National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ICCVAM-submit

Submissions of Test Methods for Evaluation

ICCVAM depends on stakeholders with appropriate capabilities and resources to carry out alternative test method research, development, and validation studies and to submit the results to ICCVAM. ICCVAM welcomes submission of innovative test methods that may be acceptable for specific regulatory use and for which adequate validation studies have been completed to characterize the usefulness and limitations of the test method in accordance with ICCVAM test method submission guidelines.

However, 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. Therefore, test method developers are encouraged to consult with NICEATM and ICCVAM throughout the test method development, prevalidation, and validation process, as well as during preparation of submissions. These interactions 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 that are conducted using the test method adequately characterize its usefulness and limitations for a particular regulatory application
  • The test method submission package contains the data and information that sponsoring agencies require to determine the extent to which a test method can generate information that will meet their regulatory needs

Test method submissions may be made by contacting ICCVAM. ICCVAM is currently revising its test method evaluation procedures. However, some 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).

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.