Focus Groups as Used by the Food and Drug Administration

Forms and Documents

Document Name	Status
0497 focus group summaries 2014 renewal.doc Supplementary Document	2014-06-26
0497 ss part B 6-18-14.doc Supporting Statement B	2014-06-26
0497 ss Part A 4-17-14.doc Supporting Statement A	2014-06-26
0497 focus group justification template.doc Supplementary Document	2011-02-02

IC Document Collections

IC ID	Document Title	Status
226155	Healthy Claims Focus Group Other-Moderators Guide	New
225620	Feasibility Study Using Hospitals Participating in the American Hernia Society Quality Collaborative (AHSQC) to Assess Patient Reported Outcomes after Ventral Hernia Repair with Mesh: Focus group Other-Informed Consent	New
223583	Menu Labeling Campaign Focus Groups Other-Participant Screener	New
223575	Focus Groups of Salon Professionals and Consumers to Determine Reactions to Labeling Statements on Cosmetic Labels Other-Salon Stylist Script	New
222346	Listeria in Pasteurized Soft Cheese Focus Groups Other-Focus Group Messages	New
222198	Food Safety Focus Groups Other-Survey	New
221775	Upper Limb Prosthetic User Needs and Preferences Study: Focus Group Protocol Other-Consent Form	New
221517	Logistics Evaluation for Implementation of Ultraviolet Decontamination and Reuse of Filtering Face Piece Respirators in Hospitals Other-focus group interview guide	New
221171	Menu Labeling Campaign Other-Study Moderator Guide	New
217647	Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials Other-Screener Guide	New
216519	FDA Unified Consumer Communications Program Other-Consent Form - Consumer	New
215494	Consumer Fact Sheet and Website Outreach Card on Medication Use during Pregnancy Instruction	New
213911	Food Safety Focus Groups Other-Focus group screener	New
213153	Spousal Influence on Consumer Understanding of and Response to DTC Prescription Drug Advertisements (Formative Research and Stimuli Testing) Other-Participant Screener - Phase I	New

ICR Details

OMB Control No: 0910-0497	ICR Reference No: 201406-0910-019
Status: Historical Active	Previous ICR Reference No: 201404-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Focus Groups as Used by the Food and Drug Administration
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/09/2014
	Date Received in OIRA: 06/26/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	1,915	0	1,915
Time Burden (Hours)	2,575	0	2,575
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:
	79 FR 9222	02/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 32555	06/05/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Upper Limb Prosthetic User Needs and Preferences Study: Focus Group Protocol
Listeria in Pasteurized Soft Cheese Focus Groups
Consumer Fact Sheet and Website Outreach Card on Medication Use during Pregnancy
FDA Unified Consumer Communications Program
Logistics Evaluation for Implementation of Ultraviolet Decontamination and Reuse of Filtering Face Piece Respirators in Hospitals
Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials
Food Safety Focus Groups
Healthy Claims Focus Group
Menu Labeling Campaign Focus Groups
Feasibility Study Using Hospitals Participating in the American Hernia Society Quality Collaborative (AHSQC) to Assess Patient Reported Outcomes after Ventral Hernia Repair with Mesh: Focus group
Menu Labeling Campaign
Food Safety Focus Groups
Spousal Influence on Consumer Understanding of and Response to DTC Prescription Drug Advertisements (Formative Research and Stimuli Testing)
Focus Groups of Salon Professionals and Consumers to Determine Reactions to Labeling Statements on Cosmetic Labels

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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	1,915	0	0	0	0
Annual Time Burden (Hours)	2,575	2,575	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: $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: 06/26/2014

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