[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Notices]
[Pages 6908-6909]
From the Federal Register Online via the Government Publishing 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 [email protected] 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