[Federal Register: February 1, 2006 (Volume 71, Number 21)]
[Notices]
[Page 5343-5344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe06-99]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 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 March 23, 2006, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg,The Ballrooms,
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
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: ReeseCi@cder.fda.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. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Click on the year 2006 and scroll down to the
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``Psychopharmacologic Drugs Advisory Committee'' meeting.
Agenda: The committee will discuss new drug application (NDA) 20-
717, S-019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255
mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed
indication is for the treatment of attention deficit hyperactivity
disorder (ADHD).
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 by March 15,
2006. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before March 15, 2006, 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.
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: January 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1222 Filed 1-31-06; 8:45 am]
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