[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 24003-24004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 June 10, 2003, from 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Dornette Spell-LeSane, 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: 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12536. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: The committee will discuss supplemental new drug 
application (sNDA) 19-604/S-033, HUMATROPER (somatropin recombinant 
deoxyribonucleic acid (rDNA) origin) for injection), Eli Lilly and Co., 
for the proposed indication of treatment of nongrowth hormone 
deficiency short stature.
    Procedure: Interested persons may present data, information, or 
views,

[[Page 24004]]

orally or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person by June 3, 2003. Oral 
presentations from the public will be scheduled between approximately 
1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before June 3, 2003, 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 Dornette Spell-
LeSane 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: April 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-11076 Filed 5-5-03; 8:45 am]
BILLING CODE 4160-01-S