[Federal Register Volume 75, Number 201 (Tuesday, October 19, 2010)]
[Notices]
[Page 64314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26247]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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.
    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 December 2, 2010, 
from 8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., 
Building 31 Conference Center, the Great Room (rm. 1503), Silver 
Spring, MD 20993-0002. Information regarding special accommodations 
due to a disability, visitor parking, and transportation may be 
accessed at http://www.fda.gov/AdvisoryCommittees/default.htm; under 
the heading ``Resources for You'', click on ``White Oak Conference 
Center Parking and Transportation Information for FDA Advisory 
Committee Meetings''.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, e-mail: [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 301-451-2542. 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 December 2, 2010, during the morning session, the 
committee will discuss biologics license application (BLA) 125377, 
with the proposed trade name Yervoy (ipilimumab), manufactured by 
Bristol-Myers Squibb Company. The proposed indication (use) for this 
product is for the treatment of advanced melanoma in patients who 
have received prior therapy. During the afternoon session, the 
committee will discuss new drug application (NDA) 022-405, with the 
proposed trade name Zictifa (vandetanib) Tablets, manufactured by 
iPR Pharmaceuticals, Inc., represented by AstraZeneca 
Pharmaceuticals LP (authorized U.S. agent). The proposed indication 
(use) for this product is for the treatment of patients with 
unresectable (non-operable) locally advanced or metastatic medullary 
thyroid 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 
November 16, 2010. 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 November 8, 2010. 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 November 9, 2010.
    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: October 14, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-26247 Filed 10-18-10; 8:45 am]
BILLING CODE 4160-01-P