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Meeting of the Risk Communication Advisory Committee

Agenda

On both days there will be a discussion of different types of prescription drug information currently available to patients in the form of Medicating Guides, Patient Package Inserts (PPIs), and Consumer Medication Information (CMI).

Meeting Materials

• Links to meeting materials will be added as they become available

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 February 19, 2009.
• Oral presentations from the public will be scheduled between approximately 1 p.m. and 3 p.m. on February 26th and 10:30 to 11:30 on February 27th. Those desiring to make formal oral presentations should notify the contact person and should 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 February 19, 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 February 20, 2009.

Contact Information

• Lee L. Zwanziger, Designated Federal Official
  5600 Fishers Lane, Rm 15-22, HFP-60
  Rockville, MD 20857
• Phone 301-827-2895
• FAX: 301-827-3285
  e-mail:  Lee.Zwanziger@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington, DC, area)
  code 8732112560
  Please call the Information Line for up-to-date information on this 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 Lee L. Zwanziger 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/oc/advisory/ 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).

Updated December 9, 2008

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