FY2010 Budget

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

National Heart, Lung, and Blood Institute(NHLBI)

• Organization chart
• Appropriation language
• Amounts available for obligation
• Budget mechanism table
• Budget authority by activity
• Major changes in budget request
• Summary of changes
• Budget graphs
• Justification narrative
• Budget authority by object
• Salaries and expenses
• Authorizing legislation
• Appropriations history
• Detail of full-time equivalent employment (FTE)
• Detail of positions
• New positions requested

Organization chart


For carrying out section 301 and title IV of the Public Health Services Act with respect to cardiovascular, lung, and blood diseases and blood products [$3,015,689,000] $3,050,356,000. (Department of Health and Human Services Appropriations Act, 2009)

Amounts Avaliable for Obligation ⁽¹⁾

Distribution by Mechanism

Change by Selected Mechanism

Justification of Budget Request

Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.

This document provides justification for the Fiscal Year (FY) 2010 activities of the National Heart, Lung, and Blood Institute (NHLBI), including HIV/AIDS activities. Details of the FY 2010 HIV/AIDS activities are in the “Office of AIDS Research (OAR)” Section of the Overview. Details on the Common Fund are located in the Overview, Volume One. Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other. In FY 2009, a total of $766,734,000 American Recovery and Reinvestment Act (ARRA) funds were transferred from the Office of the Director. These funds will be used to support scientific research opportunities that help support the goals of the ARRA. The ARRA allows NIH to execute these funds via any NIH funding mechanism. Funds are available until September 30, 2010. These funds are not included in the FY 2009 Omnibus amounts reflected in this document.

DIRECTOR'S OVERVIEW

The NHLBI provides global leadership for a research and education program to promote prevention and treatment of heart, lung, and blood diseases. The Institute supports individuals in private and public sectors working in fields related to its mission, and the education of investigators working across the spectrum of scientific discovery. The NHLBI creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and government agencies, to address the scientific and educational needs of the nation. The NHLBI collaborates with individuals, families, communities, physicians, scientists, health care professionals, professional societies, patient advocacy groups, and the media to ensure wide dissemination and maximal use of knowledge to reduce human suffering and benefit individual and public health.

While NHLBI activities are focused on diseases and conditions that fall specifically within its mandate, research efforts are highly relevant to other health issues as well. For example, the Institute supports considerable basic research on fundamental mechanisms that influence such diverse phenomena as arrhythmias, autism, and night blindness. The NHLBI has a large investment in cancer-related research. Representative topics include angiogenesis (the development of new blood vessels, a key process in tumor growth) and the pathogenesis of smoking-related airways diseases such as COPD and lung cancer. The Institute’s portfolio of research into bone marrow failure diseases includes studies of aplastic anemia, which can result from chemotherapy or radiation therapy, and other myelodysplastic syndromes and myeloproliferative disorders that are involved in certain leukemias. NHLBI-funded research on Diamond-Blackfan anemia is expected to provide new insights into cancer predisposition and recovery from chemotherapy.

The Institute has made considerable progress toward implementing the NHLBI Strategic Plan, which was completed and published more than a year ago. Shaping the Future of Research: A Strategic Plan for the National Heart, Lung, and Blood Institute is available on the NHLBI Web site at http://apps.nhlbi.nih.gov/strategicplan/.

As described previously, the plan is structured around three complementary goals that reflect the successive movement of scientific discovery from basic research through clinical applications. This crosscutting approach highlights areas where the NHLBI is well positioned to make major contributions through investigator-initiated research and through programs that enable and extend investigator-initiated activities. The plan recommends a number of broad strategies that the NHLBI will employ to facilitate the conduct of research; enhance interdisciplinary work; speed early-stage translation of basic discoveries; ensure cross-fertilization of basic, clinical, and epidemiologic discoveries, and maximize the resultant public health benefit of the information created. In consultation with the National Heart, Lung, and Blood Advisory Council and the scientific community, the Institute has already invested in a number of initiatives that address the plan’s goals.

Goal 1 is to improve understanding of the molecular and physiological basis of health and disease and to use that understanding to develop improved approaches to disease diagnosis, treatment, and prevention. The NHLBI has put forth a number of initiatives to further this goal, including an investigation of the role played by airway smooth muscle in the development of asthma, with the objective of uncovering new targets for therapy; research to identify the molecular and cellular changes that occur during the preparation and storage of red blood cells for transfusion and to characterize the body’s response to them; and a consortium of multidisciplinary projects on progenitor (“stem”) cell biology. During FY 2010, the Institute plans to support a detailed investigation of the role played by heart muscle cell components known as cardiomyocyte mitochondria in the development of heart disease, and we will continue and expand the operation of facilities that provide production assistance for the development of novel cellular therapies for heart, lung, and blood diseases.

Goal 2 is to improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment. Initiatives in support of this goal include a new program called PumpKIN (“Pumps for Kids, Infants, and Neonates”) that seeks to develop for infants and young children with congenital and acquired cardiovascular disease a family of viable mechanical circulatory support devices that would bridge these patients to heart transplantation or recovery. The Institute has also renewed a solicitation that encourages use of patient cohorts, data, and biological materials of ongoing clinical trials to carry out ancillary studies associated with heart, lung, blood, and sleep disorders. During FY 2010, we plan to renew our highly successful program in clinical proteomics, which is evaluating protein markers that may be appropriate for routine use in the diagnosis and management of heart, lung, blood, or sleep disorders; to begin a program supporting phase II clinical trials for evaluation of innovative therapies for lung diseases and sleep disorders; and to launch the Cardiac Translational Research Implementation Program to speed translation of promising new fundamental research discoveries for the treatment and prevention of heart failure and arrhythmias.

Goal 3 is to generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery. In this area, the Institute has solicited projects to develop, refine, and test innovative behavioral and/or environmental approaches for weight control in young adults at high risk for weight gain. A related initiative is establishing research centers to translate findings from basic research on human behavior into more effective clinical, community, and population interventions to reduce obesity and promote cardiovascular health. A major new clinical trial of hypertension control is being undertaken, as described in the Program Portrait, below.

The NHLBI will continue to look to its Advisory Council and to the larger research community for guidance to ensure optimal use of its resources and steady progress toward the goals articulated in its strategic plan.

FY 2010 JUSTIFICATION BY PROGRAM DETAIL

Program Descriptions and Accomplishments

Overall Budget Policy

The NHLBI will continue to support early stage investigators and to maintain an adequate number of competing RPGs. The NHLBI is providing a 2 percent inflationary increase for non-competing and competing grants. In addition, the NHLBI has targeted a portion of the funds available for competing research project grants to support high priority projects outside of the payline, including awards to early stage investigators. The Institute also seeks to maintain a balance between solicitations issued to the extramural community in areas that need stimulation and funding made available to support investigator-initiated projects. Intramural Research and Research Management and Support will receive an increase to help cover the cost of pay and other increases.

Heart and Vascular Diseases

This program supports research on the causes, diagnosis, treatment, and prevention of heart and vascular diseases. Research areas include atherothrombosis, coronary artery disease, myocardial infarction and ischemia, heart failure, arrhythmia, sudden cardiac death, adult and pediatric congenital heart disease, cardiovascular complications of diabetes and obesity, and hypertension.

In fiscal year 2008, the NHLBI extended the Framingham Study for seven years. The extension will include re-examination of each of the three Framingham cohorts (Original, Offspring, and Generation III) for measurement of complex phenotypes; rapid distribution of DNA for extensive and focused genotyping; rapid distribution of genetic and phenotypic measurements for use by investigators internal and external to the Framingham Study; and analyses of the contribution of genes, new and established risk factors, and innovative biomarkers to the development and progression of subclinical and clinical disease.

In fiscal year 2009, the NHLBI will establish eight Global Health Centers of Excellence in developing countries to combat non-communicable chronic cardiovascular and pulmonary diseases. The Centers will develop clinical research infrastructure, conduct doctoral and post-doctoral research training, and carry out research on new or improved approaches, programs, measures, and treatments to prevent, reduce, or treat chronic cardiovascular and pulmonary diseases.

Budget Policy: The FY 2010 budget estimate for the Heart and Vascular Diseases program is $1,714.125 million, an increase of $18.679 million or 1.1% over the FY 2009 estimate. During FY 2010 NHLBI plans to follow its strategic plan; which contains three sets of goals: 1) enabling technologies and methodologies, 2) clinical problems or disease states, and 3) research training and career development. One initiative the NHLBI will renew is it’s Programs of Excellence in Nanotechnology (PEN's) with an increased emphasis on translation to pre-clinical/clinical studies and commercialization.

Lung Diseases

This program supports research on the causes, diagnosis, treatment, and prevention of lung diseases and sleep disorders. Research areas include asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, critical care and acute lung injury, developmental biology and pediatric pulmonary diseases, immunology and fibrosis, lung cell and vascular biology, and pulmonary complications of AIDS and tuberculosis. The National Center on Sleep Disorders Research is administered within the Lung Diseases program.

In fiscal year 2008, the NHLBI began a project to re-define major categories of lung diseases using molecular phenotypes, a critical step toward the development of personalized and pre-emptive approaches to pulmonary medicine. Molecular phenotype is defined here as any molecular entity with complex and quantitative traits that is shaped by multiple and possibly interacting genetic and environmental factors. A central repository of findings will provide a full spectrum of molecular signatures from normal lungs and across many respiratory diseases.

In fiscal year 2009, the NHLBI will establish an Asthma Network. The Network will develop and conduct multiple clinical trials that address the most important management and new treatment questions in asthma leveraging resources across the age and disease severity spectrum.

Budget Policy: The FY 2010 budget estimate for the Lung Diseases program is $596.483 million an increase of $6.500 million or 1.1% over the FY 2009 estimate. The program plans for FY 2010 include support for the new initiative and on-going programs as described below, as well as meritorious new investigator-initiated research grants, and research training related to its mission. The NHLBI will conduct phase II clinical treatment trials of innovative and novel agents for lung diseases and sleep disorders.

Blood Diseases and Resources

This program supports research on the causes, prevention, and treatment of nonmalignant blood diseases, including anemias, sickle cell disease, and thalassemia; premalignant processes such as myelodysplasia and myeloproliferative disorders; abnormalities of hemostasis and thrombosis such as hemophilia; and immune dysfunction. Another program responsibility is to conduct research to ensure the adequacy and safety of the nation’s blood supply.

In fiscal year 2008, the NHLBI began a project to support local and collaborative basic and clinical research on venous thrombotic diseases with an emphasis on the sharing of resources to improve diagnosis, therapy, and prevention. The NHLBI also supported a project to collect and analyze outcome data from recipients of hematopoietic stem cell transplants (HSCT).

In fiscal year 2009, the NHLBI will begin an initiative to improve red blood cell transfusion therapies. Basic and translational research will be supported to identify the molecular and cellular changes that occur during red blood cell unit preparation and storage.

Budget Policy: The FY 2010 budget estimate for the Blood Diseases and Resources program is $442.777 million, an increase of $4.825 million or 1.1% over the FY 2009 estimate. The program plans for FY 2010 include support for the new initiative and ongoing programs as described below, as well as meritorious new investigator-initiated research grants, and research training related to its mission. The NHLBI will renew the Production Assistance for Cellular Therapies (PACT) program. Additional services of the program will include providing support to proof-of-principle animal and early translational research and diversifying the cell therapy expertise within the program.

Intramural Research

The Intramural Research program conducts laboratory and clinical research in heart, vascular, lung, blood, and kidney diseases and develops technology related to cardiovascular and pulmonary diseases. The program comprises four centers (Biochemistry and Biophysics, Cell Biology and Physiology, Genetics and Developmental Biology, and Immunology), three branches (Hematology, Pulmonary and Vascular Medicine, and Translational Medicine), and the Cardiothoracic Surgery Research Program.

Budget Policy: The FY 2010 budget estimate for the Intramural Research program is $183.448 million, an increase of $2.711 million or 1.5% from the FY 2009 estimate. The program plans for FY 2010, along with expected outputs, are as follows. Increases for salaries and related costs are covered in the budget request.

The budget provides support for new programs, which include: a) pediatric radiology and interventional cardiology to translate real time MRI approaches; b) Pulmonary Clinical research concentrating on pulmonary hypertension, pulmonary fibrosis and asthma; c) bench top monochromatic “soft” x-ray systems; followed by use of “hard” mono-chromatic x-rays; d) Clinical Human Immunology Center in collaboration with several other IC’s to provide the basic tools to evaluate the role of the human immune system in a variety of disease states including atherosclerosis, heart failure and diabetes; e) epigenetic modification of gene expression in the human genome.

Research Management and Support

This activity provides administrative management and scientific direction in the review, award, and monitoring of research grants, training awards and research and development contracts and in the overall planning, coordination, and evaluation of the Institute’s programs.

In fiscal year 2009, the Division of Extramural Research Activities administered the review, processing, award, and scientific performance appraisal of approximately 5,500 research grants, 750 training awards, and 600 contracts. The Division for the Application of Research Discoveries (DARD) continued its public and professional education activities in cardiovascular diseases and asthma and developed a new educational campaign, “COPD: Learn More, Breathe Better.”

Budget Policy: The FY 2010 budget estimate for Research Management and Support is $113.523 million, an increase of $1.952 million or 1.75% over the FY 2009 estimate. The program plans for FY 2009, along with expected outputs, are as follows. Increases for salaries and related costs are covered in the budget request, but decreases are planned for operating expenses such as maintenance contracts and information technology costs.

The budget provides support for health disparities issues through the expansion of community-based efforts to promote healthy lifestyle behaviors. In addition, development of clinical guidelines on Sickle Cell Disease, adult hypertension, high blood cholesterol, and overweight and obesity, are underway.

Budget Authority by Object

Salaries and Expenses

Appropriations History

Detail of Positions

New Positions Requested