6016 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices 

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and 

financial management aspects of 

this notice: Michelle N. Caraffa (see 

ADDRESSES).

Regarding the programmatic aspects 

of this notice: Stephen Toigo, 

Division of Federal-State Relations 

(DFSR), Office of Regulatory Affairs, 

Food and Drug Administration 

(HFC–150), 5600 Fishers Lane, rm. 

12–07, Rockville, MD 20857, 301–

827–6906, or access the Internet at: 

http://www.fda.gov/ora/fed_state/

default.htm. For general ORA 

program information contact your 

Regional Food Specialists at http://

www.fda.gov/ora/fed_state/

DFSR_Activities/

food_specialists.htm

On page 35653 in the first column, 

under section V.A, a sentence is added 

at the end of the paragraph that reads: 

‘‘A Current Listing of SPOCs can be 

found at http://www.whitehouse.gov/

omb/grants/spoc.html.’’

On page 35653 in the third column, 

under section VII, the paragraph is 

revised to read: ‘‘Applicants are 

encouraged to apply electronically (see 

ADDRESSES). If not, the original and two 

copies of the completed grant 

application Form PHS–5161–1 (Revised 

7/00) for State and local governments 

should be delivered to the Grants 

Management Office. The receipt date is 

March 15, 2005. No supplemental 

material or addenda will be accepted 

after the receipt date.’’

On page 35653 in the third column, 

under section VIII.A in the second 

paragraph, the last sentence should 

read: ‘‘FDA is now accepting 

applications via the Internet.’’

Dated: January 31, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2209 Filed 2–3–05; 8:45 am]

BILLING CODE 4160–01–S

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.

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 3, 2005, from 8 a.m. to 

5 p.m. and March 4, 2005, from 8 a.m. 

to 1 p.m.

Location: Hilton, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD.

Contact Person: Johanna M. Clifford, 

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–

7001, FAX: 301–827–6776, e-mail: 

cliffordj@cder.fda.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.

Agenda: On March 3, 2005, the 

committee will do the following: (1) 

Discuss new drug application (NDA) 

21–115, COMBIDEX (ferumoxtran–10), 

Advanced Magnetics, Inc., proposed 

indication for intravenous 

administration as a magnetic resonance 

imaging contrast agent to assist in the 

differentiation of metastatic and 

nonmetastatic lymph nodes in patients 

with confirmed primary cancer who are 

at risk for lymph node metastases, and 

(2) discuss prostate cancer endpoints as 

a followup to the June 2004 FDA 

workshop. On March 4, 2005, the 

committee will do the following: (1) 

Discuss the results of a confirmatory 

trial for NDA 21–399, IRESSA (gefitinib) 

AstraZeneca Pharmaceticals LP, for the 

treatment of patients with locally 

advanced or metastatic nonsmall cell 

lung cancer after failure of both 

platinum-based and docetaxel 

chemotherapies, and (2) discuss safety 

concerns, specifically osteonecrosis of 

the jaw (ONJ), associated with two 

bisphosphonates, NDA 21–223, 

ZOMETA (zoledronic acid) Injection 

and AREDIA (pamidronate disodium for 

injection), both from Novartis 

Pharmaceuticals Corp. ZOMETA is 

indicated for the treatment of patients 

with multiple myeloma and patients 

with documented bone metastases from 

solid tumors, in conjunction with 

standard antineoplastic therapy. 

Prostate cancer should have progressed 

after treatment with at least one 

hormonal therapy. It is also approved 

for hypercalcemia of malignancy. 

AREDIA is indicated, in conjunction 

with standard antineoplastic therapy, 

for the treatment of osteolytic bone 

metastases of breast cancer and 

osteolytic lesions of multiple myeloma. 

It is also indicated for the treatment of 

moderate or severe hypercalcemia 

associated with malignancy, and 

treatment of patients with moderate to 

severe Paget’s disease of bone.

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 by February 28, 2005. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. 

on March 3, 2005, and between 

approximately 10:30 a.m. to 11 a.m. on 

March 4, 2005. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before February 28, 2005, 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.

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 Trevelin 

Prysock at 301–827–7001, at least 7 days 

in advance of the meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: January 27, 2005.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 05–2208 Filed 2–3–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Development of Revised Need for 

Assistance Criteria for Assessing 

Community Need for Comprehensive 

Primary and Preventive Health Care 

Services Under the President’s Health 

Centers Initiative

AGENCY: Health Resources and Services 

Administration, HHS.