[Federal Register: July 31, 2003 (Volume 68, Number 147)]
[Notices]
[Page 44955-44956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy03-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0294]
Anesthetic and Life Support 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: Anesthetic and Life Support 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 9 and 10,
2003, from 8 a.m. to 5 p.m. Interested persons and organizations may
submit written or electronic comments until October 10, 2003, to the
Division of Dockets Management (see Addresses).
Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Select ``2003N-0294--Opiate Risk
Management'' and follow the prompts to submit your statement. Written
comments should be submitted to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Johanna M. Clifford, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
[[Page 44956]]
1093), Rockville, MD 20857, 301-827-7001, or e-mail:
cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12529.
Please call the Information Line for up-to-date information on this
meeting.
Agenda: On September 9, 2003, the committee will discuss Risk
Management Plans for opiate analgesic drug products with particular
attention to modified-release products. On September 10, 2003, the
committee will discuss the abuse liability of and Risk Management Plans
for Palladone, a modified-release hydromorphone drug product indicated
for the treatment of moderate to severe pain in opioid tolerant
patients.
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 September 2,
2003. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 1:45 p.m. on September 9, and between 11:30
a.m. and 12 noon on September 10, 2003. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 2,
2003, 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 Angie Whitacre at
301-827-7001 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: July 23, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-19506 Filed 7-30-03; 8:45 am]
BILLING CODE 4160-01-S