Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices 6015

Act) to appoint a Practicing Physicians 

Advisory Council (the Council) based 

on nominations submitted by medical 

organizations representing physicians. 

The Council meets quarterly to discuss 

certain proposed changes in regulations 

and carrier manual instructions related 

to physicians’ services, as identified by 

the Secretary. To the extent feasible and 

consistent with statutory deadlines, the 

consultation must occur before 

publication of the proposed changes. 

The Council submits an annual report 

on its recommendations to the Secretary 

and the Administrator of the Centers for 

Medicare & Medicaid Services no later 

than December 31st of each year. 

The Council consists of 15 physicians, 

each of whom must have submitted at 

least 250 claims for physicians’ services 

under Medicare in the previous year. 

Members of the Council include both 

participating and nonparticipating 

physicians, and physicians practicing in 

rural and underserved urban areas. At 

least 11 members of the Council must be 

physicians as described in section 

1861(r)(1) of the Act; that is, Statelicensed doctors of medicine or 

osteopathy. The remaining 4 members 

may include dentists, podiatrists, 

optometrists and chiropractors. 

Members serve for overlapping 4-year 

terms; terms of more than 2 years are 

contingent upon the renewal of the 

Council by appropriate action prior to 

its termination. Section 1868(a)(1) of the 

Act provides that nominations to the 

Secretary for Council membership must 

be made by medical organizations 

representing physicians.

The Council held its first meeting on 

May 11, 1992. The current members 

are—Jose Azocar, M.D.; James Bergeron, 

M.D.; Ronald Castellanos, M.D.; Rebecca 

Gaughan, M.D.; Peter Grimm, D.O.; 

Carlos R. Hamilton, M.D.; Dennis K. 

Iglar, M.D.; Joe Johnson, D.C.; 

Christopher Leggett, M.D.; Barbara 

McAneny, M.D.; Geraldine O’Shea, 

D.O.; Laura B. Powers, M.D.; Michael T. 

Rapp, M.D. (Chairperson); Anthony 

Senagore, M.D.; and Robert L. Urata, 

M.D. 

The meeting will commence with the 

swearing-in of three Council members. 

The Council’s Executive Director will 

give a status report and the CMS 

responses to the recommendations made 

by the Council at the November 22, 

2004 meeting and prior meeting 

recommendations. Additionally, 

updates will be provided on the CMS 

Report to the Congress on Contractor 

Reform, and the Physician Regulatory 

Issues Team. In accordance with the 

Council charter, CMS is requesting 

assistance with the following agenda 

topics: 

• Pay for Performance Initiatives. 

• Competitive Bidding on Drugs. 

• Physician Regulation Proposed 

Rule; and 

• Medicare Prescription Drug Benefit: 

CMS’ Physician Education Plan. 

For additional information and 

clarification on these topics, contact the 

Executive Director, listed under the FOR

FURTHER INFORMATION CONTACT section of 

this notice. Individual physicians or 

medical organizations that represent 

physicians wishing to make a 5-minute 

oral presentation on agenda issues must 

contact the Executive Director by 12 

noon (e.s.t.) on February 18, 2005, to be 

scheduled. Testimony is limited to 

agenda topics only. The number of oral 

presentations may be limited by the 

time available. A written copy of the 

presenter’s oral remarks must be 

submitted to John P. Lanigan, 

Designated Federal Official (DFO), no 

later than 12 noon (e.s.t) on February 18, 

2005, for distribution to Council 

members for review prior to the 

meeting. Physicians and medical 

organizations not scheduled to speak 

may also submit written comments to 

the DFO for distribution at the same 

times as listed for oral presentations. 

The meeting is open to the public, but 

attendance is limited to the space 

available. 

Special Accommodations: Individuals 

requiring sign language interpretation or 

other special accommodation must 

contact John P. Lanigan by e-mail at 

JLanigan@cms.hhs.gov or by telephone 

at (410) 786–2312 at least 10 days before 

the meeting.

Authority: (Section 1868 of the Social 

Security Act (42 U.S.C. 1395ee) and section 

10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, 

section 10(a).)

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: January 31, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 05–2175 Filed 2–3–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Conference Grants to Support State 

Food Safety Task Force Meetings; 

Availability of Funds Grants; Request 

for Applications; Correction

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

The Food and Drug Administration 

(FDA) is correcting notice document 04–

14395 beginning on page 35651 in the 

issue of Friday, June 25, 2004, by 

making the following corrections:

On page 35651 in the second column, 

the DATES section is corrected to read: 

‘‘DATES: The application receipt date for 

new applications is March 15, 2005. The 

application receipt date for new 

applications for each subsequent year 

this program is in effect will be March 

15.’’

On page 35651, in the second column, 

the ‘‘ADDRESSES’’ section should read: 

‘‘ADDRESSES: FDA is accepting new 

applications for this program 

electronically via Grants.gov.; 

applicants are strongly encouraged to 

apply electronically by visiting the Web 

site http://www.grants.gov. and 

following the instructions under 

‘‘APPLY.’’ The applicant must register 

in the Central Contractor Registration 

(CCR) database in order to be able to 

submit the application.’’

Information about CCR is available at 

http://www.grants.gov/CCRRegister. The 

applicant must register with the 

Credential Provider for Grants.gov.

Information about this requirement is 

available at http://www.grants.gov/

CredentialProvider. If it is necessary for 

applicants to submit applications other 

than through the electronic process, 

application forms are available from, 

and completed applications should be 

submitted to Michelle Caraffa, Division 

of Contracts and Grants Management 

(HFA–500), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

2129, Rockville, MD 20857, 301–827–

7025, e-mail: mcaraffa@oc.fda.gov. 

Application forms PHS 5161–1 are 

available via the Internet at: http://

www.psc.gov/forms (Revised 7/00). 

Applications handcarried or 

commercially delivered should be 

addressed to 5630 Fishers Lane (HFA–

500), rm. 2129, Rockville, MD 20857. 

An application not received in time for 

orderly processing will be returned to 

the applicant without consideration.

On page 35651, beginning in the 

second column, ‘‘FOR FURTHER

INFORMATION CONTACT’’ should read:

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.