Draft Guidance: Emergency Use Authorization of Medical Products

Forms and Documents

Document Name	Status
eCopy Guidance.doc Supplementary Document	2012-12-12
eCopy 83c 0910-0595 12-12-12.doc Justification for No Material/Nonsubstantive Change	2012-12-12

IC Document Collections

IC ID	Document Title	Status
43607	Requests for Consideration; Pending Application on file Other-guidance document	Modified
191144	State and Local Public Health Officials; Unapproved EUA Product Other-guidance document	Modified
191143	Manufacturers of an Unapproved EUA Product Other-guidance document	Modified
191142	Pre-EUA Submissions; No Application pending Other-guidance document	Modified
191141	Pre-EUA Submissions; Pending Application on file Other-guidance document	Modified
191140	Requests for Consideration; No Application pending Other-guidance document	Modified

ICR Details

OMB Control No: 0910-0595	ICR Reference No: 201212-0910-008
Status: Historical Active	Previous ICR Reference No: 201010-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance: Emergency Use Authorization of Medical Products
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/17/2012
	Date Received in OIRA: 12/13/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	01/31/2013	01/31/2013
Responses	496	0	496
Time Burden (Hours)	4,804	0	4,804
Cost Burden (Dollars)	0	0	0

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Abstract: The Commissioner of Food and Drugs may authorize the emergency use of unapproved medical products and unapproved uses of approved products if, among other things, data are submitted supporting a conclusion that statutory criteria for issuance of an authorization are met. The Commissioner also may establish conditions on the authorization, including recordkeeping and reporting requirements. Respondents include medical countermeasure manufacturers, as well as Federal, State, and local public health officials.

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Authorizing Statute(s): US Code: 21 USC 360bbb Name of Law: FFDCA
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Requests for Consideration; Pending Application on file
Requests for Consideration; No Application pending
Pre-EUA Submissions; Pending Application on file
Pre-EUA Submissions; No Application pending
Manufacturers of an Unapproved EUA Product
State and Local Public Health Officials; Unapproved EUA Product

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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	496	496	0	0	0	0
Annual Time Burden (Hours)	4,804	4,804	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: $8,500,000

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: 12/13/2012

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