[Federal Register Volume 68, Number 164 (Monday, August 25, 2003)]
[Notices]
[Page 51024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21626]


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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). At least one 
portion of the meeting will be closed 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 September 29, 2003, from 
8 a.m. to 5 p.m.; and on September 30, 2003, from 8 a.m. to 1 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Kimberly Topper, 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, 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: On both days, the committee will discuss the proposed 
systemic lupus erythematosis (SLE) concept paper, a preliminary 
discussion for creating a guidance document for the development of 
drugs, biologics, and devices for the treatment of SLE.
    On September 29, 2003, the committee will discuss the proposed 
sections regarding the current state of the art, the claims for 
treatments, and clinical markers. On September 30, 2003, the meeting 
will be open to the public from 8 a.m. to 11 a.m., and the committee 
will discuss the section concerning clinical trial design. From 11 a.m. 
to 1 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information.
    Procedure: On September 29, 2003, from 8 a.m. to 5 p.m.; and on 
September 30, 2003, from 8 a.m. to 11 a.m., the meeting will be open to 
the public. 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 September 19, 2003. 
Oral presentations from the public will be scheduled on September 29, 
2003, between approximately 12:30 p.m. and 1 p.m., on the topic of 
claims; between approximately 2:45 p.m. and 3:15 p.m., on the topic of 
clinical markers; and on September 30, 2003, between approximately 9 
a.m. and 9:30 a.m., on the topic of trial design. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 19, 
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 desiring to speak who 
have not registered in advanced may be recognized from the floor by the 
Chair.
    Closed Committee Deliberations: On September 30, 2003, from 11 a.m. 
to 1 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    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 Trevelin Prysock at 
301-827-7001 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: August 18, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-21626 Filed 8-22-03; 8:45 am]
BILLING CODE 4160-01-S