15. Activities Supported by the American Recovery and Reinvestment Act of 2009

• NHLBI Research Grants-Expansion of FY 2008 and FY 2009 Paylines
• NHLBI Participation in NIH-Wide ARRA RFAs
• Other RFAs Funded Under ARRA
• Signature Projects
• NHLBI Participation in NIH-Funded Competitive Revisions With Award Dates in FY 2010

The American Recovery and Reinvestment Act (ARRA), also known as the Recovery Act or the Economic Stimulus Package, was signed into law by President Barack Obama on February 17, 2009. It was an unprecedented effort to jump-start the economy, create or save millions of jobs, and address national challenges so that the Nation could move forward and thrive in the 21st century.

As stated in the legislation, the ARRA has five purposes:

• Preserve and create jobs and promote economic recovery
• Assist those most affected by the recession
• Provide investments needed to increase economic efficiency by spurring technological advances in science and health
• Invest in transportation, environmental protection, and other infrastructure that will provide long-term economic benefits
• Stabilize state and local government budgets to minimize and avoid reductions in essential services and counterproductive state and local tax increases

The ARRA provided the NIH with $10.4 billion, of which $763 million was allocated to the NHLBI. The Institute's funding plan strikes a balance between increasing the number of investigator-initiated research grants and supporting signature projects through the following mechanisms: NHLBI research grants (through expansion of FY 2008 and FY 2009 paylines), participation in NIH-wide administrative supplements, and participation in NIH-wide ARRA RFAs.

NHLBI Research Grants-Expansion of FY 2008 and FY 2009 Paylines

The NHLBI used a portion of the ARRA funds to support investigator-initiated research grant applications that had just missed the paylines in FY 2008 and FY 2009. The following proposals were funded by the NHLBI:

• Highly meritorious investigator-initiated R01 and R21 applications that ranked from the 15.1 to 25.0 percentile and were viewed as being capable of making significant advances with a 2-year grant.
• Early Stage Investigator-initiated applications up to the 35.0 percentile. The first 2 years will be supported by ARRA funds. The remaining years will be funded by regularly appropriated funds.
• New Investigator-initiated applications that ranked from the 20.1 to 30.0 percentile and were viewed as being capable of making significant advances in 2 years.

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Administrative Supplements

An administrative supplement is an increment in funding to support research that is within the original scope of an active NIH research grant (parent grant). Requests for administrative supplements for NHLBI grants do not require evaluation by an initial peer-review group but are subject to review and approval by NHLBI program and grants management staff.

The NHLBI funded administrative supplements to active R01 and R21 grants. The NHLBI's supplements under the ARRA support research employment opportunities for new full-time-equivalent employees who are predoctoral students, postdoctoral trainees or fellows, or recent college and master's degree graduates. Priority was given to requests from investigators who were qualified to receive their current awards as Early Stage Investigators or New Investigators.

The NHLBI also funded administrative supplements under the following NIH-wide initiatives:

• Administrative Supplements Providing Summer Research Experiences for Students and Science Educators:  To support summer research opportunities for high school and college students and science educators (e.g., elementary, middle, and high school teachers; community college faculty; and faculty from non-research intensive institutions).
• Research Supplements To Promote Diversity in Health-Related Research:  To provide supplements to research grants to improve the diversity of the research workforce by supporting and recruiting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in science.
• Research Supplements To Promote Reentry Into Biomedical and Behavioral Research Careers:  To support individuals with high potential to reenter an active research career after a qualifying interruption for family or other responsibilities.

NHLBI Participation in NIH-Wide ARRA RFAs

NIH Challenge Grants in Health and Science Research (RC1)

Challenge grants support research on specific biomedical and behavioral research areas that can be substantially advanced by significant 2-year jumpstart funds. The NIH identified broad Challenge Areas focused on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods, and the NHLBI identified specific Challenge Topics within the broad Challenge Areas that reflect the Institute's views about priority areas for funding.

Research and Research Infrastructure "Grand Opportunities" (GO) (RC2)

GO grants support projects that address large, specific biomedical and behavioral research endeavors that will benefit from significant 2-year investments without the expectation of continued funding from NIH. Research supported by this program is expected to provide a high short-term return and offer a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. The NHLBI identified the following priority topics for GO grants:

• Comparative Effectiveness Research
• Novel Methods of Monitoring Health Disparities
• The NHLBI BioResource Program: Creation of Resources Designed To Accelerate Scientific Progress in the Areas of Heart, Lung, and Blood Diseases; Cellular Therapies; and Blood Safety
• Large-Scale DNA Sequencing and Molecular Profiling of Well-Phenotyped NHLBI Cohorts
• Next Steps in Gene Discovery: Building Upon GWAS (Genome-wide Association Studies)
• Characterizing Differentiated Heart, Lung, and Blood Cells Derived by Reprogramming Human Embryonic and Induced Pluripotent Stem Cells
• Testing of Mechanistic Hypotheses Generated by Findings From Genetic and Genomic Studies of Heart, Vascular, Lung, and Blood Disorders
• Translation of Fundamental Research Findings Into Clinical Treatments for Heart, Lung, and Blood Diseases (including the NHLBI Translational Research Implementation Program (TRIP); the Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases; and the Ancillary Studies Program)

Supporting New Faculty Recruitment To Enhance Research Resources Through Biomedical Research Core Centers (P30)

The P30 program was designed to enable institutions to augment or expand their biomedical research efforts by hiring newly independent investigators and providing them with appropriate startup packages and the resources needed to develop pilot research projects.

Other RFAs Funded Under ARRA

Small Grants for Lung Tissue Research (R03)

This program will enable tissue-based research on two common but complex and difficult-to-treat lung diseases: interstitial fibrotic lung disease and COPD. Funds from the ARRA will expand substantially the Institute's lung tissue research program by enabling support for nine additional grants.

Functional Characterization of Genetic Variants and Interactions: The Genes, Environment, and Health Initiative (R21)

This program—which is part of the NIH Genes, Environment, and Health Initiative—will determine the functional relevance of associated genetic variant(s) to common diseases. It will focus solely on functional characterization of gene variants that are strongly suggested to be associated with common but complex human diseases identified through candidate gene, genome-wide association studies, and other approaches.

Comparative Effectiveness Research (CER)

Approximately $1.1 billion of the ARRA funds were allocated to CER, of which the NIH received $400 million. The NIH used the funds to support 2-year investigator-initiated projects, including payline expansions, Challenge grants, GO grants, and such other activities as supplements and contracts. The projects supported by the funds met the Federal Coordinating Council definition of CER, that is:

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in "real world" settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Signature Projects

DNA Sequencing of NHLBI's Well-Phenotyped Population Cohorts for the Identification of Disease-Causing Genetic Variants and Understanding of Biological Pathways

Although genome-wide association studies have been successful in identifying high frequency genetic variants of modest effect size that are associated with numerous common complex traits and diseases—including myocardial infarction, stroke, diabetes, obesity, hypertension, chronic pulmonary disease, and anemia—they are incapable of identifying actual disease-causing genetic variants, especially those of lower frequency and potentially larger effects. Finding such variants requires large-scale DNA sequencing of thousands of individuals from well-phenotyped populations. With recent technological advances, the feasibility of such a project is now within reach, and a strong argument can be made that the well-phenotyped NHLBI cohorts are the logical place to start.

The NHLBI is supporting six GO (RC2) grants, including two sequencing centers, under this signature program. The NIH Office of the Director is providing funds to help support one of the sequencing centers.

Stem Cell Biology and Regenerative Medicine

The NHLBI is committed to catalyzing basic and clinical stem cell research that will lead to the development of regenerative therapies for the treatment of heart, lung, and blood diseases. Recent advances, including the induction of pluripotent stem cells from adult somatic cells and the directed differentiation of stem cells into a variety of cellular derivatives, hold great promise for future therapeutic application. However, important gaps remain in understanding the characteristics of stem and progenitor cells, the mechanisms of their differentiation, and the unique attributes of resultant differentiated states. In addition, the degree to which differentiation of stem cells in the laboratory recapitulates the in vivo characteristics of tissues and organs remains unclear, and fundamental knowledge of cardiovascular and pulmonary stem and progenitor cell biology lags behind that for hematopoietic cells.

To address these gaps, the NHLBI is supporting four GO (RC2) grants under this signature program.

Translation of Fundamental Research Findings Into Clinical Treatments for Heart, Lung, and Blood Diseases

The ultimate goal of biomedical research is to make discoveries that can used to improve public health. Fundamental research studies in cells, tissues, and animal models and investigations of biomarkers and functional genomics have greatly expanded understanding of the pathogenesis of many heart, lung, and blood diseases and have provided a range of potential new approaches for their prevention and treatment. Yet the translation of basic research findings to clinical testing has often been disappointingly slow, with good ideas and new findings sometimes languishing for years before being tested for efficacy in a clinical setting. ARRA funds provide an excellent opportunity to stimulate translational research and thereby hasten the transition of research findings into clinical practice. The NHLBI will fund 10 GO (RC2) grants in two program areas:

• Stage 1 of the NHLBI Translational Research Implementation Program (TRIP):  To accelerate the translation of fundamental research ideas into proof-of-concept efficacy testing in patients. The 2-year Stage 1 TRIP awards will support preliminary studies that culminate in the development of ready-to-conduct clinical trials. The awards will fund the activities required to design clinical trials to evaluate safety and efficacy of new modalities to treat and prevent heart, lung, and blood diseases based on promising ideas that have emerged from basic research. For the Stage 2 TRIP, the NHLBI will use regularly appropriated funds to support the most meritorious trials developed in Stage 1.
• Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases:  To support Phase II clinical trials of novel therapies and diagnostic strategies for heart, lung, and blood diseases that offer the potential to change clinical practice and are ready to be tested in patients. It will also support the designs of innovative clinical trials. The supported research is expected to result in high-quality data that will lead to efficacy or Phase III trials. This program will assess only interventions and strategies that offer high promise for modifying current treatments or diagnostic approaches or altering the course of a disease.

NHLBI Participation in NIH-Wide ARRA RFAs With Award Dates in FY 2010

Academic Research Enhancement Awards (AREA) (R15)

The AREA program stimulates research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists but have not been major recipients of NIH support. AREA grants support small-scale health-related research projects that are proposed by faculty members of eligible domestic institutions.

Biomedical Research, Development, and Growth To Spur the Acceleration of New Technologies Pilot Program (BRDG-SPAN) (RC3)

The BRDG-SPAN is a pilot program that addresses the funding gap between promising research and development (R&D) and transition to the market by contributing funding needed by applicants to pursue the next appropriate milestone(s) toward ultimate commercialization. The goal of the BRDG-SPAN is to accelerate the transition of research innovations and technologies toward the development of products or services that will improve human health, help advance the mission of the NHLBI, and create significant value and economic stimulus. This program will also foster partnerships among a variety of R&D collaborators.

Small Business Catalyst Awards for Accelerating Innovative Research (R43)

This program accelerates innovation through high-risk, high-reward R&D that has commercial potential and is relevant to the mission of the NIH. The award supports entrepreneurs of exceptional creativity who are drawn from scientific and technological environments beyond those usually involved in NIH-supported research and who have proposed pioneering and possibly transformative approaches to addressing major biomedical or behavioral challenges with the potential for downstream commercial development.

Building Community-linked Infrastructure To Enable Health Science Research (RC4)

This program supports the development, expansion, or reconfiguration of infrastructures that are needed to facilitate collaborations between academic health centers and community-based organizations for health science research. These 3-year awards are funded by the NIH Office of the Director, and the NHLBI is administering two grants under this solicitation.

Methodology Development in CER (RC4)

This program supports projects to develop, enhance, or evaluate methodologies to improve the efficiency, validity, and credibility of CER. These 3-year awards are funded with NIH CER funds, and the NHLBI is administering three grants under this solicitation.

NIH Director's Opportunity for Research in Five Thematic Areas (RC4)

This program supports projects to develop and implement critical research innovations in one or more of the following five thematic areas:

• Applying Genomics and Other High Throughput Technologies
• Translating Basic Science Discoveries Into New and Better Treatments
• Using Science To Enable Health Care Reform
• Focusing on Global Health
• Reinvigorating the Biomedical Research Community

This program enables scientists to address these unique challenges by engaging in new avenues of research through which progress would produce a significant impact on the growth of and investment in biomedical or behavioral science and/or health research. These 3-year projects are supported by ARRA funds from the NIH Office of the Director, and the NHLBI is administering two grants under this solicitation.

NIH Basic Behavioral and Social Science Opportunity Network (BBSS OppNet) Short-Term Mentored Career Development Awards in the BBSSs for Mid-Career and Senior Investigators (K18)

This program supports short-term mentored career development awards for established, mid-career, and senior investigators to support their development of research capabilities in BBSS research. The NHLBI is administering two grants under this solicitation.

NHLBI Participation in NIH-Funded Competitive Revisions With Award Dates in FY 2010

Competitive Revisions Through the NIH BBSS OppNet (R01, R03, R15, R21/R33, R37)

This program supports competitive revision (formerly called competitive supplements) grants for relevant active research projects to accelerate, expand, and/or strengthen BBSS research. The grants are funded through the BBSS OppNet, and the NHLBI is administering two grants under this solicitation.

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NHLBI ARRA-Supported Activities Initiated in Fiscal Year 2009

^*   Does not include mechanisms with funding received after 2009.
^** Two-year total costs.

NHLBI ARRA-Supported Activities Initiated in Fiscal Year 2010

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