13502 Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 

Contact Person: Teresa Watkins, 

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: 

teresa.watkins@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512545. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

the efficacy supplement to new drug 

application (NDA) 21–077 for the 

approved product Advair Diskus 500/50 

(fluticasone propionate/salmeterol 

inhalation powder) by 

GlaxoSmithKline, for the proposed 

indication of increased survival and 

reduced exacerbations in patients with 

chronic obstructive pulmonary disease 

(COPD). 

FDA intends to make background 

material available to the public no later 

than 1 business day 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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and 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 April 11, 2007. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 April 3, 2007. 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 April 4, 2007. 

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 Teresa 

Watkins 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: March 14, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–5194 Filed 3–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

The National Cancer Advisory Board’s 

Breast Cancer Prevention Trail P–4 

Working Group will meet to discuss the 

P–4 trial which is designed to perform 

a 10-year study in risk-eligible, 

postmenopausal women to determine 

whether letrozole is more effective than 

raloxifene in reducing the incidence of 

invasive breast cancer in this otherwise 

healthy population. The meeting will be 

closed to the public. 

The thoughts and input from this 

meeting will be summarized in a report 

that will be presented to the National 

Cancer Advisory Board in open session 

at an upcoming meeting. 

Name of Work Group: National Cancer 

Advisory Board, Breast Cancer Prevention 

Trial P–4 Working Group. 

Closed: March 23, 2007, 8:30 a.m. to 4:30 

p.m. 

Agenda: The purpose of the Work Group 

will be to ensure that funds are invested 

optimally to achieve outcomes that utilize 

the best of clinical and molecular sciences to 

answer key scientific questions, produce 

extremely valuable data sets for the 

community, and, in this instance, provide 

maximal benefit to breast cancer patients. 

Place: Hyatt Regency Building, One Metro 

Center, Bethesda, MD 20814. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Advisory Board, National Cancer Institute, 

National Institutes of Health, 6116 Executive 

Boulevard, 8th Floor, Room 8001, Bethesda, 

MD 20892–8327, (301) 496–5147. 

SUPPLEMENTARY INFORMATION: 

Background 

Over the past several years the 

National Cancer Institute has performed 

a series of important prevention clinical 

trials to study the effects) of tamoxifen, 

raloxifene (Selective Estrogen Receptor 

Modulators—SERMS) and, 

subsequently, aromatase inhibitors such 

as letrozole on reducing the incidence of 

invasive breast cancer in defined 

populations of postmenopausal women. 

As follow-on to this series of breast 

cancer prevention trials, a new trial in 

the sequence, the P–4 trial, has been 

proposed and peer-reviewed. The P–4 

trial is designed to perform a 10-year 

study in risk-eligible, postmenopausal 

women to determine whether letrozole 

is more effective than raloxifene in 

reducing the incidence of invasive 

breast cancer in this otherwise healthy 

population. The trial will accrue 12,800 

patients over 4 years. The primary 

endpoint for this trial will be the first 

occurrence of invasive breast cancer. 

Secondary endpoints will include DCIS; 

LCIS; ischemic heart disease; fracture of 

the wrist, hip, and spine; DVTs; PEs; 

TIAs and stroke; death; other invasive 

cancers; and quality of life. 

P–4 trial is a significant financial 

commitment on the part of the National 

Cancer Institute and of the cancer 

research community. Additionally, the 

outcome of this trail will require more 

than 10 years of study. Given the 

magnitude of this investment, the rapid 

acceleration of progress in molecular 

genetics and molecular biology, and the 

disparate range of views on the trial, the 

National Cancer Advisory Board is 

convening a group of experts to provide 

feedback to the National Cancer 

Advisory Board. 

Any interested person may file 

written comments with the work group 

by forwarding the statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: March 16, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1408 Filed 3–21–07; 8:45 am] 

BILLING CODE 4140–01–M 


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