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

On October 26, 2022, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled ``Request for Information (RFI) on Clinical Research Infrastructure and Emergency Clinical Trials.'' This RFI invited comments on improving the U.S. clinical trials infrastructure and in particular, our ability to carry out emergency clinical trials. In accordance with the 2022 National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (National Biodefense Strategy) and the American Pandemic Preparedness Plan (AP3), OSTP, in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies. 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.

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.

The Office of Science and Technology Policy published a document in the Federal Register of October 25, 2022, concerning a request for information on Clinical Research Infrastructure and Emergency Clinical Trials. This document corrects an error in that notice.