[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
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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,
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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