Notices. Final rule
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/register/2008/01/23/08-242A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2008-01-23.xml --- 73 15 Wednesday, January 23, 2008 Contents Agriculture Agriculture Department See Commodity Credit Corporation See Farm Service Agency See Forest Service See Natural Resources Conservation Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3921 E8-1043 Census Census Bureau NOTICES Request for Nominations to Serve on the Census Advisory Committee on the Hispanic Population, 3924 E8-1035 Centers Centers for Disease Control and Prevention RULES Interstate Shipment of Etiologic Agents, 3874-3879 E8-1050 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 3977-3978 E8-1016 E8-1017 Commerce Commerce Department See Census Bureau See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Estimates of the Voting Age Population for 2007, 3923-3924 E8-1098 Commodity Commodity Credit Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3921-3922 E8-1044 Copyright Copyright Office, Library of Congress PROPOSED RULES Recordation of Notices of Termination of Transfers and Licenses:
Clarifications, 3898-3900 E8-888 Drug Drug Enforcement Administration NOTICES Medicine Shoppe-Jonesborough; Denial of Motion for Stay, 3997-3998 E8-1021 Employment Employment and Training Administration NOTICES Availability of Funds and Solicitation for Grant Applications: High Growth Job Training Initiative Grants for the Energy Industry, Construction and Skilled Trades, etc., 3998-4011 E8-1061 Energy Energy Department See Federal Energy Regulatory Commission RULES Workplace Substance Abuse Programs at DOE Sites, 3861-3863 E8-1084 NOTICES 229 Boundary Revision for the Oak Ridge Gaseous Diffusion Plant, 3950-3951 08-237 Reimbursement for Costs of Remedial Action at Active Uranium and Thorium Processing Sites, 3951 E8-1082 EPA Environmental Protection Agency PROPOSED RULES Disapproval of Plan of Nevada;
Clean Air Mercury Rule: Extension of Comment Period, 3900-3901 E8-1117 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3952-3958 E8-1094 E8-1097 E8-1100 Certain New Chemicals; Receipt and Status Information, 3958-3964 E8-1003 Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities, 3964-3967 E8-1001 National Lead Laboratory Accreditation Program: Notice of Availability of Revisions, 3967-3968 E8-1110 Project Performance Corporation;
Transfer of Data, 3968-3969 E8-809 Receipt of Application for Emergency Exemption: Chlorantraniliprole; Solicitation of Public Comment, 3969-3970 E8-875 Farm Farm Service Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3921-3922 E8-1044 FAA Federal Aviation Administration RULES Airworthiness Directives: Boeing Model 777-200 and -300 Series Airplanes Equipped with Rolls-Royce RB211-TRENT 800 Series Engines, 3863-3867 E8-843 PROPOSED RULES Airworthiness Directives:
Bell Helicopter Textron Canada
(BHTC)Models 206A, 206B, 206L, 206L-1, 206L-3, and 206L-4 Helicopters, 3887-3889 E8-1025 Bell Helicopter Textron Canada Model 222, 222B, 222U, 230 and 430 Helicopters, 3889-3891 E8-1026 Eurocopter Deutschland GMBH Model MBB-BK 117C-2 Helicopters, 3885-3887 E8-1023 Eurocopter France Model AS 355 N Helicopters, 3891-3893 E8-1027 Special Conditions: Embraer S.A.; Model EMB-500; Brakes-Designation of Applicable Regulations, 3884-3885 E8-1077 Embraer S.A.; Model EMB-500; Static Pressure System, 3882-3884 E8-1076 Embraer S.A., Model EMB-500; High Fuel Temperature, 3881-3882 E8-1075 NOTICES Approval of Finding of No Significant Impact and Record of Decision for Final Environmental Assessment: Construction of a New Land-based Airport in Akutan, AK, 4040 08-232 Finding of No Significant Impact, 4040-4043 E8-1068 Intent to Rule on Change in Use of Aeronautical Property at Louisville International Airport, KY, 4043-4044 08-233 Meetings: RTCA, Inc., 08-230 4044-4045 08-231 Federal Energy Federal Energy Regulatory Commission NOTICES Meetings; Sunshine Act, 3952 E8-1030 Federal Reserve Federal Reserve System NOTICES Proposals to Engage in Permissible Nonbanking Activities or Acquire Companies Engaged in Permissible Nonbanking Activities, 3970-3971 E8-1080 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Initiation of 5-Year Reviews of 10 Listed Species, 3991-3993 E8-1108 Environmental Impact Statement: Sears Point Wetland and Watershed Restoration Project, 3993-3994 E8-1069 Foreign Foreign Assets Control Office NOTICES Additional Designations, Foreign Narcotics Kingpin Designation Act, 4045-4046 E8-1041 Forest Forest Service NOTICES Resource Management Plans, etc.: Bull Run Watershed Management Plan, 3922-3923 08-229 Health Health and Human Services Department See Centers for Disease Control and Prevention See National Institutes of Health NOTICES Annual Update of the HHS Poverty Guidelines, 3971-3972 08-256 Decision to Evaluate a Petition to Designate a Class of Employees at Spencer Chemical Co., Jayhawks Works, Pittsburg, Kansas, etc., 3972 E8-1031 Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort, 3972 E8-1033 Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort, 3973 E8-1018 Findings of Scientific Misconduct, 3973 E8-1024 Secretarial Recognition of Certain Healthcare Information Technology Standards Panel Interoperability Specifications as Interoperability Standards, etc., 3973-3977 08-234 Homeland Homeland Security Department See U.S. Customs and Border Protection Housing Housing and Urban Development Department RULES Demolition or Disposition of Public Housing Projects; Correction, 3867-3868 E8-1014 NOTICES Funding Availability for the Section 202 Demonstration Pre-Development Grant Program, 3985-3991 E8-1119 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Surface Mining Reclamation and Enforcement Office NOTICES Meetings: Blackstone River Valley National Heritage Corridor Commission, 3991 E8-978 IRS Internal Revenue Service RULES Application of Section 338 to Insurance Companies, 3868-3874 E8-729 International International Trade Administration NOTICES Corrosion-Resistant Carbon Steel Flat Products from the Republic of Korea: Notice of Preliminary Results of Antidumping Duty New Shipper Review, 3925-3928 E8-1105 Rescission of Antidumping Duty Administrative Review, 3943 E8-1101 Export Trade Certificate of Review, 3943-3945 E8-1114 E8-1122 Frozen Fish Fillets from the Socialist Republic of Vietnam: Extension of Time Limit for Final Results of the Third Antidumping Duty Administrative Review, 3945 E8-1107 Steel Nails from People's Republic of China: Preliminary Determination of Sales at Less Than Fair Value and Partial Affirmative Determination of Critical Circumstances, etc., 3928-3942 E8-1106 Steel Nails from the United Arab Emirates: Notice of Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 3945-3950 E8-1109 International International Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3997 E8-1138 Justice Justice Department See Drug Enforcement Administration Labor Labor Department See Employment and Training Administration See Labor Statistics Bureau See Occupational Safety and Health Administration MISSING FOR: Labor Statistics Bureau Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 4011-4012 E8-1063 Land Land Management Bureau NOTICES Meetings: Carrizo Plain National Monument Advisory Committee, 3994-3995 E8-1062 Library Library of Congress See Copyright Office, Library of Congress NASA National Aeronautics and Space Administration NOTICES Meetings: NASA Advisory Council, 4012 E8-1070 NASA Advisory Committee: Renewal of NASA's International Space Station Advisory Committee Charter, 4013 E8-1067 National Environmental Policy Act; Constellation Program, 4013-4014 E8-1066 Notice of Intent to Grant an Exclusive License, 4014-4015 E8-1064 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 4015 08-235 National Highway National Highway Traffic Safety Administration PROPOSED RULES Federal Motor Vehicle Safety Standards, Child Restraint Systems: Anthropomorphic Test Drive, 3901-3920 E8-856 NIH National Institutes of Health NOTICES Meetings: Center for Scientific Review, 08-219 3978-3980 08-224 08-225 National Heart, Lung, and Blood Institute, 3980 08-220 National Institute on Drug Abuse, 08-221 3980-3981 08-222 National Library of Medicine, 3981 08-223 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod by Catcher Processors Using Pot Gear in the Bering Sea and Aleutian Islands Management Area, 3879 08-242 Pacific Cod by Catcher Vessels 60 Feet (18.3 Meters) Length Overall and Using Pot Gear in the Bering Sea and Aleutian Islands Management Areas, 3879-3880 08-239 National Park National Park Service NOTICES Inventory Completion: Florida Museum of Natural History, Gainesville, FL and Southwest Florida Water Management District, Brooksville, FL, 3995-3996 E8-1078 U.S. Department of Agriculture, Forest Service, Gila National Forest, NM and Southwest Museum of the American Indian, Autry National Center, CA, 3996-3997 E8-1112 NRCS Natural Resources Conservation Service NOTICES Proposed Changes to the Natural Resources Conservation Service's National Handbook of Conservation Practices, 3923 E8-1115 Nuclear Nuclear Regulatory Commission NOTICES Confirmatory Order: Southern California Edison Co., San Onofre Nuclear Generating Station, 4016-4019 E8-1079 Designation of Presiding Officer: Pacific Gas and Electric Co., 4019 E8-1074 Meetings; Sunshine Act, 4019-4020 08-259 Occupational Occupational Safety and Health Administration PROPOSED RULES Confined Spaces in Construction, 3893-3894 E8-1081 SEC Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-1056 4020-4022 E8-1058 E8-1060 Meetings: Improvements to Financial Reporting Advisory Committee, 4022-4023 E8-1053 Meetings; Sunshine Act, 4023 E8-1072 Northern Institutional Funds, et al.; Application, 4023-4027 E8-1057 Self-regulatory Organizations; Proposed Rule Changes: American Stock Exchange LLC, 4027-4028 E8-1054 Boston Stock Exchange, Inc., 4028-4035 E8-1037 International Securities Exchange, LLC, 4035-4036 E8-1011 New York Stock Exchange LLC, 4036-4038 E8-1055 Philadelphia Stock Exchange, Inc., 4038-4040 E8-1059 State State Department RULES Card Format Passport; Changes to Passport Fee Schedule; Correction, 3867 E8-1104 Surface Surface Mining Reclamation and Enforcement Office PROPOSED RULES Kansas Regulatory Program, 3894-3898 E8-1113 Thrift Thrift Supervision Office NOTICES Interagency Charter and Federal Deposit Insurance Application, 4046 E8-1111 Transportation Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service See Thrift Supervision Office Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-1034 E8-1038 3981-3985 08-228 08-236 Veterans Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 4046-4049 E8-1085 E8-1086 E8-1087 E8-1088 E8-1089 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 15 Wednesday, January 23, 2008 Rules and Regulations DEPARTMENT OF ENERGY 10 CFR Part 707 RIN 1992-AA38 Workplace Substance Abuse Programs at DOE Sites AGENCY: Office of Health, Safety and Security, Department of Energy. ACTION: Final rule. SUMMARY: The Department of Energy
(DOE)today publishes a final rule to amend the Department's regulations to decrease the random drug testing rate of DOE contractor employees in testing designated positions (TDP). Today's final rule also makes minor technical changes that delete: A sentence pertaining to specimen collection and handling in order to conform the section with the current U.S. Department of Health and Human Services' *Mandatory Guidelines for Federal Workplace Drug Testing Programs* ; and obsolete references to the Personnel Security Assurance Program and the Personnel Assurance Program. EFFECTIVE DATE: This rule is effective February 22, 2008. FOR FURTHER INFORMATION CONTACT: Ms. Jacqueline D. Rogers, U.S. Department of Energy, Office of Health, Safety and Security, HS-11, 1000 Independence Avenue, SW., Washington, DC 20585;
(202)586-4714 or *jackie.rogers@hq.doe.gov* . SUPPLEMENTARY INFORMATION: I. Background II. Discussion of Amendments III. Issuance of a Final Rule IV. Procedural Review Requirements A. Review Under Executive Order 12866 B. Review Under National Environmental Policy Act C. Review Under the Regulatory Flexibility Act D. Review Under the Paperwork Reduction Act E. Review Under the Unfunded Mandates Reform Act of 1995 F. Review Under the Treasury and General Government Appropriations Act, 1999 G. Review Under Executive Order 13132 H. Review Under Executive Order 12988 I. Review Under the Treasury and General Government Appropriations Act, 2001 J. Review Under Executive Order 13211 K. Congressional Notification V. Approval by the Office of the Secretary of Energy I. Background Pursuant to the Department of Energy's (DOE or the Department) statutory authority, including the Atomic Energy Act of 1954, as amended and the Drug-Free Workplace Act of 1988, DOE promulgated a rule on July 22, 1992, on DOE contractor workplace substance abuse programs (57 FR 32652). The rule established minimum requirements for DOE contractors to use in developing and implementing programs that deal with the use of illegal drugs by their employees. The rule provided for drug testing of contractor employees in, and applicants for, testing designated positions
(TDP)at sites owned or controlled by DOE and operated under the authority of the Atomic Energy Act of 1954. The Department determined that possible risks of serious harm to the environment and to public health, safety, and national security justified the imposition of a uniform rule establishing a baseline workplace substance abuse program, including drug testing. The rule created a new Part 707 of Title 10 in the Code of Federal Regulations entitled *Workplace Substance Abuse Programs at DOE Sites* . In consideration of the February 2007 report on the Task Force Review of the Departmental Personnel Security Program, the Secretary of Energy issued a memorandum on September 14, 2007 addressing drug testing for DOE positions that require access authorizations (security clearances) ( *http://www.directives.doe.gov/pdfs/reftools/Drug_Testing.pdf* ). The DOE Secretarial Memorandum stated the Secretary's determination that all Federal and contractor positions that require a security clearance (“Q” and “L”) and all positions occupied by individuals who currently have security clearances have the potential to significantly affect the environment, public health and safety, or national security. The Secretary determined that all applicants for, and employees in, such positions are considered to be in TDPs, meaning they are subject to applicant, random, and for cause drug testing. This decision regarding TDPs is being implemented in accordance with DOE Order 3792.3 (for Federal employees) and 10 CFR Part 707 (for DOE contractor employees). The Secretary further determined, with regard to random drug testing, that employees in TDPs other than those designated to be included in the 100 percent annual sample pool be tested at a 30 percent annual sample rate. II. Discussion of Amendments Today's final rule amends the Department of Energy's regulations on workplace substance abuse programs at DOE sites to decrease the random drug testing rate of contractor employees in TDPs other than those in the 100 percent rate of testing pool. Currently, 10 CFR 707.7(a)(2) provides that for these TDPs, contractor programs “shall provide for random tests at a rate equal to 50 percent of the total number of employees [in these TDPs] for each 12 month period.” Today's final rule replaces “50” with “30,” consistent with the Secretary's decision to decrease the random drug testing rate in conjunction with his decision to expand the TDPs to include all applicants for, and employees in, positions requiring a security clearance. This final rule makes a minor technical amendment to update the specimen collection and handling provision to reflect current U.S. Department of Health and Human Services'
(HHS)*Mandatory Guidelines for Federal Workplace Drug Testing Programs* . Contractor substance abuse programs are subject to the HHS Mandatory Guidelines, as well as Part 707 (see 10 CFR 707.5(a)). Section 707.12 addresses specimen collection, handling, and laboratory analysis. Section 707.12(b)(2) requires collecting a sufficient amount of urine to conduct an initial test, a confirmatory test, and a retest, in accordance with the HHS Mandatory Guidelines. If there is not a sufficient amount, the collection site person may give the individual additional time in which to provide urine for testing. In this situation, the current regulation provides that the partial specimens are to be combined in a single container. The sentence requiring the combining of partial specimens in a single container is not consistent with current HHS Mandatory Guidelines, and, therefore, this final rule removes the sentence. The final rule also makes a minor technical amendment to delete references to the Personnel Security Assurance Program and the Personnel Assurance Program since both of these programs were cancelled with the publication of 10 CFR part 712, *Human Reliability Program* . III. Issuance of a Final Rule DOE has determined, pursuant to 5 U.S.C. 553(b)(B), that prior notice and an opportunity for public comment on this rule are unnecessary. DOE has determined that the two changes DOE is making to Part 707 are so minor or technical that the public would have no particular interest in providing comments. As explained earlier in this preamble, DOE is revising section 707.7(a)(2) to reduce the annual random drug testing sample from 50 percent to 30 percent. The change in the rate of testing of Federal employees in TDPs (other than employees in the 100 percent testing pool) already is being implemented by the Office of Human Resources. Today's amendment of section 707.7(a)(2) establishes parity in the treatment of Federal employees and contractor employees, and by decreasing the frequency of testing, reduces any burden associated with drug testing of contractor employees in these positions. As to the amendment of section 707.12(b)(2), the deletion of the sentence pertaining to specimen collection and handling is a technical change that is necessary to conform the section with the current HHS Mandatory Guidelines. Based on the foregoing, DOE finds that good cause exists to waive the requirement to provide prior notice and an opportunity to comment for this rulemaking. IV. Procedural Review Requirements A. Review Under Executive Order 12866 Today's regulatory action has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993). Accordingly, this action is not subject to review under that Executive Order by the Office of Information and Regulatory Affairs
(OIRA)of the Office of Management and Budget (OMB). B. Review Under the National Environmental Policy Act DOE has determined that this final rule is covered under the Categorical Exclusion found in DOE's National Environmental Policy Act regulations at paragraph A.5 of Appendix A to Subpart D, 10 CFR, Part 1021, which applies to a rulemaking that amends an existing rule or regulation which does not change the environmental effect of the rule or regulation being amended. C. Review Under the Regulatory Flexibility Act The Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process (68 FR 7990). DOE has made its procedures and policies available on the Office of the General Counsel's Web site: *http://www.gc.doe.gov* . DOE has found that based on good cause prior notice and opportunity for public comments are unnecessary; and, therefore, the Regulatory Flexibility Act does not apply to today's rule. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. D. Review Under the Paperwork Reduction Act This rule does not impose any new collection of information subject to review and approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ). E. Review Under the Unfunded Mandates Reform Act of 1995 The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires Federal agencies to examine closely the impacts of regulatory actions on State, local, and tribal governments. Subsection 101(5) of title I of that law defines a Federal intergovernmental mandate to include any regulation that would impose upon State, local, or tribal governments an enforceable duty, except a condition of Federal assistance or a duty arising from participating in a voluntary Federal program. Title II of that law requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and tribal governments, in the aggregate, or to the private sector, other than to the extent such actions merely incorporate requirements specifically set forth in a statute. Section 202 of that title requires a Federal agency to perform a detailed assessment of the anticipated costs and benefits of any rule that includes a Federal mandate, which may result in costs to State, local or tribal governments, or to the private sector, of $100 million or more in any one year (adjusted annually for inflation). Section 204 of that title requires each agency that proposes a rule containing a significant Federal intergovernmental mandate to develop an effective process for obtaining meaningful and timely input from elected officers of State, local, and tribal governments. This final rule does not impose a Federal mandate on State, local or tribal governments. The rule would 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 one year. Accordingly, no assessment or analysis is required under the Unfunded Mandates Reform Act of 1995. F. Review Under the Treasury and General Government Appropriations Act, 1999 Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for any rulemaking that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment. G. Review Under Executive Order 13132 Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this rule and has determined that it would not preempt State law and would not have a substantial direct effect 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. No further action is required by Executive Order 13132. H. Review Under Executive Order 12988 With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements:
(1)Eliminate drafting errors and ambiguity;
(2)write regulations to minimize litigation; and
(3)provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation:
(1)Clearly specifies the preemptive effect, if any;
(2)clearly specifies any effect on existing Federal law or regulation;
(3)provides a clear legal standard for affected conduct while promoting simplification and burden reduction;
(4)specifies the retroactive effect, if any;
(5)adequately defines key terms; and
(6)addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988. I. Review Under the Treasury and General Government Appropriations Act, 2001 The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed today's rule under OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines. J. Review Under Executive Order 13211 Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that:
(1)Is a significant regulatory action under Executive Order 12866, or any successor order; and
(2)is likely to have a significant adverse effect on the supply, distribution, or use of energy, or
(3)is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. Today's rule would not have a significant adverse effect on the supply, distribution, or use of energy and is therefore not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects. K. Congressional Notification As required by 5 U.S.C. 801, the Department will submit to Congress a report regarding the issuance of today's final rule prior to the effective date set forth at the outset of this rule. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2). V. Approval by the Office of the Secretary of Energy Issuance of this rule has been approved by the Office of the Secretary. List of Subjects in 10 CFR Part 707 Classified information, Drug testing, Employee assistance programs, Energy, Government contracts, Health and safety, National security, Reasonable suspicion, Special nuclear material, Substance abuse. Issued in Washington, DC, on January 15, 2008. Glenn S. Podonsky, Chief Health, Safety and Security Officer, Office of Health, Safety and Security. For the reasons set out in the preamble, DOE amends part 707 of Chapter III of Title 10 of the Code of Federal Regulations as set forth below: PART 707—WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES 1. The authority citation for part 707 is revised to read as follows: Authority: 41 U.S.C. 701 *et seq.;* 42 U.S.C. 2012, 2013, 2051, 2061, 2165, 2201b, 2201i, and 2201p; 42 U.S.C. 5814 and 5815; 42 U.S.C. 7151, 7251, 7254, and 7256; 50 U.S.C. 2401 *et seq.* 2. Section 707.7 is amended as follows: a. Paragraph (a)(2) is amended by removing “50” and adding in its place “30” in the first sentence. b. Paragraph (b)(1) is revised; c. Paragraph (b)(2) is removed; d. Paragraphs (b)(3) and (b)(4) are redesignated as (b)(2) and (b)(3). The revision read as follows: § 707.7 Random drug testing requirements and identification of testing designated positions.
(b)* * *
(1)Positions determined to be covered by the Human Reliability Program (HRP), codified at 10 CFR part 712. HRP employees will be subject to the drug testing standards of this part and any additional requirements of the HRP rule. § 707.12 [Amended] 3. In § 707.12, paragraph (b)(2) is amended by removing the fifth sentence. [FR Doc. E8-1084 Filed 1-22-08; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25609; Directorate Identifier 2005-NM-263-AD; Amendment 39-15335; AD 2008-02-05] RIN 2120-AA64 Airworthiness Directives; Boeing Model 777-200 and -300 Series Airplanes Equipped With Rolls-Royce RB211-TRENT 800 Series Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive
(AD)for certain Boeing Model 777-200 and -300 series airplanes. This AD requires revising the airplane flight manual to provide the flightcrew with new ground procedures for shedding core ice during long taxi periods in freezing fog with visibility of 300 meters or less. For airplanes unable to perform the shedding procedure after prolonged taxiing in freezing fog with visibility of 300 meters or less, this AD requires certain investigative and corrective actions. This AD results from reports of engine surges and internal engine damage due to ice accumulation during extended idle thrust operation in ground fog icing conditions. We are issuing this AD to prevent internal engine damage due to ice accumulation and shedding, which could cause a shutdown of both engines, and result in a forced landing of the airplane. DATES: This AD becomes effective February 27, 2008. ADDRESSES: For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is the Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Margaret Langsted, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6500; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Discussion The FAA issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 777-200 and -300 series airplanes. That NPRM was published in the **Federal Register** on August 18, 2006 (71 FR 47754). That NPRM proposed to require revising the airplane flight manual to provide the flightcrew with new ground procedures for shedding core ice during long taxi periods in freezing fog. For airplanes unable to perform the shedding procedure after prolonged taxiing in freezing fog, that NPRM proposed to require certain investigative and corrective actions. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments received. Requests To Reduce Visibility Requirements Boeing, Rolls-Royce, the European Aviation Safety Agency (EASA), and Air Transport Association (ATA), on behalf of American Airlines, all request that we reduce the visibility requirements during a ground fog icing encounter. The commenters request that the current 1,000-meter or less visibility requirements be reduced to 300-meters or less visibility. Rolls-Royce has performed an analysis based on atmospheric data and service experience that demonstrates that freezing fog presents a threat to the engine only when the visibility drops below 300 meters; EASA has accepted this analysis. Boeing states that this change will minimize the need for the run-up to only those freezing fog conditions that are severe enough to pose a risk. We agree with the commenters. Sufficient data have been presented to the FAA to justify a reduction from the 1,000-meter visibility requirement to a 300-meter visibility requirement. We have revised the statement in the Summary section, and paragraphs (f),
(h)and
(i)of the final rule to state “in freezing fog with visibility of 300 meters or less.” Requests To Remove Specific Airplane Maintenance Manual
(AMM)Task References, and To Refer to Current Procedures Boeing, Rolls-Royce, and ATA, on behalf of its members Delta Airlines and American Airlines, request that we refer to the Boeing 777 AMM for the de-icing procedures, rather than specific changes in the AMM. Rolls-Royce points out that the specified tasks are only examples of an acceptable inspection method; referring to a specific task/issue of the AMM in an AD will lead to many requests for alternative methods of compliance (AMOCs) from operators after AMM revisions. ATA states that the specific tasks do not exist in the AMM available to one of its members. In addition, Boeing, Rolls-Royce, and American Airlines state that the AMM procedures for doing the engine core de-icing (referred to in paragraph
(h)of the NPRM) are outdated. The commenters explain that Rolls-Royce and Boeing did testing to determine the best way to conduct the procedure, and that the best solution is included in the latest AMM procedure. The commenters state that this is another example of why we should not refer to specific AMM tasks in the AD. For the stated reasons, we agree with the commenters that we should refer to the Boeing 777 AMM, rather than specific tasks. Therefore, we have changed paragraphs
(h)and (h)(2) of the AD to specify that Chapter 12-33-03 of the Boeing 777 AMM, rather than the specific tasks, provides acceptable methods of compliance. We also added a statement to paragraph (h)(2) of this AD indicating that the temperature of the air supplied cannot exceed 176 degrees Fahrenheit at any time during the manual de-ice process. Air that exceeds 176 degrees Fahrenheit can damage the engine. Requests To Clarify Borescope Inspection Requirements Boeing and Rolls-Royce request that we clarify and revise the requirements for the borescope inspection, and that we specify inspecting the intermediate pressure compressor
(IPC)blades unless damage indicates that material has been released. The commenters state that inspection of other compressor stages would be necessary if the material has been released. Rolls-Royce explains that if no material has been released from the IPC stage 1 blades then there will be no secondary damage to the high pressure compressor (HPC), so inspection is not required. If material is missing from the IPC stage 1, the engine must have a full borescope inspection of both the IPC and the HPC. Damage to the IPC stage 1 blades without material release would be treated under the current AMM acceptance limits. Boeing and Rolls-Royce state that the borescope procedure to look for damage is conducted routinely by the airlines, and that it is not necessary to mandate the current borescoping method in the AMM. We agree with the requests to clarify the borescope inspection procedures. The risk of engine failure is a direct result of HPC damage; if there is no material released from the IPC stage 1 blades, then there will be no resulting damage to the HPC. We have revised paragraph
(i)of the AD to clarify the borescope procedures and to specify that Chapter 72-00-00 of the Boeing 777 AMM is one approved method for complying with the requirements of that paragraph. We acknowledge that the borescope procedure is conducted routinely by the airlines; however, an AD must specify a method of compliance for all required actions and, in cases where there is no relevant service bulletin as with this AD, we generally point to the AMM as an acceptable method of compliance. Request To Place Core Ice Shedding Procedures in Operations Manual Vincent Crow, a private citizen, would like to have the core ice shedding procedures (described in paragraph
(f)of the NPRM) as a part of Operations Manual Volume 1
(OMV1)as a supplementary procedure in the adverse weather section. Paragraph
(f)of the NPRM specifies publishing these procedures in the Airplane Flight Manual
(AFM)as a certification limitation. We disagree with the request to publish the procedures in OMV1. OMV1 is not approved or mandated by the FAA. The AFM limitations are approved and mandated by the FAA. In addition, all limitations in the AFM are required to be incorporated into the operations manual. We have not changed the AD in this regard. Requests To Withdraw NPRM Boeing, and ATA, on behalf of its member American Airlines, state that the NPRM is unnecessary because the freezing fog procedure (paragraph
(f)of the NPRM) is already included in the FAA-approved AFM Limitations section. We infer that the commenters would like us to withdraw the NPRM. We do not agree. Although the AFM has been revised to reflect the proposed requirements in the NPRM, the operators are not required to adopt the latest revision of the AFM. Therefore, the procedures in paragraph
(f)of the NPRM would not be required unless we take AD action. We have not changed the AD in this regard. Request To Address Risk of Sliding When Power Is Advanced The National Transportation Safety Board
(NTSB)is concerned that the environmental conditions that cause the engine core icing could also cause the taxiway surface to become icy and slippery, thereby increasing the risk of the airplane sliding off the taxiway or into another airplane when the crew advances the power to shed the core ice. We infer that the NTSB would like us to add procedures to the AD to require actions that do not involve advancing engine power. We disagree that the procedures will result in the airplane sliding. The procedures mandated by the AD were developed with a reduced thrust setting to minimize the potential for sliding. Based on discussions with operators, we understand that the pilot will locate the airplane in a safe place to do the run-ups. We have addressed the possibility of the pilot not being able to perform the engine run-up by allowing operators to manually de-ice before takeoff, or to take off with the subsequent requirement of a borescope inspection. We have not changed the AD in this regard. Request To Redesign the Engine The NTSB suggests that, in the long term, the FAA require that engines be modified so that the airfoil surfaces where ice is building up are heated to prevent the buildup. The NTSB notes that early-generation gas turbine engines had inlet guide vanes that were pneumatically heated to prevent the formation of ice. The NTSB goes on to say that several safety recommendations have been issued concerning ice buildup on the stationary parts of the engine, causing engine core damage when shed. We disagree with the suggestion to require modification to the engines to prevent ice buildup during extended exposure to ground fog icing. The Trent 800 series engine would require extensive testing and redesign to add additional anti-ice capability. History has shown that the frequency of ground icing encounters are rare and it would not be cost effective to redesign the engine given that there are operational procedures that adequately address the unsafe condition. The NTSB refers to safety recommendations that were issued as a result of dual engine high-altitude flameouts from ice buildup on the engine core. While extended exposure to ground fog icing does cause ice buildup in the engine core, the requirement of periodic engine speed run-ups is consistent with other ground-based icing operational procedures. We have not changed the AD in this regard. Request To Include Costs of Run-Up, Manual De-Ice, and Borescope Boeing requests that we include the cost of disruption to the airline when a run-up, manual de-ice, or borescope inspection is needed. Boeing points out that the AD mandates the procedure, and if the operator conducts the procedure it will require delay, and possibly maintenance action. We disagree with the request to include these costs in the Costs of Compliance section. We recognize that this AD may impose certain additional operational costs. However, we cannot calculate those costs because we do not know how often the conditions occur and what additional time is necessary. Continued operational safety necessitates the imposition of these costs because of the severity of the unsafe condition. In addition, the cost analysis in AD actions typically does not include incidental costs such as the time required to gain access and close up, time necessary for planning, or time necessitated by other administrative actions. Those incidental costs, which might vary significantly among operators, are almost impossible to calculate. We have not changed the AD in this regard. Requests To Provide Terminating Action Boeing and Rolls-Royce request that we provide a clear terminating action for the actions proposed in the NPRM. Boeing states that the AD should be considered complied with and closed once the procedure to perform the engine run-up is inserted in the AFM. Boeing points out that the engine procedures for inspecting for ice and manually de-icing should be part of the airlines' approved de-ice/anti-ice procedures, and like the wing de-ice procedures, the methods to accomplish them are not mandated by AD. Boeing and Rolls-Royce both suggest adding information to paragraph
(g)of the NPRM that would specify that, once the procedures are incorporated into the operator's approved ground de-icing/anti-icing program, the AD should be considered complied with. We disagree with the need to add terminating action to paragraph
(g)of the AD. The Limitations section in the AFM includes maintenance actions that are not performed by the flightcrew and cannot be required without an AD. As discussed above, Boeing and Rolls-Royce do not plan to make an engine or airplane configuration change that would eliminate the need for the AFM and maintenance procedures mandated by this AD, and thus provide terminating action. We have not changed the AD in this regard. Requests To Specify Lack of Events With Trent 800 Boeing and Rolls-Royce ask that we clarify the summary and paragraph
(d)of the NPRM to specify that Trent 800 series engines (the subject of the proposed AD) have not experienced engine surges and internal engine damage due to ice accumulation during extended idle thrust operation in ground fog icing conditions. We acknowledge that Trent 800 series engines have not experienced the stated events, as described in the “Discussion” and “Similar Engine Models” sections of the NPRM. As stated in the preamble of the NPRM, both the Trent 700 series engines and the Trent 800 series engines have a similar compressor design, and therefore may be subject to the same unsafe condition. We find that this information need not be added to the AD Summary section, or to any regulatory paragraphs of the AD. Request To Clarify Paragraphs
(f)and
(h)of the NPRM EASA requests that we clarify the wording of the AFM revision by revising the phrase “there is no run-up procedure” in paragraph
(f)(sub-paragraph
(c)of the AFM revision) of the NPRM to state, instead, “do not carry out a run-up.” In that same paragraph, EASA also requests that we add after “then manually de-ice the engines” the phrase “or confirm ice is not present in the engine core before further flight.” EASA also requests that we add “or 60 minutes since the last run-up” after the phrase “if take-off is not accomplished in freezing fog within 60 minutes total taxi time” in paragraph
(h)of the NPRM. We agree that clarification is necessary. However, we do not agree that it is necessary to revise the phrase as specified. After 60 minutes, there is no run-up procedure that will shed the ice. As a clarification, we have revised the AFM wording specified in paragraph
(f)of the AD to read “Takeoff is not permitted if total taxi time in freezing fog with visibility of 300 meters or less exceeds 60 minutes without accomplishing the above core ice shed procedure. The engine core must be manually de-iced” instead of “If takeoff is not accomplished within 60 minutes total taxi time, then manually de-ice the engines.” Explanation of Revised Unsafe Condition We have revised the unsafe condition to state that internal engine damage could result in a forced landing rather than in loss of control of the airplane. Upon further review of the regulations, we determined that a power loss in this case does not leave the airplane uncontrollable, but rather leads to a forced landing. Explanation of Revised AMOC Paragraph We have removed paragraph (j)(3) of the NPRM. That paragraph refers to alternative repair methods, and this AD does not include a repair. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance There are about 208 airplanes of the affected design in the worldwide fleet. This AD affects about 53 airplanes of U.S. registry. The actions take about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $4,240, or $80 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2008-02-05 Boeing:** Amendment 39-15335. Docket No. FAA-2006-25609; Directorate Identifier 2005-NM-263-AD. Effective Date
(a)This AD becomes effective February 27, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Boeing Model 777-200 and -300 series airplanes, certificated in any category, equipped with Rolls-Royce RB211 TRENT 800 engines. Unsafe Condition
(d)This AD results from reports of engine surges and internal engine damage due to ice accumulation during extended idle thrust operation in ground fog icing conditions. We are issuing this AD to prevent internal engine damage due to ice accumulation and shedding, which could cause a shutdown of both engines, and result in a forced landing of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Airplane Flight Manual
(AFM)Revision
(f)Within 14 days after the effective date of this AD, revise the Limitations Section of the Boeing 777 Airplane Flight Manual
(AFM)to include the following statements. This may be done by inserting a copy of this AD in the AFM. “GROUND OPERATIONS IN FREEZING FOG WITH VISIBILITY OF 300 METERS OR LESS When freezing fog with visibility of 300 meters or less is reported and
(a)The OAT is 0 degrees C to −6 degrees C then run up the engines to 50% N1 for 1 minute every 45 minutes taxi time, or
(b)The OAT is −7 degrees C to −13 degrees C then run up the engines to 59% N1 for 1 minute for every 45 minutes taxi time, or
(c)The OAT is colder than −13 degrees C and taxi time exceeds 45 minutes, there is no run-up procedure; the engines must be manually de-iced. Regardless of temperature, if the core ice shedding procedure described above is not accomplished within 45 minutes total taxi time in freezing fog with visibility of 300 meters or less, but takeoff can be achieved within 60 minutes total taxi time in freezing fog with visibility of 300 meters or less, takeoff is permitted. A borescope inspection is required within 10 flights. Takeoff is not permitted if total taxi time in freezing fog with visibility of 300 meters or less exceeds 60 minutes without accomplishing the above core ice shed procedure. The engine core must be manually de-iced.”
(g)When a statement identical to that in paragraph
(f)of this AD has been included in the general revisions of the AFM, the general revisions may be inserted into the AFM, and the copy of this AD may be removed from the AFM. Inspection for Ice
(h)If takeoff is not accomplished in freezing fog, with visibility of 300 meters or less, within 60 minutes total taxi time, before further flight, perform an inspection for ice of the variable inlet guide vanes (VIGVs), inspect the low pressure compressor
(fan)for ice, and ensure that all fan, spinner, air intake splitter fairing, and VIGV surfaces are free of ice after engine operation in freezing fog with visibility of 300 meters or less, in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO). One acceptable method of compliance is Chapter 12-33-03 of the Boeing 777 Airplane Maintenance Manual (AMM).
(1)If no ice is detected, the time already completed in freezing conditions can be reset to zero for subsequent operation.
(2)If any ice is detected, before further flight, manually de-ice the engine core inlet. Upon completion of the manual de-ice process, the fan, spinner, air intake splitter fairing, and VIGV surfaces must be free of ice and all residual water removed. Two acceptable methods to manually de-ice the engine can be found in Chapter 12-33-03 of the Boeing 777 AMM. At no time during the manual de-ice process should the temperature of the air supplied exceed 176 degrees Fahrenheit. Borescope Inspection for Damage
(i)For airplanes on which the core ice shedding procedure is not accomplished within 45 minutes total taxi time, but that achieve takeoff within 60 minutes total taxi time in freezing fog with visibility of 300 meters or less, regardless of temperature during ground operations in freezing fog with visibility of 300 meters or less: Within 10 flight cycles after takeoff, perform a borescope inspection to detect missing material of the intermediate pressure compressor
(IPC)stage 1 blades. If any material is found to be missing, do a full borescope inspection of the IPC and high pressure compressor
(HPC)before further flight. Do the actions in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA. One acceptable method of compliance is to perform all applicable borescope inspections in accordance with Chapter 72-00-00 of the Boeing 777 AMM. If any damage is detected, further action in accordance with the current AMM limits must be taken before further flight. Alternative Methods of Compliance (AMOCs) (j)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Material Incorporated by Reference
(k)None. Issued in Renton, Washington, on January 10, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-843 Filed 1-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF STATE 22 CFR Parts 22 and 51 [Public Notice: 6066] RIN 1400-AC22 Card Format Passport; Changes to Passport Fee Schedule; Correction AGENCY: Department of State. ACTION: Final rule; correction. SUMMARY: This document contains a correction to the Card Format Passport; Changes to Fee Schedule published in the **Federal Register** on December 31, 2007 (72 FR 74169). DATES: Effective on February 1, 2008 FOR FURTHER INFORMATION CONTACT: Consuelo Pachon, Office of Legal Affairs and Law Enforcement Liaison, Bureau of Consular Affairs, 2100 Pennsylvania Avenue, NW., Suite 3000, Washington, DC, telephone number 202-663-2431. Correction The final rule published on December 31, 2007 (72 FR 74169) is corrected as follows: 1. In the SUPPLEMENTARY INFORMATION section, on page 74170, in the first column, the table is corrected by: a. Removing the phrase “(first time applicants only)” after the phrase “Passport Card Execution Fee;” under paragraph (9)(c). b. Removing the words “First Time” in the line reading “Total First Time Child” under paragraph (9)(c). c. Removing the line “Total renewal child” in the first column and “$10.” in the second column under paragraph (9)(c). 2. On page 74173, amendment number 2 and the corresponding text are corrected in its entirety, to read as follows: “2. In § 22.1, the table is amended by removing the text at Item nos. 9 through 10, and by adding new entries for Items 9 and 10 in their place, to read as follows: § 22.1 Schedule of fees. Schedule of Fees for Consular Services Item No. Fee Passport and Citizenship Services 9. Passport Card Services:
(a)Application fee for applicants age 16 or over [Adult Passport Card] $20
(b)Application fee for applicants under age 16 [Minor Passport Card] 10
(c)Execution fee [Passport Card Execution] 25 10. [Reserved] Dated: January 17, 2008. Maura Harty, Assistant Secretary, Bureau of Consular Affairs, Department of State. [FR Doc. E8-1104 Filed 1-22-08; 8:45 am] BILLING CODE 4710-06-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 970 [Docket No. FR-4598-C-03] RIN 2577-AC20 Demolition or Disposition of Public Housing Projects; Correction AGENCY: Office of the Assistant Secretary for Public and Indian Housing, HUD. ACTION: Correcting amendments. SUMMARY: On October 24, 2006, HUD published a final rule revising the agency's regulations on demolition or disposition of public housing projects. This publication corrects certain typographical and other non-substantive errors that occurred in the final rule. DATES: *Effective Date:* January 23, 2008. *Applicability Date:* November 24, 2006. FOR FURTHER INFORMATION CONTACT: Ainars Rodins, Director, Public and Indian Housing Special Application Center, Department of Housing and Urban Development, Ralph H. Metcalfe Federal Building, 77 West Jackson Boulevard, Room 2401, Chicago, IL 60604-3507; telephone:
(312)353-6236 (this is not a toll-free number). Persons with hearing or speech impairments may access that number toll-free through TTY by calling the Federal Relay Service at
(800)877-8339. SUPPLEMENTARY INFORMATION: I. Background On October 24, 2006 (71 FR 62354), HUD published a final rule revising the Department's regulations governing demolition or disposition of public housing projects. This final rule followed a December 15, 2004 (69 FR 75188), proposed rule. The final rule became effective on November 24, 2006. These HUD regulations implement section 18 of the United States Housing Act of 1937 (42 U.S.C. 1437p) (1937 Act), and are codified at 24 CFR part 970. A. Technical Corrections After publication, it came to HUD's attention that certain typographical and technical errors had occurred in items in the regulatory text. • 24 CFR 970.3(b)(4) (71 FR 62362). The phrase “incident to the normal operation * * *” found in this section should have read “incidental to the normal operation. * * *” This grammatical correction does not change the meaning or function of the paragraph and is a technical correction. • 24 CFR 970.3(b)(13) (71 FR 62363). Section 970.3(b)(13) refers to environmental review provisions, including the provisions at § 970.7(a)(16). The environmental provision is in paragraph (15), not paragraph (16), and therefore the intended reference should have been to § 970.7(a)(15). Section 970.7(a)(16) relates to civil rights. Because it is clear from the text that § § 970.7(a)(15) was the intended reference, this rule makes that technical correction. • 24 CFR 970.9(b)(3)(vi) (71 FR 62365). Paragraph (b)(3)(vi) paragraph is out of sequence and was therefore incorrectly and inadvertently designated. This paragraph is correctly redesignated as § 970.9(b)(3)(v). This change does not alter the meaning or function of the paragraph and is a technical correction. • 24 CFR 970.15(a) (71 FR 62367). This section makes a cross-reference to “the criteria for disapproval under 24 CFR 270.29.” There is no 24 CFR part 270. Furthermore, 24 CFR 970.29 is entitled “Criteria for disapproval of demolition or disposition applications.” The intended reference was to part 970. This reference is a typographical error and this rule corrects this error and references 24 CFR 970.29. • 24 CFR 970.27 (71 FR 62369). This section is missing a paragraph designation. The paragraph as published in the final rule is designated as § 970.27(1). However the correct designation is § 970.27(c)(1). This appears to have been the result of a GPO error. This rule makes that technical correction. List of Subjects in 24 CFR Part 970 Grant programs—housing and community development, Public housing, Reporting and recordkeeping requirements. The Catalog of Federal Domestic Assistance program number for the program affected by this final rule is 14.850. Accordingly, HUD correctly amends 24 CFR part 970 as follows: PART 970—PUBLIC HOUSING PROGRAM—DEMOLITION OR DISPOSITION OF PUBLIC HOUSING PROJECTS 1. The authority citation for part 970 continues to read as follows: Authority: 42 U.S.C. 1437p and 3535(d). § 970.3 [Amended] 2. Amend § 970.3 as follows: a. In paragraph (b)(4), revise the phrase “incident to the normal operation” to read “incidental to the normal operation;” and b. In paragraph (b)(13), revise the reference to “§§ 970.7(a)(16) and 970.13(b) of this part” with the reference “§§ 970.7(a)(15) and (b)(13) of this part.” § 970.9 [Amended] 3. In 970.9, redesignate paragraph (b)(3)(vi) as paragraph (b)(3)(v). § 970.15 [Amended] 4. In, § 970.15(a), revise the reference to “24 CFR 270.29” to read “24 CFR 970.29.” § 970.27 [Amended] 5. In § 970.27 redesignate paragraphs (b)(1) and (b)(2) as paragraphs (c)(1) and (c)(2), respectively. Dated: January 2, 2008. Orlando J. Cabrera, Assistant Secretary for Public and Indian Housing. [FR Doc. E8-1014 Filed 1-22-08; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 602 [TD 9377] RIN 1545-BF02 Application of Section 338 to Insurance Companies AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. SUMMARY: This document contains final regulations under section 197 of the Internal Revenue Code
(Code)that apply to a section 197 intangible resulting from an assumption reinsurance transaction, and under section 338 that apply to reserve increases after a deemed asset sale. The final regulations also provide guidance with respect to existing section 846(e) elections to use historical loss payment patterns. The final regulations apply to insurance companies. DATES: *Effective Date:* These regulations are effective on January 23, 2008. *Applicability Date:* For date of applicability of these regulations, see § 1.197-2(g)(5)(ii)(E), § 1.338-11(d)(7) and § 1.846-4(b). FOR FURTHER INFORMATION CONTACT: William T. Sullivan
(202)622-7052 or Donald J. Drees, Jr.
(202)622-3970 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collection of information in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-1990. The collection of information in these final regulations is in § 1.338-11(e)(2). This information is required by the IRS to allow an insurance company to choose to cease using its historical loss payment pattern, and instead use industry-wide factors, to discount unpaid losses. An agency may not conduct or sponsor, and the person is not required to respond to a collection of information unless the collection of information displays a valid control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax information are confidential, as required by 26 U.S.C. 6103. Background and Explanation of Provisions On March 8, 2002, the IRS and the Treasury Department published a notice of proposed rulemaking REG-118861-00 in the **Federal Register** (67 FR 10640) (2002-1 Cumulative Bulletin
(CB)651) (the 2002 proposed regulations) that set forth rules applying to taxable acquisitions and dispositions of insurance businesses, including those that are deemed to occur when an election under section 338 of the Code is made. (See § 601.601(d)(2)(ii)( *b* )). The CB is made available by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Written comments were received in response to the 2002 proposed regulations, and a public hearing was held. After consideration of all the comments, the IRS and the Treasury Department published final regulations in the **Federal Register** on April 10, 2006, (TD 9257) (71 FR 17990), as corrected in the **Federal Register** (TD 9257) (71 FR 26826) to remove an error that might have proven to be misleading. TD 9257 also contains temporary regulations under sections 197, 338, and 846, which serve as the basis for a cross-reference notice of proposed rulemaking published in the **Federal Register** (REG-146384-05) (71 FR 18053) with respect to issues that were the subject of comments on the 2002 proposed regulations. Specifically, § 1.197-2T(g)(5)(ii) provides guidance with regard to the interplay between section 197(f)(5) (concerning the treatment of certain reinsurance transactions) and section 848 (requiring the capitalization of certain policy acquisition expenses); § 1.338-11T(d) addresses reserve increases after a deemed asset sale that results from a section 338 election; and § 1.338-11T(e) provides guidance on the effect of a section 338 election on an insurance company's election under section 846(e) to use its historical loss payment pattern to discount certain unpaid losses. Although the 2002 proposed regulations generated a number of comments which are discussed in detail in the preamble to TD 9257, no new comments were received with respect to the temporary regulations that served as a cross-reference notice of proposed rulemaking in 2006. Accordingly, this Treasury decision adopts the proposed regulations without substantive change and removes the corresponding temporary regulations. This Treasury decision also revises cross-references where appropriate to reflect the removal of temporary regulations and their replacement with final regulations and corrects two obvious errors, one a mathematical error in the last sentence of § 1.381(c)(22)-1(b)(7)(v), Example 3, the other an error in the captioning of § 1.338(i)-1(c)(2)(ii)(B). 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 is hereby certified that the collection of information requirement in these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that these regulations do not have a substantial economic impact because they merely provide guidance about the operation of the tax law in the context of acquisitions of insurance companies and businesses. Moreover, they are expected to apply predominantly to transactions involving larger businesses. In addition, the collection of information requirement merely requires a taxpayer to prepare a written representation that contains minimal information relating to the making of an election. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Under section 7805(f) of the Code, the notice of proposed rulemaking preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Drafting Information The principal author of the final regulations is William T. Sullivan, Office of Chief Counsel (Financial Institutions and Products). However, other personnel from the IRS and the Treasury Department participated in the development of these regulations. List of Subjects 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. 26 CFR Part 602 Reporting and recordkeeping requirements. Adoption of Amendments to the Regulations Accordingly, 26 CFR parts 1 and 602 are amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 is amended by removing the entries for §§ 1.197-2T, 1.338-1T, and 1.338-11T to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.197-0 is amended by: 1. Revising the introductory text and the entries for § 1.197-2(g)(5)(ii). 2. Removing the entries for § 1.197-2T. The revisions read as follows: § 1.197-0 Table of contents. This section lists the headings that appear in § 1.197-2. § 1.197-2 Amortization of goodwill and certain other intangibles.
(g)* * *
(5)* * *
(ii)Determination of adjusted basis of amortizable section 197 intangible resulting from an assumption reinsurance transaction.
(A)In general.
(B)Amount paid or incurred by acquirer (reinsurer) under the assumption reinsurance transaction.
(C)Amount required to be capitalized under section 848 in connection with the transaction. ( *1* ) In general. ( *2* ) Required capitalization amount. ( *3* ) General deductions allocable to the assumption reinsurance transaction. ( *4* ) Treatment of a capitalization shortfall allocable to the reinsurance agreement. ( *i* ) In general. ( *ii* ) Treatment of additional capitalized amounts as the result of an election under § 1.848-2(g)(8). ( *5* ) Cross references and special rules.
(D)Examples
(E)Effective/applicability date. **Par. 3.** Section 1.197-2(g)(5)(ii) is revised to read as follows: § 1.197-2 Amortization of goodwill and certain other intangibles.
(g)* * *
(5)* * *
(ii)*Determination of adjusted basis of amortizable section 197 intangible resulting from an assumption reinsurance transaction* —(A) *In general* . Section 197(f)(5) determines the basis of an amortizable section 197 intangible for insurance or annuity contracts acquired in an assumption reinsurance transaction. The basis of such intangible is the excess, if any, of— ( *1* ) The amount paid or incurred by the acquirer (reinsurer) under the assumption reinsurance transaction; over ( *2* ) The amount, if any, required to be capitalized under section 848 in connection with such transaction.
(B)*Amount paid or incurred by acquirer (reinsurer) under the assumption reinsurance transaction* . The amount paid or incurred by the acquirer (reinsurer) under the assumption reinsurance transaction is— ( *1* ) In a deemed asset sale resulting from an election under section 338, the amount of the adjusted grossed-up basis
(AGUB)allocable thereto (see §§ 1.338-6 and 1.338-11(b)(2)); ( *2* ) In an applicable asset acquisition within the meaning of section 1060, the amount of the consideration allocable thereto (see §§ 1.338-6, 1.338-11(b)(2), and 1.1060-1(c)(5)); and ( *3* ) In any other transaction, the excess of the increase in the reinsurer's tax reserves resulting from the transaction (computed in accordance with sections 807, 832(b)(4)(B), and 846) over the value of the net assets received from the ceding company in the transaction.
(C)*Amount required to be capitalized under section 848 in connection with the transaction* —(1) *In general* . The amount required to be capitalized under section 848 for specified insurance contracts (as defined in section 848(e)) acquired in an assumption reinsurance transaction is the lesser of— ( *i* ) The reinsurer's required capitalization amount for the assumption reinsurance transaction; or ( *ii* ) The reinsurer's general deductions (as defined in section 848(c)(2)) allocable to the transaction.
(2)*Required capitalization amount* . The reinsurer determines the required capitalization amount for an assumption reinsurance transaction by multiplying the net positive or net negative consideration for the transaction by the applicable percentage set forth in section 848(c)(1) for the category of specified insurance contracts acquired in the transaction. See § 1.848-2(g)(5). If more than one category of specified insurance contracts is acquired in an assumption reinsurance transaction, the required capitalization amount for each category is determined as if the transfer of the contracts in that category were made under a separate assumption reinsurance transaction. See § 1.848-2(f)(7). ( *3* ) *General deductions allocable to the assumption reinsurance transaction* . The reinsurer determines the general deductions allocable to the assumption reinsurance transaction in accordance with the procedure set forth in § 1.848-2(g)(6). Accordingly, the reinsurer must allocate its general deductions to the amount required under section 848(c)(1) on specified insurance contracts that the reinsurer has issued directly before determining the general deductions allocable to the assumption reinsurance transaction. For purposes of allocating its general deductions under § 1.848-2(g)(6), the reinsurer includes premiums received on the acquired specified insurance contracts after the assumption reinsurance transaction in determining the amount required under section 848(c)(1) on specified insurance contracts that the reinsurer has issued directly. If the reinsurer has entered into multiple reinsurance agreements during the taxable year, the reinsurer determines the general deductions allocable to each reinsurance agreement (including the assumption reinsurance transaction) by allocating the general deductions allocable to reinsurance agreements under § 1.848-2(g)(6) to each reinsurance agreement with a positive required capitalization amount. ( *4* ) *Treatment of a capitalization shortfall allocable to the reinsurance agreement* —(i) *In general* . The reinsurer determines any capitalization shortfall allocable to the assumption reinsurance transaction in the manner provided in §§ 1.848-2(g)(4) and 1.848-2(g)(7). If the reinsurer has a capitalization shortfall allocable to the assumption reinsurance transaction, the ceding company must reduce the net negative consideration (as determined under § 1.848-2(f)(2)) for the transaction by the amount described in § 1.848-2(g)(3) unless the parties make the election provided in § 1.848-2(g)(8) to determine the amounts capitalized under section 848 in connection with the transaction without regard to the general deductions limitation of section 848(c)(2). ( *ii* ) *Treatment of additional capitalized amounts as the result of an election under § 1.848-2(g)(8)* . The additional amounts capitalized by the reinsurer as the result of the election under § 1.848-2(g)(8) reduce the adjusted basis of any amortizable section 197 intangible with respect to specified insurance contracts acquired in the assumption reinsurance transaction. If the additional capitalized amounts exceed the adjusted basis of the amortizable section 197 intangible, the reinsurer must reduce its deductions under section 805 or section 832 by the amount of such excess. The additional capitalized amounts are treated as specified policy acquisition expenses attributable to the premiums and other consideration on the assumption reinsurance transaction and are deducted ratably over a 120-month period as provided under section 848(a)(2). ( *5* ) *Cross references and special rules* . In general, for rules applicable to the determination of specified policy acquisition expenses, net premiums, and net consideration, see section 848(c) and (d), and § 1.848-2(a) and (f). However, the following special rules apply for purposes of this paragraph (g)(5)(ii)(C)— ( *i* ) The amount required to be capitalized under section 848 in connection with the assumption reinsurance transaction cannot be less than zero; ( *ii* ) For purposes of determining the company's general deductions under section 848(c)(2) for the taxable year of the assumption reinsurance transaction, the reinsurer takes into account a tentative amortization deduction under section 197(a) as if the entire amount paid or incurred by the reinsurer for the specified insurance contracts were allocated to an amortizable section 197 intangible with respect to insurance contracts acquired in an assumption reinsurance transaction; and ( *iii* ) Any reduction of specified policy acquisition expenses pursuant to an election under § 1.848-2(i)(4) (relating to an assumption reinsurance transaction with an insolvent insurance company) is disregarded.
(D)*Examples* . The following examples illustrate the principles of this paragraph (g)(5)(ii): *Example 1* .
(i)*Facts* . On January 15, 2006, P acquires all of the stock of T, an insurance company, in a qualified stock purchase and makes a section 338 election for T. T issues individual life insurance contracts which are specified insurance contracts as defined in section 848(e)(1). P and new T are calendar year taxpayers. Under §§ 1.338-6 and 1.338-11(b)(2), the amount of AGUB allocated to old T's individual life insurance contracts is $300,000. On the acquisition date, the tax reserves for old T's individual life insurance contracts are $2,000,000. After the acquisition date, new T receives $1,000,000 of net premiums with respect to new and renewal individual life insurance contracts and incurs $100,000 of general deductions under section 848(c)(2) through December 31, 2006. New T engages in no other reinsurance transactions other than the assumption reinsurance transaction treated as occurring by reason of the section 338 election.
(ii)*Analysis.* The transfer of insurance contracts and the assumption of related liabilities deemed to occur by reason of the election under section 338 is treated as an assumption reinsurance transaction. New T determines the adjusted basis under section 197(f)(5) for the life insurance contracts acquired in the assumption reinsurance transaction as follows. The amount paid or incurred for the individual life insurance contracts is $300,000. To determine the amount required to be capitalized under section 848 in connection with the assumption reinsurance transaction, new T compares the required capitalization amount for the assumption reinsurance transaction with the general deductions allocable to the transaction. The required capitalization amount for the assumption reinsurance transaction is $130,900, which is determined by multiplying the $1,700,000 net positive consideration for the transaction ($2,000,000 reinsurance premium less $300,000 ceding commission) by the applicable percentage under section 848(c)(1) for the acquired individual life insurance contracts (7.7 percent). To determine its general deductions, new T takes into account a tentative amortization deduction under section 197(a) as if the entire amount paid or incurred for old T's individual life insurance contracts ($300,000) were allocable to an amortizable section 197 intangible with respect to insurance contracts acquired in the assumption reinsurance transaction. Accordingly, for the year of the assumption reinsurance transaction, new T is treated as having general deductions under section 848(c)(2) of $120,000 ($100,000 + $300,000/15). Under § 1.848-2(g)(6), these general deductions are first allocated to the $77,000 capitalization requirement for new T's directly written business ($1,000,000 × .077). Thus, $43,000 ($120,000 − $77,000) of the general deductions are allocable to the assumption reinsurance transaction. Because the general deductions allocable to the assumption reinsurance transaction ($43,000) are less than the required capitalization amount for the transaction ($130,900), new T has a capitalization shortfall of $87,900 ($130,900 − $43,000) with regard to the transaction. Under § 1.848-2(g), this capitalization shortfall would cause old T to reduce the net negative consideration taken into account with respect to the assumption reinsurance transaction by $1,141,558 ($87,900 ÷ .077) unless the parties make the election under § 1.848-2(g)(8) to capitalize specified policy acquisition expenses in connection with the assumption reinsurance transaction without regard to the general deductions limitation. If the parties make the election, the amount capitalized by new T under section 848 in connection with the assumption reinsurance transaction would be $130,900. The $130,900 capitalized by new T under section 848 would reduce new T's adjusted basis of the amortizable section 197 intangible with respect to the specified insurance contracts acquired in the assumption reinsurance transaction. Accordingly, new T would have an adjusted basis under section 197(f)(5) with respect to the individual life insurance contracts acquired from old T of $169,100 ($300,000 − $130,900). New T's actual amortization deduction under section 197(a) with respect to the amortizable section 197 intangible for insurance contracts acquired in the assumption reinsurance transaction would be $11,273 ($169,100 ÷ 15). Example 2.
(i)*Facts.* The facts are the same as *Example 1,* except that T only issues accident and health insurance contracts that are qualified long-term care contracts under section 7702B. Under section 7702B(a)(5), T's qualified long-term care insurance contracts are treated as guaranteed renewable accident and health insurance contracts, and, therefore, are considered specified insurance contracts under section 848(e)(1). Under §§ 1.338-6 and 1.338-11(b)(2), the amount of AGUB allocable to T's qualified long-term care insurance contracts is $250,000. The amount of T's tax reserves for the qualified long-term care contracts on the acquisition date is $7,750,000. Following the acquisition, new T receives net premiums of $500,000 with respect to qualified long-term care contracts and incurs general deductions of $75,000 through December 31, 2006.
(ii)*Analysis.* The transfer of insurance contracts and the assumption of related liabilities deemed to occur by reason of the election under section 338 is treated as an assumption reinsurance transaction. New T determines the adjusted basis under section 197(f)(5) for the insurance contracts acquired in the assumption reinsurance transaction as follows. The amount paid or incurred for the insurance contracts is $250,000. To determine the amount required to be capitalized under section 848 in connection with the assumption reinsurance transaction, new T compares the required capitalization amount for the assumption reinsurance transaction with the general deductions allocable to the transaction. The required capitalization amount for the assumption reinsurance transaction is $577,500, which is determined by multiplying the $7,500,000 net positive consideration for the transaction ($7,750,000 reinsurance premium less $250,000 ceding commission) by the applicable percentage under section 848(c)(1) for the acquired insurance contracts (7.7 percent). To determine its general deductions, new T takes into account a tentative amortization deduction under section 197(a) as if the entire amount paid or incurred for old T's insurance contracts ($250,000) were allocable to an amortizable section 197 intangible with respect to insurance contracts acquired in the assumption reinsurance transaction. Accordingly, for the year of the assumption reinsurance transaction, new T is treated as having general deductions under section 848(c)(2) of $91,667 ($75,000 + $250,000/15). Under § 1.848-2(g)(6), these general deductions are first allocated to the $38,500 capitalization requirement for new T's directly written business ($500,000 × .077). Thus, $53,167 ($91,667 − $38,500) of general deductions are allocable to the assumption reinsurance transaction. Because the general deductions allocable to the assumption reinsurance transaction ($53,167) are less than the required capitalization amount for the transaction ($577,500), new T has a capitalization shortfall of $524,333 ($577,500 − $53,167) with regard to the transaction. Under § 1.848-2(g), this capitalization shortfall would cause old T to reduce the net negative consideration taken into account with respect to the assumption reinsurance transaction by $6,809,519 ($524,333 ÷ .077) unless the parties make the election under § 1.848-2(g)(8) to capitalize specified policy acquisition expenses in connection with the assumption reinsurance transaction without regard to the general deductions limitation. If the parties make the election, the amount capitalized by new T under section 848 in connection with the assumption reinsurance transaction would increase from $53,167 to $577,500. Pursuant to paragraph (g)(5)(ii)(C)( *4* ) of this section, the additional $524,333 ($577,500 − $53,167) capitalized by new T under section 848 would reduce new T's adjusted basis of the amortizable section 197 intangible with respect to the insurance contracts acquired in the assumption reinsurance transaction. Accordingly, new T's adjusted basis of the section 197 intangible with regard to the insurance contracts is reduced from $196,833 ($250,000 − $53,167) to $0. Because the additional $524,333 capitalized pursuant to the § 1.848-2(g)(8) election exceeds the $196,833 adjusted basis of the section 197 intangible before the reduction, new T is required to reduce its deductions under section 805 by the $327,500 ($524,333 − $196,833).
(E)*Effective/applicability date.* This section applies to acquisitions and dispositions of insurance contracts on or after April 10, 2006. § 1.197-2T [Removed] **Par. 4.** Section 1.197-2T is removed. **Par. 5.** Section 1.338-0 is amended by revising the entries for § 1.338-11(d) and
(e)to read as follows: § 1.338-0 Outline of topics. § 1.338-11 Effect of section 338 election on insurance company targets.
(d)Reserve increases by new target after the deemed asset sale.
(1)In general.
(2)Exceptions.
(3)Amount of additional premium.
(i)In general.
(ii)Increases in unpaid loss reserves.
(iii)Increases in other reserves.
(4)Limitation on additional premium.
(5)Treatment of additional premium under section 848.
(6)Examples.
(7)Effective/applicability date.
(i)In general.
(ii)Application to pre-effective date increases to reserves.
(e)Effect of section 338 election on section 846(e) election.
(1)In general.
(2)Revocation of existing section 846(e) election. **Par. 6.** Section 1.338-1 is amended by adding paragraph (b)(2)(vii) to read as follows: § 1.338-1 General principles; status of old target and new target.
(b)* * *
(2)* * *
(vii)Section 846(e) (relating to an election to use an insurance company's historical loss payment pattern). § 1.338-1T [Removed] **Par. 7.** Section 1.338-1T is removed. **Par. 8.** Section 1.338-11 is amended by revising paragraphs
(d)and
(e)to read as follows: § 1.338-11 Effect of section 338 election on insurance company targets.
(d)*Reserve increases by new target after the deemed asset sale* —(1) *In general.* If in new target's first taxable year or any subsequent year, new target increases its reserves for any acquired contracts, new target is treated as receiving an additional premium, which is computed under paragraph (d)(3) of this section, in the assumption reinsurance transaction described in paragraph (c)(1) of this section. New target includes the additional premium in gross income for the taxable year in which new target increases its reserves for acquired contracts. New target's increase in reserves for the insurance contracts acquired in the deemed asset sale is a liability of new target not originally taken into account in determining AGUB that is subsequently taken into account. Thus, AGUB is increased by the amount of the additional premium included in new target's gross income. See §§ 1.338-5(b)(2)(ii) and 1.338-7. Old target has no deduction under this paragraph
(d)and makes no adjustments under §§ 1.338-4(b)(2)(ii) and 1.338-7.
(2)*Exceptions.* New target is not treated as receiving additional premium under paragraph (d)(1) of this section if—
(i)It is under state receivership as of the close of the taxable year for which the increase in reserves occurs; or
(ii)It is required by section 807(f) to spread the reserve increase over the 10 succeeding taxable years.
(3)*Amount of additional premium* —(i) *In general.* The additional premium taken into account under this paragraph
(d)is an amount equal to the sum of the positive amounts described in paragraphs (d)(3)(ii) and (d)(3)(iii) of this section. However, the additional premium cannot exceed the limitation described in paragraph (d)(4) of this section.
(ii)*Increases in unpaid loss reserves.* The positive amount with respect to unpaid loss reserves is computed using the formula A/B × (C−[D + E]) where—
(A)A equals old target's discounted unpaid losses (determined under section 846) included in AGUB under paragraph 11(b)(1) of this section;
(B)B equals old target's undiscounted unpaid losses (determined under section 846(b)(1)) as of the close of the acquisition date;
(C)C equals new target's undiscounted unpaid losses (determined under section 846(b)(1)) at the end of the taxable year that are attributable to losses incurred by old target on or before the acquisition date;
(D)D (which may be a negative number) equals old target's undiscounted unpaid losses as of the close of the acquisition date, reduced by the cumulative amount of losses, loss adjustment expenses, and reinsurance premiums paid by new target through the end of the taxable year for losses incurred by old target on or before the acquisition date; and
(E)E equals the amount obtained by dividing the cumulative amount of reserve increases taken into account under this paragraph
(d)in prior taxable years by A/B.
(iii)*Increases in other reserves.* The positive amount with respect to reserves other than discounted unpaid loss reserves is the net increase of those reserves due to changes in estimate, methodology, or other assumptions used to compute the reserves (including the adoption by new target of a methodology or assumptions different from those used by old target).
(4)*Limitation on additional premium.* The additional premium taken into account by new target under paragraph (d)(1) of this section is limited to the excess, if any, of—
(i)The fair market value of old target's assets acquired by new target in the deemed asset sale (other than Class VI and Class VII assets); over
(ii)The AGUB allocated to those assets (including increases in AGUB allocated to those assets as the result of reserve increases by new target in prior taxable years).
(5)*Treatment of additional premium under section 848.* If a portion of the positive amounts described in paragraphs (d)(3)(ii) and
(iii)of this section are attributable to an increase in reserves for specified insurance contracts (as defined in section 848(e)), new target takes an allocable portion of the additional premium in determining its specified policy acquisition expenses under section 848(c) for the taxable year of the reserve increase.
(6)*Examples.* The following examples illustrate this paragraph (d): *Example 1.*
(i)*Facts.* On January 1, 2006, P purchases all of the stock of T, a non-life insurance company, for $120 and makes a section 338 election for T. On the acquisition date, old T has total reserve liabilities under state law of $725, consisting of undiscounted unpaid losses of $625 and unearned premiums of $100. Old T's tax reserves on the acquisition date are $580, which consist of discounted unpaid losses (as defined in section 846) of $500 and unearned premiums (as computed under section 832(b)(4)(B)) of $80. Old T has Class I through Class V assets with a fair market value of $800. Old T also has a Class VI asset with a fair market value of $75, consisting of the future profit stream of certain insurance contracts. During 2006, new T makes loss and loss adjustment expense payments of $200 with respect to the unpaid losses incurred by old T before the acquisition date. As of December 31, 2006, new T reports undiscounted unpaid losses of $475 attributable to losses incurred before the acquisition date. The related amount of discounted unpaid losses (as defined in section 846) for those losses is $390.
(ii)*Computation and allocation of AGUB.* Under § 1.338-5 and paragraph (b)(1) of this section, as of the acquisition date, AGUB is $700, reflecting the sum of the amount paid for old T's stock ($120) and the tax reserves assumed by new T in the transaction ($580). The fair market value of old T's Class I through V assets is $800, whereas the AGUB available for such assets under § 1.338-6 is $700. There is no AGUB available for old T's Class VI assets, even though such assets have a fair market value of $75 on the acquisition date.
(iii)*Adjustments for increases in reserves for unpaid losses.* Under paragraph
(d)of this section, new T must determine whether there are any amounts by which it increased its unpaid loss reserves that will be treated as an additional premium and an increase in AGUB. New T applies the formula of paragraph (d)(3) of this section, where A equals $500, B equals $625, C equals $475, D equals $425 ($625 − $200), and E equals $0. Under this formula, new T is treated as having increased its reserves for discounted unpaid losses attributable to losses incurred by old T by $40 ($500/$625 × ($475 − [$425 + 0]). The limitation under paragraph (d)(5) of this section based on the difference between the fair market value of old T's Class I through Class V assets and the AGUB allocated to such assets is $100. Accordingly, new T includes an additional premium of $40 in gross income for 2006, and increases the AGUB allocated to old T's Class I through Class V assets to reflect this additional premium. *Example 2.*
(i)*Facts.* Assume the same facts as in *Example 1.* Further assume that during 2007 new T deducts total loss and loss expense payments of $375 with respect to losses incurred by old T before the acquisition date. On December 31, 2007, new T reports undiscounted unpaid losses of $150 with respect to losses incurred before the acquisition date. The related amount of discounted unpaid losses (as defined in section 846) for those unpaid losses is $125.
(ii)*Analysis.* New T must determine whether any amounts by which it increased its unpaid losses during 2007 will be treated as an additional premium in paragraph (d)(3) of this section. New T applies the formula under paragraph (d)(3) of this section, where A equals $500, B equals $625, C equals $150, D equals $50 ($625 − $575), and E equals $50 ($40 divided by .8). In paragraph (d)(3) of this section, new T is treated as increasing its reserves for discounted unpaid losses by $40 during 2007 with respect to losses incurred by old T ($500/$625 × ($150−[$50 + $50]). New T determines the limitation of paragraph (d)(5) of this section by comparing the $800 fair market value of the Class I through V assets on the acquisition date to the $740 AGUB allocated to such assets (which includes the $40 addition to AGUB included during 2006). Thus, new T recognizes $40 of additional premium as a result of the increase in reserves during 2007, and adjusts the AGUB allocable to the Class I through V assets acquired from old T to reflect such additional premium. *Example 3.*
(i)*Facts.* The facts are the same as *Example 2* , except that on January 1, 2008, new T reinsures the outstanding liability with respect to losses incurred by old T before the acquisition date through a portfolio reinsurance transaction with R, another non-life insurance company. R agrees to assume any remaining liability relating to losses incurred by old T before the acquisition date in exchange for a reinsurance premium of $200. Accordingly, as of December 31, 2008, new T reports no undiscounted unpaid losses with respect to losses incurred by old T before the acquisition date.
(ii)*Analysis.* New T must determine whether any amount by which it increased its unpaid loss reserves will be treated as an additional premium under paragraph
(d)of this section. New T applies the formula of paragraph (d)(3) of this section, where A equals $500, B equals $625, C equals $0, and D equals −$150 ($625 − ($575 + $200), and E equals $100 ($80 divided by .8). Thus, new T is treated as having increased its discounted unpaid losses by $40 in 2008 with respect to losses incurred by old T before the acquisition date ($500/$625 × (0 −[−$150 + $100]). New T includes this positive amount in gross income, subject to the limitation of paragraph (d)(4) of this section. The limitation of paragraph (d)(4) of this section equals $20, which is computed by comparing the $800 fair market value of the Class I through V assets acquired from old T with the $780 AGUB allocated to such assets (which includes the $40 addition to AGUB in 2006 and the $40 addition to AGUB in 2007). Thus, New T includes $20 in additional premium, and increases the AGUB allocated to the Class I through V assets acquired from old T by $20. As a result of these adjustments, the limitation under paragraph (d)(4) of this section is reduced to zero.
(7)*Effective/applicability date* —(i) *In general.* This section applies to increases to reserves made by new target after a deemed asset sale occurring on or after April 10, 2006.
(ii)*Application to pre-effective date increases to reserves.* If either new target makes an election under § 1.338(i)-1(c)(2) or old target makes an election under § 1.338(i)-1(c)(3) to apply the rules of this section, in whole, to a qualified stock purchase occurring before April 10, 2006, then the rules contained in this section shall apply in whole to the qualified stock purchase.
(e)*Effect of section 338 election on section 846(e) election* —(1) *In general.* New target and old target are treated as the same corporation for purposes of an election by old target to use its historical loss payment pattern under section 846(e). See § 1.338-1(b)(2)(vii). Therefore, if old target has a section 846(e) election in effect on the acquisition date, new target will continue to use the historical loss payment pattern of old target to discount unpaid losses incurred in accident years covered by the election, unless new target elects to revoke the section 846(e) election. In addition, new target may consider old target's historical loss payment pattern when determining whether to make the section 846(e) election for a determination year that includes or is subsequent to the acquisition date.
(2)*Revocation of existing section 846(e) election.* New target may revoke old target's section 846(e) election to use its historical loss payment pattern to discount unpaid losses. If new target elects to revoke old target's section 846(e) election, new target will use the industry-wide patterns determined by the Secretary to discount unpaid losses incurred in accident years beginning on or after the acquisition date through the subsequent determination year. New target may revoke old target's section 846(e) election by attaching a statement to new target's original tax return for its first taxable year. § 1.338-11T [Removed] **Par. 9.** Section 1.338-11T is removed. **Par. 10.** Section 1.338(i)-1 is amended by: 1. Revising the section heading to read as set forth below. 2. Redesignating paragraph (c)(2)(ii)( *b* ) as paragraph (c)(2)(ii)(B). The revisions read as follows: § 1.338(i)-1 Effective/applicability date. **Par. 11.** Section 1.381(c)(22)-1(b)(7)(v) is amended by revising the last sentence of *Example 3* to read as follows: § 1.381(c)(22)-1 Successor life insurance company.
(b)* * *
(7)* * *
(v)* * * *Example 3.* * * * In that case, in the taxable year of the indemnity reinsurance transaction, S takes into account as ordinary income the portion of the old T's accounts ($1) that old T or S has not previously taken into account as income. § 1.846-0 [Amended] **Par. 12.** Section 1.846-0 is amended by removing the entries for §§ 1.846-2T and 1.846-4T. **Par. 13.** Section 1.846-2(d) is revised to read as follows: § 1.846-2 Election by taxpayer to use its own historical loss payment pattern.
(d)*Effect of section 338 election on section 846(e) election.* For rules regarding qualified stock purchase occurring on or after April 10, 2006, see §§ 1.338-1(b)(2)(vii) and 1.338-11(e). **Par. 14.** Section 1.846-4 is amended by revising the section heading and paragraph
(b)to read as follows: § 1.846-4 Effective/applicability date.
(b)*Section 338 election.* Section 1.846-2(d) applies to section 846(e) elections made with regard to a qualified stock purchase made on or after April 10, 2006. **Par. 15.** For each entry in the “Section” column remove the phrase in the “Remove” column and add the phrase in the “Add” column in its place. Section Remove Add § 1.338(i)-1(c)(2)(i) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(2)(i) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(2)(ii) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(2)(ii) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(2)(ii)(B) (First sentence) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(2)(ii)(B) (First sentence) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(2)(ii)(B) (Second sentence) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(2)(ii)(B) (Second sentence) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(3)(i) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(3)(i) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(3)(ii) §§ 1.338-11 and1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(3)(ii) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(3)(ii)(B) (First sentence) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(3)(ii)(B) (First sentence) 1.197-2T(g)(5)(ii), § 1.338(i)-1(c)(3)(ii)(B) (Second sentence) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.338(i)-1(c)(3)(ii)(B) (Second sentence) 1.197-2T(g)(5)(ii), § 1.1060-1(a)(2)(i) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.1060-1(a)(2)(i) 1.197-2T(g)(5)(ii), § 1.1060-1(a)(2)(ii) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.1060-1(a)(2)(ii) 1.197-2T(g)(5)(ii), § 1.1060-1(a)(2)(ii)(B) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.1060-1(a)(2)(ii)(B) 1.197-2T(g)(5)(ii), § 1.1060-1(a)(2)(iii) §§ 1.338-11T(d) and 1.338-11T(d) § 1.338-11(d) § 1.1060-1(a)(2)(iii) 1.197-2T(g)(5)(ii), § 1.1060-1(a)(2)(iii)(B) §§ 1.338-11 and 1.338-11T(d) § 1.338-11 § 1.1060-1(a)(2)(iii)(B) 1.197-2T(g)(5)(ii), PART 602—OMB CONTROL NUMBERS UNDER PAPERWORK REDUCTION ACT **Par. 16.** The authority citation for part 602 continues to read as follows: Authority: 26 U.S.C. 7805. **Par. 17.** In § 602.101, paragraph
(b)is amended by removing the entry for § 1.338-11T from the table and adding an entry to the table in numerical order to read as follows: § 602.101 OMB Control numbers.
(b)* * * CFR part or section where identified and described Current OMB control No. * * * * * 1.338-11 1545-1990 * * * * * Linda Stiff, Deputy Commissioner for Services and Enforcement. Approved: January 9, 2008. Eric Solomon, Assistant Secretary of the Treasury (Tax Policy). [FR Doc. E8-729 Filed 1-22-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR PART 72 RIN 0920-AA19 Interstate Shipment of Etiologic Agents AGENCY: Centers for Disease Control and Prevention (CDC), HHS. ACTION: Final rule. SUMMARY: HHS is removing Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation
(DOT)already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations
(UN)Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule eliminates duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. Removal of Part 72 alleviates confusion and reduces the regulatory burden with no anticipated adverse impact on public health and safety. DATES: *Effective Date:* This final rule is effective 30 days after publication in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Dr. Janet K. Nicholson, National Center for Infectious Diseases/OD, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1600 Clifton Rd., NE (MS-D10), Atlanta, GA 30333; *telephone:* 404-639-2100; e-mail *jkn1@cdc.gov.* SUPPLEMENTARY INFORMATION: On January 3, 2007, HHS published a notice of proposed rulemaking
(NPRM)to remove Part 72 of Title 42 of the Code of Federal Regulations. The comment period for the proposed rule closed on March 5, 2007. HHS received no comments on the proposed rule. With minor modification for clarification, this supplementary information is the same as was in the NPRM. Part 72 (being removed by this final rule) provides minimal requirements for packaging and shipping materials, including diagnostic specimens and biological products, reasonably believed to contain an etiologic agent. It provides more detailed requirements, including labeling, for materials containing certain etiologic agents, with a list of the biological agents and toxins provided. For agents on the list, the rule requires reporting to HHS/CDC damaged packages and packages not received. The rule also requires sending certain agents on the list by registered mail or an equivalent system. 42 CFR 72, as currently promulgated, is out-of-date, and duplicates more current regulations of DOT. Further, the regulation is inconsistent with the procedures of other transport governing bodies, such as the International Civil Aviation Organization
(ICAO)and the International Air Transport Association (IATA), for air, and the U.S. Postal Service for ground. Section 72.6, a major portion of 42 CFR 72 that dealt with transporting select agents, was superseded by the issuance of an Interim Final Rule for 42 CFR part 73 on December 13, 2002 (67 FR 76886). Part 73 implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 for transporting select agents. The continued existence of the remaining provisions of the out-of-date HHS/CDC regulation is confusing to the packaging and transport communities. The provisions serve no useful purpose that merits their retention. HHS/CDC will remain available for consultation on and response to public-health issues and emergencies, in accordance with its normal duties in the interest of public health and safety. Transition From HHS to DOT Regulations DOT has the primary statutory authority to regulate the safe and secure transportation of all hazardous materials, including infectious materials, shipped in intrastate, interstate, and foreign commerce. The etiologic agents covered by 42 CFR part 72 are considered to be hazardous materials, and, in practice, the DOT regulations, 49 CFR 171-180, have superseded 42 CFR part 72 since DOT began including more specific regulations on infectious substances. The earlier versions of the DOT regulations on etiologic agents were based on and virtually identical to the HHS regulations. These regulations have been modified over time, as necessary, to continue to provide protection for persons who handle shipments with as few impediments as possible to quick shipment. In 1990, DOT authorized the term “infectious substance” as synonymous with “etiologic agent.” In 1991, DOT expanded the definition of “etiologic agent” to include agents listed in 42 CFR part 72, plus others that cause or could cause severe, disabling or fatal human disease, thereby including agents such as human immunodeficiency virus that were not on the HHS list. DOT also issued expanded packaging requirements at that same time. In 1994 and 1995, DOT worked with other Federal agencies (including HHS/CDC, the HHS/Food and Drug Administration, the Occupational Safety and Health Administration, and the Environmental Protection Agency) to minimize differences between the DOT regulations and other Federal regulations on regulated medical waste, and to ease compliance and eliminate gaps to assure safety. United Nations Recommendations and Model Regulations The United Nations
(UN)publishes its Recommendations on the Transport of Dangerous Goods and Model Regulations, here described as the “UN Model Regulations” or “model regulations,” on a biennial basis. The model regulations are developed by the Committee of Experts on the Transport of Dangerous Goods of the UN Economic and Social Council. Although regulations for transporting infectious substances have existed in all of the editions of the UN Model Regulations, those for infectious medical waste were first adopted in December 1996, in the 10th Revised Edition. The purpose of the Model Regulations is to present a basic scheme of provisions that will allow uniform development of national and international regulations that govern the various modes of transport, thereby facilitating worldwide harmonization. In 1997, the World Health Organization
(WHO)published “Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens,” prepared by the Directors of WHO Collaborating Centers for Biosafety and other advisers to provide practical guidance to facilitate compliance with international standards. HHS/CDC has a WHO Collaborating Center for Biosafety and Training, and has provided consultation to the WHO Secretariat and to the Committee of Experts on infectious-substance issues and the development of the UN Model Regulations. DOT has also worked with the Committee of Experts, and over time has harmonized the DOT regulations with the UN Model Regulations. In October 2001, the WHO convened a meeting, which included infectious-disease and biosafety experts, to consider guidance needed for the safe transport of infectious substances, and to identify the infectious substances that need to be subject to transport regulation. The meeting developed a consensus document and presented it to the UN Committee of Experts. Subsequent deliberations resulted in development and publication of revised requirements for transporting of infectious substances in the 13th Revised Edition of the UN Model Regulations in 2004. These model regulations recommended a new classification scheme of categories A and B, based on risk during transport, instead of risk that occurs primarily in the laboratory. The WHO and the Committee of Experts assessed the risk of infection by pathogens in the transport setting and, with review by HHS/CDC and other public-health experts and scientists, refined the list of Category A agents of concern. This list is not exhaustive. Category A includes “an infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals.” Category B includes “an infectious substance which does not meet the criteria for inclusion in Category A.” Packaging requirements were clarified and simplified for each category. The “Infectious Substances” portion of the 14th Revised Edition of the UN Model Regulations, adopted in December 2004 and published in 2005, is very similar to the 13th Edition. The new edition adds a definition for “patient specimens”; adds “cultures only” to several microorganisms on the infectious-substances list for Category A; clarifies shipping names and labeling; and clarifies exemptions from regulations. In September 2005, the WHO Secretariat published “Guidance on Regulations for the Transport of Infectious Agents” (WHO/CDS/CSR/LYO/2005.22) which combined into one document the component parts of the 13th and 14th Revised Editions of the UN Model Regulations. Harmonization of DOT Regulations With UN/WHO Publications The DOT Notice of Proposed Rulemaking (NPRM), published on January 22, 2001 (66 FR 6941), for public comment, and the final rule, published on August 14, 2002 (67 FR 53118), which became effective on October 1, 2002, revised definitions and adopted packaging requirements consistent with international standards. The DOT final rule incorporated new classification criteria (WHO Risk Groups 1-4 at that time) for infectious substances, diagnostic specimens, biological products, genetically modified organisms and microorganisms, and medical wastes—consistent with the 12th Revision of the UN Model Regulations of 2001. Among other changes, the final rule revised packaging requirements for toxic and infectious substances consistent with the international performance standards. HHS/CDC and other relevant Federal agencies reviewed the DOT proposals before final publication. The DOT Notice of Proposed Rulemaking (NPRM), published on May 19, 2005 (70 FR 29170), further harmonized the DOT regulations with the 13th and 14th Revised Editions of the UN Model Regulations. DOT developed a final rule after consideration of comments received from the public, including the affected commercial, research, public-health, medical, and transport communities, and after discussion with other relevant Federal regulating authorities. The final rule was published on June 2, 2006 (71 FR 32244) and became effective on October 1, 2006. The DOT final rule is almost entirely consistent with the UN Model Regulations. One non-substantive difference is that the final rule retains the definition of “biological products” that is more consistent with the definition used by HHS/FDA and other Federal agencies. Specimens With Low Likelihood of Pathogens The DOT final rule also exempts from regulation human and animal specimens for which there is minimal likelihood that pathogens are present. The UN Model Regulations recommend exemption if the specimen is transported in a package (three components) that will prevent any leakage; is of adequate strength for its capacity, mass, and intended use; and is marked as an exempt specimen. The DOT regulations do not specify any packaging requirement for these specimens with minimal likelihood that pathogens are present. The requirement for triple packaging for these specimens, however, is included in the requirements issued by other transport-governing organizations. For example, the U.S. Postal Service Domestic Mail Manual
(DMM)requires special packaging (not subject to performance requirements it prescribes for infectious substances) for liquid diagnostic specimens that would not meet the current definitions for a Category A or B infectious substance. This packaging is consistent with the packaging recommended in the UN Model Regulations, except that for specimens that do not exceed 50 ml. the second leak-proof container may serve as the shipping container if it has enough strength to withstand ordinary postal processing. The ICAO Technical Instructions (ICAO TI) govern virtually all shipments transported internationally by air, and the majority of U.S. domestic air shipments. Addendum No. 2 to ICAO TI (Doc. 9284), issued on June 30, 2005, includes almost verbatim the language from the UN Model Regulations regarding exempt specimens, except that the UN made recommendations for packaging and the ICAO TI requires the packaging specifications. IATA does the same in Addendum III, posted on July 5, 2005, to the 46th Edition of IATA Dangerous Goods Regulations. Inclusion of the triple-packaging provision by these organizations covers virtually all shipment in commerce of routine patient specimens and biological products for which there is little likelihood of containing an infectious substance. Section by Section—Comments on Removal HHS provides a section-by-section rationale for removing the remaining portions of 42 CFR 72. Section 72.1 Definitions Current definitions consistent with UN/WHO recommendations are provided in the DOT rule that applies to intra-state and international as well as interstate transport in commerce. Section 72.2 Transportation of Diagnostic Specimens, Biological Products, and Other Materials; Minimum Packaging Requirements Section 72.2 provides that diagnostic specimens and biologic products which the shipper “reasonably believes may contain an etiologic agent” must be “packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.” The detailed DOT packaging requirements for Categories A and B have superseded this very general requirement. The term “infectious substance” has replaced “etiologic agent” in the UN Model Regulations, and in the DOT and other applicable regulations. Those regulations define “infectious substance” as a “material known or reasonably expected to contain a pathogen.” The DOT regulations define pathogens into two categories. Category A is an “infectious substance in a form that is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.” Category B is an infectious substance that does not meet the criteria for Category A. The DOT final rule exempts a “material that has a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the environment so it cannot cause disease when exposure to it occurs.” As stated above, leak-proof packaging of adequate strength is required for these materials by the U.S. Postal Service, ICAO, and IATA. The DOT final rule provides for classifying and shipping as a Category A or B a biological product “known or reasonably expected” to contain a pathogen that meets the criteria for either category, thereby covering, when transported in commerce, those same substances covered by the original intent of section 72.2. Further, the HHS rule covered the substances only in transport from one State to another or from one State through another State and back to the State of origin. The DOT regulations cover transport in commerce within State, and in international commerce, as well as from State-to-State. Section 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements This section provided a list of specific agents that cannot be shipped in interstate traffic, unless packaged, labeled, and shipped in accordance with the requirements specified in the section. Neither the list of agents, nor the packaging, labeling, and shipping requirements, have been kept up-to-date, and have now become outdated because of the extensive process undertaken biennially by the UN Committee of Experts on the Transport of Dangerous Goods and the harmonization of the DOT regulations with the resultant UN Model Regulations and the WHO “Guidance on the Transport of Infectious Substances.” The HHS/CDC WHO Collaborating Center for Biosafety was a partner in that effort. The indicative list included in the preamble of the June 2, 2006, DOT final rule differs from the list in the UN Model Regulations in the 14th Revised Edition in only two instances. The DOT list does not include hepatitis B virus (cultures only), and it includes “and other lyssaviruses” as part of the rabies listing. All microorganisms on the DOT list, and other infectious substances that meet the criteria for Category A, are to be packaged and shipped as Category A infectious substances. A comprehensive discussion of the new method of categorizing substances as Category A or B for purposes of transportation can be found in the previously referenced DOT final rule entitled “Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations; Final Rule” (71 FR 32244, June 2, 2006). HHS/CDC encourages all interested persons to read the DOT final rule for a more comprehensive understanding of the new method of categorizing and defining a Category A material, and to review the substances it lists in its preamble that meet the Category A definition. The DOT included this list as a guide (not all-inclusive) of infectious substances the WHO and HHS determined are examples of Category A agents. In brief, the UN Committee of Experts on the Transport of Dangerous Goods, with the input of HHS/CDC, the WHO Secretariat, and others, developed a classification scheme more suited for the risks inherent in transport as opposed to risks in the laboratory. The previous system of four risk groups, with “4” as the highest risk, was developed primarily to protect workers in the laboratory environment. The new Category A includes an infectious substance transported in a form that is capable of causing permanent disability or life-threatening or fatal disease to otherwise healthy humans or animals when exposure to it occurs. It includes substances previously categorized in Risk Group 4 and some in Risk Groups 2 and 3. Category B includes infectious substances (diagnostic or clinical specimens) that do not meet the criteria for Category A. HHS also encourages the public to review the current packaging requirements provided in the 2006 DOT final rule cited above, as well as those published in the DOT's final rule entitled “Revisions to Standards for Infectious Substances” published in the **Federal Register** (67 FR 53118, August 14, 2002). The requirements are consistent with the requirements adopted by the UN, and have been refined over time to be more specific than the older HHS requirements, with some liquid-volume changes from those specified in 72.2(a) and (b). Another example of refinement is that the DOT regulations require the outer packaging to release carbon dioxide gas when dry ice (72.2(c)) is used, while maintaining structural integrity of the package. 72.3(d) describes a label that is required on the outer shipping container for etiologic agents transported in interstate traffic. The UN Model Regulations have also described a label that can be recognized for transport of these agents anywhere in the world. With harmonization of the DOT regulations with the international regulations, the label required in this section of the HHS regulation is duplicative, and no longer necessary. 72.3(e) required reporting of damaged packages to HHS. The label mentioned above included the statement: “In case of damage or leakage, notify Director CDC,” and a telephone number was provided. Reporting over the years has been sporadic, and has served little direct purpose. The attention to the importance of preventing leakage and preventing exposure has resulted in the benefit that most carriers have cleanup procedures in place, and most reports are made after the persons involved have followed the company procedures for cleanup. Having procedures in place, such as the U.S. Postal Service has, is preferable to relying on a call to HHS to obtain directions. Moreover, the DOT regulations (at 49 CFR 171.15 and 171.16) require carriers to report transportation incidents that involve infectious substances. Immediate reporting by telephone is required for incidents where fire, breakage, spillage, or suspected contamination occurs that involves the shipment of infectious substances (see 49 CFR 171.15(a) (3)). In addition, a written report is required for any unintentional release of hazardous materials from a packaging during transportation; including those covered under 49 CFR 171.15 (see 49 CFR 171.16(a)). Additional reporting of incidents to HHS is redundant and unnecessary. The DOT regulations permit a carrier to provide telephoned incident reports to HHS instead of DOT. For consistency, we will ask the DOT to consider amending this provision of its regulations after rescission of Part 72. DOT regulations require packages that contain infectious substances to be labeled to indicate the infectious hazard (see 49 CFR 172.434 for a depiction of the required label). The label currently includes this statement: “In case of damage or leakage immediately notify public health authority. In USA, notify Director—CDC; Atlanta, GA; 1-800-232-0124.” We will also ask the DOT to consider revising the INFECTIOUS SUBSTANCE label after rescission of Part 72. The WHO “Guidance on Regulations for the Transport of Infectious Substances,” September 2005, provides specific recommended procedures for spill cleanup. This Guidance is available to the agencies that govern land, vessel, and air shipments. The recommended procedures reflect those contained in the WHO Laboratory Biosafety Manual, Third Edition, 2004. As discussed below, the DOT regulations provide criteria for incident reporting. The HHS regulation requires reporting of “damaged packages” without additional criteria for reporting. Nothing will be lost by withdrawing this requirement for immediate and routine reporting of damaged packages. Although routine reporting to HHS will not be required by regulation after the effective date of this final rule to remove Part 72, HHS will remain available for consultation on and in response to public-health issues and emergencies, in accordance with its normal duties in the interest of public health and safety. As part of this support, HHS will maintain the current reporting telephone number on a 7 day/24 hour basis in order to assist DOT with the management of suspected exposures. HHS/CDC and the HHS/National Institutes of Health revised the manual “Biosafety in Microbiological and Biomedical Laboratories” in 2007. Although Annex B of this 5th Edition is concerned with decontamination and disinfection primarily in the laboratory environment, it could be useful to organizations responsible for transporting packages. Having clean-up procedures in place is the most important element of response to a damaged package. The WHO publishes a “Laboratory Biosafety Manual” that includes a simpler list of procedures for spill clean-up in the section on transport of infectious substances. 72.3(f) Registered mail or an equivalent system. This section lists several agents that are required to be shipped by registered mail or an equivalent system, with required notification of receipt. All but one of these agents (Histoplasma capsulatum) is included on the list of select agents and toxins covered by 42 CFR part 73. 42 CFR part 73 establishes more strict requirements for transfer of these agents. The sender and recipient must have a certificate of registration for the agent. A form is submitted to HHS for approval of the transfer. Packaging and shipping must comply with all applicable requirements for Category A agents, including those of the DOT. The recipient must notify the sender and HHS of receipt within 2 business days or of non-receipt within 48 hours after expected time of receipt. As a result of these requirements, the requirement for registered mail for these agents is no longer applicable. Section 72.4 Notice of Delivery; Failure To Receive This section required notification of the Director of HHS of non-delivery within five days of expected delivery of the select agents or toxins listed in 72.3(f). As stated above, 42 CFR part 73 provides more strict notification requirements for these agents. Notification is required of non-delivery within 48 hours of expected delivery time; also submission of a form confirming receipt is required within two business days of receipt of a select agent or toxin. The amendment published on March 18, 2005 (70 FR 13316), which conformed this section to the new 42 CFR part 73, is no longer necessary, and is removed. Section 72.5 Requirements; Variations This section allowed the Director of HHS to approve variations in requirements if protection remains equivalent. No variations have been approved that DOT has not also approved. Removal of the rule eliminates the basis of necessity for the Director of HHS to have such authority. Section 72.6 Additional Requirements for Facilities Transferring or Receiving Select Agents This entire section, 72.6(a)-(j), was replaced or amended by publication by HHS in the **Federal Register** of 42 CFR part 73, “Possession, Use, and Transfer of Select Agents and Toxins,” as Interim Final Rules on December 13, 2002 (67 FR 76886), and November 3, 2003 (68 FR 62245), and as a Final Rule on March 18, 2005 (70 CFR 13294), with an effective date of April 18, 2005. These rulemakings also replaced the list of agents at “Appendix A to Part 72—Select Agents,” as well as the “Exemptions” section following the Appendix. The amendments published on March 18, 2005 (70 FR 13316), which conformed section 72.6(h) and Appendix A to 42 CFR 73, are no longer needed, and are removed by this final rule. Section 72.7 Penalties Penalties were specified for violations of this part, with stronger penalties for violations related to select agents. Similar penalties for violations of provisions of part 73 related to select agents have been specified by revision to 42 CFR Part 1003—Civil Money Penalties, Assessments and Exclusions. The DOT regulations provide for penalty for non-compliance, as do ICAO and other entities with instructions or regulations regarding transport of infectious substances. Authority The HHS regulation of the interstate transfer of etiologic agents is based on the general authority found in Section 264 of Title 42, United States Code, Regulations to Control Communicable Diseases, in Part G, Quarantine and Inspection. The HHS considers the intrastate, interstate, and international regulations of the DOT and UN Model Regulations for transporting infectious substances to include the majority of the HHS's etiologic agents covered under its authority. Regulatory Analysis Rescinding Part 72 reduces the regulatory burden on affected entities. The DOT Hazardous Materials Transportation regulations and the HHS Select Agent regulations already apply, and shippers are following them. DOT and HHS have completed the required analyses for rules that supersede the rule being removed, and which are already in effect. Eliminating this Federal regulation is beneficial to the regulated community by alleviating confusion and duplication. HHS does not anticipate the removal to have any impact on other Federal programs involved in transport of materials that are reasonably believed to contain infectious substances, such as the HHS/CDC Import Permit Program; the HHS/CDC Clinical Laboratories Improvement Program; the HHS/CDC Select Agent Program; and various research programs of HHS/NIH and HHS/FDA and other Agencies. Agencies will need to review and update references in their guidance and regulating documents to reflect changes brought about by this final rule. Paperwork Reduction Act This final rule does not impose any new information-collection requirements, and does not invoke any issues that make it subject to the Paperwork Reduction Act. The only impact of removal of 42 CFR part 72 is to reduce burden. It eliminates specification for a second label to be attached to the outer shipping container. This label is no longer needed since it duplicates the label recommended by the UN Model Regulations, and adopted by DOT and other organizations (such as ICAO, IATA, and the U.S. Postal Service) that govern shipments of infectious substances. Impact of paperwork previously involved with sections that dealt with notice of delivery or failure to receive (72.4) is insignificant because HHS has rarely received such paperwork. Consequently, the removal of 42 CFR part 72 will eliminate the need for the duplicative labeling requirements and the collection of data associated with the notice of delivery or failure to receive packages. However, the removal of 42 CFR 72 does not eliminate the provisions set forth in Subpart F (Importations) of the Foreign Quarantine Regulations (42 CFR part 71), which contains provisions for importation of etiologic agents, hosts, and vectors (See 42 CFR 71.54). Specifically, this provision requires persons that import or distribute after importation these materials to obtain a permit issued by the CDC (OMB Control Number 0920-0199). Executive Order 12866 and Regulatory Flexibility Act Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget unless OMB waives such review, as any regulatory action that is likely to result in a rule that may:
(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(2)Create a serious inconsistency or interfere with an action taken or planned by another agency;
(3)Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4)Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and the regulatory action has been deemed to be “ a significant regulatory action” under the Executive Order because removal of this regulation will eliminate confusing and potentially contradictory regulatory requirements which should benefit the regulated community. Regulatory Flexibility Act The HHS Secretary hereby certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Executive Order 12988 This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget. Executive Order 13132 This final rule does not include any regulation that preempts State, local and Indian tribe requirements, or that has any substantial direct effects on the States, relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. List of Subjects in 42 CFR Part 72 Biologics, Hazardous materials transportation, Packaging and containers, Penalties, Transportation. For the reasons set forth in the preamble and under the authority of 42 U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559, 3571, and 42 U.S.C. 262 note, the Department of Health and Human Services amends title 42 (Public Health) of the Code of Federal Regulations by removing part 72 (Interstate Shipment of Etiologic Agents). PART 72—[REMOVED AND RESERVED] Dated: August 15, 2007. Julie Louise Gerberding, Director, Centers for Disease Control and Prevention. Dated: October 11, 2007. Michael O. Leavitt, Secretary. [FR Doc. E8-1050 Filed 1-22-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 070213033-7033-01] RIN 0648-XF14 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Processors Using Pot Gear in the Bering Sea and Aleutian Islands Management Area AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. SUMMARY: NMFS is prohibiting directed fishing for Pacific cod by pot catcher processors in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the A season allowance of the 2008 Pacific cod allowable catch
(TAC)specified for pot catcher processors in the BSAI. DATES: Effective 1200 hrs, Alaska local time (A.l.t.), January 20, 2008, though 1200 hrs, A.l.t., June 10, 2008. FOR FURTHER INFORMATION CONTACT: Jennifer Hogan, 907-586-7228. SUPPLEMENTARY INFORMATION: NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area
(FMP)prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. The A season directed fishing allowance of the 2008 Pacific cod TAC allocated to pot catcher processors in the BSAI is 862 metric tons as established by the 2007 and 2008 final harvest specifications for groundfish in the BSAI (72 FR 9451, March 2, 2007) and revision (72 FR 71802, December 19, 2007). See § 679.20(c)(3)(iii), § 679.20(c)(5), and § 679.20(a)(7)(ii). In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS, has determined that the A season allowance of the 2008 Pacific cod TAC allocated to pot catcher processors in the BSAI has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by pot catcher processors in the BSAI. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and
(f)apply at any time during a trip. Classification This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by pot catcher processors in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 16, 2008. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment. This action is required by § 679.20 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: January 16, 2008. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 08-242 Filed 1-17-08; 2:31 pm]
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register
CFR
- Random drug testing requirements and identification of testing designated positions.§ 707.7
- Submission, approval, and implementation of a baseline workplace substance abuse program.§ 707.5
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- Applicability.§ 970.3
- Resident participation---consultation and opportunity to purchase.§ 970.9
- Specific criteria for HUD approval of demolition requests.§ 970.15
- Criteria for disapproval of demolition or disposition applications.§ 970.29
- De minimis exception to demolition requirements.§ 970.27
U.S. Code
- Rule making§ 553
- Definitions§ 601
- Purposes§ 3501
- Rules and regulations§ 3516
- SHORT TITLE.§ 801
- Congressional findings§ 2012
- Abolition and transfers§ 5814
- General transfers§ 7151
- Establishment and mission§ 2401
- Federal Aviation Administration§ 106
- Demolition and disposition of public housing§ 1437p
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Confidentiality and disclosure of returns and return information§ 6103
- Rules and regulations§ 7805
- Regulations to control communicable diseases§ 264
- SHORT TITLE.§ 9701
- Sentencing classification of offenses§ 3559
- Regulation of biological products§ 262
- Findings, purposes and policy§ 1801
26 references not yet in our index
- 10 CFR 707
- 10 CFR 712
- Pub. L. 104-4
- Pub. L. 105-277
- 41 USC 701
- 14 CFR 39
- 24 CFR 970
- 24 CFR 270.29
- 24 CFR 270
- T.D. 9377
- T.D. 9257
- 26 CFR 1
- 26 CFR 602
- 42 CFR 72
- 42 CFR 73
- 49 CFR 171
- 49 CFR 171.15
- 49 CFR 171.15(a)
- 49 CFR 171.16(a)
- 49 CFR 172.434
- 70 CFR 13294
- 42 CFR 1003
- 42 CFR 71
- 42 CFR 71.54
- 50 CFR 679
- 50 CFR 600
Citation graph
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Notices
Final rule
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Cite10 CFR 712
Pub. L.Pub. L. 104-4
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