[Federal Register Volume 64, Number 25 (Monday, February 8, 1999)]
[Notices]
[Pages 6111-6112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Services


National Toxicology Program; Meeting of the Advisory Committee on 
Alternative Toxicological Methods

    Pursuant to Section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given to 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 March 4, 1999 in the Conference 
Center, Building 101, South Campus, NIEHS, 111 Alexander Drive, 
Research Triangle Park, North Carolina 27709. The meeting will be 
entirely open to the public from 8:45 a.m. to adjournment with 
attendance limited only by space available. Individuals who plan to 
attend and need special assistance, such as sign language 
interpretation or other reasonable accommodations should notify the 
contact person listed below in advance of the meeting.

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 Public Law 103-43, Section 1301. The 
NIEHS was directed to (1) develop and validate toxicological testing 
methods, including alternative methods that 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 Interagency Coordinating 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/html. or by request to the 
Center at the address provided below.
    A standing Interagency 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 facilitates 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

[[Page 6112]]

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 method 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 
identify 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 919-541-3398, fax 919-541-0947, or email, 
[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. Specific agenda 
topics will include discussion of the outcome of the 
Corrositex test method peer review meeting previously 
convened on January 21, 1999; an update and discussion of the peer 
review meeting report and regulatory acceptance process for the murine 
local lymph node assay (LLNA) test method; an update on the status of 
the EPA and OECD plans for validation of endocrine disruptor screening 
and testing methods; and plans for future test method workshops and 
reviews.
    The Executive Secretary, Dr. Larry Hart, Environmental Toxicology 
Program, P.O. Box 12233, NIEHS, 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: January 29, 1999.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 99-3005 Filed 2-5-99; 8:45 am]
BILLING CODE 4140-01-M