
[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]               
[Page 42903-42904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au09-79]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

    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.

[[Page 42904]]

    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 October 5, 2009, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The 
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number 
is 301-977-8900.
    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: The committee will discuss the following topics:
    (1) Supplemental biologics license application (sBLA) 103949/
5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by 
Schering Corp. The proposed indication (use) for this product is as 
an adjuvant (additional) treatment for melanoma, a kind of skin 
cancer. The primary treatment for melanoma that is metastatic (has 
spread) to the lymph nodes is surgery to remove both the original 
cancer and lymph nodes surrounding the cancer. PEGINTRON's proposed 
use is as a treatment in addition to, or as an ``adjuvant,'' to 
surgery.
    (2) New drug application (NDA) 022-465, proposed trade name 
VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The 
proposed indication (use) for this product is for the treatment of 
patients with advanced renal cell carcinoma, a form of kidney 
cancer.
    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/
AdvisoryCommittees/Calendar/default.htm. 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 
September 21, 2009. Oral presentations from the public will be 
scheduled between approximately 10:30 a.m. and 11 a.m., and between 
approximately 3:30 p.m. and 4 p.m. 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 September 11, 2009. 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 September 14, 
2009.
    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/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20379 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S
