[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30045-30046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12870]


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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.

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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 July 20, 2010, from 8 
a.m. to 3 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Nicole Vesely, c/o Melanie Whelan, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver 
Spring, MD 20993-0002, FAX: 301-847-8737, to reach by telephone before 
June 8, 2010, please call 301-827-7001; to reach by telephone after 
June 8, 2010, please call 301-796-9001, e-mail: 
[email protected], 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 July 20, 2010, the committee will discuss supplemental 
biologics license applications (sBLAs) 125085/191 and 192 for AVASTIN 
(bevacizumab), manufactured by Genentech, Inc. The two proposed 
indications (uses) for this product are: (1) First-line treatment of a 
subgroup of women with metastatic breast cancer known as HER2-negative 
breast cancer, in combination with the chemotherapy drug docetaxel; and 
(2) first-line treatment of HER2-negative metastatic breast cancer in 
combination with one of two classes of chemotherapy drugs, known as 
taxanes and anthracyclines, or with the chemotherapy drug, 
capecitabine. In addition to the discussion of these two indications, 
the committee will also consider the impact of the submitted studies on 
the conversion from accelerated to regular approval of the indication 
for the treatment, in combination with the chemotherapy drug 
paclitaxel, of patients who have not received chemotherapy for their 
locally recurrent or metastatic HER2 negative breast 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 July 
6, 2010. Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. to 1:30 p.m. Those desiring to make formal 
oral presentations should

[[Page 30046]]

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 June 
25, 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 June 28, 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: May 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-12870 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S