[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55158-55160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22370]
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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 2020 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 or the Center) intends to publish in fiscal year (FY) 2020. In
addition, FDA has established a docket where interested persons 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
stakeholders. This feedback is critical to the CDRH guidance program to
ensure that we meet stakeholder needs.
DATES: Submit either electronic or written comments by December 16,
2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 16, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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 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 2020 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.
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
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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.gpo.gov/fdsys/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.
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), FDA
Reauthorization Act of 2017, (Pub. L. 115-52) maintained these
commitments.
In addition, to ensure that final guidance documents continue to
provide stakeholders with the Agency's current thinking, CDRH annually
conducts a staged review of previously issued final guidances in
collaboration with stakeholders. CDRH intends to annually provide lists
of previously issued final guidances that are subject to review through
FY 2025 so that by 2025, FDA and stakeholders will have assessed the
applicability of all guidances older than 10 years. For instance, in
the annual notice for FY 2021, CDRH expects to provide a list of the
final guidance documents that issued in 2011, 2001, 1991, and 1981; the
annual notice for FY 2022 is expected to provide a list of the final
guidance documents that issued in 2012, 2002, 1992, and 1982, and so
on.
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 2020 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
persons. FDA anticipates that feedback from interested persons will
allow CDRH to better prioritize and more efficiently draft guidances to
meet the needs of the Agency and our stakeholders.
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 assure 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.
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. CDRH Guidance Development Initiatives
A. Metrics for FY 2019 A-List and B-List Publication
Stakeholder feedback on guidance priorities is important to ensure
that the CDRH guidance program meets the needs of stakeholders. The
feedback received on the FY 2019 list was mostly in agreement, and CDRH
continued to work toward issuing the guidances on this list. Some
guidances requested for inclusion in the FY2019 list by stakeholders
have been included as part of the FY 2020 list. In FY 2019, CDRH
published 21 of 28 guidances on the FY 2019 list (17 from the A-list, 4
from the B-list).
A. Finalization of Draft Guidance Documents
Of the 23 draft guidances issued in FY 2015, CDRH finalized 87
percent within 3 years of the comment period close. Five years from the
comment period close has not yet elapsed for the remaining guidances
issued in FY 2015. In addition, in FY 2019, one draft guidance issued
prior to October 1, 2013, remains, and CDRH has been continuing to work
towards taking an action on this remaining draft guidance.
Looking forward, in FY 2020, CDRH will strive to finalize,
withdraw, or reopen the comment period for 50 percent of existing draft
guidances issued prior to October 1, 2014.
B. Applicability of Previously Issued Final Guidance
At the website where CDRH has posted the ``A-list'' and ``B-list''
for FY 2020, CDRH has also posted a list of final guidance documents
that issued in 2010, 2000, 1990, and 1980 for our annual review of
previously issued final guidances.\1\ CDRH is interested in external
feedback on whether any of these final guidances should be revised or
withdrawn. In addition, for guidances that are recommended for
revision, information explaining the need for revision, such as the
impact and risk to public health associated with not revising the
guidance, would also be helpful as the Center considers potential
action with respect to these guidances. CDRH will consider the comments
received from this retrospective review
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when determining priorities for updating guidance documents and will
revise these as resources permit.
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\1\ The retrospective list of final guidances does not include
special controls documents.
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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.
In FY 2019, CDRH received comments regarding guidances issued in
2009, 1999, and 1989, and has withdrawn three guidance documents in
response to comments received and because these guidance documents were
determined to no longer represent the Agency's current thinking. The
revision of several guidance documents is also being considered as
resources permit.
III. 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 2020. 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 this and past
guidance priority 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 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22370 Filed 10-11-19; 8:45 am]
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