[Federal Register: April 12, 2004 (Volume 69, Number 70)]
[Notices]
[Page 19193]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap04-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management 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: Drug Safety and Risk Management 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 May 5, 2004, from 8 a.m.
to 5 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville MD.
Contact Person: Shalini Jain, Center for Drug Evaluation and
Research (HFD-21), 5600 Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, e-mail:
jains@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 3014512535.
Please call the Information Line for up-to-date information on this
meeting. Background materials for this meeting when available will be
posted on the Internet 1 business day before the meeting at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Agenda: From 8 a.m. to 3 p.m., the committee will discuss
medication errors relating to the labeling and packaging of various
drug products in low-density polyethylene plastic vials. From 3 p.m. to
5 p.m., the committee will receive a progress report on the new drug
application (NDA) 21-107, LOTRONEX (alosetron hydrochloride),
GlaxoSmithKline, Risk Management Program.
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 27,
2004. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 11:30 a.m. and between approximately 3 p.m.
and 3:30 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before April 27, 2004, 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 Shalini Jain 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: April 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-8126 Filed 4-9-04; 8:45 am]
BILLING CODE 4160-01-S