[Federal Register Volume 60, Number 216 (Wednesday, November 8, 1995)]
[Notices]
[Page 56345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27616]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Advisory Committee Meetings; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Action.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Endocrinologic and Metabolic 
Drugs Advisory Committee. The meeting was announced in the Federal 
Register of October 20, 1995 (60 FR 54233). The amendment is being made 
to remove probucol, new drug application (NDA) 17-535 
(Lorelco, Hoechst Marion Roussel) for a lipid altering 
indication from the agenda, and change the time schedule. There are no 
other changes. This amendment will be announced at the beginning of the 
open portion of the meeting.

FOR FURTHER INFORMATION CONTACT:
Kathleen R. Reedy, Center for Drug Evaluation and Research (HFD-9), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-5455, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Endocrinologic and 
Metabolic Drugs Advisory Committee, code 12536.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 20, 1995, 
FDA announced that a meeting of the Endocrinologic and Metabolic Drugs 
Advisory Committee would be held on November 16 and 17, 1995.

    On page 54233, in the first column, the ``Date, time, and place'' 
and the ``Type of meeting and contact person'' portions of this meeting 
are amended, and in the second column, the ``Open committee 
discussion'' portion of the meeting is amended to read as follows:
    Date, time, and place. November 16, 1995, 1 p.m., and November 17, 
1995, 8 a.m., Holiday Inn--Silver Spring, Plaza Ballroom, 8777 Georgia 
Ave., Silver Spring, MD.
    Type of meeting and contact person. Open public hearing, November 
16, 1995, 1 p.m. to 1:30 p.m., unless public participation does not 
last that long; open committee discussion, 1:30 p.m. and 6 p.m.; open 
public hearing, November 17, 1995, 8 a.m. to 8:30 a.m., unless public 
participation does not last that long; open committee discussion, 8:30 
a.m. to 2 p.m.; Kathleen R. Reedy, Center for Drug Evaluation and 
Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455, FAX 301-443-0699, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Endocrinologic and Metabolic Drugs Advisory 
Committee, code 12536.
    Open committee discussion. On November 16, 1995, the committee will 
hear presentations and discuss data submitted regarding the safety and 
efficacy of dexfenfluramine hydrochloride, NDA 20-344 (Redux, 
Interneuron Pharmaceuticals, Inc.), for an obesity indication, as 
followup to the meeting of September 28, 1995. On November 17, 1995, 
the committee will hear presentations and discuss data submitted 
regarding the safety and efficacy of sodium fluoride USP, NDA 19-975 
(Slow Fluoride, Texas Southwest Medical Center), for an 
osteoporosis indication.

    Dated: November 2, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-27616 Filed 11-7-95; 8:45 am]
BILLING CODE 4160-01-M