Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Fogarty International Center (FIC)
Funding Opportunity Title	Limited Competition: Framework Programs for Global Health Innovation (D43)
Activity Code	D43 International Training Grants in Epidemiology
Announcement Type	New
Related Notices	October 31, 2012 - See Notice NOT-TW-13-001. Notice of Change, Clarification on Activity Code, Clarification on Number of Applications, Clarification on Trainees and Clarification on Scope.
Funding Opportunity Announcement (FOA) Number	PAR-12-003
Companion FOA	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.989
FOA Purpose	The purpose of this FOA is to provide support for the development of broadly interdisciplinary training programs in global health directed towards encouraging innovation in products, processes, and policies. Trainees should be at the postdoctoral level or have attained a terminal degree in their fields. Training projects should identify critical health needs in Low and Middle Income Countries (LMICs) that can be addressed through Innovation, and carry out the scientific research necessary to develop, validate, and test their concepts. To increase the translation of research findings into realized health benefits, project design should include considerations of implementation appropriate to low resource settings in LMICs, particularly regarding increased effectiveness, affordability, accessibility, ease of use or delivery, and/or scalability. This FOA emphasizes hands-on, problem-solving, and collaborative approaches and allows U.S. and LMIC trainees to be trained together. By engaging multiple entities within and among institutions, the proposed programs should also build institutional capacity for interdisciplinary training in global health, stimulate new collaborations, and increase the pipeline of researchers from a wide variety of fields who engage in global health research.

Posted Date	October 14, 2011
Open Date (Earliest Submission Date)	November 16, 2011
Letter of Intent Due Date	November 16, 2011, November 15, 2012
Application Due Date(s)	December 15, 2011, December 14, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	April/June 2012, April/June 2013
Advisory Council Review	August 2012, August 2013
Earliest Start Date(s)	September 2012, September 2013
Expiration Date	December 15, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide especially the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where told do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Framework Programs for Global Health Innovation (FRAME Innovation) will provide support to institutions in the U.S. and in Low and Middle Income Countries (LMICs) to build capacity within their institutions to develop broadly interdisciplinary training programs in global health directed towards encouraging Innovation in health-related products, processes, and policies. Trainees should be at the postdoctoral level or have attained a terminal degree in their fields. Training should be directed towards identifying critical health needs in LMICs that can be addressed through Innovation, and trainees should carry out the scientific research necessary to develop, validate, and test their concepts. To increase the translation of research findings into realized health benefits, project design should include considerations of implementation appropriate to low resource settings in LMICs, particularly regarding increased effectiveness, affordability, accessibility, ease of use or delivery, and/or scalability. This FOA emphasizes hands-on, problem-solving, and collaborative approaches and allows U.S. and LMIC trainees to be trained together in joint programs. By engaging multiple entities within and among institutions, the proposed programs should also create the institutional infrastructure necessary to support interdisciplinary training in global health Innovation, stimulate new collaborations, and increase the pipeline of researchers from a wide variety of fields who engage in global health research. This FOA is consistent with the goals of the Fogarty International Center (FIC) Strategic Plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) to support and facilitate global health research in both communicable and non-communicable diseases, build partnerships between health research institutions in the U.S. and abroad, and train the next generation of scientists to address global health needs.

Background and Rationale

It is important that investigators from a wide variety of fields are engaged in global health research as addressing the most urgent global health challenges will require diverse expertise. This is true, in part, because of the public health nature of these challenges, which are embedded in the complex relationships among biological, social, economic, political, and environmental determinants. However, there is also a growing literature that describes how some of the most transformative advances in Science and Technology have come from the intersection of disciplines, with collaborators working together, challenging and complementing each other’s assumptions and methodologies, and together discovering novel solutions. A recent report from the National Research Council’s Board on Life Sciences has suggested that greater integration within biology and in collaboration with physical and computational scientists and engineers will be necessary to create a New Biology for the 21st Century (http://www.nap.edu/openbook.php?record_id=12764&page=1). Indeed, collaborative research across these disciplines fueled the development of such fields as genomics, nanobiology, bioinformatics, and systems biology and is producing cutting edge advances in every field of health-related research, from cancer to immunology, brain disorders, blindness, and infectious diseases (http://web.mit.edu/dc/policy.html). While basic biomedical research has forged ahead with this paradigm, in many academic institutions worldwide there are often little awareness and few opportunities for investigators outside the Schools of Public Health and Medicine to participate in global health research or for trainees in any field to engage in interdisciplinary research. To address disease in the context of international public health, in addition to the physical sciences and engineering, fields including the social sciences, law, business, communications, veterinary sciences, agriculture, environmental sciences, and others are also likely to play critical roles.

At the same time, there is a recognized gap in the ability to translate biomedical and behavioral research findings into implementable applications, both from the bench to the clinic and to public health. Businesses have long used an innovation model to accelerate this translation, by considering the constraints and requirements for implementation and the needs of the target communities from the outset of the development process. An integrated process that considers implementation of research outcomes at an early stage in the research design process might similarly begin to close the translational gap in global health research.

There are an increasing number of opportunities from the U.S. government and other funders to compete for innovation research grants and innovation challenges. However, few universities have systematically explored the concept of innovation or have created mechanisms to prepare students and faculty to respond to these opportunities. This FOA addresses these gaps.

This is the third in a series of initiatives from FIC focused on building institutional capacity in broadly multidisciplinary global health education, research, and research training on campuses in the US and LMICS. The Framework Programs for Global Health (FRAME) supported the development of multidisciplinary global health curricula, associated research experiences, and the formation of coordinating administrative entities. FRAME Signature Innovations Initiative (FRAME-Sig), a one year program supported by funds from the American Recovery & Reinvestment Act of 2009, moved that paradigm from education to research practice by supporting the development of pilot programs in interdisciplinary research training in global health innovation. The current solicitation is based on an expansion of this pilot program. For a list of current FRAME-Sig awards, see

http://www.fic.nih.gov/recovery/framework.htm.

Definitions

Working Definition of Innovation: While many definitions of innovation are acceptable, we suggest as a working definition an implementation that is often disruptive of the prevailing product, process, policy, or paradigm and creates an outcome that is more effective, affordable, accessible, easier to use or deliver, and/or provides superior scalability. A classic example is the replacement of the main-frame computer by the PC, a product developed at the intersection of materials engineering, computer science, and business innovation. Rather than a huge, expensive machine housed in a temperature controlled room that required an expert to run, a PC (and later laptops and tablets) were affordable by individuals, could go almost anywhere, and could be used by a child of five. While not as powerful as the mainframe, it was good enough for the average individual’s needs and was widely adopted. The industry then turned its attention to increasing the power of the PC. Once in the hands of the individual, the uses to which it has been put, especially in concert with the open innovation platform provided by the internet and the worldwide web, were not imagined by its originators. The cell phone is similarly becoming an innovation platform all over the world. Both of these tools have found increasing applications to managing health and health systems. A similar paradigm can easily be imagined for the development, use, and/or delivery of needed drugs, vaccines, diagnostics, and medical devices for inaccessible and low-resource areas, and for interventions that affect health behavior, information flow and analysis, and policy.

Innovations for low resource settings: There are an increasing number of innovations under development that are relevant to low resource settings and originated with an interdisciplinary approach. These include new point of care diagnostics, such as the adaptation of lab-on-a-chip technologies and telemedicine facilitated through cell phones, which will allow faster, less expensive and more accurate diagnosis in field settings lacking expert personnel and refrigeration; sophisticated function but low cost prosthetics that can be locally manufactured for dollars (versus thousands of dollars) in the countries in which they are used; low-cost incubators for premature babies using materials sourced locally so that replacement parts are readily available; genetically engineered plants for the delivery of vaccines; use of rodents as sensors to detect landmines or TB in sputum samples; combinations of technology, monitoring, and behavioral incentives to encourage patient medication adherence to increase the likelihood that an entire course of medication is completed; intensive agricultural training to increase the nutritional status of HIV-affected families and communities and improve health outcomes for patients on anti-retroviral drugs; use of information technology to improve health care delivery, access to education, or access to clean water as these impact health; and many other examples.

Innovation and Innovative: It should be noted that innovation and innovative are not equivalent. While innovations are often innovative, in the sense of novel, and may indeed break with existing paradigms in the field, an approach may be novel but ineffective. An innovation implies a successful implementation and, indeed, may take a known product or process and modify it or adapt it to a new use, with greatly improved outcomes.

Interdisciplinary: The term interdisciplinary is used to imply an active interaction and contribution of trainees and mentors from different fields of study and not merely the participation of individuals with different expertise at different stages of a process. A team approach is one way to achieve this, with the entire team contributing from conception of the project through research and implementation. Whatever model is chosen, the purpose of the training program should be to stimulate trainees to look at a problem with unbiased eyes and find the best solution by drawing on the collective insight, expertise, and disparate methodologies of the participants.

Specifically, the objectives of this FOA are:

1. To expand the base of expertise needed and available to tackle the challenging problems of global health by developing trans-institutional, problem-solving based research training programs that will bring together trainees of widely diverse expertise to work together on research problems in Global Health. Trainees should be postdoctoral scientists, or researchers who have obtained a terminal professional degree in their fields, and may include within one program or interdisciplinary project team individuals from both the U.S. and LMICs.

2. To stimulate new knowledge, approaches, and solutions in global health, in part by exploring the question: What is an "innovation" in the context of global health and how might an institution create an enabling environment to encourage innovations in products, processes, or policy to emerge out of their research and research training activities? Training projects should identify critical health needs in LMICs that can be addressed through Innovation, and carry out the scientific research to validate the concept and test its effectiveness. Research projects should be directed towards producing specific global health research "products" that have the potential for effective implementation and are likely to contribute to improved health outcomes. These may include technological, informatics, biomedical, modeling, or other products; prevention, adherence, or other intervention strategies; as well as policy, business, educational, or other deliverables that are appropriate to the infrastructure and social context in which they will be used. Not all research problems are best served by this type of approach; consequently the problems chosen and the way they are conceptualized and framed will be critical to the success of the research training projects and the sustainability of the program. Similarly, understanding and anticipating the challenges of implementation from the outset of a research project may help determine which among many possible approaches are chosen to increase the probability that research is quickly translated into real health benefits.

3. To integrate global health research communities within and among institutions by building capacity at the institution(s) to support an interdisciplinary research training program in Global Health Innovation. This may involve raising awareness of global health issues and the goals of the program throughout the institution; developing shared research training resources and activities; developing electronic or other platforms to encourage participation across many disciplines and to assemble teams (a virtual marketplace ); creating a space to interact (a physical incubator or a virtual lab); developing an agreed-on concept of innovation and creating an enabling environment to encourage innovation in global health research; developing a course in innovation; developing mentoring and training models to ensure that teams operate effectively and have appropriate oversight; assembling an Advisory Board to provide feedback and guidance; and by many other means. In some institutions, interdisciplinary centers that already exist but carry out research that does not consider the constraints of low resource health systems, may be powerful platforms for adapting research goals towards the needs of a low-resource population. Similarly, institutions that have built Global Health Centers, either through previous Framework Program support or through other funding, may build on that administrative structure to develop this trans-institutional training application.

The proposed activities may encompass the many research fields in global health broadly or may be more focused, thematically or geographically, but should address the health concerns of populations living in low resource settings in LMICs. The applicant may propose completely new activities or build significantly on existing activities that will take these initiatives to a new level or result in a new use of available resources. The applicant should not propose to merely sustain an initiative already in place.

The specific hands-on training projects may take many forms. For example, a research team might undertake to design a product or intervention that addresses a specific health need, taking into consideration (as applicable) issues of access, infrastructure, barriers to adoption, affordability, scalability, regulatory and legal environment, sourcing of materials, data management, disposal and recycling, environmental impact and energy efficiency, technology transfer, evaluation of effectiveness, and business model, where such considerations of implementation may significantly impact initial research design.

The application must include participation by at least three Schools, departments, or entities of distinct disciplines, either at the applicant institution or among a consortium. Subspecialties within a field, such as Medicine, would not qualify as distinct disciplines, and three departments within one School are unlikely to meet this standard.

Applicants may choose to form consortia that include other academic or research institutions outside the university that could provide synergistic or special expertise and experience, or that share common goals. These may include institutions in the applicant country or foreign institutions, and may also include partners from other sectors (private, governmental, and non-governmental organizations) as needed for the program. These may or may not involve formal subcontracts. For US institutions, the development of innovations to be used within a LMIC will require working closely with scientists and other professionals in those countries and having trainees embedded within the context of the research problems to be addressed. Consequently, U.S. applicants are required to collaborate with named institutions or research entities in LMICS, such that all participating institutions realize benefits from the interdisciplinary training program, including the opportunity to nominate postdoctoral fellows to participate in the training projects. LMIC institutions, where appropriate, may wish to take advantage of advanced expertise that might complement and enhance the strengths of their own institutions by partnering with other institutions either locally or internationally. While applicants may include partners from non-U.S. high income countries, their expected roles would be as mentors or consultants. Trainees must be citizens of the U.S. or an LMIC.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Applicants may request up to $350,000 total costs per year.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

Stipends, Tuition, and Fees	D43 awards provide stipends as a subsistence allowance to help defray living expenses during the research training experiences. Where appropriate, NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award, where required for selected courses or for full-time enrollment Trainees should be paid a stipend commensurate with their professional experience and the usual rates at their institutions. Applicants should use an appropriate stipend level and can use the NRSA levels as guidance (see Ruth L. Kirschstein National Research Service Award (NRSA) site) or use grantee institutional policies for comparable trainees at the training institution.
Trainee Travel	Trainee travel for the purpose of carrying out research is allowable. In addition, trainee travel to attend scientific meetings and workshops or to obtain specialized training necessary for the individual s research training experience is an allowable trainee expense.
Training Related Expenses	NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. Trainee research expenses for individuals or teams are allowable and should be justified in the budget justification. In addition, applicants may request funds to support the development of resources or activities necessary to develop institutional capacity for an interdisciplinary training program. Applicants should include travel expenses for the PD/PI(s) to participate in an annual network meeting at NIH of all grantees supported as a result of this funding opportunity.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

All Program Director(s)/Principal Investigator(s) (PD(/)PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. NOT-OD-11-090:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-090.html (Guidance for International Applicants Blocked from Registration Websites)

All registrations must be completed by the application due date.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Non-domestic entities are restricted to institutions in "low- and middle-income" countries as defined by the World Bank according to Gross National Income per capita as low-income, lower-middle-income, and upper-middle-income ; see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLSb). See also "Additional Information on Eligibility , Section III.3 below.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. However, institutions may participate in more than one consortium, and may be both an applicant institution and a participating consortium partner.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Requirement for Interdisciplinary Participation: Participation by a minimum of three Schools, departments, or other entities representing distinct disciplines is required. Subspecialties within a field, such as Medicine, would not qualify as distinct disciplines. For consortia, the three disciplines may be distributed among the partner academic or research institutions. If there is any question about whether disciplines are distinct, please contact the FIC Scientific Contact (Section VII.1).

Pre-requisite activities in Global Health: Institutions or consortia are eligible to apply if they participate, as a recipient or significant collaborator, on a minimum of five research or research training grants or research contracts in global health topics involving significant participation by investigators in LMICs (as defined by the World Bank, above), such as a role as Program Director(s)/ Principal Investigator(s) (PD(s)/PI(s)) or key personnel or as a listed performance site. All of these awards should be from funding sources external to the institution and should be active on the application receipt date for this FOA, with at least two of these awards from the NIH. NIH R03 awards, however, do not count as qualifying grants. . If a consortium of institutions applies as partners, the institutions applying may together meet this pre-requisite (i.e. as the sum of all the partners). These pre-requisite grants are not intended to act as "parent grants" for the training program, as the training models proposed will likely not fit easily within established research programs. Indeed, in some cases this might un-necessarily restrict the possibilities of the research questions asked and the training models explored. Rather they provide a metric of the expertise available in global health research at the institution and the ability of the entire consortium community to engage and provide mentorship for trainees. They may also provide a necessary network of international collaborations for training projects. Include a Table in the Research Training Program Plan that lists the qualifying grants and contracts, as detailed below under Section IV.2. If there are questions about qualifying grants or an institution’s eligibility, please contact the FIC Scientific Contact (Section VII.1

Institutional Commitment: Applications should include letters from the appropriate head research administrator at all participating institutions confirming the institutions' commitment to the proposed research training program. The institution(s) should state their commitment to overcoming any administrative obstacles to the implementation of the application, such as accommodation for participation by multiple Schools at the university or collaboration with other institutions. Appropriate institutional commitment to the program also includes the provision of adequate staff, facilities, and resources that can contribute to the planned program.

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Trainees must be citizens of either the U.S. or of an LMIC.

In the fields in which it is appropriate, postdoctoral trainees must have received, as of the beginning date of their appointments, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well as a doctoral degree in nursing research. Since this is a broadly interdisciplinary program, however, trainees that have attained the usual terminal degree in their fields, which in many fields does not include a doctorate, are acceptable trainees for the program.

Short term training is allowed as an adjunct to the training program and will usually take the form of courses or workshops. These should be targeted towards post-terminal degree students but may include other members of the research community, including students and faculty, who might also benefit from focused and topical training in global health innovation and related material.

A research training grant must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Flora Katz, PhD
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 402-0779
Email (preferred): [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) with the following modifications:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the research training plan, and brief descriptions of planned research training program. Include the rationale and design of the program, the planned duration and projected number of trainees, including their levels (i.e., predoctoral, postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments section)

A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution(s). Please name your file Advisory_Committee.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

• Both the Training Budget Component and the R&R Budget Component are required for a complete application.
• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Omit NRSA Tables 1-12 with the following exceptions: include Tables 2; 5B (but do not indicate NRSA-training grant eligible trainees); and 6Bnew (list representative publications, no abstracts, for each mentor for any previous or current postdoctoral fellow, but omit the training grant eligible trainee, TGE, or PMCID designations. You should omit the corresponding requested text in the training plan for all other Tables..

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the Training PD(s)/PI(s). Include active research and the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PD(s)/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PD(s)/PI(s) will enhance the likelihood of success of the program. .

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this application from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The Training PD(s)/PI(s) should also describe past research career development activities/experiences including those of mentors, documenting the success of former scholars in establishing independent productive scientific careers. Programs should provide all trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the criteria to be used for candidate evaluation in the selection of Trainees. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution(s) describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors ,

Recruitment and Retention Plan to Enhance Diversity

This section only applies to U.S. trainees in this program: Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Other considerations for this FOA:

The purpose of this FOA is to create opportunities and resources for interdisciplinary training in Global Health Innovation. We expect entities within the university to work together, and some applicants may put together consortia of institutions to jointly develop training plans. As such, within the research training program plan, applicants should also address the following:

1. Describe how faculty from different Schools or other components within the institution(s) will communicate and coordinate their efforts on this program to develop the training program and to provide effective mentoring. All key faculty who will be involved in mentoring should include biosketches.

2. Describe how trainees will interact with each other and how they will be mentored to achieve the goals of the interdisciplinary training projects. U.S. and LMIC students may be trained together in joint teams and this is strongly encouraged.

3. While it may be premature to describe in detail, provide specific examples of the types of projects that might be undertaken within the training program, how training projects will be developed, and the types of "deliverables" that might emerge from the research projects.

4. For consortia, explain why the particular partnerships were chosen, how they add value to the proposed program, why these partners have the potential to successfully develop a program together, and how each will benefit from the program.

5. Define innovation in the context of this application (as consistent with the spirit of the definition in the Section I, above, and as distinct from "innovative"), and describe how the activities proposed and the partnerships assembled contribute to realizing that concept within the training paradigm.

6. Describe how you will build capacity at the participating institutions to support an interdisciplinary research training program in Global Health Innovation.

7. Provide a Table describing at least five qualifying global health grants and contracts at the institution or among the members of the consortium including the following information: source of funding, name of PD(s)/PI(s), institution holding the award, grant or contract number, total amount of award, and end date. If space constraints prevent a complete list of eligible grants within the consortium (in additional to the five required and listed in the Table), you may choose to simply indicate the number of additional eligible active research grants and contracts and research training grants held at the institutions.

For training-related research projects involving human subjects, trainees should have written documentation of education in the protection of human subjects, comply with required federal citations, and obtain 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.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115,

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Have the applicants proposed a program that will stimulate hands-on, problem solving-based training in a well-integrated and highly interactive interdisciplinary context? Are the training activities directed towards producing specific global health products , as defined in this FOA? Do the applicants justify why the specific participating disciplines were selected and how they will be engaged? Do the qualifying grants reflect significant global health experience at the institution(s)?

Do the applicants take advantage of the unique scientific environment in which the training will be done, including the availability of global health research expertise or other interdisciplinary research initiatives? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training? Are appropriate letters of support from the research leadership of the participating entities included?

Have the applicants proposed to build appropriate infrastructure or resources to facilitate the goals of the training program and create the institutional capacity to support such a program? Is there a clear plan for how the mentors will interact with each other and with the trainees? Is there a clear plan for how the trainees will interact with each other?

Does the program provide new training opportunities, new training models, and new resources for interdisciplinary research training in global health at the institution(s)? Will the program be transformative for the participating partner institutions? Is it likely that the training program will lead to new approaches to critical global health problems?

Does the research training program proposed address an important problem or critical barrier to progress in the field of global health? If the aims of the program are achieved, will scientific knowledge, technical capability, and/or clinical practice be improved? Will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the products of the training projects likely to have a significant impact on the health of populations in participating LMICs?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation or technologies, or interventions? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the program promote and support innovation in global health research, as framed in the FOA and defined by the applicants, through its training paradigm and the resource infrastructure it will establish? Do all participating components and institutions contribute to the innovation goals of the application?

Training Program Director(s)/Principal Investigator(s) (PDs/PIs)

Does the PD(s)/PI(s) have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program? Does the PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program? Do the PD(s)/PI(s) have the necessary experience in global health-related research and training to lead an effort in this area? Do the PD(s)/PI(s) have experience in leading a program involving multiple participating components?

For applications designating multiple PD(s)/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PD(s)/PIs?

Preceptors/Mentors

Are there sufficient preceptors/mentors with appropriate expertise to meet the needs of the interdisciplinary research training program proposed? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program?

Trainees

Are there adequate plans to identify, recruit, and select candidates, from all the participating disciplines, with an interest in exploring interdisciplinary, team research and Global Health Innovation?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider 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.

Recruitment & Retention Plan to Enhance Diversity

This section only applies to U.S. trainees in this program: Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent 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 research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the the FIC Advisory Board . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Considerations of geographical distribution.

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, trainees are hereby notified that they may be contacted after the completion of this award 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 program.

Not Applicable.

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Grantees will be requested to enter information concerning long- term trainees into FIC’s CareerTrac, a database to track the training history and accomplishments of trainees over time. The database will be made available to grantees after the award is made.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Flora Katz, Ph.D.
Fogarty International Center (FIC)
Telephone: (301) 402-9591
Email: [email protected]

Hilary D. Sigmon, Ph.D., R.N.
Center for Scientific Review (CSR)
Telephone: 301-357-9236
Email: [email protected]

Farah Nikhath Bader, M.P.H.
Fogarty International Center (FIC)
Telephone: 301-402-5011
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR 63A.