[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Page 8376-8377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Nonprescription 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: Nonprescription 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 23, 2005, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Washington DC North, 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: 301-827-6801, 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 3014512541. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: On March 23, 2005, the committee will discuss the 
microbiologic surrogate endpoints used

[[Page 8377]]

to demonstrate the effectiveness of antiseptic products used in health 
care settings. The discussion will also focus on related public health 
issues, trial design, and statistical issues. The background material 
will become available no later than the day before the meeting and will 
be posted under the Nonprescription Drugs Advisory Committee (NDAC) on 
FDA's Web site 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. 

(Click on the year 2005 and scroll down to NDAC).
    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 March 16, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on March 23, 2005. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 16, 2005 
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 
    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 LaNise Giles, 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: February 10, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-3115 Filed 2-17-05; 8:45 am]