Rapid Response Surveys

Forms and Documents

Document Name	Status
CDER gen IC summary FINAL.docx Supplementary Document	2023-08-16
0500 OMB Memo Template FINAL.docx Supplementary Document	2023-08-03
0500 SSA FINAL 8-3-2023.docx Supporting Statement A	2023-08-03
0500 SSB FINAL 8-3-2023.docx Supporting Statement B	2023-08-03
0500 OMB Memo Template.docx Supplementary Document	2020-08-20

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0910-0500	ICR Reference No: 202308-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202008-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Rapid Response Surveys
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/31/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2023
Responses	60,000	60,000
Time Burden (Hours)	30,000	30,000
Cost Burden (Dollars)	0	0

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Abstract: Through this ICR FDA will obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical product impacts the public health.

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Authorizing Statute(s): US Code: 21 USC 393 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:
	88 FR 24423	04/20/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 60211	08/31/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	60,000	60,000	0	-10,000	10,000	0
Annual Time Burden (Hours)	30,000	30,000	0	-5,000	5,000	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We have adjusted the total burden hours that results in a decrease of 50,000 responses and 25,000 total hours. This reduction in burden is a result of fewer rapid response surveys being conducted.

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Annual Cost to Federal Government: $338,464

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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? No

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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: 08/31/2023

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