[Federal Register: August 20, 2002 (Volume 67, Number 161)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nonprescription Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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 with
members from the following committees: Anesthetic and Life Support
Drugs Advisory Committee, Arthritis Advisory Committee, Cardiovascular
and Renal Drugs Advisory Committee, Drug Safety and Risk Management
Advisory Committee, and Gastrointestinal 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 September 19 and 20,
2002, from 8 a.m. to 5 p.m.
Location: Hilton, Maryland Ballroom, 8727 Colesville Rd., Silver
Spring, MD. The hotel phone number is 301-589-5200.
Contact Person: Sandra Titus or LaNise Giles, 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: 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 September 19, 2002, the committee will discuss safety
issues related to the use of acetaminophen. The primary area for
discussion will focus on potential hepatotoxicity related to the use of
acetaminophen in both over-the-counter (OTC) and prescription (RX)
products. On September 20, 2002, the committee will discuss safety
issues related to the use of aspirin and other OTC nonsteroidal anti-
inflammatory drugs (NSAIDS). The primary areas for discussion will
focus on potential gastrointestinal bleeding and renal insufficiency
related to the use of these products.
In rulemaking, the agency has proposed aspirin and acetaminophen as
category I ingredients for safety and effectiveness. Other NSAIDS and
combination products are marketed under new drug applications. The
agency continues to believe that these ingredients are safe and
effective in the prescription and OTC products currently on the market
when properly used. The advisory committee will discuss whether
labeling or other
measures are warranted to reduce the risk of occurrence or the severity
of these adverse reactions.
Background material will be available at http://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. Click on the year 2002 and go to the September
19th and 20th Nonprescription Drugs Advisory Committee file. As
background material becomes available from FDA and interested parties,
it will be posted.
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 August 26,
2002. Submissions received by this date will be distributed to the
committee as well as posted on the docket site for this meeting. Oral
presentations from the public will be scheduled between approximately
8:15 a.m. and 9 a.m. on both days. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before September 4, 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
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 12, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-21208 Filed 8-19-02; 8:45 am]
BILLING CODE 4160-01-S