Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop; Request for Comments, 29567-29569 [2017-13611]
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Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
current regulatory framework is
adequate and sufficiently flexible to
appropriately regulate medical gases.
FDA further explained that it can
continue to work within this framework
to appropriately regulate these products.
FDA issued a final rule promulgating
warning statements to be included in
the labeling of designated medical gases
on November 18, 2016 (81 FR 81685).
This final rule also imposes labeling,
design, and color requirements on
medical gas containers and closures to
increase the likelihood that the contents
of medical gas containers are accurately
identified and reduce the likelihood of
the wrong gas being connected to a gas
supply system or container. FDA may
undertake additional targeted
rulemaking in the future on other
specific issues if FDA determines that
such issues cannot be adequately
addressed by other means.
In addition to the applicable
regulations, FDA relies on guidance
documents (such as this one),
development of appropriate inspection
practices and inspector training, and
interaction with industry trade
associations, State regulators, and other
stakeholders on an as-needed basis in
regulating medical gases.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on current good manufacturing practice
for medical gases. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
sradovich on DSK3GMQ082PROD with NOTICES
II. Paperwork Reduction Act of 1995
This revised draft guidance includes
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3520). In
accordance with the PRA, before
publication of the final guidance
document, FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this guidance that are
new or that would represent material
modifications to previously approved
collections of information found in FDA
regulations.
503(b)(4); (2) a warning statement concerning the
use of the medical gas as determined by the
Secretary by regulation; and (3) appropriate
directions and warnings concerning storage and
handling.
VerDate Sep<11>2014
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III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulator
yInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13608 Filed 6–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3854]
Antimicrobial Susceptibility and
Resistance: Addressing Challenges of
Diagnostic Devices; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Antimicrobial
Susceptibility and Resistance:
Addressing Challenges of Diagnostic
Devices.’’ The purpose of this workshop
is to discuss potential scientific and
regulatory challenges associated with
developing traditional antimicrobial
susceptibility testing (AST) devices and
devices that detect antimicrobial
resistance markers by molecular or
novel diagnostic technologies, and to
provide an overview of relevant
provisions of the 21st Century Cures Act
that may impact the development of
such devices. Public input and feedback
gained through this workshop will aid
in the development of science-based
approaches to regulatory
decisionmaking regarding traditional
and novel AST devices. Further, this
workshop will explore opportunities for
the efficient development and
evaluation of AST devices, which may
lead to better patient care and reduce
antimicrobial resistance through
improved antibiotic stewardship.
DATES: The public workshop will be
held on September 13, 2017, from 8:30
a.m. to 5 p.m.
Submit either electronic or written
comments on this public workshop by
October 20, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
SUMMARY:
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29567
The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the
public meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 October 20, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of October 20, 2017. 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
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be public,
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
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29568
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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–
2017–N–3854 for ‘‘Antimicrobial
Susceptibility and Resistance:
Addressing Challenges of Diagnostic
Devices.’’ 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
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.
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
VerDate Sep<11>2014
18:29 Jun 28, 2017
Jkt 241001
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Natasha Townsend, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5525,
Silver Spring, MD 20993–0002, 301–
796–5927, email: natasha.townsend@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The accurate detection of
antimicrobial resistance is important
due to the emergence and spread of
highly resistant pathogenic bacteria.
Traditional AST systems continue to
provide the bulk of antimicrobial
susceptibility testing. However, the
spread of antimicrobial resistance has
spurred the development of a range of
novel diagnostic technologies (e.g.,
detection of molecular resistance
markers) that can provide more rapid
bacterial identification and
susceptibility testing results than is
possible with current phenotypic
methods. In light of the need for
accurate susceptibility information and
the development of these innovative
diagnostic technologies, there is a need
to explore and discuss new approaches
for the efficient development and
evaluation of AST devices—that are
important to patient care and antibiotic
stewardship—to allow for the timely
availability of these devices.
The purpose of the public workshop
is to discuss potential scientific and
regulatory challenges associated with
developing traditional AST devices and
devices that detect antimicrobial
resistance markers by molecular or
novel diagnostic technologies, and to
provide an overview of relevant
provisions of the 21st Century Cures Act
that may impact the development of
such devices. Specifically, section 3044
of the 21st Century Cures Act, entitled
‘‘Susceptibility Test Interpretive Criteria
for Microorganisms; Antimicrobial
Susceptibility Testing Devices,’’ adds
section 511A to the Federal Food, Drug,
and Cosmetic Act, which creates a new
regulatory framework for updating AST
devices with current susceptibility test
interpretive criteria for approved
antimicrobial drugs. Further, this
workshop will explore opportunities for
the efficient development and
evaluation of AST devices, including
new science-based approaches to
regulatory decisionmaking regarding
traditional and novel AST devices. In
addition, FDA is considering the
development of a draft guidance, and
will look to the meeting to help inform
PO 00000
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the Agency’s thinking on relevant
topics. Therefore, FDA seeks input and
feedback from industry, other
government agencies, standard-setting
organizations, clinical laboratories, and
patient care professionals with an
interest in the future development of
AST devices.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
brief presentations providing
information to frame interactive
discussions via two panel sessions. The
presentations and panel discussions
will focus on:
1. Industry and FDA perspectives on
AST device evaluation requirements,
including opportunities to streamline
the premarket review processes that
may allow for more rapid availability of
AST devices for new antimicrobial
drugs;
2. Performance review of traditional
AST devices;
3. An overview of relevant provisions
of the 21st Century Cures Act that may
impact the development of AST devices;
4. The clinical laboratory perspective
on AST result interpretation and
reporting;
5. Novel technologies for detection of
resistance markers;
6. Standards-setting organization
perspective on reference methods and
organism resources;
7. The role of new technologies for
promoting antibiotic stewardship,
improving patient care, aiding the
selection of appropriate antimicrobial
therapy, and reducing the impact of
antimicrobial resistance; and
8. Direct-from-specimen testing and
the challenges of the clinical use and
phenotypic interpretation of genotypic
results.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by September 1, 2017, 4 p.m.
Eastern Time. Early registration is
recommended because seating is
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Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting/public workshop will be
provided beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4321, Silver Spring,
MD 20993–0002, 301–796–5661, email:
susan.monahan@fda.hhs.gov no later
than August 30, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during
the public comment session, and which
topic you wish to present. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation. Following the close
of registration, we will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and begin notifying
participants by September 5, 2017. All
requests to make oral presentations
must be received by the close of
registration on September 1, 2017. If
selected for presentation, any
presentation materials must be emailed
to Natasha Townsend (see FOR FURTHER
INFORMATION CONTACT) no later than
September 8, 2017, 5 p.m. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Persons interested in
viewing the Webcast must register
online by September 8, 2017, 4 p.m. The
Webcast link will be available on the
registration Web page after September 8,
2017. Organizations are requested to
register all participants, but to view
using one connection per location.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit: https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
VerDate Sep<11>2014
18:29 Jun 28, 2017
Jkt 241001
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available approximately 45 days
after the public workshop on the
Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list).
Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13611 Filed 6–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3199]
Program for Enhanced Review
Transparency and Communication for
Original 351(k) Biologics License
Applications in Biosimilar User Fee Act
II
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
statement of work for an assessment of
the Program for Enhanced Review
Transparency and Communication for
original biologics license applications
(BLAs) (351(k)s) submitted under the
Public Health Service Act (hereafter
referred to as 351(k) applications)
(hereafter referred to as the Program).
The Program is part of the FDA
performance commitments under the
proposed reauthorization of the
Biosimilar User Fee Act (BsUFA),
which, if enacted into law, will allow
FDA to collect user fees for the review
of 351(k) applications for fiscal years
(FYs) 2018–2022. As part of the FDA
performance commitments described in
this document, the Program will be
evaluated by an independent contractor
in an interim and final assessment.
DATES: FDA is providing a period of 30
days for public comment on the
statement of work before beginning the
assessment. The statement of work can
be accessed at https://www.fda.gov/
downloads/ForIndustry/UserFees/
SUMMARY:
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29569
PrescriptionDrugUserFee/
UCM559341.pdf. Public comments will
be accepted through July 31, 2017. See
ADDRESSES section below for
information about submitting comments
to the public docket.
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 July 31, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 31, 2017. 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.’’
E:\FR\FM\29JNN1.SGM
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Agencies
[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29567-29569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13611]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3854]
Antimicrobial Susceptibility and Resistance: Addressing
Challenges of Diagnostic Devices; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Antimicrobial
Susceptibility and Resistance: Addressing Challenges of Diagnostic
Devices.'' The purpose of this workshop is to discuss potential
scientific and regulatory challenges associated with developing
traditional antimicrobial susceptibility testing (AST) devices and
devices that detect antimicrobial resistance markers by molecular or
novel diagnostic technologies, and to provide an overview of relevant
provisions of the 21st Century Cures Act that may impact the
development of such devices. Public input and feedback gained through
this workshop will aid in the development of science-based approaches
to regulatory decisionmaking regarding traditional and novel AST
devices. Further, this workshop will explore opportunities for the
efficient development and evaluation of AST devices, which may lead to
better patient care and reduce antimicrobial resistance through
improved antibiotic stewardship.
DATES: The public workshop will be held on September 13, 2017, from
8:30 a.m. to 5 p.m.
Submit either electronic or written comments on this public
workshop by October 20, 2017. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room),
Silver Spring, MD 20993. Entrance for the public meeting participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 20, 2017. 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 public, 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
[[Page 29568]]
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-2017-N-3854 for ``Antimicrobial Susceptibility and Resistance:
Addressing Challenges of Diagnostic Devices.'' 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 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: Natasha Townsend, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993-0002, 301-
796-5927, email: natasha.townsend@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The accurate detection of antimicrobial resistance is important due
to the emergence and spread of highly resistant pathogenic bacteria.
Traditional AST systems continue to provide the bulk of antimicrobial
susceptibility testing. However, the spread of antimicrobial resistance
has spurred the development of a range of novel diagnostic technologies
(e.g., detection of molecular resistance markers) that can provide more
rapid bacterial identification and susceptibility testing results than
is possible with current phenotypic methods. In light of the need for
accurate susceptibility information and the development of these
innovative diagnostic technologies, there is a need to explore and
discuss new approaches for the efficient development and evaluation of
AST devices--that are important to patient care and antibiotic
stewardship--to allow for the timely availability of these devices.
The purpose of the public workshop is to discuss potential
scientific and regulatory challenges associated with developing
traditional AST devices and devices that detect antimicrobial
resistance markers by molecular or novel diagnostic technologies, and
to provide an overview of relevant provisions of the 21st Century Cures
Act that may impact the development of such devices. Specifically,
section 3044 of the 21st Century Cures Act, entitled ``Susceptibility
Test Interpretive Criteria for Microorganisms; Antimicrobial
Susceptibility Testing Devices,'' adds section 511A to the Federal
Food, Drug, and Cosmetic Act, which creates a new regulatory framework
for updating AST devices with current susceptibility test interpretive
criteria for approved antimicrobial drugs. Further, this workshop will
explore opportunities for the efficient development and evaluation of
AST devices, including new science-based approaches to regulatory
decisionmaking regarding traditional and novel AST devices. In
addition, FDA is considering the development of a draft guidance, and
will look to the meeting to help inform the Agency's thinking on
relevant topics. Therefore, FDA seeks input and feedback from industry,
other government agencies, standard-setting organizations, clinical
laboratories, and patient care professionals with an interest in the
future development of AST devices.
II. Topics for Discussion at the Public Workshop
This public workshop will consist of brief presentations providing
information to frame interactive discussions via two panel sessions.
The presentations and panel discussions will focus on:
1. Industry and FDA perspectives on AST device evaluation
requirements, including opportunities to streamline the premarket
review processes that may allow for more rapid availability of AST
devices for new antimicrobial drugs;
2. Performance review of traditional AST devices;
3. An overview of relevant provisions of the 21st Century Cures Act
that may impact the development of AST devices;
4. The clinical laboratory perspective on AST result interpretation
and reporting;
5. Novel technologies for detection of resistance markers;
6. Standards-setting organization perspective on reference methods
and organism resources;
7. The role of new technologies for promoting antibiotic
stewardship, improving patient care, aiding the selection of
appropriate antimicrobial therapy, and reducing the impact of
antimicrobial resistance; and
8. Direct-from-specimen testing and the challenges of the clinical
use and phenotypic interpretation of genotypic results.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by September 1, 2017, 4 p.m. Eastern Time. Early
registration is recommended because seating is
[[Page 29569]]
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public meeting/public workshop will be provided beginning at 8 a.m.
We will let registrants know if registration closes before the day of
the public workshop.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring, MD 20993-0002, 301-796-5661, email:
susan.monahan@fda.hhs.gov no later than August 30, 2017.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the public comment session, and
which topic you wish to present. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and begin notifying participants by September 5,
2017. All requests to make oral presentations must be received by the
close of registration on September 1, 2017. If selected for
presentation, any presentation materials must be emailed to Natasha
Townsend (see FOR FURTHER INFORMATION CONTACT) no later than September
8, 2017, 5 p.m. No commercial or promotional material will be permitted
to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by September 8, 2017, 4 p.m. The Webcast link will be
available on the registration Web page after September 8, 2017.
Organizations are requested to register all participants, but to view
using one connection per location.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit: https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available
approximately 45 days after the public workshop on the Internet at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13611 Filed 6-28-17; 8:45 am]
BILLING CODE 4164-01-P