Document ID: FDA-2011-N-0301-0001
Agency: fda
Document Type: Notice
Title: Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity; Public Meeting; Request for Comments
Posted Date: 2011-05-19T04:00Z

[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Notices]
[Pages 28990-28991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12310]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0301]

Ultra High Throughput Sequencing for Clinical Diagnostic 
Applications--Approaches To Assess Analytical Validity; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public meeting entitled ``Ultra High Throughput Sequencing for Clinical 
Diagnostic Applications--Approaches To Assess Analytical Validity.'' 
The purpose of the public meeting is to discuss challenges in assessing 
analytical performance for ultra high throughput genomic sequencing-
based clinical applications.
    Date and Time: The public meeting will be held on June 23, 2011, 
from 8 a.m. to 6 p.m.
    Location: The public meeting will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room), 
Silver Spring, MD 20993-0002. For parking and security information, 
please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public meeting will also be available to be viewed 
online via Web cast.
    Contact Person: Zivana Tezak, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 5668, Silver Spring, MD 20993-0002, 301-796-6206, e-mail: 
zivana.tezak@fda.hhs.gov.
    Registration and Requests for Oral Presentations: If you wish to 
attend or view the Web cast of the public meeting, you must register 
online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from 
the list).
    Provide complete contact information for each attendee, including 
name, title, affiliation, e-mail, and telephone number. Registration 
requests should be received by June 9, 2011.
    If you wish to make an oral presentation during the open comment 
session at the meeting, you must indicate this at the time of 
registration. FDA has included general discussion topics for comment in 
section III of this document, Topics for Input. You should also 
identify which discussion topic you wish to address in your 
presentation. FDA will do its best to accommodate requests to speak. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and to request time for a 
joint presentation. FDA will determine the amount of time allotted to 
each presenter and the approximate time that each oral presentation is 
scheduled to begin.
    Registration is free and will be on a first-come, first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once they 
have been accepted. Onsite registration on the day of the public 
meeting will be provided on a space-available basis beginning at 7 a.m. 
Non-U.S. citizens are subject to additional security screening, and 
they should register as soon as possible.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, 
Silver Spring, MD 20993-0002, 301-796-5661, e-mail: 
susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
    Streaming Web Cast of the Public Meeting: There will be a 
registration process for the Web cast, and it will be on a first-come, 
first-served basis (maximum capacity: 900). If you have never attended 
a Connect Pro meeting 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.)
    Comments: FDA is holding this public meeting to discuss a number of 
questions regarding appropriate approaches to assess analytical 
validity of ultra high throughput sequencing for clinical diagnostic 
applications. The deadline for submitting comments to be presented at 
this public meeting is June 9, 2011.
    Regardless of attendance at the public meeting, interested persons 
may submit either electronic or written comments on any discussion 
topic(s) to the open docket. The deadline for submitting comments to 
the docket is July 23, 2011. Submit electronic comments to http://www.regulations.gov. Submit 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. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, if responding to specific 
topics as outlined in section III 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Ultra high throughput genomic sequencing technologies are currently 
extensively used in research and are entering clinical diagnostic use; 
they are expected to bring transformative public health applications. 
In order to effectively utilize new sequencing technologies for 
clinical applications, appropriate evaluation tools (e.g., standards, 
well established criteria) are needed to determine the accuracy of the 
results. Any regulatory strategy for clinical tests based on ultra high 
throughput genomic sequencing will benefit from novel and 
scientifically agreed-upon approaches to analytical validation. FDA is 
holding this public meeting to start discussion on approaches that can 
provide the most useful information in establishing safety and 
effectiveness of genomic sequencing technologies when used clinically.
    This public meeting seeks input from academia, Government, 
industry, and other stakeholders on validation methodologies, 
materials, and bioinformatics approaches needed to address unique 
analytical validation requirements of ultra high throughput sequencing 
based molecular diagnostics and confirm the sequencing quality and the 
accuracy of the tests. The ultimate goal is to accelerate and support 
the introduction of safe and effective innovative diagnostics in public 
health applications.

II. Meeting Overview

    The public meeting will consist of presentations providing 
background on

[[Page 28991]]

current and anticipated uses for sequencing technologies, an open 
public comment session, and roundtable discussions on selected topics. 
(See section III of this document.) The roundtable participants will 
not be asked to develop consensus opinions during the discussion, but 
rather to provide their individual perspectives. Others in attendance 
at the public meeting will have an opportunity to listen to the 
roundtable discussion.
    Additional information, including a meeting agenda, will be 
available on the Internet., immediately after publication of this 
Federal Register notice. This information will be placed on file in the 
public docket (docket number found in brackets in the heading of this 
document), which is available at http://www.regulations.gov. This 
information will also be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the 
appropriate meeting from the list).

III. Topics for Input

    FDA seeks input on the following issues:
    1. Technical performance:
     Acceptance criteria,
     Validation samples/panels,
     Comparator/analytical standard.
    2. Bioinformatics:
     Data format,
     Data analysis.

IV. 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 (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information, 12420 Parklawn 
Dr., rm. 1050, Rockville, MD 20857.

    Dated: May 13, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12310 Filed 5-18-11; 8:45 am]
BILLING CODE 4160-01-P