Notice2023-16924
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 151 (Tuesday, August 8, 2023)</title>
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[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53500-53501]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#4b1b190a183f2a2d2d0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="90c0c2d1c3e4f1f6f6d0f6f4f1bef8f8e3bef7ffe6">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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