Part I Overview Information

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/)
National Alliance for Autism Research (NAAR) (http://www.naar.org/)

Components of Participating Organizations
Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov)
 National Institute on Aging (NIA/NIH) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) (http://www.niaaa.nih.gov)
National Institute of Child Health and Human Development (NICHD/NIH) (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA/NIH) (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS/NIH) (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH/NIH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS/NIH) (http://www.ninds.nih.gov)
Office of Dietary Supplements, Office of the Director (ODS/OD/NIH) (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 (R01)

Announcement Type
This is a conversion of PAR-05-100, which was previously released May 3, 2005.

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 weeks prior to the grant submission date. See Section IV

Program Announcement (PA) Number: PAR-07-268

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.867, 93.866, 93.273, 93.209, 93.865, 93.279, 93.113, 93.114, 93.115, 93.242, 93.853

Key Dates
Release/Posted Date: December 22, 2006
Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 16, 2007
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, 2007
AIDS Application Submission/Receipt Date(s): August 23, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January/February 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information To Be Available Date (Activation Date): Information currently available at: http://www.fic.nih.gov/programs/research_grants/brain_disorder/index.htm
Expiration Date: August 24, 2007

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Contacts
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

This Funding Opportunity Announcement (FOA), entitled “Brain Disorders in the Developing World: Research Across the Lifespan,” solicits grant applications proposing the development and conduct of innovative, collaborative research and research training projects, between developed and developing country scientists, on brain disorders throughout life, relevant to low- and middle-income nations. The collaborative research programs are expected to: 1) involve research on neurological/neurodevelopmental (including sensory, motor, cognitive and behavioral) function and impairment throughout life, and 2) contribute to the long-term goal of building sustainable research capacity in developing countries to initiate and conduct such research.

All projects should:

The overall intent of the program is three-fold:

Relevant research for these applications may range from basic science to epidemiological, translational (e.g. translation of basic research to therapy and of clinical research to applications in the field), clinical, operational and health services research, but should build on the research and training goals and results from the R21 grant, including continued capacity building to help sustain the research.

In addition, the involvement (if any) of the developing country institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.

Collaboration

A well-developed collaboration building on the previous R21 collaborations should be demonstrated.

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

Research Capacity Building Activities

Research training for the developing country collaborators and their staff, in the context of the 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. The major portion of the proposed research must be conducted at the developing country site or sites and the majority of the funds must be used for research and research-related costs at the developing country site (including collaborator training at the foreign site). Any research at the developed (high-income) country site must also involve training for participating developing country collaborators.

The application should fully address the research and training needs and issues developed in the R21 period. The application should clearly define a research plan and associated plan for research capacity building, which should include any necessary training. This mechanism of support should not be used to circumvent or supplement National Research Service Award training mechanisms.

Background

During the past several decades, improvements in health care have led to a decrease in infant mortality in the developing world. The continuing burden of infectious disease and malnutrition, along with a growing burden of chronic disease associated with aging populations, has resulted in a complex epidemiological situation. Developed nations have relatively high proportions of people aged 65 and over, but the most rapid increases in elderly populations are in the developing world. The current aggregate growth rate of the elderly population in developing countries is more than double that in developed countries, and also double that of the total world population. This increase in life expectancy is further complicated by the widespread incidence of neurological, psychiatric, and developmental disorders. With the exception of sub-Saharan Africa, brain disorders are the leading contributor to years lived with a disability in all regions of the world.

Policy makers began to recognize the social and economic impact of brain disorders, in part as a result of the 1996 publication of the global burden of disease study (Murray CJL, Lopez AD, Eds. The Global Burden of Disease And Injury Series, Volume 1: A Comprehensive Assessment Of Mortality And Disability From Diseases, Injuries, And Risk Factors In 1990 And Projected To 2020). This report compared the total cost of various diseases on the basis of disability-adjusted life years (DALYs), a measure that accounts for the overall burden of disease by combining years of potential life lost as a result of premature death with years of productive life lost because of disability.

Measures of mortality and disability do not include the social isolation and stigma experienced by individuals affected with brain disorders, as well as the financial hardship borne by affected individuals, their families, and the communities in which they live. As a result of negative attitudes, prejudice, and stigma, many affected with brain disorders remain undiagnosed and untreated. In addition to poverty and gender inequality that underlie many of the key risk factors for brain disorders, 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 the enormous burden of disease, brain disorders have been largely absent from the international health research agenda. Responding to the growing awareness of brain disorders in the developing world, in 1999, the U.S. Institute of Medicine was charged to prepare a study that would define the increasing burden, identify opportunities for effectively reducing the burden, and identify areas for intervention, research, and capacity building. The results were compiled in a report entitled "Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenges in the Developing World" (2001, available at http://books.nap.edu/books/0309071925/html). Study sponsors included the National Institutes of Health (Fogarty International Center, the National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, and the National Institute of Mental Health), the U.S. Centers for Disease Control and Prevention, and the Global Forum for Health Research.

The report brings together a growing body of evidence indicating that the social and economic impact of neurological, psychiatric, and developmental disorders is large and increasing. Present figures almost certainly underestimate the impact of brain disorders, particularly in the developing world. A sustained, comprehensive, and integrated research effort is the key to reducing the burden of brain disorders in the developing world. Among the main recommendations of the report was the need to create both national centers for training and research, as well as programs to facilitate competitive funding for research on developmental disabilities and epilepsy in resource-poor nations. The WHO 2001 World Health Report documented and contributed to the data on the burden of brain disorders in the developed and developing world alike (“WHO World Health Report 2001: Mental Health: New Understanding, New Hope”).

This FOA focuses on conditions and influences on the nervous system that affect cognition, learning and memory across the lifespan. Examples of specific conditions that affect brain function across the lifespan include, but are not limited to, neurodevelopmental disorders, neurodegenerative diseases (such as Alzheimer's and Parkinson's Diseases), neurotoxic insults, infection of the nervous system by viral and parasitic diseases (such as HIV/AIDS and malaria), pre- and post-natal environmental insults and physical trauma (e.g., fetal alcohol syndrome, drug abuse/exposure, child abuse and neglect, shaken baby syndrome and traumatic nervous system injury due to accidents).

Neurodevelopmental disabilities include conditions such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy that result from abnormal prenatal development or influences during the prenatal period, or from injury or insult to the brain and central nervous system during infancy or childhood. In the U. S., approximately 12 to 18 percent of children are disabled. Many of the causes of developmental disabilities – including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events – are particularly common in resource-poor countries, suggesting that the prevalence is expected to be even higher.

Some disabling brain disorders are readily treatable at low cost, and yet many in developing countries suffer untreated with detrimental individual, family and societal consequences. As an example, epilepsy is a treatable brain disorder that affects an estimated 40 million people in developing countries, roughly 85 percent of the total number affected worldwide. Epilepsy commonly affects young adults in the most productive years of their lives and frequently leads to their being unemployed. Although inexpensive and effective treatments are available, epilepsy is frequently untreated and even unrecognized in the developing world 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 appropriate.

Prevention of disability due to neurological impairment is also 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.

Infectious diseases, such as HIV, can also have significant neurological consequences. Estimates from UNAIDS and WHO state that 36 to 44 million people were HIV-infected worldwide at the end of 2004. Importantly 23 to 28 million reside in sub-Saharan Africa, while nearly 7.1 million are in south and southeast Asia. Extensive research carried out in developed countries has demonstrated that neurological complications such as HIV-1 associated dementia occurred in 20-30 percent of symptomatic individuals prior to the introduction of anti-retroviral therapy. Symptoms of HIV-associated dementia include slowing of motor and mental function with memory loss and language difficulty. Other neurological complications, such as peripheral neuropathy and HIV-associated myelopathy, also occur following HIV infection. In addition, opportunistic infections such as cryptococcal meningitis, bacterial meningitis, toxoplasmosis and neurosyphilis frequently cause neurological problems. Although a large number of individuals are HIV-infected in developing countries, very limited data are available on the epidemiology, natural history and pathogenesis of neurological disease caused by HIV and associated opportunistic infections in these settings.

This FOA attempts to address, on a sustained basis, these and other health research issues relevant to brain disorders in developing countries. Applicants may propose a research and capacity building program on brain disorders with a focus on neurological (including sensory, motor, cognitive and behavioral) function and impairment throughout life.

Research Topics:

Relevant research topics should be related to neurodevelopmental disabilities and neurological disorders, including cognitive, motor, sensory and behavioral impairment from birth to advanced age. Research findings must be relevant to the collaborating developing nation(s). Some examples are: mental retardation, seizure disorders such as epilepsy, movement disorders such as Parkinson's Disease, and dementias - including those related to age and those caused by HIV, malaria or other infections.

Research relevant to this announcement includes basic research and epidemiology, as well as research on early interventions, clinical treatment, prevention, and health services that are culturally appropriate, feasible, and acceptable for implementation within the foreign country. This FOA encourages development of multidisciplinary research, whenever relevant to the research question. Expertise may involve, but is not limited to, fields such as neurology, cognitive neuroscience, developmental neurobiology, neurotoxicology, neuroendocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, and biotechnology (e.g., for development of diagnostic tools), as well as the behavioral and social sciences.

Examples of some cross-cutting areas for research incorporating social sciences are:

Suggested areas of research include, but are not limited to:

1. Epidemiological Studies

a. Descriptive epidemiology to describe and define the problem in the countries in question by assessing the needs and determining the magnitude and factors involved in the problem to be addressed (e.g., research on trends in incidence, prevalence or mortality; distribution of disease; determination of populations at risk; determination of case definition/disease classification); and

b. Analytical epidemiology to identify potential etiological factors in the populations of interest, including factors responsible for predispositions to the neurological consequences of various infections, infestations, 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).

i. Genetic factors throughout life, beginning in the prenatal period, which result in cognitive, behavioral, motor or sensory impairment or disorders;

ii. Natural history of common neurological diseases/disorders and the influence of sociocultural or other environmental variables that impact upon this course;

iii. Research on multiple insults, especially common in the developing world (e.g., neurotoxic or traumatic insult plus infectious disease and/or malnutrition); studies examining the interactions of neurobiological and environmental/social factors that affect brain development and resulting in behavioral outcomes are encouraged (e.g., expression of cognitive impairment, coping, adaptation, response to intervention, etc.); and

iv. Environmental factors across the lifespan, beginning in the prenatal period, that result in cognitive, behavioral, motor or sensory impairment including:

2. Other factors that impact on healthy brain development, such as access to appropriate health care, availability of resources, preventive or screening practices, etc.

3. Research on potential interventions and how the success or failure of interventions may be modulated by sociocultural and gender variables.

Activities undertaken under the planning grant may include, but are not limited to:

Specific Research Interests of the FOA Sponsors:

Applicants can obtain information and research interests for each of this FOA’s 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. Only R01 applications within these stated interests will be considered by that partner and potential applicants are strongly encouraged to contact the relevant partner prior to submitting a letter of intent:

National Institutes of Health (NIH)

The FIC plans to co-fund R01s that will be awarded by our funding partners on this FOA.

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 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 developing countries (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 developed and developing country colleagues.

The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research in the developing world 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 Mental Health (NIMH) is interested in research limited to areas relating to epidemiology, natural history, and pathogenesis of HIV–associated disease of the nervous system.

The National Institute of Neurological Disorders and Stroke (NINDS) encourages research across the spectrum of neurological disorders to reduce the burden of neurological disease borne by every age group and segment of society all over the world.

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

The National Alliance for Autism Research (NAAR) 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 Research Project Grant (R01) award mechanism.

The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and 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 5.4, “Modular Budget Component,” of the Application Guide). Foreign institutions must include a Detailed Budget. A modular budget will not be accepted from foreign institutions.

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 found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

At this time, it is not known if competing renewal (formerly “competing continuation”) applications will be accepted and/or if this FOA will be reissued.

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.

The components of participating organizations intend to commit approximately $4 million in fiscal year 2008 to fund six to ten applications.

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

Each R01 award will be administered by one of the participating NIH ICs or other participating agencies, although several co-sponsors may participate in the funding of any given application.

Applications, which may only be submitted by previous R21 awardees, will be considered for award by the NIH ICs or partner organizations according to their stated interests. The Fogarty International Center will consider co-funding R01s to be awarded by our funding partners.

The Canadian Institutes of Health Research (CIHR) will consider meritorious applications relevant to their missions, involving Canadian institutions.

The National Alliance for Autism Research (NAAR) will consider support for scientifically meritorious autism-related research proposals and will provide direct funding to meritorious applicants.

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. Foreign applicant organizations may now request up to 8% administrative costs (excluding equipment) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html).

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your institution/organization has any of the following characteristics:

International research organizations that are the recipient of grants, and are not an external funding organization themselves, 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 developed (high-income) country and one in a developing (low- to middle-income) country, will be involved as partners in the grant application.

See http://www.worldbank.org/data/countryclass.html 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 low- to middle-income country partner institution. A second institution in mainland China must be involved as the primary collaborating foreign 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.

This FOA provides an avenue for investigators in developed countries and those in developing countries, with shared interests in neurological and brain disorders, to explore, initiate, and implement research collaborations between themselves and their institutions. Therefore, at least two investigators, one from an institution in a developed country and one from an institution in a developing country (see definitions under “Eligible Institutions,” above) must collaborate on the application as PD/PI and Co-Investigator. The PD/PI may be from either the developed or developing country, 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does 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 eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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 PD/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

At this time it is not known if competing renewals (formerly competing continuations) will be accepted or if this FOA will be reissued.

An individual investigator may only be involved as PD/PI or primary collaborator on one application for the submission/receipt dates of this FOA.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp 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 eRA Commons.

Several additional separate actions are required before an applicant institution/organization 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 PD/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 the 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 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

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 for this FOA through Grants.gov/Apply.

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/PI’s 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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:: Select one as appropriate.(See Section IV.6., “Special Instructions,” regarding appropriate required budget component.) Research & Related Budget is required for non-domestic (non-U.S.) entity (foreign organization).

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

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:

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 15 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 of the 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” (Section 14 of the Research Plan Component in the SF424 (R&R)), 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, including 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.

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 subaward 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/subaward budget is provided in the budget justification. Separate budgets for each consortium/subaward grantee are note required when using the Modular budget format. See Section 5.4 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: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 16, 2007
Application Submission/Receipt Date(s): May 16, 2007
AIDS Application Submission/Receipt Date(s): August 23, 2007
Peer Review Date(s): October/November 2007
Council Review Date(s): January/February 2008
Earliest Anticipated Start Date(s): April 1, 2008

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 by email) to:

Dr. Kathleen Michels
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B23C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 401-0779
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/applicants/apply_for_grants.jsp 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 Fogarty International Center Referral Office by email (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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the FIC and partners. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

It is expected that the majority of the funds awarded will be used for supplies, training costs, equipment, services, travel, and personnel at the developing country site and that any funds spent at the developed country site will be directly related to the collaborative research or training under the grant and will involve the developing country collaborators.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly “competing continuation”) award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without prior NIH approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

Applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for All Applications

All applicants must carry out the following steps:

1) Contact the IC program staff at least six weeks before submitting the application (i.e., as you are developing plans for the study);

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, if the request is greater than $500,000, agreement that the IC will consider such an award; and

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly “competing continuation”) applications, resubmission (formerly “revised/amended”) applications, and revision (formerly “competing supplement”) applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Permission to Share Information with CIHR and NAAR:

Because the applications may be funded or co-funded by the NIH, CIHR, or NAAR, all applicants should submit a brief letter to the NIH indicating that the application and the Summary Statements for such applications, and the Progress Reports of funded grants, can be shared with CIHR and NAAR. Letters of authorization should be prepared by the PD/PI and co-signed by the official signing for the applicant organization. This letter may be submitted in “Other Attachments.”

Supplemental Budget Information:

A detailed budget is not required for applications requesting less than $500,000 from U.S. institutions. However, since foreign sites are involved and are the main focu