Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

Title: International Neuroscience Fellowship (F05)

Announcement Type

This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-227.

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

• February 3, 2011 - This PAR has been reissued as PAR-11-106.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• November 5, 2010 - See Notice NOT-OD-11-018 Notice of Need to Expire and Reissue Fellowship Applications (Fs) to Comply with Language in New Application Forms.

Program Announcement (PA) Number: PAR-10-167

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Catalog of Federal Domestic Assistance Number(s)
93.853, 93.866, 93.891, 93.865, 93.279, 93.173, 93.113, 93.242

Key Dates
Release/Posted Date: April 13, 2010
Opening Date: July 16, 2010 (Earliest date an application may be submitted to Grants.gov)
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).
Letters of Intent Receipt Date(s): July 16, 2010, 2011, 2012
Application Due Date(s): August 16, 2010, 2011, 2012
Peer Review Date(s): November 2010, 2011, 2012
Council Review Date(s): January 2011, 2012, 2013
Earliest Anticipated Start Date(s): April 2011, 2012, 2013
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: New Date January 8, 2011 (per issuance of NOT-OD-11-018), Original Date: August 17, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The goal of the International Neuroscience Fellowship (INF) is to advance the training of qualified foreign neuroscientists and clinicians at the early or mid-career level, by enhancing their basic, translational or clinical research skills in a research setting in the United States (U.S.). This program aims to strengthen the intellectual capital of neuroscience research in international institutions. Awardees are expected to pursue future independent and productive careers, which stimulate research in the neurosciences on a global scale.
• Mechanism of Support. This Funding Opportunity Announcement (FOA) will utilize the international research fellowship (F05) grant mechanism.
• Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Individuals may receive up to three years of support for research training at a basic, translational or clinical research facility within the U.S. (referred to as the U.S. sponsoring institution).
• Application Research Strategy Length: The F05 Research Strategy section may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI). The PD/PI is the individual Fellowship Applicant. Eligible individual applicants include non-immigrant foreign scientists at the early or mid-career level. The applicant must have a doctoral or equivalent degree, and an endorsement from their home institution, with a guaranteed appointment upon completion of the fellowship. Applicants must be proficient in English and must have a sponsor in the U.S. who is affiliated with an eligible U.S. organization. Preference will be given to applicants from low- to middle-income countries. See Section III for definitions associated with specific eligibility requirements.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. An individual may not have two or more competing NIH fellowship applications pending review concurrently.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Awards are generally not renewable and are not transferable from one PD/PI to another.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training 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
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 Training Objectives

The mission of the NIH Neuroscience Institutes is to reduce the burden of illness in the nervous system - a burden borne by every age group, by every segment of society, by people all over the world and to enhance understanding of links between the nervous system, behavior, and health. Recognizing that international advancements in biomedical research can contribute to improvements in the health of U.S. populations, it is important to develop creative approaches that promote international research, training and collaborations in the neurosciences. The main goal of the International Neuroscience Fellowship (INF) is to advance the training of qualified foreign neuroscientists and clinicians at the early or mid-career level, by enhancing their basic, translational or clinical research skills in a research setting in the U.S.

The objective of the INF is to prepare awardees for independent careers in academia, research or clinical institutions in their home country. The broader goal of this program announcement is to strengthen the intellectual capital of neuroscience research in foreign institutions, particularly those with limited economic resources. It is hoped that this FOA will enhance the quality and quantity of international neuroscience research, while fostering long lasting collaborations between foreign and U.S. neuroscientists.

Applicants must demonstrate that, upon completion of the fellowship, they will have the opportunity to use their newly acquired skills to pursue neuroscience research, and to teach or direct others in neuroscience research in their home country. Preference will be given to applicants from low- to middle-income countries based on Gross National Income per capita classified by the World Bank (http://go.worldbank.org/K2CKM78CC0).

While it is expected that the research plan of applications will be diverse, the research goals should be of global importance and also be relevant to the missions of the participating NIH Institutes. Each NIH Institute and Center (IC) has a unique scientific purview and different program priorities. Prospective applicants are strongly encouraged to contact the relevant NIH staff for Institute specific programmatic and budgetary information: Table of Institute and Center Contacts.

Specific Research Interests of Participating Institutes:

Applicants can obtain information and research interests for each of the participating Institutes website, listed at the beginning of this announcement, or by contacting the institute scientific contact listed in this announcement (see Section VII. Agency Contacts) Table of Institute and Center Contacts.

National Institute of Neurological Disorders and Stroke (NINDS) supported fellowships under this FOA are expected to have high relevance to the mission of the Institute, particularly as it relates to disorders in the nervous system that have high global health impact. Specific disease areas of interest include, but are not limited to, stroke and other cerebrovascular diseases, epilepsy, migraine, brain trauma and spinal cord injury, Parkinson's disease and other neurodegenerative disorders, neural developmental disorders, and neurological consequences of HIV/AIDS. The NINDS encourages training on basic, translational and clinical research skills, which include, but are not limited to, genetic, molecular, cellular and systems level approaches, computational, informatics and neuroimaging, therapeutics development, clinical trial design, bioethics and neuroethics, population-based natural history and epidemiological studies.

National Institute on Aging (NIA) supported fellowships under this FOA should be aimed at a better understanding of age-related normal and pathological changes in the structure and function of the nervous system and how such changes affect behavior, well-being, and health of the elderly. Expanding knowledge on the aging nervous system will allow improvement in the quality of life of older individuals. Changes in the brain that affect sensory, motor, sleep, cognitive, social, and emotional functioning have a profound influence on the quality of life of older individuals. Changes in brain functions are related to many age-related decrements that require institutional care. Decrements in functional capacity not only limit independence but also influence the attitudes of others toward the aging, affect the individual's self-image, and often determine the nature and quality of healthcare services. In addition, normal age-related neurological changes may impact functional capacity in social interaction, activities of daily living, health maintenance, and medical and economic decision making. Research training under this program could include basic and clinical studies of the nervous system, clinical trials of interventions of therapeutic modalities, epidemiological research to identify risk factors and to establish prevalence and incidence estimates of pathologic conditions, and research relevant to those geriatric problems arising from psychiatric and neurological disorders associated with aging as well as the further understanding of the normal aging brain.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) supported fellowships under this FOA are expected to focus on the neurobiological mechanisms, and behavioral and cognitive processes, related to the problems of alcohol abuse and alcohol dependence. Areas of research investigation can range across the lifespan, and include the effects of prenatal alcohol exposure and the effects of alcohol during adolescence and adulthood. Basic, clinical, and translational research studies directed toward investigation of the effects of alcohol on the nervous system and behavior, including approaches using animal models, would be considered appropriate.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supported fellowships under this FOA may include basic, clinical and translational research with multidisciplinary approaches in the biomedical and behavioral neurosciences areas, particularly as they affect developing systems and rehabilitation. Relevant neuroscience research areas include, but are not limited to: developmental behavioral and cognitive neuroscience in human and animal models; neural bases of behavior, language, and treatment of learning disabilities; regulation of early embryonic development of the central and peripheral nervous system, including mechanisms of normal and abnormal neural development; biomedical and behavioral aspects of mental retardation and developmental disabilities, neuroendocrinological and nutritional influences on brain development; neurotropic growth factors, use of drugs for neuropharmacological and psychopharmacological treatment of pediatric patients, and of women during pregnancy; intrauterine neurotoxicity; neuroprotective agents; management of maternal neurologic disorders and their affects on pregnancy and infant outcomes, neuroendocrine control of reproduction, genetics of reproductive neuroendocrine diseases and disorders; neural basis of reproductive behavior, pathophysiology and management of chronically injured nervous, such as traumatic brain injury, stroke and spinal cord injury, repair and recovery of motor and cognitive function; functional plasticity, rehabilitative interventions and strategies for all ages, including motor training, behavioral modifications, pediatric critical care and rehabilitation; neuroengineering, and assistive technologies.

National Institute on Drug Abuse (NIDA) supported fellowships under this FOA are expected to focus on the neurobiological mechanisms, and behavioral and cognitive processes, that relate to the public health problem of drug abuse and addiction. Research focusing on, but not limited to, the following areas is encouraged: (1) the transition to addiction (i.e., from controlled use to uncontrolled, compulsive use of drugs); (2) the consequences of drug abuse and addiction (e.g., drug-induced neuroadaptations, neurotoxicity, altered cognitive and behavioral processes, developmental deficits); (3) the antecedents to drug addiction and relapse (e.g., genetics, stress, environmental precipitants); (4) the neurobiological bases of pain and its alleviation by opiates, other analgesics, adjunctive medications, and alternative therapies (e.g., acupuncture, virtual reality); and (5) the complex interrelationship among HIV/AIDS progression, transmission, and drug abuse. It is expected that the scientific understanding gained from neuroscience and behavioral research will be applicable to improving treatment and prevention of drug abuse and drug addiction.

National Institute on Deafness and other Communication Disorders (NIDCD) fellowships under this FOA are expected to focus on the neurobiological mechanisms, and behavioral and cognitive processes, that relate to the public health problem of communication disorders. NIDCD fosters discovery and strives to reduce the burden of communication disorders through the support of research across the continuum of basic, epidemiologic, clinical/applied biomedical, social and behavioral health sciences. Research within the institute's scientific programs of hearing, balance/vestibular, taste, smell, voice, speech and language throughout the lifespan is encouraged. Specific disorders of interest include, but are not limited to aphasia, dysarthria, spasmodic dysphonia, stuttering, autism, and anosmia/ageusia. Research on hearing aids, cochlear implants, neural prostheses, Meniere's disease, presbycusis, noise-induced hearing loss and tinnitus is also of high programmatic interest. All research appropriate to the mission of NIDCD, which is to reduce the burden of communication disorders, will be considered.

National Institute of Environmental Health Sciences (NIEHS) supported fellowships under this FOA are expected to focus on the environmental health sciences and be appropriate to the mission of the NIEHS, which is to reduce the burden of human illness and dysfunction from environmental causes by understanding how environmental factors, individual genetic susceptibility and age (time or stage of development) interrelate in the disease process. Proposals should demonstrate a direct human health endpoint and address how an environmental exposure is, or might be, involved in a neurological or psychiatric disease process. Special interests include the effects of hazardous environmental agents on neurodevelopment, the role of the environment in cell death and neurodegeneration, and investigating gene-environment interactions by measuring the joint effects of genetic susceptibilities and environmental agents through epidemiological studies, animal models and in vitro cellular or molecular approaches. Examples of environmentally relevant factors/toxicants include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants, or biologically derived toxins. Agents considered inappropriate to the interests of the NIEHS include, but are not limited to: alcohol, chemotherapeutic agents, radiation which is not a result of an ambient environmental exposure, drugs of abuse, pharmaceuticals, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect.

National Institute of Mental Health (NIMH) supported fellowships under this FOA are expected to have high relevance to the mission of the Institute. NIMH encourages applications for the INF in the following areas:

1) fundamental neuroscience research on cognitive, affective, social, and regulatory systems and their development in humans, non-human primates, and in other animals; fundamental neuroscience research on genetic, molecular, and cellular processing underlying function and plasticity of circuits relevant to emotional regulation, cognition, and mental disorders; and genetics research to identify, localize, and understand the function of genes and other genomic elements in brain that produce susceptibility to mental disorders;

2) the neural basis of mental disorders; human and animal studies on the molecular, cellular, and systems level of brain function designed to elucidate the pathophysiology of mental disease and to translate these findings to clinical diagnosis, treatment, and prevention strategies;

3) the developmental origins of mental disorders, neurobehavioral mechanisms responsible for the development of psychopathology, trajectories of risk/illness based on the combined and interactive influences of genetics, brain development, environment, and experience, and the translation of these for personalized preventive and treatment interventions ;

4) basic and clinical HIV neuroscience research related to HIV neuropathogenesis, host and HIV viral genetics, in vivo HIV neuroimaging/biomarker research methodologies and preclinical/clinical HIV therapeutics research;

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 international research fellowship (F05) award mechanism. As a Fellowship Applicant, the individual, together with his/her U.S. sponsor and institution are jointly responsible for planning, directing, and executing the proposed fellowship research training program.

This program is designed to provide training and research opportunities for qualified, non-immigrant foreign scientists. The applicant is required to have a doctoral degree (or its equivalent) in one of the biomedical or behavioral sciences. The proposed research training must be within the broad scope of biomedical, behavioral, or clinical research as it relates to neuroscience and must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his or her potential for a productive independent research career.

2. Funds Available

Because the nature and scope of the proposed research training 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs are not allowed for fellowship awards.

Allowable Costs

Stipends: This fellowship award provides stipends to fellows as a subsistence allowance to help defray living expenses during the research training experiences at the U.S. sponsoring institution. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For the most recent stipend levels, see the following website: http://grants2.nih.gov/training/nrsa.htm. The awarding NIH Institute will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend level in effect at that time. No departure from the published Ruth L. Kirschstein National Research Service Award (NRSA) stipend schedule may be negotiated between the institution and the fellow.

While the INF is not an NRSA fellowship, the amount of the award will be determined by the NRSA postdoctoral stipend guidelines. The maximum NRSA stipend level is based on full years of relevant postdoctoral experience. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree.

Tuition and Fees: The NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Tuition, for the purposes of this policy, means the combined costs of tuition and fees. For the most recent tuition/fees levels, see the following website: http://grants2.nih.gov/training/nrsa.htm. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience of the fellow at the U.S. sponsoring institution.

Institutional Allowance: Fellows sponsored by nonfederal or nonprofit institutions will receive an institutional allowance to help defray fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings and/or to the fellow's home institution. The allowance for traveling to and from the foreign institution may include a single economy or coach round-trip airline ticket. No travel allowance is provided for the awardee's dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the U.S. and the foreign country. The allowance for travel is within the NIH-published Institutional Allowance level. Self-only health insurance (available to fellows without families) or family health insurance is an allowable cost for fellows at the sponsoring institution only if such self or family health insurance is applied consistently to all persons in a similar training status and regardless of the source of support. This allowance is intended to cover training-related expenses for the individual fellow and is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than six months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Award will be revised and the balance must be returned to the NIH.

NIH provides an institutional allowance to fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with health insurance, travel to scientific meetings and books. For fellows at for-profit institutions, the institutional allowance will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the awarding Institute or Center.

Other Training Costs: As part of this award, additional funds may be requested. In all cases, the additional funds requested must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution in the application.

Reasonable accommodations: Additional funds may be requested by the sponsoring institution to make changes or adjustments in the academic or research environment that will make it possible for an otherwise qualified individual with disabilities to perform the work necessary to meet the requirements of the degree program in which he/she is enrolled. Individuals with disabilities are defined as those with a physical or mental impairment that substantially limits one or more major life activities (see: Americans with Disabilities Act Home Page). The accommodations requested under this program must be directly related to the work required to meet the requirements as regards to both course work and laboratory experience, and must be appropriate to the special needs of the applicant. Some types of accommodations that might be provided under this award include, but are not limited to: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. This award is not meant to relieve the sponsoring institution of its obligation to provide reasonable accommodations as defined by the Americans with Disabilities Act. NIH will not provide funds for infrastructure alterations such as lowering countertops, widening doorways, etc.

Off-site research training: Additional funds may be requested by the sponsoring institution if the research training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution.

Supplementation of Stipends, Compensation, And Other Income: The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by the NIH. Such additional amounts either may be in the form of an augmented stipend (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved training program. See also: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600200.

Stipend Supplementation: Supplementation, or additional support to offset the cost of living, may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.

Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations (including Small Businesses)
• Other(s): Eligible Agencies of the Federal Government

Please note: National Institutes of Health intramural laboratories are not included as eligible agencies of the Federal Government.

The sponsoring institution must be a basic, translational or clinical research facility in the U.S and must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant.

1.B. Eligible Individuals

A non-immigrant foreign scientist 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.

Citizenship: Non-immigrant foreign scientists are eligible for this award. U.S. citizens, non-citizen nationals, or persons with U.S. permanent resident status are not eligible for this award. Individuals in the latter three categories should consult the NIH website for descriptions of other fellowship and career development awards for which they may be eligible (http://www.training.nih.gov/).

Degree Requirements: Applicants to the INF must have earned a doctoral degree (M.D., Ph.D., D.V.M., D.D.S., D.O., O.D., D.P.M., Sc.D., Eng.D., D.N.S., Pharm.D., D.S.W., Psy.D. or equivalent) in the biomedical, behavioral, or clinical sciences at an accredited U.S. or foreign institution at the time their application is submitted in response to this announcement. The applicant must provide a photocopy of his or her diploma, and a certified English translation if the original document is not in English. The diploma should be scanned and submitted as a PDF in the Other Attachments component of the SF424 (Item 12.B).

VISA Requirements: Foreign nationals who apply for this fellowship must have a visa that permits training or employment in the U.S. at the time that an award is made. It will be the responsibility of the candidate's U.S. sponsoring institution to determine and document that the candidate's visa will allow him or her to remain in the U.S. long enough to complete the proposed research training program. INF applications must contain a description of the applicant's current visa status.

Preference will be given to applicants from low- to middle-income countries. For the purpose of this announcement, the World Bank's criterion for classifying Gross National Income will be employed to determine country income status and eligibility. See http://go.worldbank.org/K2CKM78CC0 for World Bank country income classification tables.

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

Number of Applications. An individual may not have two or more competing NIH fellowship applications pending review concurrently.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these "grandfathered" applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Awards are generally not renewable and are not transferable from one PD/PI to another. Fellowship awardees requiring further research training should contact the NIH awarding component to see if they may submit a renewal application.

Duration of Support: Individuals may receive up to three years of support for research training at a basic, translational or clinical research setting within the U.S. (referred to as the U.S. sponsoring institution).

Individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. The training period should be at a minimum of 12 months and a maximum of 36 months. Awardees that have the need to return to their home institution for a short period of time during the training period must request permission from the program staff of the NIH funding institute. Funds for such travel must be approved by the sponsoring institution which authorizes expenditures from the institutional allowance.

Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in the predoctoral research training program which is determined by the NIH Program staff review of information documented in the progress report.

Sponsor: Before submitting a fellowship application, the applicant must identify a sponsor (also called mentor or supervisor) who will supervise the training and research experience. The sponsor must be affiliated with the U.S. sponsoring institution. The sponsor should be an active investigator in the area of the proposed research training and be committed both to the research training of the Fellowship Applicant and to the direct supervision the applicant's research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring predoctoral students. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant's research training program. The applicant must work with his/her sponsor(s) in preparing the application.

The sponsor should describe the research training plan for the applicant (coordinated with the applicant's research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant's qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged. A brief description of potential areas for future collaboration between the sponsor and the candidate after he or she returns to the foreign institution should also be provided.

Sponsoring Institution: Before submitting a fellowship application, the applicant must also identify a sponsoring institution. The sponsoring institution must have appropriate staff and facilities available on site to provide a suitable environment for performing high-quality research training and be demonstrably committed to research training in the particular program proposed by the applicant.

Foreign Institution: The fellowship will be awarded to the U.S. sponsoring institution only. However, no application will be accepted without an accompanying endorsement letter from the Foreign Institution to which the applicant plans to return. In this letter, the Foreign Institution must assure that the applicant has a guaranteed appointment at the institution upon his or her return. The letter should contain the following information: 1) the title and description of the applicant's appointment at this institution; 2) the duration of the appointment; and 3) a description of the research facility and environment at this institution, including facilities and equipment available to the applicant. This letter must be signed by the appropriate institutional business and academic officials (such as a university dean who is responsible for the applicant's appointment) and be submitted with the completed application. The endorsement letter should be scanned and submitted as a PDF in the Other Attachments component of the SF424 (Item 12.B).

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, use the "Apply for Grant Electronically" button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Note: All applications for the INF must be submitted from the U.S. Sponsoring Institution.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time ? (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

The PD/PI (Fellowship Applicant) should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons."
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. " 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons.
• The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) individual fellowship application forms and the SF424 (R&R) Individual Fellowship Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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
PHS Fellowship Supplemental Form
PHS398 Cover Letter File

Note: Specific instructions related to each of the components are included in the Individual Fellowship Application Guide SF424 (R&R).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: July 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 16, 2010, 2011, 2012
Application Due Date(s): August 16, 2010, 2011, 2012
Peer Review Date(s): November 2010, 2011, 2012
Council Review Date(s): January 2011, 2012, 2013
Earliest Anticipated Start Date(s): April 2011, 2012, 2013

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, e-mail, and telephone number of the PD(s)/PI(s)
• Name, address, e-mail, and telephone number of the U.S. sponsor(s)
• The name of the U.S. sponsoring institution and the foreign institution
• Number and title of this funding opportunity

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 to:

Stacey D. Chambers, M.S.
Program Analyst
Office of International Activities
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Neuroscience Center, Room 2179
Bethesda, MD 20892-9523
Telephone: 301-496-0690
FAX: 301-480-1080
Email: chambers@ninds.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered "on-time":

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the "error correction window."

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be "on-time."
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of "on-time" submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday - Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can "Reject" the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to "Reject" the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The "Reject" feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to "Reject" the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn't transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to "Reject" the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

While the INF is not an NRSA award, it is subject to NRSA Policies. For more information see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

Concurrent Awards: An INF may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Tax Liability: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact INF/Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. Note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application, the timely submission of all required forms, and the availability of funds.

Service Payback: Recipients of INF support do not incur service payback.

6. Other Submission Requirements

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

The NIH requires the PD(s)/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 U.S. sponsoring institution 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."

Cover Letter (Section 5.2 of SF424 Individual Fellowship Application Guide)

Fellowship Applicants are required to attach a cover letter to the PHS Cover Letter component of the application. The cover letter must contain the same list of referees (including name, departmental affiliation, and institution) that is included in the Other Project Information Component Item 12, Other Attachments. In addition, applicants may request assignment (referral) to a particular NIH Institute or Center, as well as a specific Scientific Review Group. See SF 424 Individual Fellowship Application Guide, Section 5.2, for additional information.

PHS Fellowship Supplemental Form (Section 5.3 of SF424 Individual Fellowship Application Guide)

All application instructions outlined in the SF424 (R&R) Individual Fellowship Application Guide are to be followed (see: http://grants2.nih.gov/grants/funding/424/index.htm), taking into consideration the following additional instructions (Note that only selected items are emphasized below). See SF 424 Individual Fellowship Application Guide, Section 5.3, for additional information.

Research Training Plan

Introduction (Item 1): Required for a resubmission or revision application. This section is limited to 1 page.

Specific Aims (Item 2): The Fellowship Applicant must describe concisely the Specific Aims, broad, long-term objectives and the goal of the proposed research to test a stated hypothesis. The Specific Aims section is required for all Fellowship applications and is limited to 1 page.

Research Strategy (Item 3):

This section, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. See Table of Page Limits. This section should address the Significance of the proposed studies, including the background leading to the present application; and the Approach (including preliminary studies, if any) to provide experimental support of the proposed hypothesis.

Fellowship Applicants must describe a tailored research training plan, including a description of how the research strategy (preferably hypothesis-driven) is well-suited to the stage of his/her career development to date. Describe the skills and techniques that the candidate will learn during the award period, and discuss the relationship of the proposed research training to the applicant's career goals. Details of how the Fellowship applicant will use his/her newly acquired skills to pursue a neuroscience research career and train others, once s/he has returned to his/her home country, must also be presented. The applicant's plan should be coordinated with the sponsor's plan (see below), and should include substantive detail that adds to the information about time allocations requested. The applicant must describe the background leading to the proposed research, the significance of the research, the research approach (design and methods) for achieving the Specific Aims (see above), the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant in the current or prior laboratory.

Other Research Training Plan Sections

Resource Sharing Plan (Item 16):

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Respective Contributions (Item 17): The Fellowship Applicant and his/her sponsor/mentor should describe how they have collaborated to develop the current research training proposal. This section is limited to 1 page.

Selection of Sponsor and Institution (Item 18): The Fellowship Applicant should discuss how he/she arrived at selecting the sponsor(s) and the institution. This section is limited to 1 page.

Training in the Responsible Conduct of Research (Item 19): Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document prior instruction in responsible conduct of research during the applicants current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicants understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. This section is limited to 1 page.

Additional Information

Goals for Fellowship Training and Career (Item 7): The Fellowship Applicant should provide details of his/her overall career goals for training, and explain how the proposed research will enable the attainment of these goals. This section is limited to 1 page.

Activities Planned Under This Award (Item 8): The Fellowship Applicant should provide a detailed description of all planned activities under the proposed research training plan, such as coursework, seminars, scientific conferences, opportunities for interaction with other groups and scientists, and any special or unique training opportunities for the applicant that are available in the training environment. Give a year-by-year accounting including an estimate the percentage of time to be devoted to each activity. This section is limited to 1 page.

Doctoral Dissertation and/or Other Research Experience (Item 9): The Fellowship Applicant should provide a summary of his/her research experience to date and discuss how the proposed research training plan will add to this experience. Advanced graduate students must include a narrative of their doctoral dissertation (may be preliminary) and any other prior research experience. All graduate students should include any applicable research experience. Please note that while the instructions direct Predoctoral Fellows to omit this section, the information is required of advanced graduate students who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research. All graduate students should include any research experience, if applicable. This section is limited to 2 pages.

Citizenship (Item 10): The fellowship applicant should check the "Non-U.S. Citizen with temporary U.S. visa" box. The fellowship applicant must have in his/her possession a valid visa allowing him/her to remain in the U.S. long enough to be productive on the proposed fellowship project. It is the responsibility of the sponsoring institution to determine and retain documentation indicating that the individual fellowship applicant's visa will allow him/her to reside in the proposed research training setting for the period of time necessary to complete the proposed fellowship. Verification may be requested by the NIH IC prior to issuance of an award.

Non-immigrant foreign scientists are eligible for this award. U.S. citizens, non-citizen nationals, or persons with U.S. permanent resident status are not eligible for this award. Foreign nationals who apply for this fellowship must have a visa that permits training or employment in the U.S. at the time that an award is made.

Appendix

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

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Other Project Information Component (Section 4.4 of SF424 (R&R) Individual Fellowship Application Guide) Other Attachments (Item 12)

Important Note: The following attachments must be included for Fellowship applications. Submit each attachment separately using the Other Attachments section of the Other Project Information Component.

Sponsor and any Co-Sponsor(s) Information (Limited to 6 pages)

a. Research Support Available: The sponsor(s) who will directly supervise the applicant's research, must currently be funded to conduct independent research in the area of the proposed research training (e.g., Principal Investigator on an R01 or equivalent)

b. Sponsor's/Co-Sponsor's Previous Fellows/Trainees: The sponsor(s) must describe past experience in the guidance of other research trainees and fellows.

c. Training Plan, Environment, Research Facilities: The sponsor(s) must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience. The sponsor(s) should describe the research training plan for the applicant (coordinated with the applicant's own research training plan). The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged. The description should also elaborate on the research environment and available research facilities and equipment, and discuss the relationship of the proposed research training to the applicant's career. The sponsor(s) must also describe potential areas for future collaboration between the sponsor(s) and the candidate after he or she returns to the foreign institution.

The application should describe the quality and appropriateness of the training environment for the applicant's development including the strength of the institutional commitment to fostering the fellows' training. Describe the quality and availability of facilities and resources (e.g. equipment, laboratory space, computer time, subject populations) for the proposed training. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

d. Number of Fellows/Trainees to be Supervised During the Fellowship: The sponsor(s) should provide information on other trainees they will be supervising during the period of this fellowship award.

e. Applicant's Qualifications and Potential for a Research Career: The sponsor(s) are also expected to provide an assessment of the applicant's qualifications and potential for a research career. The application must include statements that address the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant's needs in preparation for an independent research career upon their return to their home country. Applicants should provide evidence of their potential for a productive and successful research career based upon the quality of their previous research training and academic record.

Additional Educational Information Required:

Applicants must also provide scores for the Graduate Record Examination (GRE), if available. MD/PhD applicants should provide MCAT scores, if available.

• A listing of the applicant's courses with grades from all undergraduate and graduate institutions in which the applicant is/has been enrolled must be included in the Fellowship Applicant Biographical Sketch Format Page. Do not include transcripts with the application (applicants may be asked to send transcripts prior to award).
• A description of the graduate or combined degree program in which the applicant is enrolled must be included in the application.

Letters of Reference (Section 5.4 of SF424 (R&R) Individual Fellowship Application Guide)

Candidates must follow the Supplemental Instructions in the SF424 R&R Individual Fellowship Application Guide for Section 5.4 " Letters of Reference. Please note that the specified Fellowship Reference Form must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new and do not use Grants.gov.

Letters of reference are an important component of the application for fellowship support. Applicants for this fellowship must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the eRA Commons Web site. The letters should be from well-established scientists (referees) addressing the qualities of the Fellowship Applicant as well as his/her potential to develop research skills needed in preparation for a productive research career as a physician-scientist or clinician-scientist in scientific areas related to the mission of one of the participating Institutes. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate's qualifications, training, and interests, including advisory committee members (if applicable). Resubmission applications will require new letters of reference.

Letters of reference may be submitted any time after the FOA opens and no later than 5 business days after the application due date. The Fellowship Reference Form can be submitted through eRA Commons at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new prior to application submission through Grants.gov.

Applications that are missing the required letters of reference may be delayed in the review process or not accepted.

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

Review Process

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

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by the NINDS in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by appropriate staff within the assigned NIH Institute or Center.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact/Merit

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Fellowship Applicant.

• Are the applicant's academic record and research experience of high quality?
• Does the applicant have the potential to develop as an independent and productive researcher in biomedical, behavioral or clinical science?
• Does the applicant provide evidence of a commitment to neuroscience research?
• Is there evidence of the applicant's potential to become an independent investigator (early career candidate) or is there evidence of the applicant's ability to train and direct others (mid-career level candidate) in neuroscience research in their home country?
• Does the applicant provide acceptable post-fellowship plans from the home institution, as described in the required endorsement letter?

Sponsors, Collaborators, Consultants.

• Are the sponsor(s) research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship?
• Are there (1) evidence of a match between the research interests of the applicant and the sponsor (including an understanding of the applicant's research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?

Research Training Plan.

• Is the proposed research plan of high scientific quality, and does it relate to the applicant's training plan?
• Is the training plan consistent with the applicant's stage of research development?
• Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed for his/her independent and productive research career?
• Is the number of years requested appropriate for the proposed research and training plan?

Training Potential.

• Does the proposed research training plan have the potential to provide the fellow with the requisite individualized and supervised experiences that will develop his/her research skills?
• Does the proposed research training have the potential to serve as a sound foundation that will lead the fellow to an independent and productive career?
• Does the research training plan provide evidence of feasibility of transferring and utilizing the acquired skills in the candidate's home institution?

Institutional Environment and Commitment to Training.

• Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?
• Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows' training as an independent and productive researcher?
• Does the proposal contain plans for continued collaboration between the fellow and the U.S. sponsor(s) after the fellow has returned to his or her home country?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. Renewals are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration of Instruction, and Frequency of Instruction) as detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including; 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (Not Applicable); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research training.

Selection Process

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic balance.
• Level of need, as measured by economic resource in the applicant's home country.

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.

Activation: No funds may be disbursed until the fellow has started training under the award, and an Activation Notice (PHS 416-5) has been submitted to the NIH. A fellow has up to six months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.

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.

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the Notice of Grant Award.

Leave Policies: In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 60 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to the same paid leave for this purpose and the use of parental leave is approved by the program director (see NOT-OD-08-064).

A period of terminal leave is not permitted, and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.

Part-Time Training: While INF awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in INF supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from INF support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training.

Service Payback: Recipients of INF support do not incur service payback.

Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. Fellowship awards will not contain any provision giving PHS rights to inventions made by the fellow.

Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, fellows should make the results and accomplishments of their INF activities available to the research community and to the public at large. The grantee organization should assist fellows in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results in a timely manner.

Fellows are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to the NIH. However, NIH support must be acknowledged by a footnote in language similar to the following: "This investigation was supported by the National Institutes of Health under the International Neuroscience Fellowship Award (number)." In addition, federal funding must be acknowledged as provided in "Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding".

Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

3. Reporting

Activation Notice: The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.

Application for Continued Support. When multiple years are involved, awardees will be required to submit the Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support (PHS 416-9) annually as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year. Note that the instructions request a listing of all courses and publications completed during the past year.

Final Report: When support ends, the awardee must submit a final report to the NIH within 30 days following termination. The fellow and the U.S. sponsor are responsible for providing the following information:

• Program objectives
• Results/Findings
• Significance or application to a human health problem
• List of publications resulting from the fellowship
• Plans for continued collaboration with the U.S. sponsor
• Information describing the guaranteed appointment offered by the home institution

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Applicants should refer to Table of Institute and Center Contacts to obtain contact information.

2. Peer Review Contact(s):

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: nindsreview.nih.gov@mail.nih.gov

3. Financial/Grants Management Contact(s):

Applicants should refer to Table of Institute and Center Contacts to obtain contact information.

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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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.

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.

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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine's PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted 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 FOA 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. Awards are made under the authorization of Section307 of the Public Health Service Act (42 USC 242I) and under Federal Regulations 42 CFR 63a 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/.