On August 16, 2018, the NIH Director issued a statement describing a proposal to streamline the federal framework for oversight of gene therapy. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to eliminate duplicative review and reporting requirements for human gene transfer protocols. The statement also describes NIHs effort to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The charter of the NExTRAC reflects the shift in focus of the committee while embracing the continuity of this important advisory committee.

Federal Register Notice

Charter of the NExTRAC

NIH Directors Statement

Under the Poliscope Blog

NIH Guide to Grants and Contracts Notice

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NIH Guidelines | OSP - National Institutes of Health