Focus Groups as Used by the Food and Drug Administration

ICR 202008-0910-021

OMB: 0910-0497

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
Supporting Statement B
IC Document Collections
ICR Details
0910-0497 202008-0910-021
Active 201911-0910-015
HHS/FDA Generic
Focus Groups as Used by the Food and Drug Administration
Extension without change of a currently approved collection   No
Approved without change 11/03/2020
Retrieve Notice of Action (NOA) 10/02/2020
  Inventory as of this Action Requested Previously Approved
11/30/2023 36 Months From Approved 11/30/2020
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

Not associated with rulemaking

  85 FR 916 01/08/2020
85 FR 51450 08/20/2020

IC Title Form No. Form Name
Dietary Supplement Education Focus Groups (Formative Research)

  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

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [email protected]


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.

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