[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Notices]
[Page 29234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Pulmonary-Allergy Drugs and Endocrinologic 
and Metabolic Drugs Advisory Committees; 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: Joint meeting of the Pulmonary-Allergy Drugs 
and the Endocrinologic and Metabolic Drugs Advisory Committees.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on July 30, 1998, 8 a.m. to 
5 p.m., and on July 31, 1998, 8 a.m. to 3:45 p.m.
    Location: Bethesda Marriott Hotel, Grand Ballroom, 5151 Pooks Hill 
Rd., Bethesda, MD.
    Contact Person: Leander B. Madoo or Kathleen R. Reedy, Center for 
Drug Evaluation and Research (HFD-21), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), codes 12545 and 12536. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On July 30, 1998, the committees will: (1) Discuss the 
impact of orally inhaled and intranasal corticosteroids on growth in 
children, (2) hear from invited experts regarding the process of normal 
growth and development in children and how various factors including 
corticosteroids may impact on it, and (3) review examples from industry 
of completed ``growth studies'' testing the various inhaled and 
intranasal corticosteroid drug products. On July 31, 1998, the agency 
will: (1) Present the proposed ``class labeling'' for inhaled and 
intranasal corticosteroid drug products, (2) review the data which 
support it, and (3) lead a general scientific discussion among all 
meeting participants to reach a consensus concerning appropriate 
labeling for these products and recommendations for the design and 
conduct of future clinical trials which assess growth.
    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 July 23, 1998. 
Oral presentations from the public will be scheduled between 
approximately 3 p.m. and 4:30 p.m., on July 30, 1998. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 23, 1998, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 20, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-14106 Filed 5-27-98; 8:45 am]
BILLING CODE 4160-01-F