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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:
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
Retrieve Notice of Action (NOA)
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
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:
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
Number of Information Collection (IC) in this ICR:
25
IC Title
Form No.
Form Name
An Investigation of Allergy to Cosmetics in the United States
Consumer Knowledge Regarding Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave II: Focus Groups Exploring Consumer Reactions to Educational Concepts
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
Consumer Knowledge and Behavior Regarding Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave I: Focus Groups Exploring Consumer Reactions to Educational Concepts
Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco Use
Dietary Supplement Education Focus Groups (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 i
Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies
Financial Reporting Focus Groups
Focus Groups on Childhood Obesity Education (Formative Research)
Focus Groups on Childhood Obesity with Hispanic Primary Caregivers (CFSAN)
Focus Groups on Consumer Understanding and Behaviors Related to Plant-Based Dairy Alternatives
Focus Groups on FDA's Accelerated Approval Process
Focus Groups on Healthy Icons - Phase I
Focus Groups on Perceptions of Prescription Drug Promotion and Approval Review Process (Formative Research)
Focus Groups with Nutrition Educators (CFSAN)
Food Allergen Advisory Labeling Focus Groups
Healthy Icon (Symbol) Focus Groups – Phase III
Healthy Icon - Phase II
Healthy Icon Focus Groups - Phase II
Individual Assessments of Knowledge of the Expanded Access and Compassionate Use Programs Among Stakeholders
Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing)
Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing)
Safety Alert and Outbreak Advisory Templates Testing
Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients (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.
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
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:
11/22/2019
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