Radioactive Drug Research Committees

OMB 0910-0053

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.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2020-08-10
Approved without change
Extension without change of a currently approved collection 2017-07-19
Approved without change
Extension without change of a currently approved collection 2014-05-09
Approved without change
Extension without change of a currently approved collection 2011-03-30
Approved without change
Extension without change of a currently approved collection 2008-02-22
Approved without change
Extension without change of a currently approved collection 2004-12-01
Approved without change
Extension without change of a currently approved collection 2001-08-10
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-09-13
Approved without change
Reinstatement without change of a previously approved collection 1998-03-30
Approved without change
Revision of a currently approved collection 1994-08-12
Approved without change
Reinstatement with change of a previously approved collection 1991-07-12
Approved without change
Reinstatement with change of a previously approved collection 1987-09-02
Approved without change
Reinstatement with change of a previously approved collection 1984-06-27
Approved without change
Revision of a currently approved collection 1980-11-19
Approved with change
No material or nonsubstantive change to a currently approved collection 1978-08-30
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 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.


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