Office of Science and Technology Policy November 18, 2022 – Federal Register Recent Federal Regulation Documents

On October 28, 2022, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled ``Request for Information (RFI) on Data Collection for Emergency Clinical Trials and Interoperability Pilot.'' This RFI, issued by OSTP in partnership with the Office of the National Coordinator for Health Information Technology (ONC), invited comments on how to optimize data collection for clinical trials carried out across a range of institutions and sites, both in emergency settings and in the pre- emergency phase. OSTP and ONC are seeking input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs). OSTP and ONC also seek information about whether there is value in a pilot or demonstration project to operationalize data capture in the near term, for example within 6-12 months of the close of comments on the RFI. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP has determined that an extension of the comment period until January 27, 2023 is appropriate.