ID#

1811

Location:

Exhibit Hall

Time of Presentation:

March 24, 1:30 PM

Category (Subcategory):

Regulatory/Policy, (In Vitro/Alternative Animal Models)

ICCVAM Process for Nomination and Submission of New, Revised, and Alternative Test Methods
L.M. Schechtman¹, W.S. Stokes², M. Wind³, B.C. Blackard^{2, 4}, R.R. Tice^{2, 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.