FDA Focus Groups and Interviews

Forms and Documents

Document Name	Status
0497 Summaries final.docx Supplementary Document	2023-10-31
0497 OMB Memo Template FINAL.docx Supplementary Document	2023-10-31
0497 SSB FINAL.docx Supporting Statement B	2023-10-31
0497 SSA FINAL.docx Supporting Statement A	2023-10-31
0497 OMB Memo Template.docx Supplementary Document	2020-08-20

IC Document Collections

IC ID	Document Title	Status
267658	(CDER) Focus Groups Examining Consumer Reporting of Adverse Events Other-Screener	New

ICR Details

OMB Control No: 0910-0497	ICR Reference No: 202310-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202008-0910-021
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: FDA Focus Groups and Interviews
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: 10/31/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2023
Responses	12,000	8,800
Time Burden (Hours)	21,000	15,400
Cost Burden (Dollars)	0	0

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Abstract: This umbrella generic supports the implementation of focus groups and interviews to conduct studies involving all products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communication messages and campaigns. Focus groups and interviews play an important role in gathering information because they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings and serves the narrowly defined need for direct and informal public opinion on a specific topic.

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Authorizing Statute(s): US Code: 21 USC 355 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 21680	04/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 72083	10/19/2023
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	12,000	8,800	0	0	3,200	0
Annual Time Burden (Hours)	21,000	15,400	0	0	5,600	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 burden for the information collection reflects an overall increase of 5,600 hours and a corresponding increase of 3,200 responses. We increased these numbers based on the consolidation of ICR 0910-0677, “Focus Groups About Drug Products as Used by the Food and Drug Administration.”

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Annual Cost to Federal Government: $350,000

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.     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? 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: 10/31/2023

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