Focus Groups as Used by the Food and Drug Administration

ICR 201911-0910-015

OMB: 0910-0497

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-11-22
Supporting Statement A
2017-09-14
Supporting Statement B
2017-09-14
Supplementary Document
2017-09-14
Supplementary Document
2017-09-14
IC Document Collections
IC ID
Document
Title
Status
243281 New
243079 New
242649 New
241273 New
240858 New
239982 New
239878 New
238211 Unchanged
237685 Unchanged
237345 Modified
236674 Unchanged
235961 Unchanged
235929 Unchanged
235859 Unchanged
235547 Unchanged
235450 Unchanged
232561 Unchanged
232179 Unchanged
232062 Unchanged
231650 Unchanged
230049 Unchanged
229767 Unchanged
229723 Unchanged
229468 Unchanged
228829 Unchanged
ICR Details
0910-0497 201911-0910-015
Historical Active 201707-0910-018
HHS/FDA Generic
Focus Groups as Used by the Food and Drug Administration
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/26/2019
Retrieve Notice of Action (NOA) 11/22/2019
  Inventory as of this Action Requested Previously Approved
10/31/2020 10/31/2020 10/31/2020
8,800 0 8,800
15,400 0 15,400
0 0 0

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.

US Code: 21 USC 355 Name of Law: FFDCA
  
None

Not associated with rulemaking

  82 FR 18763 04/21/2017
82 FR 43243 09/14/2017
No

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

  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
No
No

$240,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/22/2019


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