Fiscal Year 2016: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports a broad research portfolio uniquely focused on human health and development, from before birth through adulthood.
In scientific domains encompassing developmental biology, reproductive health, pediatrics, population sciences, and medical rehabilitation, NICHD supports research that helps us better understand how health and disease develop over time, to prevent, reduce and treat illness and disability in current and future generations.
The lifelong process of human development is shaped by an array of complex physiological processes that interact with behavioral, social, and environmental factors.
Fundamental scientific knowledge about how these processes work may not yield commercially-viable new treatments quickly ? or at all.
Yet fundamental research is the foundation of medical progress.
Basic research helps identify crucial points in the disease process for treatment or prevention; reveals new compounds for testing as candidate therapies; pinpoints previously unsuspected risk factors for multiple conditions; and generates new approaches to prevention and cure.
NICHD?s support for fundamental science emphasizes technologies and tools to understand both normal development and disease, as well as creating new ways to measure progress in improving health.
NICHD actively promotes data sharing and supports publicly-available databases and biobanks to help ensure that relevant materials are available for translational research in maternal, pediatric, and reproductive health.
NICHD?s continuing efforts to understand the crucial role of the human placenta has already begun to provide an unprecedented wealth of information on how placental function affects maternal and fetal health.
NICHD also continues to prioritize continuing investment in basic and translational research related to structural birth defects, which are a major cause of infant death in the United States.
Populations of primary interest to NICHD -- children, pregnant women, and persons with physical and intellectual disabilities ? have too often and for too long been prescribed drugs, devices, and other treatments that were designed for and tested in groups from which they differ physiologically.
Parents, pregnant women, individuals with disabilities, and their health care providers are often put in an extremely difficult position in which they have little or no information to assess whether the treatment is more dangerous than the disease.
NICHD supports clinical research that specifically focuses on these populations, in the real-world settings where they receive treatment?including neonatal and pediatric intensive care units; fertility, rehabilitation, and HIV clinics; day care and schools; and physicians? offices.
For example, the neonatal intensive care units across the United States that form NICHD?s Neonatal Research Network are currently conducting clinical trials on potential treatments for neonatal sepsis, necrotizing enterocolitis, and anemia to help the smallest and most vulnerable infants.
The Zika in Infants and Pregnancy (ZIP) study intends to enroll 10,000 pregnant women in areas where Zika virus is prevalent, including Puerto Rico, Brazil, and Colombia.
Continuing this line of research will allow scientists to obtain data on the developmental effects of the virus on children, including understanding the relationship btween timing of exposure and development of microcephaly.
This will help clinicians, parents, and educators to better support children affected by prenatal exposure to Zika.
Fundamental biomedical and behavioral science is essential to prevention and health promotion.
Recent scientific findings show that pregnancy is a ?stress test? that indicates a higher risk for more serious problems as women age.
For example, NICHD-supported research has shown that women with pregnancy complications such as preeclampsia and gestational diabetes have a higher risk of developing heart disease and type 2 diabetes later in life.
NICHD research has also demonstrated that lifestyle factors such as nutrition and exercise can mitigate these risks.
Physical activity is a key component to maintaining physical health and decreasing secondary health conditions throughout life.
However, individuals with disability experience a number of physical, social, and environmental barriers that make it more difficult for them to participate in physical activity.
NICHD?s National Center for Medical Rehabilitation Research (NCMRR) studies interventions that can promote, monitor, and sustain physical activity programs for people with disabilities in real-world settings (e.g., home, community, workplace, and school).
This includes the use of engineering and social-science approaches to understand the effect of environmental factors, monitor individual participation, and promote overall health and independence.
NICHD continues to prioritize funding for new and early-stage investigators, to ensure that there is a pipeline of scientists and clinicians who are focused on the health problems of the communities NICHD serves, and to make certain that scientific progress continues to the next generation.
Over the past two years NICHD has convened a Training Task Force that has examined outcomes for a variety of different training pathways.
NICHD will use the evidence gathered from the Task Force?s analysis to preferentially fund mechanisms that require individuals, rather than institutions, to apply for training opportunities. The broad scientific opportunities at NICHD come with the recognition that thoughtful prioritization and careful stewardship are essential.
NICHD has implemented data-driven approaches to portfolio analysis, program evaluation, and performance assessment.
This will help the Institute make strategic funding choices, focusing on areas that hold the most promise to improve the health of children, pregnant women, individuals with disabilities, families, and communities.
Through a visioning process that has occurred over the past several years, NICHD has identified scientific research priorities that have been shared with the research community and the public.
NICHD will use these priorities to identify key areas for continued support.
Fiscal Year 2017: Child Health: Child health research ranges from basic scientific investigations of biological processes that control healthy and atypical development to clinical studies in pediatric pharmacology, pediatric HIV and associated infections, nutrition science, pediatric endocrinology, pediatric trauma and critical illness, and other aspects of pediatric medicine.
NICHD?s strong fundamental science portfolio in developmental biology has paved the way for efforts to understand and ultimately prevent structural and functional birth defects, a leading cause of death and disabilities in children.
Through intramural and extramural programs, NICHD supports collaborative teams of basic and clinical scientists studying the developmental biology, epidemiology, and genetics of structural birth defects.
Scientists also are utilizing and expanding the genomic sequencing data developed under the Common Fund?s Gabriella Miller Kids First Pediatric Research Program, with one of its two focal areas on structural birth defects.
Because children differ physiologically from adults, medications developed and tested in adults often work differently in children.
In some cases, children?s bodies clear medications more quickly, which may mean that effective doses need to be higher or given more often than the doses suggested by adult health care guidelines.
In other cases, a proportionally lower dose may be effective in children and reduce the potential for damaging side effects.
Lacking specific information on the safety and effectiveness of drugs in children, yet needing to treat the child, physicians often prescribe medications ?off label? ? that is, they prescribe medications that have been approved and ?labeled? for use in adults but not in children.
NICHD is working to expand the limited existing scientific knowledge base on the safety, efficacy, and appropriate doses of pharmaceuticals for children.
For example, NICHD has launched a study to assess the risks and benefits of two drugs (risperidone and aripiprazole), which are commonly used to treat schizophrenia and bipolar disorder in children and adolescents, but are not labeled for pediatric use.
Recently, researchers tested the efficacy and safety of drugs used for gastric reflux in low birth weight infants.
Histamine-2 receptor blockers (brand names include Zantac and Pepcid) have been shown to be safe and effective against gastric reflux in adults and older children.
Because of concerns about the adverse effects of gastric reflux, which exposes the esophagus to stomach acids, the drugs also have been commonly used in very low birth weight infants, although the drugs? efficacy and safety have not been tested specifically in these most fragile babies.
Many of these infants are susceptible to necrotizing enterocolitis, an infection-triggered intestinal inflammation, as well as sepsis, an overwhelming, systemic inflammatory reaction to infection.
Both conditions are difficult to prevent or treat and can swiftly prove fatal.
The research showed that use of the histamine-2 receptor blockers in very low birth weight infants was associated with a significantly increased risk of death, necrotizing enterocolitis, or sepsis.
This finding supports efforts to minimize exposure to these drugs in low birth weight infants, thus improving their care.
Children and adolescents with HIV, or who were exposed to HIV in the womb, are surviving and living full lives in greater numbers than ever before.
However, research supported by NICHD shows that both HIV and the drugs used to treat it can cause long-term health issues.
For example, NICHD-supported scientists compared two antiretroviral drug regimens in South African children with HIV.
They found that one of the drugs (efavirenz) was associated with less risk to bone formation than the other (ritonavir-boosted lopinavir or LPV/r).
Adults with HIV are known to be at elevated risk of osteoporosis and bone fractures, apparently due to the effects of HIV, inflammatory proteins (cytokines), and antiretroviral therapy on bone cells and bone turnover.
Any interference with bone formation in childhood and adolescence is of concern, because 85 to 90 percent of adult peak bone mass is achieved during this period, and shortfalls set the stage for osteoporosis and fractures in adulthood.
The LPV/r regimen, recommended by the World Health Organization, is widely used for children with HIV.
The results of this study suggest limiting LPV/r exposure in HIV positive children once viral suppression has been achieved, and using other medications to keep HIV in check.
For children affected by trauma or critical illness, evidence-based emergency and critical care can be lifesaving.
NICHD?s Collaborative Pediatric Critical Care Research Network (CPCCRN), including seven pediatric intensive care units across the United States, aims to improve care for critically ill and injured children.
For example, one of CPCCRN?s current studies is assessing the drug Granulocyte Macrophage Colony Stimulating factor (GM-CSF) for use in severely injured children.
Already FDA-approved for use in children with blood disorders, GM-CSF helps to improve immune function.
Because injured children in the pediatric intensive care unit are especially vulnerable to infection, the researchers aim to establish the optimal dose of this medication that will help improve immune function for children with severe traumatic injury.
Ultimately, scientists hope GM-CSF can reduce the risk of serious infection in these children.
Another research team seeks to learn more about developing new approaches to lessen the effects of severe burns over a large proportion of a child?s body.
In addition to the initial skin damage, serious burns can have long-term effects of multi-organ dysfunction, degradation of muscle protein, insulin resistance (pre-diabetes), and increased risk for infection.
The scientists found that even two years after a burn, mitochondrial (energy-producing structures within the muscle cells) function was altered, compared with healthy mitochondria.
The researchers hope that understanding the role of mitochondrial alterations could help pave the way for interventions to address long-term effects of severe burns.
Rehabilitation: Through the National Center for Medical Rehabilitation Research (NCMRR), NICHD fosters research and research training to enhance the health, productivity, independence, and quality of life of people with disabilities.
With a dedicated budget, this program supports a broad range of research, including efforts to understand the underlying biology of injury and disability, and the body?s mechanisms of recovery and adaptation.
Rehabilitation research investments are guided by the comprehensive five-year NIH Research Plan on Rehabilitation, developed in 2016.
The plan was developed under the leadership of NCMRR in collaboration with stakeholders across the NIH and other Federal agencies, as well as researchers and representatives of individuals with disabilities and practitioners.
The plan identifies six priority areas and details research plans and opportunities in each of them: ? Rehabilitation across the lifespan: Models of rehabilitation may require different approaches or considerations at different stages in life.
For example, play-based rehabilitation approaches can help young children build muscle strength and learn new skills, while adaptive physical exercise programs can assist seniors in maintaining their motor functions.
? Family and community: Recovery may start in a hospital, but outpatient services like speech or physical therapy and mental health services are key to successful daily and long-term functioning.
Caregivers play an essential but understudied role in rehabilitation management and improving quality of life for people with disabilities.
? Technology use and development: Technology has played a significant role in research and clinical applications in rehabilitation science, including assistive technology, orthotics, prosthetics, and others.
Computational science has also played a significant role, especially in providing advanced algorithms for device control and increased use of modeling and simulation.
Interdisciplinary collaboration will continue to be essential to harnessing technology to improve rehabilitation services.
? Research design and methodology: Improved research approaches are needed to address challenges in rehabilitation research, such as generating consistent clinical data from individuals with a variety of underlying conditions.
? Translational science: Rehabilitation research is poised to capitalize on advances in fundamental science.
Genomic and other cell-based, process-level contributors to plasticity and healing are now better understood, potentially allowing precision medicine approaches to be used in rehabilitation research.
? Building research capacity and infrastructure: To expand the potential of rehabilitation research, NIH will continue its support for training the next generation of rehabilitation scientists, and supporting interdisciplinary collaboration through courses, consultation, and collaboration.
NCMRR places a special emphasis on translational research to apply gains in fundamental science to creating real-world interventions that can help people with disabilities where they live and work.
In particular, NCMRR-supported researchers study the body?s self-repair mechanisms so they can understand and potentially harness those mechanisms.
In a recent study, scientists found that people with cerebral palsy have muscle weakness that is not related to the oxygen-fueled processes within mitochondria, the specialized structures within cells that produce the energy that cells and tissues need to function.
This may open other avenues to understanding potential causes and treatments for cerebral palsy. The rehabilitation program?s activities include a special emphasis on research related to rehabilitation for stroke, spinal cord injury, and traumatic brain injury (TBI), frequently in collaboration with other NIH ICs and outside organizations.
The long-term effects of TBIs are not well understood, since most studies are limited to irregular observations of TBI patients during a short period of time.
Researchers analyzed years of annual cognitive testing on over 7,000 participants in three longitudinal studies, with a subset consenting to autopsy.
The scientists found that people who had experienced TBI with loss of consciousness had a higher risk for symptoms of Parkinson?s disease and related conditions.
NCMRR takes a collaborative approach to rehabilitation science, working with other NIH institutes, federal agencies, the business community, advocates, and other stakeholders.
In a project supported by NCMRR and NINDS, scientists tested a new imaging technique that may one day permit diagnosis of the progressive brain disorder known as chronic traumatic encephalopathy (CTE) while a patient is still alive.
CTE is most commonly associated with repetitive blows to the head (concussions, TBI), such as those that occur in football, boxing, and hockey.
Currently, the only way to diagnose CTE definitively is examination of postmortem brain tissue, for distinctive deposits of the tau protein and other abnormalities that characterize the neurodegeneration of CTE.
The new technique uses a type of imaging known as positron emission tomography (PET) with a novel ligand a radioactive substance that localizes to the proteins of interest, which enabled the PET scans to produce visual images of tau abnormalities in the brain.
When the scientists tried the technique with a retired professional football player with early CTE symptoms and a history of 22 concussions, they found a ligand pattern that suggested extensive abnormal tau deposits.
Though further development and testing of the technique is needed, it may one day inform decisions for patients still functioning at relatively high levels despite CTE symptoms about continuing or halting high risk activities.
The technique could also help to evaluate therapies to interrupt CTE progression.
Fiscal Year 2018: Intellectual and Developmental Disabilities: The program in intellectual and developmental disabilities (IDD) supports basic, translational, and clinical research and research training to advance knowledge of origins of common and rare disorders such as Down syndrome (DS), Fragile X syndrome, Rett syndrome, inborn errors of metabolism, and autism spectrum disorders (ASD).
Evidence shows that early detection of conditions that impair a child?s intellectual development, and beginning therapy as soon as possible may increase the likelihood of better outcomes.
Accordingly, IDD research encompasses studies of newborn screening, as well as the earliest diagnosis, treatment, and management of IDDs and other conditions.
The IDD program also supports research to understand the complex processes through which these disorders compromise cognitive, emotional, social, and physical development in infants and children and throughout the lifespan.
In searching for the origins of ASD, for example, NICHD-supported researchers recently found that activation of maternal immune responses midway through a pregnancy may increase the risk of both ASD and intellectual disability (ID) in a child.
For years, many scientists believed that IDs were permanent and that it was not feasible to improve cognitive function.
Recent animal research suggests otherwise, showing that it may be possible to develop medications to improve brain function and learning in people with some types of ID.
With NICHD support, scientists are taking a critical step to develop ways to measure cognitive changes in people with ID over time.
Using NIH-developed cognitive tests originally tested in the general population, researchers conducted a pilot study with people of varying ages with Fragile X syndrome, DS, autism, and other causes of ID.
They discovered that the tests could be used to measure important functions like working memory, processing speed, and vocabulary in individuals with IDs, and to track these changes over time.
With these tools, researchers will be better able to assess both clinical and behavioral interventions to improve or maintain cognitive function in individuals with IDs.
Another core component of the IDD program focuses on understanding, describing, and managing comorbid conditions in individuals with ID.
For example, now that people with DS are living far longer than they were 50 years ago, it has become apparent that middle-aged adults with DS have a much higher risk than the general population of developing Alzheimer?s disease.
Both conditions are characterized by neurodegeneration, the breakdown of proteins and other structures of the brain.
In a recent comparison of postmortem brain tissues from individuals with DS, DS and Alzheimer?s, and those with healthy brains, researchers focused on a specific process (ubiquitinylation) in the protein breakdown.
They found patterns in this process that varied in the atypical tissue by diagnosis and by age.
The patterns suggested inefficiencies in the process that can result in a buildup of damaged proteins, which may contribute to Alzheimer?s symptoms.
Further study of the process could lead to insights on how to track or treat neurodegenerative disorders, which in turn may also have relevance for the general population of aging adults.
Research that can assist clinicians and others in helping families keep children with ID healthy and safe is an important area of IDD research.
Results from a recent analysis of national emergency department data on pediatric injury-related visits found significantly higher rates of injuries in youth with ID, especially those with ASD.
The investigators stressed the need for developing prevention and monitoring programs to keep youth with ASD or ID safe in their communities.
Additionally, individuals with DS are known to experience sleep problems, including obstructive sleep apnea and/or behavioral sleep problems, such as waking up for long periods at night and needing parental attention.
Testing for sleep problems and follow-up treatment if needed is recommended for all young children with DS.
However, NICHD-supported researchers analyzed electronic health records at a large specialized children?s hospital, and found that fewer than half of young patients with DS had undergone the recommended diagnostic testing.
These findings emphasize the importance of screening for sleep problems in children with DS, referring children with sleep problems to appropriate specialists, and educating families about the importance of diagnosing and treating any sleep problems. Demography and Behavior: The program in demography and behavior supports research and research training in the characteristics and dynamics of populations and subpopulations, to increase understanding of the causes and consequences of population structure and change in such areas as fertility, family demography and functioning, urbanization, migration, and subsequent implications for behavioral and social influences on health.
Researchers supported by this program analyze how demographic factors relate to health and health behavior.
One team of researchers used data from a nationally representative survey of over 30,000 adolescents to assess prescription opioid misuse in adolescents aged 12-17 years.
An estimated 6.8 percent of rural teens and 5.3 percent of teens in large urban areas reported misusing opioids in the previous year.
Rural adolescents perceived substance use to be less risky, and were more likely to smoke and engage in binge drinking but were less likely to use marijuana.
Regardless of whether they lived in a rural or urban area, teens that misused opioids most commonly reported friends or family as the source of the drug.
Rural teens were more likely than urban teens to report having received opioids from a physician or dealer.
These results may help public health officials improve programs to decrease opioid misuse, particularly in rural areas.
The demography and behavior program encompasses research in a wide range of developmental science areas, from trajectories of typical cognitive, affective, and social development to studies of language, attention, reasoning, problem-solving and multiple mechanisms underlying typical learning and learning disabilities.
The NICHD?s Learning Disabilities Research Centers support research to identify genetic and neurobiological characteristics of children, adolescents, and adults with learning disabilities; develop and validate classification systems for learning disabilities; expand knowledge about ways to improve comprehension for individuals who struggle with reading; assess the impact of ADHD on reading; and investigate the relationship between executive function skills and learning.
Complementing the Centers, the NICHD?s Learning Disabilities Innovation Hubs focus on understudied research topics that address the causes, symptoms, and treatments of learning disabilities that impact reading, writing, and mathematics.
Recently, NICHD researchers showed that children who do not know how to read can still recognize that written words symbolize meanings differently than pictures do.
This is an important developmental aspect in learning how to read; though this concept can appear fundamental to literate adults, it shows that children at a very early age already know more than previously thought.
Researchers presented more than 100 preschool children (aged three- to five-years-old) with a drawing or a written word, said what the word or drawing portrayed, then had a puppet illustrate the same or a different word, and asked the children whether the puppet knew what the word or drawing was.
For example, if the puppet indicated that the word ?dog? was a ?baby? or a ?puppy,? then many children said that the puppet was wrong.
However, many children were more likely to accept synonyms for the pictures, showing that the written words had more specific meanings than pictures.
By using a novel, straightforward task that did not require the children to write, the researchers demonstrated that children possess some of the most basic conceptual knowledge of the symbolic nature of printed words before they can actually read. Finally, the research interests of the demography and behavior program also include studies that identify the relationships among behavior, prevention, and risks to health.
For example, NICHD supported a study to obtain objective data on the frequency of risk factors in the infant night-time sleep environment associated with Sudden Infant Death Syndrome (SIDS) and sleep-related infant deaths, such as accidental suffocation, entrapment, and strangulation in bed.
The researchers recruited healthy newborns and their parents, and then videotaped the infants sleeping in their homes for one night at one month, three months, and six months of age.
The researchers analyzed the videos, finding that even when parents are aware they are being recorded, they often place their infants in unsafe sleep environments, including non-recommended sleep surfaces, placing infants on their sides or stomachs to sleep, or allowing loose items on the sleep surface such as bedding, bumper pads, pillows, and stuffed animals.
The results indicate that still more parent education is needed, particularly regarding safe sleep environments.
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|
|Regents Of The University Of California, San Francisco, The||$ 189,455||   ||2018-07-01||2024-05-31|
|Northwestern University||$ 647,395||   ||2018-09-01||2023-08-31|
|University Of Rochester||$ 1,800,000||   ||2018-09-13||2023-08-31|
|University Of Maryland||$ 655,888||   ||2018-09-06||2023-08-31|
|Washington University, The||$ 2,297,205||   ||2018-09-20||2023-08-31|
|Trustees Of Columbia University In The City Of New York||$ 5,661,162||   ||2007-06-08||2023-08-31|
|Case Western Reserve University||$ 688,104||   ||2018-09-14||2023-08-31|
|University Of Florida||$ 3,501,297||   ||2012-07-15||2023-08-31|
|Washington University, The||$ 1,388,368||   ||2018-09-20||2023-08-31|
|Regents Of The University Of Michigan||$ 3,669,982||   ||2002-02-11||2023-08-31|
Fiscal Year 2016: Fiscal Year 2016: Fiscal year 2016 competing and noncompeting research project grants actuals were 1,551. Of this number, 87 were SBIR/ STTR awards. A total of 50 research centers were awarded. 450 other research grants were also awarded. There were institutional training grants to support 476 trainees that were awarded in fiscal year 2016. The individual training awards were 109 for fiscal year 2016. Fiscal Year 2017: Budget Estimate: Fiscal year 2017 competing and noncompeting research project grants estimates are 1,589. Of this number, 80 are expected to be SBIR/ STTR awards. Approximately 51 research centers will be awarded. A planned 417 other research grants are anticipated to be awarded. There are projected institutional training grants to support 482 trainees that are planned to be awarded in fiscal year 2017. The individual training award are projected for fiscal year 2017 to be 142. Fiscal Year 2018: Budget Request: Fiscal year 2018 competing and noncompeting research project grants estimates are 1,247. Of this number, 65 are expected to be SBIR/ STTR awards. Approximately 51 research centers will be awarded. A planned 281 other research grants are anticipated to be awarded. There are projected institutional training grants to support 370 trainees that are planned to be awarded in fiscal year 2018. The individual training award are projected for fiscal year 2018 to be 100.
Uses and Use Restrictions
Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant.
National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas.
Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training.
Awards may be made to institutions to enable them to make NRS awards to individuals selected by them.
Each individual awardee 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 which are likely to result in commercial products or processes.
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 on Phase II application.
Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals.
National Research Service Award: 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.
Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree).
Predoctoral research training grants to institutions are also supported.
Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas.
Applicants must be citizens of the United States or be admitted to the United States for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training.
Domestic nonprofit organizations may apply for the institutional NRS grant.
SBIR: SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees).
Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project.
In both Phase I and Phase II, the research must be performed in the U.S.
or 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.
STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) 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.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical or biobehavioral research.
Applicants should submit electronically via Grants.gov as directed in the relevant NIH Funding Opportunity Announcement. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization 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 awards, and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations, 45 CFR, Part 74, 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. 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. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). Applications are submitted electronically via Grants.gov following the general guidance provided at: http://grants.nih.gov/grants/forms.htm and the specific instructions for the respective Funding Opportunities Announcement which may be found at: http://grants.nih.gov/grants/guide/index.html
Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the Eunice Kenney Shriver National Institute of Child Health and Human Development (NICHD). 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 the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the 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, or consult the specific Funding Opportunity Announcement listed in the NIH Guide for Grants and Contracts at: https://grants.nih.gov/funding/searchGuide/nih-guide-to-grants-and-contracts.cfm. General guidance about application due dates may be found at: http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/standard-due-dates.htm.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, Public Law 115-31.
Range of Approval/Disapproval Time
> 180 Days. From 6 to 9 months: National Research Service Awards: From 6 to 9 months. SBIR/STTR: approximately 6 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 web site at: http://public.csr.nih.gov/ApplicantResources/InitialReviewResultsAppeals/Pages/default.aspx.
> 180 Days. Renewal applications are accepted, as described in the relevant Funding Opportunity Announcement (FOA) found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271. National Research Service Awards: 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. Institutional Awards may be renewed.
Formula and Matching Requirements
This program has no statutory formula. This program has no matching requirements. This program does not have MOE requirements.
Length and Time Phasing of Assistance
Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years. See the following for information on how assistance is awarded/released: Each year, submitted progress reports for awarded grants are reviewed, and if satisfactory progress is demonstrated, a Notice of Grant Award is issued.
Post Assistance Requirements
NIH requires that grantees periodically submit financial and progress reports.
Other required reports may include annual invention utilization reports, lobbying disclosures, conflict of interest reports, audit reports, reports to the appropriate payment points (in accordance with instructions received from the payment office), and specialized programmatic reports.
Grantees also are expected to publish the results of research in peer-reviewed journals and to provide information to the public on the objectives, methodology, and findings of their NIH-supported research activities, as specified in Administrative Requirements?Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources. The GMO is the official receipt point for most required reports.
However, NIH has centralized the submission of annual progress reports; details are provided below.
In addition, electronic submission through the eRA Commons is required for some annual progress reports and available for all closeout documents (final grant progress reports, final invention statements and certifications, and final financial status reports).
When a paper non-competing continuation progress report is submitted, only a signed original is required; no copies are required.
Submission of these reports to an address other than the centralized one may result in delays in processing of the non-competing continuation award or the submission being considered delinquent.
FFRs must be electronically submitted to OFM (see Financial Reports below) through the eRA Commons eFFR feature unless otherwise indicated in the award?s terms and conditions. Grantees are allowed a specified period of time to submit required financial and final progress reports (see 45 CFR parts 74.51 and 74.52, 92.40 and 92.41, and the discussion in this subsection).
Failure to submit complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result in possible award delays or enforcement actions, including withholding, removal of certain NIH Standard Terms of Award, or conversion to a reimbursement payment method (also see Administrative Requirements?Enforcement Actions).
The schedule for submission of the non-competing continuation progress report is discussed in the next subsection.
The FFR has a dedicated section to report Federal cash receipts and disbursements.
For domestic grantees this information is submitted quarterly directly to the PMS using the web-based tool.
Quarterly reports are due 30 days following the end of each calendar quarter.
The reporting period for this report continues to be based on the calendar quarter.
Questions concerning the requirements for this quarterly financial report should be directed to the PMS. For awards issued to foreign institutions after October 1, 2012, even though payment is now through PMS, the requirement for quarterly cash reporting does not apply.
These awards are now administered in PMS using subaccounts and payments will be specific to each grant at the time the grantee draws funds.
Progress reports usually are required annually as part of the non-competing continuation award process.
NIH may require these reports more frequently.
The ?Non-Competing Continuation Progress Report? (PHS 2590) or equivalent documentation (e.g., Research Performance Progress Report [RPPR]) must be submitted to, and approved by, NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment).
Except for awards subject to SNAP, the progress report includes an updated budget in addition to other required information. NIH continues to transition to using the RPPR for progress reporting.
The RPPR is a federal wide format for the submission of required annual or other interim performance reporting on grant and cooperative agreement awards.
The transition to RPPR will be implemented in phases through a module in the eRA Commons.
The RPPR is now required for all SNAP and fellowship awards.
The PHS 2590 non-competing continuation progress report is currently required for all other NIH awards; however, the RPPR will eventually replace the PHS 2590 paper progress report.
Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the grantee organization.
NIH requires all financial expenditure reports to be submitted using the Federal Financial Report (FFR) system located in the eRA Commons.
This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to NIH.
The eRA Commons Federal Financial Report (FFR) system allows participants to view information on currently due and late expenditure reports and to submit these reports electronically to NIH.
Paper expenditure reports are not accepted.
Expenditure data submitted to NIH is initially reviewed and accepted by OFM.
NIH IC grants management staff also review these expenditure reports. Except for awards under SNAP and awards that require more frequent reporting, the FFR is required on an annual basis.
An annual FFR is required for awards to foreign organizations made prior to October 1, 2012 and Federal institutions made prior to October 1, 2013, whether or not they are under SNAP.
When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended.
The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter.
Failure to submit timely reports may affect future funding.
The report also must cover any authorized extension in time of the budget period.
If more frequent reporting is required, the NoA will specify both the frequency and due date. In lieu of the annual FFR expenditure data, NIH will monitor the financial aspects of grants under SNAP by using the information submitted directly to PMS.
The GMO may review the report for patterns of cash expenditures, including accelerated or delayed drawdowns, and to assess whether performance or financial management problems exist.
For these SNAP awards, FFR expenditure data is required only at the end of a competitive segment.
It must be submitted within 90 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment.
An FFR must be submitted at this time whether or not a competing continuation award is made.
If no further award is made, this report will serve as the final FFR.
The grantee institution is required to submit a progress report on an annual basis for each grant award, which includes monitoring of performance.
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. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
75-0844-0-1-552 - DHHS/NIH/ Eunice Kennedy Shriver National Institute.
(Project Grants) FY 16 $945,498,160; FY 17 est $975,664,000; and FY 18 est $704,848,000 - For FY 2016, of the $945,498,160 for Total Research Grants, $36,694,352 was for SBIR/STTR activities and awards. For FY 2017, of the estimated $975,664,000 for Total Research Grants, $39,821,000 is planned for SBIR/STTR activities and awards. For FY 2018, of the estimated $704,848,000 for Total Research Grants, $27,759,000 is planned for SBIR/STTR activities and awards.
Range and Average of Financial Assistance
For research project grants, fiscal year 2017, range is $50,000 to $5,000,000; average is $474,583. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of approximately $45,000. The sponsoring institution will be provided, on application, with an allowance of up to approximately $8,000 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $225,000 (grant activity R43 - for up to six months); Phase II awards may be made for amounts up to $1,500,000 (grant activity R44 - for up to two years).
Regulations, Guidelines, and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/; NIH Guide to Grants and Contracts, available on the NIH website at http://grants.nih.gov/grants/guide/. Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Regional or Local Office
Eugene G. Hayunga, 6710-B Rockledge Drive, Room 2216, Bethesda, Maryland 20892-7510 Email: email@example.com Phone: (301) 435-6856.
Criteria for Selecting Proposals
The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. 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 (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.