Document ID: FDA-2008-N-0038-0005
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2008-01-25T05:00Z

[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]               
[Page 4580-4581]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja08-80]                         

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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.

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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: Oncologic Drugs 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 March 12, 2008, from 8 
a.m. to 5 p.m. and on March 13, 2008, from 8 a.m. to 4 p.m.
    Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave., 
Gaithersburg, MD, 301-948-8900.
    Contact Person: Nicole Vesely, 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, 301-827-6793, FAX: 301-827-6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 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 this meeting. A notice in the Federal Register about last minute 
modifications that impact a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice. Therefore, you should always check the agency's Web site and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On March 12, 2008, the committee will discuss: (1) Biologic 
license application (BLA) 125268, proposed trade name NPLATE 
(romiplostim), Amgen Inc., proposed indication for the treatment of 
thrombocytopenia in adults with chronic immune (idiopathic) 
thrombocytopenia purpura who are nonspelenectomized and have had an 
inadequate response or are intolerant to corticosteroids and/or 
immunoglobulins; or patients who are splenectomized and have an 
inadequate response to splenectomy, and (2)

[[Page 4581]]

supplemental biologics license application (sBLA) 103949/5153, 
PEGINTRON (peginterferon alfa-2b), Schering Corp., proposed indication 
for adjuvant treatment of melanoma. On March 13, 2008, the committee 
will discuss the cumulative data, including recent study results, on 
the risks of erythropoeisis-stimulating agents when administered to 
patients with cancer. Agents to be discussed include ARANESP 
(darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa, 
Amgen, Inc.), and MIRCERA (methoxy polyethylene glycol-epoetin beta, 
Hoffman-La Roche Inc.). This is a followup to the May 10, 2007, 
Oncologic Drugs Advisory Committee Meeting.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2008 and scroll down to the appropriate advisory committee 
link.
    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 on or before 
February 27, 2008. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. on 
March 12, 2008, and between approximately 1 p.m. to 2 p.m. on March 13, 
2008. Those desiring to make formal oral presentations should notify 
the contact person 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 on or before 
February 19, 2008. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by February 20, 
2008.
    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 Nicole Vesely at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm
 for procedures on public conduct during advisory committee 

meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1295 Filed 1-24-08; 8:45 am]

BILLING CODE 4160-01-S