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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 Association for Autism Research (NAAR), (http://www.naar.org/)

Components of Participating Organizations
Fogarty International Center (FIC/NIH), (http://www.fic.nih.gov)
National Eye Institute (NEI/NIH), (http://www.nei.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 (ODS/OD/NIH), (http://dietary-supplements.info.nih.gov/)
Canadian Institutes of Health Research (CIHR)/Institute of Neuroscience, Mental Health and Addiction (INMHA), (http://www.cihr-irsc.gc.ca/e/8602.html).

Title: Brain Disorders in the Developing World: Research Across the Lifespan

Announcement Type
This Program Announcement (PA) is a modification of RFA-TW-03-007, which was previously released November 7, 2002.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-05-100

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.866, 93.273, 93.173, 93.279, 93.113, 93.114, 93.115, 93.242, 93.853, 93.867, 93.209, 93.865

Key Dates
Release Date: May 3, 2005
Letters of Intent Receipt Date(s): Applications not related to HIV/AIDS: June 13, 2005; April 16, 2006, 2007. Applications related to HIV/AIDS only: July 23, 2005, 2006, 2007.
Application Receipt Dates(s): Applications not related to HIV/AIDS: July 13, 2005; May 16, 2006, 2007. Applications related to HIV/AIDS only: August 23, 2005, 2006, 2007.
Peer Review Date(s): October-November 2005, 2006, 2007
Council Review Date(s): January - February, 2006, 2007, 2008
Earliest Anticipated Start Date: April 1, 2006, 2007, 2008
Additional Information To Be Available Date (Url Activation Date): http://www.fic.nih.gov/programs/BrainDisorders.html
 Expiration Date for R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: May 17, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: August 24, 2006

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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application 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 Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

The purpose of the Brain Disorders in the Developing World: Research Across the Lifespan PA is to support 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 R21 and R01 projects should: 1) involve a partnership between developed and developing country individuals or research teams; 2) lead to pursuit of basic, epidemiological, clinical, prevention, intervention or health services research in the area of brain disorders of relevance to developing countries; and 3) build capacity as necessary in the proposed research area to enable further research to take place.

The R21 grant will provide support to initiate preliminary studies and training, and to organize, plan, prepare, and assemble the information and data for an application for a more comprehensive R01 application involving collaboration between the Developed and Developing country investigators.

The R01 application should build on the research and training goals and results from the R21 grant, including continued capacity building to help sustain the research. Only previous R21 grantees from this program announcement or from RFA-TW-007, are eligible to apply for the R01 grant. Assignment of R21s will be to any participating NIH IC, assignment of R01s will be to a participating NIH Institute or Center other than FIC, according to the IC's stated interests in the PA. FIC plans to make R21 grant awards and will consider co-funding R01s to be awarded by our funding partners .

Research Objectives

The overall intent of the program is three-fold: 1) to encourage multidisciplinary collaborative approaches to identify and address brain disorders of particular importance to low- and middle-income countries; 2) to address brain disorders of significance to developing nations by promoting international cooperation between scientists and institutions in these countries and investigators in the U.S. and other developed nations who are pursuing relevant research programs and 3) to build and enhance the research capacity of developing nations to identify and address relevant brain/ neurodevelopmental disorders across the lifespan.

Relevant research for the R21 and R01 follow-up 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.

The main goals of the R21 application should be to: 1) assess needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question), 2) develop collaborations and needed resources; 3) show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission and 4) Integrate capacity building/ collaborator training into the proposed research program.

The R21 applicants should propose specific milestones and a timeline to meet these goals. During the R21 award period, the applicant should:

Pilot research projects should demonstrate feasibility of certain aspects of the research approaches and develop further research directions. Training, informal meetings, workshops and small conferences may be conducted as necessary to develop the research and collaboration and for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.

Each exploratory/-planning grant should also present a description of the anticipated longer-term goals of the collaboration as it develops into an application for an R01 grant. As one outcome of the work under the R21, grantees will be expected to provide a detailed assessment of the specific research issues and capacity building/training needs in the developing country that the proposed follow-up R01 will address. The relevance of the focus of the proposed research to the health of the host endemic country should be justified. The assessment may include, but is not limited to, needed skills and expertise in laboratory, clinical, epidemiological and social science research.

In addition, for both the R21 and R01, 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:

For the R01 application a well-developed collaboration building on the previous R21 collaborations should be demonstrated.

On the other hand, the purpose of the R21 mechanism is to foster initial development of collaborative work focused on brain disorders across the lifespan and relevant to developing countries; accordingly, investigators need not demonstrate any history of prior collaboration in the R21. However, those factors in the investigators' background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated.

For both R01 and R21 applications 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 proposed R21 and subsequent R01 research, may take place at any of the collaborating sites and may vary, depending on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions. 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 Follow-up R01 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 PA 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 can also have significant neurological consequences. HIV infection is an example. 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 South-East Asia. Extensive research carried out in the 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 PA 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 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 PA 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. Descriptive epidemiology to describe and define the problem in the countries in question by assessing 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);

2. 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).

1. Natural and man-made neurotoxic exposures - e.g. prenatal exposure to drugs of abuse, fetal alcohol syndrome, effects of neurotoxins/neurotoxicants in homes, the outside environment, industrial and agricultural settings;

2. Nutrition (malnutrition, undernutrition) and effects on brain development and function.

3. Infectious diseases such as cerebral malaria, neurocysticercosis/ tapeworm, HIV/AIDS and associated opportunistic infections, and other parasitic diseases;

4. Physical trauma that is both intentional and unintentional (e.g. Shaken baby syndrome, accidental injuries);

5. Psychological trauma (e.g. effects on brain function, including cognitive and behavioral function, in victims of child abuse, neglect or abandonment, torture and rape).

6. Neurological and neuropsychiatric consequences and potential interventions related to trauma following natural disasters.

7. Factors affecting cognitive, emotional and physical health and survival in older persons.

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

Specific Research Interests of the PA Sponsors:

Applicants can obtain information and research interests for each of the sponsoring ICs listed on the first page of this announcement at their web sites and by contacting the IC program contact listed in this announcement (Section VII. Agency Contacts). Some of the participating ICs have provided additional statements of interest. Only R01 applications within these stated interests will be considered by that IC and potential applicants are strongly encouraged to contact the relevant IC prior to submitting a letter of intent):

NIH:

The FIC is interested in all eligible R21 applications that are responsive to this PA. FIC also plans to co-fund R01s that will be awarded by our funding partners on this PA.

The NEI conducts and supports research that helps prevent and treat eye diseases and other disorders of vision and which leads to sight-saving treatments, reduces visual impairment and blindness, and improves the quality of life for people of all ages. In the context of this announcement NEI would particularly like to encourage research on eye diseases relevant to developing countries and involving neuronal cell dysfunction and degeneration (such as but not restricted to retinitis pigmentosa, age-related macular degeneration, cataracts and glaucoma).

The 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 NIAAA is interested in applications that address alcohol-related birth defects (such as Fetal Alcohol Syndrome).

The 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 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). 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, NIDA is interested in supporting studies on prenatal effects, cognitive consequences, epidemiological patterns, and associations with HIV/ AIDS and other transmitted diseases. NIDA will give priority to meritorious research that builds upon existing NIDA-funded collaborations between developed and developing country colleagues.

The 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 NIMH is interested in research limited to areas relating to epidemiology, natural history, and pathogenesis of HIV associated disease of the nervous system.

The 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/ 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:

National Association for Autism Research (NAAR): 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(s) of Support

This funding opportunity will use the Exploratory/Developmental Grant (R21) and NIH Research Project Grant (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Competing continuation applications for R21 grants are not accepted.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

If a consortium is involved then please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html for information on the relationship of F&A costs on subcontracts to the direct costs requested. Not quite standard language.

2. Funds Available

Consortium/Contractual Facilities and Administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. 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(s) if your organization meets the other eligibility criteria listed below and 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 country and one in a developing country institution will be involved in the grant application.

For the purposes of this PA, developed country is defined as a country with a Gross National Income per capita (GNI per capita) of $9,000 or more and a developing country is defined as a country that has a Gross National Income per capita (GNI per capita) below $9,000, according to the World Bank classification system (refer to the GNI per capita ranking in the left-hand column labeled Atlas Methodology at http://www.worldbank.org/data/databytopic/GNIPC.pdf . Do NOT refer to the right-hand column headed Purchasing Power Parity ).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research under the guidelines of this PA is invited to work with their institution to develop an application for support. Women, individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

This announcement provides an avenue for investigators in developed countries and those in developing countries, with shared interests in 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 above under Eligible Institutions ) must collaborate on the application as Principal Investigator (PI) and Co-Investigator. The Principal Investigator (PI) may be from the developing nation and institution, OR from the developed nation and institution, but the collaborators must prepare the proposal jointly.

While there is no cap on the maximum number of investigators or institutions involved, the applicant must discuss how the contributions of each member will be integrated in the proposed activities.

Only previous R21 grantees from this program are eligible to apply for the R01 grant. Assignment of R01s will be to a participating NIH Institute or Center other than FIC.

2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
An individual investigator may only be involved as PI or primary collaborator on one application per round.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Supplemental Instructions:

R21 Research Plan:

1) Page limits for the R21 research plan (PHS398 sections a-d): 15 pages. Color figures and up to 5 publications are allowed as appendices.

2) R21 Exploratory Grants need not include preliminary data although it is recommended that relevant data be included if it supports the proposed research.

3) R21 Applications should include a plan for assessment of needs for resources and capacity building to enable the proposed research to be carried out (including training in research, research ethics, and human and animal subjects guidelines as appropriate).

R01 Research Plan:

R01 applications should also 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.

3. Submission Dates and Times
See Section IV.3.C for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not HIV/AIDS-related: June 13, 2005; April 16, 2006, 2007. HIV/AIDS-related only: July 23, 2005, 2006, 2007.
Application Receipt Dates(s): Not HIV/AIDS-related: July 13, 2005; May 16, 2006, 2007. HIV/AIDS-related only: August 23, 2005, 2006, 2007.
Peer Review Date(s): October-November 2005, 2006, 2007
Council Review Date(s): January -February, 2006, 2007, 2008
Earliest Anticipated Start Date(s): April 1, 2006, 2007, 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 at the beginning of this document.

The letter of intent should be sent to:

Dr. Kathleen Michels
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications in response to a PA with specified receipt dates must be received by the date listed on the first page of the announcement. Applications will be evaluated for completeness by CSR and responsiveness by FIC and participating ICs.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

It is expected that the majority of the funds awarded will be used for supplies, 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 R21 or R01 grant and will involve the developing country collaborators.

6. Other Submission Requirements

Only previous R21 grantees from this program are eligible to apply for the R01 grant and applications must be within the interests of one of the participating organizations or NIH ICs as stated in this PA. Award of R01s will be by a participating NIH Institute or Center other than FIC. Potential R01 applicants are therefore strongly encouraged to contact the person listed in this PA for the participating IC or organization most related to their proposed area of research.

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 Principal Investigator and co-signed by the official signing for the applicant organization. This letter may be submitted as a cover letter accompanying the application.

Supplemental Budget Information:
A detailed budget is not required for R21 applications and R01 applications less than $500,000. 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 the funds requested will be used for and where they will be used, subject to the Funding Restrictions (section 5.0, above).

A networking meeting involving grantees of these awards will be held, in the Washington, D.C. area, in 2006 and 2008, to share information, discuss new insights and will include grants-writing and other workshops according to the needs of the awardees and program. For this meeting, funds should be budgeted for travel by the PIs and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award.

Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from IC staff that the IC will accept your application for consideration for award; and, 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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 website, 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 R01 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 reviewers will assess the reasonableness of the data sharing plan or the rationale for not sharing research data. 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 requires that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity with an R01 application should include a plan for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

All applicants who respond to this PA with an R01 application must propose plans for sharing data and materials generated through the grant (for example 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 for autism data and biomaterials; http://nimhgenetics.org).

The investigator's data and resource sharing plan should, when applicable, specify the following elements: (1) the creation of comprehensive and verified databases that contain, as applicable, any and all non-individually identified, clinical, diagnostic, and genetic information collected and produced in the project; (2) mechanisms by which all databases and any biomaterials are widely distributed to qualified investigators in the scientific community; (3) a protocol for wide dissemination of these data and materials; and (4) a timetable for distribution.

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

R21 applications submitted for this funding opportunity will initially be assigned to FIC. R01 Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

An appropriate scientific review group or groups c onvened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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.

1. 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?

2. 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 projects with multiple sites and/or multi-disciplinary 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 criterion, 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

3. 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?

4. Investigators. T he collaborators may each be at various stages in their respective careers. Are the investigators 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? For the R21 the investigators may or may not have prior collaborations, however for the R01 a well-developed collaboration should have been established.

5. Environment. Does the scientific environment 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, 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)?

6. 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 established (R21) or strengthened (R01)? Does the research constitute a substantial scientific endeavor for the Foreign Collaborator, including creative and scientific input to the research proposal? The foreign site and investigators should not be used merely to gather biological samples (clinical, plants, etc.) or behavioral data (interviews, surveys, etc.). In all cases, the Foreign Collaborators should be actively involved in analyzing and interpreting the data.

7. 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? For the R21: Does the proposed project describe a plan to assess research and capacity building needs and ways to address those needs? For the R01: Does the proposed program address research and research capacity building/ training needs identified in the course of the previous R21 project?

8. Specific R21 review criteria.The potential of the R21 planning grant to lay the foundation for future collaborative research grant applications and the potential significance of the proposed research and capacity building will be major considerations in the evaluation of the R21 exploratory/developmental grant mechanism. Because the R21 is designed to support planning, development and initiation of innovative collaborative research and ideas, preliminary data as evidence of feasibility of the project are not required to apply, although it is useful to include or cite pilot data where relevant and available. The applicant is, however, responsible for presenting the background literature that provides sound basis for the approach and for developing a rigorous research plan.

9. Specific R01 review criteria. Does the R01 application build on the pilot research, resources and collaborations developed in the R21? The focus in the R01 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:

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both sexes, 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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

All R01 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 with an R01 application should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reviewers will assess the reasonableness of the data sharing plan or the rationale for not sharing research data. 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 requires 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardees before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

The scored summary statements will be sent with a letter via email or postal service to the Principal Investigator at the email address provided on the application. Unscored summary statements are sent directly from the Center for Scientific Review. Notices of grant award will be sent via electronic mail (e-mail) to the grantee institution.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. In the performance site block on the PHS2590, 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.

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 Contacts:

General Inquiries regarding the scope and content of this Request for Applications should be directed to:

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]

Direct your questions about Scientific/Research Issues to the contacts below:

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:

FIC/NIH:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-435-6031
FAX: 301-402-0779
Email: [email protected]

NEI/NIH
Michael D. Oberdorfer, Ph.D.
Director, Strabismus, Amblyopia, and Visual Processing Program
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
FAX: 301-402-0528
Email: [email protected]

NIA/NIH:
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]

NIAAA/NIH:
Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute of Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301-443-2594
FAX: 301-480-1726
Email: [email protected]

NICHD/NIH:
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
National Institutes of Health
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]

NIDA/NIH
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
National Institutes of Health
6001 Executive Boulevard, Room 4232, MSC 9593
Bethesda, MD 20892-9593
Telephone: 301-402-3869
FAX: 301-443-6814
Email: [email protected]

NIEHS/NIH:
Annette Kirshner, Ph.D.
NIEHS-DERT
Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: 919-541-0488
FAX: 919-541-5064
Email: [email protected]

NIMH/NIH:
Jeymohan Joseph, Ph.D.
Chief, HIV NeuroVirology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
National Institutes of Health
Room 6202, MSC 9619
6001 Executive Blvd
Bethesda, MD 20892-9619 (courier/express mail use Rockville, MD 20852 and drop MSC code)
Telephone: 301-443-3012
FAX: 301-443-9719
Email: [email protected]

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

ODS/OD/NIH:
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 (NAAR)
Andy Shih
Chief Science Officer
99 Wall Street
Princeton, NJ 08540
Tel: 609.430.9160
Fax:609.430.9163
Email: [email protected]

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Revie
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892-7840 (for express/courier service; non-USPS service use ZIP 20817)
Telephone: 301-435-1021
FAX: 301-480-3567
Email: [email protected]

3. Financial or Grants Management Contacts:

FIC/NIH:
Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: 301-496-1670
FAX: 301-594-1211
Email: [email protected]

NEI/NIH
William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
FAX: 301-496-9997
Email: [email protected]

NIA/NIH:
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]

NIMH:
Rebecca Claycamp
Chief Grants Management Officer
Grants Management Branch
National Institute of Mental Health
National Institutes of 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 (45CFR46) 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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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.

Public 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 public 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 PA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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NIH Funding Opportunities and Notices


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