Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness

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Published

July 3, 2025

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 information collection entitled "Generic Clearance for Quick Turnaround Testing of Communication Effectiveness."

Full Text

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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29565-29567]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12417]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-0615]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quick Turnaround Testing of
Communication Effectiveness

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 information collection entitled
``Generic Clearance for Quick Turnaround Testing of Communication
Effectiveness.''

DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.

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 September 2, 2025. 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-2025-N-0615 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for Quick
Turnaround Testing of Communication Effectiveness.'' 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.
<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

[[Page 29566]]

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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#6c3c3e2d2e1e0d020f042c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="9ececcdfdcecfff0fdf6def8faffb0f6f6edb0f9f1e8">[email&#160;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 Quick Turnaround Testing of Communication
Effectiveness

OMB Control Number 0910-0876--Extension

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role consumers and stakeholders play in ensuring the safety of the food
supply, which helps ensure that suppliers produce food that meets U.S.
safety standards. Section 1003(d)(2) of the FD&C Act (21 U.S.C.
393(d)(2)) authorizes FDA to conduct food research and educational and
public information programs relating to the safety of the nation's food
supply.
This notice requests extension of OMB approval of the FDA
information collection for a generic clearance that allows FDA to
occasionally communicate with consumers and other stakeholders about
immediate health issues which could affect public health and safety.
This collection of information allows the use of fast-track methods of
communication such as quick turnaround surveys, focus groups, and
indepth interviews collected from consumers and other stakeholders to
communicate FDA issues of immediate and important public health
significance. We plan on using these methods of communication to
collect vital public health and safety information.
For example, these methods of communication might be used when
there is a foodborne illness outbreak, food recall, or other situation
requiring expedited FDA food, dietary supplement, infant formula, or
animal food or feed communications. So that FDA may better protect the
public health, the Agency needs quick turnaround information provided
by this collection of information to help ensure its messaging has
reached the target audience, has been effective, and, if needed, to
update its communications during these events.
FDA plans to use the data collected under this generic clearance to
test consumer or other stakeholder reaction to communications,
advisories, and other educational messages under development or review
when there are urgent public health matters requiring the dissemination
of FDA communications. The tests will allow FDA to better understand
consumers' responses, including behavior, knowledge, beliefs,
perceptions, and attitudes to topics and concepts included in the
communications. The data will not be directly used for the purposes of
making regulatory or other policy decisions.
FDA will only submit a collection for approval under this generic
clearance if it meets the following conditions:
<bullet> The collections are voluntary;
<bullet> The collections are low burden for participants (based on
considerations of total burden hours, total number of participants, or
burden hours per respondent) and are low cost for both the participants
and the Federal Government;
<bullet> The collections are noncontroversial;
<bullet> Personally identifiable information is collected by the
contractor for their benefit only to the extent necessary, is not
shared with FDA, and is not retained; and
<bullet> Information gathered will not be used for substantially
informing influential policy decisions.
If these conditions are not met, FDA will submit an information
collection request to OMB for approval through the normal PRA process.
To obtain approval for a 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 survey, focus group or interview guide, and stimuli).
Respondents to this collection of information include a wide range
of consumers and other FDA stakeholders such as producers and
manufacturers of FDA-regulated food, infant formula, dietary
supplements, and animal food and feed. Participation will be voluntary.
We estimate the burden of this collection of information as
follows:

[[Page 29567]]

Table 1--Estimated Reporting Burden \1\
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Number of
Survey type Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Indepth Interviews, Cognitive Interviews 45 1 45 0.083 (5 minutes)......................... 4
Screener.
Indepth Interviews, Cognitive Interviews.... 9 1 9 1......................................... 9
Indepth Interviews Screener................. 300 1 300 0.083 (5 minutes)......................... 25
Indepth Interviews.......................... 60 1 60 1......................................... 60
Survey Cognitive Interviews Screener........ 45 1 45 0.083 (5 minutes)......................... 4
Survey Cognitive Interviews................. 9 1 9 1......................................... 9
Pretest survey screener..................... 1,500 1 1,500 0.083 (5 minutes)......................... 124
Pretest survey.............................. 300 1 300 0.25 (15 minutes)......................... 76
Self-Administered Surveys--Study Screener... 30,000 1 30,000 0.083 (5 minutes)......................... 2,500
Self-Administered Surveys................... 6,000 1 6,000 0.25 (15 minutes)......................... 1,500
Focus Group/Small Group, Cognitive Groups 180 1 180 0.083 (5 minutes)......................... 15
Screener.
Focus Group/Small Group, Cognitive Groups... 60 1 60 1.5 (90 minutes).......................... 90
Focus Group/Small Group Participant 720 1 720 0.083 (5 minutes)......................... 60
Screening.
Focus Group/Small Group Discussion.......... 240 1 240 1.5 (90 minutes).......................... 360
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Total................................... .............. .............. .............. .......................................... 4,836
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12417 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P

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