[Federal Register Volume 60, Number 213 (Friday, November 3, 1995)]
[Notices]
[Pages 55849-55850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27323]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


National Toxicology Program; Request for Comments on the Draft 
Report on Validation and Regulatory Acceptance of Toxicological Test 
Methods; Announcement of the National Toxicology Program (NTP) Workshop 
on Validation and Regulatory Acceptance of Alternative Toxicological 
Test Methods

    The draft report on Validation and Regulatory Acceptance of 
Toxicological Test Methods is available and public review and comment 
are encouraged. Registration is open for an NTP Workshop scheduled for 
December 11-12, 1995, that will provide the opportunity to participate 
in the review of this Report and to comment on the recommendations 
generated at the Workshop.

Background on the Report

    One of the over-arching goals of the NTP is developing and 
validating improved alternative toxicological test methods. Consistent 
with the goal, the NIH Revitalization Act of 1993 (P.L. 103-43, sec. 
1301) stated that the National Institute of Environmental Health 
Sciences (NIEHS), the primary component of the NTP, would: (a) 
Establish criteria for the validation and regulatory acceptance of 
alternative testing methods; and (b) recommend a process through which 
scientifically validated alternative methods can be accepted for 
regulatory use.
    An ad hoc Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) was established by NIEHS to develop a 
report recommending criteria and processes for validation and 
regulatory acceptance of toxicological testing methods. Fifteen Federal 
regulatory and research agencies have participated in this effort, 
including:
     Agency for Toxic Substances and Disease Registry (ATSDR).
     Consumer Product Safety Commission (CPSC).
     Department of Agriculture (USDA).
     Department of Defense (DOD).
     Department of Energy (DOE).
     Department of the Interior (DOI).
     Department of Transportation (DOT).
     Environmental Protection Agency (EPA).
     Food and Drug Administration (FDA).
     National Institute for Occupational Safety and Health 
(NIOSH).
     National Institutes of Health (NIH).
     National Cancer Institute (NCI).
     National Institute of Environmental Health Sciences 
(NIEHS).
     National Library of Medicine (NLM).
     Occupational Safety and Health Administration (OSHA).
    The draft Report is applicable to all proposed toxicological 
testing methods for health and ecological endpoints, including those 
termed ``alternatives.'' Alternative test methods are those that 
incorporate some aspect of reduction, refinement, and replacement of 
animal use. Such methods: result in the reduction of the total number 
of animals required; incorporate refinements of procedures to lessen or 
eliminate pain or distress to animals and enhance animal well-being; or 
provide for the partial or total replacement of animals with non-animal 
systems, or the replacement of an animal species with a 
phylogenetically lower species (e.g., a mammalian species replaced by 
an invertebrate species).
    The ICCVAM determined that the goals of the Report are to:
     Communicate the criteria and processes that Federal 
agencies should employ in considering new and revised test methods;
     Encourage the development of new methods and improvement 
of existing test methods;
     Provide more effective guidance for scientists for the 
validation and evaluation of new and revised test methods;
     Contribute to the increased likelihood of regulatory 
acceptance of scientifically valid new and revised test methods;
     Encourage, when scientifically feasible, the reduction and 
refinement of animal use in testing, and the replacement of animals 
with non-animal methods and phylogenetically lower species;
     Encourage the use of validated and accepted new and 
revised test methods.

Comments on the Report

    Public review of the draft Report is critical to its completion and 
is encouraged. To receive a copy of the Report, please contact the NTP 
Liaison Office at NIEHS, P.O. Box 12233, MD A3-01, Research Triangle 
Park, NC 27709, or by FAX to: (919) 541-0295. Written comments received 
by November 20, 1995, will be distributed for consideration during the 
workshop. Written comments submitted after November 20 but before 
January 2, 1996, will be considered by the Committee in preparing a 
final Report. Submit comments to Dr. William Stokes, NIEHS, P.O. Box 
12233, MD B2-04, Research Triangle Park, NC 27709, or by FAX to (919) 
541-0719. For further information about the Report, please contact one 
of the ICCVAM co-chairs--Dr. William Stokes, NIEHS, or Dr. Richard 
Hill, EPA, Mail Code 7101, 401 M Street, S.W., Washington, DC 20460, or 
FAX (202) 260-1847.

Background on the Workshop

    A workshop on Validation and Regulatory Acceptance of Alternative 
Toxicological Test Methods will be held on December 11-12, 1995, in 
Arlington, Virginia, to receive comments from the public and invited 
review panels on the draft Report. The Workshop meeting structure will 
include opening and closing Plenary Sessions and three Breakout Groups 
that will address: (1) Validation Criteria; (2) Regulatory Acceptance 
Criteria and Processes; and (3) Proposals for Future Directions. 

[[Page 55850]]

    Specific goals of the Workshop:
     To obtain comments and recommendations and strengthen the 
usefulness of the Report for the scientific community.
     To discuss comments received in response to this notice 
and other announcements.
     To obtain comments and recommendations relevant to the 
effective implementation of the processes described in the Report.
    Comments and recommendations from the Workshop will be considered 
by the ICCVAM in preparing a final Report.

Registration for the Workshop

    Registration materials for the workshop can be obtained by 
contacting the NTP Liaison Office at NIEHS, P.O. Box 12233, MD A3-01, 
Research Triangle Park, NC 27709, or by FAX to: (919) 541-0295. Please 
indicate on the registration form if you wish to speak. Oral 
presentations from participants requesting time during the closing 
plenary session will be limited to five minutes in length to allow for 
a maximum number of presentations. Written comments accompanying the 
oral statements are encouraged and should be received by close of 
business on November 20, 1995, to ensure consideration by the workshop 
breakout groups.

    Dated: October 26, 1995.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 95-27323 Filed 11-2-95; 8:45 am]
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