[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1426-1428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4990]


Next Generation Sequencing-Based Oncology Panels; 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 a public 
workshop entitled ``Next Generation Sequencing-Based Oncology Panels.'' 
The purpose of this workshop is to obtain feedback on analytical and 
clinical validation approaches for next generation sequencing (NGS)-
based oncology panels. Comments and suggestions generated through this 
workshop will help guide the development of appropriate regulatory 
standards for evaluation of NGS-based oncology panels in cancer patient 
management.

DATES: The public workshop will be held on February 25, 2016, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on the 
public workshop by March 28, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (the Great Room), 
Silver Spring, MD 20993. Entrance for the public workshop 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.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-4990 for ``Next Generation Sequencing-Based Oncology 
Panels.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in

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its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jennifer Dickey, Center for Devices 
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 
5648, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5028, 
[email protected].

I. Background

    A number of oncology therapeutic products have been approved with 
corresponding companion diagnostics (Ref. 1). To date, approved 
companion diagnostic assays assess a single analyte or prespecified 
mutations associated with therapeutic response; however, NGS technology 
can interrogate a patient's tumor specimen for numerous biomarkers 
concurrently, introducing challenges to the current companion 
diagnostic paradigm. Additionally, NGS tumor panels are increasingly 
employed for use in similar oncology applications because the 
technology can be used to screen a cancer patient's specimen for many 
relevant mutations simultaneously.
    FDA is holding this public workshop to solicit input from external 
stakeholders on approaches to establish performance characteristics of 
NGS-based oncology panels that include variants that are intended to be 
used as companion diagnostics, as well as other variants that may be 
used for alternative therapeutic management of patients who have 
already been considered for all appropriate therapies. The Agency is 
requesting public input on strategies for establishing performance 
characteristics for NGS-based oncology panels for rare variants across 
tumor types, follow-on companion diagnostic claims, and post-approval 
assay modifications. Further details to be considered and discussed at 
the workshop will be outlined in a discussion paper that will be posted 
publicly and available prior to the workshop at the following site: 
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

    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 speakers and additional 
panelists will be asked to provide their individual perspectives. The 
presentations and discussions will focus on several topics, including a 
description of a hypothetical NGS-based oncology panel test and its 
general intended use; considerations for pre-analytical and quality 
metric approaches; challenges in analytical validation and the 
potential for development of a flexible approach for post-approval 
assay modifications; and the framework for clinical and follow-on 
companion diagnostic claims. In advance of the meeting, FDA plans to 
post a discussion paper outlining FDA's current thinking for NGS-based 
oncology panels and the issues for discussion 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 February 2, 
2016, although comments related to this document can be submitted until 
March 28, 2016. A detailed agenda will be posted on this Web site in 
advance of the workshop.
    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 February 17, 2016. 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, Center for Devices and Radiological Health, 
Office of Communication and Education, phone 301-796-5661, email: 
mailto:[email protected] no later than 4 p.m. on February 11, 
2016.
    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 meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, email, and telephone number. Those 
without Internet access should contact Susan Monahan to register (see 
special accommodations contact). 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. The Webcast link will be available on the registration 
Web page after February 17, 2016. Please visit FDA's Medical Devices 
News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select 
this meeting/public workshop from the posted events list.) 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

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subsequent discussion paper (see SUPPLEMENTARY INFORMATION). FDA will 
do its best to accommodate requests to make public comment. 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 February 2, 2016. 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 February 8, 2016. If selected for presentation, any 
presentation materials must be emailed to Jennifer Dickey (see FOR 
FURTHER INFORMATION CONTACT) no later than February 16, 2016, at 4 p.m. 
No commercial promotional material will be permitted to be presented or 
distributed at this public workshop.
    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 ADDRESSES). 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.)

III. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.
    1. Please refer to FDA's Web site on companion diagnostics, 
available at http://www.fda.gov/companiondiagnostics.

    Dated: January 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00328 Filed 1-11-16; 8:45 am]
BILLING CODE 4164-01-P