Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH)
(http://www.nih.gov)
Canadian Institutes of Health Research (CIHR) ( http://www.cihr.ca)
Autism Speaks ( http://www.autismspeaks.org)
Components of
Participating Organizations
Fogarty
International Center (FIC) (http://www.fic.nih.gov)
National Institute on Aging (NIA) ( http://www.nia.nih.gov)
National Institute on
Alcohol Abuse and Alcoholism (NIAAA) ( http://www.niaaa.nih.gov)
The Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD) ( http://www.nichd.nih.gov)
National Institute on Drug Abuse
(NIDA) (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences
(NIEHS) ( http://www.niehs.nih.gov)
National Institute of Neurological Disorders and
Stroke (NINDS) ( http://www.ninds.nih.gov)
Office of Dietary Supplements, Office of the Director
(ODS) ( http://dietary-supplements.info.nih.gov)
Institute of Neuroscience, Mental Health and
Addiction (INMHA/CIHR) ( http://www.cihr-irsc.gc.ca/e/8602.html)
Title: Brain
Disorders in the Developing World: Research Across
the Lifespan (R21)
Announcement Type
This
Funding Opportunity Announcement (FOA) is a reissue of PAR-06-420.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-08-113
Catalog of Federal Domestic Assistance Number(s)
93.989,
93.866, 93.273, 93.209, 93.865, 93.279, 93.113, 93.114, 93.115, 93.853
Key Dates
Release/Posted Date: March 18, 2008
Opening Date:April 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Applications
not related to HIV/AIDS: April 16, 2008; April 15, 2009; April 14, 2010.
HIV/AIDS-related applications: July 22, 2008; July 21, 2009; July 23, 2010
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt
Date(s): Applications not related to HIV/AIDS: May 16, 2008; May 15, 2009; May 14, 2010
AIDS Application Submission/Receipt Date(s): HIV/AIDS-related applications: August 22, 2008; August 21,
2009; August 23, 2010
Peer Review
Date(s): October/November 2008;
October/November 2009; October/November 2010
Council Review Date(s): January 2009; January 2010; January 2011
Earliest Anticipated Start Date(s): April 1, 2009; April 1, 2010; April 1, 2011
Additional Information To
Be Available Date (Activation Date): Not Applicable
Expiration Date: August 24, 2010
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1.
Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
The collaborative research programs are expected to 1) conduct research on nervous system
development, function and impairment at any stage of life and on topics
particularly relevant to LMICs and 2) build research capacity among the LMIC
partners and institutions involved in the specific research project. Both immediate objectives will contribute to the long-term
goals of building sustainable research capacity in LMICs to initiate and
conduct such research, ultimately leading to development of treatment and
prevention strategies that are applicable worldwide.
The R21 grant will provide support to assess needs, to initiate preliminary studies and training, and to organize, plan, prepare, and assemble the information and data for an application for a more comprehensive R01 application involving collaboration between the HIC and LMIC investigators.
The main goals of the application should be to: 1) assess research needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question) and training needs for conduct of a follow-up R01 submission; 2) develop collaborations and needed resources; 3) show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission; and 4) integrate capacity building/collaborator training into the proposed research program.
Applicants should propose specific milestones and a timeline to meet these goals. During the R21 award period, the applicant should:
Pilot research projects should demonstrate feasibility of certain aspects of the research approaches and develop further research directions. Training, informal meetings, workshops and small conferences may be conducted as necessary to develop the research and collaboration and for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.
Each exploratory/planning grant should also present a description of the anticipated longer-term goals of the collaboration as it develops into an application for an R01 grant. As one outcome of the work under the R21, grantees will be expected to provide a detailed assessment of the specific research issues and capacity building/training needs in the LMIC that the proposed follow-up R01 will address. The relevance of the focus of the proposed research to the health of the host endemic country should be justified. The assessment may include, but is not limited to, needed skills and expertise in laboratory, clinical, epidemiological and social science research.
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.
Collaboration:
The purpose of the R21 mechanism is to foster initial development of collaborative work focused on brain disorders across the lifespan and relevant to LMICs; accordingly, investigators need not demonstrate any history of prior collaboration in the R21. However, those factors in the investigators background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated.
Plans for coordination of research and associated collaborator training between the partner country institutions should be described and should include regular meetings (virtual and/or physical).
Research Capacity Building Activities
In addition to pilot research studies, which may lead to a future R01 application, the proposed program should contain explicit strategies or plans to assess the research and research capacity needs and to strengthen this capacity through research training, career development, mentoring and/or other models. Research training for the LMIC collaborators and their staff, in the context of the proposed R21 and subsequent R01 research, may take place at any of the collaborating sites and may vary, depending on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions in the LMIC. The major portion of the proposed research must be conducted at the LMIC site or sites and the majority of the funds must be used for research and research-related costs at the LMIC site (including collaborator training at the LMIC site). Any research at the HIC site must also involve training for participating LMIC country collaborators.
All projects should:
Activities undertaken under the R21planning grant may also include, but are not limited to:
Background
During the past several decades, improvements in health care have led to a decrease in child mortality and an increase in life expectancy in LMICs. These positive trends have set the stage for a complex epidemiology of health and disease as more children survive into adulthood handicapped by early disease, malnutrition and adverse experiences and/or later develop chronic diseases including cognitive and neurodegenerative disorders prevalent in old age. Adverse socio-economic factors, such as poverty, conflict and gender inequalities inherent in varying degrees to many countries contribute to the initial causes (such as injury, psychological trauma, chronic adversity, genetic vulnerability and infection) of many nervous system disorders. These disorders, especially those brain disorders affecting cognitive and mental function, in turn hinder the ability of individuals and their societies to address the root causes, and consequences of those adverse conditions.
World Health Organization data suggest that non-communicable diseases and disorders (NCDs) are rapidly becoming the dominant causes of poor health 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 or DALYs). Of the NCDs, nervous system diseases and disorders in aggregate contribute the most to the overall burden of disease and disability (more than a quarter, followed by cardiovascular disease and cancer) and 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.dcp2.org/pubs/GBD/7/FullText ).
In fact, nervous system disorders account for four out of the six leading causes of years lived with disability (DALYs). They are: mental disorders, especially unipolar depression and bipolar affective disorder, substance-use and alcohol-use disorders, schizophrenia, and dementias. Neurological disorders specifically reported in the DCP2 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 HICs.
Depression, the most common psychiatric disorder and the worlds fourth largest cause of DALYs also contributes substantially to mortality due to suicide, which in 2001 was a leading cause of death in many regions, ranking fifth in Eastern Europe and Central Asia, according Global Burden of Disease and Risk Factors.
Neurodevelopmental disorders and related cognitive disorders (such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy) that result from abnormal prenatal development or influences during the prenatal and perinatal period, or from injury or insult to the brain and central nervous system during infancy or childhood are also clearly burdensome in LMIC countries, however their incidence is less well characterized. Many of the causes of developmental disabilities including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events are, however, particularly common in resource-poor countries, suggesting that the prevalence there is expected to be high.
Communicable diseases along with maternal, perinatal and nutritional conditions still contribute disproportionately to DALYs in LMIC countries as compared to HIC countries (more than half of the burden for low income countries as compared to about 20 percent for middle income and less than six percent for high income countries according to 2005 WHO estimates). All of these conditions may lead to varied nervous system problems. Infectious and parasitic diseases, such as HIV and malaria, are a particular burden for LMIC countries, and especially sub-Saharan Africa, where they affect large numbers of individuals who are not adequately treated. 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.
The proportion of the global burden of disease attributable to mental, neurological and substance use disorders together is expected to rise worldwide in future because of the projected increase in the number of individuals entering the age of risk for the onset of many such disorders. However, the rise will be steeper in LMIC countries, because of the continuing and long lasting effects of early life trauma, infectious disease and malnutrition which contribute or lead to neurological and neurodevelopmental disorders and mental retardation. 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 LMIC countries, may lead to post-traumatic stress disorder (PTSD) which affects a substantial proportion of the overall population exposed to such conditions and which leads 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.
Despite their enormous burden of disease, nervous system disorders have been largely absent from the international 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 LMIC countries and are likely to have more severe and complicated effects than any one in isolation and may even 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 for effectively reducing the burden and to lay the ground work for, develop and test interventions, and promote research capacity building.
Some disabling brain disorders are readily treatable at low cost, and yet many in LMIC countries suffer untreated with detrimental individual, family and societal consequences. As an example, epilepsy is a common brain disorder that affects disproportionately people in LMIC countries, roughly 85 percent of the total number affected worldwide. Although inexpensive and effective treatments are available, epilepsy is frequently untreated and even unrecognized in LMIC countries often because of stigmatization and lack of knowledge. In such disorders, research into interventions taking social and cultural factors into account and involving education, media, policy and behavior are 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 to known neurotoxins by reduction in use or release to the environment and by appropriate safeguards in occupational settings.
Applicants are encouraged to refer for more background to the 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://www.dcp2.org/file/64/WHO_DCPP%20mental%20health%20book_final.pdf) and Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenge in the Developing World 2001, Institute Of Medicine, http://books.nap.edu/openbook.php?record_id=10111&page=R1).
Research Topics
Relevant research topics for this FOA are related to nervous system function and/or impairment from birth to advanced age and must be relevant to the collaborating LMICs.Research on co-morbidities and `conditions that affect nervous system function at different life stages as well as across the lifespan are especially encouraged. 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) 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. In all cases near-term or potential future implications for or relevance to prevention, diagnostics, treatment or other interventions should be indicated or included in the research plan.
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 etc.), 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 etc), posttraumatic stress disorder, dementias, encephalopathy, peripheral neuropathies, motor neuron diseases etc.
Examples of specific conditions that influence nervous system function across the lifespan include, but are not limited to genetic predispositions, 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, nutritional deficiencies etc.), physical and psychological trauma (exposure to violence, rape, 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, neurocysticercosis) and stroke.
Other factors affect healthy brain development, including access to appropriate health care and socioeconomic factors. Examples of some cross-cutting areas for research are:
Types of Research relevant to this announcement includes basic research and epidemiology, as well as 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 research and the capacity in the LMIC to conduct such research, whenever relevant to the research question. Expertise may involve, but is not limited to, fields such as genetics, epidemiology, neurology, cognitive neuroscience, developmental neurobiology, neurotoxicology, neuroendocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, 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.
Specific Research Interests of the FOA Sponsors
Applicants can obtain information and research interests for each of this FOAs sponsoring partners at their Web sites and by contacting the partner program contact listed in this announcement (Section VII., Agency Contacts). Some of the participating partners have provided additional statements of interest. National Institutes of Health (NIH)
The National Institute on Aging (NIA) is interested in applications relevant to Alzheimer's disease and other degenerative diseases of the nervous system, and age-related changes in cognition and memory. Of interest also are studies on reducing disability and/or preventing or slowing additional decline among persons with neurological disabilities as they continue to age.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in applications that address alcohol-related birth defects (such as Fetal Alcohol Syndrome).
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is particularly interested in encouraging studies in response to this announcement which propose to address problems in child health and development, such as mental retardation, cognitive and behavioral disorders, neurodevelopmental disabilities and learning disabilities. Relevant research includes etiology, pathophysiology, 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 biobehavioral 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 nutritional and hormonal factors in nervous system development and function.
The National Institute on Drug Abuse (NIDA) is interested in applications which focus on behavioral, cognitive and neurobiological factors as antecedents to, or impacting on, consequences of drug abuse. Of particular interest are studies aimed at reducing drug abuse and addiction and its associated adverse social, behavioral, and health consequences (e.g., violence and infectious diseases transmission and including research related to the interaction between HIV/AIDS and abuse). The NIDA especially encourages research capitalizing on unique opportunities to study adverse environmental and socio-cultural effects on drug abuse patterns and behaviors in populations of LMICs (e.g., caregiver neglect or abandonment, large orphan populations or street children at risk for both drug abuse and HIV or HCV). In countries where abuse of high doses of individual drugs is more common than in the U.S. and Europe, the NIDA is interested in supporting studies on prenatal effects, cognitive consequences, epidemiological patterns, and associations with HIV/ AIDS and other transmitted diseases. The NIDA will give priority to meritorious research that builds upon existing NIDA-funded collaborations between HIC and LMIC colleagues.
The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research in LMIC countries to identify the causes of, and opportunities to prevent or ameliorate, the consequences of, neurotoxic insult to the nervous system throughout life (pesticides, heavy metals etc.).
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 disorders, neuromuscular diseases and stroke.
Canada
The Institute of Neurosciences, Mental Health and Addiction (INMHA), of the Canadian Institutes of Health Research (CIHR), is interested in co-sponsoring collaborative proposals between Canadian and low- to middle-income country investigators. Eligible applications include those dealing with the spectrum of research related to neurological disorders, mental illnesses and addictions. CIHR will provide direct funding to meritorious Canadian applicants.
Other Participating Organizations
Autism Speaks (http://www.autismspeaks.org ) will consider support for scientifically meritorious autism-related research proposals and will provide direct funding to meritorious applicants.
See Section
VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).
U.S. applicants requesting more than $250,000 in annual direct costs and all Foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Exploratory/developmental grant support is for new projects only; renewal (formerly competing continuation) applications will not be accepted. Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
If a consortium is involved, please see NOT-OD-05-004 for information on the relationship of F&A costs on subawards to the direct costs requested.
2. Funds Available
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications relevant to the interests of each sponsor.
The participating organization(s), the Fogarty International Center (FIC), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements of the Office of the Director (ODS/OD), all of the National Institutes of Health (NIH), along with the Institute of Neuroscience, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR), and Autism Speaks, intend to commit approximately $2 million in fiscal years 2009, 2010 and 2011 to fund five to fifteen applications. .
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.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
EXCEPTIONS: Financial institutions and international intergovernmental organizations are not eligible to apply for FIC research or training programs. However, staff of such institutions, if invited by eligible applicants, may serve as unpaid collaborators or consultants on such projects.
At least two institutions, one in a HIC and one in a LMIC will be involved as partners in the grant application. See http://www.worldbank.org/data/countryclass.htm for World Bank country classification tables to identify those countries considered low- or middle-income.
Hong Kong-based institutions are not eligible as the primary LMIC partner institution. A second institution in mainland China must be involved as the primary collaborating HIC institution if an institution in Hong Kong is included as a partner institution. Taiwan is not listed in the World Bank income classification list but is considered high-income.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
This FOA provides an avenue for investigators in HICs and those in LMICs, with shared interests in brain and other nervous system disorders, to explore, initiate and implement research collaboration between themselves and their institutions. Therefore, at least two investigators, one from an institution in a HIC and one from an institution in a LMIC (see definitions above, in the Eligible Institutions section) must collaborate on the application. The contact PD/PI may be from the LMIC institution or from the HIC institution, but the collaborators must prepare the proposal jointly. While there is no cap on the maximum number of investigators or institutions involved, the applicant must discuss how the contributions of each member will be integrated in the proposed activities.
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost
Sharing or Matching
This program does not require cost sharing as
defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Exploratory/developmental grant support is for new
projects only; competing renewal (formerly competing continuation)
applications will not be accepted.
Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit more than one application, provided each application is scientifically distinct.
An individual investigator may be involved as PD/PI or primary collaborator on more than one application for the submission/receipt dates of this FOA, provided the applications are scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R)
Application Package and SF424 (R&R) SBIR/STTR Application Guide for
completing the SF424 (R&R) forms for this FOA, use the Apply for Grant
Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered.
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use any
other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.
For further assistance, contact GrantsInfo --
Telephone 301-710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related
Budget, as appropriate (See Section IV.6., Special Instructions,
regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research that provides special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources, is encouraged.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates
and Times
See Section IV.3.A for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date:April 16, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): April 16,
2008; April 15, 2009; April 14, 2010. HIV/AIDS-related
applications: July 22, 2008; July 21, 2009; July 23, 2010
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt
Date(s): May 16, 2008; May 15, 2009; May
14, 2010
AIDS Application Submission/Receipt Date(s): August 22, 2008; August 21, 2009; August 23, 2010
Peer Review
Date(s): October/November 2008;
October/November 2009; October/November 2010
Council Review Date(s): January 2009; January 2010; January 2011
Earliest Anticipated Start Date(s): April 1, 2009; April 1, 2010; April 1, 2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent (preferably
emailed) to:
Kathleen
Michels, Ph.D.
Program
Director
Division
of International Training and Research
Fogarty
International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda,
MD 20892-2220
Telephone:
(301) 496-1653
Fax:
(301) 402-0779
Email: brainfic@nih.gov
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the FIC by email to brainfic@nih.gov when the application has been submitted.Please include the FOA number and title, PD/PI name, and title of the application.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time(of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.