[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Notices]
[Pages 35943-35944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Arthritis 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: Arthritis 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 July 12, 2000, 8 a.m. to 
5 p.m.
    Location: Gaithersburg Holiday Inn, Walker and Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD.
    Contact Person: Kathleen R. Reedy or LaNise S. Giles, 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, or e-mail: [email protected], or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 12532. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The Committee will discuss biologics license application 
(BLA) 99-1234, RemicadeTM (infliximab, Centocor) for the 
treatment of rheumatoid arthritis, prevention of radiographic 
progression and prevention of physical disability. The Committee will 
also discuss general issues regarding claims based on radiographic data 
in patients with rheumatoid arthritis.
    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 6, 2000. 
Oral presentations from the public will be scheduled between 
approximately 11

[[Page 35944]]

a.m. and 12 noon. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before July 6, 2000, 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 31, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-14213 Filed 6-5-00; 8:45 am]
BILLING CODE 4160-01-F