[Federal Register Volume 73, Number 60 (Thursday, March 27, 2008)]
[Notices]
[Pages 16314-16315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anesthetic and Life Support Drugs Advisory
Committee and the 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 of a public advisory committee
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committees: Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
[[Page 16315]]
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 5 and 6, 2008, from
8 a.m. to 4:30 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel telephone number is 301-948-8900.
Contact Person: Teresa Watkins, 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, FAX: 301-827-6776, e-mail:
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572) in Washington, DC area), codes 3014512529
and 3014512535. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory hotline/phone line to learn about
possible modifications before coming to the meeting.
Agenda: On May 5, 2008, the committees will discuss new drug
application (NDA) 22-272, OXYCONTIN (oxycodone hydrochloride
controlled-release) Tablets, Purdue Pharma L.P., and its safety for the
proposed indication of management of moderate to severe pain when a
continuous, around-the-clock analgesic is needed for an extended period
of time. The sustained-release characteristics of this formulation are
purportedly less easily defeated than other formulations of OXYCONTIN.
On May 6, 2008, the committees will discuss supplemental new drug
application (sNDA) 21-947/s-005, FENTORA (fentanyl buccal tablet),
Cephalon, Inc., and its safety for the proposed indication of
breakthrough pain in opioid tolerant non-cancer patients with chronic
pain.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
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 on or before
April 21, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. each day. Those desiring to
make formal oral presentations should notify the contact person 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 on or before April 11, 2008. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 14, 2008.
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 Teresa Watkins at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-6294 Filed 3-26-08; 8:45 am]
BILLING CODE 4160-01-S