Food and Drug Administration, HHS.
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: GroupeC@cder.fda.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.
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).Start Signature
Dated: January 20, 2006.
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1069 Filed 1-27-06; 8:45 am]
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