Justia 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); Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods Recommendations on the Murine Local Lymph Node Assay, An Alternative Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability, 25866-25867 [2010-10954]

National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods Recommendations on the Murine Local Lymph Node Assay, An Alternative Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability, 25866-25867 [2010-10954]

Download as PDF 25866 Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll free number 301–402–9680 or e-mail your request to sharlipd@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: April 30, 2010. Betsy L. Humphreys, Deputy Director, National Library of Medicine, National Institutes of Health. [FR Doc. 2010–10950 Filed 5–7–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Community Services Block Grant (CSBG) Program Model Plan Application. OMB No.: New Collection. Description: Sections 676 and 677 of the Community Services Block Grant Act require States, including the District of Columbia and the Commonwealth of Puerto Rico, Tribes, Tribal organizations and U.S. territories applying for Community Services Block Grant (CSBG) funds to submit an application and plan (Model Application Plan). The application plan must meet statutory requirements prior to being funded with CSBG funds. Applicants have the option to submit a detailed application annually or biannually. Entities that submit a biannual application must provide an abbreviated application the following year if substantial changes to the initial application will occur. OMB approval is being sought. Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, Tribal Governments, Tribal Organizations, and U.S. territories. ANNUAL BURDEN ESTIMATES Number of respondents Instrument jlentini on DSKJ8SOYB1PROD with NOTICES Model State CSBG Application ....................................................................... Model Indian Tribes & Tribal Organizations CSBG Application ...................... Estimated Total Annual Burden Hours: 860 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Dated: May 4, 2010. Robert Sargis, Reports Clearance Officer. [FR Doc. 2010–10933 Filed 5–7–10; 8:45 am] BILLING CODE 4184–01–P VerDate Mar<15>2010 17:18 May 07, 2010 Jkt 220001 56 30 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); Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods Recommendations on the Murine Local Lymph Node Assay, An Alternative Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Notice of Availability. SUMMARY: U.S. Federal agency responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method recommendations on the murine local lymph node assay (LLNA), an alternative safety testing method used to assess the potential of chemicals and products to cause allergic contact dermatitis (ACD), are now available. ICCVAM recommended an updated LLNA test method protocol, a reduced PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden hours per response Total burden hours 10 10 560 300 LLNA procedure (rLLNA), and LLNA test method performance standards. In accordance with the ICCVAM Authorization Act, ICCVAM previously forwarded recommendations to Federal agencies and made these recommendations available to the public (74 FR 50212). Agencies have now notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public. Federal agency responses are available on the NICEATM–ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ immunotox/rLLNA.htm and https:// iccvam.niehs.nih.gov/methods/ immunotox/llna_PerfStds.htm. The ICCVAM recommendations are provided in ICCVAM Test Method Evaluation Reports, which are available on the NICEATM–ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ immunotox/LLNA–LD/TMER.htm and https://iccvam.niehs.nih.gov/methods/ immunotox/PerfStds/llna-ps.htm. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2– 16, Research Triangle Park, NC, 27709, (telephone) 919–541–2384, (fax) 919– 541–0947, (e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices jlentini on DSKJ8SOYB1PROD with NOTICES Background ICCVAM originally recommended the LLNA as a valid stand-alone alternative method to existing ACD test methods in 1999 (NIH publication No. 99–4494; available at https://iccvam.niehs.nih.gov/ docs/immunotox_docs/llna/ llnarep.pdf). ICCVAM recommended that the LLNA could be used as a substitute for the existing guinea pig based test methods for most testing situations, which would reduce the number of animals required and avoid pain and distress. The Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Consumer Product Safety Commission (CPSC) subsequently accepted the method as a valid substitute. The Organization for Economic Co-operation and Development (OECD) adopted the LLNA as international OECD Test Guideline 429 and the International Standards Organization (ISO) adopted the LLNA as ISO Test 10993–10. The updated LLNA test method protocol uses 20% fewer animals than the original LLNA protocol recommended by ICCVAM in 1999, and provides improved guidance on dose selection and other procedures to improve assay accuracy and reproducibility. The rLLNA procedure can further reduce the number of animals required by 40% compared to the updated LLNA protocol multi-dose procedure. ICCVAM recommends that the rLLNA test method should be routinely considered before conducting the traditional multi-dose LLNA, and should be used as the initial test for ACD where determined appropriate. ICCVAM evaluation and complete recommendations for the updated LLNA test method protocol and the rLLNA procedure are provided in 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 No. 09–6439, available at https://iccvam.niehs.nih.gov/methods/ immunotox/LLNA–LD/TMER.htm). ICCVAM also recommends that the LLNA test method performance standards can be used to efficiently evaluate the validity of modified test methods that are mechanistically and functionally similar to the traditional LLNA. The LLNA test method performance standards are provided in the ICCVAM report, Recommended Performance Standards: Murine Local Lymph Node Assay (NIH Publication No. 09–7357, available at https:// VerDate Mar<15>2010 17:18 May 07, 2010 Jkt 220001 iccvam.niehs.nih.gov/methods/ immunotox/PerfStds/llna-ps.htm). ICCVAM evaluated the updated versions of the LLNA in response to a 2007 nomination from the CPSC (https://iccvam.niehs.nih.gov/methods/ immunotox/llnadocs/ CPSC_LLNA_nom.pdf). The nomination also requested that ICCVAM evaluate the validation status of (1) new versions of the LLNA test method protocol that do not require the use of radioactive materials; (2) use of the LLNA to test mixtures, aqueous solutions, metals, and other substances; and (3) use of the LLNA to determine ACD potency categories for hazard classification and labeling purposes. ICCVAM recommendations on these new versions and applications are undergoing finalization and will be forwarded to Federal agencies in 2010. Agency Reponses to ICCVAM Recommendations In September 2009, ICCVAM forwarded final test method recommendations for the rLLNA, the updated LLNA test method protocol, and LLNA performance standards to U.S. Federal agencies for consideration, in accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3(e)(4)) (74 FR 50212). The ICCVAM Authorization Act requires member agencies to review ICCVAM test method recommendations and notify ICCVAM in writing of their findings no later than 180 days after receipt of recommendations. The Act also requires ICCVAM to make ICCVAM recommendations and agency responses available to the public. Agency responses are to include identification of relevant test methods for which the ICCVAM test method recommendations may be added or substituted, and indicate any revisions or planned revisions to existing guidelines, guidances, or regulations to be made in response to these recommendations. Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use, generate, or disseminate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, and replace animal use. The ICCVAM Authorization Act of 2000 established ICCVAM as a PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 25867 permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of U.S. Federal agencies. Additional information about ICCVAM and NICEATM can be found on their Web site (https://www.iccvam.niehs.nih.gov). Dated: April 30, 2010. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2010–10954 Filed 5–7–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): International Workshop on Alternative Methods To Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services. ACTION: Announcement of a workshop. SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM announce an upcoming ‘‘International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions.’’ The workshop will bring together an international group of scientific experts from government, industry, and academia to review the current state of the science, availability, and future need for alternative methods that can reduce, refine, and replace the use of animals for human and veterinary vaccine postlicensing potency and safety testing. Plenary and breakout sessions will address current U.S. and international regulatory requirements, currently available alternatives, and future research, development, and validation activities needed to further advance the use of alternative methods for vaccine post-licensing potency and safety testing. This workshop is free and open E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Notices]
[Pages 25866-25867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10954]


=======================================================================
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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); Federal 
Agency Responses to Interagency Coordinating Committee on the 
Validation of Alternative Methods Recommendations on the Murine Local 
Lymph Node Assay, An Alternative Test Method for Assessing the Allergic 
Contact Dermatitis Potential of Chemicals and Products: Notice of 
Availability

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Notice of Availability.

-----------------------------------------------------------------------

SUMMARY: U.S. Federal agency responses to Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) test method 
recommendations on the murine local lymph node assay (LLNA), an 
alternative safety testing method used to assess the potential of 
chemicals and products to cause allergic contact dermatitis (ACD), are 
now available. ICCVAM recommended an updated LLNA test method protocol, 
a reduced LLNA procedure (rLLNA), and LLNA test method performance 
standards. In accordance with the ICCVAM Authorization Act, ICCVAM 
previously forwarded recommendations to Federal agencies and made these 
recommendations available to the public (74 FR 50212). Agencies have 
now notified ICCVAM in writing of their findings and ICCVAM is making 
these responses available to the public. Federal agency responses are 
available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/immunotox/rLLNA.htm and https://iccvam.niehs.nih.gov/methods/immunotox/llna_PerfStds.htm. The ICCVAM 
recommendations are provided in ICCVAM Test Method Evaluation Reports, 
which are available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/immunotox/LLNA-LD/TMER.htm and https://iccvam.niehs.nih.gov/methods/immunotox/PerfStds/llna-ps.htm.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, 
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle 
Park, NC, 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail) 
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 
Davis Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

[[Page 25867]]

Background

    ICCVAM originally recommended the LLNA as a valid stand-alone 
alternative method to existing ACD test methods in 1999 (NIH 
publication No. 99-4494; available at https://iccvam.niehs.nih.gov/docs/immunotox_docs/llna/llnarep.pdf). ICCVAM recommended that the LLNA 
could be used as a substitute for the existing guinea pig based test 
methods for most testing situations, which would reduce the number of 
animals required and avoid pain and distress. The Environmental 
Protection Agency (EPA), the Food and Drug Administration (FDA), and 
the Consumer Product Safety Commission (CPSC) subsequently accepted the 
method as a valid substitute. The Organization for Economic Co-
operation and Development (OECD) adopted the LLNA as international OECD 
Test Guideline 429 and the International Standards Organization (ISO) 
adopted the LLNA as ISO Test 10993-10.
    The updated LLNA test method protocol uses 20% fewer animals than 
the original LLNA protocol recommended by ICCVAM in 1999, and provides 
improved guidance on dose selection and other procedures to improve 
assay accuracy and reproducibility. The rLLNA procedure can further 
reduce the number of animals required by 40% compared to the updated 
LLNA protocol multi-dose procedure. ICCVAM recommends that the rLLNA 
test method should be routinely considered before conducting the 
traditional multi-dose LLNA, and should be used as the initial test for 
ACD where determined appropriate. ICCVAM evaluation and complete 
recommendations for the updated LLNA test method protocol and the rLLNA 
procedure are provided in 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 No. 09-6439, available at 
https://iccvam.niehs.nih.gov/methods/immunotox/LLNA-LD/TMER.htm).
    ICCVAM also recommends that the LLNA test method performance 
standards can be used to efficiently evaluate the validity of modified 
test methods that are mechanistically and functionally similar to the 
traditional LLNA. The LLNA test method performance standards are 
provided in the ICCVAM report, Recommended Performance Standards: 
Murine Local Lymph Node Assay (NIH Publication No. 09-7357, available 
at https://iccvam.niehs.nih.gov/methods/immunotox/PerfStds/llna-ps.htm).
    ICCVAM evaluated the updated versions of the LLNA in response to a 
2007 nomination from the CPSC (https://iccvam.niehs.nih.gov/methods/immunotox/llnadocs/CPSC_LLNA_nom.pdf). The nomination also requested 
that ICCVAM evaluate the validation status of (1) new versions of the 
LLNA test method protocol that do not require the use of radioactive 
materials; (2) use of the LLNA to test mixtures, aqueous solutions, 
metals, and other substances; and (3) use of the LLNA to determine ACD 
potency categories for hazard classification and labeling purposes. 
ICCVAM recommendations on these new versions and applications are 
undergoing finalization and will be forwarded to Federal agencies in 
2010.

Agency Reponses to ICCVAM Recommendations

    In September 2009, ICCVAM forwarded final test method 
recommendations for the rLLNA, the updated LLNA test method protocol, 
and LLNA performance standards to U.S. Federal agencies for 
consideration, in accordance with the ICCVAM Authorization Act of 2000 
(42 U.S.C. 285l-3(e)(4)) (74 FR 50212). The ICCVAM Authorization Act 
requires member agencies to review ICCVAM test method recommendations 
and notify ICCVAM in writing of their findings no later than 180 days 
after receipt of recommendations. The Act also requires ICCVAM to make 
ICCVAM recommendations and agency responses available to the public. 
Agency responses are to include identification of relevant test methods 
for which the ICCVAM test method recommendations may be added or 
substituted, and indicate any revisions or planned revisions to 
existing guidelines, guidances, or regulations to be made in response 
to these recommendations.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use, generate, or 
disseminate toxicological information. ICCVAM conducts technical 
evaluations of new, revised, and alternative methods with regulatory 
applicability and promotes the scientific validation and regulatory 
acceptance of toxicological test methods that more accurately assess 
the safety and hazards of chemicals and products and that refine, 
reduce, and replace animal use. The ICCVAM Authorization Act of 2000 
established ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers ICCVAM and provides scientific and 
operational support for ICCVAM-related activities. NICEATM and ICCVAM 
work collaboratively to evaluate new and improved test methods 
applicable to the needs of U.S. Federal agencies. Additional 
information about ICCVAM and NICEATM can be found on their Web site 
(https://www.iccvam.niehs.nih.gov).

    Dated: April 30, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-10954 Filed 5-7-10; 8:45 am]
BILLING CODE 4140-01-P

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