
[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]               
[Page 40207]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au09-90]                         

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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). 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.
    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 23, 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 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 hotline/phone line to learn about 
possible modifications before coming to the meeting.
    Agenda: The committees will discuss new drug application (NDA) 21-
217, EXALGO (hydromorphone HCl), a modified-release hydromorphone drug 
product indicated for the treatment of moderate-to-severe pain in 
opioid-tolerant patients.
    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: 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 9, 2009. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 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.
    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 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-19105 Filed 8-10-09; 8:45 am]

BILLING CODE 4160-01-S
