[Federal Register: July 19, 2006 (Volume 71, Number 138)]
[Page 41027-41028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory
Committee and the Advisory Committee for Pharmaceutical Science; 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 Committees: Endocrinologic and Metabolic Drugs Advisory
Committee and the Advisory Committee for Pharmaceutical Science.
    General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 4, 2006, from 8
a.m. to 5 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD.
The hotel phone number is 301-977-8900.
    Contact Person: Victoria Ferretti-Aceto, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1076), Rockville, MD
20857, 301-827-7001, e-mail: Victoria.FerrettiAceto@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), codes 3014512536 or 3014512539. Please call
the Information Line for up-to-date information on this meeting. When
available, background materials for this meeting will be posted one
business day prior to the meeting on the FDA 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 Endocrinologic and Metabolic Drugs Advisory Committee or
the Advisory Committee for Pharmaceutical Science.)
    Agenda: The joint committee will discuss FDA's efforts to assess
the product quality of currently marketed levothyroxine sodium drug
products. Earlier this year, FDA requested that manufacturers of
currently marketed levothyroxine sodium products provide to it certain
product release and stability information. The joint committee will
consider FDA's analyses and any clinical significance.
    Procedure: Interested persons may present data, information, or

[[Page 41028]]

orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before September
13, 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 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
September 13, 2006.
    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 Victoria Ferretti-
Aceto 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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11471 Filed 7-18-06; 8:45 am]