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Submissions of Test Methods for Evaluation

ICCVAM welcomes submission of innovative test methods that may be acceptable for specific regulatory uses. Acceptability for regulatory use is generally demonstrated by completion of adequate validation studies to characterize the usefulness and limitations of a test method in accordance with ICCVAM test method submission guidelines.

To maximize the potential for effective implementation of new test methods or approaches, ICCVAM will only conduct evaluations and prepare recommendations on test method submissions proposed for regulatory uses that align with ICCVAM member agency needs and priorities. Test method developers are encouraged to consult with NICEATM and ICCVAM throughout the test method development, prevalidation, and validation process, as well as during submission preparation to ensure that:

  • The test method aligns with the needs and priorities of one or more ICCVAM agencies, and there is at least one agency willing to sponsor the test method for evaluation
  • Validation studies conducted using the test method adequately characterize its usefulness and limitations for a particular regulatory application
  • The test method submission package contains data and information required by the sponsoring agencies to determine if a test method will meet their regulatory needs

Test method submissions may be made by contacting ICCVAM. Guidance for preparing adequate submission packages is available in the ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods (NIH Publication No. 03-4508 - September 2003). Criteria for the validation and regulatory acceptance for new and alternative test methods are outlined in the report Validation and Regulatory Acceptance of Toxicological Test Methods (ICCVAM 1997).

NIEHS and other organizations offer funding for validation studies of new test methods: see our Funding Opportunities for Test Method Developers page for current opportunities.