Radioactive Drug Research Committees

OMB 0910-0053

The information collection supports agency regulations governing the use of radioactive drugs for basic scientific research. Under 21 U.S.C. section 361.1(d)(7), no basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA approved Radioactive Drug Research Committee (RDRC). The purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks.

The latest form for Radioactive Drug Research Committees expires 2023-09-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 2914 Radioactive Drug Research Committees: Reporting Form and Instruction
0053 RDRCs SSA 8-11-23.docx Supporting Statement A
Radioactive Drug Research Committees: Reporting Form and Instruction
Radioactive Drug Research Committees: Recordkeeping

All Historical Document Collections

202212-0910-016 Approved without change	Extension without change of a currently approved collection	2023-08-14
202008-0910-005 Approved without change	Extension without change of a currently approved collection	2020-08-10
201706-0910-003 Approved without change	Extension without change of a currently approved collection	2017-07-19
201404-0910-014 Approved without change	Extension without change of a currently approved collection	2014-05-09
201103-0910-012 Approved without change	Extension without change of a currently approved collection	2011-03-30
200802-0910-002 Approved without change	Extension without change of a currently approved collection	2008-02-22
200412-0910-001 Approved without change	Extension without change of a currently approved collection	2004-12-01
200108-0910-002 Approved without change	Extension without change of a currently approved collection	2001-08-10
199809-0910-014 Approved without change	No material or nonsubstantive change to a currently approved collection	1998-09-13
199803-0910-009 Approved without change	Reinstatement without change of a previously approved collection	1998-03-30
199408-0910-002 Approved without change	Revision of a currently approved collection	1994-08-12
199107-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1991-07-12
198709-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1987-09-02
198406-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1984-06-27
198011-0910-004 Approved without change	Revision of a currently approved collection	1980-11-19
197808-0910-003 Approved with change	No material or nonsubstantive change to a currently approved collection	1978-08-30
197511-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1975-11-17

OMB Details

Radioactive Drug Research Committees: Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 2915	Report on Research use on Radioactive Drugs: Study Summary	Fillable Fileable Signable	Form and instruction
Form Form FDA 2914	Report on Research Use of Radioactive Drugs: Membership Summary	Fillable Fileable Signable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.