[Federal Register Volume 63, Number 144 (Tuesday, July 28, 1998)]
[Notices]
[Pages 40302-40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; Meeting of the Advisory Committee on
Alternative Toxicological Methods
Pursuant to Public Law 92-463, notice is hereby given of a meeting
of the National Toxicology Program (NTP) Advisory Committee on
Alternative Toxicological Methods, U.S. Public Health Service. The
meeting will be held from 8:45 a.m. to 4:00 p.m. on September 25, 1998
in the Conference Center, Building 101, South Campus, NIEHS, 111
Alexander Drive, Research Triangle Park, North Carolina, 27709. The
meeting will be open to the public from 8:45 a.m. to adjournment with
attendance limited only by space available.
Background
Under authority of 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended, the Department of Health and Human Services
has established an Advisory Committee on Alternative Toxicological
Methods. The Committee functions to provide advice on the activities
and priorities of the National Toxicology Program (NTP) Interagency
Center for the Evaluation of Alternative Toxicological Methods (Center)
and the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM), and to provide advice on ways to foster
partnership activities and productive interactions among all
stakeholders. The Advisory Committee is composed of knowledgeable
representatives drawn from academia, industry, public interest
organizations, other state and Federal agencies, and the international
community.
The National Toxicology Program established the Center and ICCVAM
to fulfill specific mandates provided to the National Institute of
Environmental Health Sciences by P.L. 103-43, Section 1301. The NIEHS
was directed to (1) develop and validate toxicological testing methods,
including alternative methods than can reduce or eliminate the use of
animals in acute or chronic toxicity testing, (2) establish criteria
for the validation and regulatory acceptance of alternative testing
methods, and (3) recommend a process through which scientifically
validated alternative methods can be accepted for regulatory use.
Criteria and processes for validation and regulatory acceptance were
developed in conjunction with 14 other Federal agencies and programs
with broad input from the public. These are described in the document
``Validation and Regulatory Acceptance of Toxicological Test Methods: A
Report of the Ad Hoc Intragency Coordination Committee on the
Validation of Alternative Methods'' NIH publication 97-3981, March
1997, which is available on the internet at http://ntp-
server.niehs.nih.gov/htdocs/ICCVAM/ICCVAM htm, or by request to the
Center at the address provided below.
A standing Intragency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) was subsequently established as a
collaborative effort by NIEHS and 13 other Federal regulatory and
research agencies and programs. The ICCVAM facilities cross-agency
communication and coordination on issues relating to validation,
acceptance, and national/international harmonization of toxicological
test methods. The ICCVAM works with the Center to carry out the
scientific review of proposed methods of multi-agency interest, and
provides recommendations regarding their usefulness to appropriate
agencies. The ICCVAM also provides a mechanism for interagency
communication with stakeholders throughout the process of test method
development and validation. The following Federal regulatory and
research agencies and organizations are participating in this effort:
Consumer Product Safety Commission
Department of Defense
Department of Energy
Department of Health and Human Services
Agency for Toxic Substances and Disease Registry
Food and Drug Administration
National Institute for Occupational Safety and Health/CDC
National Institutes of Health
National Cancer Institute
National Institute of Environmental Health Sciences
National Library of Medicine
Department of the Interior
Department of Labor
Occupational Safety and Health Administration
Department of Transportation
Research and Special Programs Administration
Environmental Protection Agency
The Center was established to provide operational support for the
ICCVAM and to assist Federal Agencies by coordinating and facilitating
(1) the interagency review and adoption of toxicological test methods
of multi-agency interest and (2) the participation and communication
with other stakeholders throughout the process of test methods
development and validation. The Center organizes, in collaboration with
ICCVAM, independent scientific peer reviews and workshops for test
methods of interest to Federal agencies. Peer review panels are
convened to develop scientific consensus on the usefulness of test
methods to generate information for specific human health and/or
ecological risk assessment purposes. Expert workshops are convened to
evaluate the adequacy of current test methods for assessing specific
toxicities, to identity areas in need of improved or new methods, to
evaluate proposed validation studies, and to evaluate the validation
status of methods. The Center provides an opportunity for partnerships
with other agencies and organizations to facilitate the development,
validation, and review of alternative testing methods. The Center and
ICCVAM seek to promote the scientific validation and regulatory
acceptance of toxicological test methods that will enhance agencies'
ability to assess risks and make decisions, and that will refine,
reduce, and replace animal use whenever possible. The Center Office is
located at NIEHS and can be contacted by telephone at 919-541-3398, fax
919-541-0947, or e-mail, iccvam@niehs.nih.gov.
Agenda
The primary agenda topics are concerned with presentations and
discussions relating to processes, priorities, and recent and proposed
activities of the NTP Interagency Center for the Evaluation of
Alternative Toxicological Methods and the Interagency Coordinating
Committee on the Validation of Alternative Methods.
The Executive Secretary, Dr. Larry Hart, Environmental Toxicology
Program, P.O. Box 12233, NIEHS,
[[Page 40303]]
Research Triangle Park, North Carolina 27709, telephone (919) 541-3971,
FAX (919) 541-0295, will have available an agenda with times and a
roster of Committee members prior to the meeting and summary minutes
subsequent to the meeting.
Dated: June 17, 1998.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 98-20041 Filed 7-27-98; 8:45 am]
BILLING CODE 4140-01-M
