[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66545-66546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no06-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0414]
Psychopharmacologic Drugs 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: Psychopharmacologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 13, 2006, from
8 a.m. to 5 p.m.
Addresses: Electronic comments should be submitted tohttp://www.fda.gov/dockets/ecomments.
Select ``2006N-0414 Suicidality data
from Adult Antidepressant Trials'' and follow the prompts to submit
your statement. 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
December 1, 2006. All comments received will be posted without change,
including any personal information provided. Comments received on or
before December 1, 2006, will be provided to the committee before the
meeting.
Location: Hilton Washington DC/Silver Spring, The Maryland
Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone
number is 301-589-5200.
Contact Person: Cicely Reese, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: Cicely.Reese@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512544. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss the results of the FDA ongoing
meta-analysis of suicidality data from adult antidepressant trials. The
background material will become available no later than the day before
the meeting and will be posted on FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Under the heading ``Psychopharmacologic
Drugs Advisory Committee (PDAC).'' (Click on year 2006 and scroll down
to PDAC meetings).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written
[[Page 66546]]
submissions may be made to the contact person on or before November 21,
2006. Oral presentations from the public will be scheduled between
approximately 10 a.m. and 12 noon. Those desiring to make 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 November 21, 2006. 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 November
27, 2006.
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 Cicely Reese at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 1, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19248 Filed 11-14-06; 8:45 am]
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