FDA Seeks Comments on Radioactive Drug Research Committee Forms
Published Date: 4/17/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about radioactive drug research committees. This affects researchers using radioactive drugs for basic studies and aims to keep paperwork clear and up-to-date. You’ve got until June 16, 2026, to share your comments—no cost changes, just a chance to help shape the rules!
Analyzed Economic Effects
6 provisions identified: 2 benefits, 4 costs, 0 mixed.
Study Summary Reporting (Form FDA 2915)
RDRCs must submit Study Summary reports using Form FDA 2915. FDA estimates 324 study summaries yearly (from 35 respondents), averaging 3.5 hours per report for a total estimated burden of 1,134 hours annually.
RDRC Recordkeeping Time Burden
RDRCs must keep minutes and records, meeting at least quarterly when activity occurs. FDA estimates 55 recordkeepers producing 220 records annually, at about 10 hours per record, for a total of 2,200 recordkeeping hours each year.
Annual RDRC Membership Report
Each FDA-approved radioactive drug research committee (RDRC) must submit an annual Membership Summary using Form FDA 2914. FDA estimates 55 reports per year at about 1 hour per report, for a total of 55 hours annually.
Adverse Event Immediate Reporting
Investigators must immediately report all adverse effects linked to a radioactive drug to their RDRC, and the RDRC must report adverse reactions probably attributed to the drug to FDA. FDA estimates 10 such reports annually at 0.5 hours each (5 hours total).
Consent and Pregnancy Test Requirement
Each investigator must obtain proper consent and require that every female research subject of childbearing potential either state in writing she is not pregnant or be confirmed not pregnant by a pregnancy test. This requirement applies before administering radioactive drugs in basic research.
Human Subject Recordkeeping Burden
Investigators must keep records related to human research subjects. FDA estimates 35 recordkeepers producing 324 subject-related records annually, at about 0.75 hours (45 minutes) per record for a total of 243 hours per year.
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