[Federal Register Volume 79, Number 248 (Monday, December 29, 2014)]
[Notices]
[Pages 78092-78093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2214]


Next Generation Sequencing 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 ``Optimizing FDA's Regulatory 
Oversight of Next Generation Sequencing Diagnostic Tests.'' The purpose 
of this workshop is to discuss and receive feedback from the community 
on the questions in the discussion paper on diagnostic tests for human 
genetics or genomics using next generation sequencing (NGS) technology.

DATES:  The public workshop will be held on February 20, 2015, from 
8:30 a.m. to 5 p.m.

ADDRESSES:  The public workshop will be held at the Natcher Center at 
the National Institutes of Health Campus, 9000 Rockville Pike, Bldg. 45 
Auditorium, Bethesda, MD 20814. For parking and security information, 
please refer to http://www.nih.gov/about/visitor/.

FOR FURTHER INFORMATION CONTACT:  David Litwack, Office of In Vitro 
Diagnostics and Radiological Health, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5544, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6697, email: 
[email protected].

SUPPLEMENTARY INFORMATION:
    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. February 12, 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 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661, email: [email protected] 
no later than February 6, 2015.
    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. If you are 
unable to register online, please contact Susan Monahan (see 
Registration.) 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 February 12, 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 February 13, 2015. If you have never attended a 
Connect Pro

[[Page 78093]]

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.)
    Comments: FDA is holding this public workshop to obtain feedback 
from the community on the questions in the discussion paper. 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 March 20, 2015.
    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 
questions as outlined in section II, 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 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. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. 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).

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. Because NGS tests generate 
large amounts of data and consequently may have relatively broad or 
undefined intended uses or indications, these tests pose certain 
challenges during review of premarket submissions. At the same time, 
this large amount of data provides opportunities for novel approaches 
to assure the analytical and clinical validity of NGS tests. FDA is 
committed to providing efficient and effective oversight for NGS tests 
to assure their safety and effectiveness. By doing so, FDA will promote 
innovation and advance precision medicine. The Agency is therefore 
requesting public input on the regulatory strategy for NGS tests that 
produce results on variation in the human genome. Further details of 
current and new approaches that may be considered in the workshop are 
outlined in the discussion paper entitled ``Optimizing FDA's Regulatory 
Oversight of Next Generation Sequencing Diagnostic Tests'' available at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

II. Topics for Discussion at the Public Workshop

    The workshop discussion will focus on regulatory strategies to 
assure the analytical and clinical validity of NGS tests. Specific 
topics to be discussed at the workshop are outlined in the discussion 
paper entitled ``Optimizing FDA's Regulatory Oversight of Next 
Generation Sequencing Diagnostic Tests'' available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list). A detailed 
agenda will be posted on this Web site in advance of the workshop.

    Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30308 Filed 12-22-14; 4:15 pm]
BILLING CODE 4164-01-P