[Federal Register Volume 59, Number 234 (Wednesday, December 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30023]


[[Page Unknown]]

[Federal Register: December 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Institute of Environmental Health Sciences: Validation 
and Acceptance of Alternative Testing Methods: Request for Comments

Introduction

    Section 1301 of the National Institutes of Health Revitalization 
Act of 1993 (Public Law No. 103-43) directed the National Institute of 
Environmental Health Sciences (NIEHS) to establish an Applied 
Toxicological Research and Testing Program to conduct applied research 
and testing regarding toxicology. The Act specified that the 
toxicology-related activities to be carried out by the program would 
include: (i) Establishing criteria for the validation and regulatory 
acceptance of alternative testing methods; and (ii) recommending a 
process through which scientifically validated alternative methods can 
be accepted for regulatory use. The purpose of this announcement is to 
invite interested parties to provide information for consideration in 
the formulation of these criteria and processes.

Background

    In response to the directives in Public Law No. 103-43, the NIEHS 
has established the ad hoc Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM) to develop recommendations 
relating to the validation and acceptance of new and revised testing 
methods that would be useful to Federal agencies. Many new and revised 
test methods represent alternative methods, models, and approaches in 
that they: (a) Result in the reduction of the total number of animals 
required in a test; (b) incorporate refinements of procedures to lessen 
or eliminate pain or distress to animals; or (c) provide for the 
partial or total replacement of animals with non-animal systems, or the 
replacement of one animal species with another (e.g., a mammalian 
species replaced by a nonmammalian or invertebrate species).
    The Committee's goals include recommending criteria and processes 
that will: (1) Encourage the development of new methods and improvement 
of existing test methods to generate data useful for risk assessment; 
(2) lead to the scientific validation of new and improved test methods; 
(3) increase the likelihood of regulatory acceptance of scientifically 
valid new test methods; and (4) encourage the refinement and reduction 
of animal use in testing, and the replacement of animals with non-
animal methods and/or phylogenetically lower species, when 
scientifically feasible.

Action

    Comments and information are invited from interested parties 
regarding criteria for the validation and acceptance of alternative 
testing methods, and processes for the regulatory acceptance of 
scientifically validated alternative methods. Information is sought 
regarding the following broad topics:

    Types of information necessary to evaluate the practical utility 
of a test method;
    Essential components and processes applicable to the validation 
of test methods;
    Principles and criteria for assessing the validity of a test 
method; i.e., do considerations vary depending upon whether the test 
is: (a) in vivo vs. in vitro; (b) a screen or a replacement; or (c) 
mechanistically-based or not;
    Factors relevant to the acceptance of validated test methods by 
regulatory and scientific agencies.

    The Committee will consider such comments and information prior to 
the preparation of a draft document. Opportunity for comment on the 
Committee's draft document will be announced at a later date, and a 
public meeting will also be announced.
    Comments and information should be sent within 60 days of the 
publication of this announcement to Dr. William Stokes, NIEHS, MD-A2-
05, P.O. Box 12233, Research Triangle Park, North Carolina 27709. For 
further information regarding this request, please contact Dr. Stokes 
by mail at the above address, by FAX at 919/541-0719, by telephone at 
919/541-7997, or by Internet e-mail at [email protected].

    Dated: November 29, 1994.
Richard A. Griesemer,
Deputy Director, NIEHS.
[FR Doc. 94-30023 Filed 12-6-94; 8:45 am]
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