Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	This 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) Division of Program Coordination, Planning and Strategic Initiatives Office of Strategic Coordination (Common Fund) 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)
Funding Opportunity Title	Human Heredity and Health in Africa (H3Africa): H3Africa Research Grants (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	Reissue of RFA-RM-12-004
Related Notices	NOT-RM-12-025 October 26, 2012 - See Notice NOT-OD-13-005. Notice of Change in Due Date.
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-007
Companion Funding Opportunity	RFA-RM-12-006, U54 Human Heredity and Health in Africa (H3Africa Collaborative Centers Cooperative Agreements RFA-RM-12-008 Human Heredity and Health in Africa (H3Africa): Biorepositories (UH2/UH3) RFA-RM-11-010, U41 Human Heredity and Health in Africa (H3Africa): Bioinformatics Network Cooperative Agreements RFA-RM-12-005, U01 Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program
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, 93.865
Funding Opportunity Purpose	The purpose of this NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund (Common Fund) and participating NIH Institute(s) and Center(s), is to invite applications from Institutions in African countries for Research Projects (U01 cooperative agreements) that address one or more goals of the Human Heredity and Health in Africa (H3Africa) initiative. H3Africa is an NIH initiative in partnership with the Wellcome Trust with the goals of developing the study of genomic/genetic/environmental contributors to human health and disease within Africa using cutting-edge genomic research tools, increasing capacity for biomedical research in Africa, in terms of building the infrastructure needed for genomic research (including data and research resources), and increasing the genomic proficiency of researchers and trainees in Africa. 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.

Posted Date	August 22, 2012
Open Date (Earliest Submission Date)	September 28, 2012
Letter of Intent Due Date	September 28, 2012
Application Due Date(s)	(Extended to October 31, 2012 per NOT-OD-13-005), Originally October 29, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February/March, 2013
Advisory Council Review	May, 2013
Earliest Start Date(s)	August 1, 2013
Expiration Date	(Extended to November 1, 2012 per NOT-OD-13-005), Originally October 30, 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

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 the attendant new risk exposures. 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/whitepaper.cfm) 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 first set of FOAs soliciting applications for H3Africa was published about one year ago (see Archive Funding Opportunities at https://commonfund.nih.gov/globalhealth/grants.aspx), and funding for the program will begin in the summer of 2012.

The research program described in this and previous FOAs 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 for the study of 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 and enhanced collaborations with national and international partners, particularly in other countries within Africa, but also in countries outside the continent. The second is to support cutting-edge genomics/genetics 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 include a research component (this FOA and RFA-RM-12-006), a bioinformatics network component (to be funded in Summer 2012), a biorepository component (RFA-RM-12-008), and a social issues component (RFA RM-12-005). 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

A. Scientific scope

The objective of this FOA is to solicit applications to support H3Africa Research Projects that will address one or more of the goals of the H3Africa Program, as described above. The scientific focus of applications responsive to this FOA will be broadly 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 has 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. A small number of linkage, candidate gene, and genome-wide association studies (GWAS) have been completed and, in addition to replicating findings from other studies, have been able to identify potential new loci involved in disease. An H3Africa Research Project might involve collection of new samples or use of existing samples from one or more populations of interest. 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 one or more genomic technologies, for example genotyping, exome or whole genome sequencing, and/or functional genomics methods, to 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, and others, have historically been a major health problem in Africa. A variety of genetic and environmental factors contribute to the susceptibility to and development of disease, and genomic information may be useful in developing new approaches to treating and preventing infectious diseases. Significant attention and considerable funding have been given to the study of certain communicable diseases, and excellent research facilities for studying them are found throughout Africa. One of the striking 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 can contribute essential information. HIV/AIDS and malaria are among the most well-studied communicable diseases in Africa and, 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 to this FOA, studies of other infectious diseases are encouraged.
• The contribution of the human microbiome to health and disease in Africa. Recent advances in sequencing and other technologies have led to a burgeoning of studies of the role(s) of the human microbiome in health and disease. Changes in the microbiome at particular body sites have been correlated with the onset or progression of several diseases, such as Crohn’s disease, psoriasis 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 understanding 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 research projects for 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. African populations have been underrepresented in pharmacogenomics research, yet they 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 medications. Analysis of pharmacogenetic effects in Africans would be appropriate for an 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 also specific areas of interest to the NIH components that are participating in 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. We recognize that there are few existing neurological disease sample collections in Africa; therefore, we encourage sample collection, quality phenotyping, and analysis in a broad range of disciplines such as molecular genetics, pharmacogenomics, and epidemiology. Samples may also be collected in parallel to an ongoing neurological disease stigma project or intervention research project. Projects should have a scientific premise and should not be limited to only sample collection. Well characterized, neurological-based cohorts 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 rare 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 or knowledge 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: Human genomics research on HIV/AIDS outcomes in populations with specific patterns of addictive substance use or abuse, including tobacco, cannabis, stimulant, or opiates. Alcohol can be included as long as other substances of abuse are also included. Topics include, but are not limited to, studies of host and viral genetic and other determinants of immune response to HIV infection in substance users versus non-users; viral and human genetic factors associated with immune recovery following antiretroviral treatment in the context of chronic substance use; 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 the impact of chronic injection or non-injection substance use on the HIV genome.

B. Implementation of the objectives of H3Africa.

As described above, H3Africa has several specific objectives. Applications submitted in response to this FOA must address one or more of those objectives, as well as the following issues(note that in addition to the following discussion, specific application instructions and guidance are provided in Section IV.2 Research Plan): :

Overall Research Plan. The application should describe a well-conceived plan for a research project to investigate the genomic, and at the applicants discretion the environmental, contributor(s) to a disease or other health-related condition of importance in Africa. The application should describe a compelling justification for the choice of the condition to be studied and should clearly state how the proposed research could 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. Third, the application should clearly articulate how the proposed research project addresses one or more goals of H3Africa. It is important to note that more than 50% of the funds for this project must be spent in Africa.

Sample collection and Human Subjects Issues. The research plan must include a clear plan for sample acquisition (either collection of new samples or use of previously collected specimens), and sample handling and storage.

Consent: Applicants should note that samples that are broadly consented for genomic analysis have proven to be very useful for genomic research projects beyond those for which the samples were originally collected. Therefore, investigators are urged to try to obtain consent for the wide sharing of samples and data; justification should be provided if samples and data will not or cannot be shared or only shared in a limited manner. NHGRI has prepared a document entitled "Essential Elements of Informed Consent for H3Africa Research Projects" that may be helpful to applicants in writing their informed consent procedures and documents; it can be found at http://www.h3africa.org/informedConsent.cfm. A timeline for sample collection, as well as a timeline for developing and implementing an informed consent process, including obtaining IRB approval, must be included in the application.

Sample Storage: With respect to long-term sample storage, H3Africa anticipates establishing two or more biorepositories in Africa, but they will likely not be prepared to accept large numbers of samples until 2014. Eventually, all H3Africa samples (blood, DNA or cell lines) are expected to be deposited in the H3Africa Biorepository, consistent with the informed consent under which they were collected, from which they can be distributed and shared for further research . 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, consistent with achieving the goals of this initiative. This should include a description of the host country’s policies for sending samples out of the country.

Sample Size: The application should include a sufficiently detailed discussion and power calculations to justify the proposed sample size, a detailed discussion of the methodologies to be used, and a thorough discussion of all relevant human subjects issues and informed consent. The application should also discuss potential challenges to achieving the sample collection goals of the proposed program that might arise and how those challenges will be addressed if they do.

Phenotyping. The potential of genomics research to yield insight into the biology of disease is dependent on an accurate definition and measurement of the relevant phenotypes and, if environmental issues are addressed, a comprehensive understanding of relevant environmental factors. The application should, therefore, clearly describe the methods of ascertainment of both primary and secondary phenotypic data as well as environmental data if appropriate, and explain how accuracy will be ensured. To allow comparison to other studies, it is important that the data definitions be well-described and, to the extent possible, collected according to standardized practices (see for example, www.phenxtoolkit.org). Where relevant, the application should include questionnaires or survey instruments to be used and describe plans for follow-up or collection of longitudinal data. If samples are to be collected at different sites, the application should discuss the quality assurance and quality control measures that will be implemented to ensure that the data collected at the different sites are comparable. The application should also address the informatics aspects of data collection and storage.

Data Generation. The application should clearly describe how the samples will be prepared for genomic analysis, provide a justification for the type(s) of genomic data to be acquired, and how those data will be generated. If the genomic data are to be generated within the center, the application should discuss the applicants experience with the necessary technologies, the costs of generating the data, and the informatics aspects of data collection, storage and transfer among the participating sites. The availability of samples and supplies should be discussed, as should any issues of long-term maintenance and servicing of the necessary equipment. Any anticipated problems that may be encountered in data acquisition and planned approaches to solving such problems should be described.

However, it is not necessary that all data be generated within the H3Africa Research Project itself. For example, it may be more cost effective to send samples out to another genome center or to a commercial service provider(s), either in Africa or overseas. If this approach is chosen, the applicant should provide a justification for that choice, and 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 center for analysis. The applicant should also describe any provisions that will be made to obtain training in the relevant technologies for students or technicians.

Data Analysis and Bioinformatics. Whether the data are generated within the project or obtained from outside, the applicants must clearly describe how the resultant data will be analyzed. The bioinformatics capacity of the applicant should be clearly described. The bioinformatics tools that will be used or developed, and the applicants experience with their use should be described. Issues of data acquisition, data management, data storage, and analytical capability should all be addressed. In particular, for studies involving genomics-based analyses, the applicant should provide justification that the experimental and analytical design will have sufficient power to address the question(s) being asked.

Applicants should be aware that the H3Africa Program will fund a separate H3Africa Bioinformatics Network (see expired FOA, RFA-RM-11-010) to provide connectivity among the H3Africa participants. The H3Africa Bioinformatics Network will also have the ability to develop new bioinformatics tools for genomics research in Africa. The H3Africa Research Projects, and any other H3Africa-funded activity, will be required to interact with H3Africa Bioinformatics Network. Therefore, applicants for an H3Africa Research Project award 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.

Collaborations. Applicants should note that collaboration is no longer a required element of the H3Africa U01 Research Project program. In a previous FOA (RFA-RM-12-004), research projects were required to collaborate with an on-going effort with other support; this is no longer necessary. However, collaborations are allowed at the applicant’s discretion; if included, the collaboration should be well-justified and the ways in which the collaborative components will be coordinated should be described.

Training and Career Building. Establishing the next generation of African researchers to take advantage of genomic approaches to health research is one of the primary objectives of the H3Africa program. While not required of a U01 Research Project, the applicant may include a request for funds to provide training or career development to others.

• Training. In this FOA, training is meant to include providing experience in genomic science and research techniques for technical training of laboratory staff, for students at both the MS and PhD levels, and for post-doctoral researchers. Because of the limited amount of funding available for H3Africa Research Projects, applicants will have wide latitude in designing any training activity, which may be directed at one or more of those levels as appropriate and practical, and for any period of time. Training may include relevant courses at the MS and Ph.D. levels but may not include support for an individual's degree program. While it is expected that the majority of training will take place in African institutions, training opportunities abroad can also be included; in that case, a plan for the return of the trainees back to Africa is required. The training program may include any combination of course work, laboratory experience, and mentoring. The applicants training experience should be adequately described.
• Career development. Fostering the careers of recently trained doctoral-level students is another valuable contribution that the Research Project can make to establishing the next generation of African researchers; applicants are, therefore, allowed to include a career development component in the application. For example, sabbatical leave costs to support project-related training may be requested, as specified in the NIH Grants Policy Statement (see http://grants.nih.gov/polcy/nihgps_2011/nihgps_ch7.htm#selected_cost_items).

In Summary: This FOA solicits applications for H3Africa Research Projects to carry out the 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,
• training and career development, and
• exploration of the social implications of genomic research in Africa.

The scientific scope of the Research Project component of H3Africa 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 and its contribution to health and disease in Africa,
• Mendelian diseases in Africa,
• Pharmacogenomics, and
• Other

Funding Instrument	Cooperative Agreement
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	This initiative is supported by NIH Common Fund, Institute(s) and Center(s) and Offices of the NIH that 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 $1.4 million per year for FY13-16, contingent upon receiving scientifically meritorious applications. Up to 4 awards are anticipated from this solicitation.
Award Budget	Applications are limited to $350,000 total costs per year, which includes salaries, supplies, training, equipment, travel, and other allowed expenses for research grants.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 4 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 (Foreign Institutions)

Specifically, African institutions are eligible for the 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 4-6 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.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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

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

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

The letter of intent should be sent to:

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

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.

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

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

• The application must include a detailed research plan that is responsive to the objectives of the H3Africa program, as set forth in this FOA (see Research Objectives).

Introduction (resubmissions only): For Resubmission applications only, the Research Plan must include an introduction to the Application. The introduction is an opportunity for the PI who has revised and is resubmitting an application to address the comments from the initial review of the previous application. It is limited to one page. New applications should not include an introduction. For more information, see specific instructions in SF424.

Specific Aims: A concise set of specific aims is required that explains the goals and expected outcomes of the research. This section is limited to one page.

Research Project Plan: The Research Project Plan should include a Research Strategy that is broken down in to Significance, Innovation and Approach.

Significance: this section should describe why undertaking the proposed project in Africa is important for improving African health. It can also note how the benefits will extend to improved health outcomes elsewhere in the world, particularly in the US. The PD/PI should discuss the barriers to success of the project, how this study will address the problems and what new improvements in African genomic research, health care, therapies or technical capabilities might be expected if the project is successful.

Innovation: This section of the Research Strategy should address what innovative approaches are being proposed to meet the special challenges of doing genomic research in Africa. Describe what novel concepts, approaches and technologies will be employed to meet the challenges facing the research project and how success in this project will promote the African genomic research in general.

Approach: This section of the research should describe the overall strategy and methodologies that will be used to accomplish the specific aims of the project. The specific implementation issues mentioned above under Research Objectives should be part of the overall strategy discussion. Additionally, the PD/PI should include discussion of:

• Infrastructure. To the extent possible, a Research Project is expected to utilize existing infrastructure in the clinical and research institution(s) where the study will be carried out (as well as the H3Africa Bioinformatics Network and the H3Africa Biorepositories as described elsewhere in this FOA). A detailed, well-documented description of existing institutional infrastructure must be provided in the Resources section of the grant application. Additional infrastructure components may 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 over the course of the grant period. The applicant should discuss how the project will be assessed and how success and impact will be defined and determined. The discussion should address how any modifications that will need to be made as a result of the 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. These 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 Research 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
• Sustainability: Another of the primary 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. Dedicated funds for H3Africa by the NIH Common Fund will provide 5 years of support. Up to 5 additional years of dedicated funds may become available contingent upon the initial progress of the H3Africa Project. Beyond that, any support for continuation of the research programs and research careers initiated under the auspices of H3Africa will be dependent on other funding. Therefore, applicants need to discuss the issue of future sustainability of their research programs beyond the H3Africa program and how the H3Africa Research Project activity will contribute to success in continuing the applicant's research efforts. This discussion 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 applicant and his/her Research Project.
• Institutional and National Commitments: Applications should include letters of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) to substantiate the institution's commitment to the proposed research; if collaborations are proposed in the Research Project application, such letters will be required from all collaborating institutions. The institution should state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. It should also address commitment to collaborating and sharing data with the H3Africa Bioinformatics Network and the H3Africa Biorepository program. The letter should also briefly discuss the institution's plans for sustaining an active program of scientific research subsequent to the end of the H3Africa program.

As the programmatic activities of this initiative will support national and international collaborations, letters of support are required from the relevant national ministry, such as the Ministry of Science, Ministry of Health and/or Ministry of Education, or governing scientific organization; if collaborations are proposed in the Research Project application, such letters will be required for each participating African country. 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 the letters 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.

• 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/), and an application must have an acceptable Data and Resource Sharing and Release plan before it can be funded. Applicants are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the [H3ACC, H3Africa Research Project]. After all H3Africa awards have been made, the H3Africa Consortium (see below) will develop a unified policy for data and resource release, and the application must include a statement that the investigators will abide by the Consortium’s data and resource policy, consistent with the relevant NIH policies, laws and regulations. Examples of current data release guidelines under the H3Africa Initiative 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 2015, one of the Consortium meetings will be held in Bethesda, MD and in 2016, one meeting will be held in London, UK. It is expected that each Research Project will bring 1 to 2 people to the meetings. Appropriate travel funds for these meetings must be requested in the application.

Applications should address all of the following:

• Research plan, including (as appropriate)
  • Sample collection, including a justification for the proposed sample size, and human subjects issues
  • Phenotyping
  • Data generation
  • Data analysis and bioinformatics, including connection to the H3Africa Bioinformatics Netw
• Identification of potential challenges and foreseeable problems, along with proposed approaches to circumvent or surmount them.
• Available infrastructure,
• Monitoring and evaluation,
• Institutional commitment,
• National plans for science
• Data sharing and release

The following are optional, but may be included at the applicant’s discretion:

• Collaboration plans
• Training and/or career development

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:

• Final, uniform H3Africa policies for resource and data sharing will be determined by the Steering Committee (see below) once all the awards have been made. Preliminary to this, the applicants are expected to propose plans for resource and data sharing in the application consistent with achieving the goals of the H3Africa initiative, and such plans must be approved by H3Africa program staff before the application can be funded, consistent with achieving the goals of this initiative. See http://www.h3africa.org/dataReleasePolicy.cfm for examples of data sharing plans under the H3Africa Initiative for NIH programs The applicant should also state his/her willingness to adhere to the final H3Africa Consortium policies on resource and data sharing, once they have been determined, consistent with NIH policies, laws and regulations.

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/PI 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 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/PI name, and title of the application.

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

• Letters of support from the relevant national ministries, for example the Ministry of Science, Ministry of Health and/or Ministry of Education; Medical Council; or appropriate government official for the host country should be submitted with the application but may also be submitted post application.

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?

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? Does the project promote and support innovation that will strengthen and sustain genomics research in Africa? How important is innovation to the success of the proposed Research Project?

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 bioinformatics data handling and analysis plans adequate to address the needs of the project? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project? Has the issue of future sustainability been adequately addressed?

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 at the applicant(s ) institution(s)? Does the application identify and plan to take advantage of resources elsewhere, if appropriate?

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 plan for sustainability feasible? Will the applicant 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?

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

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

Renewals

Not Applicable.

Revisions

Not Applicable.

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

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 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 (an) appropriate Scientific Review Group(s) convened by the National Human Genome Research Institute,, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines 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 or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review
• Availability of funds
• How well the application addresses the goals of H3Africa
• Overall program balance in the H3Africa program

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 recipient’s activities by involvement in and otherwise working jointly with the award recipient 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 awardee(s) for the project as a whole, although specific tasks and activities may be shared among the awardee(s) and the NIH as defined below.

Definitions:

Steering Committee (SC):

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

Independent Expert Committee (IEC)

The IEC will be composed of senior scientists with relevant expertise who are not PD(s)/PI(s) of a cooperative agreement involved in the H3Africa Consortium. The members will be appointed by the NIH and the Wellcome Trust, the funding partners of H3Africa. The IEC will be responsible for monitoring and assessing the progress of the H3Africa Consortium. See more about the IEC 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 H3Africa 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 NIH 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 NIH H3Africa staff and will ensure that the data produced meets the quality standards agreed to at the beginning of the project by the H3Africa Consortium;
• Awardee(s) will ensure that the data are deposited in the appropriate public database (e.g., GenBank or other, as specified by NIH H3Africa program staff), that resources developed as part of this project are made publicly available according to H3Africa Consortium 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 consistent with applicable NIH policies, laws, and regulations;
• Awardee(s) will integrate with and connect to the H3Africa Bioinformatics Network;
• 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 PD(s)/PI(s) votes on the SC. They and other NIH H3Africa project team scientists may serve on sub-committees or working groups, e.g., data sharing, data release, quality control, core establishment, as appropriate. The NIH H3Africa Project Scientists may work with awardees on issues coming before the Steering Committee and other sub-committees and working groups.
• The Project Scientists will help the other Steering Committee coordinate the group process of exchanging information about research approaches and protocol designs and of the development of Consortium policies
• The Project Scientists will negotiate goals with the awardees as necessary; wlll serve as liaison between the awardees and the Panel of Scientific Consultants, the National Advisory Council for Human Genome Research and other Councils, and the larger international scientific community; will attend all Steering Committee meetings as voting members as described above; and will 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 about the H3Africa Consortium to the Director, Division of Program Coordination, Planning, and Strategic Initiatives; and the Directors NHGRI, FIC, NINDS, NIDA and OAR.
• The NIH reserves the right to withhold funding or curtail the study (or an individual award) in the event of (a) substantive changes in, or failure to make sufficient progress, toward the agreed-upon work scope with which the NIH 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 director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Steering Committee

A Steering Committee will serve as the main governing board of the H3Africa Consortium. The Steering Committee membership will include the NIH Project Scientist(s) and the PD/PI of each award. The Steering Committee Chair will not be an NIH staff member but will be appointed by NIH 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 Consortium will include investigators funded as a result of this FOA and of other H3Africa FOAs, it is possible that NIH H3Africa staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees funded as a result of a specific FOA.

The Steering Committee will:

• Discuss progress in meeting the goals of various H3Africa projects;
• Facilitate coordination and synergy across the entire H3Africa program;
• Develop recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, 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 with intermittent conference calls.
• Each full member (limited to one person per awarded Research Projcect, in the case of multiple PD(s)/PI(s)) will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The Independent Experts Committee (IEC):

The IEC will make regular assessments and provide recommendations to the Directors of NIH funding components and the Director of DPCPSI about progress of the H3Africa components toward the goals of the H3Africa program and about continued support of the components of the H3Africa Consortium.

• The IEC will meet at least once a year. During part of this meeting, there will be a joint meeting with the H3Africa Steering Committee to allow the IEC members to interact directly with the awardees.
• Annually, the IECs will provide assessments regarding the progress of the H3Africa Consortium and of the individual components and, as necessary, will present recommendations regarding any changes that may be necessary in the H3AFrica program to the Directors of the NIH funding components.

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)
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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)
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Jane L. Peterson, Ph.D.
National Human Genome Research Institute
National Institutes of Health
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

Dr. Rudy Pozzatti, Ph.D.
National Human Genome Research Institute
National Institutes of Health
Phone: 301-402-8739
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

Ms. Victoria Bishton
National Human Genome Research Institute
National Institutes of Health
Phone: 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.