As a followup to the publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies (available at https://ntp.niehs.nih.gov/go/ICCVAM-submit), ICCVAM and NICEATM will create a platform for highlighting the report’s recommendations by organizing a series of Method Developers’ Forums (MDFs), each focused on a specific endpoint/toxicity, that provide an opportunity for NAMs developers to discuss their methods and regulatory issues with relevant stakeholders.

The first MDF will focus on new approach methodologies (NAMs) for carcinogenicity testing and will be held virtually August 21-22. This will be an interactive forum at which method developers will have an opportunity to describe how the NAM is appropriate for addressing the carcinogenicity information requirements of one or more federal agencies and answer questions from agency representatives about the NAM. Developers will be selected to participate in the forum on the basis of proposals submitted to the MDF steering committee, which includes scientists from federal research and regulatory agencies with an interest in this endpoint.

Submit proposals by Friday, July 26. Your proposal should be in the form of the presentation you plan to give at the forum. It should provide an overview of the NAM and its relevance to carcinogenicity testing. Provide enough technical detail and data on the performance of the NAM for regulatory and industry stakeholders to understand how your NAM may meet their needs. Proposals should be in the form of a PowerPoint presentation exported to PDF format. The resulting file should be no larger than 100 MB. Details on how to prepare proposals are available at https://ntp.niehs.nih.gov/go/developers-forums. Resources available on this page include:

  • Instructions for submitting your proposal and important dates.
  • Video presentations from federal agencies explaining their information requirements and decision frameworks for carcinogenicity testing.
  • Guidance for developing proposals, including specific questions that should be addressed in your proposal.

A template you may use for developing your PowerPoint presentation.