Federal Register #Docket No. FDA-2026-N-3099

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

This notice concerns the FDA's request for public comment on information collection requirements related to the regulation of radioactive drugs for research purposes. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Soliciting public input on information collection for Radioactive Drug Research Committees (RDRCs) - Focus on reporting, recordkeeping, and safety protocols for research involving radioactive drugs - Products/Services: - No products, part numbers, or quantities are being procured - No OEMs or vendors are mentioned, as this is not a procurement action - Notable Requirements: - Emphasis on compliance with the Paperwork Reduction Act - Ensures research studies involving radioactive drugs adhere to federal regulations and protect human subjects - No purchase or service requirements are specified

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to regulations governing the use of radioactive drugs for basic informational research. This includes requirements for establishing and operating Radioactive Drug Research Committees (RDRCs), reporting, recordkeeping, and safety measures to ensure human subject protection. The information collection supports compliance with the Paperwork Reduction Act and aims to ensure research studies are conducted according to applicable statutes and regulations. Comments are requested by June 16, 2026.

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