Focus Groups as Used by the Food and Drug Administration

Forms and Documents

Document Name	Status
0497 Nonsub Change Request November 2019.doc Justification for No Material/Nonsubstantive Change	2019-11-22
0497_Supporting Statement Part A_9-2017.doc Supporting Statement A	2017-09-14
0497_Supporting Statement Part B_9-2017.doc Supporting Statement B	2017-09-14
0497 focus group justification template.doc Supplementary Document	2017-09-14
Summaries of Focus Groups 2017.doc Supplementary Document	2017-09-14

IC Document Collections

IC ID	Document Title	Status
243281	Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients (OC) Other-Screening Script	New
243079	Focus Groups with Nutrition Educators (CFSAN) Other-Screener	New
242649	Healthy Icon (Symbol) Focus Groups – Phase III Other-Healthy Symbols	New
241273	End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i Other-Screener	New
240858	Safety Alert and Outbreak Advisory Templates Testing Other-Participant Screener	New
239982	Dietary Supplement Education Focus Groups (Formative Research) (CFSAN Other-Participant Screener - Older Adults	New
239878	Focus Groups on Childhood Obesity with Hispanic Primary Caregivers (CFSAN) Other-Survey Instrument	New
238211	Healthy Icon Focus Groups - Phase II Other-Additional New Icon	Unchanged
237685	Healthy Icon - Phase II Other-Healthy Icons	Unchanged
237345	Focus Groups on Perceptions of Prescription Drug Promotion and Approval Review Process (Formative Research) Other-Consumer Moderator's Guide	Modified
236674	Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies Other-List of Stakeholders	Unchanged
235961	Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing) Other-Screener	Unchanged
235929	Consumer Knowledge and Behavior Re: Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave III: Focus Groups Exploring Consumer Reactions to Educational Materials Other-Moderator's Guide	Unchanged
235859	Food Allergen Advisory Labeling Focus Groups Other-Screener	Unchanged
235547	Focus Groups on Healthy Icons - Phase I Other-Healthy Icons	Unchanged
235450	Focus Groups on Consumer Understanding and Behaviors Related to Plant-Based Dairy Alternatives Other-Survey instrument	Unchanged
232561	Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing) Other-Screener	Unchanged
232179	Consumer Knowledge Regarding Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave II: Focus Groups Exploring Consumer Reactions to Educational Concepts Other-Screener	Unchanged
232062	Focus Groups on Childhood Obesity Education (Formative Research) Other-Consnet form	Unchanged
231650	Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco Use Other-Check-In Survey	Unchanged
230049	An Investigation of Allergy to Cosmetics in the United States Other-Consent Form	Unchanged
229767	Consumer Knowledge and Behavior Regarding Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave I: Focus Groups Exploring Consumer Reactions to Educational Concepts Other-Screener	Unchanged
229723	Focus Groups on FDA's Accelerated Approval Process Other-Respondent Screener	Unchanged
229468	Individual Assessments of Knowledge of the Expanded Access and Compassionate Use Programs Among Stakeholders Other-Survey	Unchanged
228829	Financial Reporting Focus Groups Other-Interview Guide	Unchanged

ICR Details

OMB Control No: 0910-0497	ICR Reference No: 201911-0910-015
Status: Historical Active	Previous ICR Reference No: 201707-0910-018
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: 11/26/2019
	Date Received in OIRA: 11/22/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	10/31/2020	10/31/2020
Responses	8,800	0	8,800
Time Burden (Hours)	15,400	0	15,400
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:
	82 FR 18763	04/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 43243	09/14/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 25

IC Title	Form No.	Form Name
Focus Groups on Healthy Icons - Phase I
Healthy Icon (Symbol) Focus Groups – Phase III
Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing)
Focus Groups on Childhood Obesity with Hispanic Primary Caregivers (CFSAN)
An Investigation of Allergy to Cosmetics in the United States
Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients (OC)
Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco Use
Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing)
Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies
Focus Groups on Childhood Obesity Education (Formative Research)
Focus Groups with Nutrition Educators (CFSAN)
Healthy Icon Focus Groups - Phase II
Consumer Knowledge and Behavior Re: Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave III: Focus Groups Exploring Consumer Reactions to Educational Materials
Healthy Icon - Phase II
End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i
Focus Groups on FDA's Accelerated Approval Process
Safety Alert and Outbreak Advisory Templates Testing
Dietary Supplement Education Focus Groups (Formative Research) (CFSAN
Individual Assessments of Knowledge of the Expanded Access and Compassionate Use Programs Among Stakeholders
Financial Reporting Focus Groups
Food Allergen Advisory Labeling Focus Groups
Focus Groups on Perceptions of Prescription Drug Promotion and Approval Review Process (Formative Research)
Consumer Knowledge and Behavior Regarding Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave I: Focus Groups Exploring Consumer Reactions to Educational Concepts
Consumer Knowledge Regarding Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave II: Focus Groups Exploring Consumer Reactions to Educational Concepts
Focus Groups on Consumer Understanding and Behaviors Related to Plant-Based Dairy Alternatives

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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	8,800	8,800	0	0	0	0
Annual Time Burden (Hours)	15,400	15,400	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: $240,000

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.     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? 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: 11/22/2019

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