[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Notices]
[Page 52775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22141]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nonprescription 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). 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 October 19, 2000, 8 a.m.
to 5 p.m.
Location: Holiday Inn, The Ballroom, Two Montgomery Ave.,
Gaithersburg, MD.
Contact Person: Sandra L. 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, or 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: The committee will consider safety issues regarding the use
of Phenylpropanolamine (PPA) in over-the-counter (OTC) drug products.
The discussion will focus on the reported results of an epidemiological
study designed to assess the risk of hemorrhagic stroke associated with
the use of PPA. The Consumer Health Products Association (CHPA)
commissioned the study which was conducted by Yale University. The
material which the committee will review will be available at least 1
business day before the meeting at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. Click on the year 2000 and then locate the
Nonprescription Drugs Advisory Committee meeting for October 20, 2000.
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 9,
2000. 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 October 9, 2000, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 21, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-22141 Filed 8-29-00; 8:45 am]
BILLING CODE 4160-01-F