Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments, 54290-54292 [2015-22675]
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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Human Cells, Tissues and Cellular and
Tissue-Based Products for Infection
with Treponema pallidum (Syphilis);
Guidance for Industry.’’ The guidance
document provides HCT/P
Establishments with updated
recommendations concerning donor
testing for evidence of T. pallidum
infection. HCT/P Establishments must,
as required under § 1271.80(a) and (c)
(21 CFR 1271.80(a) and (c)), test a donor
specimen for evidence of infection due
to T. pallidum using appropriate FDAlicensed, approved, or cleared donor
screening tests, in accordance with the
manufacturer’s instructions, unless an
exception to this requirement applies
under 21 CFR 1271.90. The guidance
clarifies that FDA does not consider
diagnostic tests or pre-amendment
devices (which have not been licensed,
approved, or cleared) to be adequate for
use in donor testing for T. pallidum
infection under the criteria specified in
§ 1271.80(c). FDA will no longer
exercise enforcement discretion that
permits the use of diagnostic syphilis
tests or pre-amendments devices for use
as an HCT/P donor screening test
because the wide availability of FDAlicensed, approved, or cleared test
systems with an indication for use in
donor screening no longer supports
such enforcement discretion. FDA
recommends that HCT/P Establishments
implement the recommendations in the
guidance as soon as feasible, but not
later than 6 months after issuance of this
guidance.
In the Federal Register of November
5, 2013 (78 FR 66366), FDA announced
the availability of the draft guidance of
the same title, dated October 2013. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. FDA did not make changes to
the recommendations in the draft
guidance. FDA made editorial changes
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated October 2013.
In the Federal Register of February
28, 2007 (72 FR 9007), FDA announced
the availability of the guidance entitled
‘‘Guidance for Industry: Eligibility
Determination for Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps),’’ dated
February 2007. FDA issued a revised
version of this guidance under the same
title, dated August 2007 (hereafter
referred to as the 2007 Donor Eligibility
guidance). The guidance announced in
this notice supersedes the
recommendations on compliance with
the requirements for testing HCT/P
donors for T. pallidum that are
VerDate Sep<11>2014
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Jkt 235001
contained in the 2007 Donor Eligibility
guidance.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Use of Donor
Screening Tests to Test Donors of
Human Cells, Tissues and Cellular and
Tissue-Based Products for Infection
with Treponema pallidum (Syphilis);
Guidance for Industry.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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. 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 https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22677 Filed 9–8–15; 8:45 am]
sixth annual scientific workshop cosponsored by FDA and the Coalition
Against Major Diseases Consortium of
the Critical Path Institute, contained
incorrect Web links for online
registration and for the FDA Meeting
Information Page (where the workshop
agenda will be made available) and an
incorrect registration deadline. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Jacqueline Brooks-Leighton, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4521,
Silver Spring, MD 20993, 240–402–
5292, FAX: 301–796–9907, email:
jacqueline.brooks-leighton@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2015–18969, appearing on page 45998,
in the Federal Register of Monday
August 3, 2015, the following
corrections are made:
On page 45998, in the second full
paragraph of the third column, the
registration link, https://
www.SignUp4.net/public/ap.aspx?EID=
SIXT10E, is corrected to read https://
www.cvent.com/events/6th-annualcoalition-against-major-diseases-foodand-drug-administration-scientificworkshop-public-/invitation-ed6c207
cbf09447185a891e4bf62ad7a.aspx?i=
70715ca1-f255-46b2-a3703fe3881bbab2.
On page 45998, in the third full
paragraph of the third column, the
registration deadline, October 14, 2015,
is corrected to read October 13, 2015.
On page 45998, in the third full
paragraph of the third column, the link
for the FDA Meeting information page,
https://www.fda.gov/Drugs/NewsEvents/
ucm410863.htm, is corrected to read
https://www.fda.gov/Drugs/NewsEvents/
ucm457486.htm.
BILLING CODE 4164–01–P
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–22674 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Sixth Annual Coalition Against Major
Diseases/Food and Drug
Administration Scientific Workshop;
Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of August 3, 2015 (80 FR
45998). That notice, announcing the
SUMMARY:
PO 00000
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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.
Notice of public workshop;
request for comments.
ACTION:
E:\FR\FM\09SEN1.SGM
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Lhorne on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
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 https://
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 https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
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Jkt 235001
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 https://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.
PO 00000
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54291
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 https://
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 https://
www.regulations.gov.
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 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
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.)
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
E:\FR\FM\09SEN1.SGM
09SEN1
54292
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
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 NGSbased diagnostic tests. (Workshop
material, including the discussion
paper, can be accessed at https://
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
https://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 https://
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
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Jkt 235001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2881]
Standards-Based Approach to
Analytical Performance Evaluation of
Next Generation Sequencing in Vitro
Diagnostic Tests; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Standards-Based Approach to
Analytical Performance Evaluation of
Next Generation Sequencing In Vitro
Diagnostic Tests’’. The purpose of this
workshop is to obtain feedback on
possible analytical standards and
approaches to develop or build on
existing standardization efforts in order
to optimize FDA’s regulatory approach
to next generation sequencing (NGS)based in vitro diagnostic tests.
Comments and suggestions generated
through this workshop will also guide
the use of regulatory science to advance
the development of appropriate and
relevant performance standards for
evaluation of NGS in vitro diagnostic
tests that produce results on variation in
the human genome.
DATES: Date and Time: The public
workshop will be held on November 12,
2015, from 8 a.m. to 5 p.m.
ADDRESSES: Location: The public
workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring,
MD 20993–0002. 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 https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Contact Person: Zivana Tezak, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
4544, Silver Spring, MD 20993, 301–
796–6206, zivana.tezak@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 permits, 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,
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 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 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 https://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.)
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[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 https://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 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 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 https://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 https://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 https://www.regulations.gov.
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 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
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.)
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 https://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 https://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
https://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]
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