Fiscal Year 2016: Division of Diabetes, Endocrinology, and Metabolic Diseases Projects:
Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group.
Intensive Diabetes Treatment and Cardiovascular Outcomes in Type 1 Diabetes: The DCCT/EDIC Study 30-Year Follow-up.
Diabetes Care 39: 686-693, 2016.
AND Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group.
Mortality in Type 1 Diabetes in the DCCT/EDIC Versus the General Population.
Diabetes Care 39: 1378-1383, 2016. Intensive Blood Glucose Management for Those with Type 1 Diabetes Preserves Heart Health and Reduces Risk of Early Mortality: A long-term NIDDK study reports that keeping blood glucose (sugar) as close to normal as possible for an average of 6.5 years early in the course of type 1 diabetes reduces cardiovascular (heart and blood vessel) disease and can reduce mortality to rates close to those seen in people of similar age in the general population.
The landmark Diabetes Control and Complications Trial (DCCT) began in 1983.
The DCCT randomly assigned half its participants to an intensive blood glucose management regimen designed to keep blood glucose levels as close to normal as safely possible, and half to the less intensive conventional treatment at the time.
When DCCT ended in 1993, it was clear that intensive management had significantly reduced eye, nerve, and kidney complications, but at that time the participants were too young to determine their rates of cardiovascular disease.
All DCCT participants were taught the intensive management regimen and invited to join the Epidemiology of Diabetes Interventions and Complications (EDIC) study.
EDIC continued to monitor participants? health, and overall blood glucose management has since been similar in both DCCT treatment groups.
To study the long-term effects of the different treatments tested in the DCCT, researchers examined differences in cardiovascular problems, which can take many years to develop, between the former intensive and conventional treatment groups.
After an impressive average 30-year follow-up, DCCT/EDIC researchers found that those who practiced intensive blood glucose management during the DCCT still had significantly reduced cardiovascular disease compared to those who did not, despite having similar blood glucose management for 20 years after the DCCT ended.
Compared to the former conventional treatment group, the former intensive management group had a 30-percent reduced incidence of cardiovascular disease and 32 percent fewer major cardiovascular events (such as non-fatal heart attack, stroke, or death from cardiovascular disease) after 30 years of follow-up.
These results were similar for both men and women who participated in the studies.
However, the beneficial effects of intensively managing blood glucose during the DCCT appeared to be wearing off over time.
For example, after 20 years of follow-up, DCCT/EDIC researchers reported that the former intensive treatment group had a 42-percent reduced risk of cardiovascular disease compared to the former conventional treatment group.
After 30 years of follow-up, that number had fallen to 30 percent.
Even with this reduction in protection, these new data show that a finite period of near-normal blood glucose management early in the course of type 1 diabetes can have beneficial effects on cardiovascular health for up to 30 years.
Historically, those with type 1 diabetes have had a higher mortality rate than the general population.
Previous DCCT/EDIC analyses compared intensive versus conventional blood glucose management and showed that those in the former intensive treatment group had reduced mortality compared with that of the former conventional treatment group.
Now, mortality in the DCCT/EDIC study from its inception through 2014 was compared to 2013 national mortality data.
Researchers found that overall mortality when both DCCT/EDIC treatment groups were combined was no greater than what would be expected in the general U.S.
However, they found that the mortality rate in the former conventional treatment group was 31 percent higher than that seen in the general population.
While the former intensive treatment group?s mortality rate was below that in the general population, the difference was not statistically significant.
Researchers also found participants? long-term blood glucose control affected mortality rates, and those who had worse control had correspondingly worse mortality rates.
This effect of blood glucose control on lifespan was more pronounced among women than among men.
In general, these results suggest that the increased mortality historically seen in those with type 1 diabetes can be reduced or eliminated through careful management of blood glucose.
Overall, these findings add to DCCT/EDIC?s decades of evidence demonstrating how people with type 1 diabetes can dramatically increase their chances of living long, healthy lives by practicing early, intensive blood glucose management.
Zhou K, Yee SW, Seiser EL,?Pearson ER.
Variation in the glucose transporter gene SLC2A2 is associated with glycemic response to metformin.
Nat Genet 48: 1055-1059, 2016. Variation in a Glucose Transporter Affects Response to the Type 2 Diabetes Drug, Metformin: New research indicates that a common variation in the gene encoding a protein that allows glucose (sugar) to move in and out of cells has a surprising impact on the effectiveness of the first-line anti-diabetes medication metformin.
Metformin is a very widely used, safe, and helpful treatment for type 2 diabetes, but it is more effective in some people than in others, and scientists are trying to understand why.
An international consortium of investigators looked at genomic variation in over 13,000 volunteers of varying ancestry who were taking metformin.
They found that a common variation in the gene for a glucose transporter protein, GLUT2, had a significant impact on metformin effectiveness.
(The gene encoding GLUT2 is known as SCL2A2.) Before treatment, people with two copies of a version of the gene (designated ?C?) typically had somewhat worse blood glucose control, as detected by higher levels of HbA1c, a marker for glucose levels.
Yet, these individuals had slightly better (lower) HbA1c when taking a standard dose of metformin than did people with two copies of the other version (?T?) of the GLUT2-encoding gene.
This effect was most pronounced in people who were obese, but was also seen in those who were not.
People with one copy of each version had an intermediate response to metformin.
GLUT2 allows glucose to move passively in and out of cells in the liver, an organ with a critical role in regulating blood glucose levels.
The GLUT2 that is produced by the C and T versions of the gene is the same, equally capable of allowing glucose movement.
However, the researchers found that liver cells with the C version make less GLUT2 than liver cells with the T version.
This suggests that in the absence of metformin, individuals with type 2 diabetes and the C version are at a disadvantage compared to those with the T version when it comes to regulating blood glucose levels, but that metformin treatment overcomes and even slightly reverses this effect.
Metformin still works in people with two copies of the T version of the gene, but more of the drug?or an additional medication?would be needed to achieve the same degree of HbA1c reduction.
This discovery has broad applicability, because the C and T versions of the gene are both common in a wide variety of racial/ethnic groups, albeit to differing degrees.
For example, about 70 percent of African Americans have at least one copy of C, while 24 percent of Latinos do.
With further research, tests to reveal a patient?s GLUT2 gene version could one day help further precision medicine by allowing health care providers to tailor metformin dosage for that individual, so that he or she takes neither more nor less of the medication than needed. Division of Digestive Diseases and Nutrition Projects: Inge TH, Courcoulas AP, Jenkins TM,? Buncher CR; for the Teen-LABS Consortium.
Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents.
N Engl J Med 374:113-123, 2016. Weight Loss and Health Benefits from Bariatric Surgery in Teens with Severe Obesity: In a study of teens with severe obesity, bariatric surgery resulted in substantial weight loss and improvements in health and quality of life 3 years after the surgeries were performed; the study also identified risks associated with the surgeries.
These findings are from the Teen Longitudinal Assessment of Bariatric Surgery, or Teen-LABS, study.
Obesity increases risk for type 2 diabetes, cardiovascular disease, and many other serious conditions.
Previous research has shown that adults with severe obesity (also known as extreme obesity) can experience dramatic health benefits from bariatric surgery.
However, very little has been known about the effects of this surgery in adolescents, particularly over the long-term?even though it is used in clinical practice for this age group.
Thus, researchers designed Teen-LABS, an observational study that enrolled adolescents who were already planning to have bariatric surgery.
Their goal was to collect outcome data on health risks and benefits that could help with treatment decisions.
Conducted at five U.S.
clinical centers, Teen-LABS enrolled 242 people ages 13-19.
Prior to surgery, all were obese, and nearly all had severe obesity, based on body mass index (BMI), a measure of weight relative to height.
The majority of the participants in the study were Caucasian females, a demographic representative of patients who seek bariatric surgery at these clinical centers.
The study focused on those who underwent either of two bariatric surgical procedures: gastric bypass (used for a majority of the teens), or sleeve gastrectomy.
Before surgery, the participants? average weight was 328 pounds.
Three years after surgery, their weight decreased by an average of 90 pounds, or 27 percent.
Some of the participants had type 2 diabetes, some had kidney disease, and many had high blood pressure or abnormal levels of blood lipids (cholesterol or triglycerides) prior to surgery.
The study found that 95 percent of the teens who had type 2 diabetes had reversal of their disease, 86 percent of those with kidney damage experienced improvements in kidney function, and most of the teens with high blood pressure or lipid abnormalities saw improvements in these conditions 3 years after surgery.
Additionally, 26 percent of the teens were no longer obese 3 years after surgery.
Although a majority still had some level of obesity, not as many had severe obesity.
The study also identified risks.
During the study period, 13 percent of participants needed additional abdominal surgery, most commonly gallbladder removal.
The study also found that although fewer than 5 percent of the teens were iron-deficient before surgery, more than half had low iron stores 3 years later.
These results contribute important knowledge about the benefits and risks of bariatric surgery in adolescents.
However, further research will be critical to determine the longer-term effects of bariatric surgery on health and well-being, including whether health improvements are sustained and whether additional risks emerge.
This information will help teens, their parents, and their health care providers make more informed treatment decisions, so that young people with obesity can have improved health during adolescence and as they become adults. Chu H, Khosravi A, Kusumawardhani IP,?Mazmanian SK.
Gene-microbiota interactions contribute to the pathogenesis of inflammatory bowel disease.
352: 1116-1120, 2016.
AND Lassen KG, McKenzie CI, Mari M,?Xavier RJ.
Genetic Coding Variant in GPR65 Alters Lysosomal pH and Links Lysosomal Dysfunction with Colitis Risk.
44: 1392-1405, 2016. Exploring the Genes That Keep the Gut?s Immune System in Check: Recent research into the genetics of inflammatory bowel disease (IBD) has pointed to abnormal interactions between the gut and the bacteria that inhabit it, implicating genetic defects in a process that cells use to break down microbial material.
IBD is a painful and debilitating collection of diseases, including Crohn?s disease and ulcerative colitis, that are marked by inflammation and damage in the gut.
The causes of IBD are unclear; however, the inflammation is believed to be caused by complicated interactions between genetic and environmental factors.
In particular, research has pointed to an improper immune response to bacteria in the gut?a reaction that can be affected by human genetics.
Variations in many areas of the genome have been associated with IBD, including some involved in immunity, but it has been difficult to determine how these variants might be contributing to the disease.
Recently, two groups of researchers have identified how certain IBD genetic risk variants may affect the way gut cells respond to bacteria.
Both groups focused on a process called autophagy, whereby damaged or unnecessary materials in cells?including bacteria and bacterial components?are packaged and broken down.
One of the research groups concentrated on the genes ATG16L1 and NOD2, both of which code for proteins that are known to play important roles in autophagy and have variants that are implicated in IBD.
The scientists found that immune cells from mice lacking the ATG16L1 protein were unable to suppress inflammation when exposed to a ?friendly? type of bacteria called Bacteroides fragilis (B.
fragilis) that normally resides in the human gut.
fragilis helps keep the gut?s immune system in check by delivering certain bacterial molecules to intestinal immune cells.
They deliver the molecules in small spheres, called outer membrane vesicles, that bud from the bacterial cells? outer coating.
These vesicles are engulfed, packaged, and broken down by immune cells in the gut, where their components suppress an immune reaction.
However, the researchers found that mouse immune cells lacking functioning ATG16L1 protein were unable to respond to these vesicles, thus potentially failing to prevent an improper inflammatory reaction to B.
fragilis and other ?friendly? gut bacteria.
Testing this idea in a mouse model of colitis, the scientists found that mice lacking functional ATG16L1 were not protected from colitis when they were given outer membrane vesicles from B.
fragilis, but mice with ATG16L1 were.
Mice and cells lacking functional NOD2 also had defective responses to these B.
fragilis vesicles, supporting the idea that NOD2 could cooperate with ATG16L1 in suppressing inflammation.
Importantly, mice or cells from male and female IBD patients with a human genetic variant of ATG16L1 that is implicated in IBD also did not respond to these vesicles, suggesting that a failure of ATG16L1-mediated autophagy could be contributing to disease in some people with IBD.
Another team of scientists investigated the role of autophagy as a cellular defense mechanism against potentially harmful bacteria.
Some types of bacteria can invade cells, causing disease, and cells typically use autophagy to package and degrade the invading microbes.
Armed with this knowledge, the researchers performed genetic screening in a human cell line to identify genes implicated in IBD that are involved in both autophagy and cellular defense against bacteria.
Among the genes they identified was GPR65, which has variants associated with IBD.
GPR65 encodes a protein that is important for the proper function of lysosomes, which are acid-rich globules in cells that break down material packaged for autophagy.
The researchers found that male and female mice without functional GPR65 protein were more prone to a disease resembling human IBD when given a type of bacteria that causes intestinal inflammation in mice.
This effect was seen when GPR65 was absent from either the cells lining the gut or the immune cells within the gut.
The lysosomes of intestinal and immune cells lacking GPR65 were unable to properly degrade invading bacteria.
This could be explained by the observation that the lysosomes were not positioned properly in the cell and were not as acidic as normal lysosomes.
Importantly, the researchers also tested a human cell line engineered to have a genetic variant found in male and female IBD patients, and immune cells from IBD patients who have this variant, and they found that these cells were also defective in destroying invading bacteria.
These results suggest that this genetic variant of GPR65 could promote IBD by crippling autophagy and cellular defense against disease-causing bacteria.
By showing that certain genetic variants identified in IBD patients can cause defects in the way cells relate to, or defend themselves from, bacteria in the gut, these results provide possible links between the genetics and the biological processes of IBD.
They also open the door to future treatments that could help restore proper relationships between bacteria and the gut immune system in people with IBD.
Division of Kidney, Urologic, and Hematologic Diseases Projects: Harper JD, Cunitz BW, Dunmire B,?Bailey MR.
First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones.
J Urol 195: 956-964, 2016. Moving Stones with Sound?New Ultrasound Technology Repositions Kidney Stones in People: Researchers have developed new ultrasonic propulsion technology that can reposition kidney stones and facilitate stone fragment passage in people.
Kidney stones are one of the most common disorders of the urinary tract.
Smaller stones may pass with little or no pain, while larger stones may get stuck along the lower urinary tract and block the flow of urine, causing severe pain and/or bleeding.
Current treatments for kidney stones, such as lithotripsy, may leave behind residual stone fragments.
Most fragments will pass on their own, but others may grow larger, cause pain, and lead to the need for additional treatment.
Toward the goals of finding safe ways to reposition kidney stones and encouraging the passage of stone fragments, scientists developed ultrasonic propulsion technology.
The technology uses a handheld device to generate a real-time ultrasound image to visualize the kidney stone, and directs controlled, short bursts of ultrasound waves toward the stone to try to make it move.
In the first human clinical trial testing this technology, scientists found that it could reposition kidney stones in 14 of 15 men and women studied, and cause some degree of movement of both large and small stones.
In fact, one person experienced pain relief after a large, obstructing stone was moved.
These findings suggest that the procedure could successfully reposition kidney stones in some people.
The scientists then examined six study participants who had residual stone fragments after previously undergoing a lithotripsy procedure to treat their kidney stones.
Four of them passed more than 30 fragments within days after undergoing the ultrasonic propulsion procedure, demonstrating that the technology could facilitate the passage of stone fragments.
An unexpected finding was that the technology may also be useful for diagnosis?in four people, what was thought to be one large stone was actually found to be a cluster of small, passable stones after they were moved.
Stone size is an important factor that doctors consider when making treatment decisions, so having this diagnostic information could aid them in making those decisions.
Importantly, the technology was found to be safe and did not cause pain.
It is also noninvasive and could be performed in a clinic setting while people are awake without the need for sedation.
Ultrasound propulsion technology is still being refined and tested in people, but with further research, it may eventually be possible to use this new technology after procedures that leave residual stone fragments to facilitate their passage and potentially reduce the need for future intervention.
The technology may also be useful for moving large, obstructing stones; repositioning stones before surgery; and serving as a diagnostic tool.
Orandi BJ, Luo X, Massie AB,?Segev DL.
Survival Benefit with Kidney Transplants from HLA-Incompatible Live Donors.
N Engl J Med 374: 940-950, 2016. Promising Result Reported from Multi-center Kidney Transplantation Study: Researchers have reported a survival benefit for people who received kidney transplants from HLA-incompatible live donors compared with either those remaining on the kidney transplant waiting list or those who received kidney transplants from immune system-compatible deceased donors.
Human leukocyte antigen (HLA) is a protein on the surfaces of human cells that identifies the cells as ?self? or ?foreign,? and performs essential roles in immune responses.
There are multiple forms of HLAs, which vary among individuals and are analyzed in laboratory tests to determine whether one person?s organs and tissues are compatible with another person?s, and could be used in a transplant.
The more closely the HLAs match between a donor and recipient, the less likely a transplant will be rejected by the recipient?s immune system.
To overcome HLA-incompatible transplants, organ transplant recipients undergo ?desensitization? protocols to remove antibodies in the blood that can harm the donated organ.
Previous research from a single center indicated a survival benefit with kidney transplants from HLA-incompatible live donors as compared with those waiting for a compatible organ.
To assess whether the survival benefit seen in the single-center study is generalizable on a national scale, a 22-center study was designed and conducted.
The researchers assessed the survival of people who received kidney transplants from HLA-incompatible live donors, at multiple time points up to 8 years after transplantation.
They compared these outcomes with the survival of two control groups?those who remained on the waiting list or received a transplant from a deceased donor, and those who remained on the waiting list but did not receive a transplant.
The multicenter study reported that a kidney transplant from an HLA-incompatible live donor was associated with a significant survival benefit compared to the two control groups.
As a compatible live kidney donor is rarely available, these results suggest that patients now could consider the option to undergo incompatible transplantation.
Fiscal Year 2017: No Current Data Available Fiscal Year 2018: No Current Data Available
The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.
|Recipient||Amount||Start Date||End Date|
|Trustees Of The University Of Pennsylvania, The||$ 1,267,631||   ||2004-02-15||2024-08-31|
|Children's Hospital Of Philadelphia, The||$ 2,585,863||   ||2002-09-30||2024-06-30|
|Duke University||$ 2,994,243||   ||1975-07-01||2024-06-30|
|University Of Wisconsin System||$ 380,900||   ||2019-07-01||2024-06-30|
|University Of Wisconsin System||$ 3,984,007||   ||1993-04-01||2024-06-30|
|University Of Washington||$ 2,985,502||   ||1993-07-15||2024-06-30|
|Children's Hospital Medical Center||$ 1,214,174||   ||1992-07-15||2024-06-30|
|Yale University||$ 3,274,556||   ||1984-07-01||2024-06-30|
|Trustees Of Indiana University||$ 151,080||   ||2019-07-01||2024-06-30|
|Louisiana State University System||$ 2,393,893||   ||2003-07-01||2024-05-31|
Fiscal Year 2016: Fiscal Year 2016 Actual: Project Grants: $1,489,668,000 with 3,176 awards; NRSA: $58,286,000 with 486 awards and 1,118 FTTPs/trainees SBIR/STTR: $58,634,000 with 115 awards. Fiscal Year 2017: FY 2017 Annualized CR Estimate: Project Grants: $1,479,263,000 with 3,205 awards are estimated NRSAs: $58,694,000 with 489 awards and 897 FTTPs/trainees are estimated SBIR: $61,933,000 with 120 awards are estimated. Fiscal Year 2018: FY 2018 President Budget: Project Grants: $1,214,613,000 with 2,727 awards are estimated NRSAs: $46,956,000 with 391 awards and 920 FTTPs/trainees are estimated SBIR: $50,207,000 with 103 awards are estimated.
Uses and Use Restrictions
Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives.
NRSAs are made directly to individuals for research training in specified biomedical shortage areas, or, to institutions to enable them to make NRSAs to individuals selected by them.
Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions.
SBIR Phase I grants (of approximately 6-months duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process.
Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or processes.
Only Phase I awardees are eligible to receive Phase II support.
STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application.
Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.
Project Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both non-profit and for-profit, and individuals who propose to establish, expand, and improve research activities in health sciences and related fields.
NRSAs: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health.
To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree).
Individuals must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program.
All awardees must be citizens or have been admitted to the United States for permanent residence.
Nonprofit domestic organizations may apply for the Institutional NRSA.
SBIR and STTR grants can be awarded only to domestic small businesses that meet the following criteria: 1) Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit; 2) Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3) Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R.
Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
STTR grants which 'partner' with a research institution in cooperative research and development.
At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution.
In both Phase I and Phase II, the research must be performed in the U.S.
and its possessions.
To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Health professionals, graduate students, health professional students, scientists, and researchers, any nonprofit or for-profit organization, company, or institution engaged in biomedical research. Project Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. NRSAs: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.
Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Individual NRSA applications for postdoctoral training must include the candidate's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training. Institutional Training grant applications for predoctoral and postdoctoral training must show the objectives, methodology and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for stipend support; and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 75, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant form PHS 398 is used to apply for SBIR and STTR Phase I Phase II and Phase I/Phase II Fast Track. 2 CFR 200, Subpart E - Cost Principles applies to this program.
Aplication and Award Process
Preapplication coordination is not applicable.
Environmental impact information is not required for this program.
This program is excluded from coverage under E.O.
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. Project Grants: Applications for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Applications may not be submitted in paper format. A registration process through Grants.gov is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. Two steps are required for on time submission: (1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date. (2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons. The standard application forms, as furnished by PHS and required by 45 CFR Part 92, must be used for this program by those applicants that are State or local units of government. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's 'Small Business Funding Opportunities' home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms.
Research Grant and Training Program applications are reviewed initially for scientific merit by an appropriate review panel, composed of scientific authorities, and by the National Diabetes and Digestive and Kidney Diseases Advisory Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. The successful applicant is sent a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495, and 498, as amended; Public Laws 78-410, 99- 158, 100-607, 106-554, and 107-360; 42 U.S.C. 241, as amended; 42 U.S.C. 285c-2, 42 U.S.C. 285c-5, 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Range of Approval/Disapproval Time
Project Grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months.
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html.
Project Grants: Renewals are determined by competitive application and review. Extensions considered upon request. Individual NRSAs: Awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.
Formula and Matching Requirements
This program has no statutory formula. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.
Length and Time Phasing of Assistance
Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: The Notice of Award (NoA) is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist. The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.
Post Assistance Requirements
Project Grants: Expenditures and other financial records, including documents supporting accounting records and substantive charges to each grant, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
NRSAs: Documentation of expenditures and other fiscal records must be kept readily available for examination by authorized Government personnel and must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions.
Cash reports are not applicable.
Annual and terminal progress reports, annual reports of inventions, and annual certification with respect to research involving human subjects are required.
Reports of expenditures are required.
NRSAs: Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions.
Performance monitoring is not applicable.
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. Records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO). Foreign grantees are subject to the same audit requirements as for-profit (commercial) organizations.
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 75.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 75.48 and 92.36 for record retention and access requirements for contracts under grants. In accordance with 45 Code of Federal Regulations, Part 75.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient?s personnel records for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
(Project Grants) FY 16 $1,606,588,000; FY 17 est $1,599,890,000; and FY 18 est $1,311,776,000 - The amounts above are the total Project Grants, NRSA and SBIR/STTR awards. The Project Grants and NRSA awards include Type 1 Diabetes funds and exclude TAPS. The SBIR/STTR awards include Type 1 Diabetes funds.
Range and Average of Financial Assistance
Project Grants: Range of $2,560 to $29,000,000; $469,000 average NRSAs: Range of $9,000 to $700,000; $120,000 average SBIR: Range of $2,000 to $1,900,000; $510,000 average.
Regulations, Guidelines, and Literature
Project Grants: 42 CFR 52; 42 CFR 66; 42 CFR 74; 45 CFR 75; 45 CFR 92. Administration Policy Directive No. 65 01 (47 Fed. Reg. 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 Fed. Reg. 38794 et seq. (1983)). Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/nihgps_2003/; Omnibus Solicitation of the Public Health Service for SBIR Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for STTR Grant Applications.
Regional or Local Office
None. Project Grants: Dr. Judith Fradkin, Director, Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 6037, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-7349; Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 6029, 6707 Democracy Blvd., Telephone: (301) 594-7680; Dr. Robert Star, Director, Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 6119, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-6325. Grants Management Contact: Mr. Robert Pike, Chief Grants Management Officer, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 7333, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8854. Use the same numbers for FTS.
Michelle Shorter 31 Center Drive, Room 9A34, Bethesda, Maryland 20892 Email: Shorterm@mail.nih.gov Phone: 3015948842
Criteria for Selecting Proposals
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.