[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, [email protected].

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