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U.S. Department of Health and Human Services

Advisory Committees

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May 17-18, 2011: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERMay 17-18, 2011
 
Day 1: 8:00 a.m. to 5:00 p.m.
Day 2: 8:00 a.m. to 12:00 noon

 
Hilton Washington DC/Silver Spring The Ballrooms
8727 Colesville Road
Silver Spring, Maryland

Agenda

On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.

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.

Background Material
2011 Meeting Materials, Nonprescription Drugs Advisory Committee

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 May 3, 2011.
  • Oral presentations from the public will be scheduled between approximately 3 p.m. and 5 p.m. on May 17, 2011. Those individuals interested in making 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 April 25, 2011. 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 April 26, 2011.
  • FDA will work with sponsors of acetaminophen products who wish to make presentations to ensure that adequate time, separate from the 3 p.m. to 5 p.m. time slots for the general open public hearing, is provided. Sponsors interested in making formal presentations to the committees should notify the contact person on or before April 25, 2011. Sponsors with common interest are urged to coordinate their oral presentations.

Contact Information

  • Diem-Kieu Ngo, Pharm.D., BCPS
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, Maryland 20993-0002
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: diem.ngo@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    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.

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 Diem-Kieu Ngo 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 at 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).