National Cancer Institute; Notice of Closed Meeting, 10771 [07-1126]

Download as PDF Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Development of Molecular Pharmacodynamic Assays for Targeted Therapies. Date: March 16, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: Marriott Bethesda North Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Rm. 8057, Bethesda, MD 20892–8329, 301– 496–7421, kerwinm@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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 5, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–1123 Filed 3–8–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health jlentini on PROD1PC65 with NOTICES National Cancer Institute; Notice of Closed Meeting The National Cancer Advisory Board’s Breast Cancer Prevention Trial 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 VerDate Aug<31>2005 21:24 Mar 08, 2007 Jkt 211001 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 Bethesda, 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: Frm 00142 Fmt 4703 Sfmt 4703 Any interested person may file written comments with the work group by forwarding the statement to the Contact Person listed in this notice. This 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 5, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–1126 Filed 3–8–07; 8:45 am] BILLING CODE 4140–01–M Background Over the past several years the National Cancer Institute has performed a series of important prevention clinical trials to study the effect(s) 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, post menopausal women to determine wether 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 DCSI; LCIA, ischemic heart disease; fracture of the wrist, hip, and spine; DVTs; PEs; TIAs and stroke; death; other invasive cancers; and quality of life. The 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 trial will require more than 10 years of study. Given the magnitude of this investment, the rapid acceleration of progress is 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. PO 00000 10771 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special Emphasis Panel, GEI Genotyping and Coordinating Centers. Date: March 30, 2007. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Rudy O. Pozzatti, PhD, Scientific Review Administrator, Office of Scientific Review, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, 301–402–0838. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Notices]
[Page 10771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1126]


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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 Trial 
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 Bethesda, 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 
effect(s) 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, post menopausal 
women to determine wether 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 DCSI; LCIA, 
ischemic heart disease; fracture of the wrist, hip, and spine; DVTs; 
PEs; TIAs and stroke; death; other invasive cancers; and quality of 
life.
    The 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 trial will require more than 10 years 
of study. Given the magnitude of this investment, the rapid 
acceleration of progress is 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 in this 
notice. This 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 5, 2007.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 07-1126 Filed 3-8-07; 8:45 am]
BILLING CODE 4140-01-M

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