[Federal Register Volume 67, Number 62 (Monday, April 1, 2002)]
[Notices]
[Page 15403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7730]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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: [email protected], 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
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 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
Relations.
[FR Doc. 02-7730 Filed 3-29-02; 8:45 am]
BILLING CODE 4160-01-S