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U.S. Department of Health and Human Services

Advisory Committees

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September 14, 2010: Drug Safety and Risk Management Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERSeptember 14, 2010
 
8:00 a.m. to 5:00 p.m.
 
The Marriott Inn and Conference Center
University of Maryland
University College (UMUC)
The Ballrooms
3501 University Blvd. East
Adelphi, Maryland
 

Agenda

The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.

Meeting Materials

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.

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 August 30, 2010
  • 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 August 20, 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 August 23, 2010.

Contact Information

  • Elaine Ferguson
    Center for Drug Evaluation and Research (HFD-21)
    Food and Drug Administration

    Through June 8, 2010:
    c/o Melanie Whelan
    10903 New Hampshire Avenue
    WO51-6100
    Silver Spring, Maryland 20993-0002
    Telephone: 301-827-7001
    FAX: 301-847-8742

    Beginning June 9, 2010:
    c/o Christine Shipe
    10903 New Hampshire Avenue
    WO31-2419
    Silver Spring, Maryland 20993-0002
    Telephone: 301-796-9001
    FAX: 301-796-8532
    E-mail: Elaine.ferguson@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 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 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.

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 Elaine Ferguson at (301) 827-7001 (through June 8, 2010) and at (301) 796-9001 (beginning June 9, 2010) 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).