ICCVAM Process for Nomination and Submission of New, Revised, and Alternative Test Methods
L.M. Schechtman1, W.S. Stokes2, M.
Wind3, B.C. Blackard2, 4, R.R. Tice2,
4.
1. NCTR, FDA, Rockville, MD, USA.
2. NICEATM, NIEHS, RTP, NC,
USA.
3. DHS, CPSC, Bethesda, MD, USA.
4. ILS,
Inc., RTP, NC, USA.
The Interagency Coordinating Committee on
the Validation of Alternative Methods (ICCVAM) coordinates (a)
the technical evaluation of new, revised and alternative test
methods of Federal agency interest, and (b) cross-agency issues
relating to the validation, acceptance and national and
international harmonization of toxicological test methods.
ICCVAM recently developed and adopted a process by which test
method nominations and submissions are considered and
prioritized for review and evaluation. Prioritization of
proposed test methods is based on several criteria, including:
the applicability of the method to regulatory testing needs; the
extent of anticipated use by one or more agencies; the level of
multi-agency interest; the potential for the method to reduce,
refine or replace animal use; the prospect of the test method to
provide improved prediction of adverse health or environmental
effects compared to current test methods accepted by regulatory
agencies; and the extent to which the test method affords other
advantages, such as reduced time or cost. The newly revised
ICCVAM Guidelines for the Nomination and Submission of New,
Revised, and Alternative Test Methods describe: 1) the ICCVAM
nomination and submission process, 2) the information that
should be provided in a test method submission or nomination and
an outline for organizing the necessary information; and 3) the
ICCVAM process for developing performance standards, which
communicate the basis on which a validated and accepted test
method has been determined to have sufficient accuracy and
reliability for a specific testing purpose. Test method
submitters/ nominators are encouraged to utilize these
Guidelines and communicate with NICEATM and ICCVAM during the
preparation of test method submissions and nominations. These
Guidelines are expected to facilitate the preparation of test
method submissions and nominations and their consideration by
ICCVAM. ILS staff supported by NIEHS Contract
NO1-ES-35504.
This page was last updated May 9, 2007
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