2009 – Federal Register Recent Federal Regulation Documents

Results 7,451 - 7,500 of 30,932
National Center for Research Resources; Notice of Closed Meeting
Document Number: E9-23598
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-23592
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-23591
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E9-23590
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: E9-23589
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E9-23588
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Pesticide Experimental Use Permit; Receipt of Application; Comment Request
Document Number: E9-23587
Type: Notice
Date: 2009-09-30
Agency: Environmental Protection Agency
This notice announces EPA's receipt of an application 67979- EUP-I from Syngenta Seeds Inc. requesting an experimental use permit (EUP) for the plant-incorporated protectant (PIP) [Event 5307] Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (vector pSYN12274) in event 5307 corn (SYN- [Oslash]53[Oslash]7-1) and combined trait hybrids with one or more of the following additional PIPs: 1) [Bt11] Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material (as contained in plasmid vector pZO1502) necessary for its production in corn, 2) [DAS-59122-7] Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material (vector PHP 17662) necessary for their production in Event DAS-59122-7 corn, 3) [MIR162] Bacillus thuringiensis Vip3Aa20 and the genetic material necessary for its production (vector pNOV1300) in event MIR162 maize (SYN-IR162-4), 4) [MIR604] Modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in corn (SYN-IR604-8), and 5) [TC1507] Bacillus thuringiensis Cry1F protein and the genetic material (vector PHP8999) for its production in Event TC1507 corn. The Agency has determined that the permit may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on this application.
Direct Investment Surveys: BE-10, 2009 Benchmark Survey of U.S. Direct Investment Abroad
Document Number: E9-23586
Type: Proposed Rule
Date: 2009-09-30
Agency: Department of Commerce, Bureau of Economic Analysis, Economic Analysis Bureau
This proposed rule would amend regulations of the Bureau of Economic Analysis (BEA), Department of Commerce, to set forth the reporting requirements for the 2009 BE-10, Benchmark Survey of U.S. Direct Investment Abroad. The benchmark survey covers the U.S. direct investment abroad universe, and is BEA's most comprehensive survey of such investment in terms of subject matter. Benchmark surveys are conducted every 5 years. The proposed changes for the 2009 benchmark survey include changes in form design and reporting criteria to simplify the forms and improve response rates and changes that would reduce detail collected while considering the current needs of data users and respondent burden. Some of the items that would no longer be collected are those that are now collected on BEA's surveys of international services.
Bureau of Political-Military Affairs: Directorate of Defense Trade Controls; Notifications to the Congress of Proposed Commercial Export Licenses
Document Number: E9-23585
Type: Notice
Date: 2009-09-30
Agency: Department of State
Notice is hereby given that the Department of State has forwarded the attached Notifications of Proposed Export Licenses to the Congress on the dates indicated on the attachments pursuant to sections 36(c) and 36(d) and in compliance with section 36(f) of the Arms Export Control Act (22 U.S.C. 2776).
Urbanized Area Formula Program: Proposed Circular
Document Number: E9-23584
Type: Notice
Date: 2009-09-30
Agency: Federal Transit Administration, Department of Transportation, Docket No. Fta-2009-0010]
The Federal Transit Administration (FTA) has placed in the docket and on its Web site, proposed guidance in the form of a circular to assist grantees in implementing the Urbanized Area Formula Program (Section 5307). The Urbanized Area Formula Program provides grants for capital, planning, and some operating projects in urbanized areas. By this notice, FTA invites public comment on the proposed circular 9030.1D, Urbanized Area Formula Program: Program Guidance and Application Instructions for the program.
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 630 of the Gulf of Alaska
Document Number: E9-23580
Type: Rule
Date: 2009-09-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is reopening directed fishing for pollock in Statistical Area 630 of the Gulf of Alaska (GOA). This action is necessary to fully use the C season allowance of the 2009 total allowable catch (TAC) of pollock specified for Statistical Area 630 of the GOA.
Advisory Committee on Disability Compensation; Notice of Meeting
Document Number: E9-23579
Type: Notice
Date: 2009-09-30
Agency: Department of Veterans Affairs
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 620 of the Gulf of Alaska
Document Number: E9-23578
Type: Rule
Date: 2009-09-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is reopening directed fishing for pollock in Statistical Area 620 of the Gulf of Alaska (GOA). This action is necessary to fully use the C season allowance of the 2009 total allowable catch (TAC) of pollock specified for Statistical Area 620 of the GOA.
Advisory Committee on Women Veterans; Notice of Meeting
Document Number: E9-23577
Type: Notice
Date: 2009-09-30
Agency: Department of Veterans Affairs
Proposed Collection; Comment Request
Document Number: E9-23575
Type: Notice
Date: 2009-09-30
Agency: Federal Housing Finance Agency
In accordance with the requirements of the Paperwork Reduction Act of 1995, the Federal Housing Finance Agency (FHFA) is seeking public comments concerning a currently approved information collection known as ``Affordable Housing Program (AHP),'' which has been assigned control number 2590-0007 by the Office of Management and Budget (OMB). The FHFA intends to submit the information collection to OMB for review and approval of a three year extension of the control number, which is due to expire on December 31, 2009.
Sentencing Guidelines for United States Courts
Document Number: E9-23574
Type: Notice
Date: 2009-09-30
Agency: United States Sentencing Commission, Agencies and Commissions
The United States Sentencing Commission is issuing this notice to advise the public that the application period for membership in the Victims Advisory Group has been extended to November 30, 2009. The deadline was originally August 10, 2009.
National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation
Document Number: E9-23573
Type: Notice
Date: 2009-09-30
Agency: Environmental Protection Agency
Under the Federal Advisory Committee Act, Public Law 92-463, EPA gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC). The National and Governmental Advisory Committees advise the EPA Administrator in her capacity as the U.S. Representative to the CEC Council. The Committees are authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC), North American Free Trade Agreement Implementation Act, Public Law 103-182, and as directed by Executive Order 12915, entitled ``Federal Implementation of the North American Agreement on Environmental Cooperation.'' The NAC is composed of 12 members representing academia, environmental non-governmental organizations, and private industry. The GAC consists of 12 members representing State, local, and Tribal governments. The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related to implementation and further elaboration of the NAAEC.
Draft Regulatory Guide: Public Meeting
Document Number: E9-23571
Type: Notice
Date: 2009-09-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Statement of Organization, Functions and Delegations of Authority
Document Number: E9-23570
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Privacy Act of 1974; Report of Modified or Altered System; Indian Health Service Scholarship and Loan Repayment Programs
Document Number: E9-23569
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, Indian Health Service
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, ``Indian Health Service Scholarship and Loan Repayment Programs,'' System No. 09-17-0002. We propose to modify the SOR to reflect current program changes, statutory and implementation changes. Under the system name, we propose to clarify language under the ``Categories of individuals covered by the system'' section; to include statutory authorities for the grants program under the ``Authority for maintenance of the system'' section; to include the IHS Grants Program (Indians Into Nursing, Indians Into Medicine, and Indians Into Psychology) and the IHS Health Professions Support Branch in the ``Purposes'' section; various minor language edits to routine use number 4 for litigation as these records are not Health Insurance Portability and Accountability Act (HIPAA) protected records; add a new routine use number 20 to comply with Office of Management and Budget (OMB) (M)emorandum 07-16 Safeguarding Against and Responding to the Breach of Personally Identifiable Information of May 22, 2007 and the HHS Directive memoranda dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and finally minor administrative and program edits to other sections of the SOR.
Ocean Transportation Intermediary License Applicants
Document Number: E9-23568
Type: Notice
Date: 2009-09-30
Agency: Federal Maritime Commission, Agencies and Commissions
Notice of Agreements Filed
Document Number: E9-23567
Type: Notice
Date: 2009-09-30
Agency: Federal Maritime Commission, Agencies and Commissions
Notice of Final Federal Agency Actions on Proposed Rail Grade Separation Project in Orange County, CA
Document Number: E9-23566
Type: Notice
Date: 2009-09-30
Agency: Federal Highway Administration, Department of Transportation
The FHWA is issuing this notice to announce actions taken by FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. Section 139(l)(1). The actions relate to the proposed Orange County Gateway rail grade separation project in the Cities of Placentia (local project proponent) and Anaheim, Orange County, California.
Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: E9-23565
Type: Notice
Date: 2009-09-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Certain Coated Paper Suitable for High-Quality Print Graphics Using Sheet-Fed Presses From China and Indonesia
Document Number: E9-23563
Type: Notice
Date: 2009-09-30
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigations Nos. 701-TA-470-471 and 731-TA-1169- 1170 (Preliminary) under sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China and Indonesia of certain coated paper suitable for high-quality print graphics using sheet-fed presses, provided for in subheadings 4810.13.11, 4810.13.19, 4810.13.20, 4810.13.50, 4810.13.60, 4810.13.70, 4810.14.11, 4810.14.19, 4810.14.20, 4810.14.50, 4810.14.60, 4810.14.70, 4810.19.11, 4810.19.19, 4810.19.20, 4810.22.10, 4810.22.50, 4810.22.60, 4810.22.70, 4810.29.10, 4810.29.50, 4810.29.60, and 4810.29.70 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of China and Indonesia. Unless the Department of Commerce extends the time for initiation pursuant to sections 702(c)(1)(B) or 732(c)(1)(B) of the Act (19 U.S.C. 1671a(c)(1)(B) or 1673a(c)(1)(B)), the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by November 9, 2009. The Commission's views are due at Commerce within five business days thereafter, or by November 17, 2009.
Certain Oil Country Tubular Goods From China
Document Number: E9-23562
Type: Notice
Date: 2009-09-30
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice of the scheduling of the final phase of countervailing duty investigation No. 701-TA-463 (Final) under section 705(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)) (the Act) and the final phase of antidumping investigation No. 731-TA- 1159 (Final) under section 735(b) of the Act (19 U.S.C. 1673d(b)) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of subsidized and less-than-fair-value imports from China of certain oil country tubular goods, primarily provided for in subheadings 7304.29, 7305.20 and 7306.29 of the Harmonized Tariff Schedule of the United States.\11\
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: E9-23561
Type: Notice
Date: 2009-09-30
Agency: Federal Reserve System, Agencies and Commissions
Black Bayou Lake National Wildlife Refuge, Ouachita Parish, LA
Document Number: E9-23559
Type: Notice
Date: 2009-09-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the Fish and Wildlife Service (Service), announce the availability of a draft comprehensive conservation plan and environmental assessment (Draft CCP/EA) for Black Bayou Lake National Wildlife Refuge (Black Bayou Lake NWR) for public review and comment. In this Draft CCP/EA, we describe the alternative we propose to use to manage this refuge for the 15 years following approval of the final CCP.
Business Loan Program Maximum Allowable Fixed Rate
Document Number: E9-23558
Type: Notice
Date: 2009-09-30
Agency: Small Business Administration, Agencies and Commissions
This Notice announces the maximum allowable fixed rate for 7(a) guaranteed loans.
Endangered and Threatened Wildlife and Plants; Draft Post-Delisting Monitoring Plan for the Brown Pelican (Pelecanus occidentalis)
Document Number: E9-23557
Type: Notice
Date: 2009-09-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft post-delisting monitoring plan for the brown pelican (Pelecanus occidentalis) (draft PDM Plan, Draft Monitoring Plan). The Endangered Species Act (Act) requires that we implement a system, in cooperation with the States, to monitor effectively, for at least 5 years, the status of all species that have been recovered and no longer need the protection afforded by the Act (i.e. delisted). The brown pelican has been proposed to be removed from the Federal List of Threatened and Endangered Wildlife and Plants due to recovery. If the brown pelican is removed from the list, we propose to monitor the status of the brown pelican over a 10-year period from 2010 through 2020, through annual evaluation of information collected by the States of California, Texas, and Louisiana; the Commonwealth of Puerto Rico and the U.S. Virgin Islands in the West Indies; Mexico; other partners; and the Service.
Amendment of the Clark County Multiple Species Habitat Conservation Plan and Issuance of an Amended Incidental Take Permit, Clark County, NV
Document Number: E9-23556
Type: Notice
Date: 2009-09-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), are advising the public that we intend to gather information necessary to prepare an EIS, under the National Environmental Policy Act (NEPA), on the proposed amendment of the Clark County Multiple Species Habitat Conservation Plan (MSHCP) and Incidental Take Permit (ITP). The proposed amendment is being prepared under section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended. The Permittees are proposing to increase the amount of species habitat disturbance that is authorized under the existing MSHCP and ITP, expand the conservation program to minimize and mitigate for the increased disturbance, reduce the number of covered species, and revise the permit term of the MSHCP Amendment to 50 years. We provide this notice to obtain suggestions, comments, and useful information from other agencies and the public on the scope of the document, including the significant issues deserving of study, the range of alternatives, and the range of impacts to be considered.
Advisory Committee on Childhood Lead Poisoning Prevention (ACCLPP)
Document Number: E9-23554
Type: Notice
Date: 2009-09-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Lee Metcalf National Wildlife Refuge, Stevensville, MT
Document Number: E9-23551
Type: Notice
Date: 2009-09-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), intend to gather information necessary to prepare a comprehensive conservation plan (CCP) and associated environmental documents for Lee Metcalf National Wildlife Refuge (NWR) in Stevensville, Montana. We furnish this notice in compliance with Service CCP policy to advise other agencies and the public of our intentions and to obtain suggestions and information on the scope of issues to consider in the planning process.
Notice of Public Meeting
Document Number: E9-23549
Type: Notice
Date: 2009-09-30
Agency: Department of the Interior, National Park Service
The Aniakchak National Monument Subsistence Resource Commission (ANIA SRC) will meet to develop and continue work on National Park Service (NPS) subsistence hunting program recommendations and other related subsistence management issues. This meeting is open to the public and will have time allocated for public testimony. The public is welcomed to present written or oral comments to the SRC. This meeting will be recorded and meeting minutes will be available upon request from the park superintendent for public inspection approximately six weeks after the meeting. The NPS SRC program is authorized under Title VIII, Section 808 of the Alaska National Interest Lands Conservation Act, Public Law 96-487, to operate in accordance with the provisions of the Federal Advisory Committee Act.
Proposed Information Collection Request Submitted for Public Comment and Recommendations; Gamma Radiation Exposure Records; Correction
Document Number: E9-23548
Type: Notice
Date: 2009-09-30
Agency: Department of Labor, Mine Safety and Health Administration
On September 23, 2009 (74 FR 48601), the Mine Safety and Inspection Service published a notice document soliciting comments concerning the extension of information collection related to Gamma Radiation Exposure Records. This document corrects a typographical error that appeared in that document.
Environmental Impact Statements; Comprehensive Trail Management Plan for Cuyahoga Valley National Park, OH
Document Number: E9-23547
Type: Notice
Date: 2009-09-30
Agency: Department of the Interior, National Park Service
Pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)), the National Park Service (NPS) is announcing its intent to prepare an environmental impact statement (EIS) for a comprehensive trail management plan (TMP) for the Cuyahoga Valley National Park (Park). The TMP will evaluate alternatives for long-term development, management, sustainability, and accessibility of Park trails for current and new users as an integral part of a larger regional trail system. Two metropolitan park districts with significant park land holdings and trail networksCleveland Metroparks (CMP) and Metro Parks, Serving Summit County (MPSSC)have agreed to be cooperators in the preparation of the TMP/EIS.
Combined Notice of Filings #1
Document Number: E9-23546
Type: Notice
Date: 2009-09-30
Agency: Department of Energy, Federal Energy Regulatory Commission
E9-23544
Document Number: E9-23544
Type: Notice
Date: 2009-09-30
Agency: Advisory Committee for Engineering; Notice of Meeting, National Science Foundation, Agencies and Commissions
Cherokee Nation Limited Mixed Beverage Sales Act
Document Number: E9-23542
Type: Notice
Date: 2009-09-30
Agency: Department of the Interior, Bureau of Indian Affairs, Indian Affairs Bureau
This notice publishes the legislation passed by the Cherokee Nation amending Cherokee Nation Legislative Act 09-04 that regulates and controls the possession, sale, and consumption of liquor within the tribal lands. The tribal lands are located in Indian country and this enactment allows for possession and sale of alcoholic beverages within their boundaries. This law will increase the ability of the tribal government to control the community's liquor distribution and possession, and at the same time will provide an important source of revenue for the continued operation and strengthening of the tribal government and the delivery of tribal services.
Proposed Agency Information Collection Activities; Comment Request
Document Number: E9-23541
Type: Notice
Date: 2009-09-30
Agency: Federal Railroad Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Requirement (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. The Federal Register notice with a 60-day comment period soliciting comments on the following collection of information was published on July 24, 2009 (74 FR 36807).
High-Speed Passenger Rail Safety Strategy; Highway-Rail Grade Crossing Guidelines for High-Speed Passenger Rail: Creation of Docket
Document Number: E9-23540
Type: Notice
Date: 2009-09-30
Agency: Federal Railroad Administration, Department of Transportation
On June 17, 2009, FRA issued a Notice of Funding Availability and Interim Program Guidance detailing the application requirements for obtaining funding for high-speed rail projects under the American Recovery and Reinvestment Act of 2009 and the Department of Transportation Appropriations Acts for fiscal year (FY) 2008 and FY 2009. The Notice and Interim Guidance was published in the Federal Register on June 23, 2009. FRA is currently evaluating grant applications submitted in the first round of the application process, in accordance with evaluation criteria included in the Interim Guidance. FRA will also develop high-speed passenger rail (HSPR) safety strategy and highway-rail grade crossing guidelines for HSPR as part of
Renewal of Charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
Document Number: E9-23539
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the U.S. Department of Health and Human Services is hereby announcing that the charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Healthy People 2020 Advisory Committee; HPAC) has been renewed.
Small Business Information Security Task Force; Request for Nominations
Document Number: E9-23538
Type: Notice
Date: 2009-09-30
Agency: Small Business Administration, Agencies and Commissions
On May 22, 2009, Public Law 111-24 was signed by the President establishing, among other things, a Small Business Information Security
Notice of Meeting of the Board of Visitors of the Marine Corps University
Document Number: E9-23537
Type: Notice
Date: 2009-09-30
Agency: Department of Defense, Department of the Navy, Navy Department
The Board of Visitors of the Marine Corps University (BOV MCU) will meet to review, develop and provide recommendations on communication aspects of the University in order to further the growth and internal communication practices of the Marine Corps University. All sessions of the meeting will be open to the public.
Chairpersons, Boards of Scientific Counselors for Institutes and Centers at the National Institutes of Health; Notice of Meeting
Document Number: E9-23536
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay, an Alternative Test Method Using Fewer Animals To Assess the Allergic Contact Dermatitis Potential of Chemicals and Products; Availability of ICCVAM Recommended Murine Local Lymph Node Assay Performance Standards; Notice of Transmittal to Federal Agencies of ICCVAM Test Method Recommendations for the Reduced Murine Local Lymph Node Assay, Updated Murine Local Lymph Node Assay Test Method Protocol, and Murine Local Lymph Node Assay Test Method Performance Standards
Document Number: E9-23534
Type: Notice
Date: 2009-09-30
Agency: Department of Health and Human Services
NICEATM announces availability of the ICCVAM Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products (NIH Publication 09-6439). The TMER provides ICCVAM's evaluation and recommendations for the reduced Murine Local Lymph Node Assay (rLLNA) test method as a reduction alternative that uses fewer animals compared to the traditional Murine Local Lymph Node Assay (LLNA) for assessing the potential of test substances to cause allergic contact dermatitis (ACD). The report includes ICCVAM's recommendations on (a) the usefulness and limitations of the rLLNA, (b) an updated ICCVAM LLNA test method protocol, which includes the procedures for conducting the rLLNA, (c) future studies to further characterize the usefulness and limitations of the rLLNA, and (d) rLLNA test method performance standards. The TMER includes the report of an international independent scientific peer review panel (hereafter, Panel) and the final rLLNA background review document (BRD). The BRD provides the data and analyses used to evaluate the current validation status of the rLLNA test method for assessing the ACD potential of chemicals and products. ICCVAM concluded that the scientific validity of the rLLNA has been adequately evaluated and that the performance of the rLLNA, when conducted in accordance with the ICCVAM-recommended LLNA test method protocol, is sufficient to distinguish between skin sensitizers and non-sensitizers. ICCVAM also concluded that the rLLNA would reduce animal use by 40% for each test compared to the traditional, multi-dose LLNA. Accordingly, ICCVAM recommends that the rLLNA test method should be routinely considered before conducting the traditional, multi-dose LLNA, and used where appropriate as the initial test to determine the potential of chemicals and products to produce ACD. For testing situations that require dose-response information, rLLNA-positive substances will need to be tested with the traditional multi-dose LLNA. This testing should be done using the updated ICCVAM-recommended test method protocol, which reduces animal use by 20% compared to the original ICCVAM-recommended test method protocol by decreasing the minimum number of animals per dose group from five to four.
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