Document ID: FDA-2009-N-0664-0077
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: 2009-08-25T04:00Z

[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]               
[Page 42906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au09-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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 September 24, 2009, 
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 the 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 
committee hot line/phone line to learn about possible modifications 
before coming to the meeting.
    Agenda: On September 24, 2009, 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.
    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. This 
formulation was previously reviewed and discussed by these 
committees on May 5, 2008, and will be considered again in light of 
new data.
    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 a http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee link.
    Procedure: On September 24, 2009, 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 September 10, 2009. Oral presentations from the 
public will be scheduled between approximately 1 p.m. and 2 p.m. 
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 
September 1, 2009. 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 
September 2, 2009.
    Closed Presentation of Data: On September 24, 2009, 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)). The meeting will be closed to permit discussion of 
confidential information regarding detailed protocols to evaluate 
the formulation of the drug product. 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 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/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20376 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S