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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 301-710-0267, Email: [email protected].

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 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: [email protected]

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 focus of the grant, applicants should include a description of the items, services, and personnel for which the funds will be used and where they will be used, subject to the Funding Restrictions described above.

Networking meetings involving grantees of these awards will be held in the Washington, D.C., area in 2008, 2010, and 2012, to share information and discuss new insights, and will include grants-writing and other workshops according to the needs of the awardees and program. Funds should be budgeted for travel for these three meetings by the PDs/PIs, foreign collaborators, and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award.

Supplemental Instructions

Research Plan:

Applications should include a plan and timeline to address and implement the results of the needs assessment previously carried out during the R21 planning grant period.

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Applicants responding to this FOA must propose plans for sharing data and materials generated through the grant (i.e., clinical and diagnostic information, surveys, software, animal models and other resources and reagents generated through the grant). Applicants should explain how funds for the storage and distribution of data and materials will be obtained, and may request such funds in the budget of the application. When possible, data and biomaterials should be placed in databases or repositories that will permit their efficient distribution to investigators throughout the scientific community (as an example, see the NIMH Human Genetics Initiative, Access to Data and Biomaterials at http://nimhgenetics.org).

The investigator s data and resource sharing plan would, when applicable, specify the following elements:

The Initial Review Group will evaluate the proposed sharing plan and comment on its adequacy in an administrative note in the Summary Statement. Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. The adequacy of the plan will be considered by NIH staff in determining whether the grant shall be awarded. The sharing plan, as approved, after negotiation with the applicant when necessary, will be a condition of the award.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research on a problem of particular relevance for the foreign country involved?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? For projects with multiple sites and/or multidisciplinary components, is there an adequate plan to coordinate and integrate the research among the sites/components?

In conducting an evaluation of the scientific assessment of Approach criteria, Scientific Review Groups (SRGs) will also evaluate the involvement of human/animal subjects, the proposed plans for inclusion of minorities and members of both sexes/genders. The evaluation will be factored into the overall score for scientific and technical merit of the application.

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project make use of unique or special expertise, resources, circumstances or environment of the foreign site to frame or address the research question? Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the foreign site?

Investigators: Although the collaborators may each be at various stages in their respective careers, are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project? A well-developed collaboration should have been established in the R21 grant period for these projects.

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Are the resources necessary to perform the research available or obtainable at the foreign site? Has the Primary Foreign Collaborator’s home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)?

International Research Collaboration: In the course of the research, what is the potential for sustainable collaborations between the developed and developing country scientists to be strengthened? Does the research constitute a substantial scientific endeavor for the Foreign Collaborator, including creative and scientific input into the research proposal? The foreign site and investigators should not be used merely to gather biological samples (e.g., clinical, plants, etc.) or behavioral data (e.g., interviews, surveys, etc.). In all cases, the Foreign Collaborators should be actively involved in analyzing and interpreting the data.

Research Capacity Building: What is the potential for the developing country institutions to improve their capacity and ability to address important issues in brain disorders research, develop independently supported research programs, and obtain financial support nationally and internationally? How will this occur? Does the proposed program contain explicit strategies or plans to strengthen this capacity through research training, career development, mentoring, and other models? Will the proposed research and collaboration lead to enhancement of specific departments in foreign institutions and contribute to overall institutional excellence?

Research Focus: Does the application build on the pilot research, resources, and collaborations developed in the R21? The focus should be on the research objectives and should include training to address necessary and previously identified needs for research capacity building at the developing country site to carry out and sustain the proposed research and collaboration.

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)..

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

In the performance site block on the PHS 2590, grantees must list both the developed and developing country sites at which the work is being carried out and the primary collaborator contact at the foreign site.

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Canada

Canadian Institutes of Health Research:
Astrid Eberhart
Institute Liaison
Institute of Neurosciences, Mental Health and Addiction
Canadian Institutes of Health Research
410 Laurier Avenue W., 9th Floor
Address Locator 4209A
Ottawa, ON K1A 0W9
Telephone: 613-941-4643
Fax: 613-941-1040
Email: [email protected]

United States

National Institutes of Health participating components

Fogarty International Center

Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 435-6031
Fax: (301) 402-0779
Email: [email protected]

National Institute on Aging

Andrew A. Monjan, Ph.D., M.P.H.
Chief, Neurobiology of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: (301) 496-9350
Fax: (301) 496-1494
Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism

Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2103, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2594
Fax: (301) 480-1726
Email: [email protected]

National Institute of Child Health and Human Development

Mary Lou Oster-Granite, Ph.D.
Health Scientist Administrator
Acting Chief
Mental Retardation and Developmental Disabilities Branch
Center for Developmental Biology and Perinatal Medicine
National Institute of Child Health and Human Development
Room 4B09G, MSC 7510
6100 Executive Boulevard
Bethesda, MD 20892-7510 (FedEx: Rockville, MD 20592)
Telephone: (301) 435-6866
Fax: (301) 496-3791
E-mail: [email protected]

National Institute on Drug Abuse

L.R. Stanford, Ph.D.
Developmental Neurobiology Program
Behavioral and Brain Development Branch
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4232, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-3869
Fax: (301) 443-6814
Email: [email protected]

National Institute of Environmental Health Sciences

Annette Kirshner, Ph.D.
National Institute of Environmental Health Sciences
Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 541-0488
Fax: (919) 541-5064
Email: [email protected]

National Institute of Mental Health

Jeymohan Joseph, Ph.D.
Chief, HIV NeuroVirology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6202, MSC 9619
6001 Executive Blvd.
Bethesda, MD 20892-9619 (FedEx: Rockville, MD 20852)
Telephone: (301) 443-3012
Fax: (301) 443-9719
Email: [email protected]

National Institute of Neurological Disorders and Stroke

Yuan Liu, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke
NSC/2110B, 6001 Executive Blvd, MSC 9529
Bethesda, MD 20892-9529
Telephone: (301) 496-1917
Fax: (301) 402-0182
Email: [email protected]

Office of Dietary Supplements

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
Fax: (301) 480-1845
Email: [email protected]

Other Participating Organizations

National Alliance for Autism Research

Andy Shih
Chief Science Officer
National Alliance for Autism Research
99 Wall Street
Princeton, NJ 08540
Telephone: (609) 430-9160
Fax: (609) 430-9163
Email: [email protected]

2. Peer Review Contact(s):

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892-7840
(FedEx ZIP 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email: [email protected]

3. Financial/Grants Management Contact(s):

Fogarty International Center

Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email: [email protected]

National Institute on Aging

Deborah Stauffer
Lead Grants Management Specialist
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: [email protected]

National Institute of Mental Health

Rebecca Claycamp
Chief Grants Management Officer
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Fax: (301) 443-6885
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress Report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible online journal articles. Publicly accessible online journal articles or PMC articles/manuscripts acceptd for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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