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

ICR 200412-0910-001

OMB: 0910-0053

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0053 200412-0910-001
Historical Active 200108-0910-002
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 02/05/2005
Retrieve Notice of Action (NOA) 12/01/2004
  Inventory as of this Action Requested Previously Approved
02/29/2008 02/29/2008 02/28/2005
340 0 411
2,142 0 2,910
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.

None
None


No

1
IC Title Form No. Form Name
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary FDA-2914, FDA-2915

  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 340 411 0 0 -71 0
Annual Time Burden (Hours) 2,142 2,910 0 0 -768 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
12/01/2004


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