Document ID: FDA-2008-N-0038-0071
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Posted Date: 2008-10-14T04:00Z

[Federal Register: October 14, 2008 (Volume 73, Number 199)]
[Notices]               
[Page 60706-60707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc08-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
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 meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committees: Anesthetic and Life Support Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    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 November 13 and 14, 
2008, from 8 a.m. to 4:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD. The hotel phone number is 301-948-8900.
    Contact Person: Kalyani Bhatt, 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: 
Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in Washington, DC area), codes 3014512529 
or 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 hot line/phone line to learn about 
possible modifications before coming to the meeting.
    Agenda: On November 13 and 14, 2008, the committees will begin with 
a closed session, from 8 a.m. to 9:15 a.m. Following the closed 
session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the 
public. On November 13, 2008, the committees will discuss new drug 
application (NDA) 22-324,

[[Page 60707]]

REMOXY XRT (oxycodone hydrochloride controlled-release) Capsules, Pain 
Therapeutics Inc., 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 
controlled-release characteristics of this formulation are purportedly 
less easily defeated than other formulations of controlled-release 
oxycodone. On November 14, 2008, the committees will discuss new drug 
application NDA 22-321, EMBEDA (morphine sulfate extended-release with 
sequestered naltrexone hydrochloride) Capsules, Alpharma 
Pharmaceuticals L.L.C., and its safety for the proposed indication of 
management of moderate to severe chronic pain. The naltrexone component 
of this formulation is intended to mitigate abuse of the product when 
attempts are made to defeat the controlled-release properties of the 
formulation.
    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: On November 13 and 14, 2008, from 9:15 a.m. to 4:30 
p.m., the meeting is open to the public. 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 October 28, 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 October 20, 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 October 21, 2008.
    Closed Committee Deliberations: On November 13 and 14, 2008, from 8 
a.m. to 9:15 a.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)). During these sessions, the committees will discuss the 
details of proprietary research reports and protocols addressing 
characteristics of different formulations.
    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 Kalyani Bhatt 301-
827-7001 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: October 6, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24263 Filed 10-10-08; 8:45 am]

BILLING CODE 4160-01-S