Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments, 54292-54293 [2015-22676]
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54292
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
driver of modern healthcare. As part of
the White House’s Precision Medicine
Initiative, FDA is exploring a novel
approach for NGS test regulation that
includes leveraging well-curated
databases of genetic variation to provide
evidence about the clinical relevance of
test results. To open this discussion,
FDA drafted a discussion paper and
held an open public workshop titled
‘‘Optimizing FDA’s Regulatory
Oversight of Next Generation
Sequencing Diagnostic Tests’’ in
February 2015 to discuss and receive
feedback from the community on
possible regulatory approaches to NGSbased diagnostic tests. (Workshop
material, including the discussion
paper, can be accessed at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm427296.htm.) The workshop
announced in this document seeks to
build on the feedback FDA received at
the public workshop in February 2015.
The Agency is therefore requesting
public input on strategies for the
regulatory use of databases for NGS tests
that produce results on variation in the
human genome.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
brief presentations that will frame the
goals of the workshop and interactive
discussions of key topics with several
panel sessions. Following the
presentations and panel discussions,
there will be a moderated discussion
where participants will be asked to
provide their individual perspectives.
The workshop discussion will focus on
the development, operation (including
curation), and use of databases of
genetic variants.
In advance of the meeting, FDA plans
to post a discussion paper outlining
FDA’s most current thinking about the
possible uses of databases of genetic
variants for NGS test regulation and a
summary of the issues FDA believes
need consideration at the workshop at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
FDA will place the discussion paper on
file in the public docket (docket number
found in brackets in the heading of this
document) and will post it at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. The deadline for
submitting comments on this document
for presentation at the public workshop
is October 26, 2015, although comments
related to this document can be
submitted until November 25, 2015. A
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
detailed agenda will be posted on this
Web site in advance of the workshop.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22675 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2881]
Standards-Based Approach to
Analytical Performance Evaluation of
Next Generation Sequencing in Vitro
Diagnostic Tests; 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
‘‘Standards-Based Approach to
Analytical Performance Evaluation of
Next Generation Sequencing In Vitro
Diagnostic Tests’’. The purpose of this
workshop is to obtain feedback on
possible analytical standards and
approaches to develop or build on
existing standardization efforts in order
to optimize FDA’s regulatory approach
to next generation sequencing (NGS)based in vitro diagnostic tests.
Comments and suggestions generated
through this workshop will also guide
the use of regulatory science to advance
the development of appropriate and
relevant performance standards for
evaluation of NGS in vitro diagnostic
tests that produce results on variation in
the human genome.
DATES: Date and Time: The public
workshop will be held on November 12,
2015, from 8 a.m. to 5 p.m.
ADDRESSES: Location: The public
workshop will be held at the FDA 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Contact Person: Zivana Tezak, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
4544, Silver Spring, MD 20993, 301–
796–6206, zivana.tezak@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. on October 30, 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
7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, 301–796–5661,
susan.monahan@fda.hhs.gov, no later
than 4 p.m. on October 29, 2015.
To register for the public workshop,
please visit FDA’s Medical Devices
News, Events, Workshops and
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 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. Persons interested in
viewing the Webcast must register
online by October 30, 2015, at 4 p.m.
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 November 3,
2015. If you have never attended a
Connect Pro event before, test your
connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
E:\FR\FM\09SEN1.SGM
09SEN1
Lhorne on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Requests for Oral Presentations: This
public workshop includes a public
comment session. During online
registration you may indicate if you
wish to present during a public
comment session, and which topics you
wish to address. FDA has included
general topics in this document which
will be addressed in greater detail in a
subsequent discussion paper (see
SUPPLEMENTARY INFORMATION). FDA will
do its best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. All requests to
make oral presentations must be
received by October 26, 2015. FDA will
determine the amount of time allotted to
each presenter and the approximate
time each oral presentation is to begin,
and will select and notify participants
by October 30, 2015. If selected for
presentation, any presentation materials
ˇ
must be emailed to Zivana Tezak (see
Contact Person) no later than November
5, 2015, at 5 p.m. No commercial or
promotional material will be permitted
to be presented or distributed at the
public workshop.
Comments: FDA is holding this public
workshop to obtain feedback on
possible analytical standards and
approaches to develop or build on
existing standardization efforts in order
to optimize FDA’s regulatory approach
to NGS-based in vitro diagnostic tests.
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 this
public workshop is November 25, 2015,
at 4 p.m.
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 topics as
described in section II of this document,
please identify the topic 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
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
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. 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
In vitro diagnostic devices, including
laboratory-developed tests, that utilize
NGS technology to generate information
on an individual’s genome are rapidly
transforming healthcare. As part of the
White House’s Precision Medicine
Initiative, FDA envisions implementing
a novel framework for NGS test
regulation that includes developing
sufficiently flexible assay performance
standards that can accommodate
innovation, including test
modifications, while assuring NGS test
safety and effectiveness. To start this
discussion, FDA drafted a discussion
paper and held an open public
workshop titled ‘‘Optimizing FDA’s
Regulatory Oversight of Next Generation
Sequencing Diagnostic Tests’’ in
February 2015 to discuss and receive
feedback from the community on
possible regulatory approaches to NGSbased diagnostic tests. Workshop
material including the discussion paper
can be accessed at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/
ucm427296.htm. The workshop
announced in this document seeks to
build on the feedback FDA received at
the public workshop in February 2015,
with a goal to assess standard needs,
propose performance standard content,
and help in the development of the
standards necessary for this effort. The
Agency is therefore requesting public
input on the proposed standards-based
regulatory strategy for NGS tests that
produce results on variation in the
human genome.
PO 00000
Frm 00035
Fmt 4703
Sfmt 9990
54293
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
brief presentations to provide
information to frame the goals of the
workshop and interactive discussions
via several panel sessions. Following
the presentations, there will be a
moderated discussion where
participants and additional panelists
will be asked to provide their individual
perspectives. The workshop discussion
will focus on standards-based regulatory
strategies to assure the analytical
validity of NGS tests that produce
results on variation in the human
genome.
The presentations and discussions
will focus on several topics, including
an example of a possible performance
standard (methods) focusing on a single
intended use; a general framework and
architecture for standard needs,
including currently existing guidelines
and standards to be developed; and
possible different approaches.
In advance of the meeting, FDA plans
to post a white paper outlining FDA’s
most current thinking for a standardsbased approach to analytical
performance evaluation of NGS
diagnostic tests and a summary of the
issues FDA believes need consideration
at the workshop at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.) FDA will place the
discussion paper on file in the public
docket (docket number found in
brackets in the heading of this
document) and will post it at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. The deadline for
submitting comments on this document
for presentation at the public workshop
is October 26, 2015, although comments
related to this document can be
submitted until November 25, 2015. A
detailed agenda will be posted on this
Web site in advance of the workshop.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22676 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54292-54293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22676]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2881]
Standards-Based Approach to Analytical Performance Evaluation of
Next Generation Sequencing in Vitro Diagnostic Tests; 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 ``Standards-Based Approach to
Analytical Performance Evaluation of Next Generation Sequencing In
Vitro Diagnostic Tests''. The purpose of this workshop is to obtain
feedback on possible analytical standards and approaches to develop or
build on existing standardization efforts in order to optimize FDA's
regulatory approach to next generation sequencing (NGS)-based in vitro
diagnostic tests. Comments and suggestions generated through this
workshop will also guide the use of regulatory science to advance the
development of appropriate and relevant performance standards for
evaluation of NGS in vitro diagnostic tests that produce results on
variation in the human genome.
DATES: Date and Time: The public workshop will be held on November 12,
2015, from 8 a.m. to 5 p.m.
ADDRESSES: Location: The public workshop will be held at the FDA 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.
FOR FURTHER INFORMATION CONTACT:
Contact Person: Zivana Tezak, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 4544, Silver Spring, MD 20993, 301-796-6206,
zivana.tezak@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. on October 30, 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 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, 301-796-5661, susan.monahan@fda.hhs.gov, no
later than 4 p.m. on October 29, 2015.
To register for the public workshop, please visit FDA's Medical
Devices News, Events, Workshops and 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 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. Persons interested in viewing the Webcast must
register online by October 30, 2015, at 4 p.m. 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 November 3, 2015. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in
this document, but FDA is not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.)
[[Page 54293]]
Requests for Oral Presentations: This public workshop includes a
public comment session. During online registration you may indicate if
you wish to present during a public comment session, and which topics
you wish to address. FDA has included general topics in this document
which will be addressed in greater detail in a subsequent discussion
paper (see SUPPLEMENTARY INFORMATION). FDA will do its best to
accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. All requests to make oral
presentations must be received by October 26, 2015. FDA will determine
the amount of time allotted to each presenter and the approximate time
each oral presentation is to begin, and will select and notify
participants by October 30, 2015. If selected for presentation, any
presentation materials must be emailed to [Zcaron]ivana Tezak (see
Contact Person) no later than November 5, 2015, at 5 p.m. No commercial
or promotional material will be permitted to be presented or
distributed at the public workshop.
Comments: FDA is holding this public workshop to obtain feedback on
possible analytical standards and approaches to develop or build on
existing standardization efforts in order to optimize FDA's regulatory
approach to NGS-based in vitro diagnostic tests. 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 this
public workshop is November 25, 2015, at 4 p.m.
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
topics as described in section II of this document, please identify the
topic 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. 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
In vitro diagnostic devices, including laboratory-developed tests,
that utilize NGS technology to generate information on an individual's
genome are rapidly transforming healthcare. As part of the White
House's Precision Medicine Initiative, FDA envisions implementing a
novel framework for NGS test regulation that includes developing
sufficiently flexible assay performance standards that can accommodate
innovation, including test modifications, while assuring NGS test
safety and effectiveness. To start this discussion, FDA drafted a
discussion paper and held an open public workshop titled ``Optimizing
FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic
Tests'' in February 2015 to discuss and receive feedback from the
community on possible regulatory approaches to NGS-based diagnostic
tests. Workshop material including the discussion paper can be accessed
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm427296.htm. The workshop announced in this document seeks to build
on the feedback FDA received at the public workshop in February 2015,
with a goal to assess standard needs, propose performance standard
content, and help in the development of the standards necessary for
this effort. The Agency is therefore requesting public input on the
proposed standards-based regulatory strategy for NGS tests that produce
results on variation in the human genome.
II. Topics for Discussion at the Public Workshop
This public workshop will consist of brief presentations to provide
information to frame the goals of the workshop and interactive
discussions via several panel sessions. Following the presentations,
there will be a moderated discussion where participants and additional
panelists will be asked to provide their individual perspectives. The
workshop discussion will focus on standards-based regulatory strategies
to assure the analytical validity of NGS tests that produce results on
variation in the human genome.
The presentations and discussions will focus on several topics,
including an example of a possible performance standard (methods)
focusing on a single intended use; a general framework and architecture
for standard needs, including currently existing guidelines and
standards to be developed; and possible different approaches.
In advance of the meeting, FDA plans to post a white paper
outlining FDA's most current thinking for a standards-based approach to
analytical performance evaluation of NGS diagnostic tests and a summary
of the issues FDA believes need consideration at the workshop at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
FDA will place the discussion paper on file in the public docket
(docket number found in brackets in the heading of this document) and
will post it at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments
on this document for presentation at the public workshop is October 26,
2015, although comments related to this document can be submitted until
November 25, 2015. A detailed agenda will be posted on this Web site in
advance of the workshop.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22676 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P