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Interim Evaluation Report on Research on the Prevention and Cure of Type 1 Diabetes Funded Through the Balanced Budget Act of 1997

Table of Contents

Executive Summary

Introduction

Background

First-Phase Evaluation: How Should the Money Be Spent?
The Development of a Scientific and Budget Plan--The Process

Second-Phase Evaluation: Peer Review of Grant Applications
Research Efforts and Strategies for Fiscal Years 1997-2002

1. Immediate Pursuit of Highly Promising, Innovative Science Through Trans-NIH Research Solicitations
   FY 1998 Funding of Research Solicitations
   FY 1999 Funding of Research Solicitations
   FY 2000 Funding of Research Solicitations
   
   
2. Establishment of CDC National Diabetes Laboratory To Be Funded From FY 1998 Through FY 2002
   
   
3. Exploitation of Other Areas of High Scientific Priority Through Short-Term Funding Strategies
   
   
4. Encouragement of Technology Development and Application To Exploit Scientific Opportunity Through One-Year Funding
   
   
5. Further Pursuit of Initiatives Deemed Most Promising
   FY 2001 and FY 2002 Strategies for Research Solicitations

Third Phase Evaluation: Assessment of Research Accomplishments

Table I --Type 1 Diabetes Research Initiatives Provided Through FY 1997 Balanced Budget Act

Appendix I--Research Solicitations Funded Through the Balanced Budget Act of 1997

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Executive Summary

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has prepared an interim evaluation report in response to Section 4921 of the Balanced Budget Act of 1997. This act provided the Secretary of the Department of Health and Human Services with $150 million to be spent, either directly or through research grants, for research on the prevention and cure of type 1 diabetes. These funds are being administered by the NIDDK through the authority given to it by the Secretary.

To help guide the initiative on type 1 diabetes, the NIDDK established a trans-NIH Planning and Evaluation Strategy Group representing nine Institutes and Centers. This NIH Group also invited ad hoc external advisors to attend meetings, including representatives from the Juvenile Diabetes Foundation International (JDF) and the American Diabetes Association (ADA). The group met numerous times to identify top scientific priorities for implementation with these funds. In pursuing these priority areas, the NIDDK developed a budget strategy to stratify deployment of funds. The NIDDK submitted a proposed funding plan through the NIH Director to the Secretary of Health and Human Services on November 11, 1997, which was subsequently approved by the Department.

In conformance with the general parameters of the approved plan, research efforts and strategies outlined in this report are broken down into five categories: (1) Immediate Pursuit of Highly Promising, Innovative Science Through Trans-NIH Research Solicitations; (2) Establishment of CDC National Diabetes Laboratory To Be Funded from FY 1998 through FY 2002; (3) Exploitation of Other Areas of High Scientific Priority Through Short-Term Funding Strategies; (4) Encouragement of Technology Development and Application to Exploit Scientific Opportunities Through One-Year Funding; and (5) Further Pursuit of Initiatives Deemed Most Promising. A summary table (Table I) is appended displaying the total expenditure of funds for initiatives described in this report over the 5-year period of funding provided by the Balanced Budget Act, FY 1998-FY 2002. Also attached is a listing of all grants funded with money from the Balanced Budget Act of 1997 (Appendix I).

Approximately $19 million provided by the Balanced Budget Act will become available for redeployment in FY 2001. The Trans-NIH Planning and Evaluation Strategy Group met on February 14, 2000, to consider approaches to ensure that these funds are used most productively. Also in attendance at this meeting were representatives from the Centers for Disease Control and Prevention, the JDF, and the ADA.

A third-phase evaluation is planned for FY 2002, the year that concludes the 5-year funding provided by the Balanced Budget Act, to review the progress made by the research funded under this act. Because some projects under this initiative will not receive their first year of funding until FY 2001 or FY 2002, the impact of the research findings will not be fully realized by 2002. The NIDDK will thus continue to track progress for several follow-up years on the research funded under this act. This information should provide a perspective for how research progress from this special congressional initiative fits within the continuum of diabetes research, and how it contributes to understanding and improving the health of people with diabetes.

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Introduction

Section 330B of the Public Health Service Act, as amended by Section 4921 of the Balanced Budget Act of 1997 states:

Sec. 330B. [254c-2] Special Diabetes Programs for Type 1 Diabetes "(a) In General. -- The Secretary, directly or through grants, shall provide for research into the prevention and cure of type 1 diabetes."

"(b) Funding. -- Notwithstanding section 2104(a) of the Social Security Act, from the amounts appropriated in such section for each of fiscal years 1998 through 2002, $30,000,000 is hereby transferred and made available in such fiscal year for grants under this section."

Sec. 4923 of the Balanced Budget Act of 1997 states:

Report on Diabetes Grant Programs
"(a) Evaluation. -- The Secretary of Health and Human Services shall conduct an evaluation of the diabetes grant programs established under the amendments made by this chapter."

"(b) Reports. -- The Secretary shall submit to the appropriate committees of Congress--

(1) an interim report on the evaluation conducted under subsection (a) not later than J00, and
(2) a final report on such evaluation not later than January 1, 2002."

This repoanuary 1, 20rting requirement is noted in the current compilation of health law with respect to Section 330B of the Public Health Service Act, as amended through December 31, 1998.

The following interim evaluation report has been prepared in response to this requirement by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services.

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Background

Diabetes is the sixth leading cause of death from disease in the U.S., afflicting an estimated 16 million people. It is the leading cause of kidney failure, blindness, and nontraumatic amputations in adults. It is a major risk factor for oral infections, tooth loss, heart disease, stroke, and premature death. Treatment of diabetes and its devastating complications results in significant health care expenditures. Currently, it is estimated that more than 1/10 health-care dollars and about 1/4 Medicare dollars are required to treat people with diabetes. At present, there are no methods to prevent or cure diabetes.

Diabetes spares no one, affecting the young and the old, the rich and the poor, and all races and ethnic groups. This problem is made more complex because diabetes mellitus is not a single disease, but occurs in several forms. The two most common forms of this disease are referred to as type 1 diabetes and type 2 diabetes. The remainder of this interim evaluation report will focus on type 1 diabetes, the form of the disease specifically addressed in the Balanced Budget Act of 1997.

Type 1 diabetes (formerly known as insulin-dependent diabetes mellitus) affects an estimated 500,000 to 750,000 Americans and is more common among children and young adults. In this form of the disease, the body's immune defense system destroys the insulin-producing (beta) cells in the islets of the pancreas--an "autoimmune" disease process. This process leads to a deficiency of insulin, a hormone secreted by the pancreas, which regulates glucose metabolism. Daily injections or infusions of insulin are therefore necessary to sustain life.

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First-Phase Evaluation: How Should the Funds Be Spent?

The Development of a Scientific and Budget Plan--The Process

The Balanced Budget Act of 1997 provided the Secretary of the Department of Health and Human Services with $150 million ($30 million annually for 5 years--FY 1998 through FY 2002) to be spent, either directly or through research grants, for research on the prevention and cure of type 1 diabetes. These funds are being administered by the NIDDK through the authority provided to it by the Secretary.

The overall goal in framing this 5-year initiative was to promote innovative, clinically relevant, and multidisciplinary research on type 1 diabetes. This initiative has brought and will continue to bring the best research talent, the most promising research ideas, and the most technologically advanced research tools to bear on combating type 1 diabetes, with special attention given to clinical and therapeutic issues.

To help guide the initiative on type 1 diabetes, the NIDDK established a trans-NIH Planning and Evaluation Strategy Group representing nine Institutes and Centers (NIDDK, NCRR, NEI, NHGRI, NHLBI, NIA, NIAID, NICHD and NINDS). This NIH Group also invited ad hoc external scientific advisors to attend these meetings, including representatives from the Juvenile Diabetes Foundation International (JDF) and the American Diabetes Association (ADA). The group met several times to identify the top scientific priorities for implementation with the funds provided by the Balanced Budget Act of 1997. These scientific areas were also developed within the context of other planning efforts for diabetes research, including recommendations emanating from a September 1997 trans-NIH symposium, "Diabetes Mellitus: Research Challenges and Opportunities," which the Director, NIH, sponsored along with nine Institute directors.

In pursuing these areas of scientific priority, the NIDDK developed a budget strategy to stratify deployment of funds so that there was not a build up of a commitment base in Fiscal Year (FY) 1998 that would preclude funding of emerging scientific opportunities in later years of this initiative. The NIH Planning and Evaluation Strategy Group wished to capitalize on research ideas that could be immediately exploited through research solicitations for new and innovative grants in FY 1998, while ensuring funding flexibility in future years to pursue advances, opportunities, and needs as they evolved. The NIDDK submitted a proposed funding plan through the NIH Director to the Secretary of Health and Human Services on November 11, 1997. This plan, including a proposal for evaluating the use of funds under this initiative, was subsequently approved by the Department. This report is prepared in conformance with the general parameters of the approved funding and evaluation plan.

In FY 1998, House and Senate appropriations report language for the NIH and the NIDDK called for the establishment of a Diabetes Research Working Group (DRWG) to develop a comprehensive research plan for the Congress recommending future directions for all NIH-funded diabetes research, including research on type 1 diabetes. During 1998, the Diabetes Research Working Group held plenary meetings and subcommittee discussions, analyzed the existing NIH diabetes research portfolio, and solicited and heard public commentary. The Working Group evaluated all aspects of diabetes, as well as the state-of-the-science, in an effort to develop a comprehensive research plan. The Diabetes Research Working Group reported its recommendations to Congress in March 1999, in a document entitled "Conquering Diabetes: A Strategic Plan for the 21st Century." The NIH has used, and will continue to use, the Diabetes Research Working Group's Strategic Plan as a guidepost for framing diabetes initiatives, within the context of the agency's available resources and its overall research mission. Thus, the scientific recommendations of the DRWG regarding type 1 diabetes have been considered in developing initiatives for type 1 diabetes with funds provided by the Balanced Budget Act.

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Second-Phase Evaluation: Peer Review of Grant Applications

Research Efforts and Strategies for Fiscal Years 1997-2002

Research strategies and efforts outlined in this section of the evaluation report are presented as the following five categories: (1) Immediate Pursuit of Highly Promising, Innovative Science Through Trans-NIH Research Solicitations; (2) Establishment of CDC National Diabetes Laboratory To Be Funded from FY 1998 through FY 2002; (3) Exploitation of Other Areas of High Scientific Priority Through Short-Term Funding Strategies; (4) Encouragement of Technology Development and Application To Exploit Scientific Opportunities Through One-Year Funding; and (5) Further Pursuit of Initiatives Deemed Most Promising. Within each of these five categories, this report describes initiatives under the year that a specific research solicitation or research project was funded. A summary table (Table I) is appended depicting the total expenditure of funds for initiatives described in this section over the 5-year period of the Balanced Budget Act.

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1. Immediate Pursuit of Highly Promising, Innovative Science Through Trans-NIH Research Solicitations

FY 1998 Funding of Research Solicitations

In FY 1997, the NIH issued four research solicitations for research grants to be funded in 1998. Each research solicitation was trans-NIH in scope and was co-sponsored by the relevant Institutes and Centers (ICs), with each IC emphasizing its scientific objectives. These research solicitations encouraged investigators to apply for either regular research grants, with an average duration of 3 years of total funding, or to apply for smaller amounts of funds for 2-year, innovative pilot studies.

Research solicitations were issued in the following areas of research: cellular and molecular approaches to achieving euglycemia; glucose sensors in the treatment of type 1 diabetes; pathogenesis and therapy of complications of diabetes; and immunopathogenesis of type 1 diabetes. Each of these is described below.

1. Cellular and Molecular Approaches To Achieving Euglycemia (RFA DK-98-007): This initiative focuses on methods to enhance the supply and sources of insulin-producing cells; identification of the cellular components necessary for glucose-responsive insulin secretion; development of methods to protect insulin-producing cells via immuno-isolation or immunomodulation/tolerance induction; development of noninvasive procedures to measure islet/beta cell mass/function or destructive disease processes; and the establishment of hematopoietic stem cell therapies for immunomodulation. It is anticipated that results obtained from studies supported by this initiative will aid in the development of improved therapies for the treatment of type 1 diabetes. Twenty awards were made under this initiative in FY 1998 for approximately $4.9 million.
   
   
2. Glucose Sensors in the Treatment of Type 1 Diabetes (RFA DK-98-008): The scope of this initiative includes the further development of glucose sensors to determine their clinical value and constraints; development and verification of fabrication methods; establishment of miniaturization procedures for the sensor and for control units; evaluation of the usefulness of the sensor in individuals with type 1 diabetes; and development of a "closed-loop" system with an accurate glucose sensing device, a controller, and an insulin delivery system. Seventeen awards were made in FY 1998 under this initiative for approximately $3.3 million.
   
   
3. Pathogenesis and Therapy of Complications of Diabetes (RFA DK-98-009): This research initiative addresses pathogenic mechanisms common to the spectrum of complications of diabetes, as well as research directed specifically at diabetic neuropathy and retinopathy, and macrovascular and oral complications. Thirty awards were made in FY 1998 under this initiative for approximately $6.7 million.
   
   
4. Immunopathogenesis of Type 1 Diabetes Mellitus (RFA DK-98-010): The objective of this initiative was to encourage research that will offer an improved understanding of the basic mechanism(s) involved in type 1 diabetes and will lead to the development of novel approaches to immunomodulation and immunoprevention. Applications exploring novel hypotheses about the pathogenesis of type 1 diabetes will identify new targets for intervention and generate new therapeutic strategies. Seventeen awards were made in FY 1998 under this initiative for approximately $4.1 million.

In summary, a total of approximately $19 million of trans-NIH type 1 funds provided by the Balanced Budget Act of 1997 was expended in FY 1998 for grants submitted in response to the previously listed research solicitations, and substantial additional funds were also provided by the Juvenile Diabetes Foundation International.

An evaluation of the distribution of funds by types of investigators showed that 26 percent of the awards were made to first-time NIH grantees; 37 percent of the awards were made to investigators new to the field of diabetes; and 30 percent of the awards were pilot and feasibility grants. The expenditure of the remaining FY 1998 funds is described later in this report.

FY 1999 Funding of Research Solicitations

In FY 1999, the NIH issued three research solicitations with funds available from the Balanced Budget Act of 1997. When developing these initiatives, recommendations from the Diabetes Research Working Group relevant to type 1 diabetes were considered. Once again, each research solicitation was trans-NIH in scope and co-sponsored by the relevant ICs, with each IC emphasizing its scientific objectives. These research solicitations also encouraged investigators to apply for either regular research grants, with an average duration of 3 years of total funding, or to apply for smaller amounts of funds for 2-year, innovative pilot studies. Each of the research solicitations is described below.

5. Neurological Complications of Diabetes (RFA NS-99-005): This initiative is to promote study of the mechanisms by which diabetes results in painful and disabling neuropathies and other neurological complications and to apply this information to the development of interventions to prevent, limit, or reverse these complications. The etiology of diabetic neuropathy is complex, involving metabolic and vascular effects. Recent studies suggest that deficiencies in neurotrophic factors may also play a role. Ten awards were made in FY 1999 under this initiative for approximately $2.2 million.
   
   
6. Functional Genomics of the Developing Pancreas (RFA DK-99-007): This initiative is intended to support the cost-effective generation of arrays of near full length coding sequences of genes involved in development and differentiation of the mammalian endocrine pancreas. Since many of these factors may be expressed at very low levels at key stages in development, strategies were proposed to increase the representation of low abundance transcripts in the cDNA libraries and to decrease the redundant sequencing of over-represented or known genes. A major objective of this initiative is to disseminate both sequence data and research reagents to the research community as rapidly as possible. Two awards were made in FY 1999 under this initiative for approximately $1.5 million.
   
   
7. Pilot Studies for New Therapies for Type 1 Diabetes and Its Complications (RFA DK-99-013): This initiative was designed to encourage submission of applications for high-risk/high-impact research. Another aim is to encourage talented new investigators and established investigators not currently working in the area of diabetes to apply their expertise to developing new approaches to prevention and treatment of type 1 diabetes and its complications. Pilot and feasibility studies proposing innovative strategies for prevention or treatment of type 1 diabetes or its complications and proposals for development of surrogate markers, which can be used as outcome measures for clinical research in diabetes, were specifically solicited in this initiative. Twenty-three awards were made in FY 1999 under this initiative for approximately $3.2 million.

FY 2000 Funding of Research Solicitations

Continuation of support for research solicitations launched in FY 1998 and FY 1999 is absorbing most of the FY 2000 funds provided through the Balanced Budget Act. Approximately $4 million is available for new initiatives. The research solicitations to be funded are described below.
5. Neurobiology of Diabetic Complications (RFA NS-00-002): Based on recommendations from the NIH Planning and Evaluation Strategy Group that NIH enhance research in diabetic neuropathy, the NIDDK and NINDS cosponsored a workshop in September 1999. The goal of this workshop was to evaluate research needs and opportunities and to explore ways to further research in this area, which was recognized as a high-priority, but under-served research area by the Diabetes Research Working Group. Following this workshop, a research solicitation, entitled "Neurological Complications of Diabetes," was issued by the NIDDK and NINDS (to be funded in FY 2000) to study the mechanisms by which diabetes results in painful and disabling neuropathies and other neurological complications. This information will help frame the development of interventions to prevent, limit, or reverse these complications. The NIDDK and NINDS will put forth $1 million each of regularly appropriated funds. The JDF will also provide $1 million. The type 1 diabetes funds from the Balanced Budget Act will provide $1 million to fund scientifically meritorious applications received under this solicitation.
   
   
6. New Strategies for Treatment of Type 1 Diabetes (RFA DK-00-001): The focus of this initiative is clinical studies in individuals with type 1 diabetes. Small trials to study cell-based therapies, glucose sensing devices, pumps, biomechanical-artificial pancreas, immunomodulation to arrest or reverse type 1 diabetes mellitus, and methods to detect and prevent hypoglycemia are encouraged. This solicitation was issued jointly by NIDDK, NICHD, and NIAID. It is estimated that $2.7 million will be expended on this initiative in FY 2000 from funds provided by the Balanced Budget Act.

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2. Establishment of CDC National Diabetes Laboratory To Be Funded from FY 1998 Through FY 2002

Members of the NIH Planning and Evaluation Strategy Group recommended transfer to the CDC of $3 million for the support of the National Diabetes Laboratory (NDL). The Laboratory, building upon existing expertise at the CDC, focuses on three main activities supportive of the following emerging scientific efforts in type 1 diabetes: (1) expanded genetic, immunologic, biochemical, clinical, epidemiologic, and health services research; (2) ongoing primary prevention trials being conducted in Europe and by NIH grantees; and (3) structured and systematic efforts to improve access to efficient and quality preventive care for patients. This initiative is estimated to cost $3 million annually for the 5-year life of the Balanced Budget Act's initiative on type 1 diabetes.

Current Activities

Advanced laboratory science is essential for researchers in diabetes working to prevent and treat the disease. The NDL has the ability to identify genetic, serologic, and immunologic factors associated with the risk for diabetes; to develop better and more precise instrumentation and measurements; to standardize reference methods; and to develop accurate, easy-to-use monitoring equipment for people with diabetes. Successful results are critically dependent on state-of-the art technology and on experts skilled in interpreting study results.

In each of the following areas, NDL has collaborated with key experts in diabetes research to ensure that resources are devoted to priority activities. The scope of activities at NDL is broad, involving not only the development of sophisticated technology, but also innovative thinking and extensive collaboration with many partners in the diabetes research community.

Current laboratory activities include (1) the development of reference measurements for glycosylated proteins, including hemoglobin A1c (HbA1c) and advanced glycation end products (AGEs); (2) the development and evaluation of laboratory technology for improving the measurement of genetic risk factors for type 1 diabetes and its complications; (3) the development of programs, in collaboration with the Immunology of Diabetes Society (IDS), for standardizing the measurement of the autoantibodies of type 1 diabetes; (4) the development of improved technologies for diagnosing and managing type 1 diabetes; (5) the development of reference methods and materials to assist in properly calibrating and standardizing blood glucose meters; (6) providing quality storage for essential samples used in scientific investigations; and (7) the development of devices and techniques for the noninvasive or minimally invasive monitoring of hypoglycemia.

Specific activities that have occurred during the past year include convening an international conference on the use of "dried blood spots" as a method for population-based surveillance for risk of type 1 diabetes; interacting with the American Association of Clinical Laboratories regarding the availability, accuracy and standardization of glycosylation hemoglobin assays, both nationally and internationally; interacting with the Diabetes Prevention Trial-Type 1 and other primary prevention studies for sample storage and analysis; developing improved assays for various lymphocyte cell types and associated activated products; addressing issues related to the non-invasive measurement of plasma glucose; and initiating plans for a major international conference on "Public Health Implications of Early Screening for Type 1 Diabetes Mellitus."

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3. Exploitation of Other Areas of High Scientific Priority Through Short-Term Funding Strategies

With respect to the allocation of the approximately $8 million in the 1-year FY 1998 funds not expended on research solicitations, the following procedure was followed. Relevant Institutes were invited to submit scientific proposals that were relevant to the type 1 initiative, of high priority, and consistent with the priorities set by external scientific advisors and the trans-NIH Planning and Evaluation Strategy Group. The NIDDK then sent out the proposals it received to the external advisors for assessment of their scientific merit and relative priority. Each reviewer provided a priority score and then scores were averaged for each project. The trans-NIH Group then met and approved all of the projects in priority-score order. The NIH Office of Research on Minority Health and the JDF also provided supplemental funds for some of these initiatives beyond funds available through the Balanced Budget Act.

10. One-Year Supplements to Ongoing Type 1 Projects: Some areas of research provided with additional funds by the special 1-year supplements include beta cell biology and function; cell signaling; autoimmunity and immunomodulation; a primate research center; glucose monitoring; clinical research, including Diabetes Prevention Trial-Type 1 (DPT-1) and Epidemiology of Diabetes Interventions and Complications (EDIC), and complications of diabetes.
    
    
11. Research Conferences: A small amount of funds was set aside for research management and support of a conference relevant to the priority area of "studies of the etiology of type 1 diabetes." In 1999, a conference on diabetic neuropathy was supported with these funds.
    
    
12. Intramural Research: In addition, funds were directed toward two intramural proposals, one related to further studies of islet cell antigens by an established NIH investigator, and another from a young investigator in the National Institute on Aging to work on mechanisms to stimulate islet cell growth using glucagon-like peptides.
    
    
13. Supplement to Diabetes Prevention Trial-Type 1: Additional funds have been used to enhance recruitment efforts and to plan for future trials of potential agents to prevent or ameliorate type 1 diabetes. An affiliate site has been added at the University of Toronto, a primary site for the CANENDIT trial which recently ended recruitment for patients at risk for developing diabetes. This site has a large pool of eligible participants for inclusion in the DPT-1.
    
    The DPT-1 Study Group hosted meetings in June 1999 and in January 2000 to explore optimal populations, eligibility markers, surrogate markers of endpoints, and potential agents for use in future prevention trials in type 1 diabetes. The meeting held in June 1999 was limited to the DPT-1 Study Group. The meeting held in January 2000 was opened to additional individuals outside the Study Group who are expert in immunology, endocrinology, biostatistics, clinical trials methodology, and ethics.

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4. Encouragement of Technology Development and Application To Exploit Scientific Opportunities Through One-Year Funding

To enhance the research infrastructure and harness technology for this initiative, 1-year funding was also recommended for several areas of technology development for FY 1998 and the subsequent fiscal years. FY 1998 1-year funding was also directed toward the development of new technologies--an area of high priority identified by the trans-NIH Planning and Evaluation Strategy Group, as well as the Diabetes Research Working Group. Such technologies include peptide-based therapies for prevention strategies. Instrumentation was identified by the NIH Planning and Evaluation Strategy Group as a high priority area. Instrumentation initiatives, as defined by the group, are efforts to apply and develop technologies to better understand the onset and progression of type 1 diabetes, such as the development of a means to assess beta cell mass and lymphocyte infiltration of islets as an index of disease progression.

In FY 1999, the NIDDK Division of Intramural Research, in collaboration with the Department of Defense, the NIH Clinical Center, and the Diabetes Research Institute of the University of Miami, initiated a clinical research program involving new approaches to both kidney transplantation and islet cell transplantation for diabetes. Funds from the Balanced Budget Act were used for partial support of this effort, that is, to purchase equipment and install a facility in the NIH Clinical Center for harvesting pancreatic islets for study and for human transplantation.

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5. Further Pursuit of Initiatives Deemed Most Promising

The NIH recognized many factors that can affect this plan, including changes in technology, new scientific discoveries, and new research challenges. Thus, it was important to stratify funding for this 5-year research initiative in ways to enable budget flexibility to take advantage of developments in the science base. The plan was developed to reserve some funds to be allocated in FY 2001 and FY 2002 for new research ideas.

FY 2001 and FY 2002 Strategies for Research Solicitations

About $19 million provided by the Balanced Budget Act of 1997 will become available for redeployment in FY 2001, as the projects initially funded in FY 1998 will be drawing to a close. The trans-NIH Planning and Evaluation Strategy Group is considering approaches to ensure that these funds are used most productively. The NIDDK requested all NIH Institutes and Centers to submit proposals for consideration for support with these funds. To leverage support for type 1 diabetes research, the NIDDK noted that high priority would be given to proposals to which the ICs would commit regularly appropriated funds to augment the funds provided by the Balanced Budget Act of 1997. In other words, an objective would be to fund new projects for a total of 4 years, using funds from the Balanced Budget Act for the first 2 years of support and funds from the regular appropriations of the ICs for the final 2 years. This concept of "matching funds" would provide an incentive to the Institutes and thus use the Balanced Budget Act funds for an important leveraging effect to intensify diabetes research across the NIH beyond 2002.

On February 14, 2000, the Director, NIDDK, held a meeting of the representatives from NIDDK, NCRR, NEI, NHGRI, NHLBI, NIA, NIAID, NICHD, NINDS, NIDCR, NIEHS, the CDC, the JDF, and the ADA for the purpose of attaining consensus on a strategy for allocation of the type 1 diabetes funds for FY 2001-2002. Notice of this meeting was also sent to NIDCD, NIGMS, CSR, NIAAA, NINR, NIMH, NIAMS, NCI, NIDA, and NCCAM. Proposals that were trans-NIH in nature and that served to attract new scientific communities with relevant expertise to diabetes research were encouraged. The NIH Planning and Evaluation Strategy Group discussed the proposals and took into consideration their relationship to recommendations for type 1 diabetes in the DRWG report. The group agreed to convene a panel of external scientific experts to review the proposals for their scientific merit and promise of advancing the prevention and cure of type 1 diabetes.

Third-Phase Evaluation: Assessment of Research Accomplishments

A third-phase evaluation is planned for FY 2002, the year that concludes the 5-year funding provided by the Balanced Budget Act of 1997. Specifically, to assess fully the special use of the funds provided, the NIDDK will convene a panel of scientific experts to review the progress made by the research as it relates to the prevention and cure of type 1 diabetes. In evaluating this initiative, the NIH will use narrative descriptions of research accomplishments put into the context of what was previously known and unknown about the prevention and cure of type 1 diabetes. Because some projects under this initiative will not receive their first year of funding until FY 2001 or FY 2002, the impact of all of the research findings will not be fully realized by 2002. The NIDDK will thus continue to track progress for several follow-up years on the research funded through the Balanced Budget Act of 1997. This information should provide a perspective for how research progress from this special congressional initiative fits within the continuum of diabetes research, and how it contributes to understanding and improving the health of people with diabetes.

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