81 FR 8079 - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 31 (February 17, 2016)

Page Range		8079-8081
FR Document		2016-03153

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 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.

Federal Register, Volume 81 Issue 31 (Wednesday, February 17, 2016)

[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8079-8081]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03153]


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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.

-----------------------------------------------------------------------

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: 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 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: 
[email protected] no later than March 4, 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 March 10, 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: 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

Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8079

Dated: February 10, 2016. manufacture, marketing, and interested in hearing from small tobacco
Jill Hartzler Warner, distribution of tobacco products to product manufacturers (STPMs) and
Associate Commissioner for Special Medical protect the public health generally and tobacco product manufacturers that use
Programs. to reduce tobacco use by minors. Among an authorized agent.
[FR Doc. 2016–03152 Filed 2–16–16; 8:45 am] its many provisions, the Tobacco
III. Applications for Participation
BILLING CODE 4164–01–P Control Act created requirements for
tobacco product manufacturers and Applications to participate in the
importers, among others, to submit pilot program should be sent
DEPARTMENT OF HEALTH AND certain regulatory documents and electronically to CTPeSub@fda.hhs.gov.
HUMAN SERVICES information to FDA, including, but not Applications should include the
limited to, new tobacco product following information: Company and
Food and Drug Administration applications, documents relating to contact name; contact phone number;
certain research activities and research contact email address; and whether you
[Docket No. FDA–2016–N–0160]
findings, and documents relating to are an STPM. Once applications for
Pilot Program for Tobacco Product tobacco product ingredients, including participation are received, FDA will
Manufacturers; Center for Tobacco harmful and potentially harmful contact interested applicants to discuss
Products eSubmissions Portal constituents. While certain of these the pilot program. FDA is seeking a
documents must be submitted limited number of participants (no more
AGENCY: Food and Drug Administration, electronically, for others an electronic than six) to participate in this pilot
HHS. format for submission currently is not program. The pilot program is expected
ACTION: Notice. required but is strongly encouraged to to last approximately 3 months.
facilitate efficiency and timeliness of Dated: February 10, 2016.
SUMMARY: The Center for Tobacco data submission and management. Also, Leslie Kux,
Products (CTP) in the Food and Drug in June 2013, CTP announced a Associate Commissioner for Policy.
Administration (FDA) is soliciting workshop to obtain public input on
applications from regulated tobacco [FR Doc. 2016–03145 Filed 2–16–16; 8:45 am]
topics related to the potential electronic
product manufacturers to participate in submission of tobacco product
BILLING CODE 4164–01–P

a voluntary pilot program to help CTP applications and other information and
evaluate a potential new portal, the CTP opened a docket for public comment on
eSubmissions Portal (CTP Portal), that is DEPARTMENT OF HEALTH AND
this topic. (For more information about HUMAN SERVICES
being designed to improve the process this workshop, please see ‘‘Electronic
in connection with providing certain Submission of Tobacco Product Food and Drug Administration
regulatory submissions electronically to Applications and Other Information;
CTP. CTP plans to accept up to six Public Workshop; Request for [Docket No. FDA–2015–N–4462]
participants for the pilot program. The Comments’’ (78 FR 34393, June 7, 2013).
pilot program is intended to provide Point of Care Prothrombin Time/
CTP has reviewed the input received
CTP regulatory review staff with an International Normalized Ratio Devices
from the comments and other sources
opportunity to evaluate the CTP Portal, for Monitoring Warfarin Therapy;
and is committed to improving the
Public Workshop; Request for
including its capability for sending and processes for providing regulatory
Comments
receiving secure messages and submissions electronically to FDA.
providing information as to the Consequently, CTP is announcing a AGENCY: Food and Drug Administration,
documents submitted to it (for example, pilot program to test the functionality of HHS.
receipt date and tracking number). the CTP Portal, an electronic submission ACTION: Notice of public workshop;
DATES: Interested parties should submit and communication tool that should request for comments.
an electronic application to participate enhance efficiency, communication, and
in this pilot program by March 2, 2016. timeliness. SUMMARY: The Food and Drug
We plan to conduct user testing Administration (FDA) is announcing the
II. Pilot Program Participation following public workshop entitled
beginning on or about March 18, 2016.
See section III of this document for The pilot program to evaluate the CTP ‘‘Point of Care Prothrombin Time/
information on applications for Portal is to last approximately 3 months. International Normalized Ratio Devices
participation. During the pilot program, CTP staff will for Monitoring Warfarin Therapy.’’ The
be available to answer any questions or purpose of this workshop is to discuss
ADDRESSES: If you are interested in concerns that may arise. Pilot program and receive input from stakeholders
participating in this pilot program, participants will receive training and regarding approaches to the analytical
please submit an electronic application will be asked to submit regulatory and clinical validation of point of care
to CTPeSub@fda.hhs.gov. submissions using data provided to (POC) Prothrombin Time/International
FOR FURTHER INFORMATION CONTACT: Ann them by CTP for testing purposes. Pilot Normalized Ratio (PT/INR) in vitro
Staten, Center for Tobacco Products, program participants also will be asked diagnostic devices for improved clinical
Food and Drug Administration, 10903 to provide written and verbal feedback management of warfarin therapy in
New Hampshire Ave., Bldg. 75, Rm. during their training and after their addition to describing the FDA’s process
G402, Silver Spring, MD 20993–0002, participation in the pilot program is for facilitating the development of safe
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ann.staten@fda.hhs.gov. over. These comments and discussions and effective POC and patient self-
SUPPLEMENTARY INFORMATION: will assist CTP in its development of the testing PT/INR devices. The goal of the
CTP Portal. CTP estimates that each workshop is to seek and identify
I. Background individual participant’s involvement potential solutions to address the
The Family Smoking Prevention and should take about 15 hours. scientific and regulatory challenges
Tobacco Control Act of 2009 (Tobacco CTP is soliciting applications from associated with POC PT/INR devices to
Control Act) (Pub. L. 111–31) grants regulated tobacco product ensure safety and effectiveness. The
FDA important authority to regulate the manufacturers and, in particular, is public workshop on ‘‘Point of Care

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Document Created: 2016-02-17 01:16:22
Document Modified: 2016-02-17 01:16:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop; request for comments.
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.
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]
FR Citation		81 FR 8079

81 FR 8079 - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 31 (February 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration