Notice2026-09244
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
May 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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 90 (Monday, May 11, 2026)</title>
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[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Pages 25582-25583]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2220]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 June 10, 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 0910-0678. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, 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#b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="653537243611040303250301044b0d0d164b020a13">[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.
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 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
[[Page 25583]]
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.
In the Federal Register of August 7, 2025 (90 FR 38155), 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 Total
Activity Number of responses per annual Average burden per Total hours
respondents respondent responses response
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Individual In-Depth 420 1 420 0.75 (45 minutes)...... 315
Interviews.
General Public Focus Group 288 1 288 1.50................... 432
Interviews.
Intercept Interviews: Central 200 1 200 0.25 (15 minutes....... 50
Location.
Intercept Interviews: 4,000 1 4,000 0.08 (5 minutes)....... 320
Telephone.
Self-Administered Surveys.... 2,400 1 2,400 0.25 (15 minutes)...... 600
Gatekeeper Reviews........... 400 1 400 0.50 (30 minutes)...... 200
Omnibus Surveys.............. 1,200 1 1,200 0.17 (10 minutes)...... 204
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Total (General Public)... 8,908 .............. ........... ....................... 2,121
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Healthcare Professional 72 1 72 0.75 (45 minutes)...... 54
Individual In-Depth
Interviews.
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09244 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P
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