Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)
National Eye Institute (NEI)
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

Global Brain and Nervous System Disorders Research Across the Lifespan (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-11-030

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-14-332

Companion Funding Opportunity

PAR-14-331, R21 Exploratory/Developmental Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.989, 93.867; 93.853; 93.173; 93.113; 93.866; 93.279; 93.865; 93.242, 93.321

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages grant applications for the conduct of innovative, collaborative research projects between U.S. and low- and middle-income country (LMIC) scientists, on brain and other nervous system function and disorders throughout life, relevant to LMICs. Scientists in upper middle income countries (UMICs) are eligible to partner directly with scientists at other LMIC institutions. Income categories are defined by the World Bank at http://data.worldbank.org/about/country-classifications/country-and-lending-groups .

The collaborative research programs are expected to contribute to the long-term goals of building sustainable research capacity in LMICs to address nervous system development, function and impairment throughout life and to lead to diagnostics, prevention, treatment and implementation strategies. The proposed work will also contribute to developing a base for research networking and evidence-based policy beyond the specific research project.

Key Dates
Posted Date

September 4, 2014

Open Date (Earliest Submission Date)

December 5, 2014

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 5, 2015; January 5, 2016; January 5, 2017, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 5, 2015; January 5, 2016; January 5, 2017 by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

March 2015, March 2016, March 2017

Advisory Council Review

May 2015, May 2016, May 2017

Earliest Start Date

June 2015

Expiration Date

January 6, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) encourages applications proposing innovative, collaborative research projects between United States (U.S.) and low- and middle-income country (LMIC) scientists (or direct collaborations between upper middle-income country (UMIC), and other LMIC scientists) on brain and other nervous system function and disorders throughout life, relevant to LMICs. These research programs are expected to contribute to the long-term goals of building sustainable research capacity in LMICs to address nervous system development, function and impairment throughout life, which may ultimately lead to diagnostics, prevention, treatment, rehabilitation and implementation strategies.

The proposed research must be relevant to the interests of one of the participating NIH Institute and Centers (ICs) (other than FIC) as stated in this FOA. Applications must be submitted as collaborations between U.S. (or UMIC) and LMIC investigators/institutions. An R01 application under this FOA must continue to build on already established research, research collaborations and research capacity building activities at the LMIC site(s). Applicants who need time and funding to develop research collaborations and capacity, and to conduct pilot studies are encouraged to apply first to the companion R21 FOA (PAR-14-331).

Background

During the past several decades, improvements in health care have led to a decrease in mortality (including and especially among children) and an increase in life expectancy in LMICs. These positive trends have set the stage for a complex and paradoxical epidemiology of health and disease as more children survive into adulthood affected by the sequelae of combined early illness, malnutrition and adverse experiences. These exposures can also advance the onset and severity of chronic diseases including cognitive and neurodegenerative disorders in later life. Similarly, socio-economic factors, such as poverty, conflict, stigma and gender inequalities contribute to the initial causes (such as injury, psychological trauma, chronic adversity, genetic vulnerability and infection) of many nervous system disorders. These disorders, in turn, handicap the physical and cognitive ability of individuals and their societies to address the root causes of the very conditions that may not only affect them but also future generations.

Data published  in the updated Global Burden of Disease 2010 (GBD 2010; http://www.who.int/healthinfo/global_burden_disease/gbd/en/) continue to show that non-communicable diseases and disorders (NCDs) are rapidly becoming the dominant causes of poor health globally and in all LMIC regions except sub-Saharan Africa (where they are second only to HIV/AIDS, as defined by contribution to “years lived with disability" [YLD]).

Disorders of the nervous system, e.g. Alzheimer’s Disease, combined with disorders affecting the nervous system, e.g. cerebral malaria, in aggregate contribute the most to the global burden of NCD disease and disability (more than a quarter of the burden, followed by cardiovascular disease and cancer). They also contribute about a third of the burden due only to NCDs in LMICs ( from the Global Burden of Disease and Risk Factors Report, DCP2, 2006, see the GBD 2010 at: http://www.who.int/healthinfo/global_burden_disease/gbd/en/ .In fact, nervous system disorders account for four out of the six leading causes of YLDs. They are: mental and behavioral disorders, especially unipolar depression and bipolar affective disorder, substance-use and alcohol-use disorders, schizophrenia, and dementias.

Maternal, perinatal and nutritional conditions including anemia, along with communicable diseases still contribute disproportionately to Disability Adjusted Life Years (DALYs, a measure of overall disease burden, expressed as the number of years lost due to ill-health and disability or early death) in LMICs as compared to high income countries. All of these conditions may also lead to nervous system problems (http://www.who.int/healthinfo/global_burden_disease/gbd/en/).

Infectious and parasitic diseases, such as HIV/AIDS, tuberculosis, malaria and other neglected tropical diseases, are a particular burden for LMICs, and especially sub-Saharan Africa, where they continue to be important causes of YLDs by themselves and due to their long term effects on the nervous system, especially of children. However, very limited data are available on the epidemiology, natural history and pathogenesis of neurological problems caused by these diseases and associated opportunistic infections and co-morbidities in these settings.

Chronic Pain, especially of the neck and back, is also now recognized for its large contribution to the burden of disability. Neurological disorders such as epilepsy, migraine, Parkinson's disease, and multiple sclerosis make smaller but significant contributions. Stroke and perinatal asphyxia, with neurological complications,  are also a significant problem in LMICs particularly since some of the causative factors of stroke such as hypertension are poorly treated in LMICs as compared to high income countries.

Mental and substance use disorders were ranked as the 3rd leading contributors to the burden of disease according to GBD 2010, when the burden attributable to suicide (which is a leading cause of death in many regions) is also considered. Depression, the most common psychiatric disorder, accounts for the largest proportion of suicide DALYs (46%).

The incidence of neuro-developmental disorders and related cognitive disorders (such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy) is less well characterized    in LMICs. However, many of the root causes of developmental disabilities – including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events (both pre- and post-natal) - are particularly common in resource-poor countries and their prevalence is high. These disorders, along with disability due to injury or insult to the brain and central nervous system during infancy or childhood, are clearly a heavy burden in LMICs.

Disability from disease and injury and the need for rehabilitation and accommodation will be an increasingly heavy burden on all health systems. GBD 2010 also puts an important spotlight on nervous system related chronic disability (and its particularly heavy toll on women)—from, for example, mental health disorders, substance use musculoskeletal disease, accidents, chronic pain and loss of vision and hearing.

Overall, the burden of neurological, mental, behavioral and substance use disorders together is expected to rise worldwide, as a proportion of the global burden of disease and disability, because of the projected increase in the number of individuals entering the ages of risk for the onset of many such disorders. As recently as 1950, about 5% of the people in the world were over 65 and about 15% under 5. Those numbers are on track to switch between 2030-2050. This transition highlights both the direct attention needed to research on diseases and disorders of later life along with the need for research on the influence and impact of early health/illness/treatment, experience and environment on development of those diseases and disorders across the lifespan. The rise of these disorders is expected to be steeper in LMICs, because of the continuing and long lasting contributing effects of early life trauma, infectious disease and malnutrition.

These problems pose a greater burden on vulnerable groups such as people living in poverty, those coping with disease and those exposed to emergencies. Disaster, war and conflict situations, especially prevalent in many LMICs, may lead to post-traumatic stress disorder (PTSD), which affects a substantial proportion of the overall population exposed to such conditions and which may lead to persistent dysfunction. In addition, stigmatization and gender inequality amplify many of the key risk factors for nervous system disorders. At the same time, available care is frequently inadequate. In some countries, the overall physician-patient ratio can be low as 1:20,000, with even fewer psychiatrists and neurologists.

Lack of adequate prevention and treatment in LMICs is a major contributor to the burden of disease and disability. Some disabling brain disorders are readily treatable at low cost, and yet many in LMICs suffer untreated; with detrimental individual, family and societal consequences. For example, epilepsy is a common brain disorder that disproportionately affects people in LMICs (roughly 85 percent of the total number affected worldwide). Although inexpensive and effective treatments are available, epilepsy is frequently untreated and even unrecognized in LMICs often because of stigmatization and lack of knowledge. For such disorders, implementation science that integrates social and cultural factors into education, media, policy and behavior change research is especially needed and appropriate.

Prevention of disability due to neurological impairment is possible in many situations with appropriate research leading to knowledge and interventions. For example, research to identify neurotoxins and their mechanisms can be combined with interventions to minimize human exposure by reduction in use or release to the environment and by appropriate safeguards in occupational settings.

Despite their enormous burden of disease, nervous system disorders have been largely absent from the global health research agenda. In addition to research on the etiology, prevention and treatment of individual conditions and disorders, more information is needed on co-morbidities among nervous system disorders and between these disorders and other chronic NCDs. Many of these conditions exist together in LMICs and are likely to have more severe and complicated effects than any in isolation and often extend beyond the individual affected (for example maternal depression as a risk factor for infant stunting). Research on the social and economic impact of neurological, psychiatric, and developmental disorders is needed to inform interventions, implementation and policy. Research is also needed to further define the burden and identify knowledge gaps, needs, opportunities and methods to effectively reduce the burden and to lay the ground work for developing and testing interventions.

Applicants are encouraged to refer for more background to recent publications summarizing the state of knowledge on the burden of nervous system disorders around the world including the following:  Disease Control Priorities Related to Mental, Neurological, Developmental and Substance Abuse Disorders (contains five chapters from the Disease Control Priorities in Developing Countries, second edition, World Health Organization 2006,  http://whqlibdoc.who.int/publications/2006/924156332x_eng.pdf. Also see http://www.who.int/healthinfo/global_burden_disease/gbd/en/.

Research Topics

Relevant research topics for this FOA are related to nervous system function and/or impairment from birth to advanced age and across generations. Applicants are especially encouraged to propose research on co-morbidities and conditions that affect nervous system function at different life stages, as well as across the lifespan. Relevant research for these applications may range from basic science to epidemiological, clinical, health services and translational (e.g. translation of basic research to therapy and of clinical research to applications in the field) and implementation research. Applicants may propose a research and capacity building program on some aspect of nervous system function and/or impairment at any stage of life.

Examples of nervous system disorders contributing to the burden of disease in LMICs and relevant to this FOA, include but are not limited to, neuro-developmental disorders (including autism, cerebral palsy, fetal alcohol syndrome, learning disabilities), neurodegenerative diseases (such as Alzheimer's and Parkinson's Diseases), addictive disorders, seizure disorders such as epilepsy, neuropsychiatric disorders (such as unipolar depression, bipolar disorder, schizophrenia), posttraumatic stress disorder, dementias, encephalopathy, peripheral neuropathies, sensory and motor neuron diseases.

Examples of influences on nervous system function across the lifespan include, but are not limited to: genetic predispositions and epigenetic changes  in response to pre-, peri- and post-natal trauma and environmental factors (such as maternal depression, in-utero drug and alcohol exposure, neuro-toxic insults, perinatal hypoxia, child abuse and neglect, inadequate environmental stimulation and nutritional deficiencies),  physical and psychological trauma (exposure to violence, sexual and  physical abuse, traumatic nervous system injury due to violence and accidents), infection of the nervous system by viral and parasitic diseases (such as HIV/AIDS, malaria, neuro-cysticercosis) and stroke. Other factors affecting healthy brain development include access to appropriate health care and socioeconomic factors.

Examples of some cross-cutting areas for research are:

  • Ethnographic studies and other areas of social science, particularly to address health systems, availability of resources, preventive or screening practices, and appropriate interventions within a given society or group;
  • Gender and socio-cultural and economic factors in the etiology, prevention and treatment of the disorders to be addressed;
  • Sex differences at all levels of brain and nervous system function and disorders;
  • Natural history of common neurological diseases/disorders and the influence of socio-cultural or other environmental variables that impact upon this course and how to use this knowledge for treatment and intervention;
  • Factors associated with aging affecting cognitive, emotional and physical health and survival in older persons along with interventions and treatments;
  • Co-occurring risk factors or conditions, especially common in the LMIC or region (e.g. neuro-toxic or traumatic insult plus infectious disease and/or malnutrition);
  • Mechanisms (e.g. neurotoxic, epigenetic) underlying genetic, physiological, environmental, social and economic factors and interactions that affect brain function or development and result in behavioral outcomes (e.g., expression of cognitive impairment, coping, adaptation, response to intervention); and
  • Epidemiology: 1)  Descriptive epidemiology to describe and define the problem in the countries in question by assessing the needs and determining the magnitude of factors involved in the problem to be addressed (e.g., research on trends in incidence, prevalence or mortality; distribution of disease; determination of population at risk; determination of case definition/disease classification). 2) Analytical epidemiology to identify potential etiological factors in the populations of interest, including factors responsible for predispositions to the neurological consequences of various infection and/or neurotoxins (e.g., identification of risk factors for neurological consequences of disease onset or progression; classification and measurement of exposure; magnitude and distribution of known risk factors).

Types of research relevant to this announcement include basic research and epidemiology, as well as translational research, research on diagnostics, early interventions, clinical treatment, prevention, and health services that are culturally appropriate, feasible, and acceptable for implementation within the LMIC. This FOA encourages development of multidisciplinary and interdisciplinary research and the capacity in the LMIC to conduct such research, relevant to the research question. Expertise may involve, but is not limited to, fields such as genetics/epigenetics, epidemiology, neurology, cognitive neuroscience, developmental neurobiology, neuro-toxicology, neuro-endocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, neurosurgery, neuro-rehabilitation and biotechnology (e.g., for development of diagnostic tools and treatments), as well as the behavioral and social sciences including health economics, health services and implementation science.

Research Capacity Building

The proposed collaborative research is expected to contribute to the long term goals of building sustainable research capacity in LMICs.  The proposed project can also contribute to the development of research networks and evidence-based policy.

For purposes of the research capacity building and networking encouraged in this FOA, and for background, applicants are also encouraged to use as a resource the compilation of the past awards under the Brain Disorders in the Developing World: Research Across the Lifespan program (http://www.fic.nih.gov/Programs/Pages/brain-disorders.aspx) and the recent symposium highlighting a decade of research under the program (http://www.fic.nih.gov/News/GlobalHealthMatters/january-february-2014/Pages/brain-disorders-program-10th-anniversary.aspx).

Specific Research Interests of the FOA Sponsors

Applicants can obtain information about research interests for each of the sponsoring partners of this FOA at their Web sites and by contacting the partner program contact listed in this announcement. Participating partners provided specific statements of interest for this FOA below.

The Fogarty International Center (FIC) Strategic plan

http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx states the following relevant goals: 1) Build  research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5)  Build and strengthen partnerships to advance global health research and research capacity.

The National Eye Institute (NEI) is interested in applications relevant to its mission as stated on the NEI website: http://www.nei.nih.gov/about/mission.asp.

The National Institute on Aging (NIA) is interested in applications relevant to Alzheimer's disease, other degenerative diseases of the nervous system in aging, and/or age-related changes in cognition, memory, sensory, and/or motor function, and in brain structural and functional connectivity at the cell, circuit, and network level. Of interest also are studies on reducing disability and/or preventing or slowing additional decline among persons with cognitive, sensory, or motor disabilities as they continue to age. The studies may be laboratory-, clinic-, or population-based. Cross-cultural studies with data harmonization are welcome if focused on the topics above.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is particularly interested in encouraging research on problems in child health and development, such as intellectual and developmental disabilities, cognitive and behavioral disorders, and learning disabilities. Relevant research includes etiology, patho-physiology, screening, prevention, treatment, and epidemiology. Also of interest are studies on cognitive, social, and affective development, including studies in high-risk settings (e.g., in violent or abusive environments, or families experiencing stressors such as poverty, unemployment or parental depression). Biomedical, behavioral, and bio-behavioral research in these areas is encouraged along with investigations of socio- and ethno-cultural, familial, individual, and biological influences. Also of interest are studies investigating the roles played by nutrition, stressors and hormonal factors in nervous system development and function. Additionally, the interaction of infectious diseases (for example, HIV, malaria, tuberculosis) with the brain/development in the fetus and infants, children and adolescents is of interest to NICHD. NICHD also encourages research on the effective use of information technologies for research, research capacity building, public health registries and tracking systems, data collection and management, point of care technologies and applications of new technologies for affordable screening and research in LMICs. NICHD is further interested in enhancing the capacity of LMIC investigators to conduct clinical trials and the inclusion of children in translational research, and the inherent ethical, legal and social issues that arise in such clinical research.

The National Center for Medical Rehabilitation Research (NCMRR/NICHD) is interested in promoting the discovery of new and cost-effective prostheses for treatment of physical disabilities in the developing world. Interface with the nervous system may be a critical part of this type of rehabilitation research and grantees should consider partnerships that explore this interface. In addition, cognitive rehabilitation is particularly effective when combined with technology through computer based games as part of therapy, telemedicine, consultations among physicians, and patient reminders for appointments, medications or exercises. NCMRR is interested in rehabilitation across the life-span for a wide range of disease/disorders including stroke, brain and spinal cord trauma, neurodegenerative disorders and diseases of the nervous system that result from infection. NCMRR is particularly interested in research on approaches to medical/cognitive rehabilitation that minimize costs and can be provided in community settings.

The National Institute on Drug Abuse (NIDA) invites research on any area currently supported by NIDA. However, the following areas of research are current priority areas:  

  • Active drug use is often associated with increased risk of HIV transmission, non-adherence to HAART or lapses in HIV treatment. Studies are needed to discern the impact of HIV and AIDS on brain development and function;
  • Amphetamine type stimulant abuse and synthetic and other designer drug abuse are growing problems in the U.S. and around the world. Studies are encouraged to assess the nature and extent of amphetamine type stimulant abuse and synthetic and other designer drug abuse, their short and long term sequelae on brain and behavior, and prevention and treatment options;
  • Inhalant abuse continues to be an under-recognized public health problem in many countries. Studies are encouraged to improve epidemiological data on the nature and extent of abuse, to develop and implement effective prevention programs, to better understand the neurobiological impacts of these agents, and to increase public awareness of their impact;
  • Smoking during pregnancy studies are encouraged to increase our knowledge of the prenatal impact of smoking and the effects of early exposure to tobacco in young people and adolescents on development of addiction and other diseases and on cognitive development; and
  • Drugged driving studies are encouraged to develop and utilize accurate drug testing technologies to assess the prevalence of driving under the influence of drugs, the role of drugs in accidents, and to assess the costs and benefits of laws and other programs to reduce the incidence and impact of drugged driving.

The National Institute on Deafness and Other Communication Disorders (NIDCD)

The NIDCD conducts and supports research in 7 scientific program areas:  hearing, balance/vestibular, voice, speech, language, taste and smell. The mission of the NIDCD is to reduce the burden of communicative disorders and improve public health. NIDCD is especially interested in applications that strengthen research capacity building & clinical intervention by otolaryngologists, audiologists, speech-language pathologists and related medical and health professionals. Areas focused on newborn screening of hearing ability and early identification and treatment of voice, speech, and language delay or disorders are highly desirable. 

Normal hearing ability is central to development of effective verbal expression. Communication disorders occur throughout the lifespan and can occur in isolation (e.g. hearing loss, stuttering) or may occur within the context of a hearing impairment or neuro-developmental disorders (e.g. autism). Communication disorders may be heritable, due to in utero exposure, or result from injury, neurologic condition (e.g. stroke), head and neck cancer, or coexist with congenital physical conditions (e.g. cleft lip/palate). Developing research capacity of a health related workforce fluent in the languages spoken in the LMIC is a plus. Applications from institutions within a geographic region which shares the same spoken language e.g. Latin America, Middle East and North Africa would offer nodes on which to build future regional networks for communication disorders or for the development of national and regional Centers of Excellence in Communication Sciences & Disorders. 

NIDCD is interested in funding the development and implementation of epidemiological studies on the incidence, prevalence, and determinants of hearing impairment and other communication disorders across the lifespan, including risks associated with behavioral, demographic, environmental, genetic, or other health factors.

The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research in LMICs to identify the causes of, and opportunities to prevent or ameliorate the consequences of neurotoxic insult to the nervous system throughout the lifespan. Research in LMICs is encouraged in how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation or progression, or affect the risk of either disease development or distribution in populations. Examples of environmental exposures of interest include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, food or bacterially derived toxins (but not infectious agents, per se) and indoor air pollutants from cooking stoves and other sources.

The National Institute of Mental Health (NIMH) encourages research that:

  • Charts the course of neuropsychiatric disorders over the lifespan in order to:  (a) understand ideal times and methods for intervention to preempt or treat mental disorders and hasten recovery; (b) examine the interactions of neurobiological systems and environmental/social factors that affect brain development, resulting in maladaptive behavioral outcomes (e.g., cognitive impairment, inability to respond to intervention); or (c) identify molecular or circuit pathways of neural function that are promising new intervention targets;
  • Assesses new psychosocial and biomedical interventions, with a focus on mediators, moderators, and predictors (e.g., biological, genetic, behavioral, experiential, environmental) of intervention response and side effects in diverse patient populations;
  • Develops and tests novel models and methods for implementing effective mental health interventions in diverse systems of health care and to meet the needs of those groups that typically have less access to evidence-based mental health services;
  • Seeks to understand sex, genetic, or other biological differences implicated in the presentation, course, severity, or disease burden of mental disorders or in treatment response; and
  • Targets HIV/AIDS related topics such as epidemiology, natural history and pathogenesis and genetics of HIV-associated neurocognitive disorders (HAND) and neuropsychiatric disorders before and after treatment initiation in adult and pediatric populations; examination of the neurobehavioral consequences, with respect to in-utero exposure to a dysregulated immune environment and/or antiretroviral medication and consequences of being born to an HIV-positive mother. NIMH encourages development of  common standardized assessment instruments with appropriate norms that can provide reliable and valid measurement of neurobehavioral consequences of HIV and its treatments throughout the age-span in low- and medium-resource environments; and develops interventions to improve neurobehavioral functioning compromised by HIV/AIDS and its associated conditions that can be implemented in LMICs.

NIMH would also like to encourage the NIMH mission-centered research network option as described in this FOA.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting mechanistic, epidemiological, prevention, translational and clinical research across the spectrum of neurological, neuromuscular and neurovascular diseases and disorders in all ages. In addition to prevalent neurological disorders and stroke, NINDS is interested in supporting research and capacity building in areas of rare and neglected neurological diseases that are relevant to the collaborating LMICs (NINDS Disorder Index http://www.ninds.nih.gov/disorders/disorder_index.htm).  NINDS would like to encourage the development of networks in topical disease-related areas (e.g., stroke, epilepsy or other high burden neurological disorders in LMICs) or linked to existing program or resources (e.g., MEPI, H3Africa, or other NIH funded projects) to share capacity building activities and conduct collaborative research as described in this FOA.

Section II. Award Information
Funding Instrument

Grant: support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of proposed project.  Direct costs do not include any consortium/contractual Facilities and Administrative (F & A) costs.

Award Project Period

Applicants may request a project period of up to five years.     

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

To determine country income categories, please view the following: http://data.worldbank.org/country.  The subcategories of LMICs are: upper-middle-income (UMIC), lower-middle-income and low-income countries.

At least two institutions, one in the U.S. or UMIC and one in a LMIC must be involved as partners in the grant application (i.e. scientists in UMIC institutions are eligible to partner directly with other LMIC institutions).

Exceptions:

Foreign high income country (HIC) institutions are not eligible institutional partners under this FOA.

Note that Hong Kong-based institutions are not eligible as an applicant institution or primary LMIC partner institutions. A second institution in mainland China must be involved as the primary collaborating UMIC institution if an institution in Hong Kong is included as a consulting partner institution.

Taiwan is not listed in the World Bank income classification list but is considered high-income and so is not eligible under this FOA.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA provides an avenue for investigators in the U.S. and LMICs, with shared interests in brain and other nervous system disorders, to continue and expand research collaboration and research capacity building activities already established between individual investigators and their institutions. Therefore, at least two investigators, one from an institution in the U.S. (or eligible UMIC) and one from an institution in a LMIC (see definitions above, in the “Eligible Institutions” section) must collaborate on the application. Use of the multiple PD/PI format is encouraged but not required. Where there are multiple PD/PIs the contact PD/PI may be from the LMIC institution or from the U.S., but the collaborators must prepare the application jointly. Applications from two or more different LMIC country institutions are eligible if one of the countries is an UMIC. Non U.S.-based HIC investigators are not eligible as PD/PIs but may be included as consultants, especially if they present special opportunities for furthering research programs through the use of unusual talent, or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. or which augment existing resources.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent preferably by email to:

Kathleen Michels, Ph.D.
Telephone: 301-496-1653
Fax:  301-402-0779
Email: brainfic@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

It is expected that the majority of funds awarded (greater than 51% total direct costs) will be used for supplies, research capacity building activity costs, equipment, services, travel, and personnel at the LMIC site(s) and that any funds spent at the U.S. (or UMIC, PD/I institution) site will be directly related to the collaborative research or research capacity building activities under the grant and will involve the LMIC collaborators.

Supplemental Budget Information:

Networking meetings (3 days) involving grantees of these awards will be held at a site in the U.S. each year, and will include a day to focus on a specific topic such as implementation research and evidence based policy.  A yearly meeting outside the U.S. focusing on evidence based dissemination and implementation policy, but in a regional context, will also be convened.

Funds should be budgeted for travel to at least one of the U.S. or regional meetings per year of the award by the PDs/PIs, LMIC collaborators, and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

As part of the rationale for the proposed specific aims describe how the proposed project builds on pilot research results, resources, collaborations and research capacity previously developed. The application should fully discuss previous assessment and results of ongoing and completed pilot activities related to research and capacity building needs and issues. In addition, the involvement (if any) of the LMIC institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.

Research Strategy

Describe  how the proposed research is relevant to the interests of one of the participating NIH Institute and Centers (ICs) as stated under Section I: "Specific Research Interests of the FOA Sponsors." Applications should include a plan and timeline for addressing and implementing the results of the needs assessment and building on the pilot studies previously carried out.

The application should clearly define a research strategy and associated plan for supporting research collaborations and strengthening overall research capabilities in the collaborating LMIC(s). All proposed programs should build on results from previous and ongoing research collaborations that:

  • Involve a partnership between U.S. or UMIC and LMIC individuals or research teams;
  • Lead to pursuit of basic, epidemiological, clinical, prevention, intervention or health services research, in the area of nervous system development, function and impairment at any stage of life and on topics particularly relevant to LMICs;
  • Contribute to long term goals of building sustainable research capability among the LMIC partners and institutions involved in the specific research project; and
  • Contribute to developing a base for research networking to inform evidence-based treatment, prevention and health system policies in the LMICs beyond the specific research project.

The relevance of the proposed research to the health of the host LMIC country should be justified. In addition, the planned involvement, if any, of the LMIC institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.

Relevant research for these applications may range from basic science to epidemiological, clinical, health services and translational (e.g. translation of basic research to therapy and of clinical research to applications in the field) and implementation research.

Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for prevention strategies.

Collaboration

Applications must be submitted as collaborations between U.S. or UMIC and LMIC investigators/institutions. A well-developed collaboration building on previous collaborative projects should be demonstrated. Those factors in the investigators' background and/or institutional circumstances that would facilitate success in such collaborations should be clearly delineated.

Plans for coordination of research and associated collaborator research capacity building activities between the partner country institutions should be described and should include regular meetings (virtual or physical).

Networking and Communication for Research Capacity Building

Applicants are encouraged to become familiar with other relevant and related research and research training being conducted at the LMIC institution (or larger region) as well as databases and tools for data and information sharing. Plans to take advantage of synergies for networking and collaboration to advance the research and to build research capacity should be discussed at local and regional levels

As an option, applications for interdisciplinary research networks focused on specific disease or disorder-related topical areas may be submitted to build sustainable institutional and ultimately country and regional research capacity. The goal would be to share research capacity building activities and collaborative research within networks involving for example: multiple departments within an institution, multiple institutions within a country, or even multiple institutions in different countries. Describe the areas of focus for the proposed research network and how this research focus is related to the research interests of specific NIH Institutes and Centers (ICs) as indicated in this FOA. Consultation with NIH Scientific/Research staff is strongly encouraged when developing this option.

Activities may include but are not limited to:

  • Leveraging NIH or other funder investments already in specific the LMIC institution(s), countr(ies) and region;
  • Using common measures/data elements across research studies in a country/region;
  • Sharing or pooling data or creating data repositories;
  • Making efficient use of local/regional oversight bodies such as IRBs and DSMBs; and
  • Sharing education platforms to develop expertise across programs.

Letters of Support

Letters of support should be provided by each collaborator and collaborating institution.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

The majority (greater than 51% of the total direct cost funds) must be used for research and research-related costs at the LMIC site. This cost includes collaborator research capacity building activities. When a UMIC collaboration is proposed, the above restriction does not apply.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the FIC Referral Office by email at brainfic@mail.nih.gov  when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research on a problem of particular relevance for the LMIC involved?

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  If a larger mission centered research network is proposed, are investigators identified who can function as hubs and nodes in that network?  Do the investigators at the LMIC sites proposed have already well-developed research collaborations as demonstrated by pilot studies and other joint research-related activities.

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project make use of unique or special expertise, resources, circumstances or environment of the LMIC site to frame or address the research question? Does the project incorporate innovative strategies for research capacity building and networking into research proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Has feasibility of the proposed research and collaborations at the LMIC sites been clearly established with previous  pilot studies involving those sites and collaborators?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

For projects with multiple sites, is there an adequate plan to coordinate and integrate the research among the sites. Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are the resources necessary to perform the research available or obtainable at the LMIC site? Has the primary LMIC Collaborators' home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)? Have the needs identified in the previous planning grant period been addressed or does the application include a plan to address specific resource and research capacity needs at the LMIC site to enable the site to successfully conduct the proposed research? If a larger network is proposed, do the site(s) and available resources and expertise provide a firm foundation? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Research Capacity Strengthening

Does the proposed research strategy include plans to enhance the LMIC research capabilities or build research networks in the context of the proposed research?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the U.S. or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the Center of Scientific Review, Study Section, BDCN, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact scores.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center (FIC) Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Assignment of R01s will be to a participating IC, other than the Fogarty International Center (FIC), according to the IC’s stated interests in this FOA. FIC will consider co-funding R01s to be awarded by our NIH funding partners.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Kathleen Michels, Ph.D.
Fogarty International Center (FIC)
Telephone:  301-496-1653
Email:  brainfic@nih.gov

Lisa Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone:  301-451-2020
Email:  lneuhold@mail.nih.gov

Dallas W. Anderson, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: Dallas.Anderson@nih.gov

Lana Shekim, Ph.D.
National Institute of Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: shekiml@nidcd.nih.gov

Danuta Krotoski, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301 496-5576
Email:  krotoskd@mail.nih.gov

Steve Gust, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1118
Email: sgust@nida.nih.gov

Annette Kirshner, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0488
Email: kirshner@niehs.nih.gov

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-3725
E-mail:  bpringle@mail.nih.gov

Yuan Liu, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0012
Email: liuyuan@ninds.nih.gov

Cindy D. Davis, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168
Email: davisci@mail.nih.gov

Peer Review Contact(s)

Suzan Nadi, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1259
Email: suzan.nadi@nih.gov

Financial/Grants Management Contact(s)

Farah Bader
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: BaderF@mail.nih.gov

William Darby
National Eye Institute (NEI)
Telephone:  301-451-2020
Email:  darbyw@mail.nih.gov

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: Lisa.McQueen@nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-435-6975
Email:  clarkb1@mail.nih.gov

Christopher Myers
National Institute of Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: cm143g@nih.gov

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone:  301-594-5614
Email:  Carol.Alderson@nih.gov

Lisa Edwards
National Institute of Environmental Sciences (NIEHS)
Telephone:  919-541-0751
Email:  archer@niehs.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone:  301-443-8811
Email:  tkees@mail.nih.gov 

Tijuanna DeCoster, Ph.D
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: Tijuanna.DeCoster@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

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