[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56656-56658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2473]


Adapting Regulatory Oversight of Next Generation Sequencing-Based 
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 ``Adapting Regulatory Oversight of 
Next Generation Sequencing-Based Tests.'' The purpose of this workshop 
is to obtain feedback on two FDA draft guidances, ``Use of Standards in 
FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In 
Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases'' and 
``Use of Public Human Genetic Variant Databases to Support Clinical 
Validity for Next Generation Sequencing (NGS)-Based In Vitro 
Diagnostics'' that describes new approaches to regulate NGS-based 
tests.

DATES: The public workshop will be held on September 23, 2016, from 9 
a.m.to 3 p.m. Submit either electronic or written comments on the 
public workshop by October 6, 2016.

ADDRESSES: The workshop will be held in Masur Auditorium at the NIH 
Campus, 9000 Rockville Pike, Bldg. 10, Bethesda, MD 20814. For parking 
and security information, please refer to the NIH Campus Visitor 
Information: http://www.nih.gov/icd/od/ocpl/VIC/index.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-2016-N-2473 for ``Adapting Regulatory Oversight of Next Generation 
Sequencing-Based Tests.'' 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 
its consideration of comments. The

[[Page 56657]]

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: David Litwack, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301-796-6206, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In Vitro diagnostic devices that utilize NGS technology to generate 
information on an individual's genome are rapidly transforming 
healthcare. As part of the Precision Medicine Initiative,\1\ FDA is 
developing and implementing a novel framework for NGS test regulation 
that can accelerate innovation while assuring NGS-based test safety and 
effectiveness. To advance this effort, FDA published two draft 
guidances on July 8, 2016. The first, entitled ``Use of Public Human 
Genetic Variant Databases to Support Clinical Validity for Next 
Generation Sequencing (NGS)-Based In Vitro Diagnostics'', describes how 
publicly accessible databases of human genetic variants can serve as 
sources of valid scientific evidence to support the clinical validity 
of genotype-phenotype relationships in FDA's regulatory review of NGS-
based tests. This draft guidance further outlines the process by which 
administrators of genetic variant databases could voluntarily apply to 
FDA for recognition, and how FDA would review such applications and 
periodically reevaluate recognized databases.
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    \1\ The Precision Medicine Initiative found on the White House's 
Web site at: https://www.whitehouse.gov/precision-medicine.
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    The second draft guidance document, entitled ``Use of Standards in 
the Food and Drug Administration's Regulatory Oversight of Next 
Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing 
Germline Diseases'', addresses DNA sequencing and whole exome 
sequencing NGS-based tests intended to aid in the diagnosis of 
individuals with suspected germline diseases or other conditions. This 
document provides recommendations for designing, developing, and 
validating NGS-based tests for germline diseases, and also discusses 
possible use of FDA-recognized standards for regulatory oversight of 
these tests. These recommendations are based on FDA's understanding of 
the tools and processes needed to run an NGS-based test along with the 
design and analytical validation considerations appropriate for such 
tests.
    Neither draft guidance is final nor in effect at this time. The 
workshop announced in this document seeks to obtain public input on the 
proposals contained in the two draft guidances. Workshop material, 
including the draft guidances, can be accessed from the workshop Web 
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 presentations that will frame 
the goals of the workshop followed by moderated discussions via panel 
sessions. The presentations and discussions will focus on the content 
of the draft guidances, as well as on additional questions that were 
posed in the Notices of Availability published in the Federal Register 
on July 8, 2016. These notices can be found at https://federalregister.gov/a/2016-1233 and https://federalregister.gov/a/2016-1270.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by September 13, 2016, at 4 p.m. 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 8 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661, [email protected], no 
later than September 12, 2016.
    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 David Litwack to register (see FOR 
FURTHER INFORMATION 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 site after September 13, 2016. To view the registration Web site, 
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. FDA has verified the Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.
    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. In addition to the subjects discussed in the two 
draft guidances, FDA has posed supplemental topics in the Notices of 
Availability for the draft guidances (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 comments, and request time for joint 
comments, or submit requests for designated representatives to 
participate in the focused sessions. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin,

[[Page 56658]]

and will select and notify participants by September 14, 2016. All 
requests to make oral presentations must be received by September 13, 
2016. If selected for presentation, any presentation materials must be 
emailed to David Litwack (see FOR FURTHER INFORMATION CONTACT) no later 
than September 16, 2016, at 5 p.m. No commercial or promotional 
material will be permitted to be presented or distributed at the public 
workshop.
    FDA is holding this public workshop to obtain feedback on its 
recently released draft guidance documents: ``Use of Public Human 
Genetic Variant Databases to Support Clinical Validity for Next 
Generation Sequencing-Based In Vitro Diagnostics'' and ``Use of 
Standards in the Food and Drug Administration's Regulatory Oversight of 
Next Generation Sequencing-Based In Vitro Diagnostics Used for 
Diagnosing Germline Diseases''. 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 October 6, 2016.
    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. 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.)

    Dated: August 17, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19939 Filed 8-19-16; 8:45 am]
 BILLING CODE 4164-01-P