[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Notices]
[Page 67093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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 December 2, 2010, 
from 8 a.m. to 4:30 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College, The Ballroom, 3501 University Blvd. 
East, Adelphi, MD. The hotel telephone number is 301-985-7300.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, e-mail: [email protected], 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 December 2, 2010, 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) 
201655, Oxymorphone HCl Extended-Release Tablets, Endo 
Pharmaceuticals, Inc., and its safety for the proposed indication of 
relief of moderate to severe pain in patients requiring continuous, 
around-the-clock opioid treatment for an extended period of time. 
The extended-release characteristics of this formulation are 
purportedly less easily defeated than other formulations of 
controlled-release oxymorphone.
    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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee link.
    Procedure: On December 2, 2010, 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 November 17, 2010. 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 
November 8, 2010. 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 
November 9, 2010.
    Closed Presentation of Data: On December 2, 2010, 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 this session, the committee will discuss 
confidential protocol and methodology.
    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: October 26, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27457 Filed 10-29-10; 8:45 am]
BILLING CODE 4160-01-P