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|CDER||September 29, 2003
September 30, 2003
|8 a.m. - 5 p.m.
8 a.m. - 1 p.m.
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.
Background material will become available no later than the day before the meeting and will be posted under the Dockets Management Branch web site (Select the appropriate committee link.)
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(ac)(4)).
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. 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.
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 email: firstname.lastname@example.org, 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.
[Full FR Notice]