[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53500-53501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1157]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
Qualitative Data To Support Social and Behavioral Research for Food, 
Dietary Supplements, Cosmetics, and Animal Food and Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by September 7, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0891. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0891--Extension

    OMB's Office of Information and Regulatory Affairs has issued 
memoranda that provides an overview of administrative flexibilities 
available to assist Agencies in complying with their statutory 
obligations under the PRA. Among these flexibilities is use of a 
generic clearance for certain information collection activities. A 
generic clearance may be appropriate when (1) the need for the data 
collection can be evaluated in advance, as part of the review of the 
proposed plan, but (2) the Agency cannot determine the details of the 
specific individual collections until a later time. Generic clearances 
cover collections that are voluntary, low-burden, and uncontroversial.
    This generic clearance supports research intended to help the 
Center for Food Safety and Applied Nutrition understand stakeholders' 
perceptions, attitudes, motivations, and behaviors. To ensure that 
communications activities have the highest effect, we will conduct 
research and studies relating to the control and prevention of disease 
and the safety and health of the public. FDA is requesting OMB approval 
for the use of this generic collection of information that allows

[[Page 53501]]

FDA to use qualitative social/behavioral science data collection 
techniques (i.e., individual indepth interviews, small group 
discussions, focus groups, and observations) to better understand 
stakeholders' perceptions, attitudes, motivations, and behaviors 
regarding various issues associated with food and cosmetic products, 
dietary supplements, and animal food and feed. Understanding these 
consumers', manufacturers', and producers' perceptions, attitudes, 
motivations, and behaviors plays an important role in improving FDA's 
communications that impact these various stakeholders and assists in 
the development of quantitative study proposals, complementing other 
important research efforts in the Agency.
    To obtain approval for an individual generic submission collection 
that meets the conditions of this generic clearance, an abbreviated 
supporting statement will be submitted to OMB along with supporting 
documentation (e.g., a copy of the interview or moderator guide, 
screening questionnaire).
    Selection for potential respondents is done via a screening process 
to match the best possible respondent to each individual generic 
submission. Respondents to individual requests made under the generic 
clearance, once approved by OMB, may include a wide range of consumers 
and other FDA stakeholders, such as producers and manufacturers who are 
regulated under FDA-regulated food and cosmetic products, dietary 
supplements, and animal food and feed. Participation is voluntary.
    In the Federal Register of April 10, 2023 (88 FR 21193), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but was not 
responsive to the four collection of information topics solicited and 
therefore will not be discussed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
          Type of interview           respondents      per         annual           response         Total hours
                                                    respondent   responses
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Individual Indepth Interview                4,800            1        4,800  0.08 (5 minutes)......          384
 Screening.
Individual Indepth Interviews.......          400            1          400  1.....................          400
Focus Group/Small Group Participant        10,800            1       10,800  0.08 (5 minutes)......          864
 Screening.
Focus Groups/Small Group Discussion.        3,600            1        3,600  1.5...................        5,400
Observation Screening...............          720            1          720  0.08 (5 minutes)......           58
Observations........................          144            1          144  2.....................          288
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    Total...........................  ...........  ...........       20,464  ......................        7,394
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Current estimates are based on both historical numbers of 
participants from past projects as well as estimates for projects to be 
conducted in the next 3 years. The collections we have conducted under 
this generic collection of information have informed and helped us 
better understand stakeholder perceptions, attitudes, motivations, and 
behaviors to help us improve our communications to them.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16924 Filed 8-7-23; 8:45 am]
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