[Federal Register: July 11, 2002 (Volume 67, Number 133)]
[Page 45982-45983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Drug Safety and Risk Management Advisory Committee; Notice of 

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: Drug Safety and Risk Management Advisory 
Committee (formerly Drug Abuse 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 July 17, 2002, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-021), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857 (for Express delivery: 5630 Fishers Lane, Room 
1093, Rockville MD 20857), 301-827-7001, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12535. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss ways to improve the usefulness 
of consumer medication information (CMI) distributed with prescriptions 
being filled at the nation's pharmacies. Findings of a recent FDA-
sponsored study(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm) showed that 
CMI is currently being distributed with more than 85 percent of 
prescriptions and that scientific accuracy of the materials is high, 
but the usefulness of materials is variable due largely to omissions of 
important risk and benefit information. The committee will consider: 
(1) Potential causes of insufficiencies in CMI, including current 
practices of the parties involved in developing and processing CMI and 
pharmacy practices that may affect the distribution and content of CMI, 
and (2) potential interventions to address causes of CMI 
insufficiencies in the current system, and scientific methods to assess 
and monitor whether effective communication of key information to 
patients is occurring.
    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 July 15, 2002. 
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 July 15, 2002, and submit

[[Page 45983]]

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 Kimberly L. Topper 
by July 15, 2002.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the Drug Safety and Risk Management Advisory Committee meeting. 
Because the agency believes there is some urgency to bring this issue 
to public discussion and qualified members of the Drug Safety and Risk 
Management Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. App. 2).

    Dated: July 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17402 Filed 7-10-02; 8:45 am]