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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0910-0497
ICR Reference No:
202008-0910-021
Status:
Historical Active
Previous ICR Reference No:
201911-0910-015
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:
11/03/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/02/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2023
36 Months From Approved
11/30/2020
Responses
8,800
0
8,800
Time Burden (Hours)
15,400
0
15,400
Cost Burden (Dollars)
0
0
0
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.
Authorizing Statute(s):
US Code:
21 USC 355
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 916
01/08/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 51450
08/20/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
30
IC Title
Form No.
Form Name
(CFSAN) Front-of-Package Nutrition Labeling Focus Groups 2
Advancing COVID-19 Health Equity Research
Attitudes and Perceptions of People Living with Hepatitis B on Participation in Clinical Trials
Birth Control Options (Digital and Print Communication Focus Groups) OC
Bridging Gaps: Recruiting African and Asian American Participants in Clinical Trials and Creating Culturally Competent Messages (OC)
Bridging Gaps: Recruiting Asian and Black/African American Participants for COVID-19 Clinical Trials and Creating Culturally Competent Messages
Co-creation of Digital Tools to Enhance Young Adult Minority Participation in COVID-19 Trials
Consumer Knowledge & Behavior Regarding Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed–Wave IV: Focus Groups Exploring Consumer Reactions to Educational Materials
Dietary Supplement Education Focus Groups (Formative Research)
Dietary Supplement Education Focus Groups – Phase 2 (Formative Research) (CFSAN)
End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women – WAVE II (CDER)
Fish Focus Groups with those who are Pregnant, Breastfeeding, and Parents of Young Children
Focus Groups Exploring Consumer Reactions to Nutrition Statements on Plant-Based Milk Alternatives (CFSAN)
Focus Groups on Consumer Perceptions of Genetically Engineered Salmon (CFSAN)
Focus Groups with Nutrition Educators (CFSAN)
Food Safety Focus Groups on Toxic Elements in Baby Food
Front-of -Pack Focus Groups
Health Care Provider Testing Associated with the Pregnancy and Lactation Labeling Rule to Improve Health Communications Related to Lactation (CDER)
Hispanic, Black and Pacific Islander Perspectives on COVID-19 Outreach Strategies and Patient Centered Outcomes (HeAR US))
Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials
Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials
MUltimorbidity and Medications: the unheard perspective of older Under-Represented Racial and Ethnic Minority Adults
Nutrition Facts Label Education and Outreach Initiative – Qualitative Evaluation of Educational Materials (CFSAN)
Online Focus Groups with Low-Income Primary Caregivers on Childhood Obesity
Provider Decision-Making about Pain Management and Opioid Prescribing Focus Group
Safety Alert and Outbreak Advisory Templates Testing Focus Group (CFSAN)
Skin Lightening Products: Understanding Consumer Perspectives and Effective Educational Messages (OC)
Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework
Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework: Follow-Up
The Shades of Beauty: Understanding African American and Asian American Women's Perception and Use of Skin Lightening Products and the Potential Health Risks (OC)
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:
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.
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
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
No
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:
10/02/2020
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