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Code · REGISTER · 2007-08-16 · Agriculture Agriculture Department See Farm Service Agency See Forest Service Air Force Air Force Department NOTICES Meetings: Air University Board of Visitors, 46045 E7-16099 Census Census Bureau NOT · Unknown

Unknown. Final rule

30,045 words·~137 min read·/register/2007/08/16/07-4001

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-2007-08-16.xml --- 72 158 Thursday, August 16, 2007 Contents Agriculture Agriculture Department See Farm Service Agency See Forest Service Air Force Air Force Department NOTICES Meetings: Air University Board of Visitors, 46045 E7-16099 Census Census Bureau NOTICES Reports and guidance documents; availability, etc.: Industrial Research and Development Surveys (2004-2009); data sharing activity with Economic Analysis Bureau, 46034-46035 E7-16141 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 46083-46085 E7-16113 E7-16119 E7-16120 Centers Centers for Medicare & Medicaid Services NOTICES Agency information collection activities; proposals, submissions, and approvals, 46085-46087 E7-16160 Civil Civil Rights Commission NOTICES Meetings;
State advisory committees: Hawaii, 46033-46034 E7-16150 Meetings; Sunshine Act, 46034 07-4043 Coast Guard Coast Guard RULES Navigation and navigable waters: Technical, organizational, and conforming amendments, 45900-45905 E7-15957 Commerce Commerce Department See Census Bureau See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration CITA Committee for the Implementation of Textile Agreements NOTICES African Growth and Opportunity Act; determinations:
Mali; handloomed, handmade, folklore articles, or ethnic printed fabrics, 46039 E7-16154 Defense Defense Department See Air Force Department See Navy Department NOTICES Meetings; Sunshine Act, 46039-46040 07-4027 07-4028 Privacy Act; systems of records, 46040-46045 E7-16133 E7-16136 E7-16137 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 46046-46049 E7-16023 E7-16024 E7-16026 E7-16155 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Electricity export and import authorizations, permits, etc.:
Rainbow Energy Marketing Corp., 46049-46050 E7-16132 RBC Energy Services L.P., 46050 E7-16105 Sierra Power Asset Marketing, LLC, 46050-46051 E7-16130 EPA Environmental Protection Agency RULES Hazardous waste program authorizations: Louisiana, 45905-45908 07-4001 PROPOSED RULES Hazardous waste program authorizations: Louisiana, 46009-46010 07-4000 NOTICES Meetings: Science Advisory Board; public teleconference, 46057-46058 E7-16147 Executive Executive Office of the President See National Drug Control Policy Office See Presidential Documents Farm Farm Service Agency RULES Emergency Conservation Program, 45879-45880 E7-16175 FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives:
Airbus, 45952-45954, 45965-45967, 45970-45972, 45976-45980, 45982-45985 E7-16094 E7-16097 E7-16109 E7-16111 E7-16112 E7-16118 Boeing, 45949-45952, 45954-45956, 45961-45963, 45968-45970, 45972-45976, 45980-45982, 45986-45991 E7-16095 E7-16100 E7-16103 E7-16110 Dassault, 45958-45961 E7-16124 Empresa Brasileira de Aeronautica S.A., 45963-45965 E7-16116 Fokker, 45956-45958 E7-16123 NOTICES Air traffic operating and flight rules, etc.: New York LaGuardia Airport, NJ and NY, 46125 07-4003 FCC Federal Communications Commission RULES Common carrier services:
Local and interexchange carriers; minimum customer account record exchange obligations; implementation, 45937-45938 E7-16159 Practice and procedure: Regulatory fees (2007 FY); assessment and collection, 45908-45937 E7-15607 PROPOSED RULES Practice and procedure: Regulatory fees (2007 FY); assessment and collection, 46010-46014 E7-15606 Television broadcasting: Digital television transition; consumer education initiative, 46014-46020 E7-16149 NOTICES Agency information collection activities; proposals, submissions, and approvals, 46058-46060 E7-15577 E7-16157 Common carrier services:
Individuals with hearing and speech disabilities; telecommunications relay services and speech-to-speech services— Video Relay Service provider employment contracts with VRS communications assistants; declaratory ruling petition, 46060-46061 E7-16158 Federal Energy Federal Energy Regulatory Commission NOTICES Hydroelectric applications, 46055-46057 E7-16039 E7-16040 Meetings: Baltimore Gas and Electric Co.; teleconference, 46057 E7-16035 *Applications, hearings, determinations, etc.:* BE Allegheny, LLC, et al., 46051 E7-16034 DTE Pontiac North LLC, 46051-46052 E7-16030 Energy East Corp., 46052 E7-16042 Heyeck, Michael, 46052 E7-16037 Hopewell Cogeneration Limited Partnership, 46052-46053 E7-16033 KeyTex Energy LLC, 46053 E7-16032 Midwest Independent Transmission System Operator, Inc., 46053-46054 E7-16029 Patton, Charles R., 46054 E7-16036 Raba, Todd M., 46054 E7-16038 Transcontinental Gas Pipe Line Corp., 46054-46055 E7-16041 Williston Basin Interstate Pipeline Co., 46055 E7-16028 FMC Federal Maritime Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 46061-46062 E7-16064 Fish Fish and Wildlife Service RULES Importation, exportation, and transportation of wildlife:
Captive Wildlife Safety Act; implementation, 45938-45947 E7-16085 PROPOSED RULES Endangered and threatened species: Findings on petitions, etc.— Goose Creek milkvetch, 46023-46030 E7-16145 Rio Grande cutthroat trout, 46030-46031 E7-16144 NOTICES Endangered and threatened species: Incidental take permits— Larimer County, CO; Preble's meadow jumping mouse, 46094-46095 E7-16122 Environmental statements; notice of intent: Little Sandy National Wildlife Refuge, TX; comprehensive conservation plan, 46095-46097 E7-16128 Environmental statements; record of decision:
San Joaquin River National Wildlife Refuge, CA; comprehensive conservation plan, 46097 E7-16107 Food Food and Drug Administration RULES Biological products: Blood, blood components, and source plasma; requirements, 45883-45888 E7-15943 PROPOSED RULES Biological products: Blood, blood components, and source plasma; requirements, 45993-45997 E7-15942 NOTICES Agency information collection activities; proposals, submissions, and approvals, 46087-46090 E7-16087 E7-16088 Meetings: Nonprescription Drugs and Pediatric Advisory Committees, 46091-46092 E7-16169 Orthopedic, cardiovascular, and skin allografts; processing methods; workshop, 46092 E7-16182 Forest Forest Service PROPOSED RULES National Environmental Policy Act; implementation, 45998-46009 E7-15867 NOTICES Meetings:
Resource Advisory Committees— Colville, 46033 07-4008 Del Norte County, 46033 07-4009 Glenn/Colusa County, 46032 07-4004 Okanogan and Wenatchee, 46032 07-4006 Tehama County, 46032 07-4005 Wrangell-Petersburg, 46032-46033 07-4007 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 46062-46063 E7-16074 Grants and cooperative agreements; availability, etc.:
Afghanistan; baccalaureate nursing education and Public Health Ministry nursing board development for registration and licensure, 46063-46073 E7-16096 Afghanistan; maternal-child health basic medical education and obstetrics and gynecology clinical and refresher training for physicians, 46073-46082 E7-16114 Meetings: Vital and Health Statistics National Committee, 46082-46083 07-4010 Homeland Homeland Security Department See Coast Guard Industry Industry and Security Bureau NOTICES Meetings:
Deemed Export Advisory Committee, 46035 07-4011 Interior Interior Department See Fish and Wildlife Service IRS Internal Revenue Service RULES Excise taxes: Return requirement and filing time Correction, 45894-45895 E7-16075 Income taxes: Disregarded entities; employment and excise taxes, 45891-45894 E7-16078 Prohibited tax shelter transactions; disclosure requirements Correction, 45890-45891 E7-16073 E7-16081 PROPOSED RULES Excise taxes: Prohibited tax shelter transactions; disclosure requirements Correction, 45997-45998 E7-16080 NOTICES Agency information collection activities; proposals, submissions, and approvals, 46128-46130 E7-16072 E7-16079 E7-16082 E7-16083 International International Trade Administration NOTICES Antidumping:
Stainless steel wire rod from— Korea, 46035-46037 E7-16156 *Applications, hearings, determinations, etc.:* Colorado College et al., 46037 E7-16152 University of— Southern California et al., 46037-46038 E7-16153 Labor Labor Department See Occupational Safety and Health Administration National National Council on Disability NOTICES Meetings; Sunshine Act, 46099 07-4031 National Drug National Drug Control Policy Office NOTICES High intensity drug trafficking areas; designation petitions, 46099-46101 E7-16174 National Highway National Highway Traffic Safety Administration PROPOSED RULES Motor vehicle safety standards:
Occupant crash protection— Dynamic Automatic Suppression System; rulemaking petition denied, 46021-46023 E7-16139 NOTICES Agency information collection activities; proposals, submissions, and approvals; correction, 46126 E7-16108 Motor vehicle defect proceedings; petitions, etc.: Bentley Motors, Inc., 46126-46127 E7-16127 Motor vehicle safety standards; exemption petitions, etc.: Sidump’r Trailer Co., Inc., 46127-46128 E7-16093 NIH National Institutes of Health NOTICES Meetings:
National Cancer Institute, 46092 07-4016 National Center for Complementary and Alternative Medicine, 46092-46093 07-4012 National Institute of Allergy and Infectious Diseases, 46093 07-4015 National Institute of Child Health and Human Development, 46093-46094 07-4018 National Institute of Neurological Disorders and Stroke, 46093 07-4014 Scientific Review Center, 46094 07-4013 National National Intelligence, Office of the Director RULES Freedom of Information Act; implementation, 45895-45900 E7-15996 National National Nanotechnology Coordination Office NOTICES Reports and guidance documents; availability, etc.:
Engineered nanoscale materials; environmental, health, and safety research; priorities, 46101-46102 E7-16077 NOAA National Oceanic and Atmospheric Administration NOTICES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Atka mackerel, 46038 E7-16166 Navy Navy Department NOTICES Privacy Act; systems of records, 46045-46046 E7-16129 Nuclear Nuclear Regulatory Commission RULES Spent nuclear fuel and high-level radioactive waste; independent storage; licensing requirements:
Approved spent fuel storage casks; list, 45880-45883 E7-16134 PROPOSED RULES Spent nuclear fuel and high-level radioactive waste; independent storage; licensing requirements: Approved spent fuel storage casks; list, 45948-45949 E7-16135 NOTICES Regulatory guides; issuance, availability, and withdrawal, 46102-46103 E7-16131 Reports and guidance documents; availability, etc.: Control rod notch surveillance frequency, SRM insert control rod action, and frequency example, 46103-46109 E7-16138 *Applications, hearings, determinations, etc.:* Exelon Generation Co., LLC, 46102 E7-16148 Occupational Occupational Safety and Health Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 46097-46099 E7-16043 National Office of National Drug Control Policy See National Drug Control Policy Office National Office of the Director of National Intelligence See National Intelligence, Office of the Director Pension Pension Benefit Guaranty Corporation NOTICES Agency information collection activities; proposals, submissions, and approvals, 46109-46110 E7-16101 E7-16102 Postal Postal Regulatory Commission NOTICES Negotiated service agreements:
Life Line Screening of America, 46110-46111 E7-16089 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Export control regulations; continuation of emergency (Notice of August 15, 2007), 46135-46137 07-4055 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 46111-46113 E7-16091 E7-16162 E7-16163 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 46113-46116 E7-16052 Boston Stock Exchange, Inc, 46116-46117 E7-16054 Chicago Board Options Exchange, Inc., 46118 E7-16053 NASDAQ Stock Market LLC, 46118-46119 E7-16090 NYSE Arca, Inc., 46119-46121 E7-16161 Social Social Security Administration PROPOSED RULES Organization and procedures:
Prescribed applications, forms, and other publications; private printing, 45991-45992 E7-16140 NOTICES Reports and guidance documents; availability, etc.: Non-Attorney Direct Payment Demonstration Project; participation requirements, 46121-46122 E7-16187 State State Department RULES Passports: Expedited passport processing; consular services fee schedule, 45888-45890 E7-16173 NOTICES Arms Export Control Act: Commercial export licenses; congressional notifications, 46122-46125 E7-16176 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Internal Revenue Service Veterans Veterans Affairs Department NOTICES Privacy Act; systems of records, 46130-46133 E7-16046 Separate Parts In This Issue Part II Executive Office of the President, Presidential Documents, 46135-46137 07-4055 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. 72 158 Thursday, August 16, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Farm Service Agency 7 CFR Part 701 RIN 0560-AH71 Emergency Conservation Program AGENCY: Farm Service Agency, USDA. ACTION: Final rule. SUMMARY: This final rule provides the change mandated by the U.S.
Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (the 2007 Emergency Supplemental). The 2007 Emergency Supplemental provided $16 million for the Emergency Conservation Program
(ECP)and required that the Adjusted Gross Income Limitation
(AGI)apply to the distribution of the funds. EFFECTIVE DATE: August 16, 2007. FOR FURTHER INFORMATION CONTACT: Clayton Furukawa, ECP Program Manager, Conservation and Environmental Programs Division, USDA/FSA/CEPD STOP 0513, 1400 Independence Avenue, SW., Washington, DC 20250-0513, telephone 202-690-0571, e-mail: *Clayton.Furukawa@wdc.usda.gov* . SUPPLEMENTARY INFORMATION: Background The ECP provides cost-share assistance to farmers and ranchers to rehabilitate farmland damaged by wind erosion, floods, hurricanes, or other natural disasters, and for carrying out emergency water conservation measures during periods of severe drought. The 2007 Emergency Supplemental (Pub. L. 110-28) appropriated $16 million for the ECP. The 2007 Emergency Supplemental also required that the Adjusted Gross Income (AGI), 7 U.S.C. 1308-3a, apply to this $16 million. This regulation incorporates the AGI provisions into the ECP. This will be the first time the AGI will be applied to the ECP; however, it has been used with other programs administered by FSA. The use of the AGI limitation is addressed in the regulations in 7 CFR part 1400, subpart G, Average Adjusted Gross Income Limitation (sections 1400.600—1400.603). Section 1400.600 specifies applicability of the AGI limitation. In general, an individual or entity is not eligible for certain program benefits during a crop, program, or fiscal year, if
(1)the preceding three-year average of the AGI for the individual or entity exceeds $2.5 million and
(2)less than 75 percent of the average AGI is derived from farming, ranching, or forestry operations. Section 1400.601 specifies the determination of average adjusted gross income. Section 1400.602 specifies the information applicants must provide to comply with the regulations. Section 1400.603 specifies the amount payment will be reduced commensurate with the AGI limitation. All other aspects of the ECP will continue to operate in the current manner; this change incorporating the AGI limitation will only apply to payment eligibility for the newly-funded $16 million. Other ECP program funds may be available for which the AGI provision does not apply. Other than the addition of the AGI limitation for the newly funded $16 million, current ECP regulations remain unchanged. Notice and Comment Due to the non-discretionary nature of this regulatory change, notice and public comment are impracticable, unnecessary, or contrary to the public interest. The 2007 Emergency Supplemental required that FSA apply the AGI to the ECP for payments under the newly-funded $16 million. FSA will apply the AGI as it does for other programs it administers; the current AGI regulations will remain unchanged. Further, allowing the rule to be effective upon publication will allow FSA to fully implement the change and more quickly distribute the $16 million to provide cost-share assistance to farmers and ranchers to rehabilitate farmland damaged by wind erosion, floods, hurricanes, or other natural disasters, and for carrying out emergency water conservation measures during periods of severe drought. Therefore, a proposed rule is not required and this regulatory change is being issued as a final rule. Executive Order 12866 This rule has been determined to be not significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget. Regulatory Flexibility Act This rule is not subject to the Regulatory Flexibility Act since the FSA is not required to publish a notice of proposed rulemaking for this rule. Environmental Review FSA has determined that the application of the AGI limitation to distribute certain funds for the Emergency Conservation Program
(ECP)does not constitute a *major* Federal action that would significantly affect the human or natural environment. Consistent with the National Environmental Policy Act (NEPA), 40 CFR part 1502.4, major Federal actions requiring the preparation of Environmental Impact Statements, and 7 CFR Part 799: Environmental Quality and Related Environmental Concerns—Compliance with NEPA implementing the regulations of the Council on Environmental Quality, 40 CFR parts 1500-1508, no environmental assessment or environmental impact statement will be prepared for this final rule. Executive Order 12372 This program is not subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983). Executive Order 12612 This rule does not have Federalism implications that warrant the preparation of a Federalism Assessment. This rule will not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various levels of government. Executive Order 12988 This rule has been reviewed in accordance with Executive Order 12988. This final rule is not retroactive and it does not preempt State law. Before any judicial action may be brought regarding the provisions of this rule the administrative appeal provisions of 7 CFR parts 11 and 780 must be exhausted. Unfunded Mandates Reform Act of 1995 This rule contains no Federal mandates under the regulatory provisions of Title II of the UMRA for State, local, and tribal government or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. Paperwork Reduction Act The Office of Management and Budget
(OMB)previously approved the information collection requirements of the ECP under OMB control number 0560-0082. This rule will not change those information collection requirements. A separate notice requesting comments was published in the **Federal Register** on July 26, 2007 (72 FR 41051) for the information collection requirements for the collection of AGI information. E-Government Act Compliance FSA is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. Federal Assistance Program The title and number of the Federal Assistance Program, as found in the Catalog of Federal Domestic Assistance, to which this rule applies are: Emergency Conservation Program (ECP)—10.054. List of Subjects in 7 CFR Part 701 Agriculture, Disaster assistance, Environmental protection, Forests and forest products, Grant programs—agriculture, Grant programs—natural resources, Reporting and recordkeeping, Rural areas, Soil conservation, Water resources, Wildlife. Accordingly, amend 7 CFR part 701 as follows: PART 701—EMERGENCY CONSERVATION PROGRAM AND CERTAIN RELATED PROGRAMS PREVIOUSLY ADMINISTERED UNDER THIS PART 1. Revise the authority citation to read as follows: Authority: Pub. L. 95-334, 92 Stat. 420, 16 U.S.C. 2201-2205; Pub. L. 109-148, Division B, sec. 101; and Pub. L. 110-28, secs. 9003-9004. 2. Add new § 701.17 to read as follows: § 701.17 Average Adjusted Gross Income Limitation To be eligible for payments issued from the $16 million provided under the U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (Pub. L. 110-28, section 9003), each applicant must meet the provisions of the Adjusted Gross Income Limitations at 7 CFR part 1400 subpart G. Signed at Washington, DC, on August 9, 2007. Glen L. Keppy, Acting Administrator, Farm Service Agency. [FR Doc. E7-16175 Filed 8-15-07; 8:45 am] BILLING CODE 3410-05-P NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 RIN 3150-AI21 List of Approved Spent Fuel Storage Casks: TN-68 Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule. SUMMARY: The Nuclear Regulatory Commission
(NRC)is amending its spent fuel storage cask regulations by revising the Transnuclear, Inc. TN-68 dry storage cask system listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 1 to Certificate of Compliance
(CoC)Number 1027. Amendment No. 1 will modify the CoC by revising several fuel parameters that include increasing fuel burnup to 60 gigawatts-day/metric ton of uranium, increasing total cask decay heat to 30 kilowatts, increasing maximum average fuel enrichment to 4.7 weight percent uranium-235, and decreasing minimum fuel assembly cooling time to 7 years. Amendment No. 1 will also add up to eight damaged fuel assemblies as authorized contents of the cask and reduce the cask spacing on the storage pad. DATES: The final rule is effective October 30, 2007, unless significant adverse comments are received by September 17, 2007. A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. If the rule is withdrawn, timely notice will be published in the **Federal Register** . ADDRESSES: You may submit comments by any one of the following methods. Please include the following number (RIN 3150-AI21) in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking web site. Personal information, such as name, address, phone, e-mail address, etc., will not be removed from your submission. *Mail comments to:* Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff. *E-mail comments to: SECY@nrc.gov.* If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at
(301)415-1966. You may also submit comments via the NRC's rulemaking Web site at *http://rulemaking.llnl.gov.* Address questions about our rulemaking Web site to Carol Gallagher
(301)415-5905; e-mail *cag@nrc.gov.* Comments can also be submitted via the Federal eRulemaking Portal *http://www.regulations.gov.* *Hand deliver comments to:* 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays [telephone
(301)415-1966]. *Fax comments to* : Secretary, U.S. Nuclear Regulatory Commission at
(301)415-1101. Publicly available documents related to this rulemaking may be viewed electronically on the public computers at the NRC's Public Document Room (PDR), O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. Selected documents, including comments, can be viewed and downloaded electronically via the NRC rulemaking Web site at *http://ruleforum.llnl.gov.* Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/NRC/ADAMS/index.html.* From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to *pdr@nrc.gov.* An electronic copy of the CoC No. 1027, the revised Technical Specifications (TS), and the preliminary safety evaluation report
(SER)for Amendment No. 1 can be found in a package under ADAMS Accession No. ML071170621. CoC No. 1027, the revised TS, the preliminary SER for Amendment No. 1, and the environmental assessment are available for inspection at the NRC PDR, 11555 Rockville Pike, Rockville, MD. Single copies of these documents may be obtained from Jayne M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301)415-6219, e-mail *jmm2@nrc.gov.* FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301)415-6219, e-mail jmm2@nrc.gov. SUPPLEMENTARY INFORMATION: Background Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended (NWPA), requires that “[t]he Secretary [of the Department of Energy (DOE)] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 218(a) for use at the site of any civilian nuclear power reactor.” To implement this mandate, the NRC approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule in 10 CFR part 72, which added a new Subpart K within 10 CFR part 72, entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new Subpart L within 10 CFR part 72, entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on April 28, 2000 (65 FR 24855), that approved the TN-68 cask design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1027. Discussion On January 14, 2005, and as supplemented on July 15 and November 15, 2005; September 22 and December 8, 2006; and February 22, March 16, and March 23, 2007; the certificate holder, Transnuclear, Inc. (TN), submitted an application to the NRC that requested an amendment to CoC No. 1027. Specifically, TN requested revisions to several fuel parameters of the TN-68 cask design that included increasing fuel burnup to 60 gigawatts-day/metric ton of uranium (GWd/MTU), increasing total cask decay heat to 30 kilowatts (kW), increasing maximum average fuel enrichment to 4.7 weight percent uranium-235, and decreasing minimum fuel assembly cooling time to 7 years. The application also requested adding up to eight damaged fuel assemblies as authorized contents of the cask and reducing the cask spacing on the storage pad. No other changes to the TN-68 dry storage cask system were requested in this application. As documented in the SER, the NRC staff performed a detailed safety evaluation of the proposed CoC amendment request and found that an acceptable safety margin is maintained. In addition, the NRC staff has determined that there continues to be reasonable assurance that public health and safety and the environment will be adequately protected. This direct final rule revises the TN-68 dry storage cask system listing in 10 CFR 72.214 by adding Amendment No. 1 to CoC No. 1027. The amendment consists of the changes described above as set forth in the revised CoC and TS. The particular TS which are changed are identified in the SER. The amended TN-68 cask design, when used under the conditions specified in the CoC, the TS, and NRC regulations, will meet the requirements of Part 72; thus, adequate protection of public health and safety will continue to be ensured. Once this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into TN-68 casks that meet the criteria of Amendment No. 1 to CoC No. 1027, in accordance with 10 CFR 72.212. Discussion of Amendments by Section Section 72.214 List of Approved Spent Fuel Storage Casks Certificate No. 1027 is revised by adding the initial certificate effective date of May 30, 2000, and the effective date of Amendment No. 1. Procedural Background This rule is limited to the changes contained in Amendment No. 1 to CoC No. 1027 and does not include other aspects of the TN-68 dry storage cask system. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on October 30, 2007. However, if the NRC receives significant adverse comments on this direct final rule by September 17, 2007, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published elsewhere in this issue of the **Federal Register** . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action. A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:
(1)The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:
(a)The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;
(b)The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or
(c)The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.
(2)The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.
(3)The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or TS. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the TN-68 cask design listed in § 72.214 (List of NRC-approved spent fuel storage cask designs). This action does not constitute the establishment of a standard that contains generally applicable requirements. Agreement State Compatibility Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the **Federal Register** on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended (AEA), or the provisions of Title 10 of the Code of Federal Regulations. Although an Agreement State may not adopt program elements reserved to NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws but does not confer regulatory authority on the State. Plain Language The Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883), directed that the Government's documents be in clear and accessible language. The NRC requests comments on this direct final rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading ADDRESSES , above. Finding of No Significant Environmental Impact: Availability Under the National Environmental Policy Act of 1969, as amended, and the NRC regulations in Subpart A of 10 CFR Part 51, the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has prepared an environmental assessment and, on the basis of this environmental assessment, has made a finding of no significant impact. This rule will amend the CoC for the TN-68 cask design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. The amendment will revise several fuel parameters that include increasing fuel burnup to 60 GWd/MTU, increasing total cask decay heat to 30 kW, increasing maximum average fuel enrichment to 4.7 weight percent uranium-235, and decreasing minimum fuel assembly cooling time to 7 years. The amendment will also add up to eight damaged fuel assemblies as authorized contents of the cask and reduce the cask spacing on the storage pad. The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 11555 Rockville Pike, Rockville, MD. Single copies of the environmental assessment and finding of no significant impact are available from Jayne M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301)415-6219, e-mail *jmm2@nrc.gov.* Paperwork Reduction Act Statement This direct final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Existing requirements were approved by the Office of Management and Budget, Approval Number 3150-0132, 10 CFR Part 72. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. Regulatory Analysis On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214. On April 28, 2000 (65 FR 24855), the NRC issued an amendment to Part 72 that approved the TN-68 cask design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214. On January 14, 2005, and as supplemented on July 15 and November 15, 2005; September 22 and December 8, 2006; and February 22, March 16, and March 23, 2007; the certificate holder, TN, submitted an application to the NRC to amend CoC No. 1027 to revise several fuel parameters that included increasing fuel burnup to 60 GWd/MTU, increasing total cask decay heat to 30 kW, increasing maximum average fuel enrichment to 4.7 weight percent uranium-235, and decreasing minimum fuel assembly cooling time to 7 years. The application also requested adding up to eight damaged fuel assemblies as authorized contents of the cask and reducing the cask spacing on the storage pad. The alternative to this action is to withhold approval of Amendment No. 1 and to require any part 72 general licensee, seeking to load spent fuel into TN-68 casks under Amendment No. 1, to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested Part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Approval of the direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the environmental assessment, the direct final rule will have no adverse effect on public health and safety. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and thus, this action is recommended. Regulatory Flexibility Certification Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and TN. These entities do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810). Backfit Analysis The NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule because this amendment does not involve any provisions that would impose backfits as defined in 10 CFR Chapter I. Therefore, a backfit analysis is not required. Congressional Review Act Under the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget. List of Subjects in 10 CFR Part 72 Administrative practice and procedure, Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72. PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, 2236, 2237, 2238, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 688, as amended (42 U.S.C. 2021); sec. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 5851); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332); secs. 131, 132, 133, 135, 137, 141, Pub. L. 97-425, 96 Stat. 2229, 2230, 2232, 2241, sec. 148, Pub. L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-10 (42 U.S.C. 2014, 2021, 2021b, 2111). Section 72.44(g) also issued under secs. 142(b) and 148(c), (d), Pub. L. 100-203, 101 Stat. 1330-232, 1330-236 (42 U.S.C. 10162(b), 10168(c), (d)). Section 72.46 also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154). Section 72.96(d) also issued under sec. 145(g), Pub. L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10165(g)). Subpart J also issued under secs. 2(2), 2(15), 2(19), 117(a), 141(h), Pub. L. 97-425, 96 Stat. 2202, 2203, 2204, 2222, 2244 (42 U.S.C. 10101, 10137(a), 10161(h)). Subparts K and L are also issued under sec. 133, 98 Stat. 2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 (42 U.S.C. 10198). 2. In § 72.214, Certificate of Compliance 1027 is revised to read as follows: § 72.214 List of approved spent fuel storage casks. Certificate Number: 1027. Initial Certificate Effective Date: May 30, 2000. Amendment Number 1 Effective Date: October 30, 2007. SAR Submitted by: Transnuclear, Inc. SAR Title: Final Safety Analysis Report for the TN-68 Dry Storage Cask. Docket Number: 72-1027. Certificate Expiration Date: May 28, 2020. Model Number: TN-68. Dated at Rockville, Maryland, this 31st day of July, 2007. For the Nuclear Regulatory Commission. Martin J. Virgilio, Acting Executive Director for Operations. [FR Doc. E7-16134 Filed 8-15-07; 8:45 am] BILLING CODE 7590-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 606, 607, 610, and 640 [Docket No. 2007N-0264] Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the **Federal Register** , we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule. DATES: This direct final rule is effective February 19, 2008. Submit written or electronic comments by October 30, 2007. If we receive no significant adverse comments during the specified comment period, we intend to publish a confirmation document on or before the effective date of this direct final rule confirming that the direct final rule will go into effect on February 19, 2008. If we receive any significant adverse comments during the comment period, we intend to withdraw this direct final rule before its effective date by a notice published in the **Federal Register** . ADDRESSES: You may submit comments, identified by Docket No. 2007N-0264, by any of the folllowing methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Direct Final Rulemaking In the **Federal Register** of November 21, 1997 (62 FR 62466), FDA described its procedures on when and how the agency will employ direct final rulemaking. We have determined that this rule is appropriate for direct final rulemaking because we believe that it is noncontroversial and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is publishing elsewhere in this issue of the **Federal Register** a companion proposed rule on the same subject matter. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comment. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to the companion proposed rule will be considered as comments regarding the direct final rule. We are providing a comment period on the direct final rule of 75 days after the date of publication in the **Federal Register** . If we receive any significant adverse comments, we intend to withdraw this direct final rule before its effective date by publication of a notice in the **Federal Register** . 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 a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of a significant adverse comment. If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures. If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document, before the effective date of the direct final rule, confirming the effective date. II. Legal Authority FDA is issuing this new rule under the biological products and communicable diseases provisions of the Public Health Service Act (PHS Act)(42 U.S.C. 262-264), and the drugs, devices, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the act)(21 U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease. III. Highlights of the Direct Final Rule FDA is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are issuing these amendments as a direct final rule because we have concluded that they are noncontroversial and that there is little likelihood that there will be comments opposing the rule. Any comment recommending additional changes to these regulations will not be considered to be a “significant adverse comment” unless the comment demonstrates that the change being made in the direct final rule represents a major departure from current regulations or accepted industry standards, or cannot be implemented without additional amendments to the regulation. Below we identify each of the changes included in this direct final rule. We are amending 21 CFR 606.3(i) by revising the definition of “processing” to mean any procedure employed after collection and before “or after” compatibility testing of blood. The current regulation states that processing means any procedure employed after collection and before compatibility testing of blood. Because blood components occasionally are further processed after compatibility testing has been performed, we are revising this definition. We are amending 21 CFR 607.65(f) by removing the words “approved for Medicare reimbursement and” and replacing with the words “that is certified under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493 or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services and which are”. As a result of the Clinical Laboratory Improvement Amendments of 1988
(CLIA)and the implementing regulations adopted by the Centers for Medicaid and Medicare Services (CMS), the inspection regime relied on in a 1983 Memorandum of Understanding
(MOU)between FDA and the Health Care Financing Administration (HCFA), now CMS, will be modified. Under the CLIA program, clinical laboratories must be surveyed by CMS (either directly or through a State survey agency), unless they are located in a CLIA-approved State, or are accredited by a CMS-approved accreditation organization. CLIA regulations apply to clinical laboratories regardless of whether or not the laboratories seek Medicare participation. FDA is amending this regulation to make it consistent with updates in the CMS regulations. We are amending 21 CFR 610.53(c) by revising the dating period in the table for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen. Although the current recommended dating period will remain unchanged for Platelets and Red Blood Cells Deglycerolized, we are adding that a different dating period could apply for these products if so specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluation and Research (CBER). This change will allow for flexible dating periods depending on the type of collecting, processing, and storage system used. In addition, under Red Blood Cells Frozen, we are revising the dating period from 3 years to 10 years, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. This change will allow for flexible dating periods depending on the type of collecting, processing, and storage system used. Under § 640.4(h) (21 CFR 640.4(h)), we are revising the temporary storage temperature for blood that is transported from the donor center to the processing laboratory. We are revising the range to between 1 and 10 ° C until the blood arrives at the processing laboratory. We are making this revision to be consistent with 21 CFR 600.15 which allows for shipping temperatures of Whole Blood to be from 1 to 10 ° C, and for consistency with current industry practice. In addition, we are revising the applicability of this requirement to Whole Blood unless it is to be further processed into another component, such as Platelets or Red Blood Cells Leukocytes Reduced. The current regulation applies only to Whole Blood unless the blood is to be used as a source for Platelets. This change will clarify that processing Whole Blood into other components, in addition to Platelets, is acceptable. For Whole Blood that is to be processed into another component, we are revising this regulation to state that the blood must be stored in an environment maintained at a temperature range that is specified for that component in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. We are also amending the term donor “clinic” to donor “center” for consistency with § 640.4(b) and current terminology. We are removing and reserving § 640.21(b) (21 CFR 640.21(b)) because this provision is obsolete, as well as removing the reference to plasmapheresis in 21 CFR 640.20(b). Improvements in technology now allow establishments to collect Platelets by automated methods eliminating the need for the collection of platelets by manual plasmapheresis. Currently, establishments may collect Platelets by automated platelet-specific apheresis collection procedures. We are amending § 640.21(c) by adding that plateletpheresis donors must meet the criteria for suitability as prescribed in 21 CFR 640.3 and 640.63(c)(6), or as described in an approved biologics license application
(BLA)or an approved supplement to a BLA, and that informed consent must be obtained as prescribed in 21 CFR 640.61. This revision will clarify that registered facilities must follow the suitability requirements for plateletpheresis donors. We are removing and reserving § 640.22(b) (21 CFR 640.22(b)) because this regulation is obsolete. As previously mentioned, improvements in technology now allow establishments to collect Platelets by automated methods, eliminating the need for the collection of platelets by manual plasmapheresis. Currently, establishments may collect Platelets by automated platelet-specific apheresis collection procedures. We are amending § 640.22(c) by adding that if plateletpheresis is used, the procedure for collection must be as prescribed in 21 CFR 640.62 - *Medical supervision* ; 21 CFR 640.64 - *Collection of blood for Source Plasma* ; and 21 CFR 640.65 - *Plasmapheresis* , or as described in an approved BLA or an approved supplement to a BLA. This revision will clarify that registered facilities must follow the collection of source material requirements for plateletpheresis donors. We are amending 21 CFR 640.24(a) to allow Platelets to be pooled under certain circumstances. That is, Platelets may be pooled if such processing is specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. We are amending the regulation to provide flexibility depending on the type of collecting, processing, and storage system used. We are amending 21 CFR 640.25(b)(2) by revising the pH level from “6.0” to “6.2” for consistency with current industry practice. Studies have shown that a lower pH may adversely affect platelet function (Refs. 1 and 2). We are amending 21 CFR 640.30(a) by revising the term “product,” to “component,” for consistency with current terminology of the proper name. We are also adding an alternative definition of Plasma, namely, “The fluid portion of human blood intended for intravenous use which is prepared by apheresis methods as specified in the directions for use for the blood collecting, processing, and storage system including closed and open systems.” We are making this change because Plasma is now collected by other methods, such as apheresis collection, in addition to being collected as a byproduct of Whole Blood collection. We are amending 21 CFR 640.32(a) to add that a different storage temperature may be used for Whole Blood intended for further manufacturing into Plasma, Fresh Frozen Plasma, or Liquid Plasma. Any different storage temperature would be specified in the directions for use for the blood collecting, processing, and storage system. This change will allow for flexible storage temperatures depending on the particular type of system used. We are amending 21 CFR 640.34(b) by adding the phrase “or collected by an apheresis procedure” in the second sentence to clarify that this section also applies to plasma collected by aphersis procedures. We require that fresh frozen plasma using the apheresis procedure also be prepared from blood collected by a single uninterrupted venipuncture with minimal damage to, and minimal manipulation of, the donor's tissue. We are amending § 640.64(b) (21 CFR 640.64(b)) by removing the second sentence that states, “The amount of anticoagulant required for the quantity of blood to be collected shall be in the blood container when it is sterilized.” This sentence is being removed because of technological advances. Now, the anticoagulant does not always have to be in the collection set. The anticoagulant can be connected by a “sterile docking” procedure or attached separately, as is the case with automated apheresis collection. We are also amending § 640.64(c) by removing the specific anticoagulant solution formulas and indicating that the anticoagulant solutions must be compounded and used according to a formula approved by the Director, CBER. We have determined that it is unnecessary to provide specific formulae for anticoagulant solutions in the regulations, and that manufacturers should be able to use any anticoagulant approved by FDA for such use by the manufacturer. We have also revised the previous regulations, where applicable, by using “must” or “is” instead of “shall”, depending on the circumstances. We have made these revisions for plain language purposes. These editorial changes are for clarity only and do not change the substance of the requirements. We will continue to make these changes in other applicable regulations as they are revised in future rulemakings. In addition, we will continue to make the change from “product” to “component” in other applicable regulations as they are revised in future rulemakings. IV. Analysis of Impacts A. Review Under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Act of 1995 FDA has examined the impacts of the direct 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 direct final rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the direct final rule amendments have no compliance costs and do not result in any new requirements, the agency certifies that the direct 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 $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this direct final rule to result in any 1-year expenditure that would meet or exceed this amount. B. Environmental Impact The agency has determined, under 21 CFR 25.31(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. C. Federalism FDA has analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the direct final 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 direct final 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. V. Paperwork Reduction Act of 1995 This direct final rule contains no collections of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required. VI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VII. 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. 1. Scott Murphy, “Platelet Storage for Transfusion,” *Seminars in Hematology* , 22(3): 165-177, July 1985. 2. L. Dumont and T. VandenBroeke, “Seven-Day Storage of Apheresis Platelets Report of an In Vitro Study,” 43: 143-150, *Transfusion* , February 2003. List of Subjects 21 CFR Part 606 Blood, Labeling, Laboratories, Reporting and recordkeeping requirements. *21 CFR Part 607* Blood. *21 CFR Part 610* Biologics, Labeling, Reporting and recordkeeping requirements. *21 CFR Part 640* Blood, Labeling, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated by the Commissioner of Food and Drugs, 21 CFR parts 606, 607, 610, and 640 are amended as follows: PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS 1. The authority citation for 21 CFR part 606 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. Section 606.3 is amended by revising paragraph
(i)to read as follows: § 606.3 Definitions.
(i)*Processing* means any procedure employed after collection, and before or after compatibility testing of blood, and includes the identification of a unit of donor blood, the preparation of components from such unit of donor blood, serological testing, labeling and associated recordkeeping. PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS 3. The authority citation for 21 CFR part 607 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271. 4. Section 607.65 is amended by revising the first sentence in paragraph
(f)to read as follows: § 607.65 Exemptions for blood product establishments.
(f)Transfusion services which are a part of a facility that is certified under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493 or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services and which are engaged in the compatibility testing and transfusion of blood and blood components, but which neither routinely collect nor process blood and blood components.* * * PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS 5. The authority citation for 21 CFR part 610 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264. 6. Section 610.53 is amended in paragraph
(c)in the table by revising the entries for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen to read as follows: § 610.53 Dating periods for licensed biological products.
(c)* * * A B C D Product Manufacturer's storage period 1 to 5 °C (unless otherwise stated) Manufacturer's storage period 0 °C or colder (unless otherwise stated) Dating period after leaving manufacturer's storage when stored at 2 to 8 °C (unless otherwise stated) * * * * * * * Platelets Not applicable do 72 hours from time of collection of source blood, provided labeling recommends storage at 20 to 24°C or between 1 and 6°C, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluation and Research (CBER). * * * * * * * Red Blood Cells Deglycerolized do do 24 hours after removal from storage at 65°C or colder, provided labeling recommends storage between 1 and 6°C, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. Red Blood Cells Frozen do do 10 years from date of collection of source blood, provided labeling recommends storage at 65°C or colder, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 7. The authority citation for 21 CFR part 640 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264. 8. Section 640.4 is amended by revising paragraph
(h)to read as follows: § 640.4 Collection of the blood.
(h)*Storage* . Whole Blood must be placed in storage at a temperature between 1 and 6°C immediately after collection unless the blood is to be further processed into another component or the blood must be transported from the donor center to the processing laboratory. If transported, the blood must be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously at a temperature range between 1 and 10°C until arrival at the processing laboratory. At the processing laboratory, the blood must be stored at a temperature between 1 and 6°C. Blood from which a component is to be prepared must be held in an environment maintained at a temperature range specified for that component in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. 9. Section 640.20 is amended by revising paragraph
(b)to read as follows: § 640.20 Platelets.
(b)*Source* . The source material for Platelets is plasma which may be obtained by whole blood collection or by plateletpheresis. 10. Section 640.21 is amended by removing and reserving paragraph
(b)and revising paragraph
(c)to read as follows: § 640.21 Suitability of donors.
(b)[Reserved]
(c)Plateletpheresis donors must meet the criteria for suitability as prescribed in §§ 640.3 and 640.63(c)(6) or as described in an approved biologics license application
(BLA)or an approved supplement to a BLA. Informed consent must be obtained as prescribed in § 640.61. 11. Section 640.22 is amended by removing and reserving paragraph
(b)and revising paragraph
(c)to read as follows: § 640.22 Collection of source material.
(b)[Reserved]
(c)If plateletpheresis is used, the procedure for collection must be as prescribed in §§ 640.62, 640.64 (except paragraph (c)), and 640.65, or as described in an approved biologics license application
(BLA)or an approved supplement to a BLA. 12. Section 640.24 is amended by revising paragraph
(a)to read as follows: § 640.24 Processing.
(a)Separation of plasma and platelets and resuspension of the platelets must be in a closed system. Platelets must not be pooled during processing unless the platelets are pooled as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluation and Research. § 640.25 [Amended] 13. Section 640.25 is amended in paragraph (b)(2) by removing “6.0” and adding in its place “6.2”. 14. Section 640.30 is amended by revising paragraph
(a)to read as follows: § 640.30 Plasma.
(a)*Proper name and definition* . The proper name of this component is Plasma. The component is defined as:
(1)The fluid portion of one unit of human blood intended for intravenous use which is collected in a closed system, stabilized against clotting, and separated from the red cells; or
(2)The fluid portion of human blood intended for intravenous use which is prepared by apheresis methods as specified in the directions for use for the blood collecting, processing, and storage system including closed and open systems. 15. Section 640.32 is amended by revising paragraph
(a)to read as follows: § 640.32 Collection of source material.
(a)Whole Blood must be collected, transported, and stored as prescribed in § 640.4. When whole blood is intended for Plasma, Fresh Frozen Plasma, and Liquid Plasma, until the plasma is removed, the whole blood must be maintained at a temperature between 1 and 6 °C or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluations and Research. Whole blood intended for Platelet Rich Plasma must be maintained as prescribed in § 640.24 until the plasma is removed. The red blood cells must be placed in storage at a temperature between 1 and 6 °C immediately after the plasma is separated. 16. Section 640.34 is amended by revising the second sentence in paragraph
(b)to read as follows: § 640.34 Processing.
(b)*Fresh Frozen Plasma* . * * * The plasma must be separated from the red blood cells or collected by an apheresis procedure, and placed in a freezer within 8 hours or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system, and stored at -18 °C or colder. 17. Section 640.64 is amended by revising paragraphs
(b)and
(c)to read as follows: § 640.64 Collection of blood for source plasma.
(b)*Blood containers* . Blood containers and donor sets must be pyrogen-free, sterile, and identified by lot number.
(c)*The anticoagulant solution* . The anticoagulant solution must be sterile and pyrogen-free. Anticoagulant solutions must be compounded and used according to a formula that has been approved for the applicant by the Director, Center for Biologics Evaluation and Research. Dated: July 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-15943 Filed 8-15-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF STATE 22 CFR Parts 22 and 51 [Public Notice: 5888] RIN 1400-AC39 Passport Procedures—Amendment to Expedited Passport Processing Regulation AGENCY: Department of State. ACTION: Interim final rule. SUMMARY: This interim final rule changes the definition of “expedited passport processing” from the 3-business day period to a number of business days as may be published from time to time on the Department's Web site, *http://www.travel.state.gov.* This change is meant to ensure that the Department can continue to offer this service consistent with its regulations, despite increases in demand for it. It is also meant to ensure that the public can easily determine the current standards for expedited passport processing. Further, this interim final rule makes a conforming amendment to the Schedule of Fees for Consular Services. DATES: *Effective date:* This interim final rule becomes effective August 16, 2007. *Comment date:* The Department of State will accept written comments from interested persons up to October 15, 2007. ADDRESSES: Interested parties may submit comments at any time by any of the following methods: • *Mail (paper, disk, or CD-ROM submissions* ): Comments by mail are to be addressed to the Office of Legal Affairs and Law Enforcement, U.S. Department of State, 2100 Pennsylvania Ave., NW., Suite 300, Washington, DC 20037. • *Internet:* Comments by Internet are to be sent to *http://www.regulations.gov.* This notice can also be viewed from this Internet address. • *Electronically:* You may submit electronic comments to *ExpediteRuleComments@state.gov.* You must include the RIN in the subject line of your message. Attachments must be in Microsoft Word. *Instructions:* All submissions must include the agency name and docket number. All comments will be posted without change to *http://www.regulations.gov,* including any personal information sent with each comment. FOR FURTHER INFORMATION CONTACT: Requests for additional information regarding this regulatory amendment should be directed to Susan M. Bozinko, Bureau of Consular Affairs, Passport Services, Division of Legal Affairs, U.S. Department of State, Washington, DC 20037, who may be reached at 202-663-2491 or e-mailed at *BozinkoSM@state.gov.* SUPPLEMENTARY INFORMATION: Section 7209 of the Intelligence Reform and Terrorism Prevention Act (IRTPA), enacted on December 17, 2004, requires the Secretary of Homeland Security, in consultation with the Secretary of State, to develop expeditiously a plan to require most U.S. citizens and certain other categories of individuals to present a passport or other documentation of identity and citizenship deemed sufficient by the Secretary of Homeland Security when entering the United States. The Department of State's Office of Passport Services (Passport Services) began planning for increased passport demand even before Congress passed IRTPA. It planned for a sharp increase in passport applications and anticipated the need for increased staff to handle the demand. Recognizing the uncertainty of passport demand and the need for reliable information to guide its planning efforts, Passport Services contracted for a passport demand study in 2005, and used the data from this study to initiate a program of resource upgrades for meeting demand. Beginning in February 2007, it became apparent that passport demand was growing faster than the study projected. While the demand study anticipated a sharp increase in applications, it did not fully anticipate the degree and speed with which the American people would comply with Western Hemisphere Travel Initiative
(WHTI)guidelines. Therefore, Passport Services has implemented additional short-term and more long-term measures to attempt to address the increase in passport demand and provide Americans with passports in a timely and secure manner. Despite these efforts, the surge in passport applications has led to increases in processing times, and concurrent increases in requests from the public for expedited passport processing. 22 CFR 51.66(b) currently sets a 3-business-day standard for processing expedited passport applications, commencing when the application reaches a Passport Agency or, if the application is already with a Passport Agency commencing when the request for expedited processing is approved. This standard was set by the Department in 1994, (59 FR 48998 (Sep. 26, 1994)), to allow Passport Services to provide expedited services to applicants with urgent departures, and to recover the costs of providing such service. In order to allow Passport Services the flexibility to meet the surge in demand for expedited processing, and to continue to offer this service to the public consistent with its regulations, Passport Services is revising this standard. Under the new standard, the public will be notified on the Department's Web site, *http://www.travel.state.gov,* of the number of business days in which the Department is completing expedited processing. This will allow the Department flexibility to alert the public without delay of the current processing time for expedited requests. The public benefits from this change by having accurate notice of the service that will be provided to them and from having the service available from the Department. We believe this will allow the public to continue to consider using expedited processing to self-select urgent cases. We are also amending the Schedule of Fees for Consular Services to reflect this change in the expedited passport processing rule. Regulatory Findings Administrative Procedure Act The Department is publishing this rule as an interim final rule, with a 60-day provision for post-promulgation public comments, based on the “good cause” exceptions set forth at 5 U.S.C. 553(b)(3)(B) and 553(d)(3). Publishing the rule this way will allow the Department to make the rule effective at the earliest opportunity, ensuring that Passport Services may continue to offer this service to the public without interruption and consistent with its regulations. The public benefits from having the service available because it allows persons wishing to obtain a passport for urgent travel or other reasons to have their passport applications processed on an expedited basis. Therefore, allowing a comment period followed by a publication of the final rule with a further 30 days before its effective date is not practicable or in the public interest. Comments received before the end of the comment period will be addressed in a final rule. Regulatory Flexibility Act The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and, by approving it, certifies that this rule is not expected to have a significant economic impact on a substantial number of small entities because only individuals can apply for passports. 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 $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. 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 on the ability of the U.S.-based companies to compete with foreign based companies in domestic and import markets. Executive Order 12866 OMB considers this rule to be a “significant regulatory action” under Executive Order 12866, section 3(f). Accordingly, this rule has been submitted to OMB for review. In addition, the Department is exempt from Executive Order 12866 except to the extent that it is promulgating regulations, in conjunction with a domestic agency, that are significant regulatory actions. The Department has nevertheless reviewed the regulation to ensure its consistency with the regulatory and philosophy and principles set forth in Executive Order 12866. Executive Order 13132 This regulation 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 section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. Paperwork Reduction Act This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. List of Subjects in 22 CFR Parts 22 and 51 Passports and Visas. Accordingly, for the reasons set forth above, Title 22, parts 22 and 51 are amended as follows: PART 22—SCHEDULE OF FEES FOR CONSULAR SERVICES—DEPARTMENT OF STATE AND FOREIGN SERVICES 1. The authority citation for part 22 continues to read as follows: Authority: 8 U.S.C. 1153 note, 1351, 1351 note; 10 U.S.C. 2602(c); 22 U.S.C. 214, 2504(a), 4201, 4206, 4215, 4219; 31 U.S.C. 9701; Pub. L. 105-277, 112 Stat. 2681 *et seq.* ; Pub. L. 108-447, 118 Stat. 2809 *et seq.* ; E.O. 10718, 22 FR 4632, 3 CFR, 1954-1958 Comp., p. 382; E.O. 11295, 31 FR 10603, 3 CFR, 1966-1970 Comp., p. 570. 2. Section 22.1 is amended by revising entry 3 of the table to read as follows: § 22.1 Schedule of Fees. Schedule of Fees for Consular Services Item No. Fee Passport and Citizenship Services * * * * * * * 3. Expedited Service: Passport processing within expedited processing period published on the Department's Web site (22 CFR 51.66(b))/or in-person service at a U.S. Passport Agency (not applicable abroad) $60 * * * * * * * PART 51—PASSPORTS 4. The authority citation for part 51 continues to read as follows: Authority: 22 U.S.C. 211a, 213, 2651a, 2671(d)(3), 2714, and 3926; 31 U.S.C. 9701; E.O. 11295, 3 CFR, 1966-1970 Comp. p. 570; Sec. 236 Pub. L. 106-113, 113 stat. 1501A-430; 18 U.S.C. 1621(a)(2); 42 U.S.C. 652, as amended by Sec. 370 Pub. L. 104-193 and Sec. 7303 Pub. L. 109-171. 5. Section 51.66(b) is revised to read as follows: § 51.66 Expedited passport processing.
(b)Expedited passport processing shall mean completing processing within the number of business days published on the Department's Web site, *http://www.travel.state.gov,* commencing when the application reaches a Passport Agency or, if the application is already with a Passport Agency commencing when the request for expedited processing is approved. The processing will be considered completed when the passport is ready to be picked up by the applicant or is mailed to the applicant. Dated: August 13, 2007. Maura Harty, Assistant Secretary, Consular Affairs, Department of State. [FR Doc. E7-16173 Filed 8-15-07; 8:45 am] BILLING CODE 4710-06-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9335] RIN 1545-BG19 Disclosure Requirements With Respect to Prohibited Tax Shelter Transactions; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. SUMMARY: This document contains correction to temporary regulations (TD 9335) that were published in the **Federal Register** on Friday, July 6, 2007 (72 FR 36869) under section 6033(a)(2) of the Internal Revenue Code that provide rules regarding the form, manner and timing of disclosure obligations with respect to prohibited tax shelter transactions to which tax-exempt entities are parties. DATES: The correction is effective August 16, 2007. FOR FURTHER INFORMATION CONTACT: Galina Kolomietz,
(202)622-6070, or Michael Blumenfeld,
(202)622-1124 (not toll-free numbers). For questions specifically relating to qualified pension plans, individual retirement accounts, and similar tax-favored savings arrangements, contact Dana Barry,
(202)622-6060 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The temporary regulations that are the subject of this correction are under section 6033 of the Internal Revenue Code. Need for Correction As published, temporary regulations (TD 9335) contain an error that may prove to be misleading and is in need of clarification. List of Subject in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.6033-5T is amended by revising paragraph (e)(1)(i) to read as follows: § 1.6033-5T Disclosure by tax-exempt entities that are parties to certain reportable transactions (temporary).
(e)* * *
(1)* * *
(i)*In general.* The disclosure required by this section shall be filed on or before May 15 of the calendar year following the close of the calendar year during which the tax-exempt entity entered into the prohibited tax shelter transaction. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-16073 Filed 8-15-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9335] RIN 1545-BG19 Disclosure Requirements With Respect to Prohibited Tax Shelter Transactions; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to temporary regulations. SUMMARY: This document contains correction to temporary regulations (TD 9335) that were published in the **Federal Register** on Friday, July 6, 2007 (72 FR 36869) under section 6033(a)(2) of the Internal Revenue Code that provide rules regarding the form, manner and timing of disclosure obligations with respect to prohibited tax shelter transactions to which tax-exempt entities are parties. DATES: The correction is effective August 16, 2007. FOR FURTHER INFORMATION CONTACT: Galina Kolomietz,
(202)622-6070, or Michael Blumenfeld,
(202)622-1124 (not toll-free numbers). For questions specifically relating to qualified pension plans, individual retirement accounts, and similar tax-favored savings arrangements, contact Dana Barry,
(202)622-6060 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The temporary regulations that are the subject of this correction are under section 6033 of the Internal Revenue Code. Need for Correction As published, temporary regulations (TD 9335) contain an error that may prove to be misleading and is in need of clarification. Correction of Publication Accordingly, the publication of the temporary regulations (TD 9335), which was the subject of FR Doc. E7-12903, is corrected as follows: On page 36870, column 1, first paragraph of the column, in the preamble, under the paragraph heading “ *Background* ”, last line of the paragraph, the language “4965 tax. See § 601.601(d)(2)(ii)( *b* ).” is corrected to read “4965 tax. See § 601.601(d)(2)(ii)( *b* ) of this chapter.” LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-16081 Filed 8-15-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 301 [TD 9356] RIN 1545-BE43 Disregarded Entities; Employment and Excise Taxes AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. SUMMARY: This document contains final regulations under which qualified subchapter S subsidiaries and single-owner eligible entities that currently are disregarded as entities separate from their owners for Federal tax purposes will be treated as separate entities for employment tax and related reporting requirement purposes. This document also contains final regulations that treat such disregarded entities as separate entities for purposes of certain excise taxes reported on Forms 720, “Quarterly Federal Excise Tax Return;” 730, “Monthly Tax Return for Wagers;” 2290, “Heavy Highway Vehicle Use Tax Return;” and 11-C, “Occupation Tax and Registration Return for Wagering;” excise tax refunds or payments claimed on Form 8849, “Claim for Refund of Excise Taxes;” and excise tax registrations on Form 637, “Application for Registration (For Certain Excise Tax Activities).” These regulations affect disregarded entities and the owners and employees of disregarded entities with respect to the payment and reporting of Federal employment taxes and the reporting of wage payments. These regulations also affect disregarded entities and their owners in the payment and reporting of certain Federal excise taxes and in registration and claims related to certain Federal excise taxes. DATES: *Effective Date:* These regulations are effective on August 16, 2007. *Applicability Dates:* With respect to employment taxes, these regulations apply to wages paid on or after January 1, 2009. With respect to excise taxes, these regulations apply to liabilities imposed and actions first required or permitted in periods beginning on or after January 1, 2008. FOR FURTHER INFORMATION CONTACT: John Richards at
(202)622-6040 (on the employment tax provisions) or Susan Athy at
(202)622-3130 (on the excise tax provisions) (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background This document contains amendments to 26 CFR parts 1 and 301. On October 18, 2005, a notice of proposed rulemaking (REG-114371-05) was published in the **Federal Register** (70 FR 60475) proposing to treat qualified subchapter S subsidiaries (QSubs) (under section 1361(b)(3)(B) of the Internal Revenue Code (Code)) and certain other single-owner eligible entities (under §§ 301.7701-1 through 301.7701-3 of the Procedure and Administrative Regulations) that currently are disregarded as entities separate from their owners (disregarded entities) as separate entities for purposes of employment tax and related reporting requirements and for purposes of certain excise taxes reported on Forms 720, 730, 2290, and 11-C; excise tax refunds or payments claimed on Form 8849; and excise tax registrations on Form 637. Comments addressing employment taxes were received from the public in response to the notice of proposed rulemaking. No comments were received regarding the excise tax provisions of the proposed regulations. No public hearing was requested or held. After consideration of all the comments, the proposed regulations are adopted as revised by this Treasury decision. Summary of Comments and Changes Made As provided in the proposed regulations, the final regulations provide that a disregarded entity is treated as a separate entity for purposes of employment taxes and related reporting requirements. The final regulations clarify that the separate entity is treated as a corporation for purposes of employment taxes and related reporting requirements. As provided in the proposed regulations, a disregarded entity continues to be disregarded for other Federal tax purposes. The final regulations clarify that an owner of a disregarded entity treated as a sole proprietorship is subject to taxes under the Self-Employment Contributions Act
(SECA)(section 1401 et seq.). Additionally, the final regulations retain the example illustrating that an individual owner of a disregarded entity continues to be treated as self-employed for purposes of SECA taxes, and not as an employee of a disregarded entity for employment tax purposes. Commentators suggested that the proposed regulations not be finalized, and that Notice 99-6 (1999-1 CB 321) be retained. Notice 99-6 provides that employment taxes and other employment tax obligations with respect to employees of a disregarded entity may be satisfied in one of two ways:
(1)Calculation, reporting, and payment of all employment tax obligations with respect to employees of the disregarded entity by its owner (as though the employees of the disregarded entity are employed directly by the owner) and under the owner's name and taxpayer identification number; or
(2)separate calculation, reporting, and payment of all employment tax obligations by each state law entity with respect to its employees under its own name and taxpayer identification number. Commentators stated that the regulations would increase administrative burden for taxpayers that currently choose to pay and report employment taxes at the owner level as permitted by Notice 99-6. Commentators also suggested that if the regulations were finalized, complications could arise for states where state employment tax filings are required at the owner level. No written comments were received from any state. The IRS and the Treasury Department continue to believe that recognizing disregarded entities as employers for Federal employment taxes will improve administration of the Federal tax laws and simplify Federal tax compliance with respect to reporting, payment, and collection of employment taxes. In addition, because most states recognize disregarded entities as employers for reporting, payment, and collection of state employment taxes, these regulations will more closely align Federal and state reporting, payment and collection of employment taxes. Accordingly, this comment is not adopted. One commentator requested clarification of the applicability of section 3306(c)(8) to services performed for a disregarded entity that is owned by an organization described in section 501(c)(3). Section 3306(c)(8) provides that services performed for an organization described in section 501(c)(3) are excepted from the definition of employment for Federal Unemployment Tax Act
(FUTA)purposes. Even though a disregarded entity owned by a section 501(c)(3) organization will be regarded for employment tax purposes, the disregarded entity will continue to be considered an unincorporated branch or division of the section 501(c)(3) organization for other Federal tax purposes. For example, the disregarded entity will be considered an unincorporated branch or division of the section 501(c)(3) organization for purposes of the organization's annual information reporting requirements under section 6033. See Announcement 99-102 (1999-2 CB 545). Because section 3306(c)(8) looks to the employer's status for income tax purposes to establish the basis for exemption from FUTA, a disregarded entity owned solely by a section 501(c)(3) organization is considered exempt from tax under section 501(c)(3) for purposes of section 3306(c)(8). Thus, a disregarded entity owned solely by a section 501(c)(3) organization will not be subject to FUTA tax on wages it pays its employees. One commentator requested clarification of the applicability of the backup withholding provisions under section 3406 to disregarded entities. Section 3406 requires the payor of certain “reportable payments” to withhold from such payments a tax at the rate of 28 percent. For instance, if the payee where required to do so does not provide a valid taxpayer identification number
(TIN)to the payor, the payor must backup withhold on reportable payments to the payee. Reportable payments are payments that must be reported to a payee on Form 1099, “U.S. Information Return for Calendar Year 1971,” such as certain payments for services made in the course of a trade or business. Wage payments are not reportable payments however, and are not subject to backup withholding under section 3406. These regulations do not apply to reportable payments under section 3406. Because the owner of a disregarded entity other than a QSub is required to file and furnish information returns with respect to non-wage reportable payments and that requirement is not affected by these regulations, the disregarded entity is not subject to the backup withholding requirements. Rather, the owner of the disregarded entity is responsible for any backup withholding that is required with respect to reportable payments considered made by the owner. Under section 1361(b)(3)(E) disregarded entities that are QSubs are subject to information reporting requirements on non-wage payments, unless the Secretary provides otherwise. These regulations do not address the information reporting for QSubs. Availability of IRS Documents The IRS notice and announcement cited in this preamble are published in the Internal Revenue Bulletin or Cumulative Bulletin and are available at *http://www.irs.gov* . Effective Date The employment tax provisions of these regulations apply to wages paid on or after January 1, 2009. The notice of proposed rulemaking provided that these regulations would become effective with respect to wages paid on January 1 following the year of publication of these final regulations in the **Federal Register** , which would have been January 1, 2008. However, in order to ensure that taxpayers have sufficient time to make any necessary changes to their systems in response to these regulations, the IRS and the Treasury Department have determined that it is appropriate to delay the effective date of these regulations until January 1, 2009. The IRS and the Treasury Department believe that the considerations that support a January 1, 2009, effective date for the employment tax provisions do not apply to the excise tax provisions. Thus, the excise tax provisions of these regulations apply to liabilities imposed and actions required or permitted in periods beginning on or after January 1, 2008. For periods beginning before that date, the IRS will treat payments made by a disregarded entity, or other actions taken by a disregarded entity, with respect to the excise taxes affected by these regulations as having been made or taken by the sole owner of that entity. Thus, for such periods, the owner of a disregarded entity will be treated as satisfying the owner's obligations with respect to the excise taxes affected by these regulations, provided that those obligations are satisfied either
(1)By the owner itself or
(2)by the disregarded entity on behalf of the owner. Effect on Other Documents Disregarded entities, and the owners of such entities may continue to use the procedures permitted by Notice 99-6 for wages paid prior to January 1, 2009. Notice 99-6 provides that if the owner calculates and pays all employment taxes and satisfies all other employment tax obligations with respect to employees of the disregarded entity under the owner's name and taxpayer identification number (as permitted under method
(1)of Notice 99-6) for a return period that begins on or after April 20, 1999, then the owner must continue to use this method unless and until otherwise permitted by the Commissioner. However, Notice 99-6 is modified such that a taxpayer may switch to method
(2)of Notice 99-6 with respect to wages paid on or after August 16, 2007 and before January 1, 2009, without seeking permission of the Commissioner. Taxpayers who switch from method
(1)to method
(2)with respect to wages paid prior to January 1, 2009, may consider wages paid by the owner to employees of the disregarded entity during the calendar year of the switch as having been paid by the disregarded entity for purposes of determining whether wages paid to the disregarded entity's employees have reached the contribution and benefit base as determined under section 230 of the Social Security Act and for purposes of the wage base under section 3306. However, as provided in Notice 99-6, regardless of whether the owner uses method
(1)or method (2), the owner is ultimately responsible for employment tax liabilities and other employment tax responsibilities with respect to all wages paid prior to January 1, 2009, to employees of the disregarded entity. Notice 99-6 is obsoleted as of January 1, 2009. 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 also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the proposed regulations preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business. Drafting Information The principal authors of these regulations are Susan Athy, Office of Associate Chief Counsel (Passthroughs and Special Industries), and John Richards, Office of Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development. List of Subjects 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. 26 CFR Part 301 Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements. Adoption of Amendments to the Regulations Accordingly, 26 CFR parts 1 and 301 are amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.34-1 is revised to read as follows: § 1.34-1 Special rule for owners of certain business entities. Amounts payable under sections 6420, 6421, and 6427 to a business entity that is treated as separate from its owner under § 1.1361-4(a)(8) (relating to certain qualified subchapter S subsidiaries) or § 301.7701-2(c)(2)(v) of this chapter (relating to certain wholly-owned entities) are, for purposes of section 34, treated as payable to the owner of that entity. §§ 1.34-2, 1.34-3, 1.34-4, 1.34-5, and 1.34-6 [Removed] **Par. 3.** Sections 1.34-2, 1.34-3, 1.34-4, 1.34-5, and 1.34-6 are removed. **Par. 4.** Section 1.1361-4 is amended as follows: 1. In paragraph (a)(1) introductory text, the language “Except as otherwise provided in paragraphs (a)(3) and (a)(6)” is removed, and the language “Except as otherwise provided in paragraphs (a)(3), (a)(6), (a)(7), and (a)(8)” is added in its place. 2. Paragraphs (a)(7) and (a)(8) are added. The additions read as follows: § 1.1361-4 Effect of QSub election.
(a)* * *
(7)*Treatment of QSubs for purposes of employment taxes—*
(i)*In general.* A QSub is treated as a separate corporation for purposes of Subtitle C—Employment Taxes and Collection of Income Tax (Chapters 21, 22, 23, 23A, 24, and 25 of the Internal Revenue Code).
(ii)*Effective/applicability date.* This paragraph (a)(7) applies with respect to wages paid on or after January 1, 2009.
(8)*Treatment of QSubs for purposes of certain excise taxes—*
(i)*In general.* A QSub is treated as a separate corporation for purposes of—
(A)Federal tax liabilities imposed by Chapters 31, 32 (other than section 4181), 33, 34, 35, 36 (other than section 4461), and 38 of the Internal Revenue Code, or any floor stocks tax imposed on articles subject to any of these taxes;
(B)Collection of tax imposed by Chapter 33 of the Internal Revenue Code;
(C)Registration under sections 4101, 4222, and 4412; and
(D)Claims of a credit (other than a credit under section 34), refund, or payment related to a tax described in paragraph (a)(8)(i)(A) of this section or under section 6426 or 6427.
(ii)*Effective/applicability date.* This paragraph (a)(8) applies to liabilities imposed and actions first required or permitted in periods beginning on or after January 1, 2008. § 1.1361-6 [Amended] **Par 5.** Section 1.1361-6 is amended by removing the language “Except as provided in §§ 1.1361-4(a)(3)(iii), 1.1361-4(a)(5)(i), and 1.1361-5(c)(2)” and by adding the language “Except as provided in §§ 1.1361-4(a)(3)(iii), 1.1361-4(a)(5)(i), 1.1361-4(a)(6)(iii), 1.1361-4(a)(7)(ii), 1.1361-4(a)(8)(ii), and 1.1361-5(c)(2)” in its place. PART 301—PROCEDURE AND ADMINISTRATION **Par. 6.** The authority citation for part 301 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 7.** Section 301.7701-2 is amended as follows: 1. A sentence is added at the end of paragraph (a). 2. Paragraph (c)(2)(i) is revised. 3. Paragraphs (c)(2)(iv), (c)(2)(v), (e)(5), and (e)(6) are added. The additions read as follows: § 301.7701-2 Business entities; definitions.
(a)* * * But see paragraphs (c)(2)(iv) and
(v)of this section for special employment and excise tax rules that apply to an eligible entity that is otherwise disregarded as an entity separate from its owner.
(c)* * *
(2)*Wholly owned entities—*
(i)*In general.* Except as otherwise provided in this paragraph (c), a business entity that has a single owner and is not a corporation under paragraph
(b)of this section is disregarded as an entity separate from its owner.
(iv)*Special rule for employment tax purposes* —(A) *In general.* Paragraph (c)(2)(i) of this section (relating to certain wholly owned entities) does not apply to taxes imposed under Subtitle C—Employment Taxes and Collection of Income Tax (Chapters 21, 22, 23, 23A, 24, and 25 of the Internal Revenue Code). Paragraph (c)(2)(i) of this section does apply to taxes imposed under Subtitle A, including Chapter 2—Tax on Self-Employment Income. The owner of an entity that is treated in the same manner as a sole proprietorship under paragraph
(a)of this section will be subject to the tax on self-employment income.
(B)*Treatment of entity.* An entity that is otherwise disregarded as an entity separate from its owner but for paragraph (c)(2)(iv)(A) of this section is treated as a corporation with respect to taxes imposed under Subtitle C—Employment Taxes and Collection of Income Tax (Chapters 21, 22, 23, 23A, 24, and 25 of the Internal Revenue Code).
(C)*Example.* The following example illustrates the application of paragraph (c)(2)(iv) of this section: Example.
(i)LLCA is an eligible entity owned by individual A and is generally disregarded as an entity separate from its owner for Federal tax purposes. However, LLCA is treated as an entity separate from its owner for purposes of subtitle C of the Internal Revenue Code. LLCA has employees and pays wages as defined in sections 3121(a), 3306(b), and 3401(a).
(ii)LLCA is subject to the provisions of subtitle C of the Internal Revenue Code and related provisions under 26 CFR subchapter C, Employment Taxes and Collection of Income Tax at Source, parts 31 through 39. Accordingly, LLCA is required to perform such acts as are required of an employer under those provisions of the Internal Revenue Code and regulations thereunder that apply. All provisions of law (including penalties) and the regulations prescribed in pursuance of law applicable to employers in respect of such acts are applicable to LLCA. Thus, for example, LLCA is liable for income tax withholding, Federal Insurance Contributions Act
(FICA)taxes, and Federal Unemployment Tax Act
(FUTA)taxes. See sections 3402 and 3403 (relating to income tax withholding); 3102(b) and 3111 (relating to FICA taxes), and 3301 (relating to FUTA taxes). In addition, LLCA must file under its name and EIN the applicable Forms in the 94X series, for example, Form 941, “Employer's Quarterly Employment Tax Return,” Form 940, “Employer's Annual Federal Unemployment Tax Return;” file with the Social Security Administration and furnish to LLCA's employees statements on Forms W-2, “Wage and Tax Statement;” and make timely employment tax deposits. See §§ 31.6011(a)-1, 31.6011(a)-3, 31.6051-1, 31.6051-2, and 31.6302-1 of this chapter.
(iii)A is self-employed for purposes of subtitle A, chapter 2, Tax on Self-Employment Income, of the Internal Revenue Code. Thus, A is subject to tax under section 1401 on A's net earnings from self-employment with respect to LLCA's activities. A is not an employee of LLCA for purposes of subtitle C of the Internal Revenue Code. Because LLCA is treated as a sole proprietorship of A for income tax purposes, A is entitled to deduct trade or business expenses paid or incurred with respect to activities carried on through LLCA, including the employer's share of employment taxes imposed under sections 3111 and 3301, on A's Form 1040, Schedule C, “Profit or Loss for Business (Sole Proprietorship).”
(v)*Special rule for certain excise tax purposes—*
(A)*In general.* Paragraph (c)(2)(i) of this section (relating to certain wholly owned entities) does not apply for purposes of— ( *1* ) Federal tax liabilities imposed by Chapters 31, 32 (other than section 4181), 33, 34, 35, 36 (other than section 4461), and 38 of the Internal Revenue Code, or any floor stocks tax imposed on articles subject to any of these taxes; ( *2* ) Collection of tax imposed by Chapter 33 of the Internal Revenue Code; ( *3* ) Registration under sections 4101, 4222, and 4412; and ( *4* ) Claims of a credit (other than a credit under section 34), refund, or payment related to a tax described in paragraph (c)(2)(v)(A)( *1* ) of this section or under section 6426 or 6427.
(B)*Example.* The following example illustrates the provisions of this paragraph (c)(2)(v): Example.
(i)LLCB is an eligible entity that has a single owner, B. LLCB is generally disregarded as an entity separate from its owner. However, under paragraph (c)(2)(v) of this section, LLCB is treated as an entity separate from its owner for certain purposes relating to excise taxes.
(ii)LLCB mines coal from a coal mine located in the United States. Section 4121 of chapter 32 of the Internal Revenue Code imposes a tax on the producer's sale of such coal. Section 48.4121-1(a) of this chapter defines a “producer” generally as the person in whom is vested ownership of the coal under state law immediately after the coal is severed from the ground. LLCB is the person that owns the coal under state law immediately after it is severed from the ground. Under paragraph (c)(2)(v)(A)( *1* ) of this section, LLCB is the producer of the coal and is liable for tax on its sale of such coal under chapter 32 of the Internal Revenue Code. LLCB must report and pay tax on Form 720, “Quarterly Federal Excise Tax Return,” under its own name and taxpayer identification number.
(iii)LLCB uses undyed diesel fuel in an earthmover that is not registered or required to be registered for highway use. Such use is an off-highway business use of the fuel. Under section 6427(l), the ultimate purchaser is allowed to claim an income tax credit or payment related to the tax imposed on diesel fuel used in an off-highway business use. Under paragraph (c)(2)(v) of this section, for purposes of the credit or payment allowed under section 6427(l), LLCB is the person that could claim the amount on its Form 720 or on a Form 8849, “Claim for Refund of Excise Taxes.” Alternatively, if LLCB did not claim a payment during the time prescribed in section 6427(i)(2) for making a claim under section 6427, § 1.34-1 of this chapter provides that B, the owner of LLCB, could claim the income tax credit allowed under section 34 for the nontaxable use of diesel fuel by LLCB.
(e)* * *
(5)Paragraph (c)(2)(iv) of this section applies with respect to wages paid on or after January 1, 2009.
(6)Paragraph (c)(2)(v) of this section applies to liabilities imposed and actions first required or permitted in periods beginning on or after January 1, 2008. Kevin M. Brown, Deputy Commissioner for Services and Enforcement. Approved: July 25, 2007. Eric Solomon, Assistant Secretary of the Treasury (Tax Policy). [FR Doc. E7-16078 Filed 8-15-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 53 and 54 [TD 9334] RIN 1545-BG20 Requirement of Return and Time for Filing; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendments. SUMMARY: This document contains corrections to final and temporary regulations (TD 9334) that were published in the **Federal Register** on Friday, July 6, 2007 (72 FR 36871) providing guidance relating to the requirement of a return to accompany payment of excise taxes under section 4965 of the Internal Revenue Code and the time for filing that return. DATES: The corrections are effective August 16, 2007. FOR FURTHER INFORMATION CONTACT: Galina Kolomietz,
(202)622-6070, Michael Blumenfeld,
(202)622-1124, or Dana Barry,
(202)622-6060 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background The final and temporary regulations that are the subject of this correction are under section 4965 of the Internal Revenue Code. Need for Correction As published, final and temporary regulations (TD 9334) contain errors that may prove to be misleading and are in need of clarification. List of Subjects 26 CFR Part 53 Excise taxes, Foundations, Investments, Lobbying, Reporting and recordkeeping requirements. 26 CFR Part 54 Excise Taxes, Pensions, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR parts 53 and 54 are corrected by making the following correcting amendments: PART 53—FOUNDATION AND SIMILAR EXCISE TAXES **Paragraph 1.** The authority citation for part 53 continues to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 53.6071-1T is amended by revising paragraph (h)(2) to read as follows: § 53.6071-1T Time for filing returns (temporary).
(h)* * *
(2)*Expiration date.* Paragraph
(g)of this section will expire on July 6, 2010. PART 54—PENSION EXCISE TAXES **Par. 3.** The authority citation for part 54 continues to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 4.** Section 54.6011-1T is amended by revising paragraph (d)(2) to read as follows: § 54.6011-1T General requirement of return, statement or list (temporary).
(d)* * *
(2)*Expiration date.* Paragraph
(c)of this section will expire on July 6, 2010. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-16075 Filed 8-15-07; 8:45 am] BILLING CODE 4830-01-P OFFICE OF THE DIRECTOR OF NATIONAL INTELLIGENCE 32 CFR Chapter XVII Freedom of Information Act Regulation AGENCY: Office of the Director of National Intelligence. ACTION: Final rule. SUMMARY: This final regulation provides the Office of the Director of National Intelligence's rules implementing the Freedom of Information Act (FOIA), 5 U.S.C. 552. The regulation addresses all aspects of FOIA processing, including how and where to submit FOIA requests, fees for record services, procedures for handling business information, requests for expedited processing, and the right to appeal denials of information. EFFECTIVE DATE: August 16, 2007. FOR FURTHER INFORMATION CONTACT: Mr. John F. Hackett,
(703)482-1707. SUPPLEMENTARY INFORMATION: The Office of the Director of National Intelligence
(ODNI)was created by the Intelligence Reform and Terrorism Prevention Act of 2004, Pub. L. 108-458, 118 Stat. 3638. The ODNI began operations on April 22, 2005, the day after the first Director of National Intelligence took office. Because the majority of documents held by the ODNI at its inception were previously maintained by the Central Intelligence Agency
(CIA)and the ODNI did not have a FOIA staff upon stand-up, the CIA agreed to handle the administrative aspects of the ODNI's FOIA processing. Through this arrangement, the ODNI makes all legal decisions regarding the handling of FOIA requests for ODNI records and the CIA assists with the administrative tasks associated with processing FOIA requests, including the intake and tracking of requests, as well as drafting correspondence to requesters. We are currently working toward having our own FOIA office handle all aspects of ODNI's FOIA processing. On June 4, 2007, the ODNI submitted a proposed regulation implementing the FOIA for public comment. The ODNI received two submissions with comments on the proposed regulation. The ODNI has reviewed and carefully considered all of the comments that were submitted and has made the following changes to the regulation:
(1)The definitions of educational institution and noncommercial scientific institution have been changed and are in accordance with the definition in the Office of Management and Budget's guidelines, 52 Fed. Reg. 10,012 (Mar. 27, 1987).
(2)We have changed the fee portion of the regulation so that a FOIA request will be considered a commitment to pay up to $25.00 unless the requester asks for a waiver of fees.
(3)The term “reasonably described record” has been removed from the definitional section of the regulation. A more detailed explanation of the type of information the ODNI needs in order to locate records responsive to a particular request has been added in a separate section.
(4)We have decided to accept FOIA requests electronically and have added the email address to the regulation. Although the FOIA does not require this, it is a growing trend within the federal government and we believe it will provide better customer service to our FOIA requesters.
(5)The expedited processing section and other sections have been clarified.
(6)Certain superfluous words in the definitional section and a paragraph regarding allocation of resources have been removed. List of Subjects in 32 CFR Part 1700 Freedom of information. Therefore, as discussed in the preamble, and under the authority of the Intelligence Reform and Terrorism Prevention Act of 2004, Pub. L. 108-458, 118 Stat. 3638, the Office of the Director of National Intelligence establishes 32 CFR Chapter XVII and adds part 1700 to read as follows: Chapter XVII—Office of the Director of National Intelligence PART 1700—PROCEDURES FOR DISCLOSURE OF RECORDS PURSUANT TO THE FREEDOM OF INFORMATION ACT Sec. 1700.1 Authority and purpose. 1700.2 Definitions. 1700.3 Contact for general information and requests. 1700.4 Preliminary information. 1700.5 Requirements as to form and content. 1700.6 Fees for records services. 1700.7 Processing of requests for records. 1700.8 Action on the request. 1700.9 Payment of fees, notification of decision, and right of appeal. 1700.10 Procedures for business information. 1700.11 Procedures for information concerning other persons. 1700.12 Requests for expedited processing. 1700.13 Right to appeal and appeal procedures. 1700.14 Action by appeals authority. Authority: 5 U.S.C. 552, 50 U.S.C. 401-442; Pub. L. 108-458, 118 Stat. 3638. § 1700.1 Authority and purpose.
(a)*Authority.* This Part is issued under the authority of and in order to implement the Freedom of Information Act, as amended, 5 U.S.C. 552; the National Security Act of 1947, as amended, 50 U.S.C. 401-442; and the Intelligence Reform and Terrorism Prevention Act of 2004, Pub. L. 108-458, 118 Stat. 3638.
(b)*Purpose in general.* This Part prescribes procedures for:
(1)ODNI administration of the FOIA;
(2)Requesting records pursuant to the FOIA; and
(3)Filing an administrative appeal of an initial adverse decision under the FOIA. § 1700.2 Definitions. For purposes of this Part, the following terms have the meanings indicated:
(a)*Days* means calendar days when ODNI is operating and specifically excludes Saturdays, Sundays, and legal public holidays;
(b)*Direct costs* means those expenditures which ODNI actually incurs in the processing of a FOIA request; it does not include overhead factors such as space;
(c)*Pages* means paper copies of standard office size or the dollar value equivalent in other media;
(d)*Reproduction* means generation of a copy of a requested record in a form appropriate for release;
(e)*Review* means all time expended in examining a record to determine whether any portion must be withheld pursuant to law and in effecting any required deletions but excludes personnel hours expended in resolving general legal or policy issues; it also means personnel hours of professional time;
(f)*Search* means all time expended in looking for and retrieving material that may be responsive to a request utilizing available paper and electronic indices and finding aids; it also means personnel hours of professional time or the dollar value equivalent in computer searches;
(g)*Expression of interest* means a written or electronic communication submitted by any person requesting information on or concerning the FOIA program, the availability of documents from ODNI, or both;
(h)*Fees* means those direct costs which may be assessed a requester considering the categories established by the FOIA; requesters should submit information to assist the ODNI in determining the proper fee category and the ODNI may draw reasonable inferences from the identity and activities of the requester in making such determinations; the fee categories include:
(1)*Commercial use request:* A request in which the disclosure sought is primarily in the commercial interest of the requester and which furthers such commercial, trade, income or profit interests;
(2)*Educational institution:* A preschool, a public or private elementary or secondary school, an institution of undergraduate higher education, an institution of graduate higher education, an institution of professional education, or an institution of vocational education, that operates a program of scholarly research. To be in this category, a requester must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are not sought for a commercial use but are sought to further scholarly research.
(3)*Noncommercial scientific institution:* An institution that is not operated on a commercial basis, as that term is defined in paragraph (h)(1) of this section, and that is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any particular product or industry. To be in this category, a requester must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are not sought for a commercial use but are sought to further scientific research.
(4)*Representative of the news media:* An individual actively gathering news for an entity that is organized and operated to publish and broadcast news to the public and pursuant to the entity's news dissemination function and not its commercial interests; the term “news” means information which concerns current events, would be of current interest to the general public, would enhance the public understanding of the operations or activities of the U.S. Government, and is in fact disseminated to a significant element of the public at minimal cost; freelance journalists are included in this definition if they provide sufficient evidence to justify an expectation of publication through such an organization, even though not actually employed by it; a publication contract or prior publication record is relevant to such status;
(5)*All other:* A request from an individual not within paragraphs (h)(1), (2), (3), or
(4)of this section;
(i)*Freedom of Information Act* , “FOIA,” or “the Act” means the statute as codified at 5 U.S.C. 552;
(j)*ODNI* means the Office of the Director of National Intelligence and its component organizations. It does not include other members of the Intelligence Community as defined in 50 U.S.C. 401a, or other federal entities subsequently designated in accordance with this authority, unless specifically designated as included in this Part or in the notice of a system of records;
(k)*Potential requester* means a person, organization, or other entity who submits an expression of interest. § 1700.3 Contact for general information and requests. For general information on this Part, to inquire about the FOIA program at ODNI, or to file a FOIA request (or expression of interest), please direct communication in writing to the Office of the Director of National Intelligence, Chief FOIA Officer c/o Director, Information Management Office, Washington, DC 20511 by mail or by facsimile at
(703)482-2144. FOIA requests can also be submitted by electronic mail to *FOIA @ dni.gov* . For general information or status information on pending cases only, call the ODNI FOIA Customer Service Center at
(571)204-4774. § 1700.4 Preliminary information. Members of the public shall address all communications to the point of contact specified in § 1700.3 and clearly delineate the communication as a request under the FOIA. ODNI staff who receive a FOIA request shall expeditiously forward the request to the Director, Information Management Office (IMO). Requests and appeals (as well as referrals and consultations) received from FOIA requesters who owe outstanding fees for information services at this or other federal agencies will not be accepted and action on all pending requests shall be terminated in such circumstances. § 1700.5 Requirements as to form and content.
(a)*Required information* . No particular form is required. A request must reasonably describe the record or records being sought and be submitted in accordance with this regulation. Documents must be described sufficiently to enable a staff member familiar with the subject to locate the documents with a reasonable amount of effort. Whenever possible, your request should include specific information about each record sought, such as the date, title or name, author, recipient, and the subject matter of the record. As a general rule, the more specific you are about the records or type of records that you want, the more likely it will be that the IMO will be able to locate records responsive to your request. The IMO will provide you an opportunity to discuss your request with it so that you may modify your request to meet the requirements of this section. If after having been asked to do so you do not provide the IMO with information sufficient to enable it to locate responsive records your request will be closed.
(b)*Additional information for fee determination* . A requester must provide sufficient personally identifying information to allow staff to determine the appropriate fee category and to contact the requester easily. § 1700.6 Fees for records services.
(a)*In general.* Search, review, and reproduction fees will be charged in accordance with the provisions below relating to schedule, limitations, and category of requester. Applicable fees will be due even if a subsequent search locates no responsive records or some or all of the responsive records must be denied under one or more of the exemptions of the FOIA.
(b)*Fee waiver requests* . Records will be furnished without charge or at a reduced rate when ODNI determines:
(1)As a matter of administrative discretion, the interest of the United States Government would be served, *or*
(2)It is in the public interest to provide responsive records because the disclosure is likely to contribute *significantly* to the public understanding of the operations or activities of the United States Government and is not primarily in the commercial interest of the requester.
(c)*Fee waiver appeals.* Denials of requests for fee waivers or reductions may be appealed to the Director of the Intelligence Staff, or his functional equivalent, through the ODNI Chief FOIA Officer. A requester is encouraged to provide any explanation or argument as to how his or her request satisfies the requirements of this regulation and the Act. See § 1700.14 for further details on appeals.
(d)*Time for fee waiver requests and appeals.* Appeals should be resolved prior to the initiation of processing and the incurring of costs. However, fee waiver requests will be accepted at any time prior to an agency decision regarding the request, except when processing has been initiated, in which case the requester must agree to be responsible for costs in the event of an adverse administrative or judicial decision.
(e)*Agreement to pay fees.* If you make a FOIA request, it shall be considered a firm commitment by you to pay all applicable fees chargeable under this regulation, up to and including the amount of $25.00, unless you ask for a waiver of fees. When making a request, you may specify a willingness to pay a greater or lesser amount.
(f)*Advance payment.* The ODNI may require an advance payment of up to 100 percent of the estimated fees when projected fees exceed $250.00, not including charges associated with the first 100 pages of production and two hours of search (when applicable), or when the requester previously failed to pay fees in a timely fashion, for fees of any amount. ODNI will hold in abeyance for 45 days those requests where advance payment has been requested.
(g)*Schedule of fees.* —(1) *In general.* The schedule of fees for services performed in responding to requests for records is as follows: Personnel Search and Review Clerical/Technical Quarter hour $5.00 Professional/Supervisory Quarter hour 10.00 Manager/Senior Professional Quarter hour 18.00 Computer Search and Production Search (on-line) Flat rate 10.00 Search (off-line) Flat rate 30.00 Other activity Per minute 10.00 Tapes (mainframe cassette) Each 9.00 Tapes (mainframe cartridge) Each 9.00 Tapes (mainframe reel) Each 20.00 Tapes (PC 9mm) Each 25.00 Diskette (3.5″) Each 4.00 CD (bulk recorded) Each 10.00 CD (recordable) Each 20.00 Telecommunications Per minute .50 Paper (mainframe printer) Per page .10 Paper (PC b&w laser printer) Per page .10 Paper (PC color printer) Per page 1.00 Paper Production Photocopy (standard or legal) Per page .10 Microfiche Per frame .20 Pre-printed (if available) Per 100 pages 5.00 Published (if available) Per item NTIS
(2)*Application of schedule.* Personnel search time includes time expended in manual paper records searches, indices searches, review of computer search results for relevance, and personal computer system searches. In any event where the actual cost to ODNI of a particular item is less than the above schedule (e.g., a large production run of a document resulting in a cost less than $5.00 per hundred pages), then the actual lesser cost will be charged.
(3)*Other services.* For all other types of output, production, or reproduction (e.g., photographs, maps, or published reports), ODNI will charge actual cost or amounts authorized by statute. Determinations of actual cost shall include the commercial cost of the media, the personnel time expended in making the item to be released, and an allocated cost of the equipment used in making the item, or, if the production is effected by a commercial service, then that charge shall be deemed the actual cost for purposes of this regulation.
(h)*Limitations on collection of fees* —(1) *In general.* No fees will be charged if the cost of collecting the fee is equal to or greater than the fee itself. That cost includes the administrative costs to ODNI of billing, receiving, recording, and processing the fee for deposit to the Treasury Department and, as of the date of these regulations, is deemed to be $10.00.
(i)*Fee categories.* There are four categories of FOIA requesters for fee purposes: Commercial use requesters, educational and non-commercial scientific institution requesters, representatives of the news media requesters, and all other requesters. The categories are defined in § 1700.2 and applicable fees will be assessed as follows:
(1)Commercial use requesters: Charges which recover the full direct costs of searching for, reviewing, and duplicating responsive records (if any);
(2)Educational and non-commercial scientific institution requesters, and representatives of the news media requesters: Only charges for reproduction beyond the first 100 pages;
(3)All other requesters: Charges which recover the full direct cost of searching for and reproducing responsive records (if any) beyond the first 100 pages of reproduction and the first two hours of search time which will be furnished without charge.
(j)*Associated requests.* If it appears a requester or a group of requesters acting in concert have requested portions of an apparently unitary request for the purpose of avoiding the assessment of fees, ODNI may aggregate any such requests and charge accordingly. Requests from multiple requesters will not be aggregated without clear evidence. ODNI will not aggregate multiple unrelated requests. § 1700.7 Processing of requests for records.
(a)*In general.* Requests meeting the requirements of § 1700.3 through § 1700.6 shall be accepted as formal requests and processed under the FOIA and this Part. A request will not be considered received until it reaches the IMO. Ordinarily upon its receipt a request will be date-stamped as received. It is this date that establishes when your request is received for administrative purposes, not any earlier date such as the date of the letter or its postmark date. For the quickest possible handling, both the request letter and the envelope should be marked “Freedom of Information Act Request.”
(b)*Electronic Reading Room.* ODNI maintains an online FOIA Reading Room on the ODNI Web site which contains the information that the FOIA requires be routinely made available for public inspection and copying as well as other information determined to be of general public interest.
(c)*Confirming the existence of certain documents.* In processing a request, ODNI shall decline to confirm or deny the existence of responsive records whenever the fact of their existence or nonexistence is itself classified under Executive Order 12,958 and its amending orders, reveals intelligence sources and methods protected pursuant to 50 U.S.C. 403-1(i)(1), or would be an invasion of the personal privacy of third parties. In such circumstances, ODNI, in its final written response, shall so inform the requester and advise of his or her right to file an administrative appeal.
(d)*Time for response.* Whenever the statutory time limits for processing a request cannot be met because of “unusual circumstances,” as defined in the FOIA, and the component determines to extend the time limits on that basis, ODNI will inform the requester in writing and advise the requester of the right to narrow the scope of his or her request or agree to an alternative timeframe for processing.
(e)*Multitrack processing.* ODNI may use two or more processing tracks by distinguishing between simple and more complex requests based on the amount of work and/or time needed to process the request, including through limits based on the number of pages involved. ODNI may provide requesters in its slower track with an opportunity to limit the scope of their requests in order to qualify for faster processing within the specified limits of its faster track. § 1700.8 Action on the request.
(a)*Initial action for access.* ODNI staff identified to search for records pursuant to a FOIA request shall search all relevant record systems within their cognizance as of the date the search is commenced. A staff member tasked to conduct a search shall:
(1)Determine whether records exist;
(2)Determine whether and to what extent any FOIA exemptions apply;
(3)Make recommendations for withholding records or portions of records that originated in the staff member's organization and for which there is a legal basis for denial or make a recommendation in accordance with § 1700.7(c). In making recommendations, ODNI staff shall be guided by the procedures specified in § 1700.10 regarding confidential commercial information and § 1700.11 regarding third party information; and
(4)Forward to the Director, IMO, all records responsive to the request.
(b)*Referrals and consultations.* ODNI records containing information originated by other ODNI components shall be forwarded to those entities for action in accordance with paragraph
(a)of this section and returned. Records originated by other federal agencies or ODNI records containing other federal agency information shall be forwarded to such agencies for processing and direct response to the requester or for consultation and return to the ODNI. ODNI will notify the requester if it makes a referral for direct response.
(c)*Release of information.* When the Director, IMO (or Appeals Authority) makes a final determination to release records, the records will be forwarded to the requester in an appropriate format promptly upon compliance with any preliminary procedural requirements, including payment of fees. If any portion of a record is withheld initially or upon appeal, the Director, IMO (or Appeals Authority) will provide a written response that shall include, at a minimum:
(1)The basis for the withholding, citing the specific statutory exemption or exemptions invoked under the FOIA with respect to each portion withheld, unless documents are withheld in accordance with § 1700.7(c);
(2)When the withholding is based in whole or in part on a security classification, the explanation shall include a determination that the record meets the cited criteria and rationale of the governing Executive Order;
(3)When the denial is based on 5 U.S.C. 552(b)(3), the statute relied upon; and
(4)Notice to the requester of the right to judicial review. § 1700.9 Payment of fees, notification of decision, and right of appeal.
(a)*Fees in general.* Fees collected under this part do not accrue to ODNI and shall be deposited immediately to the general account of the United States Treasury.
(b)*Notification of decision.* Upon completion of all required review and the receipt of accrued fees (or promise to pay such fees), ODNI will promptly inform the requester in writing of those records or portions of records that will be released and those that will be denied.
(1)For documents to be released, ODNI will provide paper copies or documents on electronic media, if requested and available;
(2)For documents not released or partially released, ODNI shall explain the reasons for any denial and give notice of a right of administrative appeal. For partial releases, redactions will be made to ensure requesters can see the placement and general length of redactions with the applicable exemption or exemptions clearly with respect to each redaction. § 1700.10 Procedures for business information.
(a)*In general.* Business information obtained by ODNI from a submitter shall not be disclosed pursuant to a FOIA request except in accordance with this section. For purposes of this section, the following definitions apply:
(1)*Business information* means commercial or financial information in which a legal entity has a recognized property interest;
(2)*Confidential commercial information* means such business information provided to the United States Government by a submitter which is reasonably believed to contain information exempt from release under Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4), because disclosure could reasonably be expected to cause substantial competitive harm; and
(3)*Submitter* means any person or entity who provides confidential commercial information to the United States Government; it includes, but is not limited to, corporations, businesses (however organized), State governments, and foreign governments.
(b)*Designation of confidential commercial information.* A submitter of business information will use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, any portions of its submission that it considers to be confidential commercial information and hence protected from required disclosure pursuant to Exemption 4 of the FOIA. Such designations shall expire 10 years after the date of the submission unless the submitter requests, and provides justification for, a longer designation period.
(c)*Process in event of FOIA request—*
(1)*Notice to submitters.* ODNI shall provide a submitter with prompt written notice of receipt of a FOIA request encompassing business information whenever:
(i)The submitter has in good faith designated the information as confidential commercial information, or
(ii)ODNI staff believe that disclosure of the information could reasonably be expected to cause substantial competitive harm, and
(iii)The information was submitted within the last 10 years unless the submitter requested and provided acceptable justification for a specific notice period of greater duration.
(2)*Form of notice.* Communication to a submitter of commercial information shall either describe the exact nature of the confidential commercial information at issue or provide copies of the responsive records containing such information.
(3)*Response by submitter.*
(i)Within seven days of the notice described in paragraph (c)(1), all claims of confidentiality by a submitter must be supported by a detailed statement of any objection to disclosure. Such statement shall:
(A)Affirm that the information has not been disclosed to the public;
(B)Explain why the information is a trade secret or confidential commercial information;
(C)Explain in detail how disclosure of the information will result in substantial competitive harm;
(D)Affirm that the submitter will provide ODNI and the Department of Justice with such litigation support as requested; and
(E)Be certified by an officer authorized to legally bind the submitter.
(ii)It should be noted that information provided by a submitter pursuant to this provision may itself be subject to disclosure under the FOIA.
(4)*Decision and notice of intent to disclose.*
(i)ODNI shall consider carefully a submitter's objections and specific grounds for nondisclosure prior to its final determination. If the Director, IMO, decides to disclose a document over the objection of a submitter, ODNI shall provide the submitter a written notice that shall include:
(A)A statement of the reasons for which the submitter's disclosure objections were not sustained;
(B)A description of the information to be disclosed; and
(C)A specified disclosure date that is seven days after the date of the instant notice.
(ii)When notice is given to a submitter under this section, the ODNI shall also notify the requester and, if the ODNI notifies a submitter that it intends to disclose information, then the requester shall be notified also and given the proposed date for disclosure.
(5)*Notice of FOIA lawsuit.* If a requester initiates legal action seeking to compel disclosure of information asserted to be within the scope of this section, ODNI shall promptly notify the submitter. The submitter, as specified above, shall provide such litigation assistance as required by ODNI and the Department of Justice.
(6)*Exceptions to notice requirement.* The notice requirements of this section shall not apply if ODNI determines that:
(i)The information should not be disclosed, pursuant to Exemption 4 and/or any other exemption of the FOIA;
(ii)The information has been published lawfully or has been officially made available to the public;
(iii)The disclosure of the information is otherwise required by law or federal regulation; or
(iv)The designation made by the submitter under this section appears frivolous, except that, in such a case, the ODNI will, within a reasonable time prior to the specified disclosure date, give the submitter written notice of any final decision to disclose the information. § 1700.11 Procedures for information concerning other persons.
(a)*In general.* Personal information concerning individuals other than the requester shall not be disclosed under the FOIA if the proposed release would constitute a clearly unwarranted invasion of personal privacy, or, if the information was compiled for law enforcement purposes, it could reasonably be expected to constitute an unwarranted invasion of personal privacy. *See* 5 U.S.C. 552 (b)(6) and (b)(7)(C). For purposes of this section, the following definitions apply:
(1)Personal information means any information about an individual that is not a matter of public record, or easily discernible to the public, or protected from disclosure because of the implications that arise from Government possession of such information.
(2)Public interest means the public interest in understanding the operations and activities of the United States Government and not simply any matter that might be of general interest to the requester or members of the public.
(b)*Determination to be made.* In making the required determination under this section and pursuant to Exemptions 6 and 7(C) of the FOIA, ODNI will balance the privacy interests that would be compromised by disclosure against the public interest in release of the requested information.
(c)*Otherwise.* A requester seeking information on a third party is encouraged to provide a signed affidavit or declaration from the third party consenting to disclosure of the information. However, any such statements shall be narrowly construed and the Director, IMO, in the exercise of that officer's discretion and administrative authority, may seek clarification from the third party prior to any or all releases. § 1700.12 Requests for expedited processing.
(a)*In general.* All requests will be handled in the order received on a strictly “first-in, first-out” basis. Exceptions to this rule will only be made in accordance with the following procedures.
(b)*Procedure.* A requester who seeks expedited processing must submit a statement, certified to be true and correct, explaining in detail the basis for requesting expedited processing. Within ten calendar days of its receipt of a request for expedited processing, the IMO shall decide whether to grant it and shall notify the requester of the decision. If a request for expedited processing is granted, the request shall be given priority and shall be processed as soon as practicable.
(c)*Determination to be made:* Requests and appeals will be taken out of order and given expedited processing treatment whenever it is determined that they involve:
(1)Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
(2)An urgency to inform the public concerning an actual or alleged Federal Government activity, if made by a person primarily engaged in disseminating information. § 1700.13 Right to appeal and appeal procedures.
(a)*Right to appeal.* Individuals who disagree with a decision not to produce a document or parts of a document, to deny a fee category request, to deny a request for a fee waiver or fee reduction, to deny expedited processing, or a decision regarding a fee estimate or a determination that no records exist, should submit a written request for review to the Chief FOIA Officer c/o Director, Information Management Office, Office of the Director of National Intelligence, Washington, DC 20511. The words “FOIA APPEAL” should be written on the letter and the envelope. The appeal must be signed by the individual or his legal counsel.
(b)*Requirements as to time and form.* Appeals of adverse decisions must be received within 45 days of the date of the ODNI's initial decision. Requesters should include a statement of the reasons supporting the request for reversal of the initial decision.
(c)*Exceptions.* No appeal shall be accepted if the requester has outstanding fees for information services at this or another federal agency. In addition, no appeal shall be accepted if the information in question has been the subject of an administrative review within the previous two years or is the subject of pending litigation in the Federal courts. § 1700.14 Action by appeals authority.
(a)The Director of the Intelligence Staff, after consultation with any ODNI component organization involved in the initial decision as well as with the Office of General Counsel, will make a final determination on the appeal. Appeals of denials of requests for expedited processing shall be acted on expeditiously.
(b)The Director, IMO, will ordinarily be the initial deciding official on FOIA requests to the ODNI. However, in the event the Director of the Intelligence Staff makes an initial decision that is later appealed, the Principal Deputy Director for National Intelligence will decide the appeal in accordance with the procedures in this section. Dated: August 9, 2007. Ronald L. Burgess, Jr., Director of the Intelligence Staff. [FR Doc. E7-15996 Filed 8-15-07; 8:45 am] BILLING CODE 3910-A7-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 1, 2, 64, 100, 109, 110, 117, 147, 150, 151, and 161 [USCG-2007-27887] RIN 1625-ZA13 Navigation and Navigable Waters; Technical, Organizational, and Conforming Amendments AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: This rule makes non-substantive changes throughout Title 33 of the Code of Federal Regulations. The purpose of this rule is to make conforming amendments and technical corrections to Coast Guard navigation and navigable water regulations. This rule will have no substantive effect on the regulated public. DATES: This final rule is effective August 16, 2007. ADDRESSES: Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2007-27887 and are available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, room PL-401, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call Mr. Ray Davis, Coast Guard, telephone 202-372-1461. If you have questions on viewing the docket, call Ms. Renee V. Wright, Program Manager, Docket Operations, telephone 202-493-0402. SUPPLEMENTARY INFORMATION: Regulatory History We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard finds this rule is exempt from notice and comment rulemaking requirements because these changes involve agency organization and practices, and good cause exists for not publishing an NPRM for all revisions in the rule because they are all non-substantive changes. This rule consists only of corrections and editorial, organizational, and conforming amendments. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . Background and Purpose Each year Title 33 of the Code of Federal Regulations is updated on July 1. This rule, which becomes effective August 16, 2007, makes technical and editorial corrections throughout Title 33. This rule does not create any substantive requirements. Discussion of Rule This rule corrects the authority citations in parts 1, 64, 109, 117, 147, and 151. The explanations in §§ 109.05(a) and 109.10 concerning the authority to regulate anchorage grounds and special anchorage areas are also updated. Five sections in part 100 pertaining to regattas and other marine events, and one paragraph, a table, and a figure in part 110 pertaining to the placement of mooring buoys are removed because they are obsolete or redundant. A note in part 151 that references a definition has been updated. Additional amendments to parts 2, 64, 150, and 161 are: *33 CFR 2.32(c)* . The Coast Guard previously revised definitions of jurisdictional terms in part 2, conforming them to statutory changes and Presidential proclamations affecting Coast Guard jurisdiction (68 FR 42595, July 18, 2003). Those amendments inadvertently omitted wreck and structure marking authority but were intended to incorporate the traditional interpretation of “high seas” that existed before the advent of the concept of an exclusive economic zone (EEZ). Prior to those amendments, the meaning of “high seas” within the context of Coast Guard wreck and structure marking authority, as applied to persons subject to U.S. jurisdiction, was intended to be similar to how the term “high seas” was understood in traditional maritime law enforcement authority, 14 U.S.C. 89(a), and as defined by Congress in the Intervention on the High Seas Act, 33 U.S.C. 1471, *et seq.* It was not our intent, in promulgating the 2003 updates to jurisdictional regulations, to change that application. Rather, our intent was to maintain, insofar as possible, the existing jurisdictional authorities of the Coast Guard to execute its missions, particularly with respect to the definition of “high seas” (see 68 FR 42595-6). *33 CFR 64.06.* A definition of “high seas” is added to the section's list of definitions to make clear that the application of this part remains unchanged by our amendments to 33 CFR Part 2 in 2003 (68 FR 42595, July 18, 2003). *33 CFR Part 150.* The geographic coordinates in § 150.940 have been revised to enable plotting using the North American Datum of 1983, and the description of the datum in § 150.930 has been amended accordingly. *33 CFR 161.35.* The names, numbers, and locations of certain navigation aids in the Houston/Galveston Vessel Traffic Service Area have been updated in Tables 161.35(B) and (C). Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. As this rule involves internal agency practices and procedures and non-substantive changes, it will not impose any costs on the public. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This rule does not require a general NPRM and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impact on small entities. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraphs (34)(a) and (b), of the Instruction from further environmental documentation because this rule involves editorial, procedural, and internal agency functions. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects 33 CFR Part 1 Administrative practice and procedure, Authority delegations (Government agencies), Freedom of information, Penalties. 33 CFR Part 2 Administrative practice and procedure, Law enforcement. 33 CFR Part 64 Navigation (water), Reporting and recordkeeping requirements. 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. 33 CFR Part 109 Anchorage grounds. 33 CFR Part 110 Anchorage grounds. 33 CFR Part 117 Bridges, Reporting and recordkeeping requirements. 33 CFR Part 147 Continental shelf, Marine safety, Navigation (water). 33 CFR Part 150 Harbors, Marine safety, Navigation (water), Occupational safety and health, Oil pollution, Reporting and recordkeeping requirements. 33 CFR Part 151 Administrative practice and procedure, Oil pollution, Penalties. Reporting and recordkeeping requirements, Water pollution control. 33 CFR Part 161 Harbors, Navigation (water), Reporting and recordkeeping requirements, Vessels, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 1, 2, 64, 100, 109, 110, 117, 147, 150, 151, and 161. Title 33—Navigation and Navigable Waters PART 1—GENERAL PROVISIONS 1. In subpart 1.05, revise the authority citation to read as follows: Authority: 5 U.S.C. 552, 553, App. 2; 14 U.S.C. 2, 631, 632, and 633; 33 U.S.C. 471, 499; 49 U.S.C. 101, 322; Department of Homeland Security Delegation No. 0170.1. PART 2—JURISDICTION 2. The authority citation for part 2 continues to read as follows: Authority: 14 U.S.C. 633; 33 U.S.C. 1222; Pub. L.89-670, 80 Stat. 931, 49 U.S.C. 108; Pub. L. 107-296, 116 Stat. 2135, 2249, 6 U.S.C. 101 not and 468; Department of homeland Security Delegation No. 0170.1. 3. In § 2.32, revise paragraph
(c)to read as follows: § 2.32 High seas.
(c)For the purposes of 14 U.S.C. 89(a), 14 U.S.C. 86, 33 U.S.C. 409, and 33 U.S.C. 1471 *et seq.,* *high seas* includes the exclusive economic zones of the United States and other nations, as well as those waters that are seaward of territorial seas of the United States and other nations. PART 64—MARKING OF STRUCTURES, SUNKEN VESSELS AND OTHER OBSTRUCTIONS 4. Revise the authority citation for part 64 to read as follows: Authority: 14 U.S.C. 633; 33 U.S.C. 409, 1231; 42 U.S.C. 9118; 43 U.S.C. 1333; Department of Homeland Security Delegation No. 0170.1. 5. In § 64.06, add a new definition for “high seas” between “Hazard to navigation” and “Markings” to read as follows: § 64.06 Definition of terms. *High seas* means those waters described in § 2.32(c) of this chapter. PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 6. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. § 100.103 [Removed] 7. Remove § 100.103. § 100.104 [Removed] 8. Remove § 100.104. § 100.120 [Removed] 9. Remove § 100.120. § 100.121 [Removed] 10. Remove § 100.121. § 100.122 [Removed] 11. Remove § 100.122. PART 109—GENERAL 12. Revise the authority citation for part 109 to read as follows: Authority: R.S. 4233, as amended, 28 Stat. 647 as amended, 30 Stat. 98, as amended, sec. 7, 38 Stat. 1053, as amended, sec. 6(g)(1), 80 Stat. 940; 33 U.S.C. 180, 258, 322, 471; 49 U.S.C. 1655(g)(1); Pub. L. 107-296, 116 Stat. 2135; Department of Homeland Security Delegation No. 0170.1. § 109.01 [Amended] 13. Remove the parenthetical at the end of § 109.01. 14. In § 109.05— a. Revise paragraph
(a)to read as set out below; and, b. Remove the parenthetical at the end of the section. § 109.05 Anchorage grounds.
(a)Section 7 of the Rivers and Harbors Act of March 4, 1915 (33 U.S.C. 471), authorizes the establishment of anchorage grounds for vessels in navigable waters of the United States whenever it is apparent that these are required by the maritime or commercial interests of the United States for safe navigation. The statute also authorizes the adoption of suitable rules and regulations regarding the establishment of anchorage grounds, which are enforced by the Coast Guard. The authority conferred by this statute was transferred to and vested in the Secretary of Homeland Security by section 902(j) of the Coast Guard and Maritime Transportation Act of 2006 (Pub. L. 109-241, 120 Stat. 516), and delegated to the Commandant of the U.S. Coast Guard in Department of Homeland Security Delegation No. 0170.1. The Commandant redelegated the authority to establish anchorage grounds to each Coast Guard District Commander as provided in 33 CFR 1.05-1(e)(1)(i). § 109.07 [Amended] 15. Remove the parenthetical at the end of § 109.07. 16. Revise § 109.10 to read as follows: § 109.10 Special anchorage areas. An Act of Congress of April 22, 1940, provides for the designation of special anchorage areas wherein vessels not more than sixty-five feet in length, when at anchor, will not be required to carry or exhibit anchorage lights. Such designation is to be made after investigation, by rule, regulation, or order, the procedure for which will be similar to that followed for anchorage grounds under section 7 of the Rivers and Harbors Act of March 4, 1915, as referred to in § 109.05. The areas so designated should be well removed from the fairways and located where general navigation will not endanger or be endangered by unlighted vessels. The authority to designate special anchorage areas was transferred to and vested in the Secretary of Homeland Security by section 902(j) of the Coast Guard and Maritime Transportation Act of 2006 (Pub. L. 109-241, 120 Stat 516), and delegated to the Commandant of the U.S. Coast Guard in Department of Homeland Security Delegation No. 0170.1. The Commandant redelegated the authority to establish anchorage grounds to each Coast Guard District Commander as provided in 33 CFR 1.05-1(e)(1)(i). § 109.15 [Amended] 17. In § 109.15, remove “guard”, and add, in its place, “Guard”. PART 110—ANCHORAGE REGULATIONS 18. The authority citation for part 110 continues to read as follows: Authority: 33 U.S.C. 471, 1221 through 1236, 2030, 2035, 2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1. § 110.60 [Amended] 19. In § 110.60, remove paragraph(x)(4), Table 110.60(x)(4), and Figure 110.60(x)(4). § 110.155 [Amended] 20. In § 110.155(l)(8), remove “Coast Guard Activities New York, Waterways Oversight Branch”, and add, in its place, “Coast Guard Sector New York, Waterways Management Division”. PART 117—DRAWBRIDGE OPERATION REGULATIONS 21. Revise the authority citation for part 117 to read as follows: Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and Department of Homeland Security Delegation No. 0170.1. PART 147—SAFETY ZONES 22. Revise the authority citation for part 147 to read as follows: Authority: 14 U.S.C. 85; 43 U.S.C. 1333; Department of Homeland Security Delegation No. 0170.1. PART 150—-DEEPWATER PORTS: OPERATION 23. The authority citation for part 150 continues to read as follows: Authority: 33 U.S.C. 1231, 1321(j)(1)(C), (j)(5), (j)(6), (m)(2); 33 U.S.C. 1509(a); E.O. 12777, sec. 2; E.O. 13286, sec. 34, 68 FR 10619; Department of Homeland Security Delegation No. 0170.1 (70), (73), (75), (80). 24. Revise § 150.930 to read as follows: § 150.930 What datum is used for the geographic coordinates in this subpart? The geographic coordinates used in this subpart have been revised to enable plotting using the North American Datum of 1983 (NAD 83) and no longer require the use of any further conversion factors for correction. 25. Revise § 150.940 to read as follows: § 150.940 Safety zones for specific deepwater ports.
(a)*Louisiana Offshore Oil Port (LOOP).*
(1)The location of the safety zone for LOOP is as described in Table 150.940(A): Table 150.940(A).—Safety Zone for LOOP, Gulf of Mexico Plotting guidance Latitude N Longitude W
(i)Starting at 28°55′24″ 90°00′37″
(ii)A rhumb line to: 28°53′51″ 90°04′07″
(iii)Then an arc with a 4,465 meter (4,883 yard) radius centered at the port's pumping platform complex 28°53′07″ 90°01′30″
(iv)To a point 28°51′08″ 90°03′06″
(v)Then a rhumb line to 28°50′10″ 90°02′24″
(vi)Then a rhumb line to 28°49′06″ 89°55′54″
(vii)Then a rhumb line to 28°48′37″ 89°55′00″
(viii)Then a rhumb line to 28°52′05″ 89°52′42″
(ix)Then a rhumb line to 28°53′11″ 89°53′42″
(x)Then a rhumb line to 28°54′53″ 89°57′00″
(xi)Then a rhumb line to 28°54′53″ 89°59′36″
(xii)Then an arc with a 4,465 meter (4,883 yard) radius centered again at the port's pumping platform complex
(xiii)To the point of starting 28°55′24″ 90°00′37″
(2)The areas to be avoided within the safety zone are:
(i)The area encompassed within a circle having a 600 meter radius around the port's pumping platform complex and centered at 28°53′07″ N, 90°01′30″ W.
(ii)The six areas encompassed within a circle having a 500 meter radius around each single point mooring
(SPM)at the port and centered at: Latitude N Longitude W 28°54′13″ 90°00′37″ 28°53′17″ 89°59′59″ 28°52′16″ 90°00′19″ 28°51′46″ 90°01′25″ 28°52′09″ 90°02′33″ 28°53′08″ 90°03′02″
(3)The anchorage area within the safety zone is an area enclosed by the rhumb lines joining points at: Latitude N Longitude W 28°52′22″ 89°57′47″ 28°54′06″ 89°56′38″ 28°52′05″ 89°52′42″ 28°50′21″ 89°53′51″ 28°52′22″ 89°57′47″
(b)*The Gulf Gateway Deepwater Port (GGDWP)—(1) Description.* The GGDWP safety zone is centered at the following coordinates: 28°05′17″ N, 93°03′07″ W. This safety zone, encompassed within a circle having a 500 meter radius around the primary component of the Gulf Gateway Deepwater Port, the submerged loading turret
(buoy)and the pipeline end manifold (STL/PLEM), is located approximately 116 miles off the Louisiana coast at West Cameron Area, South Addition Block 603 “A”.
(i)A mandatory no anchoring area contained within a circle of radius 1,500 meters centered on the following geographical position is designated as a mandatory no anchoring area: 28°05′17″ N, 93°03′07″ W.
(ii)An area to be avoided within a circle of radius 2,000 meters centered on the following geographical position is designated as an area to be avoided: 28°05′17″ N, 93°03′07″ W.
(2)*Regulations.* Deepwater port support vessels desiring to enter the safety zone must contact and obtain permission from the LNG Regasification Vessel (LNGRV) stationed at the deepwater port. The LNGRV can be contacted on VHF-FM Channel 13. PART 151—VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER 26. Revise the authority citation for part 151 to read as follows: Authority: 33 U.S.C. 1321, 1903, 1908; 46 U.S.C. 6101; Pub. L. 104-227 (110 Stat. 3034); E.O. 12,777, 3 CFR, 1991 Comp. p. 351; Department of Homeland Security Delegation No. 0170.1. § 151.09 [Amended] 27. In § 151.09— A. Remove the note following paragraph (d); and B. Add a note between paragraphs (b)(3) and (b)(4) to read “Note to § 151.09(b)(3): The term *internal waters* is defined in § 2.24 of this chapter.” PART 161—VESSEL TRAFFIC MANAGEMENT 28. The authority citation for part 161 continues to read as follows: Authority: 33 U.S.C. 1223, 1231; 46 U.S.C. 70114, 70117; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 29. Amend § 161.35 by revising the entry for Sims Bayou in Table 161.35(B) and revising Table 161.35(C) to read as follows: § 161.35 Vessel Traffic Service Houston/Galveston.
(b)*Precautionary Areas.* Table 161.35(B).—VTS Houston/Galveston Precautionary Areas Precautionary area name Radius (yds.) Center point Latitude Longitude * * * * * * * Sims Bayou 1000 29° 43.2′ N 95° 14.4′ W * * * * * * *
(c)*Reporting Points.* Table 161.35(C).—VTS Houston/Galveston Reporting Points Designator Geographic name Geographic description Latitude/ longitude Notes 1 Galveston Bay Entrance Channel Galveston Bay Entrance CH Lighted Buoy
(LB)“1C” 29° 18.2′ N; 94° 37.6′ W 2 Galveston Bay Entrance Channel Galveston Bay Entrance Channel LB 11 and 12 29° 20.6′ N; 94° 44.6′ W E Bolivar Land Cut Mile 349 Intracoastal Waterway
(ICW)29° 22.5′ N; 94° 46.9′ W Tows entering HSC also report at HSC LB 25 & 26. W Pelican Cut Mile 351 ICW 29° 21.4′ N; 94° 48.5′ W Tows entering HSC also report at HSC LB 25 & 26. G Galveston Harbor Galveston Channel Lt. 2 29° 20.2′ N; 94° 46.6′ W Coast Guard Base. T Texas City Channel Texas City Channel Lt. 12 29° 22.4′ N; 94° 50.9′ W X Houston Ship Channel ICW Intersection Houston Ship Channel
(HSC)LB 25 and 26 29° 22.2′ N; 94° 48.1′ W Tow entering HSC from ICW or Texas Cut Only. 3 Lower Galveston Bay HSC Lt. 31 and LB 32 29° 23.8′ N; 94° 48.9′ W 4 Red Fish Bar HSC Lt. 53 & 54 29° 30.3′ N; 94° 52.4′ W P Bayport Ship Channel Bayport Ship Channel Lt. 8 and 9 29° 36.8′ N; 94° 59.5′ W Bayport Land Cut. 4A Upper Galveston Bay HSC Lt. 69 and 70 29° 34.7′ N; 94° 55.8′ W Tows only. 5 Morgan's Point HSC Lt. 91 29° 41.0′ N; 94° 59.0′ W 6 Exxon HSC Lt. 109A 29° 43.5′ N; 95° 01.4′ W 7 Lynchburg Ferry crossing 29° 45.8′ N; 95° 04.8′ W 8 Shell Oil Boggy Bayou 29° 44.1′ N; 95° 08.0′ W 9 Greens Bayou HSC Lt. 152 29° 44.8′ N; 95° 10.1′ W 10 Hunting Bayou Hunting Bayou Turning Basin. 29° 44.4′ N; 95° 12.1′ W 11 Lyondell Sims Bayou Turning Basin. 29° 43.2′ N; 95° 14.4′ W 12 I-610 Bridge I-610 Bridge 29° 43.5′ N; 95° 16.0′ W 13 Buffalo Bayou Houston Turning Basin 29° 45.0′ N; 95° 17.4′ W Dated: August 9, 2007. Stefan G. Venckus, Chief, Office of Regulations and Administrative Law, United States Coast Guard. [FR Doc. E7-15957 Filed 8-15-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [FRL-84559] Louisiana: Final Authorization of State Hazardous Waste Management Program Revision AGENCY: Environmental Protection Agency (EPA). ACTION: Immediate final rule. SUMMARY: Louisiana has applied to the EPA for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). The EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this immediate final action. The EPA is publishing this rule to authorize the changes without a prior proposal because we believe this action is not controversial and do not expect comments that oppose it. Unless we receive written comments which oppose this authorization during the comment period, the decision to authorize Louisiana's changes to its hazardous waste program will take effect. If we receive comments that oppose this action, we will publish a document in the **Federal Register** withdrawing this rule before it takes effect, and a separate document in the proposed rules section of this **Federal Register** will serve as a proposal to authorize the changes. DATES: This final authorization will become effective on October 15, 2007, unless the EPA receives adverse written comment by September 17, 2007. If the EPA receives such comment, it will publish a timely withdrawal of this immediate final rule in the **Federal Register** and inform the public that this authorization will not take effect. ADDRESSES: Submit your comments by one of the following methods: 1. *Federal eRulemaking Portal:* *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. 2. *E-mail:* *patterson.alima@epa.gov.* 3. *Mail:* Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733. 4. *Hand Delivery or Courier.* Deliver your comments to Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733. *Instructions:* Do not submit information that you consider to be CBI or otherwise protected through regulations.gov, or e-mail. The Federal regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to the EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. You can view and copy Louisiana's application and associated publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following locations: Louisiana Department of Environmental Quality, 602 N. Fifth Street, Baton Rouge, Louisiana 70884-2178, phone number
(225)219-3559 and EPA, Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, phone number
(214)665-8533. Interested persons wanting to examine these documents should make an appointment with the office at least two weeks in advance. FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6, Regional Authorization Coordinator, State-Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, EPA Region 1445 Ross Avenue, Dallas, Texas 75202-2733,
(214)665-8533) and e-mail address *patterson.alima@epa.gov.* SUPPLEMENTARY INFORMATION: A. Why Are Revisions to State Programs Necessary? States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations
(CFR)parts 124, 260 through 266, 268, 270, 273, and 279. B. What Decisions Have We Made in This Rule? We conclude that Louisiana's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Louisiana final authorization to operate its hazardous waste program with the changes described in the authorization application. Louisiana has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Louisiana including issuing permits, until the State is granted authorization to do so. C. What Is the Effect of Today's Authorization Decision? The effect of this decision is that a facility in Louisiana subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Louisiana has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to: • Do inspections, and require monitoring, tests, analyses, or reports; • Enforce RCRA requirements and suspend or revoke permits and • Take enforcement actions regardless of whether the State has taken its own actions. This action does not impose additional requirements on the regulated community because the regulations for which Louisiana is being authorized by today's action are already effective under State law, and are not changed by today's action. D. Why Wasn't There a Proposed Rule Before Today's Rule? The EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today's **Federal Register** we are publishing a separate document that proposes to authorize the State program changes. E. What Happens if the EPA Receives Comments That Oppose This Action? If the EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the **Federal Register** before the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The **Federal Register** withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn. F. For What Has Louisiana Previously Been Authorized? The State of Louisiana initially received final authorization on February 7, 1985 (50 FR 3348), to implement its base Hazardous Waste Management Program. We granted authorization for changes to their program on November 28, 1989 (54 FR 48889) effective January 29, 1990; August 26, 1991 (56 FR 41958) effective August 26, 1991; November 7, 1994 (59 FR 55368) effective January 23, 1995; December 23, 1994 (59 FR 66200) effective March 8, 1995; there were technical corrections made on January 23, 1995 (60 FR 4380), effective January 23, 1995; and another technical correction was made on April 11, 1995 (60 FR 18360) effective April 11, 1995; October 17, 1995 (60 FR 53704) effective January 2, 1996; March 28, 1996 (61 FR 13777) effective June 11, 1996; December 29, 1997 (62 FR 67572) effective March 16, 1998; October 23, 1998 (63 FR 56830) effective December 22, 1998; August 25, 1999 (64 FR 46302) effective October 25, 1999; September 2, 1999 (64 FR 48099) effective November 1, 1999; February 28, 2000 (65 FR 10411) effective April 28, 2000; January 2, 2001 (66 FR 23) effective March 5, 2001; December 9, 2003 (68 FR 68526) effective February 9, 2004, June 10, 2005 (70 FR 33852) effective August 9, 2005 and November 13, 2006 (71 FR 66116) effective January 13, 2007. On September 18, 2006, Louisiana applied for approval of its program revisions for RCRA Cluster XV. In this application, Louisiana is seeking approval of RCRA Cluster XV in accordance with 40 CFR 271.21(b)(3). Since 1979, through the Environmental Affairs Act, Act 449 enabling the Office of Environmental Affairs within the Louisiana Department of Natural Resources, as well as, the Environmental Control Commission conducted an effective program designed to regulate those who generate, transport, treat, store, dispose or recycle hazardous waste. During the 1983 Regular Session of the Louisiana Legislature, Act 97 was adopted, which amended and reenacted La. R.S. 30:1051 et seq. as the Environmental Quality Act, renaming the Environmental Affairs Act (Act 1938 of 1979). This Act created Louisiana Department of Environmental Quality LDEQ), including provisions for new offices within this new Department of Environmental Quality. Act 97 also transferred the duties and responsibilities previously delegated to the Department of Natural Resources, Office of Environmental Affairs, to the new Department. The LDEQ has lead agency jurisdictional authority for administering the Resource Recovery and Conservation Act
(RCRA)Subtitle C program in Louisiana. Also, the LDEQ is designated to facilitate communication between the EPA and the State. During the 1999 Regular Session of Louisiana Legislature, Act 303 revised the La. R.S. 30:2011 et seq. allowing LDEQ to reengineer the Department to perform more efficiently and to meet its strategic goals. It is the intention of the State, through this application, to demonstrate its equivalence and consistency with the federal statutory tests, which are outlined in the United States Environmental Protection Agency regulatory requirements under 40 CFR 271, Subpart A, for final authorization. The submittal of this application is in keeping with the spirit and intent of RCRA, which provides equivalent States the opportunity to apply for final authorization to operate all aspects of their hazardous waste management programs in lieu of the Federal government. The Louisiana Environmental Quality Act authorizes the State's program, Subtitle II of Title 30 of the Louisiana Revised Statutes. With this application Louisiana is applying for authorization for specific areas of the State regulations identified as requiring authorization and the listed Checklists 206 and 207 will allow the State to implement the equivalent RCRA Subtitle C portion of the program. G. What Changes Are We Authorizing With Today's Action? On February 3, 2006, Louisiana submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of written comments that oppose this action, that Louisiana's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant the State of Louisiana Final authorization for the following changes: The State of Louisiana's program revisions consist of regulations which specifically govern RCRA Cluster XV as documented below: Description of federal requirement (include checklist #, if relevant) Federal Register date and page (and/or RCRA statutory authority) Analogous state authority 1. Nonwastewaters From Dyes and Pigments. (Checklist 206) 70 FR 9138-9180 February 24, 2005 Louisiana Revised Statutes
(LRS)30: Section 2001 *et seq.* , with specific cites of 2174, 2175, and 2180 effective December 31, 2004; Supplement effective June 2006; Louisiana Hazardous Waste Regulations
(LHWR)Sections 105.D.2.p, 105.D.2.p.i-v, 4901.C.Table 2, 4901.C.1.a, 49o.C.2, −3, 4901.C.3.a-b, 4901.C.3.b.i-iv, 4901.C.3.b.iv.(a)-(c), 4901.C.3.c, 4901.C.3.c.i-iii, 4901.C.3.c.iii.(a)-(d), 4901.3.c.iv, 4901.C.3.c.iv.(a)-(b), 4901.C.3.3.c.v-x, 4901.C.3.c.(a)-(d), 4901.C.3.c.xi, 4901.C.3.xi.(a)-(d), 4901.C.3.e, Chapter.49.Table 6, Chapter.31.Table 1, 2208.B.5, 2208.C, Chapter.22.Table, 2299.Table 7, as effective May 20, 2006. 2. Uniform Hazardous Waste Manifest Rule. (Checklist 207) 70 FR 10776-10825 March 4, 2005 Louisiana Revised Statutes
(LRS)30: Section 2001 *et seq.* , with specific cites of 2174, 2175, and 2180 effective December 31, 2004; Supplement effective June 2006; Louisiana Hazardous Waste Regulations
(LHWR)Sections 109, 1108 incorporate the federal rules by reference, 1109.F, 1109.F.l,-2, 1109.C-E, 1109.E.13, 1109.E.13.a-b, 1113, 1113.E.3, 1113.E.5, 1123.C, 1123.C.1-2, 1307, 1307.A .2, 1301, 1307.G, 1307.G.1-G4, 1309, 1309.B, 1309.B.1, 1309.B.1.a, 1309.B.1.b, 1516, 1516.A.1, 1516.A.2, 1516.B.1, 1516.B., 1516.B.1.a-e, 1516.B.5, 1516.B.5.a-b, 1516.C.1, 1516.c.1.a-c, 1516.C.3, 1516.C.4.a-b, 1516.C.5, 1516.C.5.a-g, 1516.C.6.a, 1516.C.6.a.i-iii, and 1516.D, as effective May 20, 2006. H. Where Are the Revised State Rules Different From the Federal Rules? The State's hazardous regulations for Checklists 206 and 207 are consistent, equivalent and no less stringent than the Federal regulations. There are no provisions that are more stringent or broader in scope. Broader in scope requirements are not part of the authorized program and EPA can not enforce them. I. Who Handles Permits After the Authorization Takes Effect? Louisiana will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Louisiana is not yet authorized. J. How Does Today's Action Affect Indian Country in Louisiana? Louisiana is not authorized to carry out its Hazardous Waste Program in Indian Country within the State. This authority remains with EPA. Therefore, this action has no effect in Indian Country. K. What Is Codification and Is the EPA Codifying Louisiana's Hazardous Waste Program as Authorized in This Rule? Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart T for this authorization of Louisiana's program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this **Federal Register** notice. L. Statutory and Executive Order Reviews The Office of Management and Budget
(OMB)has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866. Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective October 15, 2007. List of Subjects in 40 CFR Part 271 Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous materials transportation, Hazardous waste, Indians—lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements. Authority: This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended 42 U.S.C. 6912(a), 6926, 6974(b). Dated: July 25, 2007. Lawrence E. Starfield, Acting Regional Administrator, Region 6. [FR Doc. 07-4001 Filed 8-15-07; 8:45 am]
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  • 7 CFR 701
  • Pub. L. 110-28
  • 7 CFR 1400
  • 40 CFR 1502.4
  • 7 CFR 799
  • 7 CFR 3015
  • Pub. L. 95-334
  • 16 USC 2201-2205
  • Pub. L. 109-148
  • 10 CFR 72
  • Pub. L. 104-113
  • 10 CFR 51
  • 68 Stat. 929
  • 83 Stat. 444
  • Pub. L. 86-373
  • 73 Stat. 688
  • 88 Stat. 1242
  • Pub. L. 95-601
  • 92 Stat. 2951
  • Pub. L. 102-486
  • 106 Stat. 3123
  • Pub. L. 91-190
  • 83 Stat. 853
  • Pub. L. 97-425
  • 96 Stat. 2229
  • Pub. L. 100-203
  • 101 Stat. 1330
  • 112 Stat. 2750
  • Pub. L. 109-58
  • 119 Stat. 806
  • 68 Stat. 955
  • 96 Stat. 2230
  • 96 Stat. 2202
  • 98 Stat. 2230
  • 96 Stat. 2252
  • 42 USC 262-264
  • 42 CFR 493
  • 21 CFR 640.3
  • 21 CFR 640.61
  • 21 CFR 640.62
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