[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]
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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.
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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 http://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,
[email protected].
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, [email protected], 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 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 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 http://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 http://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 http://www.regulations.gov.
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 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 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.)
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 http://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 http://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 http://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