[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Page 16314-16315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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: 
Teresa.Watkins@fda.hhs.gov, 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 
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
    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 
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee 
    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]