[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82612-82614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1021]
Notice to Public of Website Location of Center for Devices and
Radiological Health Fiscal Year 2025 Proposed Guidance Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the website location where the Agency will post two lists of
guidance documents that the Center for Devices and Radiological Health
(CDRH) intends to publish in fiscal year (FY) 2025. In addition, FDA
has established a docket where interested parties may comment on the
priority of topics for guidance, provide comments and/or propose draft
language for those topics, suggest topics for new or different guidance
documents, comment on the applicability of guidance documents that have
issued previously, and provide any other comments that could benefit
the CDRH guidance program and its engagement with interested parties.
This feedback is critical to the CDRH guidance program to ensure that
we meet the needs of interested parties.
DATES: Either electronic or written comments on the notice must be
submitted by December 10, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 10, 2024. 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to
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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 https://www.regulations.gov.
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:
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.
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-2012-N-1021 for ``Notice to Public of website Location of CDRH
Fiscal Year 2025 Proposed Guidance Development.'' 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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations on the Medical Device User Fee Amendments of
2012, title II, Food and Drug Administration Safety and Innovation Act
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. Among these commitments included:
Annually posting a list of priority medical device
guidance documents that the Agency intends to publish within 12 months
of the date this list is published each fiscal year (the ``A-list''),
and
Annually posting a list of device guidance documents that
the Agency intends to publish, as the Agency's guidance-development
resources permit each fiscal year (the ``B-list'').
The Medical Device User Fee Amendments of 2017 (MDUFA IV), Title
II, FDA Reauthorization Act of 2017 (Pub. L. 115-52), maintained these
commitments.
In addition, to ensure that final guidance documents continue to
provide interested parties with the Agency's current thinking, CDRH
annually conducts a staged review of previously issued final guidances
in collaboration with interested parties. CDRH intends to annually
provide lists of previously issued final guidances that are subject to
review in 10-year increments to facilitate a continuous and systematic
assessment of the applicability of existing guidances. For instance, in
FY 2025, CDRH is providing a list of the final guidance documents that
issued in 2015, 2005, 1995, and 1985; in FY 2026 we expect to provide a
list of the final guidance documents that issued in 2016, 2006, 1996,
and 1986, and so on. Consistent with the Good Guidance Practices
regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions
that CDRH revise or withdraw an already existing guidance document. We
request that the suggestion clearly explain why the guidance document
should be revised or withdrawn and, if applicable, how it should be
revised. While we are requesting feedback on the list of previously
issued final guidances located in the annual agenda website, feedback
on any guidance is appreciated and will be considered.
FDA welcomes comments on any or all of the guidance documents on
the lists as explained in 21 CFR 10.115(f)(5). FDA has established
Docket No. FDA-2012-N-1021 where comments on the FY 2025 lists, draft
language for guidance documents on those topics, suggestions for new or
different guidances, and relative priority of guidance documents may be
submitted and shared with the public (see ADDRESSES). FDA believes this
docket is a valuable tool for receiving information from interested
parties. FDA anticipates that feedback from interested parties will
allow CDRH to better prioritize and more efficiently draft guidances to
meet the needs of the Agency and interested parties.
In addition to posting the lists of prioritized device guidance
documents, CDRH has identified as a priority, and has devoted resources
to, finalization of draft guidance documents. To ensure the timely
completion or reissuance of draft guidances, in FY 2015 CDRH committed
to performance goals for current and future draft guidance documents.
For draft guidance documents issued after October 1, 2014, CDRH
committed to finalize, withdraw, reopen the comment period, or issue
new draft guidance on the topic for 80 percent of the documents within
3 years of the close of the comment period and for the remaining 20
percent, within 5 years. As part of MDUFA IV commitments, FDA
reaffirmed this commitment, as resources permit.
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Fulfillment of these commitments will be reflected through the
issuance of updated guidance on existing topics, withdrawal of
guidances that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.
II. Website Location of Guidance Lists
This notice announces the website location of the document that
provides the A- and B-lists of guidance documents, which CDRH is
intending to publish during FY 2025. To access these two lists, visit
FDA's website at https:/www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development. We note that the topics on these lists may be removed or
modified based on current priorities, as well as comments received
regarding these lists. Furthermore, FDA and CDRH priorities are subject
to change at any time (e.g., newly identified safety issues). The
Agency is not required to publish every guidance on either list if the
resources needed would be to the detriment of meeting quantitative
review timelines and statutory obligations. In addition, the Agency is
not precluded from issuing guidance documents that are not on either
list.
Dated: October 7, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23544 Filed 10-10-24; 8:45 am]
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