Document ID: FDA-2014-N-0001-0037
Agency: fda
Document Type: Notice
Title: Next-Generation Sequencing Technology, Data Formats
Standardization and Promotion of Interoperability Protocols; Public
Workshop
Posted Date: 2014-04-21T04:00Z

[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Page 22147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08969]

[[Page 22147]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Next-Generation Sequencing Technology, Data Formats 
Standardization and Promotion of Interoperability Protocols; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), is announcing a public 
workshop entitled ``Next-Generation Sequencing (NGS) Technology, Data 
Format Standardization and Promotion of Interoperability Protocols.'' 
The goal of this public workshop is to facilitate establishing 
protocols for ensuring the safety and quality of next-generation 
sequencing (NGS)-related information without sacrificing scientific 
merit or interfering with innovative processes. The purpose of the 
workshop is to engage NGS stakeholders in a forum to discuss the 
current use of the technology and the development of data standards of 
NGS-related information.
    Date and Time: The public workshop will be held on September 24 and 
25, 2014, from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the National 
Institute of Health Campus, 9000 Rockville Pike, Bldg. 35, Rm. 610, 
Bethesda, MD 20892. Pre-registered participants will receive additional 
information on parking and public transportation with their email 
registration confirmation.
    Contact Person: Khaled Bouri, Office of Regulatory Science and 
Innovation, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 
4164, Silver Spring, MD 20903, 301-796-8476, email: 
Khaled.Bouri@fda.hhs.gov.
    Registration: Please go to http://ngs-data-standardization.eventbrite.com to register. There is no registration 
fee for the public workshop. Early registration is recommended because 
seating is limited. Registration will be confirmed by email. 
Registration on the day of the public workshop will be provided on a 
space available basis beginning at 8 a.m. This workshop will also be 
accessible via Webcast by following this link: https://collaboration.fda.gov/NGSStandards/.
    If you need special accommodations due to a disability, please 
contact Khaled Bouri (see Contact Person) at least 7 days in advance.
    Transcripts and Additional Information About the Workshop: The 
workshop agenda and additional background materials will be accessible 
at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm227840.htm. Please be advised that as soon as possible after the 
public workshop a transcript will be available at the same Web site. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 
20857.

    Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08969 Filed 4-18-14; 8:45 am]
BILLING CODE 4160-01-P