[Federal Register: September 17, 2004 (Volume 69, Number 180)]
[Page 56070]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 14, 2004, from 8 
a.m. to 4:30 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Shalini Jain, 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: jains@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 the following topics: (1) Issues 
related to clinical trial design and analysis in studying catheter-
related bacteremia and (2) issues related to clinical trial design and 
analysis in studying bacteremia due to staphylococcus aureus. 
Background materials for this meeting will be posted on the Internet 1 
business day before the meeting at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

    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 October 4, 
2004. Oral presentations from the public will be scheduled between 
approximately 1 p.m. to 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 4, 2004, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Shalini Jain 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).

    Dated: September 9, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-20935 Filed 9-16-04; 8:45 am]