Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments, 54290-54292 [2015-22675]

Download as PDF Lhorne on DSK5TPTVN1PROD with NOTICES 54290 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 In the Federal Register of November 5, 2013 (78 FR 66366), FDA announced the availability of the draft guidance of the same title, dated October 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. FDA did not make changes to the recommendations in the draft guidance.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 The guidance announced in this notice finalizes the draft guidance dated October 2013.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 14:19 Sep 08, 2015 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 http://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 http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// 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 http:// 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, http://www.fda.gov/Drugs/NewsEvents/ ucm410863.htm, is corrected to read http://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 Frm 00032 Fmt 4703 Sfmt 4703 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 09SEN1 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 http:// 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 http:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) VerDate Sep<11>2014 14:19 Sep 08, 2015 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 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.) 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 Frm 00033 Fmt 4703 Sfmt 4703 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 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. 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 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 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. 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 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 VerDate Sep<11>2014 14:19 Sep 08, 2015 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 http:// 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 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.) 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 http://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 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.)
    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 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. 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

    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 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. 
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 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. 2015-22675 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P