Document ID: FDA-2011-N-0002-0022
Agency: fda
Document Type: Notice
Title: Meetings: Microbiology Devices Panel of the Medical Devices Advisory Committee
Posted Date: 2011-03-16T04:00Z

[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14414-14415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. FDA-2011-N-0002]

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 June 29, 2011, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), and follow the prompts to the desired center 
or product area. Please call the Information Line for up-to-date 
information on this meeting.

[[Page 14415]]

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 and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On June 29, 2011, the committee will discuss and make 
recommendations regarding the possible reclassification of molecular 
diagnostics for the rapid detection of Mycobacterium tuberculosis 
complex and the detection of genetic mutations which confer antibiotic 
resistance in M. tuberculosis complex. Discussion would include the 
appropriate information and acceptable performance characteristics that 
would be required to assess the safety and effectiveness of rapid 
diagnostic tests for M. tuberculosis complex, and whether these can be 
sufficiently specified to support possible reclassification.
    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 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 June 
20, 2011. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11:30 a.m. on June 29, 2011. 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 June 
9, 2011. 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 June 10, 2011.
    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 AnnMarie Williams, 
Committee Management Staff, 301-796-5966, 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: March 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6081 Filed 3-15-11; 8:45 am]
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