Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Eye Institute (NEI)
Fogarty International Center (FIC)
National Institute on Aging (NIA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
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-14-332

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-17-314

Companion Funding Opportunity

PAR-17-313 R21 Exploratory/Developmental Grant

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

93.989, 93.866, 93.113, 93.321, 93.853, 93.867, 93.173, 93.242   

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 (including neurological, mental, behavioral, alcohol and substance use disorders and spanning the full range of science from basic to implementation research). Scientists in upper middle-income LMICs (UMICs) are also eligible to partner directly with scientists at other LMIC institutions with or without out a US partner. 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 and strengthening 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

June 13, 2017

Open Date (Earliest Submission Date)

October 7, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 7, 2017 November 7, 2018; November 7, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates

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)

November 7, 2017; November 7, 2018; November 7, 2019 by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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

February 2018; February 2019; February 2020 

Advisory Council Review

 May 2018; May 2019; May 2020

Earliest Start Date

October 2017

Expiration Date

November 8, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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 available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

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. This includes neurological, mental, behavioral, and alcohol substance use disorders and spans the full range of science from basic to implementation research. 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 Institutes and Centers (ICs) (other than FIC) as stated in this FOA. Applications must be submitted as collaborations between U.S. (or UMIC category of LMICs) 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-17-313).

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 and are 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 create a negative feedback loop handicapping the physical and cognitive ability of individuals and their societies to address the root causes of nervous system disorders and their risk factors. The biological and cultural effects may extend for generations.

Data published in the updated Global Health Estimates for the Global Burden of Disease (GBD) (http://www.who.int/healthinfo/global_burden_disease/en/ ), continues to show that non-communicable diseases and disorders (NCDs) are rapidly becoming the dominant causes of poor health globally, including all LMIC regions with the exception of 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. neurodegenerative disorders such as 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 (followed by cardiovascular disease and cancer). They also contribute about a third of the burden due only to NCDs in LMICs (Global Burden of Disease and Risk Factors Report, DCP2, 2006, http://www.dcp-3.org/dcp2 and see the Global Health Estimates http://www.who.int/healthinfo/global_burden_disease/en/ ). The following nervous system disorders account for four out of the six leading causes of YLDs: mental and behavioral disorders, especially unipolar depression and bipolar affective disorder, substance-use, 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. These conditions may also lead to impairment of nervous system development, function and long-term health (http://www.who.int/healthinfo/global_burden_disease/en/).

Infectious and parasitic diseases, such as HIV/AIDS, tuberculosis, malaria and other neglected tropical diseases as well as emerging diseases such as Zika, are a burden for LMICs, 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 is 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, alcohol and substance use disorders were ranked as the 3rd leading contributors to the burden of disease 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-related DALYs.

The incidence of neurodevelopmental 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. Early neurodevelopmental disorders, along with disability due to postnatal 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 (http://www.who.int/pmnch/media/news/2012/who_burdenofdisease/en/ )

put an important spotlight on nervous system related chronic disability (and its particularly heavy toll on women)—from, for example, mental health disorders, substance abuse, 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. Humans are living longer and birth rates are down. 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 reverse the years 2050. Direct attention to research on diseases and disorders of later life is therefore needed. But 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, further highlighting 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.

These problems pose a greater burden on vulnerable groups such as people living in poverty, those coping with disease, and those exposed to emergencies. For example, disaster, war and conflict situations are especially prevalent in many LMICs and may lead to post-traumatic stress disorder (PTSD), this affects a substantial proportion of the overall population exposed to such conditions which may lead to persistent dysfunction on top of already existing disorders. In addition, stigmatization and gender inequality amplify many of the key risk factors for nervous system disorders and contribute to poor access to and quality of treatment. 

Lack of adequate prevention and treatment in LMICs is a major contributor to the burden of disease and disability. In some countries, the overall physician-patient ratio can be low as 1:20,000, with even fewer psychiatrists and neurologists. 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 from adverse or toxic environmental exposures 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 a 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 impacts, 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 groundwork 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/ and special resources at https://www.fic.nih.gov/ResearchTopics/Pages/neurological-mental-disorders-diseases.aspx  including the FIC/NIH convened series of papers: "Brain disorders across the lifespan: Research to achieve nervous system health worldwide", Nature supplement, Nov 19, 2015

( http://www.nature.com/nature/supplements/collections/npgpublications/brain-disorders/index.html).

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, and must be relevant to the collaborating LMICs. 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, 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, neurodevelopmental disorders (including autism, cerebral palsy, fetal alcohol syndrome, learning disabilities, hydrocephaly, microcephaly), 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, neurotoxic 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 bacterial, viral and parasitic diseases (such as Zika, HIV/AIDS, malaria, neurocysticercosis, neonatal sepsis) and stroke. Other factors affecting healthy brain development include access to appropriate health care, environmental 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;
  • The influence of socio-cultural or other environmental variables on the natural history of common neurological diseases/disorders and how this knowledge can be used for treatment and intervention;
  • Factors associated with aging affecting cognitive, emotional/mental 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 the 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 exploratory/developmental research is expected to help build the capacity for full research programs by improving the research environment and strengthening LMIC individual and institutional research capabilities in the proposed research areas. The proposed work and follow up research are expected to contribute to the long-term goals of building sustainable research capacity in brain and nervous system diseases and disorders in LMICs. The proposed project may 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 past FOAs under the Brain Disorders in the Developing World: Research Across the Lifespan  program (http://www.fic.nih.gov/Programs/Pages/brain-disorders.aspx) along with the resources there including the 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

Participating NIH Institutes and Centers (ICs) provided specific statements of interest for this FOA below. Applicants can obtain more information on research interests for each of the NIH participants in this FOA at their websites and through their Scientific/Research contact listed in this announcement.

The Fogarty International Center (FIC) is interested in all eligible applications relevant to the focus of this FOA and its mission. The 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 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 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 Deafness and Other Communication Disorders (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 the 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 a neurodevelopmental disorder (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 share 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 studies across the research spectrum, from basic through translational science to intervention development and efficacy, effectiveness, and implementation research. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. Relevant research topics include, but are not limited to, 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.
  • 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.
  • 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.
  • Examines approaches to care for people with chronic, severe mental illnesses in institutional and community settings.
  • Examines implementation models and measures of care quality and outcomes that produce optimal results for: (a) early identification of mental disorders, (b) scaling up of training and supervision for mental health care providers, (c) integrating screening and core packages of care for mental illnesses into existing delivery platforms (e.g., primary health care, schools, HIV services, workplaces), or (d) delivering transdiagnostic interventions for mental disorders in health sector and non-health sector settings.
  • Assesses data collection and feedback models for monitoring the reach, accessibility, quality, costs, and/or effectiveness of preventive, treatment, or rehabilitative health services for mental disorders (e.g., how models enable data-driven decision-making for optimal delivery of care).
  • Targets HIV/AIDS related topics such as epidemiology, natural history and pathogenesis and genetics of HIV-associated CNS dysfunction 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 also supports research toward a cure including developing novel approaches and strategies to identify and eliminate CNS viral reservoirs that could lead toward a cure or lifelong remission of HIV infection, including studies of viral persistence, latency, reactivation, and eradication.
  • NIMH would also like to encourage the NIMH mission centered research networks 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, neuroinfectious and neurovascular diseases and disorders in all ages. In addition to prevalent neurological disorders and stroke, NINDS is also 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 programs or resources in LMICs (e.g., MEPI, H3Africa, or other NIH-funded projects) to share capacity building activities and conduct collaborative research. ADD:  Applicants interested in clinical trials for neurological disorders within the NINDS mission are also referred to NINDS clinical trial-specific funding announcements (PAR-17-102 and PAR-17-122). 

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Grant: A 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 the actual needs of the proposed project.

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

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. PLEASE NOTE: UMIC is a subcategory of LMIC but UMICs have additional eligibility options as described below.

At least one institution in the U.S. or an UMIC and at least one institution in another LMIC must be involved as partners in the grant application (UMIC institutions are eligible to partner either with U.S. institutions or directly with other LMIC institutions with or without a U.S. partner).

Exceptions:

Foreign high-income country (HIC) institutions are not eligible institutional partners under this FOA (but individual investigators may be involved as described below in "Eligible Individuals").

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

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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • 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 establish collaborative research and research capacity strengthening activities. Therefore, one or more investigators from an institution in the U.S. (or an UMIC) and one or more from an institution in an LMIC (see definitions above, in the “Eligible Institutions” section) must collaborate on the application. PLEASE NOTE: 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 are expected to prepare the application jointly.

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, present special opportunities and/or unusual talent for furthering research programs, or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. institution 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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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 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.

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 or Modular 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% of the total direct costs) will be used for supplies, research capacity building costs, equipment, services, travel, and personnel at the LMIC site(s). Any funds spent at the U.S. (or UMIC PD/PIs 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.

Funds should be budgeted for travel to the three-day networking meeting each year by the PDs/PIs, LMIC collaborators, research fellows and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award

R&R Subaward Budget

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

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.

Design of clinical trials proposed under this program must include a strong and rigorous rationale for the study (supported by high quality preclinical and/or clinical data), clear firewalls between scientific leadership and data management/statistical investigators and the appropriate independent data and safety monitoring, to ensure that the trials done in LMIC meet the standards for trials done in the US.

Where appropriate, the design of projects should consider 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), country(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 International Review Boards (IRB) and Data and Safety Monitoring Boards (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 as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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. Applications including NIH-defined clinical trials must include the protocol as an appendix.

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

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. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

To expedite review, applicants are requested to notify the {FIC} 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 a Scientific/ Research Contact 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 the policy.

Section V. Application Review Information
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? Is there a strong scientific premise for the project? 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? For clinical trials: How adequate and scientifically rigorous is the body of preliminary data supporting the study rationale?  How compelling is the justification for the development of the proposed intervention in terms of potential advances in clinical practice, public health, and/or patient quality of life?  How convincing is the evidence that equipoise (genuine uncertainty over whether a treatment will be beneficial) exists in the medical and patient communities?  Are there any ethical concerns?"

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 the research proposed? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Has feasibility of the proposed research and collaborations at the LMIC sites been clearly established through 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 investigators at 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 at the individual and institutional level 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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 of significance to the LMIC(s) in question and/or makes use of of unusual talent, resources, populations, or environmental conditions that exist in the LMIC country to address broader global health research needs..

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)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 for Scientific Review}, 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 score.
  • Will receive a written critique.

Applications will be assigned based on established PHS referral guidelines and FOA specific referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Kimberly A. Gray, Ph.D. 
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: Gray6@niehs.nih.gov

Makeda Williams, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-435-4582
Email:  Makeda.Williams@nih.gov

Claudia Moy, PhD A.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301.496.9135
Email: MoyC@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)

Samuel Edwards Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1246
Email: edwardss@csr.nih.gov

Financial/Grants Management Contact(s)

Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email:mshea@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

Christopher Myers
National Institute of Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: cm143g@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 Part 75.

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