Radioactive Drug Research Committees

Forms and Documents

Document Name	Status
Form 2914 361.1(c)(3)&(4) - Form FDA 2914 Form	Modified
Form 2915 361.1(d)(5) -- Radioactive Drugs for Certain Research Uses - Hman Research Subjects Form	Modified
Form 2915 361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman Form	Modified
Form 2915 361.1(c)(3) - Form FDA 2915 Form	Modified
SUPPORTING STATEMENT 0053 FINAL 4-30-14.doc Supporting Statement A	2014-05-06

IC Document Collections

IC ID	Document Title	Status
5709	361.1(c)(3)&(4) - Form FDA 2914 Form	Modified
183841	361.1(d)(5) -- Radioactive Drugs for Certain Research Uses - Hman Research Subjects Form	Modified
183840	361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman Form	Modified
183839	361.(d)(8) -- Adverse Reactions	Modified
183838	361.1(c)(3) - Form FDA 2915 Form	Modified

ICR Details

OMB Control No: 0910-0053	ICR Reference No: 201404-0910-014
Status: Historical Active	Previous ICR Reference No: 201103-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Radioactive Drug Research Committees
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: 07/03/2014
	Date Received in OIRA: 05/09/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	1,505	0	1,420
Time Burden (Hours)	5,007	0	4,759
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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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:
	79 FR 4348	01/27/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 24442	04/30/2014
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
361.1(c)(3)&(4) - Form FDA 2914	2914	Report on Research Use of Radioactive Drugs - Membership Summary
361.1(c)(3) - Form FDA 2915	2915	Report on Research Use of Radioactive Drugs - Study Summary
361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman	2915	Report on Research of Radioactive Drugs
361.(d)(8) -- Adverse Reactions
361.1(d)(5) -- Radioactive Drugs for Certain Research Uses - Hman Research Subjects	2915	Report on Research use on Radioactive Drugs -- Membership 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	1,505	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Revised estimates for this extension are the result of change due to adjustment in Agency estimate.

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Annual Cost to Federal Government: $103,470

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: 05/09/2014

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