Department of Health and Human Services June 11, 2024 – Federal Register Recent Federal Regulation Documents

The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or we) is announcing a meeting program, the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide applicants with an approved application and/or other relevant parties supporting industry's pharmacovigilance (PV) activities (e.g., academia, contract research organizations (CROs), pharmacovigilance vendors, software developers) who meet the eligibility and selection criteria for participation with an opportunity to meet with CDER staff to discuss their research, development, and use of Artificial Intelligence (AI) and other emerging technologies in PV. The goals of the meeting program in its initial phase are to facilitate mutual learning and discussion of the pharmaceutical industry's application of these technologies to PV, including efforts to validate and verify relevant models. While the EDSTP is specifically focused on the use of AI in PV for postmarket activities, it is part of CDER's multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product life cycle.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. The ICR is for extending the use of the approved information collection assigned OMB control number 0937-0191, which expires on June 30, 2024. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.