Part I Overview Information


Department of Health and Human Services

Components of Participating Organizations
Fogarty International Center (FIC), (http://www.fic.nih.gov)
Office of Dietary Supplements (OD/ODS), (http://ods.od.nih.gov/)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH), ( http://www.nimh.nih.gov/index.shtml)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
The National Institute on Aging (NIA), (http://www.nia.nih.gov/)

Title: Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43)

Announcement Type

New

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-10-257

Notice: Applications submitted in response to the 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)

93.989, 93.853, 93.279, 93.242, 93.113, 93.866, 93.865

Key Dates
Release/Posted Date: August 10, 2010
Opening Date: October 2, 2010 (Earliest date an application may be submitted to Grants.gov)

Key Dates Revised:

Letter of Intent of Receipt Date(s): March 17, 2013
Application Receipt Date(s): April 17, 2013
Peer Review Date(s): October/November 2013
Council Review Date(s): January 2014
Earliest Anticipated Start Date(s): March 2014
Expiration Date: April 18, 2013

Key Dates Original:

Letters of Intent Receipt Date(s): October 2 2010, August 21, 2011, August 21, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): November 2, 2010, September 21, 2011, September 21, 2012
Peer Review Date(s): February/March 2011, February/March 2012, February/March 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): July 2011, July 2012, July 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: September 22, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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

Purpose and Background

The Fogarty International Center (FIC), together with the Office of Dietary Supplements (OD/ODS), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), the National Institute of Aging (NIA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Environmental Health Sciences (NIEHS), encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program. The application must propose a collaborative research training program between US. institutions and institutions in low- and middle-income countries (LMICs, as defined by the World Bank classification system) that will sustainably strengthen the capacity of LMIC institutions and investigators to conduct research on NCDs. The ultimate goal is to provide a solid foundation for development and implementation of evidence based interventions, relevant to NCD’s across the life-span, in LMICs. In some cases sufficient evidence exists upon which to base research for interventions and implementation strategies. In other cases, the evidence base may not be well developed or not relevant to the given country or culture. Therefore, training across the spectrum of research disciplines is encouraged as needed, from basic biomedical, behavioral and social science to clinical and applied sciences , including translational and implementation science which emphasizes the resources, context and needs of multiple stakeholders in local settings.

Examples of the NCDs that could be addressed include, but are not limited to, cancer, cardio- and cerebrovascular disease and stroke, chronic lung disease, diabetes, mental illness, neurological, substance abuse, genetic disorders, birth defects and developmental disorders. Research training is encouraged that emphasizes lifecycle studies and early life determinants of chronic diseases (including genetic, epigenetic, environmental and lifestyle factors), co-morbid conditions and common risk factors and interventions relevant to multiple conditions and their prevention.

All applications to this program should have a central theme or focus although the theme may be as narrow or broad as deemed appropriate for the goals outlined in the FOA. The programs are expected to not just support trainees to conduct research but to develop multifaceted and novel training paradigms targeted to the special needs of LMIC investigators and institutions.

The program is not an individual training fellowship program. Potential trainees must apply directly to the PI of the award and not to FIC/NIH.

The proposed research training program must be developed and implemented collaboratively with all participating institutions (see Section III Eligibility Information).

Burden of Disease

Chronic NCDs are steadily increasing around the world, including in LMICs, and will soon account for more than 50% of the expenditures for health care and more than 60% of the disability adjusted life years (DALYs). For this reason, in 2008, FIC released its new strategic plan with the goal of “mobilizing the scientific community to address the shifting global burden of disease and disability” http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm). According to the Disease Control Priorities Project (http://www.dcp2.org/main/Home.html) and World Health Organization (WHO) 44% of adult disease burden in LMICs is now attributable to non-communicable diseases and is projected to increase to 54% by 2030. Among the leading causes of death in LMICs in 2004 were cerebrovascular disease, ischemic heart disease, chronic obstructive pulmonary disease, lung cancer, diabetes, and hypertensive heart disease. Mental disorders such as depression, bipolar disorder, and schizophrenia and neurological disorders such as epilepsy, and neurodegenerative disorders along with genetic conditions, and intellectual and developmental disorders such as autism are among the leading causes of disability: < http://www.dcp2.org/file/64/WHO_DCPP%20mental%20health%20book_final.pdf>.

The Need for a Multidisciplinary Approach

Risk factors for NCDs are complex and differentially amenable to control. Environmental influences, lifestyle factors and diverse socio-economic influences and epigenetic changes interact with the proximal causes (such as genetic vulnerability, trauma and infection) of many chronic disorders to influence their trajectory and severity.

Increasing evidence for the prenatal and childhood roots of chronic NCDs provide possible avenues for early prevention of and intervention for NCDs. During the past several decades, improvements in health care have led to a decrease in child mortality and an increase in life expectancy in LMICs. However, many of the factors that previously contributed to early mortality remain and influence later health outcomes. These positive trends have, therefore, set the stage for a complex epidemiology of health and disease as more children survive into adulthood predisposed by early disease, malnutrition and adverse environmental and psychological influences and experiences to later development of chronic diseases such as cardiovascular and cerebrovascular disease, diabetes, cancer, mental illness, substance abuse, developmental and neurodegenerative diseases and disorders.

During the remainder of the lifecycle social and environmental factors such as environmental pollutants and chronic stress continue to influence health. However, individual behaviors and exposures such as physical inactivity, poor diet, tobacco, alcohol and drug abuse become increasingly important risk factors influencing the trajectory of NCDs. It is critical to develop a deeper understanding of the complex motivations that contribute to decision making and risky behavior in resource poor settings.

In addition to generating evidence to prevent and treat chronic diseases, it is imperative that the research findings be incorporated into community practice in an efficient and timely manner. Because of the formidable gap between innovations in health and their delivery to communities, another goal of the FIC Strategic plan is to “bridge the training gap in implementation research.” Implementation Research is the scientific study of methods to promote the integration of research findings and evidence-based interventions into health care policy and practice with a greater emphasis on the resources and context of local care settings and the needs of multiple stakeholders. Training researchers in the nascent field of implementation science is strongly encouraged as part of research training programs under this FOA.

The factors that are responsible for onset and prevention of chronic disease are so diverse that it is essential that those trained gain a broad understanding of research across health disciplines as diverse as genetics, medicine, nutrition, psychology, behavioral health, epidemiology , population studies, health law, environmental health, public health etc as well as many disciplines not traditionally associated with health research such as business administration, economics, urban planning, information science, communications, organizational and management theory, finance, individual and systems-level behavioral change, statistics, anthropology, learning theory, marketing etc..

Specific Research Interests of the FOA Sponsors

Applicants are encouraged to review the FIC Strategic Plan http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm

Applicants can obtain information and research interests for each of the FOA’s sponsoring partners at their Web sites and by contacting the partner program contact listed in this announcement (Section VII. Agency Contacts).

Following are examples of specific areas of interest provided by the participating NIH partners:

.The National Institute on Drug Abuse (NIDA) international programs and priorities are described at: http://www.international.drugabuse.gov

Special Program Objectives and Considerations

All applications to this program should have a central theme or focus although the theme may be as narrow or broad as deemed appropriate for the goals outlined. A lifespan approach to chronic diseases is encouraged. If training in basic research is proposed it must be integrated with research training on translation, applied and implementation science to meet the needs of the LMIC country. The programs are expected to not just support trainees to conduct research but to develop multifaceted and novel training paradigms targeted to the special needs of LMIC investigators and institutions. Applicants are encouraged to review the FIC Strategic Plan.

This NCD-LIFESPAN program supports institutional research training awards for training programs designed to strengthen the capacity of the LMIC institution(s) to support independent research through the education and career development of individual researchers and key personnel. The trainees are expected to contribute to the research capacity in the LMIC upon completion of their training.

The program is not an individual training fellowship program. Potential trainees must apply directly to the PI of the award and not to FIC/NIH.

When justified an individual LMIC institution, with demonstrated capacity for research training, may also serve as a regional training site for researchers from other institutions.

The objectives of the NCD-LIFESPAN training program are:

Types of Training:

The proposed training is expected to strengthen sustainable research and research training capacity at the LMIC institution. The program application should incorporate an appropriate mix of long-, medium- and short-term training opportunities and in-country mentored research to address the research training needs for NCDs identified for the LMIC. Applicants are encouraged to design multidisciplinary research training programs and teams.

Training can take place in the U.S. or in a foreign country, with the goal for most of the training to occur within the LMIC by the end of the initial grant award period. Applications involving already existing research training collaborations under other programs at the same sites are expected to begin with a substantial level of research training within the LMIC. Training-related research and advanced in-country research should always be carried out in the LMIC. In addition to early career short-, medium- and long-term training, mid-career training is also allowed. The actual training mix should be justified according to the assessed needs and already existing infrastructure and the level of research capacity and training infrastructure in the LMIC

For example:

In LMICs with weak research infrastructure and where few established researchers and potential faculty exist, more degree-related research training in the U.S. may be necessary, to develop the initial cadre of researchers who can then go on to be mentors and faculty in the LMIC for future trainees.

In LMICs where substantial research and training infrastructure and expertise already exist, but without a strong focus on NCDs, a mix of activities that augment existing research, training and personnel resources at in-country institutions may be proposed. The in-country activities would enhance their capacity to identify, undertake and successfully complete NCD studies and to utilize the results from research that they and others conduct to influence teaching, implementation and country policy.

In the context of this FOA, “trainees” are individuals from the LMIC identified for research training in the application.

Innovative research training models for NCDs are encouraged but typically the following types of training are included, but not limited to:

All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted. Please see: Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

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

When a specific scientific course is given by one grantee, it is expected that this course may be widely publicized and open to trainees of the other grantee institutions under other D43 programs.

This NCD-LIFESPAN program strongly encourages principal investigator/program directors (PIs/PDs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as faculty at all sites.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

LMIC institutions, in collaboration with a U.S. institution, may apply for a two-year planning grant, PAR-10-277, Planning Grant for Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Planning Award (NCD-LIFESPAN) (D71) to support the development and submission of research training program proposals in a subsequent year.

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 D43 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit detailed categorical budget requests for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the Instructions for preparing a D43 institutional research training application described in Section IV 6A.

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 FIC, OD/ODS, NINDS, NIDA, NIMH, NICHD, NIA, and NIEHS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

The expected amount for individual awards will be up to $ 250,000 per year (total direct costs) for up to five years. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Facilities and administrative costs are limited to 8% for all awards and sub-awards.

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.

Allowable Costs

Stipends: Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. Trainees may be paid a stipend comparable to their professional experience. Applicants should use an appropriate stipend level and can use the NRSA levels (see Kirschstein-NRSA stipend schedule) or grantee institutional policies, of the U.S. or foreign institutions as appropriate, for trainees involved in medium- or long-term training. Partial stipends for part-time long-term trainees should reflect the amount of time they need to be supported for training in the budget and described in the budget justification.

Tuition and Fees: Funds for tuition and academic fees at the U.S. or foreign institution may be requested. However, programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees. Note that health insurance is not included as part of this budget category, and is now included under Training Related Expenses category. Tuition and fees are excluded from the F&A base. Health insurance is included in the F&A base.

Trainee Travel: Funds may be requested for: 1) round-trip economy class airfare on U.S. carriers (to the maximum extent possible). 2) lodging and per diem for short-term trainees and for in-country research/training as necessitated by distance from the trainees’ home base,, 3) participation in meetings in which current or former trainees will be presenting training-related research results.

Training-related Expenses: Applicants are encouraged to budget adequate professional development opportunities for trainees, including international scientific conference attendance. Training-related expenses (e.g., books, computers, and courses for software, English language proficiency, etc.) may be included but must be described in the budget justification. Funds for self-only or family medical insurance may be requested. Include costs for logistics for short- term courses and describe in budget justification.

One-time advanced in-country research training support of up to $15,000 direct costs should be budgeted for mentored research to be undertaken by a long-term trainee in his/her country upon completion of their training.

Salary for Senior/Key Personnel: The salary for the PD, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://grants.nih.gov/grants/policy/salcap_summary.htm.

Collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. The salary and fringe benefits for the faculty and staff should not exceed 25 percent of total direct costs.

Faculty Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for the applicant to attend the annual program network meeting, normally in the U.S. Principal Investigators are expected to attend but applicants may also budget for grant administrators, other faculty, collaborators and trainees to attend. The attendance of trainees is particularly encouraged. Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for faculty providing training at the foreign site.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs, exclusive of tuition, fees, equipment, and consortia costs in excess of $25,000, per NIH Grants policy for institutional research training grants http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm#_Toc54600212

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:

Applications may be submitted by eligible domestic (U.S.) institutions that demonstrate collaborations with LMIC institutions named in their application; or directly by foreign institutions in the LMIC(s).

Taiwan and Hong Kong are classified as high income economies so institutions there are not eligible as LMIC research training sites. Institutions in Hong Kong may be included as collaborating sites but no funds from the NCD-LIFESPAN D43 may be spent at these sites.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training as the PD/PI is invited to work with his/her organization to develop an application for support. Women and individuals from underrepresented racial, ethnic and socially disadvantaged groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The applicant PD/PI must have strong research and research-training program experience, should include the requisite faculty in the application, and have access to the requisite facilities to carry out the proposed research training activities.

The applicant PD/PI must name at least one individual at each collaborating institution as the major collaborator for that institution. Individuals chosen as major collaborators should be scientists with whom the Principal Investigator or key personnel named in the application have had prior successful collaborations. These collaborations should be described in the application.

The PI and collaborators will be responsible for the overall conduct of the grant. The role of the collaborators in setting the research agenda and in conceptualizing and mentoring research projects should be described in the application.

All applicants should explain in detail how their relevant research grant support and activities are related to the proposed research training plan.

The PD/PI and/or key personnel listed in the application must be designated as the PD of at least one active research award (with at least 18 months of support remaining as of the application due date) that is directly relevant to the research training proposed. The research awards may be funded by the NIH or by other national or international organizations. The applicants need to document this existing research support in their application. If 18 months will not remain in the parent grant award period on the application due date an applicant must provide documentation that a renewal of a research grant to meet the eligibility requirement is expected, that a no-cost extension has been/will be requested for the research grant to meet the eligibility requirement and it will have sufficient remaining resources to continue the research project, or that other research support will be available which meets the eligibility requirement.

More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for research training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary or multidisciplinary training. The decision to apply with a single PD/PI or a multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program. Applications for grants with multiple PD/PIs require additional information. When considering multiple PD/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PI will be factored into the assessment of the overall scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility for leading and directing the research training program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications with multiple Training PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary. Because training programs are intended to be coherent, a single award will be made. NIH will not allocate the budget or training positions between multiple PD/PIs. Multiple PD/PI applications should include reasonable numbers of PD/PIs and each should be included for a specific purpose. Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

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.

Applicant institutions may submit no more than two new, scientifically and regionally distinct and non-overlapping, applications (excluding revised resubmission applications) per receipt date under this FOA . No more than three, scientifically and regionally distinct and non-overlapping competing or non-competing continuation awards will be made to a single U.S. or LMIC institution at any given time. Applicants are encouraged to check at their institutions and with the FIC Scientific Research Contact listed in Section VIII. Agency Contact to determine eligibility of all individual applications. A given U.S. institution may only have one active NCD-LIFESPAN award for collaboration with a given LMIC institution at a time.

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.

Renewal applications are allowed for this research training program. PIs and institutions with research training programs currently awarded under other D43 FOAs are encouraged to apply for new (but cannot apply for recompeting renewal) awards under the NCD-LIFESPAN FOA provided they meet the eligibility requirements. See NOT-OD-09-003 and NOT-OD-09-016.

Trainee Eligibility. In the context of this FOA, “trainees” should be from the LMIC(s) for which the research training program is being designed. The program is not an individual training fellowship program. Potential trainees must apply directly to the PI of the award and not to FIC/NIH.

The NCD-LIFESPAN program strongly encourages principal investigator/program directors (PIs/PDs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as trainees.

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.

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:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PDs/PI(s) 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) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

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 Profile (Expanded)
SF424 Research and Related Budget Pages
PHS 398 Training Budget
PHS 398 Research Training Program Plan
PHS 398 Cover Page Supplement
PHS398 Checklist

Optional Components:
PHS398 Cover Letter
Research & Related Subaward Budget Attachment(s) Form
PHS 398 Training Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Training Program Plan entitled, “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.

If budget allocation is planned, the distribution of resources to specific components of the program or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Application Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: October 2, 2010 (Earliest date an application may be submitted to Grants.gov)

Key Dates Revised:

Letter of Intent of Receipt Date(s): March 17, 2013
Application Receipt Date(s): April 17, 2013
Peer Review Date(s): October/November 2013
Council Review Date(s): January 2014
Earliest Anticipated Start Date(s): March 2014
Expiration Date: April 18, 2013

Key Dates Original:

Letters of Intent Receipt Date(s): October 2 2010, August 21, 2011, August 21, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): November 2, 2010, September 21, 2011, September 21, 2012
Peer Review Date(s): February/March 2011, February/March 2012, February/March 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): July 2011, July 2012, July 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: September 22, 2012

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Kathleen Michels, Ph.D.
Program Director
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Email: FIC-NCD-D43@nih.gov

3.B. Submitting an Application Electronically to the NIH

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

Please visit http://grants.nih.gov/grants/ElectronicReceipt/support.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:

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.

Upon receipt, application will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons https://commons.era.nih.gov/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 the 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.

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Pre-Award Costs: Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

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

Follow the Instructions for SF424 Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) in Section 8. Supplemental Instructions to the SF 424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application and the instructions below.

SF 424 Research and Related (R&R) Cover Component

SF 424 R&R Project/Performance Site Locations Component - Include the applicant institution and all of the collaborating institutions, both U.S. and foreign, as performance sites.

SF 424 R&R Other Project Information Component:

SF 424 Senior/Key Person Profile (Expanded) Component –Also, include at least ONE person at each of the U.S. and foreign collaborating institutions as senior/Key Personnel and list their role as “Collaborator.” List all members of the Training Advisory Group (See 8.9.3 a Program Plan: Program: Program Administration for a description of the Training Advisory Group) as Senior/Key Personnel and list their role as TAG member. Be sure to include bio-sketches for the collaborators and TAG members.

PHS 398 Checklist

Budget Pages: Use PHS 398 Training Budget Pages for trainee specific expenses and the 424 R&R Budget pages for faculty and personnel-related expenses. Budget forms should be completed for each year (“Period”) for which funding is being sought. Follow the instructions below and refer to the relevant FOA specific allowable costs.

Training-related expenses for Periods 1 through 5

Use PHS 398 Training Budget Pages

Part A. Stipends and Tuition/Fees

Use the following instructions for categorizing the trainees since each application will have trainees with a mix of educational backgrounds and a mix of proposed training. Provide details of trainees in the budget justification and identify, by name, any continuing trainees.

NIH defines a Postdoctoral scholar as “an individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path (http://grants.nih.gov/grants/glossary.htm#P)”.

Enter the number of trainees for degree training (master’s and doctoral level) in the section labeled “Predoctoral”, for those without a doctoral degree, (MD, PhD etc.). Request tuition for the degree program and a stipend level appropriate for the educational background of the trainee and location of training.

Enter the number of post doctoral trainees (prior doctoral degree) non-degree seeking and degree seeking as indicated. Request any necessary tuition and a stipend level appropriate for the educational background of the trainee and location of training.

Enter the number of trainees without a prior doctoral degree and who will receive non-degree training in the section labeled “Other.” Request any necessary tuition and a stipend level appropriate for the educational background of the trainee and location of training.

Current NRSA stipend levels may be used as a guide and are described at Kirschstein-NRSA stipend schedule, If a category contains different stipend levels, e.g., for varying levels of postdoctoral experience and/or varying appointment periods, itemize in the appropriate blocks. Enter the total stipends and tuition for all categories. Partial stipends for part time long term trainees should reflect the amount of time they need to be supported for training in the budget and described in the budget justification.

Note that health insurance is not included as part of this budget category, and is now included under Training Related Expenses category.

Part B. Other Direct Costs

Enter the total costs for Trainee Travel, Training Related Expenses, Total Direct Costs from R&R Budget Form and Consortium Training Costs (if applicable).

Consortium Training Costs (if applicable) -If training occurs at more than one institution, and any transfer of funds between institutions occurs, the Training Sub-award Budget Attachment Form should be used for each sub-award institution for each period for which trainee funding is being sought. (See Section 4.8 of the Grants.gov SF 424 R&R Application Guide). Total the direct costs from each of the Training Sub-award Budget Attachment Forms for the period and insert here. The applicant institution is responsible and accountable for any arrangements, expenditures, and submission of all required forms when more than one institution is involved in the research training program.

Use Section F to attach one pdf file with detailed budget justification for training costs for the applicant and any sub-award institutions.

Faculty and Other Personnel-Related Expenses

Use SF 424 R&R Budget Form, Periods 1 through 5

Use Section A to submit costs for Senior/Key personnel.

Use Section B to enter salary support for administrative staff.

Use Section D to submit costs for key personnel and, if applicable, faculty travel including annual network meeting.

Use Section F for other costs and describe fully in budget justification. If consortium sub-awards include costs for faculty and administrative expenses, total these consortium costs for the period and include here.

Consortium Training Costs (if applicable) -If funding is sought for faculty and administrative costs at consortium institutions, SF 424 R&R Budget Forms should be used for each sub-award institution for each period for which trainee funding is being sought. (See Section 4.8 of the Grants.gov SF 424 R&R Application Guide). Total the direct costs from each of the sub-award SF 424 R&R Budget Forms Budget forms for that period and insert here. The applicant institution is responsible and accountable for any arrangements, expenditures, and submission of all required forms when more than one institution is involved in the research training program.

PHS 398 Training Budget, Cumulative Budget - All values on this form are calculated automatically. They present the summations of the amounts that you have entered previously, for each of the individual budget periods. Therefore, no data entry is allowed or required.

If any of the amounts displayed on this form appear to be incorrect, you may correct them by adjusting one or more of the values that contribute to that total. To make any such adjustments, you will need to revisit the appropriate budget period form(s) to enter corrected values.

PHS 398 Research Training Program Plan Component Sections

Page limitations of the Research Training Program Plan component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.

The instructions for the Data Tables required for this FOA have been adapted to the international focus of this FOA and are described below. The requested Data Tables ( http://grants.nih.gov/grants/funding/424/index.htm) should be included in the application at the point indicated (PHS 398 Research Training Plan, 13. Data Tables) and should not be inserted in the narrative for Sections 8.9.2-8.9.5. The information in the data tables will be used by reviewers and NIH staff during peer review and in reaching funding decisions.

All application instructions outlined in the SF424 (R&R) Application Guide, Section 8.7 are to be followed, incorporating “Just in Time” information concepts, with the following additional requirements:

Do not complete Tables 1 and 3.

Table 2. Participating Faculty Members

include information relevant to the proposed training program for faculty from all participating institutions and performance sites who will be involved in the training program.

Program Plan (Item 3)

The program should have a Training Advisory Group (TAG) composed of expert faculty from the applicant and collaborating countries who are not directly involved in the training program or in mentoring trainees. The TAG assists in trainee selection, scientific review of trainee projects, and evaluation of trainees and training program progress.

In addition to the Instructions for SF424 Application Guide:

If multiple PDs/PIs are involved in the research training program, applicants must describe how the research training program and trainees will benefit from the arrangement and include the required Leadership Plan. See Section III.1.B and Section IV.2 in this FOA for NIH multiple PD/PI instructions: Multiple Principal Investigators, and information in Section 8.7.10 of the Research Training Program Plan Component Instructions.

This section should describe the past research training record of the program, the PD/PI, and designated preceptors/mentors. Include a description of the success of former trainees, especially those from LMICs, in seeking further career development and in establishing productive scientific careers.

Complete per directions below and refer to data in Tables 4-6. Use these tables to document the ability of the faculty to support the research activities of the proposed trainees from LMICs and the success of their trainees in generating publishable research results.

Complete Table 4. Grant and Contract Support of the Participating Faculty Members, include a list of the active and pending research grants in which the PD/PIs, key or relevant faculty at the collaborating institutions have played a key role. Include institution name with faculty member name. Please include source of support and grant number (if applicable), grant title, project period and current year direct costs. If the faculty member was not PI of the research grant, indicate who was the PI and the role of the faculty member in the Grant Title section.

In the narrative section, provide a short description of the funded research in Table 4 that will serve as the research base for the proposed research training program. Clearly identify the grants that are being used for eligibility for this FOA in Table 4 and in the narrative.

Complete Table 5. Pre and Postdoctoral Trainees of Participating Faculty Members- Include trainee information who are from LMICs (indicate the country) for participating faculty from all collaborating institutions.

Complete Table 6. Publications of Research Completed by Trainees (or Potential Trainees). For new applications, see the instructions for Table 6 in Section 8.9.13 of the Instructions for SF424 Application Guide. For renewal applications, only include trainee publications in peer-reviewed journals, including local journals, that have been supported by the research training grant in the NCD-LIFESPAN program and for which the grant was cited. Do not include abstracts, not yet accepted papers, or conference presentations and posters. These data constitute part of the Progress Report (see item 6 Progress Report below).

Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide for Section 8.

The application should describe the system that will be used to track and document the long-term impact of this training program on the research capacity of the LMIC institution(s). Ideally, trainees should be tracked for at least ten years after completion of their training to assess the contribution of the training to their career development and the research capacity of the LMIC institution

Include a plan for data entry of trainee information into CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI 3A Additional Reporting Requirements below). CareerTrac will facilitate the tracking of trainees and can be used to assist grantees to provide current trainee data and to describe examples of career highlights of former trainees (awards, research grants, publications, influences on policy, career advancements, etc.) in their annual progress reports.(see Section VI 3. Reporting below) and in renewal applications.

Applicants should develop a plan for self-evaluation of their program, and establish some benchmarks and a mechanism to periodically review the progress of their trainees and the effectiveness of their program. This may consist of regular meetings among faculty participating in the program and periodic review by the TAG and other outside groups of consultants.

Evaluation metrics should eventually encompass measurement of both the success of the individual trainees and the impact of the program on research capacity at the LMIC institution. An evaluation of the research training on individual and institutional levels will be considered important criteria during any re-competition of this FOA.

Please use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide.

Do not complete Tables 7A, 7B, 8A, 8B, 9A and 9B.

Recruitment and Retention Plan to Enhance Diversity (Item 4): The NIH recognizes a unique and compelling need to promote diversity in the domestic biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

The FIC encourages the research training programs supporting LMIC institution to consider ways to promote the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences in the LMIC as trainees and faculty in the research training program.

Use the following instructions, rather than those for this section in the Instructions for SF424 Application

Plan for Instruction in the Responsible Conduct of Research (Item 5): For detailed guidance on Instruction in Responsible Conduct of Research, please refer to http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html and the Instructions for SF424 Application Guide.

Every trainee supported by this research training grant must receive instruction in the responsible conduct of research. Describe the plan to provide trainees with such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application

Progress Report (Item 6): Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide.

This component is not part of the 25-page limit. It should focus on describing the activities and accomplishments that occurred in the last grant period, but may include examples of career highlights of trainees from former grant periods that occurred in the last grant period (awards, research grants, publications, influences on policy, career advancements, etc.). Data from CareerTrac can be used to assemble and report this information.

State the periods covered and briefly describe the accomplishments of the training program. Describe any specific effects of this training program on curriculum and/or research directions in the collaborating institutions, both U.S. and foreign. Describe how the research training has increased the research capacity of the institution(s) in the LMIC to address the research agenda around the priority health needs of the LMIC. Describe how you have been able to leverage other NIH or non-NIH program opportunities in the LMIC as a result of the research training.

You do not need to complete Table 11 Appointments to the Training Grant For Each Year of the Past Award.

Complete Table 12A Predoctoral Trainees Supported by this Training Grant and Table 12B Postdoctoral Trainees Supported by this Training Grant.

Trainees without doctoral degrees who received medium- or long- term non-degree training should be included and the non-degree training they received should be defined on Table 12A. Do not list short-term trainees (less than 3 months of training) on these tables.

CareerTrac will facilitate the tracking of trainees and can be used to assist grantees to provide trainee data for the progress report in the competing application and accompanying data tables.

NOTE: Renewal applications: Reporting of information on completion rate and time to degree for graduate students in doctoral degree programs that have been supported by NIH training awards must be documented in the Program Statistics section of Table 12A (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-141.html). Information must include:

Use the progress report narrative to provide information that is not readily presented in the required tables.

Follow the instructions in the SF424 Application Guide for items 7-12.

Multiple PD/PI Leadership Plan (Item 10): If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration.

Data Tables (Item 13): http://grants.nih.gov/grants/funding/424/index.htm. The instructions above provide guidance for completion of Data Tables 2, 4, 5, 6, which are required for all applications. In addition, for renewal applications, Data Tables 12A and 12B must be completed, using the instructions above. The information in the data tables will be used by reviewers and NIH staff during peer review and in reaching funding decisions. CareerTrac can be used to assist grantees to provide trainee data in the required data tables.

Attach one pfd file with all of the Data Tables (1-12B), although only Tables 2, 4, 5, and 6 are required for all applications, and, in addition, Tables 12A and 12B for renewal applications for this FOA.

Letters of support (Item 14): Attach appropriate letters here from all individuals listed as Senior/Key Personnel to confirm their roles in the project. Attach letters of support from all of the participating institutions.

Appendix (Item 15): Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). A summary listing all of the items included in the appendix is required, and should be the first PDF file. Applications that do not follow the appendix requirements may be delayed in the review process. All appendix material must be submitted as PDF attachments.

Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed. Other types of publications reflecting on the activities of the program as a whole may also be included. When publications are allowed, appendix materials should be limited to those which are not publicly available, such as:

Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication.

Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.

Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices. The appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Training Program Plan without disrupting the narrative flow. Examples include:

i. Additional tables not requested in the SF424 (R&R) Application Guide instructions – designate these by letter, rather than number, to avoid confusion with the numbered required tables;

ii. Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.;

iii. Retreat, seminar series, and other program activity agendas, rosters, and schedules;

iv. Examples of forms used to document trainee progress and monitoring by the program;

v. Examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool.;

vi. Lists of meetings attended by students and their presentations;

vii. Student biosketches; and

viii. Letters of support, collaboration, and commitment of institutional resources.

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.

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

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.

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 peer review group convened by the Center for Scientific Review (CSR) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the initial merit review, all applications:

The goal of this NIH-supported research training opportunity is to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the biomedical, behavioral, and clinical research needs of LMICs for non-communicable diseases (NCD).

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research training to exert a sustained, powerful influence on the research capacity of the partner LMIC institutions involved, in consideration of the following five scored review criteria, and additional review criteria as applicable for the research training proposed.

The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program, and then consider whether the proposed mix of research training is appropriate for the program and will strengthen the NCD research capacity of the partner LMIC institutions.

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 scientific impact and contribute to the LMIC institution’s ability to conduct and manage research to address the priority problem(s) identified in the application.

Training Program and Environment:

Training Program Director(s)/Principal Investigator(s) (PD/PIs):

For applications designating multiple PD/PIs:

Preceptors/Mentors:

Trainees:

Training Record:

Based on previous D43 or similar training program as appropriate

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific 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 to assist you in determining if the Vertebrate Animals section is “Acceptable” or “Unacceptable”, please refer to Vertebrate Animals checklist.

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 program.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:

Additional Review Considerations

As applicable for the program 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.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.

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 five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed 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).

Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed institutional program and the number of proposed trainees.

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:

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 Training 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.

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

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 Fogarty International Center (FIC) to the grantee business 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.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm), annually and annual financial statements as required in the NIH Grants Policy Statement. This research training program is not subject to SNAP.

Follow the instructions for the Non-Competing Grant Progress Report for institutional research training grants in Form 2590. Use the budget pages in the PHS2590 that correspond to the budget pages submitted for the application to submit the budget for the next budget period. Use the instructions included in this FOA to guide you in requesting the budget for the next budget period. Include a budget justification. Note that a summary of the trainee page is to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Tables 12A and 12B should be completed following the guidance provided in this FOA. The Trainee Diversity Report is not required. Additional information that should be provided in the annual progress report in concert with the PHS 2590 instructions includes:

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted.

Trainee Reporting Requirements: Recipients are requested to periodically update and maintain data regarding their trainees in FIC CareerTrac, (https://careertrac.fic.nih.gov/Welcome.vm).

Peer-reviewed trainee publications that arise from support of the training grant must be submitted to PubMed Central in accord with the Public Access Policy, and the PubMed Central reference number (PMCID) or NIH Manuscript Submission reference number (NIHMS ID) provided. If the publication was already submitted because it also arose as the result of other NIH support, simply provide the PMCID or NIHMS ID. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm

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

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each journal publication that results from a trainee’s research, NIH support should be acknowledged in language similar to the following: “This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the (name of program) (grant number).” In addition, news releases and other documents about the project must acknowledge federal funding as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

Evaluation: In carrying out its stewardship of human resources-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, trainees should be notified that they may be contacted after the completion of their training for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Inventions: Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants. However, please report any inventions or patents funded under the research training grant.

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.

Final Reports: A Final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Evaluation results should be included as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC): Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

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:

FIC/NIH:

Kathleen Michels, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: FIC-NCD-D43@nih.gov

NICHD/NIH:

Daniel Singer, Ph.D.
Health Scientist Administrator
Office of the Director
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A01, MSC 7510
Rockville, MD 20852-7510
Telephone: 301-435-7565
Fax: (301) 435-0009
Email: singerda@mail.nih.gov

NIA/NIH:

John Haaga, Ph.D.
Deputy Director, Division of Behavioral and Social Research (DBSR)
7201 Wisconsin Avenue, MSC-9205
Building GWY, Room 533
Bethesda, Maryland 20892-9205
Telephone: 301-496-3132
Email: John.Haaga@nih.gov

NIH/NINDS:

Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke
National Institutes of Health
NSC, 6001 Executive Blvd. Room 2187
Bethesda, MD 20892-9523
Phone: (301) 496-0012
Fax: (301) 480-1080
Email: liuyuan@ninds.nih.gov

NIDA/NIH:

Steven Gust, Ph.D.
Director, International Programs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5-274
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
Fax: (301) 443-9127
Email: ipdirector@nida.nih.gov

NIEHS/NIH:

Carol Shreffler. PhD
NIEHS/DERT/COSPB
MSC K3-15
530 Davis Dr
Durham, NC 27713
(919) 541-1445
Email: shreffl1@niehs.nih.gov

NIMH/NIH:

Pamela Y. Collins, MD, MPH
Associate Director for Special Populations
Director, Office for Special Populations & Office of Global Mental Health
National Institute of Mental Health/NIH
6001 Executive Blvd, Room 8125
Bethesda, MD 20892
T: 301-443-2847
Pamela.Collins@nih.gov

ODS/OD/NIH:

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
ODffice of Dietary Supplements, Office of the Director
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
Fax: (301) 480-1845
Email: piccianm@od.nih.gov

FIC/International Information and Resources

Fogarty International Center
31 Center Drive, MSC-2220
Telephone: 301-496-4625
Division of International Relations: http://www.fic.nih.gov/about/dir.htm

2. Peer Review Contact(s):

Dan Gerendasy, Ph.D.
Scientific Review Administrator
International Cooperative Programs
Center for Scientific Review
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892-7843 (use ZIP 20817 for overnight mail)
Telephone: (301) 594-6830
Fax: (301) 480-1677
Email: gerendad@csr.nih.gov

3. Financial/Grants Management Contact(s):

Angela Smith
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9592
Fax: (301) 594-1211
Email: Angela.Smith@nih.gov

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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

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

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