[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41027-41028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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 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: [email protected], 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://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 
views,

[[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 
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 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]
BILLING CODE 4160-01-S