Focus Groups as Used by the Food and Drug Administration

Forms and Documents

Document Name	Status
0910-0497 Focus group change request 83c 4.1.14.docx Justification for No Material/Nonsubstantive Change	2014-04-01
0497 ss Part B 2-2-11.doc Supporting Statement B	2011-02-02
0497 focus group summaries 2013 renewal.doc Supplementary Document	2011-02-10
0497 focus group justification template.doc Supplementary Document	2011-02-02
0497 ss Part A 3-8-11.doc Supporting Statement A	2011-03-08

IC Document Collections

IC ID	Document Title	Status
211997	Qualitative Study on Nicotine: Knowledge, Beliefs, and Perceptions Other-Adult Screener	New
209537	Other Tobacco Products (OTP); A Focus Group Study - Cigar, etc. Instruction	Unchanged
208867	Establishment of a Tobacco User Panel: Focus Group Study Other-Appendix	Unchanged
207034	FDA/CTP Consumer Risk Perceptions of Tobacco Products: 2nd Focus Group Study Other-Round 2 FG Screener	Unchanged
205791	Risk and Benefit Perception Scale Development Focus Groups Other-Screener	Unchanged
204195	Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices Other-Moderator Guide	Unchanged
203455	Claims about "Natural" Other-Focus Group Screener Script/Questions	Unchanged
201564	Consumer perceptions as a foundation for CTP positioning initiative Other-Adolescent Screener	Unchanged
200707	Consumer Risk Perceptions of Tobacco Products (Initial Focus Group Study) Other-Screener	Unchanged

ICR Details

OMB Control No: 0910-0497	ICR Reference No: 201404-0910-001
Status: Historical Active	Previous ICR Reference No: 201103-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Focus Groups as Used by the Food and Drug Administration
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: 05/02/2014
	Date Received in OIRA: 04/16/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	06/30/2014	06/30/2014
Responses	1,915	0	1,440
Time Burden (Hours)	2,575	0	2,520
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) is requesting approval for collecting information through the use of focus groups for 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 play an important role in gathering information because they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. Focus group research 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:
	75 FR 74061	11/30/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6802	02/08/2011
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Claims about "Natural"
FDA/CTP Consumer Risk Perceptions of Tobacco Products: 2nd Focus Group Study
Consumer perceptions as a foundation for CTP positioning initiative
Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices
Consumer Risk Perceptions of Tobacco Products (Initial Focus Group Study)
Other Tobacco Products (OTP); A Focus Group Study - Cigar, etc.
Qualitative Study on Nicotine: Knowledge, Beliefs, and Perceptions
Establishment of a Tobacco User Panel: Focus Group Study
Risk and Benefit Perception Scale Development Focus Groups

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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	1,915	1,440	0	0	475	0
Annual Time Burden (Hours)	2,575	2,520	0	0	55	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 Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to add 55 burden hours and 475 annual responses. No other changes are occurring.

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Annual Cost to Federal Government: $200,000

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

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: 04/16/2014

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