Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments, 8079-8081 [2016-03153]
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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
Dated: February 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–03152 Filed 2–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0160]
Pilot Program for Tobacco Product
Manufacturers; Center for Tobacco
Products eSubmissions Portal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Center for Tobacco
Products (CTP) in the Food and Drug
Administration (FDA) is soliciting
applications from regulated tobacco
product manufacturers to participate in
a voluntary pilot program to help CTP
evaluate a potential new portal, the CTP
eSubmissions Portal (CTP Portal), that is
being designed to improve the process
in connection with providing certain
regulatory submissions electronically to
CTP. CTP plans to accept up to six
participants for the pilot program. The
pilot program is intended to provide
CTP regulatory review staff with an
opportunity to evaluate the CTP Portal,
including its capability for sending and
receiving secure messages and
providing information as to the
documents submitted to it (for example,
receipt date and tracking number).
DATES: Interested parties should submit
an electronic application to participate
in this pilot program by March 2, 2016.
We plan to conduct user testing
beginning on or about March 18, 2016.
See section III of this document for
information on applications for
participation.
SUMMARY:
If you are interested in
participating in this pilot program,
please submit an electronic application
to CTPeSub@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Ann
Staten, Center for Tobacco Products,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
G402, Silver Spring, MD 20993–0002,
ann.staten@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
I. Background
The Family Smoking Prevention and
Tobacco Control Act of 2009 (Tobacco
Control Act) (Pub. L. 111–31) grants
FDA important authority to regulate the
VerDate Sep<11>2014
19:05 Feb 16, 2016
Jkt 238001
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors. Among
its many provisions, the Tobacco
Control Act created requirements for
tobacco product manufacturers and
importers, among others, to submit
certain regulatory documents and
information to FDA, including, but not
limited to, new tobacco product
applications, documents relating to
certain research activities and research
findings, and documents relating to
tobacco product ingredients, including
harmful and potentially harmful
constituents. While certain of these
documents must be submitted
electronically, for others an electronic
format for submission currently is not
required but is strongly encouraged to
facilitate efficiency and timeliness of
data submission and management. Also,
in June 2013, CTP announced a
workshop to obtain public input on
topics related to the potential electronic
submission of tobacco product
applications and other information and
opened a docket for public comment on
this topic. (For more information about
this workshop, please see ‘‘Electronic
Submission of Tobacco Product
Applications and Other Information;
Public Workshop; Request for
Comments’’ (78 FR 34393, June 7, 2013).
CTP has reviewed the input received
from the comments and other sources
and is committed to improving the
processes for providing regulatory
submissions electronically to FDA.
Consequently, CTP is announcing a
pilot program to test the functionality of
the CTP Portal, an electronic submission
and communication tool that should
enhance efficiency, communication, and
timeliness.
II. Pilot Program Participation
The pilot program to evaluate the CTP
Portal is to last approximately 3 months.
During the pilot program, CTP staff will
be available to answer any questions or
concerns that may arise. Pilot program
participants will receive training and
will be asked to submit regulatory
submissions using data provided to
them by CTP for testing purposes. Pilot
program participants also will be asked
to provide written and verbal feedback
during their training and after their
participation in the pilot program is
over. These comments and discussions
will assist CTP in its development of the
CTP Portal. CTP estimates that each
individual participant’s involvement
should take about 15 hours.
CTP is soliciting applications from
regulated tobacco product
manufacturers and, in particular, is
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8079
interested in hearing from small tobacco
product manufacturers (STPMs) and
tobacco product manufacturers that use
an authorized agent.
III. Applications for Participation
Applications to participate in the
pilot program should be sent
electronically to CTPeSub@fda.hhs.gov.
Applications should include the
following information: Company and
contact name; contact phone number;
contact email address; and whether you
are an STPM. Once applications for
participation are received, FDA will
contact interested applicants to discuss
the pilot program. FDA is seeking a
limited number of participants (no more
than six) to participate in this pilot
program. The pilot program is expected
to last approximately 3 months.
Dated: February 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03145 Filed 2–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–4462]
Point of Care Prothrombin Time/
International Normalized Ratio Devices
for Monitoring Warfarin Therapy;
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) is announcing the
following public workshop entitled
‘‘Point of Care Prothrombin Time/
International Normalized Ratio Devices
for Monitoring Warfarin Therapy.’’ The
purpose of this workshop is to discuss
and receive input from stakeholders
regarding approaches to the analytical
and clinical validation of point of care
(POC) Prothrombin Time/International
Normalized Ratio (PT/INR) in vitro
diagnostic devices for improved clinical
management of warfarin therapy in
addition to describing the FDA’s process
for facilitating the development of safe
and effective POC and patient selftesting PT/INR devices. The goal of the
workshop is to seek and identify
potential solutions to address the
scientific and regulatory challenges
associated with POC PT/INR devices to
ensure safety and effectiveness. The
public workshop on ‘‘Point of Care
SUMMARY:
E:\FR\FM\17FEN1.SGM
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8080
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
Prothrombin Time/International
Normalized Ratio Devices for
Monitoring Warfarin Therapy’’ that had
been scheduled for January 25, 2016,
was postponed due to unanticipated
weather conditions and rescheduled for
March 18, 2016.
DATES: The public workshop will be
held on March 18, 2016, from 8 a.m. to
5 p.m. This public workshop is being
rescheduled because of a postponed
meeting announced in the Federal
Register of December 15, 2015 (80 FR
77641), originally scheduled for January
25, 2016. Submit either electronic or
written comments on the public
workshop by April 18, 2016.
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’’).
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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.’’
VerDate Sep<11>2014
19:05 Feb 16, 2016
Jkt 238001
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–4462 for ‘‘Point of Care
Prothrombin Time/International
Normalized Ratio Devices for
Monitoring Warfarin Therapy.’’
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
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
The public workshop will be held at
FDA’s White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, Rm. 1503 (the Great Room),
Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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.
FOR FURTHER INFORMATION CONTACT:
Rachel Goehe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5533, Silver Spring,
MD 20993, 240–402–6565, email:
Rachel.Goehe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Warfarin, an oral vitamin K
antagonist, is a commonly prescribed
anticoagulant drug used to reduce the
risk of thromboembolic events. Warfarin
inhibits the synthesis of clotting factors
II, VII, IX, and X, in addition to the
naturally occurring endogenous
anticoagulant proteins C and S. The
response of individual patients to
warfarin is highly variable because of
factors such as diet, age, and interaction
with other drugs. As a consequence, it
is important that warfarin dosage be
tailored individually to maintain
clinical benefit. The PT test is used to
determine a patient’s clotting time,
which the Clinical and Laboratory
Standards Institute defines as the time
in seconds required for a fibrin clot to
form in a plasma sample after tissue
thromboplastin and an optimal amount
of calcium chloride have been added to
the sample. It is well-recognized that a
PT result obtained with one test system
cannot be compared to a PT result
obtained with another test system
because of the variety of
thromboplastins used in different test
systems. Therefore, PT test results are
converted into a standardized unit
known as the INR, which was adopted
by the World Health Organization with
the intent to reduce intersystem
variation in test results. The INR result
is used to monitor patients’ response to
warfarin.
POC PT/INR devices offer an
alternative to laboratory-based testing
and venipuncture, enabling a rapid INR
determination from a finger stick sample
of whole blood. POC devices can be
used in a variety of settings including,
but not limited to, physician’s office
laboratory, anti-coagulation clinic,
patient bedside, hospital emergency
department, and prescription home use.
The purpose of POC PT/INR testing is
to monitor warfarin and to provide
immediate information to physicians
about the patient’s anticoagulation
E:\FR\FM\17FEN1.SGM
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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
status so that this information can be
integrated into appropriate treatment
decisions that can improve patient
outcomes. POC PT/INR testing is
increasingly being viewed as a testing
modality with performance expectations
similar to that of traditional laboratory
testing. From a regulatory standpoint,
POC PT/INR devices have been
reviewed and cleared for prescription
use under appropriate professional
supervision or prescription home use
(patient self-testing), depending on the
claimed intended use. For this
workshop, both settings will be open for
discussion.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
presentations covering the topics listed
in this document. Following the
presentations, there will be a moderated
panel discussion where participants
will be asked to provide their
perspectives. The workshop panel
discussion will focus on identifying
potential solutions to address the
scientific and regulatory challenges
associated with POC PT/INR devices. In
advance of the meeting, FDA plans to
post a discussion paper outlining FDA’s
current thinking on the various topics
mentioned in the following list, and
invite comment on this from the
community.
Topics to be discussed at the public
workshop include, but are not limited
to, the following:
• Current regulatory process involved
with the clearance of POC PT/INR
devices.
• Current benefit/risk balance of POC
PT/INR devices.
• Technological differences amongst
marketed POC PT/INR devices,
advantages and limitations of each
technology, and comparability of test
results obtained using different
technologies.
• Challenges associated with
correlating results from whole blood
POC PT/INR devices to conventional
plasma-based laboratory tests.
• Appropriate study design for
validation and usability studies from the
perspectives of the Agency,
manufacturers and end users to help
improve our understanding of the
accuracy, reliability and safety of POC
PT/INR devices.
• Types of quality control and the test
system elements assessed by the
controls.
• Challenges associated with different
sample matrices (venous, fingerstick,
arterial).
Registration: Registration is free and
available on a first-come, first-served
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19:05 Feb 16, 2016
Jkt 238001
basis. Persons interested in attending
this public workshop must register
online by 4 p.m., March 10, 2016. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permits, onsite registration on the
day of the public workshop will be
provided beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Office of
Communication and Education, 301–
796–5661, email: Susan.Monahan@
fda.hhs.gov no later than March 4, 2016.
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. Those without
Internet access should contact Susan
Monahan (contact for special
accommodations) to register. Registrants
will receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. The Webcast link will
be available on the workshop Web page
after March 10, 2016. 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.)
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, 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 is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. A link to the
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8081
transcripts 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: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03153 Filed 2–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Career Development Program in Emergency
Care Research (K12).
Date: March 10, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington, DC/Rockville
1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Pathophysiology and Treatment of Bicuspid
Aortic Valve Disease.
Date: March 11, 2016.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7188, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
E:\FR\FM\17FEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8079-8081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4462]
Point of Care Prothrombin Time/International Normalized Ratio
Devices for Monitoring Warfarin Therapy; 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) is announcing the
following public workshop entitled ``Point of Care Prothrombin Time/
International Normalized Ratio Devices for Monitoring Warfarin
Therapy.'' The purpose of this workshop is to discuss and receive input
from stakeholders regarding approaches to the analytical and clinical
validation of point of care (POC) Prothrombin Time/International
Normalized Ratio (PT/INR) in vitro diagnostic devices for improved
clinical management of warfarin therapy in addition to describing the
FDA's process for facilitating the development of safe and effective
POC and patient self-testing PT/INR devices. The goal of the workshop
is to seek and identify potential solutions to address the scientific
and regulatory challenges associated with POC PT/INR devices to ensure
safety and effectiveness. The public workshop on ``Point of Care
[[Page 8080]]
Prothrombin Time/International Normalized Ratio Devices for Monitoring
Warfarin Therapy'' that had been scheduled for January 25, 2016, was
postponed due to unanticipated weather conditions and rescheduled for
March 18, 2016.
DATES: The public workshop will be held on March 18, 2016, from 8 a.m.
to 5 p.m. This public workshop is being rescheduled because of a
postponed meeting announced in the Federal Register of December 15,
2015 (80 FR 77641), originally scheduled for January 25, 2016. Submit
either electronic or written comments on the public workshop by April
18, 2016.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-4462 for ``Point of Care Prothrombin Time/International
Normalized Ratio Devices for Monitoring Warfarin Therapy.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
The public workshop will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the Great
Room), Silver Spring, MD 20993-0002. 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.
FOR FURTHER INFORMATION CONTACT: Rachel Goehe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5533, Silver Spring, MD 20993, 240-402-6565, email:
Rachel.Goehe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Warfarin, an oral vitamin K antagonist, is a commonly prescribed
anticoagulant drug used to reduce the risk of thromboembolic events.
Warfarin inhibits the synthesis of clotting factors II, VII, IX, and X,
in addition to the naturally occurring endogenous anticoagulant
proteins C and S. The response of individual patients to warfarin is
highly variable because of factors such as diet, age, and interaction
with other drugs. As a consequence, it is important that warfarin
dosage be tailored individually to maintain clinical benefit. The PT
test is used to determine a patient's clotting time, which the Clinical
and Laboratory Standards Institute defines as the time in seconds
required for a fibrin clot to form in a plasma sample after tissue
thromboplastin and an optimal amount of calcium chloride have been
added to the sample. It is well-recognized that a PT result obtained
with one test system cannot be compared to a PT result obtained with
another test system because of the variety of thromboplastins used in
different test systems. Therefore, PT test results are converted into a
standardized unit known as the INR, which was adopted by the World
Health Organization with the intent to reduce intersystem variation in
test results. The INR result is used to monitor patients' response to
warfarin.
POC PT/INR devices offer an alternative to laboratory-based testing
and venipuncture, enabling a rapid INR determination from a finger
stick sample of whole blood. POC devices can be used in a variety of
settings including, but not limited to, physician's office laboratory,
anti-coagulation clinic, patient bedside, hospital emergency
department, and prescription home use. The purpose of POC PT/INR
testing is to monitor warfarin and to provide immediate information to
physicians about the patient's anticoagulation
[[Page 8081]]
status so that this information can be integrated into appropriate
treatment decisions that can improve patient outcomes. POC PT/INR
testing is increasingly being viewed as a testing modality with
performance expectations similar to that of traditional laboratory
testing. From a regulatory standpoint, POC PT/INR devices have been
reviewed and cleared for prescription use under appropriate
professional supervision or prescription home use (patient self-
testing), depending on the claimed intended use. For this workshop,
both settings will be open for discussion.
II. Topics for Discussion at the Public Workshop
This public workshop will consist of presentations covering the
topics listed in this document. Following the presentations, there will
be a moderated panel discussion where participants will be asked to
provide their perspectives. The workshop panel discussion will focus on
identifying potential solutions to address the scientific and
regulatory challenges associated with POC PT/INR devices. In advance of
the meeting, FDA plans to post a discussion paper outlining FDA's
current thinking on the various topics mentioned in the following list,
and invite comment on this from the community.
Topics to be discussed at the public workshop include, but are not
limited to, the following:
Current regulatory process involved with the clearance of
POC PT/INR devices.
Current benefit/risk balance of POC PT/INR devices.
Technological differences amongst marketed POC PT/INR
devices, advantages and limitations of each technology, and
comparability of test results obtained using different technologies.
Challenges associated with correlating results from whole
blood POC PT/INR devices to conventional plasma-based laboratory tests.
Appropriate study design for validation and usability
studies from the perspectives of the Agency, manufacturers and end
users to help improve our understanding of the accuracy, reliability
and safety of POC PT/INR devices.
Types of quality control and the test system elements
assessed by the controls.
Challenges associated with different sample matrices
(venous, fingerstick, arterial).
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m., March 10, 2016. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health,
Office of Communication and Education, 301-796-5661, email:
Susan.Monahan@fda.hhs.gov no later than March 4, 2016.
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. Those without
Internet access should contact Susan Monahan (contact for special
accommodations) to register. Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The Webcast link will be available on the workshop Web
page after March 10, 2016. 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.) 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, 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 is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
https://www.fda.gov. A link to the transcripts 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: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03153 Filed 2-16-16; 8:45 am]
BILLING CODE 4164-01-P
