Guidance on Emergency Use Authorization of Medical Products and Related Authorities

Forms and Documents

Document Name	Status
0595_Supporting Statement_2019.docx Supporting Statement A	2019-07-25

IC Document Collections

IC ID	Document Title	Status
43607	Requests to Issue an EUA or a Substantive Amendment to an Existing EUA Other-Guidance	Modified
236302	Public Health Authorities; Request for Expiration Date Extension Other-Guidance	New
191144	State and Local Public Health Officials; Unapproved EUA Product Other-Guidance	Modified
191143	Manufacturers of an Unapproved EUA Product Other-Guidance	Modified
191142	Public Health Authorities; Unapproved EUA Product Other-Guidance	Modified
191141	Manufacturers of an Unapproved EUA Product Other-Guidance	Modified
191140	FDA Review of a Pre-EUA Package or an Amendment Thereto Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0595	ICR Reference No: 201905-0910-009
Status: Active	Previous ICR Reference No: 201603-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Guidance on Emergency Use Authorization of Medical Products and Related Authorities
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/27/2019
	Date Received in OIRA: 07/29/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	08/31/2019
Responses	361	0	224
Time Burden (Hours)	4,435	0	1,622
Cost Burden (Dollars)	0	0	0

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Abstract: This Information Collection Request (ICR) collects information from manufacturers and public health authorities applicable to the authorization of the emergency use of certain medical products during a declared emergency. Respondents submit information as recommended in Food and Drug Administration (FDA or Agency) guidance, including a description of the medical product and the intended use, reports after administration of such a product, and requests for extension of the expiration date of eligible products.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 13299	04/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 34396	07/18/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
FDA Review of a Pre-EUA Package or an Amendment Thereto
Requests to Issue an EUA or a Substantive Amendment to an Existing EUA
Manufacturers of an Unapproved EUA Product
Public Health Authorities; Unapproved EUA Product
Manufacturers of an Unapproved EUA Product
State and Local Public Health Officials; Unapproved EUA Product
Public Health Authorities; Request for Expiration Date Extension

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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	361	224	0	0	137	0
Annual Time Burden (Hours)	4,435	1,622	0	0	2,813	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: The estimated annual hourly burden, formerly estimated as 1,622 hours, has increased by 2,813 hours to a total estimated annual hourly burden of 4,435 hours. This program adjustment/increase in total annual burden is a result of calculations based on the numbers of submissions over the past three years. FDA anticipates that there will be a similar number of pre-EUA, EUA, and expiration date extension request submissions in future years.

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Annual Cost to Federal Government: $5,950,000

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.     Yes

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: 07/29/2019

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