Authorization of Medical Products for Use Emergencies

Forms and Documents

Document Name	Status
0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-25
0595 EUAs SSA Ext 2022.docx Supporting Statement A	2022-07-22

IC Document Collections

IC ID	Document Title	Status
43607	Requests for substantive amendment to an existing EUA Other-Guidance	Unchanged
254792	3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Other-Statutory Authority	Unchanged
254791	RECORDKEEPING: EUA holders Other-Statutory Authority	Unchanged
236302	RECORDKEEPING: Public Health Authorities Other-Guidance	Unchanged
191144	Public Health Authorities; request for extension of expiration date Other-Guidance	Unchanged
191143	Public Health Authorities; request for EUA dispensing order Other-Guidance	Unchanged
191142	Public Health Authorities; unapproved EUA product Other-Guidance	Unchanged
191141	Submitting information required under conditions of aurhorization Other-Guidance	Unchanged
191140	Pre-EUA submissions or amendments Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0595	ICR Reference No: 202209-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202207-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Authorization of Medical Products for Use Emergencies
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/27/2022

	Requested	Previously Approved
Expiration Date	09/30/2025	09/30/2025
Responses	10,127	10,127
Time Burden (Hours)	352,834	352,834
Cost Burden (Dollars)	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-3 through 360bbb-3b Name of Law: FFDCA; Emergency Use of Medical Products
  

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:
	87 FR 12175	03/03/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 40252	07/06/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder
Pre-EUA submissions or amendments
Public Health Authorities; request for EUA dispensing order
Public Health Authorities; request for extension of expiration date
Public Health Authorities; unapproved EUA product
RECORDKEEPING: EUA holders
RECORDKEEPING: Public Health Authorities
Requests for substantive amendment to an existing EUA
Submitting information required under conditions of aurhorization

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ICR Summary of Burden

	Total Request	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	10,127	10,127	0	0	0	0
Annual Time Burden (Hours)	352,834	352,834	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: $2,545,092

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? Yes

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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: 09/27/2022

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