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

Forms and Documents

Document Name	Status
Form FDA 2914 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
Form FDA 2915 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
Form FDA 2915 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
Form FDA 2915 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
pra0053-ss 3 2011final.doc Supporting Statement A	2011-03-15

IC Document Collections

IC ID	Document Title	Status
5709	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
183841	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
183840	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified
183839	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary	Modified
183838	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary Form	Modified

ICR Details

OMB Control No: 0910-0053	ICR Reference No: 201103-0910-012
Status: Historical Active	Previous ICR Reference No: 200802-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/20/2011
	Date Received in OIRA: 03/30/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	36 Months From Approved	05/31/2011
Responses	1,420	0	1,420
Time Burden (Hours)	4,759	0	4,759
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 361 Name of Law: Prescription Drugs for Human Use Generally regognized as safe and effective and Not Misbranded
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 74059	11/30/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 11786	03/03/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

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

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ICR Summary of Burden

	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	1,420	0	0	0	0
Annual Time Burden (Hours)	4,759	4,759	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $105,470

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/30/2011

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