[Federal Register: March 13, 2002 (Volume 67, Number 49)]
[Notices]
[Page 11358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr02-124]
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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
liason@starbase.niehs.nih.gov.
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]
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