- I. CALL TO ORDER – Dr. Susan B. Shurin
- II. VISION FOR THE NIH – Dr. Francis S. Collins
- III. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST - Dr. Susan B. Shurin
- IV. REPORT OF THE ACTING DIRECTOR – Dr. Susan B. Shurin
- V. BEYOND HEMATOLOGY, BEYOND 2010 – Dr. Neal S. Young
- VI. RESEARCHING RARE DISEASES – Dr. Stephen C. Groft
- VII. Vascular Disorders: From Phenotype to Genotype to Disease Mechanism – Dr. Manfred Boehm
- VIII. ANNUAL REVIEW OF DELEGATED AUTHORITIES FROM THE NHLBAC – Dr. Stephen C. Mockrin
- IX. REVIEW OF APPLICATIONS
Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), opened the meeting at 8:00 am and welcomed members to the 237th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
Dr. Francis S. Collins, Director of the National Institutes of Health (NIH), identified major opportunities for NIH investment and highlighted recent contributions of the NIH, and the NHLBI in particular, to biomedical research.
Dr. Collins thanked Dr. Shurin for her many contributions to the NIH, including her current activities as Acting Director of the NHLBI. He assured the Council that the search for a permanent Director of the NHLBI is underway and that he will be involved personally in the process.
Dr. Collins discussed five areas of special opportunities for the NIH (see "Research Agenda: Opportunities for Research and NIH" by Dr. Collins in Science, 1 January 2010: 36-37):
- High-throughput technologies
- Translational medicine
- Benefiting health care reform
- Focusing more on global health
- Reinvigorating and empowering the biomedical research community
Dr. Collins noted that the FY 2010 final NIH budget of $30.988 billion includes about $26.0 billion in spending outside the NIH. He expressed his appreciation for the President’s FY 2011 budget request which seeks an increase of $1 billion over the FY 2010 budget level.
As the steward of medical and behavioral research for the nation, the NIH contributes by:
- Advancing knowledge through basic research — Dr. Collins emphasized the importance of investigator-initiated research, the bedrock of biomedical advances. He highlighted a recent genome-wide association study (GWAS) supported in part by the NHLBI that has increased understanding about fetal hemoglobin expression and may lead to a new therapeutic intervention for sickle cell disease (see Science, 19 December 2008: 1839-1842).
- Using discoveries to improve health — Dr. Collins presented statistics illustrating the benefits of biomedical and public health advances, and noted the results of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial (funded by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Disorders [NIDDK], and industry), which used a comparative effectiveness approach to compare treatment strategies for patients with type 2 diabetes and cardiovascular disease (see NEJM, June 11, 2009: 2503-2515).
- Benefiting the economy — Dr. Collins cited estimates that each $1.00 of NIH funding generates $2.21 in state economic output in one year, and that each NIH grant generates seven jobs. He summarized ways in which the NIH is spending the $10.4 billion provided by the American Recovery and Reinvestment Act of 2009 (ARRA), and reported that 50,000 jobs over 2 years are estimated to have been created and/or maintained due to NIH ARRA investments.
- Ensuring the future — The NIH is investing in transformative ideas (for example, via the Transformative R01 mechanism) and innovative researchers (for example, via the NIH Director’s Pioneer Award and the New Innovator Award). Dr. Collins noted a Transformative R01 project awarded by the NHLBI entitled "Regulatory Roles of Variable Mechanical Stimuli in Cell Function."
- Making the case for NIH — Outreach is essential for educating the nation about the importance of biomedical research and inspiring passion for science in the next generation. NHLBI outreach programs have been communicating research results and educational messages throughout the United States for many years.
The Council was reminded that under Public Law 92-463, the Federal Advisory Committee Act, a portion of the meeting would be closed to the public, for the consideration of grant applications. A notice of this meeting was published in the Federal Register. Dr. Shurin also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.
Dr. Shurin paid tribute to Dr. Marshall Nirenberg who died January 15, 2010, by acknowledging his extraordinary contributions to biomedical science. While an investigator at the NIH, Dr. Nirenberg uncovered the RNA sequences that encode all 20 amino acids (the "building blocks" of proteins). He received a Nobel Prize for this work in 1968—the first NIH researcher and federal employee to receive the honor. Dr. Nirenberg helped set the stage for the genomic era of today. He remained an integral part of the NHLBI intramural program for 47 years.
Dr. Shurin announced several leadership appointments within the NHLBI:
- Dr. Carl Roth - Acting Deputy Director, National Heart, Lung, and Blood Institute
- Dr. Jodi Black - Deputy Director, Division of Extramural Research Activities
- Dr. Donna DiMichelle - Deputy Director, Division of Blood Diseases and Resources
- Ms. Sally McDonough - Director, Office of Communications
- Mr. James Schlicht - Legislative Liaison
- Dr. Denise Simons-Morton - Director, Division for the Application of Research Discoveries
The NHLBI FY 2010 Conference budget (regular appropriations only) totals $3,096,916,000, a 2.7 percent increase over FY 2009. However, based on the Biomedical Research and Development Price Index (BRDPI), the FY 2010 budget increase is still below the level of inflation. Allocations among budgetary categories (e.g., research project grants, research centers, contracts) have remained stable from FY 2009 - FY 2010.
American Recovery and Reinvestment Act of 2009 (ARRA) Update:
The ARRA was signed into law by President Obama in February 2009. It provides $10.4 billion to the NIH (available for 2 years—through September 2010) to support programs to stimulate the economy, create and preserve jobs, and advance biomedical research.
Dr. Shurin reviewed the NHLBI FY 2009/FY 2010 ARRA funding plan. The Institute received $763 million in ARRA monies, most of which has been obligated or committed. The Institute's ARRA funding plan comprises approximately $292 million for expanding the payline for traditional research project grants (R01s) and exploratory/developmental research grants (R21s); $359 million for specific NIH-wide ARRA initiatives; $90 million for administrative supplements; and a limited amount for contracts and other mechanisms. A small number of potential ARRA research and training awards are pending review in FY 2010.
The NHLBI ARRA Web site summarizes the Institute's Recovery Act policies and investments, and includes illustrative stories about researchers' use of NHLBI Recovery Act funds. Dr. Shurin played a video (available on the Web site) featuring Dr. Deborah Nickerson, a key project leader on the ARRA-supported NHLBI Large-Scale DNA Sequencing Project, in which five academic institutions are working together to identify genetic connections to heart, lung, and blood diseases.
Comparative Effectiveness Research—NHLBI Involvement:
In the ARRA, Congress designated $1.1 billion for comparative effectiveness research (CER) with $400 million allocated to the NIH ($68 million of which is managed by the NHLBI). In June 2009, the Institute of Medicine (IOM) issued a report on national priorities for CER (see "Prioritizing Comparative-Effectiveness Research — IOM Recommendations" in NEJM 2009; 361:325-328). The NHLBI has primary responsibilities in three of the IOM's highest priority areas—Cardiovascular and Peripheral Vascular Disease; Oncology and Hematology; and Respiratory Disease—and supports CER research in these areas. Furthermore, the NHLBI has made major investments in the two areas of highest IOM priority—Health Care Delivery and Health Disparities.
FY 2010 R01 Payline:
Dr. Shurin updated the Council on the Institute's new funding policy regarding amendment status (see "Funding Guidelines" under FY 2010 Funding and Operating Guidelines on the NHLBI Web site). In order to fund meritorious science earlier, the NHLBI has adopted a new funding policy that decreases the need for investigators to submit revised applications. The Institute will develop separate lists ranking applications according to amendment status, resulting in comparable success rates for both unamended (A0) and amended (A1/A2) applications. As a result, paylines may differ by amendment status. Although the paylines may be updated throughout the year, the current FY 2010 percentile payline for competing R01s is 16.0 for initial applications; 12.0 for first amendments; and 10.0 for second amendments. (Note that the NIH is phasing out second amendments.)
Global Health Activities:
The NHLBI has established an Office of Global Health to provide leadership and coordination for its global health activities. The Institute has also joined with UnitedHealth Group to support Collaborating Centers of Excellence to combat non-communicable chronic cardiovascular and pulmonary diseases in developing countries. In addition, the NHLBI is a founding member of the Global Alliance for Chronic Diseases, launched June 2009, which is the first collaboration of government research funding agencies to address the needs of chronic non-communicable diseases. Illnesses related to hypertension, tobacco use, and indoor air pollution from crude cooking stoves in developing countries are three priority areas of the Alliance.
Dr. Neal S. Young, Chief, Hematology Branch, NHLBI Division of Intramural Research, reported on research progress in areas related to aplastic anemia and other bone marrow failure syndromes. He focused on three areas of opportunity in which he and other investigators have been involved:
- Pathophysiology and Treatment of Aplastic Anemia
- Telomere Diseases
- International Epidemiology and Teaching
Dr. Young also serves as Director of the Trans-NIH Center for Human Immunology, Autoimmunity, and Inflammation, the mission of which is to support cooperative research based on advanced technologies in order to translate enhanced understanding of immune function and pathophysiology to the clinic. Dr. Young summarized the Center's goals and progress made in its first fully-budgeted year.
NIH Office of Rare Diseases Research, Collaborative Efforts
Dr. Stephen C. Groft, Director, NIH Office of Rare Diseases Research, briefed the Council on the mission and activities of the NIH Office of Rare Diseases Research (ORDR). Working with NIH Institutes/Centers (ICs), the ORDR coordinates and supports rare diseases research, responds to research opportunities for rare diseases, and provides information on rare diseases. It supports the Rare Diseases Clinical Research Network (together with NIH ICs), which comprises 19 consortia that work together to improve availability of rare disease information, treatment, clinical studies, and general awareness for patients and the medical community. Over a fifteen year period, the ORDR has supported numerous other research activities, including a long-term collaboration with the NIH ICs to support over 1,100 scientific conferences focused on rare disease research opportunities and priorities.
Dr. Manfred Boehm, Translational Medicine Branch, NHLBI Division of Intramural Research, presented research results on the vascular implications of several human genetic disorders. He discussed research on a newly identified rare vascular disease now known as Focal Artery and Joint Calcification in Adults disease, an autosomal recessive disorder of vascular calcification. Dr. Boehm also discussed research that led to increased understanding about two other rare diseases—Prolidase Deficiency and Job's Syndrome—which involve defective wound repair and tissue remodeling. Dr. Boehm suggested directions for further research in these areas.
Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, thereby adding flexibility and decreasing the burden on the Council. Dr. Mockrin reported that in FY 2009, the Institute undertook 12 actions (totaling $847,855) using its delegated authorities (excluding the expedited en bloc concurrence). The Council accepted the report and agreed to continue the current policy of Delegated Authorities.
This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2).
The Council considered 1,362 applications requesting $1,760,893,155 in total direct costs. The Council recommended 1,362 applications with total direct costs of $1,760,893,155.
The meeting was adjourned at 2:15 p.m. on February 2, 2010.