Radioactive Drug Research Committees

ICR 202212-0910-016

OMB: 0910-0053

Federal Form Document

Forms and Documents
Form and Instruction
Supporting Statement A
ICR Details
0910-0053 202212-0910-016
Received in OIRA 202008-0910-005
Radioactive Drug Research Committees
Extension without change of a currently approved collection   No
Regular 08/14/2023
  Requested Previously Approved
36 Months From Approved 09/30/2023
1,030 1,188
3,689 4,392
0 0

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.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act

Not associated with rulemaking

  88 FR 16272 03/16/2023
88 FR 54326 08/10/2023

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,030 1,188 0 0 -158 0
Annual Time Burden (Hours) 3,689 4,392 0 0 -703 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall decrease of 703 hours and a corresponding decrease of 158 responses. We attribute this adjustment to a decrease in the average burden per response, from 3.5 hours to 3 hours per response, associated with the public reporting burden for Form FDA 2915. The decrease is based on our program experience and matches the burden hours reflected on the form. In addition, this adjustment is also attributable to the Agency receiving fewer submissions over the last few years.

Rachel Showalter 202 693-2146 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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