80 FR 54290 - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 174 (September 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 174 (September 9, 2015)
| Page Range | 54290-54292 | |
| FR Document | 2015-22675 |
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)] [Notices] [Pages 54290-54292] From the Federal Register Online [www.thefederalregister.org] [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: [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 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: [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 & 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
![54290 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Human Cells, Tissues and Cellular and contained in the 2007 Donor Eligibility sixth annual scientific workshop co-
Tissue-Based Products for Infection guidance. sponsored by FDA and the Coalition
with Treponema pallidum (Syphilis); The guidance is being issued Against Major Diseases Consortium of
Guidance for Industry.’’ The guidance consistent with FDA’s good guidance the Critical Path Institute, contained
document provides HCT/P practices regulation (21 CFR 10.115). incorrect Web links for online
Establishments with updated The guidance represents the current registration and for the FDA Meeting
recommendations concerning donor thinking of FDA on ‘‘Use of Donor Information Page (where the workshop
testing for evidence of T. pallidum Screening Tests to Test Donors of agenda will be made available) and an
infection. HCT/P Establishments must, Human Cells, Tissues and Cellular and incorrect registration deadline. This
as required under § 1271.80(a) and (c) Tissue-Based Products for Infection document corrects those errors.
(21 CFR 1271.80(a) and (c)), test a donor with Treponema pallidum (Syphilis); FOR FURTHER INFORMATION CONTACT:
specimen for evidence of infection due Guidance for Industry.’’ It does not Jacqueline Brooks-Leighton, Center for
to T. pallidum using appropriate FDA- establish any rights for any person and Drug Evaluation and Research, Food
licensed, approved, or cleared donor is not binding on FDA or the public. and Drug Administration, 10903 New
screening tests, in accordance with the You can use an alternative approach if Hampshire Ave., Bldg. 21, Rm. 4521,
manufacturer’s instructions, unless an it satisfies the requirements of the Silver Spring, MD 20993, 240–402–
exception to this requirement applies applicable statutes and regulations. 5292, FAX: 301–796–9907, email:
under 21 CFR 1271.90. The guidance II. Comments jacqueline.brooks-leighton@fda.hhs.gov.
clarifies that FDA does not consider SUPPLEMENTARY INFORMATION: In FR Doc.
diagnostic tests or pre-amendment Interested persons may submit either 2015–18969, appearing on page 45998,
devices (which have not been licensed, electronic comments regarding this in the Federal Register of Monday
approved, or cleared) to be adequate for document to http://www.regulations.gov August 3, 2015, the following
use in donor testing for T. pallidum or written comments to the Division of corrections are made:
infection under the criteria specified in Dockets Management (see ADDRESSES). It On page 45998, in the second full
§ 1271.80(c). FDA will no longer is only necessary to send one set of paragraph of the third column, the
exercise enforcement discretion that comments. Identify comments with the registration link, https://
permits the use of diagnostic syphilis docket number found in brackets in the www.SignUp4.net/public/ap.aspx?EID=
tests or pre-amendments devices for use heading of this document. Received SIXT10E, is corrected to read http://
as an HCT/P donor screening test comments may be seen in the Division www.cvent.com/events/6th-annual-
because the wide availability of FDA- of Dockets Management between 9 a.m. coalition-against-major-diseases-food-
licensed, approved, or cleared test and 4 p.m., Monday through Friday, and and-drug-administration-scientific-
systems with an indication for use in will be posted to the docket at http:// workshop-public-/invitation-ed6c207
donor screening no longer supports www.regulations.gov. cbf09447185a891e4bf62ad7a.aspx?i=
such enforcement discretion. FDA III. Electronic Access 70715ca1-f255-46b2-a370-
recommends that HCT/P Establishments 3fe3881bbab2.
Persons with access to the Internet On page 45998, in the third full
implement the recommendations in the
may obtain the guidance at either paragraph of the third column, the
guidance as soon as feasible, but not
http://www.fda.gov/BiologicsBlood registration deadline, October 14, 2015,
later than 6 months after issuance of this
Vaccines/GuidanceCompliance is corrected to read October 13, 2015.
guidance.
RegulatoryInformation/Guidances/ On page 45998, in the third full
In the Federal Register of November default.htm or http://
5, 2013 (78 FR 66366), FDA announced paragraph of the third column, the link
www.regulations.gov. for the FDA Meeting information page,
the availability of the draft guidance of
Dated: September 2, 2015. http://www.fda.gov/Drugs/NewsEvents/
the same title, dated October 2013. FDA
Leslie Kux, ucm410863.htm, is corrected to read
received several comments on the draft
Associate Commissioner for Policy. http://www.fda.gov/Drugs/NewsEvents/
guidance and those comments were
ucm457486.htm.
considered as the guidance was [FR Doc. 2015–22677 Filed 9–8–15; 8:45 am]
finalized. FDA did not make changes to BILLING CODE 4164–01–P Dated: September 2, 2015.
the recommendations in the draft Leslie Kux,
guidance. FDA made editorial changes Associate Commissioner for Policy.
to improve clarity. The guidance DEPARTMENT OF HEALTH AND [FR Doc. 2015–22674 Filed 9–8–15; 8:45 am]
announced in this notice finalizes the HUMAN SERVICES BILLING CODE 4164–01–P
draft guidance dated October 2013.
Food and Drug Administration
In the Federal Register of February
28, 2007 (72 FR 9007), FDA announced [Docket No. FDA–2015–N–0001] DEPARTMENT OF HEALTH AND
the availability of the guidance entitled HUMAN SERVICES
‘‘Guidance for Industry: Eligibility Sixth Annual Coalition Against Major
Determination for Donors of Human Diseases/Food and Drug Food and Drug Administration
Cells, Tissues, and Cellular and Tissue- Administration Scientific Workshop; [Docket No. FDA–2015–N–3015]
Based Products (HCT/Ps),’’ dated Public Workshop; Correction
February 2007. FDA issued a revised AGENCY: Food and Drug Administration, Use of Databases for Establishing the
version of this guidance under the same HHS. Clinical Relevance of Human Genetic
Lhorne on DSK5TPTVN1PROD with NOTICES
title, dated August 2007 (hereafter Variants; Public Workshop; Request
ACTION: Notice; correction.
referred to as the 2007 Donor Eligibility for Comments
guidance). The guidance announced in SUMMARY: The Food and Drug AGENCY: Food and Drug Administration,
this notice supersedes the Administration (FDA) is correcting a HHS.
recommendations on compliance with notice that appeared in the Federal
ACTION: Notice of public workshop;
the requirements for testing HCT/P Register of August 3, 2015 (80 FR
request for comments.
donors for T. pallidum that are 45998). That notice, announcing the
VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1](https://thefederalregister.org/doc/80_FR_54464/page/1.svg)
![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](https://thefederalregister.org/doc/80_FR_54464/page/3.svg)
Document Created: 2015-12-15 09:53:21
Document Modified: 2015-12-15 09:53:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| FR Citation | 80 FR 54290 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR