80_FR_54466 80 FR 54292 - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments

80 FR 54292 - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 174 (September 9, 2015)

Page Range54292-54293
FR Document2015-22676

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.

Federal Register, Volume 80 Issue 174 (Wednesday, September 9, 2015) 
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54292-54293]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22676]


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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.

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 ``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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: 
    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, 
[email protected].
    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, [email protected], 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 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 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 http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in 
this document, but FDA is not responsible for any subsequent changes to 
the Web sites after this document publishes in the Federal Register.)

[[Page 54293]]

    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 [Zcaron]ivana Tezak (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 
possible analytical standards and approaches to develop or build on 
existing standardization efforts in order to optimize FDA's regulatory 
approach to NGS-based in vitro diagnostic tests. 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 http://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 http://www.regulations.gov.
    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 Comments). 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.)

SUPPLEMENTARY INFORMATION: 

I. Background

    In vitro diagnostic devices, including laboratory-developed tests, 
that utilize NGS technology to generate information on an individual's 
genome are rapidly transforming healthcare. As part of the White 
House's Precision Medicine Initiative, FDA envisions implementing a 
novel framework for NGS test regulation that includes developing 
sufficiently flexible assay performance standards that can accommodate 
innovation, including test modifications, while assuring NGS test 
safety and effectiveness. To start 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 http://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, 
with a goal to assess standard needs, propose performance standard 
content, and help in the development of the standards necessary for 
this effort. The Agency is therefore requesting public input on the 
proposed standards-based regulatory strategy 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 to provide 
information to frame the goals of the workshop and interactive 
discussions via several panel sessions. Following the presentations, 
there will be a moderated discussion where participants and additional 
panelists will be asked to provide their individual perspectives. The 
workshop discussion will focus on standards-based regulatory strategies 
to assure the analytical validity of NGS tests that produce results on 
variation in the human genome.
    The presentations and discussions will focus on several topics, 
including an example of a possible performance standard (methods) 
focusing on a single intended use; a general framework and architecture 
for standard needs, including currently existing guidelines and 
standards to be developed; and possible different approaches.
    In advance of the meeting, FDA plans to post a white paper 
outlining FDA's most current thinking for a standards-based approach to 
analytical performance evaluation of NGS diagnostic tests and a summary 
of the issues FDA believes need consideration at the workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) 
FDA will place the discussion paper on file in the public docket 
(docket number found in brackets in the heading of this document) and 
will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments 
on this document for presentation at the public workshop is 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. 2015-22676 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P

54292 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices driver of modern healthcare. As part of detailed agenda will be posted on this Contact Person: Zivana Tezak, Center the White House’s Precision Medicine Web site in advance of the workshop. for Devices and Radiological Health, Initiative, FDA is exploring a novel Dated: September 2, 2015. Food and Drug Administration, 10903 approach for NGS test regulation that Leslie Kux, New Hampshire Ave., Bldg. 66, Rm. includes leveraging well-curated 4544, Silver Spring, MD 20993, 301– Associate Commissioner for Policy. databases of genetic variation to provide 796–6206, zivana.tezak@fda.hhs.gov. evidence about the clinical relevance of [FR Doc. 2015–22675 Filed 9–8–15; 8:45 am] Registration: Registration is free and test results. To open this discussion, BILLING CODE 4164–01–P available on a first-come, first-served FDA drafted a discussion paper and basis. Persons interested in attending held an open public workshop titled this public workshop must register ‘‘Optimizing FDA’s Regulatory DEPARTMENT OF HEALTH AND online by 4 p.m. on October 30, 2015. Oversight of Next Generation HUMAN SERVICES Early registration is recommended Sequencing Diagnostic Tests’’ in Food and Drug Administration because facilities are limited and, February 2015 to discuss and receive therefore, FDA may limit the number of feedback from the community on [Docket No. FDA–2015–N–2881] participants from each organization. If possible regulatory approaches to NGS- time and space permits, onsite based diagnostic tests. (Workshop Standards-Based Approach to registration on the day of the public material, including the discussion Analytical Performance Evaluation of workshop will be provided beginning at paper, can be accessed at http:// Next Generation Sequencing in Vitro 7 a.m. www.fda.gov/MedicalDevices/ Diagnostic Tests; Public Workshop; If you need special accommodations NewsEvents/WorkshopsConferences/ Request for Comments due to a disability, please contact Susan ucm427296.htm.) The workshop Monahan, 301–796–5661, announced in this document seeks to AGENCY: Food and Drug Administration, HHS. susan.monahan@fda.hhs.gov, no later build on the feedback FDA received at than 4 p.m. on October 29, 2015. the public workshop in February 2015. ACTION: Notice of public workshop; To register for the public workshop, The Agency is therefore requesting request for comments. please visit FDA’s Medical Devices public input on strategies for the News, Events, Workshops and regulatory use of databases for NGS tests SUMMARY: The Food and Drug Administration (FDA) is announcing the Conferences calendar at http:// that produce results on variation in the www.fda.gov/MedicalDevices/ human genome. following public workshop entitled ‘‘Standards-Based Approach to NewsEvents/WorkshopsConferences/ II. Topics for Discussion at the Public Analytical Performance Evaluation of default.htm. (Select this public Workshop Next Generation Sequencing In Vitro workshop from the posted events list.) This public workshop will consist of Diagnostic Tests’’. The purpose of this Please provide complete contact brief presentations that will frame the workshop is to obtain feedback on information for each attendee, including goals of the workshop and interactive possible analytical standards and name, title, affiliation, address, email, discussions of key topics with several approaches to develop or build on and telephone number. Those without panel sessions. Following the existing standardization efforts in order Internet access should contact Susan presentations and panel discussions, to optimize FDA’s regulatory approach Monahan to register. Registrants will there will be a moderated discussion to next generation sequencing (NGS)- receive confirmation after they have where participants will be asked to based in vitro diagnostic tests. been accepted. You will be notified if provide their individual perspectives. Comments and suggestions generated you are on a waiting list. The workshop discussion will focus on through this workshop will also guide Streaming Webcast of the Public the development, operation (including the use of regulatory science to advance Workshop: This public workshop will curation), and use of databases of the development of appropriate and also be Webcast. Persons interested in genetic variants. relevant performance standards for viewing the Webcast must register In advance of the meeting, FDA plans evaluation of NGS in vitro diagnostic online by October 30, 2015, at 4 p.m. to post a discussion paper outlining tests that produce results on variation in Early registration is recommended FDA’s most current thinking about the the human genome. because Webcast connections are possible uses of databases of genetic DATES: Date and Time: The public limited. Organizations are requested to variants for NGS test regulation and a workshop will be held on November 12, register all participants, but to view summary of the issues FDA believes 2015, from 8 a.m. to 5 p.m. using one connection per location. need consideration at the workshop at Webcast participants will be sent ADDRESSES: Location: The public http://www.fda.gov/MedicalDevices/ technical system requirements after NewsEvents/WorkshopsConferences/ workshop will be held at the FDA White registration and will be sent connection default.htm. (Select this public Oak Campus, 10903 New Hampshire access information after November 3, workshop from the posted events list.) Ave., Bldg. 31 Conference Center, the 2015. If you have never attended a FDA will place the discussion paper on Great Room (Rm. 1503), Silver Spring, Connect Pro event before, test your file in the public docket (docket number MD 20993–0002. Entrance for the public connection at https:// found in brackets in the heading of this meeting participants (non-FDA collaboration.fda.gov/common/help/en/ document) and will post it at http:// employees) is through Building 1 where support/meeting_test.htm. To get a www.fda.gov/MedicalDevices/ routine security check procedures will quick overview of the Connect Pro be performed. For parking and security Lhorne on DSK5TPTVN1PROD with NOTICES NewsEvents/WorkshopsConferences/ program, visit http://www.adobe.com/ default.htm. The deadline for information, please refer to http:// go/connectpro_overview. (FDA has submitting comments on this document www.fda.gov/AboutFDA/ verified the Web site addresses in this for presentation at the public workshop WorkingatFDA/BuildingsandFacilities/ document, but FDA is not responsible is October 26, 2015, although comments WhiteOakCampusInformation/ for any subsequent changes to the Web related to this document can be ucm241740.htm. sites after this document publishes in submitted until November 25, 2015. A FOR FURTHER INFORMATION CONTACT: the Federal Register.) VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1

Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54293 Requests for Oral Presentations: This posted to the docket at http:// II. Topics for Discussion at the Public public workshop includes a public www.regulations.gov. Workshop comment session. During online Transcripts: Please be advised that as registration you may indicate if you soon as a transcript is available, it will This public workshop will consist of wish to present during a public be accessible at http:// brief presentations to provide comment session, and which topics you www.regulations.gov. It may be viewed information to frame the goals of the wish to address. FDA has included at the Division of Dockets Management workshop and interactive discussions general topics in this document which (see Comments). A transcript will also via several panel sessions. Following will be addressed in greater detail in a be available in either hardcopy or on the presentations, there will be a subsequent discussion paper (see CD–ROM, after submission of a moderated discussion where SUPPLEMENTARY INFORMATION). FDA will Freedom of Information request. A participants and additional panelists do its best to accommodate requests to transcript will also be available in either will be asked to provide their individual make public comments. Individuals and hardcopy or on CD–ROM, after perspectives. The workshop discussion organizations with common interests are submission of a Freedom of Information will focus on standards-based regulatory urged to consolidate or coordinate their request. The Freedom of Information strategies to assure the analytical presentations, and request time for a office address is available on the validity of NGS tests that produce joint presentation, or submit requests for Agency’s Web site at http:// results on variation in the human designated representatives to participate www.fda.gov. A link to the transcripts genome. in the focused sessions. All requests to will also be available approximately 45 make oral presentations must be days after the public workshop on the The presentations and discussions received by October 26, 2015. FDA will Internet at http://www.fda.gov/ will focus on several topics, including determine the amount of time allotted to MedicalDevices/NewsEvents/ an example of a possible performance each presenter and the approximate WorkshopsConferences/default.htm. standard (methods) focusing on a single time each oral presentation is to begin, (Select this public workshop from the intended use; a general framework and and will select and notify participants posted events list.) architecture for standard needs, by October 30, 2015. If selected for SUPPLEMENTARY INFORMATION: including currently existing guidelines presentation, any presentation materials and standards to be developed; and must be emailed to Živana Tezak (see I. Background possible different approaches. Contact Person) no later than November In vitro diagnostic devices, including In advance of the meeting, FDA plans 5, 2015, at 5 p.m. No commercial or laboratory-developed tests, that utilize to post a white paper outlining FDA’s promotional material will be permitted NGS technology to generate information most current thinking for a standards- to be presented or distributed at the on an individual’s genome are rapidly based approach to analytical public workshop. transforming healthcare. As part of the performance evaluation of NGS Comments: FDA is holding this public White House’s Precision Medicine diagnostic tests and a summary of the workshop to obtain feedback on Initiative, FDA envisions implementing issues FDA believes need consideration possible analytical standards and a novel framework for NGS test at the workshop at http://www.fda.gov/ approaches to develop or build on regulation that includes developing MedicalDevices/NewsEvents/ existing standardization efforts in order sufficiently flexible assay performance to optimize FDA’s regulatory approach WorkshopsConferences/default.htm. standards that can accommodate to NGS-based in vitro diagnostic tests. (Select this public workshop from the innovation, including test In order to permit the widest possible posted events list.) FDA will place the modifications, while assuring NGS test opportunity to obtain public comment, safety and effectiveness. To start this discussion paper on file in the public FDA is soliciting either electronic or discussion, FDA drafted a discussion docket (docket number found in written comments on all aspects of the paper and held an open public brackets in the heading of this public workshop topics. The deadline workshop titled ‘‘Optimizing FDA’s document) and will post it at http:// for submitting comments related to this Regulatory Oversight of Next Generation www.fda.gov/MedicalDevices/ public workshop is November 25, 2015, Sequencing Diagnostic Tests’’ in NewsEvents/WorkshopsConferences/ at 4 p.m. February 2015 to discuss and receive default.htm. The deadline for Regardless of attendance at the public feedback from the community on submitting comments on this document workshop, interested persons may possible regulatory approaches to NGS- for presentation at the public workshop submit either electronic comments based diagnostic tests. Workshop is October 26, 2015, although comments regarding this document to http:// material including the discussion paper related to this document can be www.regulations.gov or written can be accessed at http://www.fda.gov/ submitted until November 25, 2015. A comments to the Division of Dockets MedicalDevices/NewsEvents/ detailed agenda will be posted on this Management (HFA–305), Food and Drug WorkshopsConferences/ Web site in advance of the workshop. Administration, 5630 Fishers Lane, Rm. ucm427296.htm. The workshop Dated: September 2, 2015. 1061, Rockville, MD 20852. It is only announced in this document seeks to necessary to send one set of comments. build on the feedback FDA received at Leslie Kux, Identify comments with the docket the public workshop in February 2015, Associate Commissioner for Policy. number found in brackets in the with a goal to assess standard needs, [FR Doc. 2015–22676 Filed 9–8–15; 8:45 am] heading of this document. In addition, propose performance standard content, BILLING CODE 4164–01–P Lhorne on DSK5TPTVN1PROD with NOTICES when responding to specific topics as and help in the development of the described in section II of this document, standards necessary for this effort. The please identify the topic you are Agency is therefore requesting public addressing. Received comments may be input on the proposed standards-based seen in the Division of Dockets regulatory strategy for NGS tests that Management between 9 a.m. and 4 p.m., produce results on variation in the Monday through Friday, and will be human genome. VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\09SEN1.SGM 09SEN1


Document Created: 2015-12-15 09:53:49
Document Modified: 2015-12-15 09:53:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; request for comments.
DatesDate and Time: The public workshop will be held on November 12, 2015, from 8 a.m. to 5 p.m.
ContactContact 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, [email protected]
FR Citation80 FR 54292 
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