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5. Institute-Initiated Programs Starting in FY 2008

More than two-thirds of the research supported by the NHLBI is initiated by individual investigators; the remainder is initiated by the Institute. Institute-initiated programs are developed in response to evolving national needs, Congressional mandates, and advances in scientific knowledge. Each initiative represents the outcome of extensive discussions and thorough reviews by representatives of the scientific community, Institute advisory committees, the Board of Extramural Experts (BEE), and the National Heart, Lung, and Blood Advisory Council (NHLBAC). The advisory committees and the BEE, together with professional societies and NHLBI staff, continually review the progress of research within the NHLBI program areas, assess newly acquired knowledge, and identify research topics that offer the best opportunities or constitute the greatest needs. This planning process contributes to policy development at the national level by setting priorities among programs and establishing budgets for individual programs and projects.

Initiatives generally emanate as Requests for Applications (RFAs) for grants, including cooperative agreements, or Requests for Proposals (RFPs) for contracts. Other initiatives take the form of Program Announcements (PAs). Applications and proposals submitted in response to RFAs and RFPs compete among themselves for specific "set-aside" funds. Applications submitted in response to PAs generally compete with other investigator-initiated applications for funding.

RFA, RFP, and PA concepts prepared by the Institute are presented to the BEE, which reviews and prioritizes them. The concepts, along with the comments from the BEE, are then sent to the NHLBAC for review, comment, and concurrence. Initiatives that receive the concurrence of the NHLBAC are considered further by the NHLBI Director in the context of the Institute's budget, program priorities, review workload, and proposed mechanisms. These considerations guide the Director's subsequent decisions to approve initiatives for release. RFAs, RFPs, and PAs are announced in the NIH Guide to Grants and Contracts.

Applications and proposals submitted in response to RFAs and RFPs are reviewed by the NHLBI. Applications submitted in response to PAs are reviewed by the NIH Center for Scientific Review.

Descriptions of the Institute-initiated programs that began or were renewed (i.e., were funded) in FY 2008 are presented below according to NHLBI scientific programs. Also described are trans-NIH, trans-PHS, interagency, and private-public partnership initiatives in which the NHLBI participates.

Heart and Vascular Diseases Program

Initiatives Being Renewed

Cardiovascular Health Study (CHS): Transition Phase

The purpose of this renewal is to maintain the infrastructure that provides access to CHS resources and expertise, scientific collaborations, and mentorship of early-career investigators.

Framingham Heart Study

The purpose of this renewal is to continue support for the Framingham Heart Study in order to increase understanding about the complex influences of genes and environment on development and progression of heart, lung, and blood diseases and sleep disorders.

Multi-Ethnic Study of Atherosclerosis (MESA)

The purpose of this renewal is to capitalize and expand upon the resources of data, samples, and infrastructure of the MESA cohort, which was established to identify factors associated with the progression of subclinical CVD in four major racial/ethnic groups within the U.S. population (white, black, Hispanic, and Chinese).

Women's Health Initiative Memory Study

The purpose of this renewal is to continue to test the effects of hormone therapy on cognitive decline, mild cognitive impairment, and probable dementia in postmenopausal women.

New Initiatives

Mechanisms and Management of Cardiovascular and Metabolic Complications of HIV/AIDS

The purpose of this RFA is to elucidate the underlying mechanisms of metabolic and anthropometric abnormalities in HIV patients receiving highly active antiretroviral therapy and to determine their relationship to CVD risk; to evaluate biomarkers and imaging modalities in the assessment of coronary artery disease and risk; and to identify treatment strategies and interventional approaches to reduce cardiovascular risk while optimizing medical management of HIV infection.

New Approaches in Arrhythmia Detection and Treatment

The purpose of this PA is to develop new or improved methods, tools, and technologies to detect, treat, and prevent cardiac arrhythmias.

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Lung Diseases Program

New Initiatives

Molecular Phenotypes for Lung Disease

The purpose of this initiative is to identify molecular phenotypes of major lung diseases that will lead to improved diagnosis, prognosis, and personalized treatment of these diseases.

Protein Interactions Governing Membrane Transport in Pulmonary Health and Disease

The purpose of this PA is to delineate the protein interactions and pathways governing membrane trafficking pathways operative in pulmonary health and disease and develop innovative therapeutic interventions.

Small Grants for Lung Tissue Research

The purpose of this RFA is to conduct tissue-based research on COPD and interstitial fibrotic lung conditions. Scientists will use biospecimens and clinical data collected by the Lung Tissue Research Consortium to study the correlation of lung molecular characteristics with histopathology and presence, severity, and phenotypic manifestations of interstitial lung diseases and COPD.

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Blood Diseases and Resources Program

Initiatives Being Renewed

Basic and Translational Research Program

The NHLBI reconfigured the Comprehensive Sickle Cell Centers program to the Basic and Translational Research Program. This program emphasizes fundamental investigations and their translation into initial studies in humans, as well as community translation to promote evidence-based clinical practice. It continues to support the Sickle Cell Disease Scholars program for the career development of young investigators and the Summer-for-Sickle Cell-Science program for research training and mentoring of high school students.

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-Up Study

The purpose of this renewal is to follow up for 2 years the infants and toddlers who have sickle cell anemia who participated in the BABY HUG trial to identify toxicities and any persistent effects from treatment with hydroxyurea to prevent chronic organ damage.

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Initiatives Being Renewed

NHLBI Career Transition Award

The purpose of this renewal is to enable highly qualified postdoctoral fellows to obtain research training in the NHLBI Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers.

Short-Term Research Education Program To Increase Diversity in Health-Related Research

The purpose of this renewal is to provide opportunities to students who are from underrepresented racial and ethnic minorities or disadvantaged backgrounds, or who have disabilities to become exposed to biomedical research to stimulate career development in areas relevant to cardiovascular, lung, and blood diseases and sleep disorders.

New Initiatives

Biorepository and Limited Access Data Set Information Coordinating Center

The purpose of this RFP is to establish a Biorepository and Limited Access Data Information Coordinating Center (BioLINCC), which will be responsible for establishing and maintaining an infrastructure to facilitate and maximize access to the NHLBI Biologic Specimen Repository and Limited Access Data Set programs.

Deep Vein Thrombosis and Venous Disease

The purpose of this RFA is to support collaborative basic and clinical research on deep vein thrombosis and venous thrombotic diseases to improve diagnosis, treatment, and prevention of venous thrombotic diseases.

Elucidating Nature's Solutions to Heart, Lung, and Blood Diseases and Sleep Disorder Processes

The purpose of this PA is to elucidate the natural molecular and cellular adaptations of mammalian species to extreme environmental conditions that would rapidly evoke life-threatening cardiovascular or respiratory responses.

Individual Predoctoral MD/PhD Fellowships

The purpose of this PA is to provide research training to applicants in combined MD/PhD programs who have the potential to become productive, independent physician-scientists in areas relevant to the mission of the NHLBI.

Investigator-Initiated Multi-Site Clinical Trials

The purpose of this PA is to support investigator-initiated multisite (Phase II or Phase III) randomized, controlled clinical trials related to the mission of the NHLBI. The trials may involve clinical or behavioral interventions.

New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases

The purpose of this PA is to develop efficient non-viral vectors that can overcome limitations of viral vectors for gene therapy clinical trials in heart, lung, and blood diseases.

Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy

The purpose of this RFP is to determine whether use of a genotype-enhanced dosing algorithm to initiate warfarin treatment improves anticoagulation status compared to a dosing algorithm using only clinical information.

Research Demonstration and Dissemination Grants

The purpose of this PA is to test the effectiveness of interventions that are based on strategies designed to promote healthy lifestyles and prevent or ameliorate disease in defined populations and improve delivery of proven efficacious treatment in clinical practice.

Right Heart Function in Health and Chronic Lung Diseases

The purpose of this PA is to stimulate research on cellular, molecular, and physiological determinants of right ventricular function in health and dysfunction in chronic lung diseases. The goal is to gain knowledge that can be used to develop improved methods for preventing, diagnosing, and treating right heart failure.

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Initiatives Being Renewed

Bioengineering Nanotechnology Initiative

The purpose of this renewal is to develop and apply nanotechnology to biomedicine.

Chronic Fatigue Syndrome: Pathophysiology and Treatment

The purpose of this renewal is to examine the etiology, diagnosis, pathophysiology, and treatment of chronic fatigue syndrome in diverse groups and across the lifespan.

Chronic Illness Self-Management in Children and Adolescents

The purpose of this renewal is to improve the self-management and quality of life of children and adolescents with chronic illnesses. Self-management is intended to enhance individual well-being and strengthen patient participation in health care while reducing inappropriate health care use and health care costs.

Data Resource for Analyzing Blood and Marrow Transplants

The purpose of this renewal is to continue support of the Center for International Blood and Marrow Transplant Research, a resource for data from blood and bone marrow transplant centers throughout the world.

Innovations in Biomedical Computational Science and Technology

The purpose of this renewal is to support fundamental research in biomedical information science and technology and to develop new informatics, computational and mathematical tools, and technologies that can speed progress in biomedical research.

Mind-Body Interactions and Health

The purpose of this renewal is to increase understanding of the processes underlying mind-body interactions and health and to apply the knowledge gained to interventions and clinical practice to promote health and prevent or treat disease and disabilities.

Novel Approaches To Enhance Animal Stem Cell Research

The purpose of this renewal is to enhance the utility of animal stem cells as model biological systems. Researchers will focus on isolation and characterization of embryonic and other multipotent stem cells in a variety of animal species.

Pathogenesis and Treatment of Lymphedema and Lymphatic Diseases

The purpose of this renewal is to stimulate research on the lymphatic system, characterize its function and pathophysiologic mechanisms that cause disease, develop new methods for imaging and quantitating lymph flow, and discover new therapeutic interventions for lymphatic diseases.

Social and Cultural Dimensions of Health

The purpose of this renewal is to encourage the development of health research that integrates knowledge from biomedical and social sciences.

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New Initiatives

Advancing Novel Science in Women's Health Research

The purpose of this PA is to support innovative, interdisciplinary research that will develop new concepts in women's health research and the study of gender differences. Researchers are encouraged to examine the role of gender on women's health.

Clinical Trials in Organ Transplantation in Children

The purpose of this RFA is to improve graft acceptance and patient/graft survival in pediatric heart, lung, liver, kidney or intestinal transplant recipients by assessing risk factors, testing novel drug treatments, and developing diagnostic tools.

Collaborations With National Centers for Biomedical Computing

The purpose of this PA is to support investigators working in collaboration with the National Centers for Biomedical Computing (NCBCs) of the NIH Roadmap for Medical Research to build a computational infrastructure for biomedical computing and expand the scope of biological, behavioral, and computational problems currently being addressed by the NCBCs.

Development and Application of New Technologies to Targeted Genome-Wide Resequencing in Well-Phenotyped Populations

The purpose of this RFA is to develop and validate resequencing applications for cost-effective, high-throughput sequencing of every exon of all protein coding genes in the human genome by assembling current and emerging technologies in the areas of DNA target capture and sequencing. The purpose of developing these resequencing applications is to enable the sequencing of thousands of individual DNA samples in well-phenotyped populations in a cost-effective manner.

Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases

The purpose of this PA is to stimulate exploratory/developmental investigations in primary immunodeficiency diseases by supporting research to characterize and determine the molecular basis for the diseases and develop clinical strategies for their diagnosis and treatment.

Improving Diet and Physical Activity Assessment

The purpose of this PA is to improve the quality of measurements of diet and physical activity for use in general and diverse populations through development of better instruments, technologies, and statistical/analytical techniques.

Lymphatic Biology in Health and Disease

The purpose of this PA is to stimulate research to identify developmental, molecular, and cellular mechanisms that contribute to health and disease of the lymphatic system.

Methodology and Measurement in the Behavioral and Social Sciences

The purpose of this PA is to improve the quality and scientific power of data collected in behavioral and social sciences relevant to the missions of the Institute through innovations in research design, data collection techniques, measurement, and data analysis techniques.

Multidisciplinary Translational Research in Critical Care

The purpose of this PA is to promote multidisciplinary translational research that will improve treatment, diagnosis, and outcome of patients with critical illness and increase understanding of fundamental processes causing critical illness.

Sarcoidosis: Research Into the Cause of Multi-Organ Disease and Clinical Strategies for Therapy

The purpose of this PA is to stimulate research on the etiology and management of sarcoidosis, an immune-mediated granulomatous inflammatory disorder, and to delineate possible causes and phenotypic host characteristics in susceptible people so that preventive strategies can be developed, early diagnosis improved, and better therapies devised to lessen initial disease immunopathology.


New Initiatives

Small Business Innovation Research Contract Solicitation

The purpose of this SBIR contract solicitation is to encourage scientific and technological innovations in areas identified by the Institute. Specific projects include production of generic modified hemoglobin for research purposes and development of a computational model library of cardiovascular and pulmonary anatomy and related blood and tissue material properties.

Subpopulations and Intermediate Outcome Measures in COPD Study

The purpose of this RFP is to define pathogenetically homogeneous subgroups of COPD subjects on the basis of biomarkers, genotypes, and computed tomography images and to identify intermediate outcome measures for use in future clinical trials.


New Initiative

Enabling Technologies for Tissue Engineering and Regenerative Medicine

The purpose of this PA is to develop innovative technologies, tools, methods, and devices that will enhance tissue engineering and regenerative medicine. The overall goal is to engineer functional tissues in vitro for implantation in vivo or to foster tissue regeneration directly in vivo with the purpose of replacing, repairing, preserving, or enhancing organ function lost due to disease, injury, or aging or for use as 3D tissue model systems for drug development.

Private-Public Partnership

New Initiative

Understanding and Treating Ataxia-Telangiectasia

The purpose of this PA is to stimulate multidisciplinary research to improve understanding of and develop treatments for ataxia-telangiectasia.

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