Part I Overview Information

Issuing Organization
John E. Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov)

Participating Organizations
Office of the U.S. Global AIDS Coordinator (OGAC) (http://www.pepfar.gov)
National Institutes of Health (NIH) (http://www.nih.gov)
Health Resources and Services Administration (HRSA) (http://www.hrsa.gov)
Centers for Disease Control and Prevention (CDC) (http://cdc.gov/)
Department of Defense (DoD) HIV/AIDS Prevention Program (http://www.med.navy.mil/sites/nhrc/dhapp/Pages/default.aspx)

Components of Participating Organizations
NIH Common Fund/Office of the Director (OD/OSC/CF/NIH)(http://dpcpsi.nih.gov/osc/)
Office of AIDS Research, Office of the Director (OAR/NIH) (http://www.oar.nih.gov/)
Office of Research on Women s Health (ORWH/NIH) (http://orwh.od.nih.gov/)
John E. Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov)
National Cancer Institute (NCI/NIH) (http://www.cancer.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH) (http://www.nhlbi.nih.gov/)
National Human Genome Research Institute (NHGRI/NIH) (http://www.genome.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH) (http://www3.niaid.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH) (http://www.nibib1.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH) (http://www.nidcr.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH/NIH) (http://www.nimh.nih.gov/index.shtml)
National Institutes of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR/NIH) (http://www.ninr.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM/NIH) (http://nccam.nih.gov/)
National Center for Research Resources (NCRR/NIH) (http://www.ncrr.nih.gov/)
HIV/AIDS Bureau, Global HIV/AIDS Program (GHAP/HAB/HRSA) (http://hab.hrsa.gov/global)
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Global AIDS Program (GAP/NCHHSTP/CDC) (http://www.cdc.gov/globalaids/default.html)
United States Agency for International Development (USAID) (http://www.usaid.gov/)

Title: The Medical Education Partnership Initiative (MEPI) (R24)

Announcement Type
New

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

• April 2, 2010 - See Notice NOT-TW-10-004 Participation of NINDS and USAID.

Request for Applications (RFA) Number: RFA-TW-10-008

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.310, 93.145, 93.242, 93.272, 93.279, 93.389, 93.869, 12.350, 93.837, 93.286, 93.397, 93.213

Key Dates
Release/Posted Date: March 15, 2010
Letters of Intent Receipt Date: April 12, 2010
Application Due Date: May 12, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s): June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date(s): September 30, 2010
Additional Information to Be Available Date (Activation Date): Early Conference calls open to all potential applicants will be held on pre-selected dates. Potential applicants should visit (http://www.fic.nih.gov/) for additional information.
Expiration Date: May 13, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH and HRSA under the Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293 (more commonly known as the U.S. President’s Emergency Plan for AIDS Relief [PEPFAR]), invites proposals from foreign Institutions in Sub-Saharan African countries which receive PEPFAR support (http://www.pepfar.gov/countries/index.htm) and their partners to develop or expand and enhance models of medical education in Sub-Saharan Africa. These models are intended to support PEPFAR’s goal of increasing the number of new health care workers by 140,000, strengthen medical education systems in the countries in which they exist, and build clinical and research capacity in Africa as part of a retention strategy for faculty of medical schools and clinical professors.
• The strategy of this initiative is to build human capacity for health in Africa by strengthening the medical education system in an environment that values and nurtures research and which will contribute to the sustainability and quality of the overall effort. These models will also contribute to the sustainability of the PEPFAR investments through the provision of excellence in clinical training and the capacity of medical students and faculty to participate in and carry out multidisciplinary locally driven research (e.g. implementation science and/or clinical, health services, and operations research) that responds to the health needs of their communities and country and improves health outcomes for men, women, and children. In addition to PEPFAR support for strengthening medical education in African institutions, funds are also being provided from the Office of AIDS Research (OAR), located within the NIH Office of the Director, in support of the research capacity building component of this initiative and building on OAR’s long-term support for NIH efforts to build sustainable research and training partnerships between U.S. and African educational and research institutions.
• Linked awards that focus on diseases and priority health areas related to and/or beyond HIV/AIDS will also be available through the NIH Common Fund initiative (http://commonfund.nih.gov/), managed by the Office of Strategic Coordination (OSC), located within the NIH Office of the Director. These awards are part of the NIH Director’s decision to make global health one of the NIH’s highest priorities.
• Mechanism of Support. This FOA will utilize the NIH Resource-Related Research Project (R24) grant award mechanism for all applications submitted.
• Funds Available and Anticipated Number of Awards. The Office of the U.S. Global AIDS Coordinator intends to provide support for five to nine PEPFAR focused awards, referred to as Programmatic awards in this FOA, and one Coordinating Center award starting in FY 2010, pending the number and quality of applications and availability of funds. The NIH OAR will also contribute funds in FY 2010 to support the Programmatic awards.
• In addition, up to $3 million will be available in FY 2010 for awards, referred to as Linked awards in this FOA, which focus on non-communicable diseases and/or priority health areas (e.g. maternal and child health, women’s health, cardiovascular disease and stroke, injury, environmental health concerns, and mental health) related to and/or beyond HIV/AIDS; it is anticipated that up to six of these linked programmatic awards will be made starting in FY 2010. The Linked awards will be supported by the NIH Common Fund through the Office of the NIH Director (http://commonfund.nih.gov/) and will be administered by the Fogarty International Center on behalf of the NIH.
• Budget and Project Period. The requested budget may not exceed $2,000,000 total costs per year for either the Programmatic awards or the Coordinating Center award. The Linked award application budget may not exceed $500,000 total costs per year per award. The total project period for all awards may not exceed five years.
• Application Research Strategy Length: The R24 application Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research resources program are invited to work with their institution to develop an application. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Only one application per institution (normally identified by having a single DUNS number or NIH IPF number) is allowed for either the Coordinating Center or Programmatic awards, although applicant institutions may also participate as members of consortia on applications submitted through other institutions. To be eligible for the Linked awards, an African institution must have submitted an application for a Programmatic award; up to two Linked award applications may be submitted per applicant institution in differing focus areas.
• Resubmissions: Resubmission applications are not permitted in response to this FOA.
• Renewals: Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Education 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. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Resources Program Objectives

The Medical Education Partnership Initiative (MEPI) is a coordinated effort led by the Office of the U.S. Global AIDS Coordinator (OGAC) at the Department of State and supported by the National Institutes of Health s (NIH) Common Fund, the Office of AIDS Research (OAR), and the Office of Research on Women’s Health (ORWH) in the Office of the NIH Director and the Health Resources and Services Administration s (HRSA) Administrator. Awards from this initiative will be jointly managed by NIH and HRSA under the guidance of OGAC in collaboration with the participating organizations. These awards will provide support to African institutions working in partnership with a U.S. and/or other African university-based medical school to strengthen and build the clinical and research capacity of medical educational institutions in Sub-Saharan Africa and thereby help to strengthen the human capacity for health in Africa. Specifically, applicants should:

1) Propose to expand and/or enhance innovative medical education models that have the potential to improve the quality of clinical education and clinical care in countries in Sub-Saharan Africa;

2) Develop strategies that enable graduating medical students to remain in their home country to practice, serve as faculty, and/or conduct research related to the implementation of PEPFAR and other public health priorities; and

3) Enhance the recruitment and retention of qualified academic faculty through partnerships and research opportunities.

Three award types will be made to facilitate the objectives of MEPI:

1. Awards focused on PEPFAR priority areas (Programmatic awards),

2. Linked programmatic awards that support non-communicable diseases and priority health areas related to and/or beyond HIV/AIDS (Linked awards), and a

3. Coordinating Center.

Programmatic Awards: MEPI encourages innovative community-based training, problem-based learning, clinical preceptorships, and the development of training resources and activities that will provide students and faculty with the tools, concepts, mentoring, and opportunities that will facilitate innovative multidisciplinary approaches to medical education. The medical education models under MEPI should also create opportunities for medical education to be used as the platform for developing locally driven research (e.g. implementation science and/or clinical, health services, and operations research) to improve health outcomes in local communities and countries in Sub-Saharan Africa. The research platform is considered an important strategy to develop new generations of clinical leaders, retaining experts in country, and promoting quality clinical practice. The MEPI Programmatic Award applications must be built on existing partnerships that contribute to these goals.

As the programmatic activities of this initiative will support national strategies, letters of support from the Ministry of Health and Ministry of Education for each African country with a Programmatic application will be required. It is highly recommended that these letters of support be included with the application. If these are submitted later, this could impact and delay the review of the application. An award will not be made without receipt of these letters of support.

Linked Awards: While most of the current global heath investments in Africa justifiably focus on HIV/AIDS, tuberculosis, and malaria, investments in other priority health areas (e.g. maternal and child health, women’s health, cardiovascular disease and stroke, injury, environmental health concerns, and mental health) and chronic non-communicable diseases will be critical to supporting health systems strengthening and reducing levels of morbidity and pre-mature mortality throughout Sub-Saharan Africa. The NIH Director has identified global health as an area of significant promise for furthering major advances that can play a significant role in the development of prevention, diagnostics, and therapeutics that can reduce the burdens of illness and disability around the world.

In support of this interest in global health, the Office of the NIH Director through the NIH Common Fund, will provide additional support for programmatic partnerships (Linked Awards) which help to build research capacity and research training opportunities in other priority health areas and chronic non-communicable diseases of importance to the applicant’s country related to and/or beyond HIV/AIDS; some of these diseases may also be important for HIV/AIDS co-morbidities (e.g. cancer, cardiovascular disease, mental health, and others). The NIH Common Fund supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The Linked award applications may support either existing or new partnerships but must be well integrated with the activities of the related Programmatic award. If the Linked award application proposes a new relationship, the application must include a planning phase during the first year of the award. Linked award applications must be submitted separately from the Programmatic award submissions and will be individually evaluated and receive a separate score from the applicant’s Programmatic application. A Linked award will not be made unless the related Programmatic application is also funded. The Linked awards funded through this initiative will be administered by the Fogarty International Center (FIC) on behalf of the NIH.

Coordinating Center (CC): Under this FOA a CC will be awarded to a U.S. institution with extensive knowledge of medical education in Sub-Saharan Africa, experience working with and documenting medical education practices, and which can demonstrate existing partnerships with African educational and ministerial leaders. The primary function of the CC will include coordinating activities across the Programmatic programs, including Linked awards, and working with their African partner(s) to develop an African leadership network to guide, support, and advocate for the effort. The CC will use this network of African educational, ministerial, and scientific leaders to share information and experiences, to evaluate the educational models identifying best practices, to provide technical assistance to further build capacity, and to promote educational models that demonstrate success in meeting the objectives of this FOA. The African partner should be one that has the potential capacity to, either singularly or dually, function in the CC role and by the end of the initial 5-year project period substantially contribute to the sustainability of the initiative.

This FOA will help to achieve the PEPFAR goals to 1) support training and retention of more than 140,000 new health care workers and 2) invest in innovative education and build research capacity to increase the number of highly qualified clinicians, to improve faculty retention, to evaluate impact, to improve service delivery, and to maximize outcomes (http://www.pepfar.gov/documents/organization/133035.pdf). MEPI will also help to achieve the NIH Director’s goal to invest in global health and chronic non-communicable diseases and/or health conditions beyond HIV/AIDS.

Background: The Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, has set a goal to support treatment for 3 million people, prevent more than 12 million new infections, and care for more than 12 million people - including 5 million orphans and vulnerable children.

PEPFAR has called for immediate action to turn the tide of HIV/AIDS in Africa, Asia, and the Caribbean. The important aspect of PEPFAR’s bold vision is to treat at least 3 million HIV-infected persons with ART within 10 years. The goal of the PEPFAR initiative is to provide the resources to organizations with excellent HIV care and treatment programs to rapidly expand ART for low income HIV-infected persons in a manner that is consistent with national plans and policies in Sub-Saharan Africa and the Caribbean, as well as for countries in Central Asia, Eastern Europe, Latin America, and other countries and areas. Particular emphasis is on refugee populations or those in post conflict settings in these countries and in areas with significant or increasing HIV incidence rates. An additional intent is to develop sustainable local partner capacity to continue these programs and improve health outcomes.

The NIH Director has also highlighted investment in global health, to include chronic non-communicable and neglected tropical diseases, as one of his five high priority areas. Support for these areas through the NIH Director’s Common Fund will build upon and complement PEPFAR goals.

The MEPI approach acknowledges that local health issues in Africa are complex, cross national borders, and have biomedical, social/political, technological, legal/regulatory, and economic dimensions that frequently require novel and integrated solutions. MEPI will support medical education partnerships that will assist universities in responding to a growing demand by their faculty and students for more training and more varied pathways to address critical local clinical and research needs. Participating medical schools within these institutions are encouraged to develop multidisciplinary models that incorporate various health services disciplines and their respective schools to include Nursing, Public Health, Arts and Sciences, Social Sciences, Health Economics, Computer Science, Dentistry, and others. These multidisciplinary models, if proposed, should provide both the expertise necessary to address pressing health concerns in the country, as well as provide career pathways into health research for students in these disciplines.

The models developed through MEPI will address identified gaps in the quality of medical education, support innovative medical education models, and build or enhance local health services and biomedical research capacity. The initiative should provide faculty and students with an environment that will challenge them to try novel approaches and seek out unfamiliar or emerging technologies and complementary expertise to incorporate into innovative solutions that have the capacity to be transformative and sustainable. It is expected that this will require innovative training models and new partnerships within and beyond the university community and Sub-Saharan Africa.

Objectives: Applicants should propose activities that will build the infrastructure and opportunities at the participating institution(s) to improve the quality of medical education, retain graduates in their country, and support faculty development as well as opportunities for multidisciplinary locally driven research training for faculty and students. Specifically, the objectives of this FOA are as follows:

For the Programmatic Awards:

Programmatic applicants must build on established partnership(s) (applicants must discuss how partnerships are part of an existing partnership and/or relationship) with U.S. and/or African based universities with schools of medicine. Specifically, applicants should propose to:

• Develop new training and career development opportunities for medical students and faculty to engage in hands-on, community-based, and problem-based clinical education and research training. This should include clinical preceptorships and may also include fellowships of up to two years or the development of multidisciplinary fellowship programs, courses, summer institutes, practicum opportunities, mentored clinical and research experiences, and others. For the purposes of this initiative, the target participant population must be at the medical student level or above. Should trainees be selected for fellowship opportunities, applicants should discuss the plan for trainee selection, to include an equal opportunity for men and women, and how these opportunities will contribute to the success of the applicant’s proposed educational model and the use of an Advisory Committee to ensure that selected trainees and fellowships are appropriate for facilitating the objectives of this FOA. The applicant is encouraged to present an innovative teaching model that includes multidisciplinary clinical education and locally driven research and training opportunities directed towards improving local health outcomes. These may include activities in clinical care, prevention, outreach, informatics, modeling, policy, education, research training, or other opportunities that are appropriate to developing the infrastructure of the medical school and institution.
• Create an enabling academic environment to promote locally driven research, to include equal opportunities for women who are faculty and/or students. This environment might be realized through the challenges provided by training activities; through innovative curriculum development, to include pre-med curriculum; through clinical preceptorships and mentoring; through the development of a physical or virtual space that allows multidisciplinary teams of students to work on projects together; through the creation of electronic tools to facilitate multi-site or multi-country multidisciplinary education and research networks; through developing courses using distance learning pedagogy; or through many other means. Opportunities might also be developed to enhance expertise in research integrity, ethical review, financial management, grants management and administration to include (but not be limited to) bioethics, IRBs, and how to search for, apply for, and administer grants so that a strong infrastructure for supporting research at the institution may be created. The applicant should also consider addressing how grants administration at the institution could be improved and how selected partners might be involved.
• Develop educational models which have the potential to demonstrate a sustainable increase in the recruitment and retention of medical students and academic faculty, to include women; an increase in the number of graduating medical students who begin local practice, become members of academic faculty, and/or conduct research related to the implementation of PEPFAR and other public health priorities in the home country; and encourage institutional support of local research efforts.
• Participate in annual grantee meetings and site visits organized by the Coordinating Center.

For the Linked Awards:

Building on the objectives of the Programmatic awards, the Linked awards will provide additional funding to selected Programmatic awardees at the same institution to support research capacity building and research training in other priority health areas (e.g. maternal and child health, women’s health, cardiovascular disease and stroke, injury, environmental health concerns, and mental health) and chronic non-communicable diseases related to and/or beyond HIV/AIDS. The Linked awards will be funded as separate, but administratively linked, to the Principal Investigator(s) of the Programmatic Awards (e.g. the same contact PI). In contrast to the Programmatic awards which must be built on existing relationships, these awards may be used to support either existing or new partnerships that will contribute to health systems strengthening and the use of research to improve treatment, identify preventative measures, and groom future generations of scientists who can ultimately improve the health outcomes related to these areas in the applicant’s community and country. Specifically, applicants should propose to:

• Substantially increase the expertise of faculty and students in chronic non-communicable diseases and/or other health priorities related to and/or beyond HIV/AIDS which significantly impact morbidity and pre-mature mortality in the applicant’s community and country.
• Strengthen the implementation and sustainability of education and research training related to chronic non-communicable diseases, co-morbidities between infectious and non-communicable diseases, and/or the integration of infectious and non-communicable disease management at the applicant’s institution and/or consortium.
• Strengthen faculty contributions and student participation in medical education and locally driven research for chronic non-communicable diseases, as well as other priority, locally relevant health issues to include sex and gender factors in health and disease, and encourage creative and innovative teaching, mentoring, and research training models to support addressing these priorities.

Applicants for Linked awards are encouraged to consider developing partnerships across the range of the NIH mission areas supported by NIH extramural programs (http://www.nih.gov/icd/index.html) or with NIH intramural programs (http://www1.od.nih.gov/oir/sourcebook/sci-prgms/sci-prgms-toc.htm) in building new areas of expertise related to and/or beyond HIV/AIDS. These partnerships could include, for example, linkages with the NIH funded Clinical and Translational Science Awards (CTSAs) (http://www.ctsaweb.org/index.cfm?fuseaction=home.showHome), Comprehensive Cancer Centers (http://cancercenters.cancer.gov/cancer_centers/index.html), Collaborating Centers of Excellence Set to Combat Chronic Diseases in Developing Countries (http://www.nhlbi.nih.gov/about/globalhealth/), and many others. Partnerships with NIH intramural programs must include a letter of support from the Scientific Director of the collaborating institute or center committing resources from the institute or center.

For the Coordinating Center:

• The Coordinating Center (CC) will act as a source of technical support for all aspects of the multi-site initiative to include the implementation of activities, refinements to educational models, training, establishing quality control mechanisms, and dissemination of project results. As such, the CC must have an in-depth knowledge of evaluation (including impact evaluation), medical education, research training, and public health priorities across Sub-Saharan Africa.
• The CC will perform a needs assessment across all sites within the first 6 months of the initiative; if appropriate, develop working groups to respond to identified gaps (e.g. informatics, research training, grants administration, and others); and provide specific technical support via listservs, discussions, and periodic meetings. The CC will also assist the sites in developing output, outcome, and impact metrics that will guide data collection, monitoring, and evaluation activities.
• The CC is expected to provide sound methodological consultation and technical assistance to achieve scientific excellence and improve the quality of medical education, medical research, and ultimately medical care. As such, the CC must be able to guide actions necessary to assist programmatic sites to design and conduct evaluations and identify the technical assistance needs of the Programmatic and Linked awardees. The CC is also expected to utilize an evaluation framework to conduct an overall evaluation of the entire program including its processes, outputs, outcomes, and impacts. Process evaluations of MEPI should be conducted annually with a comprehensive outcome evaluation to be completed by the final year of the award.
• In collaboration with the programmatic awardees, the CC must develop a Web-based data system for the collection of output, outcome, and impact data elements related to MEPI. This may include (but not be limited to) tracking medical curriculum development, faculty training and retention, local health professional s training and retention, and students trained at Programmatic and Linked award sites. The CC is also expected to assist African institutions funded under this initiative with tracking trainees careers as a part of the web-based data system. The FIC will make CareerTrac (https://careertrac.fic.nih.gov/Welcome.vm) available to both the CC and programmatic sites to be used for this purpose if appropriate.
• The CC will coordinate grantee meetings, site visits, and conference calls. At a minimum, one site visit assessment with each Programmatic and Linked awardees site and one grantee meeting per year involving all Programmatic and Linked awardees will be held in Sub-Saharan Africa or another venue identified by awarding agency program staff.
• The CC will act as a source of technical assistance to participating countries on developing national policies with Ministries of Health and Education, network development, developing public-private partnerships, and developing coalitions and networks to support the advancement of medical education and health services research in Sub-Saharan Africa. As such, it is expected that the African partner selected can provide the necessary support and linkages to other African leaders, institutions, and organizations that can be of assistance in moving the initiative forward. The African partner should also be one who has the potential to, either singularly or dually, function in the CC role by the end of the initial 5-year project period and substantially contribute to the sustainability of the initiative.
• In addition to providing technical assistance to the individual site evaluations, the CC will also be expected to conduct focused evaluation studies (e.g. impact evaluations). Topics will be generated by the CC in collaboration with Programmatic and Linked awardees, NIH, HRSA, and OGAC.
• The CC Principal Investigator is expected to be in frequent communication with NIH and HRSA program staff.

Scope: The proposed activities for the programmatic awards should address the health concerns of populations living in the applicant’s home country and other low and middle income countries within the consortium as applicable. The applicant should provide a discussion of available resources and a needs assessment for medical education in their country. The applicant should build on existing partnerships but may also propose completely new activities or build significantly on initiatives already in place at the university 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. Projects may also benefit from integration with other PEPFAR-funded care and treatment programs, educational programs, research, and research training.

Participants and Consortia: The application must include the participation of at least one partner outside of the applicant institution. For the Programmatic awards, an existing partnership with at least one U.S. based institution and/or another African based medical education program must be demonstrated. The Coordinating Center partnerships must be with organizations or institutions in PEPFAR funded Sub-Saharan African countries which are not otherwise involved in the Programmatic or Linked award applications. Partnerships should contribute to the probability of success of applicants in meeting the objectives of this FOA, as well as provide support for capacity building efforts and contribute to addressing applicants technical assistance needs (e.g. supporting capacity building efforts in administration, management, financing, education, and/or research) and should provide a benefit for all participants. Applicants for any MEPI award must demonstrate experience in managing global health grants, contracts, and/or cooperative agreements. Applicants and their partners should be committed to sharing resources and curricula using modern information technology.

Applicants and or consortia partners may only be funded as 1) partners of both the Programmatic and Linked awards or 2) as the Coordinating Center; institutions and organizations may not participate in both capacities.

Interests of Participating Organizations:

The Office of the U.S. Global AIDS Coordinator (OGAC) is appointed by the President and confirmed by the Senate to coordinate and oversee the U.S. global response to HIV/AIDS. Reporting directly to the Secretary of State, OGAC leads the U.S. Government's (USG) international HIV/AIDS efforts; ensures program and policy coordination among the relevant USG agencies and departments and nongovernmental organizations, avoiding duplication of effort; pursues coordination with other countries and international organizations; resolves policy, program, and funding disputes among the relevant USG agencies and departments; directly approves all activities of the United States relating to combating HIV/AIDS in developing countries; and promotes program accountability and monitors progress toward meeting PEPFAR's goals.

OGAC is interested in supporting programs which help to meet its goals to support HIV/AIDS treatment for 3 million people, prevent more than 12 million new infections, and care for more than 12 million people affected by HIV/AIDS and to work toward achieving these goals by training and supporting retention of 140,000 new health care workers.

The National Institutes of Health (NIH) is the primary U.S. Federal agency for conducting and supporting biomedical research. The NIH helps to lead the way toward important medical discoveries that improve health and save lives. NIH-supported scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Building capacity and research training opportunities in the developing world is part of the NIH global health response to the growing challenge of chronic non-communicable diseases and injury, in addition to the global health research already being conducted in HIV/AIDS, tuberculosis, and malaria.

The Office of Strategic Coordination (OSC), located within the NIH Office of the Director, manages the Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The Office of AIDS Research (OAR), located within the NIH Office of the Director, coordinates the scientific, budgetary, legislative, and policy elements of NIH AIDS research. The NIH represents the largest and most significant public investment in AIDS research in the world. OAR has a history of supporting NIH programs to build long-term research and research training partnerships between institutions in the U.S. and in Sub-Saharan Africa.

The Office of Research on Women’s Health (ORWH), located within the NIH Office of the Director, stimulates, encourages, and supports meritorious research on women’s health and sex and gender factors in health and disease. ORWH also ensures the inclusion of women and minorities in NIH clinical research and promotes the recruitment, retention, re-entry, and advancement of women in biomedical careers.

The Fogarty International Center (FIC) supports and conducts Global Health research training and research across the spectrum of health sciences in the U.S. and abroad. FIC, the international component of the NIH, addresses Global Health challenges through innovative and collaborative research and research training programs, and supports and advances the NIH mission through international partnerships. FIC also supports an extensive network of programs to build HIV/AIDS research capacity in low and middle income countries, including many countries in Africa.

The Health Resources and Services Administration (HRSA) is the primary Federal agency for improving access to quality health care services for people who are uninsured, isolated, or medically vulnerable in the United States. HRSA provides leadership and financial support to address challenges in maternal and child health, health professional workforce development, HIV/AIDS, and other critical health/medical sectors through its six Bureaus and 13 Offices.

Through the Bureau of Health Professions, HRSA has taken a leadership role in supporting health professions workforce development in the U.S. The HRSA-supported grantees have trained health professionals, improved care systems, and developed medical and nursing curricula. In addition, the Bureau of Health Professions has led the study of current issues affecting the physician workforce, surveyed the registered nurse population, and provided grants to address healthcare workforce unmet needs.

The HIV/AIDS Bureau (HAB) administers one of the largest federally funded domestic HIV/AIDS Programs, the Ryan White Program, for HRSA. The Ryan White Program provides HIV-related services to more than half a million people each year. The program is for those who do not have sufficient health care coverage or financial resources for coping with HIV disease. Ryan White fills gaps in care not covered by other sources. The Global HIV/AIDS Program is the international office of HAB working through PEPFAR to strengthen clinical and administrative systems and services to build networks of comprehensive HIV/AIDS care and treatment; design innovative care and support models to remove barriers to care and treatment; strengthen quality improvement integration to enhance clinical services; support training activities and partnerships to develop human and organizational capacity; assess the effectiveness of specific models of care to promote adaptation of best practices; and enhance the capacity of its partners to collect, monitor, and evaluate data for quality HIV/AIDS health services.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Resource-Related Research Project (R24) award mechanism for all applications, which is a flexible and specialized mechanism designed to provide resources to address problems where multiple expertise is needed to focus on a single complex problem in research or to enhance research infrastructure. 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. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

This initiative is supported by funds provided to the NIH and HRSA under the Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293 (more commonly known as the U.S. President’s Emergency Plan for AIDS Relief [PEPFAR]). OGAC intends to provide support for five to nine Programmatic grants and one Coordinating Center, contingent upon receipt of a sufficient number of scientifically meritorious applications starting in FY 2010. The NIH OAR will also contribute funds in FY 2010 to support the Programmatic awards. In addition, up to $3 million will be available for up to six programmatic (Linked) awards under this FOA that will focus on non-communicable diseases and priority health areas related to and/or beyond HIV/AIDS. These Linked awards will be supported as a Common Fund initiative through the Office of the NIH Director.

Budget proposals for the Coordinating Center and Programmatic applications are limited to $2,000,000 total costs per year per applicant with a project period not greater than five years. Coordinating Center applicants must partner with at least one African institution or organization based in a Sub-Saharan African country which receives PEPFAR support; the African partners to the CC are not eligible to participate in either the Programmatic or Linked awards. Programmatic applicants must partner with at least one U.S. and/or African institution outside the applicant university. For the Programmatic applications, the funding agencies expect that beginning with the first year the majority of funds will be expended at the foreign site with an increasing amount of funds spent at the foreign site in subsequent years.

The Linked applications may not exceed $500,000 total costs per year per award and must not exceed the project period of the associated Programmatic award. Linked applications must be submitted by the same Institution and Contact PI as the Programmatic application. For the Linked applications, the funding agencies expect that beginning with the first year the majority of funds will be expended at the foreign site with an increasing amount of funds spent at the foreign site in subsequent years.

Alterations and renovations are allowable costs for only the Programmatic applications. Alterations and renovations are allowable for up to $75,000 direct costs over the life of the project. Alterations and renovations must be clearly justified and in direct support of the activities proposed for this initiative. All alterations and renovations must be requested specifically and approved by the awarding agency.

Programmatic and Linked awards can request up to 8% of total direct costs (less equipment) within the total cost cap.

Because the nature and scope of the proposed resource-related research program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Funding Agencies and the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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.

For the Programmatic and Linked Awards:

• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Specifically:
  • The following foreign institutions with a medical school and based in a Sub-Saharan African country which receives PEPFAR support (http://www.pepfar.gov/countries/index.htm) are eligible for the Programmatic and Linked awards:
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

For the Coordinating Center:

• U.S. Public/State Controlled Institutions of Higher Education
• U.S. Private Institutions of Higher Education

1.B. Eligible Individuals

The following applies to applicants for each Programmatic and Linked Award as well as the Coordinating Center.

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

The PD/PI should be an established leader in the academic and scientific area in which the application is targeted and capable of providing administrative, clinical, and scientific leadership to the development and implementation of the proposed program.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH 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 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. In the case of Linked awards who partner with NIH intramural programs this does not apply, as the Scientific Director of the collaborating institute or center must commit resources from the NIH institute or center.

3. Other-Special Eligibility Criteria

Number of Applications. The initiative will fund only one Programmatic award or Coordinating Center application to any single institution. However, applicant institutions may also participate in consortia through applications submitted by other institutions as long as the programs are scientifically and programmatically distinct. Applicants and/or consortia partners may only be funded as partners of either the programmatic awards or the Coordinating Center; institutions and organizations may not participate in both capacities. Applicants to the Linked awards must also apply to the Programmatic award and be selected for funding as a Programmatic awardee to be eligible to receive a Linked award.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Developing country collaboration: Primary consortia members may include collaborating institutions and organizations from the U.S. and other countries in Sub-Saharan Africa which receive PEPFAR support (http://www.pepfar.gov/countries/index.htm). Partners from other geographic regions may be part of a consortium arrangement if they add value to the overall project.

Pre-requisite activities in Global Health: Institutions are eligible to apply if they can demonstrate that the applicant institution and its partners are collectively involved in a minimum of five active global health (to include PEPFAR-funded) grants, cooperative agreements, contracts, or awards from the U.S. government (USG) (e.g. CDC, DOD, HRSA, NIH, USAID, and others) or non - USG funders (e.g. Wellcome Trust, Doris Duke, Gates Foundation, and others) involving low and middle income countries. At least two awards must be research or research training grants, cooperative agreements, or research contracts in Global Health areas important to the public health concerns of the applicant’s country; at least one of these awards must be from the NIH. These awards must be active on the application receipt date for this FOA. The institution may be the direct recipient of the award or may be the foreign component/subcontract on an award to another institution or be a listed collaborating site for an existing FIC research training or other capacity building award. Alternatively, if a consortium of institutions applies as partners, the institutions applying must together meet this pre-requisite (i.e. as the sum of global health awards to all the partners).

Section IV. Application and Submission Information

1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

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

Applications from foreign organizations must:

• Request budgets in U.S. dollars.
• Contain detailed budgets. See NOT-OD-06-096.

In addition, for applications from foreign organizations:

• Charge back of customs and import fees is not allowed.
• Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 .
• Funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment, tuition, and fees) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements

Applications with Multiple PDs/PIs

The following applies to applicants for each Programmatic and Linked Award as well as the Coordinating Center.

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research 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.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: April 12, 2010
Application Due Date(s): May 12, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010

3.A.1. Letter of Intent

Prospective applicants are strongly encouraged to submit a letter of intent (LOI) that includes the following information:

• Descriptive title of proposed research resources program and the award(s) (Programmatic, Linked, or Coordinating Center) applying to.
• 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.

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 NIH staff to estimate and plan for the potential review workload.

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:

Letitia Robinson, Ph.D., R.N.
International Program Officer for Sub-Saharan Africa
Division of International Relations
Fogarty International Center
National Institutes of Health
Building 31 Room B2C11
Bethesda, MD 20892-2220
Telephone: (301) 496-4784
FAX: (301) 480-3414
Email (preferred): [email protected]

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be received on or before the application receipt date (adherence to the application receipt date will be strictly enforced) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the issuing organization. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

6. Other Submission Requirements

The purpose of this FOA is to create opportunities and resources to strengthen medical education and multidisciplinary training for innovation in locally driven research in Sub-Saharan African institutions in countries which receive PEPFAR support and to strengthen human capacity for health in Africa. It is expected that additional schools (e.g., nursing, public health, social sciences, computer science, dentistry, and others) within the university might work together, and some applicants may put together consortia of institutions to jointly develop training and resource plans. As such, within the research resources program plan, applicants should also address the following:

• Describe how the faculty from different Schools, Departments, and Institutions (where applicable) will communicate and coordinate their efforts on this program.
• Describe any barriers to the implementation of the proposed plan (administrative or other) and how these might be overcome.
• For consortia, explain why the particular partnerships were chosen, how they add value to the proposed program, and why these partners have the potential to successfully develop a program together.
• Where this initiative will be integrated with other ongoing initiatives at the institution(s) or in the country (e.g. Global Fund, Wellcome Trust, Gates Foundation, Doris Duke, Millennium Villages, and others), explain the relationship of the projects, the proposed value added if this grant is awarded, and how duplication will be minimized and synergies enhanced.
• Address how the proposed activities might be catalytic and lead to a sustained opportunity at the institution(s) and within the country.
• If a Programmatic applicant is also applying for a Linked award, explain how the Linked award will be closely integrated and coordinated with the Programmatic award.

Institutional Commitment: Applications should include letters from the University President, Dean or Director of the Medical School, and the head research administrator or equivalent at all participating institutions (for the Coordinating Center, letters should be included from the participating institutions leadership [to include the University President and Dean or Director of the Medical School] as appropriate) substantiating the institution’s commitment to the proposed research resource development and to sustaining the results of the proposed activities. The institution should state their commitment to overcoming any administrative obstacles to the implementation of the proposal, such as accommodation for participation by multiple Schools at the university or collaboration with other institutions. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program.

Monitoring and Evaluation Plan: Programmatic, Linked, and Coordinating Center applications must contain a monitoring and evaluation plan for the institution’s award and activities supported by this FOA. Applications should include goals, objectives, and metrics and take into account the need for an annual evaluation. Applications should discuss how the project will be assessed and how each applicant will define, identify, and determine impact and implement modifications to improve program impact. Monitoring and evaluation activities should generate sufficient information to assess the project’s sustainability and specifically whether the project s initiation will have a strong likelihood of being continued and supported by the country’s Ministries of Health and Education and other institutions in the country or region as appropriate.

Programmatic applicants, to include Linked award applicants, must also establish a plan to participate in site visits, grantee meetings, and collaborate on an overall evaluation with the Coordinating Center.

Linked Awards: The contact Principal Investigator for a Linked award application must be the same as the contact Principal Investigator of the Programmatic application. The time period for the proposed Linked award may not exceed the Programmatic award project period. The Linked award applications must be written and submitted as a separate application, including a Research Strategy that adheres to the page limitation of 12 pages (See: http://enhancing-peer-review.nih.gov/page_limits.html). The application should also include:

• A detailed explanation of the scientific and administrative relationship between the Linked award activities proposed and the objectives of the Programmatic award;
• A needs assessment for the proposed activities of the Linked award;
• A detailed discussion as to how the objectives of the Linked award will be accomplished and also integrate with and enhance the activities of the Programmatic award and the health system of the applicant’s country;
• A detailed explanation about how the partnerships established in the Linked award application (new or existing) will enhance and strengthen the project. Specifically, how partnerships might be utilized to enhance and coordinate country and subject area efforts in medical education and research; and
• A non-modular budget.

PHS398 Research Plan Component Sections

All application instructions outlined in the PHS398 Application Guide are to be followed, with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

Budget Component

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed or disqualified from the review process.

Pre-requisite activities in Global Health: Applicants must provide a Table in the appendix that lists the qualifying Global Health grants, cooperative agreements, and/or contracts from all collaborating institutions to meet the eligibility requirements (Section III.3), including the following information: source of funding; name of PD/PI; institution holding the award; grant, cooperative agreement, or contract number; total amount of award; and end date. If there are questions about an institution’s (or consortium s) eligibility, please contact the FIC Scientific Contact (Section VII.1)

No supplemental/update information will be accepted. The only exception will be letters of support from the Ministries of Health or Education.

Training in the Responsible Conduct of Research: Every trainee supported by this research resources grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction as part of the research strategy. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. See http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html.

Students who will participate in research training involving human subjects must meet the NIH policy requirement for education in human subjects protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Students participating in research training with live vertebrate animals must also be enrolled in the institutional animal welfare training program for personnel who have contact with animals. The requirements for specific human subjects education and participation in the institutional animal welfare training program may be included as elements of required training in the Responsible conduct of Research.

All Institutions: Failure to meet the following criteria at the time of application will disqualify the application from consideration:

For the Programmatic Awards:

1. The Face Page and Specific Aims section of the application clearly identifies the specific award (Programmatic) the application is in response to. On the Face Page, block 1 should begin with Programmatic: and then followed by the specific title.

2. The Research Strategy adheres to the page limitation of 12 pages (See: Table of Page Limits).

3. The applicant institution is in a Sub-Saharan African country which receives PEPFAR support and has attached documentation of the pre-requisite number and type of currently funded Global Health awards (see Section III, 3 below);

4. At least one partner, U.S. and/or African based, which strengthens the technical merit of the application is included as a participant (the applicant must discuss how the partner is part of an existing partnership or relationship with the applicant institution);

5. Appropriate letters of support from participating University leadership (Specifically letters from the University President, Dean or Director of the Medical School, and Dean or Director of Research or an appropriate equivalent) are included;

6. Appropriate letters of support from the Ministry of Health and Ministry of Education are included;

7. The budget is within the cost cap; and

8. An innovative model of medical education, including building capacity for research and clinical training, is proposed.

For the Linked Awards:

1. The Face Page and Specific Aims section of the application clearly identifies the specific award (Linked) the application is in response to. On the Face Page, block 1 should begin with Linked: and then followed by the specific title.

2. The Research Strategy adheres to the page limitation of 12 pages (See: Table of Page Limits).

3. The applicant institution has applied to and meets the above Programmatic Awards criteria; up to two Linked award applications may be submitted per institution in differing focus areas. If two applications are submitted, one must be in a non-communicable disease area. Linked applications must be submitted by the same Institution and Contact PI as the Programmatic application.

4. The budget is within the cost cap; and

5. An innovative model of medical education, including building capacity for research and clinical training, focusing on priority health issues and/or non-communicable diseases related to and/or beyond HIV/AIDS in the applicant’s community and country is proposed and which demonstrates linkage to the Programmatic award.

For the Coordinating Center:

1. The Face Page and Specific Aims section of the application clearly identifies the specific award (Coordinating Center) the application is in response to. On the Face Page, block 1 should begin with Coordinating Center: and then followed by the specific title.

2. The Research Strategy adheres to the page limitation of 12 pages (See: Table of Page Limits).

3. The applicant institution has attached documentation of the pre-requisite number and type of currently funded Global Health awards (see Section III, 3 below);

4. At least one African partner in a Sub-Saharan African country which receives PEPFAR support, which strengthens the technical merit of the application, is included as a participant (the African partner(s) must not be applying as a primary applicant or consortia partner of the Programmatic or Linked awards). The applicant must discuss how the partner is part of an existing partnership or relationship with the applicant institution.

5. Appropriate letters of support from the participating institutions leadership(to include the University President and Dean or Director of the Medical School); and

6. The budget is within the cost cap.

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data (including curricula) will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to this FOA 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 scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Subsequent to the peer review, applications deemed meritorious will receive a second level of review by the FIC Advisory Board and the Advisory Council or Advisory Boards of co-funding NIH Institutes and Centers or Participating Organizations.

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research resources program (Programmatic, Linked, and Coordinating Center applications) to exert a sustained, powerful influence on the research fields involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the program proposed).

For the Programmatic Awards:

Scored Review Criteria

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

Significance. Does the project address an important problem or a critical barrier to progress in medical education? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How does the research resources program proposed remove critical barriers to progress in implementation of PEPFAR and other public health priorities? How will the program be transformative and sustainable for the participating schools and institutions?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? How will the past collaborations of the investigators (and their institutions) contribute to the likelihood of success in the proposed program?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How does the program promote and support innovation that will strengthen medical education and health services research? How will all participating entities, both among the components of the university and within the partnership or a consortium (where applicable), contribute to the innovation goals of the proposal?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? How will the applicant’s strategy and experience in returning/keeping trainees and faculty in the host country be amenable to scale-up and sustainability? Do the applicants include a plan for trainee selection and, if so, how will the function and membership of a trainee advisory committee support the identification of training needs, programs, and appropriate trainees? How will other resources and funders at the institutions be involved? How do the other participating disciplines and/or institutions and their previous collaborations contribute to the likelihood of success? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? How is the proposed partnership a previously existing partnership or collaboration between the Applicant University and selected partner(s)? How does the applicant identify and plan to take advantage of other resources at their institution or in their country (e.g. Global Fund, Wellcome Trust, Gates Foundation, Doris Duke, Millennium Villages, and others)?

For the Linked Awards:

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How does the program provide new training opportunities, new training models, and new resources for multidisciplinary research on the health concerns of the local community and country at the institution(s) related to and/or beyond HIV/AIDS? How will collaborations with existing programs in the country or region be included so as not to duplicate but to coordinate efforts? How will the program be transformative and sustainable for the participating schools and institutions?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How does the program propose innovative ways to integrate training and research across disease and health areas to address strengthening the health system as a whole?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? How does the program take advantage of local health research expertise in non-communicable diseases and other priority health areas related to and/or beyond HIV/AIDS at the participating institution(s)? Do the applicants include a plan for trainee selection and, if so, how will the function and membership of a trainee advisory committee support the identification of training needs, programs, and appropriate trainees? How will other resources and funders at the institutions be involved? How do the other participating disciplines and/or institutions and their collaborations contribute to the likelihood of success? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? How is the Linked award proposal integrated and coordinated with the Programmatic proposal?

For the Coordinating Center:

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How do the proposed role, activities, and value added as a consultation resource/Coordinating Center contribute to the initiative? How will the applicant provide leadership and sound methodological consultation to Programmatic and Linked awardees sites? Does the application demonstrate in-depth knowledge of medical education and an in-depth understanding of the public health priorities across Sub-Saharan Africa?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? How will the investigators (and their institutions) and/or selected partners previous collaborations increase the likelihood of success in the proposed program?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the applicant have the ability to develop a web-based system to adequately support the collection and reporting on MEPI to include necessary output, outcome, and impact data elements as well as data on trainee careers? How will proposed public-private partnerships, coalitions, and networks of African scientists and educators in leadership roles support collaboration with and enlist the cooperation of Ministries of Health and Education across Sub-Saharan Africa?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? How will the applicant conduct annual assessments to determine technical support needs and best practices for Programmatic and Linked awards and complete a comprehensive evaluation of the overall program by the final year of the project? Is there appropriate logistical support to plan necessary grantee meetings, site visits, and conference calls?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? How does the selected African partner(s) add to the technical merit of the application and what is the African partner’s capacity to function in the CC role by the end of the initial 5-year project period? Will the applicant be in a position to offer potential training opportunities to faculty and students in the Programmatic and/or Linked awards and support building local evaluation capabilities?

Additional Review Criteria

The following applies to applicants for each Programmatic and Linked Award as well as the Coordinating Center.

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

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

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

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

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

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

Resubmission Applications. Resubmission applications are not permitted in response to this FOA.

Renewal Applications. Renewal applications are not permitted in response to this FOA.

Revision Applications. Not applicable to this FOA.

Additional Review Considerations

The following applies to applicants for each Programmatic and Linked Award as well as the Coordinating Center.

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

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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

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

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 or the unique circumstances for short-term training programs, detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. See also: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html.

Selection Process

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

• Scientific and technical merit of the proposed project as determined by peer review.
• Diversity or variation of educational models and innovation to be awarded.
• Geographic balance throughout Sub-Saharan African countries which receive PEPFAR support.
• Relevance of the proposed project to program priorities and strategic plans of the OGAC, NIH, and HRSA.
• Applicants collaboration with other implementing USG PEPFAR partners (e.g. USAID, CDC, DOD, and others).
• Availability of funds and interests of U.S. collaborating partners.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. See Also Section IV.5. Funding Restrictions.

FIC/NIH and HAB/HRSA will work together to support awardees activities, and this will be closely coordinated with OGAC, although some awards will be administered directly by FIC/NIH and others directly by HAB/HRSA. The Linked awards funded by the Common Fund or awards supported by the OAR through this initiative will be administered by the FIC on behalf of the NIH.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Web-based monitoring, evaluation, and reporting system: Programmatic and Linked Awardees are expected to work with the Coordinating Center to document and report on progress (to include tracking faculty and student recruitment, training, retention, and practice/research efforts) under the grant. The CC will develop a web-based monitoring, evaluation, and reporting system for this purpose. Curriculum development, training, publications and other significant accomplishments of the program and trainees must be reported and described in annual progress reports. The CC will coordinate the collection of this data to use in assessing and evaluating how the overall objectives of the MEPI are being met.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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:

Early Conference calls open to all potential applicants will be held on pre-selected dates. Please see (www.fic.nih.gov) for additional information.

1. Scientific/Research Contact(s):

Letitia B. Robinson, Ph.D., R.N.
International Program Officer for Sub-Saharan Africa
Division of International Relations
Fogarty International Center
National Institutes of Health
Building 31 Room B2C11
Bethesda, MD 20892-2220
Telephone: (301) 496-4784
FAX: (301) 480-3414
Email (preferred): [email protected]

2. Peer Review Contact(s):

Dan Gerendasy, Ph.D.
Scientific Review Officer
Division of Neuroscience, Development and Aging
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892
Telephone: (301) 408-9164
FAX: (301) 594-6363
Email: [email protected]

3. Financial/Grants Management Contact(s):

Ms. Rhea Hubbard
Grants Management Specialist
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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/.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. 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 (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 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.