[Federal Register: October 28, 2005 (Volume 70, Number 208)]
[Page 62126-62127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 2, 2005, from 8 
a.m. to 5 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 
    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

[[Page 62127]]

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
 under the heading ``Psychopharmacologic Drugs Advisory 

Committee (PDAC).'' (Click on the year 2005 and scroll down to PDAC 
    Agenda: The committee will discuss new drug application (NDA) 21-
514, proposed trade name METHYPATCH (Methylphenidate) Tdp, 
(Methylphenidate Transdermal System), Noven Pharmaceuticals, proposed 
indication 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 November 18, 
2005. 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 November 18, 2005, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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: October 21, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-21524 Filed 10-27-05; 8:45 am]