[Federal Register Volume 67, Number 49 (Wednesday, March 13, 2002)]
[Notices]
[Page 11358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences; Notice of 
Establishment; Scientific Advisory Committee on Alternative 
Toxicological Methods

    Pursuant to the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2), the Director of the National Institute of 
Environmental Health Sciences (NIEHS) announces the establishment of 
the Scientific Advisory Committee for Alternative Toxicological Methods 
(SACATM).

SACATM

    The SACATM was chartered January 9, 2002, to fulfill section 3(d) 
of Pub. L. 106-545, the ICCVAM Authorization Act of 2000 (42 U.S.C. 
285l-3(d)). The committee will function as an advisory committee in 
compliance with the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2). The charter is posted on the web (http://iccvam.niehs.nih.gov) or is available in hard copy upon request from 
the National Toxicology Program (NTP) Liaison and Scientific Review 
Office, NIEHS, PO Box 12233, Research Triangle Park, NC 27709; 
telephone: 919-541-3971; facsimile: 919-541-0295 or 
[email protected].
    The SACATM will provide advice to the Director of the NIEHS, the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM), and the NTP Interagency Center for the Evaluation of 
Alternative Toxicological Methods (NICEATM) regarding statutorily 
mandated duties of ICCVAM. The duties of the ICCVAM include:
    (1) Review and evaluate new or revised or alternative test methods, 
including batteries of tests and test screens, that may be acceptable 
for specific regulatory uses, including the coordination of technical 
reviews of proposed new or revised or alternative test methods of 
interagency interest.
    (2) Facilitate appropriate interagency and international 
harmonization of acute or chronic toxicological test protocols that 
encourage the reduction, refinement, or replacement of animal test 
methods.
    (3) Facilitate and provide guidance on the development of 
validation criteria, validation studies, and processes for new or 
revised or alternative test methods and help facilitate the acceptance 
of such scientifically valid test methods and awareness of accepted 
test methods by Federal agencies and other stakeholders.
    (4) Submit ICCVAM test recommendations for the test methods 
reviewed by the ICCVAM, through expeditious transmittal by the 
Secretary of Health and Human Services (Secretary) (or the designee of 
the Secretary), to each appropriate Federal agency, along with the 
identification of specific agency guidelines, recommendations, or 
regulations for a test methods, including batteries of tests and test 
screens, for chemicals or class of chemicals within a regulatory 
framework that may be appropriate for scientific improvement, while 
seeking to reduce, refine, or replace animal test methods.
    (5) Consider for review and evaluation, petitions received from the 
public that--(A) identify a specific regulation, recommendation, or 
guideline regarding a regulatory mandate; and (B) recommend new or 
revised or alternative test methods and provide valid scientific 
evidence of the potential of the test method.
    (6) Make available to the public final ICCVAM test recommendations 
to appropriate Federal agencies and the response from the agencies 
regarding these recommendations.
    (7) Prepare reports to be made available to the public on its 
progress under the Act.
    The SACATM will also provide advice to the Director of the NIEHS 
and the NICEATM on activities and directives relating to the NICEATM in 
three areas:
    (1) Priorities and opportunities for alternative test methods that 
may provide improved prediction of adverse health effects compared to 
currently used methods or advantages in terms of reduced expense and 
time, reduced animal use, and reduced animal pain and distress;
    (2) Development and implementation of more effective and efficient 
processes for determining the scientific validity and acceptability of 
proposed new test methods; and
    (3) Ways to foster more effective and productive interactions 
between Federal agencies and other involved stakeholders, including 
test method developers.
    Future meetings of the SACATM will be posted on the NICEATM/ICCVAM 
web site (http://iccvam.niehs.nih.gov) and announced in the Federal 
Register. Additional information about the ICCVAM and the NICEATM is 
also available on the web.

    Dated: March 1, 2002.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.
[FR Doc. 02-5932 Filed 3-12-02; 8:45 am]
BILLING CODE 4140-01-P