Notice2026-18528
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
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Published
September 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) 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.
Full Text
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<title>Federal Register, Volume 91 Issue 175 (Friday, September 11, 2026)</title>
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[Federal Register Volume 91, Number 175 (Friday, September 11, 2026)]
[Notices]
[Pages 57895-57896]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2917]
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 or the Agency) 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.
DATES: Submit written comments (including recommendations) on the
collection of information by October 13, 2026.
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: Christopher Colburn, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8758,
<a href="/cdn-cgi/l/email-protection#c9999b889abda8afaf89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="6d3d3f2c3e190c0b0b2d0b090c4305051e430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 57896]]
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 (OIRA) 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 for certain information collection
activities supports research conducted by FDA, as authorized under
section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)), and is intended to help FDA's Human
Foods Program (HFP) understand stakeholders' perceptions, attitudes,
motivations, and behaviors. Understanding these perceptions, attitudes,
motivations, and behaviors plays an important role in improving FDA's
communications which impact various stakeholders and assists in the
development of quantitative study proposals to complement other
important research efforts in the Agency. 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,
HFP and related FDA offices conduct research and studies relating to
the control and prevention of disease as authorized by section 301(a)
of the Public Health Service Act (42 U.S.C. 241(a)).
To ensure that communications activities have the greatest effect,
we 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 FDA to use qualitative social/behavioral science data collection
techniques (i.e., individual in-depth interviews (IDIs), small group
discussions, focus groups, and observations) to better understand
stakeholders' perceptions, attitudes, motivations, and behaviors
regarding various issues associated with food, dietary supplements,
cosmetics, 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 in assisting 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 provisions applicable to FDA-regulated food, dietary
supplements, cosmetics, and animal food and feed. Participation is
voluntary.
In the Federal Register of April 17, 2026 (91 FR 20693), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Individual In-Depth Interview Screening......... 2,400 1 2,400 .08 (5 minutes)........................... 192
Individual In-Depth Interviews.................. 200 1 200 1......................................... 200
Focus Group/Small Group Participant Screening... 5,400 1 5,400 .08 (5 minutes)........................... 432
Focus Groups/Small Group Discussion............. 1,800 1 1,800 1.5....................................... 2,700
Observation Screening........................... 720 1 720 .08 (5 minutes)........................... 58
Observations.................................... 144 1 144 2......................................... 288
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Total....................................... ............ .............. 10,664 .......................................... 3,870
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
These 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. Based on a review of the information
collection since our last request for OMB approval, we have adjusted
our burden estimate based on actual usage of this collection of
information and have decreased the number of responses and hours by
half for the first four rows in table 1 with the other rows remaining
the same. For the first four rows, we have reduced our estimate for the
number of responses from 19,600 to 9,800 responses (a decrease of 9,800
responses) and reduced the number of hours from 7,048 to 3,524 hours (a
decrease of 3,524 hours) based on our experience conducting these
collections of information. The new burden is estimated at 10,664
responses and 3,870 hours.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18528 Filed 9-10-26; 8:45 am]
BILLING CODE 4164-01-P
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