Cardiac Troponin Assays; Public Workshop; Request for Comments, 35532-35534 [2017-16007]
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Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
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sradovich on DSKBCFCHB2PROD with NOTICES
III. Copies of the Charter
The Secretary’s Charter for the APOE
is available on the CMS Web site at:
https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/Downloads/
APOECharter2017.pdf or you may
obtain a copy of the charter by
submitting a request to: Thomas Dudley,
Designated Federal Official (DFO),
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Security Boulevard, Mailstop S1 05–06,
Baltimore, MD 21244 1850 or via email
at Thomas.Dudley@cms.hhs.gov.
VerDate Sep<11>2014
17:38 Jul 28, 2017
Jkt 241001
Dated: July 21, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–15960 Filed 7–28–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4179]
Cardiac Troponin Assays; 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 ‘‘Cardiac Troponin
Assays.’’ The purpose of the workshop
is to discuss the development of
innovative troponin assays designed to
aid in the diagnosis of myocardial
infarction (MI) and additional clinical
uses of these assays. The workshop is
intended to enhance engagement with
stakeholders to facilitate device
development and to discuss scientific
and regulatory challenges associated
with the analytical and clinical
validation methods for troponin assay
devices. Public input and feedback
gained through this workshop may aid
in the development of science-based
approaches to aid in the efficient
development of innovative, safe and
effective, troponin diagnostic assays,
which may lead to better patient care.
DATES: The public workshop will be
held on November 28, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by November 27, 2017. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the
public workshop 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.
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Electronic comments must be submitted
on or before November 27, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 27, 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: Go to
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–
2017–N–4179 for ‘‘Cardiac Troponin
Assays.’’ 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
E:\FR\FM\31JYN1.SGM
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Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Paula Caposino, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4644,
Silver Spring, MD 20993, 301–796–
6160, Paula.Caposino@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSKBCFCHB2PROD with NOTICES
I. Background
Since first discovered, cardiac
troponin has become increasingly
valuable as a biomarker of MI. In 2007,
the National Academy of Clinical
Biochemistry Laboratory Medicine
Practice Guidelines and the Joint
European Society of Cardiology,
American College of Cardiology
VerDate Sep<11>2014
17:38 Jul 28, 2017
Jkt 241001
Foundation, American Heart
Association, and the World Heart
Federation Task Force Guidelines
recommended the use of cardiac
troponin as a biomarker for the
diagnosis of MI when used in
conjunction with clinical evidence of
myocardial ischemia (Refs. 1 and 2).
Cardiac troponin has also been
recommended in current clinical
guidelines as a prognostic marker in
patients with symptoms of acute
coronary syndrome with respect to
mortality, MI, or ischemic events. These
recommendations solidified troponin’s
importance in MI diagnosis and triage;
at the same time, they formalized an
adjustment in the clinical cutoffs and
changed the way troponin results were
interpreted and used. There is a lot of
interest in developing innovative
troponin assays that aid in the diagnosis
of MI and to support additional clinical
uses of these assays. We are holding this
public workshop to discuss several
topics of interest that are important for
the development of innovative cardiac
troponin assays. The goal of the
workshop is to enhance engagement
with stakeholders concerning the
development and validation of
innovative troponin assay devices.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
brief presentations providing
information to frame the discussion,
followed by interactive panel
discussions. Following the
presentations, a moderated discussion is
planned to ask speakers and additional
panelists to provide their individual
perspectives. Topics for discussion
include:
• Clinical study design considerations
and challenges
• Subgroup differences for troponin’s
clinical use (e.g., the need for sexspecific cutoffs)
• Reference range study design
considerations and best practices for
reference range study design and
methods for calculating upper
reference limits
• The use of deltas in the diagnosis of
MI
• Point of care testing
In light of the changes to how
troponin is used clinically, there is a
need to explore and discuss troponin
assay device development and
evaluation. We are soliciting comments
and feedback from stakeholders
regarding additional topics for FDA to
consider for discussion. These
comments can be submitted to the
docket prior to the meeting (see
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
35533
ADDRESSES). We anticipate that the
comments and discussion at this public
workshop will help facilitate the
development of innovative troponin
devices and lessen regulatory burden.
The ultimate goal is to facilitate the
availability of innovative, safe and
effective troponin assay devices for
patient care.
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.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by November 17, 2017, by 4
p.m. Eastern Time. Early registration is
recommended because seating is
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 workshop will be provided
beginning at 7:30 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 November 14, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session, and which
topic(s) you wish to address. 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 notify participants by
November 20, 2017. All requests to
make oral presentations must be
received by the close of registration on
E:\FR\FM\31JYN1.SGM
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Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
November 17, 2017 by 4 p.m. If selected
for presentation, any presentation
materials must be emailed to Paula
Caposino (see FOR FURTHER INFORMATION
CONTACT) no later than November 21,
2017. 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. The Webcast link will
be available on the registration Web
page after November 21, 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).
IV. References
sradovich on DSKBCFCHB2PROD with NOTICES
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov.
1. ‘‘National Academy of Clinical
Biochemistry Laboratory Medicine
Practice Guidelines: Clinical
Characteristics and Utilization of
Biochemical Markers in Acute Coronary
Syndromes.’’ Circulation, 2007; 115,
356–375.
2. ‘‘Universal Definition of Myocardial
Infarction.’’ Circulation, 2007: 116,
2634–2653.
VerDate Sep<11>2014
17:38 Jul 28, 2017
Jkt 241001
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
Hampshire Ave., Bldg. 51, Rm. 6314,
Silver Spring, MD 20993, (301) 796–
7578, Kayla.Garvin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–16007 Filed 7–28–17; 8:45 am]
I. Background
RWD (data relating to patient health
status and/or the delivery of health care
routinely collected from a variety of
sources) and RWE (clinical evidence
regarding the usage and potential
benefits or risks of a drug derived from
analysis of RWD) are increasingly being
used by multiple stakeholders within
the health care system. Payers may rely
on RWD and RWE to refine formularies
or assist in coverage decisions.
Physicians and professional societies
can utilize RWE to further tailor clinical
practice guidelines and decisionsupport tools. Medical product
developers can use RWE to further
develop a product’s benefit-risk profile,
monitor postmarket safety and adverse
events, or generate additional
hypotheses for continued clinical
development.
The 21st Century Cures Act, section
3022 (Pub. L. 114–255), enacted on
December 13, 2016, directed FDA to
establish a program to evaluate the
potential use of RWE. The framework of
the program was to include information
describing the sources of RWE, the gaps
in data collection, standards and
methods for collection and analysis, and
the priority areas and challenges.
To date, RWD and RWE have been
used in very specific regulatory
contexts. Some treatments for rare
diseases, for example, have utilized
RWE as part of the historical controls
used for clinical study and, ultimately,
regulatory submission. Postmarket
safety surveillance has also relied
heavily on RWD-generating networks.
As part of exploring the opportunities
for enhanced use of these types of data
and evidence in additional regulatory
decision-making contexts, FDA is
seeking input on the opportunities and
challenges in using RWE to support the
approval of a new indication for an
already approved drug, and to help
support or satisfy postapproval study
requirements.
This public workshop is being held to
engage external stakeholders in
discussions around the current state of
RWE development and potential
challenge areas for using RWE in
regulatory decisions beyond postmarket
safety surveillance.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Developing a Framework for
Regulatory Use of Real-World
Evidence; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Developing a
Framework for Regulatory Use of RealWorld Evidence.’’ Convened by the
Duke-Robert J. Margolis, MD, Center for
Health Policy at Duke University and
supported by a cooperative agreement
with FDA, the purpose of the public
workshop is to bring the stakeholder
community together to discuss a variety
of topics related to the use of real-world
data (RWD) and real-world evidence
(RWE) in drug development and
regulatory decision making. Topics will
include an update on FDA’s activities to
address the use of RWE in regulatory
decisions and the development of a
framework for tackling challenges
related to RWE’s regulatory
acceptability. In addition, panelists will
discuss opportunities to improve data
development activities, study designs,
and analytical methods used to create
robust RWE.
DATES: The public workshop will be
held on September 13, 2017, from 9 a.m.
to 4:30 p.m., Eastern Time.
ADDRESSES: The public workshop will
be held at the Conference Center at 1777
F Street NW., Washington, DC 20006.
For additional travel and hotel
information, please refer to the
following Web site: https://
healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence.
There will also be a live webcast for
those unable to attend the meeting in
person (see Streaming Webcast of Public
Workshop).
FOR FURTHER INFORMATION CONTACT:
Kayla Garvin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
PO 00000
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II. Topics for Discussion at the Public
Workshop
During the course of the public
workshop, speakers and participants
will cover a range of issues related to
E:\FR\FM\31JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)]
[Notices]
[Pages 35532-35534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4179]
Cardiac Troponin Assays; 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 ``Cardiac Troponin
Assays.'' The purpose of the workshop is to discuss the development of
innovative troponin assays designed to aid in the diagnosis of
myocardial infarction (MI) and additional clinical uses of these
assays. The workshop is intended to enhance engagement with
stakeholders to facilitate device development and to discuss scientific
and regulatory challenges associated with the analytical and clinical
validation methods for troponin assay devices. Public input and
feedback gained through this workshop may aid in the development of
science-based approaches to aid in the efficient development of
innovative, safe and effective, troponin diagnostic assays, which may
lead to better patient care.
DATES: The public workshop will be held on November 28, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop by November 27, 2017. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the public workshop 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 November 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 27, 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: Go to 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-2017-N-4179 for ``Cardiac Troponin Assays.'' 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
[[Page 35533]]
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: Paula Caposino, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796-
6160, Paula.Caposino@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Since first discovered, cardiac troponin has become increasingly
valuable as a biomarker of MI. In 2007, the National Academy of
Clinical Biochemistry Laboratory Medicine Practice Guidelines and the
Joint European Society of Cardiology, American College of Cardiology
Foundation, American Heart Association, and the World Heart Federation
Task Force Guidelines recommended the use of cardiac troponin as a
biomarker for the diagnosis of MI when used in conjunction with
clinical evidence of myocardial ischemia (Refs. 1 and 2). Cardiac
troponin has also been recommended in current clinical guidelines as a
prognostic marker in patients with symptoms of acute coronary syndrome
with respect to mortality, MI, or ischemic events. These
recommendations solidified troponin's importance in MI diagnosis and
triage; at the same time, they formalized an adjustment in the clinical
cutoffs and changed the way troponin results were interpreted and used.
There is a lot of interest in developing innovative troponin assays
that aid in the diagnosis of MI and to support additional clinical uses
of these assays. We are holding this public workshop to discuss several
topics of interest that are important for the development of innovative
cardiac troponin assays. The goal of the workshop is to enhance
engagement with stakeholders concerning the development and validation
of innovative troponin assay devices.
II. Topics for Discussion at the Public Workshop
This public workshop will consist of brief presentations providing
information to frame the discussion, followed by interactive panel
discussions. Following the presentations, a moderated discussion is
planned to ask speakers and additional panelists to provide their
individual perspectives. Topics for discussion include:
Clinical study design considerations and challenges
Subgroup differences for troponin's clinical use (e.g., the
need for sex-specific cutoffs)
Reference range study design considerations and best practices
for reference range study design and methods for calculating upper
reference limits
The use of deltas in the diagnosis of MI
Point of care testing
In light of the changes to how troponin is used clinically, there
is a need to explore and discuss troponin assay device development and
evaluation. We are soliciting comments and feedback from stakeholders
regarding additional topics for FDA to consider for discussion. These
comments can be submitted to the docket prior to the meeting (see
ADDRESSES). We anticipate that the comments and discussion at this
public workshop will help facilitate the development of innovative
troponin devices and lessen regulatory burden. The ultimate goal is to
facilitate the availability of innovative, safe and effective troponin
assay devices for patient care.
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.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by November 17, 2017, by 4 p.m. Eastern Time.
Early registration is recommended because seating is 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 workshop will be provided beginning at 7:30 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 November 14, 2017.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session, and
which topic(s) you wish to address. 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 notify participants by November 20, 2017.
All requests to make oral presentations must be received by the close
of registration on
[[Page 35534]]
November 17, 2017 by 4 p.m. If selected for presentation, any
presentation materials must be emailed to Paula Caposino (see FOR
FURTHER INFORMATION CONTACT) no later than November 21, 2017. 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. The Webcast link will be available on the registration
Web page after November 21, 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).
IV. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov.
1. ``National Academy of Clinical Biochemistry Laboratory Medicine
Practice Guidelines: Clinical Characteristics and Utilization of
Biochemical Markers in Acute Coronary Syndromes.'' Circulation,
2007; 115, 356-375.
2. ``Universal Definition of Myocardial Infarction.'' Circulation,
2007: 116, 2634-2653.
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16007 Filed 7-28-17; 8:45 am]
BILLING CODE 4164-01-P