Document ID: FDA-2015-N-3015-0001
Agency: fda
Document Type: Notice
Title: Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments
Posted Date: 2015-09-09T04:00Z

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54290-54292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22675]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3015]

Use of Databases for Establishing the Clinical Relevance of Human 
Genetic Variants; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

[[Page 54291]]

    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Use of Databases for Establishing the 
Clinical Relevance of Human Genetic Variants.'' The purpose of this 
workshop is to obtain feedback on ways in which FDA can use curated 
databases containing information about human genetic variation as 
sources of valid clinical evidence for the Agency's oversight of the 
next-generation sequencing (NGS)-based in vitro diagnostic tests 
(IVDs). Comments and suggestions generated through this workshop will 
guide the development of best practices and regulatory standards for 
reliance on external curated databases.
    Date and Time: The public workshop will be held on November 13, 
2015, from 8 a.m.to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Rm. 
1503 (the Great Room), Silver Spring, MD 20993. 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.
    Contact Person: David Litwack, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 4548, Silver Spring, MD 20993, 301-796-6697, email: 
ernest.litwack@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 permit, 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: 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 & 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.)
    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 David Litwack (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 
how it may use databases that contain information linking human genetic 
variations to disease, where such information has been curated by 
qualified professionals, to inform regulatory oversight of the clinical 
performance of genetic tests. Specifically, the information gained from 
the workshop will be used to optimize FDA's regulatory approach for 
NGS-based IVDs. 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. 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

    IVDs, including laboratory-developed tests that utilize NGS 
technology to reveal information about an individual's genome, are 
rapidly becoming a major

[[Page 54292]]

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 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. 
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 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. 2015-22675 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P