Notice2025-14946
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
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 7, 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 generic clearance for testing communications on medical devices and radiation-emitting products by FDA's Center for Devices and Radiological Health (CDRH). This generic ICR facilitates CDRH's efforts to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations.
Full Text
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<title>Federal Register, Volume 90 Issue 150 (Thursday, August 7, 2025)</title>
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[Federal Register Volume 90, Number 150 (Thursday, August 7, 2025)]
[Notices]
[Pages 38155-38157]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14946]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2220]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Medical Devices and
Radiation-Emitting Products
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 generic clearance for testing
communications on medical devices and radiation-emitting products by
FDA's Center for Devices and Radiological Health (CDRH). This generic
ICR facilitates CDRH's efforts to assess the need for communications on
specific topics and to assist in the development and modification of
communication messages to promote public health and compliance with
regulations.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 6, 2025.
[[Page 38156]]
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 October 6, 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-2220 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Testing Communications On Medical
Devices and Radiation-Emitting Products.'' 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 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: 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#025250435176636464426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="f5a5a7b4a681949393b5939194db9d9d86db929a83">[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.
Testing Communications on Medical Devices and Radiation-Emitting
Products
OMB Control Number 0910-0678--Extension
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs. FDA must conduct needed research to
ensure that such programs have the highest likelihood of being
effective. Improving communications by FDA's Center for Devices and
Radiological Health (CDRH) involves many research methods, including
individual in-depth interviews, mall-intercept interviews, focus
groups, self-administered surveys, gatekeeper reviews, and omnibus
telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about product use.
Knowledge of consumer, caregiver, and healthcare professional decision-
making processes will provide a better
[[Page 38157]]
understanding of target audiences that FDA needs to design effective
communication strategies, messages, and labels.
Second, as initial testing, the collected information will allow
FDA to assess the potential effectiveness of messages and materials in
reaching and successfully communicating with intended audiences.
Testing messages with a sample of the target audience will allow FDA to
refine messages while still in the developmental stage. Respondents
will be asked to give their reaction to the messages in either
individual or group settings.
Third, as evaluative research, the collected information will allow
FDA to ascertain the effectiveness of the messages and the distribution
method in achieving the objectives of the message campaign. Evaluation
of message campaigns is a vital link in continuous improvement of
communications at FDA.
FDA expects to conduct studies under this generic information
collection using a variety of research methods. We estimate that the
burden to respondents will average 16 minutes each (varying from 5
minutes to 90 minutes). FDA estimates the burden of this collection of
information based on prior experience with the various types of data
collection methods described earlier.
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 Total hours
respondents respondent responses per response
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Individual In-Depth Interviews.. 420 1 420 0.75 (45 315
minutes)
General Public Focus Group 288 1 288 1.50 432
Interviews.....................
Intercept Interviews: Central 200 1 200 0.25 (15 50
Location....................... minutes
Intercept Interviews: Telephone. 4,000 1 4,000 0.08 (5 320
minutes)
Self-Administered Surveys....... 2,400 1 2,400 0.25 (15 600
minutes)
Gatekeeper Reviews.............. 400 1 400 0.50 (30 200
minutes)
Omnibus Surveys................. 1,200 1 1,200 0.17 (10 204
minutes)
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TOTAL (General Public)...... 8,908 .............. .............. .............. 2,121
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Healthcare Professional 72 1 72 0.75 (45 54
Individual In-Depth Interviews. minutes)
Healthcare Professional Focus 144 1 144 1.50 216
Group Interviews...............
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TOTAL (Healthcare 216 .............. .............. .............. 270
Professionals).........
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TOTAL (Overall)......... 9,124 .............. .............. .............. 2,391
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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: July 31, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14946 Filed 8-6-25; 8:45 am]
BILLING CODE 4164-01-P
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