[Federal Register Volume 71, Number 19 (Monday, January 30, 2006)]
[Notices]
[Pages 4921-4922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 March 6, 2006, from 8:30 
a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research, Advisory Committee Conference Room, rm. 1066, 5630 
Fishers Lane, Rockville, MD.
    Contact Person: Cathy A. Groupe, 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: [email protected], 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.
    Agenda: The committee will discuss new drug application (NDA) 21-
572/S-008, CUBICIN (daptomycin for injection 500 mg/vial), Sponsor 
Cubist Pharmaceuticals, for the proposed indication of the treatment of 
Staphylococcus aureus bacteremia, including those with known or 
suspected endocarditis caused by methicillin-susceptible and 
methicillin-resistant strains.
     The background material will become available no later than the 
day before the meeting and will be posted on FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm under heading ``Anti-Infective 
Drugs Advisory Committee (AIDAC).'' (Click on the year 2006 and scroll 
down to AIDAC meetings.)
    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 by February 27, 
2006. Oral presentations from the public will be scheduled between 1 
p.m. and 2 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before February 27, 2006, 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.
    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 Cathy A. Groupe at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 4922]]


    Dated: January 20, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1069 Filed 1-27-06; 8:45 am]
BILLING CODE 4160-01-S