Radioactive Drug Research Committees

ICR 202008-0910-005

OMB: 0910-0053

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2020-08-10
ICR Details
0910-0053 202008-0910-005
Active 201706-0910-003
HHS/FDA CDER
Radioactive Drug Research Committees
Extension without change of a currently approved collection   No
Regular
Approved without change 09/15/2020
Retrieve Notice of Action (NOA) 08/10/2020
  Inventory as of this Action Requested Previously Approved
09/30/2023 36 Months From Approved 09/30/2020
1,188 0 1,335
4,392 0 4,917
0 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
  
None

Not associated with rulemaking

  85 FR 3390 01/21/2020
85 FR 39913 07/02/2020
No

  Total Approved 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 1,188 1,335 0 0 -147 0
Annual Time Burden (Hours) 4,392 4,917 0 0 -525 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted our estimate to reflect a decrease of 525 hours and 147 responses to correspond with a decrease in submissions that we have observed since last review of the information collection.

$103,530
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  No

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.
08/10/2020


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