Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/ ) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Human Genome Research Institute (NHGRI/NIH), (http://genome.gov) on behalf of the NIH. Participating Institutes: National Human Genome Research Institute (NHGRI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Neurological Disorders and Stroke (NINDS) Office of AIDs Research (OAR) Fogarty International Center (FIC) Office of Strategic Coordination (Common Fund)
Funding Opportunity Title	Human Health and Heredity in Africa (H3Africa): Research Grants (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	Reissue of RFA-RM-11-009.
Related Notices	August 9, 2016 - This RFA has been reissued as RFA-RM-16-015. August 22, 2012 - This RFA has been reissued as RFA-RM-12-007. June 13, 2012 - See Issuance of RFA-RM-12-005: Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program (U01). May 25, 2012 - See Notice NOT-RM-12-025. Notice of Intent to Publish Human Heredity and Health in Africa (H3Africa): Research Projects FOA.
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-004 Applicants who have successfully submitted an application in response to RFA-RM-11-009 have the opportunity to either (a) allow the accepted application to remain at NIH, where it will be reviewed as submitted, or (b) withdraw that application and submit an updated version for the January 6, 2012 receipt date. Applicants are advised to contact NIH Program Staff to discuss this option.
Companion FOA	RFA-RM-11-008, U54 Human Heredity and Health in Africa (H3Africa) Collaborative Centers RFA-RM-11-010, U41 Human Health and Heredity in Africa (H3Africa) Bioinformatics Network
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310, 93.172, 93.279, 93.853, 93.989
FOA Purpose	This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund (Common Fund) and participating NIH Institute(s) and Center(s), invites applications from foreign Institutions in African countries who wish to develop the study of genomic/genetic/environmental contributors of human health and disease within Africa, using cutting edge research tools to understand health and diseases affecting African populations more completely and increase capacity for biomedical research, in terms of building infrastructure (including data and research resources), genomic proficiency of researchers and numbers of trainees. In partnership with the Wellcome Trust, the H3Africa initiative is focused on supporting these efforts as part of an effort to promote sustainable research in Africa that will promote health and combat disease. The purpose of this FOA is to call for applications for research projects. Awards will focus on supporting research on the genetic/environmental contributors to health and disease in Africa that fall within the mission of the NIH, which is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

Posted Date	December 21, 2011
Open Date (Earliest Submission Date)	December 21, 2011
Letter of Intent Due Date	N/A
Application Due Date(s)	January 6, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February/March 2012
Advisory Council Review	May, 2012
Earliest Start Date(s)	July, 2012
Expiration Date	January 7, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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

Purpose

Low- and middle-income nations suffer over ninety percent of the world’s burden of premature mortality, as measured in lost years of life. These countries, constituting three-quarters of the world’s population, now must deal with a triple burden: the persistent cluster of infectious diseases, malnutrition, and a growing incidence of chronic disease and disabilities due to increased life spans and new risk exposures that accompany it. The NIH has a long-standing commitment to address both communicable and non-communicable diseases around the world through health research and training, and one of NIH’s stated priorities is enhancing efforts in global health. Genomics and other large-scale biological studies provide cutting-edge approaches to research on the genetic and environmental contributors to health and disease, the understanding of which will lead to unimagined advances in medical science and powerful new ways for improving human health. To maximize the impact on the health of people globally, advances in the fields of genetics/genomics/environmental studies must be integrated into the research conducted in developing countries, as well as into their medical education and health services. Notably, however, African researchers and populations are substantially underrepresented in genomics and environmental research endeavors. For example, it has been found, as documented in a recent review, that, worldwide, the majority of the thousands of genetic studies completed to date (about 75%) were conducted exclusively in populations of European descent and only a fraction of the studies done with non-European populations came from Africa (Rosenberg NA, Huang L, et al. (2010). Nat Rev Genet 11(5):356-366). The paradox of limited genomics research conducted in Africa and the centrality of contemporary African populations for our understanding of human evolution and population genetics has been widely noted.

While there are pockets of research excellence in genetics and environmental studies on the African continent done by African and other scientists, a limited number of individuals have the expertise to engage in this work compared to the overall population size and burden of disease there. It is the objective of the H3Africa Initiative to enhance the capability of African scientists and research institutions to use genomics and other powerful new approaches to address problems of African health and disease. Increasing African research capacity by building infrastructure, expanding the genomic proficiency of researchers, and increasing the number of well-trained individuals is essential to promote sustainable efforts to address the challenges to advancing health and combating disease in Africa. While focused on benefitting the people of Africa, such research may also be relevant to the health of individuals in the U.S. and other countries worldwide, particularly those of African descent. For example, many scientists believe that different environmental exposures for a population whose genetic architecture evolved in environments with a scarcity of available resources are an underlying contributor to disease in the U.S.

H3Africa is a partnership among the National Institutes of Health (NIH, USA), the Wellcome Trust (WT, UK), and the African Society of Human Genetics (AfSHG). A set of recommendations for H3Africa was developed by a pair of working groups, composed primarily of African scientific experts, who addressed the major scientific, ethical and practical issues in the development of a large-scale genomics research program in Africa. The working groups formulated a detailed proposal (which can be found in a white paper at www.h3africa.org) to address the goal of creating and sustaining a network of African Centers that could carry out training and research based on state-of-the-art genomics approaches. Through support for infrastructure development, training, and specific research projects, the working group recommendations were designed to catalyze genomics and environmental research concerning human diversity, health, and disease biology of particular relevance and benefit to African populations and societies. The proposal was discussed at a public meeting held in Cape Town, South Africa in March 2011 and the attendees ratified the white paper’s recommendations.

The research program described in this FOA (and a similar call for applications from the Wellcome Trust) is a response to the disparities in research capacity noted above and is based, in significant part, on the recommendations of the H3Africa white paper and from discussions at the Cape Town meeting. The H3Africa Initiative aims to contribute to the establishment of a viable, productive, and eventually sustainable, African research infrastructure to study the genetic and environmental contributors to disease and health. It aims to do so through a combination of the leveraging of existing capacity, expertise and infrastructure with investment in new research, infrastructure-building and training efforts.

H3Africa has three interrelated, interdependent objectives. The first is to increase the human resources for conducting cutting-edge genomics-based research in Africa through training, career development, and through enhanced collaborations within Africa and with the African scientific diaspora. The second is to support cutting-edge research that will not only generate important findings and discoveries, but will serve as a vehicle for research training and for the improvement of the research capacity of African laboratories where the research is carried out. The third is to support the improvement of specific types of infrastructure, i.e., bioinformatics and biorepository capacity, which are needed to do genomics-based and environmental research. To achieve these objectives, the H3Africa program at NIH will comprise the following: Infrastructure improvement will be addressed by support for an H3Africa Bioinformatics Network (see http://grants.nih.gov/grants/guide/notice-files/NOT-RM-11-014.html ) and for biorepositories in Africa (see: http://grants.nih.gov/grants/guide/notice-files/NOT-RM-11-015.html). It is anticipated that one or more full-scale H3Africa Biorepositories will be established in Africa after the planning grant/feasibility phase. The current FOA is a call for applications from new or established genomicists who propose to establish a collaboration between their independently funded H3Africa genomics/genetics project and an ongoing, funded project that does not currently have a genomics focus. The ongoing project may be an NIH or other US government funded grant, cooperative agreement or contract, for example from the CDC, or may be an award from non-US government entities such as the Wellcome Trust, Doris Duke Charitable Foundation, The Bill and Melinda Gates, Foundation and others. A companion FOA to this document (RFA-RM-11-008) calls for H3Africa Collaborative Centers for genomic/genetic research (also see a similar call for proposals from the Wellcome Trust at: http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm). Finally, there will also be a small grant program to support research on the societal implications of genomics in Africa; this program will be funded in FY13. All awards under the NIH H3Africa program will be made to African institutions, and the majority of the awarded funds must be spent in Africa. All awardees will participate in the H3Africa Consortium to further enhance the collaborative nature of this Initiative.

H3Africa is funded, in part, through the NIH 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.

Research Objectives:

A. Scientific scope

The objective of this FOA is to solicit applications to establish independent H3Africa Research Projects that will collaborate with ongoing 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 Charitable Foundation, The Bill & Melinda Gates Foundation, and others) to add a genomics-based approach to the study of a chronic or infectious disease to an on-going funded study that does not currently have a genetics component. Applications must include a description of the currently funded project and should clearly describe how the proposed genomics research will complement the research already being done in that project.

The scientific focus of applications responsive to this FOA will broadly be within the scope of human genetic/environmental contributors to disease and other health-related traits in Africa. The following list provides examples of the types of topics that may be addressed. It is important to note, however, that this list is meant only to provide guidance; it is not exhaustive and appropriate topics are not limited to the examples given here.

• The genetic/environmental contributors to non-communicable disease in Africa. The burden of chronic diseases in Africa has been difficult to measure because of the absence of a coordinated process to estimate disease prevalence. However, a small set of prospective studies and hospital experiences have identified the increasingly important impact of chronic disease. Examples include a substantial burden from hypertension, a high mortality rate from stroke, a rapidly growing threat from diabetes, and an increasing recognition of the prevalence of mental illnesses. Some clinical and epidemiologic research on such chronic conditions has been conducted in several sites on the continent, and clinical expertise can be found in many hospitals and tertiary care settings related to these conditions. A small number of linkage, candidate gene, and genome-wide association studies (GWAS) have been completed and have been able to identify potential new loci involved in disease, as well as replicate findings from other studies. An appropriate H3Africa project might involve collection of new or existing samples from one or more populations of interest from specific site(s). The individuals from whom samples are collected should be well-phenotyped to ensure that the disease being studied has been properly diagnosed. Samples may be assayed by, for example, genotyping, exome or whole genome sequencing, and/or functional genomics methods to fully elucidate the genetic underpinnings of the disease or trait of interest. Analysis of exposure data on these individuals could provide evidence about the environmental factors that, in conjunction with the genetic determinants, could help explain the etiology of the disease under investigation.
  
  
• The genetic/environmental contributors to communicable disease in Africa. Infectious diseases, including HIV/AIDS, malaria, tuberculosis, leishmaniasis, trypanosomiasis, schistosomiasis, as well as many others, have historically been a major health problem in Africa. A variety of genetic and environmental factors contribute to developing, treating and preventing infectious diseases and their impact. Significant attention and considerable funding have been given to the study of communicable diseases, and excellent research facilities for studying them are found throughout Africa. One of the important aspects of the widespread nature of infectious diseases and the high rates of infection in populations living in similar environmental conditions is the considerable inter-individual phenotypic variability in susceptibility and response to infection, which can range from asymptomatic to death. Contemporary genomic approaches can help to understand the role that host genetics plays in these diseases. Similarly, additional genomic analysis and studies of the genetics of the parasites and vectors involved in the diseases are needed. HIV/AIDS and malaria are among the most well-studied communicable diseases in Africa. While NIH will consider study of the host factors involved in susceptibility to HIV infection and diseases that are co-morbid with HIV/AIDS (see below) as being responsive, studies of other infectious diseases are encouraged.
  
  
• The contribution of the human microbiome to health and disease in Africa. The field of metagenomics has been enabled by recent advances in sequencing and other technologies, and studies of the role(s) of the human microbiome in health and disease have burgeoned. Changes in the microbiome at particular body sites have been correlated with the onset or progression of several diseases, such as Crohn’s disease, psoraisis and bacterial vaginosis. Most microbiome studies have been done outside of Africa, but given the expectation that microbiome composition is highly dependent on many environmental factors, including geographical location, diet, socio-economic status, as well as host genetics, the relevance of the results of those studies to health and disease in Africa cannot be assumed. As an individual’s microbiome is expected to make a significant contribution to health status, studies of the role of the microbiome in diseases of African interest, and comparative analyses of microbiomes from healthy cohorts, would be appropriate H3Africa research projects.
  
  
• Mendelian diseases in Africa. Local founder effects and the cultural practice of consanguineous marriages in many African communities have resulted in the increased prevalence of monogenic traits across the continent. Recent studies have demonstrated that exome sequencing of a limited number of individuals can be used effectively to identify causative mutations in several Mendelian diseases. An analysis of individuals affected by Mendelian diseases to identify causative mutations and modifier genes in African populations would be appropriate H3Africa research projects.
  
  
• Pharmacogenomics: Pharmacogenomics research seeks to identify genetic factors that are responsible for individual differences in drug efficacy and susceptibility to adverse drug reactions (ADRs). African populations have been underrepresented in pharmacogenomics research. Yet these populations show the highest levels of genetic diversity among human populations. Pharmacogenomics can be applied to numerous treatments of illnesses that plague the African continent, for example, identification of the genetic variant(s) involved in inter-individual variability in the response to chemotherapy drugs used in cancer treatment, drugs used for the treatment of HIV, malaria, and other infectious diseases, as well as pain medication. Analysis of pharmacogenetic effects in Africans would be an appropriate H3Africa research project.

While applications submitted in response to this FOA may propose research in any disease or health area that falls within the broad areas of genetic/environmental contributors to disease or health research, there are certain specific areas of interest to the NIH components that have contributed funding to H3Africa. These include:

• AIDS and co-morbidities. Research examining the genetic and genomic basis of HIV/AIDS disease and its co-morbidities including, but not limited to, host immune response to HIV infection; interaction of HIV with the host immune system; genomics in the context of HIV vaccine and microbicide development; host factors involved in co-infection, including tuberculosis, hepatitis C and hepatitis B in the context of HIV infection; host factors involved in AIDS-defining and non-AIDS defining malignancies in HIV-infected individuals; and host factors involved in complications associated with long-term HIV disease and antiretroviral therapy (ART), including metabolic disorders, cardiovascular disease, conditions associated with aging, and neurologic and neurocognitive disorders.

Neurological disorders and stroke: Research in neurological projects that address the H3 goals are of interest. Study designs may include a broad range of disciplines, such as molecular genetics, pharmacogenomics, epidemiology, stigma research, and intervention research. Quality phenotyping is essential for genetic research; therefore, collection and analysis of genetic material from individuals participating in well characterized, neurological-based cohorts materials are of high interest, particularly in the areas of stroke and stroke risk factors, epilepsy, and susceptibility to peripheral neuropathy due to infection or inflammation, as well as other neurological diseases and disorders. Applications that enhance the NIH-funded Medical Education Partnership Initiative (MEPI) training experience are encouraged (http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-MEPI.aspx). Applications that use technologies such as mobile technologies that enhance health, knowledge, or care delivery of neurological disorders are also of interest.

• Genetic and genomic basis of HIV/AIDS disease, abuse of licit or illicit substances (including alcohol, tobacco, cannabis, stimulants, opiates), and related co-infections or co-morbidities: Topics include, but are not limited to studies of the host and viral determinants of immune responses to HIV infection in substance users, particularly related to specific disease phenotypes; the factors related to immune recovery following antiretroviral treatment in the context of substance use; determinants of susceptibility to HIV infection among substance users; complications associated with long-term HIV disease and substance use, such as tuberculosis, HIV/HCV-associated liver disease, cardiovascular disease, metabolic disorders, and neurologic and neurocognitive disorders; and viral evolution in association with injection or non-injection substance use.

B. Implementation of the objectives of H3Africa.

As noted in the Background section, there are several specific objectives that the H3Africa Program is trying to achieve. Applications submitted in response to this FOA must address the following:

• Research plan. The application should describe a well-conceived plan for the investigation of the genomic, and at the applicant’s discretion the environmental, contributor(s) to a disease or other health-related condition. The applicant should clearly state how the research proposed will lead to an improved understanding of its genetic and environmental origin(s). The application should provide a description of the health impact of the condition in Africa, and the relationship (if any) to the condition in other parts of the world. The applicant should present a well-considered plan for accomplishing the goals of the research application. The research plan should discuss identification and acquisition of the samples to be analyzed, the generation of the data, and the management and analysis of the data.

If the data are to be generated by the research project itself, the applicant’s experience with the necessary technologies, the costs of generating the data, and the anticipated uses should be addressed. The availability of samples and supplies should be discussed, as should any issues of long-term maintenance and servicing of the necessary equipment.

Alternatively, the applicant may choose to send the samples elsewhere for data generation, for example to a research center or to service providers. Such an approach could be taken, for example, for genotyping, microarray analysis or sequencing. In either case, the data generator may be in Africa or overseas. In describing this approach, the applicant should describe how the samples will be prepared for shipment to the data generator, the type of data expected, and how the data will be returned to the research site for analysis.

The applicant should describe how the resultant data, whether produced in-house or obtained externally, will be analyzed, including a discussion of the applicant’s experience with the relevant analytical technologies and methods.

• Collaboration: The H3Africa research projects are expected to work closely with the 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 Charitable Foundation, The Bill & Melinda Gates Foundation, and others). The nature of the collaboration, its benefits to the H3Africa research project and how the H3Africa research project will benefit the funded grant/contract should be described. Other collaborations, outside of the PD(s)/PI(s) institution are encouraged if they are important to promote the interests of the project. Letters of collaboration from the PD(s)/PI(s) of the funded research and other collaborators are mandatory. These letters should describe any resources, equipment, or other infrastructure from the ongoing work that will be available for the U01 research through the collaboration.
  
  
• Sample collection and Human Subjects Issues. The research plan must include a detailed plan for sample acquisition (where applicable), storage, preparation of material needed etc. In particular, investigators are urged to obtain consent for the wide sharing of samples and data; justification should be provided if samples and data will not be shared or only shared in a limited manner. A document entitled "Essential Elements of Informed Consent for H3Africa Research Projects" may be helpful to applicants in writing their informed consent documents; this can be found at http://www.h3africa.org/informedConsent.cfm. A timeline for developing and implementing an informed consent process, including obtaining IRB approval, must be included in the application.

H3Africa anticipates establishing a biorepository in Africa starting in 2014. All samples (blood, DNA or cell lines) are expected to be deposited in the H3Africa Biorepository where they can be distributed and shared for further research consistent with achieving the goals of this funding initiative. Sample deposition must occur expeditiously, no later than the date of the first publication that describes the samples or by the end of the project, whichever comes first. A statement of commitment from the applicant institution to send samples to the H3Africa Biorepository must be included in the application. This should include a description of the host country’s policies for sending samples out of the country.

Bioinformatics. The bioinformatics capacity of the research project should be clearly described. Issues of data acquisition, data management, data storage, and analytical capability should be addressed. The bioinformatics tools that will be used for each of those functions, and the applicant’s experience should be described in the application.

Please note the H3Africa Program will fund a separate H3Africa Bioinformatics Network (see companion FOA, RFA-RM-11-010) to provide connectivity among the H3Africa participants, and eventually beyond H3Africa. The H3Africa Bioinformatics Network will also have the ability to develop new bioinformatics tools for genomics research in Africa. The research projects and any other H3Africa-funded activity will be required to interact with H3Africa Bioinformatics Network. Therefore, applicants for a research projects funded under this FOA must include a statement from the applicant institution committing it to collaborating and sharing data with the H3Africa Bioinformatics Network consistent with achieving the goals of H3Africa.

• Infrastructure: To the extent possible, the research projects are expected to utilize existing infrastructure in the research institutions where the studies will be carried out. The description of existing institutional infrastructure must be provided in the Resources section of the grant application. This section should be detailed and well documented. Additional infrastructure components may be requested in the application.
  
  
• Sustainability: One of the major goals of the H3Africa program is to enable African scientists to demonstrate their world-class skills through the establishment of cutting-edge research programs that will lead to more publications and other evidence of productivity, thereby increasing their opportunities for future funding through normal competitive grant processes, as well as through increased investment in research by national governments and private sources. Applicants should discuss the issue of future sustainability of their research programs beyond the H3Africa program. This section of the application should refer to the letters of Institutional and National commitments (see below) to provide an overview of the long term prospects for sustained research by the research project.
  
  
• Data Sharing and Release plan: A plan for data and resource sharing and release is expected for all NIH applications (http://grants.nih.gov/grants/policy/data_sharing/). Applicants are expected to provide a well thought-out plan for widely sharing data and resources generated by H3Africa. An application must have an acceptable Data and Resource Sharing and Release plan before it can be funded. After the awards are made, the H3Africa Consortium (see below) will develop a unified plan for data and resource release, and the application must include a statement that the investigators in the H3ACC will abide by the Consortium’s data and resource policy. Examples of current data release guidelines for NIH programs can be found at: http://www.h3africa.org/dataReleasePolicy.cfm
  
  
• H3Africa Consortium Meetings: The NIH and the Wellcome Trust plan to hold two H3Africa Consortium meetings per year, and applicants should request funds to travel to these meetings in their application. Most of the meetings will be held in Africa. However, in the first year, one of the Consortium meetings will be held in London, UK, and in year three, one will be held in Bethesda, MD. It is expected that each research project will bring 1 to 2 people to the meeting. For the meetings in London and Bethesda, each research project should be represented by at least the PD/PI and one trainee. Appropriate travel funds for these meetings must be requested in the application.
  
  
• Monitoring and Evaluation Plan: Applications must contain a plan for how the funds and supported activities will be monitored and evaluated. The plan should discuss how the project will be assessed and how the applicant will define, identify, and determine impact. The plan should also discuss how any necessary modifications indicated as a result of monitoring and evaluation activities will be effected. To facilitate monitoring and evaluation, applications should include a well-defined set of yearly milestones for the proposed research and training activities. The milestones will be negotiated and finalized at the time of award, and will then be included in the Terms and Conditions of the award. The milestones will be subject to change only with the NIH Program Director’s agreement, but will be reconsidered on an annual basis to account for the project's experience and progress. An example of the level of detail and specificity needed for the milestones can be found in an example set of acceptable milestones from past genomics projects, posted at http://www.h3africa.org/genomicsProjectMilestones.cfm.
  
  
• Institutional and National Commitments: Applications should include letters from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from all collaborating institutions substantiating the institution’s commitment to the proposed research. The institution should state its commitment to overcoming any administrative obstacles to the implementation of the application, such as accommodation for participation by multiple Schools at the university or collaboration with other institutions within or outside of the applicant s country. If the PD(s)/PI(s) is a new investigator, the institution should state its long term commitment to the career of the investigator, in terms of salary support, protected time for research, and lab space. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program. It should also address commitment to collaborating and sharing data with the H3Africa Bioinformatics Network. The letter should also briefly discuss the institution's plans for sustaining an active program of scientific research.

As the programmatic activities of this initiative will support national and international collaborations, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component will be required. The letter should briefly describe the national policy concerning the development of a national scientific research program and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development (R&D). 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.

In Summary: This FOA calls for applications for H3Africa research projects to carry out the research goals of H3Africa, which include:

• establishment of viable, productive, and eventually sustainable, African research programs for the study of the genetic and environmental contributors to disease and health,
• improving the research environment by leveraging current expertise and existing infrastructure with new investments, and
• training and career development

The scientific scope of the H3Africa research projects is broad, and may address:

• the genetic/environmental contributors to non-communicable disease in Africa,
• the genetic/environmental contributors to communicable disease in Africa,
• the human microbiome in Africans and its contribution to health and disease,
• Mendelian diseases,
• Pharmacogenomics,
• Other

Applications should address the following:

• Research plan, including the qualifications of the PD/PI(s) of the overall research project.
• Sample collection and human subjects issues
• Training and career development
• Bioinformatics, including connection to the H3Africa Bioinformatics Network
• Available infrastructure,
• Data sharing and release,
• Monitoring and evaluation,
• Institutional commitment,
• National plans for science

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	This initiative is supported by NIH Common Fund, Institute(s) and Center(s) of the NIH who have signed on to support the H3Africa initiative. The amount of funding and the number of awards will rely upon the outcome of peer review, the interests of the NIH institutes, and the availability of funds. The total amount of funds available for these awards is approximately $1.25 million per year for FY12-16 contingent upon receiving scientifically meritorious applications. Up to 4 awards are anticipated from this solicitation.
Award Budget	Applications are limited to $275,000 direct costs per year which includes salaries, supplies, training, equipment, travel, and other allowed expenses for research grants.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

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.

• Non-domestic (non-U.S.) Entities (African Institutions)
• Specifically:
  • African institutions that are eligible for the NIH awards:
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

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

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

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

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

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

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

The PD(s)/PI(s) may have recently completed postdoctoral training or may be an established investigator. In either case, the PD(s)/PI(s) must have established him/herself as an expert 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(s)/PI(s) (i.e., multiple PD(s)/PI(s)), 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(s)/PI(as) on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PD(s)/PI(s) 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).

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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

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

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

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The UH2 and UH3 Sections are each limited to 12 pages for the Research Strategy section of the application.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• H3Africa resource and data sharing plans will be agreed to by the entire network once all the applications are funded. However, applicants must provide a plan in the application that must be approved by H3Africa program staff before the application can be funded consistent with achieving the goals of this program
• All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource Sharing Plan.

Appendix

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

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

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

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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 will the goals of the proposed research project address the goals of H3Africa? Is the collaboration with the 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 Charitable Foundation, The Bill & Melinda Gates Foundation, and others) appropriate and will it further our knowledge on the larger research questions being addressed by both the funded project and the H3Africa-funded project?

Investigator(s)

Are the PD(s)/PI(s), 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(s)/PI(s), 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 promote and support innovation that will strengthen and sustain genomics research in 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? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project? 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? Does the project take advantage of resources available within the associated funded project? Do the letters of collaboration and institutional support show strong commitment to the project, and for new investigators, to the PD(s)/PI(s)?

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

Sustainability

Is the Center's plan for sustainability feasible? Will the Center and/or its components be well-positioned to apply for continued funding at the end of the project period?

Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained research enterprise?

Do the collaborations among the institutions suggest viable long-term partnerships?

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

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 Africa and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• 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 overall impact/priority score.
• Will receive a second level of review by the appropriate National Advisory Council
• Will receive a written critique.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Quality of resource sharing and data release policies
• How well the application addresses the goals of H3Africa
• Institutional commitment and national plans for science

Appeals of initial peer review will not be accepted for applications submitted to this FOA.

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

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Definitions

Steering Committee (SC):

The Steering Committee is the primary governing body of the H3 Africa Research Network. PI(s)/PD(s) of grants, and NIH Program Directors serve on the committee. See further details about the Steering Committee under "Joint Responsibilities".

Panel of Scientific Consultants (PSC)

The PSC will be composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the H3Africa Research Network. It will be responsible for reviewing and evaluating the progress of the H3Africa Research Network. See more about the PSC below under this topic.

The PD(s)/PI(s) will have the primary responsibility for:

• All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.
  
  
• Awardees agree to the governance of the Consortium through the Steering Committee and recommendations from the Panel of Scientific Consultants.
  
  
• Awardee(s) will agree to accept close coordination, cooperation, and participation of H3Africa staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
  
  
• Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by H3Africa staff and ensure that the data produced meets the quality standards agreed to at the beginning of the project by the Research Network;
  
  
• Awardee(s) will ensure that the data are deposited in the appropriate public database (e.g., GenBank or other, as specified by H3Africa program staff), that resources developed as part of this project are made publicly available according to H3Africa policies, and that results are published in a timely manner;
  
  
• Awardee(s) will adhere to the H3Africa policies regarding intellectual property, data release and other policies that might be established during the course of this activity that are consistent with applicable NIH policies, laws, and regulations.;
  
  
• Awardee(s) will integrate with and connect to the H3Africa Bioinformatics Network (see FOA RFA-RM-11-010) and deposit samples in the H3Africa Biorepository that is anticipated to be established;
  
  
• Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• One H3Africa Project Scientist from each participating Institute will serve on the Steering Committee and have one vote; the number of NIH votes may not exceed the number of PI votes on the SC. They and other H3Africa project team scientists may serve on other study committees, when appropriate. The H3Africa Project Scientists may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., data sharing, data release, quality control, core establishment.
  
  
• The Project Scientists will participate (with the other Steering Committee members) in the group process of deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
  
  
• The Project Scientists will negotiate goals with the awardees as necessary, serve as a liaison between the awardees and the Panel of Scientific Consultants, the appropriate NIH Institute and Center National Advisory Councils, the NIH H3Africa Working Group made up of program staff that collectively manage the program, and the larger international scientific community, attend all Steering Committee meetings as voting members and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
  
  
• The Project Scientists will periodically report progress to the Director of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), of which the Office of Strategic Coordination that manages the NIH Common Fund is part of as well as OAR, and to the Directors of NHGRI, FIC, NINDS, NIDA, and NICHD.
  
  
• The Office of Strategic Coordination (OSC), NHGRI, NIDA, NINDS, NICHD, and OAR reserve the right to withhold funding or curtail the study (or an individual award) in the event of (a) substantive changes in the agreed-upon work scope with which OSC, NHGRI, NIDA, NINDS, NICHD, and OAR cannot concur, (b) human subject ethical issues that may dictate a premature termination.
  
  
• Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH.
  
  
• Additionally, an agency program official or NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Officer may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

• Participate in the Steering Committee. A Steering Committee will serve as the main governing board of the H3Africa Research Network. The Steering Committee membership will include the NHGRI, NIDA, NINDS, and NICHD Project Scientist(s) and the P.I. of each awarded cooperative agreement. The Steering Committee Chair will not be an NIH staff member but will be appointed by H3Africa staff. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. Because the Research Network will include investigators funded by this FOA and other FOA's for H3Africa, it is possible that H3Africa staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees under a specific FOA.

The Steering Committee will:

• Discuss progress in meeting the goals of various H3Africa projects;
• Develop recommendations for uniform procedures and policies necessary to meet the goals of the Research Network, for example for data quality measures and assessment, conventions for data deposition;
• Schedule the time for, and prepare concise (3 to 4 pages) summaries of, the Steering Committee meetings, which will be delivered to members of the group within 30 days after each meeting. The SC will meet twice a year in conjunction with network meetings and with intermittent conference calls.
• Each full member (limited to one person per awarded project) will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The Panel of Scientific Consultants:

The NIH will convene an expert committee, termed the Panel of Scientific Consultants (PSC), to provide advice to the Directors of DPCPSI, NHGRI, FIC, NINDS, NIDA, and NICHD about the progress and achievements of the H3Africa Research Program. The PSC members will be experts in genomics-based research and research in Africa, who are not associated with any of the funded H3Africa projects.

• The PSC will meet at least once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the PSC members to interact directly with the awardees.
• Annually, the PSCs will make recommendations regarding progress of the H3Africa Research Network and present recommendations regarding changes, if any, which may be necessary in the H3AFrica Research Network program to the Directors of DPCPSI, NHGRI, FIC, NIDA and NINDS.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, 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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

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

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

Jane L. Peterson, Ph.D.
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: 301 496 7531
Fax: 301 480 2770
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9305
Rockville, MD 20852

Joni L. Rutter, Ph.D.
Acting Director
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd, Room 4282
Bethesda MD 20892-9555
Ph: 301.435.0298
Email: [email protected]

Salina Waddy, M.D
Program Director
National Institute of Neurological Disorders and Stroke, NIH
Office of Clinical Research
6001 Executive Blvd, NSC, Suite 2153
Bethesda, MD 20892-9525
Rockville, MD 20852 (for Express/Courier Service)
Telephone: (301) 496-9135
FAX: (301) 402-1501
Email: [email protected]

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Phone: 301-402-0838.
Fax: 301 435 1580
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9306
Rockville, MD 20852.

Victoria Bishton
National Human Genome Research Institute
Telephone: 301.451.7928
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.