Federal Register #FDA-2026-N-3099

FDA Seeks Public Comment on Information Collection for Radioactive Drug Research Committees

This opportunity is a request for public comment from the Food and Drug Administration (FDA) regarding information collection for Radioactive Drug Research Committees (RDRCs): - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Soliciting public input on proposed information collection activities related to RDRCs - Ensures compliance with 21 CFR 361.1 for research involving radioactive drugs - Requirements: - Annual reporting by RDRCs using FDA Forms 2914 and 2915 - Recordkeeping of committee activities and research subject data - Reporting of adverse events and study summaries - Quarterly committee meetings - Strict protocols for informed consent and adverse event reporting - No products, OEMs, or vendors are being procured; this is an information collection notice only - Unique/Notable Requirements: - Emphasis on regulatory compliance and human subject safety in basic scientific research - Detailed reporting and recordkeeping obligations for RDRCs

Description

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection supports regulations governing the use of radioactive drugs for basic scientific research, specifically the establishment and operation of Radioactive Drug Research Committees (RDRCs). The information collection includes reporting and recordkeeping requirements to ensure research studies comply with applicable statutes and regulations and to assure human subject safety. Public comments on this collection are invited and must be submitted by August 26, 2026.

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