[Federal Register: April 1, 2002 (Volume 67, Number 62)]
[Page 15403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Meeting of the Nonprescription Drugs Advisory Committee With 
Consultation From the Pulmonary and Allergy Drugs Advisory Committee 
and the Dermatologic and Ophthalmologic 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). At least one 
portion of the meeting will be closed 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 April 22, 2002, from 8 
a.m. to 5 p.m. and on April 23, 2002, from 9 a.m. to 12 noon.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Sandra Titus, 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, e-mail: Tituss@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: On April 22, 2002, the committee will consider the safety 
and efficacy of new drug applications (NDA): NDA 19-658, CLARITIN 
Tablet; NDA 20-704, CLARITIN RediTab; and NDA 20-641, CLARITIN Syrup. 
These three CLARITIN products (loratadine, Schering-Plough Corp.) are 
immediate release formulations of the products that are proposed for 
over-the-counter (OTC) use for the relief of symptoms associated with 
allergic rhinitis and chronic idiopathic urticaria (CIU). The primary 
purpose of the meeting is to discuss CIU as an OTC indication. The 
background material for this meeting 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 2002 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 April 12, 
2002. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on April 22, 2002, and the meeting will 
be closed to the public between approximately 9 a.m. and 12 noon on 
April 23, 2002. Time allotted for each presentation may be limited. 
Priority for presentations will be given to those who demonstrate that 
they plan to address CIU as an OTC indication. Those desiring to make 
formal oral presentations should notify the contact person before April 
12, 2002, 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 Sandra Titus at 
least 7 days in advance of the meeting.
    Closed Committee Deliberations: On April 23, 2002, from 
approximately 9 a.m. to 12 noon, the meeting will be closed to provide 
an annual update and review of trade secret and/or confidential 
information (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 25, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-7730 Filed 3-29-02; 8:45 am]