Notice2026-07501
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
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Published
April 17, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information which allows the submission of individual generic requests for obtaining qualitative data to support social and behavioral research for food, dietary supplements, cosmetics, and animal food and feed.
Full Text
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<title>Federal Register, Volume 91 Issue 74 (Friday, April 17, 2026)</title>
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[Federal Register Volume 91, Number 74 (Friday, April 17, 2026)]
[Notices]
[Pages 20693-20695]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2917]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information which allows
the submission of individual generic requests for obtaining qualitative
data to support social and behavioral research for food, dietary
supplements, cosmetics, and animal food and feed.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 16, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 16, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-2917 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for Qualitative
Data to Support Social and Behavioral Research for Food, Dietary
Supplements, Cosmetics, and Animal Food and Feed.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
[[Page 20694]]
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#26767467755247404066404247084e4e5508414950"><span class="__cf_email__" data-cfemail="a4f4f6e5f7d0c5c2c2e4c2c0c58accccd78ac3cbd2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(D)), 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 of
the Public Health Service Act (42 U.S.C. 241(a)).
To ensure that communications activities have the highest 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 FDA-regulated food, dietary supplements, cosmetics, and
animal food and feed. Participation is voluntary.
We estimate the burden of this collection of information as
follows:
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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 these items, as listed in the first four rows in table 1. 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 total
reduction in burden, therefore, is estimated as 9,800 responses and
3,524 hours. 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. 2026-07501 Filed 4-16-26; 8:45 am]
BILLING CODE 4164-01-P
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