Notice2025-21320
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
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
November 28, 2025
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 90 Issue 227 (Friday, November 28, 2025)</title>
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[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Notices]
[Pages 54695-54696]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21320]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0348]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Center for Devices
and Radiological Health Appeals Processes
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 December 29, 2025.
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 0910-0738. Also include the FDA docket
number found in brackets in the heading of this document.
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#9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="124240534166737474527476733c7a7a613c757d64">[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.
Center for Devices and Radiological Health Appeals Processes
OMB Control Number 0910-0738--Revision
This information collection supports implementation of
recommendations found in FDA guidance. As discussed in the document
entitled ``Guidance for Industry and Food and Drug Administration
Staff; Center for Devices and Radiological Health (CDRH) Appeals
Processes'' (March 2022), there
[[Page 54696]]
are various processes by which appeals requests regarding review of
decisions or actions by CDRH may be submitted to the Agency. The
guidance is available for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes</a>. The
guidance document provides general format and content recommendations
in this regard, discusses applicable regulations with regard to the
timing of such submissions, and describes the collection of information
not expressly specified under existing regulations such as the
submission of the request for review, minor clarifications as part of
the request, and supporting information. While CDRH already possesses
in the administrative file the information that would form the basis of
a decision on a matter under appeal, the submission of information as
recommended in the guidance regarding the appeal request itself, as
well as data and information relied on by the requestor in the appeal,
will help facilitate timely resolution of the decision under review. We
are accounting for burden respondents may incur as a result of these
Agency recommendations in this collection request. Additional
information about the CDRH appeals process is described in the
companion guidance entitled ``Center for Devices and Radiological
Health (CDRH) Appeals Processes: Questions and Answers About 517A--
Guidance for Industry and Food and Drug Administration Staff'' (March
2020), also available for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes</a>-
questions-and-answers-about-517a.
In the Federal Register of July 3, 2025 (90 FR 29563), 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 Total hours
respondents respondent responses per response
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CDRH Appeals Processes............................................. 75 1 75 8 600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase of 320 hours and a corresponding increase of 40
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years. A review of prior
renewals revealed that additional information about the CDRH appeals
process is described in the companion guidance entitled ``Center for
Devices and Radiological Health (CDRH) Appeals Processes: Questions and
Answers About 517A--Guidance for Industry and Food and Drug
Administration Staff'' (March 2020) was omitted in the last approval
cycle. This current revision adds this missing guidance to provide
clarity and ensure completeness. No other changes affect the scope or
burden of this information collection.
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2025-21320 Filed 11-26-25; 8:45 am]
BILLING CODE 4164-01-P
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