Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary

ICR 200802-0910-002

OMB: 0910-0053

Federal Form Document

ICR Details
0910-0053 200802-0910-002
Historical Active 200412-0910-001
HHS/FDA
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
Extension without change of a currently approved collection   No
Regular
Approved without change 03/26/2008
Retrieve Notice of Action (NOA) 02/22/2008
  Inventory as of this Action Requested Previously Approved
03/31/2011 36 Months From Approved 03/31/2008
1,420 0 340
4,759 0 2,142
0 0 0

The information is needed for the collection requirements contained in 21 CFR 361.1. The information will be reviewed to determine the qualifications of the membership and the appropriateness of approved studies. The respondents are the Chairpersons, investigators, and members of the approved Radioactive Drug Research Committees.

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

  72 FR 54044 09/21/2007
72 FR 70329 12/11/2007
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 1,420 340 0 0 1,080 0
Annual Time Burden (Hours) 4,759 2,142 0 0 2,617 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$82,850
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Eliazabeth Berbakos 3018271482

  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.
02/22/2008


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