Document ID: FDA-2008-N-0226-0001
Agency: fda
Document Type: Notice
Title: Risk Communication Advisory Committee; Notice of Meeting
Posted Date: 2008-04-28T04:00Z

[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]               
[Page 22959-22960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap08-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0226]

 
Risk Communication Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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,

[[Page 22960]]

2008, 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).

    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