Delegation of Authority, 67148 [06-9264]
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Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices
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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
sroberts on PROD1PC70 with NOTICES
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.
VerDate Aug<31>2005
17:10 Nov 17, 2006
Jkt 211001
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
National Heart, Lung, and
Blood Institute, NIH, HHS.
ACTION: Notice.
AGENCY:
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
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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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[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Page 67148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9264]
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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
