[Federal Register: August 20, 2002 (Volume 67, Number 161)]
[Page 53955-53956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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 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

[[Page 53956]]

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]