detailed discussion of DMM obligations, the trade data. The eighteen week phase-in period 26 The Exchange will submit a separate fee filing see Securities Exchange Act Release No. 58845 contemplates a two-week period to roll-out the pilot detailing the rebate structure for trading Nasdaq (October 24, 2008), 73 FR 64379 (October 29, 2008) program. Securities at a later date. (SR–NYSE–2008–46). 25 For clarification, a DMM Unit facilitates trading 27 This provision is modeled on a provision in 23 See Rules 72–, 104(d)– and 1000—NYSE Amex in slow markets by either conducting an auction or NYSE Rule 36.30, approved by the Commission. Equities concerning parity and CCS. For trading out of the slow market in order to resume See Securities Exchange Act Release No. 44616 information on the rebate structure, see the a ‘‘fast’’ (i.e. quote protected) market. It does not (July 30, 2001), 66 FR 40761 (August 3, 2001) (SR– Exchange’s price list, available on the Exchange mean, however, that a DMM Unit must participate NYSE–2001–08) (order approving amendments to Web site at http://www.nyse.com. on the contra-side of the market when it is slow. NYSE Rule 36.30).
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b. SLPs purchasers of such an ETF with a For an ETF where a net asset value or SLPs registered in one or more written description of the terms and disclosed portfolio is disseminated, the Nasdaq Securities must fulfill their characteristics of the product at the time Exchange will immediately halt trading responsibilities and duties for those confirmation of the first transaction in in such product upon notification by the securities in accordance with all the product is delivered to the UTP Listing Market that the net asset applicable NYSE Amex Equities Rules purchaser. In addition, members and value or disclosed portfolio is not being and requirements, including, but not member organizations will be required disseminated to all market participants limited to, the requirements of Rule to include a written description with at the same time. The Exchange may 107B—NYSE Amex Equities, and the any sales material relating to the resume trading in the product only SLP quoting requirements for Nasdaq product that they provide to customers when dissemination of the net asset Securities shall be the same as for or the public. Any other written value or disclosed portfolio to all market securities listed on the Exchange. materials provided by a member or participants at the same time resumes or member organization to customers or trading in the product resumes on the 8. Proposed NYSE Amex Equities Rule the public making specific reference to UTP Listing Market. 510 (Derivative Securities Products) the ETF as an investment vehicle must For an ETF that is listed on Nasdaq, The Exchange also proposes some include a statement that such materials such as the QQQs, Nasdaq rules require specific additional provisions that will are available. and/or permit it to halt trading in such apply to the trading of Exchange Traded Members or member organizations securities when net asset value or other Funds that are ‘‘new derivative carrying omnibus accounts for non- information is not being properly securities products,’’ as defined in Rule members will be required to inform disseminated as required (see Nasdaq 19b–4(e) under the Act and traded non-members that execution of an order Rule 4120(a)(9)–(10)).29 Pursuant to the pursuant to Rule 19b–4(e) thereunder.28 to purchase an ETF for the omnibus UTP Plan, Nasdaq is required to use the For each such ETF, the Exchange will account will be deemed to constitute national market system communication file a Form 19b–4(e) with the agreement by the non-member to make media (‘‘Hoot-n-Holler’’) to notify other Commission. In addition, the Exchange such written description available to its participants of such a halt and upon will distribute an information circular customers on the same terms as are such notification the Exchange would prior to the commencement of trading in directly applicable to members and halt trading in the QQQs in accordance each such product that generally member organizations under this Rule. with the proposed rules. includes the same information as Upon request of a customer, a member Finally, due to the nature of ETFs contained in the information circular or member organization shall also such as the QQQs, the Exchange provided by the UTP Listing Market for provide a prospectus for the particular proposes to restrict the allocation of that the product, including: (a) The special product. security and its components. See risks of trading the new product; (b) the In order to accommodate the trading proposed Rule 504—NYSE Amex Exchange Rules that will apply to the of ETFs that qualify under this Rule, the Equities. In addition, the Exchange will new product, including Rule 405— Exchange is also proposing additional enter into a comprehensive surveillance NYSE Amex Equities; (c) information requirements for trading halts. If a sharing agreement with markets trading about the dissemination of the value of temporary interruption occurs in the components of the index or portfolio on the underlying assets or indexes; and (d) calculation or wide dissemination of the which the product is based to the same the risks of trading outside of the regular intraday indicative value, the value of extent as the UTP Listing Market’s rules trading session for the product due to the underlying index, portfolio or require the UTP Listing Market to enter the lack of calculation or dissemination instrument, or similar value of a product into a comprehensive surveillance of the value of the underlying assets or and the UTP Listing Market halts sharing agreement with such markets. index, the intra-day indicative value or trading in the product, the Exchange, upon notification by the UTP Listing 9. Proposed NYSE Amex Equities Rule a similar value. 511 (Off-Hours Trading) Members and member organizations Market of such halt due to such that trade these ETFs will be subject to temporary interruption, shall also Nasdaq Securities will be accepted by the prospectus delivery requirements of immediately halt trading in that the Exchange’s Off-Hours Trading the Securities Act of 1933, unless the product. Facility as part of an aggregate-price product is the subject of an order by the If the interruption in the calculation (‘‘basket’’) order, or as a closing-price Commission exempting the product or wide dissemination of the intraday order entered to offset a transaction from certain prospectus delivery indicative value, the value of the made in error, as those terms are requirements under Section 24(d) of the underlying index, portfolio or defined under Rule 900—NYSE Amex Investment Company Act of 1940 or the instrument, or similar value continues Equities.30 product is not otherwise subject to as of the commencement of trading on the Exchange on the next business day, 10. Proposed NYSE Amex Equities Rule prospectus delivery requirements under 512 (Liquidity Replenishment Points) the Securities Act of 1933. As a result, the Exchange shall not commence members and member organizations trading of the product on that day. If the Given the different trading will be required to provide all interruption in the calculation or wide characteristics of Nasdaq Securities, the dissemination of the intraday indicative Exchange proposes to amend the values 28 These provisions are based on similar rules value, the value of the underlying index, used to calculate Liquidity adopted by other exchanges and/or approved by the portfolio or instrument, or similar value Replenishments Points (LRPs) for these Commission for the generic trading of derivative continues, the Exchange may resume securities in accordance with Rule securities products based on unlisted trading 1000—NYSE Amex Equities. privileges. See, e.g., Securities Exchange Act trading in the product only if Release No. 57448 (March 6, 2008), 73 FR 13597 calculation and wide dissemination of (March 13, 2008) (SR–NSX–2008–05) (order the intraday indicative value, the value 29 See April 9 e-mail. approving NSX Rule 15.9) and Securities Exchange of the underlying index, portfolio or 30 The Exchange is proposing to amend the Act Release No. 59663 (March 31, 2009), 74 FR definition of ‘‘aggregate-price order’’ under Rule 15552 (April 6, 2009) (SR–Nasdaq–2009–018) instrument, or similar value resumes or 900—NYSE Amex Equities in order to (notice of filing and immediate effectiveness for trading in the product resumes on the accommodate trading Nasdaq Securities in the Off- Nasdaq Rule 5740). UTP Listing Market. Hours Trading Facility. See Exhibit 5.
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The Exchange expects that Nasdaq Amex Equities for the purposes of member organizations acting as market Securities will be much more thinly trading Nasdaq Securities. makers on other markets, (iv) to correct traded on the Exchange, with lower There are several reasons for adopting bona fide errors, and (v) as intermarket volume and less liquidity than its listed a Manning-like set of rules rather than sweep orders made in compliance with securities, and that prices for Nasdaq applying Rule 92—NYSE Amex Regulation NMS.33 Securities will be more volatile. As a Equities. To begin with, all Exchange By comparison, the Manning Rule result, in order to avoid triggering too member organizations that have public operates to prohibit a member firm from many ‘‘slow’’ trading situations, the customers are also FINRA members and executing, rather than entering, a Exchange proposes wider LRP are therefore subject to FINRA’s proprietary trade at a price equal to or parameters for trading Nasdaq Securities Manning Rule when trading off- better than an unexecuted customer than for its listed securities. Exchange. In addition, because the order unless the firm immediately Specifically, the Exchange proposes Manning Rule and Rule 92—NYSE executes the customer order at the same that, for each Nasdaq Security (except Amex Equities differ in certain key price (or better) it executed its own for ETFs), the value used to calculate aspects, the Exchange believes that proprietary order.34 Like Rule 92— the LRP ranges shall be ten percent requiring member organizations to NYSE Amex Equities, the Manning Rule (10%) of the Closing Price of the comply with two sets of potentially has an exception for Institutional/Large- relevant security from the prior regular conflicting standards when trading size Orders, subject to disclosure to the trading session on the Exchange, Nasdaq Securities would be confusing customer. However, unlike Rule 92— rounded to the nearest penny. These and would require programming NYSE Amex Equities, the Manning Rule values will be recalculated by the changes by member organizations.31 does not require affirmative consent Exchange on a daily basis. For the first Rule 92—NYSE Amex Equities from the customer. In addition, the day of trading of each Nasdaq Security, prohibits, subject to some exceptions, Manning Rule does not limit the the LRP will be calculated using the members and member organizations specific types of transactions to which Nasdaq closing price from the prior from entering proprietary orders if the this exception applies. The Manning trading session. person responsible for the entry of that Rule has other exceptions that mirror Upon the phase-in period, the order has knowledge of an unexecuted those of Rule 92—NYSE Amex Equities, Exchange intends to evaluate these customer order on the same side of the including for transactions made by a parameters to determine if they need to market that could be executed at the member as a riskless principal or be adjusted in light of trading activity same price as the proprietary order.32 involving intermarket sweep orders. The for Nasdaq Securities on the Exchange. Rule 92 does, however, permit a Manning Rule does not, however, 11. Proposed NYSE Amex Equities member or member organization to permit exceptions for transactions on Rules 513 (Trading Ahead of Customer enter a proprietary order for certain delivery terms different from those for Limit Orders) and 514 (Trading Ahead specified purposes while representing a the unexecuted customer order, by of Customer Market Orders) customer order that can be executed at members or member organizations the same price where the customer acting as market makers on other As described more fully below, order is not held and is for either an markets, or to correct bona fide errors.35 proposed Rules 513— and 514—NYSE institutional account or is greater than As is evident, Rule 92—NYSE Amex Amex Equities prescribe limitations on 10,000 shares and $100,000 in value Equities differs from the Manning Rule, proprietary trading by members and (‘‘Institutional/Large-size Order’’), most notably in its focus on order entry member organizations holding provided that the member or member rather than execution. Moreover, Rule unexecuted customer orders in Nasdaq organization has provided written 92—NYSE Amex Equities provides Securities. In summary, a member firm disclosures and obtained documented exceptions for certain types of handling an unexecuted customer order affirmative consent from the customer. transactions that the Manning Rule does in a Nasdaq Security will not be Rule 92 also permits an exception where not. Thus, any dual NYSE Amex permitted to execute a proprietary trade a member or member organization Equities and FINRA member attempting for that security at a price that would enters a proprietary order to facilitate a to comply with both Rule 92—NYSE satisfy the customer’s order without riskless principal transaction. In Amex Equities and the Manning Rule executing the customer’s order at that addition, the prescriptions of Rule 92 do while trading Nasdaq Securities on the price. not apply to transactions made (i) by Exchange would be subject to differing In order to harmonize the obligations odd-lot dealers, (ii) on delivery terms standards for the same security solely for members and member organizations different from those for the unexecuted because of where an order has trading Nasdaq Securities on the customer order, (iii) by members or executed.36 Exchange with their existing obligations
for trading those securities off- 33 31 Although there may be Exchange-only See generally Rule 92—NYSE Amex Equities. Exchange, proposed Rules 513— and members that trade Nasdaq Securities, such 34 FINRA has proposed to combine NASD 514—NYSE Amex Equities are members are not subject to the Manning Rule Interpretive Material 2110–2 and NASD Rule 2111 substantially similar to FINRA’s because they do not have public customers. into a single FINRA Rule 5320. See Securities ‘‘Manning Rule’’ (NASD Interpretive Moreover, all Exchange members that are registered Exchange Act Release No. 61168 (December 15, as Floor brokers are also required to be FINRA 2009), 74 FR 68084 (October 22, 2009) (SR–FINRA– Material 2110–2 and NASD Rule 2111). members and, unless proposed Rules 513— and 2009–090). See also FINRA Regulatory Notice 09– Subject to some technical amendments 514—NYSE Amex Equities are approved, would be 15 (March 12, 2009). to apply the Rules to the Exchange, required to comply with both Rule 92—NYSE Amex 35 See NASD Interpretive Material 2110–2 and proposed Rule 513—NYSE Amex Equities and the Manning Rule. NASD Rule 2111. 32 Technically, Rule 92—NYSE Amex Equities 36 There are other differences between Rule 92— Equities is based on NASD IM–2110–2 refers to transactions involving ‘‘Exchange-listed NYSE Amex Equities and the Manning Rule, and proposed Rule 514—NYSE Amex securit[ies]’’, which would not encompass Nasdaq including each Rule’s definition of ‘‘institutional Equities is based on NASD Rule 2111. Securities traded on the Exchange. However, the account’’, the reporting requirements for executing Correspondingly, proposed Rules 513— Exchange recognizes that, whether it applies Rule riskless principal transactions, and minimum price 92 or the Manning Rule, some form of limitation improvement standards. The Exchange notes that it, and 514—NYSE Amex Equities exempt will be prescribed on proprietary trading of Nasdaq NYSE and FINRA are in the process of harmonizing Exchange members and member Securities by members and member organizations their respective customer order protection rules. For organizations from Rule 92—NYSE due to customer orders. Continued
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Moreover, the Exchange understands UTP Listing Market or FINRA and the accept any new orders for the affected that firms generally code their order federal securities laws and the rules security for the duration of the halt. entry, routing and execution systems to thereunder, related to proprietary 13. Proposed Rules 516— and 518— comply with Rule 92—NYSE Amex trading while holding unexecuted NYSE Amex Equities (Reporting and Equities when trading on the Exchange 37 customer orders in the same security. Recordkeeping; Clearance and and the Manning Rule when trading on Settlement) NASDAQ and other markets. It would 12. Proposed NYSE Amex Equities Rule be impractical and unnecessarily 515 (Trading Halts) As described more fully below, under burdensome to require member Generally, as prescribed in proposed proposed Rule 516—NYSE Amex organizations to add Rule 92—NYSE Rule 515—NYSE Amex Equities, the Equities: (1) Members and member Amex Equities parameters to their Exchange will follow all applicable organizations trading Nasdaq Securities systems to account for both the Manning NYSE Amex Equities Rules governing on the Exchange are subject to Rules Rule and Rule 92—NYSE Amex Equities halts or suspensions, for both regulatory 123— and 132B—NYSE Amex Equities; when trading Nasdaq Securities on the and/or non-regulatory purposes, of the (2) if a member or member organization Exchange. trading of Nasdaq Securities on the is also a FINRA member subject to Requiring firms to comply with Exchange, including Rules 51—, FINRA’s Rule 7400 Series, such a firm proposed Rules 513— and 514—NYSE 80B—, 123D— and 510—NYSE Amex is exempt from Rules 123— and 132B— Amex Equities rather than Rule 92— Equities. NYSE Amex Equities; and (3) regardless NYSE Amex Equities when trading In addition, the Exchange will halt or of whether or not a FINRA member, a Nasdaq Securities comports with the suspend trading in a Nasdaq Security Floor broker that receives an order in a broader goals of regulating the market when trading in that security has been Nasdaq Security from another member for these securities. The majority of halted or suspended by the UTP Listing via Exchange systems will be subject to trading in Nasdaq Securities takes place Market for regulatory reasons in Rules 123— and 132B—NYSE Amex on other markets in accordance with the accordance with its rules and/or the Equities and exempt from FINRA’s Rule requirements of the Manning Rule, and UTP Plan.38 The Exchange will also halt 7400 Series. FINRA and other SROs conduct or suspend trading in a Nasdaq Security Rules 123— and 132B—NYSE Amex surveillance based on those parameters. when the authority under which the Equities, inter alia, make up the Requiring member firms to comply with Exchange’s transaction audit trail security trades on the Exchange or the 40 proposed Rules 513— and 514—NYSE UTP Listing Market has been revoked. system. Specifically, Rule 132B— Amex Equities rather than Rule 92— This can occur when the Nasdaq NYSE Amex Equities prescribes order NYSE Amex Equities ensures that, when Security at issue is no longer designated tracking requirements for transactions Nasdaq Securities are traded on the as an ‘‘eligible security’’ pursuant to the conducted on the Exchange. In relevant part, members and member Exchange, FINRA and/or other SROs UTP Plan or is no longer listed with the organizations are required to record and can properly surveil these trades in the UTP Listing Market. Also, if the maintain certain details of an order in context of the overall market for those Exchange has removed a Nasdaq an electronic order tracking system securities. Security from dealings trading will be (‘‘OTS’’). In addition, Rules 123(e)— and Although firms will be required to halted or suspended.39 (f)—NYSE Amex Equities require comply with proposed Rules 513— and In the event that trading of a Nasdaq members and member organizations that 514—NYSE Amex Equities rather than Security or Nasdaq Securities is halted act as Floor brokers to record certain Rule 92—NYSE Amex Equities, there or suspended pursuant to proposed Rule details of orders received on the Floor will not be any regulatory gaps. 515—NYSE Amex Equities, trading of and executed on the Exchange in the Currently, FINRA and the Exchange the affected security or securities on the have an agreement pursuant to Section Exchange’s Front-End System Capture Exchange will resume in accordance 17(d) of the Act and Rule 17d–2 (‘‘FESC’’). Because the Exchange’s with the procedures of applicable NYSE thereunder (the ‘‘17d–2 Agreement’’) to members and member organizations Amex Equities Rules, including Rule allocate regulatory responsibility for must already comply with these 508—NYSE Amex Equities, the rules of oversight of certain Exchange Rules. The requirements for the purposes of trading the UTP Listing Market and/or the UTP Exchange has proposed to FINRA to listed securities, trading Nasdaq Plan. Any orders for a Nasdaq Security extend the regulatory oversight Securities on the Exchange does not that are unexecuted at the time trading provided under the 17d–2 Agreement to present any difficulties under these is halted on the Exchange shall be include customer order protection of particular Rules. cancelled and the Exchange shall not Nasdaq Securities and compliance with However, the Exchange’s OTS and proposed Rules 513— and 514—NYSE FESC requirements are not the only 37 All Exchange members or member Amex Equities, and, based on organizations that send customer orders to the audit trail requirements for trading discussions with FINRA representatives, Exchange and have a public business are currently, Nasdaq Securities on the Exchange. it is anticipated that FINRA will or will be required to also be, FINRA members (see Currently, most of the Exchange’s approve. Rule 2(b)—NYSE Amex Equities), and thus would members and member organizations are need to comply with the Manning Rule when Notwithstanding the proposed trading Nasdaq Securities off-Exchange. also FINRA members and FINRA exemption from Rule 92—NYSE Amex 38 Under proposed Rule 501—NYSE Amex requires all trades in Nasdaq-listed Equities, the Exchange will still require Equities, the Exchange defines the term ‘‘UTP securities by its members, regardless of members and member organizations to Listing Market’’ to have the same meaning as the the market, to be reported to its Order comply with all other applicable NYSE term ‘‘Listing Market’’, as defined under the ‘‘UTP Audit Trail System (‘‘OATS’’), FINRA ’’ Amex Equities Rules, any and all Plan (also defined therein). 39 The provisions of Rule 123D(4)—NYSE Amex Rule Series 7400. Although FINRA’s applicable rules or regulations of the Equities, which prescribe a special trading halt of ‘‘Structured Products’’ that were listed on the 40 In addition, Rule 132A—NYSE Amex Equities a full discussion comparing the two Rules and the Exchange at the time the trading of equities requires members and member organizations to proposed harmonization, see NYSE and NYSE securities migrated from the Exchange’s legacy synchronize their business clocks for recording and Amex Equities Information Memo 09–13 (March 12, systems and facilities at 86 Trinity Place to 11 Wall Rule 132C—NYSE Amex Equities requires members 2009) and FINRA Regulatory Notice 09–15 (March Street, shall not apply to the trading of Nasdaq and member organizations to transmit audit trail 12, 2009). Securities. records to the Exchange upon request.
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OATS contains substantially the same addition, any Floor broker member firm error, delay or omission of any data or order information as the Exchange’s approved to route orders away from the information regarding Nasdaq OTS and FESC, FINRA’s OATS data is Exchange pursuant to Rule 70.40— Securities, including, but not limited to, in a different format from the data NYSE Amex Equities, and orders in the collection, calculation, compilation, recorded by OTS and FESC and the Nasdaq Securities handled by such reporting or dissemination of any systems are not directly compatible. As firms, would be subject to FINRA’s Nasdaq Security Information, as defined a result, for those dual NYSE Amex/ OATS requirements. in Rule 522—NYSE Amex Equities, FINRA members and member Under proposed Rule 516—NYSE except as provided in Rules 17— and organizations that intend to enter and/ Amex Equities the Exchange with [sic] 18—NYSE Amex Equities. In addition, or execute orders in Nasdaq Securities have access to a complete audit trail and the Exchange also expressly disclaims on both the Exchange and other there will be no gap in regulatory making any express or implied markets, compliance with both the oversight. For dual NYSE Amex/FINRA warranties with respect to any Nasdaq Exchange’s and FINRA’s audit trail members, FINRA’s OATS rules will Security, any Nasdaq Security requirements for the purposes of trading apply to an order in a Nasdaq Security Information, or the underlying index, Nasdaq Securities on the Exchange is up to when it is routed to the Exchange. portfolio or instrument that is the basis not readily feasible. At that point, if the order is transmitted for determining the component Due to this conflict, proposed Rule to a Floor broker via an Exchange securities of an ETF. See Exhibit 5. 516—NYSE Amex Equities includes an system, the Exchange’s OTS and FESC Proposed Amendments to Current NYSE exemption from the requirements of requirements will capture its Amex Equities Rules Rules 123— and 132B—NYSE Amex subsequent handling and execution on Equities for any members or member the Exchange. And, all Exchange-only, The Exchange proposes to amend organizations that are also FINRA non-FINRA members or member certain existing NYSE Amex Equities members and subject to the organizations will be subject to the rules to accommodate the trading of requirements of FINRA’s OATS (FINRA Exchange’s OTS and FESC requirements Nasdaq Securities on the Exchange. Rule 7400). In addition, because NYSE throughout the handling of an order for a Nasdaq Security. To ensure proper 1. Rule 2A—NYSE Amex Equities Amex has not previously traded (Jurisdiction) Nasdaq-listed securities on the oversight of trading Nasdaq Securities, Exchange, some members and member the Exchange and FINRA can provide Rule 2A(b)—NYSE Amex Equities organizations, particularly Floor brokers each other with copies of relevant audit currently provides that the Exchange that have previously only conducted trail records and/or data pursuant to the has jurisdiction to approve listings transactions in Exchange-listed Intermarket Surveillance Group (‘‘ISG’’). applications for securities admitted to securities, do not have OATS-compliant Similarly, NYSE Amex will disseminate dealings on the Exchange and may also systems and procedures. With the reports of executions of Nasdaq suspend or remove such securities from introduction of trading Nasdaq Securities on the Exchange in trading. The Exchange proposes to Securities on NYSE Amex, certain accordance with applicable NYSE Amex amend this Rule to include the approval members and member organizations Equities Rules and the UTP Plan. of the trading of Nasdaq Securities (and/or the Exchange) could incur Finally, under proposed Rule 518— admitted to dealings on the Exchange. NYSE Amex Equities, members and significant expense and/or delay if 2. Rule 103B—NYSE Amex Equities forced to convert to OATS-compliant member organizations that conduct transactions involving Nasdaq (Security Allocation and Reallocation) systems. Rule 103B—NYSE Amex Equities To address this issue, the Exchange Securities on the Exchange will be prescribes the criteria and procedures has sought, and expects to receive required to comply with all applicable for the allocation and/or reallocation of formal confirmation of, interpretive NYSE Amex Equities Rules related to NYSE Amex-listed equities securities to guidance from FINRA that its Rule clearance and settlement of such registered and qualified DMM Units. In 7440(c)(6) exempts from FINRA’s OATS transactions. particular, part IX of the Rule currently requirements those Floor brokers who, Including Rules 123— and 132B— provides that NYSE Amex-listed regardless of their FINRA membership, NYSE Amex Equities, Rules 342— and equities securities must be allocated to receive an order in a Nasdaq Security 351—NYSE Amex Equities, which posts on the Exchange Trading Floor that is first routed to the Exchange require members and member that are exclusively designated for the through Exchange systems (i.e. the organizations to provide any trading trading of NYSE Amex securities. Common Customer Gateway, or information requested by the Exchange, also need to be amended. In particular, NYSE Amex-listed equities securities ‘‘CCG’’).41 Most orders received by a the Exchange proposes to add language currently trade on Posts 1 and 2 on the Floor broker are received through CCG, to each of these rules specifying that Trading Floor. However, there are not where the orders are automatically they apply to both securities listed on enough panels on those posts to captured in the systems that feed the the Exchange and securities ‘‘traded’’ on accommodate the trading of additional Exchange’s audit trail and then the Exchange, which includes Nasdaq hundreds of Nasdaq Securities. In order processed in accordance with their Securities. See, e.g., Rule 123—NYSE to accommodate the trading of Nasdaq instructions. However, in the case of Amex Equities, Exhibit 5. Securities, the Exchange needs to be orders in Nasdaq Securities that are able to trade NYSE Amex-listed and received by a Floor broker by means 14. Proposed Rule 522—NYSE Amex Nasdaq Securities on additional posts. other than an Exchange system (e.g., Equities (Limitation of Liability) The Exchange therefore proposes to orders received over the telephone), the Because the Exchange will be relying amend Rule 103B—NYSE Amex Floor broker would need to comply with on data feeds from the UTP Listing Equities to permit NYSE Amex-listed FINRA’s OATS requirements. In Market for the trading of Nasdaq securities and securities admitted to Securities, the Exchange proposes to dealings on the Exchange on a UTP 41 When acting in the capacity of a market maker for a Nasdaq Security, a DMM Unit is exempt from include a specific provision limiting basis to trade on posts throughout the FINRA’s OATS requirements. See FINRA Rule liability for any loss, damage, claim or Trading Floor. To prevent any confusion 7410(j). expense arising from any inaccuracy, that could arise among members trading
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both NYSE-listed and NYSE Amex- Securities that are derivative securities and interaction with, the NYSE Amex listed or traded securities, which trade products. Equities market, and provide market under different rules, proposed Rule • Rules 513— and 514—NYSE Amex participants with improved price 103B(IX) would provide that NYSE Equities prohibitions on proprietary discovery, increased liquidity, more Amex-listed and/or traded (i.e. Nasdaq trading ahead of customer orders. competitive quotes and greater price Securities) securities shall only be • Rule 516—NYSE Amex Equities improvement for Nasdaq Securities. assigned to panels designated for the requirements for reporting and B. Self-Regulatory Organization’s trading of such securities. recordkeeping of transactions in Nasdaq A DMM Unit that is registered to trade Securities. Statement on Burden on Competition both NYSE and NYSE Amex-listed • Rule 518—NYSE Amex Equities The Exchange does not believe that securities, as well as Nasdaq Securities, requirements for clearance and the proposed rule change will impose could trade these securities at the same settlement of transactions in Nasdaq any burden on competition that is not post. However, DMM Unit staff would Securities. necessary or appropriate in furtherance not be permitted to simultaneously Violations of these Rules will be of the purposes of the Act. trade both NYSE and NYSE Amex/ subject to the fine schedule in Rule 476A. For individuals, first offenses C. Self-Regulatory Organization’s Nasdaq securities, and the DMM Unit Statement on Comments on the would need to commit staff to trade may be charged $500.00, second offenses may be charged $1,000.00, and Proposed Rule Change Received From NYSE listed securities separate from Members, Participants or Others staff committed to trade NYSE Amex subsequent offenses may be charged listed or traded securities at any given $2,500.00. For member firms, first No written comments were solicited time during the trading day. Intraday offenses may be charged $1,000.00, or received with respect to the proposed staff moves between panels would be second offenses may be charged rule change. permitted, however. $2,500.00, and subsequent offenses may be charged $5,000.00. III. Date of Effectiveness of the Proposed Amendments to Non-NYSE Proposed Rule Change and Timing for Amex Equities Rule 476A 2. Statutory Basis Commission Action Finally, the Exchange proposes to The Exchange believes that the Within 35 days of the date of amend Non-NYSE Amex Equities Rule proposed rule changes are consistent publication of this notice in the Federal 476A Part 1A to include certain of the with, and further the objectives of, Register or within such longer period (i) 42 proposed NYSE Amex Equities Rule 500 Section 6(b)(5) of the Act, in that they as the Commission may designate up to Series in the Exchange’s Minor Rule are designed to promote just and 90 days of such date if it finds such Violation Plan. Included are: equitable principles of trade, to remove longer period to be appropriate and • Rule 502—NYSE Amex Equities impediments to and perfect the publishes its reasons for so finding or prohibition on making a bid, offer or mechanism of a free and open market (ii) as to which the self-regulatory transaction, or routing an order, for and a national market system and, in organization consents, the Commission Nasdaq Securities on or from Exchange general, to protect investors and the will: systems before 9:30 a.m. or after the public interest. The proposed rule (A) By order approve such proposed close of the Off-Hours Trading session. changes also support the principles of rule change, or • Rule 504(b)(5)—NYSE Amex Section 11A(a)(1) 43 of the Act in that (B) institute proceedings to determine Equities requirement for a DMM Unit they seek to ensure the economically whether the proposed rule change registered in a Nasdaq Security that is efficient execution of securities should be disapproved. transactions and fair competition among an Exchange Traded Fund to report the IV. Solicitation of Comments listed concentration measures. brokers and dealers and among • Rule 504(b)(6)—NYSE Amex exchange markets. The proposed rule Interested persons are invited to Equities requirement to commit staff for changes also support the principles of submit written data, views, and the trading of NYSE-listed securities Section 12(f) of the Act, which govern arguments concerning the foregoing, separate from that for the trading of the trading of securities pursuant to a including whether the proposed rule Exchange-listed securities and/or grant of unlisted trading privileges change is consistent with the Act. Nasdaq Securities and prohibition on consistent with the maintenance of fair Comments may be submitted by any of trading NYSE-listed securities together and orderly markets, the protection of the following methods: with Exchange-listed securities and/or investors and the public interest, and Electronic Comments the impact of extending the existing Nasdaq Securities at the same time. • • Rule 508(a)(2)—NYSE Amex markets for such securities. Use the Commission’s Internet Equities requirement for a DMM Unit to The Exchange believes that the comment form (http://www.sec.gov/ open trading in Nasdaq Securities at proposed rule changes are consistent rules/sro.shtml); or • 9:30 a.m. or as soon thereafter as with these principles. By providing for Send an e-mail to rule- possible. the trading of Nasdaq Securities on the [email protected]. Please include File • Rule 508(b)(2)—NYSE Amex Exchange on a UTP basis, the Exchange Number SR–NYSEAmex–2010–31 on Equities requirements for closing a believes its proposal will lead to the the subject line. Nasdaq Security in a manual or slow addition of liquidity to the broader Paper Comments market for these securities and to market. • • Rule 509(a)—NYSE Amex Equities increased competition among the Send paper comments in triplicate requirements for DMM Units. existing group of liquidity providers. to Elizabeth M. Murphy, Secretary, • Rule 509(b)—NYSE Amex Equities The Exchange also believes that, by so Securities and Exchange Commission, requirements for DMM communications doing, the proposed rule changes will Station Place, 100 F Street, NE., from the Floor. encourage the additional utilization of, Washington, DC 20549–1090. • Rule 510(c)—NYSE Amex Equities All submissions should refer to File requirements for dissemination and 42 15 U.S.C. 78f(b)(5). Number SR–NYSEAmex–2010–31. This distribution of information for Nasdaq 43 15 U.S.C. 78k–1(a)(1). file number should be included on the
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subject line if e-mail is used. To help the (‘‘Commission’’) the proposed rule Lead Market Maker Rights Fee Commission process and review your change as described in Items I, II, and Presently, the Exchange charges Lead comments more efficiently, please use III below, which Items have been Market Makers (‘‘LMMs’’) a monthly only one method. The Commission will prepared by the Exchange. On April 9, rights fee for each appointed issue. post all comments on the Commission’s 2010, NYSE Arca filed Amendment No. Effective April 1, 2010, the Exchange Internet Web site (http://www.sec.gov/ 1 to this filing. NYSE Arca has will reduce the rights fee by 50% in rules/sro.shtml). Copies of the designated this proposal as one each tier as shown below. submission, all subsequent establishing or changing a member due, amendments, all written statements fee, or other charge imposed under Average national daily cus- Monthly base with respect to the proposed rule Section 19(b)(3)(A)(ii) of the Act 3 and tomer contracts per issue rate change that are filed with the Rule 19b–4(f)(2) thereunder,4 which 0 to 2,000 ...... [$150] $75 Commission, and all written renders the proposal effective upon communications relating to the 2,001 to 5,000 ...... [$400] $200 filing with the Commission. The 5,001 to 15,000 ...... [$750] $375 proposed rule change between the Commission is publishing this notice to 15,001 to 100,000 ...... [$1,500] $750 Commission and any person, other than solicit comments on the proposed rule Over 100,000 ...... [$3,000] $1,500 those that may be withheld from the change from interested persons. public in accordance with the Transaction Fee Changes provisions of 5 U.S.C. 552, will be I. Self-Regulatory Organization’s available for Web site viewing and Statement of the Terms of Substance of The Exchange proposes to restructure printing in the Commission’s Public the Proposed Rule Change certain trade related charges for non- Reference Room, 100 F Street, NE., electronic trades. These trades are Washington, DC 20549, on official The Exchange proposes to amend its executed in the Firm range (clearance business days between the hours of 10 Schedule of Fees and Charges for account ‘‘F’’) and are currently billed a.m. and 3 p.m. Copies of such filing Exchange Services (the ‘‘Schedule’’). either the Firm Facilitation rate or the also will be available for inspection and While changes to the Schedule pursuant Broker Dealer & Firm rate. Under the copying at the principal office of the to this proposal will be effective upon current rate schedule trades by a firm Exchange. All comments received will filing, the changes will become that facilitate a customer, or Firm be posted without change; the operative on April 1, 2010. The Facilitation trades, are subject to a $0.00 Commission does not edit personal amended section of the Schedule is rate per contract. Firm transactions not identifying information from included as Exhibit 5 hereto. A copy of facilitating a customer are subject to a submissions. You should submit only this filing is available on the Exchange’s $0.25 Broker/Dealer & Firm Manual rate. information that you wish to make Web site at http://www.nyse.com, at the Under the revised rate schedule all publicly available. All submissions Exchange’s principal office, at the manual trades clearing in the Firm range should refer to File Number SR– Commission’s Public Reference Room, will be subject to a rate of $0.18 per NYSEAmex–2010–31 and should be and on the Commission’s Web site at contract and further capped at $2,000 submitted on or before May 10, 2010. http://www.sec.gov. per issue per day, per trading For the Commission, by the Division of participant. Firm Proprietary electronic Trading and Markets, pursuant to delegated II. Self-Regulatory Organization’s trades will continue to be charged $0.50 authority.44 Statement of the Purpose of, and per contract in non-Penny Pilot issues, Florence E. Harmon, Statutory Basis for, the Proposed Rule $0.45 per contract for taking liquidity in Change Deputy Secretary. Penny Pilot issues, and receive a credit [FR Doc. 2010–8859 Filed 4–16–10; 8:45 am] of $0.25 per contract for posting In its filing with the Commission, the liquidity in Penny Pilot issues, BILLING CODE 8011–01–P self-regulatory organization included consistent with the current rates, but statements concerning the purpose of, now a separate line in the Schedule. and basis for, the proposed rule change The Exchange also proposes to SECURITIES AND EXCHANGE and discussed any comments it received COMMISSION introduce a Premium Tier for electronic on the proposed rule change. The text transactions in certain Penny Pilot [Release No. 34–61894; File No. SR– of those statements may be examined at Issues. Electronic executions in options NYSEArca–2010–24] the places specified in Item IV below. overlying SPY, C, BAC, QQQQ, AAPL, The Exchange has prepared summaries, IWM, XLF, GLD, EEM, GE, UNG, FAZ, Self-Regulatory Organizations; NYSE set forth in sections A, B, and C below, Arca, Inc.; Notice of Filing and DIA, GDX, and USO will qualify for the of the most significant parts of such Premium Tier, and will receive an Immediate Effectiveness of a Proposed statements. Rule Change, as Modified by additional $.05 per contract credit above Amendment No. 1, Amending Its Fee A. Self-Regulatory Organization’s the stated Post Liquidity credit. This is Schedule Statement of the Purpose of, and consistent with similar billing treatment Statutory Basis for, the Proposed Rule of select symbols currently in place at 5 April 13, 2010. Change Nasdaq OMX PHLX. Pursuant to Section 19(b)(1) of the NYSE Arca also proposes to introduce Securities Exchange Act of 1934 1. Purpose Tiered Pricing for certain high monthly (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 volume levels in non-Premium Tier notice is hereby given that on April 1, The Exchange is proposing changes to Penny Pilot issues. This new tiered 2010, NYSE Arca, Inc. (‘‘NYSE Arca’’ or certain fees to improve competitiveness pricing structure will replace the ‘‘Exchange’’) filed with the Securities and encourage participation and current Market Maker Post Liquidity and Exchange Commission liquidity by Customer, Firms, Broker Incentive Credit that provided Market Dealers, and Market Makers. Makers with an additional $0.01 credit 44 17 CFR 200.30–3(a)(12) and 200.30–3(a)(44). 1 15 U.S.C. 78s(b)(1). 3 15 U.S.C. 78s(b)(3)(A)(ii). 5 See Nasdaq OMX PHLX Fee Schedule dated 2 17 CFR 240.19b–4. 4 17 CFR 240.19b–4(f)(2). March 26, 2010.
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for posting liquidity of greater than The changes are part of the or otherwise in furtherance of the 1,000,000 executed contracts per month Exchange’s continued effort to attract purposes of the Act. and $0.05 for posting liquidity greater and enhance participation on the NYSE IV. Solicitation of Comments than 5,000,000 executed contracts per Arca options marketplace. The month. The Exchange also proposes to Exchange believes these proposed fee Interested persons are invited to delete the accompanying footnote eight changes are reasonable and equitable in submit written data, views, and in its entirety. For each Electronic that they apply uniformly to all arguments concerning the foregoing, Transaction contract in these issues similarly situated participants on the including whether the proposed rule above 999,999 contracts per month up NYSE Arca options marketplace. change is consistent with the Act. to 1,999,999 per month, the Customer 2. Statutory Basis Comments may be submitted by any of Take Fee will be reduced by $0.05 per the following methods: contract, and the Market Maker Credit The Exchange believes that the will be increased by $0.05 per contract. proposed rule change is consistent with Electronic Comments For each Electronic Transaction contract the provisions of Section 6 of the • Use the Commission’s Internet in these issues above 1,999,999 Securities Exchange Act of 1934 (the comment form (http://www.sec.gov/ 7 contracts per month up to 2,999,999 per ‘‘Act’’), in general, and Section 6(b)(4) rules/sro.shtml); or month, the Customer Take Fee will be of the Act,8 in particular, in that it is • Send an e-mail to rule- reduced by a total of $0.10 per contract, designed to provide for the equitable [email protected]. Please include File and the Market Maker Credit will be allocation of reasonable dues, fees, and Number SR–NYSEArca–2010–24 on the increased by $0.10 per contract. For other charges among its members and subject line. each Electronic Transaction contract in other persons using its facilities. The these issues above 2,999,999 contracts proposed changes to the Schedule are Paper Comments part of the Exchange’s continued effort per month, the Customer Take Fee will • be reduced by a total of $0.15 per to attract and enhance participation on Send paper comments in triplicate contract, and the Market Maker Credit the Exchange, by offering attractive rates to Secretary, Securities and Exchange will be increased by $0.15 per contract. for removing liquidity and rebates for Commission, Station Place, 100 F Street, providing liquidity to the Exchange. The NE., Washington, DC 20549–1090. Limit of Fees on Strategy Executions proposed changes to the Schedule are All submissions should refer to File In addition, NYSE Arca also proposes equitable in that they apply uniformly Number SR–NYSEArca–2010–24. This to make permanent the pilot program for to all similarly situated OTP Holders. file number should be included on the a cap on transaction fees for Strategy B. Self-Regulatory Organization’s subject line if e-mail is used. To help the Executions associated with (a) Reversals Statement on Burden on Competition Commission process and review your and conversions, (b) dividend spreads, comments more efficiently, please use (c) box spreads, (d) short stock interest The Exchange does not believe that only one method. The Commission will spreads, (e) merger spreads, and (f) jelly the proposed rule change will impose post all comments on the Commission’s rolls. The Strategy Fee Cap pilot any burden on competition that is not Internet Web site (http://www.sec.gov/ program expired on March 1, 2010. necessary or appropriate in furtherance rules/sro.shtml). Copies of the Under the program, transactions fees of the purposes of the Act. submission, all subsequent were capped at $750 per transaction, C. Self-Regulatory Organization’s amendments, all written statements and, in addition, such transaction fees Statement on Comments on the with respect to the proposed rule for these strategies are further capped at Proposed Rule Change Received From change that are filed with the $25,000 per month per initiating firm. Members, Participants or Others Commission, and all written This proposal is consistent with the communications relating to the Nasdaq OMX PHLX filing to make No written comments were solicited proposed rule change between the permanent a similar Strategy fee cap or received with respect to the proposed Commission and any person, other than pilot program.6 The Exchange proposes rule change. those that may be withheld from the to make the pilot permanent, effective III. Date of Effectiveness of the public in accordance with the upon filing of this proposed rule Proposed Rule Change and Timing for provisions of 5 U.S.C. 552, will be change. Commission Action available for Web site viewing and printing in the Commission’s Public The Exchange also proposes, effective The foregoing rule change is effective Reference Room, 100 F Street, NE., April 1, 2010, that Manual Broker upon filing pursuant to Section Washington, DC 20549, on official Dealer and Firm Strategy Trades that do 19(b)(3)(A) 9 of the Act and business days between the hours of 10 not reach the $750 cap be billed at a rate subparagraph (f)(2) of Rule 19b–4 10 a.m. and 3 p.m. Copies of such filing of $0.25 per contract. Further, the thereunder, because it establishes a due, also will be available for inspection and Exchange proposes to clarify that FLEX fee, or other charge imposed by NYSE copying at the principal office of the Option executions are not considered Arca on its members. Exchange. All comments received will Strategy executions. At any time within 60 days of the be posted without change; the filing of the proposed rule change, the Report Fees Commission does not edit personal Commission may summarily abrogate identifying information from Finally, the Exchange proposes to such rule change if it appears to the submissions. You should submit only reduce the fee for User Activity extracts Commission that such action is information that you wish to make from $0.0075 per trade to $0.002 per necessary or appropriate in the public publicly available. All submissions trade, plus development and set-up interest, for the protection of investors, costs. should refer to File Number SR– 7 15 U.S.C. 78f(b). NYSEArca–2010–24 and should be 8 submitted on or before May 10, 2010. 6 See Securities Exchange Act Release No. 59566 15 U.S.C. 78f(b)(4). (March 12, 2009), 74 FR 11793 (March 19, 2009) 9 15 U.S.C. 78s(b)(3)(A). (SR–PHLX–2009–18). 10 17 CFR 240.19b–4(f)(2). 11 17 CFR 200.30–3(a)(12).
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For the Commission, by the Division of rules, or by issuing a press release public announcement either by filing a Trading and Markets, pursuant to delegated disclosing receipt of the notification and Form 8–K, where required by SEC rules, authority.11 the Rule(s) upon which the deficiency is or by issuing a press release. [Before Florence E. Harmon, based. However, note that in the case of release of the public announcement, Deputy Secretary. a deficiency related to the requirement Companies must provide a copy of the [FR Doc. 2010–8948 Filed 4–16–10; 8:45 am] to file a periodic report contained in announcement to Nasdaq’s BILLING CODE 8011–01–P Rule 5250(c)(1) or (2), the Company is MarketWatch Department.] As described required to make the public in Rule 5250(b)(1) and IM–5250–1, announcement by issuing a press [notice to the] the Company must notify SECURITIES AND EXCHANGE release. As described in Rule 5250(b)(1) Nasdaq’s MarketWatch Department COMMISSION and IM–5250–1, [notice to the] the [must be made] about the [Release No. 34–61887; File No. SR– Company must notify Nasdaq’s announcement through the electronic NASDAQ–2010–041] MarketWatch Department [must be disclosure submission system available made] about the announcement through at www.nasdaq.net, except in Self-Regulatory Organizations; The the electronic disclosure submission emergency situations when notification NASDAQ Stock Market LLC; Notice of system available at www.nasdaq.net, may instead be provided by telephone Filing and Immediate Effectiveness of except in emergency situations when or facsimile. If the public announcement Proposed Rule Change To Make notification may instead be provided by is made during Nasdaq market hours, Conforming Changes to Certain telephone or facsimile. If the public the Company must notify MarketWatch Notification Requirements announcement is made during Nasdaq at least ten minutes prior to the [public] market hours, the Company must notify announcement. If the public April 12, 2010. MarketWatch at least ten minutes prior announcement is made outside of Pursuant to Section 19(b)(1) of the to the [public] announcement. If the Nasdaq market hours, the Company Securities Exchange Act of 1934 public announcement is made outside must notify MarketWatch of the (‘‘Act’’),1 and Rule 19b–4 thereunder,2 of Nasdaq market hours, the Company announcement prior to 6:50 a.m. ET. notice is hereby given that on March 26, must notify MarketWatch of the The Company should make the public 2010, The NASDAQ Stock Market LLC announcement prior to 6:50 a.m. ET. announcement as promptly as possible (‘‘Nasdaq’’) filed with the Securities and (c)–(f) No change. but not more than four business days Exchange Commission (‘‘Commission’’) * * * * * following receipt of the notification. the proposed rule change as described (c)–(d) No change. 5810. Notification of Deficiency by the in Items I and II below, which Items * * * * * have been prepared by Nasdaq. Nasdaq Listing Qualifications Department has designated the proposed rule change When the Listing Qualifications 5840. Adjudicatory Process: General as effecting a change described under Department determines that a Company Information Rule 19b–4(f)(6) under the Act,3 which does not meet a listing standard set forth (a)–(j) No change. renders the proposal effective upon in the Rule 5000 Series, it will (k) Disclosure of Public Reprimand filing with the Commission. The immediately notify the Company of the Letter Commission is publishing this notice to deficiency. As explained in more detail A Company that receives an solicit comments on the proposed rule below, deficiency notifications are of Adjudicatory Body Decision that serves change from interested persons. four types: as a Public Reprimand Letter must make (1)–(4) No change. a public announcement by filing a Form I. Self-Regulatory Organization’s Notifications of deficiencies that 8–K, where required by SEC rules, or by Statement of the Terms of the Substance allow for submission of a compliance issuing a press release disclosing the of the Proposed Rule Change plan or an automatic cure or compliance receipt of the Decision, including the Nasdaq proposes to modify the Listing period may result, after review of the Rule(s) upon which the Decision was Rules to make conforming changes to compliance plan or expiration of the based. [Prior to the release of the public certain notification requirements. cure or compliance period, in issuance announcement, the Company must The text of the proposed rule change of a Staff Delisting Determination or a provide such disclosure to Nasdaq’s is below. Proposed new language is in Public Reprimand Letter. MarketWatch Department.] As described italic; proposed deletions are in (a) No change. in Rule 5250(b)(1) and IM–5250–1, [brackets].4 (b) Company Disclosure Obligations [notice to the] the Company must notify A Company that receives a Nasdaq’s MarketWatch Department 5250. Obligations for Companies Listed notification of deficiency, Staff Delisting [must be made] about the on The Nasdaq Stock Market Determination, or Public Reprimand announcement through the electronic (a) No change. Letter is required to make a public disclosure submission system available (b) Obligation to Make Public announcement disclosing receipt of the at www.nasdaq.net, except in Disclosure notification and the Rule(s) upon which emergency situations when notification (1) No change. the deficiency is based. A Company that may instead be provided by telephone (2) As set forth in Rule 5810(b), a receives a notification of deficiency or or facsimile. If the public announcement Company that receives a notification of Staff Delisting Determination related to is made during Nasdaq market hours, deficiency from Nasdaq is required to the requirement to file a periodic report the Company must notify MarketWatch make a public announcement by filing contained in Rule 5250(c)(1) or (2) is at least ten minutes prior to the [public] a Form 8–K, where required by SEC required to make the public announcement. If the public announcement by issuing a press release announcement is made outside of 1 15 U.S.C. 78s(b)(1). disclosing receipt of the notification and Nasdaq market hours, the Company 2 17 CFR 240.19b–4. the Rule(s) upon which the deficiency is must notify MarketWatch of the 3 17 CFR 240.19b–4(f)(6). 4 Changes are marked to the rule text that appears based, in addition to filing any Form 8– announcement prior to 6:50 a.m. ET. in the electronic manual of Nasdaq found at K required by SEC rules. In all other The Company should make the public http://nasdaq.cchwallstreet.com. cases, the Company may make the announcement [should be made] as
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promptly as possible[,] but not more or facsimile.8 Finally, Nasdaq proposes 19(b)(3)(A) of the Act 11 and Rule 19b– than four business days following to make other non-substantive changes 4(f)(6) thereunder.12 receipt of the Decision. to these rules so that they each use A proposed rule change filed * * * * * consistent language. pursuant to Rule 19b–4(f)(6) under the Act 13 normally does not become II. Self-Regulatory Organization’s 2. Statutory Basis operative for 30 days after the date of its Statement of the Purpose of, and Nasdaq believes that the proposed filing. However, Rule 19b–4(f)(6)(iii) 14 Statutory Basis for, the Proposed Rule rule change is consistent with the permits the Commission to designate a Change provisions of Section 6 of the Act,9 in shorter time if such action is consistent In its filing with the Commission, general and with Sections 6(b)(5) of the with the protection of investors and the Nasdaq included statements concerning Act,10 in particular in that it is designed public interest. The Exchange has the purpose of and basis for the to prevent fraudulent and manipulative requested that the Commission waive proposed rule change and discussed any acts and practices, to promote just and the 30-day operative delay. comments it received on the proposed equitable principles of trade, to foster The Commission believes that waiver rule change. The text of these statements cooperation and coordination with of the operative delay is consistent with may be examined at the places specified persons engaged in regulating, clearing, the protection of investors and the in Item IV below. Nasdaq has prepared settling, processing information with public interest because the proposed summaries, set forth in Sections A, B, respect to, and facilitating transactions rule change would merely conform and C below, of the most significant in securities, to remove impediments to Rules 5250(b)(2), 5810(b) and 5840(k) to aspects of such statements. and perfect the mechanism of a free and the notification requirements when open market and a national market companies release material information A. Self-Regulatory Organization’s system, and, in general, to protect outside of market hours in Nasdaq’s Statement of the Purpose of, and investors and the public interest. The other rules,15 thereby reducing company Statutory Basis for, the Proposed Rule proposed change will conform Nasdaq’s and investor confusion. As such, the Change notification requirements in the rules Commission believes that the proposed 1. Purpose amended in the Press Release Filing rule change raises no new regulatory with Nasdaq’s notification requirements issues. Additionally, Nasdaq’s Nasdaq recently adopted changes to for the disclosure of material clarification that in emergencies, certain of its press release requirements information, thereby reducing confusion companies are not required to notify for Nasdaq-listed companies (the ‘‘Press among listed companies and investors. MarketWatch through the electronic Release Filing’’).5 Subsequent to disclosure system but may do so via Nasdaq’s filing and the Commission’s B. Self-Regulatory Organization’s telephone or facsimile aligns the rules to publication of this proposal,6 Nasdaq Statement on Burden on Competition the existing requirements of Nasdaq made an immediately effective change Nasdaq does not believe that the Rule 5250(b)(1) and IM–5250–1, further to its rules to clarify when listed proposed rule change will result in any reducing confusion for companies.16 For companies must provide notification to burden on competition that is not these reasons, the Commission Nasdaq of material information necessary or appropriate in furtherance designates that the proposed rule disclosed outside of market hours.7 As of the purposes of the Act, as amended. change become operative immediately revised, when the material information upon filing.17 is made public outside of Nasdaq C. Self-Regulatory Organization’s Statement on Comments on the At any time within 60 days of the market hours, Nasdaq companies must filing of the proposed rule change, the provide notification of the information Proposed Rule Change Received From Members, Participants, or Others Commission may summarily abrogate to MarketWatch by 6:50 a.m. ET. Nasdaq the rule change if it appears to the proposes to make conforming changes to Written comments were neither Commission that such action is the rules modified in the Press Release solicited nor received. necessary or appropriate in the public Filing, such that Rules 5250(b)(2), interest, for the protection of investors, 5810(b) and 5840(k) would each specify III. Date of Effectiveness of the Proposed Rule Change and Timing for or otherwise in furtherance of the that if a required public announcement purposes of the Act. is made during market hours, the Commission Action company must notify Nasdaq’s Because the proposed rule change: (i) IV. Solicitation of Comments MarketWatch Department at least ten Does not significantly affect the Interested persons are invited to minutes prior to making the protection of investors or the public submit written data, views, and announcement to the public; otherwise interest; (ii) does not impose any arguments concerning the foregoing, the company must notify the significant burden on competition; and MarketWatch Department prior to 6:50 (iii) does not become operative for 30 11 15 U.S.C. 78s(b)(3)(A). am ET. Nasdaq also proposes to clarify days after the date of the filing, or such 12 17 CFR 240.19b–4(f)(6). Pursuant to Rule 19b– that companies are not required to use shorter time as the Commission may 4(f)(6)(iii) under the Act, the Exchange is required the electronic disclosure submission designate if consistent with the to give the Commission written notice of its intent to file the proposed rule change, along with a brief system to notify MarketWatch in protection of investors and the public description and text of the proposed rule change, emergency situations, when notification interest, the proposed rule change has at least five business days prior to the date of filing may instead be provided by telephone become effective pursuant to Section of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement. 5 Securities Exchange Act Release No. 61713 8 IM–5250–1 already provides that companies do 13 (March 15, 2010), 75 FR 13629 (March 22, 2010) not have to use the electronic disclosure submission 17 CFR 240.19b–4(f)(6). (SR–NASDAQ–2010–006). system in an emergency situation and provides 14 17 CFR 240.19b–4(f)(6)(iii). 6 Securities Exchange Act Release No. 61461 examples of emergency situations, such as the lack 15 See Nasdaq Rule 5250(b)(1) and IM–5250–1. (February 1, 2010), 75 FR 6241 (February 8, 2010) of computer or internet access, technical problems, 16 See supra note 8. (SR–NASDAQ–2010–006). and cases where no draft disclosure document is 17 For purposes only of waiving the 30-day 7 Securities Exchange Act Release No. 61521 available. operative delay, the Commission has considered the (February 16, 2010), 75 FR 8156 (February 23, 2010) 9 15 U.S.C. 78f. proposed rule’s impact on efficiency, competition, (SR–NASDAQ–2010–008). 10 15 U.S.C. 78f(b)(5). and capital formation. 15 U.S.C. 78c(f).
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including whether the proposed rule SECURITIES AND EXCHANGE strategy executions are capped at $750 change is consistent with the Act. COMMISSION per transaction, and, in addition, Comments may be submitted by any of transaction fees for these strategies are [Release No. 34–61895; File No. SR– the following methods: NYSEArca–2010–28] further capped at $25,000 per month per initiating firm. This Program previously Electronic Comments Self-Regulatory Organizations; NYSE expired on March 1, 2010. Extending • Use the Commission’s Internet Arca, Inc.; Notice of Filing of a this Program retroactively from March 1, comment form (http://www.sec.gov/ Proposed Rule Change Amending Its 2010 through April 1, 2010 facilitates rules/sro.shtml); or consistent treatment with respect to fees • Schedule of Fees Send an e-mail to rule- for strategy executions. [email protected]. Please include File April 13, 2010. No. SR–NASDAQ–2010–041 on the Pursuant to Section 19(b)(1) of the 2. Statutory Basis subject line. Securities Exchange Act of 1934 The proposed rule change is (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 3 Paper Comments consistent with Section 6(b) of the notice is hereby given that on April 12, Securities Exchange Act of 1934 (the • Send paper comments in triplicate 2010, NYSE Arca, Inc. (‘‘NYSE Arca’’ or ‘‘Act’’), in general, and furthers the to Elizabeth M. Murphy, Secretary, the ‘‘Exchange’’) filed with the Securities objectives of Section 6(b)(5) 4 in Securities and Exchange Commission, and Exchange Commission particular in that it is designed to 100 F Street, NE., Washington, DC (‘‘Commission’’) the proposed rule prevent fraudulent and manipulative 20549–1090. change as described in Items I, II, and acts and practices, to promote just and All submissions should refer to File No. III below, which Items have been equitable principles of trade, to foster SR–NASDAQ–2010–041. This file prepared by NYSE Arca. The cooperation and coordination with number should be included on the Commission is publishing this notice to persons engaged in facilitating subject line if e-mail is used. To help the solicit comments on the proposed rule transactions in securities, and to remove Commission process and review your change from interested persons. impediments to and perfect the comments more efficiently, please use I. Self-Regulatory Organization’s mechanisms of a free and open market only one method. The Commission will Statement of the Terms of Substance of and a national market system. In post all comments on the Commission’s the Proposed Rule Change addition, the proposed extension of the Internet Web site (http://www.sec.gov/ Program is reasonable in that the fees rules/sro.shtml). Copies of the The Exchange proposes to extend the are equitable as they apply uniformly to submission, all subsequent pilot program regarding a cap on all similarly situated OTP Holders. amendments, all written statements transaction fees for strategy executions. with respect to the proposed rule A copy of this filing is available on the B. Self-Regulatory Organization’s change that are filed with the Exchange’s Web site at http:// Statement on Burden on Competition Commission, and all written www.nyse.com, at the Exchange’s The Exchange does not believe that communications relating to the principal office, at the Commission’s the proposed rule change will impose proposed rule change between the Public Reference Room, and on the any burden on competition that is not Commission and any person, other than Commission’s Web site at http:// necessary or appropriate in furtherance those that may be withheld from the www.sec.gov. of the purposes of the Act. public in accordance with the II. Self-Regulatory Organization’s C. Self-Regulatory Organization’s provisions of 5 U.S.C. 552, will be Statement of the Purpose of, and Statement on Comments on the available for Web site viewing and Statutory Basis for, the Proposed Rule Proposed Rule Change Received From printing in the Commission’s Public Change Members, Participants or Others Reference Room, 100 F Street, NE., In its filing with the Commission, the No written comments were solicited Washington, DC 20549, on official self-regulatory organization included or received with respect to the proposed business days between the hours of 10 statements concerning the purpose of, rule change. a.m. and 3 p.m. Copies of such filing and basis for, the proposed rule change also will be available for inspection and and discussed any comments it received III. Date of Effectiveness of the copying at the principal office of on the proposed rule change. The text Proposed Rule Change and Timing for NASDAQ. All comments received will of those statements may be examined at Commission Action be posted without change; the the places specified in Item IV below. Commission does not edit personal Within 35 days of the date of The Exchange has prepared summaries, publication of this notice in the Federal identifying information from set forth in sections A, B, and C below, submissions. You should submit only Register or within such longer period (i) of the most significant parts of such as the Commission may designate up to information that you wish to make statements. available publicly. All submissions 90 days of such date if it finds such should refer to File No. SR–NASDAQ– A. Self-Regulatory Organization’s longer period to be appropriate and 2010–041 and should be submitted on Statement of the Purpose of, and publishes its reasons for so finding or or before May 10, 2010. Statutory Basis for, the Proposed Rule (ii) as to which the self-regulatory Change organization consents, the Commission For the Commission, by the Division of will: Trading and Markets, pursuant to delegated 1. Purpose (A) by order approve the proposed authority.18 NYSE Arca proposes to extend the rule change, or Florence E. Harmon, pilot program regarding a cap on (B) institute proceedings to determine Deputy Secretary. transaction fees for strategy executions whether the proposed rule change [FR Doc. 2010–8947 Filed 4–16–10; 8:45 am] (‘‘Program’’). Under this Program, should be disapproved. BILLING CODE 8011–01–P 1 15 U.S.C. 78s(b)(1). 3 15 U.S.C. 78f(b). 18 17 CFR 200.30–3(a)(12). 2 17 CFR 240.19b–4. 4 15 U.S.C. 78f(b)(5).
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IV. Solicitation of Comments For the Commission, by the Division of II. Self-Regulatory Organization’s Trading and Markets, pursuant to delegated Statement of the Purpose of, and Interested persons are invited to authority.5 Statutory Basis for, the Proposed Rule submit written data, views, and Florence E. Harmon, Change arguments concerning the foregoing, Deputy Secretary. In its filing with the Commission, the including whether the proposed rule [FR Doc. 2010–8946 Filed 4–16–10; 8:45 am] Exchange included statements change is consistent with the Act. BILLING CODE 8011–01–P concerning the purpose of and basis for Comments may be submitted by any of the proposed rule change and discussed the following methods: any comments it received on the SECURITIES AND EXCHANGE Electronic Comments proposed rule change. The text of these COMMISSION statements may be examined at the • Use the Commission’s Internet [Release No. 34–61883; File No. SR–BATS– places specified in Item IV below. The comment form (http://www.sec.gov/ 2010–007] Exchange has prepared summaries, set rules/sro.shtml); or forth in Sections A, B, and C below, of Self-Regulatory Organizations; BATS • Send an e-mail to rule- the most significant parts of such Exchange, Inc.; Notice of Filing and [email protected]. Please include File statements. Immediate Effectiveness of Proposed Number SR–NYSEArca–2010–28 on the Rule Change Related to Fees for Use (A) Self-Regulatory Organization’s subject line. of BATS Exchange, Inc. Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Paper Comments April 9, 2010. Change • Send paper comments in triplicate Pursuant to Section 19(b)(1) of the 1. Purpose to Elizabeth M. Murphy, Secretary, Securities Exchange Act of 1934 (the The Exchange proposes to modify its Securities and Exchange Commission, ‘‘Act’’),1 and Rule 19b–4 thereunder,2 notice is hereby given that on March 31, fee schedule applicable to use of the Station Place, 100 F Street, NE., Exchange effective April 1, 2010, in Washington, DC 20549–1090. 2010, BATS Exchange, Inc. (the ‘‘Exchange’’ or ‘‘BATS’’) filed with the order to: (i) Increase the fee charged by All submissions should refer to File Securities and Exchange Commission the Exchange for its ‘‘CYCLE’’ and Number SR–NYSEArca–2010–28. This (‘‘Commission’’) the proposed rule ‘‘RECYCLE’’ routing strategies from file number should be included on the change as described in Items I, II and III $0.0027 per share to $0.0028 per share; subject line if e-mail is used. To help the below, which Items have been prepared (ii) amend the fees for certain Commission process and review your by the Exchange. BATS has designated destination specific routing options to comments more efficiently, please use the proposed rule change as one continue to offer a ‘‘one under’’ pricing only one method. The Commission will establishing or changing a member due, model; (iii) adopt pricing for ‘‘BATS + ’’ post all comments on the Commission’s fee, or other charge imposed by the DART Destination Specific Orders ; and (iv) make other technical changes to the Internet Web site (http://www.sec.gov/ Exchange under Section 19(b)(3)(A)(ii) fee schedule. rules/sro.shtml). Copies of the of the Act 3 and Rule 19b–4(f)(2) submission, all subsequent thereunder,4 which renders the (i) Increase in Routing Fees for ‘‘CYCLE’’ amendments, all written statements proposed rule change effective upon and ‘‘RECYCLE’’ Routing filing with the Commission. The with respect to the proposed rule Based on increased fees at various Commission is publishing this notice to change that are filed with the market centers to remove liquidity, the solicit comments on the proposed rule Commission, and all written Exchange proposes to modify the fee change from interested persons. communications relating to the charged by the Exchange for its proposed rule change between the I. Self-Regulatory Organization’s ‘‘CYCLE’’ and ‘‘RECYCLE’’ routing Commission and any person, other than Statement of the Terms of Substance of strategies from $0.0027 per share to those that may be withheld from the the Proposed Rule Change $0.0028 per share. To be consistent with public in accordance with the The Exchange proposes to modify its this change, the Exchange proposes to provisions of 5 U.S.C. 552, will be fee schedule applicable to Members 5 of charge 0.28%, rather than 0.27%, of the available for Web site viewing and the Exchange pursuant to BATS Rules total dollar value of the execution for printing in the Commission’s Public 15.1(a) and (c). While changes to the fee any security (all Tapes) priced under Reference Room, 100 F Street, NE., schedule pursuant to this proposal will $1.00 per share that is routed away from Washington, DC 20549, on official be effective upon filing, the changes will the Exchange through CYCLE or business days between the hours of 10 become operative on April 1, 2010. RECYCLE. a.m. and 3 p.m. Copies of such filing The text of the proposed rule change (ii) One Under Pricing for Destination also will be available for inspection and is available at the Exchange’s Web site Specific Orders copying at the principal office of NYSE at http://www.batstrading.com, on the The Exchange has previously Arca. All comments received will be Commission’s Web site at http:// provided a discounted price fee for posted without change; the Commission www.sec.gov, at the principal office of Destination Specific Orders routed to does not edit personal identifying the Exchange, and at the Commission’s certain of the largest market centers information from submissions. You Public Reference Room. measured by volume (NYSE, NYSE Arca should submit only information that and NASDAQ), which, in each instance you wish to make publicly available. All 5 17 CFR 200.30–3(a)(12). has been $0.0001 less per share for 1 submissions should refer to File 15 U.S.C. 78s(b)(1). orders routed to such market centers by 2 17 CFR 240.19b–4. Number SR–NYSEArca–2010–28 and 3 15 U.S.C. 78s(b)(3)(A)(ii). the Exchange than such market centers should be submitted on or before May 4 17 CFR 240.19b–4(f)(2). currently charge for removing liquidity 10, 2010. 5 A Member is any registered broker or dealer that (referred to by the Exchange as ‘‘One has been admitted to membership in the Exchange. Under’’ pricing). Based on changes in
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pricing at such market centers, BATS is site of the Exchange’s secondary data IV. Solicitation of Comments proposing various changes to its prices center. for Destination Specific Orders to align Interested persons are invited to 2. Statutory Basis its fees so they are $0.0001 less per submit written data, views, and share for orders routed to such market The Exchange believes that the arguments concerning the foregoing, centers as of April 1, 2010. Specifically, proposed rule change is consistent with including whether the proposed rule because NASDAQ has eliminated the the requirements of the Act and the change is consistent with the Act. distinction in its fees between Tape A, rules and regulations thereunder that Comments may be submitted by any of B, and C securities the Exchange are applicable to a national securities the following methods: proposes to eliminate that same exchange, and, in particular, with the Electronic Comments distinction for BATS + NASDAQ requirements of Section 6 of the Act.6 Destination Specific Orders. Thus, the Specifically, the Exchange believes that • Use the Commission’s Internet Exchange proposes to normalize the fee the proposed rule change is consistent comment form (http://www.sec.gov/ charged for BATS + NASDAQ 7 with Section 6(b)(4) of the Act, in that rules/sro.shtml); or Destination Specific Orders executed at it provides for the equitable allocation • NASDAQ at $0.0029 per share. Also, of reasonable dues, fees and other Send an e-mail to rule- based on a change to pricing at NYSE charges among members and other [email protected]. Please include File Arca, the Exchange proposes to increase persons using any facility or system Number SR–BATS–2010–007 on the the charge from $0.0027 per share to which the Exchange operates or subject line. $0.0028 per share for BATS + NYSE controls. The Exchange notes that it Paper Comments Arca Destination Specific Orders operates in a highly competitive market executed at NYSE Arca in Tape A and in which market participants can • Send paper comments in triplicate C securities. The Exchange will retain readily direct order flow to competing to Elizabeth M. Murphy, Secretary, the fee of $0.0027 per share for BATS venues if they deem fee levels at a Securities and Exchange Commission, + NYSE Arca Destination Specific particular venue to be excessive. In 100 F Street, NE., Washington, DC Orders executed at NYSE Arca in Tape addition, the Exchange believes that the 20549–1090. B securities. Each of the changes proposed rates are equitable in that they All submissions should refer to File described above will result in the apply uniformly to all Members. Exchange charging $0.0001 less per Number SR–BATS–2010–007. This file share for orders routed to certain market (B) Self-Regulatory Organization’s number should be included on the centers as Destination Specific Orders. Statement on Burden on Competition subject line if e-mail is used. To help the Commission process and review your (iii) Pricing for BATS + DART The Exchange does not believe that Destination Specific Orders the proposed rule change imposes any comments more efficiently, please use burden on competition. only one method. The Commission will Effective April 1, 2010, the Exchange post all comments on the Commission’s will offer functionality that will permit (C) Self-Regulatory Organization’s Internet Web site (http://www.sec.gov/ Users to designate orders to route to Statement on Comments on the rules/sro.shtml). Copies of the various Alternative Trading Systems Proposed Rule Change Received From submission, all subsequent selected by the Exchange after first Members, Participants or Others being exposed to the BATS Book (a amendments, all written statements ‘‘BATS + DART Destination Specific No written comments were solicited with respect to the proposed rule Order’’). In conjunction with this new or received. change that are filed with the Commission, and all written functionality, the Exchange is proposing III. Date of Effectiveness of the communications relating to the to amend the fee schedule to include Proposed Rule Change and Timing for proposed rule change between the pricing for BATS + DART Destination Commission Action Specific Orders. The Exchange currently Commission and any person, other than offers DART routing as part of its The foregoing proposed rule change those that may be withheld from the general best execution routing. has been designated as a fee change public in accordance with the Consistent with the current pricing for pursuant to Section 19(b)(3)(A)(ii) of the provisions of 5 U.S.C. 552, will be the DART best execution routing Act 8 and Rule 19b–4(f)(2) thereunder,9 available for Web site viewing and functionality, the Exchange proposes to because it establishes or changes a due, printing in the Commission’s Public charge $0.0020 per share for a BATS + fee or other charge imposed on members Reference Room, 100 F Street, NE., DART Destination Specific Order by the Exchange. Accordingly, the Washington, DC 20549, on official executed by an Alternative Trading proposal is effective upon filing with business days between the hours of 10 System. the Commission. a.m. and 3 p.m. Copies of such filing At any time within 60 days of the (iv) Technical Changes to Fee Schedule also will be available for inspection and filing of the proposed rule change, the copying at the principal office of the The Exchange proposes to correct a Commission may summarily abrogate Exchange. All comments received will typographical error on the fee schedule. such rule change if it appears to the be posted without change; the Also, the Exchange proposes to add a Commission that such action is clarifying parenthetical to its Commission does not edit personal necessary or appropriate in the public identifying information from description of physical connection interest, for the protection of investors, submissions. You should submit only charges, which are charged based on or otherwise in furtherance of the information that you wish to make ‘‘pairs.’’ As it does within the Equities purposes of the Act. Pricing/Port Fees section of the fee available publicly. All submissions should refer to File Number SR–BATS– schedule, the Exchange proposes to 6 15 U.S.C. 78f. make clear that a pair is comprised of 7 15 U.S.C. 78f(b)(4). 2010–007 and should be submitted on one port at site of the Exchange’s 8 15 U.S.C. 78s(b)(3)(A)(ii). or before May 10, 2010. primary data center and one port at the 9 17 CFR 240.19b–4(f)(2).
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For the Commission, by the Division of of Transportation Statistics, United • The employee’s name and home Trading and Markets, pursuant to delegated States Department of Transportation, telephone number will be used to notify authority.10 1200 New Jersey Ave., SE., Washington, the employee that BTS has received the Florence E. Harmon, DC 20590. employee’s C3RS report and to schedule Deputy Secretary. an interview time with the employee for CATEGORIES OF INDIVIDUALS COVERED BY THE [FR Doc. 2010–8860 Filed 4–16–10; 8:45 am] SYSTEM OF RECORDS: further discussion of the close call BILLING CODE 8011–01–P incident; Railroad employees who report close • The employee’s name and home calls to BTS, either by telephone or telephone number will be used to mail, as part of a five-year DEPARTMENT OF TRANSPORTATION initiate the close call interview; demonstration/research project are • The employee’s name and home Office of the Secretary covered by this system of records. These address will be used to create and mail individuals are employees of three rail out a confirmation/rejection letter 3 Privacy Act of 1974: System of carriers participating in the C RS notifying the employee about the status Records demonstration project. The rail carriers of his/her close call report; and are: Union Pacific Railroad, Canadian • The employee’s job classification AGENCY: Bureau of Transportation Pacific Railroad, and New Jersey will be used to understand the Statistics, DOT. Transit. 3 employee’s role in the close call ACTION: Notice to establish a system of The C RS demonstration project is a incident. records. research effort to improve safety by using information from close call events ROUTINE USES OF RECORDS MAINTAINED IN THE SUMMARY: DOT intends to establish a to prevent serious accidents in the rail SYSTEM, INCLUDING CATEGORIES OF USERS AND system of records under the Privacy Act industry. A close call or near miss is an THE PURPOSES OF SUCH USES: of 1974. unsafe event with the potential for a BTS does not share PII information DATES: Effective Date: June 1, 2010. If no more serious incident resulting in collected for the C3RS study with other comments are received, the proposal greater injury to personnel or damage to entities. A primary goal of the C3RS is will become effective on the above date. equipment above FRA’s reportable to protect the identity of any employee If comments are received, the comments threshold level. who reports a close call incident to BTS. will be considered and, where adopted, Employees can report about a near Reports collected and maintained in the the documents will be republished with miss event that happened to their crew C3RS are protected from disclosure as changes. or an event they witnessed about provided in the BTS confidentiality ADDRESSES: Send comments to: Habib another crew (third party reporting). In statute (49 U.S.C. 111(k)) and the Azarsina, Departmental Privacy Officer, the case of third party reporting, the Confidential Information Protection and S–80, United States Department of employee does not provide any PII Statistical Efficiency Act (CIPSEA) of Transportation, Office of the Secretary information on those involved in the 2002. reported close call. Reporting employees of Transportation, 1200 New Jersey DISCLOSURE TO CONSUMER REPORTING are not allowed to make anonymous Ave., SE., Washington, DC 20590, or AGENCIES: close call reports. [email protected]. None. FOR FURTHER INFORMATION CONTACT: CATEGORIES OF RECORDS IN THE SYSTEM: POLICIES AND PRACTICES FOR STORING, Habib Azarsina, Departmental Privacy 3 Records in the C RS system contain RETRIEVING, ACCESSING, RETAINING AND Officer, S–80, United States Department information pertinent to an actual close DISPOSING OF RECORDS IN THE SYSTEM: of Transportation, Office of the call event submitted to BTS in a C3RS Secretary of Transportation, 1200 New report. The following PII data elements STORAGE: Jersey Ave., SE., Washington, DC 20590, are included in every C3RS report The C3RS Demonstration Project telephone 202–366–1965 or accepted into the system: The reporting stores all data in an electronic database [email protected] employee’s name, age, job classification, in a stand-alone desktop computer attached to a non-network printer. The SUPPLEMENTARY INFORMATION: The home address, and home and mobile telephone number(s) (if available). computer and printer are in a secure Department of Transportation system of data collection room. Hard-copy records notice subject to the Privacy Act AUTHORITY FOR MAINTENANCE OF THE SYSTEM: documents (work papers) are stored in of 1974 (5 U.S.C. 552a), as amended, has Safe, Accountable, Flexible, Efficient the secure room and shredded after been published in the Federal Register Transportation Equity Act: A Legacy for project completion. and is available from the above Users (SAFETEA–LU), which was mentioned address. enacted August 10, 2005 as Public Law RETRIEVABILITY: Records are retrieved from the C3RS SYSTEM NUMBER: DOT/ALL 21 109–59. database by confirmation number, PURPOSES: SYSTEM NAME: which uniquely identifies individual 3 Close Call Confidentiality Reporting The C RS collects name, home reports and by employee identification address, and telephone number(s) of System (C3RS). numbers. railroad employees reporting close calls SECURITY CLASSIFICATION: events to BTS. Qualified BTS/C3RS staff SAFEGUARDS: Unclassified, sensitive. will use the contact information as All the information BTS obtains, follows: including the PII data, is kept in a SYSTEM LOCATION: • The employee’s name and home secure room in the Department of The system is housed on a stand- telephone number will be used to Transportation Headquarters building in alone desktop in the C3RS secure room generate and give the employee his/her Washington, DC. Only members of the located in room E36–311 at the Bureau unique confirmation number, upon C3RS team who have taken receiving the employee’s close call confidentiality training and signed a 10 17 CFR 200.30–3(a)(12). phone message; non-disclosure agreement have access to
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the secure room. The door of the secure DEPARTMENT OF TRANSPORTATION • Tuesday, May 11, 2010 at Rowan room is kept closed during work hours University (Henry M. Rowan Bldg.), 201 and kept locked when the room is not Federal Transit Administration Mullica Hill Road, Glassboro, NJ 08028 in use. The stand-alone workstation that from 5:30 to 8:30 p.m. contains the database is password Intent To Prepare an Environmental An informational session explaining protected. All paper working documents Impact Statement for Expansion of the proposed project will occur during are stored in the secure room and Light Rail Transit Service From the first hour of each meeting, followed shredded immediately after case Glassboro, NJ to Camden, NJ by the opportunity for the public and/ or agency representatives to provide oral completion. AGENCY: Federal Transit Administration (FTA), DOT. comments on the scope of the EIS. RETENTION AND DISPOSAL: Those individuals wishing to speak at The C3RS project is a five-year ACTION: Notice of Intent to prepare an the meetings are required to register at research/feasibility study subject to Environmental Impact Statement. the particular meeting location on the availability of funds. BTS will retain the SUMMARY: FTA, in coordination with the day of that meeting. Anyone who entire C3RS database for up to ten years Delaware River Port Authority (DRPA)/ requires special assistance at a scoping after completion of the project (i.e., up Port Authority Transit Corporation meeting should contact Ms. Victoria to fifteen years total). The system is (PATCO), is issuing this Notice of Intent Malaszecki, Public Involvement currently unscheduled; pending (NOI) to advise the public that it Coordinator at (856) 223–0800, via approval of a retention schedule by the proposes to prepare an Environmental e-mail at publicinvolvement National Archives and Records Impact Statement (EIS) to assess the @GlassboroCamdenLine.com, or at the Administration (NARA), the records potential environmental impacts address listed below at least 3 days prior must be kept indefinitely. The retention associated with the construction and to the meeting. periods that will be proposed to NARA operation of the Glassboro-Camden Line An agency scoping meeting will be are as follows: upon project completion, (GCL) light rail system, as well as assess held on Monday, May 3, 2010 at 2 p.m., all PII data fields will be destroyed, and and document a No-Action Alternative at DRPA, One Port Center, 2 Riverside all non-PII data will be retired to the and a Transportation System Drive, Camden, NJ. Representatives Federal Records Center (FRC). The non- Management (TSM) Alternative. The from federal, state, regional, tribal, and PII data will be destroyed 10 years after proposed GCL system is approximately local agencies that may have an interest completion of the study. 18 miles long and would operate in the project will be invited to serve as either participating or cooperating SYSTEM MANAGER(S) AND ADDRESS: between the Borough of Glassboro in agencies. C3RS Data Collection Officer, Bureau Gloucester County and the City of of Transportation Statistics, Research & Camden in Camden County along, and ADDRESSES: Comments will be accepted Innovative Technology Administration, primarily within, the existing Conrail orally at the public scoping meetings, or Department of Transportation, 1200 railroad right-of-way. Light Rail they may be sent to Ms. Victoria New Jersey Ave., SE., RTS–31, technology along this alignment was Malaszecki, Public Outreach Liaison, Washington, DC 20590. selected as the Recommended Envision Consultants, Ltd. by mail at PO Alternative based on a two-year Box 536, Mullica Hill, NJ 08062, by fax NOTIFICATION PROCEDURE: Alternatives Analysis completed by (856)–223–8886, or by e-mail at Individuals seeking to determine DRPA/PATCO in 2009. publicinvolvement@Glassboro whether their information is contained FTA is issuing this notice to solicit CamdenLine.com. The addresses of the in this system should address written public and agency input regarding the scoping meetings are listed above under inquiries to: C3RS Data Collection scope of the EIS and to advise the public DATES. Officer, Bureau of Transportation and agencies that outreach activities FOR FURTHER INFORMATION CONTACT: Statistics, Research & Innovative conducted by DRPA/PATCO and its Either Mr. Keith Lynch, Project Advisor, Technology Administration, Department representatives will be considered in the Federal Transit Administration, 1716 of Transportation, 1200 New Jersey preparation of the EIS. FTA is the lead Market Street, Suite 500, Philadelphia, Ave., SE., RTS–31, Washington, DC federal agency for the environmental PA 19103 or (215) 656–7056; or Mr. 20590. Requests should include name, review, with DRPA/PATCO as the joint Michael Venuto, Project Manager, address and telephone number and a lead agency. Delaware River Port Authority, One Port description of the request. DATES: Written comments on the scope Center, 2 Riverside Drive, Camden, NJ RECORD ACCESS PROCEDURES: of the EIS, including the project’s 08101 or (856) 968–2079. Additional project information and Same as ‘‘Notification Procedure.’’ purpose and need, the alternatives to be considered, and the impacts to be scoping materials will be available at CONTESTING RECORD PROCEDURES: evaluated should be sent to DRPA on or the meetings and on the project Web site Same as ‘‘Notification Procedure.’’ before June 10, 2010. See ADDRESSES (http:// below for the address to which written www.GlassboroCamdenLine.com). RECORD SOURCE CATEGORIES: comments may be sent. Oral comments SUPPLEMENTARY INFORMATION: Information is obtained directly from on the scope of the EIS can be made at the individuals who report close call Public Scoping Meetings on the I: Scoping incidents to BTS. following dates: FTA and DRPA/PATCO will EXEMPTIONS CLAIMED FOR THE SYSTEM: • Thursday, May 6, 2010 at Camden undertake a scoping process that will None. County College—Camden Technology allow the public and interested agencies Center, 200 North Broadway, Camden, to comment on the scope of the Dated: April 13, 2010. NJ 08102 from 5:30 to 8:30 p.m. environmental review process. Scoping Habib Azarsina, • Tuesday, May 11, 2010 at Rowan is the process of determining the scope, Departmental Privacy Officer, 202–366–1965. University (Henry M. Rowan Bldg.), 201 focus, and content of an EIS. NEPA [FR Doc. 2010–8908 Filed 4–16–10; 8:45 am] Mullica Hill Road, Glassboro, NJ 08028 scoping has specific objectives, BILLING CODE 4910–62–P from 1:30 to 4:30 p.m. identifying the significant issues that
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will be examined in detail during the modal shift from auto to transit, and 45. The northern segment in Camden EIS, while simultaneously limiting contribute to reduced congestion, would follow a new right-of-way consideration and development of vehicle miles of travel, air pollutants adjacent to I–676 before entering an in- issues that are not truly significant. FTA and greenhouse gases, and travel times. street alignment to reach Walter Rand and DRPA/PATCO invite all interested Aligning the GCL with the existing Transportation Center where riders individuals and organizations, public Conrail railroad right-of-way would could transfer to the PATCO agencies, and Native American tribes to minimize property acquisition and take Lindenwold Line and the NJ TRANSIT comment on the scope of the Draft EIS. advantage of an underutilized River Line. To facilitate public and agency transportation corridor. Moreover, its The Light Rail Alternative would use comment, a Draft Scoping Document location amid established communities diesel-powered light rail vehicles, will be prepared for review. Included in would encourage growth and economic operating on new dedicated tracks and/ this document will be draft descriptions development consistent with ‘‘Smart or sharing portions of Conrail track with of: The purpose and need for the Growth’’ programs and policies at the temporal separation. Approximately project; the alternatives to be studied; local, State, and regional level. fourteen (14) new stations would be the impacts to be assessed; and the located along the alignment. III: Proposed Alternatives public outreach and agency IV: Probable Effects coordination process. The alternatives expected to be included in the EIS include: FTA and DRPA/PATCO will evaluate II: Proposed Purpose and Need No Action Alternative: The No Action both project-specific as well as indirect The purpose of this project is to Alternative represents future conditions and cumulative effects to the existing improve transit service along the in the EIS analysis year of 2035 without physical, social, economic and Glassboro to Camden corridor in the GCL Project. The No Action environmental setting in which the GCL southern New Jersey with a focus on Alternative includes the existing transit will be located. The permanent, long- increasing mobility and improving links and transportation system in southern term effects to the region could include between the established communities New Jersey plus planned improvements effects to traffic and transportation; land and activity centers. for which the need, commitment, use and socioeconomics; visual The Glassboro to Camden corridor is financing and public and political character and aesthetics; noise and characterized by older, densely support have been identified, and which vibration; historical and archaeological populated communities that developed may reasonably be expected to be resources; community impacts; and along the rail line, as well as by major implemented. This Alternative is natural resources. Temporary impacts employment and activity centers included in the Draft EIS as a means of during construction of the project could including universities, medical centers comparing and evaluating the impacts include effects to air quality; noise and and other institutions. However, and benefits of the GCL alternatives. vibration; natural resources; and connections between these activity Transportation System Management contaminated and hazardous materials. centers and the people who access them (TSM) Alternative: The TSM alternative The analysis will be undertaken in are not efficient and travel along the consists of enhancements and upgrades conformity with NEPA, Council on corridor is difficult. With regard to to the existing transportation system to Environmental Quality regulations, FTA transit service especially, the corridor address some of the needs and purpose guidance and relevant environmental lacks competitive and reliable transit of the project at less capital cost. These guidelines, Section 106 of the National options between the major communities upgrades can include bus route Historic Preservation Act, section 4(f) of and activity centers. restructuring and headway reductions, the DOT Act, Executive Order 12898 Trips along the corridor are primarily express and limited-stop service, regarding minority and low-income made by car. Major roadways intersection improvements, and other populations, the Clean Water Act and experience congestion during peak limited infrastructure improvements the Clean Air Act of 1970, along with hours, and even greater travel demands that enhance the transportation system. other applicable Federal and State are predicted for the future in The specific combination of regulations. Opportunities for comment Gloucester and Camden counties, improvements to be incorporated into on the potential effects to be studied associated with growth in population the TSM will be developed during the will be provided to the public, and and employment. This growth will EIS process. comments received will be considered contribute to continued increases in Light Rail Alternative: Based on the in the development of the final scope vehicle miles of travel, air pollutants results of the 2009 Alternatives Analysis and content of the environmental and greenhouse gases, and travel times. of transit options, light rail service from documents. In addition, this auto dependence has Glassboro to Camden was selected as contributed to and continues to the Recommended Alternative to V: Public and Agency Involvement encourage development ‘‘sprawl’’ into provide expanded transit service in Procedures open space and agricultural land, Gloucester and Camden counties, New The regulations implementing NEPA, requiring new supporting infrastructure, Jersey. This alternative will be the focus as well as provisions of the Safe, and does not encourage growth in the of the Draft EIS assessment and Accountable, Flexible, Efficient established communities as promoted documentation. Transportation Equity Act: A Legacy for by state and local ‘‘Smart Growth’’ The Light Rail Alternative would Users (SAFETEA–LU), call for public initiatives. traverse the communities of Glassboro, involvement in the EIS process. In The proposed 18-mile GCL traverses Pitman, Sewell, Mantua Township, accordance with Section 6002 of established communities and would Deptford Township, Wenonah, SAFETEA–LU, FTA and DRPA/PATCO provide a new reliable transit system Woodbury Heights, Woodbury, will: (1) Extend an invitation to other competitive with auto travel, linking Westville, Brooklawn, Gloucester City, Federal and non-Federal agencies and activity centers, employment and Camden. The new line would Native American Tribes that may have destinations and established residential primarily run along Conrail’s freight an interest in the proposed project to areas. This reliability and alignment, which is roughly parallel to become participating agencies (any competitiveness would encourage a Woodbury-Glassboro Road and NJ Route interested party that does not receive an
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invitation to become a participating Standards for Air Traffic Data • SC–214/WG–78 TORs and Work agency can notify any of the contact Communication Services. Plan persons listed earlier in this NOI); (2) • Review of Position Papers Provide opportunity for involvement by SUMMARY: The FAA is issuing this notice • Oceanic/Continental Integration participating agencies and the public to to advise the public of a meeting of the Position paper help define the purpose and need for RTCA Special Committee 214: Working • Seamless ATS Datalink (Airbus) • the proposed project, as well as the Group 78: Standards for Air Traffic Data Security paper (FAA) Communication Services. 13h30–17h00: Plenary Session range of alternatives for consideration in • DATES: New Sub-groups organization the EIS; and (3) Establish a plan for The meeting will be held May 3– • 7, 2010 from 9 a.m.–5 p.m. Announcement of Sub-group Chairs coordinating public and agency • Approval of Organization & Process, participation in, and comment on, the ADDRESS: The meeting will be held at review preliminary activities environmental review process. Palma de Majorca, SPAIN, Air Europa • Configuration Sub-group (CSG–SG) A Public Involvement Plan and an Lineas Aereas, S.A., Centro Empresarial • Validation Sub-group (VSG–SG) Agency Coordination Plan will be Globalia, Ctra. Arenal—Llucmajor, km • VDL Sub-group (VDL–SG) developed outlining public and agency 21,5, Poligono Industrial Son Noguera, • Approval of Sub-group Meeting involvement for the project. These will C.P: 07620 Mallorca, Illes Balears, Objectives be available on the project Web site or SPAIN. through written request. Opportunities Hosts: Mr. Juan Rossello— Day 2 (Tuesday 4th Marc 2010) 9h00– for comment will be provided [email protected] and Capt. 17h00: Sub-Group Sessions throughout the EIS process, including Jordi Manzano jordi.manzano@air- Day 3 (Wednesday 5th May 2010) 9h00– public and agency meetings, the project europa.com. 17h00: Sub-Group Sessions Web site, a mailing address, and a SUPPLEMENTARY INFORMATION: Pursuant Day 4 (Thursday 6th May 2010 9h00– phone information line. Comments to section 10(a)(2) of the Federal 17h00): Plenary Session received from any of these sources will Advisory Committee Act (Pub. L. 92– • be considered in the development of the Configuration Sub-Group Report & 463, 5 U.S.C., Appendix 2), notice is Assignment of Action Items final scope and content of the hereby given for a RTCA Special • environmental documents. Validation Sub-group Report & Committee 214: Working Group 78: Assignment of Action Items VI. Summary/Next Steps Standards for Air Traffic Data • VDL Sub-group Report & Communication Services meeting. The With the publication of this NOI, the Assignment of Action Items agenda will include: • Review Dates and Locations scoping process for the project begins. Additional Information Upcoming Meetings After the publication of the Draft • Any Other Business Scoping Document, a public comment Additional information and all the • Adjourn period will begin, allowing the public to documents to be considered can be offer input on the scope of the EIS until found in the Web site http:// Day 5 (Friday 7th May 2010): Sub-Group June 10, 2010. Public comments will be www.faa.gov/go/SC214. Sessions received through those methods 9h00–16H00: Sub-Group Sessions Meeting Objectives explained earlier in this NOI and will be Attendance is open to the interested incorporated into a Final Scoping • Approval new Sub-groups, public but limited to space availability. Document. This document will detail Organization & Process, review With the approval of the chairmen, the scope of the EIS and the potential preliminary activities members of the public may present oral environmental effects that will be • Coordination with SC–217/WG–44 statements at the meeting. Persons considered during the study period. and SC–186/WG–51 wishing to present statements or obtain After the completion of the Draft EIS, • Agree on approach for Oceanic/ information should contact the person another public commenting period will Continental Integration listed in the FOR FURTHER INFORMATION allow for input on the EIS, and these • Review of Position Papers CONTACT section. Members of the public comments will be incorporated into the • Progress on D–RVR & D–HZWX may present a written statement to the Final EIS report before publication. Service assessment committee at any time. • Review and Update the work plan Issued on: April 12, 2010. Issued in Washington, DC on April 12, as required Letitia A. Thompson, 2010. FTA Region III Administrator. Agenda Francisco Estrada C., [FR Doc. 2010–8965 Filed 4–16–10; 8:45 am] Day 1 (Monday 3rd May 2010) RTCA Advisory Committee. BILLING CODE 4910–57–P [FR Doc. 2010–8849 Filed 4–16–10; 8:45 am] 09h00–12h30: Plenary Session BILLING CODE 4910–13–P • Welcome/Introductions/ DEPARTMENT OF TRANSPORTATION Administrative Remarks • Approval of the Agenda DEPARTMENT OF TRANSPORTATION Federal Aviation Administration • Approval of the Summary of Plenary 9 National Highway Traffic Safety Tenth Meeting: RTCA Special • Review Action Item Status Administration Committee 214: Working Group 78: • Coordination Activities Standards for Air Traffic Data • Briefing from SC–217/WG–44 (D– [Docket No. NHTSA–2010–0041; Notice 1] Communication Services TAXI, Airport Data Base) Fuji Heavy Industries USA, Inc., • Briefing from SC–186/WG–51 AGENCY: Federal Aviation Receipt of Petition for Decision of (CPDLC support for Interval Inconsequential Noncompliance Administration (FAA), DOT. Management) ACTION: Notice of RTCA Special • Review of the work so far Fuji Heavy Industries USA, Inc. (Fuji), Committee 214: Working Group 78: • SPR & INT documents version H on behalf of Subaru of America, Inc.,
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and Fuji Heavy Industries, Ltd., has deactivated and does not emit light whenever affected the front passenger airbag determined that the front passenger the passenger air bag system is activated, suppression status telltale.4 airbag suppression status telltale in except that the telltale(s) need not illuminate On July 10, 2009, Fuji completed the some 2010 Subaru Legacy passenger car when the passenger seat is unoccupied. Each inspection of 5,400 of its vehicles telltale: awaiting shipment and corrected the and Outback multipurpose vehicle (a) Shall emit yellow light; models, manufactured from the start of (b) Shall have the identifying words noncompliance of 45 vehicles by their 2010 model year production 1 ‘‘PASSENGER AIR BAG OFF’’ or ‘‘PASS AIR ‘‘pushing tight’’ the harness connector. through June 30, 2009, did not comply BAG OFF’’ on the telltale or within 25 mm In addition, Subaru of America, Inc. with paragraph S19.2.2 of 49 CFR (1.0 in) of the telltale; and notified its U.S. dealers and distributors 571.208, Federal Motor Vehicle Safety (c) Shall not be combined with the on July 16, 2009, and included complete Standard (FMVSS) No. 208, Occupant readiness indicator required by S4.5.2 of this repair instructions for vehicles in their Crash Protection. Fuji estimates that less standard. inventory which had not been inspected than 1 percent (0.8%) or about 27 out (d) Shall be located within the interior of or repaired prior to shipment from the the vehicle and forward of and above the of a total of 3,405 vehicles potentially design H-point of both the driver’s and the Company. 2 involved have the noncompliance. Fuji right front passenger’s seat in their Fuji believes that the noncompliance has filed an appropriate report pursuant forwardmost seating positions and shall not is inconsequential to motor vehicle to 49 CFR Part 573, Defect and be located on or adjacent to a surface that can safety. Fuji argues that: Noncompliance Responsibility and be used for temporary or permanent storage Based on the inspection of approximately Reports. of objects that could obscure the telltale from 5,400 vehicles still at Subaru Automotive Pursuant to 49 U.S.C. 30118(d) and either the driver’s or right front passenger’s Indiana and a finding that the wiring harness 30120(h), Fuji has petitioned for an view, or located where the telltale would be connector to the front passenger airbag exemption from the notification and obscured from the driver’s view if a rear- suppression status telltale or other multi- remedy requirements of 49 U.S.C. facing child restraint listed in appendix A or function display had been loose on 45 A–1, as appropriate, is installed in the right vehicles, Subaru has determined that the Chapter 301 on the basis that this front passenger’s seat. noncompliance is inconsequential to expected occurrence rate is about 0.8% [less (e) Shall be visible and recognizable to a than one percent]. motor vehicle safety. driver and right front passenger during night This notice of receipt of Fuji’s petition [Subaru] * * * has determined that 3,405 and day when the occupants have adapted to vehicles were shipped to dealers prior to the is published under 49 U.S.C. 30118 and the ambient light roadway conditions. discovery of this problem. Using the above 30120 and does not represent any (f) Telltales need not be visible or frequency rate, agency decision or other exercise of recognizable when not activated. * * * [the Company] expect that only judgment concerning the merits of the (g) Means shall be provided for making about 27 vehicles will have a noncompliance petition. telltales visible and recognizable to the driver with FMVSS 208. Fuji estimated that 3,405 3 2010 and right front passenger under all driving All other aspects of the front passenger conditions. The means for providing the Legacy passenger cars and Outback advanced airbag suppression system will required visibility may be adjustable continue to function properly. multipurpose passenger vehicles, manually or automatically, except that the produced at the Company’s Subaru Since Subaru has both an OFF and ON telltales may not be adjustable under any indication in the suppression telltale, a Automotive Indiana plant between the driving conditions to a level that they complete absence of illumination is a start of model year 2010 production become invisible or not recognizable to the warning that the lamp is not functioning. through June 30, 2009, are involved. driver and right front passenger. Since power to the telltale is also power to Fuji also estimated that 0.8% of those (h) The telltale must not emit light except the multi-function display, the owner will 3,405 have the subject noncompliance. when the passenger air bag is turned off or have a clear indication to quickly report a Paragraph S19.2.2 of FMVSS No. 208 during a bulb check upon vehicle starting. problem to a Subaru dealer. requires: Fuji explained that the Vibration bench testing in Japan by the noncompliance is that front passenger [Company’s] supplier revealed that no S19.2.2 The vehicle shall be equipped with disengagement of a wiring harness connector at least one telltale which emits light airbag suppression status telltale lamp did not illuminate as required by that originally worked properly will occur whenever the passenger air bag system is during the use of vehicle. paragraph S19.2.2 of FMVSS No. 208. Dealers will receive a TSB with repair 1 On April 8, 2010, Fuji provided the actual start Fuji expressed the belief that the cause instructions on July 16, 2009 for any vehicles of production dates. The start of production for the of the noncompliance is an open circuit in their inventory, which had not been subject Subaru Legacy passenger cars was June 1, 2009, and the start of production date for the in the power supply to the lamp. The inspected or repaired prior to shipment to subject Outback multipurpose passenger vehicles Company said that ‘‘installation of the dealers or for vehicles where the owner was June 15, 2009. wiring harness to the multifunction reports a telltale/multi-function display 2 The estimate of a less than one percent display and passenger airbag problem. Dealers will also be instructed to frequency rate for the noncompliance was based on suppression status telltale was routed at check both the telltale and display at the first Fuji’s inspection of approximately 5,400 vehicles the instrument panel subsupplier such scheduled service (at 3,750 or 7,000 miles on July 2–10, 2009, at their Subaru Automotive depending on variant). Indiana plant after the noncompliance was that tension was put on the wiring discovered. Of this total, the Company found 45 harness connector’’ which can cause it In summary, Fuji/Subaru states that it models with the noncompliance, or about 0.8% of to come loose. To correct this problem, believes the noncompliance is the inspected vehicles. inconsequential to motor vehicle safety 3 Fuji’s petition, which was filed under 49 CFR the Company has re-routed the wiring Part 556, requests an agency decision to exempt harness to ‘‘push’’ rather than ‘‘pull’’ on because the expected occurrence rate for Fuji as importer from the notification and recall the wiring harness connector in vehicles the noncompliance is less than one responsibilities of 49 CFR Part 573 for 3,405 manufactured after July 10, 2009. percent (about 0.8%); a complete vehicles manufactured prior to July 1, 2009. absence of illumination on the telltale However, the agency cannot relieve Fuji The noncompliance was discovered distributors of the prohibitions on the sale, offer for on July 1, 2009, at the Company’s gives a clear indication to the vehicle sale, or introduction or delivery for introduction Subaru Indiana plant during a quality into interstate commerce of any of the subject inspection process that revealed a 4 The 2010 Subaru Legacy and Outback models’ vehicles under their control after Fuji recognized telltale has both an air bag suppression status that the subject noncompliance existed. Those number of multi-function displays that indicator for ON and OFF. Thus, either ON or OFF vehicles must be brought into conformance, did not illuminate and further on the telltale should be illuminated whenever the exported, or destroyed. inspection revealed that this also ignition is on.
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owner to quickly report a problem to the www.regulations.gov, including any Electronic and Facsimile Availability Subaru dealer; the Company’s vibration personal information provided. This document and additional testing supports the conclusion that this Documents submitted to a docket may information concerning OFAC are noncompliance is not likely to later be viewed by anyone at the address and available on OFAC’s Web site (http:// occur in vehicles that were produced times given above. The documents may www.treas.gov/ofac) or via facsimile without the noncompliance; and Dealers also be viewed on the Internet at http:// through a 24-hour fax-on demand will also be instructed to check both the www.regulations.gov by following the service at (202) 622–0077. telltale and display at the first online instructions for accessing the scheduled service (at 3,750 or 7,000 dockets. DOT’s complete Privacy Act Background miles depending on variant) and will Statement is available for review in the The Kingpin Act became law on receive a technical service bulletin Federal Register published on April 11, December 3, 1999. The Kingpin Act (TSB) with repair instructions for any 2000 (65 FR 19477–78). establishes a program targeting the vehicles in their inventory, which had The petition, supporting materials, activities of significant foreign narcotics not been inspected or repaired prior to and all comments received before the traffickers and their organizations on a shipment to dealers or for vehicles close of business on the closing date worldwide basis. It provides a statutory where the owner reports a telltale/multi- indicated below will be filed and will be framework for the President to impose function display problem. considered. All comments and sanctions against significant foreign NHTSA notes that the statutory supporting materials received after the narcotics traffickers and their provisions (49 U.S.C. 30118(d) and closing date will also be filed and will organizations on a worldwide basis, 30120(h)) that permit manufacturers to be considered to the extent possible. with the objective of denying their file petitions for a determination of When the petition is granted or denied, businesses and agents access to the U.S. inconsequentiality allow NHTSA to notice of the decision will be published financial system and the benefits of exempt manufacturers only from the in the Federal Register pursuant to the duties found in sections 30118 and trade and transactions involving U.S. authority indicated below. companies and individuals. 30120, respectively, to notify owners, Comment closing date: May 19, 2010. purchasers, and dealers of a defect or The Kingpin Act blocks all property noncompliance and to remedy the Authority: (49 U.S.C. 30118, 30120: and interests in property, subject to U.S. defect or noncompliance. delegations of authority at CFR 1.50 and jurisdiction, owned or controlled by 501.8) Interested persons are invited to significant foreign narcotics traffickers submit written data, views, and Claude H. Harris, as identified by the President. In addition, the Secretary of the Treasury arguments on this petition. Comments Director, Office of Vehicle Safety Compliance. must refer to the docket and notice consults with the Attorney General, the [FR Doc. 2010–8981 Filed 4–16–10; 8:45 am] Director of the Central Intelligence number cited at the beginning of this BILLING CODE P notice and be submitted by any of the Agency, the Director of the Federal following methods: Bureau of Investigation, the a. By mail addressed to: U.S. Administrator of the Drug Enforcement Department of Transportation, Docket DEPARTMENT OF THE TREASURY Administration, the Secretary of Operations, M–30, West Building Defense, the Secretary of State, and the Ground Floor, Room W12–140, 1200 Office of Foreign Assets Control Secretary of Homeland Security when New Jersey Avenue, SE., Washington, designating and blocking the property DC 20590. Additional Designations, Foreign and interests in property, subject to U.S. b. By hand delivery to U.S. Narcotics Kingpin Designation Act jurisdiction, of persons who are found to be: (1) Materially assisting in, or Department of Transportation, Docket AGENCY: Office of Foreign Assets Operations, M–30, West Building Control, Treasury. providing financial or technological Ground Floor, Room W12–140, 1200 support for or to, or providing goods or ACTION: Notice. New Jersey Avenue, SE., Washington, services in support of, the international DC 20590. The Docket Section is open SUMMARY: The Department of the narcotics trafficking activities of a on weekdays from 10 a.m. to 5 p.m. Treasury’s Office of Foreign Assets person designated pursuant to the except Federal Holidays. Control (‘‘OFAC’’) is publishing the Kingpin Act; (2) owned, controlled, or c. Electronically: by logging onto the names of two individuals whose directed by, or acting for or on behalf of, Federal Docket Management System property and interests in property have a person designated pursuant to the (FDMS) Web site at http:// been blocked pursuant to the Foreign Kingpin Act; or (3) playing a significant www.regulations.gov/. Follow the online Narcotics Kingpin Designation Act role in international narcotics instructions for submitting comments. (‘‘Kingpin Act’’) (21 U.S.C. 1901–1908, 8 trafficking. Comments may also be faxed to 1–202– U.S.C. 1182). On April 8, 2010, the Director of 493–2251. OFAC designated two individuals DATES: Comments must be written in the The designation by the Director whose property and interests in English language, and be no greater than of OFAC of the two individuals property are blocked pursuant to section 15 pages in length, although there is no identified in this notice pursuant to 805(b) of the Foreign Narcotics Kingpin limit to the length of necessary section 805(b) of the Kingpin Act is Designation Act. The names of the two attachments to the comments. If effective on April 8, 2010. individuals are as follows: comments are submitted in hard copy FOR FURTHER INFORMATION CONTACT: 1. NA TCHUTO, Jose Americo Bubo form, please ensure that two copies are Assistant Director, Compliance (a.k.a. NA TCHUTE, Jose Americo provided. If you wish to receive Outreach & Implementation, Office of Bubo); DOB 12 Jun 1952; POB N’cala, confirmation that your comments were Foreign Assets Control, Department of Guinea-Bissau; nationality Guinea- received, please enclose a stamped, self- the Treasury, Washington, DC 20220, Bissau; Former Navy Chief of Staff of addressed postcard with the comments. tel.: 202/622–2490. Guinea-Bissau (individual) [SDNTK] Note that all comments received will be SUPPLEMENTARY INFORMATION: 2. CAMARA, Ibraima Papa (a.k.a. posted without change to http:// CAMARA, Ibrahima Papa); nationality
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Guinea-Bissau; Air Force Chief of Staff Street, NW., #10235, Washington, DC authorities, as well as filing a timely of Guinea-Bissau (individual) [SDNTK] 20503, or by fax to (202) 395–6974. SAR in situations in which Federal Dated: April 8, 2010. FOR FURTHER INFORMATION CONTACT: You criminal violations require immediate Adam J. Szubin, can request additional information or a attention, such as when a reportable violation is ongoing; Director, Office of Foreign Assets Control. copy of the collection from Mary H. Gottlieb, OCC Clearance Officer, (202) [FR Doc. 2010–8915 Filed 4–16–10; 8:45 am] (4) Taking appropriate steps to 874–5090, Legislative and Regulatory contain and control the incident in an BILLING CODE 4810–AL–P Activities Division, Office of the effort to prevent further unauthorized Comptroller of the Currency, 250 E access to, or use of, customer DEPARTMENT OF THE TREASURY Street, SW., Washington, DC 20219. information, for example, by SUPPLEMENTARY INFORMATION: The OCC monitoring, freezing, or closing affected Office of the Comptroller of the is proposing to extend, without revision, accounts, while preserving records and Currency the approval of the following other evidence; and information collection: (5) Notifying customers when Agency Information Collection Title: Notice Regarding Unauthorized warranted. Activities: Submission for OMB Access to Customer Information. Review; Comment Request OMB Control No.: 1557–0227. This collection of information covers Description: Section 501(b) of the the notice provisions in the Breach AGENCY: Office of the Comptroller of the Gramm-Leach-Bliley Act (15 U.S.C. Notice Guidance. Currency (OCC), Treasury. 6901) requires the OCC to establish Type of Review: Extension of a ACTION: Notice and request for standards for national banks relating to currently approved collection. comment. administrative, technical, and physical Affected Public: Individuals; safeguards to: (1) Insure the security and SUMMARY: The OCC, as part of its Businesses or other for-profit. confidentiality of customer records and continuing effort to reduce paperwork Estimated Number of Respondents: information; (2) protect against any and respondent burden, invites the 25. anticipated threats or hazards to the general public and other Federal security or integrity of such records; and Estimated Time per Respondent: agencies to take this opportunity to (3) protect against unauthorized access Developing notices: 16 hours. comment on a continuing information to, or use of, such records or collection, as required by the Paperwork Notifying customers: 20 hours. information that could result in Reduction Act of 1995. An agency may Estimated Total Annual Burden: 900 substantial harm or inconvenience to not conduct or sponsor, and a hours. any customer. respondent is not required to respond The Interagency Guidelines Frequency of Response: On occasion. to, an information collection unless it Establishing Information Security The OCC issued a 60-day Federal displays a currently valid OMB control Standards, 12 CFR part 30, Appendix B Register notice on February 3, 2010 (75 number. The OCC is soliciting comment (Security Guidelines), implementing FR 5641). No comments were received. concerning its information collection section 501(b), require each bank to Comments continue to be invited on: ‘‘ titled, Notice Regarding Unauthorized consider and adopt a response program, ’’ (a) Whether the collection of Access to Customer Information. The if appropriate, that specifies actions to OCC is also giving notice that it has information is necessary for the proper be taken when the bank suspects or performance of the functions of the submitted the collection to OMB for detects that unauthorized individuals review. OCC, including whether the information have gained access to customer has practical utility; DATES: You should submit comments by information. May 19, 2010. The Interagency Guidance on (b) The accuracy of the OCC’s estimate of the information collection; ADDRESSES: Communications Division, Response Programs for Unauthorized Office of the Comptroller of the Customer Information and Customer (c) Ways to enhance the quality, Currency, Mailstop 2–3, Attention: Notice (Breach Notice Guidance),1 utility, and clarity of the information to 1557–0227, 250 E Street, SW., which interprets the Security be collected; Washington, DC 20219. In addition, Guidelines, states that, at a minimum, a (d) Ways to minimize the burden of comments may be sent by fax to (202) bank’s response program should contain the collection on respondents, including 874–5274 or by electronic mail to procedures for the following: through the use of automated collection [email protected]. You may (1) Assessing the nature and scope of techniques or other forms of information personally inspect and photocopy the an incident, and identifying what technology; comments at the OCC, 250 E Street, customer information systems and types (e) Estimates of capital or start-up SW., Washington, DC. For security of customer information have been costs and costs of operation, reasons, the OCC requires that visitors accessed or misused; maintenance, and purchase of services make an appointment to inspect (2) Notifying its primary Federal to provide information; and comments. You may do so by calling regulator as soon as possible when the bank becomes aware of an incident (f) Whether the estimates need to be (202) 874–4700. Upon arrival, visitors adjusted based upon banks’ experiences will be required to present valid involving unauthorized access to, or use of, sensitive customer information; regarding the number of actual security government-issued photo identification breaches that occur. and to submit to security screening in (3) Consistent with the OCC’s order to inspect and photocopy Suspicious Activity Report regulations, Dated: April 13, 2010. comments. notifying appropriate law enforcement Michele Meyer, Additionally, you should send a copy Assistant Director, Legislative and Regulatory 1 12 CFR part 30, Appendix B, Supplement A, Activities Division. of your comments to: OCC Desk Officer, Interagency Guidance on Response Programs for 1557–0227, by mail to U.S. Office of Unauthorized Access to Customer Information and [FR Doc. 2010–8828 Filed 4–16–10; 8:45 am] Management and Budget, 725 17th Customer Notice. BILLING CODE P
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DEPARTMENT OF VETERANS services as well as customer NW., Washington, DC 20420, (202) 461– AFFAIRS expectations and desires. 7485, FAX (202) 273–0443 or e-mail An agency may not conduct or [email protected]. Please [OMB Control No. 2900—New (Insurance sponsor, and a person is not required to refer to ‘‘OMB Control No. 2900–0092.’’ Surveys)] respond to a collection of information SUPPLEMENTARY INFORMATION: unless it displays a currently valid OMB Agency Information Collection Title: Rehabilitation Needs Inventory control number. The Federal Register (Insurance Surveys) Activities Under (Chapter 31, Title 38 U. S. Code, VA Notice with a 60-day comment period OMB Review Form 28–1902w. soliciting comments on this collection OMB Control Number: 2900–0092. AGENCY: Veterans Benefits of information was published on Type of Review: Extension of a Administration, Department of Veterans February 20, 2010, at pages 6792–6793. currently approved collection. Affairs. Affected Public: Individuals or Abstract: VA Form 28–1902w is Households. ACTION: Notice. mailed to service-connected disabled Estimated Annual Burden: 48 hours. veterans who submitted an application SUMMARY: In compliance with the Estimated Average Burden per for vocational rehabilitation benefits. Paperwork Reduction Act (PRA) of 1995 Respondent: 6 minutes. VA will use data collected to determine (44 U.S.C. 3501–3521), this notice Frequency of Response: Monthly. the types of rehabilitation program the Estimated Number of Respondents: announces that the Veterans Benefits veteran will need. 480. Administration (VBA), Department of An agency may not conduct or Veterans Affairs, will submit the Dated: April 13, 2010. sponsor, and a person is not required to collection of information abstracted By direction of the Secretary. respond to a collection of information below to the Office of Management and Denise McLamb, unless it displays a currently valid OMB Budget (OMB) for review and comment. Program Analyst, Enterprise Records Service. control number. The Federal Register The PRA submission describes the [FR Doc. 2010–8801 Filed 4–16–10; 8:45 am] Notice with a 60-day comment period nature of the information collection and BILLING CODE 8320–01–P soliciting comments on this collection its expected cost and burden and it of information was published on includes the actual data collection February 10, 2010, at page 6793. instrument. DEPARTMENT OF VETERANS Affected Public: Individuals or DATES: Comments must be submitted on AFFAIRS households. or before May 19, 2010. Estimated Annual Burden: 45,000 [OMB Control No. 2900–0092] hours. ADDRESSES: Submit written comments Agency Information Collection Estimated Average Burden per on the collection of information through Respondent: 45 minutes. http://www.Regulations.gov; or to VA’s (Rehabilitation Needs Inventory) Activity Under OMB Review Frequency of Response: On occasion. OMB Desk Officer, OMB Human Estimated Number of Respondents: Resources and Housing Branch, New AGENCY: Veterans Benefits 60,000. Executive Office Building, Room 10235, Administration, Department of Veterans Dated: April 13, 2010. Washington, DC 20503, (202) 395–7316. Affairs. Please refer to ‘‘OMB Control No. 2900— By direction of the Secretary. ACTION: Notice. New (Insurance Surveys)’’ in any Denise McLamb, correspondence. SUMMARY: In compliance with the Program Analyst, Enterprise Records Service. FOR FURTHER INFORMATION CONTACT: Paperwork Reduction Act (PRA) of 1995 [FR Doc. 2010–8802 Filed 4–16–10; 8:45 am] Denise McLamb, Enterprise Records (44 U.S.C. 3501–3521), this notice BILLING CODE 8320–01–P Service (005R1B), Department of announces that the Veterans Benefits Veterans Affairs, 810 Vermont Avenue, Administration, Department of Veterans DEPARTMENT OF VETERANS NW., Washington, DC 20420, (202) 461– Affairs, will submit the collection of AFFAIRS 7485, FAX (202) 273–0443 or e-mail: information abstracted below to the [email protected]. Please Office of Management and Budget [OMB Control No. 2900—New (VA Form refer to ‘‘OMB Control No. 2900—New (OMB) for review and comment. The 0857c)] (Insurance Surveys).’’ PRA submission describes the nature of Agency Information Collection SUPPLEMENTARY INFORMATION: the information collection and its (Reasonable Accommodation) Titles: Insurance Surveys. expected cost and burden; it includes Activities Under OMB Review OMB Control Number: 2900—New the actual data collection instrument. DATES: (Insurance Surveys). Comments must be submitted on AGENCY: Office of Human Resources and Type of Review: New collection. or before May 19, 2010. Administration, Department of Veterans Abstract: VBA administers integrated ADDRESSES: Submit written comments Affairs. on the collection of information through programs of benefits and services, ACTION: Notice. established by law for veterans and their http://www.Regulations.gov; or to VA’s survivors, and service personnel. OMB Desk Officer, OMB Human SUMMARY: In compliance with the Executive Order 12862, Setting Resources and Housing Branch, New Paperwork Reduction Act (PRA) of 1995 Customer Service Standards, requires Executive Office Building, Room 10235, (44 U.S.C. 3501–21), this notice Federal agencies and departments to Washington, DC 20503 (202) 395–7316. announces that the Office of Human identify and survey its customers to Please refer to ‘‘OMB Control No. 2900– Resources and Administration determine the kind and quality of 0092’’ in any correspondence. (OHR&A), Department of Veterans services they want and their level of FOR FURTHER INFORMATION CONTACT: Affairs, will submit the collection of satisfaction with existing service. Denise McLamb, Enterprise Records information abstracted below to the Customer satisfaction surveys are used Service (005R1B), Department of Office of Management and Budget to gauge customer perceptions of VA Veterans Affairs, 810 Vermont Avenue, (OMB) for review and comment. The
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PRA submission describes the nature of claim for reasonable accommodation, Tuesday, May 11, 2010, in room GL–20 the information collection and its applicants must complete VA Form at the Greenhoot Cohen Building, 1722 expected cost and burden; it includes 0857e to authorize their provider to Eye Street NW., Washington, DC. The the actual data collection instrument. release medical information to VA. The meeting will convene at 9:30 a.m. and DATES: Comments must be submitted on data collected will be used to determine end at 4 p.m. The meeting is open to the or before May 19, 2010. the applicant’s entitlement to reasonable public. ADDRESSES: Submit written comments accommodation. The purpose of the Council is to on the collection of information through An agency may not conduct or provide external advice and review for http://www.Regulations.gov or to VA’s sponsor, and a person is not required to VA’s research mission. The agenda will OMB Desk Officer, OMB Human respond to a collection of information include a review of the VA research Resources and Housing Branch, New unless it displays a currently valid OMB portfolio, ethics training and a scientific Executive Office Building, Room 10235, control number. The Federal Register presentation on basic sciences research. Washington, DC 20503 (202) 395–7316. Notice with a 60-day comment period The Council will also provide feedback Please refer to ‘‘OMB Control No. 2900— soliciting comments on this collection on the direction/focus of VA’s research New (VA Form 0857c)’’ in any of information was published on initiatives. correspondence. February 10, 2010, at page 6792. Time will be allocated for receiving Affected Public: Individuals or public comments at 3:15 p.m. to 4 p.m. FOR FURTHER INFORMATION CONTACT: households. Public comments will be limited to five Denise McLamb, Enterprise Records Estimated Annual Burden: 18 hours. minutes each. Individuals who speak Service (005R1B), Department of Estimated Average Burden per are invited to submit a 1–2 page Veterans Affairs, 810 Vermont Avenue, Respondent: 30 minutes. summary of their comments at the time NW., Washington, DC 20420, (202) 461– Frequency of Response: One-time. of the meeting for inclusion in the 7485, fax (202) 273–0443 or e-mail Estimated Number of Respondents: official meeting record. [email protected]. Please refer to 35. Members of the public may direct ‘‘ OMB Control No. 2900—New (VA Dated: April 13, 2010. questions or submit written statements Form 0857c)’’. By direction of the Secretary. for review by the Committee in advance SUPPLEMENTARY INFORMATION: Denise McLamb, of the meeting to Ms. Margaret Hannon, Titles: Enterprise Records Service. Designated Federal Officer, Department a. Request for Reasonable of Veterans Affairs, Office of Research [FR Doc. 2010–8803 Filed 4–16–10; 8:45 am] Accommodation, VA Form 0857c. and Development (12) 810 Vermont b. Authorization for Limited Release BILLING CODE 8320–01–P Avenue, NW., Washington, DC 20420 or of Medical Information, VA Form 0857e. e-mail at [email protected]. Any OMB Control Number: 2900—New member of the public wishing to attend (VA Form 0857c). DEPARTMENT OF VETERANS AFFAIRS the meeting or wishing further Type of Review: Existing collection in information should contact Ms. Hannon use without an OMB control number. National Research Advisory Council; at (202) 461–1696. Abstract: Applicants with a disability Notice of Meeting Dated: April 13, 2010. who are seeking a position at VA complete VA Form 0857c to request The Department of Veterans Affairs By Direction of the Secretary: reasonable accommodation such as an (VA) gives notice under Public Law 92– Vivian Drake, interpreter or adaptive equipment 463 (Federal Advisory Committee Act) Acting Committee Management Officer. during the application and interview that the National Research Advisory [FR Doc. 2010–8823 Filed 4–16–10; 8:45 am] process. In order to substantiate their Council will hold a meeting on BILLING CODE P
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Part II
Department of Health and Human Services Food and Drug Administration
Amended Authorizations of Emergency Use of Zanamivir, Oseltamivir Phosphate, and Peramivir; Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability; Notices
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DEPARTMENT OF HEALTH AND Administration, 5600 Fishers Lane, products incorporated the July 2009 HUMAN SERVICES Rockville, MD 20857, 301–827–4067. amendment in its entirety, the July 2009 SUPPLEMENTARY INFORMATION: amendment to the Authorization letter Food and Drug Administration for certain oseltamivir phosphate I. Amendment to the April 27, 2009, products is not reprinted in this [Docket No. FDA–2009–N–0276] Authorizations for Certain Products document. From the Neuraminidase Class of On October 29, 2009, CDC submitted Amended Authorizations of Antivirals, Zanamivir and Oseltamivir another request to amend both of the Emergency Use of Certain Antiviral Phosphate Authorizations for certain zanamivir Drugs Zanamivir and Oseltamivir On April 26, 2009, under section and oseltamivir phosphate products to Phosphate; Availability 564(b)(1)(C) of the act (21 U.S.C. address, among other things, issues 360bbb-3(b)(1)(C)), the Acting Secretary relating to certain zanamivir inhalation AGENCY: Food and Drug Administration, powder and oseltamivir phosphate HHS. of the Department of Health and Human Services (the Acting Secretary) capsules deployed from the Strategic ACTION: Notice. determined that a public health National Stockpile (SNS) that were beyond or would be beyond their SUMMARY: The Food and Drug emergency exists involving Swine Influenza A (now known as 2009 H1N1 expiration date before the declaration of Administration (FDA) is announcing emergency underlying the EUA amendments to the two Emergency Use Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to terminated. FDA also became aware of Authorizations (EUAs) (the other zanamivir inhalation powder and Authorizations) for certain products affect, national security. The determination of emergency has been oseltamivir phosphate capsules in from the neuraminidase class of addition to those held in or deployed renewed. On April 26, 2009, under antivirals, zanamivir and oseltamivir from the SNS that were beyond or section 564(b) of the act, and on the phosphate, issued on April 27, 2009, would be beyond their expiration date basis of such determination, the Acting under the Federal Food, Drug, and before the declaration of emergency Secretary declared an emergency Cosmetic Act (the act), as requested by underlying the EUA terminated. FDA justifying the authorization of the the Centers for Disease Control and amended both of the Authorization emergency use of certain products from Prevention (CDC). On July 14, 2009, in letters to address both of these the neuraminidase class of antivirals, response to a request from CDC, FDA categories products. Among the other zanamivir and oseltamivir phosphate, amended and reissued in its entirety the reasons that FDA amended the accompanied by emergency use Authorization for certain oseltamivir Authorization for certain oseltamivir information subject to the terms of any phosphate products. On October 30, phosphate products was to update the authorization issued under 21 U.S.C. 2009, in response to a request from CDC, information for health care providers to 360bbb-3(a). On April 26, 2009, CDC among other reasons, FDA amended and include dosing recommendations based requested and, on April 27, 2009, FDA reissued in their entirety the on weight for children younger than 1 issued EUAs for zanamivir inhalation Authorization letters for certain year of age. Therefore, in response to powder and certain oseltamivir zanamivir and oseltamivir phosphate CDC’s October 2009 request, among phosphate capsules and oral suspension products. Finally, on November 4, 2009, other reasons, FDA amended and for the treatment and prophylaxis of FDA amended and reissued in its reissued both of the Authorization influenza, accompanied by emergency entirety the Authorization letter for letters in their entirety on October 30, use instructions, which are authorized certain zanamivir inhalation powder. 2009. Finally, on November 4, 2009, to under the EUAs. On April 27, 2009, The Authorization letter for certain include a condition of Authorization FDA also amended the EUAs for oseltamivir phosphate products, as inadvertently omitted, FDA again zanamivir and oseltamivir phosphate, amended on October 30, 2009, and the amended the Authorization letter for including the emergency use Authorization letter for certain certain zanamivir inhalation powder. zanamivir inhalation powder, as instructions authorized under the EUAs. amended on November 4, 2009, On August 4, 2009, notice of the II. Electronic Access including explanations for their determination and declaration was An electronic version of this reissuance, are reprinted in this published in the Federal Register (74 document and the full text of the document. FR 38628, August 4, 2009), as was the Authorizations are available on the notice of the April 27, 2009, Internet at http://www.regulations.gov. DATES: The amended Authorizations are Authorizations (74 FR 38648, August 4, effective as of October 30, 2009. 2009). III. The Authorizations ADDRESSES: Submit written requests for On July 7, 2009, CDC submitted a Having concluded that the criteria for single copies of the EUAs to the Office request to amend the Authorization for issuance of the Authorizations under of Counterterrorism and Emerging certain oseltamivir phosphate products section 564(c) of the act were met, on Threats (HF–29), Food and Drug to address, among other things, issues April 27, 2009, FDA authorized the Administration, 5600 Fishers Lane, rm. relating to certain oseltamivir phosphate emergency use of certain zanamivir 14C–26, Rockville, MD 20857. Send one oral suspension products that had inhalation powder and certain self-addressed adhesive label to assist passed testing under the Federal oseltamivir phosphate capsules and oral that office in processing your request or Government’s Shelf Life Extension suspension for the treatment and include a fax number to which the Program for use beyond their expiration prophylaxis of influenza, accompanied Authorization(s) may be sent. See the dates. In response to CDC’s request, on by emergency use information, subject SUPPLEMENTARY INFORMATION section for July 14, 2009, FDA amended the to the terms and conditions of the electronic access to the Authorizations. Authorization letter and reissued the authorizations. FOR FURTHER INFORMATION CONTACT: Authorization letter in its entirety. The Authorization (as amended on RADM Boris Lushniak, Office of Because the subsequent October 30, October 30, 2009) for certain oseltamivir Counterterrorism and Emerging Threats 2009, amendment to the Authorization phosphate capsules and oral suspension (HF–29), Food and Drug for certain oseltamivir phosphate follows and provides an explanation of
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the reasons for its issuance, as required by section 564(h)(1) of the act:
October 30, 2009
Thomas R. Frieden, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Rd, MS D–14 Atlanta, GA 30333
Dear Dr. Frieden:
On April 27, 2009, a letter was issued authorizing the emergency use of certain oseltamivir phosphate capsules and oral suspension for treatment and prophylaxis of influenza subject to the terms of that letter. On the same day, an amendment to the letter was also issued.1 On July 14, 2009, an amendment to the letter was issued addressing certain oseltamivir phosphate products identified by FDA that have passed testing under the federal government’s Shelf Life Extension Program (SLEP). I am issuing this letter in response to your October 29, 2009 request to address, among other things, issues that have arisen relating to certain oseltamivir phosphate capsules deployed from the Strategic National Stockpile (SNS) that are beyond or will be beyond their expiration date before the declaration of emergency underlying this EUA has terminated. FDA has also become aware of certain oseltamivir phosphate capsules in addition to those held in or deployed from the Strategic National Stockpile that are beyond or will be beyond their expiration date before the declaration of emer- gency underlying the EUA has terminated. FDA is issuing this amendment to address both of these categories of oseltamivir phosphate capsules, as further described below. The letter of authorization, as amended, appears below in its entirety:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of certain oseltamivir phosphate capsules and oral suspension for treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a public health emergency exists involving Swine Influenza A (now called 2009- H1N1 flu) that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb- 3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain oseltamivir phosphate products subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. § 360bbb-3(a)). The Secretary’s determination of emergency has been renewed. The Secretary’s April 26, 2009 declara- tion of emergency justifying an EUA remains in effect.
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are met, I am authorizing the emergency use of certain oseltamivir phosphate products2 for the treatment and prophylaxis of influenza, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) 2009-H1N1 flu can cause influenza, a serious or life-threatening disease or condition;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain oseltamivir phosphate prod- ucts may be effective for the treatment and prophylaxis of influenza, and that the known and potential benefits of certain oseltamivir phosphate products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of such prod- ucts; and
(3) There is no adequate, approved, and available alternative to the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza.3
Therefore, I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influ- enza meets the above statutory criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized oseltamivir phosphate products for the treatment and prophylaxis of influenza for individuals exposed to 2009-H1N1 flu. The emergency use of authorized oseltamivir phosphate products under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.
The authorized oseltamivir phosphate products are as follows:
• Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules • Tamiflu (oseltamivir phosphate) oral suspension
Oseltamivir phosphate products are approved and indicated for the treatment of uncomplicated acute illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days. Oseltamivir phosphate products are also approved and indicated for the prophylaxis of influenza in patients 1 year and older.4
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1. The above oseltamivir phosphate products are authorized for use in patients less than 1 year old. Such products are also authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hos- pitalization (i.e., patients who do not have ‘‘uncomplicated acute illness’’ per se).
2. The above oseltamivir phosphate products labeled consistent with the manufacturer’s label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription), except for product de- scribed in paragraph 3c. below that is held by entities that are not public health authorities.
3a. The above oseltamivir phosphate products may include products that are deployed from the SNS and that have passed testing under the federal government’s Shelf Life Extension Program (SLEP) for use beyond their expiration dates.
3b. Certain oseltamivir phosphate products that are: (i) identified by FDA, (ii) deployed from the SNS, and (iii) have passed SLEP testing are authorized to be distributed or dispensed without information on the label about the use of the products beyond their expiration dates. The appropriate public health authorities are authorized to label these products with information about the use of the products be- yond their expiration dates should the appropriate public health authorities choose to do so.
3c. Certain oseltamivir phosphate capsules that are (i) identified by FDA and (ii) are beyond or will be beyond their expiration dates be- fore the declaration of emergency underlying this EUA has terminated are authorized to be distributed or dispensed subject to the terms and conditions of this authorization.
4. The above oseltamivir phosphate products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care providers5 and recipients:
• Fact Sheet for Health Care Provider • Fact Sheet for Patients and Parents/Caretakers
CDC and the appropriate public health authorities are also authorized to make available additional information relating to the emergency use of authorized oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of au- thorized oseltamivir phosphate products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reason- able to believe that the authorized oseltamivir phosphate products may be effective for the treatment and prophylaxis of influenza pursu- ant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the con- clusions described in Section I above, and concludes that the authorized oseltamivir phosphate products, when used for the treatment and prophylaxis of influenza in the specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and po- tential effectiveness.6
Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS’s determination under section 564(b)(1)(C) described above and the Secretary of DHHS’s corresponding declaration under section 564(b)(1), the oseltamivir phosphate products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to 2009-H1N1 flu.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
In the letter dated April 27, 2009, current good manufacturing practice (CGMP) requirements were waived with respect to the holding of authorized oseltamivir phosphate products by CDC and other public health authorities for a period of ninety days (the ‘‘First Waiver’’). As of the date of the July 14, 2009 letter, I terminated the First Waiver and replaced it with the following waiver, which remains in effect:
Although authorized oseltamivir phosphate products should be held in accordance with CGMP holding requirements, including appro- priate product storage conditions7, I am waiving CGMP requirements with respect to the holding of authorized oseltamivir phosphate products by CDC and other public health authorities for a maximum of 90 days (consecutive or non-consecutive) from the date of ship- ment to the public health authority. However, this waiver is also limited in that the products may be stored with temperature excursions in excess of 40°C for a total cumulative period of 14 days (consecutive or non-consecutive) within that 90 days. Other temperature excur- sions outside labeled temperature storage conditions and not in excess of 40°C are permitted within the 90-day period.
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
CDC
A. CDC will verify that oseltamivir phosphate products distributed to the Receive, Stage, Storage (RSS) sites: (i) are within unexpired labeled dates, (ii) have passed SLEP testing, whether relabeled or not, and are within the dates supported by SLEP testing, or (iii) are beyond or will be beyond their expiration dates before the termination of the Secretary’s declaration of emergency and have been identified by FDA under Section II.3.c.
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B. For oseltamivir phosphate products identified in Section II.3.b. and c. of this letter, information on the lot numbers of the oseltamivir phosphate products identified by FDA will be made available by CDC to the appropriate public health authorities, healthcare providers, and recipients (patients and parents) through appropriate means.
C. CDC will ensure that the appropriate public health authorities are informed of this EUA, including the terms and conditions herein.
D. CDC will make available to the appropriate public health authorities through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and Parents/Caretakers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.
E. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Patients and Parents/Caretakers. Such requests will be made by contacting FDA concerning FDA review and approval.
Public Health Authorities8
F. The appropriate public health authorities will ensure that authorized oseltamivir phosphate products are distributed to recipients in ac- cordance with applicable laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employ- ees, contractors, or volunteers following a declaration of an emergency.9 However, the appropriate public health authorities will ensure that authorized oseltamivir phosphate products are distributed, dispensed, and/or administered to patients less than 1 year old only under the supervision of a licensed healthcare provider.
G. The appropriate public health authorities will make available through appropriate means authorized Fact Sheet for Health Care Pro- viders, Fact Sheet for Patients and Parents/Caretakers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.
H. The appropriate public health authorities are authorized to label the oseltamivir phosphate products identified in Section II.3.b. with in- formation about the use of the products beyond their expiration dates, should the appropriate public health authorities choose to do so.
Entities That Are Not Public Health Authorities
I. Entities acting under Section II.3.c. that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures will ensure that authorized oseltamivir phosphate capsules are prescribed and dispensed to recipients in accordance with applicable laws that are consistent with this letter of authorization and with applicable federal public health guidelines that are consistent with this letter of authorization.
J. Entities acting under Section II.3.c. that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and that dispense authorized oseltamivir phosphate products, will make available through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and Parents, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate capsules.
K. Entities acting under Section II.3.c. that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and that dispense authorized oseltamivir phosphate products, will verify that the oseltamivir phosphate products that are beyond or will be beyond their expiration dates before the termination of the Secretary’s declaration of emergency have been iden- tified by FDA under Section II.3.c.
CDC and Public Health Authorities
L. CDC and the appropriate public health authorities are also authorized to make available additional information relating to the emer- gency use of authorized oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of author- ization.
The emergency use of authorized oseltamivir phosphate products as described in this letter of authorization must comply with the condi- tions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Specifically, the letter was amended in the following two respects: (1) the reference on page 3 to ‘‘Fact Sheet for Patients and Recipi- ents’’ was revised to read ‘‘Fact Sheet for Patients and Parents’’; and (2) the correct authorized versions of the Tamiflu Fact Sheet for Health Care Providers and Tamiflu Fact Sheet for Patients and Parents were attached to the letter. 2 FDA is authorizing the emergency use of Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules and oral suspension for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For ease of reference, this letter of author- ization will use the terms ‘‘certain oseltamivir phosphate product(s)’’ and ‘‘authorized oseltamivir phosphate product(s).’’ 3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
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4 The approved labeling also states the following: ‘‘The following points should be considered before initiating treatment or prophylaxis with [oseltamivir phosphate products]: [Oseltamivir phosphate products are] not a substitute for early vaccination on an annual basis as rec- ommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility pat- terns and treatment effects when deciding whether to use [oseltamivir phosphate products.]’’ 5 It is possible that public health officials or other volunteers might distribute authorized oseltamivir phosphate products to recipients (ex- cept as limited in IV.F below) , if permitted, in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of ref- erence, this letter will use the term ‘‘health care provider(s)’’ to refer collectively to these individuals. 6 Please note that with respect to authorized oseltamivir phosphate products for use in patients less than 1 year old, the conclusions above are based on limited data available for review under the limited timeframe given the circumstances of the emergency. The conclu- sions above may evolve as the emergency circumstances evolve and as more information becomes available. 7 See Tamiflu Capsule and Oral Suspension product labeling or http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, %20021246s033lbl.pdf for oseltamivir phosphate product storage conditions. 8 Conditions F, G, and H apply to entities that are not public health authorities, but are acting under the public health and medical emer- gency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures. 9 For more information about the terms ‘‘Authority Having Jurisdiction’’ and ‘‘covered countermeasures,’’ see Public Readiness and Emer- gency Preparedness (PREP) Act, sections 319F-3 and 319F-4 of the Public Health Service Act (codified at 42 U.S.C. §§ 247d-6d, 247d-6e), and the PREP Act declaration regarding pandemic influenza antivirals. See http://www.hhs.gov/disasters/discussion/planners/prepact/.
The Authorization (as amended on inhalation powder follows and provides issuance, as required by section November 4, 2009) for certain zanamivir an explanation of the reasons for its 564(h)(1) of the act:
November 4, 2009
Thomas R. Frieden, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Rd, MS D–14 Atlanta, GA 30333
Dear Dr. Frieden:
On April 27, 2009, a letter was issued authorizing the emergency use of certain zanamivir inhalation powder for treatment and prophy- laxis of influenza subject to the terms of that letter. On the same day, an amendment to the letter was also issued.1 On October 30, 2009, the Food and Drug Administration (FDA) issued an amendment to the April letter in response to your October 29, 2009 request to address, among other things, issues that have arisen relating to certain zanamivir products deployed from the Strategic National Stock- pile (SNS) that are beyond or will be beyond their expiration date before the declaration of emergency underlying this Emergency Use Authorization (EUA) has terminated. FDA had also become aware of certain zanamivir products in addition to those held in or deployed from the SNS that are beyond or will be beyond their expiration date before the declaration of emergency underlying the EUA has termi- nated. FDA issued the October 30, 2009 amendment to address both categories of zanamivir products, as further described below. I hereby amend the October 30 letter to include condition J below and to make other minor corrections. The letter of authorization, as amended, is being reissued in its entirety with the amendments incorporated.
This letter is in response to your request that FDA issue an EUA for the emergency use of zanamivir inhalation powder for treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a public health emergency exists involving Swine Influenza A (now called 2009- H1N1 flu) that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb- 3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain zanamivir products subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. § 360bbb-3(a)). The Secretary’s determination of emergency has been renewed. The Secretary’s April 26, 2009 declaration of emer- gency justifying an EUA remains in effect.
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are met, I am authorizing the emergency use of certain zanamivir products2 for the treatment and prophylaxis of influenza, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) 2009-H1N1 flu can cause influenza, a serious or life-threatening disease or condition;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain zanamivir products may be ef- fective for the treatment and prophylaxis of influenza, and that the known and potential benefits of certain zanamivir products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of such products; and
(3) There is no adequate, approved, and available alternative to the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza.3
Therefore, I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the above statutory criteria for issuance of an authorization.
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II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized zanamivir products for the treatment and prophylaxis of influenza for individuals exposed to 2009-H1N1 flu. The emergency use of au- thorized zanamivir products under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.
The authorized zanamivir products are as follows:
• Relenza (zanamivir) Inhalation Powder
Zanamivir products are approved and indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days. Zanamivir products are also ap- proved and indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.4
1. The above zanamivir products are authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have ‘‘uncomplicated acute illness’’ per se).
2. The above zanamivir products labeled consistent with the manufacturer’s label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient, if stat- ed on prescription, directions for use and cautionary statements, if contained in the prescription), except for product described in para- graph 3 below that is held by entities that are not public health authorities.
3. Certain zanamivir products that are (i) identified by FDA and (ii) are beyond or will be beyond their expiration dates before the dec- laration of emergency underlying this EUA has terminated are authorized to be distributed or dispensed subject to the terms and condi- tions of this authorization.
4. The above zanamivir products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care providers5 and recipients:
• Fact Sheet for Health Care Provider • Fact Sheet for Patients and Parents/Caregivers
CDC and the appropriate public health authorities are also authorized to make available additional information relating to the emergency use of authorized zanamivir products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of au- thorized zanamivir products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reason- able to believe that the authorized zanamivir products may be effective for the treatment and prophylaxis of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the conclusions de- scribed in Section I above, and concludes that the authorized zanamivir products, when used for the treatment and prophylaxis of influ- enza in the specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS’s determination under section 564(b)(1)(C) described above and the Secretary of DHHS’s corresponding declaration under section 564(b)(1), the zanamivir products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to 2009-H1N1 flu.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
In the letter dated April 27, 2009, current good manufacturing practice (CGMP) requirements were waived with respect to the holding of authorized zanamivir products by CDC and other public health authorities for a period of ninety days (the ‘‘First Waiver’’). As of the date of this letter, I terminate the First Waiver and replace it with the following waiver:
Although authorized zanamivir products should be held in accordance with CGMP holding requirements, including appropriate product storage conditions,6 I am waiving CGMP requirements with respect to the monitoring and calculating of mean kinetic temperature by CDC and other public health authorities so long as, to the extent practicable given the circumstances of the emergency, temperature is monitored. I also am waiving CGMP requirements with respect to holding at the labeled storage conditions in that the products may be stored with temperature excursions up to 40°C for a total cumulative period of 7 days (consecutive or non-consecutive) from the date of shipment to the public health authority.
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
CDC
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A. CDC will verify that zanamivir products distributed to the Receive, Stage, Storage (RSS) sites are within their labeled expiration dates, or are beyond or will be beyond their expiration dates before the termination of the Secretary’s declaration of emergency and have been identified by FDA under Section II.3.
B. For zanamivir products identified in Section II.3 of this letter, information on the lot numbers of the zanamivir products identified by FDA will be made available by CDC to the appropriate public health authorities, healthcare providers, and recipients (patients and par- ents/caregivers) through appropriate means.
C. CDC will ensure that the appropriate public health authorities are informed of this EUA, including the terms and conditions herein.
D. CDC will make available to the appropriate public health authorities through appropriate means the authorized Fact Sheet for Health Care Providers, authorized Fact Sheet for Patients and Parents/Caregivers, and at least one representative FDA-approved package in- sert that covers the dosage forms and strengths of authorized zanamivir products.
E. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Patients and Parents/Caregivers. Such requests will be made by contacting FDA concerning FDA review and approval.
Public Health Authorities7 F. The appropriate public health authorities will ensure that authorized zanamivir products are distributed to recipients in accordance with applicable laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.8
G. The appropriate public health authorities will make available through appropriate means authorized Fact Sheets for Health Care Pro- viders, authorized Fact Sheets for Patients and Parents/Caregivers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.
Entities That Are Not Public Health Authorities
H. Entities acting under Section II.3 that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense covered countermeasures will ensure that authorized zanamivir products are prescribed and dispensed to recipients in accordance with appli- cable laws that are consistent with this letter of authorization and with applicable federal public health guidelines that are consistent with this letter of authorization.
I. Entities acting under Section II.3 that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and that dispense authorized zanamivir products, will make available through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and Parents/Caregivers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.
J. Entities acting under Section II.3 that are neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and that dispense authorized zanamivir products, will verify that the zanamivir products that are beyond or will be beyond their expiration dates before the termination of the Secretary’s declaration of emergency have been identified by FDA under Section II.3.
CDC and Public Health Authorities
K. CDC and the appropriate public health authorities are also authorized to make available additional information relating to the emer- gency use of authorized zanamivir products that is consistent with, and does not exceed, the terms of this letter of authorization.
The emergency use of authorized zanamivir products as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Specifically, the letter was amended in the following respect: the correct authorized versions of the Zanamivir Fact Sheet for Health Care Providers and Zanamivir Summary Fact Sheet for Patients and Parents were attached to the letter. 2 FDA is authorizing the emergency use of Relenza (zanamivir) inhalation powder for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For ease of reference, this letter of authorization will use the terms ‘‘certain zanamivir prod- uct(s)’’ and ‘‘authorized zanamivir product(s).’’ 3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
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4 Zanamivir products are not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm. Zanamivir products have not been proven effec- tive for treatment of influenza in individuals with underlying airways disease. Zanamivir products have not been proven effective for prophy- laxis of influenza in the nursing home setting. Zanamivir products are not a substitute for early vaccination on an annual basis as rec- ommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility pat- terns and treatment effects when deciding whether to use zanamivir products. There is no evidence for efficacy of zanamivir in any illness caused by agents other than Influenza A and B. Patients should be advised that the use of zanamivir products for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others. 5 It is possible that public health officials or other volunteers might distribute authorized zanamivir products to recipients, if permitted, in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Author- ity Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, em- ployees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term ‘‘health care provider(s)’’ to refer collectively to these individuals. 6 See FDA-approved product labeling for zanamivir products storage conditions (http://www.accessdata.fda.gov/drugsatfda_docs/label/ 2008/021036s017lbl.pdf) 7 Conditions F and G apply to entities that are not public health authorities, but are acting under the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures. 8 For more information about the terms ‘‘Authority Having Jurisdiction’’ and ‘‘covered countermeasures,’’ see Public Readiness and Emer- gency Preparedness (PREP) Act, sections 319F-3 and 319F-4 of the Public Health Service Act (codified at 42 U.S.C. §§ 247d-6d, 247d-6e), and the PREP Act declaration regarding pandemic influenza antivirals. See http://www.hhs.gov/disasters/discussion/planners/prepact/.
Dated: April 9, 2010. DATES: The amended Authorization is FDA issued an EUA for the emergency Leslie Kux, effective as of November 19, 2009. use of the unapproved drug peramivir Acting Assistant Commissioner for Policy. ADDRESSES: Submit written requests for administered intravenously. On [FR Doc. 2010–8603 Filed 4–16–10; 8:45 am] single copies of the EUA to the Office November 2, 2009, notice of the BILLING CODE 4160–01–S of Counterterrorism and Emerging determination and declaration was Threats (HF–29), Food and Drug published in the Federal Register (74 Administration, 5600 Fishers Lane, rm. FR 56640, November 2, 2009), as was DEPARTMENT OF HEALTH AND 14C–26, Rockville, MD 20857. Send one the notice of the Authorization (74 FR HUMAN SERVICES self-addressed adhesive label to assist 56644, November 2, 2009). In response that office in processing your request or to inquiries about dosing of Peramivir Food and Drug Administration include a fax number to which the IV in certain patients with severe renal [Docket No. FDA–2009–N–0521] Authorization may be sent. See the impairment, including those who SUPPLEMENTARY INFORMATION section for require continuous renal replacement Amended Authorization of Emergency electronic access to the Authorization. therapy or hemodialysis, on November Use of the Antiviral Product Peramivir FOR FURTHER INFORMATION CONTACT: 19, 2009, FDA amended the Accompanied by Emergency Use RADM Boris Lushniak, Office of Authorization letter to amend the Fact Information; Availability Counterterrorism and Emerging Threats Sheet for Health Care Providers to (HF–29), Food and Drug provide additional clarification AGENCY: Food and Drug Administration, regarding the dosing recommendations HHS. Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4067. for IV peramivir and reissued the ACTION: Notice. Authorization letter in its entirety. The SUPPLEMENTARY INFORMATION: SUMMARY: The Food and Drug amended dosing recommendations are Administration (FDA) is announcing an I. Amendment to the October 23, 2009, provided in the amended authorized amendment to the Emergency Use Authorization for Peramivir IV version of the Fact Sheet for Health Care Authorization (EUA) (the Authorization) On April 26, 2009, under section Providers. for peramivir injection 200 milligrams 564(b)(1)(C) of the act (21 U.S.C. II. Electronic Access (mg)/20 milliliter (mL) (10 mg/mL) 360bbb–3(b)(1)(C)), the Acting Secretary single use vial manufactured for of Health and Human Services An electronic version of this notice BioCryst Pharmaceuticals, Inc. determined that a public health and the full text of the Authorization are (BioCryst) for intravenous (IV) emergency exists involving Swine available on the Internet at http:// administration in certain adult and Influenza A (now known as 2009 H1N1 www.regulations.gov. pediatric patients issued on October 23, Influenza A, or 2009 H1N1 flu) that III. The Authorization 2009, under the Federal Food, Drug, and affects, or has the significant potential to Cosmetic Act (the act), as requested by affect, national security. The Having concluded that the criteria for the Centers for Disease Control and determination of emergency has been issuance of the Authorization under Prevention (CDC). FDA received renewed. On October 20, 2009, under section 564(c) of the act were met, on inquiries related to the recommended section 564(b) of the act, and on the October 23, 2009, FDA authorized the dosing for patients with renal basis of such determination, the emergency use of the unapproved drug impairment. On November 19, 2009, Secretary declared an emergency peramivir administered intravenously FDA amended the Authorization letter justifying the authorization of the for treatment of 2009 H1N1 influenza and reissued the Authorization letter in emergency use of the antiviral virus in certain adult and pediatric its entirety to provide additional peramivir, accompanied by emergency patients. The letter of Authorization in clarification. The Authorization letter, use information subject to the terms of its entirety (not including the amended as amended and reissued, which any authorization issued under 21 authorized version of the Fact Sheet for includes explanations for its reissuance, U.S.C. 360bbb–3(a). On October 23, Health Care Providers), as amended on is reprinted in this notice. 2009, in response to a request from CDC, November 19, 2009, follows:
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Thomas R. Frieden, MD, MPH Director, Centers for Disease Control and Prevention 1600 Clifton Rd, MS D–14 Atlanta, GA 30333
Dear Dr. Frieden:
On October 23, 2009, a letter was issued authorizing the emergency use of the unapproved drug peramivir in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of peramivir administered intra- venously for treatment of 2009 H1N1 influenza virus (hereafter ‘‘2009 H1N1’’) in certain adult and pediatric patients, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb–3). FDA has received inquiries related to the recommended dos- ing for patients with renal impairment. The purpose of this letter is to amend the Fact Sheet for Health Care Providers to provide additional clarification regarding the dosing recommendations for IV peramivir in patients with severe renal impairment, including those who require con- tinuous renal replacement therapy or hemodialysis. The amended authorized version of the Fact Sheet for Health Care Providers is enclosed with this letter. In addition, this version of the letter includes minor editorial changes. The letter of authorization, as amended, appears below in its entirety:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of the unapproved drug peramivir administered intravenously for treatment of 2009 H1N1 influenza virus (hereafter ‘‘2009 H1N1’’) in certain adult and pediatric patients, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb–3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb–3(b)(1)(C)), the then Acting Secretary of the Department of Health and Human Services (HHS) determined that a public health emergency exists involving Swine Influenza A (now referred to as ‘‘2009 H1N1’’) that affects or has significant potential to affect national security. The Secretary has renewed the determination. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb–3(b)), and on the basis of such determination, the Secretary of HHS declared an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. § 360bbb–3(a)).
Having consulted with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and having con- cluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb–3(b)) are met, I am authorizing the emergency use of peramivir1 administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) 2009 H1N1 can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that peramivir may be effective when adminis- tered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients, and that the known and potential benefits of peramivir, when administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients, outweigh the known and potential risks of peramivir; and
(3) there is no adequate, approved, and available alternative to the emergency use of peramivir administered intravenously for the treat- ment of 2009 H1N1 in certain adult and pediatric patients.2
Therefore, I have concluded that the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients meets the above statutory criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the emergency use of authorized peramivir for the treatment of 2009 H1N1 in certain adult and pediatric patients. The emergency use of authorized peramivir under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.
Peramivir (a neuraminidase inhibitor) is an unapproved drug that it is currently being studied in clinical investigations. Peramivir is not cur- rently approved by FDA for any use in the United States.
The authorized peramivir is as follows:
• Peramivir injection: 200mg/20mL (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst). (See Section IV.D.3. of this letter).
1. The above peramivir product is authorized only for intravenous (IV) administration.
2. The above peramivir product is authorized for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, the peramivir product is authorized only for the following patients who are admitted to a hospital and under the care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medica- tion-related adverse events): a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons: (i) patient not responding to either oral or inhaled antiviral therapy, or
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(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or (iii) the clinician judges IV therapy is appropriate due to other circumstances. b. Pediatric patients for whom an IV agent is clinically appropriate because: (i) patient not responding to either oral or inhaled antiviral therapy, or (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.
3. The above peramivir product may only include product distributed from Strategic National Stockpile (SNS), in which case such product is authorized only to be labeled with the enclosed label.
4. The above peramivir product is authorized to be accompanied by the following written information pertaining to the emergency use, which is enclosed and authorized to be made available to health care providers and patients (and parents/caregivers):
• Fact Sheet for Health Care Providers • Fact Sheet for Patients and Parents/Caregivers
CDC, hospitals, and health care providers receiving authorized peramivir are also authorized to make available additional written information relating to the emergency use of authorized peramivir that is consistent with and does not exceed the terms of this letter of authorization (in- cluding the above referenced facts sheets).
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized peramivir, when used for the treatment of H1N1 in certain adult and pediatric patients, outweigh the known and potential risks of such prod- uct.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized peramivir may be effective for the treatment of 2009 H1N1 in certain adult and pediatric patients pursuant to sec- tion 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the conclusions de- scribed in Section I of this letter above, and concludes that the authorized peramivir when used for the treatment of 2009 H1N1 in certain adult and pediatric patients, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the peramivir described above is authorized for the treatment of 2009 H1N1 in certain adult and pediatric patients.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
This letter covers authorized peramivir as previously manufactured for BioCryst as of the date of this letter as well as authorized peramivir that may be manufactured for BioCryst after such date, insofar as FDA has determined that the methods used in, and the facilities and con- trols used for, the manufacturing, processing and packing of authorized peramivir are adequate to preserve its identity, strength, quality and purity.
Authorized peramivir should be held in accordance with its labeled and appropriate product storage conditions (ambient temperature, 15°C– 30°C or 59°F–86°F). However, in order to ensure the delivery and availability of authorized peramivir, I am waiving current good manufac- turing practice (CGMP) requirements with respect to proper storage conditions of temperature during the shipment and holding of authorized peramivir by CDC and/or its designees for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to CDC and/or its designees. Significant excursions from labeled storage conditions should be documented to the extent practicable given the circumstances of the emergency, and need not be supported by additional testing by CDC or its designees.
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
A. CDC
A.1. CDC will decide how authorized peramivir will be distributed under its direction to Hospitals upon request by licensed treating clinicians at the Hospitals to the extent such decisions are consistent with and do not exceed the terms of this letter; except that CDC will ensure that authorized peramivir will be distributed to Hospitals as soon as possible within 24 hours of CDC’s decision to distribute such product, to the extent practicable given the circumstances of the emergency.
A.2. CDC will maintain adequate records regarding distribution under its direction of authorized peramivir (i.e., lot numbers, quantity, receiv- ing site, receipt date, unique identifier(s) (e.g., Peramivir Request number(s))).
A.3. CDC will notify FDA on a weekly basis (unless otherwise specified by FDA) of the quantity of and to which Hospitals authorized peramivir is distributed under its direction. CDC will also include in the notification the unique identifier(s) (e.g., Peramivir Request number(s)).
A.4. CDC will ensure that authorized peramivir is distributed for use under its direction only within the expiry dates identified by FDA. CDC will inform Hospitals receiving authorized peramivir under its direction of the expiry dates by which authorized peramivir is to be used if au- thorized peramivir is nearing expiry. CDC will maintain adequate records regarding the expiry dates by which authorized peramivir is to be used.
A.5. CDC will ensure that Hospitals receiving authorized peramivir under its direction are informed of this letter, including the terms and con- ditions as well as any authorized amendments thereto.
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A.6. CDC will make available through appropriate means to the Hospitals receiving authorized peramivir under its direction the authorized Fact Sheet for Health Care Providers and Fact Sheet for Patients and Parents/Caregivers as well as any authorized amendments thereto.
A.7. CDC will perform adverse event monitoring and compliance activities (e.g., follow-up surveys) designed: (1) to ensure that selected ad- verse events and all medication errors associated with the use of authorized peramivir are reported to FDA as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at http://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) to ensure that such reports include in the description section of the MedWatch Form 3500 the words ‘‘Peramivir EUA’’ and include unique identifier(s) (e.g., Peramivir Request number(s)), and (3) to ensure that such reports are made within seven calendar days from the onset of the event. CDC will report such information to FDA upon request.
A.8. CDC will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed the terms of this letter (including the facts sheets referenced in Section II of this letter).
A.9. CDC will make available to FDA upon request any records maintained in connection with this letter.
B. Hospitals to Which Authorized Peramivir is Distributed
B.1 Such Hospitals will make available through appropriate means to relevant health care providers this letter, including the terms and con- ditions as well as any authorized amendments thereto.
B.2. Such Hospitals will make available through appropriate means to relevant health care providers and patients and/or parents/caregivers the authorized Fact Sheet for Health Care Providers and Fact Sheet for Patients and Parents/Caregivers as well as any authorized amend- ments thereto.
B.3. Such Hospitals will ensure that relevant health care providers abide by the institutional procedures regarding drug accountability. Such Hospitals will maintain adequate records showing receipt, use, and disposition of authorized peramivir.
B.4. Such Hospitals will ensure that the emergency use of authorized peramivir is limited to patients who are under the care or consultation of a licensed clinician (e.g., skilled in the diagnosis and management of patients with systemic illness, including recognition and management of medication-related adverse events).
B.5. Such Hospitals will conduct any follow-up requested by FDA and/or CDC regarding medication errors and adverse events.
B.6. Such Hospitals will only make available additional written information relating to the emergency use of authorized peramivir to the ex- tent that it is consistent with and does not exceed the terms of this letter of authorization (including the facts sheets referenced in Section II of this letter).
B.7. Such Hospitals will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon re- quest, such Hospitals will report to FDA and/or CDC information with respect to the emergency use of authorized peramivir.
C. Health Care Providers Conducting Activities With Respect to Authorized Peramivir3
C.1. Health Care Providers will be aware of this letter, including the terms and conditions as well as any authorized amendments thereto. Health Care Providers will read the Fact Sheet for Health Care Providers, including the sections on Mandatory Requirements for Peramivir Administration Under Emergency Use Authorization and Considerations Prior to Peramivir Use Under EUA as well as any amendments there- to. (See Fact Sheet for Health Care Providers).
C.2. Health Care Providers prescribing and/or administering authorized peramivir will ensure that the authorized Fact Sheet for Patients and Parents/Caregivers, as well as any authorized amendments thereto, have been made available to patients and/or parents/caregivers through appropriate means. Such Health Care Providers (to the extent practicable given the circumstances of the emergency) will document in the pa- tient’s medical record that: (a) patients/caregivers have been given the Fact Sheet for Patients and Parents/Caregivers, (b) patients/caregivers have been informed of the alternatives to receiving authorized peramivir, and (c) patients/caregivers have been informed that peramivir is an unapproved drug that is authorized for use under Emergency Use Authorization.
C.3. Prescribing Health Care Providers (or their designees) will ensure that: (1) selected adverse events and all medication errors associ- ated with the use of authorized peramivir are reported as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at http://www.fda.gov/medwatch/safety/FDA- 3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) that such reports include in the description section of the MedWatch Form 3500 the words ‘‘Peramivir EUA’’ and include unique identifier(s) (e.g., Peramivir Request number(s)); and (3) that such re- ports are made within seven calendar days from the onset of the event. Such Health Care Providers or their designees will conduct any fol- low-up requested by FDA and/or CDC.
C.4. Health Care Providers will prescribe and/or administer authorized peramivir only for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on commu- nity epidemiology. Specifically, peramivir is authorized only for the following patients who are admitted to a hospital and under the care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-related adverse events):
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons: (i) patient not responding to either oral or inhaled antiviral therapy, or (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not fea- sible, or
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(iii) the clinician judges IV therapy is appropriate due to other circumstances. b. Pediatric patients for whom an IV agent is clinically appropriate because: (i) patient not responding to either oral or inhaled antiviral therapy, or (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not fea- sible.
C.5. Health Care Providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to peramivir dose calculation and first administration. (See Fact Sheet For Health Care Providers; Dosage and Administration for Impaired Renal Function Dosing).
C.6. Health Care Providers prescribing and/or administering authorized peramivir will ensure that patients with history of severe allergic re- action to any other neuraminidase inhibitor (zanamivir or oseltamivir) or any ingredient of peramivir will not receive authorized peramivir. (See Fact Sheet for Health Care Providers; Product Description.)
C.7. Health Care Providers will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed the terms of this letter of authorization (including the facts sheets referenced in Sec- tion II of this letter).
C.8. Heath Care Providers will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon request, Health Care Providers will report to FDA and/or CDC information with respect to the emergency use of authorized peramivir.
D. BioCryst
D.1. BioCryst will post on its website the following statement: ‘‘For information about the FDA-authorized emergency use of peramivir, please see www.cdc.gov/h1n1flu/eua.’’
D.2. BioCryst will distribute authorized peramivir only to CDC and/or its designees subject to the terms and conditions of this letter.
D.3 BioCryst will contact FDA concerning the need for any FDA review and approval before any changes are made to the manufacturing, packaging, and labeling processes authorized as of the date of this letter.
D.4. BioCryst (or anyone acting on behalf of BioCryst) will not represent authorized peramivir in a promotional context or otherwise promote authorized peramivir.
D.5. BioCryst will make available to FDA and (as reasonably appropriate) CDC upon request any records maintained in connection with this letter. Upon request, BioCryst will report to FDA and/or (as reasonably appropriate) CDC information with respect to the emergency use of authorized peramivir.
The emergency use of authorized peramivir as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Joshua M. Sharfstein, M.D. Principal Deputy Commissioner Food and Drugs
1 FDA is authorizing the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric pa- tients as described in the scope section of this letter (Setion II of thie letter). For ease of reference, this letter of authorization will also use the term ‘‘authorized peramivir.’’ 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 3 The activites with respect to authorized peramivir refer to requesting, preparing, prescribing, and/or administering authorized peramivir, unless otherwise specified.
Dated: April 9, 2010. DEPARTMENT OF HEALTH AND Authorizations (EUAs) (the Leslie Kux, HUMAN SERVICES Authorizations) several of which were Acting Assistant Commissioner for Policy. amended after initial issuance, for Food and Drug Administration [FR Doc. 2010–8604 Filed 4–16–10; 8:45 am] certain in vitro diagnostic devices. FDA also is announcing an amendment to the BILLING CODE 4160–01–S [Docket No. FDA–2009–N–0277] EUA for the Centers for Disease Control Authorization of Emergency Use of and Prevention (CDC) Swine Influenza Certain In Vitro Diagnostic Devices; Virus Real-time RT-PCR Detection Panel Availability authorized on April 27, 2009. FDA is AGENCY: Food and Drug Administration, issuing the Authorizations and HHS. amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). ACTION: Notice. The Authorizations contain, among SUMMARY: The Food and Drug other things, conditions on the Administration (FDA) is announcing the emergency use of the authorized in vitro issuance of 10 Emergency Use diagnostics. The Authorizations follow
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the determination by the Acting life-threatening diseases or conditions (1) that an agent specified in a Secretary of the U.S. Department of caused by such agents, when there are declaration of emergency can cause a Health and Human Services, Charles E. no adequate, approved, and available serious or life-threatening disease or Johnson (the Acting Secretary), that a alternatives. condition; public health emergency exists Section 564(b)(1) of the act provides (2) that, based on the totality of involving Swine Influenza A (now that, before an EUA may be issued, the scientific evidence available to FDA, known as 2009 H1N1 Influenza A, or Secretary must declare an emergency including data from adequate and well- 2009 H1N1 flu) that affects, or has the justifying the authorization based on controlled clinical trials, if available, it significant potential to affect, national one of the following grounds: is reasonable to believe that: security. On the basis of such (1) a determination by the Secretary of • the product may be effective in determination, the Acting Secretary Homeland Security that there is a diagnosing, treating, or preventing— declared an emergency justifying the domestic emergency, or a significant Æ such disease or condition; or Æ authorization of the emergency use of potential for a domestic emergency, a serious or life-threatening disease certain in vitro diagnostics, involving a heightened risk of attack or condition caused by a product accompanied by emergency use with a specified biological, chemical, authorized under section 564 of the information subject to the terms of any radiological, or nuclear agent or agents; act, approved or cleared under the authorization issued under the Federal (2) a determination by the Secretary of act, or licensed under Section 351 Food, Drug, and Cosmetic Act (the act). Defense that there is a military of the PHS Act, for diagnosing, The Authorizations, which include emergency, or a significant potential for treating, or preventing such a explanations of the reasons for their a military emergency, involving a disease or condition caused by such issuance or reissuance, are reprinted in heightened risk to United States military an agent; and • this document. forces of attack with a specified the known and potential benefits of the product, when used to diagnose, DATES: See the SUPPLEMENTARY biological, chemical, radiological, or prevent, or treat such disease or INFORMATION section of this document nuclear agent or agents; or for effective dates of the Authorizations. (3) a determination by the Secretary of condition, outweigh the known and a public health emergency under section potential risks of the product; ADDRESSES: Submit written requests for 319 of the Public Health Service Act Æ that there is no adequate, approved, single copies of the EUAs to the Office and available alternative to the of Counterterrorism and Emerging (PHS Act) (42 U.S.C. 247d) that affects, or has a significant potential to affect, product for diagnosing, preventing, Threats (HF–29), Food and Drug or treating such disease or Administration, 5600 Fishers Lane, rm. national security, and that involves a specified biological, chemical, condition; and 14C–26, Rockville, MD 20857. Send one Æ radiological, or nuclear agent or agents, that such other criteria as the self-addressed adhesive label to assist Secretary may by regulation that office in processing your request or or a specified disease or condition that may be attributable to such agent or prescribe are satisfied. include a fax number to which the No other criteria of issuance have Authorization(s) may be sent. See the agents. Once the Secretary has declared an been prescribed by regulation under SUPPLEMENTARY INFORMATION section for emergency justifying an authorization Section 564(c)(4) of the act. Because the electronic access to the Authorizations. under section 564 of the act, FDA may statute is self-executing, FDA does not FOR FURTHER INFORMATION CONTACT: authorize the emergency use of a drug, require regulations or guidance to RADM Boris Lushniak, Office of device, or biological product if the implement the EUA authority. However, Counterterrorism and Emerging Threats agency concludes that the statutory FDA published guidance in July 2007 (HF–29), Food and Drug criteria are satisfied. Under section entitled ‘‘Emergency Use Authorization Administration, 5600 Fishers Lane, 564(h)(1) of the act, FDA is required to of Medical Products’’ to provide more Rockville, MD 20857, 301–827–4067. publish in the Federal Register a notice information for stakeholders and the SUPPLEMENTARY INFORMATION: of each authorization, and each public about the EUA authority and the agency’s process for the consideration of I. Background termination or revocation of an authorization, and an explanation of the EUA requests. Section 564 of the act (21 U.S.C. reasons for the action. Section 564 of the 360bbb-3), as amended by the Project II. EUA Request for Certain In Vitro act permits FDA to authorize the Diagnostic Products BioShield Act of 2004 (Public Law 108– introduction into interstate commerce of 276), allows FDA to strengthen the a drug, device, or biological product On April 26, 2009, under section public health protections against intended for use in a declared 564(b)(1)(C) of the act, the Acting biological, chemical, nuclear, and emergency. Products appropriate for Secretary determined that a public radiological agents. Among other things, emergency use may include products health emergency exists involving section 564 of the act allows FDA to and uses that are not approved, cleared, Swine Influenza A (now known as 2009 authorize the use of an unapproved or licensed under sections 505, 510(k), H1N1 Influenza A, or 2009 H1N1 flu) medical product or an unapproved use and 515 of the act (21 U.S.C. 355, that affects, or has the significant of an approved medical product during 360(k), and 360e, respectively) or potential to affect, national security. The a public health emergency that affects, section 351 of the PHS Act (42 U.S.C. determination has been renewed. On or has a significant potential to affect, 262). FDA may issue an EUA only if, April 26, 2009, under section 564(b) of national security, and that involves after consultation with the National the act, and on the basis of such biological, chemical, radiological, or Institutes of Health (NIH) and the CDC determination, the Acting Secretary nuclear agent or agents, or a specified (to the extent feasible and appropriate declared an emergency justifying the disease or condition that may be given the circumstances of the authorization of certain in vitro attributable to such agent or agents. diagnostics for detection of Swine emergency), FDA1 concludes: With this EUA authority, FDA can help Influenza A (2009 H1N1 flu), assure that medical countermeasures 1 The Secretary has delegated his authority to accompanied by emergency use may be used in an emergency to issue an EUA under section 564 of the act to the information subject to the terms of any diagnose, treat, or prevent serious or Commissioner of Food and Drugs. authorization issued under section
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564(a) of the act. Notice of the Diatherix H1N1-09 Influenza Test with issued an EUA for the GeneSTAT 2009 determination and the declaration of the certain written information, including A/H1N1 Influenza Test with certain Acting Secretary was published in the fact sheets for healthcare providers and written information, including fact Federal Register on August 4, 2009 (74 patients and adequate directions for use, sheets for healthcare providers and FR 38628). which are authorized under the EUA. patients and adequate directions for use, (1) On July 23, 2009, in response to The Authorization letter, which which are authorized under the EUA. a request from Focus Diagnostics, Inc., includes an explanation for its issuance, The Authorization letter, which FDA issued an EUA for the Focus is reprinted in this document. includes an explanation for its issuance, Diagnostics Influenza A H1N1 (2009) (4) On October 16, 2009, in response is reprinted in this document. Real-Time RT-PCR IVD device with to a request from Focus Diagnostics, (9) On December 16, 2009, in certain written information, including Inc., FDA issued an EUA for the Focus response to a request from TessArae, fact sheets for healthcare providers and Diagnostics Simplexa Influenza A H1N1 LLC, FDA issued an EUA for the patients and adequate directions for use, (2009) with certain written information, TessArray Resequencing Influenza A which are authorized under the EUA. In including fact sheets for healthcare Microarray Detection Panel with certain response to requests from Focus providers and patients and adequate written information, including fact Diagnostics, Inc., FDA amended the directions for use, which are authorized sheets for healthcare providers and Authorization letter and reissued the under the EUA. On December 18, 2009, patients and adequate directions for use, Authorization letter in its entirety two in response to a request from Focus which are authorized under the EUA. times. On August 14, 2009, FDA Diagnostics, Inc., FDA amended the The Authorization letter, which amended the Authorization letter to Authorization letter to authorize use of includes an explanation for its issuance, authorize certain changes to the additional upper respiratory tract is reprinted in this document. authorized labeling and permit future samples and lower respiratory tract (10) On April 27, 2009, in response to changes to the authorized labeling with specimens, and for other reasons, and a request from CDC, FDA issued an EUA written permission from FDA. On reissued the Authorization letter in its for the CDC Swine Influenza Virus Real- December 18, 2009, FDA amended the entirety. The Authorization letter, as time rRT-PCR Detection Panel. On May Authorization letter to authorize use of amended and reissued on December 18, 2, 2009, in response to a request from additional upper respiratory tract 2009, which includes an explanation for CDC, FDA amended the Authorization samples and lower respiratory tract its reissuance, is reprinted in this letter to authorize the use of different specimens, and for other reasons. The document. The original October 2009 sample types and reagents, and on Authorization letter, as amended and Authorization letter is not reprinted in August 4, 2009, notice of the initial reissued on December 18, 2009, which this document. Authorization and the amended includes an explanation for its (5) On October 27, 2009, in response Authorization was published in the reissuance, is reprinted in this to a request from Prodesse, Inc., FDA Federal Register (74 FR 38636, August document. Because the December 2009 issued an EUA for the Prodesse ProFlu- 4, 2009). On December 18, 2009, in amendment incorporated both the July ST Influenza A Subtyping Assay with response to a request from CDC, FDA 2009 Authorization letter and the certain written information, including amended the Authorization letter again August 2009 amendment to the fact sheets for healthcare providers and Authorization letter in their entirety, the patients and adequate directions for use, to authorize the use of an additional original July 2009 Authorization letter which are authorized under the EUA. upper respiratory tract specimen and and the August 2009 amendment to the The Authorization letter, which use of lower respiratory tract specimens, ‘‘ ’’ Authorization letter are not reprinted in includes an explanation for its issuance, to remove the word presumptive from this document. is reprinted in this document. the Intended Use, to allow the use of the (2) On August 24, 2009, in response (6) On November 13, 2009, in CDC Swine Influenza Virus Real-time to a request from the Department of response to a request from Epoch rRT-PCR Detection Panel as a stand Defense (DOD), FDA issued an EUA for BioSciences, FDA issued an EUA for the alone test, and for other reasons. FDA the CDC Swine Influenza Virus Real- ELITech Molecular Diagnostics 2009- reissued the Authorization letter in its time rRT-PCR Detection Panel on H1N1 Influenza A Virus Real Time RT- entirety. The Authorization letter, as JBAIDS with certain written PCR test with certain written amended and reissued on December 18, information, including fact sheets for information, including fact sheets for 2009, which includes an explanation for healthcare providers and patients and healthcare providers and patients and its reissuance, is reprinted in this adequate directions for use, which are adequate directions for use, which are document. authorized under the EUA. On authorized under the EUA. The (11) On December 24, 2009, in December 18, 2009, in response to a Authorization letter, which includes an response to a request from Cepheid, request from DOD, FDA amended the explanation for its issuance, is reprinted FDA issued an EUA for the Cepheid Authorization letter to authorize use of in this document. Xpert Flu A Panel with certain written additional upper respiratory tract (7) On November 13, 2009, in information, including fact sheets for samples and lower respiratory tract response to a request from Roche healthcare providers and patients and specimens, and for other reasons, and Diagnostics GmbH, FDA issued an EUA adequate directions for use, which are reissued the Authorization letter in its for the Roche RealTime ready Influenza authorized under the EUA. The entirety. The Authorization letter, as A/H1N1 Detection Set with certain Authorization letter, which includes an amended and reissued on December 18, written information, including fact explanation for its issuance, is reprinted 2009, which includes an explanation for sheets for healthcare providers and in this document. its reissuance, is reprinted in this patients and adequate directions for use, III. Effective Dates of the document. The original August 2009 which are authorized under the EUA. Authorizations Authorization letter is not reprinted in The Authorization letter, which this document. includes an explanation for its issuance, The Authorizations are effective as (3) On October 9, 2009, in response to is reprinted in this document. follows: a request from Diatherix Laboratories, (8) On December 9, 2009, in response (1) The Authorization for Focus Inc., FDA issued an EUA for the to a request from DxNA, LLC, FDA Diagnostics Influenza A H1N1 (2009)
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Real-Time RT-PCR IVD device is Influenza A virus Real-Time RT-PCR IV. Electronic Access effective as of July 23, 2009; test by Associated Regional and (2) The Authorization for CDC Swine University Pathologists Laboratories is An electronic version of this Influenza Virus Real-time rRT-PCR effective as of November 13, 2009; document and the full text of the Detection Panel on the Joint Biological (7) The Authorization for Roche Authorizations are available on the Agent Identification and Diagnostic RealTime ready Influenza A/H1N1 Internet at http://www.regulations.gov. System Instrument (CDC Swine Detection Set is effective as of V. The Authorizations Influenza Virus Real-time rRT-PCR November 13, 2009; Detection Panel JBAIDS) is effective as (8) The Authorization for GeneSTAT Having concluded that the criteria for of August 24, 2009; 2009 A/H1N1 Influenza Test is effective issuance of the Authorizations, one as (3) The Authorization for Diatherix as of December 9, 2009; amended, under section 564(c) of the act H1N1-09 Influenza Test is effective as of (9) The Authorization for TessArray are met, FDA has authorized the October 9, 2009; Resequencing Influenza A Microarray emergency use of certain in vitro (4) The Authorization for Focus Detection Panel is effective as of diagnostic devices. Diagnostics Simplexa Influenza A H1N1 December 16, 2009; (1) The Authorization for Focus (2009) is effective as of October 16, (10) The amendment to the EUA for Diagnostics Influenza A H1N1 (2009) 2009; the CDC Swine Influenza Virus Real- Real-Time RT-PCR IVD device issued on (5) The Authorization for Prodesse time rRT-PCR Detection Panel is July 23, 2009, as amended and reissued ProFlu-ST Influenza A Subtyping Assay effective as of December 18, 2009; and in its entirety on December 18, 2009, is effective as of October 27, 2009; (11) The Authorization for Cepheid follows and provides an explanation of (6) The Authorization for ELITech Xpert Flu A Panel is effective as of the reasons for its issuance, as required Molecular Diagnostics 2009-H1N1 December 24, 2009. by section 564(h)(1) of the act:
John G. R. Hurrell, Ph.D. Vice President and General Manager Focus Diagnostics, Inc. 11331 Valley View Street Cypress, CA 90630
Dear Dr. Hurrell:
On July 23, 2009 FDA issued a letter authorizing the emergency use of the Focus Diagnostics Influenza A H1N1 (2009) Real- Time RT-PCR (Flu A H1N1 (2009) rRT-PCR ) for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests (CLIA High Complexity Laboratories). On November 20, 2009, Focus submitted a request for an amendment to the Emergency Use Authorization. In response to that re- quest, the letter authorizing emergency use of the Flu A H1N1 (2009) rRT-PCR is being reissued in its entirety with the amend- ments incorporated.1
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.2 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus in- fection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus in- fection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Flu A H1N1 (2009) rRT-PCR may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Flu A H1N1 (2009) rRT-PCR, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and poten- tial risks of such product; and
(3) There is no adequate, approved, and available alternative to the emergency use of the Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus infection.3
II. Scope of Authorization
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I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized Flu A H1N1 (2009) rRT-PCR:
The Focus Diagnostics Influenza A H1N1 (2009) Real Time RT-PCR test is a real-time RT-PCR assay that utilizes fluorogenic hy- drolysis (Taqman®) probes for use on the ABI 7500 Real-Time PCR instrument for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/throat swabs (NPS/TS)), and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate (BA); bronchial wash (BW); endotracheal aspirate (EA); endotracheal wash (EW); tracheal aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step reverse transcription and PCR amplification with human influenza A virus and the 2009 H1N1 influenza virus-specific primers and real-time detection with influenza A and 2009 H1N1 influenza virus-specific probes.
The Flu A H1N1 (2009) rRT-PCR includes the following primer and probe sets: • FLU A detects a well-conserved region of the matrix gene from influenza A viruses in both human influenza A virus and 2009 H1N1 influenza virus. • SWINE 1 and SWINE 2 specifically detect two separate regions of the 2009 H1N1 influenza virus strain’s HA gene. The SWINE 1 and SWINE 2 reactions are not multiplexed and are performed in parallel in separate wells.
The Flu A H1N1 (2009) rRT-PCR also includes control materials: • Internal Positive Amplification Control (IPC): Exogenous IPC Reagent available separately from Applied Biosystems (Catalog No. 4308323). An internal positive control is included to confirm the absence of PCR inhibition. • External Positive Control: Swine influenza virus stock (ATCC VR-897) diluted at 1:800. • External Negative Control: Nuclease free water.
The above described Flu A H1N1 (2009) rRT-PCR test, when labeled consistently with the labeling authorized by FDA, entitled Influenza A H1N1 (2009) Real-Time RT-PCR Package Insert, (see http://www.fda.gov/MedicalDevices/Safety/ EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described Flu A H1N1 (2009) rRT-PCR test is authorized to be accompanied by the following information per- taining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR Test Results • Fact Sheet For Patients: Understanding The Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR Test Re- sults
As described in section IV below, Focus Diagnostics and CLIA High Complexity Laboratories are also authorized to make avail- able additional information relating to the emergency use of the authorized Flu A H1N1 (2009) rRT-PCR that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Flu A H1N1 (2009) rRT-PCR in the specified population, when used for diagnosis of 2009 H1N1 influenza virus in- fection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Flu A H1N1 (2009) rRT-PCR may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized Flu A H1N1 (2009) rRT- PCR when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized Flu A H1N1 (2009) rRT-PCR under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the Flu A H1N1 (2009) rRT-PCR described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the Flu A H1N1 (2009) rRT-PCR during the duration of this emergency use authoriza- tion:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the Flu A H1N1 (2009) rRT-PCR.
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• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Focus Diagnostics
A. Focus Diagnostics will distribute the Flu A H1N1 (2009) rRT-PCR with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. Focus Diagnostics will provide to the CLIA High Complexity Laboratories the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Healthcare Providers and the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Patients.
C. Focus Diagnostics will make available on its website the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Healthcare Providers and the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Patients.
D. Focus Diagnostics will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized Flu A H1N1 (2009) rRT-PCR shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other require- ments set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the Flu A H1N1 (2009) rRT-PCR shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized Flu A H1N1 (2009) rRT-PCR may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
H. Focus Diagnostics will ensure CLIA High Complexity Laboratories using the authorized Flu A H1N1 (2009) rRT-PCR have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as ap- propriate.
I. Focus Diagnostics will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, Focus Diagnostics will maintain records of device usage.
K. Focus Diagnostics will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Focus Diagnostics becomes aware.
CLIA High Complexity Laboratories
L. CLIA High Complexity Laboratories will include with reports of the results of the Flu A H1N1 (2009) rRT-PCR the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
M. CLIA High Complexity Laboratories will perform the assay on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO marketed Applied Biosystems 7500 Real-time PCR instrument.
N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Focus Diagnostics any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
Focus Diagnostics and CLIA High Complexity Laboratories
P. Focus Diagnostics is authorized to make available additional information relating to the emergency use of the authorized Flu A H1N1 (2009) rRT-PCR that is consistent with, and does not exceed, the terms of this letter of authorization.
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Q. Only Focus Diagnostics may request changes to the authorized Fact Sheet for Healthcare Providers or the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and ap- proval.
R. Focus Diagnostics will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized Flu A H1N1 (2009) rRT-PCR as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 The amendments to the July 23, 2009 letter authorize use of additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal as- pirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue. There are also corrections to the waiver section and minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic de- vices. 2 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
(2) The Authorization for the CDC on August 24, 2009, as amended and explanation of the reasons for its Swine Influenza Virus Real-time rRT- reissued in its entirety on December 18, issuance, as required by section PCR Detection Panel on JBAIDS issued 2009, follows and provides an 564(h)(1) of the act:
Robert E. Miller, Ph.D., RAC Director United States Army Medical Material Development Activity 1430 Veterans Drive Ft. Detrick, Maryland 21702-9232
Dear Dr. Miller:
On August 24, 2009, FDA issued a letter authorizing the emergency use of the CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS)1 Instrument (rRT-PCR Swine Flu Panel on JBAIDS) for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3) by qualified Department of Defense (DoD) laboratories that are equipped with the JBAIDS instruments. On November 16, 2009, the Office of the Surgeon General, Department of the Army sub- mitted a request for an amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emer- gency use of the rRT-PCR Swine Flu Panel on JBAIDS is being reissued in its entirety with the amendments, as requested by the Office of the Surgeon General, Department of the Army, incorporated.2
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. § 247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.3 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the rRT-PCR Swine Flu Panel on JBAIDS (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Swine Flu Panel on JBAIDS may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential bene- fits of the rRT-PCR Swine Flu Panel on JBAIDS, when used in the diagnosis of 2009 H1N1 influenza virus infection, out- weigh the known and potential risks of such products; and
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(3) There is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of 2009 H1N1 influenza virus infection.4
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The authorized rRT-PCR Swine Flu Panel on JBAIDS:
rRT-PCR Swine Flu Panel on JBAIDS is a panel of oligonucleotide primers and dual-labeled hydrolysis (Taqman®) probes for use in the real-time RT-PCR assay on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instrument for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens, such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens (LRTS), such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue, from patients with signs and symptoms of respiratory infection and in viral culture.
The rRT-PCR Swine Flu Panel on JBAIDS includes the following primer and probe sets: • InfA detects universal influenza A strains • swInfA specifically detects swine influenza A strains (NP gene) • swH1 is specific for swine influenza A, subtype H1 (HA gene)
The rRT-PCR Swine Flu Panel on JBAIDS also includes control materials: • RNase P (RP) detects human RNase P and is used as a positive control with human clinical specimens to indicate that ade- quate isolation of nucleic acid resulted from the extraction of the clinical specimen. • Swine Influenza Panel Real-Time RT-PCR Positive Control (SIPC) is a positive control designed to react with all the prim- er and probe sets including RNase P.
The rRT-PCR Swine Flu Panel on JBAIDS requires the following hardware and software: • JBAIDS Instrument is a real-time polymerase chain reaction (PCR) instrument developed as part of a biothreat detection system for the Department of Defense (DoD). It comes with a ruggedized laptop computer loaded with specific, user-friendly system software. • JBAIDS Influenza Specific Macro is a compact disc (CD) provided by the JBAIDS Training Facility that contains the Influ- enza specific macro with Operating Instructions.
The rRT-PCR Swine Flu Panel on JBAIDS requires the use of the following nucleic acid extraction kit: • Qiagen QIAamp Viral RNA Mini kit and protocol
The above described rRT-PCR Swine Flu Panel on JBAIDS, when labeled consistently with the labeling authorized by FDA, enti- tled CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) on JBAIDS (see http:// www.fda.gov/medicaldevices/Safety/emergencysituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by qualified Department of Defense (DoD) laboratories5 that are equipped with the JBAIDS instruments under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described rRT-PCR Swine Flu Panel on JBAIDS is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting Test Results Obtained with the CDC swH1N1 (swine) Influenza Virus Real- time RT-PCR Detection Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument • Fact Sheet For Patients: Understanding Test Results Obtained with the CDC swH1N1 (swine) Influenza Virus Real-time RT- PCR Detection Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument
As described in section IV below, DoD and JBAIDS are also authorized to make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized rRT-PCR Swine Flu Panel on JBAIDS in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized rRT-PCR Swine Flu Panel on JBAIDS may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized rRT-PCR Swine Flu Panel on JBAIDS, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the rRT-PCR Swine Flu Panel on JBAIDS described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of res- piratory infection.
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This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the rRT-PCR Swine Flu Panel on JBAIDS during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the rRT-PCR Swine Flu Panel on JBAIDS
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
DoD/ Joint Project Management Office (JPMO), Chemical Biological Medical Systems (CBMS)
A. DoD/JPMO,CBMS will distribute the rRT-PCR Swine Flu Panel on JBAIDS with the authorized labeling, as may be revised with written permission of FDA, only to qualified DoD laboratories that are equipped with the JBAIDS instruments.
B. DoD/JPMO,CBMS will provide to the qualified DoD laboratories the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Healthcare Providers, and the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Patients.
C. DoD/JPMO,CBMS will make available on its website the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Healthcare Providers, and the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Patients.
D. DoD/JPMO,CBMS will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.
E. DoD/JPMO,CBMS will ensure that qualified DoD laboratories using the authorized rRT-PCR Swine Flu Panel on BAIDS have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as ap- propriate.
F. DoD/JPMO,CBMS will track adverse events and report to FDA as required under 21 CFT part 803..
G. Through a process of inventory control, DoD/JPMO,CBMS will maintain records of device usage.
H. DoD/JPMO,CBMS will collect information on the performance of the assay, to include the incidence of false positive and nega- tive results.
Qualified DoD Laboratories
I. Qualified DoD laboratories will include with reports of the results of the rRT-PCR Swine Flu Panel on JBAIDS, the authorized Fact Sheets for Healthcare Providers and the authorized Fact Sheet for Patients.
J. Qualified DoD laboratories will perform the assay on a JBAIDS instrument.
K. Qualified DoD laboratories will have a process in place for reporting test results to health care providers and federal, state and/ or local public health authorities, as appropriate.
L. Qualified DoD laboratories will collect information on the performance of the assay, and report to DoD/JPMO,CBMS any sus- pected occurrence of false positive or false negative results of which Qualified DoD laboratories become aware.
DoD/ Joint Project Management Office (JPMO), Chemical Biological Medical Systems (CBMS) and Qualified DoD Labora- tories
M. DoD/JPMO,CBMS is authorized to make available additional information relating to the emergency use of the authorized rRT- PCR Swine Flu Panel on JBAIDS that is consistent with, and does not exceed, the terms of this letter of authorization.
N. Only DoD/JPMO,CBMS may request changes to the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheet for Healthcare Providers or the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
O. DoD/JPMO,CBMS and the qualified DoD laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS as described in this letter of authorization must com- ply with the conditions above and all other terms of this authorization.
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V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 For ease of reference, this letter will use the term the ‘‘rRT-PCR Swine Flu Panel on JBAIDS.’’ 2 The amendments to the August 24, 2009 letter authorize use of additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal as- pirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue. There are also corrections to the waiver section, an ad- ditional condition for DoD Laboratories, and minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices. 3 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 4 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 5 All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to qualified Department of Defense (DoD) laboratories equipped with the JBAIDS instruments. See ‘‘Conditions of Authorization’’ below.
(3) The Authorization for Diatherix October 9, 2009, follows and provides issuance, as required by section H1N1-09 Influenza Test issued on an explanation of the reasons for its 564(h)(1) of the act:
Dennis L. Grimaud Chairman and Chief Executive Officer DIATHERIX Laboratories, Inc. 601 Genome Way, Suite 4208 Huntsville, AL 35806
Dear Mr.Grimaud:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by DIATHERIX Labora- tories, Inc., a CLIA High Complexity Laboratory certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the DIATHERIX H1N1-09 Influenza Test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
1. The recently isolated 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to hu- mans infected by this virus.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the DIATHERIX H1N1-09 Influ- enza Test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential bene- fits of the DIATHERIX H1N1-09 Influenza Test, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection.2
Therefore, I have concluded that the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the above criteria for issuance of an authorization.
II. Scope of Authorization
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I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized DIATHERIX H1N1-09 Influenza Test:
The DIATHERIX H1N1-09 Influenza Test is a multiplexed molecular diagnostic assay that performs target enriched multiplex PCR nucleic acid amplification on the ABI 9700 thermocycler followed by probe hybridization and subsequent detection on the Qiagen Luminex LiquiChip 100 platform for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, and nasopharyngeal aspirates specimens from patients with signs and symptoms of respiratory infection.
The DIATHERIX H1N1-09 Influenza Test includes the following primer and probe sets:
• H1 (H109C): a total of 4 primers designed for nested PCR to detect the presence of the hemagglutinin gene specifically found in the 2009 H1N1 influenza A virus.
• N1 (N109B): a total of 4 primers designed for nested PCR to detect the presence of the neuraminidase gene specifically found in the 2009 H1N1 influenza A virus.
• Probes: each amplicon is hybridized to complementary capture probes (H109C De and N109B De, respectively), which are covalently coupled to color coded beads detectable by the Luminex technology.
The DIATHERIX H1N1-09 Influenza Test also includes the following control materials:
• ABM, extraction positive control: Acinetobacter baumannii, ATCC strain 19606, will be used as a culture stock diluted and subjected to extraction as an additional sample during each batch of patient specimen extractions to demonstrate the effec- tiveness of the extraction method (rule out false negatives due to extraction failure and false positives due to carryover con- tamination).
• PCR Blank, negative control: A water blank will be run as an additional PCR sample during each batch of patient specimen testing to demonstrate that no carryover contamination has occurred during the PCR process (rule out false positives).
• PCR positive control: Nucleic acid from Haemophilus influenzae, ATCC strain 10211, will be run as a separate PCR sample with each batch run of patient specimens. The PCR positive control demonstrates the effectiveness of the PCR reaction to amplify targets in the assay (rule out PCR false negatives).
• PCR positive internal control: DNA from Acinetobacter baumannii ATCC strain 19606 will be added to each PCR to act as an internal amplification control. For each sample, if either the ABM target or any other target is positive, the PCR passes. If both ABM and all other targets fail to produce a positive signal, the PCR has failed and must be repeated.
The DIATHERIX H1N1-09 Influenza Test requires the following hardware with corresponding software:
• Thermo Fisher Kingfisher 96, software version 2.6.2: nucleic acid extraction instrument.
• ABI 9700 Thermocycler, software version 3.09: PCR amplification instrument.
• Qiagen Luminex LiquiChip 100, software version 2.3.182: bead detection instrumentation.
The DIATHERIX H1N1-09 Influenza Test requires the use of the following additional reagent kits:
• Starplex Collection Kit (tube, swab, medium, biohazard bag and shipping box) (Catalog number: SP132-FL75).
• Scigenix MagnetX Extraction Kit (Catalog number: R2-2400-DTX-I0).
• Qiagen OneStep RT-PCR Kit (Catalog number: 210212).
• BioRad Luminex beads (Catalog number: 171506xx).
The above described DIATHERIX H1N1-09 Influenza Test, when labeled consistently with the labeling authorized by FDA, entitled Diatherix Laboratories H1N1-09 Influenza Test Package Insert, as may be revised with written permission of FDA, is authorized to be used by DIATHERIX Laboratories, Inc.,3 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described DIATHERIX H1N1-09 Influenza Test is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to be made available to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Interpretation of the DIATHERIX H1N1-09 Influenza Virus Test Results
• Fact Sheet for Patients: Understanding the DIATHERIX H1N1-09 Influenza Virus Test Results
As described in section IV below, DIATHERIX Laboratories, Inc., is also authorized to make available additional information relat- ing to the emergency use of the authorized DIATHERIX H1N1-09 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.
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I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized DIATHERIX H1N1-09 Influenza Test in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized DIATHERIX H1N1-09 Influenza Test may be effective in the diagnosis of 2009 H1N1 in- fluenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available in- cluding the information supporting the conclusions described in Section I above, and concludes that the authorized DIATHERIX H1N1-09 Influenza Test, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the cri- teria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized DIATHERIX H1N1-09 Influenza Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’ determination under section 564(b)(1)(C) described above and the Secretary of HHS’ corresponding declaration under section 564(b)(1), the DIATHERIX H1N1-09 Influenza Test described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infec- tion.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the DIATHERIX H1N1-09 Influenza Test during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, and storage of the DIATHERIX H1N1-09 Influenza Test.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
DIATHERIX Laboratories, Inc.
A. DIATHERIX Laboratories, Inc., will not sell or distribute the DIATHERIX H1N1-09 Influenza Test to other laboratories.
B. DIATHERIX Laboratories, Inc., will include with reports of the results of the DIATHERIX H1N1-09 Influenza Test the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Healthcare Providers and the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Patients.
C. DIATHERIX Laboratories, Inc., will make available on its Web site the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Healthcare Providers and the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Patients.
D. DIATHERIX Laboratories, Inc., will clearly and conspicuously state on reports of the results of the DIATHERIX H1N1-09 Influ- enza Test that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other pathogen.
E. DIATHERIX Laboratories, Inc., will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
F. All advertising and promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
G. All advertising and promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
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H. No advertising or promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test assay may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
I. DIATHERIX Laboratories, Inc., will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
J. DIATHERIX Laboratories, Inc., will track adverse events and report to FDA as required under 21 CFR part 803.
K. Through a process of inventory control, DIATHERIX Laboratories, Inc., will maintain records of device usage.
L. DIATHERIX Laboratories, Inc., will collect information on the performance of the assay, and report to FDA any suspected oc- currence of false positive or negative results of which DIATHERIX Laboratories, Inc., becomes aware.
M. DIATHERIX Laboratories, Inc., is authorized to make available additional information relating to the emergency use of the au- thorized DIATHERIX H1N1-09 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authoriza- tion.
N. Only DIATHERIX Laboratories, Inc., may request changes to the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheet for Healthcare Providers or the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
O. DIATHERIX Laboratories, Inc., will perform the assay on the Applied Biosystems 9700 Thermocycler, coupled to the Qiagen Luminex LiquiChip 100 detection platform.
P. DIATHERIX Laboratories, Inc., will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized DIATHERIX H1N1-09 Influenza Test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act. Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 3 This EUA does not authorize the DIATHERIX H1N1-09 Influenza Test to be sold or distributed to or used by other laboratories.
(4) The Authorization for the Focus amended and reissued in its entirety on for its issuance, as required by section Diagnostics Simplexa Influenza A H1N1 December 18, 2009, follows and 564(h)(1) of the act: (2009) issued on October 16, 2009, as provides an explanation of the reasons
John G. R. Hurrell, Ph.D. Vice President and General Manager Focus Diagnostics, Inc. 11331 Valley View Street Cypress, CA 90630
Dear Dr. Hurrell:
On October 16, 2009 FDA issued a letter authorizing the emergency use of the Focus Diagnostics SimplexaTM Influenza A H1N1 (2009) (SimplexaTM Inf A H1N1-09) for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Fed- eral Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) by laboratories certified under the Clinical Laboratory Im- provement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests (CLIA High Complexity Laboratories). On No- vember 20, 2009, Focus submitted a request for an amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the Focus Diagnostics SimplexaTM Inf A H1N1-09) is being reissued in its entirety with the amendments incorporated.1
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.2 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the SimplexaTM Inf A H1N1-09 for the diagnosis of 2009 H1N1 influenza virus infec- tion in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
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I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the SimplexaTM Inf A H1N1-09 for the diagnosis of 2009 H1N1 influenza virus infec- tion in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under sec- tion 564(c) of the Act, because I have concluded that:
(1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the SimplexaTM Inf A H1N1-09 may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the SimplexaTM Inf A H1N1-09, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and po- tential risks of such product; and
(3) There is no adequate, approved, and available alternative to the emergency use of the SimplexaTM Inf A H1N1-09 for the diagnosis of 2009 H1N1 influenza virus infection.3
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized SimplexaTM Inf A H1N1-09 for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized SimplexaTM Inf A H1N1-09
The Focus Diagnostics SimplexaTM Inf A H1N1-09 is a real-time RT-PCR assay that utilizes a fluorescent probe-primer for use on the 3M Integrated Cycler for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract speci- mens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/throat swabs (NPS/TS)), and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate (BA); bronchial wash (BW); endotracheal aspirate (EA); endotracheal wash (EW); tracheal aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. The assay is composed of two principal steps: (1) ex- traction of RNA from patient specimens, (2) a bi-functional fluorescent probe-primer is used together with a reverse primer to am- plify a specific target (for each analyte and internal control).
The SimplexaTM Inf A H1N1-09 kit includes the following primer sets: • FLUA detects a well-conserved region of the matrix gene from influenza A viruses in both human influenza A virus and 2009 H1N1 influenza virus. • H1N1 specifically detects the 2009 H1N1 influenza virus strain’s hemagglutinin gene. The FLUA and H1N1 reactions are mul- tiplexed and are performed in the same well.
The SimplexaTM Inf A H1N1-09 kit also includes control materials: • Armored RNA Internal Control (AR IC): An internal positive control is included to confirm the absence of PCR inhibition. • External Positive Control: Inactivated 2009 H1N1 Virus. • External Negative Control: Nuclease free water.
The SimplexaTM Inf A H1N1-09 requires the following hardware with corresponding software:
• Roche MagNA Pure LC: Nucleic acid extraction instrument. • 3M Integrated Cycler: PCR amplification instrument.
The SimplexaTM Inf A H1N1-09 requires the use of the following additional reagent kit:
• MagNA Pure LC Total Nucleic Acid Isolation Kit (Roche Cat. No 3038505001)
The above described SimplexaTM Inf A H1N1-09, when labeled consistently with the labeling authorized by FDA, entitled SimplexaTM Influenza A H1N1 (2009) Package Insert, (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described SimplexaTM Inf A H1N1-09 is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting Focus Diagnostics SimplexaTM Influenza A H1N1 (2009) Test Re- sults • Fact Sheet For Patients: Understanding The Focus Diagnostics SimplexaTM Influenza A H1N1 (2009) Test Results
As described in section IV below, Focus Diagnostics and CLIA High Complexity Laboratories are also authorized to make avail- able additional information relating to the emergency use of the authorized SimplexaTM Inf A H1N1-09 that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized SimplexaTM Inf A H1N1-09 in the specified population, when used for diagnosis of 2009 H1N1 influenza virus in- fection, outweigh the known and potential risks of such a product.
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I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized SimplexaTM Inf A H1N1-09 may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized SimplexaTM Inf A H1N1- 09 when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized SimplexaTM Inf A H1N1-09 under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the SimplexaTM Inf A H1N1-09 described above is au- thorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the SimplexaTM Inf A H1N1-09 during the duration of this emergency use authoriza- tion:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the SimplexaTM Inf A H1N1-09.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Focus Diagnostics
A. Focus Diagnostics will distribute the SimplexaTM Inf A H1N1-09 with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. Focus Diagnostics will provide to the CLIA High Complexity Laboratories the authorized SimplexaTM Inf A H1N1-09 Fact Sheet for Healthcare Providers and the authorized SimplexaTM Inf A H1N1-09 Fact Sheet for Patients.
C. Focus Diagnostics will make available on its website the authorized SimplexaTM Inf A H1N1-09 Fact Sheet for Healthcare Pro- viders and the authorized SimplexaTM Inf A H1N1-09 Fact Sheet for Patients.
D. Focus Diagnostics will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized Focus Diagnostics SimplexaTM Inf A H1N1-09 shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the Focus Diagnostics SimplexaTM Inf A H1N1- 09 shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized SimplexaTM Inf A H1N1-09 may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
H. Focus Diagnostics will ensure CLIA High Complexity Laboratories using the authorized SimplexaTM Inf A H1N1-09 have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as ap- propriate.
I. Focus Diagnostics will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, Focus Diagnostics will maintain records of device usage.
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K. Focus Diagnostics will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Focus Diagnostics becomes aware.
CLIA High Complexity Laboratories
L. CLIA High Complexity Laboratories will include with reports of the results of the SimplexaTM Inf A H1N1-09 the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
M. CLIA High Complexity Laboratories will perform the assay on a 3M Integrated Cycler as part of the Microfluidic Molecular Sys- tem.
N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Focus Diagnostics any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
Focus Diagnostics and CLIA High Complexity Laboratories
P. Focus Diagnostics is authorized to make available additional information relating to the emergency use of the authorized SimplexaTM Inf A H1N1-09 that is consistent with, and does not exceed, the terms of this letter of authorization.
Q. Only Focus Diagnostics may request changes to the authorized Fact Sheet for Healthcare Providers or the authorized SimplexaTM Inf A H1N1-09 Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
R. Focus Diagnostics will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized SimplexaTM Inf A H1N1-09 as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 The amendments to the October 16, 2009 letter authorize use of additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal as- pirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue. There are also minor wording changes made to be con- sistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices. 2 Memorandum, Determination Pursuant to §564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
(5) The Authorization for Prodesse issued on October 27, 2009, follows and for its issuance, as required by section ProFlu-ST Influenza A Subtyping Assay provides an explanation of the reasons 564(h)(1) of the act:
Thomas M. Shannon President and Chief Executive Officer Prodesse, Inc. W229 N1870 Westwood Drive Waukesha, WI 53186
Dear Mr. Shannon:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Prodesse ProFlu-ST Influenza A Subtyping Assay for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in individ- uals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3) by CLIA High Complexity Laboratories, which are labora- tories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests.
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On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. § 247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the basis of such determination, the Secretary of the Department of Health and Human Services then declared an emergency justifying the authorization of the emer- gency use of certain in vitro diagnostics for the detection of Swine Influenza A (2009 H1N1 influenza virus), subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of the Prodesse ProFlu-ST Influenza A Subtyping Assay (Prodesse ProFlu-ST Assay)2 for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in individuals who are diagnosed with influenza A by currently available FDA-cleared or au- thorized devices, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the Prodesse ProFlu-ST Assay for the diagnosis of 2009 H1N1 influenza virus infec- tion aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices, meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
(2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Prodesse ProFlu-ST Assay may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Prodesse ProFlu-ST Assay, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and po- tential risks of such product; and
(3) There is no adequate, approved, and available alternative to the emergency use of the Prodesse ProFlu-ST Assay for the diagnosis of 2009 H1N1 influenza virus infection.3.4
Therefore, I have concluded that the emergency use of the Prodesse ProFlu-ST Assay for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in indi- viduals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices meets the above criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the Prodesse ProFlu-ST Assay for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices
The Authorized Prodesse ProFlu-ST Assay:
The Prodesse ProFlu-ST Assay is a multiplex real-time RT-PCR assay that utilizes fluorogenic hydrolysis (Taqman) probes for use on the Cepheid SmartCycler II instrument for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in nasopharyngeal swabs (NPS) from patients who are diagnosed with influenza A by currently available FDA-cleared or authorized devices. The assay is com- posed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step multiplex reverse transcription and PCR amplification with human seasonal influenza A virus subtypes and the 2009 H1N1 influenza virus specific primers, and real-time detection with seasonal influenza A virus subtypes and the 2009 H1N1 influenza virus specific probes.
The Prodesse ProFlu-ST Assay kit includes: • ProFlu-ST Supermix that contains buffer, MgCl2, nucleotides (dNTPs), Fast Start Taq polymerase, 4 pairs of oligonucleotide primers and 4 probes (4 sets) • M-MLV Reverse Transcriptase • RNase Inhibitor • Influenza A subtyping RNA Control (pooled RNA control for all three detections) • Internal Control
The Prodesse ProFlu-ST Assay includes the following primer and probe sets: • Seasonal H1 detects a conserved area of the seasonal influenza A/H1 Hemagglutinin (HA) gene. • Seasonal H3 detects a conserved area of the seasonal influenza A/H3 Hemagglutinin (HA) gene. • 2009 H1N1 Influenza (S-OIV) detects a conserved area of the 2009 H1N1 Influenza Nucleoprotein (NP) gene. • Internal RNA Control III detects an 1158 base-long RNA transcript (MS2 Bacteriophage sequence) that is noncompetitive with the other targets of the ProFlu-ST Assay.
Control materials to be used with the Prodesse ProFlu-ST Assay include: • Internal RNA Control III (IC) is a non-infectious in vitro transcribed 1158 base-long RNA (MS2 Bacteriophage sequence). The IC is incorporated into every sample and is carried through all steps of the procedure from nucleic acid isolation and pu- rification through amplification to monitor for inhibitors present in the specimen or reaction tube. The IC also serves as a gen- eral process control ensuring that each step of the procedure is performed correctly, assay and instrument parameters are set correctly, and that general reagents are working.
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• Influenza A Subtyping RNA Control (PC) is a pooled control containing three RNA transcripts, one each for the A/H1, A/ H3, and A/2009 H1N1 detections targeted by the ProFlu-ST Assay. The PC does not go through nucleic acid isolation and purification, but is included during set-up of the RT-PCR reaction. The PC is required for each ProFlu-ST assay run. The PC in conjunction with the IC is used to verify reagent and system performance. • Negative Control (NC) is blank viral transport medium used to monitor reagent and/or environmental contamination. • Extraction Control (EC) is a previously characterized positive seasonal influenza A (H1 or H3) sample, positive 2009 H1N1 influenza sample, or a negative sample spiked with a well characterized seasonal influenza (H1 or H3) strain or 2009 H1N1 influenza strain. Good laboratory practice recommends including a positive extraction control in each nucleic acid isolation run. The extraction control should be treated like a sample during assay performance and analysis.
The Prodesse ProFlu-ST Assay requires the following instruments with corresponding software: • The ProFlu-ST Assay utilizes the Roche MagNA Pure LC System with software version 3.0.11 or the bioMe´rieux NucliSENS easyMAG System with software version 1.0.1 or 2.0 for nucleic acid extraction. • The ProFlu-ST Assay utilizes the Cepheid SmartCycler II system with Dx software versions 1.7b, 3.0a, or 3.0b for ampli- fication and detection.
The above Prodesse ProFlu-ST Assay, when labeled consistently with the labeling agreed to by FDA and titled Prodesse ProFlu- ST Assay Instructions for Use, as may be revised with written permission of FDA, is authorized to be distributed to CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described Prodesse ProFlu-ST Assay is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting the Prodesse ProFlu-ST Assay Results • Fact Sheet For Patients: Understanding the Prodesse ProFlu-ST Assay Results
As described in section IV below, Prodesse Inc. CLIA High Complexity Laboratories are also authorized to make available addi- tional information relating to the emergency use of the authorized Prodesse ProFlu-ST Assay that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Prodesse ProFlu-ST Assay in the specified population, when used for diagnosis of 2009 H1N1 influenza virus in- fection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, outweigh the known and potential risks of such product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Prodesse ProFlu-ST Assay may be effective in the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results pursu- ant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized Prodesse ProFlu-ST Assay, when used to diag- nose 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influ- enza A/H3 virus results in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized Prodesse ProFlu-ST Assay under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the Prodesse ProFlu-ST Assay described above is au- thorized to diagnose 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in individuals who are diagnosed with influenza A by currently available FDA-cleared or au- thorized devices.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the Prodesse ProFlu-ST Assay during the duration of this emergency use authoriza- tion:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the Prodesse ProFlu-ST Assay. • Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Prodesse Inc.
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A. Prodesse, Inc. will distribute the Prodesse ProFlu-ST Assay with the labeling agreed to by FDA and titled Prodesse ProFlu-ST Assay Instructions for Use, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. Prodesse, Inc. will provide to the CLIA High Complexity Laboratories the authorized Prodesse ProFlu-ST Assay Fact Sheet for Healthcare Providers and the authorized Prodesse ProFlu-ST Assay Fact Sheet for Patients.
C. Prodesse, Inc. will make available on its website the authorized Prodesse ProFlu-ST Assay Fact Sheet for Healthcare Pro- viders and the authorized Prodesse ProFlu-ST Assay Fact Sheet for Patients.
D. Prodesse, Inc. will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.
E. As a condition of this EUA, all advertising and promotional descriptive printed matter relating to the use of the Prodesse ProFlu-ST Assay shall be consistent with the Fact Sheets and labeling agreed to by FDA and titled Prodesse ProFlu-ST Assay Instructions for Use, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. As a condition of this EUA, all advertising and promotional descriptive printed matter relating to the use of the Prodesse ProFlu-ST Assay shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved; • This test has been authorized by FDA under an Emergency Use Authorization; • This test has been authorized only for the diagnosis of 2009 H1N1 influenza virus infection in patients who have already been diagnosed with influenza A by currently available FDA-cleared or authorized devices; • This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and • The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the Prodesse ProFlu-ST Assay may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus, seasonal influenza A/H1 virus, or sea- sonal influenza A/H3 virus.
H. Prodesse, Inc. will ensure CLIA High Complexity Laboratories have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
I. Prodesse, Inc. will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, Prodesse, Inc. will maintain records of device usage.
K. Prodesse, Inc. will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Prodesse, Inc becomes aware.
CLIA High Complexity Laboratories
L. CLIA High Complexity Laboratories will test a patient sample using the Prodesse ProFlu - ST Assay only when the patient sample has already been tested positive for Influenza A by a currently available FDA-cleared nucleic acid amplification tech- nologies (NAAT)-based Influenza A device with high performance5.
M. CLIA High Complexity Laboratories will include with reports of the results of the Prodesse ProFlu-ST Assay the authorized fact sheets for health care providers and the authorized fact sheets for patients.
N. CLIA High Complexity Laboratories will use the Roche MagNA Pure LC System or the bioMe´rieux NucliSENS easyMAG Sys- tem for nucleic acid extraction, and perform the assay on the Cepheid SmartCycler II Real-time PCR instrument.
O. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
P. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Prodesse, Inc. any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
Prodesse, Inc. and CLIA High Complexity Laboratories
Q. Prodesse, Inc. is authorized to make available additional information relating to the emergency use of the authorized Prodesse ProFlu-ST Assay that is consistent with, and does not exceed, the terms of this letter of authorization.
R. Only Prodesse, Inc. may request changes to the authorized Prodesse ProFlu-AT Assay Fact Sheet for Healthcare Providers or the authorized Prodesse ProFlu-AT Assay Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
S. Prodesse, Inc. and CLIA High Complexity Laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized Prodesse ProFlu-ST Assay as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
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This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 FDA is authorizing the emergency use of the Prodesse ProFlu-ST Assay as described in the scope section of this letter (Section II). 3 Although there are no approved or cleared tests for the diagnosis of 2009 H1N1 influenza virus, to date, several devices have been FDA authorized under EUA to help address diagnostic needs. The information on the authorized devices is available at http:// www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm. 4 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 5 An FDA-cleared NAAT-based Influenza A device with high performance is an FDA cleared NAAT-based IVD device detecting In- fluenza A that demonstrates sensitivity (compared to viral culture) of at least 95% and specificity of at least 92% with a lower bound of 95% (two-sided) confidence interval exceeding 90% and that does not require culture confirmation for negative results.
(6) The Authorization for the ELITech test issued on November 13, 2009, the reasons for its issuance, as required Molecular Diagnostics 2009-H1N1 follows and provides an explanation of by section 564(h)(1) of the act: Influenza A Virus Real Time RT-PCR
Dr. Walt Mahoney VP R&D and Operations Managing Director Epoch BioSciences 21720 23rd Drive S.E. Suite 150 Bothell, WA 98021
Dear Dr. Mahoney:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test by Associ- ated Regional and University Pathologists (ARUP) Laboratories for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). ARUP Laboratories is a CLIA High Complexity Laboratory, certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individ- uals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and poten- tial risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection.2
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influ- enza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test:
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The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is a real-time reverse-transcription PCR for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs, nasal swabs, throat swabs, and nasal aspirates from patients with signs and symptoms of respiratory infection. Amplification and detection are accomplished using PCR primers and Pleiades hybridization probes manufactured by Epoch BioSciences, a Division of Wescor, Inc. The testing procedure consists of nucleic acid extraction on the Qiagen BioRobot 9604 instrument followed by real-time reverse-transcription PCR on the Applied Biosystems 7900HT Real-Time PCR System.
The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test includes the following primer and probe sets:
• 2009H1: detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 influenza A virus.
• M1: detects a conserved region of the Matrix Protein 1 (M1) gene that is present in seasonal and 2009-H1N1 influenza A vi- ruses.
• Bacteriophage MS2 Internal Control: detects RNA sequence in whole bacteriophage MS2 that is noncompetitive with the 2009-H1N1 and M1 targets.
The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test also includes the following control ma- terials:
• Bacteriophage MS2 Internal Control (IC) is added to every patient sample and is carried through all steps of the procedure from nucleic acid isolation and purification through amplification to monitor for inhibitors present in the specimen or reaction tube. The IC also serves as a general process control ensuring that each step of the procedure was performed correctly, assay and instrument parameters were set correctly, and that general reagents were working.
• Negative Control consists of IC diluted with water and is taken through both nucleic acid extraction and PCR processes to demonstrate that no carryover contamination has occurred during the test process (rule out false positives caused by con- tamination). The Negative Control is incorporated into each batch of patient specimen processing.
• Positive Controls consists of separate RNA templates containing targets recognized by the 2009H1 and M1 detection sys- tems. Each Positive Control is taken through both nucleic acid extraction and PCR processes to demonstrate that nucleic acid extraction and PCR are effective (rule out false negatives caused by test failure). The Positive Controls are incorporated into each batch of patient specimen processing.
The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the following hardware with corresponding software:
• Applied Biosystems 7900HT Real-Time PCR System with ABI Software: SDS 7900HT, v2.2.2.
• Qiagen BioRobot 9604 with QIAsoft 3.0 PLUS software.
The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the use of the following addi- tional reagents/materials:
• Qiagen QuantiTect Probe RT-PCR Master mix (Qiagen Cat. No 204443)
• Consumables for Qiagen BioRobot 9604
• QIAamp Virus Biorobot 9604 Kit (Qiagen Cat. No 965662)
• RNase Inhibitor (Applied Biosystems Cat. No N8080119)
• Heat-labile Uracil N-Glycosylase (Roche Cat No 11775367001)
• MasterAmp 10X PCR Enhancer (Epicentre Cat No ME81210)
The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when labeled consist- ently with the labeling authorized by FDA, entitled ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT- PCR test Package Insert (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be re- vised with written permission of FDA, is authorized to be distributed to and used by ARUP Laboratories,3 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to be made avail- able to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Interpretation of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real- Time RT-PCR Test Results
• Fact Sheet for Patients: Understanding the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test Results
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As described in section IV below, Epoch Biosciences, is also authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of author- ization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’ deter- mination under section 564(b)(1)(C) described above and the Secretary of HHS’ corresponding declaration under section 564(b)(1), the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Epoch Biosciences
A. Epoch Biosciences will distribute the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test with the authorized labeling, as may be revised with written permission of FDA, only to ARUP Laboratories.
B. Epoch Biosciences will provide to ARUP Laboratories the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
C. Epoch Biosciences will make available on its website the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
D. Epoch Biosciences will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. Epoch Biosciences will ensure ARUP Laboratories has a process in place for reporting test results to health care providers and federal, state, and/or local public health authorities, as appropriate.
F. Epoch Biosciences will track adverse events and report to FDA as required under 21 CFR part 803.
G. Through a process of inventory control, Epoch Biosciences will maintain records of device usage.
H. Epoch Biosciences will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Epoch Biosciences becomes aware.
I. Epoch Biosciences is authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test that is consistent with, and does not ex- ceed, the terms of this letter of authorization.
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J. Only Epoch Biosciences may request changes to the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers or the authorized ELITech Molecular Diagnostics 2009-H1N1 In- fluenza A virus Real-Time RT-PCR test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
ARUP Laboratories
K. ARUP Laboratories will include with reports of the results of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real- Time RT-PCR test Fact Sheets for Patients.
L. ARUP Laboratories will clearly and conspicuously state on reports of the results of the ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, respiratory syncytial virus (RSV) or any other pathogen.
M. ARUP Laboratories will use the Qiagen BioRobot 9604 for nucleic acid extraction and perform the assay on the Applied Bio- systems 7900HT Real-time PCR instrument.
N. ARUP Laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
O. ARUP Laboratories will collect information on the performance of the assay, and report to Epoch Biosciences any suspected occurrence of false positive or false negative results of which ARUP Laboratories becomes aware.
Epoch Biosciences and ARUP Laboratories
P. Epoch Biosciences and ARUP Laboratories will make available on their Web sites the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
Q. Epoch Biosciences and ARUP Laboratories will ensure that any records associated with this EUA are maintained until noti- fied by FDA. Such records will be made available to FDA for inspection upon request.
R. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
S. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009- H1N1 Influenza A virus Real-Time RT-PCR test shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or patho- gens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
T. No advertising or promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
The emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 3 This EUA does not authorize the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test to be sold or distributed to or used by other laboratories.
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(7) The Authorization for the Roche 2009, follows and provides an issuance, as required by section RealTime ready Influenza A/H1N1 explanation of the reasons for its 564(h)(1) of the act: Detection Set issued on November 13,
Dr. Bernd Schmidt Head of RAS Global Quality Management & Regulatory Affairs Roche Diagnostics GmbH Roche Applied Science Nonnenwald 2 82377 Penzberg / Germany
Dear Dr. Schmidt:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Roche RealTime ready Influenza A/H1N1 Detection Set for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the Roche RealTime ready Influenza A/H1N1 Detection Set (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the Roche RealTime ready Influenza A/H1N1 Detection Set for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Roche RealTime ready Influ- enza A/H1N1 Detection Set may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Roche RealTime ready Influenza A/H1N1 Detection Set, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the Roche RealTime ready Influenza A/ H1N1 Detection Set for the diagnosis of 2009 H1N1 influenza virus infection.2
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized Roche RealTime ready Influenza A/H1N1 Detection Set for the diagnosis of 2009 H1N1 influenza virus infection in individ- uals with signs and symptoms of respiratory infection.
The Authorized Roche RealTime ready Influenza A/H1N1 Detection Set:
The Roche RealTime ready Influenza A/H1N1 Detection Set is a real-time reverse-transcription PCR for the in vitro qualitative de- tection of 2009 H1N1 influenza viral RNA in nasal swabs, nasopharyngeal swabs, nasal washes, or nasal aspirates from patients with signs and symptoms of respiratory infection. The Roche RealTime ready Influenza A/H1N1 Detection Set is to be used in combination with the Roche RealTime ready RNA Virus Master kit which is a reaction mix for one-step RT-PCR using the LightCycler® system. The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step reverse transcription and PCR amplification using fluorogenic hydrolysis (Taqman) probes for detection.
The Roche RealTime ready Influenza A/H1N1 Detection Set includes the following primer and probe sets:
• Inf A/M2: detects a well-conserved region of the Matrix Protein 2 (M2) gene from influenza A viruses in both seasonal human influenza A virus and 2009 H1N1 virus.
• Inf A/H1: detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 virus. Detection with Inf A/M2 and Inf A/H1 systems are carried out in separate reactions.
• Internal Control: detects the human Myostatin gene as a common nucleic acid in patient samples and verifies adequacy of sample and reaction. The primers and probes for Inf A/M2 and Internal Control are combined by the user and the reactions are performed in the same capillary.
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The Roche RealTime ready Influenza A/H1N1 Detection Set also includes the following control materials:
• External Positive Control for Inf A/M2 consists of lyophilized plasmid DNA containing the cloned target sequence of the M2 gene. The Inf A/M2 Positive Control is incorporated into each batch of patient specimen testing for the Inf A/M2 target.
• External Positive Control for Inf A/H1 consists of lyophilized plasmid DNA containing the cloned target sequence of the he- magglutinin gene of the 2009 H1N1 virus. The Inf A/H1 Positive Control is incorporated into each batch of patient specimen testing for the Inf A/H1 target.
• Negative Control consists of nuclease free water and is taken through both nucleic acid extraction and PCR processes to demonstrate that no carryover contamination has occurred during the test process. The Negative Control is incorporated into each batch of patient specimen processing.
The Roche RealTime ready Influenza A/H1N1 Detection Set requires the following hardware with corresponding software:
• MagNA Pure LC 1.0 Instrument or • MagNA Pure LC 2.0 Instrument • LightCycler® 2.0 Instrument • LightCycler® Software Version 4 • LightCycler® Capillaries (20 ml) • LightCycler® Centrifuge Adapters • LightCycler® Capping Tool
Optional hardware:
• LC Carousel Centrifuge 2.0 including rotor buckets or • LC Carousel Centrifuge and LC Carousel Centrifuge 2.0 Rotor Set
The Roche RealTime ready Influenza A/H1N1 Detection Set requires the use of the following additional reagents/materials:
• MagNA Pure LC Total Nucleic Acid Isolation Kit - High Performance • RealTime ready RNA Virus Master
The above described Roche RealTime ready Influenza A/H1N1 Detection Set, when labeled consistently with the labeling author- ized by FDA, entitled RealTime ready Influenza A/H1N1 Detection Set Package Insert, (see http://www.fda.gov/MedicalDevices/ Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described Roche RealTime ready Influenza A/H1N1 Detection Set is authorized to be accompanied by the fol- lowing information pertaining to the emergency use, which are authorized to be made available to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Interpreting the Roche RealTime ready Influenza A/H1N1 Detection Set Test Results
• Fact Sheet for Patients: Understanding the Roche RealTime ready Influenza A/H1N1 Detection Set Test Results
As described in section IV below, Roche Diagnostics GmbH, is also authorized to make available additional information relating to the emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Roche RealTime ready Influenza A/H1N1 Detection Set may be effective in the diag- nosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific in- formation available including the information supporting the conclusions described in Section I above, and concludes that the au- thorized Roche RealTime ready Influenza A/H1N1 Detection Set, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’ determination under section 564(b)(1)(C) described above and the Secretary of HHS’ corresponding declaration under section 564(b)(1), the Roche RealTime ready Influ- enza A/H1N1 Detection Set described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the Roche RealTime ready Influenza A/H1N1 Detection Set during the duration of this emergency use authorization:
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• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the Roche RealTime ready Influenza A/ H1N1 Detection Set.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Roche Diagnostics GmbH
A. Roche Diagnostics GmbH will distribute the authorized Roche RealTime ready Influenza A/H1N1 Detection Set with the au- thorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. Roche Diagnostics GmbH will provide to the CLIA High Complexity Laboratories the authorized Roche RealTime ready Influ- enza A/H1N1 Detection Set Fact Sheets for Healthcare Providers and the authorized Roche RealTime ready Influenza A/ H1N1 Detection Set Fact Sheets for Patients.
C. Roche Diagnostics GmbH will make available on its website the authorized Roche RealTime ready Influenza A/H1N1 Detec- tion Set Fact Sheets for Healthcare Providers and the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheets for Patients.
D. Roche Diagnostics GmbH will inform state and/or local public health authority(ies) of this EUA, including the terms and con- ditions herein.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influ- enza A/H1N1 Detection Set shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influ- enza A/H1N1 Detection Set shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or patho- gens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influ- enza A/H1N1 Detection Set may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influ- enza virus.
H. Roche Diagnostics GmbH will ensure that CLIA High Complexity Laboratories using the authorized Roche RealTime ready Influenza A/H1N1 Detection Set have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
I. Roche Diagnostics GmbH will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, Roche Diagnostics GmbH will maintain records of device usage.
K. Roche Diagnostics GmbH will collect information on the performance of the assay and report to FDA any suspected occur- rence of false positive or negative results of which Roche Diagnostics GmbH becomes aware.
CLIA High Complexity Laboratories
L. CLIA High Complexity Laboratories will include with reports of the results of the Roche RealTime ready Influenza A/H1N1 Detection Set the authorized Fact Sheets for Healthcare Providers and the authorized Fact Sheets for Patients.
M. CLIA High Complexity Laboratories will use the MagNA Pure LC Instrument and the MagNA Pure LC Total Nucleic Acid Iso- lation Kit - High Performance for nucleic acid extraction and perform the assay on the LightCycler® V2.0 instrument.
N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate
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O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Roche Diagnostics GmbH any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories be- come aware.
Roche Diagnostics GmbH and CLIA High Complexity Laboratories
P. Roche Diagnostics GmbH is authorized to make available additional information relating to the emergency use of the author- ized Roche RealTime ready Influenza A/H1N1 Detection Set that is consistent with, and does not exceed, the terms of this letter of authorization.
Q. Only Roche Diagnostics GmbH may request changes to the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheet for Healthcare Providers or the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
R. Roche Diagnostics GmbH will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set as described in this letter of author- ization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
(8) The Authorization for the issued on December 9, 2009, follows reasons for its issuance, as required by GeneSTAT 2009 A/H1N1 Influenza Test and provides an explanation of the section 564(h)(1) of the act:
Mark J. Rosenfeld, M.S., Ph.D. Chief Science Advisor, DxNA, LLC 3879 S. River Road, Bldg. A St. George, UT 84790
Dear Dr. Rosenfeld:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Labora- tory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of res- piratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influ- enza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authoriza- tion under section 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the GeneSTAT 2009 A/H1N1 In- fluenza Test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential ben- efits of the GeneSTAT 2009 A/H1N1 Influenza Test, when used in the diagnosis of 2009 H1N1 influenza virus infection, out- weigh the known and potential risks of such product; and
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3. There is no adequate, approved, and available alternative to the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection.2
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized GeneSTAT 2009 A/H1N1 Influenza Test:
The GeneSTAT 2009 A/H1N1 Influenza Test is a reverse-transcription polymerase chain reaction assay for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs or nasal swabs from patients with signs and symptoms of respiratory infection. The GeneSTAT 2009 A/H1N1 Influenza Test is to be used in combination with the Roche High Pure RNA Isolation Kit and the GeneSTAT Analytical Platform. The assay is composed of two principal steps: (1) extraction of RNA from pa- tient specimens, (2) one-step reverse transcription and PCR amplification using fluorogenic probes for detection.
The GeneSTAT 2009 A/H1N1 Influenza Test includes the following primer and probe sets:
• H1: a primer-probe set designed to detect the presence of the hemagglutinin gene specifically found in the 2009 H1N1 influ- enza A virus. • N1: a primer-probe set designed to detect the presence of the neuraminidase gene specifically found in the 2009 H1N1 influ- enza A virus. • MA: a primer-probe set designed to detect the presence of a well conserved region of the matrix gene found in both, sea- sonal human influenza A virus and 2009 H1N1 influenza A virus. • P28: a primer-probe set designed to detect the presence of the Caprine Arthritis-Encephalitis Virus core polypeptide p28 gene (Exogenous Reaction Control).
The GeneSTAT 2009 A/H1N1 Influenza Test also includes the following control materials:
• Influenza A Matrix-Positive Control Swab. • H1-Positive Control Swab (2009 H1N1 specific).
The GeneSTAT 2009 A/H1N1 Influenza Test requires the following hardware with corresponding software:
• GeneSTAT Analytical Platform.
The GeneSTAT 2009 A/H1N1 Influenza Test requires the use of the following additional reagents/materials:
• GeneSTAT H1N1 Test Module. • GeneSTAT Sample Prep Vial. • Roche High Pure RNA Isolation Kit.
The above described GeneSTAT 2009 A/H1N1 Influenza Test, when labeled consistently with the labeling authorized by FDA, en- titled GeneSTATTM 2009 A/H1N1 Influenza Test Package Insert, (see http://www.fda.gov/MedicalDevices/Safety/ EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described GeneSTAT 2009 A/H1N1 Influenza Test is authorized to be accompanied by the following informa- tion pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Interpreting GeneSTAT 2009 A/H1N1 Influenza Test Results
• Fact Sheet for Patients: Understanding the GeneSTAT 2009 A/H1N1 Influenza Test Results
As described in section IV below, DxNA, LLC, is also authorized to make available additional information relating to the emer- gency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized GeneSTAT 2009 A/H1N1 Influenza Test in the specified population, when used for diagnosis of 2009 H1N1 influ- enza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized GeneSTAT 2009 A/H1N1 Influenza Test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information avail- able including the information supporting the conclusions described in Section I above, and concludes that the authorized GeneSTAT 2009 A/H1N1 Influenza Test, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
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The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’ determination under section 564(b)(1)(C) described above and the Secretary of HHS’ corresponding declaration under section 564(b)(1), the GeneSTAT 2009 A/H1N1 Influenza Test described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of res- piratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the GeneSTAT 2009 A/H1N1 Influenza Test during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the GeneSTAT 2009 A/H1N1 Influenza Test.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
DxNA, LLC
A. DxNA, LLC will distribute the authorized GeneSTAT 2009 A/H1N1 Influenza Test with the authorized labeling, as may be re- vised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. DxNA, LLC will provide to the CLIA High Complexity Laboratories the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Healthcare Providers and the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Patients.
C. DxNA, LLC will make available on its website the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Healthcare Providers and the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Patients.
D. DxNA, LLC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influ- enza Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influ- enza Test shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or patho- gens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influ- enza Test may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
H. DxNA, LLC will ensure that CLIA High Complexity Laboratories using the authorized GeneSTAT 2009 A/H1N1 Influenza Test have a process in place for reporting test results to healthcare providers and federal, state and/or local public health au- thorities, as appropriate.
I. DxNA, LLC will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, DxNA, LLC will maintain records of device usage.
K. DxNA, LLC will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or negative results of which DxNA, LLC becomes aware.
CLIA High Complexity Laboratories
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L. CLIA High Complexity Laboratories will include with reports of the results of the GeneSTAT 2009 A/H1N1 Influenza Test the authorized Fact Sheets for Healthcare Providers and the authorized Fact Sheets for Patients.
M. CLIA High Complexity Laboratories will use the Roche High Pure RNA Isolation Kit for nucleic acid extraction and perform the assay on the GeneSTAT Analytical Platform, ensuring that at least once per day that specimens are to be tested, a known sample (2009 H1N1 positive or influenza A positive specimen) is tested as a positive control for RNA extraction and subsequent protocol steps.
N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to DxNA, LLC any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
DxNA, LLC and CLIA High Complexity Laboratories
P. DxNA, LLC is authorized to make available additional information relating to the emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.
Q. Only DxNA, LLC may request changes to the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheet for Healthcare Providers or the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
R. DxNA, LLC will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
(9) The Authorization for the December 16, 2009, follows and for its issuance, as required by section TessArray Resequencing Influenza A provides an explanation of the reasons 564(h)(1) of the act: Microarray Detection Panel issued on
Clark Tibbetts, PhD Executive Vice President TessArae, LLC 46090 Lake Center Plaza Suite 304 Sterling, VA 20165
Dear Dr. Tibbetts:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) for emergency use of the TessArray® Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) for the diagnosis of 2009 H1N1 in- fluenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus re- sults, in patients with signs and symptoms of respiratory infection, by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.1 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
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Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the TessArray RM-Flu (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and sea- sonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection, subject to the terms of this au- thorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the TessArray RM-Flu for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the TessArray RM-Flu may be ef- fective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the TessArray RM-Flu, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the TessArray RM-Flu for the diagnosis of 2009 H1N1 influenza virus infection.2
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized TessArray RM-Flu for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal in- fluenza A/H1 virus and seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection.
The Authorized TessArray RM-Flu:
The TessArray RM-Flu is a resequencing microarray assay for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in throat swabs from patients with signs and symptoms of respiratory infection. The TessArray RM-Flu is to be used in combina- tion with the EPICENTRE MasterpureTM Complete DNA and RNA Purification Kit and the Affymetrix® GeneChip® Microarray In- strumentation System. The assay protocol follows a number of steps, starting from RNA extraction from patient specimens, through reverse transcription and amplification by multiplex PCR, followed by labeling of fragmented DNA and hybridization to a microarray. After washing, the array is stained with fluorescent dye and subsequently scanned. The image analysis readout se- quence from the detector tiles in the array is scored and also submitted for BLAST homology determination, to define the most similar homology with any known flu virus sequence.
The gene resequencing detector tiles of the TessArray RM-Flu assay represent:
• 2009 H1N1 influenza virus • NA1av an avian type A influenza virus neuraminidase gene sequence • NSav an avian type A influenza virus non-structural gene sequence • M1hu a representative matrix gene sequence from seasonal A/H1N1 • M3hu a representative matrix gene sequence from seasonal A/H3N2 • M5Av an avian type A influenza virus matrix gene sequence • Seasonal A/H1N1 • HA1hu a representative hemagglutinin gene sequence from A/H1N • NA1hu a representative neuraminidase gene sequence from A/H1N1 • M1hu a representative matrix gene sequence from seasonal A/H1N1 • M3hu a representative matrix gene sequence from seasonal A/H3N2 • M5Av an avian type A influenza virus matrix gene sequence • Seasonal A/H3N2 • HA3hu a representative hemagglutinin gene sequence from A/H1N1 • NA2hu a representative neuraminidase gene sequence from A/H1N1 • M1hu a representative matrix gene sequence from seasonal A/H1N1 • M3hu a representative matrix gene sequence from seasonal A/H3N2 • M5Av an avian type A influenza virus matrix gene sequence
The TessArray RM-Flu assay also includes the following control detector tiles:
Negative/Background Controls: 25 non-analyte resequencing detector tiles as background control detector tiles representing a variety of different type A influenza virus HA and NA genes, from subtypes that rarely infect humans. They are used to set a threshold for detection of the assay’s targeted influenza viruses and to monitor resequencing data quality of the assay.
Positive/Protocol Controls: Each batch of specimens to be tested should include a known sample, such as that of a seasonal influenza virus vaccine, as a positive control for RNA extraction and subsequent protocol steps. Two additional resequencing de- tector tiles represent over 1,000 nucleotides of sequences of the TIM and NAC1 genes from Arabidopsis thaliana (wild mustard weed). Template controls are included in each specimen. Positive scoring of these controls provides assurance of successful exe- cution of the different steps in the sample processing.
The TessArray RM-Flu assay requires the following hardware with corresponding software:
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• Thermal Cyclers that were tested with the RM-Flu Multiplex PCR: • Bio-Rad MJ Mini • Bio-Rad MyCycler • Bio-Rad Peltier DNA Engine Tetrad • Affymetrix® GeneChip® Microarray Instrumentation Systems tested: • GCS 3000 7G (RUO) • GCS 3000Dx (IVD) • GCS 3000Dx2 (IVD) • Workstation and Software: • GCOS/GSEQ • AGCC/GSEQ • AGCC-Dx or AGCC-Dx2
The TessArray RM-Flu assay requires the use of the following additional reagents/materials:
• EPICENTRE® Biotechnologies MasterpureTM Complete DNA and RNA Purification Kit • Life TechnologiesTM SuperscriptTM III Reverse Transcriptase • Life TechnologiesTM RNaseOUTTM Recombinant Ribonuclease Inhibitor • Promega®, GoTaq® Flexi DNA Polymerase • USB (Affymetrix®) Uracil-DNA Glycosylase (UDG), Heat-Labile • Qiagen® QIAquick® PCR Purification Kit • Affymetrix® GeneChip® Resequencing Assay Kit
The above described TessArray RM-Flu test, when labeled consistently with the labeling authorized by FDA, entitled TessArray RM-Flu Package Insert, (available at http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described TessArray RM-Flu is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Interpreting TessArray® Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) Test Results
• Fact Sheet for Patients: Understanding the TessArray® Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) Test Results
As described in section IV below, TessArae, LLC, is also authorized to make available additional information relating to the emer- gency use of the authorized TessArray RM-Flu that is consistent with, and does not exceed, the terms of this letter of authoriza- tion.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized TessArray RM-Flu in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized TessArray RM-Flu may be effective in the diagnosis of 2009 H1N1 influenza virus infec- tion aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, pursuant to sec- tion 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized TessArray RM-Flu, when used to diagnose 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential ef- fectiveness.
The emergency use of the authorized TessArray RM-Flu under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Sec- retary of HHS’s corresponding declaration under section 564(b)(1), the TessArray RM-Flu described above is authorized to diag- nose 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influ- enza A/H3 virus results, in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the TessArray RM-Flu during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the TessArray RM-Flu.
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• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
TessArae, LLC
A. TessArae, LLC will distribute the authorized TessArray RM-Flu with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
B. TessArae, LLC will provide to the CLIA High Complexity Laboratories the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers and the authorized TessArray RM-Flu Fact Sheet for Patients.
C. TessArae, LLC will make available on its website the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers and the authorized TessArray RM-Flu Fact Sheet for Patients.
D. TessArae, LLC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions here- in.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or patho- gens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu may rep- resent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
H. TessArae, LLC will ensure that CLIA High Complexity Laboratories using the authorized TessArray RM-Flu have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appro- priate.
I. TessArae, LLC will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, TessArae, LLC will maintain records of device usage.
K. TessArae, LLC will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or false negative results of which TessArae, LLC becomes aware.
L. TessArae, LLC is authorized to make available additional information relating to the emergency use of the authorized TessArray RM-Flu that is consistent with, and does not exceed, the terms of this letter of authorization.
M. Only TessArae, LLC may request changes to the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers or the authorized TessArray RM-Flu Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
CLIA High Complexity Laboratories
N. CLIA High Complexity Laboratories will include with reports of the results of the TessArray RM-Flu the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
O. CLIA High Complexity Laboratories will use the EPICENTRE MasterpureTM Complete DNA and RNA Purification Kit for nu- cleic acid extraction and perform the assay on the Affymetrix® GeneChip® Microarray Instrumentation System, ensuring that at least once per day specimens are tested, a known sample (such as that of a seasonal influenza virus vaccine) is tested as a positive control for RNA extraction, and is processed through all subsequent protocol steps.
P. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
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Q. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to TessArae, LLC any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
R. CLIA High Complexity Laboratories will clearly and conspicuously state on reports of the results of the TessArray RM-Flu that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other pathogen.
TessArae, LLC and CLIA High Complexity Laboratories
S. TessArae, LLC, and CLIA High Complexity Laboratories will ensure that any records associated with this EUA are main- tained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized TessArray RM-Flu test as described in this letter of authorization must comply with the con- ditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
(10) The Authorization for the CDC 2009, amended on May 2, 2009, and as and provides an explanation of the Swine Influenza Virus Real-time rRT- amended again and reissued in its reasons for its issuance, as required by PCR Detection Panel issued on April 27, entirety on December 18, 2009, follows section 564(h)(1) of the act:
Thomas R. Frieden, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Rd, MS D-14 Atlanta, GA 30333
Dear Dr. Frieden:
On April 27, 2009, FDA issued a letter authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) assay for the presumptive diagnosis of 2009 H1N1 influenza virus infection, pursuant to sec- tion 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3) by public health and other qualified lab- oratories. On May 1, 2009, CDC submitted a request for an amendment to the Emergency Use Authorization.1 On August 31, 2009 CDC submitted a request for a second amendment2 and on November 30, 2009 CDC submitted a request for a third amendment3 to the Emergency Use Authorization G090072. In response to those requests, the letter authorizing emergency use of the rRT-PCR Swine Flu Panel is being reissued in its entirety with the amendments, as requested by CDC.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. § 247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents -- in this case, 2009 H1N1 influenza virus.4 Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in indi- viduals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the rRT-PCR Swine Flu Panel for the diagnosis of 2009 H1N1 influenza virus infec- tion in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under sec- tion 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Swine Flu Panel may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the rRT-PCR Swine Flu Panel, when used in the diagnosis of 2009 H1N1influenza virus infection, outweigh the known and po- tential risks of such products; and
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3. There is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Swine Flu Panel for the di- agnosis of 2009 H1N1 influenza virus infection.5
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized rRT-PCR Swine Flu Panel for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
The Authorized rRT-PCR Swine Flu Panel:
The Swine Influenza Virus Real-time RT-PCR Detection Panel is a panel of oligonucleotide primers and dual-labeled hydrolysis (Taqman®) probes for use in the real-time RT-PCR assay on the Roche LightCycler® 2.0, and the Applied Biosystems (ABI) 7500 Fast Dx Real-time PCR, and the RUO marketed 7500 Fast Real-time PCR instruments for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), dual NPS/TS swabs, or nasal aspirates (NA)) and the lower respiratory tract specimens (such as bronchoalveolar lavage (BAL), bronchial aspirate (BA); bronchial washes (BW), endotracheal aspirates (EA) and endotracheal wash (EW), tracheal aspirates (TA), and lung tissue) from patients with signs and symptoms of respiratory infection and from viral culture. The universal influenza A (Matrix gene), 2009 H1N1 influenza swInfA (NP gene), and swH1 (HA gene) primer and probe sets are designed for detection of 2009 H1N1 influenza viruses.
The rRT-PCR Swine Flu Panel includes the following primer and probe sets: • InfA detects a well-conserved region of the Matrix Protein (M) gene from influenza A viruses in both seasonal human influ- enza A virus and 2009 H1N1 virus. • swInfA specifically detects the 2009 H1N1 influenza strains (NP gene). • swH1 is specific for the 2009 H1N1 influenza and detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 virus.
The rRT-PCR Swine Flu Panel also includes control materials: • RNase P (RP) detects human RNase P and is used as a positive control with human clinical specimens to indicate that ade- quate isolation of nucleic acid resulted from the extraction of the clinical specimen. • Swine Influenza Panel Real-Time RT-PCR Positive Control (SIPC) is a positive control designed to react with all the prim- er and probe sets including RNase P.
The above rRT-PCR Swine Flu Panel, when labeled consistently with the labeling authorized by FDA, entitled the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) (see http://www.fda.gov/MedicalDevices/Safety/ EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to public health and other qualified laboratories6 under this EUA, despite the fact that it does not meet certain requirements otherwise re- quired by federal law.
The above described rRT-PCR Swine Flu Panel is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to be made available to health care providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting the Swine Influenza Virus Real-time RT-PCR Detection Panel Test Results
• Fact Sheet For Patients: Understanding rRT-PCR Swine Influenza Detection Panel Test Results
As described in section IV below, CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized rRT-PCR Swine Flu Panel in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infec- tion, outweigh the known and potential risks of such product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized rRT-PCR Swine Flu Panel may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized rRT-PCR Swine Flu Panel, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in sec- tion 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized rRT-PCR Swine Flu Panel under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’ determination under section 564(b)(1)(C) described above and the Secretary of HHS’ corresponding declaration under section 564(b)(1), the rRT-PCR Swine Flu Panel described above is author- ized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
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I am waiving the following requirements for the rRT-PCR Swine Flu Panel during the duration of this emergency use authoriza- tion:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the rRT-PCR Swine Flu Panel;
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12);
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
CDC
A. CDC will distribute the rRT-PCR Swine Flu Panel with the authorized labeling, as may be revised with written permission of FDA only to qualified laboratories.
B. CDC will provide to the qualified laboratories and state and/or local public health authority(ies) the authorized rRT-PCR Swine Flu Panel Fact Sheets for Health Care Providers, and the authorized rRT-PCR Swine Flu Panel Fact Sheets for Patients.
C. CDC will make available on its website the authorized rRT-PCR Swine Flu Panel Fact Sheets for Health Care Providers, and the authorized rRT-PCR Swine Flu Panel Fact Sheets for Patients.
D. CDC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. CDC will ensure that qualified laboratories using the rRT-PCR Swine Flu Panel have a process in place for reporting test re- sults to health care providers and federal, state and/or local public health authorities, as appropriate.
F. CDC will track adverse events and report to FDA as required under 21 CFR part 803.
G. Through a process of inventory control, CDC will maintain records of device usage.
H. CDC will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive and negative results of which CDC becomes aware.
Public Health and Other Qualified Laboratories
I. Public health and other qualified laboratories will include with reports of the results of the rRT-PCR Swine Flu Panel, the author- ized Fact Sheets for Health Care Providers and the authorized Fact Sheet for Patients.
J. Qualified laboratories will perform the assay on the Roche LightCycler® 2.0 Real-time PCR system, or an Applied Biosystems 7500 Fast Dx Real-time PCR instrument, or the RUO marketed Applied Biosystems 7500 Real-time PCR instrument that is vali- dated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory perform- ance (proficiency testing with the CDC sample panel not performed).
K. Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
L. Qualified laboratories will collect information on the performance of the assay, and report to CDC any suspected occurrence of false positive or false negative results of which qualified laboratories become aware.
CDC and State and/or Local Public Health Authority(ies)
M. CDC and the appropriate state and/or local public health authority(ies) are authorized to make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization.
N. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers or the authorized rRT-PCR Swine Flu Panel Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
O. CDC and the appropriate state/and or local public health authority(ies) will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized rRT-PCR Swine Flu Panel as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
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Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
1 The amendment to the April 27, 2009 letter allow use of different sample types (throat swabs (TS), dual NPS/TS swab, or nasal aspirate (NA) specimens) and different reagents. 2 The amendment to the May 2, 2009 letter allow use of the LightCycler® 2.0 Real-time PCR system, in addition to the ABI 7500 Fast Dx system, with the CDC rRT-PCR Swine Flu Panel . 3 The amendment to the May 2, 2009 letter authorize use of nasal washes as additional upper respiratory tract specimen and use of lower respiratory tract specimens (such as bronchoalveolar lavage (BAL), bronchial aspirate (BA); bronchial wash (BW); endo- tracheal aspirate (EA); endotracheal wash (EW); tracheal aspirate (TA), and lung tissue) as acceptable clinical specimens with the CDC rRT-PCR Swine Flu Panel; to remove the word ‘‘presumptive’’ from the Intended Use; to allow the use of the CDC rRT-PCR Swine Flu Panel as a stand alone test; to include Human Specimen Control (HSC) that was previously included in the CDC rRT-PCR Flu Panel (IVD, K080570); and to update packaging by removing product from foam envelopes and segregating into boxes. There are also minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diag- nostic devices. 4 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 5 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 4 All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by a CDC instructor or designee prior to use. CDC Influenza Division will limit the distribution of this device to those users who have successfully completed training provided by CDC instructors or designees. Use is limited to des- ignated laboratories that are qualified to receive and use the CDC rRT-PCR Flu Panel (IVD) 510(K) 080570. See ‘‘Conditions of Au- thorization’’ below.
(11) The Authorization for the December 24, 2009, follows and for its issuance, as required by section Cepheid Xpert Flu A Panel issued on provides an explanation of the reasons 564(h)(1) of the act:
Russel K. Enns, Ph.D. Senior Vice President Regulatory, Clinical & Government Affairs and Quality Systems Cepheid 904 Caribbean Drive Sunnyvale, CA 94089
Dear Dr. Enns:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Cepheid Xpert® Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests.1
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influ- enza virus.2 Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Sec- retary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the Xpert® Flu A Panel (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the Xpert® Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection in in- dividuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Xpert® Flu A Panel may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Xpert® Flu A Panel, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the Xpert® Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection.3
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the author- ized Xpert® Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of res- piratory infection.
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The Authorized Xpert® Flu A Panel:
The Cepheid Xpert Flu A Panel is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of 2009 H1N1 influenza virus RNA. The assay is performed on the Cepheid GeneXpert Dx System. The system automates and integrates sample purification, nucleic acid amplification, and detection of the target viral RNA sequences using real-time reverse transcriptase polymerase chain reaction (rRT-PCR). The system consists of an instrument, personal computer, and preloaded software for running tests and viewing the results.
The assay detects specific viral gene sequences for the Flu A matrix (Flu A target), and the hemagglutinin gene of 2009 H1N1 in- fluenza virus (2009 H1N1 target). The specimen types for which analytical and method comparison in clinical samples perform- ance data are provided include nasal aspirates/washes (NA/W) and nasopharyngeal (NP) swab specimens in viral transport media (VTM) or universal transport media (UTM) collected from patients suspected of having influenza.
Components of the Test: The Xpert Flu A Panel includes the following assays:
• Flu A Matrix: four forward primer sequences, three reverse primers and one probe sequence for detecting the matrix gene in Flu A • 2009 H1: two forward primer sequences, one reverse primer and one probe sequence for detecting the hemagglutinin gene in 2009 Flu A H1.
The Xpert Flu A Panel also includes the following controls:
• SPC: Armored RNA in the form of a dry bead that is included in each cartridge to verify adequate processing of the sample virus. • PCC: The Probe Check Control PCC indicates that the probes and dyes are present and intact
The Xpert Flu A Panel requires the following hardware with corresponding software:
• Cepheid GeneXpert Dx System and software package
The above described Xpert Flu A Panel , when labeled consistently with the labeling authorized by FDA, entitled Xpert Flu A Panel Assay Package Insert, (available at http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA Moderate and High Com- plexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described Xpert® Flu A Panel is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:
• Fact Sheet For Healthcare Providers: Interpreting Cepheid® Xpert® Flu A Panel Test Results
• Fact Sheet For Patients: Understanding Cepheid® Xpert® Flu A Panel Test Results
As described in section IV below, Cepheid is also authorized to make available additional information relating to the emergency use of the authorized Xpert® Flu A Panel that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Xpert® Flu A Panel in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Xpert® Flu A Panel may be effective in the diagnosis of 2009 H1N1 influenza virus in- fection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the infor- mation supporting the conclusions described in Section I above, and concludes that the authorized Xpert® Flu A Panel, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized Xpert® Flu A Panel under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under section 564(b)(1), the Xpert® Flu A Panel described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for the Xpert® Flu A Panel during the duration of this emergency use authorization:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with re- spect to the design, manufacture, packaging, labeling, storage, and distribution of the Xpert® Flu A Panel.
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• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
Cepheid
A. Cepheid will distribute the authorized Xpert® Flu A Panel with the authorized labeling, as may be revised with written per- mission of FDA, only to CLIA Moderate and High Complexity Laboratories.
B. Cepheid will provide to the CLIA Moderate and High Complexity Laboratories the authorized Xpert® Flu A Panel Fact Sheet for Healthcare Providers and the authorized Xpert® Flu A Panel Fact Sheet for Patients.
C. Cepheid will make available on its website the authorized Xpert® Flu A Panel Fact Sheet for Healthcare Providers and the authorized Xpert® Flu A Panel Fact Sheet for Patients.
D. Cepheid will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
E. All advertising and promotional descriptive printed matter relating to the use of the authorized Xpert® Flu A Panel shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
F. All advertising and promotional descriptive printed matter relating to the use of the authorized Xpert® Flu A Panel shall clear- ly and conspicuously state that:
• This test has not been FDA cleared or approved;
• FDA has not determined that this test may be performed in settings with certificates of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or patho- gens;
• This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is revoked sooner; and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated sooner or renewed.
G. No advertising or promotional descriptive printed matter relating to the use of the authorized Xpert® Flu A Panel may rep- resent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
H. Cepheid will ensure that CLIA Moderate and High Complexity Laboratories using the authorized Xpert® Flu A Panel have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
I. Cepheid will track adverse events and report to FDA as required under 21 CFR part 803.
J. Through a process of inventory control, Cepheid will maintain records of device usage.
K. Cepheid will collect information on the performance of the assay and report to FDA any suspected occurrence of false posi- tive or false negative results of which Cepheid becomes aware.
L. Cepheid is authorized to make available additional information relating to the emergency use of the authorized Xpert® Flu A Panel that is consistent with, and does not exceed, the terms of this letter of authorization.
M. Only Cepheid may request changes to the authorized Xpert® Flu A Panel Fact Sheet for Healthcare Providers or the au- thorized Xpert® Flu A Panel Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
CLIA Moderate and High Complexity Laboratories
N. CLIA Moderate and High Complexity Laboratories will include with reports of the results of the Xpert® Flu A Panel the au- thorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
O. CLIA Moderate and High Complexity Laboratories will perform the assay on the Cepheid GeneXpert Dx System.
P. CLIA Moderate and High Complexity Laboratories will have a process in place for reporting test results to healthcare pro- viders and federal, state and/or local public health authorities, as appropriate.
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Q. CLIA Moderate and High Complexity Laboratories will collect information on the performance of the assay, and report to Cepheid any suspected occurrence of false positive or false negative results of which CLIA Moderate and High Complexity Laboratories become aware.
R. CLIA Moderate and High Complexity Laboratories will clearly and conspicuously state on reports of the results of the Xpert Flu A that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other pathogen.
Cepheid and CLIA Moderate and High Complexity Laboratories
S. Cepheid and CLIA Moderate and High Complexity Laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized Xpert® Flu A Panel as described in this letter of authorization must comply with the condi- tions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is re- voked under section 564(g) of the Act.
Joshua M. Sharfstein, M.D. Principal Deputy Commissioner of Food and Drugs
1 For ease of reference this letter will refer to these two types of laboratories together as ‘‘CLIA Moderate and High Complexity Laboratories.’’ 2 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
Dated: April 9, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–8605 Filed 4–16–10; 8:45 am] BILLING CODE 4160–01–S
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Part III
Department of Commerce National Oceanic and Atmospheric Administration
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to an Exploration Drilling Program Near Camden Bay, Beaufort Sea, Alaska; Notice
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DEPARTMENT OF COMMERCE visiting the Internet at: http:// Except with respect to certain www.nmfs.noaa.gov/pr/permits/ activities not pertinent here, the MMPA National Oceanic and Atmospheric incidental.htm. The following defines ‘‘harassment’’ as: Administration associated documents are also available Any act of pursuit, torment, or annoyance at the same internet address: Shell’s RIN 0648–XU80 which (i) has the potential to injure a marine 2010 Exploration Drilling mammal or marine mammal stock in the wild Takes of Marine Mammals Incidental to Communication Plan Beaufort Sea, [‘‘Level A harassment’’]; or (ii) has the Specified Activities; Taking Marine Alaska, and Shell’s 2010 Plan of potential to disturb a marine mammal or Mammals Incidental to an Exploration Cooperation (POC) Camden Bay, Alaska. marine mammal stock in the wild by causing Drilling Program Near Camden Bay, Documents cited in this notice may also disruption of behavioral patterns, including, Beaufort Sea, AK be viewed, by appointment, during but not limited to, migration, breathing, regular business hours, at the nursing, breeding, feeding, or sheltering AGENCY: National Marine Fisheries aforementioned address. [‘‘Level B harassment’’]. Service (NMFS), National Oceanic and FOR FURTHER INFORMATION CONTACT: Atmospheric Administration (NOAA), Candace Nachman, Office of Protected Summary of Request Commerce. Resources, NMFS, (301) 713–2289, ext NMFS received an application on ACTION: Notice; proposed incidental 156. harassment authorization; request for May 11, 2009, from Shell for the taking, comments. SUPPLEMENTARY INFORMATION: by harassment, of marine mammals incidental to offshore exploration Background SUMMARY: NMFS received an drilling on OCS leases in the Beaufort application from Shell Offshore Inc. Sections 101(a)(5)(A) and (D) of the Sea, Alaska. NMFS reviewed Shell’s (Shell) for an Incidental Harassment MMPA (16 U.S.C. 1361 et seq.) direct application and identified a number of Authorization (IHA) to take marine the Secretary of Commerce to allow, issues requiring further clarification. mammals, by harassment, incidental to upon request, the incidental, but not After addressing comments from NMFS, offshore exploration drilling on Outer intentional, taking of small numbers of Shell modified its application and Continental Shelf (OCS) leases in the marine mammals by U.S. citizens who submitted a revised application on Beaufort Sea, Alaska. Pursuant to the engage in a specified activity (other than December 10, 2009. However, after some Marine Mammal Protection Act commercial fishing) within a specified additional discussions regarding certain (MMPA), NMFS is requesting comments geographical region if certain findings activities, NMFS determined that a on its proposal to issue an IHA to Shell are made and either regulations are second revision to the application was to take, by Level B harassment only, six issued or, if the taking is limited to warranted. The latest revised species of marine mammals during the harassment, a notice of a proposed application was submitted to NMFS on specified activity. authorization is provided to the public March 18, 2010. NMFS carefully DATES: Comments and information must for review. evaluated Shell’s application, including be received no later than May 19, 2010. Authorization for incidental takings their analyses, and determined that the ADDRESSES: Comments on the shall be granted if NMFS finds that the application is complete and that it is application should be addressed to taking will have a negligible impact on appropriate to make the necessary Michael Payne, Chief, Permits, the species or stock(s), will not have an preliminary determinations pursuant to Conservation and Education Division, unmitigable adverse impact on the the MMPA. The March 18, 2010, Office of Protected Resources, National availability of the species or stock(s) for application is the one available for Marine Fisheries Service, 1315 East- subsistence uses (where relevant), and if public comment (see ADDRESSES) and West Highway, Silver Spring, MD the permissible methods of taking and considered by NMFS for this proposed 20910. The mailbox address for requirements pertaining to the IHA. providing email comments is PR1.0648– mitigation, monitoring and reporting of Shell intends to drill two exploration [email protected]. NMFS is not such takings are set forth. NMFS has wells at the Torpedo and Sivulliq responsible for e-mail comments sent to defined ‘‘negligible impact’’ in 50 CFR prospects in Camden Bay, Beaufort Sea, addresses other than the one provided 216.103 as ‘‘* * * an impact resulting Alaska, during the 2010 Arctic open- here. Comments sent via e-mail, from the specified activity that cannot water season (July through October). including all attachments, must not be reasonably expected to, and is not Impacts to marine mammals may occur exceed a 10-megabyte file size. reasonably likely to, adversely affect the from noise produced by the drillship Instructions: All comments received species or stock through effects on and supporting vessels and aircraft. are a part of the public record and will annual rates of recruitment or survival.’’ Shell has requested an authorization to generally be posted to http:// Section 101(a)(5)(D) of the MMPA take 11 marine mammal species by www.nmfs.noaa.gov/pr/permits/ established an expedited process by Level B harassment. However, some of incidental.htm without change. All which citizens of the U.S. can apply for these species are not expected to be Personal Identifying Information (for an authorization to incidentally take found in the activity area. Therefore, example, name, address, etc.) small numbers of marine mammals by NMFS is proposing to authorize take of voluntarily submitted by the commenter harassment. Section 101(a)(5)(D) six marine mammal species, by Level B may be publicly accessible. Do not establishes a 45-day time limit for harassment, incidental to Shell’s submit Confidential Business NMFS review of an application offshore exploration drilling in Camden Information or otherwise sensitive or followed by a 30-day public notice and Bay. These species include: beluga protected information. comment period on any proposed whale (Delphinapterus leucas); A copy of the application used in this authorizations for the incidental bowhead whale (Balaena mysticetus); document may be obtained by writing to harassment of marine mammals. Within gray whale (Eschrichtius robustus); the address specified above, telephoning 45 days of the close of the comment bearded seal (Erignathus barbatus); the contact listed below (see FOR period, NMFS must either issue or deny ringed seal (Phoca hispida); and spotted FURTHER INFORMATION CONTACT), or the authorization. seal (P. largha).
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Description of the Specified Activity will be nearby for its storage capability (IMP). Ice-management vessels, anchor of recovered liquids. tenders, and OSR vessels will remain in Shell plans to conduct an offshore Shell’s base plan is for two ice- close proximity to the drillship during exploration drilling program on U.S. management/anchor handling vessels, drilling operations. Department of the Interior, Minerals the M/V Vladimir Ignatjuk and the ice- Shell recognizes that the drilling Management Service (MMS) Alaska management/anchor handling vessel program is located in an area that is OCS leases located north of Point M/V Nordica or similar vessels, to characterized by active sea ice Thomson near Camden Bay in the accompany the Discoverer traveling movement, ice scouring, and storm Beaufort Sea, Alaska, during the 2010 north of Dutch Harbor through the surges. In anticipation of potential ice open-water season. During the 2010 Bering Strait, after July 1, 2010, then hazards that may be encountered, Shell drilling program, Shell plans to through the Chukchi Sea, around Pt. has developed and will implement an complete two exploration wells at two Barrow, and east through the Alaskan IMP to ensure real-time ice and weather drill sites, one well each on the Torpedo Beaufort Sea, before arriving on location forecasting is conducted in order to (NR06–04 Flaxman Island lease block at the Torpedo ‘‘H’’ location on or about identify conditions that might put 6610, OCS–Y–1941 [Flaxman Island July 10, or Sivulliq ‘‘N’’ if adverse operations at risk and will modify its 6610]) and Sivulliq prospects (NR06–04 surface conditions or other factors activities accordingly. The IMP also Flaxman Island lease block 6658, OCS– dictate a reversal of drilling sequence. contains ice threat classification levels Y 1805 [Flaxman Island 6658]). See At the completion of the drilling season depending on the time available to Figure 1–1 in Shell’s application for the on or before October 31, 2010, one or suspend drilling operations, secure the lease block and drill site locations (see two ice-management vessels, along with well, and escape from advancing ADDRESSES). All drilling is planned to be various support vessels, such as the hazardous ice. Real-time ice and vertical. OSR fleet, will accompany the weather forecasting will be available to Shell plans to drill the Torpedo Discoverer as it travels west through the operations personnel for planning prospect well first, followed by the Beaufort Sea, then south through the purposes and to alert the fleet of Sivulliq well, unless adverse surface Chukchi Sea and the Bering Strait. impending hazardous ice and weather conditions or other factors dictate a Subject to ice conditions, alternate exit conditions. Ice and weather forecasting reversal of drilling sequence. In that routes may be considered. Shell has is provided by Shell’s Ice and Weather case, Shell will mobilize to the Sivulliq planned a suspension of all operations Advisory Center. The center is prospect and drill there first. The beginning on August 25 for the Nuiqsut continuously manned by experienced Torpedo H drill site is located 22 mi (Cross Island) and Kaktovik subsistence personnel, who rely on a number of data (35.4 km) from shore in water 120 ft bowhead whale hunts. The Discoverer sources for ice forecasting and tracking, (36.6 m) deep. The Sivulliq N drill site and support vessels will leave the including: is located 16 mi (25.7 km) from shore Camden Bay project area, will move to • Radarsat and Envisat data— with a water depth of 107 ft (32.6 m). a location at or north of 71.25°N. satellites with Synthetic Aperture ° The ice reinforced drillship latitude and at or west of 146.4 W. Radar, providing all-weather imagery of Discoverer will be used to drill the longitude and will return to resume ice conditions with very high wells. The Discoverer is 514 ft (156.7 m) activities after the Nuiqsut (Cross resolution; • long with a maximum height (above Island) and Kaktovik subsistence Moderate Resolution Imaging keel) of 274 ft (83.7 m). Additional rig bowhead whale hunts conclude. Spectroradiometer—a satellite providing specifications for the Discoverer can be Shell will cease drilling on or before lower resolution visual and near found in Attachment A of Shell’s October 31, after which the Discoverer infrared imagery; will exit the Alaskan Beaufort Sea. In • application (see ADDRESSES). While on Aerial reconnaissance—provided location at the drill sites, the Discoverer total, Shell anticipates that the by specially deployed fixed wing or exploration drilling program will will be affixed to the seafloor using rotary wing aircraft for confirmation of require approximately 74 drilling days, eight 7-ton Stevpris anchors arranged in ice conditions and position; excluding weather delays, the shutdown • a radial array. Reports from ice specialists on the period to accommodate the fall ice-management and anchor handling During the 2010 drilling season, the bowhead whale harvests at Kaktovik vessels and from the ice observer on the Discoverer will be attended by a and Cross Island (Nuiqsut), or other drillship; minimum of seven vessels that will be operational delays. Shell assumes • Incidental ice data provided by used for ice-management, anchor approximately 11 additional days will commercial ships transiting the area; handling, oil spill response (OSR), be needed for drillship mobilization, and refueling, resupply, and servicing of the drillship moves between locations, and • Information from NOAA ice centers drilling operations. The ice-management drillship demobilization. and the University of Colorado. vessels will consist of an icebreaker and Activities associated with the 2010 The ice-management/anchor handling an anchor handler. Table 1–1 in Shell’s Beaufort Sea exploration drilling vessels would manage the ice by application provides a list of the program include operation of the deflecting any ice floes that could affect support vessels that will be used during Discoverer, associated support vessels, the Discoverer when it is drilling and the drilling program, as well as crew change support and re-supply. The would also handle the Discoverer’s information about trip frequency and Discoverer will remain at the location of anchors during connection to and duration for each vessel. the designated exploration drill sites separation from the seafloor. The ice Re-supply between the drill sites and except when mobilizing and floe frequency and intensity are West Dock will use a coastwide demobilizing to and from Camden Bay, unpredictable and could range from no qualified vessel. An ice-capable OSR transiting between drill sites, and ice to ice sufficiently dense that the fleet barge (OSRB), with an associated tug, temporarily moving off location if it is has insufficient capacity to continue will be located nearby during the determined ice conditions require such operating, and the Discoverer would planned drilling program. The OSRB a move to ensure the safety of personnel need to disconnect from its anchors and will be supported by a berthing vessel and/or the environment in accordance move off site. If ice is present, ice- for the OSR crew. An OSR tanker also with Shell’s Ice-management Plan management activities may be necessary
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in early July and towards the end of from a similar drillship, the Northern Description of Marine Mammals in the operations in late October, but it is not Explorer II, were measured at two Area of the Specified Activity expected to be needed throughout the different times and locations in the proposed drilling season. Shell has Beaufort Sea (Miles et al., 1987; Greene, The Beaufort Sea supports a diverse indicated that when ice is present at the 1987a). The underwater received sound assemblage of marine mammals, drill site, ice disturbance will be limited pressure level (SPL) in the 20–1,000 Hz including: bowhead, gray, beluga, killer (Orcinus orca), minke (Balaenoptera to the minimum needed to allow band for drilling activity by the acutorostrata), and humpback drilling to continue. First-year ice will Northern Explorer II, including a nearby (Megaptera novaeangliae) whales; be the type most likely to be support vessel, was 134 dB re 1 μPa encountered. The ice-management harbor porpoises (Phocoena phocoena); (rms) at 0.1 mi (0.2 km; Greene, 1987b). vessels will be tasked with managing ringed, ribbon (Histriophoca fasciata), The back-propagated source levels (175 the ice so that it will flow easily around μ spotted, and bearded seals; polar bears and past the Discoverer without dB re 1 Pa at 1 m) from these (Ursus maritimus); and walruses building up in front of it. This type of measurements were used as a proxy for (Odobenus rosmarus divergens; see ice is managed by the ice-management modeling the sounds likely to be Table 4–1 in Shell’s application). The vessel continually moving back and produced by drilling activities from the bowhead and humpback whales are forth across the drift line, directly up- Discoverer. NMFS has determined that listed as ‘‘endangered’’ under the drift of the Discoverer and making turns the sound measurements for the Endangered Species Act (ESA) and as at both ends. During ice-management, Northern Explorer II constitute a good depleted under the MMPA. Certain the vessel’s propeller is rotating at proxy for estimating sound radii for the stocks or populations of gray, beluga, approximately 15–20 percent of the Discoverer. Sound propagation and killer whales and spotted seals are vessel’s propeller rotation capacity. Ice- measurements will be performed on the listed as endangered or are proposed for management occurs with slow Discoverer in 2010 once on location listing under the ESA; however, none of movements of the vessel using lower near the Camden Bay drill sites in the those stocks or populations occur in the power and therefore slower propeller Beaufort Sea. The results of those proposed activity area. Additionally, the rotation speed (i.e., lower cavitation), measurements will be used during the ribbon seal is considered a ‘‘species of allowing for fewer repositions of the drilling season to implement proposed concern’’ under the ESA, and the vessel, thereby reducing cavitation mitigation measures described later in bearded and ringed seals are ‘‘candidate effects in the water. Occasionally, there this document (see the ‘‘Proposed species’’ under the ESA, meaning they may be multi-year ice ridges that would Mitigation’’ section). are currently being considered for be managed at a much slower speed listing. Both the walrus and the polar than that used to manage first-year ice. Although there will be several bear are managed by the U.S. Fish and Shell has indicated that they do not support vessels in the drilling Wildlife Service (USFWS) and are not have any intention of breaking ice with operations area, NMFS considers the considered further in this proposed IHA the ice-management vessels but, rather, possibility of collisions with marine notice. intend to push it out of the area as mammals highly unlikely. Once on described here. Should ice become so location, the majority of the support Of these species, six are expected to occur in the area of Shell’s proposed prevalent in the drilling area that it is vessels will remain in the area of the operations. These species include: The difficult to continue operations without drillship throughout the 2010 drilling the breaking of ice, Shell has indicated bowhead, gray, and beluga whales and season and will not be making trips the ringed, spotted, and bearded seals. that they would stop operations and between the shorebase and the offshore move off site instead of breaking ice (S. The marine mammal species that is vessels. Aircraft travel would be likely to be encountered most widely (in Childs, Shell, 2010, pers. comm.). Shell controlled by Federal Aviation has indicated that ice breaking would space and time) throughout the period Administration approved flight paths. of the proposed drilling program is the only be conducted if the ice poses an Shell has agreed to a flight altitude of immediate safety hazard at the drill ringed seal. Bowhead whales are also 1,500 ft (457 m; except during takeoffs sites. anticipated to occur in the proposed Crew change/re-supply vessels will and landings or during emergencies) for project area more frequently than the transit to and from the drillship at the all non-marine mammal monitoring other cetacean species; however, their estimated frequency shown in Table 1– flights to minimize impacts on marine occurrence is not expected until later in 1 in Shell’s application. Helicopters are mammals. As the crew change/resupply the season. Where available, Shell used planned to provide support for crew activities are considered part of normal density estimates from peer-reviewed change, provision re-supply, and search- vessel traffic and are not anticipated to literature in the application. In cases and-rescue operations during the impact marine mammals in a manner where density estimates were not drilling season. The aircraft operations that would rise to the level of taking, readily available in the peer-reviewed will principally be based in Deadhorse, those activities are not considered literature, Shell used other methods to Alaska. further in this document. Additionally, derive the estimates. NMFS reviewed Potential impacts to marine mammals ice-management activities are not the density estimate descriptions and could occur from the noise produced by anticipated to impact marine mammals articles from which estimates were the drillship and its support vessels and in a manner that would rise to the level derived and requested additional aircraft. The drillship produces of taking. This is based on the fact that information to better explain the density continuous noise into the marine the propeller rotation (i.e., cavitation) estimates presented by Shell in its environment. NMFS currently uses a will be similar to that of vessels under application. This additional information threshold of 120 dB re 1 μPa (rms) for was included in the revised IHA normal operations and will not be used the onset of Level B harassment from application. The explanation for those at 100 percent power as is the case in continuous sound sources. Sound derivations and the actual density measurements from the Discoverer have other situations rising to the level of estimates are described later in this not previously been conducted in the taking (e.g., thruster use for dynamic document (see the ‘‘Estimated Take by Arctic or elsewhere; however, sounds positioning at terminals). Incidental Harassment’’ section).
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Other cetacean species that have been can also be found in the NMFS Stock environmental sounds such as surf observed in the Beaufort Sea but are Assessment Reports (SAR). The Alaska noise; uncommon or rarely identified in the 2009 SAR is available at: http:// (6) If mammals remain in an area project area include harbor porpoise, www.nmfs.noaa.gov/pr/pdfs/sars/ because it is important for feeding, narwhal, and killer, minke, humpback, ak2009.pdf. breeding, or some other biologically and gray whales. These species could important purpose even though there is Potential Effects of the Specified chronic exposure to noise, it is possible occur in the project area, but each of Activity on Marine Mammals these species is uncommon or rare in that there could be noise-induced the area and relatively few encounters Potential effects of Shell’s proposed physiological stress; this might in turn with these species are expected during drilling program in Camden Bay on have negative effects on the well-being the exploration drilling program. The marine mammals would most likely be or reproduction of the animals involved; narwhal occurs in Canadian waters and acoustic in nature. Petroleum and occasionally in the Beaufort Sea, but it development and associated activities (7) Very strong sounds have the is rare there and is not expected to be introduce sound into the marine potential to cause a temporary or encountered. There are scattered records environment. Potential acoustic effects permanent reduction in hearing of narwhal in Alaskan waters, including on marine mammals relate to sound sensitivity. In terrestrial mammals, and reports by subsistence hunters, where produced by drilling activity, vessels, presumably marine mammals, received the species is considered extralimital and aircraft. The potential effects of sound levels must far exceed the (Reeves et al., 2002). Point Barrow, sound from the proposed exploratory animal’s hearing threshold for there to Alaska, is the approximate northeastern drilling program might include one or be any temporary threshold shift (TTS) extent of the harbor porpoise’s regular more of the following: Tolerance; in its hearing ability. For transient range (Suydam and George, 1992), masking of natural sounds; behavioral sounds, the sound level necessary to though there are extralimital records disturbance; non-auditory physical cause TTS is inversely related to the east to the mouth of the Mackenzie effects; and, at least in theory, duration of the sound. Received sound River in the Northwest Territories, temporary or permanent hearing levels must be even higher for there to Canada, and recent sightings in the impairment (Richardson et al., 1995a). be risk of permanent hearing Beaufort Sea in the vicinity of Prudhoe However, for reasons discussed later in impairment. In addition, intense Bay during surveys in 2007 and 2008 this document, it is unlikely that there acoustic or explosive events may cause (Christie et al., 2009). Monnett and would be any cases of temporary, or trauma to tissues associated with organs Treacy (2005) did not report any harbor especially permanent, hearing vital for hearing, sound production, porpoise sightings during aerial surveys impairment resulting from these respiration and other functions. This in the Beaufort Sea from 2002 through activities. As outlined in previous trauma may include minor to severe 2004. Humpback and minke whales NMFS documents, the effects of noise hemorrhage. have recently been sighted in the on marine mammals are highly variable, Brief Background on Marine Mammal Chukchi Sea but very rarely in the and can be categorized as follows (based Hearing Beaufort Sea. Greene et al. (2007) on Richardson et al., 1995a): (1) The noise may be too weak to be When considering the influence of reported and photographed a humpback heard at the location of the animal (i.e., various kinds of sound on the marine whale cow/calf pair east of Barrow near lower than the prevailing ambient noise environment, it is necessary to Smith Bay in 2007, which is the first level, the hearing threshold of the understand that different kinds of known occurrence of humpbacks in the animal at relevant frequencies, or both); marine life are sensitive to different Beaufort Sea. Savarese et al. (2009) (2) The noise may be audible but not frequencies of sound. Based on available reported one minke whale sighting in strong enough to elicit any overt behavioral data, audiograms derived the Beaufort Sea in 2007 and 2008. behavioral response; using auditory evoked potential Ribbon seals do not normally occur in (3) The noise may elicit reactions of techniques, anatomical modeling, and the Beaufort Sea; however, two ribbon variable conspicuousness and variable other data, Southall et al. (2007) seal sightings were reported during relevance to the well being of the designate ‘‘functional hearing groups’’ vessel-based activities near Prudhoe Bay marine mammal; these can range from for marine mammals and estimate the in 2008 (Savarese et al., 2009). Due to temporary alert responses to active lower and upper frequencies of the rarity of these species in the avoidance reactions such as vacating an functional hearing of the groups. The proposed project area and the remote area at least until the noise event ceases functional groups and the associated chance they would be affected by but potentially for longer periods of frequencies are indicated below Shell’s proposed Beaufort Sea drilling time; (though, animals are less sensitive to activities, these species are not (4) Upon repeated exposure, a marine sounds at the outer edge of their discussed further in this proposed IHA mammal may exhibit diminishing functional range and most sensitive to notice. responsiveness (habituation), or sounds of frequencies within a smaller Shell’s application contains disturbance effects may persist; the range somewhere in the middle of their information on the status, distribution, latter is most likely with sounds that are functional hearing range): seasonal distribution, and abundance of highly variable in characteristics, • Low frequency cetaceans (13 each of the species under NMFS infrequent, and unpredictable in species of mysticetes): Functional jurisdiction mentioned in this occurrence, and associated with hearing is estimated to occur between document. When reviewing the situations that a marine mammal approximately 7 Hz and 22 kHz; application, NMFS determined that the perceives as a threat; • Mid-frequency cetaceans (32 species descriptions provided by Shell (5) Any anthropogenic noise that is species of dolphins, six species of larger correctly characterized the status, strong enough to be heard has the toothed whales, and 19 species of distribution, seasonal distribution, and potential to reduce (mask) the ability of beaked and bottlenose whales): abundance of each species. Please refer a marine mammal to hear natural Functional hearing is estimated to occur to the application for that information sounds at similar frequencies, including between approximately 150 Hz and 160 (see ADDRESSES). Additional information calls from conspecifics, and underwater kHz;
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• High frequency cetaceans (eight their variations with time, distance, and management, the vessel’s propeller is species of true porpoises, six species of direction from the drillship. Based on rotating at approximately 15–20 percent river dolphins, Kogia, the franciscana, the similarities of the two drillships, of the vessel’s propeller rotation and four species of cephalorhynchids): NMFS has preliminarily determined capacity. Instead of actually breaking Functional hearing is estimated to occur that the radii produced by the ice, during ice-management, the vessel between approximately 200 Hz and 180 Discoverer would be similar to those redirects and repositions the ice by kHz; and recorded for the Northern Explorer II. pushing it away from the direction of • Pinnipeds in Water: Functional the drillship at slow speeds so that the Vessel Sounds hearing is estimated to occur between ice floe does not slip past the vessel approximately 75 Hz and 75 kHz, with In addition to the drillship, various bow. Basically, ice-management occurs the greatest sensitivity between types of vessels will be used in support at slower speed, lower power, and approximately 700 Hz and 20 kHz. of the operations, including ice- slower propeller rotation speed (i.e., As mentioned previously in this management vessels, anchor handlers, lower cavitation), allowing for fewer document, six marine mammal species and oil-spill response vessels. Sounds repositions of the vessel, thereby (three pinniped and three cetacean from boats and vessels have been reducing cavitation effects in the water species) are likely to occur in the reported extensively (Greene and than would occur during icebreaking. proposed drilling area. Of the three Moore, 1995; Blackwell and Greene, Once on location at the drill sites in cetacean species likely to occur in 2002, 2005, 2006). Numerous Camden Bay, Shell plans to measure the Shell’s project area, two are classified as measurements of underwater vessel sound levels produced by vessels low frequency cetaceans (i.e., bowhead sound have been performed in support operating in support of drilling and gray whales), and one is classified of recent industry activity in the operations. These vessels will include as a mid-frequency cetacean (i.e., beluga Chukchi and Beaufort Seas. Results of crew change vessels, tugs, ice- whale) (Southall et al., 2007). these measurements were reported in management vessels, and spill response various 90-day and comprehensive Drilling Sounds vessels. reports since 2007 (e.g., Aerts et al., Exploratory drilling will be conducted 2008; Hauser et al., 2008; Brueggeman, Aircraft Sound from a vessel specifically designed for 2009; Ireland et al., 2009). For example, Helicopters may be used for personnel such operations in the Arctic. Garner and Hannay (2009) estimated and equipment transport to and from Underwater sound propagation results sound pressure levels of 100 dB at the drillship. Under calm conditions, from the use of generators, drilling distances ranging from approximately rotor and engine sounds are coupled machinery, and the rig itself. Received 1.5 to 2.3 mi (2.4 to 3.7 km) from into the water within a 26° cone beneath sound levels during vessel-based various types of barges. MacDonald et the aircraft. Some of the sound will operations may fluctuate depending on al. (2008) estimated higher underwater transmit beyond the immediate area, the specific type of activity at a given SPLs from the seismic vessel Gilavar of and some sound will enter the water time and aspect from the vessel. 120 dB at approximately 13 mi (21 km) outside the 26° area when the sea Underwater sound levels may also from the source, although the sound surface is rough. However, scattering depend on the specific equipment in level was only 150 dB at 85 ft (26 m) and absorption will limit lateral operation. Lower sound levels have from the vessel. Like other industry- propagation in the shallow water. been reported during well logging than generated sound, underwater sound Dominant tones in noise spectra from during drilling operations (Greene, from vessels is generally at relatively helicopters are generally below 500 Hz 1987b), and underwater sound appeared low frequencies. (Greene and Moore, 1995). Harmonics of to be lower at the bow and stern aspects The primary sources of sounds from the main rotor and tail rotor usually than at the beam (Greene, 1987a). all vessel classes are propeller dominate the sound from helicopters; Most drilling sounds generated from cavitation, propeller singing, and however, many additional tones vessel-based operations occur at propulsion or other machinery. associated with the engines and other relatively low frequencies below 600 Hz Propeller cavitation is usually the rotating parts are sometimes present. although tones up to 1,850 Hz were dominant noise source for vessels (Ross, Because of doppler shift effects, the recorded by Greene (1987a) during 1976). Propeller cavitation and singing frequencies of tones received at a drilling operations in the Beaufort Sea. are produced outside the hull, whereas stationary site diminish when an aircraft At a range of 558 ft (170 m) the 20–1,000 propulsion or other machinery noise passes overhead. The apparent Hz band level was 122–125 dB for the originates inside the hull. There are frequency is increased while the aircraft drillship Explorer I. Underwater sound additional sounds produced by vessel approaches and is reduced while it levels were slightly higher (134 dB) activity, such as pumps, generators, moves away. during drilling activity from the flow noise from water passing over the Aircraft flyovers are not heard Northern Explorer II at a range of 656 ft hull, and bubbles breaking in the wake. underwater for very long, especially (200 m), although tones were only Icebreakers contribute greater sound when compared to how long they are recorded below 600 Hz. Underwater levels during ice-breaking activities than heard in air as the aircraft approaches sound measurements from the Kulluk at ships of similar size during normal an observer. Helicopters flying to and 0.62 mi (1 km) were higher (143 dB) operation in open water (Richardson et from the drillship will generally than from the other two vessels. Shell al., 1995a). This higher sound maintain straight-line routes at altitudes used the measurements from the production results from the greater of at least 1,000 ft (305 m), thereby Northern Explorer II to model the amount of power and propeller limiting the received levels at and below various sound radii (which are cavitation required when operating in the surface. discussed later in this document) for the thick ice. Discoverer. Once on location at the drill Sound levels during ice-management Tolerance sites in Camden Bay, Shell plans to take activities would not be as intense as Numerous studies have shown that measurements of the Discoverer to during icebreaking, and the resulting underwater sounds from industry quantify the absolute sound levels effects to marine species would be less activities are often readily detectable by produced by drilling and to monitor significant in comparison. During ice- marine mammals in the water at
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distances of many kilometers. exposure resulted in whales being occur closer to a sound source, and Numerous studies have also shown that deflected from the sound energy and distant anthropogenic sound is less marine mammals at distances more than changing behavior. These minor likely to mask short-distance acoustic a few kilometers away often show no changes are not expected to affect the communication (Richardson et al., apparent response to industry activities beluga whale population (Richardson et 1995a). of various types (Miller et al., 2005; Bain al., 1991; Richard et al., 1998). Brewer Although some masking by marine and Williams, 2006). This is often true et al. (1993) observed belugas within 2.3 mammal species in the area may occur, even in cases when the sounds must be mi (3.7 km) of the drilling unit Kulluk the extent of the masking interference readily audible to the animals based on during drilling; however, the authors do will depend on the spatial relationship measured received levels and the not describe any behaviors that may of the animal and Shell’s activity. If, as hearing sensitivity of that mammal have been exhibited by those animals. described later in this document, certain group. Although various baleen whales, Please refer to the Arctic Multiple-Sale species avoid the proposed drilling toothed whales, and (less frequently) Draft Environmental Impact Statement locations, impacts from masking will be pinnipeds have been shown to react (USDOI MMS, 2008), available on the low. behaviorally to underwater sound such Internet at: http://www.mms.gov/alaska/ Behavioral Disturbance Reactions as airgun pulses or vessels under some ref/EIS%20EA/ArcticMultiSale_209/ conditions, at other times mammals of _DEIS.htm, for more detailed Behavioral responses to sound are all three types have shown no overt information. highly variable and context-specific. reactions (e.g., Malme et al., 1986; Many different variables can influence There is evidence of other marine an animal’s perception of and response Richardson et al., 1995; Madsen and mammal species continuing to call in Mohl, 2000; Croll et al., 2001; Jacobs to (in both nature and magnitude) an the presence of industrial activity. For acoustic event. An animal’s prior and Terhune, 2002; Madsen et al., 2002; example, bowhead whale calls are Miller et al., 2005). In general, experience with a sound or sound frequently detected in the presence of source affects whether it is less likely pinnipeds and small odontocetes seem seismic pulses, although the number of to be more tolerant of exposure to some (habituation) or more likely calls detected may sometimes be (sensitization) to respond to certain types of underwater sound than are reduced (Richardson et al., 1986; Greene baleen whales. Richardson et al. (1995a) sounds in the future (animals can also et al., 1999; Blackwell et al., 2009). found that vessel noise does not seem to be innately pre-disposed to respond to Additionally, annual acoustical strongly affect pinnipeds that are certain sounds in certain ways; Southall monitoring near BP’s Northstar already in the water. Richardson et al. et al., 2007). Related to the sound itself, production facility during the fall (1995a) went on to explain that seals on the perceived nearness of the sound, bowhead migration westward through haul-outs sometimes respond strongly to bearing of the sound (approaching vs. the Beaufort Sea has recorded thousands the presence of vessels and at other retreating), similarity of a sound to of calls each year (for examples, see times appear to show considerable biologically relevant sounds in the Richardson et al., 2007; Aerts and tolerance of vessels, and (Brueggeman et animal’s environment (i.e., calls of Richardson, 2008). Construction, al., 1992; cited in Richardson et al., predators, prey, or conspecifics), and 1995a) observed ringed seals hauled out maintenance, and operational activities familiarity of the sound may affect the on ice pans displaying short-term have been occurring from this facility way an animal responds to the sound escape reactions when a ship for nearly 10 years. To compensate and (Southall et al., 2007). Individuals (of approached within 0.25–0.5 mi (0.4–0.8 reduce masking, some mysticetes may different age, gender, reproductive km). alter the frequencies of their status, etc.) among most populations communication sounds (Richardson et will have variable hearing capabilities, Masking al., 1995a; Parks et al., 2007). Masking and differing behavioral sensitivities to The term ‘‘masking’’ refers to the processes in baleen whales are not sounds that will be affected by prior obscuring of sounds of interest by amenable to laboratory study, and no conditioning, experience, and current interfering sounds, generally at similar direct measurements on hearing activities of those individuals. Often, frequencies. Masking effects of sensitivity are available for these specific acoustic features of the sound underwater sounds on marine mammal species. It is not currently possible to and contextual variables (i.e., proximity, calls and other natural sounds are determine with precision the potential duration, or recurrence of the sound or expected to be limited. For example, consequences of temporary or local the current behavior that the marine beluga whales primarily use high- background noise levels. However, mammal is engaged in or its prior frequency sounds to communicate and Parks et al. (2007) found that right experience), as well as entirely separate locate prey; therefore, masking by low- whales altered their vocalizations, factors such as the physical presence of frequency sounds associated with possibly in response to background a nearby vessel, may be more relevant drilling activities is not expected to noise levels. For species that can hear to the animal’s response than the occur (Gales, 1982, as cited in Shell, over a relatively broad frequency range, received level alone. 2009). If the distance between as is presumed to be the case for Exposure of marine mammals to communicating whales does not exceed mysticetes, a narrow band source may sound sources can result in (but is not their distance from the drilling activity, only cause partial masking. Richardson limited to) no response or any of the the likelihood of potential impacts from et al. (1995a) note that a bowhead whale following observable responses: masking would be low (Gales, 1982, as 12.4 mi (20 km) from a human sound Increased alertness; orientation or cited in Shell, 2009). At distances source, such as that produced during oil attraction to a sound source; vocal greater than 660–1,300 ft (200–400 m), and gas industry activities, might hear modifications; cessation of feeding; recorded sounds from drilling activities strong calls from other whales within cessation of social interaction; alteration did not affect behavior of beluga whales, approximately 12.4 mi (20 km), and a of movement or diving behavior; even though the sound energy level and whale 3.1 mi (5 km) from the source avoidance; habitat abandonment frequency were such that it could be might hear strong calls from whales (temporary or permanent); and, in heard several kilometers away within approximately 3.1 mi (5 km). severe cases, panic, flight, stampede, or (Richardson et al., 1995b). This Additionally, masking is more likely to stranding, potentially resulting in death
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(Southall et al., 2007). On a related note, exposure to projected icebreaker operations. In general, little or no many animals perform vital functions, sounds. Other bowheads, however, response was observed in animals such as feeding, resting, traveling, and tolerated projected icebreaker sound at exposed at received levels from 90–120 socializing, on a diel cycle (24-hr cycle). levels 20 dB and more above ambient dB re 1 μPa (rms). Probability of Behavioral reactions to noise exposure sound levels. The source level of the avoidance and other behavioral effects (such as disruption of critical life projected sound, however, was much increased when received levels were functions, displacement, or avoidance of less than that of an actual icebreaker, from 120–160 dB re 1 μPa (rms). Some important habitat) are more likely to be and reaction distances to actual of the relevant reviews contained in significant if they last more than one icebreaking may be much greater than Southall et al. (2007) are summarized diel cycle or recur on subsequent days those reported here for projected next. (Southall et al., 2007). Consequently, a sounds. Baker et al. (1982) reported some behavioral response lasting less than Brewer et al. (1993) and Hall et al. avoidance by humpback whales to one day and not recurring on (1994) reported numerous sightings of vessel noise when received levels were subsequent days is not considered marine mammals including bowhead 110–120 dB (rms) and clear avoidance at particularly severe unless it could whales in the vicinity of offshore 120–140 dB (sound measurements were directly affect reproduction or survival drilling operations in the Beaufort Sea. not provided by Baker but were based (Southall et al., 2007). One bowhead whale sighting was on measurements of identical vessels by Detailed studies regarding responses reported within approximately 1,312 ft Miles and Malme, 1983). to anthropogenic sound have been (400 m) of a drilling vessel although Malme et al. (1983, 1984) used conducted on humpback, gray, and other sightings were at much greater playbacks of sounds from helicopter bowhead whales and ringed seals. Less distances. Few bowheads were recorded overflight and drilling rigs and detailed data are available for some near industrial activities by aerial platforms to study behavioral effects on other species of baleen whales, sperm observers, but observations by surface migrating gray whales. Received levels whales, small toothed whales, and sea observers suggested that bowheads may exceeding 120 dB induced avoidance otters. The following sub-sections have been closer to industrial activities reactions. Malme et al. (1984) calculated provide examples of behavioral than was suggested by results of aerial 10 percent, 50 percent, and 90 percent responses that provide an idea of the observations. probabilities of gray whale avoidance variability in behavioral responses that Richardson et al. (2008) reported a reactions at received levels of 110, 120, would be expected given the differential slight change in the distribution of and 130 dB, respectively. Malme et al. sensitivities of marine mammal species bowhead whale calls in response to (1986) observed the behavior of feeding to sound and the wide range of potential operational sounds on BP’s Northstar gray whales during four experimental acoustic sources to which a marine Island. The southern edge of the call playbacks of drilling sounds (50 to 315 mammal may be exposed. distribution ranged from 0.47 to 1.46 mi Hz; 21-min overall duration and 10 Baleen Whales—Baleen whale (0.76 to 2.35 km) farther offshore, percent duty cycle; source levels of 156– responses to pulsed sound (e.g., seismic apparently in response to industrial 162 dB). In two cases for received levels airguns) have been studied more sound levels. This result, however, was of 100–110 dB, no behavioral reaction thoroughly than responses to only achieved after intensive statistical was observed. However, avoidance continuous sound (e.g., drillships). analyses, and it is not clear that this behavior was observed in two cases Baleen whales generally tend to avoid represented a biologically significant where received levels were 110–120 dB. operating airguns, but avoidance radii effect. Richardson et al. (1990) performed 12 are quite variable. Whales are often Patenaude et al. (2002) reported fewer playback experiments in which reported to show no overt reactions to behavioral responses to aircraft bowhead whales in the Alaskan Arctic pulses from large arrays of airguns at overflights by bowhead compared to were exposed to drilling sounds. Whales distances beyond a few kilometers, even beluga whales. Behaviors classified as generally did not respond to exposures though the airgun pulses remain well reactions consisted of short surfacings, in the 100 to 130 dB range, although above ambient noise levels out to much immediate dives or turns, changes in there was some indication of minor greater distances (Miller et al., 2005). behavior state, vigorous swimming, and behavioral changes in several instances. However, baleen whales exposed to breaching. Most bowhead reaction McCauley et al. (1996) reported strong noise pulses often react by resulted from exposure to helicopter several cases of humpback whales deviating from their normal migration activity and little response to fixed-wing responding to vessels in Hervey Bay, route (Richardson et al., 1999). aircraft was observed. Most reactions Australia. Results indicated clear Migrating gray and bowhead whales occurred when the helicopter was at avoidance at received levels between were observed avoiding the sound altitudes ≤ 492 ft (150 m) and lateral 118 to 124 dB in three cases for which source by displacing their migration distances ≤ 820 ft (250 m; Nowacek et response and received levels were route to varying degrees but within the al., 2007). Restriction on aircraft altitude observed/measured. natural boundaries of the migration will be part of the proposed mitigation Palka and Hammond (2001) analyzed corridors (Schick and Urban, 2000; measures (described in the ‘‘Proposed line transect census data in which the Richardson et al., 1999; Malme et al., Mitigation’’ section later in this orientation and distance off transect line 1983). document) during the proposed drilling were reported for large numbers of Richardson et al. (1995b) reported activities, and overflights are likely to minke whales. The authors developed a changes in surfacing and respiration have little or no disturbance effects on method to account for effects of animal behavior and the occurrence of turns baleen whales. Any disturbance that movement in response to sighting during surfacing in bowhead whales may occur would likely be temporary platforms. Minor changes in locomotion exposed to playback of underwater and localized. speed, direction, and/or diving profile sound from drilling activities. These Southall et al. (2007, Appendix C) were reported at ranges from 1,847 to behavioral effects were localized and reviewed a number of papers describing 2,352 ft (563 to 717 m) at received levels occurred at distances up to 1.2–2.5 mi the responses of marine mammals to of 110 to 120 dB. (2–4 km). Some bowheads appeared to non-pulsed sound, such as that Biassoni et al. (2000) and Miller et al. divert from their migratory path after produced during exploratory drilling (2000) reported behavioral observations
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for humpback whales exposed to a low- sensitivity at frequencies much higher ranges, which includes toothed whales, frequency sonar stimulus (160- to 330- than that of baleen whales and may be Southall et al. (2007) reported that Hz frequency band; 42-s tonal signal less responsive to low-frequency sound combined field and laboratory data for repeated every 6 min; source levels 170 commonly associated with oil and gas mid-frequency cetaceans exposed to to 200 dB) during playback experiments. industry exploratory drilling activities. non-pulse sounds did not lead to a clear Exposure to measured received levels Richardson et al. (1995b) reported that conclusion about received levels ranging from 120 to 150 dB resulted in beluga whales did not show any coincident with various behavioral variability in humpback singing apparent reaction to playback of responses. In some settings, individuals behavior. Croll et al. (2001) investigated underwater drilling sounds at distances in the field showed profound responses of foraging fin and blue greater than 656–1,312 ft (200–400 m). (significant) behavioral responses to whales to the same low frequency active Reactions included slowing down, exposures from 90 to 120 dB, while sonar stimulus off southern California. milling, or reversal of course after which others failed to exhibit such responses Playbacks and control intervals with no the whales continued past the projector, for exposure to received levels from 120 transmission were used to investigate sometimes within 164–328 ft (50– to 150 dB. Contextual variables other behavior and distribution on time scales 100 m). The authors concluded (based than exposure received level, and of several weeks and spatial scales of on a small sample size) that the probable species differences, are the tens of kilometers. The general playback of drilling sounds had no likely reasons for this variability. conclusion was that whales remained biologically significant effects on Context, including the fact that captive feeding within a region for which 12 to migration routes of beluga whales subjects were often directly reinforced 30 percent of exposures exceeded 140 migrating through pack ice and along with food for tolerating noise exposure, dB. the seaward side of the nearshore lead may also explain why there was great Frankel and Clark (1998) conducted east of Pt. Barrow in spring. disparity in results from field and playback experiments with wintering At least six of 17 groups of beluga laboratory conditions—exposures in humpback whales using a single speaker whales appeared to alter their migration captive settings generally exceeded 170 producing a low-frequency ‘‘M- path in response to underwater dB before inducing behavioral sequence’’ (sine wave with multiple- playbacks of icebreaker sound responses. A summary of some of the phase reversals) signal in the 60 to 90 (Richardson et al., 1995b). Received relevant material reviewed by Southall Hz band with output of 172 dB at 1 m. levels from the icebreaker playback et al. (2007) is next. For 11 playbacks, exposures were were estimated at 78–84 dB in the 1/3- LGL and Greeneridge (1986) and between 120 and 130 dB re 1 μPa (rms) octave band centered at 5,000 Hz, or 8– Finley et al. (1990) documented belugas and included sufficient information 14 dB above ambient. If beluga whales and narwhals congregated near ice regarding individual responses. During reacted to an actual icebreaker at edges reacting to the approach and eight of the trials, there were no received levels of 80 dB, reactions passage of ice-breaking ships. Beluga measurable differences in tracks or would be expected to occur at distances whales responded to oncoming vessels bearings relative to control conditions, on the order of 6.2 mi (10 km). Finley by (1) fleeing at speeds of up to 12.4 mi/ whereas on three occasions, whales et al. (1990) also reported beluga hr (20 km/hr) from distances of 12.4–50 either moved slightly away from (n = 1) avoidance of icebreaker activities in the mi (20–80 km), (2) abandoning normal or towards (n = 2) the playback speaker Canadian High Arctic at distances of pod structure, and (3) modifying vocal during exposure. The presence of the 22–31 mi (35–50 km). In addition to behavior and/or emitting alarm calls. source vessel itself had a greater effect avoidance, changes in dive behavior and Narwhals, in contrast, generally than did the M-sequence playback. pod integrity were also noted. However, demonstrated a ‘‘freeze’’ response, lying Finally, Nowacek et al. (2004) used while the Vladimir Ignatjuk (an motionless or swimming slowly away controlled exposures to demonstrate icebreaker) is anticipated to be one of (as far as 23 mi [37 km] down the ice behavioral reactions of northern right the vessels attending the Discoverer, it edge), huddling in groups, and ceasing whales to various non-pulse sounds. will only be conducting ice- sound production. There was some Playback stimuli included ship noise, management activities (which were evidence of habituation and reduced social sounds of conspecifics, and a described in the ‘‘Description of the avoidance 2 to 3 days after onset. complex, 18-min ‘‘alert’’ sound Specified Activity’’ section earlier in The 1982 season observations by LGL consisting of repetitions of three this document) and not physical and Greeneridge (1986) involved a different artificial signals. Ten whales breaking of ice. Thus, NMFS does not single passage of an icebreaker with were tagged with calibrated instruments anticipate that marine mammals would both ice-based and aerial measurements that measured received sound exhibit the types of behavioral reactions on June 28, 1982. Four groups of characteristics and concurrent animal as those noted in the aforementioned narwhals (n = 9 to 10, 7, 7, and 6) movements in three dimensions. Five studies. responded when the ship was 4 mi (6.4 out of six exposed whales reacted Patenaude et al. (2002) reported that km) away (received levels of strongly to alert signals at measured beluga whales appeared to be more approximately 100 dB in the 150- to received levels between 130 and 150 dB responsive to aircraft overflights than 1,150-Hz band). At a later point, (i.e., ceased foraging and swam rapidly bowhead whales. Changes were observers sighted belugas moving away to the surface). Two of these individuals observed in diving and respiration from the source at more than 12.4 mi (20 were not exposed to ship noise, and the behavior, and some whales veered away km; received levels of approximately 90 other four were exposed to both stimuli. when a helicopter passed at ≤820 ft dB in the 150- to 1,150-Hz band). The These whales reacted mildly to (250 m) lateral distance at altitudes up total number of animals observed conspecific signals. Seven whales, to 492 ft (150 m). However, some fleeing was about 300, suggesting including the four exposed to the alert belugas showed no reaction to the approximately 100 independent groups stimulus, had no measurable response helicopter. Belugas appeared to show (of three individuals each). No whales to either ship sounds or actual vessel less response to fixed-wing aircraft than were sighted the following day, but noise. to helicopter overflights. some were sighted on June 30, with ship Toothed Whales—Most toothed In reviewing responses of cetaceans noise audible at spectrum levels of whales have the greatest hearing with best hearing in mid-frequency approximately 55 dB/Hz (up to 4 kHz).
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Observations during 1983 (LGL and (source level: 163 dB) to belugas in Pinnipeds—Pinnipeds generally seem Greeneridge, 1986) involved two ice- Alaska. They reported avoidance to be less responsive to exposure to breaking ships with aerial survey and reactions at 984 and 4,921 ft (300 and industrial sound than most cetaceans. ice-based observations during seven 1,500 m) and approach by groups at a Pinniped responses to underwater sampling periods. Narwhals and belugas distance of 2.2 mi (3.5 km; received sound from some types of industrial generally reacted at received levels levels approximately 110 to 145 dB over activities such as seismic exploration ranging from 101 to 121 dB in the 20- these ranges assuming a 15 log R appear to be temporary and localized to 1,000-Hz band and at a distance of up transmission loss). Similarly, (Harris et al., 2001; Reiser et al., 2009). to 40.4 mi (65 km). Large numbers Richardson et al. (1990) played back Blackwell et al. (2004) reported little (100s) of beluga whales moved out of drilling platform sounds (source level: or no reaction of ringed seals in the area at higher received levels. As 163 dB) to belugas in Alaska. They response to pile-driving activities noise levels from icebreaking operations conducted aerial observations of eight during construction of a man-made diminished, a total of 45 narwhals individuals among approximately 100 island in the Beaufort Sea. Ringed seals returned to the area and engaged in spread over an area several hundred were observed swimming as close as diving and foraging behavior. During the meters to several kilometers from the 151 ft (46 m) from the island and may final sampling period, following an 8-h sound source and found no obvious have been habituated to the sounds quiet interval, no reactions were seen reactions. Moderate changes in which were likely audible at distances from 28 narwhals and 17 belugas (at movement were noted for three groups <9,842 ft (3,000 m) underwater and 0.3 received levels ranging up to 115 dB). swimming within 656 ft (200 m) of the mi (0.5 km) in air. Moulton et al. (2003) The final season (1984) reported in sound projector. reported that ringed seal densities on ice LGL and Greeneridge (1986) involved Two studies deal with issues related in the vicinity of a man-made island in aerial surveys before, during, and after to changes in marine mammal vocal the Beaufort Sea did not change the passage of two ice-breaking ships. behavior as a function of variable significantly before and after During operations, no belugas and few background noise levels. Foote et al. construction and drilling activities. narwhals were observed in an area (2004) found increases in the duration Southall et al. (2007) reviewed approximately 16.8 mi (27 km) ahead of of killer whale calls over the period literature describing responses of the vessels, and all whales sighted over 1977 to 2003, during which time vessel pinnipeds to non-pulsed sound and 12.4–50 mi (20–80 km) from the ships traffic in Puget Sound, and particularly reported that the limited data suggest were swimming strongly away. whale-watching boats around the exposures between approximately 90 Additional observations confirmed the animals, increased dramatically. and 140 dB generally do not appear to spatial extent of avoidance reactions to Scheifele et al. (2005) demonstrated that induce strong behavioral responses in this sound source in this context. belugas in the St. Lawrence River pinnipeds exposed to non-pulse sounds Buckstaff (2004) reported elevated increased the levels of their in water; no data exist regarding dolphin whistle rates with received vocalizations as a function of the exposures at higher levels. It is levels from oncoming vessels in the 110 background noise level (the ‘‘Lombard important to note that among these to 120 dB range in Sarasota Bay, Florida. Effect’’). studies, there are some apparent These hearing thresholds were Several researchers conducting differences in responses between field apparently lower than those reported by laboratory experiments on hearing and and laboratory conditions. In contrast to a researcher listening with towed the effects of non-pulse sounds on the mid-frequency odontocetes, captive hydrophones. Morisaka et al. (2005) hearing in mid-frequency cetaceans pinnipeds responded more strongly at compared whistles from three have reported concurrent behavioral lower levels than did animals in the populations of Indo-Pacific bottlenose responses. Nachtigall et al. (2003) field. Again, contextual issues are the dolphins. One population was exposed reported that noise exposures up to 179 likely cause of this difference. to vessel noise with spectrum levels of dB and 55-min duration affected the Jacobs and Terhune (2002) observed approximately 85 dB/Hz in the 1- to 22- trained behaviors of a bottlenose harbor seal reactions to AHDs (source kHz band (broadband received levels dolphin participating in a TTS level in this study was 172 dB) approximately 128 dB) as opposed to experiment. Finneran and Schlundt deployed around aquaculture sites. approximately 65 dB/Hz in the same (2004) provided a detailed, Seals were generally unresponsive to band (broadband received levels comprehensive analysis of the sounds from the AHDs. During two approximately 108 dB) for the other two behavioral responses of belugas and specific events, individuals came within sites. Dolphin whistles in the noisier bottlenose dolphins to 1-s tones 141 and 144 ft (43 and 44 m) of active environment had lower fundamental (received levels 160 to 202 dB) in the AHDs and failed to demonstrate any frequencies and less frequency context of TTS experiments. Romano et measurable behavioral response; modulation, suggesting a shift in sound al. (2004) investigated the physiological estimated received levels based on the parameters as a result of increased responses of a bottlenose dolphin and a measures given were approximately 120 ambient noise. beluga exposed to these tonal exposures to 130 dB. Morton and Symonds (2002) used and demonstrated a decrease in blood Costa et al. (2003) measured received census data on killer whales in British cortisol levels during a series of noise levels from an Acoustic Columbia to evaluate avoidance of non- exposures between 130 and 201 dB. Thermometry of Ocean Climate (ATOC) pulse acoustic harassment devices Collectively, the laboratory observations program sound source off northern (AHDs). Avoidance ranges were about suggested the onset of a behavioral California using acoustic data loggers 2.5 mi (4 km). Also, there was a response at higher received levels than placed on translocated elephant seals. dramatic reduction in the number of did field studies. The differences were Subjects were captured on land, days ‘‘resident’’ killer whales were likely related to the very different transported to sea, instrumented with sighted during AHD-active periods conditions and contextual variables archival acoustic tags, and released such compared to pre- and post-exposure between untrained, free-ranging that their transit would lead them near periods and a nearby control site. individuals vs. laboratory subjects that an active ATOC source (at 939-m depth; Awbrey and Stewart (1983) played were rewarded with food for tolerating 75-Hz signal with 37.5-Hz bandwidth; back semi-submersible drillship sounds noise exposure. 195 dB maximum source level, ramped
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up from 165 dB over 20 min) on their mammals in close proximity to at their best frequencies (Clark and return to a haul-out site. Received industrial sound sources, and beaked Ellison, 2004), meaning that baleen exposure levels of the ATOC source for whales do not occur in the proposed whales require sounds to be louder (i.e., experimental subjects averaged 128 dB activity area. The following subsections higher dB levels) than odontocetes in (range 118 to 137) in the 60- to 90-Hz discuss in somewhat more detail the the frequency ranges at which each band. None of the instrumented animals possibilities of TTS, permanent group hears the best. From this, it is terminated dives or radically altered threshold shift (PTS), and non-auditory suspected that received levels causing behavior upon exposure, but some physiological effects. TTS onset may also be higher in baleen statistically significant changes in TTS—TTS is the mildest form of whales. Since current NMFS practice diving parameters were documented in hearing impairment that can occur assumes the same thresholds for the nine individuals. Translocated northern during exposure to a strong sound onset of hearing impairment in both elephant seals exposed to this particular (Kryter, 1985). While experiencing TTS, odontocetes and mysticetes, the non-pulse source began to demonstrate the hearing threshold rises and a sound threshold is likely conservative for subtle behavioral changes at exposure to must be stronger in order to be heard. mysticetes. received levels of approximately 120 to At least in terrestrial mammals, TTS can In free-ranging pinnipeds, TTS 140 dB. last from minutes or hours to (in cases thresholds associated with exposure to Kastelein et al. (2006) exposed nine of strong TTS) days. For sound brief pulses (single or multiple) of captive harbor seals in an approximately exposures at or somewhat above the underwater sound have not been 82 × 98 ft (25 × 30 m) enclosure to non- TTS threshold, hearing sensitivity in measured. However, systematic TTS pulse sounds used in underwater data both terrestrial and marine mammals studies on captive pinnipeds have been communication systems (similar to recovers rapidly after exposure to the conducted (Bowles et al., 1999; Kastak acoustic modems). Test signals were noise ends. Few data on sound levels et al., 1999, 2005, 2007; Schusterman et frequency modulated tones, sweeps, and and durations necessary to elicit mild al., 2000; Finneran et al., 2003; Southall bands of noise with fundamental TTS have been obtained for marine et al., 2007). Kastak et al. (1999) frequencies between 8 and 16 kHz; 128 mammals, and none of the published reported TTS of approximately 4–5 dB to 130 [± 3] dB source levels; 1- to 2-s data concern TTS elicited by exposure in three species of pinnipeds (harbor duration [60–80 percent duty cycle]; or to multiple pulses of sound. seal, Californian sea lion, and northern 100 percent duty cycle. They recorded For toothed whales exposed to single, elephant seal) after underwater seal positions and the mean number of short pulses, the TTS threshold appears exposure for approximately 20 minutes individual surfacing behaviors during to be, to a first approximation, a to noise with frequencies ranging from control periods (no exposure), before function of the energy content of the 100 Hz to 2,000 Hz at received levels exposure, and in 15-min experimental pulse (Finneran et al., 2002, 2005). 60–75 dB above hearing threshold. This sessions (n = 7 exposures for each sound Given the available data, the received approach allowed similar effective type). Seals generally swam away from level of a single seismic pulse (with no exposure conditions to each of the each source at received levels of frequency weighting) might need to be subjects, but resulted in variable approximately 107 dB, avoiding it by approximately 186 dB re 1 μPa2.s (i.e., absolute exposure values depending on approximately 16 ft (5 m), although they 186 dB sound exposure level [SEL]) in subject and test frequency. Recovery to did not haul out of the water or change order to produce brief, mild TTS. near baseline levels was reported within surfacing behavior. Seal reactions did Exposure to several strong seismic 24 hours of noise exposure (Kastak et not appear to wane over repeated pulses that each have received levels al., 1999). Kastak et al. (2005) followed exposure (i.e., there was no obvious near 175–180 dB SEL might result in up on their previous work using higher habituation), and the colony of seals slight TTS in a small odontocete, sensitive levels and longer exposure generally returned to baseline assuming the TTS threshold is (to a first times (up to 50-min) and corroborated conditions following exposure. The approximation) a function of the total their previous findings. The sound seals were not reinforced with food for received pulse energy. Given that the exposures necessary to cause slight remaining in the sound field. SPL is approximately 10–15 dB higher threshold shifts were also determined than the SEL value for the same pulse, for two California sea lions and a Hearing Impairment and Other an odontocete would need to be juvenile elephant seal exposed to Physiological Effects exposed to a sound level of 190 dB re underwater sound for similar duration. Temporary or permanent hearing 1 μPa (rms) in order to incur TTS. The sound level necessary to cause TTS impairment is a possibility when marine For baleen whales, there are no data, in pinnipeds depends on exposure mammals are exposed to very strong direct or indirect, on levels or properties duration, as in other mammals; with sounds. Non-auditory physiological of sound that are required to induce longer exposure, the level necessary to effects might also occur in marine TTS. The frequencies to which baleen elicit TTS is reduced (Schusterman et mammals exposed to strong underwater whales are most sensitive are lower than al., 2000; Kastak et al., 2005, 2007). For sound. Possible types of non-auditory those to which odontocetes are most very short exposures (e.g., to a single physiological effects or injuries that sensitive, and natural background noise sound pulse), the level necessary to theoretically might occur in mammals levels at those low frequencies tend to cause TTS is very high (Finneran et al., close to a strong sound source include be higher. Marine mammals can hear 2003). For pinnipeds exposed to in-air stress, neurological effects, bubble sounds at varying frequency levels. sounds, auditory fatigue has been formation, and other types of organ or However, sounds that are produced in measured in response to single pulses tissue damage. It is possible that some the frequency range at which an animal and to non-pulse noise (Southall et al., marine mammal species (i.e., beaked hears the best do not need to be as loud 2007), although high exposure levels whales) may be especially susceptible to as sounds in less functional frequencies were required to induce TTS-onset injury and/or stranding when exposed to be detected by the animal. As a result, (SEL: 129 dB re: 20 μPa2.s; Bowles et al., to strong pulsed sounds. However, as auditory thresholds of baleen whales unpub. data). discussed later in this document, there within their frequency band of best NMFS (1995, 2000) concluded that is no definitive evidence that any of hearing are believed to be higher (less cetaceans and pinnipeds should not be these effects occur even for marine sensitive) than are those of odontocetes exposed to pulsed underwater noise at
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received levels exceeding, respectively, that marine mammals located response to the types of sound produced 180 and 190 dB re 1 μPa (rms). The immediately adjacent to a drillship such during the proposed exploratory established 180- and 190-dB re 1 μPa as the Discoverer would likely not be activities. Also, most evidence for such (rms) criteria are not considered to be exposed to received sound levels of a effects has been in beaked whales, the levels above which TTS might magnitude strong enough to induce which do not occur in the proposed occur. Rather, they are the received PTS, even if the animals remain in the survey area. levels above which, in the view of a immediate vicinity of the proposed The low levels of continuous sound panel of bioacoustics specialists activity location for a prolonged period that will be produced by the drillship convened by NMFS before TTS of time. are not expected to cause such effects. measurements for marine mammals Non-auditory Physiological Effects— Additionally, marine mammals that started to become available, one could Non-auditory physiological effects or show behavioral avoidance of the not be certain that there would be no injuries that theoretically might occur in proposed activities, including most injurious effects, auditory or otherwise, marine mammals exposed to strong baleen whales, some odontocetes to marine mammals. Based on the underwater sound include stress, (including belugas), and some summary provided here and the fact neurological effects, bubble formation, pinnipeds, are especially unlikely to that modeling indicates the back- and other types of organ or tissue incur auditory impairment or other propagated source level for the drillship damage. If any such effects do occur, physical effects. μ they probably would be limited to to be 175 dB re 1 Pa at 1 m, TTS is Stranding and Mortality not expected to occur in any marine unusual situations when animals might mammal species that may occur in the be exposed at close range for unusually Marine mammals close to underwater proposed drilling area since the source long periods. It is doubtful that any detonations of high explosives can be level will not reach levels thought to single marine mammal would be killed or severely injured, and the induce even mild TTS. exposed to strong sounds for sufficiently auditory organs are especially PTS—When PTS occurs, there is long that significant physiological stress susceptible to injury (Ketten et al., 1993; physical damage to the sound receptors would develop. Ketten, 1995). Underwater sound from in the ear. In some cases, there can be Until recently, it was assumed that drilling and support activities is less total or partial deafness, whereas in diving marine mammals are not subject energetic and has slower rise times, and other cases, the animal has an impaired to the bends or air embolism. This there is no proof that they can cause ability to hear sounds in specific possibility was first explored at a serious injury, death, or stranding. frequency ranges. workshop (Gentry [ed.], 2002) held to However, the association of mass There is no specific evidence that discuss whether the stranding of beaked strandings of beaked whales with naval exposure to underwater industrial whales in the Bahamas in 2000 exercises and, in one case, a Lamont- sound associated with oil exploration (Balcomb and Claridge, 2001; NOAA Doherty Earth Observatory seismic can cause PTS in any marine mammal and USN, 2001) might have been related survey, has raised the possibility that (see Southall et al., 2007). However, to bubble formation in tissues caused by beaked whales exposed to strong pulsed given the possibility that mammals exposure to noise from naval sonar. sounds may be especially susceptible to might incur TTS, there has been further However, the opinions were injury and/or behavioral reactions that speculation about the possibility that inconclusive. Jepson et al. (2003) first can lead to stranding. The potential for some individuals occurring very close to suggested a possible link between mid- stranding to result from exposure to such activities might incur PTS. Single frequency sonar activity and acute and strong pulsed sound suggests that or occasional occurrences of mild TTS chronic tissue damage that results from caution be used when exposing marine are not indicative of permanent auditory the formation in vivo of gas bubbles, mammals to pulsed or other underwater damage in terrestrial mammals. based on the beaked whale stranding in sound. Most of the stranding events Relationships between TTS and PTS the Canary Islands in 2002 during naval associated with exposure of marine thresholds have not been studied in exercises. Fernandez et al. (2005a) mammals to pulsed sound however, marine mammals but are assumed to be showed those beaked whales did indeed have involved beaked whales which do similar to those in humans and other have gas bubble-associated lesions as not occur in the proposed area. terrestrial mammals. PTS might occur at well as fat embolisms. Fernandez et al. Additionally, the sound produced from a received sound level at least several (2005b) also found evidence of fat the proposed activities will be at much decibels above that inducing mild TTS. embolism in three beaked whales that lower levels than those reported during It is highly unlikely that marine stranded 62 mi (100 km) north of the stranding events, as the source levels of mammals could receive sounds strong Canaries in 2004 during naval exercises. the drillship are much lower than those enough (and over a sufficient duration) Examinations of several other stranded other sources. Pulsed sounds, such as to cause PTS during the proposed species have also revealed evidence of those produced by seismic airgun exploratory drilling program. As gas and fat embolisms (Arbelo et al., arrays, are transient and have rapid rise mentioned previously in this document, 2005; Jepson et al., 2005a; Mendez et al., times, whereas the non-impulsive, the source levels of the drillship are not 2005). Most of the afflicted species were continuous sounds produced by the considered strong enough to cause even deep divers. There is speculation that drillship to be used by Shell do not have slight TTS. Given the higher level of gas and fat embolisms may occur if rapid rise time. Rise time is the sound necessary to cause PTS, it is even cetaceans ascend unusually quickly fluctuation in sound levels of the less likely that PTS could occur. In fact, when exposed to aversive sounds or if source. The type of sound that would be based on the modeled source levels for sound in the environment causes the produced during the proposed drilling the drillship, the levels immediately destabilization of existing bubble nuclei program will be constant and will not adjacent to the drillship may not be (Potter, 2004; Arbelo et al., 2005; exhibit any sudden fluctuations or sufficient to induce PTS, even if the Fernandez et al., 2005a; Jepson et al., changes. animals remain in the immediate 2005b). Even if gas and fat embolisms The potential effects to marine vicinity of the activity. The modeled can occur during exposure to mid- mammals described in this section of source level from a similar drillship frequency sonar, there is no evidence the document do not take into (i.e., the Northern Explorer II) suggests that that type of effect occurs in consideration the proposed monitoring
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and mitigation measures described later Beaufort Sea suggest that anchor scars are the frequency of the signal and the in this document (see the ‘‘Proposed would be refilled faster than in the strength of the signal in relation to the Mitigation’’ and ‘‘Proposed Monitoring North Sea. natural background noise level. and Reporting’’ sections). Vessel mooring and MLC construction The level of sound at which a fish would result in increased suspended Anticipated Effects on Habitat will react or alter its behavior is usually sediment in the water column that well above the detection level. Fish The primary potential impacts to could result in lethal effects on some have been found to react to sounds marine mammals and other marine zooplankton (food source for baleen when the sound level increased to about species are associated with elevated whales). However, compared to the 20 dB above the detection level of 120 sound levels produced by the overall population of zooplankton and dB (Ona, 1988); however, the response exploratory drilling program. However, the localized nature of effects, any threshold can depend on the time of other potential impacts to the mortality that may occur would not be year and the fish’s physiological surrounding habitat from physical considered significant. Due to fast condition (Engas et al., 1993). In disturbance are also possible. regeneration periods of zooplankton, general, fish react more strongly to Potential Impacts From Seafloor populations are expected to recover pulses of sound rather than a Disturbance quickly. continuous signal (Blaxter et al., 1981), Impacts on fish resulting from There is a possibility of some seafloor such as the type of sound that will be suspended sediments would be produced by the drillship, and a quicker disturbance or temporary increased dependent upon the life stage of the fish turbidity in the seabed sediments during alarm response is elicited when the (e.g., eggs, larvae, juveniles, or adults), sound signal intensity rises rapidly anchoring and excavation of the the concentration of the suspended mudline cellars (MLCs). The amount compared to sound rising more slowly sediments, the type of sediment, and the to the same level. and duration of disturbed or turbid duration of exposure (IMG Golder, Investigations of fish behavior in conditions will depend on sediment 2004). Eggs and larvae have been found relation to vessel noise (Olsen et al., material and consolidation of specific to exhibit greater sensitivity to 1983; Ona, 1988; Ona and Godo, 1990) activity. suspended sediments (Wilber and have shown that fish react when the Both the anchor and anchor chain Clarke, 2001) and other stresses, which sound from the engines and propeller will disturb sediments and create an is thought to be related to their relative ‘‘anchor scar,’’ which is a depression in lack of motility (Auld and Schubel, exceeds a certain level. Avoidance the seafloor caused by the anchor 1978). Sedimentation could affect fish reactions have been observed in fish embedding. The anchor scar is a by causing egg morbidity of demersal such as cod and herring when vessels depression with ridges of displaced fish feeding near or on the ocean floor approached close enough that received sediment, and the area of disturbance (Wilber and Clarke, 2001). Surficial sound levels are 110 dB to 130 dB will often be greater than the size of the membranes are especially susceptible to (Nakken, 1992; Olsen, 1979; Ona and anchor itself because the anchor is abrasion (Cairns and Scheier, 1968). Godo, 1990; Ona and Toresen, 1988). dragged along the seafloor until it takes However, most of the abundant Beaufort However, other researchers have found hold and sets. The drilling units will be Sea fish species with demersal eggs that fish such as polar cod, herring, and stabilized and held in place with a spawn under the ice in the winter well capeline are often attracted to vessels system of eight 7,000 kg anchors during before MLC excavation would occur. (apparently by the noise) and swim operations, which are designed to Exposure of pelagic eggs would be much toward the vessel (Rostad et al., 2006). embed into the seafloor. Each anchor shorter as they move with ocean Typical sound source levels of vessel may impact an area of 775 ft2 (72 m2) currents (Wilber and Clarke, 2001). noise in the audible range for fish are of the seafloor. Minimum impact Suspended sediments, resulting from 150 dB to 170 dB (Richardson et al., estimates from each well or mooring by vessel mooring and MLC excavation, are 1995a). (Based on measurements from the Discoverer is 9,300 ft2 (864 m2) of not expected to result in permanent the Northern Explorer II, the 160 dB seafloor. This estimate assumes that the damage to habitats used by the marine radius for the Discoverer was modeled anchors are set only once and not mammal species in the proposed project by JASCO to be approximately 115 ft [35 moved by outside forces such as sea area or on the food sources that they m]; therefore, fish would need to be in current. However, based on the vast size utilize. Rather, NMFS considers that close proximity to the drillship for the of the Beaufort Sea, the area of such impacts will be temporary in noise to be audible). In calm weather, disturbance is not anticipated to nature and concentrated in the areas ambient noise levels in audible parts of adversely affect marine mammal use of directly surrounding vessel mooring and the spectrum lie between 60 dB to 100 the area. MLC excavation activities—areas which dB. Once the drillship ends operation, the are very small relative to the overall Sound will also occur in the marine anchors will be retrieved. Over time, the Beaufort Sea region. environment from the various support anchor scars will be filled through vessels. Reported source levels for natural movement of sediment. The Potential Impacts From Sound vessels during ice-management have duration of the scars depends upon the Generation ranged from 175 dB to 185 dB (Brewer energy of the system, water depth, ice With regard to fish as a prey source et al., 1993, Hall et al., 1994). However, scour, and sediment type. Anchor scars for odontocetes and seals, fish are ice-management activities are not were visible under low energy known to hear and react to sounds and expected to be necessary throughout the conditions in the North Sea for 5–10 to use sound to communicate (Tavolga entire drilling season, so impacts from years after retrieval. Scars typically do et al., 1981) and possibly avoid that activity would occur less frequently not form or persist in sandy mud or predators (Wilson and Dill, 2002). than sound from the drillship. Sound sand sediments (such as those found in Experiments have shown that fish can pressures generated while drilling have the Beaufort Sea) but may last for 9 sense both the strength and direction of been measured during past exploration years in hard clays (Centaur Associates sound (Hawkins, 1981). Primary factors in the Beaufort and Chukchi seas. Inc., 1984). The energy regime plus determining whether a fish can sense a Sounds generated by drilling and ice- possible effects of ice gouge in the sound signal, and potentially react to it, management are generally low
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frequency and within the frequency and Nuiqsut (Cross Island) hunts, which region it will occupy and will likely not range detectable by most fish. typically ends around mid- to late cause marine mammals to deflect Based on a sound level of September (see the ‘‘Plan of Cooperation greatly from their typical migratory approximately 140 dB, there may be (POC)’’ subsection later in this route. Also, even if animals may deflect some avoidance by fish of the area near document for more details). If other because of the presence of the drillship, the drillship while drilling, around ice- individual bowheads stop to feed in the the Beaufort Sea’s migratory corridor is management vessels in transit and Camden Bay area after Shell resumes much larger in size than the length of during ice-management, and around drilling operations in mid- to late the drillship (many dozens of miles vs. other support and supply vessels when September, they may potentially be less than two football fields), and underway. Any reactions by fish to exposed to sounds from the drillship. animals would have other means of these sounds will last only minutes However, injury to the bowhead whales passage around the drillship. In sum, (Mitson and Knudsen, 2003; Ona et al., is not anticipated, as the source level of the physical presence of the drillship is 2007) longer than the vessel is operating the drillship is not loud enough to cause not likely to cause a significant at that location or the drillship is even mild TTS, as discussed earlier in deflection to migrating marine drilling. Any potential reactions by fish this document. As mentioned earlier in mammals. would be limited to a relatively small this document, some bowhead whales Potential Impacts From Ice Management area within about 0.21 mi (0.34 km) of have demonstrated avoidance behavior the drillship during drilling (JASCO, in areas of industrial sound (e.g., Ice-management activities include the 2007). Avoidance by some fish or fish Richardson et al., 1999) and some have physical pushing or moving of ice to species could occur within portions of continued to feed even in the presence create more open-water in the proposed this area. No important spawning of industrial activities (Richardson, drilling area and to prevent ice floes habitats are known to occur at or near 2004). However, Camden Bay is one of from striking the drillship. Ringed, the drilling locations. Additionally, a few feeding locations for bowhead bearded, and spotted seals (along with impacts to fish as a prey species for whales in the Beaufort Sea. Also, as the ribbon seal and walrus) are odontocetes and seals are expected to be discussed previously, drilling dependent on sea ice for at least part of minor. operations are not expected to adversely their life history. Sea ice is important for Some mysticetes, including bowhead affect bowhead whale prey species or life functions such as resting, breeding, whales, feed on concentrations of preclude bowhead whales from and molting. These species are zooplankton. Some feeding bowhead obtaining sufficient food resources along dependent on two different types of ice: whales may occur in the Alaskan their traditional migratory path. Pack ice and landfast ice. Should ice- Beaufort Sea in July and August, and management activities be necessary others feed intermittently during their Potential Impacts From Drillship during the proposed drilling program, westward migration in September and Presence Shell would only manage pack ice in October (Richardson and Thomson The Discoverer is 514 ft (156.7 m) either early to mid-July or mid- to late [eds.], 2002; Lowry et al., 2004). long. If an animal’s swim path is October. Landfast ice would not be Reactions of zooplankton to sound are, directly perpendicular to the drillship, present during Shell’s proposed for the most part, not known. Their the animal will need to swim around operations. ability to move significant distances is the ship in order to pass through the The ringed seal is the most common limited or nil, depending on the type of area. The length of the drillship pinniped species in the proposed zooplankton. A reaction by zooplankton (approximately one and a half football project area. While ringed seals use ice to sounds produced by the exploratory fields) is not significant enough to cause year-round, they do not construct lairs drilling program would only be relevant a large-scale diversion from the animals’ for pupping until late winter/early to whales if it caused concentrations of normal swim and migratory paths. spring on the landfast ice. Therefore, zooplankton to scatter. Pressure changes Additionally, the eastward spring since Shell plans to conclude drilling on of sufficient magnitude to cause that bowhead whale migration will occur October 31, Shell’s activities would not type of reaction would probably occur prior to the beginning of Shell’s impact ringed seal lairs or habitat only very close to the sound source, if proposed exploratory drilling program. needed for breeding and pupping in the any would occur at all due to the low The westward fall bowhead whale Camden Bay area. Ringed seals can be energy sounds produced by the migration begins in late August/early found on the pack ice surface in the late drillship. Impacts on zooplankton September and lasts through October. spring and early summer in the Beaufort behavior are predicted to be As discussed throughout this document, Sea, the latter part of which may overlap inconsequential. Thus, feeding Shell plans to suspend all operations on with the start of Shell’s proposed mysticetes would not be adversely August 25, move the drillship and all drilling activities. If an ice floe is affected by this minimal loss or support vessels out of the area to a pushed into one that contains hauled scattering, if any, of reduced location north and west of the well sites, out seals, the animals may become zooplankton abundance. and will not resume drilling activities startled and enter the water when the Aerial surveys in recent years have until the close of the Kaktovik and two ice floes collide. Bearded seals sighted bowhead whales feeding in Nuiqsut bowhead subsistence hunts. breed in the Bering and Chukchi Seas, Camden Bay on their westward This will reduce the amount of time that as the Beaufort Sea provides less migration through the Beaufort Sea. the Discoverer may impede the suitable habitat for the species. Spotted Individuals feeding in the Camden Bay bowheads’ normal swim and migratory seals are even less common in the area at the beginning of the migration paths as they move through Camden Camden Bay area. This species does not (i.e., approximately late August or early Bay. Moreover, any deflection of breed in the Beaufort Sea. Therefore, ice September) are not expected to be bowhead whales or other marine used by bearded and spotted seals impacted by Shell’s proposed drilling mammal species due to the physical needed for life functions such as program, primarily because of Shell’s presence of the drillship or its support breeding and molting would not be proposal to suspend operations and vessels would be very minor. The impacted as a result of Shell’s drilling depart the area on August 25 and not drillship’s physical footprint is small program since these life functions do return until the close of the Kaktovik relative to the size of the geographic not occur in the proposed project area.
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For ringed seals, ice-management would safety and disturbance zones and enough to cause a temporary reduction occur during a time when life functions shutting down activities for a portion of in hearing sensitivity or permanent such as breeding, pupping, and molting the open-water season. hearing damage to marine mammals. do not occur in the proposed activity Safety radii for marine mammals Consequently, Shell believes that area. Additionally, these life functions around sound sources are customarily mitigation as described for seismic normally occur on landfast ice, which defined as the distances within which activities including ramp ups, power will not be impacted by Shell’s activity. received sound levels are greater than or downs, and shutdowns should not be In conclusion, NMFS has equal to 180 dB re 1 μPa (rms) for necessary for drilling activities. NMFS preliminarily determined that Shell’s cetaceans and greater than or equal to has also preliminarily determined that proposed exploration drilling program 190 dB re 1 μPa (rms) for pinnipeds. these types of mitigation measures, in Camden Bay, Beaufort Sea, Alaska, is These safety criteria are based on an traditionally required for seismic survey not expected to have any habitat-related assumption that sounds at lower operations, are not practical or effects that could cause significant or received levels will not injure these necessary for this proposed drilling long-term consequences for individual animals or impair their hearing abilities, activity. Seismic airgun arrays can be marine mammals or on the food sources but that higher received levels might turned on slowly (i.e., only turning on that they utilize. have such effects. It should be one or some guns at a time) and understood that marine mammals inside powered down quickly. The types of Proposed Mitigation these safety zones will not necessarily sound sources used for exploratory In order to issue an incidental take be injured, seriously injured, or killed, drilling have different properties and authorization (ITA) under Sections as the received sound thresholds which are unable to be ‘‘powered down’’ like 101(a)(5)(A) and (D) of the MMPA, determine these zones were established airgun arrays or shutdown NMFS must, where applicable, set forth prior to the current understanding that instantaneously without posing other the permissible methods of taking significantly higher levels of sound risks. However, Shell plans to use pursuant to such activity, and other would be required before injury, serious marine mammal observers (MMOs) means of effecting the least practicable injury, or mortality could occur (see onboard the drillship and the various impact on such species or stock and its Southall et al., 2007). With respect to support vessels to monitor marine habitat, paying particular attention to Level B harassment, NMFS’ practice has mammals and their responses to rookeries, mating grounds, and areas of been to apply the 120 dB re 1 μPa (rms) industry activities and to initiate similar significance, and on the received level threshold for underwater mitigation measures should in-field availability of such species or stock for continuous sound levels. measurements of the operations indicate taking for certain subsistence uses Initial safety and behavioral radii for that such measures are necessary. (where relevant). the sound levels produced by the Additional details on the MMO program drilling activities have been modeled. are described in the ‘‘Proposed Mitigation Measures Proposed in Shell’s These radii will be used for mitigation Monitoring and Reporting’’ section IHA Application purposes, should they be necessary, found later in this document. Shell submitted a Marine Mammal until direct measurements are available Drilling sounds are expected to vary Monitoring and Mitigation Plan (4MP) early during the exploration activities. significantly with time due to variations as part of its application (Attachment B; However, it is not anticipated that in the level of operations and the see ADDRESSES). Shell’s planned source levels from the Discoverer will different types of equipment used at offshore drilling program incorporates reach the 180- or 190-dB (rms) levels. different times onboard the drillship. both design features and operational Sounds from the Discoverer have not Once on location in Camden Bay, Shell procedures for minimizing potential previously been measured in the Arctic will conduct sound source verification impacts on marine mammals and on or elsewhere, but sounds from a similar (SSV) tests to establish safety zones for subsistence hunts. The design features drillship, Explorer II, were measured in the previously mentioned sound level and operational procedures have been the Beaufort Sea (Greene, 1987; Miles et criteria. The objectives of the SSV tests described in the IHA and LOA al., 1987). The underwater received SPL are: (1) To quantify the absolute sound applications submitted to NMFS and in the 20 to 1,000 Hz band for drilling levels produced by drilling and to USFWS, respectively, and are activity by the Explorer II, including a monitor their variations with time, summarized here. Survey design nearby support vessel, was 134 dB re distance, and direction from the features include: 1 μPa (rms) at 0.1 mi (0.2 km; Greene drillship; and (2) to measure the sound • Timing and locating drilling and 1987). The back-propagated source levels produced by vessels operating in support activities to avoid interference levels (175 dB re 1 μPa at 1 m) from support of drilling operations, which with the annual fall bowhead whale these measurements were used as a include crew change vessels, tugs, ice- hunts from Kaktovik, Nuiqsut (Cross proxy for modeling the sounds likely to management vessels, and spill response Island), and Barrow; be produced by drilling activities from vessels. The methodology for • Identifying transit routes and timing the Discoverer. Based on the models, conducting the SSV tests is fully to avoid other subsistence use areas and source levels from drilling are not described in Shell’s 4MP (see communicating with coastal expected to reach the 180 dB rms level ADDRESSES). Please refer to that communities before operating in or and are expected to fall below 160 dB document for further details. Upon passing through these areas; and rms at 115 ft (35 m) from the drillship. completion of the SSV tests, the new • Conducting pre-season sound The 120 dB rms radius is expected to be radii will be established and monitored, propagation modeling to establish the 3 mi (4.9 km) from the drillship. These and mitigation measures will be appropriate safety and behavioral radii. estimated source measurements were implemented in accordance with Shell’s Shell indicates that the potential used to model the expected sounds 4MP. disturbance of marine mammals during produced at the exploratory well sites Additional mitigation measures operations will be minimized further by the Discoverer. proposed by Shell include: (1) Reducing through the implementation of several Based on the best available scientific speed and/or changing course if a ship-based mitigation measures, which literature, the source levels noted above marine mammal is sighted from a vessel include establishing and monitoring for exploration drilling are not high in transit (NMFS has proposed a
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specific distance in the next subsection); • The proven or likely efficacy of the maximum of 4 consecutive hours on (2) resuming full activity (e.g., full specific measure to minimize adverse watch per MMO; and (3) maximum of support vessel speed) only after marine impacts as planned; and 12 hours of watch time per day per mammals are confirmed to be outside • The practicability of the measure MMO. Shell anticipates that there will the safety zone; (3) implementing flight for applicant implementation. be provision for crew rotation at least restrictions prohibiting aircraft from Based on our evaluation of the every 6 weeks to avoid observer fatigue. flying below 1,500 ft (457 m) altitude applicant’s proposed measures, as well Biologist-observers will have previous (except during takeoffs and landings or as other measures considered by NMFS, marine mammal observation experience, in emergency situations); and (4) NMFS has preliminarily determined and field crew leaders will be highly keeping vessels anchored when that the proposed mitigation measures experienced with previous vessel-based approached by marine mammals to provide the means of effecting the least marine mammal monitoring projects. avoid the potential for avoidance practicable impact on marine mammal Resumes for those individuals will be reactions by such animals. species or stocks and their habitat, provided to NMFS so that NMFS can Shell has also proposed additional paying particular attention to rookeries, review and accept their qualifications. mitigation measures to ensure no mating grounds, and areas of similar Inupiat observers will be experienced in unmitigable adverse impact on the significance. the region, familiar with the marine availability of affected species or stocks Proposed Monitoring and Reporting mammals of the area, and complete a for taking for subsistence uses. Those NMFS approved observer training measures are described in the ‘‘Impact In order to issue an ITA for an course designed to familiarize on Availability of Affected Species or activity, Section 101(a)(5)(D) of the individuals with monitoring and data Stock for Taking for Subsistence Uses’’ MMPA states that NMFS must, where collection procedures. A MMO ‘‘ section found later in this document. applicable, set forth requirements handbook, adapted for the specifics of pertaining to the monitoring and the planned Shell drilling program, will Additional Mitigation Measures reporting of such taking’’. The MMPA Proposed by NMFS be prepared and distributed beforehand implementing regulations at 50 CFR to all MMOs. 216.104(a)(13) indicate that requests for In addition to the mitigation measures MMOs will watch for marine ITAs must include the suggested means proposed in Shell’s IHA application, mammals from the best available of accomplishing the necessary NMFS proposes the following measures vantage point on the drillship and monitoring and reporting that will result be included in the IHA, if issued, in support vessels. MMOs will scan in increased knowledge of the species order to ensure the least practicable systematically with the unaided eye and and of the level of taking or impacts on impact on the affected species or stocks: 7 x 50 reticle binoculars, supplemented populations of marine mammals that are (1) All vessels should reduce speed with 20 x 60 image-stabilized Zeiss expected to be present in the proposed when within 300 yards (274 m) of Binoculars or Fujinon 25 x 150 ‘‘Big- action area. whales. The reduction in speed will eye’’ binoculars and night-vision vary based on the situation but must be Monitoring Measures Proposed in equipment when needed. Personnel on sufficient to avoid interfering with the Shell’s IHA Application the bridge will assist the MMOs in whales. Those vessels capable of The monitoring plan proposed by watching for marine mammals. steering around such groups should do Information to be recorded by marine so. Vessels may not be operated in such Shell can be found in the 4MP (Attachment B of Shell’s application; mammal observers will include the a way as to separate members of a group same types of information that were of whales from other members of the see ADDRESSES). The plan may be modified or supplemented based on recorded during recent monitoring group; programs associated with industry (2) Avoid multiple changes in comments or new information received activity in the Arctic (e.g., Ireland et al., direction and speed when within 300 from the public during the public 2009). When a mammal sighting is yards (274 m) of whales; and comment period or from the peer review (3) When weather conditions require, panel (see the ‘‘Monitoring Plan Peer made, the following information about such as when visibility drops, support Review’’ section later in this document). the sighting will be recorded: vessels must reduce speed and change A summary of the primary components (A) Species, group size, age/size/sex direction, as necessary (and as of the plan follows. categories (if determinable), behavior when first sighted and after initial operationally practicable), to avoid the (1) Vessel-Based MMOs likelihood of injury to whales. sighting, heading (if consistent), bearing Vessel-based monitoring for marine and distance from the MMO, apparent Mitigation Conclusions mammals will be done by trained reaction to activities (e.g., none, NMFS has carefully evaluated the MMOs throughout the period of drilling avoidance, approach, paralleling, etc.), applicant’s proposed mitigation operations. MMOs will monitor the closest point of approach, and measures and considered a range of occurrence and behavior of marine behavioral pace; other measures in the context of mammals near the drillship during all (B) Time, location, speed, activity of ensuring that NMFS prescribes the daylight periods during operation and the vessel, sea state, ice cover, visibility, means of effecting the least practicable during most daylight periods when and sun glare; and impact on the affected marine mammal drilling operations are not occurring. (C) The positions of other vessel(s) in species and stocks and their habitat. Our MMO duties will include watching for the vicinity of the MMO location. evaluation of potential measures and identifying marine mammals, The ship’s position, speed of support included consideration of the following recording their numbers, distances, and vessels, and water temperature, water factors in relation to one another: reactions to the drilling operations. A depth, sea state, ice cover, visibility, and • The manner in which, and the sufficient number of MMOs will be sun glare will also be recorded at the degree to which, the successful required onboard each vessel to meeting start and end of each observation watch, implementation of the measure is the following criteria: (1) 100 percent every 30 minutes during a watch, and expected to minimize adverse impacts monitoring coverage during all periods whenever there is a change in any of to marine mammals; of drilling operations in daylight; (2) those variables.
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Distances to nearby marine mammals 2002; Patterson, 2007). This will position (latitude and longitude) for will be estimated with binoculars facilitate comparison and pooling of sightings and transect waypoints, and at (Fujinon 7 x 50 binoculars) containing data where appropriate. However, the pre-selected intervals along the a reticle to measure the vertical angle of specific survey grids will be tailored to transects. Ice observations during aerial the line of sight to the animal relative Shell’s operations. During the 2010 surveys will be recorded and satellite to the horizon. MMOs may use a laser drilling season Shell will coordinate imagery may be used, where available, rangefinder to test and improve their and cooperate with the aerial surveys during post-season analysis to abilities for visually estimating conducted by MMS/NMFS and any determine ice conditions adjacent to the distances to objects in the water. other groups conducting surveys in the survey area. These are standard However, previous experience showed same region. practices for surveys of this type and are that a Class 1 eye-safe device was not For marine mammal monitoring necessary in order to interpret factors able to measure distances to seals more flights, aircraft will be flown at responsible for variations in sighting than about 230 ft (70 m) away. The approximately 120 knots (138 mph) rates. device was very useful in improving the ground speed and usually at an altitude During the late summer and fall, the distance estimation abilities of the of 1,000 ft (305 m). Surveys in the bowhead whale is the primary species observers at distances up to about 1968 Beaufort Sea are directed at bowhead of concern, but belugas and gray whales ft (600 m)—the maximum range at whales, and an altitude of 900–1,000 ft are also present. To address concerns which the device could measure (274–305 m) is the lowest survey regarding deflection of bowheads at distances to highly reflective objects altitude that can normally be flown greater distances, the survey pattern such as other vessels. Humans observing without concern about potential aircraft around drilling operations has been objects of more-or-less known size via a disturbance. Aerial surveys at an designed to document whale standard observation protocol, in this altitude of 1,000 ft (305 m) do not distribution from about 25 mi (40 km) case from a standard height above water, provide much information about seals east of the drilling operations to about quickly become able to estimate but are suitable for both bowhead and 37 mi (60 km) west of operations (see distances within about ±20 percent beluga whales. The need for a 900– Figure 1 of Shell’s 4MP). when given immediate feedback about 1000+ (374–305 m) ft cloud ceiling will Bowhead whale movements during actual distances during training. limit the dates and times when surveys the late summer/autumn are generally can be flown. from east to west, and transects should (2) Aerial Survey Program Two primary observers will be seated be designed to intercept rather than Shell proposes to conduct an aerial at bubble windows on either side of the parallel whale movements. The transect survey program in support of the aircraft and a third observer will observe lines in the grid will be oriented north- drilling program in the Beaufort Sea part time and record data the rest of the south, equally spaced at 5 mi (8 km) and during the summer and fall of 2010. time. All observers need bubble randomly shifted in the east-west Shell’s objectives for this program windows to facilitate downward direction for each survey by no more include: viewing. For each marine mammal than the transect spacing. The survey (A) To advise operating vessels as to sighting, the observer will dictate the grid will total about 808 mi (1,300 km) the presence of marine mammals species, number, size/age/sex class in length, requiring approximately 6 (primarily cetaceans) in the general area when determinable, activity, heading, hours to survey at a speed of 120 knots of operation; swimming speed category (if traveling), (138 mph), plus ferry time. Exact (B) To collect and report data on the sighting cue, ice conditions (type and lengths and durations will vary distribution, numbers, movement and percentage), and inclinometer reading to somewhat depending on the position of behavior of marine mammals near the the marine mammal into a digital the drilling operation and thus of the drilling operations with special recorder. The inclinometer reading will grid, the sequence in which lines are emphasis on migrating bowhead whales; be taken when the animal’s location is flown (often affected by weather), and (C) To support regulatory reporting 90° to the side of the aircraft track, the number of refueling/rest stops. related to the estimation of impacts of allowing calculation of lateral distance Weather permitting, transects making drilling operations on marine mammals; from the aircraft trackline. up the grid in the Beaufort Sea will be (D) To investigate potential deflection Transect information, sighting data flown in sequence from west to east. of bowhead whales during migration by and environmental data will be entered This decreases difficulties associated documenting how far east of drilling into a GPS-linked computer by the third with double counting of whales that are operations a deflection may occur and observer and simultaneously recorded (predominantly) migrating westward. where whales return to normal on digital voice recorders for backup The survey sequence around the drilling migration patterns west of the and validation. At the start of each operation is designed to monitor the operations; and transect, the observer recording data distribution of whales around the (E) To monitor the accessibility of will record the transect start time and drilling operation. bowhead whales to Inupiat hunters. position, ceiling height (ft), cloud cover Aerial survey flights will begin 5 to 7 (in 10ths), wind speed (knots), wind (3) Acoustic Monitoring days before operations at the direction (°T) and outside air As discussed earlier in this document, exploration well sites get underway. temperature (°C). In addition, each Shell will conduct SSV tests to establish Surveys will be flown daily throughout observer will record the time, visibility the isopleths for the applicable safety drilling operations, weather and flight (subjectively classified as excellent, radii. In addition, Shell proposes to use conditions permitting, and continued good, moderately impaired, seriously acoustic recorders to study bowhead for 5 to 7 days after all activities at the impaired or impossible), sea state deflections. site have ended. (Beaufort wind force), ice cover (in Shell plans to deploy arrays of The aerial survey procedures will be 10ths) and sun glare (none, moderate, acoustic recorders in the Beaufort Sea in generally consistent with those used severe) at the start and end of each 2010, similar to that which was done in during earlier industry studies (Davis et transect, and at 2 min intervals along 2007 and 2008 using Directional al., 1985; Johnson et al., 1986; Evans et the transect. The data logger will Autonomous Seafloor Acoustic al., 1987; Miller et al., 1997, 1998, 1999, automatically record time and aircraft Recorders (DASARs). These directional
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acoustic systems permit localization of In attempting to assess the responses capacity of 10 months at that recording bowhead whale and other marine of bowhead whales to the planned rate. This should be ample space to mammal vocalizations. The purpose of industrial operations, it will be essential allow over-wintering from the array will be to further understand, to monitor whale locations at sites both approximately mid-October 2010, define, and document sound near and far from industry activities. through mid-July 2011. characteristics and propagation Shell plans to monitor at five sites along Additional details on methodology resulting from vessel-based drilling the Alaskan Beaufort coast as shown in and data analysis for the three types of operations that may have the potential Figure 10 of Shell’s 4MP. The eastern- monitoring described here (i.e., vessel- to cause deflections of bowhead whales most site (#5 in Figure 10 of the 4MP) based, aerial, and acoustic) can be found from their migratory pathway. Of will be just east of Kaktovik in the 4MP in Shell’s application (see particular interest will be the east-west (approximately 62 mi [100 km] west of ADDRESSES). extent of deflection, if any (i.e., how far the Sivulliq drilling area) and the east of a sound source do bowheads western-most site (#1 in Figure 10 of the Monitoring Plan Peer Review begin to deflect and how far to the west 4MP) will be in the vicinity of Harrison The MMPA requires that monitoring beyond the sound source does Bay (approximately 109 mi [175 km] plans be independently peer reviewed deflection persist). Of additional interest west of Sivulliq) . Site 2 will be located ‘‘where the proposed activity may affect will be the extent of offshore (or towards west of Prudhoe Bay (approximately 68 the availability of a species or stock for shore) deflection that might occur. mi [110 km] west of Sivulliq). Site 4 will taking for subsistence uses’’ (16 U.S.C. In previous work around seismic and be approximately 6.2 mi (10 km) east of 1371(a)(5)(D)(ii)(III)). Regarding this drillship operations in the Alaskan the Sivulliq drilling area, and site 3 will requirement, NMFS’ implementing Beaufort Sea, the primary method for be approximately 15.5 mi (25 km) west regulations state, ‘‘Upon receipt of a studying this question has been aerial of Sivulliq. These five sites will provide complete monitoring plan, and at its surveys. Acoustic localization methods information on possible migration discretion, [NMFS] will either submit will provide supplementary information deflection well in advance of whales the plan to members of a peer review for addressing the whale deflection encountering an industry operation and panel for review or within 60 days of question. Compared to aerial surveys, on ‘‘recovery’’ after passing such receipt of the proposed monitoring plan, acoustic methods have the advantage of operations should a deflection occur. schedule a workshop to review the providing a vastly larger number of The proposed geometry of DASARs at plan’’ (50 CFR 216.108(d)). whale detections, and can operate day each site is comprised of seven DASARs NMFS has established an or night, independent of visibility, and oriented in a north-south pattern so that independent peer review panel to to some degree independent of ice five equilateral triangles with 4.3-mi review Shell’s 4MP for Exploration conditions and sea state—all of which (7-km) element spacing is achieved. Drilling of Selected Lease Areas in the prevent or impair aerial surveys. DASARs will be installed at planned Alaskan Beaufort Sea in 2010. The panel However, acoustic methods depend on locations using a GPS. However, each met in late March 2010, and will the animals to call, and to some extent, DASAR’s orientation once it settles on provide comments to NMFS in mid- assume that calling rate is unaffected by the bottom is unknown and must be April 2010. After completion of the peer exposure to industrial noise. Bowheads determined to know how to reference review, NMFS will consider all call frequently in fall, but there is some the call angles measured to the whales. recommendations made by the panel, evidence that their calling rate may be Also, the internal clocks used to sample incorporate appropriate changes into the reduced upon exposure to industrial the acoustic data typically drift slightly, monitoring requirements of the IHA (if sounds, complicating interpretation. but linearly, by an amount up to a few issued), and publish the panel’s findings The combined use of acoustic and aerial seconds after 6 weeks of autonomous and recommendations in the final IHA survey methods will provide a suite of operation. Knowing the time differences notice of issuance or denial document. information that should be useful in within a second or two between assessing the potential effects of drilling DASARs is essential for identifying Reporting Measures operations on migrating bowhead identical whale calls received on two or (1) SSV Report whales. more DASARs. Using passive acoustics with Bowhead migration begins in late A report on the preliminary results of directional autonomous recorders, the August with the whales moving the acoustic verification measurements, locations of calling whales will be westward from their feeding sites in the including as a minimum the measured observed for a 6- to 10-week continuous Canadian Beaufort Sea. It continues 190-, 180-, 160-, and 120-dB (rms) radii monitoring period at five coastal sites through September and well into of the drillship and the support vessels, (subject to favorable ice and weather October. However, because of the will be submitted within 120 hr after conditions). Essential to achieving this drilling schedule, Shell will attempt to collection and analysis of those objective is the continuous install the 21 DASARs at three sites (3, measurements at the start of the field measurement of sound levels near the 4 and 5) in early August. The remaining season. This report will specify the drillship. 14 DASARs will be installed at sites 1 distances of the safety zones that were Shell plans to conduct the whale and 2 in late August. Thus, Shell adopted for the exploratory drilling migration monitoring using the passive proposes to be monitoring for whale program. acoustics techniques developed and calls from before August 15 until (2) Technical Reports used successfully since 2001 for sometime before October 15. monitoring the migration past Northstar At the end of the season, the fourth The results of Shell’s 2010 Camden production island northwest of Prudhoe DASAR in each array will be Bay exploratory drilling monitoring Bay and from Kaktovik to Harrison Bay refurbished, recalibrated, and program (i.e., vessel-based, aerial, and during the 2007 and 2008 migrations. redeployed to collect data through the acoustic) will be presented in the ‘‘90- Those techniques involve using winter. The other DASARs in the arrays day’’ and Final Technical reports, as DASARs to measure the arrival angles of will be recovered. The redeployed required by NMFS under IHAs. Shell bowhead calls at known locations, then DASARs will be programmed to record proposes that the Technical Reports will triangulating to locate the calling whale. 35 min every 3 hours with a disk include: (1) Summaries of monitoring
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effort (e.g., total hours, total distances, March, 2009, Shell released a final, discovery, observed behaviors (if alive), and marine mammal distribution peer-reviewed edition of the Joint and photo or video (if available). through study period, accounting for sea Monitoring Program in the Chukchi and In the event that an injured or dead state and other factors affecting Beaufort Seas, Open Water Seasons, marine mammal is found by Shell that visibility and detectability of marine 2006–2007 (Ireland et al., 2009). This is not in the vicinity of the proposed mammals); (2) analyses of the effects of report is also available on the NMFS drilling program, Shell will report the various factors influencing detectability Protected Resources Web site (see same information listed above to NMFS of marine mammals (e.g., sea state, ADDRESSES). A draft comprehensive as soon as operationally feasible. number of observers, and fog/glare); (3) report for 2008 (Funk et al., 2009) was Estimated Take by Incidental species composition, occurrence, and provided to NMFS and those attending Harassment distribution of marine mammal the Arctic Stakeholder Open-water sightings, including date, water depth, Workshop in Anchorage, Alaska, on Except with respect to certain numbers, age/size/gender categories (if April 6–8, 2009. The 2008 report activities not pertinent here, the MMPA determinable), group sizes, and ice provides data and analyses from a defines ‘‘harassment’’ as: any act of cover; (4) sighting rates of marine number of industry monitoring and pursuit, torment, or annoyance which (i) mammals during periods with and research studies carried out in the has the potential to injure a marine without drilling activities (and other Chukchi and Beaufort Seas during the mammal or marine mammal stock in the variables that could affect detectability); 2008 open-water season with wild [Level A harassment]; or (ii) has (5) initial sighting distances versus comparison to data collected in 2006 the potential to disturb a marine drilling state; (6) closest point of and 2007. Reviewers plan to provide mammal or marine mammal stock in the approach versus drilling state; (7) comments on the 2008 report to Shell. wild by causing disruption of behavioral patterns, including, but not limited to, observed behaviors and types of Once Shell is able to incorporate migration, breathing, nursing, breeding, movements versus drilling state; (8) reviewer comments, the final 2008 feeding, or sheltering [Level B numbers of sightings/individuals seen report will be made available to the harassment]. Only take by Level B versus drilling state; (9) distribution public. The 2009 draft comprehensive behavioral harassment is anticipated as around the drillship and support vessels report is due to NMFS by mid-April a result of the proposed drilling versus drilling state; and (10) estimates 2010. NMFS will make this report program. Anticipated impacts to marine of take by harassment. This information available to the public upon receipt. will be reported for both the vessel- mammals are associated with noise Following the 2010 drilling season a propagation from the drillship and based and aerial monitoring. comprehensive report describing the Analysis of all acoustic data will be associated support vessels. Additional vessel-based, aerial, and acoustic prioritized to address the primary disturbance to marine mammals may monitoring programs will be prepared. questions, which are to: (a) Determine result from aircraft overflights and The comprehensive report will describe when, where, and what species of visual disturbance of the drillship or animals are acoustically detected on the methods, results, conclusions and support vessels. However, based on the each DASAR; (b) analyze data as a limitations of each of the individual flight paths and altitude, impacts from whole to determine offshore bowhead data sets in detail. The report will also aircraft operations are anticipated to be distributions as a function of time; (c) integrate (to the extent possible) the localized and minimal in nature. quantify spatial and temporal variability studies into a broad based assessment of The full suite of potential impacts to in the ambient noise; and (d) measure industry activities, and other activities marine mammals from various received levels of drillship activities. that occur in the Beaufort and/or industrial activities was described in The bowhead detection data will be Chukchi seas, and their impacts on detail in the ‘‘Potential Effects of the used to develop spatial and temporal marine mammals during 2010. The Specified Activity on Marine Mammals’’ animal distributions. Statistical analyses report will help to establish long-term section found earlier in this document. will be used to test for changes in data sets that can assist with the The potential effects of sound from the animal detections and distributions as a evaluation of changes in the Chukchi proposed exploratory drilling program function of different variables (e.g., time and Beaufort Sea ecosystems. The report might include one or more of the of day, time of season, environmental will attempt to provide a regional following: tolerance; masking of natural conditions, ambient noise, vessel type, synthesis of available data on industry sounds; behavioral disturbance; non- operation conditions). activity in offshore areas of northern auditory physical effects; and, at least in The initial technical report is due to Alaska that may influence marine theory, temporary or permanent hearing NMFS within 90 days of the completion mammal density, distribution and impairment (Richardson et al., 1995a). of Shell’s Beaufort Sea exploratory behavior. The comprehensive report As discussed earlier in this document, drilling program. The ‘‘90-day’’ report will be due to NMFS within 240 days the most common impact will likely be will be subject to review and comment of the date of issuance of the IHA (if from behavioral disturbance, including by NMFS. Any recommendations made issued). avoidance of the ensonified area or changes in speed, direction, and/or by NMFS must be addressed in the final (4) Notification of Injured or Dead diving profile of the animal. For reasons report prior to acceptance by NMFS. Marine Mammals discussed previously in this document, (3) Comprehensive Report Shell will notify NMFS’ Office of hearing impairment (TTS and PTS) are In November, 2007, Shell (in Protected Resources and NMFS’ highly unlikely to occur based on the coordination and cooperation with other Stranding Network within 48 hours of fact that most of the equipment to be Arctic seismic IHA holders) released a sighting an injured or dead marine used during Shell’s proposed drilling final, peer-reviewed edition of the 2006 mammal in the vicinity of drilling program does not have source levels Joint Monitoring Program in the operations. Shell will provide NMFS high enough to elicit even mild TTS. Chukchi and Beaufort Seas, July– with the species or description of the Additionally, non-auditory November 2006 (LGL, 2007). This report animal(s), the condition of the animal(s) physiological effects are anticipated to is available on the NMFS Protected (including carcass condition if the be minor, if any would occur at all. Resources Web site (see ADDRESSES). In animal is dead), location, time of first Finally, based on the proposed
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mitigation and monitoring measures the project area. The area of water that exposed to sounds ≥120 dB by the described earlier in this document and may be ensonified to the above sound drilling vessel will be in ice margin the fact that the back-propagated source levels is described further in the habitat. Therefore, ice-margin densities level for the drillship is estimated to be ‘‘Potential Number of Takes by of marine mammals in both seasons 175 dB re 1 μPa (rms), no injury or Harassment’’ subsection. have been multiplied by 33 percent of mortality of marine mammals is Marine mammal densities near the the area exposed to sounds by the anticipated as a result of Shell’s operation are likely to vary by season drilling vessel, while open-water proposed exploratory drilling program. and habitat. However, sufficient (nearshore) densities have been For continuous sounds, such as those published data allowing the estimation multiplied by the remaining 67 percent produced by drilling operations, NMFS of separate densities during summer of the area. uses a received level of 120-dB (rms) to (July and August) and fall (September To provide some allowance for the indicate the onset of Level B and October) are only available for uncertainties, ‘‘maximum estimates’’ as harassment. Shell provided calculations beluga and bowhead whales. As noted well as ‘‘average estimates’’ of the for the 120-dB isopleths produced by above, exposures of bowhead whales numbers of marine mammals potentially the Discoverer and then used those during the fall are not calculated using affected have been derived. For a few isopleths to estimate takes by densities (see below). Therefore, marine mammal species, several density harassment. Shell also included summer and fall densities have been estimates were available, and in those modeling results of the 160-dB isopleths estimated for beluga whales, and a cases the mean and maximum estimates for the Discoverer and associated summer density has been estimated for were determined from the survey data. estimated takes by harassment. bowhead whales. Densities of all other In other cases, no applicable estimate However, NMFS has used the 120-dB species have been estimated to represent (or perhaps a single estimate) was calculations to make the necessary the duration of both seasons. available, so correction factors were MMPA preliminary findings. Shell Marine mammal densities are also used to arrive at ‘‘average’’ and provides a full description of the likely to vary by habitat type. In the ‘‘maximum’’ estimates. These are methodology used to estimate takes by Alaskan Beaufort Sea, where the described in detail in the following harassment in its IHA application (see continental shelf break is relatively subsections. NMFS has determined that ADDRESSES), which is also provided in close to shore, marine mammal habitat the average density data of marine the following sections. However, this is often defined by water depth. mammal populations will be used to document only discusses the take Bowhead and beluga occurrence within calculate estimated take numbers estimates at the 120 dB level. Please nearshore (0–131 ft, 0–40 m), outer because these numbers are based on refer to Shell’s application for the full continental shelf (131–656 ft, 40–200 surveys and monitoring of marine explanation and estimates at the 160 dB m), slope (656–6,562 ft, 200–2000 m), mammals in the vicinity of the proposed level. basin (>6,562 ft, 2000 m), or similarly project area. NMFS only used the Shell has requested authorization for defined habitats have been described ‘‘maximum’’ estimate for marine bowhead, gray, and beluga whales and previously (Moore et al., 2000; mammal species that are less likely to ringed, spotted, and bearded seals. Richardson and Thomson, 2002). The occur in the project area and for which Additionally, Shell provided exposure presence of most other species has little to no density information exists estimates and requested takes of ribbon generally only been described relative to (i.e., gray whales and spotted seals). seals, humpback whales, minke whales, the entire continental shelf zone (0–656 Detectability bias, quantified in part harbor porpoise, and narwhal. However, ft, 0–200 m) or beyond. Sounds by f(0), is associated with diminishing as stated previously in this document, produced by the drilling vessel are sightability with increasing lateral sightings of these species are rare, and expected to drop below 120 dB within distance from the trackline. Availability the likelihood of occurrence of these the nearshore zone (0–131 ft, 0–40 m, bias [g(0)] refers to the fact that there is species in the proposed drilling area is water depth) while sounds produced by <100 percent probability of sighting an minimal. ice-management activities, if they are animal that is present along the survey necessary, are likely to also be present Basis for Estimating ‘‘Take by trackline. Some sources of densities in the outer continental shelf (131–656 Harassment’’ used below included these correction ft, 40–200 m). Sounds ≥120 dB are not factors in their reported densities. In ‘‘Take by Harassment’’ is described in expected to occur in waters >656 ft (200 other cases the best available correction this section and was calculated in m). Since the only instance in which factors were applied to reported results Shell’s application by multiplying the sounds at the indicated levels may be when they had not been included in the expected densities of marine mammals introduced to the outer continental shelf reported data (e.g., Moore et al., 2000). that may occur near the exploratory would be during ice-management drilling operations by the area of water activities, and therefore ice-margin (1) Cetaceans likely to be exposed to continuous densities are more applicable, separate As noted above, the densities of sound levels of ≥120 dB. The single beluga and bowhead densities for the beluga and bowhead whales present in exception to this method is for the outer continental shelf have not been the Beaufort Sea are expected to vary by estimation of exposures of bowhead used in the calculations. season and location. During the early whales during the fall migration where In addition to water depth, densities and mid-summer, most belugas and more detailed data were available, of marine mammals are likely to vary bowheads are found in the Canadian allowing an alternate approach, with the presence or absence of sea ice Beaufort Sea and Amundsen Gulf or described below, to be used. NMFS (see later for descriptions by species). At adjacent areas. Low numbers are found evaluated and critiqued the methods times during either summer or fall, in the eastern Alaskan Beaufort Sea. provided in Shell’s application and pack-ice may be present in some of the Belugas begin to move across the determined that they were appropriate area around the drilling operation. Alaskan Beaufort Sea in August, and in order to make the necessary However, the retreat of sea ice in the bowheads do so toward the end of preliminary MMPA findings. This Alaskan Beaufort Sea has been August. section describes the estimated densities substantial in recent years, so Shell has Beluga Whales—Beluga density of marine mammals that may occur in assumed that only 33 percent of the area estimates were derived from data in
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Moore et al. (2000). During the summer, conditions in summer in the Beaufort Beaufort Sea belugas occurred in beluga whales are most likely to be Sea, so the same density was used for moderate to heavy ice at higher rates encountered in offshore waters of the both nearshore and ice-margin estimates than in light ice, so ice-margin densities eastern Alaskan Beaufort Sea or areas (Table 6–1 in Shell’s application and were estimated to be twice the with pack ice. The summer beluga Table 1 here). The fall beluga whale nearshore densities. Based on the CV of whale nearshore density (Table 6–1 in nearshore density was based on group size maximum estimates in both Shell’s application and Table 1 here) 45,180.5 mi (72,711 km) of on-transect season and habitats were estimated as was based on 7,447 mi (11,985 km) of effort and 28 associated sightings that ‘‘ ≤ four times the average estimates. Takes on-transect effort and nine associated occurred in water 164 ft (50 m) by harassment’’ of beluga whales during sightings that occurred in water ≤164 ft reported in Moore et al. (2000). A mean the fall in the Beaufort Sea were not (50 m) in Moore et al. (2000; Table 6– group size of 2.9 (CV=1.9), calculated calculated in the same manner as 2 in Shell’s application and Table 2 from all Beaufort Sea fall beluga here). A mean group size of 1.63, a f(0) sightings in ≤164 ft (50 m) of water described for bowhead whales because value of 2.841, and a g(0) value of 0.58 present in the Bowhead Whale Aerial of the relatively lower expected from Harwood et al. (1996) were also Survey Program database, along with densities of beluga whales in nearshore used in the calculation. Moore et al. the same f(0) and g(0) values from habitat near the exploration drilling (2000) found that belugas were equally Harwood et al. (1996) were also used in program and the lack of detailed data on likely to occur in heavy ice conditions the calculation. Moore et al. (2000) the likely timing and rate of migration as open-water or very light ice found that during the fall in the through the area.
TABLE 1—EXPECTED SUMMER (JUL–AUG) DENSITIES OF BELUGA AND BOWHEAD WHALES IN THE EASTERN ALASKAN BEAUFORT SEA. DENSITIES ARE CORRECTED FOR F(0) AND G(0) BIASES. SPECIES LISTED UNDER THE U.S. ESA AS ENDANGERED ARE SHOWN IN ITALIC
Nearshore Ice margin Species Average Maximum Average Maximum density density density density (# /km2) (# /km2) (# /km2) (# /km2)
Beluga ...... 0.0030 0.0120 0.0030 0.0120 Bowhead whale ...... 0.0186 0.0717 0.0186 0.0717
TABLE 2—EXPECTED FALL (SEP–NOV) DENSITIES OF BELUGA AND BOWHEAD WHALES IN THE EASTERN ALASKAN BEAU- FORT SEA. DENSITIES ARE CORRECTED FOR F(0) AND G(0) BIASES. SPECIES LISTED UNDER THE U.S. ESA AS EN- DANGERED ARE SHOWN IN ITALIC
Nearshore Ice margin Species Average Maximum Average Maximum density density density density (# /km2) (# /km2) (# /km2) (# /km2)
Beluga ...... 0.0027 0.0108 0.0054 0.0216 Bowhead whalea ...... NA NA NA NA a See text for description of how bowhead whales estimates were made.
Bowhead Whales—Industry aerial density, and the estimate of 0.0717 calculating the number of individual surveys of the continental shelf near whales/km2 was used as the maximum. bowheads exposed to sounds produced Camden Bay in 2008 recorded eastward Sea ice was not present during these by the exploration drilling program from migrating bowhead whales until July 12 surveys. Moore et al. (2000) reported the method used to calculate the (Lyons and Christie, 2009). No bowhead that bowhead whales in the Alaskan number of exposures for bowheads in sightings were recorded again, despite Beaufort Sea were distributed uniformly summer and the other marine mammal continued flights until August 19. Aerial relative to sea ice, so the same nearshore species for the entire season. The surveys by industry operators did not densities were used for ice-margin method is founded on estimates of the begin until late August of 2006 and habitat. proportion of the population that would 2007, but in both years bowheads were During the fall, most bowhead whales pass within the ≥120 dB zone on a given also recorded in the region before the will be migrating west past the day in the fall during the exploration end of August (Christie et al., 2009). The exploration drilling program, so it is less drilling program. Based on the fact that late August sightings were likely of accurate to assume that the number of most bowhead whales will be engaged bowheads beginning their fall migration, individuals present in the area from one in the fall migration at this time, NMFS so the densities calculated from those day to the next will be static. However, preliminarily determined that this surveys were not used to estimate feeding, resting, and milling behaviors method was appropriate for estimating summer densities in this region. The are not entirely uncommon at this time the number of individual bowhead three surveys in July 2008, resulted in and location either. In order to whales that may be exposed to drilling density estimates of 0.0099, 0.0717, and incorporate the movement of whales sounds after August 25. 0.0186 whales/km2, respectively. The past the planned operations, and Exploration drilling will be estimate of 0.0186 whales/km2 was used because the necessary data are available, suspended on August 25 prior to the as the average summer nearshore Shell developed an alternate method of start of the bowhead subsistence hunts
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at Kaktovik and Nuiqsut (Cross Island) also calculated the proportion of the number of exposures calculated by and will be resumed when the hunts are animals within water depth bins (<66 ft Shell would be an overestimate, as Shell concluded. After the completion of the [20m], 66–131 ft [20–40m], 131–656 ft will still need to end active operations subsistence hunts (expected in mid- [40–200m], and >656 ft [200m]). Using by the end of October because of the September), approximately 40 days of this information, Shell multiplied the increased chance of their being activity will be required to complete the total number of whales expected to pass additional ice covering the drill sites planned drilling operations. The current the drilling program each day by the later in the season. population size would be approximately proportion of whales that would be in Gray Whales—For gray whales, 14,247 individuals based on a 2001 each depth category to estimate how densities are likely to vary somewhat by population of 10,545 (Zeh and Punt, many individuals would be within each season, but differences are not expected 2005) and a continued annual growth depth bin on a given day. The to be great enough to require estimation rate of 3.4 percent (Allen and Angliss, proportion of each depth bin falling of separate densities for the two seasons. 2010). Based on data in Richardson and within the ≥120 dB zone was then Gray whales are not expected to be Thomson (2002, Appendix 9.1), the multiplied by the number of whales present in large numbers in the Beaufort number of whales expected to pass each within the respective bins to estimate Sea during the fall but small numbers day after conclusion of the bowhead the total number of individuals that may be encountered during the summer. subsistence hunts (assumed to be would be exposed on each day. This They are most likely to be present in September 15) was estimated as a was repeated for a total of 40 days nearshore waters. Since this species proportion of the population. Minimum (September 15 to October 24), and the occurs infrequently in the Beaufort Sea, and maximum estimates of the number results were summed to estimate the little to no data are available for the of whales passing each day were not total number of bowhead whales that calculation of densities. Minimal available, so a single estimate based on might be exposed to ≥120 dB during the densities have therefore been assigned the 10-day moving average presented by migration period in the Beaufort Sea. If for calculation purpose and to allow for Richardson and Thomson (2002) was the hunts at Kaktovik and Cross Island chance encounters (see Table 6–3 in used. Richardson and Thomson (2002) (Nuiqsut) end later than September 15, Shell’s application and Table 3 here).
TABLE 3—EXPECTED DENSITIES OF CETACEANS (EXCLUDING BELUGA AND BOWHEAD WHALE) AND SEALS IN THE ALASKAN BEAUFORT SEA
Nearshore Ice margin Species Average Maximum Average Maximum density density density density (# /km2) (# /km2) (# /km2) (# /km2)
Odontocetes: Monodontidae: Narwhal ...... 0.0000 0.0000 0.0000 0.0001 Phocoenidae: Harbor porpoise ...... 0.0001 0.0004 0.0000 0.0000 Mysticetes: Gray whale...... 0.0001 0.0004 0.0000 0.0000 Pinnipeds: Bearded seal...... 0.0181 0.0724 0.0128 0.0512 Ribbon seal...... 0.0001 0.0004 0.0001 0.0004 Ringed seal...... 0.3547 1.4188 0.2510 1.0040 Spotted seal ...... 0.0037 0.0149 0.0001 0.0004
(2) Pinnipeds of ship–based surveys at times without zones (Table 6–3 in Shell’s application Extensive surveys of ringed and seismic operations reported by Moulton and Table 3 here). bearded seals have been conducted in and Lawson (2002; Table 6–3 in Shell’s Potential Number of Takes by the Beaufort Sea, but most surveys have application and Table 3 here). Harassment been conducted over the landfast ice, Densities of bearded seals were (1) Estimates of the Number of and few seal surveys have occurred in estimated by multiplying the ringed seal open-water or in the pack ice. Kingsley Individuals That May Be Exposed to densities by 0.051 based on the Sounds ≥120 dB (1986) conducted ringed seal surveys of proportion of bearded seals to ringed the offshore pack ice in the central and seals reported in Stirling et al. (1982; Just because a marine mammal is ≥ eastern Beaufort Sea during late spring Table 6–3 in Shell’s application and exposed to drilling sounds 120 dB (late June). These surveys provide the Table 3 here). Spotted seal densities in (rms), this does not mean that it will most relevant information on densities the nearshore zone were estimated by actually exhibit a disruption of of ringed seals in the ice margin zone of behavioral patterns in response to the summing the ringed seal and bearded the Beaufort Sea. The density estimate sound source. Rather, the estimates seal densities and multiplying the result in Kingsley (1986) was used as the provided here are simply the best average density of ringed seals that may by 0.015 based on the proportion of estimates of the number of animals that be encountered in the ice margin (Table spotted seals to ringed plus bearded potentially could have a behavioral 6–3 in Shell’s application and Table 3 seals reported in Moulton and Lawson modification due to the noise. However, here). The average ringed seal density in (2002; Table 6–3 in Shell’s application not all animals react to sounds at this the nearshore zone of the Alaskan and Table 3 here). Minimal values were low level, and many will not show Beaufort Sea was estimated from results assigned as densities in the ice–margin strong reactions (and in some cases any
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reaction) until sounds are much (2) Estimated Area Exposed to Sounds individual cetaceans exposed, in stronger. There are several variables that ≥120 dB descending order, are bowhead whale determine whether or not an individual The total area of a 4.6 mi (7.4 km) (1,968 and 1,977), beluga whale (1 and animal will exhibit a response to the radius circle (66.4 mi2 [172 km2]; 4), and gray whale (0 and 5). Table 6– sound, such as the age of the animal, representing 1.5 × the ≥120 dB radius of 7 in Shell’s application and Table 4 here previous exposure to this type of 3.06 mi [4.93 km] modeled by JASCO summarize the number of marine anthropogenic sound, habituation, etc. for the Discoverer) was used to calculate mammal species or stocks that may Numbers of marine mammals that the area ensonified to ≥120 dB around experience Level B harassment. might be present and potentially the Discoverer operating at either of the The estimates show that one disturbed (i.e., Level B harassment) are planned drill sites (Sivulliq N and endangered cetacean species (the estimated below based on available data Torpedo H). This area falls within water bowhead whale) is expected to be about mammal distribution and less than 131 ft (40 m) deep at both exposed to sounds ≥120 dB unless densities at different locations and times planned locations. The area exposed to bowheads avoid the area around the ≤ of the year as described previously. sounds by drilling occurs in waters 131 drill sites (Tables 6–4 and 6–5 in Shell’s Exposure estimates are based on a single ft (40 m) deep, so 67 percent was application). Migrating bowheads are drillship (Discoverer) operating in multiplied by the nearshore zone likely to do so to some extent, though Camden Bay beginning in July. Shell densities and the remaining 33 percent many of the bowheads engaged in other will not operate the Discoverer and by the ice-margin densities. activities, particularly feeding and associated vessels in Camden Bay For analysis of potential effects on socializing, probably will not during the 2010 Kaktovik and Nuiqsut migrating bowhead whales, Shell (Richardson, 2004). calculated the total distance (Cross Island) fall bowhead whale Pinnipeds—The ringed seal is the perpendicular to the migration path subsistence harvests. Shell will suspend most widespread and abundant ensonified to ≥120 dB (4.6 mi [7.4 km] exploration activities on August 25, pinniped in ice-covered arctic waters, radius × 2 = 9.2 mi [14.8 km]) by the prior to the beginning of the hunts, will and there appears to be a great deal of Discoverer. This represents 41 percent resume activities in Camden Bay after year-to-year variation in abundance and of the 22 mi (36 km) between the barrier conclusion of the subsistence harvests, distribution of these marine mammals. islands and the 131 ft (40 m) bathymetry and complete exploration activities on Ringed seals account for a large number line, so it was assumed that 41 percent or about October 31, 2010. Actual of the bowheads migrating within the of marine mammals expected to be drilling may occur on approximately 74 nearshore zone (water depth 0–131 ft encountered during the exploration days while the Discoverer is in Camden drilling program, and hence exposed to [0–40 m]) may be exposed to sounds ≥ Bay, approximately half of which would ≥120 dB, if they showed no avoidance sounds with received levels 120 dB. occur before and after the fall bowhead of the drilling operations. The average (and maximum) estimate is subsistence hunts. Cetaceans—Cetacean species that 109 (436) ringed seals might be The number of different individuals potentially exposed to drilling program exposed to sounds with received levels ≥ of each species potentially exposed to sounds with received levels ≥120 dB 120 dB from the exploration drilling received levels ≥120 dB re 1 μPa within would involve bowhead, gray, and program. each season and habitat zone was beluga whales. Shell also included some Two additional seal species are estimated by multiplying: maximum exposure estimates for expected to be encountered. Average • narwhal, harbor porpoise, humpback and maximum estimates for bearded The anticipated area to be ≥ ensonified to the specified level in the whale, and minke whale. However, as seal exposures to sound levels 120 dB time period and habitat zone to which stated previously in this document, were 6 and 22, respectively. For spotted a density applies, by NMFS has determined that authorizing seal these exposure estimates were 1 take of these four cetacean species is not and 3, respectively. Table 6–7 in Shell’s • The expected species density. warranted because the probability of application and Table 4 here summarize The numbers of exposures were then these species being present in the the number of marine mammal species summed for each species across the drilling area is remote. Average and or stocks that may experience Level B seasons and habitat zones. maximum estimates of the number of harassment.
TABLE 4—SUMMARY OF THE NUMBER OF POTENTIAL EXPOSURES OF MARINE MAMMALS TO RECEIVED SOUND LEVELS IN THE WATER OF ≥120 DB AND (≥160 DB) DURING SHELL’S PLANNED EXPLORATION DRILLING PROGRAM NEAR CAM- DEN BAY IN THE BEAUFORT SEA, ALASKA, JULY–OCTOBER 31, 2010
Total number of exposure to sound levels >120 dB and Species (≥160 dB) Avg. Max.
Odontocetes: Monodontidae: Beluga ...... 1 (0) 4 (0) Narwhal ...... 0 (0) 5 (5) Phocoenidae: Harbor porpoise ...... 0 (0) 5 (5) Mysticetes: Bowhead whale a ...... 1968 (14) 1977 (14) Gray whale ...... 0 (0) 5 (5) Humpback whale ...... 0 (0) 5 (5)
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TABLE 4—SUMMARY OF THE NUMBER OF POTENTIAL EXPOSURES OF MARINE MAMMALS TO RECEIVED SOUND LEVELS IN THE WATER OF ≥120 DB AND (≥160 DB) DURING SHELL’S PLANNED EXPLORATION DRILLING PROGRAM NEAR CAM- DEN BAY IN THE BEAUFORT SEA, ALASKA, JULY–OCTOBER 31, 2010—Continued
Total number of exposure to sound levels >120 dB and Species (≥160 dB) Avg. Max.
Minke whale ...... 0 (0) 5 (5)
Total Cetaceans ...... 1968 (14) 1992 (29) Pinnipeds: Bearded seal ...... 6 (0) 22 (0) Ringed seal ...... 109 (0) 436 (0) Ribbon seal ...... 0 (0) 5 (5) Spotted seal ...... 1 (0) 5 (5)
Total Pinnipeds ...... 115 (0) 467 (10)
Estimated Take Conclusions anthropogenic sound (see Table 4 in Although the 120–dB isopleth for the Southall et al. (2007)). Tables 15, 17, drillship may seem fairly expansive As stated previously, NMFS’ practice (i.e., 4.6 mi [7.4 km], which includes the μ and 21 in Southall et al. (2007) outline has been to apply the 120 dB re 1 Pa the numbers of low-frequency and mid- 50 percent inflation factor), the zone of (rms) received level threshold for frequency cetaceans and pinnipeds in ensonification begins to shrink underwater continuous sound levels to water, respectively, reported as having dramatically with each 10–dB increase determine whether take by Level B behavioral responses to non-pulses in in received sound level. Table 5 here harassment occurs. However, not all 10–dB received level increments. These depicts the radii for the 120, 130, 140, animals react to sounds at this low tables illustrate, especially for low- and 150, and 160 dB received levels for the level, and many will not show strong mid-frequency cetaceans, that more drillship. As stated previously, source reactions (and in some cases any intense observed behavioral responses levels are expected to be 175 dB (rms). reaction) until sounds are much did not occur until sounds were higher For an animal to receive a sound at this stronger. Southall et al. (2007) provide level, it would have to be within several than 120 dB (rms). Many of the animals a severity scale for ranking observed meters of the vessel, which is unlikely, had no observable response at all when behavioral responses of both free- especially give the fact that certain ranging marine mammals and laboratory exposed to anthropogenic sound at species are likely to avoid the area (as subjects to various types of levels of 120 dB (rms) or even higher. described earlier in this document).
TABLE 5—MODELED SOUND LEVELS AT THE 120, 130, 140, 150, AND 160 DB ISOPLETHS FOR THE DRILLSHIP—THESE DISTANCES DO NOT INCLUDE THE 50 PERCENT INFLATION FACTOR USED FOR ESTIMATING TAKE
Received levels Drillship (dB re 1 μPa rms) (distance in m)
160 ...... 35 150 ...... 55 140 ...... 216 130 ...... 1,358 120 ...... 4,930
Table 6–7 in Shell’s application and mi (7.4 km) of the drillship, which is an to be exposed to sounds at the 140–, Table 4 here present the number of each area 1.5 × greater than the 120 dB 150—, or 160—dB levels. Moreover, species that may be exposed to sounds radius, only a small percentage of the fewer studies have been conducted on ≥160 dB. This number is substantially animals would occur in areas with the reactions of pinnipeds to continuous less than the number of individuals received sound levels that may elicit sound sources. However, it appears that from each species that may be exposed more intense observed behavioral most pinnipeds are more tolerant and to sounds at the 120 dB level. For responses. less responsive to sounds at lower example, 1,968 bowhead whales are The ringed seal is the species with the received levels than most cetaceans, estimated to be exposed to sounds ≥120 second highest predicted encounter rate especially mysticetes. dB; however, only 14 bowhead whales during Shell’s proposed drilling NMFS is proposing to authorize the are estimated to be exposed to sounds program. Although there is the potential average take estimates provided in Table ≥160 dB. Additionally, using the same for 109 ringed seals to be exposed to 6–7 of Shell’s application and Table 4 calculations, only 541, 86, and 22 sounds ≥120 dB, this number drops to here. The only exceptions to this are for bowhead whales are estimated to be zero at the 160 dB level. Additionally, the gray whale since the average exposed to sounds ≥130, 140, and 150 using the same calculations, only 8 estimate is zero and for the beluga dB, respectively. Therefore, while 1,968 ringed seals are estimated to be exposed whale to account for group size. bowhead whales may occur within 4.6 to sounds ≥130, and none are expected Therefore, NMFS proposes to authorize
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the take of 4 beluga whales, 1,968 annual rates of recruitment or survival.’’ Additionally, if an animal is excluded bowhead whales, 5 gray whales, 6 In making a negligible impact from Camden Bay for feeding because it bearded seals, 109 ringed seals, and 1 determination, NMFS considers a decides to avoid the ensonified area, spotted seal. For beluga and gray variety of factors, including but not this may result in some extra energy whales, this represents 0.01 percent of limited to: (1) The number of expenditure for the animal to find an the Beaufort Sea population of anticipated mortalities; (2) the number alternate feeding ground. However, approximately 39,258 beluga whales and nature of anticipated injuries; (3) Camden Bay is one of a few feeding (Angliss and Allen, 2009) and 0.03 the number, nature, intensity, and areas for bowhead whales in the U.S. percent of the Eastern North Pacific duration of Level B harassment; and (4) Arctic Ocean. The disruption to feeding stock of approximately 17,752 gray the context in which the takes occur. is not anticipated to have more than a whales. This also represents 13.8 No injuries or mortalities are negligible impact on the affected species percent of the Bering-Chukchi-Beaufort anticipated to occur as a result of Shell’s or stock. population of 14,247 individuals proposed Camden Bay exploratory Some bowhead whales have been assuming 3.4 percent annual population drilling program, and none are proposed observed feeding in the Camden Bay growth from the 2001 estimate of 10,545 to be authorized. Additionally, animals area in recent years. There has also been animals (Zeh and Punt, 2005). The take in the area are not expected to incur recent evidence that some bowhead estimates presented for bearded, ringed, hearing impairment (i.e., TTS or PTS) or whales continued feeding in close and spotted seals represent 0.1, 0.04, non-auditory physiological effects. proximity to seismic sources (e.g., and 0.1 percent of the Bering-Chukchi- Takes will be limited to Level B Richardson, 2004). The sounds Beaufort populations for each species, behavioral harassment. Although it is produced by the drillship are of lower respectively. possible that some individuals may be intensity than those produced by With the exception of the subsistence exposed to sounds from drilling seismic airguns. Therefore, if animals mitigation measure of shutting down operations more than once, during the remain in ensonified areas to feed, they during the Nuiqsut and Kaktovik fall migratory periods it is less likely that would be in areas where the sound bowhead whale hunts, these take this will occur since animals will levels are not high enough to cause estimates do not take into account any continue to move westward across the injury (based on the fact that source of the mitigation measures described Beaufort Sea. This is especially true for levels are not expected to reach levels previously in this document. bowhead whales that will be migrating known to cause even slight, mild TTS, Additionally, if the fall bowhead hunts past the drilling operations beginning in a non-injurious threshold shift). end after September 15, and Shell still mid- to late September (depending on Beluga whales are more likely to concludes activities on October 31, then the date Shell resumes activities after occur in the project area after the fewer animals will be exposed to the shutdown period for the fall recommencement of activities in drilling sounds, especially bowhead bowhead subsistence hunts by the September than in July or August. whales, as more of them will have villages of Kaktovik and Nuiqsut). Should any belugas occur in the area of migrated past the area in which they Some studies have shown that active drilling, it is not expected that would be exposed to sound levels of 120 bowhead whales will continue to feed they would remain in the area for a dB or greater prior to Shell resuming in areas of seismic operations (e.g., prolonged period of time, as their active operations. Richardson, 2004). Therefore, it is westward migration usually occurs Lastly, even though Shell has possible that some bowheads may further offshore (more than 37 mi [60 indicated that the Camden Bay drilling continue to feed in an area of active km]) and in deeper waters (more than program will occur for 74 days between drilling operations. It is important to 656 ft [200 m]) than that planned for the July 10 and October 31, 2010, Shell has note that the sounds produced by location of Shell’s Camden Bay well requested that the IHA (if issued) be drilling operations are of a much lower sites. Gray whales do not frequently valid for a full year. NMFS is proposing intensity than those produced by occur in the Camden Bay area of the to grant this request in the event that seismic airguns. Should bowheads Beaufort Sea, so exposures to industrial Shell is unable to conduct active chose to feed in the ensonified area sound are not expected to last for operations for the full 74 days. instead of avoiding the sound, prolonged periods (i.e., several days or Therefore, depending on the expiration individuals may be exposed to sounds weeks). The exposure of cetaceans to date of the IHA (if issued), Shell could at or above 120 dB (rms) for several sounds produced by exploratory drilling potentially work early in the 2011 open- hours to days, depending on how long operations is not expected to result in water season. The take numbers the individual animal chooses to remain more than Level B harassment and is presented here (and in Shell’s in the area to feed. As noted previously, anticipated to have no more than a application) are based on 74 days of many animals perform vital functions, negligible impact on the affected species active operations. Therefore, these such as feeding, resting, traveling, and or stock. numbers account for this situation. In socializing on a diel cycle (24-hr cycle). Some individual pinnipeds may be fact, these numbers may then be an As discussed here, some bowhead exposed to drilling sounds more than overestimate, as fewer animals, whales may decide to remain in once during the time frame of the especially bowhead and beluga whales, Camden Bay for several days to feed; project. This may be especially true for would be expected at the drill sites in however, they are not expected to be ringed seals, which occur in the early July 2011. feeding for 24 hours straight each day. Beaufort Sea year-round and are the While feeding in an area of increased most frequently encountered pinniped Negligible Impact and Small Numbers anthropogenic sound may potentially species in the area. However, as stated Analysis and Preliminary Determination result in increased stress, it is not previously in this document, pinnipeds NMFS has defined ‘‘negligible impact’’ anticipated that the level of sound appear to be more tolerant of in 50 CFR 216.103 as ‘‘* * * an impact produced by the exploratory drilling anthropogenic sound, especially at resulting from the specified activity that operations and the amount of time that lower received levels, than other marine cannot be reasonably expected to, and is an individual whale may remain in the mammals, such as mysticetes. NMFS not reasonably likely to, adversely affect area to feed would result in extreme has preliminarily determined that the the species or stock through effects on physiological stress to the animal. exposure of pinnipeds to sounds
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produced by exploratory drilling that could be taken by Level B (As mentioned previously in this operations is not expected to result in behavioral harassment if each animal is document, both the walrus and the more than Level B harassment and is taken only once. Additionally, these polar bear are under the USFWS’ anticipated to have no more than a numbers are likely an overestimate, as jurisdiction.) The importance of each of negligible impact on the animals. these take numbers were calculated these species varies among the Of the six marine mammal species using a 50 percent inflation factor of the communities and is largely based on likely to occur in the proposed drilling 120-dB radius, which is a conservative availability. area, only the bowhead whale is listed approach recommended by some The subsistence communities in the as endangered under the ESA. The acousticians when modeling a new Beaufort Sea that have the potential to species is also designated as ‘‘depleted’’ sound source in a new location. This is be impacted by Shell’s Camden Bay under the MMPA. Despite these fairly conservative given the fact that drilling program include Kaktovik, designations, the Bering-Chukchi- the radii were based on results from a Nuiqsut, and Barrow. Kaktovik is a Beaufort stock of bowheads has been similar drillship (i.e., the Northern coastal community 60 mi (96.6 km) east increasing at a rate of 3.4 percent Explorer II). SSV tests may reveal that of the project area. Nuiqsut is 118 mi annually for nearly a decade (Allen and the Level B harassment zone may in fact (190 km) west of the project area and Angliss, 2010). Additionally, during the be smaller than that used to estimate about 20 mi (32 km) inland from the 2001 census, 121 calves were counted, take. If the SSV tests reveal that the coast along the Colville River. Cross which was the highest yet recorded. The Level B harassment zone is slightly Island, from which Nuiqsut hunters calf count provides corroborating larger than that of the Northern Explorer base their bowhead whaling activities, is evidence for a healthy and increasing II, the 50 percent inflation factor should 47 mi (75.6 km) southwest of the project population (Allen and Angliss, 2010). cover the discrepancy. Moreover, the area. Barrow, the community farthest There is no critical habitat designated in mitigation and monitoring measures from the project area, lies 298 mi (479.6 the U.S. Arctic for the bowhead whale. (described previously in this document) km) west of Shell’s Camden Bay drill The bearded and ringed seals are proposed for inclusion in the IHA (if sites. ‘‘candidate species’’ under the ESA, issued) are expected to reduce even (1) Bowhead Whales meaning they are currently being further any potential disturbance to Of the three communities, Barrow is considered for listing but are not marine mammals. designated as depleted under the Based on the analysis contained the only one that currently participates MMPA. None of the other three species herein of the likely effects of the in a spring bowhead whale hunt. However, this hunt is not anticipated to that may occur in the project area are specified activity on marine mammals be affected by Shell’s activities, as the listed as threatened or endangered and their habitat, and taking into spring hunt occurs in late April to early under the ESA or designated as depleted consideration the implementation of the May, and Shell’s Camden Bay drilling under the MMPA. mitigation and monitoring measures, program will not begin until July 10, at Potential impacts to marine mammal NMFS preliminarily finds that Shell’s the earliest. habitat were discussed previously in proposed Camden Bay exploratory ‘‘ All three communities participate in a this document (see the Anticipated drilling program may result in the Effects on Habitat’’ section). Although fall bowhead hunt. In autumn, incidental take of small numbers of westward-migrating bowhead whales some disturbance is possible to food marine mammals, by Level B sources of marine mammals, the typically reach the Kaktovik and Cross harassment only, and that the total Island (Nuiqsut hunters) areas by early impacts are anticipated to be minor taking from the exploratory drilling enough as to not affect rates of September, at which points the hunts program will have a negligible impact recruitment or survival of marine begin (Kaleak, 1996; Long, 1996; on the affected species or stocks. mammals in the area. Based on the vast Galginaitis and Koski, 2002; Galginaitis size of the Arctic Ocean where feeding Impact on Availability of Affected and Funk, 2004, 2005; Koski et al., by marine mammals occurs versus the Species or Stock for Taking for 2005). Around late August, the hunters localized area of the drilling program, Subsistence Uses from Nuiqsut establish camps on Cross any missed feeding opportunities in the Island from where they undertake the Relevant Subsistence Uses direct project area would be minor fall bowhead whale hunt. The hunting based on the fact that other feeding The disturbance and potential period starts normally in early grounds exist elsewhere. displacement of marine mammals by September and may last as late as mid- The estimated takes proposed to be sounds from drilling activities are the October, depending mainly on ice and authorized represent 0.01 percent of the principal concerns related to weather conditions and the success of Beaufort Sea population of subsistence use of the area. Subsistence the hunt. Most of the hunt occurs approximately 39,258 beluga whales remains the basis for Alaska Native offshore in waters east, north, and (Angliss and Allen, 2009), 0.03 percent culture and community. Marine northwest of Cross Island where of the Eastern North Pacific stock of mammals are legally hunted in Alaskan bowheads migrate and not inside the approximately 17,752 gray whales, and waters by coastal Alaska Natives. In barrier islands (Galginaitis, 2007). 13.8 percent of the Bering-Chukchi- rural Alaska, subsistence activities are Hunters prefer to take bowheads close to Beaufort population of 14,247 often central to many aspects of human shore to avoid a long tow, but Braund individuals assuming 3.4 percent existence, including patterns of family and Moorehead (1995) report that crews annual population growth from the 2001 life, artistic expression, and community may (rarely) pursue whales as far as 50 estimate of 10,545 animals (Zeh and religious and celebratory activities. mi (80 km) offshore. Whaling crews use Punt, 2005). The take estimates Additionally, the animals taken for Kaktovik as their home base, leaving the presented for bearded, ringed, and subsistence provide a significant portion village and returning on a daily basis. spotted seals represent 0.1, 0.04, and 0.1 of the food that will last the community The core whaling area is within 12 mi percent of the Bering-Chukchi-Beaufort throughout the year. The main species (19.3 km) of the village with a periphery populations for each species, that are hunted include bowhead and ranging about 8 mi (13 km) farther, if respectively. These estimates represent beluga whales, ringed, spotted, and necessary. The extreme limits of the the percentage of each species or stock bearded seals, walruses, and polar bears. Kaktovik whaling limit would be the
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middle of Camden Bay to the west. The did not account for any of the harvested the potential to impact marine mammals timing of the Kaktovik bowhead whale animals between 1987 and 1989. hunted by Native Alaskans. In the case hunt roughly parallels the Cross Island There has been minimal harvest of of cetaceans, the most common reaction whale hunt (Impact Assessment Inc, beluga whales in Beaufort Sea villages to anthropogenic sounds (as noted 1990b; SRB&A, 2009: Map 64). In recent in recent years. Additionally, if belugas previously in this document) is years, the hunts at Kaktovik and Cross are harvested, it is usually in avoidance of the ensonified area. In the Island have usually ended by mid- to conjunction with the fall bowhead case of bowhead whales, this often late September. harvest. Shell will not be operating means that the animals divert from their Westbound bowheads typically reach during the Kaktovik and Nuiqsut fall normal migratory path by several the Barrow area in mid-September, and bowhead harvests. kilometers. Helicopter activity also has the potential to disturb cetaceans and are in that area until late October (3) Ice Seals (Brower, 1996). However, over the years, pinnipeds by causing them to vacate the local residents report having seen a Ringed seals are available to area. Additionally, general vessel small number of bowhead whales subsistence users in the Beaufort Sea presence in the vicinity of traditional feeding off Barrow or in the pack ice off year-round, but they are primarily hunting areas could negatively impact a Barrow during the summer. Recently, hunted in the winter or spring due to hunt. autumn bowhead whaling near Barrow the rich availability of other mammals In the case of subsistence hunts for has normally begun in mid-September in the summer. Bearded seals are bowhead whales in the Beaufort Sea, to early October, but in earlier years it primarily hunted during July in the there could be an adverse impact on the began as early as August if whales were Beaufort Sea; however, in 2007, bearded hunt if the whales were deflected observed and ice conditions were seals were harvested in the months of seaward (further from shore) in favorable (USDI/BLM, 2005). The recent August and September at the mouth of traditional hunting areas. The impact decision to delay harvesting whales the Colville River Delta. An annual would be that whaling crews would until mid-to-late September has been bearded seal harvest occurs in the have to travel greater distances to made to prevent spoilage, which might vicinity of Thetis Island (which is a intercept westward migrating whales, occur if whales were harvested earlier in considerable distance from Shell’s thereby creating a safety hazard for the season when the temperatures tend proposed Camden Bay drill sites) in July whaling crews and/or limiting chances to be warmer. Whaling near Barrow can through August. Approximately 20 of successfully striking and landing continue into October, depending on the bearded seals are harvested annually bowheads. quota and conditions. through this hunt. Spotted seals are Plan of Cooperation (POC) Shell anticipates arriving on location harvested by some of the villages in the summer months. Nuiqsut hunters Regulations at 50 CFR 216.104(a)(12) in Camden Bay around July 10 and require IHA applicants for activities that continuing operations until August 25. typically hunt spotted seals in the nearshore waters off the Colville River take place in Arctic waters to provide a Shell has stated that it will suspend all POC or information that identifies what operations on August 25 for the Nuiqsut delta, which is more than 100 mi (161 km) from Shell’s proposed drill sites. measures have been taken and/or will (Cross Island) and Kaktovik subsistence be taken to minimize adverse effects on bowhead whale hunts. The Discoverer Although there is the potential for some of the Beaufort villages to hunt ice the availability of marine mammals for and support vessels will leave the subsistence purposes. Shell has seals during the summer and fall Camden Bay project area, will move to developed a Draft POC for its 2010 months while Shell is conducting a location at or north of 71.25°N. Camden Bay, Beaufort Sea, Alaska, exploratory drilling operations, the latitude and at or west of 146.4°W. exploration drilling program to primary sealing months occur outside of longitude, and will return to resume minimize any adverse impacts on the Shell’s operating time frame. activities after the Nuiqsut (Cross availability of marine mammals for Additionally, some of the more Island) and Kaktovik bowhead hunts subsistence uses. A copy of the Draft established seal hunts that do occur in conclude. Depending on when Nuiqsut POC was distributed to the the Beaufort Sea, such as the Colville and Kaktovik declare their hunts closed, communities, subsistence user groups, delta area hunts, are located a drilling operations may resume in the NMFS, and other Federal and State middle of the Barrow fall bowhead significant distance (in some instances agencies in May 2009. An updated hunt. 100 mi [161 km] or more) from the Communications Plan was then proposed project area. (2) Beluga Whales submitted to NMFS as an attachment to Potential Impacts to Subsistence Uses the POC in July 2009. Shell conducted Beluga whales are not a prevailing POC meetings throughout 2009 NMFS has defined ‘‘unmitigable subsistence resource in the communities regarding its planned 2010 activities in adverse impact’’ in 50 CFR 216.103 as: of Kaktovik and Nuiqsut. Kaktovik both the Beaufort and Chukchi Seas. hunters may harvest one beluga whale * * * an impact resulting from the During these meetings, Shell focused on in conjunction with the bowhead hunt; specified activity: (1) That is likely to reduce lessons learned from prior years’ however, it appears that most the availability of the species to a level activities and presented mitigation insufficient for a harvest to meet subsistence households obtain beluga through needs by: (i) Causing the marine mammals to measures for avoiding potential exchanges with other communities. abandon or avoid hunting areas; (ii) Directly conflicts, which are outlined in the 2010 Although Nuiqsut hunters have not displacing subsistence users; or (iii) Placing POC and this document. For this hunted belugas for many years while on physical barriers between the marine Camden Bay drilling program, Shell’s Cross Island for the fall hunt, this does mammals and the subsistence hunters; and POC with Chukchi Sea villages not mean that they may not return to (2) That cannot be sufficiently mitigated by primarily addresses the issue of transit this practice in the future. Data other measures to increase the availability of of vessels, whereas the POC with presented by Braund and Kruse (2009) marine mammals to allow subsistence needs Beaufort Sea villages addresses vessel indicate that only one percent of to be met. transit, drilling, and associated Barrow’s total harvest between 1962 and Noise and general activity during activities. Communities that were 1982 was of beluga whales and that it Shell’s proposed drilling program have consulted regarding Shell’s 2010 Arctic
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Ocean operations include: Barrow, The following mitigation measures, current as to the timing and status of the Kaktovik, Wainwright, Kotzebue, plans and programs, are integral to the bowhead whale migration, as well as the Kivalina, Point Lay, and Point Hope. POC and were developed during timing and status of other subsistence Attempts were made to meet consultation with potentially affected hunts. The Communication Plan individually with whaling captains and subsistence groups and communities. includes procedures for coordination to hold a community meeting in These measures, plans, and programs with Com and Call Centers to be located Nuiqsut; however, after receipt of a will be implemented by Shell during its in coastal villages along the Chukchi request by the Mayor, the scheduled 2010 exploration drilling operations in and Beaufort Seas during Shell’s meeting was cancelled. Shell both the Beaufort and Chukchi Seas to proposed activities in 2010; subsequently sent correspondence to all monitor and mitigate potential impacts (3) Shell will employ local post office box holders in Nuiqsut on to subsistence users and resources. The Subsistence Advisors from the Beaufort February 26, 2009, indicating its mitigation measures Shell has adopted and Chukchi Sea villages to provide willingness to visit and have dialogue and will implement during its 2010 consultation and guidance regarding the on the proposed plans. Camden Bay exploration drilling whale migration and subsistence hunt. Beginning in early January 2009, Shell operations are listed and discussed There will be a total of nine subsistence held one-on-one meetings with below. This most recent version of advisor-liaison positions (one per representatives from the North Slope Shell’s planned mitigation measures village), to work approximately 8-hours Borough (NSB) and Northwest Arctic was presented to community leaders per day and 40-hour weeks through Borough (NWAB), subsistence-user and subsistence user groups starting in Shell’s 2010 exploration project. The group leadership, and Village Whaling January of 2009 and has evolved since subsistence advisor will use local Captain Association representatives. in response to information learned knowledge (Traditional Knowledge) to Shell’s primary purpose in holding during the consultation process. gather data on subsistence lifestyle individual meetings was to inform and To minimize any cultural or resource within the community and advise as to prepare key leaders, prior to the public impacts to subsistence whaling ways to minimize and mitigate potential meetings, so that they would be activities from its exploration impacts to subsistence resources during prepared to give appropriate feedback operations, Shell will suspend drilling the drilling season. Responsibilities on planned activities. activities on August 25, 2010, prior to include reporting any subsistence Shell presented the proposed project the start of the Kaktovik and Cross concerns or conflicts; coordinating with to the NWAB Assembly on January 27, Island bowhead whale hunting season. subsistence users; reporting subsistence- 2009, to the NSB Assembly on February The drillship and associated vessels will related comments, concerns, and 2, 2009, and to the NSB and NWAB remain outside of the Camden Bay area information; and advising how to avoid Planning Commissions in a joint during the hunt. Shell will resume subsistence conflicts. A subsistence meeting on March 25, 2009. Meetings drilling operations after the conclusion advisor handbook will be developed were also scheduled with of the hunt and, depending on ice and prior to the operational season to representatives from the Alaska Eskimo weather conditions, continue its specify position work tasks in more Whaling Commission (AEWC), and exploration activities through October detail; presentations on proposed activities 31, 2010. In addition to the adoption of (4) Shell will recycle drilling muds were given to the Inupiat Community of this project timing restriction, Shell will (e.g., use those muds on multiple wells), the Arctic Slope, and the Native Village implement the following additional to the extent practicable based on of Barrow. A full list of POC meetings measures to ensure coordination of its operational considerations (e.g., conducted by Shell between January activities with local subsistence users to whether mud properties have and April 2009 can be found in Table minimize further the risk of impacting deteriorated to the point where they 4.2–1 of Shell’s POC. Shell has marine mammals and interfering with cannot be used further), to reduce successfully completed additional POC the subsistence hunts for marine discharges from its operations. At the meetings with several communities mammals: end of the season excess water base since submitting the Draft POC, (1) The drillship and support vessels fluid will be pre-diluted to a 30:1 ratio including: will transit through the Chukchi Sea with seawater and then discharged; • June 1, 2009: NSB Assembly along a route that lies offshore of the (5) Shell will implement flight meeting; polynya zone. In the event the transit restrictions prohibiting aircraft from • June 2, 2009: Point Lay meeting outside of the polynya zone results in flying within 1,000 ft (305 m) of marine with village leadership; Shell having to break ice (as opposed to mammals or below 1,500 ft (457 m) • June 3, 2009: Kaktovik meeting with managing ice by pushing it out of the altitude (except during takeoffs and village leadership; way), the drillship and support vessels landings or in emergency situations) • June 17, 2009: Point Hope meeting will enter into the polynya zone far while over land or sea; and with village leadership; enough so that ice breaking is not (6) No routine vessel traffic will • August 5, 2009: NWAB Assembly necessary. If it is necessary to move into traverse the subsistence area. Vessels meeting; and the polynya zone, Shell will notify the within 900 ft (274 m) of marine • August 27, 2009: NSB Planning local communities of the change in the mammals will reduce speed, avoid Commission meeting. transit route through the separating members from a group, and On December 8, 2009, Shell held Communication Centers (Com Centers); avoid multiple changes in direction. consultation meetings with (2) Shell has developed a For several years, a Conflict representatives from the various marine Communication Plan and will Avoidance Agreement (CAA) has been mammal commissions. Prior to drilling implement the plan before initiating negotiated between the AEWC, affected in 2010, Shell will also hold additional exploration drilling operations to whaling captains’ associations, and the consultation meetings with the affected coordinate activities with local oil and gas industry to avoid conflicts communities and subsistence user subsistence users as well as Village between industry activity and bowhead groups, NSB, and NWAB to discuss the Whaling Associations in order to whale subsistence hunts. While the mitigation measures included in the minimize the risk of interfering with signing of a CAA is not a requirement POC. subsistence hunting activities and keep to obtain an IHA, often times, the CAA
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contains measures that help NMFS Kaktovik is located 60 mi (96.6 km) Endangered Species Act (ESA) make its no unmitigable adverse impact east of the project area. Therefore, determination for bowhead whales. westward migrating whales would reach There is one marine mammal species Shell is currently reviewing the draft Kaktovik before reaching the area of listed as endangered under the ESA 2010 CAA and is expected to make a Shell’s activities or any of the with confirmed or possible occurrence decision on whether or not it will sign ensonified zones. Although Cross Island in the proposed project area: The the 2010 CAA prior to commencing and Barrow are west of Shell’s drill bowhead whale. NMFS’ Permits, operations this year. sites, sound generating activities from Conservation and Education Division Shell’s drilling program will have has initiated consultation with NMFS’ Unmitigable Adverse Impact Analysis Endangered Species Division under and Preliminary Determination ceased prior to the whales passing through the area. Additionally, Barrow section 7 of the ESA on the issuance of NMFS has preliminarily determined lies 298 mi (479.6 km) west of Shell’s an IHA to Shell under section that Shell’s proposed Camden Bay Camden Bay drill sites, so whalers in 101(a)(5)(D) of the MMPA for this exploration drilling program will not that area would not be displaced by any activity. Consultation will be concluded have an unmitigable adverse impact on of Shell’s activities. prior to a determination on the issuance the availability of species or stocks for of an IHA. Adverse impacts are not anticipated taking for subsistence uses. This on sealing activities since the majority National Environmental Policy Act preliminary determination is supported of hunts for seals occur in the winter (NEPA) by information contained in this and spring, when Shell will not be document and Shell’s POC. Shell has operating. Sealing activities in the NMFS is currently preparing an adopted a spatial and temporal strategy Colville River delta area occur more Environmental Assessment, pursuant to for its Camden Bay operations that than 100 mi (161 km) from Shell’s NEPA, to determine whether or not this should minimize impacts to subsistence Camden Bay drill sites. proposed activity may have a significant hunters. First, Shell’s activities will not effect on the human environment. This commence until after the spring hunts Shell will also support the village analysis will be completed prior to the have occurred. Additionally, Shell will Com Centers in the Arctic communities issuance or denial of the IHA. traverse the Chukchi Sea far offshore, so and employ local Subsistence Advisors as to not interfere with July hunts in the from the Beaufort and Chukchi Sea Proposed Authorization villages to provide consultation and Chukchi Sea and will communicate As a result of these preliminary guidance regarding the whale migration with the Com Centers to notify local determinations, NMFS proposes to and subsistence hunt. The Subsistence communities of any changes in the authorize the take of marine mammals Advisors will provide advice to Shell on transit route. Once Shell is on location incidental to Shell’s 2010 Camden Bay, ways to minimize and mitigate potential in Camden Bay, Beaufort Sea, whaling Beaufort Sea, Alaska, exploration impacts to subsistence resources during will not commence until late August/ drilling program, provided the the drilling season. early September. Shell has agreed to previously mentioned mitigation, cease operations on August 25 to allow Based on the measures described in monitoring, and reporting requirements the villages of Kaktovik and Nuiqsut to Shell’s Draft POC, the proposed are incorporated. prepare for the fall bowhead hunts, will mitigation and monitoring measures move the drillship and all support (described earlier in this document), Dated: April 12, 2010. vessels out of the hunting area so that and the project design itself, NMFS has James H. Lecky, there are no physical barriers between determined preliminarily that there will Director, Office of Protected Resources, the marine mammals and the hunters, not be an unmitigable adverse impact on National Marine Fisheries Service. and will not recommence activities until subsistence uses from Shell’s Camden [FR Doc. 2010–8790 Filed 4–15–10; 8:45 am] the close of both villages’ hunts. Bay exploration drilling activities. BILLING CODE 3510–22–P
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Reader Aids Federal Register Vol. 75, No. 74 Monday, April 19, 2010
CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING APRIL
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 3 CFR 1170...... 17555 Executive orders and proclamations 741–6000 1245...... 18396 The United States Government Manual 741–6000 Proclamations: 1400...... 19185 8485...... 18747 1412...... 19185 Other Services 8487...... 17025 1421...... 19185 Electronic and on-line services (voice) 741–6020 8488...... 17837 1435...... 17555 Privacy Act Compilation 741–6064 8489...... 17839 3431...... 20239 Public Laws Update Service (numbers, dates, etc.) 741–6043 8490...... 17841 Proposed Rules: TTY for the deaf-and-hard-of-hearing 741–6086 8491...... 17843 210...... 20316 8492...... 17845 215...... 20316 ELECTRONIC RESEARCH 8493...... 17847 220...... 20316 8494...... 18749 World Wide Web 225...... 20316 8495...... 19181 226...... 20316 Full text of the daily Federal Register, CFR and other publications 8496...... 19183 is located at: http://www.gpoaccess.gov/nara/index.html 916...... 17072 8497...... 19876 917...... 17072 Federal Register information and research tools, including Public Executive Orders: 956...... 18428 Inspection List, indexes, and links to GPO Access are located at: 13537...... 20237 1245...... 18430 l http://www.archives.gov/federal register 19536...... 19869 4279...... 20044 E-mail Administrative Orders: 4287...... 20044 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is Memorandums: 4288...... 20073, 20085 an open e-mail service that provides subscribers with a digital Memorandum of April form of the Federal Register Table of Contents. The digital form 6, 2010 ...... 18045 9 CFR of the Federal Register Table of Contents includes HTML and Memorandum of April 206...... 16641 PDF links to the full text of each document. 7, 2010 ...... 19533 Proposed Rules: Presidential 94...... 19915 To join or leave, go to http://listserv.access.gpo.gov and select Determinations: Online mailing list archives, FEDREGTOC-L, Join or leave the list No. 2010-05 of April 7, 10 CFR (or change settings); then follow the instructions. 2010 ...... 19537 51...... 20248 PENS (Public Law Electronic Notification Service) is an e-mail No. 2010-06 of April 7, 140...... 16645 service that notifies subscribers of recently enacted laws. 2010 ...... 19535 430...... 20112 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 431...... 17036 and select Join or leave the list (or change settings); then follow 4 CFR Proposed Rules: the instructions. Proposed Rules: 200...... 20298 51...... 16360 FEDREGTOC-L and PENS are mailing lists only. We cannot 430 ...... 16958, 17075, 19296 respond to specific inquiries. 5 CFR 431 ...... 17078, 17079, 17080, Reference questions. Send questions and comments about the Proposed Rules: 19297 Federal Register system to: [email protected] 532...... 17316 11 CFR The Federal Register staff cannot interpret specific documents or 550...... 18133 regulations. Ch. LXXX...... 19909 8...... 19873 Reminders. Effective January 1, 2009, the Reminders, including 831...... 20299 111...... 19873 Rules Going Into Effect and Comments Due Next Week, no longer 841...... 20299 12 CFR appear in the Reader Aids section of the Federal Register. This 890...... 20314 information can be found online at http://www.regulations.gov. 892...... 20314 4...... 17849 CFR Checklist. Effective January 1, 2009, the CFR Checklist no 205...... 16580 7 CFR longer appears in the Federal Register. This information can be 370...... 20257 found online at http://bookstore.gpo.gov/. 1...... 17555 611...... 18726 3...... 17555 613...... 18726 615...... 18726 FEDERAL REGISTER PAGES AND DATE, APRIL 91...... 17281 205...... 17555 619...... 18726 16325–16640...... 1 226...... 16325 620...... 18726 16641–17024...... 2 274...... 18377 918...... 17037 17025–17280...... 5 319...... 17289 1261...... 17037 17281–17554...... 6 735...... 17555 Proposed Rules: 17555–17846...... 7 760...... 19185 701...... 17083 17847–18046...... 8 800...... 17555 708a...... 17083 18047–18376...... 9 900...... 17555 708b...... 17083 18377–18746...... 12 916...... 17027 1203...... 17622 18747–19180...... 13 917...... 17027 1705...... 17622 19181–19532...... 14 925...... 17031 19533–19872...... 15 929...... 18394 14 CFR 19873–20236...... 16 944...... 17031 25...... 18399 20237–20510...... 19 948...... 17034 27...... 17041
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29...... 17041 1010...... 16351 100...... 20294 372...... 17333, 19319 39 ...... 16646, 16648, 16651, 1020...... 16351 117 ...... 17561, 18055, 19245 721...... 16706 16655, 16657, 16660, 16662, 1030...... 16351 147...... 18404, 19880 761...... 17645 16664, 17295, 19193, 19196, 1040...... 16351 165 ...... 18055, 18056, 18058, 19199, 19201, 19203, 19207, 1050...... 16351 18755, 19246, 19248, 19250, 42 CFR 19209, 20265 Proposed Rules: 19882 417...... 19678 61...... 19877 165...... 16363 167...... 17562 422...... 19678 63...... 19877 814...... 16365 334...... 19885 423...... 19678 65...... 19877 882...... 17093 Proposed Rules: 480...... 19678 67...... 17047 890...... 17093 100 ...... 16700, 17099, 17103 71 ...... 16329, 16330, 16331, 150...... 16370 44 CFR 16333, 16335, 16336, 17851, 24 CFR 165 ...... 16370, 16374, 16703, 64...... 18408, 19891 17852, 18047, 18402, 18403, 570...... 17303 17106, 17329, 18449, 18451, 65 ...... 18070, 18072, 18073, 19212 1003...... 20269 18776, 18778, 19304, 19307 18076, 18079, 18082, 18084, 73...... 17561 Proposed Rules: 18086, 18088, 18090 91...... 17041 1000...... 19920 34 CFR 67...... 18091, 19895 97...... 19539, 19541 Ch. II...... 16668, 18407 Proposed Rules: 121...... 17041 26 CFR 67...... 19320, 19328 125...... 17041 1...... 17854 36 CFR 135...... 17041 301...... 17854 1200...... 19555 45 CFR 234...... 17050 602...... 17854 1253...... 19555 89...... 18760 Proposed Rules: Proposed Rules: 1280...... 19555 286...... 17313 21...... 18134 54...... 19297 Proposed Rules: Proposed Rules: 23...... 16676 1191...... 18781 146...... 19297, 19335 25...... 16676 27 CFR 1193...... 18781 148...... 19297, 19335 27...... 16676 17...... 16666 1194...... 18781 29...... 16676 19...... 16666 1206...... 17638 46 CFR 39 ...... 16361, 16683, 16685, 20...... 16666 393...... 18095 16689, 16696, 17084, 17086, 22...... 16666 37 CFR 17630, 17632, 17879, 17882, 24...... 16666 41...... 19558 47 CFR 17884, 17887, 17889, 18446, 25...... 16666 Proposed Rules: 2...... 19277 18774, 19564 26...... 16666 380...... 16377 11...... 19559 71 ...... 17322, 17637, 17891, 27...... 16666 36...... 17872 17892, 20320, 20321, 20322, 28...... 16666 38 CFR 54...... 17584, 17872 20323 31...... 16666 1...... 17857 73...... 17874, 19907 40...... 16666 74...... 17055 15 CFR 59...... 17859q 44...... 16666 Proposed Rules: 78...... 17055 740...... 17052 46...... 16666 1...... 20299 90...... 19277 748...... 17052 70...... 16666 17...... 17641 95...... 19277 750...... 17052 Proposed Rules: 28 CFR 51...... 17644 762...... 17052 59...... 17641 27...... 17349 902...... 18262 20...... 18751 36...... 17109 922...... 17055 Proposed Rules: 39 CFR 73 ...... 19338, 19339, 19340 540...... 17324 16 CFR 111...... 17861 90...... 19340 Proposed Rules: 29 CFR 40 CFR 48 CFR 312...... 17089 2203...... 18403 9...... 16670 Ch. I...... 19168, 19179 2204...... 18403 2...... 19168 17 CFR 50...... 17004 4022...... 19542 51...... 17004, 17254 7...... 19168 190...... 17297 Proposed Rules: 52 ...... 16671, 17307, 17863, 17...... 19168 232...... 17853 2590...... 19297 17865, 17868, 18061, 18068, 22...... 19168 18757, 19468, 19886 52...... 19168 18 CFR 30 CFR 60...... 19252 204...... 18030 40...... 16914 18...... 17512 61...... 19252 206...... 18035 284...... 16337 74...... 17512 63...... 19252 225...... 18035 75...... 17512 70...... 17004 234...... 18034 20 CFR 250...... 20271 71...... 17004 235...... 18030, 18034 618...... 16988 936...... 18048 93...... 17254 252...... 18030, 18035 Proposed Rules: 180 ...... 17564, 17566, 17571, Ch. XIV ...... 19828 31 CFR 350...... 20299 17573, 17579, 19261, 19268, Proposed Rules: 404...... 20299 103...... 19241 19272 31...... 19345 416...... 20299 Proposed Rules: 272...... 17309 223...... 18041 212...... 20299 721...... 16670 252...... 18041 21 CFR Proposed Rules: 32 CFR Ch. I ...... 16353 51...... 19567 49 CFR 2...... 19213 199...... 18051 52 ...... 16387, 16388, 16706, 22...... 19285 10...... 16345 279...... 19878 17894, 18142, 18143, 18782, 23...... 16357 118...... 18751 2004...... 17305 19567, 19920, 19921, 19923 350...... 17208 522...... 20268 Proposed Rules: 60...... 19310 385...... 17208 524...... 16346 108...... 18138 61...... 19310 395...... 17208 814...... 16347 655...... 19302 63...... 19310 396...... 17208 1002...... 16351 1701...... 16698 98 ...... 17331, 18455, 18576, 571 ...... 17590, 17604, 17605 1003...... 16351 18608, 18652 Proposed Rules: 1004...... 16351 33 CFR 228...... 19311 172...... 17111 1005...... 16351 83...... 19544 272...... 17332 173...... 17111
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176...... 17111 50 CFR 300...... 18110 Proposed Rules: 17 ...... 16404, 17352, 17363, 383...... 16391 17 ...... 17062, 17466, 18107, 622...... 18427 17667, 18960, 19575, 19591, 384...... 16391 18782 648 ...... 17618, 18113, 18262, 390...... 16391 18356 19592, 19925 32...... 18413 391...... 16391 665...... 17070 223...... 16713 36...... 16636 392...... 16391 679 ...... 16359, 17315, 19561, 224...... 16713 1244...... 16712 92...... 18764 19562 648...... 16716
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Register but may be ordered H.J. Res. 80/P.L. 111–156 enacted public laws. To in ‘‘slip law’’ (individual Recognizing and honoring the subscribe, go to http:// LIST OF PUBLIC LAWS pamphlet) form from the Blinded Veterans Association listserv.gsa.gov/archives/ Superintendent of Documents, on its 65th anniversary of publaws-l.html This is a continuing list of U.S. Government Printing representing blinded veterans public bills from the current Office, Washington, DC 20402 and their families. (Apr. 7, Note: This service is strictly session of Congress which (phone, 202–512–1808). The 2010; 124 Stat. 1114) have become Federal laws. It text will also be made for E-mail notification of new Last List April 2, 2010 may be used in conjunction available on the Internet from laws. The text of laws is not with ‘‘P L U S’’ (Public Laws GPO Access at http:// available through this service. Update Service) on 202–741– www.gpoaccess.gov/plaws/ PENS cannot respond to Public Laws Electronic 6043. This list is also index.html. Some laws may specific inquiries sent to this available online at http:// not yet be available. Notification Service address. www.archives.gov/federal- (PENS) register/laws.html. H.R. 4621/P.L. 111–155 Prevent Deceptive Census The text of laws is not Look Alike Mailings Act (Apr. PENS is a free electronic mail published in the Federal 7, 2010; 124 Stat. 1112) notification service of newly
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