[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Pages 22959-22960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9177]
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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