Unknown. Final rule; technical amendments

4,807 words·~22 min read·/register/2005/06/23/05-12394

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

--- schema: federal-register doc_type: fedreg source_file: FR-2005-06-23.xml --- 70 120 Thursday, June 23, 2005 Contents AID Agency for International Development RULES Protection of human subjects; Federal policy, 36325-36328 05-12394 Agricultural Agricultural Research Service NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive: iSoy Technologies Corp., 36367-36368 05-12398 Agriculture Agriculture Department See Agricultural Research Service See Animal and Plant Health Inspection Service See Forest Service RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Agency information collection activities; proposals, submissions, and approvals, 36367 05-12434 Alcohol Alcohol and Tobacco Tax and Trade Bureau PROPOSED RULES Alcoholic beverages: Labeling and advertising; wines, distilled spirits, and malt beverages, 36359-36360 05-12396 Animal Animal and Plant Health Inspection Service RULES Livestock and poultry disease control: Highly pathogenic avian influenza; additional restrictions, 36332-36333 05-12435 Plant-related quarantine, domestic:

Bay leaves, 36330-36332 05-12437 Citrus canker, 36328-36330 05-12436 Army Army Department See Engineers Corps Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Grant and cooperative agreement awards: American Society for Clinical Pathology, 36388 05-12412 Clinical and Laboratory Standards Institute, 36388-36389 05-12411 Grants and cooperative agreements; availability, etc.:

STD surveillance network, 36389-36394 05-12410 Workplace HIV/AIDS Programs/Public Service Private Partnerships, 36394-36399 05-12413 Children Children and Families Administration NOTICES Grant and cooperative agreement awards: A+ for Abstinence, et al., 36399-36402 05-12431 Coast Guard Coast Guard RULES Navigation and navigable waters; technical, organizational, and conforming amendments, 36347-36350 05-12441 PROPOSED RULES Rulemaking petitions: Fall River, MA; marine spills of liquefied natural gas, 36363 05-12399 Commerce Commerce Department See International Trade Administration RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 Consumer Consumer Product Safety Commission RULES Protection of human subjects; Federal policy, 36325-36328 05-12394 PROPOSED RULES Flammable Fabrics Act: Mattresses and Mattress and foundation sets; flammability (open flame) standard, 36357-36359 05-12387 Corporation Corporation for National and Community Service NOTICES Meetings; Sunshine Act, 36375 05-12502 Defense Base Closure Defense Base Closure and Realignment Commission NOTICES Meetings; correction, 05-12423 36376-36377 05-12427 Defense Defense Department See Engineers Corps RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Committees; establishment, renewal, termination, etc.: Defense Acquisition Performance Assessment Project, 36377 05-12425 Meetings: Defense Acquisition Performance Assessment Project, 36377 05-12424 Independent Review Panel to Study the Relationships Between Military Department General Counsels and Judge Advocates General, 36377-36378 05-12428 Drug Drug Enforcement Administration RULES Controlled substances; manufacturers, distributors, and dispensers; registration:

Authority for practioners to dispense or prescribe approved narcotic controlled substances for maintenance or detoxification treatment, 36338-36344 05-12440 Education Education Department RULES Protection of human subjects; Federal policy, 36325-36328 05-12394 NOTICES Agency information collection activities; proposals, submissions, and approvals, 36378 05-12393 Grants and cooperative agreements; availability, etc.: Special education and rehabilitative services— Centers for Independent Living, 36378-36382 05-12472 Energy Energy Department RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Electricity export and import authorizations, permits, etc.: H.Q. Energy Services (U.S.) Inc., 36382 05-12426 Engineers Engineers Corps PROPOSED RULES Danger zones and restricted areas: Parris Island, SC; Marine Corps Recruit Depot, 36363-36365 05-12461 EPA Environmental Protection Agency RULES Hazardous waste program authorizations: Vermont, 36350-36354 05-12454 Protection of human subjects; Federal policy, 36325-36328 05-12394 PROPOSED RULES Hazardous waste program authorizations:

Maine, 36365 05-12453 NOTICES Agency information collection activities; proposals, submissions, and approvals, 36382-36383 05-12450 Air pollution control: Citizens suits; proposed settlements— AK Steel Corp., et al., 36383-36384 05-12449 National Lime Association, 36384-36386 05-12448 Superfund; response and remedial actions, proposed settlements, etc.: Welsicole/Hardeman County Landfill Site, TN et al., 36386 05-12452 Water pollution control: National Pollutant Discharge Elimination System— Hope Basin and OCS, 36383 05-12451 FAA Federal Aviation Administration RULES Airworthiness directives:

Sikorsky, 36333-36334 05-12417 Standard instrument approach procedures and weather takeoff minimums, 36334-36336 05-12362 PROPOSED RULES Airworthiness directives: Turbomeca, 36355-36357 05-12414 NOTICES Air traffic operating and flight rules, etc.: National parks air tour management; commercial air tour operators authorization, 36456-36463 05-12380 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 36386 05-12547 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Motor carrier safety standards:

Parts and accessories necessary for safe operation— Shifting and falling cargo protection; correction, 36366 05-12442 Federal Railroad Federal Railroad Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 36463-36464 05-12406 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Embutramide, Chloroquine, and Lidocaine solution; implantation or injectable dosage form, 36336-36337 05-12422 Moxidectin injectable, 36337-36338 05-12421 Ophthalmic and topical dosage, etc., 36338 05-12402 NOTICES Meetings:

Medical Devices Advisory Committee, 36402 05-12401 Forest Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 36368 05-12408 GSA General Services Administration NOTICES Acquisition regulations: Personal Data (Warning) Label (Large) (OF 86); form cancellation, 36386 05-12416 Geological Geological Survey NOTICES Agency information collection activities; proposals, submissions, and approvals, 36407 05-12409 Health Health and Human Services Department See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Organization, functions, and authority delegations: Medicare Hearings and Appeals Office, 36386-36387 05-12468 Homeland Homeland Security Department See Coast Guard See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Mortgage Review Board; administrative actions, 36403-36407 E5-3269 Indian Indian Affairs Bureau NOTICES Tribal-State compacts approval; Class III (casino) gambling: Apache Tribe, OK, 36407 05-12395 Otoe-Missouria Tribe, OK, 36407 05-12400 Interior Interior Department See Geological Survey See Indian Affairs Bureau See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service RULES Income taxes:

Qualified amended returns; temporary regulations Correction, 36344-36345 05-12385 05-12386 Qualified intellectual property contributions; information returns by donees, 36346 05-12403 Correction, 36345-36346 05-12384 NOTICES Agency information collection activities; proposals, submissions, and approvals, 36464-36465 E5-3258 E5-3260 Meetings: Taxpayer Advocacy Panels, E5-3259 36466 E5-3261 International International Trade Administration NOTICES Antidumping: Corrosion-resistant carbon steel flat products from— Japan, 36369-36374 E5-3270 Honey from— Argentina, 36374-36375 E5-3271 Polyvinyl alcohol from— China, 36375 E5-3272 Justice Justice Department See Drug Enforcement Administration RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Meetings: Heavy Duty Diesel Engine Consent Decrees; teleconference, 36407-36408 05-12465 Pollution control; consent judgments: National Railroad Passenger Corp., et al., 36408 05-12389 Newark Group, Inc., 36408-36409 05-12390 Paul J. Mraz, et al., 36409 05-12464 Stauffer Management Co. LLC and Bayer CropScience, Inc., 36409 05-12391 Sunoco, 36409-36410 05-12462 Valero Refining Co., et al., 36410 05-12463 Labor Labor Department See Mine Safety and Health Administration See Occupational Safety and Health Administration Mine Mine Safety and Health Administration RULES Coal mine safety and health, and education and training:

Emergency evacuations; emergency temporary standard, 36346-36347 05-12371 NASA National Aeronautics and Space Administration RULES Protection of human subjects; Federal policy, 36325-36328 05-12394 National Archives National Archives and Records Administration NOTICES Public availability and use: Regional archives temporary hours change, 36411-36412 05-12388 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Humanities Panel, 36412-36413 05-12397 National Science National Science Foundation RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 NOTICES Environmental statements; availability, etc.: Arctic Ocean; marine geophysical survey; Coast Guard cutter HEALY, 36413 05-12460 Environmental statements; notice of intent: Haleakala High Altitude Observatory Site; Maui, HI; Advanced Technology Solar Telescope project, 36413-36414 05-11970 Occupational Occupational Safety and Health Administration NOTICES Committees; establishment, renewal, termination, etc.: Maritime Advisory Committee for Occupational Safety and Health, 36410-36411 05-12433 Meetings:

Occupational Safety and Health National Advisory Committee, 36411 05-12420 Pipeline Pipeline and Hazardous Materials Safety Administration PROPOSED RULES Hazardous materials: Transportation— Cylinders and multi-element gas containers; design, construction, maintenance, and use; United Nations recommended standards adoption; comment extension, 36365-36366 05-12459 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 36414 05-12473 SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940:

Business Men's Assurance Company of America, et al., 36414-36426 E5-3257 Self-regulatory organizations; proposed rule changes: National Association of Securities Dealers, Inc., E5-3263 36427-36451 E5-3264 E5-3267 E5-3268 New York Stock Exchange, Inc., 36451-36453 E5-3262 Social Social Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 36454-36455 05-12286 State State Department RULES Exchange Visitor Program: Professor and research scholar participation; correction, 36344 05-12456 NOTICES Cultural property:

Nicaragua; pre-hispanic archaeological material; U.S. import restrictions; memorandum of understanding, 36455 05-12457 Meetings: Cultural Property Advisory Committee, 36455 05-12458 Surface Surface Mining Reclamation and Enforcement Office PROPOSED RULES Permanent program and abandoned mine land reclamation plan submissions: Alaska, 36360-36363 05-12439 Surface Surface Transportation Board NOTICES Rail carriers: Cost recovery procedures— Adjustment factor, 36464 05-12443 Railroad operation, acquisition, construction, etc.:

BNSF Railway Co., 36464 05-12382 Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board RULES Protection of human subjects; Federal policy, 36325-36328 05-12394 NOTICES Aviation proceedings: Agreements filed; weekly receipts, 36455-36456 05-12430 Certificates of public convenience and necessity and foreign air carrier permits; weekly applications, 36456 05-12429 Transportation Transportation Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 36402-36403 05-12404 Treasury Treasury Department See Alcohol and Tobacco Tax and Trade Bureau See Internal Revenue Service Veterans Veterans Affairs Department RULES Protection of human subjects;

Federal policy, 36325-36328 05-12394 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. 70 120 Thursday, June 23, 2005 Rules and Regulations DEPARTMENT OF AGRICULTURE 7 CFR Part 1c DEPARTMENT OF ENERGY 10 CFR Part 745 NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 14 CFR Part 1230 DEPARTMENT OF COMMERCE 15 CFR Part 27 CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1028 AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 225 DEPARTMENT OF JUSTICE 28 CFR Part 46 DEPARTMENT OF DEFENSE 32 CFR Part 219 DEPARTMENT OF EDUCATION 34 CFR Part 97 DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 16 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 26 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 46 NATIONAL SCIENCE FOUNDATION 45 CFR Part 690 DEPARTMENT OF TRANSPORTATION 49 CFR Part 11 Federal Policy for the Protection of Human Subjects AGENCIES:

Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; Agency for International Development; Department of Justice; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and Department of Transportation. ACTION: Final rule; technical amendments. SUMMARY:

The agencies listed in this document are amending the Federal Policy for the Protection of Human Subjects, which was published in the **Federal Register** on June 18, 1991, to change all references to the Office for Protection from Research Risks

(OPRR)to the Office for Human Research Protections (OHRP); revise the footnote found at the end of § _.101(i) by deleting references to research involving fetuses, pregnant women, or human in vitro fertilization and subpart B of 45 CFR part 46; and update the Control Number for the approval by the Office of Management and Budget

(OMB)of the information collection requirements of this Federal Policy. DATES: Effective Date: June 23, 2005. FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., OHRP, The Tower Building, Suite 200, 1101 Wootton Parkway, Rockville, MD 20852; telephone: 301-496-7005; facsimile: 301-402-2071; e-mail: *mcarome@osophs.dhhs.gov.* SUPPLEMENTARY INFORMATION: I. Background The Federal Policy for the Protection of Human Subjects (hereafter referred to as the Federal Policy) was promulgated by 15 Federal departments and agencies on June 18, 1991 (56 FR 28003). The Central Intelligence Agency also is required to comply with this policy under Executive Order 12333. On July 10, 1996, the Department of Housing and Urban Development revised its codification of the Federal Policy at 24 CFR part 60 to cross-reference the provisions of the Department of Health and Human Services

(HHS)regulations at 45 CFR part 46, subpart A (61 FR 36462). Except for research that is exempt under § __.101(b), the Federal Policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal department or agency which has taken appropriate administrative action to make the Federal Policy applicable to such research. The basic provisions of the Federal Policy include, among other things, requirements related to the review of human subjects research by an institutional review board, the obtaining and documenting of informed consent of human subjects, and the submission of a written assurance of institutional compliance with the Federal Policy. II. Description of Changes to the Federal Policy The Federal Policy has several provisions that reference OPRR. For example, the Federal Policy includes provisions that require submission of certain reports and notices to OPRR (see § __.101(i), § __.103(a), and § __.103(b)(3)). At the time the Federal Policy was promulgated, OPRR was a unit of the National Institutes of Health, HHS, and was responsible for fulfilling responsibilities set forth in section 491 of the Public Health Service Act (42 U.S.C. 289). On June 18, 2000, OPRR was dissolved, OHRP was established, and all responsibilities and authorities for human subject protections held by OPRR were transferred to OHRP (65 FR 37136, June 13, 2000). The Federal Policy is being amended throughout to reflect this name and organizational change from OPRR to OHRP. At the time the Federal Policy was promulgated, the HHS regulations for the protection of human subjects at 45 CFR part 46 included the following three subparts that provided additional protections for specific groups of vulnerable subjects: subpart B (Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization); subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects); and subpart D (Additional Protections for Children Involved as Subjects in Research). These subparts are not part of the Federal Policy. However, the Federal Policy includes a footnote at the end of § __.101(i) which states, in part, that “the exemptions at 45 CFR 46.101(b) do not apply to research involving * * * fetuses, pregnant women, or human in vitro fertilization, subparts B * * *.” On November 13, 2001, HHS published a revised version of 45 CFR part 46, subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research) after soliciting public comment through a Notice of Proposed Rulemaking (66 FR 56775; 66 FR 35576). The revised subpart B, which became effective on December 13, 2001, states that the exemptions at 45 CFR 46.101(b)(1) through

(6)are applicable to this subpart. In order to make the footnote at the end of § __.101(i) of the Federal Policy consistent with the revised subpart B of 45 CFR part 46, references to research involving fetuses, pregnant women, or human in vitro fertilization and subpart B are being deleted from the footnote. Finally, the information collection requirements of the Federal Policy (see §§ __.103, 109, 113, 115, 116, and 117) were approved by OMB on July 30, 1991 under Control Number 9999-0020. OMB approval under Control Number 9999-0020 expired on December 31, 1997. The current OMB approval of the information collection requirements of the Federal Policy is under Control Number 0990-0260. Therefore, all references to Control Number 9999-0020 are being changed to Control Number 0990-0260. III. Implementation Pursuant to 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, 5 U.S.C. 551-559, the agencies find that there is good cause to issue these amendments without advance notice and an opportunity for public comment. Because these amendments merely

(i)change references in the Federal Policy from the OPRR to the OHRP, to reflect the organizational change that already dissolved OPRR and moved its responsibilities to OHRP;

(ii)delete references to research involving fetuses, pregnant women, or human in vitro fertilization and to subpart B of 45 CFR part 46 to conform the Federal Policy to recent amendments to subpart B of 45 CFR part 46; and

(iii)update the Control Number for the approval by OMB of the information collection requirements of the Federal Policy, public comment is unnecessary. Pursuant to 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, the agencies also find there is good cause to make these amendments effective immediately because the changes in the Federal Policy are merely conforming amendments to reflect changes that have already been made and are in effect with respect to OHRP and 45 CFR part 46. IV. Legal Authority Department of Agriculture, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Energy, 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). National Aeronautics and Space Administration, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Commerce, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Consumer Product Safety Commission, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Agency for International Development, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Justice, 5 U.S.C. 301; 28 U.S.C. 509-510; 42 U.S.C. 300v-1(b). Department of Defense, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Education, 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b). Department of Veterans Affairs, 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). Environmental Protection Agency, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Health and Human Services, 5 U.S.C. 301; 42 U.S.C. 289; 42 U.S.C. 300v-1(b). National Science Foundation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Transportation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). V. Executive Order 12866 Executive Order 12866 requires that all regulatory actions of Executive Branch departments and agencies reflect consideration of the costs and benefits that they generate and that they meet certain standards, such as avoiding imposition of unnecessary burdens on the affected public. If an action is deemed to fall within the scope of the definition of the term “significant regulatory action” contained in Sec. 3(f) of the order, a pre-publication review by OMB's Office of Information and Regulatory Affairs

(OIRA)is necessary. OMB deemed these amendments of the Federal Policy not to be a significant regulatory action. Therefore, these amendments were not submitted to OIRA for review prior to publication. VI. Regulatory Flexibility Act Under the Regulatory Flexibility Act (5 U.S.C. 601-612), an agency is generally required to review proposed regulations to analyze whether they create a significant impact on a substantial number of small entities unless the agency can certify that there is no such impact. Agencies must similarly analyze any final rules that were preceded by proposed rules. Because these technical amendments did not require the agencies to publish a proposed rule, they are not required to prepare a Regulatory Flexibility Act analysis for this final rule. However, even if the agencies were required to consider that impact, the agencies would certify that there was no impact at all on small entities because these amendments make no substantive change to the Federal Policy. VII. Paperwork Reduction Act of 1995 These amendments to the Federal Policy do not contain any new information collection requirements which are subject to OMB approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). VIII. Federalism These amendments to the Federal Policy have been analyzed in accordance with the principles set forth in Executive Order 13132. These amendments to the Federal Policy do not contain policies that have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the departments and agencies that have promulgated the Federal Policy have concluded that these amendments do not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required. Department of Agriculture 7 CFR Part 1c RIN 0518-AA02 List of Subjects in 7 CFR Part 1c Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Agriculture amends 7 CFR part 1c, as set forth at the end of this document. The authority for part 1c continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: August 18, 2004. Ann M. Veneman, Secretary of Agriculture. Department of Energy 10 CFR Part 745 RIN 1901-AB14 List of Subjects in 10 CFR Part 745 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Energy amends 10 CFR part 745, as set forth at the end of this document. The authority for part 745 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). Dated: April 5, 2005. Samuel W. Bodman, Secretary of Energy. National Aeronautics and Space Administration 14 CFR Part 1230 RIN 2700-AC99 List of Subjects in 14 CFR Part 1230 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the National Aeronautics and Space Administration amends 14 CFR part 1230, as set forth at the end of this document. The authority for part 1230 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: February 18, 2005. Richard S. Williams, Chief Health and Medical Officer, Office of Health and Medical Systems. Department of Commerce 15 CFR Part 27 RIN 0605-AA17 List of Subjects in 15 CFR Part 27 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Commerce amends 15 CFR part 27, as set forth at the end of this document. The authority for part 27 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: February 18, 2005. Michael S. Sade, Director, Office of Acquisition Management. Consumer Product Safety Commission 16 CFR Part 1028 RIN 3041-AC21 List of Subjects in 16 CFR Part 1028 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Consumer Product Safety Commission amends 16 CFR part 1028, as set forth at the end of this document. The authority for part 1028 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: July 22, 2004. Harold D. Stratton, Chairman. Agency for International Development 22 CFR Part 225 RIN 0412-AA53 List of Subjects in 22 CFR Part 225 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Agency for International Development amends 22 CFR part 225, as set forth at the end of this document. The authority for part 225 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: June 10, 2004. James D. Shelton, Cognizant Human Subjects Officer. Department of Justice 28 CFR Part 46 RIN 1121-AA70 List of Subjects in 28 CFR Part 46 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Justice amends 28 CFR part 46, as set forth at the end of this document. The authority for part 46 continues to read as follows: Authority: 5 U.S.C. 301; 28 U.S.C. 509-510; 42 U.S.C. 300v-1(b). Dated: March 14, 2005. Alberto R. Gonzales, Attorney General. Department of Defense 32 CFR Part 219 RIN 0790-AH79 List of Subjects in 32 CFR Part 219 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Defense amends 32 CFR part 219, as set forth at the end of this document. The authority for part 219 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: August 4, 2004. Ronald M. Sega, Director, Defense Research and Engineering. Department of Education 34 CFR Part 97 RIN 1890-AA08 List of Subjects in 34 CFR Part 97 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Education amends 34 CFR part 97, as set forth at the end of this document. The authority for part 97 continues to read as follows: Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b). Dated: June 30, 2004. Rod Paige, Secretary of Education. Department of Veterans Affairs 38 CFR Part 16 RIN 2900-AL99 List of Subjects in 38 CFR Part 16 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 16, as set forth at the end of this document. The authority for part 16 continues to read as follows: Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). Dated: August 27, 2004. Anthony J. Principi, Secretary of Veterans Affairs. Environmental Protection Agency 40 CFR Part 26 RIN 2080-AA10 List of Subjects in 40 CFR Part 26 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 26, as set forth at the end of this document. The authority for part 26 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: May 16, 2005. Stephen L. Johnson, Acting Administrator. Department of Health and Human Services 45 CFR Part 46 RIN 0940-AA10 List of Subjects in 45 CFR Part 46 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Health and Human Services amends 45 CFR part 46, as set forth at the end of this document. The authority for part 46 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 289; 42 U.S.C. 300v-1(b). Dated: June 15, 2005. Ann Agnew, Executive Secretary to the Department. National Science Foundation 45 CFR Part 690 RIN 3145-AA42 List of Subjects in 45 CFR Part 690 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the National Science Foundation amends 45 CFR part 690, as set forth at the end of this document. The authority for part 690 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: June 30, 2004. Lawrence Rudolph, General Counsel. Department of Transportation 49 CFR Part 11 RIN 2105-XX97 List of Subjects in 49 CFR Part 11 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Department of Transportation amends 49 CFR part 11, as set forth at the end of this document. The authority for part 11 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Dated: September 18, 2004. Norman Y. Mineta, Secretary of Transportation. Editorial Note: This document was received at the Office of the Federal Register on June 17, 2005. Accordingly, the Federal Policy for the Protection of Human Subjects is amended as follows: § __.101 [Amended] 1. Amend § __.101 as follows: a. In paragraph (i), remove the words “Office for Protection from Research Risks, Department of Health and Human Services (HHS),”and add, in their place, “Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office,”. b. In footnote 1 at the end of paragraph (i), remove the words “prisoners, fetuses, pregnant women, or human in vitro fertilization, subparts B and C.” and add, in their place, “prisoners, subpart C.”. § __.103 [Amended] 2. Amend § __.103 as follows: a. In paragraph (a), in the second and last sentences, remove the words, “Office for Protection from Research Risks, HHS” and add, in their place, “Office for Human Research Protections, HHS, or any successor office”. b. In paragraph (b)(3), remove the words “Office for Protection from Research Risks, HHS” and add, in their place, “Office for Human Research Protections, HHS, or any successor office”. c. Revise the parenthetical at the end of the section to read as follows: § __.103 Assuring compliance with this policy—research conducted or supported by any Federal Department or Agency. (Approved by the Office of Management and Budget under Control Number 0990-0260.) 3. Revise the parenthetical at the end of § __.109 to read as follows: § __.109 IRB review of research. (Approved by the Office of Management and Budget under Control Number 0990-0260.) § __.110 [Amended] 4. In paragraph (a), remove the words “Office for Protection from Research Risks, National Institutes of Health, HHS, Bethesda, Maryland 20892.” and add, in their place, “Office for Human Research Protections, HHS, or any successor office.”. 5. Revise the parenthetical at the end of § __.113 to read as follows: § __.113 Suspension or termination of IRB approval of research. (Approved by the Office of Management and Budget under Control Number 0990-0260.) 6. Revise the parenthetical at the end of § __.115 to read as follows: § __.115 IRB records. (Approved by the Office of Management and Budget under Control Number 0990-0260.) 7. Revise the parenthetical at the end of § __.116 to read as follows: § __.116 General requirements for informed consent. (Approved by the Office of Management and Budget under Control Number 0990-0260.) 8. Revise the parenthetical at the end of § __.117 to read as follows: § __.117 Documentation of informed consent. (Approved by the Office of Management and Budget under Control Number 0990-0260.) [FR Doc. 05-12394 Filed 6-22-05; 8:45 am]

Connectionstraces to 9

Traces to 9 documents

U.S. Code