The ICCVAM nomination and submission process and guidelines for new, revised, and alternative test methods

LM Schechtman¹, ML Wind², WS Stokes³

1. U.S. FDA, NCTR, Rockville, MD, USA
2. U.S. CPSC, Directorate for Health Sciences, Bethesda, MD, USA
3. NICEATM, RTP, NC, USA

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has developed and implemented a process for the nomination and submission of test methods and for their prioritization for review and evaluation. Prioritization of proposed test methods is a function of their regulatory applicability, anticipated multi-agency interest and use, responsiveness to the replacement, reduction, and refinement of animal use, potential for improved predictivity of adverse effects relative to currently employed methods, and efficiency and economic savings. The newly revised ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods were developed to assist test method sponsors/nominators in organizing the information needed to assess the validation status of test methods at any stage of the validation process and the extent to which the ICCVAM validation and acceptance criteria have been or will be addressed. The original guidelines, in use since 1998 to evaluate the scientific validity of test methods that have since achieved regulatory acceptance, have been updated to reflect experience gained and help to facilitate a more efficient process. Adherence to these revised guidelines will help ensure the sufficiency of data and information for independent peer review and for regulatory authorities to determine the scientific validity and regulatory acceptability of test methods. The elements comprising these guidelines have now been incorporated into international guidance for the evaluation of methods proposed for new test guidelines. The ICCVAM nomination, submission, and prioritization process and the content and organization of submissions or nominations will be described.

Date: Wednesday, August 24, 2005, 14.00-16.00 h, Estrel Hall A

5.13 Workshop: Strategies for Priorotizing and Streamlining the Validation Process