OMB control number

Radioactive Drug Research Committees

OMB 0910-0053 ยท HHS/FDA.

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 2026-09-30 and is listed under ICR 202212-0910-016.

Latest Forms, Documents, and Supporting Material

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202607-0910-008 Extension without change of a currently approved collection 2026-07-28
202212-0910-016 Extension without change of a currently approved collection 2023-08-14 Approved without change
202008-0910-005 Extension without change of a currently approved collection 2020-08-10 Approved without change
201706-0910-003 Extension without change of a currently approved collection 2017-07-19 Approved without change
201404-0910-014 Extension without change of a currently approved collection 2014-05-09 Approved without change
201103-0910-012 Extension without change of a currently approved collection 2011-03-30 Approved without change
200802-0910-002 Extension without change of a currently approved collection 2008-02-22 Approved without change
200412-0910-001 Extension without change of a currently approved collection 2004-12-01 Approved without change
200108-0910-002 Extension without change of a currently approved collection 2001-08-10 Approved without change
199809-0910-014 No material or nonsubstantive change to a currently approved collection 1998-09-13 Approved without change
199803-0910-009 Reinstatement without change of a previously approved collection 1998-03-30 Approved without change
199408-0910-002 Revision of a currently approved collection 1994-08-12 Approved without change
199107-0910-003 Reinstatement with change of a previously approved collection 1991-07-12 Approved without change
198709-0910-001 Reinstatement with change of a previously approved collection 1987-09-02 Approved without change
198406-0910-003 Reinstatement with change of a previously approved collection 1984-06-27 Approved without change
198011-0910-004 Revision of a currently approved collection 1980-11-19 Approved without change
197808-0910-003 No material or nonsubstantive change to a currently approved collection 1978-08-30 Approved with change
197511-0910-001 New collection (Request for a new OMB Control Number) 1975-11-17 Approved without change

OMB Details

Radioactive Drug Research Committees: Reporting

Federal Enterprise Architecture: Health - Public Health Monitoring

Information collection instruments
FormNameElectronic accessType
Form Form FDA 2915Report on Research use on Radioactive Drugs: Study SummaryFillable Fileable SignableForm and instruction
Form Form FDA 2914Report on Research Use of Radioactive Drugs: Membership SummaryFillable Fileable SignableForm and instruction

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