Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development, 59399-59401 [2021-23392]
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: January 3, 2019. FDA
has verified the applicant’s claims that
the new drug application (NDA) for
INREBIC (NDA 212327) was initially
submitted on January 3, 2019.
3. The date the application was
approved: August 16, 2019. FDA has
verified the applicant’s claims that NDA
212327 was approved on August 16,
2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,271 days, 1,523
days or 1,796 days of patent term
extension.
III. Petitions
lotter on DSK11XQN23PROD with NOTICES1
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23388 Filed 10–26–21; 8:45 am]
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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 2022 Proposed
Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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) 2022. 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 stakeholders’ needs.
DATES: Submit either electronic or
written comments by November 26,
2021.
SUMMARY:
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 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 27, 2021.
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.
ADDRESSES:
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
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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
2021 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
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
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-201509-18/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:
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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
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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
2023, CDRH expects to provide a list of
the final guidance documents that
issued in 2013, 2003, 1993, and 1983;
the annual notice for FY 2024 is
expected to provide a list of the final
guidance documents that issued in
2014, 2004, 1994, and 1984, 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 2022 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.
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II. CDRH Guidance Development
Initiatives
A. Metrics for FY 2021 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 2021 list was mostly
in agreement, and CDRH continued to
work toward issuing the guidances on
this list. In FY 2021, CDRH published
11 of 27 guidances on the FY 2021 list
(8 from the A-list, 3 from the B-list). In
addition, FDA is committed to
providing timely guidance to support
response efforts to the Coronavirus
Disease 2019 (COVID–19) pandemic. As
such, FDA has shifted resources to issue
5 guidances and 8 guidance revisions in
FY 2021, as well as to support other
activities to address the pandemic.
B. Finalization of Draft Guidance
Documents
Of the 29 draft guidances issued FY
2016 onward, CDRH finalized 79
percent within 3 years of the comment
period close and 86 percent within 5
years. In addition, in FY 2021, 5 draft
guidances issued prior to October 1,
2015, remain for which no action has
been taken yet, and CDRH has been
continuing to work towards taking an
action on these remaining draft
guidances.
Looking forward, in FY 2022, CDRH
will strive to finalize, withdraw, or
reopen the comment period for 50
percent of existing draft guidances
issued prior to October 1, 2016.
C. Applicability of Previously Issued
Final Guidance
At the website where CDRH has
posted the ‘‘A-list’’ and ‘‘B-list’’ for FY
2021, CDRH has also posted a list of
final guidance documents that issued in
2012, 2002, 1992, and 1982 for our
annual review of previously issued final
guidances. 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
when determining priorities for
updating guidance documents and will
revise these as resources permit.
Consistent with the Good Guidance
Practices regulation at 21 CFR
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
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 2021, CDRH received comments
regarding guidances issued in 2011,
2001, 1991, and 1981 and has
withdrawn 1 guidance document
because the guidance document was
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 2022. To access these
two lists, visit FDA’s website at https://
www.fda.gov/medical-devices/guidancedocuments-medical-devices-andradiation-emitting-products/cdrhproposed-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 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23392 Filed 10–26–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2021–N–0758]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
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The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
November 30, 2021, from 9 a.m. to
5 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0758.
The docket will close on November 29,
2021. Submit either electronic or
written comments on this public
meeting by November 29, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before November 29, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 29, 2021. 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.
Comments received on or before
November 15, 2021, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
DATES:
Electronic Submissions
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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59401
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–
2021–N–0758 for ‘‘Antimicrobial Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ 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.’’ FDA
will review this copy, including the
claimed confidential information, in its
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]]>Agencies
[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59399-59401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23392]
-----------------------------------------------------------------------
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 2022 Proposed Guidance Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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) 2022. 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 stakeholders' needs.
DATES: Submit either electronic or written comments by November 26,
2021.
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 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. 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 2021 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
[[Page 59400]]
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), 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 2023, CDRH expects to provide a list of the
final guidance documents that issued in 2013, 2003, 1993, and 1983; the
annual notice for FY 2024 is expected to provide a list of the final
guidance documents that issued in 2014, 2004, 1994, and 1984, 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 2022 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 2021 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 2021 list was mostly in agreement, and CDRH
continued to work toward issuing the guidances on this list. In FY
2021, CDRH published 11 of 27 guidances on the FY 2021 list (8 from the
A-list, 3 from the B-list). In addition, FDA is committed to providing
timely guidance to support response efforts to the Coronavirus Disease
2019 (COVID-19) pandemic. As such, FDA has shifted resources to issue 5
guidances and 8 guidance revisions in FY 2021, as well as to support
other activities to address the pandemic.
B. Finalization of Draft Guidance Documents
Of the 29 draft guidances issued FY 2016 onward, CDRH finalized 79
percent within 3 years of the comment period close and 86 percent
within 5 years. In addition, in FY 2021, 5 draft guidances issued prior
to October 1, 2015, remain for which no action has been taken yet, and
CDRH has been continuing to work towards taking an action on these
remaining draft guidances.
Looking forward, in FY 2022, CDRH will strive to finalize,
withdraw, or reopen the comment period for 50 percent of existing draft
guidances issued prior to October 1, 2016.
C. Applicability of Previously Issued Final Guidance
At the website where CDRH has posted the ``A-list'' and ``B-list''
for FY 2021, CDRH has also posted a list of final guidance documents
that issued in 2012, 2002, 1992, and 1982 for our annual review of
previously issued final guidances. 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 when determining priorities for
updating guidance documents and will revise these as resources permit.
Consistent with the Good Guidance Practices regulation at 21 CFR
[[Page 59401]]
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 2021, CDRH received comments regarding guidances issued in
2011, 2001, 1991, and 1981 and has withdrawn 1 guidance document
because the guidance document was 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 2022. 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 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23392 Filed 10-26-21; 8:45 am]
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