Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments, 56656-56658 [2016-19939]
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[FR Doc. 2016–19923 Filed 8–19–16; 8:45 am]
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[Docket No. FDA–2016–N–2473]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Adapting Regulatory Oversight of Next
Generation Sequencing-Based Tests;
Public Workshop; Request for
Comments
Food and Drug Administration
AGENCY:
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2016
Proposed Guidance Development;
Correction
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2016
Proposed Guidance Development’’ that
appeared in the Federal Register of
December 29, 2016 (80 FR 81335). The
document announced the Web site
location where the Agency will post two
lists of guidance documents that the
Center for Devices and Radiological
Health (CDRH or the Center) intends to
publish in Fiscal Year (FY) 2016. The
document was published with the
incorrect number of years in which
CDRH committed to finalize, withdraw,
re-open the comment period, or issue
another draft guidance on the topic for
80 percent of the documents. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, December
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:13 Aug 19, 2016
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Food and Drug Administration,
HHS.
[Docket No. FDA–2012–N–1021]
Notice of public workshop;
request for comments.
ACTION:
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: https://
www.nih.gov/icd/od/ocpl/VIC/
index.htm.
You may submit comments as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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 https://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
E:\FR\FM\22AUN1.SGM
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Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
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: https://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 https://
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,
ernest.litwack@fda.hhs.gov.
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
1 The Precision Medicine Initiative found on the
White House’s Web site at: https://
www.whitehouse.gov/precision-medicine.
VerDate Sep<11>2014
17:13 Aug 19, 2016
Jkt 238001
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.
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 NGSbased 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 FDArecognized 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: https://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
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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,
susan.monahan@fda.hhs.gov, 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 https://
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
https://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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Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 https://
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 https://
www.fda.gov. A link to the transcripts
will also be available approximately 45
days after the public workshop on the
Internet at https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2016–N–2474]
[Docket No. FDA–2016–N–0001]
National Mammography Quality
Assurance Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the National Mammography Quality
Assurance Advisory Committee. This
meeting was announced in the Federal
Register of August 5, 2016. The
amendment is being made to reflect a
change in the ADDRESSES portion of the
document. There are no other changes.
SUMMARY:
S.J.
Anderson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1552, Silver Spring,
MD 20993–0002, Sara.Anderson@
fda.hhs.gov, 301–796–6875, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code MA. Please
call the Information Line for up-to-date
information on this meeting.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of August 5, 2016 (81
FR 51918), FDA announced that a
meeting of the National Mammography
Quality Assurance Advisory Committee
would be held on September 15, 2016.
On page 51919, in the first column, in
the ADDRESSES portion: Hilton
Washington, DC/North, Salons A, B, C
and D, 620 Perry Pkwy., Gaithersburg,
MD 20877. The hotel’s telephone
number is 301–977–8900, is changed to
read as follows: Gaithersburg Holiday
Inn—Grand Ballroom, 2 Montgomery
Village Ave., Gaithersburg, MD 20878.
The hotel’s telephone number is 301–
948–8900.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: August 17, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
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Food and Drug Administration,
HHS.
[FR Doc. 2016–19957 Filed 8–19–16; 8:45 am]
VerDate Sep<11>2014
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting
Associated With Designated New
Animal Drugs for Minor Use and Minor
Species
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting associated with
designation under the Minor Use and
Minor Species Animal Health Act of
2004.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by October 21, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
E:\FR\FM\22AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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,
ernest.litwack@fda.hhs.gov.
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.
---------------------------------------------------------------------------
\1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.
---------------------------------------------------------------------------
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: https://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, susan.monahan@fda.hhs.gov, 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 https://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 https://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 https://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 https://www.fda.gov. A
link to the transcripts will also be available approximately 45 days
after the public workshop on the Internet at https://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
