67148 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices 

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For purpose of access, use the same 

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also specify the record contents being 

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SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

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[FR Doc. E6–19506 Filed 11–17–06; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Delegation of Authority 

Notice is hereby given that I have 

delegated to the Administrator, Health 

Resources and Services Administration 

(HRSA), with authority to re-delegate, 

the authority vested in the Secretary of 

Health and Human Services under Title 

III, Part B, Section 319F–4, titled 

‘‘Covered Countermeasure Process,’’ of 

the Public Health Service Act, as 

amended, by the Public Readiness and 

Emergency Preparedness Act of 2006 

(Pub. L. 109–148), only insofar as it 

pertains to the compensation program. 

This delegation shall be exercised 

under the Department’s existing 

delegation of authority and policy on 

regulations. 

This delegation is effective upon 

signature. In addition, I hereby affirmed 

and ratified any actions taken by the 

HRSA Administrator or other HRSA 

officials which involved the exercise of 

this authority prior to the effective date 

of this delegation. 

This delegation is effective upon date 

of signature. 

Dated: November 8, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 06–9264 Filed 11–17–06; 8:45 am] 

BILLING CODE 4165–15–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute: Circulating Biomarkers of 

Cardiovascular Risk in the NHLBI’s 

Framingham Heart Study 

AGENCY: National Heart, Lung, and 

Blood Institute, NIH, HHS. 

ACTION: Notice. 

SUMMARY: National Heart, Lung, and 

Blood Institute (NHLBI) seeks partners 

in a biomarker consortium to promote 

research on novel serum/plasma/urine 

biomarkers of cardiovascular disease 

(CVD) and related risk factors including 

atherosclerosis, obesity, insulin 

resistance, hypertension, and metabolic 

syndrome. An immediate consequence 

of this project will be the development 

of new diagnostic tests to identify 

individuals at high risk for CVD and its 

risk factors at a time when intervention 

is most feasible. A downstream result of 

the identification of novel biomarkers of 

CVD (and its risk factors) will be the 

discovery of disease promoting 

pathways, which may serve as new 

therapeutic targets for treating and 

preventing our nation’s leading cause of 

death. 

Background: Despite steady declines 

in CVD mortality, CVD remains the 

leading cause of death in the developed 

world. The NHLBI’s Framingham Heart 

Study (FHS) has been instrumental in 

the identification and elucidation of key 

modifiable risk factors for CVD, which 

in turn have facilitated modern 

approaches to the prevention and 

treatment of CVD. Because of its 

prospective study design, the NHLBI’s 

FHS is ideally positioned to enable 

identification of novel risk factors for 

CVD. The availability of frozen serum/ 

plasma/urine samples from over 7000 

FHS participants in the Offspring and 

Third Generation cohorts, in concert 

with new high-throughput quantitative 

biomarker technology available from 

commercial collaborators, provides a 

unique opportunity to explore the 

biochemical signatures of key CVD 

phenotypes. In addition, by the end of 

2007 genotyping of 550k SNPs will be 

completed in nearly all the FHS 

participants as part of the NHLBI’s 

SHARe project and these data will 

permit analysis of the associations of 

gene variants with biomarker levels. 

Scientific Scope: The proposed study 

will measure 150 or more evolving and 

novel biomarkers from the FHS in 7000 

FHS subjects for whom subclinical and 

clinical CVD and its risk factors have 

been carefully characterized. Analyses 

will be conducted for association of 

biomarkers—individually and 

collectively—with clinically relevant 

phenotypes. 

The aims of the project are to: 

1. Identify the biochemical signature 

of atherosclerosis as determined by: (a) 

Aortic and coronary calcification on CT 

(data available in 3500 people), (b) 

aortic plaque burden by MRI (n=2000), 

(c) carotid intimal-medial thickness by 

ultrasound (n=3500), (d) clinical 

atherosclerotic CVD (n=500), and (e) the 

dynamic balance between arterial 

calcification and bone demineralization 

(n=3500). 

2. Identify the biochemical signature 

of metabolic syndrome components 

including (a) systolic and diastolic 

blood pressure (n=7000), (b) obesity 

(n=7000) and visceral adiposity by CT 

(n=3500), (c) dyslipidemia (n=7000), 

and (d) impaired fasting glucose, 

diabetes, and insulin resistance. 

Biomarkers for this project will be 

selected by expert consensus on the 

basis of (a) a careful review of the 

literature for biomarkers of 

atherosclerosis and metabolic 

syndrome, and (b) genes implicated in 

atherosclerosis and metabolic syndrome 

(and their constituent components and 

pathways), or showing evidence of 

association with the phenotypes of 

interest. 

Technology: As part of this project, 

new quantitative tests will be developed 

to measure circulating biomarker levels 

using antibody sandwich assays and/or 

proteomic approaches that are amenable 

to high throughput application. Critical 

to this project is the implementation of 

methods to measure large numbers of 

biomarkers with minimal sample 

volume; proteomic, bead-linked 

immunoassays, and nanotechnology 

methods may be necessary to 

accomplish this aim. Pathways to be 

studied include but are not limited to: 

Adhesion/chemoattraction, adipokines, 

cytokines, growth factors, heat shock 

proteins, inflammation, lipoproteins, 

neurohormones, thrombosis/ 

fibrinolysis, and vascular calcification. 

Demonstrated rigorous assay validation 

using non-FHS samples will be 

necessary before FHS biospecimens can 

be used for this project. 

Study Sample: The NHLBI’s FHS is 

community-based[N1], which should 

contribute to the generalizability of 


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