[Federal Register: August 25, 2003 (Volume 68, Number 164)]
[Notices]
[Page 51024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au03-48]
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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: topperk@cder.fda.gov, 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