Radioactive Drug Research Committees

ICR 201404-0910-014

OMB: 0910-0053

Federal Form Document

ICR Details
0910-0053 201404-0910-014
Historical Active 201103-0910-012
HHS/FDA CDER
Radioactive Drug Research Committees
Extension without change of a currently approved collection   No
Regular
Approved without change 07/03/2014
Retrieve Notice of Action (NOA) 05/09/2014
  Inventory as of this Action Requested Previously Approved
07/31/2017 36 Months From Approved 07/31/2014
1,505 0 1,420
5,007 0 4,759
0 0 0

Section 361.1, which governs the use of radioactive drugs for basic scientific research, sets forth regulations regarding the establishment and composition of radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration fo a radioactive drug to research subjects is permitted without the authorization of an FDA approved RDRC. The types of research that may be undertaken with a radiopharmaceutical drug are specified in the regulation and include studies of metabolism, human physiology, pathophysiology, or biochemistry.

US Code: 21 USC 361 Name of Law: Prescription Drugs for Human Use Generally regognized as safe and effective and Not Misbranded
  
None

Not associated with rulemaking

  79 FR 4348 01/27/2014
79 FR 24442 04/30/2014
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 1,505 1,420 0 0 85 0
Annual Time Burden (Hours) 5,007 4,759 0 0 248 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Revised estimates for this extension are the result of change due to adjustment in Agency estimate.

$103,470
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
05/09/2014


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