82 FR 56245 - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 227 (November 28, 2017)

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology.'' The purpose of the public workshop is to engage stakeholders and solicit input from experts in oncology precision medicine on how to best weigh and evaluate evidence for classification and interpretation of sequencing results for precision oncology.

[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56245-56246]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Weighing the Evidence: Variant Classification and Interpretation 
in Precision Oncology; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled

[[Page 56246]]

``Weighing the Evidence: Variant Classification and Interpretation in 
Precision Oncology.'' The purpose of the public workshop is to engage 
stakeholders and solicit input from experts in oncology precision 
medicine on how to best weigh and evaluate evidence for classification 
and interpretation of sequencing results for precision oncology.

DATES: The public workshop will be held on January 29, 2018, from 8:30 
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver 
Spring, MD 20993-0002. Entrance for the public workshop 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.

FOR FURTHER INFORMATION CONTACT: Hisani Madison, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993, 240-402-
6581, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The goal of precision oncology is to use a cancer patient's genetic 
data to help determine which therapeutic(s) might be most effective in 
treating their disease. Next generation sequencing is increasingly 
employed in oncology because the technology can be used to screen a 
large number of mutations simultaneously to optimize and personalize 
patient care. The increasing number of reported mutations may lead to 
uncertainty for clinicians in the interpretation and prioritization of 
the variants with respect to the clinical significance and optimal 
course of action, respectively.
    In January 2017, the Association for Molecular Pathology, the 
American Society of Clinical Oncology, and the College of American 
Pathologists published a joint consensus recommendation for standards 
and guidelines for the interpretation and reporting of sequence 
variants in cancer. However, the implementation of these 
recommendations is not consistently applied across all stakeholders. 
FDA is holding this public workshop to engage stakeholders and solicit 
input from internal and external experts in precision oncology to 
discuss how genetic sequencing data is best implemented in patient 
management so that innovative regulatory strategies can be advanced to 
support the development of safe and effective precision-based drugs and 
devices for marketing.

II. Topics for Discussion

    Topics for discussion at the public workshop include:
     An overview of the state of the science for sequence 
variant classification in oncology and its practical use in treating 
patients;
     The level of evidence required for reporting variants and/
or guiding patient treatment;
     Best practices for the use of public/private databases for 
variant classification and interpretation in oncology; and
     Future directions for data sharing, standardization, and 
establishing consistency in precision oncology.
    The workshop will include a series of brief presentations to 
provide information to frame the main topics and interactive 
discussions via several panel sessions. Following the presentations, 
there will be a moderated discussion where speakers and additional 
panelists may be asked to provide their individual perspectives.

III. Participating in the Public Workshop

    Registration: 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.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by January 19, 2018, by 4 p.m. Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning at 8 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact Peggy Roney, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5671, email: 
[email protected] no later than January 10, 2018.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
Web page after January 10, 2018. Organizations are requested to view 
using one connection per location.
    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, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. A link to the transcript will also be available on the 
internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the 
posted events list.).

    Dated: November 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25584 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P