6016
Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices
FOR FURTHER INFORMATION CONTACT:
Name of Committee: Oncologic Drugs
metastases of breast cancer and
Regarding the administrative and
Advisory Committee.
osteolytic lesions of multiple myeloma.
financial management aspects of
General Function of the Committee:
It is also indicated for the treatment of
this notice: Michelle N. Caraffa (see
To provide advice and
moderate or severe hypercalcemia
ADDRESSES).
recommendations to the agency on
associated with malignancy, and
Regarding the programmatic aspects
FDA's regulatory issues.
treatment of patients with moderate to
of this notice: Stephen Toigo,
Date and Time: The meeting will be
severe Paget's disease of bone.
Division of Federal-State Relations
held on March 3, 2005, from 8 a.m. to
Procedure: Interested persons may
(DFSR), Office of Regulatory Affairs,
5 p.m. and March 4, 2005, from 8 a.m.
present data, information, or views,
Food and Drug Administration
to 1 p.m.
orally or in writing, on issues pending
Location: Hilton, The Ballrooms, 620
(HFC­150), 5600 Fishers Lane, rm.
before the committee. Written
Perry Pkwy., Gaithersburg, MD.
12­07, Rockville, MD 20857, 301­
submissions may be made to the contact
Contact Person: Johanna M. Clifford,
827­6906, or access the Internet at:
person by February 28, 2005. Oral
Center for Drug Evaluation and Research
http://www.fda.gov/ora/fed_state/
presentations from the public will be
(HFD­21), Food and Drug
default.htm. For general ORA
scheduled between approximately 10:30
Administration, 5600 Fishers Lane (for
program information contact your
express delivery, 5630 Fishers Lane, rm.
a.m. to 11 a.m., and 2:30 p.m. to 3 p.m.
Regional Food Specialists at http://
1093), Rockville, MD 20857, 301­827­
on March 3, 2005, and between
www.fda.gov/ora/fed_state/
7001, FAX: 301­827­6776, e-mail:
approximately 10:30 a.m. to 11 a.m. on
DFSR_Activities/
cliffordj@cder.fda.gov, or FDA Advisory
March 4, 2005. Time allotted for each
food_specialists.htm
Committee Information Line, 1­800­
presentation may be limited. Those
On page 35653 in the first column,
741­8138 (301­443­0572 in the
desiring to make formal oral
under section V.A, a sentence is added
Washington, DC area), code
presentations should notify the contact
at the end of the paragraph that reads:
3014512542. Please call the Information
person before February 28, 2005, and
``A Current Listing of SPOCs can be
Line for up-to-date information on this
submit a brief statement of the general
found at http://www.whitehouse.gov/
meeting.
nature of the evidence or arguments
omb/grants/spoc.html.''
Agenda: On March 3, 2005, the
they wish to present, the names and
On page 35653 in the third column,
committee will do the following: (1)
addresses of proposed participants, and
under section VII, the paragraph is
Discuss new drug application (NDA)
an indication of the approximate time
revised to read: ``Applicants are
21­115, COMBIDEX (ferumoxtran­10),
requested to make their presentation.
encouraged to apply electronically (see
Advanced Magnetics, Inc., proposed
Persons attending FDA's advisory
ADDRESSES). If not, the original and two
indication for intravenous
committee meetings are advised that the
copies of the completed grant
administration as a magnetic resonance
agency is not responsible for providing
application Form PHS­5161­1 (Revised
imaging contrast agent to assist in the
access to electrical outlets.
7/00) for State and local governments
differentiation of metastatic and
FDA welcomes the attendance of the
should be delivered to the Grants
nonmetastatic lymph nodes in patients
public at its advisory committee
Management Office. The receipt date is
with confirmed primary cancer who are
meetings and will make every effort to
March 15, 2005. No supplemental
at risk for lymph node metastases, and
accommodate persons with physical
material or addenda will be accepted
(2) discuss prostate cancer endpoints as
disabilities or special needs. If you
after the receipt date.''
a followup to the June 2004 FDA
require special accommodations due to
On page 35653 in the third column,
workshop. On March 4, 2005, the
a disability, please contact Trevelin
under section VIII.A in the second
committee will do the following: (1)
Prysock at 301­827­7001, at least 7 days
paragraph, the last sentence should
Discuss the results of a confirmatory
in advance of the meeting.
read: ``FDA is now accepting
trial for NDA 21­399, IRESSA (gefitinib)
Notice of this meeting is given under
applications via the Internet.''
AstraZeneca Pharmaceticals LP, for the
the Federal Advisory Committee Act (5
treatment of patients with locally
Dated: January 31, 2005.
U.S.C. app. 2).
advanced or metastatic nonsmall cell
Jeffrey Shuren,
lung cancer after failure of both
Dated: January 27, 2005.
Assistant Commissioner for Policy.
platinum-based and docetaxel
Sheila Dearybury Walcoff,
[FR Doc. 05­2209 Filed 2­3­05; 8:45 am]
chemotherapies, and (2) discuss safety
Associate Commissioner for External
BILLING CODE 4160­01­S
concerns, specifically osteonecrosis of
Relations.
the jaw (ONJ), associated with two
[FR Doc. 05­2208 Filed 2­3­05; 8:45 am]
bisphosphonates, NDA 21­223,
BILLING CODE 4160­01­S
DEPARTMENT OF HEALTH AND
ZOMETA (zoledronic acid) Injection
HUMAN SERVICES
and AREDIA (pamidronate disodium for
injection), both from Novartis
DEPARTMENT OF HEALTH AND
Food and Drug Administration
Pharmaceuticals Corp. ZOMETA is
HUMAN SERVICES
Oncologic Drugs Advisory Committee;
indicated for the treatment of patients
Health Resources and Services
Notice of Meeting
with multiple myeloma and patients
Administration
with documented bone metastases from
AGENCY: Food and Drug Administration,
solid tumors, in conjunction with
Development of Revised Need for
HHS.
standard antineoplastic therapy.
Assistance Criteria for Assessing
ACTION: Notice.
Prostate cancer should have progressed
Community Need for Comprehensive
after treatment with at least one
Primary and Preventive Health Care
This notice announces a forthcoming
hormonal therapy. It is also approved
Services Under the President's Health
meeting of a public advisory committee
for hypercalcemia of malignancy.
Centers Initiative
of the Food and Drug Administration
AREDIA is indicated, in conjunction
(FDA). The meeting will be open to the
with standard antineoplastic therapy,
AGENCY: Health Resources and Services
public.
for the treatment of osteolytic bone
Administration, HHS.
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