[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77641-77643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31404]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled
[[Page 77642]]
``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.
DATES: The public workshop will be held on January 25, 2016, from 8
a.m. to 5 p.m. Submit either electronic or written comments on the
public workshop by February 25, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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: http://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:
[email protected].
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
[[Page 77643]]
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
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., January 15, 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:
[email protected] no later than January 11, 2016.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://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 January 18, 2016. Please visit FDA's Medical Devices News &
Events--Workshops & Conferences calendar at http://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 http://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 http://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
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31404 Filed 12-14-15; 8:45 am]
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