Radioactive Drug Research Committees

ICR 201706-0910-003

OMB: 0910-0053

Federal Form Document

ICR Details
0910-0053 201706-0910-003
Historical Active 201404-0910-014
HHS/FDA CDER
Radioactive Drug Research Committees
Extension without change of a currently approved collection   No
Regular
Approved without change 09/18/2017
Retrieve Notice of Action (NOA) 07/19/2017
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved 09/30/2017
1,335 0 1,505
4,917 0 5,007
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

  82 FR 19052 04/25/2017
82 FR 32828 07/18/2017
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 1,335 1,505 0 0 -170 0
Annual Time Burden (Hours) 4,917 5,007 0 0 -90 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Information collection reflection reflects 170 fewer annual responses and a corresponding 90 fewer burden hours.

$103,530
No
    No
    No
No
No
No
Uncollected
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.
07/19/2017


© 2021 OMB.report | Privacy Policy