OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed

ICR 202302-0910-006 · OMB 0910-0891 · Received in OIRA

Forms and Documents
Document
Name
Status
Supplementary Document
2023-08-08
Supplementary Document
2023-08-08
Supporting Statement B
2023-08-08
Supporting Statement A
2023-08-08
IC Document Collections
IC ID
Document
Title
Status
263183 New
262283 New
ICR Details
0910-0891 202302-0910-006
Received in OIRA 202007-0910-001
HHS/FDA CFSAN
Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
Extension without change of a currently approved collection   No
Regular 08/08/2023
  Requested Previously Approved
36 Months From Approved 08/31/2023
20,464 20,464
7,394 7,394
0 0
This information collection supports FDA under section 505 of the FD&C Act, which provides that FDA may take appropriate action to protect the public health when necessary. The act also authorizes FDA to conduct educational and public information programs. In addition to overseeing food and cosmetic products, dietary supplements, and animal food and feed, CFSAN also conducts studies to support communications with the public on these topics. To ensure that regulatory actions and communications activities have the highest potential to be received, understood, and accepted by those for whom they are intended, CFSAN and related FDA offices conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act. FDA is requesting approval of this new generic for collecting information using qualitative methods (i.e., individual in-depth interviews (IDIs), focus groups, small group discussions, and observations) for studies about food and cosmetic products, dietary supplements, and animal food and feed. This information will be used to inform the regulatory science knowledge base, as well as to explore areas 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 communications and educational messages related to public health
None
None
Not associated with rulemaking
  88 FR 21193 04/10/2023
88 FR 53500 08/08/2023
No
0
  Total Request 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 20,464 20,464 0 0 0 0
Annual Time Burden (Hours) 7,394 7,394 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,056,031
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
08/08/2023