Document ID: FDA-2010-N-0001-0062
Agency: fda
Document Type: Notice
Title: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Posted Date: 2010-06-07T04:00Z

[Federal Register: June 7, 2010 (Volume 75, Number 108)]
[Notices]               
[Page 32188]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn10-43]                         

[[Page 32188]]

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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). 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 July 22 and 23, 2010, 
from 8 a.m. to 4:30 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College, 3501 University Boulevard East, Adelphi, 
MD. The conference center telephone number is 301-985-7300.
    Contact Person: Kristine T. Khuc, c/o Melanie Whelan, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver 
Spring, MD 20993-0002, FAX: 301-847-8737, to reach by telephone before 
June 8, 2010, please call 301-827-7001; to reach by telephone after 
June 8, 2010, please call 301 796-9001, e-mail: 
Kristine.khuc@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 
3014512529 and 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: The committees will discuss Risk Evaluation and Mitigation 
Strategies (REMS) for extended-release and long-acting opioid 
analgesics. As a part of the materials for the meeting, FDA anticipates 
presenting a proposal for a class-wide opioid REMS and will solicit 
feedback from the advisory committees and public on the components of 
that proposal. The need for adequate pain control is an element of good 
medical practice. In this context, some persons suffering from pain 
need access to potent opioid drug products; however, inappropriate 
prescribing, addiction, and death due to prescription opioid abuse and 
misuse have been increasing over the last decade.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. For this particular 
meeting, FDA anticipates that the briefing materials will not contain 
information that, under certain circumstances, could be considered 
exempt from public disclosure under the Freedom of Information Act. 
Therefore, FDA anticipates making the briefing materials available on 
our Web site no later than 2 weeks before the day the advisory 
committee meeting is scheduled to occur. 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 July 
8, 2010. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 9:15 a.m. on July 23, 2010. 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 June 29, 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 July 2, 2010.
    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 Kristine T. Khuc 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: June 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-13535 Filed 6-4-10; 8:45 am]
BILLING CODE 4160-01-S