Agency Information Collection Activities; Proposals, Submissions, and Approvals: Radioactive Drug Research Committees

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees

DATES:

Submit written comments (including recommendations) on the collection of information by August 26, 2026.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Radioactive Drug Research Committees-21 CFR 361.1

OMB Control Number 0910-0053-Extension

This information collection request supports regulations and associated Agency forms. Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371) establish provisions under which FDA issues regulations governing the use of radioactive drugs for basic scientific research. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and must not carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry.

Section 361.1(c)(2) requires that each RDRC will select a chairman, who will sign all applications, minutes, and reports of the committee. Each committee will meet at least once each quarter in which research activity has been authorized or conducted. Minutes will be kept and will include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC will submit an annual report to FDA. The annual report will include the names and qualifications of the members of, and of any consultants used by, the RDRC, using Form FDA 2914 (Report on Research Use of Radioactive Drugs-Membership Summary). The annual report will also include a summary of each study conducted during the preceding year, using Form FDA 2915 (Report on Research Use of Radioactive Drugs-Study Summary).

We developed a guidance for industry and researchers titled "Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application" (August 2010) available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application. The guidance provides information to help determine whether research studies may be conducted under an FDA-approved RDRC, or whether research studies must be conducted under an investigational new drug application (IND). The guidance also offers answers to frequently asked questions on conducting research with radioactive drugs and provides information on the membership, functions, and reporting requirements of an FDA-approved RDRC. All Agency guidance documents are issued consistent with our good guidance practice regulations at 21 CFR 10.115.

Under § 361.1(d)(5), each investigator will obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant or, based on a pregnancy test, be confirmed as not pregnant.

Under § 361.1(d)(8), the investigator will immediately report to the RDRC all adverse effects associated with use of the drug, and the committee will then report to FDA all adverse reactions probably attributed to the use of the radioactive drug.

Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).

Types of research studies not permitted under the regulations are also specified in § 361.1(a) and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes ( i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an IND under 21 CFR part 312, and the associated information collections, are covered in OMB control number 0910-0014.

The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with applicable statutes and regulations specified under 21 CFR 361.1 and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson or chairpersons of each individual RDRC, investigators, and participants in the studies. The burden estimates are based on our experience with these reporting and recordkeeping requirements and the number of submissions we received under the regulations over the past 3 years.

In the Federal Register of April 17, 2026 (91 FR 20659), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Our estimated burden for the information collection reflects an overall decrease of 52 hours and a corresponding decrease of 97 responses. This is attributed to the Agency receiving fewer submissions over the last few years due to decreased subject enrollment during the pandemic.