FY2011 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 [$3,095,812,000] $3,187,516,000. (Public Law 111-117, Consolidated Appropriations Act, 2010)

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) 2011 activities of the National Heart, Lung, and Blood Institute (NHLBI), including HIV/AIDS activities. Details of the FY 2011 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.

DIRECTOR'S OVERVIEW

The NHLBI provides global leadership for a research and education program to promote prevention and treatment of heart, blood vessel, lung, and blood diseases. Guided by Shaping the Future of Research: A Strategic Plan, the NHLBI supports a robust, collaborative research enterprise, in partnership with private and public organizations, to address the scientific and educational needs of the nation. Illustrative activities that align with the NIH Director’s Themes are described below.

The Institute is making a substantial investment in use of cutting-edge approaches to assess the importance of genetic influences in heart, lung, and blood diseases. In recent years detailed knowledge about the human genome made it possible to look at markers spaced across all of the chromosomes and identify small regions containing potential or candidate genes associated with disease. Tremendous technological advances in DNA sequencing and computing now allow for vastly greater amounts of sequencing to be performed relatively cheaply. Instead of using markers to identify regions, we can sequence all of the important areas of the genome involved in the production of proteins that are key to the functioning of cells and tissues. By selecting only the more important regions, the relevant information about an individual can be obtained at a much lower cost than would be entailed in sequencing a person’s entire genome. The genomic data can then be coupled with the wealth of information in NHLBI population studies—Framingham and other cohorts designed to capture the ethnic diversity and diseases prevalent in the U.S. population—to determine the genetic basis or causes for heart, lung, and blood diseases. The new knowledge will bring us much closer to a time when personal genomic information can be used to tailor prevention, management, or treatment of a disease to the individual.

Translation of basic science findings into new and better treatments is an area of strong emphasis for NHLBI. For instance, we have launched a novel pediatric cardiovascular translational initiative, the Bench to Bassinet (B2B) program that will create a critical mass of collaborative research across three interacting consortia. The Cardiovascular Development Consortium will probe the details of the transcriptional regulatory networks that govern cardiac development, using complementary animal models. The Pediatric Cardiac Genomics Consortium will recruit children into a common protocol to speed discovery of causative genes and evaluate the effects of genetic variation on short- and long-term outcomes in patients with congenital heart disease. These two Consortia will align with the third component of B2B, the ongoing Pediatric Heart Network, a multi-center clinical research enterprise funded by NHLBI in 2001. B2B is designed to accelerate the pace of fundamental discovery while simultaneously establishing a new paradigm for conducting translational research.

NHLBI has also developed a range of new programs to foster translation of basic research discoveries to clinical application for the diagnosis and treatment of lung and sleep diseases. The Translational Program Project Grant in Lung Diseases initiative supports interrelated projects designed to become progressively more clinical during the grant period. The Phase II Clinical Trials of Novel Therapies for Lung Diseases will conduct proof-of-concept testing of interventions that have the potential to revolutionize clinical management of a lung disease or sleep disorder. In addition, two ambitious programs for translational research will be launched in 2011. Cross Organ Mechanism-Associated Phenotypes for Genetic Analyses of Heart, Lung, Blood, and Sleep Diseases will help to re-define diseases at the level of pathogenetic mechanisms. Furthermore, it will enable the development of strategies for prevention, diagnosis, and treatment that can account for the individual patient’s unique genetic makeup and environmental background. The Centers for Advancing Lung Diagnostics and Therapeutics will support exploratory and validation research in humans that relates to promising diagnostic or therapeutic targets.

The NHLBI supports an extensive portfolio of comparative effectiveness research. For example, two recent clinical trials evaluated strategies to reduce cardiovascular complications in patients with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial found no preventive benefit from aggressive blood sugar control; on the contrary, there was actually an increased risk of death. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI2D) determined that medical therapy worked as well as stents or bypass surgery for most diabetic patients who already had heart disease. In the area of global health, NHLBI has joined the UnitedHealth Chronic Disease Initiative in establishing a network of 11 Collaborating Centers of Excellence in low- and middle-income countries to build sustainable programs for combating chronic cardiovascular and lung diseases. The Centers are located in Argentina, Bangladesh, China, Guatemala, India (2 centers), Kenya, Peru, South Africa, Tunisia and at the U.S.–Mexico Border. Each includes a research institution in a developing country paired with at least one partner academic institution in a developed country, nine of which are in the United States. The program is expected to stimulate research in clinical medicine, epidemiology, health services and outcomes, health policy, translation, and behavioral sciences. Also NHLBI has played a major role with the World Health Organization in continuing to implement the global alliance for respiratory disease program, and the Institute is building global consortia to identify major genes and their function in the etiology of asthma and COPD. In addition, the Institute supports international studies in Asia and South America to prevent the transmission of HIV/AIDS and other known and emerging infectious agents through blood transfusion. Other research on mosquito-borne viruses such as West Nile virus and Dengue virus will guide U.S. and international donor screening policies for these infectious agents and provide unique insights into the factors that influence the acquisition and severity of these diseases.

The Institute continues to place strong emphasis on fostering talent and diversity in the biomedical research community. The Institutional Training Program in Vascular Medicine, for instance is preparing clinicians for academic and scientific leadership roles by providing comprehensive training in research methodology, risk assessment, diagnosis, treatment, and prevention of arterial, venous, and lymphatic vascular diseases. A new scientific training initiative for clinical research conducted in emergency settings is being planned for FY 2010.

Overall Budget Policy: The FY 2011 request for NHLBI is $3,187.516 million, an increase of $91.704 million or +3.0 percent over the FY 2010 enacted level. The NHLBI will continue to support early stage investigators and competing RPGs. In FY 2011, NHLBI will support new investigators on R01 equivalent awards at success rates equivalent to those of established investigators submitting new R01 equivalent applications. The NHLBI is providing a 2 percent inflationary increase for non-competing and competing grants. In addition, the NHLBI is providing increases of 6 percent for research training stipends and approximately 3 percent for other non-RPG extramural mechanisms. The Institute also seeks to maintain a balance between solicitations issued to the extramural community 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. Funds are included in R&D contracts to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program (TRND), the Basic Behavioral and Social Sciences Opportunity Network (OppNet), and support for a new synchrotron at the Brookhaven National Laboratory, as well as increased support for other HHS agencies through the program evaluation set-aside.

FY 2011 JUSTIFICATION BY PROGRAM DETAIL

Program Descriptions and Accomplishments

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. The program’s efforts encompass basic, translational, clinical, epidemiological, behavioral, nutritional, comparative-effectiveness, international, and health services research disciplines. In fiscal year 2009, the NHLBI funded nine Global Health Centers in Bangladesh, China, Guatemala, India (Bangalore and New Delhi), South Africa, Argentina, Kenya, and Peru. In fiscal year 2010, the Institute will fund a combined renewal of its Proteomic Centers and its Clinical Proteomic Program. The ultimate goal is to bring greater precision, reliability, and sensitivity to detection, diagnosis, treatment, and prevention strategies for the individual patient. The initiative will integrate expertise from the disciplines of proteomics, physiology, clinical medicine, molecular biology, genomics, chemistry, physics, engineering, computational biology, bioinformatics, and biostatistics. Each of seven centers will focus on proteomic technology development and molecular mechanistic and functional studies related to a specific clinical need, problem, or disease.

Budget Policy: The FY 2011 budget estimate for the Heart and Vascular Diseases program is $1,755.367 million, an increase of $48.843 million or 2.86% over the FY 2010 estimate. During FY 2011 NHLBI plans to continue two major initiatives. The first will evaluate strategies for advancing the diagnosis and management of acute and chronic heart failure. The second will evaluate new treatment methods and management strategies designed to benefit children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, and arrhythmias. NHLBI also plans to support an initiative that will develop multidisciplinary clinical research training programs to prepare clinician-scientists for academic leadership roles and independent research careers in emergency-setting diagnosis and treatment of patients who have sustained severe trauma or have acute manifestations of cardiovascular, pulmonary, or hematologic diseases.

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 2009, the NHLBI initiated a study to identify subtypes of COPD based on disease mechanism and identify and validate intermediate outcome measures; translational research to improve prevention, diagnosis, and treatment of lung diseases and sleep disorders; support for proof-of-concept phase II clinical trials of novel interventions for lung diseases or sleep-associated cardiopulmonary disorders; and a new asthma clinical research network. In FY 2010, the NHLBI will initiate programs to develop early molecular markers of chronic respiratory disease risk in premature newborns; to identify the biological and structural components that create airflow limitation in congenital or acquired disorders of the upper airway of infants, children, and adolescents; and to evaluate how treatment of sleep apnea modifies the appearance and progression of cardiovascular disease in high-risk individuals.

Budget Policy: The FY 2011 budget estimate for the Lung Diseases program is $664.275 million an increase of $18.484 million or 2.86% over the FY 2010 estimate. The program plans for FY 2011 include support for an initiative to identify potential biomarkers, surrogate markers, and drug targets, in concert with early disease detection, population stratification, and prognostic indicators, and to validate in humans their effects on target pathways that may be shared by multiple lung diseases. Another new initiative will seek to identify the fundamental etiologic, pathologic, and genetic commonalities between lung cancer and chronic obstructive pulmonary disease in order to characterize the determinants of individual susceptibility and the shared biochemical and immunological pathways involved in the origin and progression of the two diseases.

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 support research and research training on the use , safety, efficacy, and availability of blood and blood components for transfusion and cellular therapeutics. In fiscal year 2009, the NHLBI initiated research to identify the molecular and cellular changes that occur during red blood cell unit preparation and storage and their effects on transfusion recipients. The Institute also supported a program to increase understanding of the pathogenesis of pain syndromes in sickle cell disease. In FY 2010 the NHLBI will begin an initiative to develop clinical research capacity in hemoglobinopathies. The NHLBI will also renew funding for the Production Assistance for Cellular Therapies (PACT) program to support up to six geographically dispersed U.S. facilities with the capacity to provide consulting, manufacturing, and regulatory expertise essential for the development of clinical-grade cellular products for evaluation as therapies for heart, lung, and blood disorders.

Budget Policy: The FY 2011 budget estimate for the Blood Diseases and Resources program is $456.781 million, an increase of $12.710 million or 2.86% over the FY 2010 estimate. The program plans for FY 2011 include support to accelerate research on the management of hematopoietic stem cell transplantation, standardize and compare the effectiveness and toxicities of existing treatments, and evaluate new therapies. Another initiative will seek to translate emerging discoveries in glycosciences (the study of complex carbohydrates and their roles in metabolism) into new diagnostics and clinical applications as well as to build research capacity by training 30-35 postdoctoral trainees over seven years.

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. In fiscal year 2009, Intramural Research program contributed to establishing the Center for Human Immunology as a trans-NIH initiative administratively within the NHLBI. The program continued its support for the Imaging Probe Development Center, another trans-NIH initiative, which brings together synthetic chemists to make imaging probes available for both basic and clinical studies. In fiscal year 2010 the tenure-track search system will be expanded to include the entire NIH with the initiation of the Earl Stadtman Investigator program. A new Clinical Pulmonary Research Program will be started in collaboration with regional hospitals to improve the impact of the Intramural clinical program in the surrounding community and also seek specific opportunities for working on innovative research and therapeutic approaches for clinical pulmonary conditions in the Clinical Center. A program on Pediatric Imaging using MRI will be initiated at the Children’s National Medical Center with the goals of minimizing ionizing radiation exposure, applying real-time MRI approaches to simple diagnostic procedures that avoid general anesthetics, and providing visual guides for minimally invasive surgery in pediatric cases.

Budget Policy: The FY 2011 budget estimate for the Intramural Research program is $189.416 million, an increase of $5.873 million or 3.2% from the FY 2010 estimate. Increases for salaries and related costs are covered in the budget request. A new Intramural-based computational biology program will support systems medicine and biology. It will require a state-of-the-art computational facility and recruitment of investigators with specialized expertise in computer and simulation sciences as well as biomedicine. Specific plans for 2011 are to double the computational capacity and the number of junior faculty associated with this program. The Intramural Research Program will also begin planning for a new clinical cardiology research program.

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 an initiative to increase the implementation of asthma evidence-based guidelines recommendations. The DARD also secured new partners such as SUBWAY Restaurants and the Cherokee Nation to continue the We Can! education program to address the growing overweight and obesity problem in children ages 8 through 13 years. In all, more than 1,100 community sites and 40 partners have committed to implementing We Can! In fiscal year 2010, the DARD will complete the development of the pediatric integrated cardiovascular disease (CVD) guidelines and initiate relevant implementation activities, as well as complete sickle cell disease guidelines. Work will continue on the initiatives started in FY 2009 in the areas of asthma, health disparities, and obesity.

Budget Policy: The FY 2011 budget estimate for Research Management and Support is $121.677 million, an increase of $5.794 million or 5.0% over the FY 2010 estimate. Increases for salaries and related costs are covered in the budget request.

Budget Authority by Object

Salaries and Expenses

Appropriations History

Detail of Positions

New Positions Requested