NHLBI Topics and Funding Opportunities in PHS 2006-2 Omnibus
Solicitation of the National Institutes of Health, Centers for Disease
Control and Prevention, and Food and Drug Administration for

SBIR and STTR Grant Applications

National Center on Sleep Disorders Research

The National Center on Sleep Disorders Research (NCSDR) was established
within the National Heart, Lung, and Blood Institute (NHLBI) as a result
of the National Institutes of Health (NIH) Revitalization Act of 1993.
Its mandate is to conduct and support research, training, health
information dissemination, and other activities with respect to sleep
disorders, including biological and circadian rhythm research, basic
understanding of sleep, chronobiological and other sleep related
research and to coordinate the activities of the Center with similar
activities of other Federal agencies, including the other agencies of
the National Institutes of Health, and similar activities of other
public entities and nonprofit entities.

Three specific types of research are emphasized: basic research using
state-of-the-art approaches to elucidate the functions of sleep and the
fundamental molecular and cellular processes underlying sleep;
patient-oriented research to improve the diagnosis and treatment of
sleep disorders; and applied research to evaluate the scope and health
consequences of sleepiness and sleep disorders.

Research opportunities of potential interest to small businesses may
include, but are not limited to the following examples:

A. Portable instrumentation for diagnostic in-home assessment of sleep
disorders especially sleep disordered breathing.

B. Countermeasures for excessive daytime sleepiness, including methods
that alter the output of the circadian clock to optimize sleep and
wakefulness.

C. New technologies and instrumentation scaled for high-throughput
phenotypic characterization of sleep in mice.

D. High volume, inexpensive assays to assess variations in gene
expression related to circadian and behavioral state (sleep and
wakefulness) related .

E. Improved methods for the diagnosis of sleep disordered breathing in
infants, children, and adults.

F. Educational interventions to improve worksite productivity and school
performance through the prevention and management of insufficient sleep
and poor sleep environment conditions.

G. Portable inexpensive devices for ambulatory assessment of both sleep
and physical activity in population-based biomedical research studies.

H. Methods to improve patient compliance with sleep disordered breathing
treatments.

I. New pharmacological for the treatment of sleep disorders, especially
sleep disordered breathing.

J. Noninvasive imaging technologies to assess neurophysiological and
regional brain blood flow changes associated with sleep disorders and
other causes of excessive daytime sleepiness.

For additional information on research topics, please see the National
Sleep Disorders Research Plan
(<http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/index.html>) and
contact:

Mr. Al Golden, MPH

Public Health Advisor

National Center on Sleep Disorders Research

NHLBI, 6701 Rockledge Drive

Bethesda, MD 20892

\(301\) 435-0199; Fax: (301) 480-3451

Email: <goldena@nhlbi.nih.gov>

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI plans, conducts and supports research, clinical trials and
demonstration and education projects related to the causes, prevention,
diagnosis and treatment of heart, blood vessel, lung, and blood diseases
and sleep disorders. The NHLBI SBIR/STTR program fosters basic, applied,
and clinical research on all product and service development related to
the mission of the NHLBI. Research may be targeted to gender, race, or
age subgroups.

For more specific information about areas of interest to the NHLBI,
please visit our home page at
[http://www.nhlbi.nih.gov](http://www.nhlbi.nih.gov/).

Research topics of interest include, but are not limited to research and
development under the following specific initiatives as well as the
topic areas listed under each of the NHLBI Divisions below:

New Technology for Proteomics and Glycomics

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-128.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-129.html> (STTR)

Directed Stem Cell Differentiation for Cell Based Therapies for Heart,
Lung, Blood, and Aging Diseases. See:
[http://grants.nih.gov/grants/guide/
pa-files/PA-06-124.html](http://grants.nih.gov/grants/guide/pa-files/PA-06-124.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-125>
(STTR)

Bioengineering Approaches to Energy Balance and Obesity.

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-055.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-056.html> (STTR)

Technologies for Monitoring and Performing Resuscitation.

See: [http://grants.nih.gov/grants/
guide/pa-files/PA-06-126.html](http://grants.nih.gov/grants/guide/pa-files/PA-06-126.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-127>
(STTR)

Integration of Heterogeneous Data Sources

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-011.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-010.html> (STTR)

Bioengineering Nanotechnology Initiative

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-009.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-008.html> (STTR)

Small Business Innovation Research to Improve the Chemistry and Targeted
Delivery of RNAi Molecules

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-003.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-004.html>

Manufacturing Processes of Medical, Dental, and Biological Technologies

See: <http://grants.nih.gov/grants/guide/pa-files/PA-06-013.html> (SBIR)
and

<http://grants.nih.gov/grants/guide/pa-files/PA-06-012.html> (STTR)

Research Supplements to Promote Diversity in Health Related Research

See: <http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html>

Phase II Competing Renewal Awards

The NHLBI will accept Phase II SBIR Competing Renewal grant applications
from NHLBI-supported Phase II SBIR awardees that propose to perform
research required to obtain Food and Drug Administration (FDA)
acceptance or approval of the Phase II product in the form of an
Investigational New Drug (IND), Investigational Device Exemption (IDE),
510K, Pre-market Approval (PMA) or a Humanitarian Device Exemption
(HDE). This renewal grant should allow small businesses to get to a
stage where interest and investment by third parties is more likely.
Such products include, but are not limited to biological products,
devices, drugs, vaccines, medical implants, etc. related to the mission
of the NHLBI. The Competing Renewal application must be a renewal and
logical extension of a previously completed NHLBI-supported Phase II
(R44) SBIR grant. NHLBI grantees seeking SBIR Phase II Competing Renewal
funding must submit an application no later than the first six receipt
dates following expiration of the previous Phase II project budget
period.

Budgets up to \$1,000,000 total costs per year and time periods up to 3
years may be requested for this Phase II Competing Renewal opportunity.
An applicant must provide evidence that their research plan and
objectives follow FDA guidance for the development of a drug, biologic,
or medical device. Examples of acceptable FDA guidance includes, but is
not limited to, published guidelines and direct letters of communication
from FDA personnel for an investigational new drug (IND) application,
investigational device exemption (IDE), 510K, Pre-Market Approval (PMA),
or Humanitarian Device Exemption (HDE). The applicant should also
provide the status of their project in a timeline related to Federal
regulatory approval processes. An updated commercialization plan is also
required.

Prospective applicants are strongly encouraged to contact NHLBI program
staff prior to submission of an SBIR Phase II Competing Renewal
application. Although it is not required, prospective applicants are
strongly encouraged to submit to the program contact a letter of intent
that includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

Examples of research that would be considered responsive to this
announcement are listed below for illustrative purposes and are not
exclusive of other appropriate activities.

-   FDA-required pre-clinical studies beyond those conducted under the
    Phase I (R43) and initial Phase II (R44) grants.

-   Completion of pre-clinical and clinical studies required by the FDA
    for an Investigational New Drug (IND) application and New Drug
    Application (NDA).

-   FDA-required pre-clinical and clinical safety and effectiveness
    studies of medical devices and tissue engineered products for an IDE
    or Pre-market Approval (PMA).

-   FDA-required biocompatibility studies of surface materials of
    putative medical implants or other studies needed for 510k approval.

-   FDA-required assessments of novel imaging systems.

Heart and Vascular Diseases

The Division of Heart and Vascular Diseases plans and directs the
NHLBI\'s research grant, contract, and training programs in heart and
vascular diseases. These programs encompass institute- and
investigator-initiated basic research, targeted research, specialized
centers and clinical trials. The DHVD maintains surveillance over
developments in its program areas and assesses the national need for
research on the causes, prevention, diagnosis, and treatment of
cardiovascular disease. The DHVD ensures that effective new techniques,
treatments and strategies resulting from medical research are
transferred to the community through professional, patient, and public
education programs in a timely manner.

The Division has three major programs: the Heart Research Program, the
Vascular Biology Research Program, and the Clinical & Molecular Medicine
Program, in addition to a Research Training and Special Programs Group.

*[Heart Research Program]{.underline}*. Supports basic, applied, and
clinical research in cardiac diseases, from embryonic life to adulthood.

*[Vascular Biology Research Program]{.underline}*. Supports research in
atherosclerosis, hypertension, cerebrovascular disease, cardiovascular
complications of diabetes and obesity, basic vascular biology and gene
and cell-based therapy for the prevention and/or treatment of vascular
diseases.

*[Clinical & Molecular Medicine Program]{.underline}*. Supports
clinical, basic and engineering research on cardiovascular disease and
health. Its scope includes genetic, genomic and proteomic research;
cellular and molecular imaging; engineering theory and practice applied
to biology and medicine including therapeutic cardiovascular devices and
diagnostic instrumentation; nanotechnology; informatics and simulation;
and cohort, case-control, and randomized clinical trials.

Research topics of interest to the Division of Heart and Vascular
Diseases include but are not limited to the following:

A. Materials and Devices

1\. Angioscopes with increased flexibility and enhanced resolution.

2\. Medical implants (heart valves, vascular grafts, stents, pacemakers,
defibrillators, etc.).

a\. Novel designs and materials.

b\. Failure prediction/analysis.

c\. Manufacturing.

d\. Monitoring.

e\. Preservation methods.

f\. Quality assurance and quality control.

g\. Reference biomaterials for evaluation of biocompatibility.

h\. Reliability.

i\. Biological response

3\. Circulatory support systems.

a\. Artificial heart.

b\. Ventricular assistance.

c\. Automatic control.

d\. New animal models for in vivo testing.

e\. Percutaneous and transcutaneous transmission of electrical energy.

f\. Implantable rechargeable batteries and alternate power sources.

4\. Biological, chemical, and mechanical sensors.

5\. Diagnostic instrumentation for the mouse and rat.

B. Methods

1\. Resuscitation-enabling technologies.

2\. Tissue engineering approaches and technologies that can be used to
engineer functional tissue for repair or replacement of damaged or
diseased tissue.

3\. Development of phenotypic screening methods in the mouse for heart,
lung, and blood diseases and sleep disorders.

4\. Animal models for assessing genetic determinants of disease.

5\. Animal models of cardiovascular complications of diabetes mellitus.

6\. Nutrition and dietary interventions, products, software and
databases.

7\. Lipid measurements and standardization in fresh human serum, without
matrix effects.

8\. Systems biology approaches to study complex disease.

9\. Computational modeling approaches to study vessel wall biology.

10\. Mathematical and computer modeling of structure, function, and
electrical activity of the normal and diseased heart.

11\. Computer modeling of hemodynamics in complex congenital heart
disease.

12\. Metabolomics

13\. Development of new and improved antisense agents and RNA
interference (RNAi) technologies for cardiovascular disease therapies.

14\. Gene and gene product relationship, structure, and function.

15\. Gene discovery technologies.

16\. Genetics of complex diseases\--gene/gene and gene/environment
interactions.

17\. Gene assessment and diagnostic technologies.

18\. Non-invasive methods of detecting cardiac rejection, particularly
in infants and young children.

19\. Non-toxic and selective molecular cages for delivering short-lived
vasoactive agents to the vasculature.

20\. Preservation methods for cardiovascular tissues or organs for use
in transplantation and in research studies.

21\. Technologies to assess energy balance and control weight.

22\. Luminescent dyes to measure toxic metabolic intermediates in living
cells in real time.

23\. Novel use of information technology to enhance adherence to medical
regimens or promote translational research.

24\. Optimization of implantable defibrillator algorithms for arrhythmia
prediction, efficient intervention, device fault detection or early
failure detection.

25\. Methods to increase success of cardiac xeno-transplants.

26\. Methods to induce tolerance to cardiac allografts.

27\. Non-invasive methods to diagnose cardiac allograft vasculopathy.

28 Animal models of cerebrovascular disease.

29\. Novel techniques to study cerebrovascular disease.

C. Diagnostics and Treatment

1\. Non-invasive diagnostic test for salt sensitivity.

2\. Pharmacogenetics/Pharmacogenomics and personalized medicine.

3\. Vascular and renal tubular fluid dynamics, non-invasive assessment.

4\. Heart failure, early detection and treatment strategies.

5\. Anti-hypertensive drugs from natural and synthetic sources.

6\. Pro- and anti-angiogenic and vasculogenic genes, proteins and drugs.

7\. Development of viral and non-viral vectors for gene therapy for
cardiovascular diseases.

8\. Vaccines for the prevention or treatment of atherosclerosis.

D. Imaging

1\. Molecular imaging including imaging to detect gene expression.

2\. New medical imaging systems, enhancements and applications.

3\. Imaging characterizing vessel walls and lesions.

4\. Neuro-imaging in hypertension.

5\. Radiologic phantoms mimicking the human cardiovascular system.

6\. Specific agents for high resolution imaging of the human lymphatic
system.

Lung Diseases

The NHLBI Division of Lung Diseases (DLD) maintains surveillance over
developments in pulmonary research and assesses the Nation\'s need for
research on the causes, prevention, diagnosis, and treatment of
pulmonary diseases. Also within the purview of the Division are:
technology development, application of research findings, and research
training and career development in pulmonary diseases. The DLD plans and
directs the research and training programs which encompass basic
research, applied research and development, clinical investigations,
clinical trials, and demonstration and education research. Two programs
comprise the Division of Lung Diseases: the Airway Biology and Disease
Program, and the Lung Biology and Disease Program.

*[Airway Biology and Disease Program]{.underline}*. Focuses on basic and
clinical research, education and training related to chronic obstructive
pulmonary diseases, asthma, cystic fibrosis, control of breathing,
bronchiolitis, respiratory neurobiology, sleep, and other adult airway
diseases.

*[Lung Biology and Disease Program]{.underline}*. Supports research,
education, and training programs in lung cell and vascular biology; lung
growth and development and pediatric lung disease; acute lung injury and
critical care medicine; interstitial lung diseases, including pulmonary
fibrosis and sarcoidosis; and AIDS and tuberculosis.

Research topics of interest to the Division of Lung Diseases include but
are not limited to the following:

A. Diagnostic Tools.

1\. Computer algorithms for reading and comparing chest radiographs and
scans (computed tomography, radioisotopes, etc.) using digitized images.

2\. Diagnose and treat respiratory abnormalities during sleep in
infants, children, and adults.

3\. Imaging techniques to monitor lung cell functions in vivo.

4\. Non-invasive measurement of blood gases, hemodynamics and
respiratory function in infants, in children, and in adults.

5\. Non-invasive methodologies for measuring airways inflammation in
asthma.

6\. Non-invasive markers of lung disease activity.

7\. Non-invasive methods to detect pulmonary thromboembolism,
hypertension, and edema.

8\. Probes to monitor peripheral tissue oxygenation in vivo.

9\. Use of ambulatory monitoring techniques to diagnose and manage
respiratory disorders of sleep.

10\. Computerized tomography to quantify and monitor pulmonary disease
processes.

11\. Novel methods for bioassays.

B. Information and Health Education Tools.

1\. Computer technologies to promote adoption and implementation of
asthma clinical practice guidelines in medical practice.

2\. Health education methodologies for patients, families, or
communities to prevent or cope with lung diseases or to reduce their
impact, especially among people with asthma who are minorities or living
in poverty.

3\. Improve smoking cessation programs.

4\. Information systems to coordinate patient management and monitoring
among patients and health care professionals.

5\. Interventions to reduce passive smoking in infants and children.

6\. Use of interactive and computer technology to teach self management
to asthma and chronic obstructive lung disease patients.

7\. Health education interventions on the recognition, management, or
prevention of problem sleepiness and sleep disorders for the public,
physicians, and other health care professionals.

C. Materials and Devices.

1\. Blood substitutes to improve gas exchange.

2\. Emergency, portable, and servo-controlled ventilatory support
devices.

3\. Improved aerosol delivery systems.

4\. Improved devices for continuous oxygen administration, including
airline travel.

5\. Improved extracorporeal or implantable devices for blood gas
exchange (artificial lung).

6\. New approaches and technologies that can be used to engineer
functional tissue, in vitro, for replacement or repair of damaged or
diseased lung tissue, in vivo.

7\. Personal exposure monitors for aeroallergens and other environmental
pollutants.

8\. Personal exposure monitors for measures of environmental exposures.

9\. Thrombo-resistant materials for extracorporeal or implantable
devices for blood gas exchange and for indwelling catheters.

D. Methods.

1\. "Clean" animal models for Pneumocystis carinii infections.

2\. Culture Pneumocystis carinii in vitro.

3\. Determine viability and enumeration of infectious Pneumocystis
carinii organisms.

4\. Development and standardization of in vitro systems for the study of
pulmonary epithelial (airway) cells and pulmonary endothelial (vascular)
cells.

5\. Identification of genes causing and modifying lung diseases.

6\. Identify and detect lung cell specific differentiation markers.

7\. Identify lung stem cell types.

8\. Identify species and strain differences of Pneumocystis carinii.

9\. Isolate, identify, and characterize cells found in pulmonary
granulomas.

10\. Methods to monitor levels of alertness or sleepiness continuously
over extended periods of time.

11\. Three-dimensional static, mathematical, cell culture models of
airways and alveoli to define parameters determining aeropollutant
absorption, deposition, and effects.

12\. Develop technologies and tools for use in genomic or proteomic
investigations of pulmonary diseases.

E. Treatments.

1\. Delivery of specific drugs (e.g., antioxidants, artificial
proteinase inhibitors, surfactant) and cell-based reagents to the lungs
for treatment of pulmonary and non-pulmonary diseases.

2\. Gene therapy for cystic fibrosis, alpha1antitrypsin deficiency,
primary pulmonary hypertension, and other inborn errors of metabolism
affecting the lungs.

3\. Improved aerosol delivery systems.

4\. Novel pharmacologic and gene therapy approaches for asthma, acute
lung injury, idiopathic pulmonary fibrosis, and bronchopulmonary
dysplasia.

5\. Novel pharmacologic approaches for treatment of sleep apnea.

6\. Pharmacological means of stimulating growth and repair of alveoli
and reparative or restorative elastogenesis in lungs suffering
emphysematous changes.

Blood Diseases and Resources

The NHLBI Division of Blood Diseases and Resources (DBDR) plans and
directs research and research training and career development programs,
emphasizing non-malignant blood diseases and disorders of thrombosis and
hemostasis. The Division also has a major responsibility to improve the
adequacy and safety of the nation\'s blood supply and to advance the
study of stem cell biology and disease and novel cellular therapies. The
Division has three major programs, the Blood Diseases Program, the
Thrombosis and Hemostasis Program, and the Blood Resources Program.

*[Blood Diseases Program]{.underline}*. Supports research and training
for sickle cell disease, thalassemia, aplastic anemia and other red cell
disorders from basic research on globin genes to clinical management.

*[Thrombosis and Hemostatis Program.]{.underline}* Supports research and
training in occlusive disorders involved in deep vein thrombosis, in
cardiovascular diseases and stroke, and in bleeding disorders.

*[Blood Resources Program]{.underline}*. Supports research and training
in transfusion medicine, stem cell biology and disease, and clinical
cellular medicine.

Research topics of interest to the Division of Blood Diseases and
Resources include but are not limited to the following:

A. Animal models for blood diseases such as:

1\. Anemias including: sickle cell disease, thalassemia, Fanconi anemia,
Diamond Blackfan anemia, and other congenital anemias.

2\. Bleeding disorders including: hemophilia, von Willebrand disease,
and thrombocytopenia.

3\. Platelet diseases.

4\. Thrombosis and thrombolysis.

5\. Hereditary hemorrhagic telangiectasia.

6\. Paroxysmal nocturnal hemoglobinuria.

7\. Hemochromatosis.

8\. Myelodysplastic syndrome (MDS) and myeloproliferative disorders
(MPD).

9\. Hematologic malignancies.

B. Tools, reagents, and assays for hematologic research in mouse and
other animals.

1\. Nanotechnologies.

2\. Non-invasive approaches to analytes.

C. Assays and technologies for:

1\. Automated screening of therapeutic agents for blood diseases.

2\. Anti-thrombotic drug monitoring and thrombosis screening.

3\. Platelet functional tests.

4\. von Willebrand disease.

5\. Thrombotic Thrombocytopenia Purpura (TTP).

6\. Multiplexed system for hemostatic factors, cytokines, and
inflammatory agents.

7\. Iron overload.

8\. Blood-borne infectious agents transmitted by blood transfusion,
including agents of transmissible spongiform encephalopathies and
Creutzfeldt-Jakob Disease (CJD).

9\. Diagnosis of inherited blood disorders.

10\. Prolonging the in vivo lifetime of transfused red cells for
therapeutic uses.

11\. In vitro inactivation or removal of microorganisms from blood,
blood components, and plasma derivatives.

12\. Platelet storage methods that preserve biological efficacy.

13\. Synthesizing, screening, and evaluating the safety and efficacy of
therapeutic oxygen carriers.

14\. Synthesizing or purifying plasma proteins for therapeutic use.

15\. Measuring iron non-invasively.

16\. Non-invasive measurement of blood cell counts or other blood
components.

D. Drugs to Treat Hematologic Diseases and Cytopenic States

1\. Anti-coagulants.

2\. Anti-thrombotic agents.

3\. Anti-sickling agents or other pharmacologic approaches to sickle
cell disease.

4\. Fetal hemoglobin enhancing agents.

5\. Fibrinolytic and anti-fibrinolytic agents.

6\. Iron chelators.

7\. Replacement agents for hematologic factor deficiencies.

E. Cellular Therapies

1\. Expansion of cell populations.

2\. Production and standardization of immune-modulating cytokines or
monoclonal antibodies.

3\. Development of in vivo techniques to monitor survival, growth and
development of engrafted cells.

4\. Animal models for the demonstration of safety and efficacy of novel
cellular therapies.

F. Gene therapy vectors and delivery systems for the treatment of
hematologic genetic diseases.

G. Prothrombotic and hemorrhagic biomarkers and risk factors.

H. Computational models for blood diseases.

I. Bioinformatics to store and analyze genes, proteins, and biomarkers
for hemostasis.

J. Equipment and procedures for the collection, separation, processing,
preservation, storage, and distribution of blood and blood components.

K. Patient and physician health education programs to improve patient
management and to prevent or reduce the impact of blood diseases.

L. Public Health Education.

1\. Tutorials for community-based providers.

2\. Community health education programs in sickle cell disease, suitable
for use in faith-based organizations or other community settings.

M. Newborn Screening.

1\. Genetic counseling programs for families of infants with
hemoglobinopathies or trait.

2\. Innovative data or surveillance systems to track follow-up and
patient outcomes.

Epidemiology and Clinical Applications

The NHLBI Division of Epidemiology and Clinical Applications (DECA)
plans and directs programs in epidemiologic studies, clinical trials of
cardiovascular therapies, basic and applied behavioral research,
demonstration and education research, and projects for disease treatment
and prevention as well as health promotion, including large scale
clinical trials. The research supported by the Division provides
multidisciplinary approaches to heart and blood vessel, lung, and blood
diseases, and sleep disorders with a primary focus on cardiovascular
disease.

DECA comprises two programs, the Clinical Applications and Prevention
Program and the Epidemiology and Biometry Program, as well as the Office
of Biostatistics Research.

*[Clinical Applications and Prevention Program]{.underline}*. Supports
research into prevention and treatment of heart and vascular, pulmonary,
and blood diseases through activities such as efficacy and effectiveness
clinical trials, health promotion/disease prevention trials, community
intervention studies, nutrition research, and behavioral medicine
research.

*[Epidemiology and Biometry Program]{.underline}*. Supports and conducts
epidemiological studies of heart and vascular, lung, and blood diseases
in defined populations.

Research topics of interest to the Division of Epidemiology and Clinical
Applications include but are not limited to the following:

A. Clinical research/intervention studies designed to improve
cardiovascular disease outcomes.

1\. Approaches to facilitating adoption of evidence-based guidelines.

2\. Approaches to reducing clinical inertia in implementation of
evidence-based guidelines for control of cardiovascular risk factors,
including hypertension.

3\. Approaches to improving care of cardiovascular patients
transitioning from hospital to ambulatory or home care.

4\. Approaches to improving prevention and treatment of ischemic heart
disease (IHD), including prevention of recurring events and optimization
of functional capacity in patients with IHD.

B. Clinical trial methodologies.

C. Community education and demonstration research studies.

D. Studies of cardiovascular disease information, education, prevention,
and treatment systems for use in primary medical care and home care,
including care by family caregivers.

E. Interactive databases.

F. Measures of patient adherence/compliance.

G. Assessment of polypharmacy, particularly for the elderly.

H. Methods for:

1\. Lifestyle intervention, including matching patients to lifestyle,
intervention, or treatment.

2\. Health-care systems and outcomes research, including development of
new quality measures for evidence-based cardiovascular health care.

3\. Quantitative measurement systems for behavioral and lifestyle
variables, e.g., diet and physical activity.

I. Models of behavior modification and other approaches to behavior
change.

J. Interventions in patients to promote healthy lifestyles, adherence to
medications, and cardiac rehabilitation, including stress and exercise.

K. Treatment agents or strategies, including medications and devices.

L. Assay systems/techniques to measure patient responses to behavioral
or medical interventions.

M. Materials, equipment and software for enhanced medical Imaging
systems.

N. Methods for communication of research results.

O. Methods for collection, transmission, management and analysis of
clinical data.

P. Nutrition, physical activity, obesity, stress reduction and smoking
cessation interventions.

Q. Nutrition and physical activity measurement methods and devices.

R. Pharmaceutical development and toxicologic evaluation.

S. Population tracking mechanisms.

T. Psychosocial measurement instruments, especially in minority
populations, including chronic social stress, depression, and
discrimination.

U. Communication techniques for minority and low-income populations.

V. Prognostic assays.

W. Quality of life measurement and analytic methods.

X. Software for:

1\. Clinical trials.

2\. Epidemiology studies.

3\. Literature abstracting.

4\. Meta-analysis

5\. Statistical analysis.

6\. Shared clinical decision-making.

7\. Monitoring and providing feedback to patients and providers in
clinical care settings.

8\. Analysis of context-dependent genetic effects.

9\. Longitudinal data analysis

10\. Microarray data analysis.

11\. Automated systems for genotyping quality control and error
checking.

Y. Screening, assessment, and tracking tools including biomarkers for
hypertension, coronary heart disease, heart failure and other
cardiovascular risk factors and diseases.

Z. Survey questionnaires.

AA. Training techniques and modules.

BB. Interactive web-based programs for health promotion.

CC\. Computerized systems to support evidence-based clinical practice in
prevention and treatment of hypertension, coronary heart disease, heart
failure and other cardiovascular risk factors and diseases.

DD. Biomarkers for long term exposure to environmental factors including
diet, physical activity, smoking, alcohol, and contaminants.

EE. Measures of gene expression in individuals.

FF. Cell immortalization, storage and distribution service.

GG. Standardized assays of glycosolated hemoglobin.

HH. Better measures of impaired glucose tolerance.

II\. Simplified measures of sleep useful for population based studies.

JJ. Better measures of heart failure, including diastolic heart failure.

KK. Measures of small vessel disease.

Other Research Topic(s) Within the Mission of the Institute

For additional information on research topics, contact:

***Heart and Vascular Diseases***

J. Timothy Baldwin, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 9150

Bethesda, MD 20892-9150

\(301\) 435-0513, Fax: (310) 480-1335

Email: <baldwint@nhlbi.nih.gov>

Pothur R. Srinivas, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 10188

Bethesda, MD 20892-7940

\(301\) 435-0550, Fax: (310) 480-2858

Email: <srinivap@nhlbi.nih.gov>

Bishow Adhikari, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9161

Bethesda, MD 20892-9150

Phone: 301-435-0513

Fax: (301) 435-1335

Email: <adikarb@nhlbi.nih.gov>

***Lung Diseases***

Ms. Ann Rothgeb

Division of Lung Diseases

6701 Rockledge Drive, Room 10124

Bethesda, MD 20892-7952

\(301\) 435-0202, Fax: (301) 480-3557

Email: <ar31t@nih.gov>

***Blood Diseases and Resources***

Ms. Phyllis Mitchell

Division of Blood Diseases and Blood Resources

6701 Rockledge Drive, Room 10166

Bethesda, MD 20892-7950

\(301\) 435-0481, Fax: (301) 480-1060

Email: <pm154p@nih.gov>

***Epidemiology and Clinical Applications***

Dr. Paula Einhorn

Division of Epidemiology and Clinical Applications

6701 Rockledge Drive, Room 8111

Bethesda, MD 20892-7938

\(301\) 435-0563, Fax: (301) 480-1773

Email: <einhornp@nhlbi.nih.gov>

For program information, contact:

Ms. Susan Pucie

Division of Blood Diseases and Resources

6701 Rockledge Dr

Two Rockledge Ctr, Room 10166

Bethesda, MD 20892-7950

\(301\) 435-0079, Fax: (301) 480-0867

Email: <sp34j@nih.gov>

For administrative and business management questions, contact:

Ms. Suzanne White

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 7160

Bethesda, MD 20892-7926

\(301\) 435-0144, Fax: (301) 480-3310

Email: <sw52h@nih.gov>