Document ID: FDA-2013-N-0001-0128
Agency: fda
Document Type: Notice
Title: Molecular and Clinical Genetics Panel of the Medical Devices Advisory
Committee; Notice of Meeting
Posted Date: 2014-02-05T05:00Z

[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Notices]
[Pages 6908-6909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02395]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Molecular and Clinical Genetics Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Molecular and Clinical Genetics Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 26 and 27, 2014, 
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900.
    Contact Person: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-3063, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On March 26, 2014, the committee will discuss, make 
recommendations and vote on information related to the premarket 
approval application sponsored by Epigenomics, Inc. for the Epi 
proColon. The Epi proColon test is a qualitative in vitro diagnostic 
method for the detection of methylated Septin 9 DNA in plasma derived 
from patient whole blood specimens. Methylation of the target Septin 9 
DNA sequence has been associated with the occurrence of colorectal 
cancer (CRC). The test is indicated to screen patients for CRC who are 
defined as average risk for CRC by current screening guidelines. The 
Epi proColon test is not intended to replace colorectal screening by 
colonoscopy. Patients with a positive Epi proColon test result should 
be referred for diagnostic colonoscopy. The Epi proColon test results 
are intended to be used in conjunction with the physician's assessment 
of history, other risk factors, and professional guidelines.
    On March 27, 2014, the committee will discuss, make recommendations 
and vote on information related to the premarket approval application 
for the Cologuard device, sponsored by Exact Sciences. Cologuard is an 
in vitro diagnostic device designed to analyze patients' stool for 
detection of hemoglobin, multiple DNA methylation and mutational 
markers, and the total amount of human DNA. Cologuard is intended for 
use as an adjunctive screening test for the detection of colorectal 
neoplasia associated DNA markers and for the presence of occult 
hemoglobin in human stool. A positive result may indicate the presence 
of colorectal cancer or premalignant colorectal neoplasia. Cologuard is 
not intended as a replacement for colonoscopy. Cologuard is intended to 
be used in conjunction with colonoscopy and other test methods in 
accordance with recognized screening guidelines.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 17, 2014. On

[[Page 6909]]

March 26 and 27, 2014, oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before March 10, 2014. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by March 13, 2014.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact James Clark, 
Conference Management Staff, at james.clark@fda.hhs.gov or 301-796-5293 
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 29, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-02395 Filed 2-4-14; 8:45 am]
BILLING CODE 4160-01-P