[Federal Register: May 6, 2003 (Volume 68, Number 87)]
[Page 24004]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0143]

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 June 12, 2003, from 8 
a.m. to 5 p.m. Interested persons and organizations may submit written 
or electronic comments until August 1, 2003, to the Dockets Management 
Branch (see Addresses).
    Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
 Select ``03N-0143--Continued over-the-
counter status of ipecac syrup'' and follow the prompts to submit your 
statement. Written comments should be submitted to Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, 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, or e-mail: SomersK@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area) code 12541. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will consider the safety and efficacy of 
ipecac syrup, indicated for emergency use to cause vomiting in 
poisoning, for continued over-the-counter (OTC) status under 21 CFR 
201.308. The primary areas of consideration are: (1) The status of the 
role of ipecac syrup in gastrointestinal decontamination; (2) whether 
the literature clearly defines the risk/benefit ratio of ipecac syrup; 
(3) the role of ipecac syrup in poison treatment for populations with 
limited access to emergency medical treatment; (4) if there is 
significant abuse of ipecac syrup; and (5) alternative therapies to 
ipecac syrup.
    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) docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
 (Click on the year 2003 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 for discussion or presentation at the meeting may 
be made to the contact person by June 5, 2003. Oral presentations from 
the public will be scheduled between approximately 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 
June 5, 2003, 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. However, until August 1, 2003, 
other submissions containing the docket number 03N-0143 and information 
relevant to the may be submitted for consideration to Dockets 
Management Branch (see Addresses).
    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 Karen Templeton-
Somers 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: April 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-11075 Filed 5-5-03; 8:45 am]