In Vitro Diagnostic Testing for Direct Oral Anticoagulants; Public Workshop; Request for Comments, 51823-51824 [2015-21095]
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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Docket No. (FDA–
2015–D–2537) for this notice of draft
guidance availability and public
meeting. All comments received may be
posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
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.
FOR FURTHER INFORMATION CONTACT:
Lesley DeRenzo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5161,
Silver Spring, MD 20993–0002, 240–
402–4612.
SUPPLEMENTARY INFORMATION:
I. Background
rmajette on DSK7SPTVN1PROD with NOTICES
In the Federal Register of July 28,
2015, and August 7, 2015, FDA
published a notice of draft guidance
availability and public meeting with a
60-day comment period and requested
comments on a number of specific
questions identified throughout the
document. Comments on the notice of
draft guidance availability and public
meeting will inform FDA’s development
and planned implementation of a
quality metrics program launched under
the authority of the Federal Food, Drug,
and Cosmetic Act.
FDA is extending the comment period
for an additional 60 days, until
November 27, 2015. The Agency
believes that an additional 60-day
extension of the comment period for the
notice of draft guidance availability and
public meeting will allow adequate time
for interested persons to submit
comments without significantly
delaying Agency decisionmaking on
these important issues.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES).
You should annotate and organize your
VerDate Sep<11>2014
14:29 Aug 25, 2015
Jkt 235001
comments to identify the specific
questions or topic to which they refer.
It is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21149 Filed 8–25–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2919]
In Vitro Diagnostic Testing for Direct
Oral Anticoagulants; 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 a public workshop
entitled ‘‘In Vitro Diagnostic Testing for
Direct Oral Anticoagulants’’. The
objective of the workshop is to gain
public input and to discuss analytical
performance requirements for the
diagnostic assessment of direct oral
anticoagulants (DOACs) and the clinical
circumstances under which patients
receiving these agents would require
testing. Specifically, this workshop aims
to do the following: (1) Evaluate the
impact of DOACs on traditional
coagulation testing results; (2) identify
clinical circumstances where testing of
DOACs anticoagulant activity or
concentration would be relevant; (3)
discuss clinically meaningful
interpretation of coagulation testing
results for patients on DOACs; and (4)
review the regulatory requirements for
granting clearance for in vitro diagnostic
devices intended for coagulation testing
in patients treated with DOACs.
Date and Time: The public workshop
will be held on October 26, 2015, from
9 a.m. to 5 p.m.
Location: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
51823
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.
Contact Person: Claudia Dollins,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66
Rm. 5262, Silver Spring, MD 20993–
0002, 301–796–4807, Claudia.Dollins@
fda.hhs.gov.
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., October 16, 2015.
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
8 a.m.
Contact for Special Accommodations:
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, susan.monahan@fda.hhs.gov
no later than October 9, 2015.
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, email, and
telephone number. Those without
Internet access should contact Susan
Monahan to register (see Contact for
Special Accommodations). 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. Persons interested in
viewing the Webcast must register
online by October 16, 2015. Early
registration is recommended because
Webcast connections are limited.
Organizations are requested to register
all participants, but to view using one
connection per location. Webcast
participants will be sent technical
system requirements after registration
and will be sent connection access
information after October 20, 2015. If
you have never attended a Connect Pro
E:\FR\FM\26AUN1.SGM
26AUN1
rmajette on DSK7SPTVN1PROD with NOTICES
51824
Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
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, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register).
Comments: FDA is holding this public
workshop to obtain information on in
vitro diagnostic testing for direct oral
anticoagulants. In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
on all aspects of the public workshop
topics. The deadline for submitting
comments related to the public
workshop is November 25, 2015.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. In addition,
when responding to specific questions
as outlined in section II of this
document, please identify the question
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
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 Comments). 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).
SUPPLEMENTARY INFORMATION:
I. Background
Coagulation is the process of forming
a clot to stop bleeding. Blood clotting is
initiated by injury to a blood vessel
VerDate Sep<11>2014
14:29 Aug 25, 2015
Jkt 235001
resulting in the exposure of various
proteins on the inner surface of the
vessels. These proteins trigger the serial
activation of coagulation factors that
make up the coagulation cascade that
culminates in the formation of the
insoluble clot.
Although immediate clot formation is
critical to prevent severe blood loss,
excessive clot formation outside of
wound healing obstructs blood flow and
poses serious medical consequences. To
prevent unwanted coagulation, a
number of anticoagulant drugs have
been developed. Historically,
anticoagulation drug therapy was
limited to the administration of nonspecific anticoagulants, such as heparin
or vitamin K antagonists, that act by
inhibiting the coagulation cascade at
several points. Although effective, these
anticoagulants have numerous
drawbacks, such as delayed onset and
offset of action, a narrow therapeutic
window, and interactions with food and
drugs that necessitate frequent
monitoring and dose adjustments.
Several tests have been cleared for
monitoring of patients undergoing
vitamin K antagonist therapy.
A new class of DOACs has been
developed in the last decade to
overcome limitations of traditional
anticoagulants. Thus far, FDA has
approved four DOACs: PRAXADA
(dabigatran), XARELTO (rivaroxiban),
ELIQUIS (apixaban), and SAVAYSA
(edoxaban). DOAC therapy creates a
need for coagulation testing, which in
turn poses new challenges.
Currently there are no FDA cleared
devices for the characterization of
DOAC effects on coagulation.
Differences in individual responses to
the drugs require laboratories to develop
unique testing schemes to assess a
patient’s coagulation status while on
DOAC regimens. Thus, the first aim of
this workshop is to discuss the effect of
DOACs on traditional coagulation test
methods currently on the market and
the impact these effects may have on
patient management.
We will also examine clinical
scenarios that would warrant DOAC
testing. Instructions for coagulation
monitoring as required for vitamin K
antagonists are not specified in DOAC’s
instructions for use. However, in certain
clinical settings assessment of DOACinduced anticoagulation may be
advantageous. The second aim of the
workshop will focus on medical
conditions that require coagulation
testing of patients taking DOACs.
There are a limited number of
strategies to assess coagulation in
patients taking DOACs. We will review
options for quantitative and qualitative
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
determination of the drug effects and
discuss problems related to
interpretation of results. Also, we will
consider the corresponding analytical
performance criteria of DOAC testing
required to provide reliable and
informative test results.
Thus, the Center for Devices and
Radiological Health plans to provide an
overview of the scientific, clinical, and
regulatory challenges that need to be
addressed to ultimately support the
development of in vitro testing for
patients on DOAC regimens that would
translate into clinically meaningful
results.
II. Topics for Discussion at the Public
Workshop
The public workshop seeks to involve
industry and academia in addressing
analytical performance requirements for
the diagnostic assessment of DOACs.
Furthermore, the workshop aims to
focus on the clinical circumstances
under which patients receiving these
agents would require testing, including
but not limited to, the following topic
areas:
1. Overview of the effects of DOACs
on traditional coagulation tests;
2. identification of clinical scenarios
that necessitate DOAC testing;
3. interpretation of coagulation testing
results for patients on DOACs; and
4. considerations for regulatory
review of devices assessing the effect of
DOACs on coagulation.
Dated: August 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21095 Filed 8–25–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Meeting on American Indian/Alaska
Native Lesbian, Gay, Bisexual, and
Transgender Health Issues
Indian Health Service.
Notice of meeting.
AGENCY:
ACTION:
The Indian Health Service
(IHS) is continuing to seek broad public
input as it continues efforts to advance
and promote the health needs of the
American Indian/Alaska Native (AI/AN)
Lesbian, Gay, Bisexual, and Transgender
(LGBT) community.
DATES: The meeting will be held as
shown below:
1. September 11, 2015 from 12:00
p.m. EST to 2:00 p.m. EST.
ADDRESSES: The meeting location is:
SUMMARY:
E:\FR\FM\26AUN1.SGM
26AUN1
Agencies
[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51823-51824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2919]
In Vitro Diagnostic Testing for Direct Oral Anticoagulants;
Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``In Vitro Diagnostic Testing for Direct Oral
Anticoagulants''. The objective of the workshop is to gain public input
and to discuss analytical performance requirements for the diagnostic
assessment of direct oral anticoagulants (DOACs) and the clinical
circumstances under which patients receiving these agents would require
testing. Specifically, this workshop aims to do the following: (1)
Evaluate the impact of DOACs on traditional coagulation testing
results; (2) identify clinical circumstances where testing of DOACs
anticoagulant activity or concentration would be relevant; (3) discuss
clinically meaningful interpretation of coagulation testing results for
patients on DOACs; and (4) review the regulatory requirements for
granting clearance for in vitro diagnostic devices intended for
coagulation testing in patients treated with DOACs.
Date and Time: The public workshop will be held on October 26,
2015, from 9 a.m. to 5 p.m.
Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503), 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.
Contact Person: Claudia Dollins, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66 Rm. 5262, Silver Spring, MD 20993-0002, 301-796-4807,
Claudia.Dollins@fda.hhs.gov.
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., October 16, 2015. 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 8 a.m.
Contact for Special Accommodations: 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, susan.monahan@fda.hhs.gov no later than
October 9, 2015.
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, email, and telephone number. Those without Internet
access should contact Susan Monahan to register (see Contact for
Special Accommodations). 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. Persons interested in viewing the Webcast must
register online by October 16, 2015. Early registration is recommended
because Webcast connections are limited. Organizations are requested to
register all participants, but to view using one connection per
location. Webcast participants will be sent technical system
requirements after registration and will be sent connection access
information after October 20, 2015. If you have never attended a
Connect Pro
[[Page 51824]]
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, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register).
Comments: FDA is holding this public workshop to obtain information
on in vitro diagnostic testing for direct oral anticoagulants. In order
to permit the widest possible opportunity to obtain public comment, FDA
is soliciting either electronic or written comments on all aspects of
the public workshop topics. The deadline for submitting comments
related to the public workshop is November 25, 2015.
Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question you are addressing. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
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 Comments). 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).
SUPPLEMENTARY INFORMATION:
I. Background
Coagulation is the process of forming a clot to stop bleeding.
Blood clotting is initiated by injury to a blood vessel resulting in
the exposure of various proteins on the inner surface of the vessels.
These proteins trigger the serial activation of coagulation factors
that make up the coagulation cascade that culminates in the formation
of the insoluble clot.
Although immediate clot formation is critical to prevent severe
blood loss, excessive clot formation outside of wound healing obstructs
blood flow and poses serious medical consequences. To prevent unwanted
coagulation, a number of anticoagulant drugs have been developed.
Historically, anticoagulation drug therapy was limited to the
administration of non-specific anticoagulants, such as heparin or
vitamin K antagonists, that act by inhibiting the coagulation cascade
at several points. Although effective, these anticoagulants have
numerous drawbacks, such as delayed onset and offset of action, a
narrow therapeutic window, and interactions with food and drugs that
necessitate frequent monitoring and dose adjustments. Several tests
have been cleared for monitoring of patients undergoing vitamin K
antagonist therapy.
A new class of DOACs has been developed in the last decade to
overcome limitations of traditional anticoagulants. Thus far, FDA has
approved four DOACs: PRAXADA (dabigatran), XARELTO (rivaroxiban),
ELIQUIS (apixaban), and SAVAYSA (edoxaban). DOAC therapy creates a need
for coagulation testing, which in turn poses new challenges.
Currently there are no FDA cleared devices for the characterization
of DOAC effects on coagulation. Differences in individual responses to
the drugs require laboratories to develop unique testing schemes to
assess a patient's coagulation status while on DOAC regimens. Thus, the
first aim of this workshop is to discuss the effect of DOACs on
traditional coagulation test methods currently on the market and the
impact these effects may have on patient management.
We will also examine clinical scenarios that would warrant DOAC
testing. Instructions for coagulation monitoring as required for
vitamin K antagonists are not specified in DOAC's instructions for use.
However, in certain clinical settings assessment of DOAC-induced
anticoagulation may be advantageous. The second aim of the workshop
will focus on medical conditions that require coagulation testing of
patients taking DOACs.
There are a limited number of strategies to assess coagulation in
patients taking DOACs. We will review options for quantitative and
qualitative determination of the drug effects and discuss problems
related to interpretation of results. Also, we will consider the
corresponding analytical performance criteria of DOAC testing required
to provide reliable and informative test results.
Thus, the Center for Devices and Radiological Health plans to
provide an overview of the scientific, clinical, and regulatory
challenges that need to be addressed to ultimately support the
development of in vitro testing for patients on DOAC regimens that
would translate into clinically meaningful results.
II. Topics for Discussion at the Public Workshop
The public workshop seeks to involve industry and academia in
addressing analytical performance requirements for the diagnostic
assessment of DOACs. Furthermore, the workshop aims to focus on the
clinical circumstances under which patients receiving these agents
would require testing, including but not limited to, the following
topic areas:
1. Overview of the effects of DOACs on traditional coagulation
tests;
2. identification of clinical scenarios that necessitate DOAC
testing;
3. interpretation of coagulation testing results for patients on
DOACs; and
4. considerations for regulatory review of devices assessing the
effect of DOACs on coagulation.
Dated: August 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21095 Filed 8-25-15; 8:45 am]
BILLING CODE 4164-01-P