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Code · REGISTER · 2008-07-15 · PROPOSED RULES · Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40479 E8-16163 Alcohol Alcohol and Tobacco Tax and Trade Bureau PROPOSED RUL · Unknown

Unknown. Final rule

29,814 words·~136 min read·/register/2008/07/15/08-1432

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2008-07-15.xml --- 73 136 Tuesday, July 15, 2008 Contents Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40479 E8-16163 Alcohol Alcohol and Tobacco Tax and Trade Bureau PROPOSED RULES Proposed Expansion of the Paso Robles Viticultural Area (2008R-073P), 40474-40478 E8-16167 Broadcasting Broadcasting Board of Governors NOTICES Meetings; Sunshine Act, 40480 08-1432 Centers Centers for Disease Control and Prevention NOTICES Meetings:
National Institute for Occupational Safety and Health, 40582 E8-16065 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration Copyright Copyright Royalty Board, Library of Congress NOTICES Distribution of the 2004 and 2005 Cable Royalty Funds, 40623-40624 E8-16137 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40538-40539 E8-16164 Drug Drug Enforcement Administration RULES Redelegation of Functions, 40463-40464 E8-16012 Education Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40539-40541 E8-16086 E8-16087 E8-16089 Office of Special Education and Rehabilitative Services: Disability and Rehabilitation Research Projects and Centers Program; Technologies for Successful Aging With Disability, 40541-40545 E8-16116 Rehabilitation Engineering Research Centers;
Technologies for Successful Aging With Disability, 40545-40548 E8-16125 Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities, 40548-40556 E8-16128 Employment Employment and Training Administration NOTICES Amended Certification Regarding Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance: Best: Artex LLC, Currently Known as Best Textiles International Ltd., Highland, IL, 40617 E8-16074 Carrier Access Corporation, Currently Known As Turin Networks, Boulder, CO, 40617-40618 E8-16076 Delphi Corp. et al., Vandalia, OH, 40618 E8-16075 Delphi Corporation Automotive Holdings Group et al., Moraine, OH, 40618 E8-16073 Determinations Regarding Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance, 40618-40620 E8-16072 Negative Determination on Reconsideration:
Norcal Pottery Products, Richmond, CA, 40621 E8-16078 Negative Determination Regarding Application for Reconsideration: Gramercy Jewelry Manufacturing Corporation, New York, NY, 40621-40622 E8-16079 Request for Certification of Compliance: Rural Industrialization Loan and Grant Program, 40622 E8-16145 Revised Determination on Reconsideration: Bolton Metal Products Co. et al., Bellefonte, PA, 40622 E8-16077 Termination of Investigation: Excello Engineered Systems, Macedonia, OH, 40623 E8-16080 Holophane, Newark, OH, 40623 E8-16071 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: 2008 Department of Energy Nuclear Suppliers Outreach Meeting, 40557 E8-16028 State Energy Advisory Board;
Teleconference, 40557 E8-16162 EPA Environmental Protection Agency RULES Deletion Withdrawal: National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List, 40467 E8-16124 National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List, 40467-40468 E8-16123 PROPOSED RULES Approval and Promulgation of Implementation Plans: Texas; Control of Emissions of Nitrogen Oxides from Stationary Sources, E8-15814, [ **Editorial Note:** This document appearing at 73 FR 39900 in the **Federal Register** of July 11, 2008, was incorrectly indexed in that issue's Table of Contents.] NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40575-40576 E8-16117 Meetings: Science Advisory Board Particulate Matter Research Centers Program Advisory Panel, 40576-40577 E8-16118 Receipt of Petition and Tentative Affirmative Determination: New York State Prohibition of Marine Discharges of Vessel Sewage, 40577-40579 E8-16119 E8-16120 FAA Federal Aviation Administration NOTICES Policy Revisions and Requests for Comments: Percentage of Fabrication and Assembly that Must be Completed by an Amateur Builder to Obtain an Experimental Airworthiness Certificate, etc., 40652-40654 E8-16093 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 40468-40470 E8-16013 NOTICES Meetings:
National Advisory Council, 40592-40593 E8-15978 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Public Service Company of Colorado, 40558-40560 E8-16047 E8-16049 Union Electric Co., dba AmerenUE, 40560 E8-16210 Wellesley Rosewood Maynard Mills LP, 40560-40561 E8-16207 Combined Notice of Filings, 40561-40574 E8-16056 E8-16057 E8-16058 E8-16199 E8-16200 Environmental Impact Statements; Availability, etc.: Central Nebraska Public Power and Irrigation District, 40574 E8-16048 Filings:
Starwood Energy Group Global, L.L.C., 40574 E8-16046 TexMex Energy, LLC, 40574-40575 E8-16050 Federal Housing Federal Housing Enterprise Oversight Office RULES Risk-Based Capital Regulation; Loss Severity Amendments; Correction, 40656 Z8-13378 FMC Federal Maritime Commission NOTICES Meetings, 40579 E8-16138 Federal Railroad Federal Railroad Administration NOTICES Petition for Approval; Railroad Safety Program Plan, 40654 E8-16133 Petition for Waiver of Compliance, 40654-40655 E8-16130 E8-16131 Federal Reserve Federal Reserve System NOTICES Meetings;
Sunshine Act, 40579-40580 08-1439 Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities, 40580 E8-16097 FTC Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40580-40582 E8-16092 Food Food and Drug Administration RULES Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials, 40453-40463 E8-16011 NOTICES Determination:
SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 40582-40583 E8-15998 Global Harmonization Task Force, Study Groups 1 and 3 Proposed and Final Documents; Availability, 40583-40584 E8-16000 Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs; Availability, 40584-40585 E8-16002 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Federal Emergency Management Agency See U.S.
Citizenship and Immigration Services See U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40588-40589 E8-16166 Published Privacy Impact Assessments on the Web, 40589-40592 E8-16044 E8-16045 Housing Housing and Urban Development Department See Federal Housing Enterprise Oversight Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40594-40595 E8-16017 Meetings:
Manufactured Housing Consensus Committee, 40595 E8-16136 Indian Indian Affairs Bureau NOTICES Privacy Act; Systems of Records, 40595-40613 E8-16098 E8-16099 E8-16100 E8-16101 E8-16102 E8-16103 E8-16104 E8-16105 E8-16106 Interior Interior Department See Indian Affairs Bureau See Land Management Bureau See National Park Service IRS Internal Revenue Service PROPOSED RULES Postponement of Certain Tax-related Deadlines by Reason of Presidentially Declared Disaster or Terroristic or Military Actions, 40471-40474 E8-15939 International International Trade Administration NOTICES Extension of Time Limit for Final Results of the Antidumping Duty Administrative Review:
Glycine from the People's Republic of China, 40480 E8-16155 Final Affirmative Countervailing Duty Determination and Final Negative Determination of Critical Circumstances: Certain New Pneumatic Off-the-Road Tires from the People's Republic of China, 40480-40485 E8-16154 Final Affirmative Determination of Sales at Less Than Fair Value, etc.: Certain New Pneumatic Off-The-Road Tires from China, 40485-40492 E8-16156 Final Results and Partial Rescission of Antidumping Duty Administrative Review:
Certain Frozen Warmwater Shrimp from India, 40492-40499 E8-16152 Rescission of Administrative Review: Polyethylene Retail Carrier Bags from Malaysia, 40499-40500 E8-16153 International International Trade Commission NOTICES Investigations: Certain Short Wavelength Semiconductor Lasers and Products Containing Same, 40615 E8-16023 Meetings; Sunshine Act, 40615-40616 E8-16033 E8-16034 E8-16035 Justice Justice Department See Drug Enforcement Administration NOTICES Consent Decrees:
Bristol-Myers Squibb Co., 40616-40617 E8-16107 Waste Management of Illinois, Inc. et al., 40617 E8-16110 Labor Labor Department See Employment and Training Administration Land Land Management Bureau NOTICES Realty Action: Application for Conveyance of Federal Mineral Interests, Maricopa County, AZ., 40613 E8-16081 Resource Management Plan and Environmental Assessment: Kingman Resource Area, AZ, 40613-40614 E8-16082 Library Library of Congress See Copyright Royalty Board, Library of Congress National Archives National Archives and Records Administration NOTICES Records Schedules;
Availability and Request for Comments, 40624-40626 E8-16236 National National Institute for Literacy NOTICES Meetings: National Institute for Literacy Advisory Board, 40626 E8-16029 National Institute National Institute of Standards and Technology NOTICES Alternative Personnel Management System; Modifications, 40500-40502 E8-16066 Request for Nominations to Serve on National Institute of Standards and Technology Federal Advisory Committees, 40502-40507 E8-16064 Technology Innovation Program:
Availability of Funds and Announcement of Public Meetings, 40507-40511 E8-16068 NIH National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 40585-40588 E8-16134 Meetings: National Cancer Institute, 40588 E8-16139 NOAA National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species (HMS): Atlantic Shark Management Measures; Republication, 40658-40713 R8-13961 NOTICES Meetings: Gulf of Mexico Fishery Management Council, 40511-40512 E8-16108 Pacific Fishery Management Council, 40512 E8-16109 Small Takes of Marine Mammals Incidental to Specified Activities:
Ocean Bottom Cable Seismic Survey in the Liberty Prospect, Beaufort Sea, AK (2008), 40512-40538 E8-15962 National Park National Park Service NOTICES General Management Plan; Environmental Impact Statement: Golden Spike National Historic Site, UT, 40614-40615 E8-16083 National Science National Science Foundation NOTICES Permits Issued Under the Antarctic Conservation Act, 40626 E8-16025 Nuclear Nuclear Regulatory Commission NOTICES Confirmatory Order Modifying License (Effective Immediately):
Chevron Environmental Management Co.; Washington, PA Decommissioning Project Site, 40626-40628 E8-16090 Facility Operating Licenses Involving No Significant Hazards Considerations; Biweekly Notice, 40629-40638 E8-15684 Meetings; Sunshine Act, 40638-40639 08-1434 Office Office of Federal Housing Enterprise Oversight See Federal Housing Enterprise Oversight Office Pension Pension Benefit Guaranty Corporation RULES Benefits Payable in Terminated Single-Employer Plans; Allocation of Assets in Single Employer Plans;
Interest Assumptions for Valuing and Paying Benefits, 40464-40465 E8-16150 SEC Securities and Exchange Commission NOTICES Applications: ING Clarion Real Estate Income Fund, et al., 40639-40643 E8-15988 Meetings; Sunshine Act, 40643 E8-16085 Self-Regulatory Organizations; Proposed Rule Changes: American Stock Exchange LLC, New York Stock Exchange LLC, and NYSE Arca, Inc., 40643-40645 E8-16059 Chicago Board Options Exchange, Inc., 40645-40647 E8-16060 E8-16061 Financial Industry Regulatory Authority, Inc., 40647-40648 E8-15989 SBA Small Business Administration NOTICES Disaster Declarations:
Indiana, 40648-40649 E8-16111 E8-16113 E8-16114 West Virginia, 40649 E8-16112 State State Department NOTICES Privacy Act; Systems of Records, 40649-40652 E8-16159 E8-16161 Transportation Transportation Department See Federal Aviation Administration See Federal Railroad Administration Treasury Treasury Department See Alcohol and Tobacco Tax and Trade Bureau See Internal Revenue Service MISSING FOR: U.S. Citizenship and Immigration Services U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40593 E8-16063 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40593-40594 E8-16127 Veterans Veterans Affairs Department RULES Eligibility Reporting Requirements, 40465-40467 E8-15996 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 40658-40713 R8-13961 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 136 Tuesday, July 15, 2008 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 210 [Docket No. FDA-2005-N-0170] (formerly Docket No. 2005N-0285) Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials AGENCY:
Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the current good manufacturing practice
(CGMP)regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a guidance document entitled “Guidance for Industry: CGMP for Phase 1 Investigational Drugs” dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process. DATES: This rule is effective September 15, 2008. FOR FURTHER INFORMATION CONTACT: Monica Caphart, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3248, or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5000. SUPPLEMENTARY INFORMATION: I. Rulemaking Procedure In the **Federal Register** of January 17, 2006 (71 FR 2458), FDA published a direct final rule to amend § 210.2 (21 CFR 210.2) to exempt most phase 1 investigational drugs from complying with the CGMP requirements in parts 210 and 211 (21 CFR parts 210 and 211). We explained that we issued this rule as a direct final rule because we believed it was non-controversial and that there was little likelihood of receiving significant adverse comments. We concurrently published in the **Federal Register** of January 17, 2006 (71 FR 2494) a companion proposed rule, identical in substance to the direct final rule, that provided a procedural framework from which to proceed with standard notice-and-comment rulemaking in the event we were required to withdraw the direct final rule because of significant adverse comments. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without change. Any comments received under the companion proposed rule were treated as comments regarding the direct final rule and vice versa. A full description of FDA's policy on direct final rule procedures may be found in a guidance document published in the **Federal Register** of November 21, 1997 (62 FR 62466). We received 14 comments on the proposed rule, of which several were considered to be significant adverse comments. Therefore, in the **Federal Register** of May 2, 2006 (71 FR 25747), we withdrew the direct final rule. This final rule summarizes and responds to the comments received on the direct final rule and proposed rule. See section V of this document for a discussion of the comments and FDA's responses. Together with the companion guidance, this final rule will assist the drug development process by streamlining the application of CGMP that is more appropriate to the manufacture of the earliest stage investigational drug products—those intended for use in phase 1 clinical trials. II. Background A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects. This is in contrast to phase 2 and phase 3 clinical trials when a substantially greater number of subjects are involved, more subjects are exposed to the drug product, and the effectiveness of the drug product is also tested in addition to safety. During phase 2 or phase 3, drug products may also be made available for treatment use through one of several mechanisms for expanded access to investigational drugs. FDA's general CGMP regulations for human drugs are set forth in parts 210 and 211. Although the preamble to a final rule published in the **Federal Register** of September 29, 1978 (43 FR 45014) (the 1978 final rule) issuing these regulations expressly stated that the CGMP regulations applied to investigational drug products, it also raised the possibility of proposing an additional CGMP regulation to cover drugs being used in research: “The Commissioner finds that, as stated in § 211.1, these CGMP regulations apply to the preparation of any drug product for administration to humans or animals, including those still in investigational stages. It is appropriate that the process by which a drug product is manufactured in the development phase be well documented and controlled in order to assure the reproducibility of the product for further testing and for ultimate commercial production. The Commissioner is considering proposing additional CGMP regulations specifically designed to cover drugs in research stages” (43 FR 45014 at 45029). Such additional regulations have never been issued. On February 21, 1991, FDA issued a guidance document entitled “Preparation of Investigational New Drug Products (Human and Animal)” (56 FR 7048) (the 1991 guidance). That document, however, did not discuss all manufacturing scenarios, and did not clearly address small- or laboratory-scale production of drug products for use in phase 1 clinical trials. Additionally, the 1991 guidance did not fully discuss FDA's expectations on appropriate approaches to manufacturing controls for batches produced during drug development. For several reasons, FDA believes that production of human drug products, including biological drug products, intended for use in phase 1 clinical trials (phase 1 investigational drugs) should be exempted from complying with the specific regulatory requirements set forth in parts 210 and 211. First, even if exempted from the requirements of parts 210 and 211, investigational drugs remain subject to the statutory requirement that deems a drug adulterated if “* * * the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to assure that such drug meets the requirements of this chapter [of the Federal Food, Drug, and Cosmetic Act (the act)] as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess” (section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B))). Second, FDA oversees drugs for use in phase 1 trials through its existing IND authority. Every IND must contain, among other things, a section on chemistry, manufacturing, and control information that describes the composition, manufacture, and control of the investigational drug product (§ 312.23(a)(7) (21 CFR 312.23(a)(7))). Submission of this information, along with other information required in the IND, informs FDA of the steps that the manufacturer is taking to ensure the safety and quality of the investigational drug. Under this IND authority, FDA has the option to place an IND on clinical hold if the study subjects would be exposed to unreasonable and significant risk or if the IND does not contain sufficient information to assess the risks to subjects (21 CFR 312.42). FDA also may terminate an IND if the methods, facilities, and controls used for the manufacturing, processing, and packing of the investigational drug are inadequate to establish and maintain appropriate standards of identity, strength, quality, and purity as needed for subject safety (21 CFR 312.44(b)(1)(iii)). Thus, even though FDA is exempting phase 1 drug products from compliance with the specific requirements of the CGMP regulations, FDA retains the ability to take appropriate actions to address manufacturing issues. For example, in addition to the authority to put an IND on clinical hold or terminate an IND, FDA may initiate an action to seize an investigational drug or enjoin its production if its production does not occur under conditions sufficient to ensure the identity, strength, quality, and purity of the drug, which may adversely affect its safety. FDA believes this change in the CGMP regulations (parts 210 and 211) is appropriate because many of the issues presented by the production of investigational drugs intended for use in the relatively small phase 1 clinical trials are different from issues presented by the production of drug products for use in the larger phase 2 and phase 3 clinical trials or for commercial marketing. We are considering additional guidance and regulations to clarify FDA's expectations with regard to fulfilling CGMP requirements when producing investigational drugs for phase 2 and phase 3 clinical trials. Additionally, many of the specific requirements in the regulations in part 211 do not apply to the conditions under which many drugs for use in phase 1 clinical trials are produced. For example, the concerns underlying the regulations' requirement for fully validated manufacturing processes, rotation of the stock for drug product containers, the repackaging and relabeling of drug products, and separate packaging and production areas are generally not concerns for these very limited production investigational drug products used in phase 1 clinical trials. Consequently, in this final rule, FDA is amending the scope section of the drug CGMP regulations in part 210 to make clear that production of investigational drugs for use in phase 1 clinical trials conducted under an IND does not need to comply with the regulations in part 211. However, once an investigational drug product has been manufactured by, or for, a sponsor and is available for use in a phase 2 or phase 3 study, thus demonstrating an intent to expose more subjects to the investigational drug and requiring that the regulations' CGMP requirements be met, the same investigational drug product used in any subsequent phase 1 study by the same sponsor must be manufactured in compliance with part 211. In addition to drug products that, if eventually approved, would be approved under section 505 of the act (21 U.S.C. 355), this rule applies to investigational biological products that are subject to the CGMP requirements of section 501(a)(2)(B) of the act. Examples of such products include recombinant and non-recombinant therapeutic products, vaccine products, allergenic products, in vivo diagnostics, plasma derivative products, blood and blood products, gene therapy products, and somatic cellular therapy products (including xenotransplantation products) that are subject to the CGMP requirements of section 501(a)(2)(B) of the act. Therefore, this final rule exempts the production of phase 1 investigational drugs from complying with the regulatory requirements set forth in parts 210 and 211. III. Legal Authority Under section 501(a)(2)(B) of the act, a drug is deemed adulterated if the methods used in, or the facilities, or controls used for, its manufacture, processing, packing or holding do not conform to, or are not operated in conformity with, CGMPs to ensure that such drug meets the requirements of the act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. The rulemaking authority conferred on FDA by Congress under the act permits FDA to amend its regulations as contemplated by this final rule. Section 701(a) of the act (21 U.S.C. 371(a)) gives FDA, through delegation from the Secretary of the Department of Health and Human Services, general rulemaking authority to issue regulations for the efficient enforcement of the act. We refer readers to section V of the preamble of the 1978 final rule for a fuller discussion of our CGMP rulemaking authority (43 FR 45014 at 45020-45026). IV. Summary of the Final Rule This final rule adds paragraph
(c)to § 210.2, exempting certain investigational drugs for use in a phase 1 clinical trial (including biological drugs) from compliance with part 211. However, these drugs remain subject to the statutory requirements under section 501(a)(2)(B) of the act, i.e., CGMP. The regulation also explains that the exemption from compliance with part 211 does not apply to an investigational drug that a sponsor has made available for a phase 2 or phase 3 clinical trial, or has lawfully been marketed, and is being used for a phase 1 clinical trial. Such investigational drug products used for a phase 1 clinical trial must comply with part 211. We have also changed the term “defined” to “described” for clarification. V. Comments on the Proposed Rule and FDA's Responses We received approximately 14 comments on the proposed rule. Several comments were duplicate submissions by the same entity; several other comments submitted to the docket pertained to the draft guidance under a separate docket number. These comments were also considered in revising the draft guidance. The following responses are specific to the comments on the proposed rule. A. General Comments (Comment 1) Several comments welcome the proposed changes and commend FDA for revising the regulations to exempt phase 1 investigational drugs from regulatory CGMP under part 211. One comment adds that, because most products do not proceed beyond the clinical trial phase of development, the burden of full compliance with CGMP at the phase 1 stage far outweighs any perceived benefit and suggests that FDA devise a progressive scale for CGMP compliance beginning with phase 1 clinical trials through approval to market the product. (Response) We appreciate these supportive comments. Our expectation in issuing this final rule is that sponsors will take an appropriate approach to instituting manufacturing controls appropriate for the stage of investigational drug development. (Comment 2) Some comments oppose exempting phase 1 investigational drugs from compliance with part 211 because they are concerned that there could be an effect on product safety and human subject protection. Another comment believes that FDA's proposed approach to exempt phase 1 investigational drugs from the applicability of part 211 not only invites greatly reduced product standards, but affects FDA's ability to take remedial action. One reason given was that FDA does not have the personnel to monitor the manufacture of phase 1 investigational drugs during clinical trials. Another comment believes that if the phase 1 investigational drugs are not reproducible, not well-documented, or not well-controlled, the results of the trial will be meaningless and delay availability of new drugs for commercial use. The comment continued to state that an establishment could interpret FDA's proposal as loosening the basic requirements needed for phase 1 material, which would not only jeopardize patients and the results of the phase 1 clinical trial, but also the investigational stages of development that follow. (Response) We are confident that exempting phase 1 investigational drugs from the CGMP regulations in part 211 will not jeopardize product safety or human subject protection. This action is intended to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials, while also ensuring the products' safety and quality. An additional consequence of this action is to streamline and promote the drug development process. The companion guidance provides our current thinking on ways to comply, through the use of specified quality controls, with statutory CGMP for the production of phase 1 investigational drugs. As previously described, we will continue to oversee product safety and human subject protection through articulation of statutory CGMP requirements, clarified in the companion guidance, and a thorough review of the chemistry, manufacturing, and control information submitted in the IND application for identity, quality, purity, strength, and potency of the investigational drug necessary to ensure the safety of the subjects in the phase 1 clinical trial. We believe that this exemption does not “loosen” the requirements, but establishes quality control principles that are appropriate and comprehensive for the manufacture of phase 1 investigational drugs, i.e., interpreting and implementing CGMP consistent with good scientific methodology. We also believe that the exemption will not affect or change our ability to take remedial action if necessary, or to monitor the manufacture of such investigational drugs; nor do we believe that this action will delay availability of new drugs for commercial use. As stated elsewhere in this document and in the proposed rule, compliance with CGMP is required by section 501(a)(2)(B) of the act and a drug can be deemed adulterated by FDA for failure to comply with statutorily mandated CGMP. (Comment 3) One comment states that the proposed rule was misleading and unclear. The comment asserts, correctly, that a phase 1 investigational drug used in phase 2 and phase 3 clinical trials must comply with part 211, but argues that the progression of the study to phase 2 and phase 3 is unknown at the time of the phase 1 investigational drug production. Therefore, the sponsor will most likely produce the phase 1 investigational drug in compliance with part 211 in lieu of not being able to use data from the phase 1 study for phase 2 and phase 3. (Response) We disagree that the proposed rule was misleading and unclear. In the preamble to the direct final rule (71 FR 2458 at 2459), we explained that we believe the exemption for phase 1 investigational drugs “is appropriate because many of the issues presented by the production of investigational drugs intended for use in the relatively small Phase 1 clinical trials are different from issues presented by the production of drug products for use in the larger Phase 2 and Phase 3 clinical trials or for commercial marketing.” Given the differences between phase 1 clinical trials and phase 2 and phase 3 clinical trials discussed in section II of this document, we believe compliance with the particular regulations in part 211 is not appropriate for phase 1 investigational drugs because many of the specific requirements in part 211 do not apply to the manufacture of phase 1 investigational drugs in the same manner because they were intended to apply to commercial drug manufacture. For example, rotation of the stock for drug product containers, the repackaging and relabeling of drug products, and separate packaging and manufacturing areas are generally not of concern for the limited production of phase 1 investigational drugs. Additionally, the requirement for fully validated manufacturing processes may not be appropriate for this early stage of development. We believe that recommending approaches and considerations, and allowing the manufacturer to develop specific controls appropriate for the particular product, manufacturing process, and facility in order to comply with statutory CGMP requirement is less burdensome and more efficient for the sponsor. We agree that drug products used in phase 2 and phase 3 clinical trials may be improved or refined (i.e., manufacturing process and/or product) based on the results of the phase 1 clinical trial. However, limiting the exemption from compliance with the regulations in part 211 to drugs for use in phase 1 clinical trials (and not extending it to drugs that a sponsor has made available for a phase 2 or phase 3 clinical trial, or has lawfully marketed) does not preclude the use of data from a phase 1 clinical trial for phase 2 and phase 3. While it is true that some sponsors may choose to manufacture phase 1 investigational drugs in compliance with the regulatory requirements in part 211 in anticipation of expansion of the product into phase 2 clinical trials, this rule does not require that they do so, and it is up to the manufacturer to determine whether it makes sense in their particular case to manufacture the phase 1 drug in compliance with the regulations in part 211. (Comment 4) One comment states that FDA is ignoring past reports of phase 1 clinical trial failure, i.e., the two subject deaths in phase 1 clinical trials conducted at Johns Hopkins University and the University of Pennsylvania, and the six subjects who experienced major organ failure in a phase 1 clinical trial in England. The comment also adds that there have been several deaths and recalls due to drugs compounded by pharmacists and an increase of recalls of medical devices due to CGMP noncompliance. The comment also makes the statement that FDA should not assume that a medical researcher or other employee would be able to make safe phase 1 materials following guidance. (Response) We disagree with the comment highlighting the cases as a reason for not issuing this final rule. Investigations of the referenced cases found no evidence to suggest that the adverse events were caused by the manufacturing of the phase 1 investigational drug (Refs. 1, 2, and 3), and neither the British not the Johns Hopkins studies had been submitted to FDA under IND, and so had consequently not been prospectively reviewed by FDA (See *http://www.fda.gov/cder/warn/2003/02-hfd-45-0303.pdf* ), and thus, we are of the opinion that nothing in this final rule would have affected the outcome of any of the specific cases mentioned as we are not aware that CGMP was deficient or contributed to the deaths. As to the implication in the comment that these three cases indicate that there are risks in the manufacture of drugs for use in phase 1 clinical trials, we believe that there is risk in the manufacture of any drug, whether investigational or not and regardless of the stage of testing. We note, again, that investigational drugs for use in phase 1 clinical trials remain subject to statutory CGMP, and a companion guidance is being issued concurrent with this rule to provide suggested approaches for complying with statutory CGMP for phase 1 investigational drugs. With regard to the comment on pharmacy compounding errors, the reported instances of recalls due to drugs compounded by pharmacists are not analogous to producing drugs for phase 1 clinical trials, which is the subject of this rulemaking. Moreover, the comment concerning an increase of medical device recalls due to CGMP noncompliance apparently assumes that this final rule relieves phase 1 investigational drugs of compliance with any CGMP requirements. However, as previously discussed, this final rule exempts phase 1 investigational drugs only from regulatory CGMP requirements in parts 210 and 211. The statutory requirement to comply with CGMP still applies. We note that, in addition to the considerations described in the guidance, reference to technical information and appropriate training are necessary to comply with statutory CGMP. B. CGMP Regulation Specific to Phase 1 Investigational Drugs (Comment 5) Several comments request that FDA engage stakeholders and issue a new rulemaking for CGMP specific to phase 1 investigational drugs. One comment suggests that FDA apply the comments submitted to the docket on the proposed rule and draft guidance in proposing a new rule. Another comment suggests that FDA amend only the relevant requirements, e.g., on the repackaging and relabeling of drug products, retaining the oversight in all phases of a clinical trial of a drug. (Response) We appreciate the comments and will consider the appropriateness of such a proposed rule. For current purposes, however, we intend to proceed directly from the statute, and direct the public to the companion guidance that is being issued concurrently with this rule, suggesting some approaches to comply with statutory CGMP for phase 1 investigational drugs. C. Scope (Comment 6) One comment requests FDA to clarify the scope of the rulemaking, i.e., that the scope does not include active pharmaceutical ingredients (API). (Response) The scope of the exemption from compliance with part 211 includes investigational new human drug and biological products, including finished dosage forms used as placebos, for human use in a phase 1 study or trial. Examples of such investigational drugs include, but are not limited to, the following: • Investigational recombinant and non-recombinant therapeutic products, • Vaccine products, • Allergenic products, • In vivo diagnostic products, • Plasma derivative products, • Blood and blood components 1 , • Gene therapy products, and • Somatic cellular therapy products (including xenotransplantation products). However, if such products have already been manufactured by an IND sponsor for use during phase 2 or phase 3 clinical trials or have been lawfully marketed, the manufacture of such a product must comply with the appropriate requirements of part 211 for the product to be used in any subsequent phase 1 clinical trial, irrespective of the trial size or duration of dosing. 1 You should consult with the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), to determine circumstances when an IND would be required for blood or a blood component. Manufacturers of blood and blood components intended for transfusion and for further manufacture must still comply with the applicable regulations in 21 CFR parts 600 through 660. Manufacturers of new active pharmaceutical ingredients (also referred to as “API” or “drug substance”) are already exempt from compliance with part 211 and must also conform with CGMP as required in section 501(a)(2)(B) of the act. Thus, this rule does not change in any way how APIs are regulated with regard to CGMP. As stated in the companion guidance, limited guidance on CGMP for the manufacture of new API for some IND products used in clinical trials is also available (see International Conference on Harmonisation
(ICH)Q7A GMP Guide for API (ICH Q7A guidance)). Manufacturers of APIs should implement controls appropriate to the stage of development and, thus, should also consider the recommendations described in the companion guidance for manufacture of API used in investigational drug products for phase 1 clinical trials. (Comment 7) In the direct final rule, FDA makes the statement “[T]his action is intended to streamline and promote the drug development process” (71 FR 2458 at 2459). One comment believes that this proposal is outside the scope of FDA's mission mandated by Congress, i.e., to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” and “with respect to such products, protect the public health by ensuring that * * * human and veterinary drugs are safe and effective.” The comment further states that FDA was established to serve as a consumer protection agency and a check and balance on regulated industry. (Response) As section III of this document notes, CGMP is required by section 501(a)(2)(B) of the act, and FDA has been given the general authority to issue regulations for the efficient enforcement of the act. We note here as well that, under section 505(i) of the act, FDA is directed to issue regulations for exempting from the requirements of section 505 “drugs intended solely for investigational use by experts qualified by scientific training and experience to investigation the safety and effectiveness of drugs,” which include drugs for use in phase 1 clinical trials. While we agree that FDA is an agency whose public health mission demands an emphasis on safety, we note that this does not require us to impose burdens on drug development that do not have a commensurate public health benefit. We believe that this final rule is appropriate because many of the regulatory requirements in part 211 simply are not applicable to the manufacture of products intended for use in phase 1 clinical trials, and that the agency can continue to protect human subjects via interpretation of statutory CGMP and the IND process. D. Direct Final Rule and Companion Proposed Rule Approach (Comment 8) A couple of comments object to the direct final rule/companion proposed rule approach (rulemaking approach). One comment believes that the process did not allow for a discussion regarding the quality of clinical trial material, i.e., the establishment of meaningful, consistent standards that balance patient protection with speed of development. The comment then suggests that FDA work with industry to address industry-wide questions about quality for clinical trial materials, e.g., equipment qualification, water quality, method validation or qualification, sterility assurance, control of contractors, complaints, cleaning, and specifications. (Response) We disagree with the assertion that we did not allow for a discussion regarding the quality of clinical trial material. In developing the companion guidance, we utilized our experience with IND submissions and facility inspections. In addition, comments submitted to the docket were considered in finalizing the rule and the companion guidance, as well as stakeholder comments provided in multiple venues where FDA representatives discussed the proposed rule and draft guidance. Both the companion guidance and relevant IND regulations emphasize safety as the primary focus of phase 1 clinical trials. The companion guidance is written to allow for flexibility in utilizing appropriate CGMP controls for the product, manufacturing process, and facility to assure product safety. We will continue to work with stakeholders to refine appropriate standards as needed through continued discussions and meetings in various venues with stakeholders. (Comment 9) One comment states that FDA does not have the expertise to issue guidance or regulation without stakeholder input and adds that the manufacture of clinical supplies is a complex matter in which FDA has almost no experience. The comment also states that FDA lacks expertise in clinical GMP compliance because FDA has performed few inspections of early clinical supply material. (Response) We disagree with this comment. The decision to generate guidance for this early phase of clinical trial manufacture was due primarily to the constant requests for guidance in this area from the pharmaceutical industry, academia, and other research organizations. The publication of the draft guidance and the direct final and proposed rules in January 2006 was to address this apparent need, and to seek broader stakeholder input. Additionally, we have experience from numerous sources, such as participation with stakeholders in related workshops and conferences, facility inspections, and other interactions that result in sufficient understanding necessary to issue rulemaking and companion guidance. Contrary to the suggestion of the comment, conducting inspections of early clinical trial material is not the exclusive source of FDA expertise in this area. (Comment 10) One comment believes that FDA's finding that the subject is suitable for this rulemaking approach is based on assumptions, not data, such as the results of “for cause” inspections, treatment IND inspections, or reports of adverse drug events occurring during phase 1 clinical trials. (Response) We disagree with the comment. In the direct final rule, we stated that the rulemaking approach is appropriate because many of the issues present in the manufacture of phase 1 investigational drugs are different from those issues presented by the manufacture of drugs for later investigational phases or for commercial marketing, and that many of the specific requirements in part 211 are not applicable in the manufacture of the smaller batches of investigational drugs usually used in phase 1. These statements are not based on assumptions, as the comment suggests, but on the knowledge of, and experience with, good manufacturing practice for phase 1 investigational drugs. (Comment 11) One comment states that the proponents of the rulemaking approach cite the successful use of ICH Q7A guidance and its use during inspections without the need for a regulation. The comment suggests that the possible reason for the successful use is that the ICH Q7A guidance is more detailed than the draft guidance and is used to manufacture material that is further processed before being delivered to patients. (Response) We disagree with the comment. Due to the more defined routes of manufacture of APIs, and the general application of CGMP to APIs in the companion guidance, the ICH Q7A guidance was able to provide more detail for the commercial manufacture of APIs. Early phase clinical trial material may use many different routes of manufacture, some of which may be new and innovative. In addition, the recommendations or expectations contained in the ICH Q7A guidance (see section XIX of that guidance, on APIs for use in clinical trials) utilize an approach to CGMP similar to that outlined in the companion guidance. For the reason stated in response to comment 4, we believe that the companion guidance provides adequate considerations when supplemented with additional technical information and appropriate training to comply with CGMP. E. Exemption From Part 211 (Comment 12) One comment believes that compliance with statutory CGMP requirements and exemption of phase 1 investigational drugs from the requirements in part 211 subjects phase 1 investigational drugs to unwritten standards, developed case-by-case without any input from the public or industry. The comment also states that unwritten standards would lead to differing interpretations within FDA, e.g., by individual investigators, district offices, and review divisions. Inconsistency, non-transparency, and uncertainty slow product development as the industry tries to comply on a shifting landscape of uncertain legal basis. (Response) We disagree with the comment. We believe that we have provided sufficient opportunity for the public and industry to comment on the proposed exemption of phase 1 investigational drugs from compliance with part 211, the draft guidance, and the impact of such action. The purpose of the companion guidance is to provide recommendations for compliance with statutory CGMP and to promote consistency in compliance. The companion guidance is intended for use not only by industry, but also by FDA staff to assist in fulfilling their review and enforcement responsibilities. It bears emphasis that, because FDA has set forth its interpretation of some acceptable approaches to statutory CGMP in the companion guidance, as opposed to a rule, we remain open to alternative approaches to compliance, so long as they provide comparable safety and protection for human subjects. We believe this approach maximizes flexibility and minimizes burden, without diminishing safety protections. (Comment 13) One comment states that unclear rules erode quality. For example, financially strapped companies will not be able to justify expenses based on recommendations in a draft guidance. Inevitably, some companies will stumble, and quality will drop. (Response) Industry is not obligated to implement draft guidance. Draft guidance is for the purpose of soliciting comments on FDA's current thinking on a subject. In § 10.115(d)(1) (21 CFR 10.115(d)(1)), we explain that guidance does not legally bind the public or FDA. Therefore, a financially strapped company may choose to use a less expensive approach other than the one recommended in a guidance, but the alternative approach must comply with the relevant statutes and regulations in assuring patient safety, and the company would be prudent to consult FDA before using the alternative approach. As previously stated in our response to comment 12, we believe this rule maximizes flexibility and minimizes burden without diminishing safety protections. (Comment 14) One comment believes that regulatory CGMP provides minimum, legal requirements to safely make drugs or biologics made for use in humans. Another comment states that, instead of the detailed, enforceable standards laid out in part 211, FDA proposes to rely upon three sources of authority that are variously lacking in detail and/or enforceability, i.e., the statutory authority (section 501(a)(2)(B) of the act), the IND submission requirements in § 312.23, and the draft guidance. (Response) We disagree with this comment, and believe the comment confuses the requirements of the statute and the regulations. Many of the regulatory requirements in part 211 are not readily applicable to the manufacture of investigational drugs for use in phase I clinical trials. As previously stated, because such products still must comply with statutory CGMP, and because FDA has offered suggestions for acceptable methods for complying with statutory CGMP, we believe that manufacturers will have sufficient guidance to know what they must do to safely make drugs or biologics for such early stage clinical trial use in humans. We dispute the assertion that we are eschewing detailed, enforceable standards in favor of relying upon three sources of authority that are variously lacking in detail and/or enforceability. Statutory CGMP remains enforceable and we are issuing a companion guidance that details acceptable approaches for complying with statutory CGMP, and FDA's authority to place clinical trials on hold (under its IND authority) remains unchanged. (Comment 15) One comment states that FDA assumes that, once this rulemaking is final and phase 1 investigational drugs are exempt from complying with part 211, new sponsors would keep proper records, perform necessary testing, or keep retention samples for later investigations, or that they would take the time to learn and follow CGMP if there were no regulations requiring them to do so. Another comment states that FDA, without evidence, claims that having to actually produce drug or biological products according to accepted international standards is a barrier too high for entry into phase 1 studies. The comment continues to say that such barriers do serve a social purpose, i.e., preventing those incapable of following or unwilling to follow CGMP from administering investigational products to humans. (Response) As mentioned in the preamble to the proposed rule and draft companion guidance, application of part 211 is not appropriate to the production of IND products used in phase 1 studies. The type and extent of CGMP for investigational studies differs from those typically employed for routine commercial manufacturing, and in some cases may even include more stringent controls for certain manufacturing operations of investigational products. We believe that the proposed rule and the draft companion guidance better communicate FDA expectations and facilitates compliance with CGMP for the production of phase 1 investigational drugs rather than trying to apply existing part 211 regulations. Our expectation that phase 1 investigational drugs be manufactured following appropriate CGMP in adequate manufacturing facilities has not diminished with the adoption of this approach. FDA is not claiming that the manufacture of a drug or biological product for use in phase 1 studies according to international standards presents too high a barrier. FDA's position is that the United States' good manufacturing practice regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture. The final rule and companion guidance are intended to address these differences, while still requiring all drugs for human consumption, including those used in clinical trials, to be manufactured in accordance with CGMP as required by section 501(a)(2)(B) of the act. F. Risk to Patients (Comment 16) One comment maintains that FDA understates the risk to patients. The comment continues to say that the CGMP regulations are designed to protect patients from mishaps that would have major impact on the clinical subject, e.g., contamination with bacteria, penicillin, or industrial cleaning agents; and product mix-ups. Another comment believes that § 312.23, which requires companies to submit information about the clinical material, has nonexistent patient protections, and that submitting general information is no substitute for compliance with CGMP. (Response) We disagree with the assertion that we understated the risk to subjects (patients). We believe that there is no additional risk to subjects with this exemption, and have provided recommendations that interpret and implement CGMP consistent with good scientific methodology. In complying with section 501(a)(2)(B) of the act, a manufacturer must manufacture the drug in conformity with good manufacturing practice to assure that the drug meets the requirements of the act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. If the drug does not meet these criteria, the drug is considered adulterated and therefore a possible risk to subjects. Because the statutory requirements allow for flexibility in describing CGMP, we have issued the companion guidance to recommend CGMP for phase 1 investigational drugs. These recommended quality controls for producing a phase 1 investigational drug are specifically designed to ensure subject safety. (Comment 17) One comment believes that the exemption of phase 1 investigational drugs from part 211 puts patients at risk because it is difficult to prove what CGMP is, and makes it difficult for FDA to investigate or prosecute serious cases. The comment also states that a quality assurance
(QA)unit is required for preclinical studies and a quality control
(QC)unit is required for phase 2 and phase 3 studies. However, the new approach does not provide for a QA or QC unit for phase 1 studies. (Response) We disagree with this comment. As previously discussed in section II of this document, CGMP consists of steps that a manufacturer takes to ensure the safety and quality of the investigational drug. This information is submitted to FDA in the IND. Through FDA's IND authority, FDA has the ability to take appropriate actions to address manufacturing issues if there is a safety risk to subjects, i.e., place an IND on clinical hold, terminate an IND, seize an investigational drug, or prohibit its production. The functions performed by QA and/or QC unit(s) appropriate for this early phase of clinical trial material manufacture were clearly spelled out in the draft companion guidance. We describe in the companion guidance the QC functions that should be in effect to manufacture in compliance with CGMP for phase 1 clinical trials. It is at the discretion of the manufacturer if it wishes to implement these responsibilities through separate QA and QC groups. (Comment 18) One comment asserts that if the study subjects are exposed to unreasonable and significant risk or if the IND does not contain sufficient information to assess risk to patients, any action by FDA, i.e., placing a clinical hold or terminating an IND, would occur after the fact and well after patients are injured in the trial. (Response) Sponsors must inform the subjects of clinical trials of inherent, unknown risks (21 CFR 50.25). FDA will typically place a clinical hold or terminate an IND as a result of evaluating safety information provided as part of the IND review. Such evaluations are conducted prior to the initiation of the clinical trial. Therefore, we can and will, when appropriate, take such actions before the clinical trial proceeds. In addition to taking action before the clinical trial begins, we also have the ability under statutory CGMP to take enforcement actions once the phase 1 clinical trial begins. (Comment 19) One comment points out that FDA recognizes that, although part 211 applies to phase 2 and phase 3 investigational drugs, the extent of the controls varies based on the phase of the clinical study. The comments also state that FDA agrees that not all sections of part 211 may apply to phase 2 and phase 3 investigational drugs. For this reason, the comment suggests revising the last sentence of proposed § 210.2(c) to require that the drug for use in phase 1 study comply with the appropriate sections of part 211. Another comment also provided alternative language to § 210.2(c) stating that if the investigational drug has been made available for a phase 2 or phase 3 study or the drug has been lawfully marketed, and the manufacturer needs to conduct further phase 1 studies to generate data to support the registration of the clinical indication being developed, the drug used in the phase 1 clinical trial need not comply with part 211. (Response) We disagree with the comment. Because of the wide variability in the possible manufacturing processes used to produce early phase clinical trial material, it is not feasible to specify what parts of part 211 are appropriate in a companion guidance, because what may be appropriate for one manufacturing situation may be inappropriate for another. We decline to use the alternative codified language proposed by the comment, which would exempt from the requirements of parts 210 and 211 investigational drugs used in phase 1 clinical trials where the drugs have been lawfully marketed or used in phase 2 or phase 3 clinical trials. Because the drug products in question have already been manufactured using CGMP as indicated in part 211, the manufacturing knowledge is already available and should be fully utilized. (Comment 20) One comment reiterates the proposal that phase 1 investigational drugs would be manufactured following statutory requirements and recommendations through guidance for CGMP, and if used for a phase 1 clinical trial after available for phase 2 and phase 3 clinical trials or marketed, the phase 1 material would be manufactured using regulatory CGMP. The comment raises the question of the possibility that the phase 1 investigational drugs not manufactured per the same standard and used on human subjects is unethical. Another comment suggests that if only certain phase 1 investigational drugs follow CGMP while others are exempt it promotes a situation where subject safety may be at risk. (Response) We believe that the comment fails to recognize that the scope of the specific recommendations for CGMP in support of the statutory requirements provides the same, if not additional, protection of the phase 1 clinical trial subject. Given that FDA retains oversight over these part 211-exempt phase 1 products via the IND mechanism, and that the agency is issuing guidance on ways to comply with statutory CGMP in the manufacture of such products, we firmly believe that this rule presents no safety or ethical issue. However, as discussed elsewhere in this preamble, we are requiring that phase 1 investigational drugs that the sponsor makes available for phase 2 and phase 3 clinical trials or as lawfully marketed drugs comply with part 211. This is because, given the manufacturing scale of a product that will be administered beyond a phase 1 trial, such products are more like products manufactured for use in phase 2 and phase 3 clinical trials or lawfully marketed drugs. The fact that we are requiring investigational drugs manufactured in significant enough quantities that they are available for phase 2 or phase 3 testing or lawful marketing to comply with regulatory CGMP, does not mean that product that is manufactured only for use in a phase 1 trial, and is thus exempt from complying with regulatory CGMP, is unsafe. The current rulemaking exempting products from compliance with part 211 is limited to products manufactured exclusively for use in a phase 1 trial and the fact that some products used in phase 1 trials will be manufactured in compliance with the requirements of part 211 does not mean that products that are not so manufactured in compliance with statutory CGMP are unsafe. G. Use of Guidance (Comment 21) One comment believes that FDA should not use guidance in place of minimum CGMP requirements for the safe manufacture of drugs or biologics for human beings. Another comment requests that FDA not exempt the manufacture of phase 1 investigational drugs from part 211, but instead issue guidance to help manufacturers find innovative, simple, and inexpensive approaches to comply with CGMP regulations and keep their products safe for the trial subjects. (Response) We are not issuing the companion guidance in place of minimum CGMP requirements. CGMP is required by statute, and the companion guidance provides our current thinking on complying with statutory CGMP. As previously stated, this action is intended to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for phase 1 investigational drugs, and to streamline and promote the drug development process while ensuring the safety and quality of the earliest stage investigational drug products. We also expect this action to help promote innovative, simple, and inexpensive approaches to complying with the statutory CGMP requirements. As discussed in our response to comment 13, we are willing to discuss with the manufacturer alternative approaches that comply with the statutory requirements and that may be more innovative, simple, or inexpensive than the recommendations in the companion guidance. (Comment 22) Several comments express concern that guidance is not legally binding and therefore, not enforceable. One of the comments states that relying on guidance invites misunderstandings and inconsistencies, while another comment believes that if not required under part 211, manufacturers may not take the time to read or familiarize themselves with guidance related to CGMP, i.e., testing, manufacturing sterile or aseptic dosage forms, and employee qualification/training. A comment also believes that guidances do not undergo the same level of notice and comment, and lacks the complete input of interested parties. (Response) We agree with the comment that the companion guidance is not legally binding and not enforceable. However, the statutory requirement that drugs, including investigational drugs for use in phase 1 trials, comply with CGMP is legally binding and enforceable. We believe that a sponsor, guided by its knowledge, experience, and technical information applying good scientific methodology, following FDA recommendations, and undertaking appropriate activities (e.g., training), can adequately and appropriately comply with statutory CGMP. We disagree that relying on guidance invites misunderstandings and inconsistencies. In fact, to the contrary, we believe that guidance reduces misunderstandings and inconsistencies because guidance provides FDA's interpretation of or policy on a regulatory issue, while still allowing for flexibility and innovation. With regard to adequate notice to, and comment by, interested parties on guidance documents, the public can participate in the development and issuance of guidance documents as described in § 10.115(f) and (g), i.e., provide comment on issued draft guidance documents, suggest areas for guidance document development, submit drafts of proposed guidance documents for FDA to consider, suggest that FDA revise or withdraw an already existing guidance document, or comment on FDA's annually published list of possible topics for future guidance document development or revision. Therefore, we disagree with the comment that guidance does not undergo sufficient notice and comment, and lacks the complete input of interested parties. Moreover, we received extensive comments on the draft companion guidance from numerous entities and have considered these comments in preparing the companion guidance. (Comment 23) Two comments express concern regarding the effect of the companion guidance on the 1991 guidance on preparation of INDs, which recommends the application of certain sections of parts 210 and 211 to phase 2 and phase 3 clinical trials. The comments also request that FDA clarify the status of the 1991 guidance for phase 2 and phase 3 materials with regard to complying with CGMP requirements. Another comment asks if FDA expects an incremental application of CGMP for the production and testing of phase 2 and phase 3 clinical supplies, or if the 1991 guidance will remain in effect for phase 2 and phase 3 materials until the new phase 2 and phase 3 guidance document is available. (Response) As stated in the introduction of the companion guidance, the companion guidance will replace the 1991 guidance only as it applies to phase 1 investigational drugs. This action does not affect the scope of the 1991 guidance as it applies to phase 2 and phase 3 investigational drugs, which remains in effect until superseded by a subsequent guidance document. (Comment 24) One comment states that the guidance would allow the same person manufacturing the material (a non-QC unit employee) to also release the material to the clinic. The comment further states that the release of material by a non-member of the QC unit violates United States CGMP and a non-Qualified Person violates European Union CGMP, and does not appear to recognize the importance of having an experienced and knowledgeable unit or person to safely release the materials. (Response) We agree with this comment in part. The companion guidance recognizes the need to have quality control in this early phase of clinical trial material manufacture and has provided recommendations for the quality control procedures that should be used. We provide flexibility for operations where a very small amount of clinical material is produced. While we agree that release of material by an untrained person violates United States CGMP, this is not what is recommended in the companion guidance, which indicates that, under very limited circumstances and where justified, only a person trained in CGMP and quality control functions should be given the dual responsibility of manufacture and release. The interpretation in the companion guidance is consistent with the quality unit functions under part 211 and the nature of commercial and investigational products. H. Impact (Comment 25) FDA makes the following statement in the direct final rule (71 FR 2458 at 2461). “For drug manufacturers that produce Phase 1 drug products in-house and also produce approved drug products, this direct final rule is expected to reduce the amount of documentation they produce and maintain when they manufacture a Phase 1 drug. In some cases, it should also reduce the amount of component and product testing.” Two comments state that because it is unknown at the time of clinical manufacture if a phase 1 drug will continue to phase 2, manufacturers will likely elect to take a conservative approach and manufacture a drug to phase 2 requirements (part 211) to allow the phase 1 drug to be used in future phase 2 studies. Because of availability concerns in the clinical phase, manufacturers would most likely elect to not discard phase 1 material that could be used in phase 2. Therefore, the statement regarding savings is questionable. (Response) We agree with the comment that some manufacturers may decide to follow part 211 when manufacturing phase 1 investigational drugs. However, the saving estimate was intended to be an estimate of incremental savings should manufacturers chose to follow the companion guidance, as some manufacturers will. (Comment 26) One comment requests that FDA evaluate the cost of compliance against the hypothetical public health risk of a product that did not reach the market and the likelihood and severity of risks to volunteers. Another comment states that the additional risk to patients in a phase 1 clinical trial does not justify the proposed savings of $1,440 per IND in documentation, training, and other “reduced” requirements. The comment also states that the potential costs of $810 per IND is a gross underestimation of how much it will cost to manufacture a sterile or aseptic product for the first time. (Response) In section V.F of this document, the responses to comments 16 through 20 state that there will be no change in the risk to patients in phase 1 clinical trials as a result of the final rule. The cost estimate was intended to capture the incremental cost of complying with the proposed rule given current practice under part 211; it does not reflect total costs. A cost-benefit analysis of phase 1 clinical trials or clinical trials in general is beyond the scope of this document. (Comment 27) One comment believes that the expense is not for compliance with CGMP, especially if systems and procedures are simple, but for the training of personnel. (Response) Training personnel is a cost of complying with the current CGMP regulation; the estimate in the proposed rule captured the incremental increase in training costs to comply with the proposed rule. VI. Analysis of Impacts FDA has examined the impacts of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. Because exempting production of drugs for use in phase 1 clinical trials from compliance with specific regulatory requirements does not add to the compliance burden of small entities, and in most cases reduces it, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. The purpose of this final rule is to amend our current CGMP regulations to exempt the manufacture of investigational drugs used in phase 1 clinical trials from compliance with the requirements in part 211. The rule affects drug manufacturers, chemical manufacturers, and laboratories that manufacture drugs on a small scale for use in phase 1 clinical trials. For drug manufacturers that produce in-house investigational drugs for use in phase 1 clinical trials and also produce approved drug products for marketing, this final rule is expected to reduce the amount of documentation they produce and maintain when they manufacture an investigational drug for use in a phase 1 clinical trial. In some cases, it should also reduce the amount of component and product testing. Because they currently may not supply the pharmaceutical industry, some chemical manufacturers and laboratories may experience a slight increase in documentation if they do not have written standard operating procedures
(SOPs)or if they need to modify existing methods of documentation. Although formats may be different, the rule should not require more information than is already collected as part of standard laboratory practices. Because the actual SOPs and manufacturing requirements are different for each new drug product and manufacturing facility, the procedures to comply with the statutory CGMP requirements for phase 1 manufacturing are generated as part of product development. The savings or costs would be incurred on a per-IND and not per-facility basis. This rule is intended to clarify compliance with the statutory CGMPs that are necessary in the manufacture of investigational drugs used in phase 1 clinical trials, and to exempt certain drugs produced under IND and used for phase 1 clinical trials from regulatory CGMP requirements under part 211. Some manufacturers may realize savings because they no longer must meet certain requirements. The savings to drug manufacturers that manufacture in-house the investigational drugs used in phase 1 clinical trials will vary greatly from product to product. FDA lacks data to estimate where the cost savings will occur in the manufacture of investigational drugs. Some substantial savings may be realized in testing and analyzing components and in-process materials. These costs can typically range from $50 to $1,200 per component tested. The extent of the need for SOPs and methods validation may also be greatly reduced. We estimate that large drug manufacturers that manufacture in-house investigational drugs used in phase 1 clinical trials could potentially save between 24 to 40 hours per IND 2 . In addition, the clarifications we have made could lead some large firms to produce in-house future investigational drugs for use in phase 1 clinical trials, rather than contracting the work out. 2 Eastern Research Group (1195), *Economic Threshold and Regulatory Flexibility Assessment of Proposed Changes to the Current Good Manufacturing Practice Regulations for Manufacturing, Processing, Packing, or Holding Drugs (21 CFR 210 and 211)* , submitted to the Office of Planning and Evaluation, FDA. Estimated hours to change minor and major SOPs for large establishments (p. 24, table 7). For previously described chemical manufacturers and laboratories, the requirements in this rule may increase the time required for developing SOPs for quality, process, and procedural controls and will be incurred on a recurring basis for each new product manufactured. There may also be an incremental increase in training costs to educate employees on the CGMP requirements. We estimate that an additional 12 to 24 hours may be required for these activities depending on the experience of the entity and its employees with our current CGMP rule. 3 3 Eastern Research Group (1995), ibid., Estimated hours to change SOPs for small establishments. The facility that manufactures the investigational drugs used in phase 1 clinical trials is identified in the IND. We do not keep a database of these facilities and, therefore, we do not have a precise number of entities that might be affected by this final rule. To estimate the economic impact, we derived an estimate of the number affected annually based on the number of INDs we receive. We receive an average of 1,410 INDs each year. 4 However, this rule would not apply to the majority of these INDs because they are for drug products that already have premarket approvals and, thus, are subject to part 211. To derive an estimate of the percentage of INDs that would be affected by this rule, we used the percentage of total new drug applications
(NDAs)that were for new molecular entities
(NMEs)and applied that percentage to the number of annual IND applications. Historically, about 30 percent of NDAs are for NMEs each year. Assuming the relationship would be the same for the INDs and that the number of INDs will remain at about 1,410, this rule would affect about 425 INDs per year. A firm may produce multiple drug products for phase 1 clinical trials in a given year and use different companies to manufacture each of these drugs. Therefore, we do not know how many individual entities would be affected by this rule each year. 4 The annual number of INDs received varies from year to year; 1,410 is the mean of the total number of research and commercial INDs received by the Center for Drug Evaluation and Research and CBER between 2001 and 2005. The Small Business Administration
(SBA)defines manufacturers of biologic drugs as small entities if they employ fewer than 500 people and other drug manufacturers as small if they employ fewer than 750 people. FDA estimates that about 65 percent of the entities that submit NDAs and biologics license applications to the agency meet SBA's definition of a small entity. We assume that the distribution of large to small entities that submit INDs would be about the same. Although many of the entities that produce investigational drugs used in phase 1 clinical trials are laboratories, they are usually part of much larger institutions and are not considered small under SBA's definition. All of the entities affected by this rule have personnel with the skills necessary to comply with the requirements. Because we do not know the experience levels the affected entities have with our current CGMP requirements, we used the midpoint of the estimated ranges to estimate the potential recurring savings or costs. Savings to large manufacturers from reduced SOP and validation requirements for phase 1 drug manufacturing in-house, assuming a time savings of 32 hours per application, a fully loaded wage rate of $46, 5 and 150 INDs per year (approximately 35 percent of 425) would total $220,800 per year or $1,472 per IND. This would be in addition to any other savings from decreased component testing. 5 Bureau of Labor Statistics, *National Compensation Survey* , 2005. Wage rate is the average of the hourly rate for postsecondary chemistry teachers ($38.82) and postsecondary biochemistry teachers ($27.01) plus 40 percent to account for benefits and rounded to the nearest whole dollar, *www.bls.gov* , data accessed September 2006. The incremental average annual cost to chemical manufacturers and laboratories, assuming all would incur costs and assuming an average increase of 18 hours per application for writing SOPs and training, a fully loaded wage rate of $46, and 275 INDs (approximately 65 percent of 425) affected per year, would total $227,700 per year or $828 per IND. Although we do not know the number and size distribution of the entities affected by this rule, the impact on them will be negligible and should actually reduce the compliance burden for some. Manufacturers of drug products for phase 1 clinical trials are currently required to manufacturer them using CGMP, but some of the requirements in part 211 are not applicable for the manufacture of small quantities used in phase 1 clinical trials. While exempting these products from part 211, the companion guidance clarifies FDA's thinking on how to manufacture phase 1 investigational drugs under CGMP and does not include recommendations that would increase the burden of compliance. VII. Paperwork Reduction Act of 1995 This final rule contains no new information collection requirements that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Under the final rule, the production of human drug products, including biological drug products, intended for use in phase 1 clinical trials are exempted from complying with the requirements under part 211. Part 211 contains information collection requirements that are approved by OMB under control number 0910-0139. As explained in the following paragraph, the information collection requirements in part 211 are reduced in this final rule. The OMB-approved hourly burden to comply with the information collection requirements in part 211 (OMB control number 0910-0139) is 848,625 hours. FDA estimates that, under the final rule, approximately 425 investigational drugs are exempted from complying with the requirements under part 211. Based on this number and the total number of drugs that are subject to part 211 (122,795), FDA estimates that the burden hours approved under OMB control number 0910-0139 will be reduced by approximately 2,936 hours (425/122,795 x 848,625). Thus, as a result of the final rule, the amended burden hours in OMB control number 0910-0139 are approximately 845,689 hours. VIII. Environmental Impact The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IX. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. X. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the **Federal Register** .) 1. Wood, A.J.J., J. Darbyshire, “Injury to Research Volunteers—The Clinical-Research Nightmare,” *The New England Journal of Medicine* , 354:1869-1871, 2006. 2. Steinbrook, R., “Protecting Research Subjects—The Crisis at Johns Hopkins,” *The New England Journal of Medicine* , 346:716-720, 2002. 3. Savulescu, J., “Harm, Ethics Committees and the Gene Therapy Death,” *The Journal of Medical Ethics* , 27:148-150, 2001. List of Subjects in 21 CFR Part 210 Drugs, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 210 is amended as follows: PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 1. The authority citation for 21 CFR part 210 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. In § 210.2, add paragraph
(c)to read as follows: § 210.2 Applicability of current good manufacturing practice regulations.
(c)An investigational drug for use in a phase 1 study, as described in § 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in § 312.21(b) and
(c)of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211. Dated: July 9, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-16011 Filed 7-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 28 CFR Part 0 [Docket No. DEA-310F] Redelegation of Functions AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. SUMMARY: This rule makes one revision to the Drug Enforcement Administration's
(DEA)regulations concerning agency management. Additional personnel are authorized to sign and issue administrative subpoenas. DATES: *Effective Date:* July 15, 2008. FOR FURTHER INFORMATION CONTACT: Wendy H. Goggin, Chief Counsel, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone
(202)307-1000. SUPPLEMENTARY INFORMATION: This Final Rule implements one change to Title 28, Code of Federal Regulations (CFR), Part 0 by adding three officials to the list of officials who may sign and issue administrative subpoenas pursuant to the Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law No. 91-513, 84 Stat. 1236 (1970), as amended (the Act), codified at 21 U.S.C. 801-971. In addition to the Attorney General and the DEA Administrator, the current list of such officials is set forth at 28 CFR, Chapter I, part 0, Appendix to Subpart R, Section 4. Title 21, U.S.C. 875 and 876, provide the authority to issue such subpoenas. By 28 CFR 0.100, the Attorney General has delegated this authority to issue administrative subpoenas in support of his functions and duties under the Act to the DEA Administrator. The DEA Administrator is permitted by 28 CFR 0.104 to redelegate this authority “to any of [her] subordinates[.]” By this Final Rule, DEA now extends this administrative subpoena authority to its senior officials overseas who often supervise investigations with leads back in the United States, *i.e.* , DEA's Regional Directors, Assistant Regional Directors, and Country Attachés. As Title 28 CFR, Chapter I, Part 0, Appendix to Subpart R, Section 4 is presently written, DEA Resident Agents in Charge and Special Agent Group Supervisors posted outside the United States have such authority while their superiors, *i.e.* , Regional Directors, Assistant Regional Directors, and Country Attachés, do not. The amendment to section 4 is designed, in part, to rectify this anomaly. Title 28 CFR, Chapter I, Part 0, Appendix to Subpart R, Section 4 currently lists twelve categories of DEA and FBI officials who are empowered to sign and issue administrative subpoenas under 21 U.S.C. 875 and 876. To this list of senior officials DEA now adds its Regional Directors, Assistant Regional Directors, and Country Attachés. This is being done to rectify an oversight. While both DEA Resident Agents in Charge and Special Agent Group Supervisors posted outside the U.S. have authority to sign and issue such administrative subpoenas, unlike the case of Resident Agents in Charge and Special Agent Group Supervisors within the U.S., the superior officials (Regional Directors, Assistant Regional Directors, and Country Attachés) of such Resident Agents in Charge and Group Supervisors serving overseas have not heretofore been listed at Title 28 CFR, Chapter I, Part 0, Appendix to Subpart R, Section 4, as officials to whom the Administrator has redelegated her authority to sign and issue administrative subpoenas. Regulatory Certifications Administrative Procedure Act This rule relates to a matter of agency management or personnel and is a rule of agency organization, procedure, and practice. As such, this rule is exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date. *See* 5 U.S.C. 553(a)(2), (b)(3)(A), (d)(3). Regulatory Flexibility Act The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Drug Enforcement Administration. Further, a Regulatory Flexibility Analysis was not required to be prepared for this final rule because the Drug Enforcement Administration was not required to publish a general notice of proposed rulemaking for this matter. Executive Order 12866 This rule has been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, section 1(b), Principles of Regulation. This rule is limited to agency organization, management and personnel as described by Executive Order 12866 section (3)(d)(3) and, therefore, is not a “regulation” or “rule” as defined by that Executive Order. Accordingly, this rule has not been reviewed by the Office of Management and Budget. Executive Order 12988 This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform. Executive Order 13132 This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, Federalism, the Drug Enforcement Administration has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120 million or more (adjusted for inflation) in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 *et seq.* Congressional Review Act This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. The Drug Enforcement Administration has determined that this action is a rule relating to agency organization, procedure or practice that does not substantially affect the rights or obligation of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1966). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply. List of Subjects in 28 CFR Part 0 Authority delegations (Government agencies), Government employees, Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements, Whistleblowing. Accordingly, and for the reasons set forth above, 28 CFR Part 0 is amended as follows: PART 0—ORGANIZATION OF THE DEPARTMENT OF JUSTICE [AMENDED] 1. The authority citation for Part 0 continues to read as follows: Authority: 5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519. 2. In section 4 of the Appendix to Subpart R, paragraph
(a)is revised to read as follows: Appendix to Subpart R of Part 0—Redelegation of Functions *Sec. 4. Issuance of subpoenas.*
(a)The Chief Inspector of the DEA; the Deputy Chief Inspectors and Associate Deputy Chief Inspectors of the Office of Inspections and the Office of Professional Responsibility of the DEA; all Special Agents-in-Charge of the DEA and the FBI; DEA Inspectors assigned to the Inspection Division; DEA Associate Special Agents-in-Charge; DEA and FBI Assistant Special Agents-in-Charge; DEA Resident Agents-in-Charge; DEA Diversion Program Managers; FBI Supervisory Senior Resident Agents; DEA Special Agent Group Supervisors; those FBI Special Agent Squad Supervisors who have management responsibility over Organized Crime/Drug Program Investigations; and DEA Regional Directors, Assistant Regional Directors, and Country Attachés, are authorized to sign and issue subpoenas with respect to controlled substances, listed chemicals, tableting machines or encapsulating machines under 21 U.S.C. 875 and 876 in regard to matters within their respective jurisdictions. Dated: July 1, 2008. Michele M. Leonhart, Acting Administrator. [FR Doc. E8-16012 Filed 7-14-08; 8:45 am] BILLING CODE 4410-09-P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Benefits Payable in Terminated Single-Employer Plans; Allocation of Assets in Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits AGENCY: Pension Benefit Guaranty Corporation. ACTION: Final rule. SUMMARY: The Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating single-employer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in August 2008. Interest assumptions are also published on the PBGC's Web site ( *http://www.pbgc.gov* ). DATES: Effective August 1, 2008. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion, Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.) SUPPLEMENTARY INFORMATION: The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Three sets of interest assumptions are prescribed:
(1)A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to part 4044),
(2)a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to part 4022), and
(3)a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to part 4022). This amendment
(1)adds to Appendix B to part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during August 2008,
(2)adds to Appendix B to part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during August 2008, and
(3)adds to Appendix C to part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during August 2008. For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 6.05 percent for the first 20 years following the valuation date and 5.12 percent thereafter. These interest assumptions represent an increase (from those in effect for July 2008) of 0.10 percent for the first 20 years following the valuation date and 0.10 percent for all years thereafter. The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 3.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent a decrease (from those in effect for July 2008) of 0.25 percent in the immediate annuity rate and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022). The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible. Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during August 2008, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication. The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866. Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2). List of Subjects 29 CFR Part 4022 Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements. 29 CFR Part 4044 Employee benefit plans, Pension insurance, Pensions. In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows: PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority: 29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344. 2. In appendix B to part 4022, Rate Set 178, as set forth below, is added to the table. Appendix B to Part 4022—Lump Sum Interest Rates for PBGC Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate (percent) Deferred annuities (percent) i <sup>1</sup> i <sup>2</sup> i <sup>3</sup> n <sup>1</sup> n <sup>2</sup> * * * * * * * 178 08-1-08 09-1-08 3.25 4.00 4.00 4.00 7 8 3. In appendix C to part 4022, Rate Set 178, as set forth below, is added to the table. Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate (percent) Deferred annuities (percent) i <sup>1</sup> i <sup>2</sup> i <sup>3</sup> n <sup>1</sup> n <sup>2</sup> * * * * * * * 178 08-1-08 09-1-08 3.25 4.00 4.00 4.00 7 8 PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS 4. The authority citation for part 4044 continues to read as follows: Authority: 29 U.S.C. 1301(a), 1320(b)(3), 1341, 1344, 1362. 5. In appendix B to part 4044, a new entry for August 2008, as set forth below, is added to the table. Appendix B to Part 4044—Interest Rates Used to Value Benefits For valuation dates occurring in the month— The values of i <sup>t</sup> are: i <sup>t</sup> for t = i <sup>t</sup> for t = i <sup>t</sup> for t = * * * * * * * August 2008 .0605 1-20 .0512 >20 N/A N/A Issued in Washington, DC, on this 8th day of July 2008. Vincent K. Snowbarger, Deputy Director for Operations, Pension Benefit Guaranty Corporation. [FR Doc. E8-16150 Filed 7-14-08; 8:45 am] BILLING CODE 7709-01-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AM89 Eligibility Reporting Requirements AGENCY: Department of Veterans Affairs. ACTION: Final rule. SUMMARY: This document amends the Department of Veterans Affairs
(VA)adjudication regulations regarding eligibility verification reports for certain parents receiving dependency and indemnity compensation. This amendment is necessary to conform the regulation to statutory provisions. EFFECTIVE DATE: This amendment is effective July 15, 2008. FOR FURTHER INFORMATION CONTACT: Maya Ferrandino, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,
(727)319-5847. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: VA has two income-based benefit programs: pension and parents' dependency and indemnity compensation (DIC). VA may require a beneficiary of these programs to submit an eligibility verification report
(EVR)in order to determine or verify entitlement under these programs. *See* 38 U.S.C. 1315, 1506; 38 CFR 3.256, 3.277, 3.661. The authorizing statute for allowing VA to require an EVR from a parents' DIC beneficiary, section 1315(e), provides an exception for parents who have attained 72 years of age and have been paid DIC during two consecutive calendar years. In the past, VA has interpreted section 1315(e) as allowing VA the discretion to continue requiring EVRs from this category of parents' DIC beneficiaries. *See* 60 FR 25877, 25877-78 (May 15, 1995). However, on current review, we have determined that the statute does not allow VA to require EVRs from this group, and we are, therefore, amending the implementing regulation, § 3.256(b)(3), to state that VA will not request an EVR from these beneficiaries. This regulatory amendment does not change the requirement that parents' DIC beneficiaries who have attained 72 years of age and have been paid DIC during two consecutive calendar years must report material changes in income to VA. *See* 38 U.S.C. 1315(e) and 38 CFR 3.256(a). Administrative Procedures Act This final rule is an interpretative rule and the changes made by this rule merely reflect VA's interpretation of statutory requirements. The primary purpose of the amendment is to implement VA's statutory interpretation of 38 U.S.C. 1315 and to align § 3.256 to the statute. Section 553(b) of title 5, U.S. Code, does not apply to interpretive rules. Accordingly, there is a basis for dispensing with prior notice and opportunity to comment. Moreover, under section 553(d), interpretive rules do not require 30 days prior notice before they may become effective. Therefore, because the amendment to § 3.256 is an interpretive rule, the amendment may have an immediate effect. Accordingly, there is a basis for dispensing with the delayed effective date provisions of 5 U.S.C. 553(d). Paperwork Reduction Act This document contains no provisions constituting a new collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). The Office of Management and Budget
(OMB)assigns a control number for each collection of information it approves. VA may not sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Control number 2900-0101 has been assigned for the collection of information under § 3.256. The amendments to § 3.256 in this final rule remain within the scope of the approved collections of information. This document will not increase the information burden, nor is it a complete discontinuance because VA will continue to request EVRs from individuals who do not meet the exception requirements under section 1315(e). The amendments are a slight modification that applies to the narrow group of people who meet the exception. Any reduction in the burdens imposed by this approved collection will be identified and addressed in the extension request that VA must submit to OMB before July 31, 2008. Regulatory Flexibility Act The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule would not affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by OMB unless OMB waives such review, as any regulatory action that is likely to result in a rule that may:
(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(2)create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3)materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4)raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance Numbers and Titles The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death. List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam. Approved: June 12, 2008. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. For the reasons set forth in the preamble, 38 CFR part 3 is amended as follows: PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for part 3, subpart A, continues to read as follows: Authority: 38 U.S.C. 501(a), unless otherwise noted. 2. Revise § 3.256(b)(3) introductory text to read as follows: § 3.256 Eligibility reporting requirements.
(b)* * *
(3)Except for a parent who has attained 72 years of age and has been paid dependency and indemnity compensation during two consecutive calendar years, the Secretary shall require an eligibility verification report from individuals receiving parents' dependency and indemnity compensation under the following circumstances: [FR Doc. E8-15996 Filed 7-14-08; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-1989-0008, Notice 4; FRL-8691-8] National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List AGENCY: Environmental Protection Agency. ACTION: Withdrawal of direct final Notice of Deletion. SUMMARY: On June 13, 2008 EPA published a Notice of Intent to Delete (73 FR 33758) and a direct final Notice of Deletion (73 FR 33721) for the Fourth Street Abandoned Refinery Superfund Site from the National Priorities List. The EPA is withdrawing the Final Notice of Deletion due to adverse comments that were received during the public comment period. After consideration of the comments received, if appropriate, EPA will publish a Notice of Deletion in the **Federal Register** based on the parallel Notice of Intent to Delete and place a copy of the final deletion package, including a Responsiveness Summary, if prepared, in the Site repositories. EFFECTIVE DATE: This withdrawal of the direct final action is effective as of *July 15, 2008* . ADDRESSES: *Information Repositories:* Comprehensive information on the Site, as well as the comments that we received during the comment period, are available in docket EPA-HQ-SFUND-1989-0008, Notice 4, accessed through the *http://www.regulations.gov* Web site. Although listed in the docket index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at: U.S. EPA Online Library System at *http://www.epa.gov/natlibra/ols.htm* ; U.S. EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733,
(214)665-6617, by appointment only Monday through Friday 9 a.m. to 12 p.m. and 1 p.m. to 4 p.m.; Ralph Ellison Library, 2000 Northeast 23, Oklahoma City, OK 73111,
(409)643-5979, Monday through Wednesday 9 a.m. to 9 p.m., Thursday and Friday 9 a.m. to 6 p.m., Saturday 10 a.m. to 4 p.m.; Oklahoma Department of Environmental Quality (ODEQ), 707 North Robinson, Oklahoma City, Oklahoma, 73101,
(512)239-2920, Monday through Friday 8 a.m. to 5 p.m. FOR FURTHER INFORMATION CONTACT: Bartolome Canellas, Remedial Project Manager, U.S. Environmental Protection Agency, Region 6, 6SF-RL, 1445 Ross Avenue, Dallas, Texas 75202-2733, *canellas.bart@epa.gov* or
(214)665-6662 or 1-800-533-3508. SUPPLEMENTARY INFORMATION: List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous Waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water Supply. Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193. Dated: June 26, 2008. Richard E. Greene, Regional Administrator, Region 6. Accordingly, the amendment to Table “1” of Appendix B to 40 CFR Part 300 to remove the entry “Fourth Street Abandoned Refinery”, “Oklahoma City, Oklahoma” is withdrawn as of July 15, 2008. [FR Doc. E8-16124 Filed 7-14-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-1989-0008, Notice 3; FRL-8691-9] National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List AGENCY: Environmental Protection Agency. ACTION: Withdrawal of direct final Notice of Deletion. SUMMARY: On June 13, 2008 EPA published a Notice of Intent to Delete (73 FR 33760) and a direct final Notice of Deletion (73 FR 33718) for the Double Eagle Refinery Co. from the National Priorities List. The EPA is withdrawing the Final Notice of Deletion due to adverse comments that were received during the public comment period. After consideration of the comments received, if appropriate, EPA will publish a Notice of Deletion in the **Federal Register** based on the parallel Notice of Intent to Delete and place a copy of the final deletion package, including a Responsiveness Summary, if prepared, in the Site repositories. EFFECTIVE DATE: This withdrawal of the direct final action is effective as of *July 15, 2008.* ADDRESSES: *Information Repositories:* Comprehensive information on the Site, as well as the comments that we received during the comment period, are available in docket EPA-HQ-SFUND-1989-0008, Notice 3, accessed through the *http://www.regulations.gov* Web site. Although listed in the docket index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at: U.S. EPA Online Library System at *http://www.epa.gov/natlibra/ols.htm;* U.S. EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733,
(214)665-6617, by appointment only Monday through Friday 9 a.m. to 12 p.m. and 1 p.m. to 4 p.m.; Ralph Ellison Library, 2000 Northeast 23, Oklahoma City, OK 73111,
(409)643-5979, Monday through Wednesday 9 a.m. to 9 p.m., Thursday and Friday 9 a.m. to 6 p.m., Saturday 10 a.m. to 4 p.m.; Oklahoma Department of Environmental Quality (ODEQ), 707 North Robinson, Oklahoma City, Oklahoma, 73101,
(512)239-2920, Monday through Friday 8 a.m. to 5 p.m. FOR FURTHER INFORMATION CONTACT: Bartolome Canellas, Remedial Project Manager, U.S. Environmental Protection Agency, Region 6, 6SF-RL, 1445 Ross Avenue, Dallas, Texas 75202-2733, *canellas.bart@epa.gov* or
(214)665-6662 or 1-800-533-3508. SUPPLEMENTARY INFORMATION: List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous Waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water Supply. Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193. Dated: June 26, 2008. Richard E. Greene, Regional Administrator, Region 6. Accordingly, the amendment to Table “1” of Appendix B to 40 CFR Part 300 to remove the entry “Double Eagle Refinery Co.”, “Oklahoma City, Oklahoma” is withdrawn as of July 15, 2008. [FR Doc. E8-16123 Filed 7-14-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA-8031] Suspension of Community Eligibility AGENCY: Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency
(FEMA)receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the **Federal Register** on a subsequent date. DATES: *Effective Dates:* The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables. FOR FURTHER INFORMATION CONTACT: If you want to determine whether a particular community was suspended on the suspension date or for further information, contact David Stearrett, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 *et seq.* , unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the **Federal Register** . In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. *National Environmental Policy Act* . This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared. *Regulatory Flexibility Act* . The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. *Regulatory Classification* . This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism* . This rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform* . This rule meets the applicable standards of Executive Order 12988. *Paperwork Reduction Act* . This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. § 64.6 [Amended] 2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal assistance no longer available in SFHAs Region III Pennsylvania: Coal, Township of, Northumberland County 421936 Aug. 12, 1974, Emerg; July 3, 1990, Reg; July 16, 2008, Susp. July 17, 2008 July 16, 2008 Delaware, Township of, Northumberland County 421010 Nov. 19, 1973, Emerg; Nov. 19, 1980, Reg; July 16, 2008, Susp. ......do* Do. East Cameron, Township of, Northumberland County 421937 Sept. 3, 1975, Emerg; Sept. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. East Chillisquaque, Township of, Northumberland County 422599 Oct. 15, 1975, Emerg; May 4, 1987, Reg; July 16, 2008, Susp. ......do Do. Herndon, Township of, Northumberland County 420735 Dec. 6, 1973, Emerg; Aug. 1, 1979, Reg; July 16, 2008, Susp. ......do Do. Jackson, Township of, Northumberland County 421938 Sept. 24, 1974, Emerg; Aug. 15, 1979, Reg; July 16, 2008, Susp. ......do Do. Jordan, Township of, Northumberland County 421939 Nov., Emerg; Aug. 15, 1980, Reg; July 16, 2008, Susp. ......do Do. Kulpmont, Borough of, Northumberland County 420736 Feb. 1, 1974, Emerg; May 1, 1978, Reg; July 16, 2008, Susp. ......do Do. Lewis, Township of, Northumberland County 421940 Mar. 8, 1976, Emerg; Apr. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. Little Mahanoy, Township of, Northumberland County 421015 Jan. 30, 1974, Emerg; Sept. 5, 1979, Reg; July 16, 2008, Susp. ......do Do. Lower Augusta, Township of, Northumberland County 421017 Jan. 28, 1974, Emerg; Aug. 1, 1979, Reg; July 16, 2008, Susp. ......do Do. Lower Mahanoy, Township of, Northumberland County 421941 July 25, 1975, Emerg; Aug. 2, 1982, Reg; July 16, 2008, Susp. ......do Do. McEwensville, City of, Northumberland County 421935 Feb. 14, 1983, Emerg; Sept. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. Milton, Borough of, Northumberland County 425384 Apr. 9, 1971, Emerg; Mar. 10, 1972, Reg; July 16, 2008, Susp. ......do Do. Mount Caramel, Borough of, Northumberland County 420738 Dec. 17, 1973, Emerg; July 17, 1978, Reg; July 16, 2008, Susp. ......do Do. Mount Caramel, Township of, Northumberland County 421942 Oct. 24, 1974, Emerg; May 3, 1990, Reg; July 16, 2008, Susp. ......do Do. Northumberland, Borough of, Northumberland County 420739 June 6, 1974, Emerg; Feb. 2, 1977, Reg; July 16, 2008, Susp. ......do Do. Point, Township of, Northumberland County 421026 Nov. 19, 1973, Emerg; May 2, 1977, Reg; July 16, 2008, Susp. ......do Do. Ralpho, Township of, Northumberland County 421027 Nov. 19, 1973, Emerg; Feb. 15, 1979, Reg; July 16, 2008, Susp. ......do Do. Riverside, Borough of, Northumberland County 420740 Nov. 19, 1973, Emerg; Apr. 15, 1977, Reg; July 16, 2008, Susp. ......do Do. Rockefeller, City of, Northumberland County 421152 Apr. 12, 1974, Emerg; Apr. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. Rush, Township of, Northumberland County 421943 Nov. 11, 1974, Emerg; Jan. 28, 1977, Reg; July 16, 2008, Susp. ......do Do. Shamokin, City of, Northumberland County 420741 Apr. 5, 1974, Emerg; Dec. 16, 1980, Reg; July 16, 2008, Susp. ......do Do. Shamokin, Township of, Northumberland County 421159 Apr. 23, 1974, Emerg; Mar. 5, 1990, Reg; July 16, 2008, Susp. ......do Do. Snydertown, Borough of, Northumberland County 420742 May 27, 1975, Emerg; Sept. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. Sunbury, City of, Northumberland County 420743 Sept. 3, 1971, Emerg; July 18, 1977, Reg; July 16, 2008, Susp. ......do Do. Turbot, Township of, Northumberland County 420744 Mar. 16, 1973, Emerg; Aug. 15, 1979, Reg; July 16, 2008, Susp. ......do Do. Upper Augusta, Township of, Northumberland County 420745 Jan. 19, 1973, Emerg; May 2, 1977, Reg; July 16, 2008, Susp. ......do Do. Upper Mahanoy, Township of, Northumberland County 421944 Oct. 24, 1975, Emerg; Sept. 1, 1986, Reg; July 16, 2008, Susp. ......do Do. Washington, Township of, Northumberland County 421945 Nov. 7, 1975, Emerg; Dec. 15, 1978, Reg; July 16, 2008, Susp. ......do Do. Watsontown, Township of, Northumberland County 420746 Nov. 19, 1973, Emerg; Jan. 2, 1980, Reg; July 16, 2008, Susp. ......do Do. West Cameron, Township of, Northumberland County 421946 Oct. 15, 1975, Emerg; Jan. 17, 1990, Reg; July 16, 2008, Susp. ......do Do. West Chillisquaque, Township of, Northumberland County 421033 Jan. 28, 1974, Emerg; Apr. 15, 1977, Reg; July 16, 2008, Susp. ......do Do. Zerbe, Township of, Northumberland County 421947 Aug. 20, 1974, Emerg; Jan. 17, 1990, Reg; July 16, 2008, Susp. ......do Do. Region V Illinois: Chenoa, City of, McLean County 170492 Mar. 27, 1975, Emerg; June 11, 1976, Reg; July 16, 2008, Susp. ......do Do. Colfax, City of, McLean County 170493 June 17, 1975, Emerg; Jan. 18, 2002, Reg; July 16, 2008, Susp. ......do Do. Cooksville, Village of, McLean County 170494 July 1, 1975, Emerg; June 11, 1976, Reg; July 16, 2008, Susp. ......do Do. Danvers, Village of, McLean County 170495 Aug. 7, 1975, Emerg; Aug. 19, 1986, Reg; July 16, 2008, Susp. ......do Do. Downs, Village of, McLean County 171072 May 31, 2000, Emerg; Feb. 9, 2001, Reg; July 16, 2008, Susp. ......do Do. Heyworth, Village of, McLean County 170497 Mar. 7, 1983, Emerg; Dec. 1, 1983, Reg; July 16, 2008, Susp. ......do Do. Hudson, Village of, McLean County 170498 May 12, 1975, Emerg; June 11, 1976, Reg; July 16, 2008, Susp. ......do Do. Leroy, City of, McLean County 170499 May 6, 1975, Emerg; May 2, 1980, Reg; July 16, 2008, Susp. ......do Do. Lexington, City of, McLean County 170500 Aug. 10, 1998, Emerg; Feb. 9, 2001, Reg; July 16, 2008, Susp. ......do Do. McLean, Village of, McLean County 170501 Mar. 15, 1976, Emerg; Sept. 30, 1976, Reg; July 16, 2008, Susp. ......do Do. McLean County, Unincorporated Areas 170931 Sept. 19, 1979, Emerg; Dec. 18, 1985, Reg; July 16, 2008, Susp. ......do Do. Normal, Town of, McLean County 170502 June 19, 1975, Emerg; Sept. 1, 1983, Reg; July 16, 2008, Susp. ......do Do. Saybrook, Village of, McLean County 171074 __, Emerg; Feb. 24, 2003, Reg; July 16, 2008, Susp. ......do Do. Towanda, Village of, McLean County 170504 May 12, 1975, Emerg; Sept. 4, 1987, Reg; July 16, 2008, Susp. ......do Do. Region VIII South Dakota: Aurora, Town of, Brookings County 460051 Jan. 16, 2007, Emerg;____, Reg; July 16, 2008, Susp. ......do Do. Brookings, City of, Brookings County 460004 Apr. 16, 1974, Emerg; Oct. 17, 1978, Reg; July 16, 2008, Susp. ......do Do. Brookings County, Unincorporated Areas 460253 July 19, 1987, Emerg; Jan. 1, 1987, Reg; July 16, 2008, Susp. ......do Do. Bruce, Town of, Brookings County 460005 Aug. 20, 1975, Emerg; Feb. 5, 1980, Reg; July 16, 2008, Susp. ......do Do. *-do-=Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: July 1, 2008. Michael K. Buckley, Deputy Assistant Administrator for Mitigation, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E8-16013 Filed 7-14-08; 8:45 am] BILLING CODE 9110-12-P 73 136 Tuesday, July 15, 2008 Proposed Rules DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [REG-142680-06] RIN 1545-BG16 Postponement of Certain Tax-Related Deadlines by Reason of Presidentially Declared Disaster or Terroristic or Military Actions AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: This document contains a proposed regulation that proposes to amend existing regulations issued under section 7508A of the Internal Revenue Code (Code). The purpose of the proposed regulation is to clarify rules relating to the postponement of certain tax-related acts by reason of a Presidentially declared disaster or terroristic or military action. The proposed regulation clarifies the scope of relief under section 7508A and specifies that interest may be suspended during the postponement period. These changes are necessary to reflect changes in the law made by the Victims of Terrorism Tax Relief Act and current IRS practice. The proposed regulation will affect taxpayers determined by the Secretary to be affected by a Presidentially declared disaster or terroristic or military action. DATES: Written or electronically generated comments and requests for a public hearing must be received by October 14, 2008. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-142680-06), room 5203, Internal Revenue Service, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-142680-06), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington DC, or sent electronically, via the Federal eRulemaking Portal at *www.regulations.gov* (IRS REG-142680-06). FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulation, Mary Ellen Keys
(202)622-4570; concerning submission of comments, Oluwafunmilayo Taylor,
(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background This document contains proposed amendments to the Procedure and Administration Regulations (26 CFR part 301). Section 7508A of the Internal Revenue Code
(Code)relates to the postponement of certain tax-related acts by reason of Presidentially declared disaster or terroristic or military action. Section 7508A was added by section 911(a) of the Taxpayer Relief Act of 1997, Public Law 105-34 (111 Stat. 788, 877-78 (1997)) (the 1997 Act), which was effective for any period for performing an act that had not expired before December 5, 1997. Section 7508A authorizes the Secretary to postpone the deadlines for the performance of certain tax-related acts for taxpayers determined to be affected by a Presidentially declared disaster or a terroristic or military action. Section 301.7508A-1 provides guidance for taxpayers seeking relief under section 7508A. Since the publication of § 301.7508A-1 on December 14, 2000, section 7508A was amended by the Victims of Terrorism Tax Relief Act of 2001, Public Law 107-134 (115 Stat. 2427, 2433-35 (2002)) (the 2002 Act). The 2002 Act amended the statute by extending the time period during which the Secretary may postpone certain tax-related acts and allowing the Secretary to suspend the accrual of interest, penalties, additional amounts, or additions to the tax during the period of postponement. The proposed regulation incorporates amendments to section 7508A. Explanation of Provisions The proposed regulation reflects that the period of time the Secretary may postpone certain tax-related acts has been increased from 90 days to one year. Additionally, the proposed regulation reflects that the Secretary is authorized under section 7508A to suspend interest, penalties, additional amounts, and additions to tax which would normally accrue during the time the tax-related act is postponed. Before the 2002 Act, generally, a taxpayer was responsible for interest that accrued during the postponement period (with a limited exception under former section 6404(h) when the taxpayer received both an extension of time to file under section 6081 and an extension of time to pay under section 6161). The proposed regulation sets forth how the IRS generally implements postponements of time under section 7508A. The proposed regulation provides, however, that the IRS may grant further relief to taxpayers under section 7508A by revenue ruling, revenue procedure, notice, announcement, news release or other guidance published in the Internal Revenue Bulletin, in addition to that relief provided by the proposed regulation. The proposed regulation demonstrates that although specific tax-related acts may be due on different dates within the postponement period, the acts may be postponed under section 7508A until the last day of the period. Under the proposed regulation, when an affected taxpayer is required to perform a tax-related act by a due date that falls within the postponement period, the taxpayer is entitled to postponement of the act and is eligible for relief from interest, penalties, additional amounts, and additions to tax during the postponement period. The proposed regulation provides that the postponement period under section 7508A runs concurrently with extensions of time to file or pay, if any, under other sections of the Code. Thus, when the original due date falls within the postponement period, an affected taxpayer has until the last day of the postponement period to file for an extension of time to file or pay, but any resulting extension runs from the original due date. The proposed regulation also provides that, where the extended due date, but not the original due date, falls within the postponement period, relief under section 7508A is specific to the type of extension received. Thus, an affected taxpayer who received an extension of time to file, but not an extension of time to pay, is eligible for a postponement of time to file and relief from penalties relating to the failure to file. The taxpayer is not eligible for penalty and interest relief relating to the failure to pay, as the payment due date was not extended. The regulation also clarifies that a postponement of time under section 7508A to perform a tax-related act does not extend the due date to perform the act, but instead, merely allows the IRS to disregard a time period of up to one year for performance of the act. Proposed Effective Date The regulation, as proposed, applies to Presidentially declared disasters or terroristic or military actions occurring on or after the date of publication of a Treasury decision adopting these rules as final regulations in the **Federal Register** . Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation. The regulation does not impose a collection of information requirement on small business entities, thus the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Comments and Requests for a Public Hearing Before this proposed regulation is adopted as a final regulation, consideration will be given to any written (a signed original and eight
(8)copies) and electronic comments that are submitted timely to the IRS. All comments will be available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person that timely submits comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the **Federal Register** . Drafting Information The principal authors of this proposed regulation are Melissa Quale and Mary Ellen Keys of the Office of the Associate Chief Counsel (Procedure and Administration). List of Subjects in 26 CFR Part 301 Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements. Amendments to the Regulations Accordingly, 26 CFR part 301 is proposed to be amended as follows: PART 301—PROCEDURE AND ADMINISTRATION **Paragraph 1.** The authority citation for part 301 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 301.7508A-1 is amended by 1. Revising the section heading of paragraphs
(b)and (e). 2. Adding paragraph (d)(3). 3. Removing paragraph
(f)and redesignating paragraphs
(g)and
(h)as paragraphs
(f)and (g), respectively, and revising them. The revisions and addition read as follows. § 301.7508A-1 Postponement of certain tax-related deadlines by reasons of a Presidentially declared disaster or terroristic or military action.
(b)*Postponed deadlines* —(1) *In general* . In the case of a taxpayer determined by the Secretary to be affected by a Presidentially declared disaster (as defined in section 1033(h)(3)) or a terroristic or military action (as defined in section 692(c)(2)), the Secretary may specify a postponement period (as defined in paragraph (d)(1) of this section) of up to one year that may be disregarded in determining under the internal revenue laws, in respect of any tax liability of the affected taxpayer (as defined in paragraph (d)(1) of this section)—
(i)Whether any or all of the acts described in paragraph
(c)of this section were performed within the time prescribed;
(ii)The amount of interest, penalty, additional amount, or addition to the tax; and
(iii)The amount of credit or refund.
(2)*Effect of postponement period* . When an affected taxpayer is required to perform a tax-related act by a due date that falls within the postponement period, the affected taxpayer is eligible for postponement of time to perform the act until the last day of the period. The affected taxpayer is eligible for relief from interest, penalties, additional amounts, or additions to tax during the postponement period.
(3)*Interaction between postponement period and extensions of time to file or pay* —(i) *In general* . The postponement period under section 7508A runs concurrently with extensions of time to file and pay, if any, under other sections of the Internal Revenue Code.
(ii)*Original due date prior to, but extended due date within, the postponement period* . When the original due date precedes the first day of the postponement period and the extended due date falls within the postponement period, the following rules apply. If an affected taxpayer received an extension of time to file, filing will be timely on or before the last day of the postponement period, and the taxpayer is eligible for relief from penalties or additions to tax related to the failure to file during the postponement period. Similarly, if an affected taxpayer received an extension of time to pay, payment will be timely on or before the last day of the postponement period, and the taxpayer is eligible for relief from interest, penalties, additions to tax and additional amounts related to the failure to pay during the postponement period.
(4)*Due date not extended* . The postponement of the deadline of a tax-related act does not extend the due date for the act, but merely allows the IRS to disregard a time period of up to one year for performance of the act. To the extent that other statutes may rely on the date a return is due to be filed, the postponement period will not change the due date of the return.
(5)*Additional relief* . The rules of this paragraph
(b)demonstrate how the IRS generally implements section 7508A. The IRS may determine, however, that additional relief to taxpayers is appropriate and may provide additional relief to the extent allowed under section 7508A. To the extent that the IRS grants additional relief, the IRS will provide specific guidance on the scope of relief in the manner provided in paragraph
(e)of this section.
(d)* * *
(3)*Postponement period* means the period of time (up to one year) that the IRS postpones deadlines for performing tax-related acts under section 7508A.
(e)*Notice of postponement of certain acts* . If a tax-related deadline is postponed under section 7508A and this section, the IRS will publish a revenue ruling, revenue procedure, notice, announcement, news release, or other guidance in the Internal Revenue Bulletin (see § 601.601(d)(2) of this chapter) describing the acts postponed, the postponement period, and the location of the covered disaster area. Guidance under this paragraph
(e)will be published as soon as practicable after the occurrence of a terroristic or military action or declaration of a Presidentially declared disaster.
(f)*Examples* . The rules of this section are illustrated by the following examples: Example 1.
(i)Corporation X, a calendar year taxpayer, has its principal place of business in County M in State W. Pursuant to a timely filed request for extension of time to file, Corporation X's 2005 Form 1120, “U.S. Corporation Income Tax Return,” is due on September 15, 2006. Also due on September 15, 2006, is Corporation X's third quarter estimated tax payment for 2006. Corporation X's 2006 third quarter Form 720, “Quarterly Federal Excise Tax Return,” and third quarter Form 941, “Employer's Quarterly Federal Tax Return,” are due on October 31, 2006. In addition, Corporation X has an employment tax deposit due on September 15, 2006.
(ii)On September 1, 2006, a hurricane strikes County M in State W. On September 6, 2006, the President declares a disaster within the meaning of section 1033(h)(3). Also on September 6, 2006, the IRS determines that County M in State W is a covered disaster area and publishes guidance announcing that the time period for affected taxpayers to file returns, pay taxes and perform other time-sensitive acts falling on or after September 1, 2006, and on or before November 30, 2006, has been postponed to November 30, 2006, pursuant to section 7508A.
(iii)Because Corporation X's principal place of business is in County M, Corporation X is an affected taxpayer. Accordingly, Corporation X's 2005 Form 1120 will be timely if filed on or before November 30, 2006. Corporation X's 2006 third quarter estimated tax payment will be timely if made on or before November 30, 2006. In addition, pursuant to paragraph
(c)of this section, Corporation X's 2006 third quarter Form 720 and third quarter Form 941 will be timely if filed on or before November 30, 2006. However, because deposits of taxes are excluded from the scope of paragraph
(c)of this section, Corporation X's employment tax deposit is due on September 15, 2006. In addition, Corporation X's deposits relating to the third quarter Form 720 are not postponed. Absent reasonable cause, Corporation X is subject to the failure to deposit penalty under section 6656 and accrual of interest. Example 2. The facts are the same as in *Example 1* , except that because of the severity of the hurricane the IRS determines that postponement of government acts is necessary under these circumstances and publishes guidance accordingly. During 2006, Corporation X's 2002 Form 1120 is being examined by the IRS. Pursuant to a timely filed request for extension of time to file, Corporation X timely filed its 2002 Form 1120 on September 17, 2003 (because March 15, 2003, falls on a Saturday, Corporation X's 2002 Form 1120 was due to be filed on March 17, 2003). Without application of this section, the statute of limitation on assessment for the 2002 income tax year will expire on September 17, 2006. However, pursuant to paragraph
(c)of this section, assessment of tax is one of the government acts for which up to one year may be disregarded. Because September 17, 2006, falls within the period in which government acts are postponed, the statute of limitation on assessment for Corporation X's 2002 income tax will expire on November 30, 2006. Because Corporation X did not timely file an extension to pay, payment of its 2002 income tax was due on March 17, 2003. As such, Corporation X will be subject to the failure to pay penalty and related interest beginning on March 18, 2003. The due date for payment of Corporation X's 2002 income tax preceded the postponement period. Therefore, Corporation X is not entitled to the suspension of interest or penalties during the disaster period with respect to its 2002 income tax liability. Example 3. The facts are the same as in *Example 2* , except that the examination of the 2002 taxable year was completed earlier in 2006, and on July 28, 2006, the IRS mailed a statutory notice of deficiency to Corporation X. Without application of this section, Corporation X has 90 days (or until October 26, 2006) to file a petition with the Tax Court. However, pursuant to paragraph
(c)of this section, filing a petition with the Tax Court is one of the taxpayer acts for which a period of up to one year may be disregarded. Because Corporation X is an affected taxpayer, Corporation X's petition to the Tax Court will be timely if filed on or before November 30, 2006, the last day of the postponement period. Example 4.
(i)H and W, individual calendar year taxpayers, intend to file a joint Form 1040, “U.S. Individual Income Tax Return,” for the 2007 taxable year and are required to file a Schedule H, “Household Employment Taxes.” The joint return is due on April 15, 2008. H's and W's principal residence is in County M in State Q.
(ii)On April 2, 2008, a severe ice storm strikes County M. On April 5, 2008, the President declares a disaster within the meaning of section 1033(h)(3). Also on April 5, 2008, the IRS determines that County M in State Q is a covered disaster area and publishes guidance announcing that the time period for affected taxpayers to file returns, pay taxes and perform other time-sensitive acts falling on or after April 2, 2008, and on or before June 2, 2008, has been postponed to June 2, 2008.
(iii)Because H's and W's principal residence is in County M, H and W are affected taxpayers. April 15, 2008, the due date for the filing of H's and W's 2007 Form 1040 and Schedule H, falls within the postponement period described in the IRS published guidance. Thus, H's and W's return will be timely if filed on or before June 2, 2008. If H and W request an extension of time to file under section 6081 on or before June 2, 2008, the extension is deemed to have been filed by April 15, 2008. Thus, H's and W's return will be timely if filed on or before October 15, 2008.
(iv)April 15, 2008, is also the due date for the payment due on the return. This date falls within the postponement period described in the IRS published guidance. Thus, the payment of tax due with the return will be timely if paid on or before June 2, 2008, the last day of the postponement period. If H and W fail to pay the tax due on the 2007 Form 1040 by June 2, 2008, and do not receive an extension of time to pay under section 6161, H and W will be subject to failure to pay penalties and accrual of interest beginning on June 3, 2008. Example 5.
(i)H and W, residents of County D in State G, intend to file an amended return to request a refund of 2007 taxes. H and W timely filed their 2007 income tax return on April 15, 2008. Under section 6511(a), H's and W's amended 2007 tax return must be filed on or before April 15, 2011.
(ii)On April 1, 2011, an earthquake strikes County D. On April 5, 2011, the President declares a disaster within the meaning of section 1033(h)(3). Also on April 5, 2011, the IRS determines that County D in State G is a covered disaster area and publishes guidance announcing that the time period for affected taxpayers to file returns, pay taxes and perform other time-sensitive acts falling on or after April 1, 2011, and on or before September 28, 2011, has been postponed to September 28, 2011.
(iii)Under paragraph
(c)of this section, filing a claim for refund of tax is one of the taxpayer acts for which up to one year may be disregarded. The postponement period for this disaster begins on April 1, 2011, and ends on September 28, 2011. Accordingly, H's and W's claim for refund for 2007 taxes will be timely if filed on or before September 28, 2011. Moreover, in applying the lookback period in section 6511(b)(2)(A), which limits the amount of the allowable refund, the period from September 28, 2011, back to April 1, 2011, is disregarded under paragraph (b)(1)(C) of this section. Thus, if the claim is filed on or before September 28, 2011, amounts deemed paid on April 15, 2008, under section 6513(b), such as estimated tax and tax withheld from wages, will have been paid within the lookback period of section 6511(b)(2)(A). Example 6.
(i)A is an unmarried, calendar year taxpayer whose principal residence is located in County W in State Q. A intends to file a Form 1040 for the 2007 taxable year. The return is due on April 15, 2008. A timely files Form 4868, “Application for Automatic Extension of Time to File U.S. Individual Income Tax Return.” Due to A's timely filing of Form 4868, the extended filing deadline for A's 2007 tax return is October 15, 2008. Because A timely requested an extension of time to file, A will not be subject to the failure to file penalty under section 6651(a)(1), if A files the 2007 Form 1040 on or before October 15, 2008. However, A failed to pay the tax due on the return by April 15, 2008, and did not receive an extension of time to pay under section 6161. Absent reasonable cause, A is subject to the failure to pay penalty under section 6651(a)(2) and accrual of interest.
(ii)On September 30, 2008, a blizzard strikes County W. On October 3, 2008, the President declares a disaster within the meaning of section 1033(h)(3). Also on October 3, 2008, the IRS determines that County W in State Q is a covered disaster area and announces that the time period for affected taxpayers to file returns, pay taxes and perform other time-sensitive acts falling on or after September 30, 2008, and on or before December 2, 2008, has been postponed to December 2, 2008.
(iii)Because A's principal residence is in County W, A is an affected taxpayer. Because October 15, 2008, the extended due date to file A's 2007 Form 1040, falls within the postponement period described in the IRS's published guidance, A's return is timely if filed on or before December 2, 2008. However, the payment due date, April 15, 2008, preceded the postponement period. Thus, A will continue to be subject to failure to pay penalties and accrual of interest during the postponement period. Example 7.
(i)H and W, individual calendar year taxpayers, intend to file a joint Form 1040 for the 2007 taxable year. The joint return is due on April 15, 2008. After credits for taxes withheld on wages and estimated tax payments, H and W owe tax for the 2007 taxable year. H's and W's principal residence is in County J in State W.
(ii)On March 1, 2008, severe flooding strikes County J. On March 5, 2008, the President declares a disaster within the meaning of section 1033(h)(3). Also on March 5, 2008, the IRS determines that County J in State W is a covered disaster area and publishes guidance announcing that the time period for affected taxpayers to file returns, pay taxes and perform other time-sensitive acts falling on or after March 1, 2008, and on or before May 30, 2008, has been postponed to May 30, 2008.
(iii)Because H's and W's principal residence is in County J, H and W are affected taxpayers. Pursuant to the IRS's grant of relief under section 7508A, H and W received a postponement of the time to file the joint return and pay the tax due until May 30, 2008. Therefore, H's and W's joint return without extension is timely if filed on or before May 30, 2008. Similarly, H's and W's 2007 income taxes will be timely paid if paid on or before May 30, 2008.
(iv)On April 30, 2008, H and W timely file Form 4868, “Application for Automatic Extension of Time to File U.S. Individual Income Tax Return.” H's and W's extension will be deemed to have been filed on April 15, 2008. Thus, H's and W's 2007 income tax return is timely filed if filed on or before October 15, 2008.
(v)H and W did not request or receive an extension of time to pay. Therefore, pursuant to section 7508A, H's and W's 2007 income tax payment is due on May 30, 2008. H and W will be subject to the failure to pay penalty under section 6651(a)(2) and interest if H and W do not pay the tax due on the 2007 joint return on or before May 30, 2008. H and W will be subject to failure to pay penalties and accrual of interest beginning on May 31, 2008. Example 8. The facts are the same as in *Example 7* except that H and W file the joint 2007 return and pay the tax due on June 15, 2008. Later, H and W discover additional deductions that would lower their taxable income for 2007. On June 15, 2011, H and W file a claim for refund under section 6511(a). The amount of H and W's overpayment exceeds the amount of taxes paid on June 15, 2008, the amount paid within three years of filing the claim. Section 6511(a) requires that a claim for refund be filed within three years from the time the return was filed or two years from the time the tax was paid, whichever period expires later. Section 6511(b)(2)(A) includes within the lookback period the period of an extension of time to file. Thus, payments that H and W made on or after May 30, 2008, would be eligible to be refunded. Since the period from April 15, 2008, to May 30, 2008, is disregarded, payments H and W made on April 15, 2008 (including withholding or estimated tax payments deemed to have been made on April 15, 2008), would also be included in the section 6511(b)(2)(A) lookback period. Thus, H and W are entitled to a full refund in the amount of their overpayment.
(g)*Proposed effective date* . The regulation, as proposed, applies to Presidentially declared disasters or terroristic or military actions occurring on or after the date of publication of the Treasury decision adopting these rules as final regulations in the **Federal Register** . Linda E. Stiff, Deputy Commissioner for Services and Enforcement. [FR Doc. E8-15939 Filed 7-14-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 9 [Notice No. 85; Docket No. TTB-2008-0005] RIN 1513-AB47 Proposed Expansion of the Paso Robles Viticultural Area (2008R-073P) AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau proposes to expand by 2,635 acres the existing 609,673-acre Paso Robles American viticultural area in San Luis Obispo County, California. If this change is approved, the expanded Paso Robles viticultural area would continue to lie entirely within San Luis Obispo County and within the multi-county Central Coast viticultural area. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. We invite comments on this proposed change to our regulations. DATES: We must receive written comments on or before September 15, 2008. ADDRESSES: You may send comments to one of the following addresses: • *http://www.regulations.gov* (via the online comment form for this notice as posted within Docket No. TTB-2008-0005 at “Regulations.gov,” the Federal e-rulemaking portal); or • Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. See the Public Participation section of this notice for specific instructions and requirements for submitting comments, and for information on how to request a public hearing. You may view copies of this notice, selected supporting materials, and any comments we receive about this proposal at *http://www.regulations.gov* within Docket No. TTB-2008-0005. A link to that docket is posted on the TTB Web site at *http://www.ttb.gov/wine/wine_rulemaking.shtml* under Notice No. 85. You also may view copies of this notice, all related petitions, maps or other supporting materials, and any comments we receive about this proposal by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. Please call 202-927-2400 to make an appointment. FOR FURTHER INFORMATION CONTACT: N.A. Sutton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 925 Lakeville St., No. 158, Petaluma, CA 94952; phone 415-271-1254. SUPPLEMENTARY INFORMATION: Background on Viticultural Areas TTB Authority Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels, and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau
(TTB)administers the regulations promulgated under the FAA Act. Part 4 of the TTB regulations (27 CFR part 4) allows the establishment of definitive viticultural areas and the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) contains the list of approved American viticultural areas. Definition Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region distinguishable by geographical features, the boundaries of which have been recognized and defined in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to its geographic origin. The establishment of viticultural areas allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of a viticultural area is neither an approval nor an endorsement by TTB of the wine produced in that area. Requirements Section 4.25(e)(2) of the TTB regulations outlines the procedure for proposing an American viticultural area and provides that any interested party may petition TTB to establish a grape-growing region as a viticultural area. Petitioners may use the same procedure to request changes involving existing viticultural areas. Section 9.3(b) of the TTB regulations requires the petition to include— • Evidence that the proposed viticultural area is locally and/or nationally known by the name specified in the petition; • Historical or current evidence that supports setting the boundary of the proposed viticultural area as the petition specifies; • Evidence relating to the geographic features, such as climate, soils, elevation, and physical features, that distinguish the proposed viticultural area from surrounding areas; • A description of the specific boundary of the proposed viticultural area, based on features found on United States Geological Survey
(USGS)maps; and • A copy of the appropriate USGS map(s) with the proposed viticultural area's boundary prominently marked. Paso Robles Expansion Petition Background Previous Petitions On October 4, 1983, the Bureau of Alcohol, Tobacco and Firearms
(ATF)published a final rule, T.D. ATF-148 (48 FR 45239), to establish the “Paso Robles” American viticultural area
(AVA)in northern San Luis Obispo County, California (see 27 CFR 9.84). As established, the Paso Robles AVA was entirely within the Central Coast AVA (27 CFR 9.75) and, to the west, it bordered the much smaller York Mountain AVA (27 CFR 9.80). In 1983, the Paso Robles AVA contained approximately 5,000 acres of vineyards. As established, the Paso Robles AVA was defined by the San Luis Obispo-Monterey county line in the north, the Cholame Hills to the east, and the Santa Lucia Mountains to the south and west. According to T.D. ATF-148, the Santa Lucia Mountains largely protect the Paso Robles AVA from the intrusion of marine air and fog from the Pacific Ocean, giving the Paso Robles AVA a drier and warmer summer time climate than regions to the west and south. The Paso Robles AVA also is characterized by day to night temperature changes of 40 to 50 degrees, annual rainfall of 10 to 25 inches, 600 to 1,000 foot elevations, and well-drained alluvial soils in terrace deposits. Lacking a feasible way to use physical features, such as ridge lines, to define the Paso Robles AVA's boundary, the original petitioner largely used a series of township and range lines and point-to-point lines to delineate the AVA's boundary. The southern-most portion of the Paso Robles AVA was delineated to the south by the east-west T29S/T30S township boundary line and to the east by the north-south R13E/R14E range line. On June 13, 1996, ATF published a final rule, T.D. ATF-377 (61 FR 29952) expanding the Paso Robles AVA along a portion of its western boundary. This expansion added 52,618 acres of land similar to that found in the original AVA. The expansion added to the AVA seven vineyards planted after the Paso Robles AVA's 1983 establishment, containing 235 acres of grapes. The Paso Robles AVA, as expanded, remained entirely within San Luis Obispo County and the Central Coast AVA, and this westerly expansion did not extend into the York Mountain AVA or change the AVA's original southern boundary. Current Southern Expansion Petition In 2007, the Paso Robles AVA Committee (PRAVAC) submitted a petition to TTB requesting a 2,635-acre expansion of the Paso Robles AVA. The petition states that the PRAVAC represents a broad cross-section of the Paso Robles wine industry and notes that its 59 grape-grower and winery members collectively own or manage over 10,000 acres of vineyards within the Paso Robles AVA. The proposed expansion area is immediately south of the Paso Robles AVA's current southern-most boundary, which is delineated by the T29S/T30S township line, as shown on the 1:250,000-scale USGS San Luis Obispo map used to define the AVA's boundary. As noted in the petition, the Paso Robles AVA's current southern-most boundary line bisects the southern portion of the Santa Margarita Valley, leaving a significant portion of the valley's southern end outside the AVA boundary as currently defined. The proposed expansion would, therefore, bring most of the remainder of the Santa Margarita Valley within the AVA, as shown on the 1:24,000 USGS Lopez Mountain map submitted with the petition. (TTB notes that, while not used to formally define the AVA's boundary in the proposed regulatory text, the Lopez Mountain map provides significantly more geographical detail regarding the expansion area due to its smaller scale.) The proposed southern expansion also lies totally within San Luis Obispo County and the existing Central Coast AVA, and it would not overlap or otherwise affect any other established or currently-proposed new AVA. According to the petition, the distinguishing features of the proposed expansion area, including its geological history, geomorphology, soils, topography, and climate, are similar to those found in the southern region of the original Paso Robles AVA. Name Evidence The petition states that the “Paso Robles” geographical name applies to the proposed southern expansion of the Paso Robles AVA due to the historic, geographic, commercial, and cultural ties between the Santa Margarita Valley and the Paso Robles region of San Luis Obispo County. This is due to that valley's northward orientation, which is enclosed to the south and west by the Santa Lucia Mountains. Historically, travel was easier going northward through the valley to the city of Paso Robles than it was going southward over the mountains to the city of San Luis Obispo. The petition also states that, due to the stated historic and other ties, local residents and members of the Paso Robles wine industry have assumed that the entire Santa Margarita Valley was within the original Paso Robles AVA boundary line and reference the area as such. According to the petition, other sources also show the entire Santa Margarita Valley as falling within the Paso Robles region. For example, the Paso Style Living real estate Web site ( *http://www.pasostyleliving.com/pages/pasoarea.htm* ) describes the Santa Margarita area as “the Southern edge of Paso wine country.” A 1928 soil survey map of the Paso Robles area submitted with the petition also shows the entire Santa Margarita Land Grant as being within the Paso Robles region. In addition, the “1978 General Soil Map of the Paso Robles Area—San Luis Obispo County,” published by the U.S. Department of Agriculture, Soil Conservation Service, University of California Agricultural Experiment Station, includes the proposed Paso Robles AVA expansion area within the Paso Robles region of the county. Boundary Evidence The proposed triangle-shaped expansion of the Paso Robles AVA would move its southern-most point approximately 2.6 miles south in order to encompass most of that portion of the Santa Margarita Valley currently not included within the AVA. Also, the proposed expansion area would increase the length of the commonly-shared eastern boundary of the Paso Robles and Central Coast AVAs by the same distance. The petition describes the proposed expansion area as part of the “cohesive geographical unit” of the Santa Margarita Valley. Nestled between the Santa Lucia Range and the Salinas River, the Santa Margarita Valley lies on both sides of the Paso Robles AVA's existing southern boundary line. The petition describes the original Paso Robles AVA southern-most boundary line, which follows the T29S/T30 township line and which bisects the Santa Margarita Valley, as an “imaginary, indiscernible boundary in the landscape, not defined by any topographic or other environmental parameters.” As explained in T.D. ATF-148, the Paso Robles AVA “is bounded on the west and south by the Santa Lucia Mountain range” which protects the AVA “from marine air intrusion and coastal fogs.” The proposed southern expansion, the petition explains, would more closely align the Paso Robles AVA's southern-most boundary with the Santa Lucia Range by encompassing most of the portion of the Santa Margarita Valley that is currently outside the AVA. The petition explains that beyond the proposed expansion area to the south is the narrowed terminus of the Santa Margarita Valley, with steep terrain on three sides and inadequate groundwater and warmth to sustain commercial viticulture. According to the petition, the viticultural history of the Santa Margarita Valley began with the arrival of Spanish missionaries, who, among other things, brought grapes and winemaking to the Paso Robles area over 200 years ago. Near present-day Santa Margarita, the missionaries built the Santa Margarita de Cortona Asistencia in 1787, which functioned as an outpost of the mission located at San Luis Obispo. See page 39 of the “History of San Luis Obispo County, California, with Illustrations and Biographical Sketches of its Prominent Men and Pioneers” (Thompson & West, 1883), by Myron Angel, (reprinted 1966, Howell-North Books, Berkeley, California), which was included with the petition. The Santa Margarita Asistencia served as a chapel, farmstead, and storehouse for grain grown in the valley. In 1861, the land surrounding the Asistencia site was purchased by Mary and Martin Murphy, who also owned portions of other land grants within the Paso Robles region, according to page 68 of the Angel publication. Under the Martin's ownership, the petition states, the Santa Margarita area developed a strong attachment to the more commercialized Paso Robles area to its north. By 1889, the petition explains, an extension of the Southern Pacific Railroad ran south from Paso Robles along the Salinas River to the small settlement of Santa Margarita. See pages 34 and 75 of “Rails Across the Ranchos,” by Loren Nicholson, 1993. The USGS San Luis Obispo regional map shows the Southern Pacific Railway running south from the city of Paso Robles across the relatively flat valley to the town of Santa Margarita where it begins a twisting climb up and over the Santa Lucia Mountains to the city of San Luis Obispo. In 2000, the petition explains, the Robert Mondavi Winery leased more than 1,000 acres in the southern Santa Margarita Valley for commercial vineyard development. This acreage is bisected by the current southern-most boundary of the Paso Robles AVA. At the time of the petition, vineyards covered 800 of the 1,000 acres, with plantings located on both sides of the existing Paso Robles AVA boundary line, according to the petition. Distinguishing Features The proposed expansion of the Paso Robles AVA relies on the Santa Margarita Valley's uniform topography, climate, soils, geologic history, and geomorphology. These geographical features, the petition notes, are the same throughout the valley, which is currently bisected by the existing Paso Robles AVA's southern-most boundary line. The Santa Margarita Valley, which makes up the portion of the Salinas River valley containing Santa Margarita and Rinconada Creeks, extends south from the city of Atascadero, through the town of Santa Margarita, and continues south-southeastward through the proposed expansion area, according to the USGS San Luis Obispo regional map and the petition. Professor Deborah L. Elliott-Fisk, Ph.D, of the University of California, Davis, an expert on the geography and terroir of California and viticultural area designations, researched and provided the distinguishing features information used in the petition. According to the petition, Dr. Elliott-Fisk also coordinated the data and analyses supplied by meteorologist Donald Schukraft, Western Weather Group, LLC, and other experts. Climate The climate of the Paso Robles AVA as a whole, according to Dr. Elliott-Fisk, has smaller monthly temperature ranges and less continental influence than the inland areas further to the east, but is less influenced by Pacific marine air and fog than the coastal regions to the west due to the blocking effect of the Santa Lucia Mountains. As part of the larger Paso Robles region, the Santa Margarita Valley has climatic conditions similar to the AVA, Dr. Elliot-Fisk notes, and these conditions exist on both sides of the existing southern-most boundary of the AVA, which passes from west to east through the valley. Dr. Elliott-Fisk adds that other climate similarities found within the valley on either side of the existing AVA boundary include cold air drainage, cold air ponding under temperature inversions, and similar frost patterns, especially early in the growing season. Also, annual precipitation in the valley averages 29 inches, while regions to the east are drier and the coastal mountains to the west are wetter. These climate similarities also are evidenced by various climate classification systems. For example, the petition states, the global scale climate classification system of Koppen, Geiger and Pohl
(1953)labels the great majority of the Paso Robles region as a Mediterranean warm summer climate (Csb), while the region to the east has a Mediterranean hot summer climate (Csa). Dr. Elliott-Fisk states that the Santa Margarita Valley's climate is classified as a cool region II climate of approximately 2,900 growing degree-days under the Winkler climate classification system, which is based on annual growing season heat accumulation. This classification is found on both sides of the existing southern-most Paso Robles AVA boundary. (As a measurement of heat accumulation during the growing season, 1 degree day accumulates for each degree Fahrenheit that a day's mean temperature is above 50 degrees, which is the minimum temperature required for grapevine growth. In the Winkler system, climatic region I has less than 2,500 growing degree days per year; region II, 2,501 to 3,000; region III, 3,001 to 3,500; region IV, 3,501 to 4,000; and region V, 4,001 or more. See pages 61-64 of “General Viticulture,” by Albert J. Winkler, University of California Press, 1974.) Regarding the southern end of the Santa Margarita Valley that lies beyond the proposed expansion, Dr. Elliott-Fisk explains that the steep topography east, south and west of the narrow valley floor causes increases in relief precipitation and evening settling of cold, dense air at the valley's terminus. Local farmers, the petition explains, state that air temperatures at the far southern end of the valley are too cold to produce quality wine grapes. Geology The geological features that characterize the southern region of the Paso Robles AVA continue across the AVA's southern-most boundary line and are found throughout the Santa Margarita Valley, including the proposed expansion area. Dr. Elliott-Fisk explains that the Salinas River originally formed the Santa Margarita Valley through a process of soil erosion and deposition, while the complex faulting of the Santa Lucia Range formed a graben basin that extends along the valley floor and crosses the existing Paso Robles AVA southern-most boundary line. Later, Dr. Elliott-Fisk notes, the Salinas River carved a new channel to the east through the soft Monterey Formation shales along the Rinconada Fault as the San Andreas Fault zone became more active. Rinconada Creek, a primary Salinas River tributary in the Santa Margarita Valley area, then deposited a series of broad alluvial fans and terraces across the older Salinas River alluvial fill, Dr. Elliott-Fisk explains. She notes that these alluvial terraces extend north and south of the current Paso Robles AVA boundary line and exist throughout the proposed expansion area. To the east, south, and west of the proposed Paso Robles AVA expansion, Dr. Elliott-Fisk explains, the geology of the landscape is unsuitable for commercial production of wine grapes. She states that, to the east, granitic rocks on the mountainsides make the area difficult to farm, and the weathering and failure of near-surface rock makes road building difficult. Also, to the south, and at the narrowed southern terminus of the Santa Margarita Valley, Franciscan conglomerate rock underlies the shallow alluvium creating an environment lacking in adequate groundwater. To the west, the landscape includes massive units of the late Cretaceous Franciscan and Great Valley formations, consisting of hard marine sandstones and conglomerates on steep mountain slopes, making the terrain unsuitable for viticulture. Soils Similar soils exist on both sides of the current Paso Robles AVA southern boundary line, according to the current USDA soil survey for the Paso Robles Area of San Luis Obispo County (Lindsey, 1978). Climate, parent material, topography, and time, Dr. Elliott-Fisk states, all contribute to the soil type similarities that extend the length of the Santa Margarita Valley. The soils of the Santa Margarita Valley, Dr. Elliott-Fisk explains, include the deep gravelly loam soils of late-mid Quaternary age, grading into shallower clay loam soils against bedrock on the hillsides. Also, younger alluvial deposits dominate the flood plains of the valley's creeks. Soils and terrain to the south, east, and west of the Paso Robles AVA proposed southern expansion are, however, unsuitable for commercial viticulture, Dr. Elliott-Fisk explains. To the south, the soils of the valley floor include clay loams with low water permeability and high water capacity with moderate shrink-swell potential, while the mountain slopes to the east and west have shallow top soil, small rooting zones for grapevines, and erosion potential, making those areas unsuitable for viticulture. Evidence Summary The PRAVAC petition, including Dr. Elliott-Fisk's discussion of the proposed expansion area's distinguishing features and a detailed letter from vineyard developer and manger Neil Roberts, emphasize that similar geological, geographical, and climatic conditions extend through the Santa Margarita Valley, which encompasses a portion of the existing Paso Robles AVA as well as the proposed expansion area. The landforms, topography, and geology features that form the Santa Margarita Valley, the petition explains, are similar both north and south of the existing Paso Robles AVA southern-most boundary line. Also, the valley's climate, as reflected by Winkler's degree-day values, and its soil types, as documented in the 1978 USDA soil survey for the Paso Robles Area of San Luis Obispo County, show strong similarities on both sides of the current Paso Robles AVA southern-most boundary line. The petition adds that vineyards are farmed the same way north and south of the current Paso Robles AVA boundary line through the valley and these vineyards grow the same varietals. TTB Determination TTB concludes that the petition to expand the Paso Robles American viticultural area merits consideration and public comment, as invited in this notice. Boundary Description See the narrative boundary description covering the petitioned-for viticultural area expansion in the proposed regulatory text amendment published at the end of this notice. Maps The petitioner provided the required map to document the proposed boundary change, and we list that map below in the proposed regulatory text amendment. Impact on Current Wine Labels The proposed expansion of the Paso Robles viticultural area will not affect currently approved wine labels. The approval of this proposed expansion may allow additional vintners to use “Paso Robles” as an appellation of origin on their wine labels. Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be eligible to use a viticultural area name as an appellation of origin or a term of viticultural significance in a brand name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name or other term, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). Different rules apply if a wine has a brand name containing a viticultural area name or other viticulturally significant term that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details. Public Participation Comments Invited We invite comments from interested members of the public on whether we should expand the Paso Robles viticultural area as described above. We are especially interested in comments concerning the similarity of the proposed expansion area to the currently existing Paso Robles viticultural area. Please support your comments with specific information about the proposed expansion area's name, proposed boundaries, or distinguishing features. Submitting Comments You may submit comments on this notice by using one of the following two methods: • *Federal e-Rulemaking Portal:* You may send comments via the online comment form posted with this notice within Docket No. TTB-2008-0005 on “Regulations.gov,” the Federal e-rulemaking portal, at *http://www.regulations.gov.* A direct link to that docket is available under Notice No. 85 on the TTB Web site at *http://www.ttb.gov/wine/wine_rulemaking.shtml* . Supplemental files may be attached to comments submitted via Regulations.gov. For complete instructions on how to use Regulations.gov, visit the site and click on “User Guide” under “How to Use this Site.” • *U.S. Mail:* You may send comments via postal mail to the Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. Please submit your comments by the closing date shown above in this notice. Your comments must reference Notice No. 85 and include your name and mailing address. Your comments also must be made in English, be legible, and be written in language acceptable for public disclosure. We do not acknowledge receipt of comments, and we consider all comments as originals. If you are commenting on behalf of an association, business, or other entity, your comment must include the entity's name as well as your name and position title. If you comment via Regulations.gov, please enter the entity's name in the “Organization” blank of the online comment form. If you comment via postal mail, please submit your entity's comment on letterhead. You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine whether to hold a public hearing. Confidentiality All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure. Public Disclosure We will post, and you may view, copies of this notice, selected supporting materials, and any online or mailed comments we receive about this proposal within Docket No. TTB-2008-0005 on the Federal e-rulemaking portal, Regulations.gov, at *http://www.regulations.gov.* A direct link to that docket is available on the TTB Web site at *http://www.ttb.gov/wine/wine_rulemaking.shtml* under Notice No. 85. You may also reach the relevant docket through the Regulations.gov search page at *http://www.regulations.gov.* For instructions on how to use Regulations.gov, visit the site and click on “User Guide” under “How to Use this Site.” All posted comments will display the commenter's name, organization (if any), city, and State, and, in the case of mailed comments, all address information, including e-mail addresses. We may omit voluminous attachments or material that we consider unsuitable for posting. You also may view copies of this notice, all related petitions, maps and other supporting materials, and any electronic or mailed comments we receive about this proposal by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. You may also obtain copies at 20 cents per 8.5- x 11-inch page. Contact our information specialist at the above address or by telephone at 202-927-2400 to schedule an appointment or to request copies of comments or other materials. Regulatory Flexibility Act We certify that this proposed regulation, if adopted, would not have a significant economic impact on a substantial number of small entities. The proposed regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of a viticultural area name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required. Executive Order 12866 This proposed rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, it requires no regulatory assessment. Drafting Information N.A. Sutton of the Regulations and Rulings Division drafted this notice. List of Subjects in 27 CFR Part 9 Wine. Proposed Regulatory Amendment For the reasons discussed in the preamble, we propose to amend title 27, chapter 1, part 9, Code of Federal Regulations, as follows: PART 9—AMERICAN VITICULTURAL AREAS 1. The authority citation for part 9 continues to read as follows: Authority: 27 U.S.C. 205. Subpart C—Approved American Viticultural Areas 2. Section 9.84 is amended by revising paragraphs (b), (c)(7), and (c)(8), redesignating paragraphs (c)(9) and (c)(10) as (c)(10) and (c)(11), and adding a new paragraph (c)(9). The revisions and addition read as follows: § 9.84 Paso Robles.
(b)*Approved Maps.* The appropriate map for determining the boundary of the Paso Robles viticultural area is the United States Geological Survey 1:250,000-scale map of San Luis Obispo, California, 1956, revised 1969, shoreline revised and bathymetry added 1979.
(c)Boundaries. * * *
(7)Then in an easterly direction along the T.29S. and T.30S. line for approximately 3.1 miles to its intersection with the eastern boundary line of the Los Padres National Forest;
(8)Then in a southeasterly direction along the eastern boundary line of the Los Padres National Forest for approximately 4.1 miles to its intersection with the R.13E. and R.14E. line;
(9)Then in a northerly direction along the R.13E. and R.14E. line for approximately 8.7 miles to its intersection with the T.28S. and T.29S. line; Signed: July 8, 2008. John J. Manfreda, Administrator. [FR Doc. E8-16167 Filed 7-14-08; 8:45 am] BILLING CODE 4810-31-P 73 136 Tuesday, July 15, 2008 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request July 10, 2008. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Animal and Plant Health Inspection Service *Title:* Nomination Request Form; Animal Disease Training. *OMB Control Number:* 0579-NEW. *Summary of Collection:* Under the Animal Health Protection Act (7 U.S.C., 8301), the Animal and Plant Health Inspection Service (APHIS) is authorized among other things, to prohibit or restrict the importation and interstate movement of animals and animal products to prevent the introduction into and dissemination within the United States. The Professional Development Staff
(PDS)of Veterinary Services within APHIS provides vital training to State, Industry, and University personnel which prepare them for animal disease response. To determine the need and demand for such courses, PDS must collect information from individuals who wish to attend training events facilitated by PDS. *Need and Use of the Information:* Information will be collected from State, industry, and university personnel who desire to attend a PDS-sponsored training event. Prior to every PDS-facilitated event, respondents will submit a completed Nomination/Registration Request Form (VS Form 1-5) to the Regional Training Coordinators. Names, work addresses, work phone numbers, work e-mail addresses, agency/organization affiliation, and job title as well as supervisor and region approval is needed to produce participant rosters once course selections are made. Without the collection of this information, PDS cannot conduct training events to educate Federal, State and private veterinarians on eradication of diseases and sample collection. *Description of Respondents:* Business or other for-profit; State, Local or Tribal Government. *Number of Respondents:* 552. *Frequency of Responses:* Recordkeeping; Reporting: On occasion. *Total Burden Hours:* 712. Animal & Plant Health Inspection Service *Title:* Gypsy Moth Identification Worksheet. *OMB Control Number:* 0579-0104. *Summary of Collection:* Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary of Agriculture either independently or in cooperation with the States, is authorized to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests new to the United States or not widely distributed throughout the United States. The Plant Protection and Quarantine Service
(PPQ)of the Animal and Plant Health Inspection Service (APHIS) engage in detection surveys to monitor the presence of the European gypsy moth and the Asian gypsy moth. The European gypsy moth is one of the most destructive pests of fruit and ornamental trees as well as hardwood forests. The Asian gypsy moth is an exotic strain of gypsy moth that is closely related to the European variety already established in the U.S. This strain is considered to pose an even greater threat to trees and forested areas. In order to determine the presence and extent of a European gypsy moth or an Asian gypsy moth infestation, APHIS sets traps in high-risk areas to collect specimens. *Need and Use of the Information:* APHIS will collect information from the Gypsy Moth Identification Worksheet, PPQ Form 305, to identify and track specific specimens that are sent for test based on DNA analysis. This information collected is vital to APHIS's ability to monitor, detect, and eradicate gypsy moth infestations, and the worksheet is completed only when traps are found to contain specimens. Information on the worksheet includes the name of the submitter, the submitter's agency, the date collected, the trap number, the trap's location (including the nearest port of entry), the number of specimens in the trap, and the date the specimen was sent to the laboratory. *Description of Respondents:* State, Local or Tribal Government; Federal Government. *Number of Respondents:* 120. *Frequency of Responses:* Reporting; On occasion. *Total Burden Hours:* 41. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E8-16163 Filed 7-14-08; 8:45 am] BILLING CODE 3410-34-P BROADCASTING BOARD OF GOVERNORS Sunshine Act Meeting Date and Time: Wednesday, July 16, 2008, 2:45 p.m.-4 p.m. Place: Cohen Building, Room 3321, 330 Independence Ave., SW., Washington, DC 20237. Closed Meeting: The members of the Broadcasting Board of Governors
(BBG)will meet in closed session to review and discuss a number of issues relating to U.S. Government-funded non-military international broadcasting. They will address internal procedural, budgetary, and personnel issues, as well as sensitive foreign policy issues relating to potential options in the U.S. international broadcasting field. This meeting is closed because if open it likely would either disclose matters that would be properly classified to be kept secret in the interest of foreign policy under the appropriate executive order (5 U.S.C. 552b.(c)(1)) or would disclose information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action. (5 U.S.C. 552b.(c)(9)(B)) In addition, part of the discussion will relate solely to the internal personnel and organizational issues of the BBG or the International Broadcasting Bureau. (5 U.S.C. 552b.(c)(2) and (6)) Contact Person for More Information: Persons interested in obtaining more information should contact Timi Nickerson Kenealy at
(202)203-4545. Timi Nickerson Kenealy, Acting Legal Counsel. [FR Doc. 08-1432 Filed 7-11-08; 8:57 am]
Connectionstraces to 46
Traces to 46 documents
U.S. Code
25 references not yet in our index
  • 21 CFR 210
  • 5 USC 601-612
  • Pub. L. 104-4
  • 44 USC 3501-3520
  • 28 CFR 0
  • Pub. L. 91-513
  • 21 USC 801-971
  • 29 CFR 4022
  • 29 CFR 4044
  • 38 CFR 3
  • 44 USC 3501-3521
  • 40 CFR 300
  • 42 USC 9601-9657
  • 44 CFR 64
  • 44 CFR 59
  • 44 CFR 10
  • 26 CFR 301
  • Pub. L. 105-34
  • 111 Stat. 788
  • Pub. L. 107-134
  • 115 Stat. 2427
  • 27 CFR 9
  • 27 CFR 4
  • Pub. L. 104-13
  • 7 USC 7701-7772
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C.F.R.§ 312.23
C.F.R.§ 312.42
C.F.R.§ 312.44
U.S.C.§ 355
U.S.C.§ 371
C.F.R.§ 10.115
C.F.R.§ 50.25
Cite21 CFR 210
Cite5 USC 601-612
Pub. L.Pub. L. 104-4
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