Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development, 58429-58431 [2017-26721]
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Written/Paper Submissions
[Docket No. FDA–2012–N–1021]
Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2018 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 CDRH (or the
Center) intends to publish in fiscal year
(FY) 2018. 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 February 12, 2018.
ADDRESSES: You may submit comments
as follows:
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
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
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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
2018 Proposed Guidance Development.’’
Received comments 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
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/201523389.pdf.
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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
(MDUFA III), Title II, Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–114), 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.
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 2018 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 and will update
these lists after considering public
comments, where appropriate. 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,
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
FDA has committed to updating its
website in a timely manner to reflect the
Agency’s review of previously
published guidance documents,
including the deletion of guidance
documents that no longer represent the
Agency’s interpretation of or policy on
a regulatory issue.
Fulfillment of these commitments
will be reflected through the issuance of
updated guidance on existing topics,
removal 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. Finalization of Draft Guidance
Documents
CDRH has identified as a priority, and
has devoted resources to, finalization of
draft guidance documents. To assure the
timely completion or re-issuance 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,
re-open 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. In
addition, in FY 2017, CDRH withdrew
4 of 8 draft guidances issued prior to
October 1, 2011, and has been
continuing to work towards taking an
action on the remaining draft guidances.
Looking forward, in FY 2018, CDRH
will strive to finalize, withdraw, or reopen the comment period for 50 percent
of existing draft guidances issued prior
to October 1, 2012.
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B. Earlier Stakeholder Involvement in
Guidance Development
CDRH has received feedback that
stakeholders desire earlier involvement
in the guidance process and has taken
steps to create a mechanism to address
this request. In FY 2016, in anticipation
of guidance documents expected to be
developed, CDRH sought stakeholder
input regarding electromagnetic
compatibility of electrically powered
medical devices and regarding utilizing
animal studies to evaluate the safety of
organ preservation devices and
solutions. FDA appreciated the feedback
received and considered it in the
development of these guidances.
Demonstrating commitment to
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incorporating stakeholder input, CDRH
issued a draft guidance in FY17 on
utilizing animal studies to evaluate the
safety of organ preservation devices, and
is progressing toward issuance of draft
policies reflecting early stakeholder
input as appropriate.
FDA also welcomes any additional
feedback for improving the guidance
program and the quality of CDRH
guidance documents.
C. Applicability of Previously Issued
Final Guidance
CDRH has issued over 600 final
guidance documents to provide
stakeholders with the Agency’s thinking
on numerous topics. Each guidance
reflected the Agency’s current position
at the time that it was issued. However,
the guidance program has issued these
guidances over a period of 30 years,
raising the question of how current
previously issued final guidances
remain. CDRH has resolved to address
this concern through a staged review of
previously issued final guidances in
collaboration with stakeholders. At the
website where CDRH has posted the ‘‘Alist’’ and ‘‘B-list’’ for FY 2018, CDRH
has also posted a list of final guidance
documents that issued in 2008, 1998,
1988, and 1978.1 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 intends to provide these lists of
previously issued final guidances
annually 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
2019, CDRH expects to provide a list of
the final guidance documents that
issued in 2009, 1999, 1989, and 1979;
the annual notice for FY 2020 is
expected to provide a list of the final
guidance documents that issued in
2010, 2000, 1990, and 1980, and so on.
CDRH will consider the comments
received from this retrospective review
when determining priorities for
1 The retrospective list of final guidances does not
include the following: (1) Documents that are not
guidances but were inadvertently categorized as
guidance such as scientific publications, advisory
opinions, and interagency agreements; (2)
guidances actively being revised by CDRH; and (3)
special controls documents.
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updating guidance documents and will
revise these as resources permit.
In FY 2017, CDRH received comments
regarding guidances issued in 2007,
1997, and 1987, and has withdrawn 32
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.
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.
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 2018. To access these
two lists, visit FDA’s website at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm580172.htm.
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.
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 2017 list was mostly
in agreement, and CDRH continued to
work toward issuing the guidances on
this list. In FY 2017, CDRH issued 9 of
27 guidances on the FY 2017 list (6 from
the A-list, 3 from the B-list). At this
time, CDRH has decided not to pursue
several guidances that were on the FY
2017 A or B list, due to factors including
feedback from industry.
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Secretary, Department of Health and
Human Services.
ACTION: Notice.
[FR Doc. 2017–26721 Filed 12–11–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee;
Amendment
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice; amendment.
AGENCY:
A notice was published in the
Federal Register on November 27, 2017,
announcing an in-person meeting of the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) on Wednesday,
December 13, 2017, from 9:00 a.m. until
3:30 p.m. and Thursday, December 14,
2017, from 9:00 a.m. until 5:00 p.m. The
meeting will be held at the U.S.
Department of Health and Human
Services, Hubert H. Humphrey Building,
Room 800, 200 Independence Avenue
SW, Washington, DC 20201. The notice
is being amended to provide security
procedures to enter the Hubert H.
Humphrey Building. Individuals
interested in attending the meeting in
person need to show a state or federal
government issued I.D. with a
photograph. Individuals can also email
the CFSAC inbox (cfsac@hhs.gov) in
order to have their names added to a list
of attendees. However, it is still
necessary for individuals to present a
photo I.D. to gain entrance to Hubert H.
Humphrey Building. All participants
will be escorted to the meeting room.
Space is limited.
FOR FURTHER INFORMATION CONTACT: CDR
Gustavo Ceinos, 202–690–7650; Email
address: cfsac@hhs.gov.
SUMMARY:
Dated: December 6, 2017.
Gustavo Ceinos,
CDR, USPHS, Designated Federal Officer,
Chronic Fatigue Syndrome Advisory
Committee.
[FR Doc. 2017–26739 Filed 12–11–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
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As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
on January 24, 2018, of the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council). The meeting will be open to
the public; a public comment session
will be held during the meeting. Preregistration is required for members of
the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should send an email to CARB@hhs.gov.
Registration information is available on
the website https://www.hhs.gov/ash/
carb/ and must be completed by January
15, 2018; all in-person attendees must
pre-register by this date. Additional
information about registering for the
meeting and providing public comment
can be obtained at https://www.hhs.gov/
ash/carb/ on the Meetings page.
DATES: The meeting is scheduled to be
held on January 24, 2018, from 9:00 a.m.
to 5:00 p.m. ET (times are tentative and
subject to change). The confirmed times
and agenda items for the meeting will be
posted on the website for the Advisory
Council at https://www.hhs.gov/ash/
carb/ when this information becomes
available. Pre-registration for attending
the meeting in person is required to be
completed no later than January 15,
2018; public attendance at the meeting
is limited to the available space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW, Washington,
DC 20201.
The meeting can also be accessed
through a live webcast on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory
Council on Combating AntibioticResistant Bacteria, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services, Hubert H. Humphrey Building,
200 Independence Avenue SW, Room
715H, Washington, DC 20201. Phone:
(202) 690–5566; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
SUMMARY:
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58431
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The public meeting will be dedicated
to two main activities. The Advisory
Council will deliberate and vote on a
letter drafted by the Immediate Action
Subcommittee. The remainder of the
day will be focused on the topic of
antibiotic stewardship in food and
companion animals. The meeting
agenda will be posted on the Advisory
Council website at https://www.hhs.gov/
ash/carb/ when it has been finalized.
All agenda items are tentative and
subject to change.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Advisory Council at the
address/telephone number listed above
at least one week prior to the meeting.
For those unable to attend in person, a
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Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58429-58431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26721]
[[Page 58429]]
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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 2018 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 CDRH (or the Center) intends to publish in
fiscal year (FY) 2018. 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 February 12,
2018.
ADDRESSES: You may submit comments as follows:
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 2018 Proposed Guidance Development.'' Received comments
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 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 (MDUFA III), Title II, Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-114), 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.
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 2018 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 and will update these lists after considering public comments,
where appropriate. 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,
[[Page 58430]]
FDA has committed to updating its website in a timely manner to reflect
the Agency's review of previously published guidance documents,
including the deletion of guidance documents that no longer represent
the Agency's interpretation of or policy on a regulatory issue.
Fulfillment of these commitments will be reflected through the
issuance of updated guidance on existing topics, removal 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. Finalization of Draft Guidance Documents
CDRH has identified as a priority, and has devoted resources to,
finalization of draft guidance documents. To assure the timely
completion or re-issuance 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, re-open 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. In addition, in FY
2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1,
2011, and has been continuing to work towards taking an action on the
remaining draft guidances. Looking forward, in FY 2018, CDRH will
strive to finalize, withdraw, or re-open the comment period for 50
percent of existing draft guidances issued prior to October 1, 2012.
B. Earlier Stakeholder Involvement in Guidance Development
CDRH has received feedback that stakeholders desire earlier
involvement in the guidance process and has taken steps to create a
mechanism to address this request. In FY 2016, in anticipation of
guidance documents expected to be developed, CDRH sought stakeholder
input regarding electromagnetic compatibility of electrically powered
medical devices and regarding utilizing animal studies to evaluate the
safety of organ preservation devices and solutions. FDA appreciated the
feedback received and considered it in the development of these
guidances. Demonstrating commitment to incorporating stakeholder input,
CDRH issued a draft guidance in FY17 on utilizing animal studies to
evaluate the safety of organ preservation devices, and is progressing
toward issuance of draft policies reflecting early stakeholder input as
appropriate.
FDA also welcomes any additional feedback for improving the
guidance program and the quality of CDRH guidance documents.
C. Applicability of Previously Issued Final Guidance
CDRH has issued over 600 final guidance documents to provide
stakeholders with the Agency's thinking on numerous topics. Each
guidance reflected the Agency's current position at the time that it
was issued. However, the guidance program has issued these guidances
over a period of 30 years, raising the question of how current
previously issued final guidances remain. CDRH has resolved to address
this concern through a staged review of previously issued final
guidances in collaboration with stakeholders. At the website where CDRH
has posted the ``A-list'' and ``B-list'' for FY 2018, CDRH has also
posted a list of final guidance documents that issued in 2008, 1998,
1988, and 1978.\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 intends to provide these lists of previously issued
final guidances annually 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 2019,
CDRH expects to provide a list of the final guidance documents that
issued in 2009, 1999, 1989, and 1979; the annual notice for FY 2020 is
expected to provide a list of the final guidance documents that issued
in 2010, 2000, 1990, and 1980, and so on. CDRH will consider the
comments received from this retrospective review 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
the following: (1) Documents that are not guidances but were
inadvertently categorized as guidance such as scientific
publications, advisory opinions, and interagency agreements; (2)
guidances actively being revised by CDRH; and (3) special controls
documents.
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In FY 2017, CDRH received comments regarding guidances issued in
2007, 1997, and 1987, and has withdrawn 32 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.
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.
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 2018. To access these two lists, visit
FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm. 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.
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 2017 list was mostly in agreement, and CDRH
continued to work toward issuing the guidances on this list. In FY
2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-
list, 3 from the B-list). At this time, CDRH has decided not to pursue
several guidances that were on the FY 2017 A or B list, due to factors
including feedback from industry.
[[Page 58431]]
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26721 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P