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U.S. Department of Health and Human Services

Advisory Committees

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July 22–23, 2010: Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERJuly 22-23, 2010
 
8:00 a.m. - 4:30 p.m.Marriott Inn and Conference Center
University of Maryland
University College
3501 University Blvd. East
Adelphi, Maryland

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.

Meeting Materials

FDA intends to make background material available to the public at least 2 days before the meeting. For this particular meeting, the FDA anticipates that the briefing materials will not contain information that, under certain circumstances, could be considered exempt from public disclosure under FOIA. Therefore the 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.

Public Participation Information

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. to 9:15 a.m., 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.

Contact Information

  • Kristine T. Khuc, Pharm.D.
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2434
    Silver Spring, MD 20993-0002
    Phone: 301-796-9015
    Fax: 301-847-8533
    E-mail: Kristine.Khuc@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA intends to make background material available to the public no later than 2 weeks 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.

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 (301) 796-9001 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 Public Conduct During FDA Advisory Committee Meetings 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).