[Federal Register Volume 73, Number 199 (Tuesday, October 14, 2008)]
[Notices]
[Pages 60706-60707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24263]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[email protected], 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