[Federal Register Volume 68, Number 220 (Friday, November 14, 2003)]
[Notices]
[Page 64636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences (NIEHS); 
National Toxicology Program (NTP); Request for Nominations and 
Submissions of Alternative Test Methods for Evaluation by ICCVAM; 
Notice of the Availability of the Updated Document, ``ICCVAM Guidelines 
for Nomination and Submission of New, Revised, and Alternative Test 
Methods''

Summary

    The National Toxicology Program Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM) requests the 
nomination and submission of new, revised, and alternative test methods 
for potential evaluation by the Interagency Coordinating Committee on 
Alternative Toxicological Methods (ICCVAM). The nominations and 
submissions should be sent to Dr. William Stokes, NICEATM Director at 
the address provided below. Instructions for making nominations and 
submissions are described in the document, ``ICCVAM Guidelines for 
Nomination and Submission of New, Revised, and Alternative Test 
Methods,'' September 2003, NIH Publication 03-4508. The guidelines are 
available electronically in PDF and HTML formats from the NICEATM/
ICCAVM Web site (http://iccvam.niehs.nih.gov) and in hardcopy from 
NICEATM (contact information provided below).

Nominations and Submissions of Alternative Test Methods for Evaluation 
by ICCVAM

    Those persons nominating or submitting test methods are referred to 
the guidelines noted below for details on information required for an 
ICCVAM evaluation. Test methods for which adequate validation studies 
have been completed can be submitted to ICCVAM as test method 
submissions. Test method submissions should contain sufficient 
information to characterize the relevance and reliability of a test 
method for a specific, proposed regulatory testing application. Test 
methods for which complete submissions are not available may be 
nominated for further evaluation, including test methods that may 
require validation studies or a comprehensive review of their current 
validation status. Both nominations and submissions are prioritized for 
formal evaluation as described in the ICCVAM guidelines. Nominations 
should also be accompanied by as much information as possible as 
outlined in the ICCVAM guidelines. While there is no minimum 
requirement for information to provide with nominations, complete 
information will expedite ICCVAM's consideration of the proposed test 
method. All nominations and submissions should be sent to Dr. William 
S. Stokes, Director, NICEATM, P. O. Box 12233, MD EC-17, Research 
Triangle Park, NC 27709, phone: 919-541-2384, fax: 919-541-0947, or 
email: [email protected].

ICCVAM Guidelines

    The NICEATM announces the availability of the document, ``ICCVAM 
Guidelines for Nomination and Submission of New, Revised, and 
Alternative Test Methods,'' September 2003, NIH Publication No. 03-
4508. The updated guidelines replace the document previously published 
in 1999. The ICCVAM guidelines provide guidance for test method 
sponsors and nominators on the information needed by ICCVAM to evaluate 
the validation status of new, revised, and alternative test methods 
proposed for regulatory testing applications. A framework for 
organizing the information supporting the validity of a test method is 
provided. This framework can also be used to organize information to 
support test methods nominated for further evaluation, including 
validation study proposals. The updated ICCVAM nomination and 
submission guidelines are available electronically (PDF and HTML) on 
the NICEATM/ICCVAM Web site at http://iccvam.niehs.nih.gov. A limited 
number of printed guidelines are available from the NICEATM at the 
address given above.

Background Information on ICCVAM and NICEATM

    The NIEHS established the ICCVAM in 1997 to coordinate the 
interagency technical review of new, revised, and alternative test 
methods of interagency interest, and to coordinate cross-agency issues 
relating to the validation, acceptance, and national/international 
harmonization of toxicological testing methods. ICCVAM was established 
as a permanent interagency committee of the NIEHS under the NICEATM on 
December 19, 2000, by the ICCVAM Authorization Act of 2000 (Public Law 
106-545, available at http://iccvam.niehs.nih.gov/about/PL106545.pdf). 
The committee is composed of representatives from 15 Federal regulatory 
and research agencies that use or generate toxicological information. 
ICCVAM seeks to promote the scientific validation and regulatory 
acceptance of toxicological test methods that will improve the 
agencies' ability to accurately assess the safety or hazards of 
chemicals and various types of products, while refining (less pain and 
distress), reducing, and replacing animal use wherever possible. 
NICEATM administers the ICCVAM and provides scientific and operational 
support for ICCVAM and ICCVAM-related activities. NICEATM and ICCVAM 
work collaboratively to evaluate new and improved test methods 
applicable to the needs of Federal agencies. Additional information 
about ICCVAM and NICEATM can be found at the following Web site: http://iccvam.niehs.nih.gov.

    Dated: November 5, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-28560 Filed 11-13-03; 8:45 am]
BILLING CODE 4140-01-P