70 FR 68 pgs. 18406-18407 - Oncologic Drugs Advisory Committee; Notice of Meeting
Type: NOTICEVolume: 70Number: 68Pages: 18406 - 18407
FR document: [FR Doc. 05-7130 Filed 4-8-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
This notice announces a forthcoming meeting of a public advisorycommittee of the Food and Drug Administration (FDA). The meeting will beopen to the public.
Name of Committee : Oncologic Drugs AdvisoryCommittee.
General Function of the Committee : To provide advice andrecommendations to the agency on FDA's regulatory issues.
Date and Time : The meeting will be held on May 5, 2005,from 8:30 a.m. to 4:30 p.m.
Location : FDA, Center for Drug Evaluation and ResearchConference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person : Johanna M. Clifford, Center for DrugEvaluation and Research (HFD-21), Food and Drug Administration, 5600Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093),Rockville, MD 20857, 301-827-7001, FAX:301-827-6776, e-mail: cliffordj@cder.fda.gov , orFDA Advisory Committee Information Line, 1-800-741-8138(301-443-0572 in the Washington, DC area), code 3014512542.Please call the Information Line for up-to-date information on thismeeting.
Agenda : The committee will discuss new drug application(NDA) 21-824, proposed trade name ZARNESTRA (tipifarnib) Film CoatedTablets, Tibotec Therapeutics, a Division of Ortho Biotech, L.P., proposedindication for the treatment of elderly patients with newly diagnosedpoor-risk acute myeloid leukemia.
Procedure : Interested persons may present data,information, or views, orally or in writing, on issues pending before thecommittee. Written submissions may be made to the contact person by April28, 2005. Oral presentations from the public will be scheduled betweenapproximately 11:30 a.m. to 12:30 p.m. Time allotted for eachpresentation may be limited. Those desiring to make formal oralpresentations should notify the contact person before April 28, 2005, andsubmit a brief statement of the general nature of the evidence or argumentsthey wish to present, the names and addresses of proposed participants, andan indication of the approximate time requested to make theirpresentation.
Persons attending FDA's advisory committee meetings are advised that theagency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committeemeetings and will make every effort to accommodate persons with physicaldisabilities or special needs. If you require special accommodations dueto a disability, please contact Liza Saavedra 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: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7130 Filed 4-8-05; 8:45 am]
BILLING CODE 4160-01-S