Radioactive Drug Research Committees

Forms and Documents

Document Name	Status
Form Form FDA 2914 Radioactive Drug Research Committees: Reporting Form and Instruction	Modified
Form 2915 361.1(d)(5) -- Radioactive Drugs for Certain Research Uses - Hman Research Subjects Form	Removed
Form 2915 361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman Form	Removed
0053 SS for 2017 Extension.pdf Supporting Statement A	2017-07-18

IC Document Collections

IC ID	Document Title	Status
5709	Radioactive Drug Research Committees: Reporting Form and Instruction	Modified
183841	361.1(d)(5) -- Radioactive Drugs for Certain Research Uses - Hman Research Subjects Form	Removed
183840	361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman Form	Removed
183839	361.(d)(8) -- Adverse Reactions	Removed
183838	Radioactive Drug Research Committees: Recordkeeping	Modified

ICR Details

OMB Control No: 0910-0053	ICR Reference No: 201706-0910-003
Status: Historical Active	Previous ICR Reference No: 201404-0910-014
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: 09/18/2017
	Date Received in OIRA: 07/19/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	1,335	0	1,505
Time Burden (Hours)	4,917	0	5,007
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency regulations governing the use of radioactive drugs for basic scientific research. Under 21 U.S.C. section 361.1(d)(7), no basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA approved Radioactive Drug Research Committee (RDRC). The purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	82 FR 19052	04/25/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32828	07/18/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Radioactive Drug Research Committees: Reporting	Form FDA 2915, Form FDA 2914	Report on Research Use of Radioactive Drugs: Membership Summary ,   Report on Research use on Radioactive Drugs: Study Summary
Radioactive Drug Research Committees: Recordkeeping
361.(d)(8) -- Adverse Reactions
361.1(c)(2) -- Radioactive Drugs for Certain Research Uses - Chairman	2915	Report on Research of Radioactive Drugs
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	1,335	1,505	0	0	-170	0
Annual Time Burden (Hours)	4,917	5,007	0	0	-90	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: Information collection reflection reflects 170 fewer annual responses and a corresponding 90 fewer burden hours.

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Annual Cost to Federal Government: $103,530

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 07/19/2017

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