Food and Drug Administration, HHS.
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 Committee: Risk Communication Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on effective risk communication.
Date and Time: The meeting will be held on May 15, 2008, from 8 a.m. to 5 p.m. and May 16, 2008, from 8 a.m. to 2 p.m.
Addresses: Submit electronic comments and information to http://www.regulations.gov . Comments are to be identified with the docket number found in brackets in the heading of this document. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on June 16, 2008. All comments received will be posted without change, including any personal information provided. Comments received on or before May 8, 2008, will be provided to the committee before or at the meeting; comments received after that time will still be considered in preparing the report that was specified in the FDA Amendments Act of 2007 (see docket and committee background for further information).
Location: Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD, 20852-1699.
Contact Person: Lee L. Zwanziger, Office of the Commissioner, Office of Planning (HFP-60), Food and Drug Administration, 5600 Fishers Lane (for express delivery: rm. 15-22), Rockville, MD, 20857, 301-827-2895, FAX: 301-827-5340, Food and Drug Administration, or 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. A notice in the Federal Register about last minute modifications that affect 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: On May 15, 2008, the committee will meet for presentations and discussion of direct-to-consumer (DTC) advertising, including how it relates to communicating to subsets of the general population, such as the elderly, children, and racial and ethnic minority communities, and increased access to health information and decreased health disparities for these populations. On May 16, 2008, the committee will discuss studying the appropriateness of including, in televised DTC ads, a statement encouraging consumers to report negative side effects of prescription drugs to MedWatch, as is currently required for print DTC prescription drug ads.
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 is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and 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 May 8, 2008. Written submissions may also be made to the docket at the address above (see the docket for further information on topics of particular interest for comment in connection with this meeting). Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on May 15th and between 10:30 a.m. and 11:30 a.m. on May 16th. Those desiring to make formal oral presentations should notify the contact person on or before May 8, Start Printed Page 229602008, 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. 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 May 9, 2008.
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/default.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).Start Signature
Dated: April 18, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-9177 Filed 4-25-08; 8:45 am]
BILLING CODE 4160-01-S