Document ID: FDA-2014-N-0001-0008
Agency: fda
Document Type: Notice
Title: Microbiology Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
Posted Date: 2014-01-21T05:00Z

[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3388-3389]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00939]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Microbiology Devices 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: Microbiology Devices 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 12, 2014, from 8 
a.m. to 6 p.m.
    Location: College Park Holiday Inn, Ballroom, 10000 Baltimore Ave., 
College Park, MD 20740; 301-345-6700.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, Shanika.Craig@fda.hhs.gov, 301-796-6639, 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 12, 2014, the committee will discuss, make 
recommendations, and vote on a premarket approval application for a new 
indication for the cobas Human Papillomavirus (HPV) Test, sponsored by 
Roche Molecular Systems, Inc. The cobas HPV Test is a qualitative in 
vitro test for the detection of HPV that is currently approved for use 
in conjunction with cervical cytology. Roche is seeking a claim whereby 
the cobas HPV Test can be used as a first-line primary cervical 
screening test. The test utilizes amplification of target DNA by the 
polymerase chain reaction and nucleic acid hybridization for the 
detection of 14 high risk (HR) HPV types in a single analysis. The test 
specifically identifies types HPV 16 and HPV 18 while concurrently 
detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 
56, 58, 59, 66, and 68). Per the proposed indication, women who test 
negative for high risk HPV types by the cobas HPV Test would be 
followed up in accordance with the physician's assessment of screening 
and medical history, other risk factors, and professional guidelines. 
Women who test positive for HPV genotypes 16 and/or 18 by the cobas HPV 
Test would be referred to colposcopy. Women who test high risk HPV 
positive and 16/18 negative by the cobas HPV Test (12 other HR HPV 
positive) would be evaluated by cervical cytology to determine the need 
for referral to colposcopy.
    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

[[Page 3389]]

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 3, 2014. On March 12, 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 
February 21, 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 February 25, 
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, 
Committee Management Staff, 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 14, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00939 Filed 1-17-14; 8:45 am]
BILLING CODE 4160-01-P