Document ID: FDA-2015-N-2881-0001
Agency: fda
Document Type: Notice
Title: Standards-Based Approach to Analytical Performance Evaluation of
Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop;
Request for Comments
Posted Date: 2015-09-09T04:00Z

[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, 
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 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