
[Federal Register: September 29, 2009 (Volume 74, Number 187)]
[Notices]               
[Page 49880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0443]

 
Anti-Infective Drugs 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: Anti-Infective Drugs 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 October 26, 2009, 
from 8:30 a.m. to 4 p.m.
    Addresses: Electronic comments should be submitted to http://
www.regulations.gov. Enter ``FDA-2009-N-0443'' and follow the 
prompts to submit your statement. Written comments should be 
submitted to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. All comments received will be posted without change, 
including any personal information provided. Comments received on or 
before October 5, 2009, will be provided to the committee before the 
meeting.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 
301-589-5200.
    Contact Person: Minh Doan, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
Minh.Doan@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington DC area), code 
3014512530. Please call the Information Line for up-to-date 
information on this meeting. 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: The committee will discuss updating susceptibility test 
information in systemic antibacterial drug product labeling.
    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 
October 16, 2009. Oral presentations from the public will be 
scheduled between approximately 12:45 p.m. and 1:45 p.m. Those 
desiring to make 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 October 9, 2009. 
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 October 12, 
2009.
    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 Minh Doan 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: 9/23/09.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9-23437 Filed 9-28-09; 8:45 am]

BILLING CODE 4160-01-S
